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REPORT 0

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LABORAT~ORY SERVI S

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SEMINAR ON HEALTH IJIBORATORY SERVICES , Sponsored by the

v-TORill HEAL'lH CRGANIZATION REGIONAL OFFICE FOR THE WES'lERN PACJFIC

WPR/468/61

NlINILA, FHILIPPINES

5 - 16 December 1960

FJNAL REroRT

World Health Organization Western Pacific Regional Office

Manila, Fhilippines August, 1961

~ TABIE OF CON'IENTS ~

~

I. INTRODUCTION • • • • • • • • • · · · • · · · · • · • • • · 1 II. OBJECTIVES • • • · · · • · · · · · · • • · • · • • • · • 1

III. OBGANlZATlOO · • · • • • · · · • · · · · · · • 1 N. PROORAMl£ • • • • • · · · · · · · · · • • • • · · • • • • .3 V. SEMINAR mOOR»ll-E • · · · · · · · • • · · · • 3

1. Opming Session • · · · · · · · • · · • • • 3 2. Technical Discussions • · • • · · • • • · · · · • 4 3. Closing Se ssion · • · • · • • • • · · · • · • · • · • • 5

VI. SUMMARY OF DISCUSSIOOS • · · • • · • • · • • • · · • · 5 . 04~ 1. Terms of Reference • · • · • · • · • · · • • 5

2. Purposes and Function of the Laboratory • • • • · • · • 6 2.1 Services • • · • · • • · • • • • • • • • · • 6 2.2 Teaching and training • · • · • · • • • · · • 6 2.3 Research · • · · · • · • • · · • • • • 6

3. Scope of Various Types of Laboratorie s · · · • · 7 "':- 3.1 level No. 1 • · · • · • · • • • • • · • • · 7

3.2 level No. 2 • · • · • · • • · • 7 3.3 Level No. .3 · · · • · • · • • • • • • 8 3.4 Level No. 4 • • • · • • • • · · • · • 9 Planning. · • · • · • • · · • • • • • • · • • • 9

• 4.1 Survey of resources and needs. · · · · · · • • · 10 4.2 Utilization of existing facilities • · • • • 10 4..3 Preparation of laboratory personnel • · · · • · • 10 4.4 Consideration of costs and financing • • • • • • 10 4.5 Priorities in the typlS of laboratory most needed 10

5. Organization of a National Laboratory Service · · • • • II 5.1 The need for an integrated national

health laboratory service · • · · • · • · • • • • 11 5.2 Schemes to illustrate different organizational

patterns of the health laboratory service · • • • II 5.3 National advisory council on laboratory service • J2

6. Staffing • · • · · · • · · · · • • · · · . • · · • · · • J2 6.1 Principal categories of laboratory personnel • • J2 6.2 Qualification and training of staff • · • • • · • 13

k 6.3 Staff qualifications necessary for the

different typls of laboratories • • · • · · · • 1'3 7. Laboratory Requirements and Equipnent · • • • • • • • • 15

7.1 Space and building · • · · • • · • • • · • • 15 7.2 Organizational segmentation in a laboratory • · • 15 7.3 Equipnent · • · · • · • · · • · · • · · • • • 15 7.4 Services · • · • · · · · · • · · 16 7.5 Animals • • • • • · · • • · • · · · · · · • • • • 16 7.6 Laboratory safety • · · · · · • · · · · · • 16

8. General Aspects • · • · · · • · · • • · • · • · · · · • 17 8.1 The essentials of effective laboratory operation. 17 8.2 Standardization of laboratory results. · • · · • J.J 8.3 Central services of a laboratory • • • · • • 18

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9.

10.

11.

12.

Collection, TrmlSportation and Registration of Laborato~ SpecirnBns and Reports • • • • • • • • • • • • Ldministrati ve Lspects of the nealth Laboratory Service . • . . . . . . . . . . . . . . . . . 10.1 I.egislc.tion .•.•.... .••• 10.2 Nationcl standard. laboratory procedure s

and methods • . .. . •...•. Scientific meetings and publications • • Central technical supervision . • • • Relationship between health laboratories and other government agencies. . • .

International Collaboration in Public Health Laboratory Service s • • • • • • • . • • • • • • ll.l Purposes and limits • • • ••• 11. 2 External sources of assistance •••• 11.3 Role of h1JfO. • • • ••• • • • . • • Country- Reports . . . . . . • . . . • • . • . . 12.1 Policy and legislative as:p'Jcts • • •

12.1.1 Fees for laboratory service 12.1.2 SU:p'Jrvision and control of

. . . . . • •

diagnostic laboratories .•.•.•.•.•.•.•••.• 12.1.3 Biological production by private

12.2

12.3

agencie s . . . . . . . • . • . . 12.1. 4 Legislation to ensure effective

laboratory performance . • • 12.1.5 Combined hospital and public health

laboratory. • • • . • 12.1. 6 Regional laboratorie s 12.1. 7 Reference laboratories 12.1. 8 }lobile lab oratorie s furs"Ormel • • • • • • • . • • 12.2.1 Promotion of training and teaching

programmGs . . • .• •...• 12.2.2 Personnel shortage .•.•.• 12.2.3 Full-time requirement for health

\tl0rkers . . • . . . . . • . 12.2.4 Remuneration and security of terrore of

laboratory workers • • • • • • • • • • 12.2.5 Tec;mical supervision of laboratory

p6;rsormel . . • • . . • • • • . . . • • • Organization and technical aspects • • . • 12.3.1 Organization of an integrated national

health laboratory service in a country 12.3.2 Utilization of health Inboratories by

physiCians and health officers . • • • • • 12.3.3 The r ole of the oontral laboratory in

improving quality of technical service of local laboratories • • • . . . . .

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18

18 18

18 18 19

19

19 19 20 20 20 20 20

21

21

21 21 21 22 22

22 22

22

22

22 23

23

23

23

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12.3.4 Collection, transportation and registration of specimens and reporting of results . • • • • •

12.3.5 Examples of administrative and/or technical problems occurring within a C01.mtry • • • • • • • • • • •

VII. CONCLUSIONS AND RECWMENDATIONS • • • • • • • • • •

ANNEX I LIST CF STAFF, PARTICIPANTS AND OBSERVERS

ANl'EX II A REVlEH ON THE FUBLIC HEALTH LABORATCRY SERVICES IN GCUHTRJES AND 'IERRITORJES OF THE vJES'lERN PACJFIC REGION • • • • • • • • • • • • • • •

APIENDlX 1 - A SYSTEM OF Cli:NTRALLY DIRECTED NATIONAL PUBLIC HEALTH LABORATORY SERVICE • • • • • • •

APIENDIX 2 - A SYSTEM OF CCF1PIE'lELY DECENTRALIZED NATIONAL RJBLIC HEALTH LABORATORY SERVICE • • • • • ••

APffiNDIX 3 - A SYSTEH OF DUALLY DIRECTED NATIONAL FUBLIC HEALTH LABORATCRY SERVICE • • • • • • • • •

TECHNICAL REQUIRElVlENTS FOR PUBLIC HEALTH LABORATORJES • • • • • • • • • • • • • • . . .

APIENDIX 4 CARE, HANDLING AND BREEDIMJ OF LABORATORY It:ND''IALS • • • • • • • • • • . . . . . . .

APFENDlX 5 - BIBLICGRAFHY ON ANIlVlAL CARE AND BREEDING APFENDIX 6 SIECJFIC£TIONS USED BY THE COOMUNICABIE

DISEil.SE CENTER FOR THE !'UlNUF ACTURE OF Al'JTIJIAL FEEDS • • • • • • • • • • • • •

APFENDIX 7 - PREPARATION OF SCIENTIFIC GLASSI'JARE •• APIENDIX 8 - POSSIBIE fJ1ERICAN SOURCES OF EQUUNENT AND

HATERIJ.LS • • • • • • • • • • • • • • • • • APIENDlX 9 -

· .

· .

· . APFENDIX 10 -APIENDIX 11 -APIENDIX J2 -APIENDIX 13 -APIENDIX l4 -APIENDIX 15 -

roSSIBIE fJ1ERICAN SOURCES OF EQUIH1ENT AND MATERIAlS FOR MEDIA HlEPARATION • • • SlillITliRY BACTERIOLCGICAL EXAl1INATIONS • EXAMINATION CF AIR • • • • • • • • • • • RllDIOLOOICAL EXlu"lINATIONS ••

. . . BACTERIOLCGICAL EXAMINATIONS PAMSITOLOG ICAL EXAl1INATIONS HEDICAL MYCOLOOICAL EXAMINATIONS

. . .

lJlBORATORY HAZARDS IN HEALTH LABORATORJES

INTERNATIONAL AND BILh.'lERAL COLLllBORi~TION IN PUBLIC HE.hLTH IJ.BCRATORY ACTIVITIES • • •

APIENDIX 16 - HORLD HEALTH ORGANIZATIOO CENTRE FOR AUTHENTIC CHEMICAL SUBSTANCES ••••

APIENDIX 17 - WHO INTERNATIONAL CENTRES AND REFERENCE LABORATORIES AND Iffi:O/FAO REFERENCE CENTRES

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· .

· .

24

24 24

27

31

45

61

63

65

85 93

99 101

105

107 109 ill 113 115 117 ill

121

127

l43

l45

ANE< III -

. ANNEX IV

SCHEDUIE OF FIEW VISITS • • • • • • • • • •

SUMM.J'.RY OF INTERTI1 EVALUATION OF THE SEMINAR

APIENDJX l8 - SUMMARY OF INDIVIDUAL IN'lERTI1 APPRAISAL

. . .

. . .

CF THE lillMINISTRATIVE ASIECTS OF H SEMINAR APlENDJX 19 - SUMMARY OF INDIVIDUAL INTER]}1 APHl.AISAL

OF THE IMMEDIATE EFFECT OF THE SEMINAR • APIENDJX 20 - COOlENTS AND SUGGESTIONS ON THE SEMINAR

( Interim) . . . .. .. .. .. . .. .. . .. .. .. .. .. . .

153

l55

157

159

1.6l

SUMMARY OF FINAL EVALUATION CF THE SEMINAR • • 165

APlENDJX 21 - SUMMARY OF INDIVIDUAL FINAL APPRJI.ISAL OF THE ADMINISTRATIVE ASFECTS OF THE SEMIWlR • • • •• 167

APfENDJX 22 - SU!1MARY OF INDIVIDUAL FINAL APFRAISAL OF THE TI1MEDIATE EFFECTS OF THE SEMINAR • • • • • 169

APfENDJX 23 - COOlENTS AND SUGGE:STIONS ON lliE SEHINl..R (End of the Seminar) •••••••••••• l71

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I. INTRODUCTION

The first Seminar on Health Laboratory Services convened by the World Health Organization in the v.Jestern Pacific was held in Manila from 5 to 16 December 1960. There were seventeen participants from fifteen countries in the Region and four observers, one coming from the 406th Medical General Laboratory of the United States Medical Command in Japan and three from laboratory institutions in Hanila (Annex I).

L

2.

3.

4.

II. OBJECTIVES

The objectives of the Seminar were:

To determine the role of, as well as the needs and problems connected with, health laboratory services and exchange information on how countries in the Region are dealing with them.

To formulate guiding principles in the planning, organization and operation of henlth laboratory services.

To explore means of utilizing existing resources, co-ordinating health laborato~J activities and effective~ training personnel.

To promote effective utilization of available assistance from bilateral and international agencies.

III. ORGANIZATION

The Seminar took place at the WHO Building in Hanila, the Staff Conference Room being used for plenary sessions and t,.;o other rooms being assigned for group meetings and secretariat purposes. A reference library of books and periodicals on health laboratories was placed at the disposal of the participants. The working language of the Seminar was English.

Some months before the Seminar, the following consultants were appointed:

Seminar Director Dr. C. H. Yen Commissioner of Health Taiwan Provincial Government Wufeng HSiang Taichung, TailJan Republic of China

Consultants

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Dr. Ralph B. Hogan Medical Director Chief Laboratory Branch Communicable Disease Center P.O. Box 185 Atlanta, Georgia U. S. A.

Dr. R. Sansonnens Chief Medical Officer Health Laboratory Services WHO Headquarters Geneva Switzerland

Each consultant contributed a working document. Too country reports prepared by the participants were consolidated into one document by the Seminar Director. A fifth paper was prepared by Dr. G. Briggs Phillips, Research SCientist, Center for Safety Education of the New York University, United States of AnErica; he was, however, unable to attend. These five documents formed the basis of the seminar discussion (Annex II).

Arrangements were made for too consultants to pay a number of field visits prior to the Seminar and the countries visited were as fol­lows:

Dr. Yen Dr. Hogan Dr. Sansonnens

Hong Kong and Saigon (Vietnam) TokyO (Japan) and Seoul (Korea). Kuala Lumpur (Federation of Malaya) and Singapore.

Following the arrival of the consultants in Manila, programme arrangements were finalized, including the selection and organization of the topiCS to be discussed. During the Seminar they assisted in the panel presentations and acted generally as resource persons in the group and plenary discussions.

Although the Philippine Government did not act as host, its laboratory facilities in and around Manila were made available for field visits. Visits were, therefore, paid to a regional public health lab­oratory serving both public health and hospital services; the national or central laboratory, including its administrative offices and the clinical, research and biological products laboratories; the clinical laboratory of a national general hospital and the public health laboratory of a city health department (Annex III).

Evaluation questionnaires were distributed tWice during the seminar sessions, viz., (1) two days after the opening, and (2) on the last day. The results are summarized in Annex IV of this report.

Dr. A. A. Angara, Regional Public Health Administrator, acted as Secretary.

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IV. FROGRJ,MME

For each subject, this consisted of the topic presentation in plenary session,; discussion of the topic separately by two working groups; and consideration of the reports of the working groups in plenary session.

It was decided that the consultant who would lead the discussion would be responsible for preparing the discussion guideline to be used by the working groups. In general, the topic was presented by a consultant and additional remarks were made by members of the seminar staff. This was followed by questions from participants and observers. In one topic, that which dealt with the international aspects of laboratory services, two resource persons, the Regional Public Health Administrator who served as Seminar Operational Officer, and the UNICEF Country Representative, were invited to participate in the panel presentation.

The participants were then divided into two working groups. To foster full participation of all members and share equally the task of preparing the group reports a chairman and a rapporteur were selected for each topic. A consultant sat as resource person with each group for the duration of the discussion and the consultant who had led the discussion in the plenary session was made available to both groups. When the reports of the working groups were presented in plenary session, each group chairman sat with the consultant panel. The whole body then par­ticipated in the discussion until different viewpoints were either reconciled or spelt out as problems for further stUdy. The result of the deliberations formed the basis of the topic report.

Notion picture films related to each topic under discussion were loaned by the United States Public Health Service. These were shown at appropriate times during the sessions.

V. SEMINilR FROORANME

1. Opening Session

The Seminar was formally opened on 5 December 1960 by Dr. I. C. Fang, Regional Director, who stated that he had high expectations of the work to be accomplished. He noted that the staff consisted of inter­nationally renowned exports while the partiCipants and observers revealed a group which had achieved leadership in their own countries in the health laborato~J field. He anticipated that there would emerge from the meetings a clearer perspective of the laboratory services as part of the general public health organization. He hoped that countries in the \Jestern PacifiC Region, irrespective of their stage of socio-economic development, would take note of the conclusions of the Seminar so that they might serve as a guide for the planning of health laborato~ activities as part of the public health programne.

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Dr. Yen, Seminar Director, observed that in many areas the importance of health laboratory services had not yet been ful~ appreciated, either due to lack of laboratory facilities in many countries, or to the lack of appreciation by physicians and health officers of the role played by the public health laboratory. He further noted that, historically, laboratory services had been applied in the field of medicine for diagnosis, prevention and treatment of patients but thair use was later extended to the field of prevention of infectious diseases and the occurrence of epidemics.

Dr. Hogan, Consultant, said that fifty years ago most medical diagnostic work in public health had depmded sole~ on the clinical acumen of the }ilysician. This was no longer true. In medicine and public health practice, it waSnGT essential to utilize the information that could be made available through the use of the laboratory. Referring to the role of the consultants in too Seminar, Dr. Hogan stated that they were tOOre on~ to give the assistance required by the participants in the .'ay of background information. Tho success of the meeting depended less on the consultants and more on the participants.

Dr. Sansonnens, Consultant, spoke of the work of WHO in qynamically aSSisting in the developnent and promotion of laboratory services. It wouJ.d be of considerable value to WHO, and in particular to the viestern Pacific Regional Office, to know how far the services, international~ established, were being utilized, how international assistance could best meet the needs of the countries in this field, and how a fruitful collabora­tion between national laboratory services could be strengthened.

2. Technical Discussions

Four discussion topics were selected and discussed in sequence as follows:

Topic I

Topic II

Topic III

Topic IV

Planning, Organization and Administration of a National Health Laboratory Service (Horking paper prepared by Dr. C. H. Yen)

TeChnical Requirements for Public Health Laboratories (Working paper prepared by Dr. R. Hogan)

Discussion of Country Reports (Consolidated report prepared by Dr. C.H. Yen)

International and Bilateral Collaboration in Public Health Laboratory Services (Working paper prepared by Dr. R. Sansonnens)

Each topic was presented in plenary session, discussed separate~ by two working groups and their reports reviewed in another plenary meeting. Where indicated, a topic was broken down into sub-topics which were presented and discussed in the same order.

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The number of plenary and group meetings held to consider the topics are summarized below:

Topic I panel presentations - 3 group meetings 3 rep~t~ 1

Topic II panel presentations - 6 group meetings - 6 report~ 1

Topic III panel presentations - 3 group meet~s 3 reporting 1

Topic IV panel presentations - 1 group meet~s 2 report~ 1

Two further plenary meetings were held to review and adopt the consolidated group reports on the above topics.

3. ClOSing Session

The closing session was held on 16 December. The consultants gave brief statements of their assessment of the seminar deliberations. This was followed by a statement from Dr. G. Balbin of the Philipp:ires who, as spokesman for the seminar group, expressed their appreciation of the privilege of participat~ in the discussions and thanked the Regional Direct~ for having made the Seminar possible.

In his concluding remarks, the Regional Director said:

". •• I understand that this Seminar has really been a w~king seminar. To accomplish your task you have had to work under pressure ••• (of time) ••• I hope, however, that you have found stimulus in the Seminar and particularly in meeting your colleagues frem other countries. • • We in ,.rna trust that you will keep the aim of the Seminar in mind • • • for your work during the last ten days will c orne to little unless you follow up your own recommendations and do your best to have your Government implement them, adjusted, of course, to each country1s individual needs."

VI. SUMMARY OF DISCUSSIONS

1. Terms of Reference

At the beginning of the discussions, it was realized that the sug­gested title "Seminar on Public Health Laboratory Services" needed clarifica­tion so that all participants could deliberate on the subject fully. Since in several countries most of the bacteriological work for hospitals

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is done by public health laboratories and, conversely, in others, the hos­pitals perfann work of a public health nature, it was thought that con­sideration should be given not only to public health laboratar.r services but also to hospital laboratory services. Hence, it was unanimously agreed that the Seminar should be referred to as "Seminar on Health Laboratory Servicesll • Three general terms designating the different types of lab­oratories were recognized and defined as follows:

(a) A hospital laboratory is a service unit primarily for the diagnosis andmanugemcnt of the individual patient. It might serve as a source of information of interest to health authorities.

(b) A public l-.calth laboratory is a unit primarily for iden­tifying and investigating the causative factors of ill health in the com­munity.

(c) A health laboratory has the combined functions of both the hospital and the public health laboratories. This is necessary in certain situations especially in developing countries where personnel and material resources are limited. The two services, however, might operate indepilndently under a central co-ordinating body.

2. Purposes and Function of the Laboratory

The principal functions of a laboratory are thought to provide the following activities: services, teaching and training, and research.

2.1 Services

A laboratar.r might provide services for diagnostic purposes, for environmental sanitation and collaborate in epidemiological investigation and control of diseases. Some laboratories might provide services for the preparation of biological products and reagents for diagnosis, treatment and immunizatiom for control and standardization of biological and pharmacological products; and for collaborative investigations in nutri­tional studie s.

2.2 TeaChing and training

Laboratories should be utilized whenever possible for the teaching of undergraduate medical and para-medical personnel and the training of technicians. A fully developed health laboratar.r might serve to conduct proficiency surveys and give technical supervision to peripheral health laboratories.

2.) Research

The importance of conducting research especially in laboratory methods and techniques was stressed. Well-qualified personnel might be persuaded to join the laboratory service when a research opportunity was available.

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• .1

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3. Scope of Various Types of Laboratories

This subject was treated in two working papers indepmdently presented by two of the consultants (Dr. Yen and Dr. Hogan). Although these two pa:r:ers touched on different subjects, reference was made in the introduction of both papers to the different types of existing laboratories. One approached the subject from the point of view of activities and func­tions and described nine cC!lllT.lon types of laboratories, while the other, based on administrative and organizational patterns, presented four levels of laboratories.

After careful consideration, the seminar partiCipants correlated these two schemes of classification and the services which would be rendered at each level. They suggested the following breakdown:

3. 1 Level No. 1

(a) Clinical side room (ward) laboratory

This is usually conneoted with the nut-patient services of a hos­pital clinic, ward or a local health centre. Its activities should be limited to simple laboratory procedures such as routine examination of blood stools, urine and simple microscopical examination. Such simple examinations may be carried out by specifically trained personnel whose findings should preferably be checked.

(b) MObile laboratory

In certain countries where peripheral health laboratory units are not established, it may be necessary to have a mobile laboratory for servicing rural areas. Such a laboratory could be very useful during an epidemic. The equipment has to be fairly simple and the number and kinds of tests performed would be limited. The mobile unit can also be utilized to collect specirrens for examination at the base laboratory. It is always preferable, however, to have a permanent type of laboratory.

3.2 Level No.2

Hospital laboratory

This is an integral part of the hospital. Its activities, depending on the staff available, may be:

(1)

(2 ) 0) (4) (5) (6) (7) ( 8) ( 9)

histopathology - microscopic examination of tissues and diagnostic cytology,

histochemistry, chemical pathology or biochemistry, bacteriology, parasitology, mycology, serology, haematology biophysics (including isotope detection),

(10) (n)

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chemical physiology ) allergology )

mB\Y be undertaken under c8rtain circumstances under the supervision of a clinician.

(b) Public health (basic type) laboratory

This is usu~ a part of the city or county health service and it mayor may not be integrated with the hospital laboratories in the area. Its activities may consist of:

(c)

(1) (2) (3) (4) (5) (6)

( 7) (8) ( 9)

bacteriology , parasi tology, mycology, virology, serology, histopathology - limited to the collection of data, e.g.,

tmor registry service and cancer control, sanitation chemistry (including milk and water examination), food and drug control (limited service), and research

Health laboratory

There is a tendency in certain laboratori8s to integrate partially or completely the hospital laboratory service with the public health lab­oratory. Such an arrangement has the advantage of better utilization of technical IErsonnel, uniformity of procedures, quality of service and savings on op>rational expenses and equipnent. In developing countries with limited resources and shortage of trained personnel, the setting up of a health laboratory service is recommended.

3.3 Level No.3

(a) Public health (full type) laboratoIZ

This is usualJ.y situated at the provincial or state level. It mayor may not be integrated with the hospital laboratory in the same area. Its activities may be:

( 1) bacter io logy , (2) parasitology, 0) mycology, (4) virology, (5) serology, (6) histopathology - limited to the collection of data, e.g.,

tumor registry service and cancer control, (7) haematology ) to be provided if such facilities are ( 8) coomical pathology) not a vai lable in other agenc is s (9) sanitation chemistry (milk, water, sewerage, waste, air

pollution, isotope detection), (10) entcmology, (n) production of d:iagnostic sera and antigens, (12) maintenance of stock cultures and biological standards, (13) Iilarmaceutical analysis, standardization and control,

< (l4) (15) (16)

(17)

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food analysis and examination, industrial hygiene (physiology, e.g., fatigue test), toxicology, only if separate service is not available, and epidemiology - epidemiological and statistical studies on epidemics, cardiovascular diseases, cancer, mental diseases, etc.; should function only in 3!l advisory capacity.

(b) Regional laboratory

This is similar to the full-type public health laboratory, but it may serve more than one province or state. Sometimes, it is a branch of the central laborato~J.

3.4 level No.4

(a) Reference (specialized or research) laboratory

This is a specialized independent unit which is usually situated at provincial or at national level but not necessarily so. It may be situated at the university or may be developed in a peripheral laboratory or area as a separate organization. A reference laboratory should only be established if an expert in the particular field of activity is available. Its activities are:

(1) to provide a selective health laboratory service for elaborate investigations in a special field. It should not be over-burdened with unneoessary routine request~

(2) to extend advisory and consultative services to other laboratories;

to prepare and standardize diagnostic reagents;

to serve as a training centre for laboratory personne~ and

(5) research.

(b) Central (national laboratory)

This is always established at the national level. Generally, there is only one such laboratory m ih:; country. vlhile functionally similar to the full-type public health laboratory its activities are more extensive and it is better equipped. Very often, the central laboratory is an aggregate of many reference laboratories.

4. Planning

It was felt that there was no standard pattern of a national health laboratory service that could fit all countries. However, in planning a national health laboratory service, it was always necessary to note the following:

4.1

country.

4.2

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Survey of resources and needs

Planning should start with a survey of resources and needs in the In particular, the following factors must be determined:

(a) current health problems and needs as revealed by existing information or by an accurate survey;

(b) economic situatio~

(c) existing health personnel and facilities;

(d) size of territory;

(e) distribution of populatio~ and

(f) geographic conditions and means of communications.

Utilization of eXisting facilities

On the basis of the above information, consideration could be given to adding more units to 8xisting facilities. In developing countri8s the start could be modest, but provision should be made for the future expansion of the health laboratory service as funds and trained personnel became avail-able. It might be necessary to remodel or make additions and alterations to the existing facilities but these must be utilized to the greatest extent possible.

4. 3 Preparation of laboratory personnel

The provision of adequate and well-tr2ined laboratory workers was considered a very important factor. When establishing a laboratory, it was always necessary to consider the availability of qualified laboratory workers. Sometimes, highly-qualified personnel might be drawn frOOl university departments and research centres, but often, especially in a developing country, this was not possible. In this case, it was important to arrange in advance for the training of the required personnel.

4. 4 Consideration of costs and financing

Government laboratories must be provided with an adequate budget. It was a general principle not to depend entirely on the income of the laboratory for its maintenance. In charging laboratory fees, one loses the chance of obtaining or receiving specimens which might be of major public health importance.

4. 5 Priorities in the types of laboratory most needed

Based on the survey, the type of services most needed, including facilities and health personnel, should be determined and priorities should be established pending budgetary prOvision. It is desirable that the lrooratory should be established as part of an existing health agency.

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It is possible to reduce the number of health laboratories because a basic type of health laboratory could be made to service several hGalth units in an area. One health laboratory for each city or county health department was deemed sufficient, provided the size and population of the area were not too large and the moans of communication satisfactory. At provincial level, one full-type health laboratory is usually needed and is sufficient in most countries. l.t national level, dependent on the size of the country, one central (national) laboratory is needed and branch laboratories may sometimes be necessary. Reference laboratories are usua1J¥ found in well­developed countries. Hhenever possible, it is desirable either to organize a unit or develop close working relationships between laboratories of the public health and hospital services. When planning new hospitals, provision must be made for laboratory services.

5. Organization of a National Laboratory Service

5.1 The need for an integrated national health laboratory service

As discussed earlier in 4.5 above, it is desirable to have the laboratory established as part of an existing health agency. When individual countries are considered, one frequently finds a lack of co­ordination between the various laboratories existing in an area. It was thought that a system could be established in a country to ensure correlation, collaboration, and uniformity in the standard of services for all laboratories. This "Jould also p3rmit an inter-flow of personnel and facilitate the exchange of information.

5.2 Schemes to illustrate different organizational patterns of the health laboratory service

A lengthy discussion took place on three illustrative types of integrated national health laboratory services, nrunely:

(a) Type I - Autonomous centrally-controlled system

The direction of the whole system of health laboratories originates from one central laboratory to the peripheral units. The system has an autonomous administration which is distinct from and parallel to other health units. This system is advantageous in ensuring uniformity in policies, procedures, and quality of service and rermits better collection and exchange of inform.."l.tion. It also permits the inter-flow of technical personnel between lcl:Joratories. But often, it is not conducive to the exercise of initiative and does not respond fully to the needs and require­ments of the health ngemy it normally serves. Very few countries could establish this typ:: of autonomous, centrally-controlled system.

(b) 'I;n:e II - il. completely decentralized laboratory service

In this type, the health laboratory service is canpletely decentralized. It is attached to an individual health agency at the periphery with no central direction. This is the situation in most coun­tries tod~. It has the disadvantage of lacking uniformity in technical

- 12 -

procedures with subsequent difficulty in interpreting and comparing results. Often the quality of technical service deteriorates when resronsible heads are health administrators leeking either interest or competency in lab­oratory technology. It was thought that this should be improved.

(c) ~pe III - A partially centralized system

In this type, all laboratories in the country are placed under the existing administrative pattern but technical supervision and direction as regards standards of technical service should be the direct responsibility of the central laboratory. This duty could be discharged at different levels through prOVincial, regional and peripheral laboratories if the country is big in size. In addition to this, the appointment of key per­sonnel to the laboratories could best be made in consultation with, and on the recommendation of, the director of the central laboratory, or his deputy at the prOvincial or regional level if necessary. It was thought this system was quite flexible and perhaps should be consioored for adoption by each country to fit its own administrative pattern.

S.3 National advisory council on laboratory service

It was considered desirable to have a national advisory council on laboratory services to assist the Minister of Health on matters such as th6se pertaining to poliCies, standards and legislation relating to lab­oratory service.

6. Staffing

The importance of having qualified p;lrsonnel in a health lab­oratory was stressed, discussed thoroughly and is briefly summarized below:

6.1 PrinCipal categories of laboratory personnel

It was genor~ agreed that the terminology and classification employed in various countries differed greatly. The classification recom­mended by the WHO Expert Committee on Health Laboratory Methodsl covered such categories as

(a) medical graduates, (b) non-medical graduates, (c) technicians, and (d) laboratoIY aides (unqualified technicians).

However, the seminar group considered that tho term "non-medical graduates" should be repleeed by "science graduates"; "unqualified technician" was a misnomer and the term "laboratory assistant" should be adopted.

lvnd Hlth Org. tecm. Rep. Ser., 1959, 161, page 2S.

c ....

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The nomenclature adopted by the seminar group was as follows:

(a) medical graduates, (b) science graduates, (c) laboratory technicians, Cd) laboratory assistants.

6.2 Qualification and training of staff

Having discussed and agreed upon the categories of laboratory staff, the pre-training course was fully studied. It was found that there .Tas considerable variation in the different countries, chiefly due to differences in the system of education. However, it was generally agreed that a comparative term of reference was desirable and the table shown on page 14 was formulated by the seminar group.

It was recognized that while standardization of training was desirable, it was not enough. It was felt very strongly that emphasis in training should be on the acquisition of supervised experience. The attendance at a formal course providing balanced theoretical and practical experience would be advantageous. The training of medical and science graduates should be conducted at the national level. The training of technical staff, technicians and laboratory assistants should be provided at all leve Is. This 1-muld, of course, de pend on the availability of adequate facilities. Fonnal courses for those with a higher general elementary education or secondary education could be organized, while regular refresher courscs were deemed essential for both scientific and technical staff and should have as one of their aims the review of standardized techniqucs and recent advances. Technical guidance provided by the scientific st2£f was important in the training of technicians and would prevent the introduction of unorthodox methods. Consultations with medical and scientific staff contributed to tho development of the technical staff and helped chock the introduction of unorthodox methods in their daily work.

6.3 Staff qualifications necessarY-f~ the different types of laboratories

The seminar group thought that the qualifications of the required medical, scientific and technician staff would depend on the type of lab­oratory and to some extent on the personnel available. The seminar group made the follOwing suggestions:

At the lowest level (the clinical laboratory), the single technical staff should have collegiate academic training and a minimum of one year's practical training and experience.

The optimum ratio of professional to technical personnel would vary with the size of the laboratory and the degree of specialization of laboratory procedure carried out. In the central laboratory where profes­sional training was desirable in view of research activities and the need to perform more exacting techniques, a higher proportion of professional personnel was needed.

r--

CBlegoty Designation Minimum Educational Experience

Requiremem

c;::ientific 1) For medical graduates: Medical degree Five yean laboratoty experience aod/ or

Laboratoty Director and other Medical degree • peciaJized training in laborBloty work.

medical staff Classified into various grades according

to experience and performance

2) For SCience graduates: Classified into various grades according to

Bacteriologist experience and/ or training and performance.

Par &sito logist Bachelor of Science

Technologist degree

Pharmacist, etc.

Technical 1) Laboratoty technician High school graduate or Two yean on-the- job training under

following traiDing as supervision or service training counes

laboratoty assistants plus actual experience under super-

vision

2) Laboratory assistant elementary school no previous experience

. ~

AClministrative Stenograpbel typist. store- Same requirements for Same requirements for administrative

keeper. etc, administrative service service staff in the coumry

staff in the countty,

-- _.- -- ---

In certain countries the L\ niversity provides a coune in medical technology which coven various fields of laboratory practice, In these

countries, a chief or senior laboratoty technician may be promoted to a technOlogist on the completion of thcunl·. enity course

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The group felt that it was possible for a science graduate to supervise a laboratory provided no medical consultative functions were involved and no interpretation of results was required.

The different sections of a laboratory might be satisfactorily staffed by science graduates. In certain situations (in level No.4) a medically trained director was essential but it might be desirable to have a qualified science graduate in charge of a section of the laboratory. In the opinion of the group, there was a definite need for the extension of international advisoFS services to countries whose p3rsonncl still have limited qualifications.

The direction at different levels were suggested as follows:

(a) Level No. 1 A medically trained director vms not essential. The staff employed at this level should bo assisted by medically trained p3rsonS wherever necessary. However, even at this level, technical super­vision should be provided from a laboratory (level No.2) which also func­tions as a reference unit. This would provide for a functional integration with the clinical services.

(b) Levels No. 2 and No.3 The employment of a medicallY trained director was considered essential as medical consultative and collaborative functions were of primary importance.

(c) Level No.4 The employment of a medically trained director was essential. However, a science graduate could provide the necessary leadership in certain selected fields of laboratory activitics. It was felt that uniformity in nomenclature of laboratory staff was desirable.

In th~ case of shortage of medical personnel for full-time service the seminar group recommencbd the employment of a part-time consultant.

7. Laboratory ReqUirements and Equipment

7.1 Space and building

It was pointed out that the minimum '-lorking space requirement should be related to the overall space available and correlated with the room arrange­ments and the distribution of equipment and laboratory functions. It was agreed that the minimum space should be in excess of 200 square feet/person, taking into account ancillary space (such as toilets, office quarters, stairs, corridors, etc.) which might take as much as 40% of the overall space. In the building special attention should be paid to heating ventilation, air­conditioning, light, "Hater and interior fittings.

7.2 Organizational segmentation in a laboratory

It was agreed that in countries where laboratory services are not yet developed and planning is about to commence, organizational segmentation is not advisable. It was suggested that the microbiology of communicable diseases and sanitary bacteriology should be undertaken in integrated institutions.

7.3 Equipment

1,ccurate inwstigations should be undertaken on the operational cost of any lIultra-mooorn facilities ll (building and equipnent), and there should be

- 16 -

adequate consultation with laboratory key personnel in the p~anning stage. However, in countries where laboratory work is not fully understood and where qualified p3rsonnel axe not readily available, the "ultra-illodern facilitiesl! should not be entertained as an essential pre-requisite for any health prograrrune.

7.4 Services

The pattern of services carried out at various levels in a lab­oratory had to be sufficiently flexible to permit adjustment to the situation of available facilities and personnel. The semin2~ group, however, emphasized that a viral diagnostic service should only be undertaken by larger laboratories starting fram the regional level. Research in virology should be delegated to the nationru. or central laboratory.

7.5 .Animals

\>Ihile animals properly bred and reared in a controlled environment result in healtly animals of more standardized reactivity, there was little advantage in raising them if an adequate quality of laboratory animals were available fram commercial sources. The importance of traffic control between animal quarters and brooding quarters was stressed. Hinimum requirem::mts in the care of animals relating to space, cage, washing, sterilization, feeding and watering were noted. 1 It was thought that animal breeding should be car­ried out in laboratories at l.evels No. 3 or No. 4. It was recc:xnmended that the responsibility for all laboratory animal activities should be placed in the hands of an individual with professional training in animal husbandry or veterinary science.

7.6 Laboratory safoty

The minimum physical requirements of a properly designed and con­structed building as regards ventilation, air current, air filtration, separation of areas of different risk lave Is, usc of germicidal gases and radiation were noted. 1 It wns also reconunended that carcasses and infested material should preferably be incinerated.

Immunization of the worker to prevent laboratory infection was re­commended. It was further suggested that pre-employment physical examinations and subsequent regular checks of personnel should be made.

The following suggestions were made in connection with the manage­ment approach to the control of laboratory hazards;

(a) establish "Tritton safety regulations regarding danger areas nnd procedures thntare read and understood by aJ..l;

(b)

(c)

train each nev, employee until it is certain that he understands the rules and vJhy;

folloH a schedule of re-training old employees;

l,.s suggested in Annex II, working paper entitled "Technical Require­ments for Public Health Laboratories".

-

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- 17 -

keep the safety needs in mind when screening and selecting new employces;

(e) whenever possible, dosign safety precautions as techniques nnd procedure s are developed;

(f) determine tho responsibility for safety. Each super­vioor should be responsible for the safety of his people, but each employee should have a personal responsibility; safety should be a part of every job;

( g) establish a fonnal system for reporting accidents .• lost-time, injuries aid infections, and insist on prompt reporting;

(h) investigate each illness and each accident to determine "hat should be done to prevent recurrence;

enc our age sugge stions for e l:i.minating laboratory hazards from workers at all J.l;lvels;

establish a car8ful pre-employment physical examination end regulur IOOdical examinntion of p:lrsonnel (x-ray, Mantoux, etc.);

an infection acquired in the laboratory ::tJ.ould be recognized as an occupational disease and comp:::nsation should be allowed by J.l;lgislation.

8. Gemral Aspects

8.1 The essentials of effective laboratory operation

The seminar group agreed that the following reqUirements must be satisfied to ensure an effective laboratory operation. The se are taken up in an nnnox of this reportl and need only enumeration here:

(a) (b)

(c) ( d) (e)

adequately trained staff, building (special requirements for heating, vsntilation,

air condhioning, light and interior fittings), equipment, adequate budgetary prOvision, and satisfactory planning.

8.2 Standardization of laboratory results

To make results comparable and valuable, it was suggested that diagnostic reagents, techniqres and reperting must be standardized. It was also necessary that reagents and sera from all sources of supply should

lAnnex II, "forking paper entitled "Planning, Organization and Administration of a National Health Laboratory Service".

- 18 -

con:o~ to estab1~shed standards of the official agency. The best way of ach~evUlg toose a:uns was through co-ordination of pOlicies at national level and cOllaborative efforts muong international agencies. The training of laboratory .-rorkers was also emphasized.

8.3 Central services of a laboratorz

In larger laboratories, it was thought desirable to have a central service insofar as items such as glassware, media and water were concerned.

9. Collection, Transportation and Registration of Le.boratory Specimens and Re ports

The proper collection, handling and shipnent of laboratory specimens were emphasized. Accurate registration and uniform report:ing were also essential especially in connection with the control of communicable diseases.

10. Administrative ASpects of the Health Laboratory Service

10.1 Legislation

Legislation and/or regulation is needed in many countries to provide for the orgunization, staffing pattern and scope of activities. Adequate budgetary provisions should be assured for government laboratories. There should be some legislation to cover supervision and control of the standards of service rendered by private diagnostic laboratories. Regula­tions covering the qualifications of laboratory workers should also be provided and enforced. Hinimum requirements for safety of foods, drugs, cosmetics, milk and water have to be established.

10.2 National standard laboratory procedures and methods

These should be laid down by the national health administration. They should be based on recommendations of the central laboratory following consultation with national lcboratory experts <ll1d follow the lines of recommended or established international standards.

Scientific meetings and publications

It was considered important for laboratory workers to organize SOcieties, hold scientific meetings and publish technical journals. This was the best way to ensure free exchange of information which could lead to improvement in knowledge and the adoption of new methods and techniques. These societies should collaborate with those of other countries. Govern­ments should recognize the importance of national and international scientific meetings and should encourage attendance by appropriate lab­oratory workers. Free access to li teraturc and information through a good library service was considered essential.

•

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10.4 Central technical supervision

It was considered desirable to have technical supervision and proficiency surveys of all laboratories in a region through the central or regional laboratories.

10.5 Relationship between health laboratories and other government agencies

National agricultural, industrial, veterinary and waterworks agencies might also have laboratories whose relationships with health lab­oratories should not be overlooked. These include such fields as zoonoses, industrial health, food, drug, milk, l"ater and pharmaceutical control. Health laboratories should keep close contact and collaborate with research institutes and university departments which could assist in training categories of workers besides serving as reference centres.

11. International Collaboration in Public Health Laboratory Services

11.1 Purposes and limits

(a) Exchange of inform.:1.tion and comparison of results

It was agreed that international collaboration was essential in the exchange of knowl£dge, techniques and information and would facilitate improvement in the quality and efficiency of national laboratory services. It would also help to revelop standards and mthods enabling comparison of results.

(b) Establishment of reference centres

International services for the irentification, diagnOSiS, collec­tion of strains and distribution of standard reagents were considered very useful and their dewloprnent was urged. Stress was also given by the seminar group to collaboration at the regional level.

(c) lissistance in planning, organization and providing technical service

International experts might be recruited to assist in the lab­oratory servi~es of requesting countries.

(d) Promotion and research

Certain problems might require investigation on a regional or international scale and should be of importance to research programmes in the fight against certain diseases.

(e) The limitations of international collaboration were usually due to lack of understanding between countries and lack of resources.

- 2.0-

11.2 External sources of assistance

(a) Various sources

There were a number of international, bilateral, multilateral and private agencies which could render assistance.

(b) Planning

In planning an assistance programme, a proper survey was essential to establish the area where assistance would be reeded.

(c) Co-or din [ffiion

When outside assistance was to be received, it was desirable that a single national agency should co-ordinate all help received from external agenCies.

( d) Utilization

For better utilization of external assistance, laboratories should be kept informod of possible sources, the nature of assistance available and procedures for making the requests.

11.3 Role of I'lHG

'WHO assists and co-ordinates lclloratory services for Member Countries in the following ways:

(a) by the collection and dissemination of information, (b) by pranoting and co-ordinating reference centres, (c) by providing technical consultant services, (d) by co-ordinating at international level, (0) by the award of training fellowships, (f) by sponsoring expert commi twes and seminars.

12. Coun~ Reports

After reviewing the reports on health laboratory services in various countries in the Region (Armex II) , it was recognized that the si tuation varied fran one country to another. However, there were many problems and conditions commOn to all or most of them, the most important of whicl1 are:

12.1 Policy and lcgisla ti ve aspects

12.1.1 Fees far laboratory service

The group rec<llllOOnded that investigations undertaken in the interest of public health and/or towards the detection of notifiable diseases should be rendered free of charge. Other laboratory charges should be left to the discretion of the respective governments. While

.. ~

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_ 21_

some countries had rondered all diagnostic services free of charge, other countries levied charges on selective items. It WQS pointed out that an unlimited free service might be open to abuse.

12.1.2 Supervision and control of diagnostic laboratories

There should be a central service established to render super­vision to government and private diagnostic laboratories. Private diag­nostic laboratories should be encouraged, subject to regulations covering standards of premises, equipnent and performance.

12.1.3 Biological production by private agencies

The group had no objection to the pro duct ion of biological products by private agencies, where feasible, provided they conformed to' prescribed requirements as laid down by appropriate regulatory authority. In developing countries, however, the manufacture of biological products should not be left entireJ.y to private agencie s in order to safeguard against shortages during national emergencies. Governments should have the facilities a~d be prepared to produce biological products to meet special circumstances.

12.L4 Legislation to ensure effective laboratory performance

It was pointed out that in many countries, it was desirable to have Jegislatiom or regula.tiom such as: provisions for adequate staffing, including the minimum qualifications required, suitable working conditions and salary levels comparable with other government agencie~ provision for adequate equipnent and supplies; and standards for technical preparations.

12.1.5 Combined hospital and public health laboratory

While the hospital and public health laboratories differed in their functions, they did have common services. In developing countries, it is advisable to have a combined service whenever possible as it contri­butes to econcrny in the utilization of personnel. Tm group thought that this was especialJ.y important in less developed countries.

12.1.6 Regional la.boratories

Regional laboratories, with or without branch laboratories, might be set up in countrie s to serve a district or a group of provinces with no other facilities.

12 .1.7 Reference laboratorie s

Reference laboratories at the national level are essential in any country. In certain very small and less-developed countries, however, such facilities might have to be negotiated with neighbouring countries.

- 2-2· -

12. L 8 Mobile laboratorie s

Mobile laboratories might serve rural areas where peripheral laboratory units are not yet established, or in emergency situations such as an epidemic. HObilc units must be attached to and sent out by a larger laboratory rlhich could give competent direction. It is not, however, advisable to concentrate efforts on such a service at the expense of the developnent of the laboratory service in general.

12.2 Personnel

12.2.1 Promotion of training and teaching programmes

This subject was adequately treated on several occasions during the discussions and presented in 6.2 above.

12.2.2 Personnel shortage

The group felt that there was a definite shortage of trained laboratory personnel, boih scientific and technical. Consultations with medically qualified Inboratory personnel were encouraged. Factors such as increased remuneration, encouragement of research, availability of advanced studies and attendance at scientific meetings and other ways of inducements were considered necessary if scientific and teclmical personnel were to be encouraged to join laboratory service.

12.2.3 Full-time reguirement for health workers

In general, the government laboratory worker should be on a full-time basis. irlhen there is difficulty in recruiting a full-time medical staff, particularly medical directors, the employment of a con­sultant on a part-time basis from a clinical department or other teaching departments might be the solution.

12.2.4 Remuneration and security of tenure of laboratory workers

Laboratory workers must be given a basic salary and security of tenure equal to that given to other employees of a government. Extra compensation had been provided in certain countries for unusual exposure to 1cboratory risk.

12.2.5 Technil"al supervision of laboratory personnel

It was emphasized that laboratory personnel especially those working in a peripheral unit should receive periodic inspection from a top level or a deputized person of the regional or central laboratory. Their teclmical competence could be crncked through split sample testjng and evalua:liion of their accuracy in the testing of "unknowns".

.....

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12.3

12.3.1

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Organization and technical aspects

Organization of an integrated national health laboratory service in a country

The review of the country reports revealed that there was a need to organize a national integrated health laboratory service for all the countries in the Region. However, the choice of organizational pattern depended upon so many attendant conditions and systems of ad­ministration and consequont~ no single pattern was thought applicable for all. The types of schemes as discussed in 5.2 were considered to be of interest. In particular, it was thought that the partially centralized system (Type III) described in 5.2(c) above could be modified to fit the needs of each country. It was also stressed that an integrated national health laboratory system might on~ be achieved by legislation in most countries.

12.3.2 Utilization of health laboratories by physicians and health officers

Health laboratories could be better utilized by phYSicians and health workers by:

12.3.3

( a) (b) (c)

(d)

(e)

(f)

(g)

(h)

stimulating awareness of the laboratory service, inviting them to attend conferences regular~J rendering free laboratory services concerning diseases of public health importance, encouraging research of interest to the general practitioners, encouraging personal and consultative services between practitioners and laboratory directors, giving more emphasiS to laboratoIY work in under­graduate teaching, reporting prampt~ of requested tests to physiCians and health officers, integrating laboratoIY service in the general health service.

The role of the central laboratory in imprOving quality of teclmical service of local laboratories

It was stressed that the central laboratory might be utilized as the co-ordinating agency for the whole laboratory service. However, in same countries where the political pattern precluded the applicability of this ~stemJ co-ordination and collaboration could be done on a voluntary basis. The central laboratory might offer in-service training and refresher course~ disseminate information on recent advances in techniques; render reriodic technical supervision; and evaluate the performance of local laboratorie s. In same cases, it might standardize and distribute diagnostic reagents and sera. It should offer consultative and advisory services to local laboratories.

12.3.4

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Collection. transportation and registration of specimens and reporting of results

These might be improved by proper instructions for the collec­tion, handling and transportation of specimens; prOVision of suitable containers; safe and fast means of transportation,; an efficient system of registration,; prompt reporting; and efficient compiling of test results by indexing and cross-indexmg.

12.3.5 Examples of administrative and/or technical problems occurring within a country

The country reports showed that too problems encountered varied great~ from country to country, the more genercl. and important problems being:

(a) lack of nationa~ integrated health laboratory service,

(c)

lack of local, area and national co-ordination among various health laboratories,

look of a central technical planning advisory board to the Ministry of Health,

(d) lack of a central technical supervisory service,

(e) lack of co-ordination between other departments of government such as industrial, agricultural, veterinary and waterworks agencies and the ooalth laboratory services,

(f) shortage of trained laboratory workers,

(g) lack of public appreciation fer laboratory services, and

(h) inadequate legislation or regulation on the qualifica­tion of laboratory workers and standards and require­ments for laboratory premises.

VII. CONCLUSIONS AND RECCMMENDATIONS

1. For the successful promotion of public health services in ruv country, an organized health laboratory service is desirable.

2. A health laboratory service could be illustrated by three main types, namely, (a) completely centralized system, (b) completely decen­tralized system, and (c) partially centralized system.

3. The advantages and disadvantages of the three main types were discussed and no single type was thought to be applicable in all countrie s.

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4. It was suggested that on the basis of its own administrative pattern a country might modify and adopt a type of service that would provide central technical supervision over the peripheral units either directly or through provincial or regional laboratory levels.

5. There seemed to be a need to establish a national advisory board or counciL on health lnboratory service. This body could advise the Minister of Health on poliCies, standards and legislations relating to health lab­oratory service.

6. The important steps and problems to be noted in the planning, organization and administration of a public health laboratory service were analyzed and discussed. This information might be of value as reference material when a new plan for such a service was contemplated.

7. The importance of a preliminary survey, ear~ preparation of qualified personnel, and consideration of an organizational pattern in relation to otter health units was stressed.

8. A description was made of the activities and functions including technical requirements of the common existing types of laboratories ranging from a mobile laboratory unit, clinical side room, hospital laboratory, . basic type public health laboratory, full-type public health laboratory, canbined hOspital and public health laboratory (health laboratory), regional health laboratory, reference laboratory and central (national) health laboratory. These laboratories were classified b.r the seminar group into four types of organizational pattern.

9. The problem of lcl>oratory staff was discussed and the seminar group presented a classification of the categories required, specifying at the same time the pre-training qualifications, duration and nature of training they should have.

10. Requirements for the operation of laboratory services, including notes on collection, transportation and registration of specimens and reporting of laboratory results were discussed.

11. The establislment of a combined health laboratory to serve the hospital and public health services is desirable for developing countries as this would mean econcrny in resources and personnel.

12. More co-ordination was urged for health Jaborator:iJ3s within an area and between the health and other laboratories of government services and private establishments, such as industrial, agricultural, veterinary and waterworks agencies.

13. Comprehensive legislation is needed to ensure uniform standards for the qualifications of laboratory workers and the requireroonts for lab­oratory premises.

14. There is a need for more international, bilateral and multi-lateral collaboration in the field of laboratory service. WHO could serve as the co-ordinating agency and render technical advice and assistance to countries seeking such aid.

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ANNEX I

LIST OF STAFF, PilRTICIPANTS AND OBSERVERS

1. STAFF

Seminar Director Dr. C. H. Yen Commissioner of Health Taiwan Provincial Government vlufeng Hsiang

Consultant

Consultant

Operational Officer

Taichung, Taiwan Republic of China

Dr. Ralph B. Hogan 11edica1 Director Chief Laboratory Branch Communicable Diseasec Center P. O. Box: 185 Atlanta, Ge orgia U. S. A.

Dr. R. Sansonnens Chief M3dical Officer Health Laboratory Services "WHO Headquarters Geneva, Switzerland

Dr. A. 11.. Angara Regional Public Health Administrator World Health Organization Regional Office for the

Western Pacific Manila, Philippines

2. PARTICIPANTS

Australia

Dr. Eric John De Salis Medical Officer-in-Charge Commonwealth Health Laboratory Institute of Anat~ Canberra

China (Taiwan)

Dr. Kong-fuci Tsung Director of Taichung Health Laboratory Taichung, Taiwan

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Federation of Malgya

Korea --

Dr. R. Bhagwan Singh Acting Senior Bacteriologist Institute for Medical Research Kuala Lumpur

Dr. William Gillespie MacIntosh Acting Pathologist Pathological Laboratory Suva

Dr. Masuo Takabe Chief Communicable Diseases Control Section Public Health Bureau Ministry of Health and Welfare Tokyo

Dr. Ken Yanagisawa Vice-Director National Institute of Health Ministry of Health and Welfare Tokyo

Dr. Il Chyu Chief, Department of Parasitology National Institute of Health Seoul

New Zealand

Dr. Harold Trevor Knights Epidemiologist National Health Institute Wellington

North Borneo

Dr. Cecil HerbertJ ames Medical Officer-in-Charge Queen Elizabeth Hospital Jesselton

(

, -~

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Philippine s

Dr. Gabino V. Balbin Regional Health Director Dagupan City

Dr. Trinidad P. Rlsigan acting Director Bureau of Research and Laboratories fupartment of Health Manila

Ryukyu Islands

Dr. Minoru Hara Director of Koza Health Department USCIlR

Sarawak

Dr. Dinshaw Tavaria Medical Officer-in_Charge Central Laboratory Kuching

Singapore

Mr. Lim Chin Kuan City Analyst Singapore

Territory of Papua and New Guinea

Dr. J. J. Saave Assistant Director Department of Public Health

Vietnam

Dr. Do-chi-Nang Pasteur Institute Saigon

Western Samoa

¥lI'. Peter Rasmussen Bacteri ologist Health Department Apia

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OBSERVERS

Colonel Carl F. Tessmer United States 406th Medical General Laboratory United States Army Medical CC!IIlIland APO 343, San Francisco California

Dr. Potenciano R. Aragon Professor and Head Department of Medical Microbiology Institute of Hygiel);! University of the Philippines Manila

Dr. Tirso M. Briones Chief Division of PUblic Health Laboratory Manila Health Department Manila

Dr. Filomena Sadili-Montalbo Medical Officer II Regional Public Health Laboratory for Health District No. III Manila

,

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A REV!E.W ON THE PUBLIC HEALTH IABORATORY SERVICES IN COUNTRlES AND 'lERRITORlES OF THE WES'lERN PACIFIC REGICN

by

C. H. Yen, M.D., D.P.H. Provincial Health Administration

Taiwan, Republic of China

1. INTRODUCTION

This pap;r is a consolidated information on public health lab­oratory services in countries of the Western Pacific Region. It is based on individual country reports of seminar participants received between August and September 1960 from the following cou.~tries and territories: Australia, China, Fiji, Japan, Korea, Malaya, New ZeaJ.and, North Borneo, Rlilippines, Ryukyu Islands, Sarawak, Singapore, Vietnam and \·Jestern Samoa.

The situations existing in these countries and territories vary tremendously in such aspects as geographical and climatic conditions; cultural, educational and economic development; availability of health facilities and health personnel, population size and distributio~ and means of communications. The influences exerted by these factors in the development of public health laboratory services are obvious and any attempt to generalize on them would not onl¥ be difficult but also con­fusing.

The 'vorld Health Organization Regional Office for the Western Pacific has, therefore, prepared an outline of topiCS sent to participating countries as guideline in the writing of country reports. It is of interest to note that when the fourteen countl"'J reports were received, they differed greatly in the detail of information furnished varying from a very brief note by scme to extended reports by other countries, thus maldng comparativ~ stuc\v somewhat difficult. HOlfCver, au reports were illuminating and informative and they are treated here in line with the guideline used for the preparation of the country reports.

2. PUBLIC HEALTH IABORATORY SERVICES

2.1 Policy and legislative prOvisions

All the countries concerned provide curative and preventive medical. services which vary in extent. Laboratory services are uniformly governmental institutions functioning either as an independent entity or as a division in an existing clinic, hospital or health department. In a number of countries, there are both non-profit as well as profit-making private laboratories. Private laboratories real chiefly with chemical analysis and clinical diagnostic tests. There appears to be morc private laboratories in the better develop;d countries.

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All countries have the appropriate legislation or authority pro­viding for the organization of laboratory services and srecifying their functions, scope of work, staffing pattern and budget. Regulations also provide for a system of fees for individual laboratory services. Some countries require the registration of private laboratories and specify minimum requirements including qualifications of the laboratory chief and standard equipnent •. The health authOrity is vested with the right to inspect laboratories. There does not seem to be any specification as regards qualifications for technicians. Many countries did not report on how private laboratories are regulated by the appropriate governmental authority. On the whole, oven when there is a regulatory authority, it appears that many health oopartments do not actuaJ..Jy have the personnel to perform the function.

Legislations and regulations on disease control and control of food, drug, water, milk, beverage, meat, narcotics and dangerous drugs exist in all the countries. They specify reporting of certain epidemic diseases, the safety standards for food, drug, water, milk, meat, etc. Penalties are imposed on violation of these laws, regulations and ordinances.

Most countries state that laboratory fees are minimal and are charged from patients, physicians, hospitals and food or drug manufacturers. Tests and examinations for articles and speci.rnens of public health importance are invariably free of charge, e. g., examination of sputa for acid fast bacilli, sera for venereal diseases, blood for malaria and fila­riasis, specimens for cholera, plague, smallpox, enteric fevers and leprosy are absolutely free of charge. No fees are charged on laboratory examina­tions made in the course of a survey. North Borneo stated that all public heal th te sts are free of charge.

2.2 Planning. organization and administration

The organization of public health laboratory services differ from country to country in the liestern Pacific Region. Their type s can be grouped roughly into the follOwing categories.

2.2.1 Essential hospital laboratory service

North Borneo and Western Samoa have no separate public health laboratory services. They maintain hospital laboratory services which are also utilized for conducting tests for essentially public health require­ments. Their routine clinical laboratory examinations also assist in focussing attention to conditions of public health importance as in the laboratory diagnosis of infectious diseases.

North Borneo has a separate laboratory for malaria control, a water laboratory in the public works department, and veterinary and soil testing laboratories in the agriculture department. Other specimens of public health importance are referred to nearby countries.

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Essentially research centres with hospital laborato£1 service

In Vietnam there is no full-fledged public health laboratory but there are three highJ;y developed research centres (i.e., the three Pasteur Institutes) which examine specimens referred by the health department and prepare vaccines, sera and other standard reagents for the country. The health department also utilizes clinical laboratories of provincial hospitals for the ex~ination of speoimens of public health importance. The responsibility of op:lrating and;' or co-ordinating public health laboratory services does not seom to be located at the public health department.

The Pasteur Institutes are autonomous financially and in technical op:lration. They assist concerned ministriGs in the following manner:

(a) for tho Minist£1 of Health

(b)

i. serve as reference laboratories for more complicated medical analysis;

ii. supply VaCCines, sera and antigens prepared· in Vietnnm or imported frem Paris.

for the Minist£1 of Agriculture

i. serve as reference laboratories for the study of infectious diseases of an:imals;

ii. suppJ;y veterinary vaccines and sera.

(c) for the Minist£1 of Economy

i. control puritr,r and detection of imitations of all ldnds of products, particularly foodstuffs;

ii. examine agricultural and mining products, etc.

The Ministry of Health maintains a laboratory for pharmaceutical products, a nutrition laboratory and a laboratory in connection with its malaria eradication programme.

2.2.3 Distinct central public health laboratory integrated within hospital laborato£1

This group is exemplified by Fiji and Sarawak with some dif­ferences between thorn. Both have a distinct public health laboratory which is a section of the public health department. In Fiji, the central laboratory is located in a hospital which operates as an independent section of the medical department. Its small branch laboratory at Lau­loka, however, is only for routine clinical work. Thore is also a small laboratory for the tuberculosis hospital and a laboratory at the central

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leprosy hospital. In Sarawak, there is no separate public health labora­tory service, but there is a central laboratory of the medical and health department in Kuching. In these countries the need seems to be more on the clinical rather than on the public health aspects of disease control. It has seemed more econcmical on their part to combine the clinical and public health laboratories. There also seems to be a definite assignment of responsibility of laboratory services under the medical (and health) depart­ment.

2.2.4 Distinct central publiC health and local laborato;r services

This type of organization is seen in Japan, China and the R~ Islands. Although differing in size, extent and stage of developnent, they are similar in having a distinct public health laboratory service in addi­tion to the hospital laboratory service. In Ryukyu, there are one central public health laboratory, 5 health centre laboratories and 10 hospital lab­oratories. Although there is sorre overlappiilg in the activities of the health centres and the hospital laboratories, the main public health lab­oratory work is done at the health centre laboratories. Ryukyu derives the services of reference laboratories from Japan. In the province of Taiwan, China, there are a central public health laboratory (the Provincial Hygiene Laboratory) with 22 health centre laboratories (county or municipal), 18 hospital laboratories and 472 health station laboratory rooms. At the provinCial level there are six reference laboratories in six institutions for sera and vaccines, venereal diseases, tuberculOSis, sanitation, leprosy and malaria. A joint laboratory where a regional public health laboratory was integrated to a provinCial hospital laboratory was established on~ recent~.

Japan has public health laboratories that are among the most extensiveJy cbveloped in the Western Pacific Region. At the national level the ~entral public health laboratory services are carried out by an aggregate of five national (reference) laboratorios: namely, the Institute of Health, the Institute of Public Health, the Institute of Leprosy, the Institute of Hygienic Laboratory and the Institute of Nutrition. At the local level, there are 51 (prefectural and municipal) local health lab­oratories, and 790 health centre laboratories.

Distinct central public health laborato;y service with regional laboratories

This group inclucbs Korea, Malaya and the Fhilippines. These countries provide distinct publiC health laboratory and hospital labora­tory services. But the difference lies in the fact that full-type public health laboratories mentioned in paragraph 2.2.4, page 48 have a number of regional or branch laboratories aside from the central (national) lab­oratory.

In Korea the central public health laboratory is the National Institute of Health. It has a chemical laboratory and serves as a reference laboratory. T:-~e National In;:;titute of Veterinary Medicine serves also as referenc2 loborator;:". The country has 10 regional health, 76 health centre and 100 hospital laboratories.

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In Malaya, there is a national laboratory with 2 branch (regional) laboratories and 5 laboratories for clinical p~thology. Local public health laboratory services aro performed in the district hospitals.

In the Fhilippines, toore is a national (central) public health laboratory, five regional public health laboratories and a number of provincial and city public health laboratories attached to provincial or city health offices. One rogional public health laboratory is attached operationally to a provincial hospital.

2.2.6 Distinct public health laboratory service without a central laboratory

This typo is found in Australia and Singapore.

There are fourteen public health labordories in Australia. All are under the control of commonwealth agencies. There are national reference laboratories for salmonella, typhOid, shigella, mycology, virus, and parasitology. Each state has a diagnostic laboratory at its capital.

In Singapore, at the central government level, there are depart­ments of pathology and chemistry under the Ministry of Health. The former provides laboratory services for governm(mt hospitals, clinics and general practitioners but is housed, together with the university's pathology department, in the premises of the general hospital. The latter has a separate chemical laboratory rendering an island-ivide service and sp3cializes in criminal investigation, examination of hazardous materials and dutiable articles. There is no consolidated single central health laboratory. At the ci~ level, there are separate laboratories for bacteriology, the ana~st's laboratory, plague prevention and anti­mosquito work. These laboratories perform the main public health labora­tory services. Clinical laboratories are frequentJ;r attached to the hospitals.

2.2.7 Distinct public health laboratory with advisory committees for laboratory service

This is exemplified in the National Institute of Health of New Zealand. The Institute serves as a national reference centre for infections with salmonella, toxoplasma, viruses (e.g., influenza, small­pox, etc.), staphylococci, and for the typing of enteric phage~ it also produces anti-typhoid and smallpox vaccines. At lower levels, public health laboratories arc attached to small and large hospitals and perform clinical pathology and public health microbiology and pathology. Sanitary laboratory services such as water and milk examinations are performed by four main centres under a Department of Scientific and Industrial Research. There is an advisory committee on laboratory services f'or too hospital services and for private laboratories, These committees are of' interest as there is no mention of one in arry other country. Whether or not these committees also give advices to the national reference laboratories is not apparent •

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2.3 Functions of laboratories at different levels

At the national level mnny countries have a national institute of health or its equivalent (e.g., research institute, central laboratory). These institutes often serve in one or more capacities as reference lab­oratories. Their functions cover such fields as microbiology, serology, chemistry, biochemistry, pathology, forensic medicine, food and drug con­trol, sanitary analysis, biophysics, allergology, physiology, nutrition and in conne('tion with the control of special diseases. 1rlhile functions of laboratories vary from country to country they cl.l essentially provide services connected with preventive and curative medicine, perhaps with more emphasis in the former. Another usual function is research. In a few countries or territories such as North Borneo, Sarawak and Western Samoa, the hospital laboratory serves as the central laboratory and performs to a certain extent essential public health laboratory services. vJhcn needed they avail of the reference labor3.tories of other countries.

At the regional and prOvincial levels .there usually operate distinct public health laboratories in regional or provincial health depa -t·· ments or tmy -may be combined with the hospital laboratory service. The functions of the public health laboratory are mainly directed towards the fields of preventive medicine and sanitation, including foods and drugs, water and milk control. When the public health laboratory is independently operating, clinical pathology is included in its scope of activities. When combined with the hospital laboratory, the public health laboratory is managed under tho hospital administration.

At the country or city level, the public health laboratory is usually a part of the appropriate health service. Its functions are similar but lesser in scope than the provincial health laboratories.

At the townShip and village levels, laboratory service is usually conducted in a roam or section of the health centre and health station. Its activities are mainly confined to clinical microscopy. These small units also serve as collecting centres for specimens in the control of diseases such as venereal disease, tuberculosis, etc., for referrals to the proper agencies.

The hospital laboratory very frequently is the site where regional, prOvinCial, county and city public health laboratories are located. To a certain extent, an integrated hospital and public health laboratory has the advantage of pooling or saving on facilities and technical persormel.

Where other agencies such as public \.,orks, agriculture, veterinary medicine and industry have special laboratories, efforts should be taken to co-ordinate their activities with the public health laboratory.

2.4 Distribution of laborato~ services

National public health laboratories are usually located at their capitals; the same is true of reference laboratories. Regional, provincial, county and ci~ or other local laboratories are frequently distributed in proximity to and along similar lines as the public health

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service of their corresponding level. Suffice it to say that public health laboratories are usua~ strategical~ located in terms of the population to be served.

It was unifo~ stated in the country reports that laboratory services are available to general practitioners and to private hospitals. It was not possible, however, to gauge the extent of utilization made by physiCians and institutions. One gathers the impression that in some countries, the utilization of the laboratory by public health and private parties is not great.

2.5 Services rendered and population coverage.

The services rendered by the public health laboratory have been presented above and in the next pap3r. It is difficult to generalize on the population covero.ge by the different types of lD.boratory services. There seems to be a min:llnum number of 5 000 to 50 000 p30ple at the health station (village) level and 50 000 to 800 000 in countries or cities served by health laboratories. The potential of the population served at the provinCial and national levels will coincide with the respective popula­tion of each. Estimates such as these are obvious~ rough sin~e the population that could be covered would depend on the accessibility of com­munications by roads, trains, boats and air services.

2.6 System of collecting Specimens

Most countries indic2.ted that individual sp;cimens are usua~ collected at the clinics and hospitals and by practitioners ~d home visitors who deliver them to the laboratory. Non-p3rsonal sp:3c:llnens (e. g., water, milk, etc.) are collected by health inspectors and delivered to the labora­tory. Food products and drugs are submitted e ither direct~ by the manufacturers or obtained on the spot during insp3ctions by the health inepector ••

Postal services for the delivery of some specimens to laboreto­ries are indicated in the country reports fram China, Korea, Malaya and New Zealand. In J ap<m, the law prohibits the sending of pathologic material by mail unless done by a government office, the bacteriology institute or by a phYSician or veterinarian. As collection and packing of sp3cimens great~ influence results of examinations, there is need for laboratories to provide appropriate containers with instructions on how the specimen should be taken, handJnd and sent.

2.7 Registration of specimens, records and reports and filing

In most countries there is a" registry for specimens received u.r the laboratory noting thereon the kind, when received, serial number and results obtained. The findings are sent back to the originator of the request with copios to the health department on items required u.r law or regulation. Laboratories periodic~ compile their reports which are sanetimes published with the annual reports. In Korea, records are by law kept for at least three yonrs.

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2.8 Budget

The individual country reports provided information on the bud­getary position and exrx::nditurcs covering the past five years. As expected budgetary outlays differed between countries. It is impossible to compare the figures as the expenditures, per se, are of no significance unless their proportion to the totnl health budget is known. From the statements made in the reports, most countries expressed the need and desirability of increasing budgetary prOvisions for laboratories.

3.1

3. LABORJlT<:RY IERSONNE:L

Classification and number of various categories, training and minimum qualifications for laborato~ personnel

Countries use different nomenclatures and the categories of per­sonnel employed vary even between J.'£,boratories in the same country. In general, hen-rever, the technical staff may be classified into the following categories:

3.1.1 Medical staff

These are medicnl graduates who have had one or more years of practical experience in the laboratory field. In some instances the medical staff may- have a diploma in public health, microbiological sciences or pathology. The more senior of them are generally chosen to serve as chief of either the central, reference, regional and prOvincial laboratories. More junior personnel serve as chiefs of departments or divisions of the bigger laboratories. In other countries the situation is less favourable in that they do not have enough medically qualified p3rsonnel and use is made of others in the technical categories. In all functions, however, tissue pathology is always done by a medical staff member.

3.1.2 Scientist staff

The scientist staff nrc science graduates with specialization in the fields of microbiology, chemistry, veterinary medicine, pharmacy, etc. who after graduation have had two or more years exrx::rience in their specialty in a laboratory. They fill laboratory pOSitions of biochemist, chemist, bacteriologist, paraSitologist, etc. In some reference laboratories there are positions provided for pharmacists, dentists and sanitary engineers.

3.1. 3 Technological staff

It is evident from the country reports that this category con­stitutes the largest group of laboratory workers. They are generally known as technologists or technicians. In some countries as in China, a four­year college course is given in medical technology. They receive a bachelor of science degree and arc designated as technologists in contra­distinction to the technicians who have not had the requisite baccalaureate attainment. Certificate courses in medical technology, ranging frcm two to

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three years after senior high school, 2.I'C offered in some countries. In Japan and Vietnam, there is 11 two-year course given at a training school for laboratory technicians. In New Zealand, a three to five-year course for the certificate of proficiency in hospital laboratory is offered depending upon the stuoont I s academic standing at the time of admission. Aside from the diploma and certificate courses, most countries offer refresher and in-service training courses for junior technicians to raise their performance standards.

3.2 System of technical sUpervision and promotion

Most of the country reports stated that the conduct of laboratory services is the responsibility of the director or chief of the laboratory. He in turn is responsible to the medical or hospital administrator under whan the laboratory is established. Th(;re appears to be no technical super­vision from a technical body outside the laboratory. There is also no men­tion of a proviSion for direct supervision. There seems to be a need for regular supervision of laboratories by a canpctent technical group. This function can best be done by the central public health laboratory staff.

In New Zealand, there arc two advisory conrrnittees, viz., one for hospital laboratories and one for private laboratories.

Promotion in terms of appointments or salaries of health workers in c~l countries are based on two factors, viz., availability of post and ability. Every country has a system of grading positions and individual promotions are in accordance with civil service regulations.

3.3 Refresher and post-graduate courses for laboratory personnel

These have been part~ discussed under 3.1 above but further examples might be added.

In China, refresher courses are given from time to time by the provincial hygiene laboratories, Malaria Research Institute, Institute of ~nvironmental Sanitation, Venereal Diseases Centre and the Tuberculosis Control Centre. Post-graduate courses are given at the Institute of Medical Technology and Institute of Pathology at the National Taiwan University.

In Fiji, refresher courses are given at the central laboratory.

In Japan, short and long-term courses are given at the National Institute of Public Health.

In Malnya, in-service training takes three years and is conducted at the Institute of Medical Research. Written, practical and oral examina­tions are required to pass the course.

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Remuneration [1lld security of tenure

Since public health laboratory workers are government employees, they are governed by the civil service laws. The scale of pay inclucting adjustment allowances, promotions and tenure of office are all stipulated in the law or regulntion. Except for cause, there is always a security of tenure with opportunities for promotion. Their positions invariab~ are J:6nsionable and the retirement age ranges fran 55 to 60 years. The pay scale varies with the country.

From the available data given by the reports, the pay scale would seem to range as follows:

A Central Laboratory In lowest paying In highest p~ing country country

US$ US$ Chief of the laboratory 800 - NOD/year 5ODO - 8ODO/year

Departm.ent heads, medical 650 700/yoar 3500 5OCYJ/year staff, senior scientists

Scientists 600 - 650/yoar 3000 - 3500/year

Senior technicians 550 - 2ODO - ~OOD/year

Intermediate 400 2200 2400/year technicians - -

Junior technicians 300 950 2000/year

In the lowest p~ing countries, employees may receive food rations, housing allowance and nteclmical allowance", so that the actual comJ:6nsation may be greater than what the figures above would show. In certain countries the laboratory workers receive an extra allowance for risk of exposure to infectious materials.

It would have been helpful to compare salary scales :::-eceived by laboratory workers with those employed in the hospital or medical institu­tions and with other governmental agencies. Unfortunately, no data along this line was reeeived. As there was no information about income tax and cost of living in each reporting country, it would be difficult to compare and interpret figures received frem the participating countries. On the whole, however, the country reports revealed the difficulty of recruiting health lDrkers principally because of the low salary offered.

3.5 Full-time or part-time service

The country reports confirm the fact that all laboratory workers serve on a full-time basis. Exceptions are chiefs of laboratories or senior eXJ:6rts, especially when full-time officers are difficult to recruit. If, for instance, certain t?fpes of eXJ:6rts frem a research institute or professors in a university are few, they are recruited with the understancting that they would be able to concurrent~ work in the public health laboratory as well as in their other activities. Sometimes,

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in order to co-ordinato the laboratory work of a hospital and health service, the post of head of the laboratory is assigned to the administra­tor of the hospital or health service. "!hila it is agreed that laboratory workers must serve full t:i1ne in the laboratory, arrangements to avail of the part-t:iJne services of consultants in sp3cific subjects would also seem desirable.

4. mOBIEMS AND NEEDS IN THE lJEVELOFMENT OF A RJBLlC HEALTH IABCRATORY SERVICE IN A COONTRY

The following is a stlIlllTlaI'Y of the problems and needs of public health laboratories as indicated in the country reports:

(0.) lack of public appreCiation of the work of laboratories and their utilization by the general public, physicians and even health workers;

shortage of well-trained laboratory personnel;

(c) lack of virologists and specialists in tissue pathOlogy;

(d) very low P1'W for laboratory workers;

(e) need for giving more emphasis on the statistical approach rather than on clinical pathology;

(f) lack of proper technical supervision of laboratories;

(g) difficulty of getting medica~ qualified personnel to engage in health laboratory work,;

need for more laboratory aspects of environmental sanitation and nutriti~

(i) need for more intra-country programmes;

(j) need for strengthening inter-departmental co­ordination in the laboratory field;

(k) need for more budgetary allotment and facilities for the laboratory service; and

(1) need for more international collaboration in laboratory technology.

5.. C()olMENTS

In reviewing the reports fran various countries, the following points of importance be cane apparent.

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5.1 Lack of an organized service

Usually, there are central and reference laboratories as well as regional, provincial, health centre and hospital laboratories. Although these laboratories are responsible to their j,nnoodiate agency heads, there is no provision for a centralized sup;orvisory authority nor of a central planning and co-ordinating authority or direction of the laboratory services. Marw laboratories at different levels in the country function independently of each other. They are nol:; organized into a system of servicing which is desirable on a national basis so that well co-ordinated public health lab­oratory services can op;orate efficiently throughout the country.

5 .. 2 The lack of a central supervision

In n:ost countries the conduct of services in a laboratory is guided and supervised by its own director. The director in turn is responsible to the health officer or hospital sup;orintendent. Too often the health officer or hospital administrator is too occupied with his duties or is unfamiliar with the technological asp;octs of laboratory work. It would be advantageous for raising or maintaining the quality of services if local health laboratories were placed under the technical supervision of a central unit at the national level.

The lack of a national adviso council or committee on the health laboratory service

Except; for New Zealand, no country report has mentioned the existence of an advisory body on laboratory services at the national or local level. Such body seems desirable to assist the national health ad­ministration in determining policy and in recommending overall planning of laboratory services. Standard procedures and legislations could also be recommended by this body.

5.4 The need to strengthen training programme

Although most countries offer courses leading to diploma certi­ficates or provide in-service training courses under government sponsor­ship, there is obserred a lack of uniformity in the requirements for admission and the curriculum content of the courses given. Every country should endeavoU':' to provide intra-country training programmes in order that its laboratory service mqy have enhanced standards.

5.5 Response to changing needs

Frcm the country reports, it is noted that disease prevalence and major health problems have been undergoing changes during the past dec a.Cte s. Many countries have reported tho successful control or even eradication of marw diseases such as smallpox, cholera and plague and the steady decline in '\he incidence of diseases like malaria, diphtheria, p;lrtussis) enteric fevers, tuberculosis, etc. On the other hand, an increase in the incidence of other diseases is being observed, e.g., poliomyelitis, encephalitis and other virus infections. With the changes in tho health picture, laboratory services should be geared to cop;o with

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new problems. Laboratories must be equip~d to meet new needs and provi­sions taken for the training of more workers in -the field of virology. In better developed countries, cardiovascular disease, cancer and mental dis­orders constitute the maj or health problems. Their laboratories should be mobilized to assist in the unravelling and tackling of the problems they pose. Fhysiological, bio:lilysical, epidemiological and statistical methodologies are being added to the laboratory disciplines. In develop­ing countries, however, sanitation, water, food and drug control and the control of infectious diseases will for a long time remain the principal fields in which laboratory assistance will be required.

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PLANNOO, ORGANIZATION .AND ADMINISTRATION OF A NATIONAL HEALTH IABORATORY S&RVlCE

by

c. H. Yen, M.D., D.P.H. Provincial Health Administration

Taiwan, Republic of China

1. INTRODUCTION

The :importance of the role played by the public health laboratory in a national health serv:Lce can har~ be over-emphasized. In earlier da;rs, public health laboratories were established to deal specifically with tre detection of the spread and control of infectious diseases. A brief account of the historical evolution of public health laboratories is given in the first report of the WHO Expert Camnittee on Health Laboratory Methodsl and need not be repeated here. But it is worthwhile to note that in recent years there has been a rapid and constant expansion in the activities of public health laboratOries dLB to the increasing demand made by health -officers, cliniCians, sanitary engineers, etc. Today, in many countries, the public ooalth laboratory does not only ooal with too problems~ detection on the mode of spread, diagnosis, coo.trol and prevention of diseases and in the prognosis and treatment of patients but also with the determination and control of envirormmtal factors detri­mental t-o man. Thus, the public "health laboratory serves in the fields of preventive and curative nedicine, in the sanitary" control of water suppq, of sewerage and-waste disposal, of vector control, of air pollution, of industrial hazards, and in the fields of milk, food aild drug control. In addition to the above, tCDdcolog,V (forensic nedic:l.ne), radiation hygiene and nutritional investigations are in S0m3 countries also included in the activities of the public health laboratory. As problems confronting realth workers are still llllJOOrous, new laboratory methods to tackle them are being devised and will in tho future result in further activities of the public health laboratory.

- With the increasing fields of activities of the public health laboratory, there has developed a variety of terms to" designate the dif­ferent types of laboratory, e.g., clinical laboratory, medical laboratoxy, hospital laboratory, hygienic laboratory, sanitary laboratory, patholo­gical laboratory, public health laboratory, health laboratory, etc. Although by usage the functions and scope of activities of each of these types are well known, there seems to be a general lack of precise defini­tion for each. Just where does the scope ani functions of one end and the other begin? Does one type JOOrge with another? Where are the duplications and the overlapping?

!wld Hlth erg. techno Rep. Ser. 1957, 128

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In the second report of tre vJHO EXI=8rt Committee on Health Lab­oratory l'iethodsl mention was made of the "definition and philosophy" of the hospital laboratory. It was pointed out that hospital bacteriology forms part of the hospital service but in several countries most of the bac­teriological work for hospitals are unoorta1<Bn by the public health lab­oratory and, conversely, some of the laboratory aSI=8cts of public health are undertaken by the hospital laboratory.

To elaborate on too definition of these laboratories must be dif­ficult and perhaps not important. Yet for the sake of having a clear tenn of reference in our minds when we consider the topiC of this working paper, it is necessary to denote what is meant by a "public health laboratoryll and a "national public health laboratory service". vIi thout getting too much involved in terminology and oofinition, we shall consioor the public health laboratory as a unit of public health service employing laboratory methods to study, determine and identify the causative and contributory factors or agents (animate or inanimate) related to the health and disease of man including the host response to such factors or agents.

Thus, the public health laboratory, in a narrower sense, may limit its functions to fields dealing with the protection of the health of the community against infections, epidemics and occupational disease while, in a broader sense, its function mew cover the services for the restoration and preservation of the health of an individual. In this papJr the term "public health laboratory" is used in the latter or broader sense ani its functions would inclucb those fields covered by oro or more of the types of laboratory mentioned above. The "national public health laboratory service", on the other hand, 1trould mean an organized system of services canposed of indi vidual public health laboratorie s in a country or territory.

2. SCOPE AND FUNCTION

Although not easy to define, the scopJ of the public health lab­oratory is related to its assigned functions.

2.1 Principal functions of a public health laboratory

Service

The public health laboratory is intended to assist and guide the health officer and the clinician in the maintenance and promotion of public health services and medical care. It is important to stress that lab­oratory findings should not be interpreted separateJ.y but must be con­sidered by the health officer and tb9 clinician in the light of other findings. As the laboratory assists practising physicians in arriving at an accurate diagnosis, they must in turn acquaint themselves with the servicos offered and when to avail of them so that they can better utilize the laboratory.

\ad Hlth erg. techno Rep. Sere 1959, 161

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2.1. 2 Research

It is extremely important to conduct research in a public health laboratory if only partly to stimulate incentive for work and attract into the service qualified personnel. Research would be futile unless carried out by well-trained and canpctent personnel in a suitably equipped labora­tory. One of the principal objectives of a laboratory is to develop new tests, techniques and methods as well as to improve existing ones. Even in a less equipped laboratory, some kind of research activity, usually on the more practical aspects, is to be encouraged.

2.1. 3 Teaching and training

Laboratories should be utilized whenever possible for the teach­ing of undergraduate medical and para-medical p:;rsonnel and the training of technicians. The laboratory is the logical place where stuoonts and trainees can gain practical experience. The fully developed public health laboratory should not only conduct training and teaching but must be able to render supervision to maintain the quality and stmldard of service of peripheral health laboratories.

2.2 Principal 5YPos of laboratories

Health laboratories vary in type and size depending upon the level of the health service with which they are connected.

2.2.1 The clinical laboratory (ward laboratory)

This is usually connected with the OID service of a hospital, clinic, ward, or at a local health station and centre. Its main activitie s are:

2.2.2

(a)

(b) (c) ( d) (e) (f)

clinical microscopy stained smears for diphtheria, gonorrhea, etc., urine sediment, stool examination for parasites and ova, sputum specimen for tubercle bacilli, etc. J

routine urine examinations, blood counts and srears (darkfiild for spirochetes, etc.), examination of" exudates, blood grouping, and determination of icterus index.

The hospital laboratoEY

This is an integral part of the hospital. Sanctimes part of its activities are carried out in a public health laboratory or vice versa. Its main activities are:

(a) histopathology - microscopic examination of tissues

(b) (c)

- diagnostic cytology, histochemistry, chemical pathology,

2.2.3

(d) bacteriology, (e) parasitology, (f) ~cology,

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(g) virology (including rickettsia), (h) serology, (i) hematology, (j) biophysic s - (including isotopo datermination) (k) clinical physiology - (including electrocardiography

and basal metabolism determination), and (1) allergology - (laboratory tests for allergy).

The public health laborato!y (basic type)

This is usually a part of the city or county health service and mayor may not be integrated with hospital laboratories in the same area. Its main activitie s are:

2.2.4

(a) bacteriology, (b) paraSitology, (c) ~cology, (d) viro logy, (e) serology, (f) histopathology, (g) chemical pathology, (h) sanitation chemistry (incJnding milk and water examination),

and (i) food and drug control.

The public health laboratory (full typo)

This is usually pr'ovided by the pr'ovincial or state health department. It mayor may not be integrated with the hospital laboratory in the .same area. Activities of this type consist of:

(a) bacteriology, (b) parasi to logy, (c) mycology, ( d) viro logy, (e) sorology, (f) histopathology, (g) hematology, (h) chemical pnthology, (i) sanitation chemistry (milk, water, sewerage, waste,

air pollution, isotopo contamination), (j ) ent omology, (k) production of diagnostic sera and antigens, (1) maintenance of stock cultures and biological standards, (m) pharmaceutical anaJysis and standardization, (n) food analysis and examination, (0) drug anaJ.y sis and control, (p) industrial hygiene (physiology - fatigue test), (q) toxicology, and (r) epidcmXiogy - epidemiological and statistical studies

on epiclumics, cardiovascular diseases, cancer, mental diooases, etc.

•

- 49 -

2.2.5 The reference (specialized or research) laboratory

This is usually an independent unit established at the provincial or national level or us part of a university activity. Its main activities are limited to one or two functions such as:

2.2.6

(a) institute for biological standards -- to standardize biologicals and to maintain standard diagnostic sera, antigens, hormones, Vitamins, and other test reagents,

(b) and/ or institute production of biologicals (e. g., vaccine, sera, etc.),

(c) institute for food and drug control, and

(d) institute of nutrition.

The central (national) laboratory

This is always established at the national level. Gemrally, there is only one such laboratory in a country. Its main activities are similar to the full-tyro public realth laboratory but its activities are more extensive and it is better equiprod. Very often, the central labora­tory may be an aggregate of many reference laboratories, e.g., the National Inati tute of Health in Bethesda, Maryland, U. S. A,.

2.2.7 Regional or district laborato~

This is similar to the full-tyro public health laboratory, but it may serve more than one province or district which has no county or city public health laboratory. Sometimes it is a branch of the central labora­tory •.

2.2.8 The joint laboratory

There is a tendency in certain countries to integrate partially or completely the hospital Inboratory service to tho public health lab­oratory. Such arrangelTlmt has the advantage of better utilization of technical personnel, savings on operational expmses and equipment. In tieveloping countries with limited resources and shortage of trained personnel, a joint laboratory for the hospital and public health service may be the one of choice.

2.2.9 The mobile laboratory

In certain countriDs where roripheral health laboratory units are not established, it may be necessary to have a mobile laboratory for servicing rural areas. This should normally be considered as a temporary or emergency measure as during an epidemic. The equipment has to be fairly simple and the number and kinds of tests performed may be quite limited. The mobile unit can also be utilized to collect srocimens for examination at the base laboratory. It is always better, however, to have a permanent type of laboratory.

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3. PLANNING

There is no standard. pattern for a national health laboratory service that can fit all countries. The pattern for each country is naturally dependent on many factors. Yet points of practical importance have to be observed insofar as planning of the service is concerned. These points arec

3.1 Factors influencing the planning of a national health laboratory service

The type of service for each country Tmries according to its health problems. In scme countries the problem may be concerned with the prevalence of epidemic diseaala such as cholera, smallpox, and plague; in others the disease may be poliomyelitis, encephalitiS, etc., while in still others, it may be malaria and filariasis. One country's health needs m9r deal with microbiological investigations and water sanitation while in others they may be concerned with vector control.

3.1.1 Existing heal til facilities and p::rsonnel

Availability of both qualified health personnel and the physical facilities of health organizations (governmental and private) influence the planning of a national public health laboratory service. A laboratory is best established within or in connection with an existing health unit. The laboratory must be run by technically qualified and compctent personneL The availability of personnel affects the planning of staffing and the type of laboratory to be established. Also, the traditional attitude of physi­cians and health worlrors toward a laboratory service should be determined. Too often in some countries, the utilization of laboratory service by practising JXlysicians is very limited.

3.1.2 Geographical, population and communication status

Population distribution, size of country, geographical condition and means of communication certainly influence the recision on the location of the central laboratory and the extent of its peripheral units.

3.1.3 Economic support

No public health laboratory service can be set up unless it has a suffici,mt budgctm-y support. It is a general prinCiple not to depend entirely on the income of the laboratory for its maintenance. There is also the danger that by charging fees one loses the opportunity of obtaining or receiving materials and specimens which may be of major public health importance. In somE: countries the public health laboratory offers an entirely free service while in others charges are levied seIe ctive],y, e. g., on examinations not considered of public health importance.

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3.2 Essential steps in planning

3.2.1 The survey

As a first step, it is desirable to makn an accurate survey of the major health problems, economic situation, availability of health facilities and personnel, size of the territory, distribution of population and condition of cOOllllunications.

3.2.2 Preparation of laborato~ staff

Many countries lack well-trained laboratory workers. A poor lab­oratory service is worse than none at all as inaccuracy or error in the findings can do more harm than good. To safeguard against this defiCiency which may arise from inadequate J.;y trained staff, it is important to start training laboratory workers at an early stage of the programme. Highly­qualified personnel can sometimes be drawn from the university departments and research centres although in some countries, it is not always possible to do so. It may be stated that when an organized public health laboratory is not yet developed in a country" it is important to train the key personnel either in the country or abroad.

3.2.3 Preparation of facilities

In most countrie s certain types of laboratory invariably exist. Therefore, in planning an organized national public health laboratory service, existing facilities should be utilized as much as possible. New units might be added depmding on the survey result, the country's need and the means available to support it. In developing countries with meager facilities, there invariabJ.;y is also a lack of trained personnel as well as funds. In these cases, however, the scheme can be modest at the beginning to provide the simpler type of laboratory which will be the basis for future expansion.

3.2.4 Choice of a system of service

Based on the survey, the type of service including facilities and health personnel will depend upon the budgetary provision. It is desirable that the laboratory must be established as part of an existing health agency. For example, clinical laboratories should be simple units which should meet the needs of a health station, centre or clinic while the hospital laboratories should be able to meet the more complex demands of the hospital services.

It is possibJ£ to reduce the number of public health laboratories because a basic type of public health laboratory can be made to service several health units in an area. One public health laboratory for each city or county health department should suffice when the size and popula­tion of the area are not too large and where the means of communication is satisfactory. Provincial health departments should have the full-type

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public health laboratory as in most countries this is the level of adminis­tration where such t~ is convenient. At the national level, one central laboratory is usually sufficient although branch laboratories m~ be set up. Wherever possible, it is desirable to either organize a unit or cevelcp close working relationship between the laboratories of the public health and hospital services. Reference laboratories are usually found in well­developed countries. For developing countries, it may be necessary in certain conditions to avail of the reference laboratories of other countries. The co-ordination, direction and administration of the public health lab­oratories raise the question of an organized national public laboratory service. This subject deserves careful consideration and is discussed below.

4. ORGANIZATION

Having reviewed the types of health laboratories generally located at different levels of government, it will be noted that in general they ~ction independently of each other. Some countries have approved private laboratories but in general public health laboratories are govern­ment operated.

4.1 Is it desirable to have an integrated national public health laboratoEY service?

Except in a few countries, many laboratories at the local, prOvincial and national J0VBls receive no direction or supervision fran a central authority (sec Appendix 1).

Under central direction, public health laboratories can maintain uniformity in policies and procedures and ensure the quality of service. Such a system also permits the interflow of personnel and facilitates exchange of information between units. One disadvantage, howcVBr, is that an o1l'lrating unit uncbr central direction may not feel free to take the initiative or to fully respond to the needs and requirements of the health agency which it norma.lJ¥ serves. On the other hand, a lrooratory that is staffed and directed by the county health department (see Appendix 2) may suffer fran quality of service. From the national viewpoint, absence of central direction for public health laboratories may be responsible for the lack of uniformity in the procedures for the teclmical services and difficulty in collecting information and interpreting results. Normally, the central laboratory provides public health laboratories with standard stock cultures, strains and other reagents.

In view of the above, ~ may consider the need for a dual con­trol of laboratories as illustrated in Appendix 3. The public health laboratory should be estoblished at various levels under the public health service. The type may range from the small and simple like the clinical laboratory at the rural health unit level, through too basic type public health laboratory at the city or county health oopartment level, the fuil­type public health laboratory at the state or provincial health department

-

-

•

".<

- 53 -

level, and the central public health laboratory at the national level. Budgetary provisions and employment of personnel and general direction of work should be the responsibility of the health officer at the appropriate level. It is thought, however, that the recruitment of the director of laboratory, although normally the responsibility of the health officer, should be made only upon the recommendation of the central laboratory authority. The central laboratory should, in addition, be responsible for the technical guidance of the public health laboratories at lower levels.

In addition to the three schemes shown in Aprendices 1, 2 and 3, there can, of course, be many other schemes and it would be the responsibil­ity of individual governments to choose, modify and evolve one to fit the country's conditions.

4.2 A national advisory council (board) on the laboratory service

Few countries have a council (board) that serves as an advisory body to the minister of health (or his equivalent). This body can advise and assist the minister in Cbtermining policies on laboratory activities, recOlTl111ending standard procedures and suggesting necessary ~gislation. Membership of the council may be composed of public health administrators, directors of central and reference laboratories, scientists, epidemiologists and physicians ..

Actual ovorall direction of the national public health laboratory service could be executed by an office of the minister of health or by the central laboratory or such other organizations delegated by the minister.

4.3 Staffing

4.3.1 Categories of the staff

The number and kind of staff employed in a laboratory vary greatly in a country or from country to country and depend on the t:rre and volume of work. Generally sp3aking, laboratory staff falls into four main categories, viz., administrative, medical, scientific and techno­logical. In the central, provinCial and county or city public health laboratory~ the administrative staff is headed by a director of laboratory and ma;y' receive assistance from sections p:lrsonne1 on the compilation of reports, statistics and library. The director should be a medically qualified person with adequate experience in public health laboratory work. In developing countries, however, this may not be possibl£; and a qualified non-medical worker or scientist may temporarily be utilized until a medical man can be enlisted.

In smaller laboratories the administrative staff should be at a m:Ulllnum and dispensed with in the smallest Unit as with the rural health station clinical laboratory. Medical staff, aside from serving in such position as laboratory chief, may also be needed in various departments of larger laboratories, e.g., in pathology. Other specialized departments

- 54 -

of laboratories may be headed by the scientific staff, e. g., microbiologists, chemists, veterinarians, pharmacists or science graduates, with the required s~cia1ized training in their respective fields. The technological staff composed of laboratory technologists (junior college) and technicians con­stitute the :ilI1portant service ~rsonnel in any laboratory. However, in no laboratory should a non-medical staff be called upon to serve consultativeq in a medical capacity. Even in the smallest unit, such as the rtU"al health station clinical laboratory, findings should be confirmed by medical ~rson­nel, preferably from the health station.

4. 3.2 Qualification and training of the staff

The medical staff usually are medical graduates who have had one or more years of ex~rience in practical laboratory work. \"lhen suuh staff is to be selected for a key position, it is desirable to include in his training eleIlBnts of statistics and general administration.

The scientific staff is composed of college graduates in science majoring in subjects such as microbiology, chemistry, veterinary medicine, Iilarmacy, etc., who after graduation have had at least two or more years of practical laboratory e~rience. In seme countries special post-graduate courses which are open to non-medical graduates are given leading to a diploma in bacteriology, parasitology and tropical hygiene.

The technological staff have varied levels of qualification. At the higher level, the worker m~ have had two to three ar mare years of college dealing with laboratory work for which a school certificate may be given,; these are the technologists or senior technicians. They are not frequently found in ooveloping countries. Lower level technicians may have had only an elementary school education and first entered the laboratory as helpers but who gradually learned various laboratory techniques through apprenticeship. The medium category of technicians are those who, after passing through apprenticeship, have undcrgow a short-term training course in laboratory work.

Technicians ~onstitute the majority of workers in most lab­oratories; they perform clair-to-da,y routine laboratory duties which require reliability of performance.

In view of their :ilI1portance, there is a need for each country to provide refresher, certificate or diploma oourses far the training of technologists and technicians.

s. ADMINISTRATION

5.1 Legislation

Laws and regulations are needed to promote the developnent and :ilI1prove the standards of public health laboratory services.

,

- 55 -

5.1.1 Public laboratories

Health laboratories in countries differ in organization and ad­ministration as may be provided by law or regulation with reference to functions, scope of work, staffing pattern, scale of pay, source of financial support, authority for action, etc. Very fei" countries have a law or regulation which defines or stipulates qualifications and academic requirements of laboratory workers especially of the technological category.

5.1.2 Private laboratories

Private laboratorie s are generally required by law to be registered but there frequently are no p:'ovisions for the minimum qualifications of their staff.

5.1.3 Quality control

Most countries have mIDJJ1lUIn requirements for the safety of foods, drugs, cosmetics, milk and water. Usually, there are laws and regulations condemning unfit articles which m~ invoke severe penalties for violations.

5.1.4 Biological standards and reagents

In most countries, there are national standards and requirerrents for biologicals such as vaccines, sera, toxins, etc. Although the standards are similar for cosmetics, there should be more uniformity of acceptable standards throughout the world.

5.2 Maintenance of standard strains and diagnostic reagents

Almost every laboratory keeps stock cultures and strains of virus for diagnostic , .. ork and other tests. It also keeps antisera and prepares reagents. But too often, mutation and other cha~ges occur in the sub­culture of bacteria or in the sub-passage of virus. Many countries have national institutes responsible for maintaining standard cultures and strains which help in maintaining uniformity in laboratory tests and making results obtained ccmparable. It is important, too, that there should be a world standard centre for this purpose. Through the auspices of the VJorld Health Organization, there are such centres, and each Hcmber Country should utilize them as much as possible.

5.3 Relationship with laboratories of other governmental agencies

National agricultural and industrial agencies may also have laboratories whose relationship with health laboratories cannot be over­looked. For instance, in many countries there are veterinary laboratories under the agricultural ministry. Because of the importance of zoonoses and animal intermediate hosts to public health, there should be co­operation and c~ordination of activities between them, particularly through exchange of relevant infonnation in animal disease control programmes

such as rabies, bovine tuberculosis, psitacosis, etc. The co-operation of industrial agencies (e.g., those related to the processing and manufacturing of food products and drugs) which ffi8Y have laboratories whose activities are of direct concern to the public should also be cultivated.

Public health laboratori~s should collaborate with special govern­mental or private research insti tutes and university cepar'bnents as they can be of assistance in the training of the laboratory workers and servo as reference laboratorie s.

5.4 Standard laboratory procedures and rrcthods

Procedures and methods for the collection, treatment and testing of specoons, the isolation, identification and the storage of bacterial cultures and virus strains, the determination of toxin and anti-toxin, the preparation of reagents and the reading and interpretation of tests are usually adopted indi vichlally through general usage and bear the name of the original investigator, sometines with modifications. In the performance of tests, it is important to denote distinctly too name of the method indica~ing also the modification, if any. Most countries compile their own IIStandard Laboratory Methods ll or adopt ore from other countries. They are usually derived from some internationally known publication such as Wadsworth's Standard Methods or Borgyl s Determinative Bacteriology, etc., which in turn draws information fran publications by investigators. The in-oornational scientific societies fran time to time publish the approved methods. But many newer methods are being evolved and the laboratory has to depend constantly on newly cbvoloped techniques which are published by laboratory workers. As a rule it 3.s desirable, however, for a national oentral labora- . tory to compile a laboratory manual for use in the country.

5.5 Scientific meetingS and publications

It is extreroly important that laboratory workers should organize societies, hold scientific meetings and publish technical journals. It is through journals and other literature that free exchange of information and improveront of new methods can be ceveloped. International societies and meetings of this nature are even more important and Significant. As a general principle, it is only after a method advocated by one original worker is confirmed by others that it can be adopted for general use.

In developing countries where original laboratory research is usually lacking, it is desirable to hold regular discussion meetings and seminars on current litereture. Free access to literature and information through a good library service is essential to the public health laboratory workers.

5.6 Supervision of public health laboratory services

Many laboratories are without the benefit of receiving a periodic check of the quality of their performance. The diversity of techniques involved in the }reeping of stock cultures and standard strains, preparation

"

. ~.

- 57 -

of antisera and other reagents, and in the perfonnance and reading of lab­oratory tests render standard techniques and procedures subject to deviations and errors. Their detection is as important as the performance of the test itself. It is, therefore, desirable to have a competent technical group to check over tho conduct of services in laboratories. This responsibility should normally be assumGd by the central public health laboratory.

6. INTERNATIONAL COLLABORATION

CloSG intGrnational collaboration in the field of public health laboratory service is extreme~ important. "There should be an exchange of infonnation of experiGncG, stock materials and personnel between countries • This exchange can best be mediated by the World Health Organization.

7. SUMMARY

For the successful promotion of public health services and medical care in any country, it is necessary to have an organized publiC health laboratory service.

7.2 The public health laboratory may vary frOOl the simple to the high~ specialized type and should be a part of the operating units of the national public hGalth service. Their number and distribution can folloW the general distribution of the public health services, viz., at the central, provincial, county or municipal and local (rural village) J!lvels.

7.3 Regional or branch public health laboratories may be established to serve more than one county and city.

A joint laboratory combining the functions of a public health and hospital laboratory in a local area is desirable.

7.5 A mobile laboratory is necessary only when the territory is still under-developed and must be ccnsidered as a temporary measure.

7.6 It is important for a specialized laboratory to serve as a reference laboratory for its specialty.

7.7 It is desirable to co-ordinate activities of the public health laboratory with thore of vetGrinary and industrial agencies as well as with university departments, research institutions and private laboratories.

7.8 The public health laboratory of a country needs integration under a system with a central authority which should direct and supervise technical operations and maintain standards. The general achninistration of each unit should be independent­~ controlled by the appropriate public health laboratory department or unit to which it may be attached.

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7.9 It seems desirable to have a national advisory body (council or board) on laboratory services which can advise the minister of health on policies, standards and J£gislations required.

7.10 Public health laboratories have three main functions, viz., service, research and training.

7.11 Staffing problems still IBrsist in many countries. More attention should be paid by goverrurents to the training and preparation of highly ~ualified laboratory workers as well as laboratory technicians.

7. J2

7.13

legislation is needed to ensure satisfactory developnent and operation of public health laboratory services. Many countries lack regulations providing for minimum qualifications of lab­oratory workers.

It is desirable to keep at a minimum the imposition of laborll­tory fees so that specimens of public health importance may not be missed.

International collaboration in the fiGld of public health lab­oratory services is important; this can be promoted through mediation of the World Health Organization.

--

r

(J~dvis or7) --I Nation~l Council of Health

I Laboratories

Clinical Laboratory

Provincial Health

Department

1..-____ "

1. R:lrsonne.l. recruitment

2. Administrative Direction and Budgetary ProviSlon

w 59/60

Scheme I

l,btion&l Health Administration

1 2 3

1 I J J Central

Laboratory

I1r Full _T:y-pe

P\;blic health Labora&ory

J

--1-+ -,~,. 2 -,'

-3-4

APJENDJX 1

Reference Laboratory

Basio Type Publio Health Laboratory

All by the National Government

throt-gh the central laboratory

except reference laboratories 3. Technical Servioe Direotion

l f

)1

\

- 6J/6Z'-

APFENDIX 2

Scheme II

(Advisory) National Council on Health Lab.

National Health Reference Laboratory

1 2 ~ ! J •

Clinical Lab.

1. 2.

3.

P.rov:i.ncial Health

Laboratory

,

III 1 2 J

! 11 Central

Laboratory

-l~

2 --t - 3---,

v

,

,

)

Full-type fublic-Health

Laboratory

/

Basic Type P.R.

Lab.

Personnel Recruitment Administrative Direction and

Budget~~o¥ision Technical Service Direction

}

All decentralized and public health laboratories are responSible to respective health administrators.

- 6}j64 -

APIENDIX 3

Scheme III

i. SYSTEM <F DUJ.LLY DTIb;CTED Ni.TIOnALRmLIC HEALTH IJJ30RATORY SERVICE

( Advisory) 1 National Counc' -----.>;0 on Health Labs.

-1--+ -2_

··-3~

/ /

/ /

~

/ /

Rei'erence Laboratory

;'

/

Village or Township Health

Centre ~ 1 f r-------------------~ ~

/

Central Laboratory

~\ '-----City or County Health Department

I'J 1

Clinical Laboratory

Provincial Heal th

Department

\

1. Personnel Recruitment

2. Administrative Direction and Budgetar.r PVovision

3. Technical Service Direction

·-2 ....

v

Full-type P.H. Lab.

Basic type P.H. Lab.

I Appointment by health administra­tion upon recommendation of the central lAburatory

Re3ponsibili ty of the health administration

Responsibility of the Central Laboratory

TECHNICAL REQUIREMENTS FOR PUBLIC HEALTH LABORATORIES

by

Dr. RalJil B. Hogan Medical Director

Chief Laborato~ Branch Cc:mmunicable Disease Center

Georgia, U. S. A.

1. TY!ES OF PUBLIC HEALTH LABORATORIES

In discussing the technical requirements for public health lab­oratories, same arbitr~ classification of public health laboratories is necessaI"J. Generally sp3aldng, four types of laboratories rendering health services are recognizable throughout the world: the small clinic lab­oratory, the local hospital (county) and public health laboratory (combined), the regional public health laboratory (associated with state hospital or medical school), and the national reference laboratory. While four general types of laboratories are described, each individual labora­tory will represent some degree of transition between types, dependent largely on needs and conditions locally.

1.1 The small clinic laborat~ (Level No.1)

This is essentially a rural health unit. The staff usually con­sists of a physician, nurse, clerk, and a laboratory technician. The physician may be a part-time employee who holds various types of clinics at specified times. All or part of the staff might travel from place to place to provide outpatient service at various areas. Only limited laboratory equipnent and supplies are available (a microscop:>, lamp, a few simple stains, collecting equipnent, etc.). At this level, major emphasis is placed on clinical diagnosis and relatively few specimens are referred to better equipped laboratories, Usually only fresh primary specimens are examined.

1.2 Local hospital (county) and public health laboratory (Level No.2)

Fresh primary specimens are received from both patients attending the outpatient clinics and those in the hospital. In some instances, mailed primary spec:iJoons may b<.l received from practising phySicians. Additional laborato~ equipment such as centrifuges, incubators, autoclaves, etc. and Simple media and other reagents are available at this level. A larger, better trained staff is available who can provide in-service training for new employees.

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1.3 school)

Although essentially a bona fide public health laboratory, it is frequently associated with a large hospital caring for both in- and out­patients. In addition to supplying the services offered at the second level, the laboratory is probably the first level to provide a reference diagnostic service. It is well equipped and has a well trained staff. In addition to the usual equipment for microbiology, laboratories at this lovel should be capable of determination at least of the baseline of radioactivity of its water supplies. Minimal equipment required is a Geiger Muller counter, preferably with automatic sample changer. It m~ provide training for tech­n~c~ans. Occasionally some investigative work concerned with control programmes may be conducted. In a number of smaller laboratories, this might constitute the top JEvcl of laboratories.

1.4 National reference laboratory (wvcl No.4)

Although in some instances this laboratory may be associated with a large hospital or medical school, its primary function is a reference centre. It m~ receive mailed primary specimens fran physicians in a given area, but generalJ.;y these specimens should be sent to wvel No.3. As a national laboratory, it would receive check specimens from lower levels for final identification or confirmation. Immuno-diagnostic work is primariJ.;y concerned with epidemiological studies on prevalence. 1~ certain amount of research and evaluation of diagnostic procedures is expected at this level (see 4.1, last paragraph). Refresher training is offered at this level and evaluations of the lower level laboratories are conducted.

In view of the nuclear power age into which we are entering, lab­oratories at this level should be capable of ana~zing samples for individual mucleotidcs. In addition to radiolsotope equipment available in the regional laboratory, a single channel analyzer is required, and a multichannel analyzer is proferred.

2. MINllIDM SP1,CE REQU:rREME:NTS

The minimum space requirements for these laboratories depend on the typa of laboratory. The laboratory associated 'I-lith a hospital requires a minimum of 4.5 square feet per bed to provide the laboratory facilities for the hospital. Additional space should be made available if public health services are performed for outpatient clinics, private physicians, or the health clepartmont. Hospitals of less than one hundred beds usually perform laboratory services in one-room laboratories. Larger laboratories require separate rooms for dish-washing, preparations, bacteriology, clinical chemistry, radiology, etc. Analysis of fourteen state laboratories (U.S.) reveals floor space varying from 1260 to 40 000 square feet.. This repro sents a variation of 135 square feet per laboratory employee to more than 650 square feet. Most public health laboratories in the United States are not associated with hospitals. Space is, therefore, givcn as square feet per

!I

II II

II

•

' .....

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}:€rson. Those laboratories with less than 200 square feet p:lr person are obviously crowded, do not allow sufficient working space for adequate storage space. The minimum desirable space is, therefore, something in excess of 200 square feet, the optimum oop:lnding largely on the type of laboratory and the kind of procedures undertaken. Large rooms accommodat­ing a number of workers generally require less floor space rer individual. Where small rooms for individual workers are required, the optimum floor space required is increased.

3. STAFF

The staff is compored of professional, technical and administra­tive (clerical and diener) personnel. The optimum ratio of professional to technical personnel will vary with the size of the laboratory and the degree of specialization of laboratory procedures carried out. Analysis of fourteen state laboratories (U.S.) with staff varying from 4 to 140 reveals roughly one-half of the personnel as professional; the other one­half technical and achninistrative. In the central laboratories (and some regional laboratories) where greater professional training is required to }:€rform more exacting techniques and to undertake research, a higher pro­portion of professional personnel is needed.

3.1 Professional qualifications

The qualifications of the scientific and technical staff required will depend on the type of laboratory and to some extent on the personnel available. At the lowest level, the clinic laboratory, the single technician should have academic training through the college level and a minimum of one year I s practical training and experience.

It is gerorally felt, particularly throughout Europe, that the director of a central laboratory (Levels No. 3 and No.4) should hold a medical qualification. In the United States, approximately one-half of the state laboratories are headed by a Ph.D. The qualifications, particularly of the professional staff, are subject to considerable variation of opinion and represent an excellent subject for discussion.

4. LABORATORY SERVICES

4. 1 Bacteriological examinations

The primary level laboratory (the clinic laboratory) should be equipped with a microscope and lamp, laboratory centrifuge, and simple biological stains, and should be able to examine sputum as well as gastric washings, and should also be able to examine pharyngeal swabs and urenthral smears. With these materials the laboratory personnel may be able to make presUlllptiw identification of the organisms causing tuber­culosis, pneUlllonias of bacterial origin, and gonorrhea. They would not be equipped to do ~ culture work, biochemical tests, serology, patho­genicity tests, or histopathology. Only limited clinical pathology such

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as urinaqsis and blood CO'lll1ts would ordinarily be 'lll1oortaken. Presumably specimens collected at this level would be oont on to the next level for further work if the collecting laboratory could not process them becauoo of l~k of comp3tency and/or equiJ1llent or facilities.

A second level laboratory should be equipped with autoclaves, a media kitchen, and other equiJ1llent necessary far general bacteriological diagnostic work. It would receive specimens frClll the lower level laboratories or physicians, by mail or courier, and would collect fresh primery specimens as well from patients on the promises. This laboratory should be able to do isolation· and pre liminary identification work, including serology and bio­chemistry, on a wide variety of bacterial pathogens, including the organisms causing tuberculosis, bacterial pneumonias, meningococcus meningitis, diphtheria, various saJmonelioses and enteric fevers, brucellosis, and tularemia, but perhaps excluding culturing of such organisms as the IGPto­spiras. It should also be able to culture and identi~ staphylococci and streptococci, and perhaps to "group" the latter. Isolates frClll this lab­oratory, after preliminary identification, might be sent to the third level laboratory which serves as a reference laboratory and which is better able.. to characterizG many of the organisms for epicbrniological purposes.

The third level laboratory, equivalent to a state or provincial laboratory, serves as a reference laboratory for tho lower levels and may cClllpleteJ;y- process all routine sp3cimens, although much of its work would probably be composed of isolates referred by the second level laboratory. This laboratory should be a fully-equipped bacteriological diagnostic lab­oratory with a stcl'f cClllpetent to identify and characterize all but a relatively few difficult or "research-tyr:sl1 isolates, which would be referred to a national level reference laboratory far identification or confirmation. (MaI\Y' of the isolates received frClll the second level lab­oratory presumably would be sent for confirmation of work already done at that level.) It might also engage in such activities as phage typing of typhoid or staphyloccocal isolates, since these activities would ordinarily not be done at lower levels. R:lrsonnel of the third or state leve 1 lab­oratory presumably would do a limited amount of research on public health problems in areas of concern to them.

A national laboratory, which has as its primary function to act as a reference centre, represents the highest level of laboratory COInp3tency. This is a well-equiprcd and well-staffed laboratory that is able to under­take evaluation programmes for lower level laboratories as well as to carry out final identifications of difficult or controversial isolates referred frClll lower levels. It would also be engaged in an active research programme concerned with public health problems in microbiology, radiology, and related disciplines, and Should be the highest level of applied laboratory sciences in its particular country.

4. 2 Sanitary bacteriology, milk, water, sewage

Level No. 1 laboratories, primarily clinical in nature, would probably not be concerned at all with sanitary bacteriology, since equip­ment and personnel would not be available. Level No. 2 laboratories might well handle the bulk of local sanitary bacteriolog".f involving public eating

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establishments since this is essontialJy a local problem. Milk and water bacteriology, including laboratory work on outbreaks of food poisoning, could probably best be done in a centralized laboratory such as a level No. 3 laboratory, unless the transportation network were such that rapid transport of the primary specimens could not be accomplisred. If this were the case, the work would of necessity have to be done at the next lower level or not done ::.t all. The national reference laboratory would not be expected to be involved in routine milk and water analyses, but probably would be concerned with food poisoning outbreaks and the setting of standards on inter-state carriers. In any case, standard techniques recomrnenood by the state or national lnboratory should be used to achieve uniformity in testing and to maintain adequate sanitary standards.

Parasitological examinations

4.3.1 level No. I laboratory

(a) Ibrforms direct wet mount examinations of feces for tropho­zoites and cysts of protozoa, eggs, larvae and adults of helminths; or urine for eggs of schistosomes (primarily S.hematobium); of sputum for eggs of Paragonimus westermani; of blood for-motile microfilaria (primarily Wuche­reria bancrofti and W. mairi); and of rectal biopsies and aspirates (if collected by sigmoidoscop,r for schistosome eggs and Entamoeba histo~ytica.

(b) Stains and examines thin and thick blood films for malaria and filariasis.

4.3.2 level No. 2 laboratory

(a) On spJcimens collected from in- and outpatients, examines wet mounts and stained blood films as at level No.1.

(b) On certain cases performs concentration techniques on feces (formalin-ether procedure) for intestinal protozoa and helminths and on blood (Knott's or saponin procedure) for micro-filariae.

(c) If mailed primary spJcimens are received from practising physicians at this level, examines the direct wet mounts of specmens suitably preserved (formalin, etc.); stained blood films (promptly delivered); stained feces and rectal aspirates (preserved in PIA-fixative); concentrations of feces (preserved in formalin) and blood (in anti­coagulant) •

level No. 3 laboratory

(a) Fbrforms the same examinations as of level No. 2 on specimens from in- and outpatients and on mailed primary specimens received frem physicians.

(b) If therap,r control programmes for intestinal nematodes are conducted at this level, performs egg counts (Beaver's or Stoll's procedures) on either fresh or formalin preserved feces.

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(c) If this level serves as a reference centre for level No. 2 and other divisions of the government, examines stained blood films, fecal specimens in PVA-fixative or stained fecal smears and rectal aspirates and concentrations of feces and blood. On occasion, might perform direct examination of feces, urine, and sputum; and egg counts on feces.

4.3.4 Level No. 4 laboratory

(a) As primarily a reference laboratory, examines wet mounts of certain materials, stained blood films, fecal smears and rectal aspirates, and concentrations of feces and blood from patients examined at a lower level. On occasion, check egg counts performed at level No.3.

(b) Identifies unusual arthropods, snails, etc., referred.

(c) For investigative purposes (prevalence studies, control evaluations, etc.) ma({ perform arrr of the above examinations on primary specimens.

(d) For investigative purposes and methodology evaluations, performs as needs indicate, the following immuno-diagnostic tests:

complement fixation test for schistosomiasis, paragOnimiasis, echinococcosis, leishmaniasis, and filariasis;

hemagglutination test for echinococcosis;

bentonite flocculation test for trichinosi~ J:Crhaps the Methylene blue dye or fluorescence inhibition test for toxoplasmosi~ and the Intradermal test for schistosomiasis.

Mycological examinations

ievel No. 1 laborat9ry

(a) Collects clinical specimens fram suspected cases of ring­worm, piedra, chramob1ast~cosis, rhinosprodiosis and pulmonary infections.

(b) Examines skin, hair and soil specimen for evidence of ring­worm infection with use of 10% KCH mounts.

(c) Examines hair under ultra-violet light for evidence of tinea.

(d) Runs grams and acid-fast stains on spltum and pus for evidence of infection with Candida albicans or sYstematic fungi.

(e) Level No.2

Inoculates media with clinical specimen. Refers them to

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level No. 2 laboratory

(a) Carries out all activities performed at level No.1. In addition, tentatively icbntifies cultures. Refers unknowns to next higher level.

(b) Collects tissue specimen for histologic stuqy and refers them to level No.3.

level No. 3 laboratory

(a) Rlrforms all service s handled by levels No. 1 and No.2. In addition, idontifies Doll fungus cultures. Refers problem cultures to level No.4.

(b) Carries out histological work.

(c) Carries out D.nimal pathogenicity te sts.

(d) Performs biochemic Dol tests when needed for the identifica­tion of pathogenic fungi.

Level No. 4 laboratory

(a) Serves as roferenoo laboratory to lower levels.

(b) Carries out canplement-fixation and other serological tests for histoplasmosis.

levels.

(c) Carries out skin test surveys and other epicbmiological work.

(d) Trains personnel for staffing of laboratories of the lower

(e) Develops and runs a research programme.

4.S Virology

Diagnostic procedures and laboratory activities pertinent to viral diseases are determined on the basis of the current 1imi tations experienced in this field. These restrictions necessarily guide the role which a particular laboratory may be expected to play within its area of responsibility and consist of factors involving budget, procurement of trained personnel, reagents, and special medical problems. Thus, smaller laboratory units (levels No.~ and No 2) repre sent the immediate focal point of contact with clinicians and epicbmiologists in the field. Their activities are con-oorned mainly with collection of specimens appropriate to the clinical problem, furnishing information on the types of examination available, assisting in the dissemination of information pertaining to incidence of infection and contributing assistance for collection of specimens in the field and pertinent epidemiologic data. The actual amount of diagnostic laboratory studies availablo at this level may be limited to some of the

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more frequentq required serological tests (level No.2) generalq using complement fixation techniques which could be co-ordinated with Venereal Disease serology, and such presumptive diagnostic procedures which must be performed rapi~, and for which complicated equipnent or exceptional competence is not required. The examination of suspected rabid animals by direct smears may be included in this category. In any event, emphasis is placed on providing storage facilities, refrigerants for shipnent, shipping containers, information on sample preservation, local area for collection of information, and to act as an intermediary for collection of additional specimens and sampling as required by laboratories of a higher echelon.

The regional laboratory (level No.3) is intermediate in function between the local and central laboratories and the first level where oofinitive laboratory facilities for the diagnosis of diseases of virus etiology can be rationally established. At this level, serology of a broader spectrum of Virus diseases may be made available. The cC11lplement fixation tests are limited only by the type of antigens obtainable but should inclucb the arthropod transmitted encephalitides appropriate to the area, mumps, herpes, Influenza A and B, the group specific antigen for Adenoviruses, the psittacosis-1GV group, the poliovirus antigens, possibly the rickettsial antigens and the variola-vaccinia group. The number and types should be determined by the enoomicity of the infectious agents in ~ specific area.

Isolation and ioontificntion of viruses will be limited by the availability of host systems. These should include embryonated eggs for isolation of influenza and pox viruses, a mouse colony to provicb suckling and mature mice, and a limited number of guinea pigs and rabbits. Hemag­glutination may be used as an accessory procedure for detecting and typing several groups of viruses and the completed study of rabies infection can be performed readily by mouse inoculation.

If at all, the use of cell cultures should be limited to con­tinuous passage lines which can be established and carried with minimum difficulty. HeLa and/or human amnion lines may be carried in commercially available reagents and secd cultures are readily obtainable in the event of laboratory failure. These lines offer the widest supplemmentary aid in detecting and typing of enteroviruses most frequently involved in epidemic diseases, the adenoviruses, herpes, variola-vaccinia group, measles, etc.

Additional functions of regional laboratories should incluoo service as an intermediary between local and central laboratories in ship­ment and storago of specimens, integration and dissemination of information of local health problems, and training and evaluation of local laboratory personnel.

The director of the regional laboratory should have a broad back­ground in microbiology in addition to his ability related to other duties associated with his laboratory. A well-trained serologist and a virologist should be part of his staff, augmented by competent and appropriate numbers of technical assistants.

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The central laboratory should be equipped to offer as complete reference service ns possible to regional and locnl laboratories in the field of virus isolation nnd identification. It should be able to duplicate and extend serological procedures offered by the lower echelon laboratories. It should be capable of preparing a limited number of reagents for diagnostic and special studies in sufficient quantities to supp~ standardized control biologicals to its satellite stations. As an extension of this activity, the central laboratory should provide evaluation and training services and be prepared to eValuate commercial~ available reagents, acting in addition to advisory capacity to local manufacturers of biologicals to assist in such improvements and changes as are deemed necessary.

The central laboratory should serve as a repository for stock proto.typc strains of viral and rickettsial types and a reservoir for seed cultures of a number of colI lines. Information of professional progress including novel test procedures, recovery and standardization of new infectious agents, confirmntion of etiologic relationships, and other information of a similnr nature should be harvested by the central labora­tory and transmitted to regional and local laboratories as soon as adequate confirmation and standardization for routine use can be established.

A part of central laboratory function should be the maintenance of facilities for breeding standard strains of anjJnals for diagnostic pur­poses to assure adequate supplies to the associated laboratories.

lows: The functions of the central laboratory are summarized as fol-

1.

2.

Scrolo!!y

Complement fixation and neutralization to determine diagnostic antibody levels for all viruses and rickettsiae to Which these procedures arc applicable.

Isolation

(a) In primary and continuous passage cell lines.

(b) In embryonated eggs: influenza, herpes, and pox viruses.

(c) Suckling and adult mice: Coxsackie, psittacosis, rabies and ARBCR viruses.

(d) Other anjJnals: as required, e.g., guinea pigs for rickettsia.

3. Evaluation and reference

(a) SpecjJnens submitted for extension of studies.

(b) EvalUation for technical competence.

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4.6.1

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(c) Evaluation of connnercial reagents.

(d) Standardization of new procedures.

4. Information and training

(a) Distribution of information of professional progress.

(b) Training facilities in basic and newly developsd techniques.

S. Reagents -- preparation, storage and distribution of

(a) Antigens not available commercially.

6.

(b) Antisera for diagnosis and controls for complement fixation, neutralization and hemagglutination­inhibition tests, not commercially available.

(c) Seed stocks of prototype viruses and cell lines.

Expsrimental animals

(a) Supply centre.

(b) Animal husbandry.

7. Methodology research

In a central laboratory, the department dealing with problems of viral and rickettsial diseases should be a functionally separate unit from other clinical laboratory activities. Rlrsonnel staffing should be established on this principle. A director with extensive academic and practical training in virology is highly desirable to supsrvise diagnostic activities and to indicate and direct fruitful areas of investigation. Assisting, as heads of unit activities, should be individuals with specialty experience in the appropriate field segments. Technical assistants should possess higher technical skills than those assigned to lower echelon laboratories. Because of the technical requirements in viral diagnostic procedures as well as the t:illle consumed in carrying them out, staffing should be some'What greater than the minimal requirements for routine demands in order to provide for unantiCipated circumstances.

Production of biologicals

Diagnostic reagents

If these are not available commerciaDy, they must obviously be produced in the laboratory. Frcm the standpoint of economy and standardiza­tion the advantages are all on the side of production in the central

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laboratory with distribution to local laboratories. The cost of production, testing and standardization of a large lot is frequent13" no greater than a small ono. In addition to the economy involved, all laboratories within the governmental jurisdiction utilize the same standardized materials and thus more uniform results are obtained. To assure adequate quality and standardization, it is recommended that the reagent be subjected to a double check. The reagent should be checked by the unit producing the reagents to determine that it meets its "quality specifications". Those reagents meeting these established criteria should be further checked by the s}Dcialty unit engaged in diagnosis and! or research in that area. No reagent should be released that is not acceptable to both units.

4.6.2 Biologicals

Official laboratories have produced biologicals -- vaccines, toxoids, anti-toxinS, skin test antigens, etc. -- for the diagnosis, prophylaxis and therapy of infectious diseases, sanetimes as the on13" agency from which these are available and sometimes to supplement those available from commercial sources. In the United States, most state laboratories have discontinued production of such biologicals and with few exceptions re13" on commercial sources as most efficient. A central laboratory assumes the obligation of establishing standards and licensing production by com­mercial companies. On the other hand, the State Serum Institute in Denmark produces all biologicals for the country. In some instances, production of certain (or all) biologicals may be necessary. Obvious),v, these should be produced only in those laboratories where full competency is available.

5. COLLECTION, TRANSPORT, AND REGISTRATION OF UlBORATOOY SIECIMENS

5.1 Collection of specimens

S}Dcimens, unless properly collected, serve no useful purpose. Manuals on collection and shipncnt of biological specimens prepared by several laboratories will be available for reference and discussion. The individual specimen and its container must be identified beyond question. A legible copy, listing specimens, giving origin (physician's name, hospital), patient's name, number, type (serum, water sample, stool, throat washing, etc. ), date obtained, disease suspected, and tests cbsired should be included with the material sent to the laboratory. The original and first carbon should be sent direct13" to the laboratory involved. A third copy should be retained until the results of tm laboratory findings are returned.

Packaging of specimens must ensure their arrival at the labora­tory in such condition that a laboratory test can be performed. Trite though it may seem, leaking or crushed specimens are usually useless. Refrigeration or sane other preservation is sometimes necessary. The amount and type of preservation depend a great deal on the time (dinstance) it takes to get the specimen to the laboratory, as well as temperature condi­tions on route and the nature of the specimen to be tested.

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$.2 Transportation of spec:ilnens

T~ansportation should be by the most rapid method possible. It is difficult to generalize on best methods without knowing local condition~ however, messenger service has been found satisfactory intracity and air mail intercity where distances are 500 kilometres or more. Arrangements can be made for scheduled transport (bus, train, mail) for distances less than $00 kilCJlletres.

5.3 Reports and registration

A register or log book is usually used to note the receipt of specimens in the laboratory. This register lists the pertinent information concerning the specimen and notes the results and disposition. The registrar frequently is responsible for seeing that the laboratory results are sent to the requesting physician, sanitaria~ health officer, etc. This type of register does require transcription of data and hence is t:ilne con­suming and costly.

A report system based on carbon copies, or mechanical copying devices, limits transcription errors, reduces personnel costs, and can pro­vide copies for filing and quick reference. This type of system merits consideration. Each spec:imen should be assigned a number, running con­secutively, as it is received and this should be noted on the specimen receipt (returned to the sender if this is deemed practical), the spec:i.loon and its container, and the laboratory report. This has been found desirable for tracing shipments, laboratory results, requests for additional informa­tion, and reports of activities.

5.4 Records

Records of laboratory activities should be kept uncomplicated. There is a tendency to gather more information than is needed or is ever used. Here again local conditions are the deciding factor. The type of record kept depends on what use is to be made of it. Various types of report forms will be available for review and discussion.

What information is needed fran records? How can records and filing systems be established so that this information is readily available? A good records system frequently provides the basis for future planning. Information may be needed as to what diseases are prevalent in order to establish proper measures for control and prevention. Information may be needed as to what water system lBS regularly contaminated. It may be desirable to know what tests are most frequently requested and by whom. How many typhoid carriers are present in a 10caJity and who are they? How many cases of venereal. diseases and where are they concentrated?

One filing system has already been mentioned, i.e., the regis­tration of specimens. This gives a reference by number to individual spec:ilnens. A cross index by name and laboratory finding may also be desirable. Files may also be necessary for regional activities, water and milk supplies, sewage disposal systems, transport systems serving food, etc.

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A simple tabulation of daily results may provide the information necessary or rapid c anpilation of results can be done by machinery. Examples of summary sheets and record forms will be available for review and discussion. An example is the JJ3M punch card system where eighty items of infonnation can be cross indexed on a single card. There are also several s:impler punch card devices which can give the same infonnation but require fran 5 to 200 time s as many manhours of effort for sorting and counting.

Uniform size report fonns arc helpful in ~ filing system. Dif­ferent color report forms aid in routing information to the proper individual or office. Some information needed for permanent records may be microfilmed and cross indexed. These mew be duplicated and stored in a number of places and of course take up very little space. They have the advantage of being inexpensive and resistant to almost everything but fire.

Codes are useful in indexing files and preparing tabulations. The Horld Health Organization has established codes for death reports and several other tYP'ls of reports. If coding is contemplated, 1:JHO codes should bo considered rather than establishing new code numbers.

5.5 Invento~ control

(Sample inventory systems will 00 available for review and dis-cussion.)

5.5.1 Laborato~ supplies

Regardless of the capability of the staff, a laboratory can be on4r as productive as the availability of supplies. Rmming out of sup­plies can, therefore, be exp:msive in terms of time and accanplishment. An inventory control system based on accurate records of supplies placed in and withdrawn from stock is essential to avoid unexpected depletion of critioal supplies. An accurate inventory control permits planning to pur­chase once or twice yearJy in J£.rge lots thus taking advantage of appreciable discounts.

5.5.2 Biologicals

Accurate records as to available stock are essential to avoid dep:wtion of items and to plan for proper production schedules.

6. GENERAL SERVICES

6.1 Media preparation

The approach to media preparation will depend upon the size of the laboratory and the amount of media required. In the small laboratory undertaking limited culture activities, tho media may well be prepared by the laboratory assistant under the general supervision of the bacteriologist. In these laboratories where several bacteriologists require media, central­ization of media preparations in a central media kitchen is usua14r more efficient.

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6.1.1 Space required and layout

In the preparation of media for a bacteriological laboratory, the space required and the equipment layout would be wtermined by the demand on the work unit. In consiwring minimum. requirerents, preparation could be accomplished in an area of approximate~ 120 square feet. This area allows ample space for a weighing and mixing station, work tables and sterilizing eqUipment. Layout should be such to facilitate operations with a minimum of movement fran one work station to another. Weighing stations should be located where air currents are at a minimum. SteriliZing equipment (autoclave) must be located or shielded to minimize heat transfer to other work stations. Dispensing and packaging stations should be centrally located to facilitate handling. It would be desirable to have a separate roan for dispensing sterile media. This room should be cleaned frequent~ with decontaminating solution to minimize the possibility of contamination. In an area of this size, two trained technicians should be able to produce approximate~ ten to twelve litres of completed media per eight-hour work day.

6.1.2 Personnel

Personnel responsible for supervising operations in media prepara­tion should be required to have technical training and experience in the chemical and biological fields. A knowledge of chemical formulation and growth requireIlBnts of micro-organisms would be invaluable. Non-supervisory personnel should have an educational background which would allow them to grasp basic concepts of sterility, preparation, and operation of necessary equipment. Training programmes should be condu::ted to familiarize personnel with changes and new developments in IlBdia preparation.

6.1.3 Eguipoont

(a) Essential

(1) A trip balance graduated in 0.1 grams for measuring de sired ingredients.

(2) Cylinders graduated in cubic centimetres or milli­litres for measuring liquid volumes.

0) A filter wvice for sterilizing materials which cannot be subjected to heat. A Seitz type filter has proven satisfactory if prepared and used proper~.

(4) A sterilizing unit (autoclave) operating under approximate~ 15 pounds pressure at 120 degrees centigrade.

(5) A heat source such as Bunsen type burner or small cook stove to boil media requiring heat to dissolve ingradients.

(6) A hand or automatic pipetting device of the Corn­wall or Brewer type for disrensing accurate amounts of prepared material into test tubes and other containers.

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(7) Preparation manuals supplied by companies manufacturing standardized dehydrated media and other media supplies. These manuals are excellent reference books for the preparation of many types of media.

(8) rH adjustment equipnent such as rH test paper or a Beckman type metre.

(9) Glassware such as test tubes, petri plates, flasks, beakers, pipettes and such material essential to the operation of biological laboratories.

(10) lfork tables ani cabinets as required for adequate working space and storage.

(b) Desired

(1) 1m. electricaJ.J.y operated automatio pipetting device which is accurate and has the capability of delivering 1 to 30 ml. per stroke at speeds ranging from 10 to 150 strokes per minute.

(2) Electrical au tomatic cycling control f or autoclave operation.

(3) Constant temperature water baths for holding materials at tcmpJrature levels resirablc for pouring agar plates.

(4) Electrical IiI metre for highly accurate adjust-ment.

Basic materials needed

(a) Standardized dehydrated culture media or other necessary media ingredients which arc pertinent to the 0PJration.

(b) Inhibitory compounds, dyes and color indicators.

(c) Varied assortment of cromicals as needed for preparation procedures.

(d) Cotton for stopper material and papdr supplies for packaging.

(e) DistiJJe d and! or demineralized water.

6.1.5 Water

For general microbiological purposes, the quality of water is seldom critical. Either distilled or demineralized water should be satis­factory in most parts of the world. Some chemical analyti()al procedures of

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course required triple distilled water. Water docs becane a problem when a laboratory undertakes to use tissue cultures in diagnosis or research. For tissue culture onJ,v the very purest water possible is good enough. In same places with heavy industrial or other water pollution, the triple distilled water must be filtered through charcoal before all chemical sub­stances toxic to sensitive growing tissues are removed. A device which is said to produce high quality p,rrogen-free water at very low cost was recently marketed by American Sales Corporation. It operates by blowing steam through porco lain baffle s.

6.2 Preparation of scientific glassware

Except for too very small laboratory -- the clinic laboratory -­where the single technician usually washes his om limited glassware, pro­vision of a separate kitchen for washing and sterilization is strong~ recommended. A separate room for washing, drying and sterilizing not only removes the clutter from the laboratory but contributes to better working conditions in the laboratory through reducing traffiC and eliminating the heat produced by 'Tashing, drying and sterilizing. Glassware used for research and clinical purposes must be chemically c]J3 an and in many instances sterile.

6.2.1 Space required and la.yout

Space requirements are determined by type and scope of operations. In consirering minimum requirements as to type of oreration, the following space allotments should be adequate.

6.2.2

(a) Handwashing approx:imate~ 100 square feet per p3rson. The area should be equipped with separate sinks for washing and rinsing and a source of appropriate processing water such as tap, demineralized, or disti)J.ed, and possib~ boiled tap water, and a drying oven.

(b) Machine washing approximately 150 square feet per person. The area should be equipped with washing mach:ine (Turbomatic type), dryer, sink and a work table for sorting glassware. Appropriate processing water should be available for various cycles of washing machine.

Fersonnel

The supervisor should be required to have thorough lalowledge of standard concepts and systems of sterilization and be familiar with equip­ment and materials employed. Non-supervisory - with proper training can be recruited from common labour pool.

6.2.3 General procedures

(a) Handling of used glassware and related items - Items being returned for washing should be separated as to size, submerged in water or mild decontaminant (O-Syl or Liquor Gresoles 2%) in appropriate closed conta:iners and sterilized.

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(b) Cleaning

(1) Handwashing - caps, plugs, labels, media and foreign matter should be removed prior to cleaning in solution of mild handwashing-type detergent (Tetrox). A recommended procedure for washing is to boil the items in detergent solution for 5-10 minutes and rinse 6-8 times in running tap water. Final rinse in distilled, demineralized water or boiled water is sometimes necessary. Especially careful rinsing procedure is a must for glassware used in tissue culture laboratories.

(2) Hachine washing (Turbomatic type) - It is not necessary to remove media and foreign materials, but caps, plugs and labels should be remoVBd prior to washing. Glassware is placed on appropriate washer racks (headers) and cycled for pre-wash 'Nash, and rinse with tap and demineralized water.

Detergent - "Soil-A-Way" (1 part to 1000 parts vlater) with Ji! of 12.0 - 12.5 for best results.

Temperature levels - vJash solution - 850 C

Rinse solution- 700

C

(3) Acid cleaning - Potassium dichromate solution used in cJ!laning special items and periodic cleanSing of various types of glassware such as pipettes, funnels, etc. Complete removal of a'lid is essential.

Cc) Inspection and preparation - Check for cleanliness and imperfections. Glassware to be sterilized is cappJd, stoppered, or plugged vlith cotton and covered with paper or aluminum foil prior to sterilization. Glassware not requiring sterilization is placed in cartons or containers to preserve cleanliness.

Cd) Sterilization

Electric sterilizer (hot air) 1800 C

Thin wall items require 60 minutes. Thick wall items and items enclosed in containers (piJEtte and petri dish cans) require 120 minutes -sterili~ control.

Steam sterilizer 1210 C

Loosely packed items require 15 minutes. Closely packed items require 30 minu.tes.

(8) Storage - Place in dust-free room •

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6.3 Care, handling and breeding of laboratory animals

If adequate quality of laboratory animals were available from commercial sources, little advantage if any would be obtained by breeding animals by the laboratory. Experience has demonstrated, however, that good quality animals, free of disease, are seldom if ever consistently available from commercial producers, or shipping ccnditions result in delivery of animals in poor condition. l>nimals properly bred and reared in a scientific environment result in animals of more standardized reactivity, freedom from disease, and better livability.

Quarters for eXp3rimental animals should be readily accessible to the laboratories. Several small rooms are preferable to one large room for housing experimentally infected animals or animals used for disease diagnosis.

Masonry and metal are generally~eferred over other constru~ion materials. Otoor materials may be used but special attention must be given to rodent proofing of the animal quarters. All outside doors and windows should be provided with screens.

A temperature range of 7.0o_80oF is generally satisfactory for

laboratory animals. Air conditioners and ventilating fans may be used for cooling and ventilating. Central heating without recirculation is preferred. If other methods of heating are used, c antrol of room temperature is difficult.

Animal quarters should be provided with adequate lighting, not only for the convenience of those who work in the animal quarters, but for the physiological well being of too animals as well.

There are many factors which should be considered in the design and construction of laboratory animal cages. Factors which determine the size of cage needed are:

Species to be housed; Length of holding period, and Number of animals to be housed per cage.

In designing cages for laboratory animals, the following guides

should be used:

Should be simple in construction,; As comfortable as possible for animals; Should be easily cleaned; Design cages for more than one species when possible; Feed and water to be added without opening too cage; Should be escape proof and for certain spocies should

have wire or perforated floors.

Cages may be constructed of stainless steel, galvanized steel, plastic, fiberglass, and wood with wire. Generally stainless steel is preferred due to the long life and ease of cleaning of cages constructed

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of this material. The other materials me ntioned deteriorate when exposed to the action of urine and/or autoclaving.

It has been stated that good sanitation is only second in importance to good nutrition ill animal colony management. Animal house sanitation includes wild rodent and insect control, frequent decontamination of floors, sterilization and cle1ll1ing of cages and watering and feeding revices, and control of traffic in the animal quarters.

The director of laboratory animal activities in a large central laboratory should be an individual with professional training in animal husbandJ.oy or veterinary science. Animal caretakers in small laboratories should be trained at the central laboratory.

Facilities should be provided for storage of feed and clean sterile cages, sterilization or chemical decontamination of cages, etc., incineration of animals and refuse, and cage washing (machine or manual).

Generally, it is more satisfactory to feed manufactured diets Ll p311et form than laboratory prepared diets from the standpoint of unifonnity of mixing of nutrients, and the fact that pelleted feeds can be fed in hoppers to prevent fecal contamination. Manufactured feeds should be packed in multiple wall paper bags.

Diets composed of natural feedstuffs and containing the follOwing p3rcentages of nutrients are generally adequate:

Mice, rats, and hamsters - 17-25% protein (at least a part from an:ilnal sources if possible). 4-11% fat, 40-55% carbohydrate (NFE) and not more than 8% fiber.

Guinea pigs and rabbits - 15-20% protein, 3-6% fat, 40-50% carbohydrate (NFE), and 12-20% fiber. For the guinea pig, Vitamin "G" must be furnished in the form of green vegetables or be incorporated in the r.clleted diet so that there is 300 mg. of Vitamin lIe" p3r pound of feed.

Monkeys - For the m~ the same percentages of nutrients previously given for mice are adequate except for Vitamin "G" - 200 mg. JBr pound of feed is required.

There are tivO general principles to be observed in restraining and handling animals. These are

1. Restrain the animal so that the animal does not injure the handler, and

2. The handler does not injure the animals.

(Techniques illustrated by slides.)

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Litter and bedding are necessary- for some speCies, and there are several satisfactory materials which may be used. Among these are dry saw­dust or shavings (soft wood), rice husks, and ground corn cobs.

Some of the more troublesome diseases and parasites of laboratory animals are Salmonellosis in rodents and primates; infantile diarrhoea in young mice; tuberculosis in primates; snuffle and coccidiosis in rabbits, and ear mange or canker in rabbits. The best method of disease control is prevention. Prevention consists of applying the sanitation measures previously mentioned, isolation of new animals before· introduction to the laboratory colonies, adequate ventilation of quarters, use of properly designed cages, and tho use of adequate diets. Chemotherapy is generally of little value.

The selection of a strain or breed of a species of laboratory animal should be based primarily on tho intended use of too animals, i.e., select a recognized strain or breed which is most susceptible to the agents to be studied.

Random bred animals are satisfactory for most routine laboratory investigations and diagnostic procedures. Inbreeding should be attempted only by those who are thoroughly familiar with genetics.

The most efficient breeding system for mice, rats and guinea pigs is the family system. A family consists of 5 to J.5 females and a male, with the females remaining with the male at all times. Variations of this system are employed in the breoding of rabbits and hamsters. il. family of rabbits consists of II females and a male housed separately, tho female being trans­ported to the male's cage for mating. A family of hamsters consists of 5 or 6 females and a male. The females are isolated as soon as obviously pregnant and are not returned to the family cage lIDtil the YOlIDg are weaned.

The general recommendations made previously for the design and construction of cages and quarters for housing experimental animals apply for breeding animals also.

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APIENDIX 4

CARE, HANDLING AND BREEDING OF IJJ3OR.I.TORY ANlMALS

This appendix is not intended to be a complete manual on labora­tory animal care, but onJy outlines some of the basic procedures followed in laboratory animal care, handling and breeding. See bibliography for more complete references on this subject (Appendix 5).

1. Location of animal quarters

Laboratory animal space should be provided near research and diag­nostic laboratories, either within the same building or in a nearby build­ing. imimals should not be kept in the laboratory, and the experimental animal quarters should be isolated from the animal breeding quarters.

1.1 Size of units or rooms

The roms should be small in size so that infected animals can be isolated to prevent cross infections with other animals infected with dif­ferent agents. If this is not possible, separate the animals within the room.

1.2 Construction

Buildings housing laboratory animals ideally should be constructed of masonry or metal because of ease of rodent proofing and long life. If these materials are not available, then every effort must be made to prevent entry of wild rodents into the animal quarters. The outside walls and ceilings of these buildings should be insulated. If commercial insulating materials are not available, use 10calJy available materials such as thatching which is used for roofing in many tropical areas.

All windows and doors should be screened to prevent entry of flies and mosquitoes and to allow opening of Windows for ventilation.

1.3 Heating, cooling, ventilCition, and lighting

A temperature range of 70-800F is desirable for all laboratory

animals. The temperature should be as constant as is possible to main­tain.

Ventilating fans can be used not only to cool but to change the air within the animal rooms. A water sprinkler system installed on the roof of the animal building is very effective in lowering the roam temperature.

Heating -Central heating, thermostatically controlled is the most desirable method of heating animal quarters. If this heating method is not feasible and room heaters (stoves) must be used, be sure to provide adequate ventilation.

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Lighting - Provide adequate lighting. Fluorescent lighting is the lighting method of choice but ordinary incandescent lamps are satis­factory. Provido at least eight hours of light par day.

2. Cages

Cages propcrJ;v designed and constructed are equalJ;v as important as good animal quarters.

2.1 Cage material

Stainless steel is the best material for most animal cages due to its wearing qualities and ease of cleaning.

Other materials used for cages are aluminum, fiberglass, plastiCS, galvanized iron, and wood.

2.2 Cage rosign and space requirements for cxp:rimental animals

Whenever possible cages should be designed to house more than one species. Cages should be designed to allow feeding and watering from outside the cage, and should be easiJ;v cleaned.

Mouse - Allow 8-10 square inches of floor space p3r weanling animal and 15 square inches of floor space per adult animal. j, simple shoe box type of cage 5-6 inches in depth is very satisfactory for mice. This type of cage usualJ;v has a feeder built into the cage cover (wire IOOsh or slotted metal) and the water is supplied by a bottle with a drinking tube which protrudes through the cage cover.

Guinea pig - 0.5-1. 0 square foot of cage floor space is recom­mended per animal. Cages with wire floors and dropping pans are generally recommended for experimental animals and cages with solid floors with litter are generally used for breeding animals.

Hamster - 15-20 square inches of cage floor space per weanling animal and 30-40 square inches per adult animal. Cages for hamsters must be constructed of metal to prevent the animals frOOl gnawing out of the cages. A shoe box type cage is very satisfactory for the hamster, but should be at least 10" deep, or have a heavy cover to prevent the hamsters from escaping.

Rabbit - Allow 2-3 square feet of cage floor space per adult rabbit and a minimum inside cage height of 16". Wire floored cages should be used for housing rabbits, and they should be caged individually to prevent fighting.

Monkey - 8-12 cubic feet should be allowed per monkey. Expe­rimentally infected monkeys should be housed one p3r cage. Door latches should be located out of reach of the monkeys' fingers to prevent escape.

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3. Sanitation cages and quarters

Cages used for ex~rimental1y infected animals should be sterilized or decontaminated before re-use. Sterilization by autoclaving for thirty minutes at 2500 F is recommended, but chemical decontamination can be used.

Floors should be cleaned and disinfected regularly. Cage dropping pans should be cleaned of dirty litter or at least twice weekly to prevent fly breeding, and pans should be sprayed with a decontaminant before adding new litter. Dirty litter should be collected in metal cans with covers for transporting to the incineration facilities.

Watering and feeding devices should not be interchanged between cages, and they should be cleaned and sterilized frequently.

Wild rodents and insects must be controlled by routine spraying and use of pOison bait stations.

Traffic control - Only authorized staff members should be ~r­mitted in the animal quarters. There should be no traffic between the infected animal quarters and the animal breeding quarters. imimal care­takers should be required to change clothing and shoes before entering the animal quarters, and should bathe and change back to street clothes before leaving at the end of the day. Personnel should be instructed not to smoke or eat until they have thoroughly washed their hands. These precautions are necessary to prevent the animal caretakers from contracting and spreading diseases being studied in the animals.

4. Organizational structure and management

4.1 Central laboratories

It is recommended that the responsibility for all laboratory animal activities be placed in the hands of an individual with professional training in animal husbandry or veterinary science. The director of laboratory animal activities should be responsible for the selection, assignment, and training of laboratory animal caretakers, and the assign­ment of experimental animal space.

4.2 Branch and local laboratories

The Laboratory Director should designate a professional staff member to be responsible for laboratory animal activities. The staff member responsible should follow procedures recommended by the central laboratory animal activities director, and the animal caretakers should be trained at the central laboratory.

4.3 Service facilities

Feed and litter storage facilities should be provided near the animal quarters. These facilities should be rodent proof.

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Sterilization facilities should be provided for sterilizing animal cage~ and related equipment. leeally this would be accomplished by auto­clav~. However, chemical sterilization can be use~

InCineration facilities should be provided for disposing of dead animals and animal refuse.

LOcker - Shower facilities should be provided for the animal care-takers.

Cage storage space should be provieed for storage of clean cages, cage racks and related equipnent.

-Cage washing space should be provided for washing cages and related equipment after it has been sterilized. This can best be accom­plished by the use of a machine, but can be done manualJ,y when plenty of labour is available.

5. Care and handling

5.1 Nutrition

Manufactured laboratory animal diets in ~llet form should be used if available in preference to laboratory prepared diets. Manufactured feeds should be packaged in multiple wall heavy paper bags to facilitate handling and storage and prevent contamination from outside sources.

Hice, rats and hamsters have essentially the same requirements. Basically a diet consisting of the following nutrients is adequate:

Protein 17% Min. Fat 7% HiD. N. F. E. 45% Min. Fiber 5% Max.

nutritional percentages of

The guinea pig and rabbit are herbivorous animals and require a high percentage of fiber in their diets.

Protein 20% Min. Fat 5% Min. N.F.E. 44% Min. Fiber 18% Max. Vitamin IICII fortified - to contain 500 mg. Vitamin IICII

~r pound of feed (guinea pig only)

Monkey

Protein 20% Hin. Fat 5% Min. N. F.E. 52% Min. Fiber 5% Max. 200 mg. Vitamin lIC" per pound of feed.

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5.2 Handling and restraining techniques

Mice may be lift'ed and carried by the base of the tail, but never on the terminal end.

Hamsters may be handled by placing one hand on either side of the animal and forming a cup. imother method which may be used is to grasp the loose fold of skin directly behind the neck with thumb and forefinger and restraining the left rear foot by grasping between the third and fourth fingers of same hand. Another hand method is to place the hand over the animal's back (paJ.m downward) grasping the animal with thumb and fore­finger on either side of head and below the ears. This is the least desirable method since a great deal of pressure is exerted on either side of the head.

Guinea pigs resent being held tightly and try to free themselves while be ing re strained. When lifting a guine a pig, the hand (palm down) should be placed over the back grasping the animal by the neck directly in front of the shoulders with the thumb and forefinger. Place the other haYld under the rump of the animal to support the weight of its body.

Rabbi ts should never be carried by their eers. To lift a rabbit, grasp the loose fold of skin over the shoulders with one hand and place the other hand under the animal's hind quarters to support its weight.

Monkeys - In restraining a monkey, the animal's arms should be drawn behind its back and held with one hand. Gloves with gauntlets are recommended for restraining monkeys. Nets may be used for catching monkeys in large stock cages. Every precaution should be t'aken on the part of the caretaker to prevent being bitten by the monkey.

5.3 Litter or bedding

'There are several types of bedding or litter that are satis­factory for laboratory animals. Among them are wood shavings, sawdust, rice husks, and ground corn cobs. Cane fiber and similar materials are not recommended since these are eaten and the fiber particles may irritate or puncture the intestinal tract.

6. Diseases and parasites

Salmonellosis is one of the most troublesome diseases of lab­oratory animals. S. typhimarium and S, enteriditis are largely responsible for SaJ.monellosis in laboratory rodents. However, other Salmonella types are also isolated from rodents and primates with diarrhoea. Symptoms are loss of condition, rough hair coat, diarrhoea, and death.

Prevention is effected by strict sanitation, isolation of new animals before introduction into the laboratory colony, rodent control to prevent access by wild rodents to feedstuffs, litter and colony animals.

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Chemotherapeutic measures are ineffective. If an outbreak occurs, destroy all animals in the unit and sterilize or decontaminate all cages and related equipnent before introducing new stock.

Infantile diarrno3a is an important and costlY disease in certain strains of mice. It oCCUl'S most frc.quentlY in first litter mice 2 to 15 days of age. There is evidence that the cause is one or more viruses. Symptoms range from slightly loose stools to a foul smelling profuse yellowish diarrhoea. Bortality may be 100 percent in those animals affected with the al"·ute form 'of the d.i..sease. There is no known effective treatment.

Rabbit snuffles in chronic fom are characterized by sneezing, nasal discharge, matted fur on forepaws (from wiping nose), slow loss of condition, and eventual death. Cause is believed to be Brucella bronchi­septium and Pasteurella lepisepticum, the latter being the more pathogenic.

Prevention or control - Obviously infected animals should be disearded and nasal swab cultures should be performed on the remaining animals. Discard all positive animals and check remaining animals by periodic nasal swab cultures.

Chemotherap,r - There is no successful chemotherapeutic treat­ment. Prevention consists of providing plenty of space, draft-free ventilation, and good nutrition.

Coccidia infections occur in the rabbit and guinea pig, but are a much more serious problem in the rabbit. There are two forms of Coccidia which cause disease in the rabbit, the intestinal (E. perforans) and the hepatic (E. stiedae).

Symptoms (Rabbit) - ':'he severe hepatic form (E. stiedae) causes enlargement of the liver, loss of condition, and distention of the abdomen. In the severe intestinal t:rJ:.e (E. perforans), the young rabbits show a ravenous appetite, become emaciated, and scour badlY.

COntrol measures consist of providL,g adequate floor space, ventilation, nutrit,ion, a'1d strict sanitation. To reduce fatalities, SuJ.J:.badimidine may be added to drinking water or feed in the amount of one percent.

Symptoms (Guinea pigs) - Eimeria carviae is re sponsible for coccidiosis in guinea pigs and is host specific. The symptoms are loss of appetite, listlessness and diarr:1oea.

Control is best accomplished by strict sanitation, adequate ventilation, adequate cage space, and good nutrition.

Ear mange is prevalent in many rabbit colonies. The condition is caused by two species of mites - Psoroptes communes and Chorioptes cuniculi.

Symptoms are scratching of cars, shaking of head and wry neck (middle ear involvement). 'l'lhen the cal's are examined, encrusted areas will be observed in the outer car.

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Treatment consists of applying mineral oil or vegetable oil until scabs are loosened. Remove scabs with cotton tipped swabs or for­ceps, continue treatment three or four weeks and crock animals each week thereafter. All hutches or cages and related equipment housing affected animals should be thoroughly disinfected.

7. Laboratory animal breeding

7.1 Selection of strain or breed

Tho selection of strains or breeds of laboratory animals should be based on the following consideration - The strain or breed most sus­ceptible to the diseases or parasites which are to be studied, or are likely to be encountered in diagnostic procedures.

Methods of breeding used are inbreeding, random breeding, and crossbreeding. Random bred animals are satisfactory for most routine laboratory investigations and diagnostic procedures. Inbred animals are required only in special fields of research such as tumor investigations.

7.2 Breeding system for random bred animals

The family system is tre most widely used. This system con­sists of family (cage) units of one male and om or more females. The females may be left with the male at all times or may be removed to isolation cages for littering. The system whoreby the females remain with the male at all times is recommended for mice, rats and guinea pigs unless exact date of birth is required.

Inbreeding should not be attempted unless supervised by a geneticist.

Miscellaneous breeding information

Mice - At tho Communicable Disease Center the family system is practised. A family consists of five females and a male, and the females litter in the family cage. l'lice are generally bred when 6-8 weeks of age. The complete estrus cycle occurs about every five days. The gestation r.eriod is completed in 19-21 days. Mice are normally weaned at about three weeks of age at which time they should weigh 8-12 grams.

Complete cage pedigree and production records should be main­tained. The useful breeding life ranges from 8-12 months, dep:mding on strain, adequacy of diet, and colony management.

Hamsters (Syrian and Albino) are bred 'When six weeks of age. At the Communicable Disease Center, tho family system of breading is practised. A family consists of five females and a male. Pregnant females are isolated for littering. 1,-Jhen the young are weaned at three weeks of age, the female is returned to the family unit. The complete estrus cycle occurs every four days. The gestation period is cClllpleted in sixteen days. Hamsters have a useful breeding life of approximately one year. Identical records are maintained for hamsters and mice.

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Guinea pigs are bred when 3-4 months of age. At the Communicable Disease Center the family system of breeding is practised. A family unit consists of five females and a male. The females remain in the unit at all times. The average gestation p>riod is sixty-eight days. The complete estrus cycle occurs every 16 days. The young are weaned at 2-3 weeks of age. The breeding span is approximately two yoars for SCMS ani one year for boars.

Rabbits are bred when 4-8 months of age depending on the breed and stage of development. At the Communicable Diseaso Center we have observed that maturity docs not necessarily coincide 'torith age. A colony of the New Zealand vJhite breed is maintained at the Communicable Disease Center and the family system of breeding is practised. A familyoonsists of eleven females and a male. All family members are caged separately. Females are placed in the cage of the male for breeding. TIe female ovulates approximately ten hours after copulation, and the gestation period ranges from 28-36 days. The useful breeding life is approximately two years. The young are weaned at eight weeks of age. Individual pedigrees should be maintained within the breeding colony.

8. Cage design and space requirements for breeding laboratory animals

The same general recommendations as to design, materials, etc. given previously for exp>rimental animal cages apply here also.

Mice require 30-40 inches of cage floor space per breeding animal. A shoe box type cage 5 .. 6 n deep with a plrforated metal or wire cover is generally used. The feeder is either built into the cover or is inserted through a hole in the cover. 1rJater is supplied by use of a bottle and drinking tube. Cages constructed of stainless steel are preferred, but many breeders now use plastic and fiberglass-plastic cages. Cages con­structed of the latter two materials cannot be autoclaved without deteriora­tion. Cages constructed of wood with wire covers can be used satisfactorily.

Rabbits require 7-8 square feet of cage floor space per breeding female and young. Cages should be at least sixteen inches high inside. Cages constructed of stainless steel with perforated floors are preferred but creaper materials can be used. Nest boxes should be provided for females a few days before kindling date.

Guinea pigs require approx:imately one square foot of cage floor area per breeding animal. Both solid and perforated floors are used for breeding. Litter is placed on the cage floor when solid floors are used.

Hamsters require 30-40 square inches of cage floor space per breeding animal. A shoe box type cage is satisfactory. The pregnant females should be removed from the breeding cage and placed in an isolation cage for littering. The isolation or littering cage should have a minimum of 150 square inches of floor space.

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APPENDIX: 5

BIBLlOORAHIY ON ANn1AL CARE AND BREED ING

General

Arndt, H.J. and Benda, C. (1931) In: Jaffe, R., ed., imatomie und Pathologie dar Spontanerkrankungen dar Kleinen Laboratoriumstiere, Kaninchen, Neerschweinchen, Ratte, Maus (icnatomy and pathology of spontaneous disease of the small laboratory animals), Berlin, J. Springer (Also translation by Nell Conw~, Vols. I and III at Kettering Laboratory, College of Medicine, CinCinnati, Ohio).

Asdell, S.A. (1946) Patterns of mammalian reproduction, Ithaca, New York, COOlstock Publishing Company.

Becker, E.R. (1934) Coccidia and coccidiosis of dOOlosticated game and lab­oratory anjJnals and of man, Ames, Iowa, Collegiate Press, Inc.

Brumley, O. v. (1931) A textbook of the diseases of the small domestic animals, 2nd ed., Thilade1phia, Lea and Febiger.

Carworth Farms, Inc., Quarterly Letters, New City, ROCkland Country, New York.

Dukes, H.H. (1937) The ~ysiology of dOOlestic animals, 4th rev. ed., Ithaca, New York, Comstock Publishing Co., Inc.

EWing, H.E.. (1934) A manual of external parasites, Springfield, Ill., C.C. Thomas Publishing Co.

FarriS, E.J. (1944) Anatany and ~iology laboratory guide. 4th rev. ed., Thiladelphia, J. B. Lippincott Co.

Farris, E.J., et al (1945) imimal colony maintenance. i.nn. N.Y. Acad. Sci. ~ Art. I.

FarriS, E.J. (1950) ed., The care and breeding of laboratory animals, New York, John Wiley & Sons, Inc.

Fox, H. (1924) Disease in captive wild maroinals and birds; incidence, description, comparison, Thi1adelphia, J.B. Lippincott Co.

Great Britain, Ministry of 1.grieulture and Fisheries (1930) Diseases of animals, Report of Proceedings, London, H.M. Stationery Office.

Gruneberg, H. (1947) lmimal genetics and mo die ine , New York, London, Paul B. Hoeber, Inc.

Hegner, R., Root, F.M. and il.Ugustine, D.L. (1929) J:.nimal parasitology, New York, The Century Co.

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Journal of the Animal Technicians i<ssociation (1950) Nottingham, An:iJnal Technicians Association.

Laboratory Animals Bureau Technical notes and bulletins published by Medical Research Laboratories.

Leahy, J.R. and Barro, P. (1951) Restrain of animals, Department of Anatomy, New York State Veterinary College, Cornell University.

Maynard, L.A. (1951) Animal nutrition, New York, McGraw-Hill Book Co.

Morris, M.L. (1951) ed., Prescription diets. Series of discussions, including questions and answers on subject of nutrition and the clinical and therapeutic use of prescription diets, Hill Packing Co., No.1.

Morrison, F.B~ (1951) Feeds and feeding; a handbook for the student and stoclanan, 21st ed. unabridged. Ithaca, Morrison Publishing Co.

Merck and Co., Inc~ (1952) Fharmacological activity and clinical use of sulfanilamide, sulfathiazole, and sulfapyridine in veterinary medicine, rev., Rahway, New Jersey.

Merck and Go., Inc. (1952) Stremptomycin and dihydrostre pt omyc in; their practical application in veterinary medicine, Rahway, New Jersey.

Nutrition News Bulletin (1944), St. LouiS, Ralston Purina Company.

Parish, H.J. (1950) Notes on communicable diseases of laboratory animals, Edinburgh, L. and S. Livingstone, Ltd.

Ralston Purina Company (1942) The care and feeding of laboratory an:iJnals, St. Louis, Ralston Purina Co., Research Laboratories.

Reyniers, J.A. (1943) Micrurgical and germ-free teChniques; their applica­tion to experimental biology and medicine, Springfield, C. C. Thomas.

Sisson, S. (1936) In: Grossman, J.D., ed., The anat<Jlli.V of the domestic animals, Philadelphia, W. B. Saunoors Co.

United States Department of Agriculture (1942) Keeping livestock healthy; Yearbook of Agriculture, Washington, United States Government Printing Office, House Document No. 527.

Whitney, L.F. (1950) Complete book of home pet care, New York, Doubleday and Co., Inc.

Worden, A.N. and Lane-Petter, Wm. (1957), ed. Care and management of lab­oratory animals, rev. cd., Chicago, The Animal Care Panel.

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Cat

Bigelow, R. P. (1935) Directions for the dissection of the cat, rev. ed. New York, Ma~millan Co.

Davison, A. (1937) Mammalian anatcmy with special reference to the cat, 6th ed. Fhiladelphia, Blakiston.

Gates, G.S. (1928) The modern cat. Her mind and manners. Jm introduction to comparative psychology, New York, Macmillan Co.

Horsburgh, D.B. and Heath, J. P. (1939) j,tlas of cat anatomy, California, Stanford University Pross.

Kirk, Hamilton (1951) Index of treatment in small-animal practice, 2d. ed. Baltimore, \Hlliams and Wilkins Co.

Reighard, J .E. and Jennings, H. S. (1935) Anatomy of the cat, 3rd and enl. ed. New York, H. Holt and Co.

Saunders, C.G. (1920) Rabbit and cat diseases, Chicago, k'nerican Veterinary Publishing Co., (Veterinary Medicine Series No. 13).

Poultry

Biester, H.E. and Schwarte, L.H. ad (1948) Diseases of poultry, 2d. ed. Ames Iowa, The Iowa State College Press.

Chamberlain, F. (1943) Atlas of avin anatomy, Lansing Michigan, Hallenbeck Printing Co.

Levi, W.M. (1951) The pigeon, Columbia, S.C., R.L. Bryan Co.

ltHnter, A.R. and Funk, E.M. (1951) Poultry science and practice, Phila­delphia, J. B. Lippincott.

Dog

Bradley, ~.C. (1912) Guide to the dissection of the dog, New York, Long­mans Green and Co., Inc.

Bradley, O.C. (1948) Topographical anatomy of the dog, 5th ed. London, Oliver and Boyd.

Gaines Dog Research Center (1951) The newer knowledge about dogs. In: A veterinary symposium held in COnjunction with tho Dedication of the New Gaines Researah Kennels, Kankakee, Ill.

Johnson, H.M. (1913) Audition and habit formation in the dog, Boston, Henry Holt and Company.

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McCay, C.M. (1943) Nutrition of the dog, Ithaca, New York, Comstock Publishing Co., Inc.

Morris, MoL. (1949 and 1950) Prescription bulletin service (dog diet). Bulletins 1-17 inclusive, contents and index, 1. Copyright, Hill Packing Co.

Stockard, C.R. (1941) The genetic and endocrine basis for differences in form and behavior as elucidated by studies of contrasted pure-line dog breeds and their hybrids, I1mer. Anat. Mom. 19.

United States, National Institutes of Health, Surgery StuQy Section (1949) Care of the dog used in medical research, vTashington, United States Government Printing Office.

Whitney, L.F., and Vlhitnoy, G.D. (1953) The distemper complex, Orange, Conn., Practical SCience Publishing Co.

Dickerson, M.C. (1906) Tho frog book; North i1merican toads and frogs, with a study of the habits and lifo histories of those of the Northeastern States, New York, Doublodqy and Co., Inc.

Pr:iInates

Bast, T.A. (1933) In: Hartman, C.G. and Straus, W.L., Jr. ed., The anatomy of the Rhesus monkey (Macaca malatta), Bal t:iInoro, vJillians and Wilkins Co.

Forbes, H.O. (1894) A handbook of tho primates, London, George hllen and Unwin, Ltd. 2 vols.

Hartmann, R. (1901) Arthropoid apes, Now York, Appleton-Century-Crofts, Inc.

Schultz, A.H. (1930) Notes on the growth of anthropoid apes, with special reference to de ciduous oonti tion. Re port of the Laboratory and Museum of Comparative Pathology of the Zoological Society of fuiladelJilia.

Stiles, C.E. and Hasell, 11. (1929) Key catnlogue of parasites reported for pr:iInates (monkeys and lemurs) with their possible public health :iInportance. U. S. Pub 1. Hlth Ser. Hyg. Lab. Bull. 152, 409.

Mouse

Dingle, H.H. (1956) Infectious disoases of mice, In: Snell, G.D, et. aI, ed., Biology of the laboratory mouse. New York, Dover Publications, Inc.

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Gruneberg, H. (1943) The genetics of the mouse, Cwmbridge, University Press, (New York - M~cmillan Co.)

Keeler, C.E. The Inboratory mouse: its origin, heredity and culture, Harvard University Press.

Rabbit

Benoit, R. nnd Daccord, A. (1948) lela in: elev e - rnces - maladies, (The rabbit: rearing-breeding-diseases , Lausanne, Librairie Payot, p. 202, 83 figs. (Vet. Bull. 21:3758, 1951)

Bensley, B.i .. (1938) Practical anatomy of the rabbit, 6th ed. rev. Phila­delphia, P. Blakiston's Son & Co., Inc.

Crabb, E.D. (1946) Principles of functional anntomy of the rabbit, St. LouiS, J.S. Swift Co., Inc.

Craigie, E.H. (1948) Bensley's practical anatomY of the rabbit. An elementary laboratory textbook in mammalian anatomy, 8th ed., Toronto, University Toronto Press. London, Oxford University Press. pp. XII-391 (Vet. Bull. 21:3360, 1951)

Lund, E.E. (1949) Considerations in the actical control of intestinal coccidiosis of domestic rabbits, N. Y. i.cad. Sci. d.. i.rt. 4.

Meek, M.W. (1943) Diseases and paraSites of rabbits and their control, 3d ed. Montebello, California, Reliable Fur Industries.

Rat

Greene, E.C. (1955) lmatomy of the rat. Trans. Amer. Phil. Soc. (new series) 27 New York, Hainer Publishing Co.

Greenman, M. H. and Duhring, F. L. (1931) Bree ding and care of the albino rat for research purposes, 2nd ed., Philadelphia, l-Jistar Press.

Griffith, J;Q. and Farris, E.J. ed., (1942) The rat in laboratory investi­gation, Philadelphia, J.B. Lippincott Co.

Hunt, H.R. (1924) A laboratory manual of the anatomy of the rat, New York, Macmillan Co.

King, H.D. (1939) Life processes in gray Norway rats during fourteen years in captivity, Philadelphia, the Wistar Institute of i..natoroy and Biology. (The l~erican iU1ntomical Memoirs, No. 17)

King, H.D. and Donaldson, H.H. (1929) Life processes and size of and or ans of the ra Norw rat durin ten enerations in Philadelphia, the Wistar Institute of bnat~ and Biology • American Anatomical Memoirs, No. 14).

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Long, J.i.. and Evans, H.M. (1922) The oestrous cycle in the rat and its associated phenomena, Berkeley, California UniverSity California Press.

Main, R.J~ (1939) The care or a small rat colony, St. Louis, C. V. Mosby Co.

Nicholas, J.S. (1935) The normal st es in the clavelo ant of the rat (Embryological drawings and photographs New Haven, Conn., Osborn Zoological Laboratory, Yale University.

Wiesner, B. P. and Sheard, N.M. (1933) Maternal behaviour in the rat, Edin­burgh, Oliver and Boyd.

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APIENDIX 6

SIEClFICNrIONS USED BY THE COMMUNICABIE DISEASE CENTER FOR THE MLNUF ACWRE OF ANIMAL FEEDS

Guinea pig eliet, size of pellets 3/811 eliametre by 111 long • Guaranteed 1mnlysis: Protein;.. 20% minimum; Fat - 5%; Fiber - 18% maximum; N. F .E. - 44% minimum.

Vitamins and minerals - A - 4000 1. U/lb.; B-12 - 150 micrograms/lb.; D - 600 I. U/lb.; K- 25 mg/lb.; 1.1phatocopherol - 75 mg/lb.; Choline - 500 mg/lb. Calcium (availnble) - 0.6% of diet; Phosphorus (available) -0.5% of diet; Folic l,.cid - 3 mg/lb.; Niacin - 10 mg/lb.; Pantothenic l,.cid - 10/mg/lb.; Riboflavin - 4 mg/lb.; Thiamine -4 mg/lb.

Feed shnll be fortified to contain a mLnLffium of 1000 rugs. of vitamin C p:lr pound of feed prior to tplleting and 500 mgs. 40 days after date of manufacture; moisture conwnt not more than 12%.

2.

3.

Rabbit pellets, same formula as Item 1, except vitamin C not required.

Mouse diet (for breeding mice). fullet size 3/8-3/411 diametre and not more than 111 long. 1,.11 particles should be finely ground and mixed adequately so that the feed does not contain any large grain particles. Protein - 17% minimum; Fat - 7% minimum; N.F.E. - 45% minim1JIll; Fiber - 5% maximum; J.sh - 5.5% maximum; Moisture content not more than 12%.

Vitamins - A - 4000 I. U/lb.; D - 600 U.S.P. units/lb.; J.lphatocopherol - 25 mg/lb.; K - 2 mg/lb.; Thiamine - 6 mg/lb.; Riboflavin - 6 mg/lb.; Niacin - 10 mg/lb.; Pantothenic Acid -30 mg/lb.; Choline - 700 mg/lb.; Pyridoxide - 2.3 mg/lb.; Inositol - 0.5 mg/lb.; Folic Lcid - 5 mg/lb.; B-12 - 50 micrograms/lb.; Biotin - 150 micrograms/lb.

ercent of diet (chemical determination): Calcium availnble 0.670; Phosphorus available - O. ; Magnesium -

0.02%; M<mgane se - 0.035%; Potassium - 0.15%; Iron - 0.0025%; Copper- 0.0024%; Zinc - 0.0004%; Iodine - 0.0002%; Sodium Chloride - 1. a/o.

4. Monkey eliet, pellet size same as Item 3. Jill particles shall be finely ground and mixed adequately so that the feed does not contain any largo grain particles. Protein - 20%; Fat - 5% minimum; N. F .E. - 52% minimum; Fiber - 4% maximum •

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Vitamins - Contents may be 2aj, J.e ss than breeding diet, Item 3. Feed shall be fortified to contain a minimum of 200 milligrams of vitamin C J2r pound of feed 40 days after date of manufacture.

Minerals - Same as breeding diet, Item 3. Moisture content not more than 12%.

5. Dog pellets: Protein - 24% minimum (half or more must be animal pr()tein); Fat - 5% minimum; N.F.E. - 45% minimum; Fiber - 5% max:imum. Moisture not more than 12%.

Vitamins and minerals - J.. • 3000 I. U/lb.; D - 400 u. s. P. units/ lb.; Alphatocopherol - 25 mg/lb. min:iJnum; Thiamine - 0.6 rng/lb. minimum; Riboflavin - 1.0 mg/lb., Niacin - 15 mg/lb. minimum; Choline - 500 mg/lb. minimum; B-12 - 15 micrograms/lb. minimum; Pyridoxine - 1. 5 mg/ lb.; Calcium FhosJ;horus ratio - 1.2: 1. 0; Available calcium - 0.6% of diet; Available J;hosphorus - 0.5% of diet; Pantothenic al1id - 10 rng/lb.

General specifications

1. Vendor must guarantee a constant formula for all feeds, both as to J2rcentages and amount of nutrients and ingredients.

2. All feeds arc to be packaged in paper containers consisting of a min;ilnum of three layers of heavy parx;r.

3.

5.

The following certification must be made on the analysis tag of each bag of feed: "No antibiotics or estrogens have been added to this feed. 11 Consignee may analyze the feed at ~ tizoo for estrogenic activity or antibiotics. If the estrogenic activity exceeds five parts per billion or if antibiotics are present, all feed of this "I;yJX3 and shipnent will be rejected.

fulleted feeds containing mold;v grains, numerous large grain particles, weevils, or bags containing more than 2% dust or IOOal will be rejected.

All torn or broken bags will be rejected.

6. Vendor will stamp date of manufacture on analysis tag of each bag of feed.

7. All feeds must be delivered to the government within ten days after manufacture.

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APPENDIX 7

PREPARATION OF SCIENTIFIC GLASs.JARE

Glassware used for research and clinical purposes must be chemi­call;y- cleaned and in many instances sterile.

1. Handling of used glassware and related items in laboratories

1.1 Items being returned to washroom should be placed in containers that can be closed. These items should be separated as to size, i.e., medium and large pieces and test tubes should be disassembled and kept separated from all other types of glassware. Water or a solution of water and mild decontaminant, such as a 2% solution of O-~l or Liquor Cresolis, should be put in the containers and all items submerged before sterilizing. If sterilizing facilities are available, used items should be sterilized in the laboratories before being returned to the washroom. Otherwise sterilization should be accomplished in the washroom prior to handling.

1.2 All caps, plugs and labels should be removed and, if glassware contains any media, agar, or foreign matter, this should also be removed if items are to be washed by hand. If glassware is to be machine washed, removal of media, agar, etc., is not necessary.

2. Cleaning

2.1 If glassware is to be washed by hand, it should be placed in a solution of mild handwashing type detergent, such as Tetrox, and boiled for 5 to 10 minutes. The glassware should then be rinsed from 6 to 18 times in running tap water (or change water after each rinse). The final rinse should be with distilled or demineralized water if available. If especiall;y­treated waters are not available, rinsing could be accomplished with pre­viousl;y- boiled water.

2,2 If glassware is to be machine washed, it should be placed on appropriate washer racks (headers) according to the type of glassware. This machine (approximate l¥ 5' x 4' X 4') has different headers for various typ3s of glassware. The complete cycle (8 minutes) includes pre-wash (2 minutes), wash (3 minutes), tap water rinse (2 minutes), and deminera­lized water rinse (1 minute). The detergent used as the cleaning solution in this machine (IiSon-A-Wayll - approximatel;y- one part detergent to 1000 parts water) should have a pH 12.0 to 12.5 for best results. Temperature levels of 85°C for wash solution and 700C for rinsing waters should be maintained for satisfactory cleaning.

2.3 Potassium dichromate (crystal form) solution can be utilized satisfactoril;y- for special processing of glassware. Acid bath mixtures are prepared as follows:

- 102 -

24 grams of sodium or potassium dichranate 200 cubic cent:iJnetres of tap water 160 cubic cent:iJnetres of coo.centrated sulfuric acid

Extreme caution should be exercised in handling and mixing these ingredients. Acid resistant gloves and aprons should be worn. This solution is used in cleaning special items that cannot be hand or machine washed and also is used in cleaning glassware for special use. In some instances it is necessary to periodica~ cJsan various types of glassware, such as pipettes, dispensing funnels, etc. It is absolutely necessary that glass­ware be repeate~ rinsed to ensure complete removal of acid. 1m automatic pipette washer is effective in removing acid from treated pipettes.

3. Inspection and preparation

JUter washing by hand or machine, the glassware is dried and then inspected by holding before a bright light to crock for cleanliness or im­perfections (etching and cracks). Glassware requiring sterilization can be prepared in various ways, i. e., capped, stoppered (rubber or cork), plugged with cotton and gauze, and capped with paper or aluminum foil. Paper covers should be tied securely with string. Syringes should be wrapped unassembled but with mated plunger and barrel in the same package, using muslim, paper, or aluminum foil. Item capacity should be clearly indicated on the wrapper. Syringes, 3cc and smaller, can be placed in test tubes and plugged with cotton. Tubing of small syringes eliminates the necessity of marking and wrapping, and reduces cost of preparation. After washing, inoculating needles are inspected for damaged points and the openings tested by forcing water through with a syringe. If sharpening is required, inspection should be made for burrs inside of bevel. Large quantities of needles can be processed in common containers such as petri dishes. When needles are prepared separately in test tubes, gauze, cotton, or glass inserts should be used to protect the point. Items not requiring sterilization should be placed in cartons or containers to keep as clean as possible until ready for us.

Sterilization

A:rry item that has been prepared with caps, stop}llrs and rubber tubing, and any other material that will not withstand temperatures up to 1800 C (3560 F), must be sterilized with steam. If sterilized with steam (autoclave), loosely packed items should be exposed to temperatures of 12loC (250ClF), for a period of fifteen minutes. Closely packed items require thirty minutes. If sterilized in an electric sterilizer (hot air), thin-walled items should ~ exposed to I80ac (3560F) for a period of sixty minutes. Thick-walled items and those packed in containers such as pipette and petri dish cans require a sterilization period of 120 minutes. Empty containers, such as flasks, bottles, etc., should be placed in auto­claves horiZontally, never up-right, unless they contain a liquid. If items have caps or stoppers, trey should be placed on loosely until after sterilization. If items are not used immediate:!8", caps and stoppers should be tightened to avoid possible contamination. Items requiring storage should be placed in a dust-free room.

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5.

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Space and eguipnont reguired for the preparation of scientific glassware and related items

5.1 The minimum amount of space required for handwashing would be approximately 100 square feet per r:erson. This area should be equipped with separate sinks for washing and rinsing and a source of appropriate processing water. An electric hot plate or some heating apparatus can be used for boiling purposes if boiled water is required. Containers (prefer­ably stainless steel) should be available for soaking, boiling and rinsing. Carts or some type of carriage should be available for transporting glass­ware from the wash area to an area for inspection and preparation.

5.2 The minimum amount of space required for machine washing should be approximately 150 square feet r:er person. This area should be equipped with a sink, washing machine, a1d a work table for sorting glassware. Wire baskets or some type of container would be necessary to contain, transport and dry the glassware after removal from the washing machine racks (headers). A steam heated cabinet or an electric dryer should be available for drying the glassware as soon as possible to prevent dust from accumulating on the wet glasswareA Glassware should be inspected and packaged in an area separate from the washing.

6. Personnel

Personnel responsible for supervlSLng glassware preparation should have a thorough knowledge of standard concepts and systems of sterilization and be familiar with various ty:p::s of necessary equipment and materials employed in processing glassware. Non-supervisory personnel can be recruited from a cCJTll1lon labour pool and with pror:er training can be utilized in most phases of the operation •

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APIENDIX 8

pOSSIBIE AMERICAN SOURCES OF EQUlOONT AND MATERIALS

L Turbomatic Ivasher - Better Built Machine Company, New York, N. Y. Approximate cost - $5000. Headers for various types of glass­ware - approximately $450 each.

2. Electric Hot Air Sterilizer - Precision Scientific Canpany, Chicago, Illinois. Catalog number 1256. Approximate cost, $1500.

3. Temperature recorder (used with electric hot air sterilizer) -The Electric l.uto-Lite Canpany, Toledo, Ohio. Approximate cost, $65.

Water Demineralizer - Barnstead Still and Demineralizer Compaqr, Lanesville Terrace, Boston 31, Massachusetts. Model number MM5. Approximate coet, $8000 (produces 1500 gallons p:>r hour - smaller capacity apparatus can be purchased).

5. Still for single distilled water - Consolidated Machine Corpora­tion, Boston 14, Massachusetts. Model N. P. S. 30, approximate cost, $1000. (Produces 30 gallons per hour).

6. Autoclave (steam sterilizer), Type 21. iuoorican Sterilizer Co., Erie 1, Rmnsylvania. Approximate cost, $1500.

7. Acid Vats - any of such constructed with acid resistant materials (stainless steel, etc.).

8. Technicon-automatic Pipette \-Iasher - Technicon Company, New York, New York. Approximate cost, $75.

9. Machine lJashing Detergent - Brand narre, "Soil-A-Way" - Economics Laboratory, Inc., St. Paul 1, Minnesota. Approximate cost, 18 cents per pound.

10. A mild hand washing detergent - brand name, lITetroxll - Economics Laboratory, Inc., St. Paul 1, Minnesota. Approximate cost - 2 cents per pound.

11. Decontaminant - Brand name:

a. "O-Syl" - I.ehn & Fink Products Corporation, Bloomfield, New Jersey.

b. "Liquor Cresoles Saponatus", U. S. P. XIII NF -Baird & McGuire, Inc., Holbrook, Massachusetts.

- 106 -

12. Glassware

a. Corning Glass Works, Corning, New York.

b. Kimble Laboratory Glassware, Owens-Illinois, TOledo 1, Ohio.

A reference for sterilization procedures - IIA Textbook of Sterilizationll , by vJeeden B. Underwood, obtainable from ilmerican Sterilizer Cc:rnpany.

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APIENDIX 9

FOSSIBIE AMERICAN SOURCES CF EQUIFMENT AND MATERIALS FOR MEDIA PREPARATION

1. Eguipnent

a. Harvard Trip Balance, !-1odel 3450, double beam, maicimum capacity two kilos. Cost, $25. Will Corporation, ROChester 3, New York.

b. Steam Autoclave, various sizes, obtainable from .American Sterilizer Company, Erie, Pennsylvania.

c. Glassware - all standard tn;es available from:

(1) Fisher Scientific Company, Chicago, Illinois. (2) A.S. Aloe Company, St. Louis, Mo.

d. Brewer Automatic Pipettor, electrically operated model 40. Approximate cost, $180. Viill Corporation, Rochester 3, New York.

e. Cornwall Pipettor, hand operated. Cost approximately $8 plus $2.50 for a two-way valve for continuous pipetting. Will Corporation.

f. Seitz Filter Unit, 2 litre capacity. Cost, approximately ~175. Republic Seitz Filter Corporation, 17 Stone Street, Newark 4, New Jersey. (Filter material obtainable in sized pads or sheets).

g. Beckman pH Meter, Mode 1 G. Approximate cost, $450. Will Corporation. (pH test paper also obtainable from this source, Cost, $2 and up. Ccmplete set, $15).

2. Materials

a. Standardized dehydrated culture media and other supplies.

(1) Difco Laboratories, Inc., Detroit 1, Hichigan. (2) Baltimore Biological Laboratories, 1640 Gorsuch

Avenue, Baltimore 18, Maryland.

(Preparation manuals are available from both ccmpanies and are valuable aids in pre paration of media.)

b. Dyes and Color Indicators

(1) Difco Laboratories, Inc., Detroit 1, Michigan. (2) National Aniline Division, Allied Chemical and

~ Corporation, 40 Rector Street, New York, N.Y. 0) Fisher Scientific Ccmpany, Chicago, Illinois.

- 108 -

c. Chemicals

(1) J. T. Baker Chemical Company, Phillipsburg, N. J. (2) Nutritional Biochemical Corporation, Cleveland 28, Ohio. (3) Fisher Scientific Company, Chicago, Illinois.

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Specimens or Procedures

A. Milk

B. Water

C. Food

• ~ "

t

SANITARY BACTERIOLOGICAL EXAMINATIONS

Small Clinic Regional Public

Laboratory County Hospital Health Laboratory

. Plate Counts Yes + Chemistry

. Yes Yes

Co Hection of Collection of Yes Specimens Specimens

--- ---- -

\ r ~

National Reference Laboratory

2~J.!l!L Yes+Ref. +Evaluation

Yes~Ref. +Evaluation

Yes + Ref.

~ -- -~- ---

, . ..

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b

I

~ ~

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EXAMINATION OF AIR

Specimens or Small Clinic County Regional Public Procedures Laboratory Hospital Health Laboratory

Air pollution - Collection of Collection of specimens specimens

Analysis in spe-cific problem areas

• ~ ,

National Reference Laboratory

Reference. Training Analyses:

Spectrophotometry Differential miGration Chemical Radiochemical

I I

1 , ,

II>

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I:!

•

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•

RADIOLOGICAL EXAMINATIONS

Specimens or Small Clinic Regional Public County Hospital

Procedures Laboratory Health Laboratory

A. W'ater - ? Gross Radioactivity

B. Food - ? Gross Radioactivity

~

National Reference

Laboratory

Chemical Separation Specific nucleotide

determination Reference. training

Chemical Separation S:Jecific nucleotide

determination Reference, training

~

, I

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~

~ E3 !;:!

~

.... . ~

.. ,. k

Procedures Deases or Agent I. Stained Smears

A. Gastric washings T.B. B. Sputum or saliva T. B. and pneumonia C. Spinal fluid Meningitis D. G. C. smears Gononhoea

E. Pharyngeal swabs Diphtheria staph, Strep &

Penumonia . II.

A. Gastric washings T.B.

B. Sputum or saliva T. B. &, Penumonia C. Spinal fluid Meningitis D. G. C. exudate Gonollhoea E. Pharyngeal swabs Diphtheria

Staph, Strep. & Pneumonia

F. Fecal swab or stool Enteric pathogens

G. Blood Enterics, ;:,:·-"'~'_1·1,

,':.; 'x'oo';::::' Leptospira

H. Urine T.B.

-- Leptospira

III. Biochemical Tests '0 •• -..:_ v

T.n. Fer.nentation, inhibit ion Meningitis by dye, or drugs. metabolic Gonorrhoea activity measuremer.ts. Diphtheria nitrate reduction. ea:'oon Staph & Strep. assimilation. etc. Enteries

B.-ucella Tula~ense

_ .. - ~ --~---------

Key: F. P. M.P. R.C.

Fresh primary specimen Mailed primary lpecimen Reference check specimen

" ,

BACTERIOLOGICAL EXAMINATIONS

I Level No. I Level No.2

Small County HO!pital Clinic Lab.

F.P. M.P.

Yes Yes Yes Yes Yes Yes - Yes Yes

Yes Ye s Yes Yes Yes Yes - Yes Yes

- Yes Yes - Yes YES - Yes Yes - - -- - -

- Yes Yes - Yes Yes' -

Yes Yes - Yes ±::~ - -

- Prelim. Pr~1im.

- Yes Yes - - -- Prelim. PrelIm. - Prelim Prelim. - Prelim. Prelim. - Prelim. Prelim.

- I!)elim. Prelim. _._----- ~-----.-

.. -)l It ,

Level No.8 Regional Public Health Lab.

F. P. M.P. &R.C.

Yes Yes Yes Yes ~ Yes Yes Yes Ye s Yes Yes Yes

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes Yes

Yes Yes Yes Yes Yes Yes

Confirm. Confirm. Confirm. Confirm. ~ ~e; . Vel

Confirm. Confirm. Confirm. Confirm. Confirm. Confirm. Conflrm. Confirm. Confirm. Confirm. -----~-.--

• •

Level No.4 Nauonal Ref. Lab.

R.C.

Yes Yes Yes Yes Yes Yes

Yes "6s Yes Yes Yes

Yes Yes

Yes Yes Yes

TInal ident. Final ident. Co::~itm.

Cu;..nrm. Confirm. Confirm.

Confirm. Confirm.

,

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I

1--' 1--' V1

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Level No. I Level No.2 .. evel No.3 Level No.4 Small ~l1nlC County Hospital Regional Public Health Lab. National Ref.

Procedures Disease or Aeent Laboratory Laboratory

IV. :serolOCY F. P. M. P. F. P. M. P. & R.C. R.C.

C. F.. precipitin. agglutina- Syphilis - C. F. Tests C. F. Tests C. F. Tests C. F. Tests Confirm. tion. quellung. agar- gel Enteries - Prelim. Prelim Confirm. Confirm. Confirm. techniques, etc. Brucella - Yes Yes Confirm. Confirm. Confirm.

Tularense - Yes Yes Confirm. Confirm. Confirm. Staph & Strep. - - - Yes Yes Confirm. Pneumonia - Yes Yes Yes Yes Confirm. Suep. - Yes Yes Yes Yes Confirm. Leptospira - Prelim Prelim Confirm. Confirm. Confirm.

V. Pathogenicity Tests

(Laboratory animals) T.B. - Yes Yes Yes Yes . Confirm .

Diphtheria - Yes Yes Yes Yes Confirm.

~ Leptospira - Yes Yes Yes Yes Yes rl

VI. Histopathology I tI'issue sections. biopsy. etc. Leprosy - - - Prelim. Prelim. Confirm or refer

IV II. Anaerobic Techniques

Clostridial infections. - - - Yes Yes Final ident.

clostridial food poisoning

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PARASITOLOGICAL EXAMINATIONS

Level No.1 Level NO.2 Level No.3 Level No.4

Procedures Diseases or Small Clinic Regional Public National Reference

and Organisms Laboratory County Hospital Healtb Laboratory Laboratory

Specimens F. P. F. P. M.P. F. P. M.P. R.C. M.P. RoC.

I. Wet Mounts A. Feces Protozoa & Helmintb Yes Yes Yes Yes Yes 1 - -B. Urine Schistosomes Yes Yes Yes Yes Yes 1 - -C. Sputum Paragonimus Yes Yes Yes Yes Yes 1 - Yes

D. Blood Mi crofilariae Yes Yes - Yes - - - -E. Rectal Biopsy or Amebae. Schistosomes Yes (if col- Yes - Yes - - - -

Aspirates lected)

II. Stained Thin and I Thick Blood Films Malaria, Filaria Yes Yes Yes Yes Yes Yes - Yes

I III. Stained Fecal Smears

I aDd Rectal ASl!itates Ameboe, Schistosomes - - Yes - Yes Yes - Yes

I IV. Concentration

A. Feces ~tozoa (cysts) , Helminths (eggs, larvae) - Yes Yes Yes Yes Yes - Yes

B. Blood Microfilariae - Yes Yes Yes Yes Yes - Yes

V. Egg Counts on Estimation of worm burden - - - Yes - Yes - Yes

Intestinal Helminths

VI. Direct examina- Identification of vectolS. inter- - - - - Yes - - Yes

tion of Arthropods. mediate host. etc. snails. etc.

VII. Immune-diag-nostic

A. Elmmplement- Schistosomes. Paragon, Echino •• Fixation Leishm ania. Filaria - - - - - - Yes -

B. Hemagglud- Echinococcosis - - - - - - Yes -nation

C. Bentonite Trichina - - - - - - Yes -flocculation

D. Dye test or F. A. inhibition Tox0.l!lasma - - - - - - 1 -

• • •• k f' .~

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MEDICAL' MYCOLOGICAL EXAMINATIONS

Level No, I Level No.2 Level No.3 Level No.4

Procedures and Diseases or Small Clinic Lab. County Hospital Regional PUblic Health Lab. NaUonal Ref. Lab.

Specimen s Organisms F. 1'. ~'. 1'. M.P. F. P. t..r.v. I<.~. I<. \,;. ~

I. Wood's Light Exam. Yes Yes Yes ~ [" Yes Yes Yes Yes

A. Hair Ipermatophytes , !l. Wet Mounts

A. Hair Piedra Yes Yes Yes Yes YeA Yes Yes

B. Hair. skin. nails (KOH) Dermatophytes Yes Yes Yes Yes Yes Yes Yes C. Skin Chromoblastomycosis Yes Yes Yes Yes Yes Yes Yes D. Sputum Rhinosporidiosis Yes Yes Yes Yes Yes Yes Yes

E. Bronchia! washings Yeasts. mycelium. granules Yes Yes Yes Yes Yes Yes Yes F. Pus Yeasts. mycelium. granules Yes Yes Yes Yes Yes Yes Yes G. Spinal fluid (India ink) Yeasts. mycelium. granules - Yes - Yes Yes Yes Yes

IIi. Stained Smears

A. Sputum (gram & Yeasts. Actinomycetes Yes Yes Yes Yes Yes Yes Yes

acid- fast) B. Mucous memb.

scrapings (Gr~ & Wrighll Yeasts.- Histoplasma Yes Yes Yes Yes Yes Yes Yes

«llpsulatum ~ C. Blood (Wright or '. o

Giemsa) H. capsulatum Yes Yes Yes Yes Yes Yes Yes

I D. Bronchial washings Yeasts. Actinomycetes - Yes Yes Yes Yes Yes Yes

IV. Cultures ~

A. All clinical materials All pathogenic fungi 1. Inoc. 0 f media Yes Yes Yes Yes Yes Yes Yes

- 2. Ideot. of isolates - Prov. ident Prov. Ident. Yes Yes Yes Yes

V, Biochemical tests for ident Dermatophytes. yeasts. of fungus cultures Actinomycetes - - - Yes Yes Yes Yes

VI. Pathogeniclty tests Ident. of fungus cultures C. neoformans. Actina- - - - Yes Yes Yes Yes

mycetes ~

VII Histopathology >-tJ ttl

A. Biopsy spec. & autopsy All subcutaneous and sys- S SpecimEn. tematic mycoses - Col. biopsy Col. biopsy Yes Yes Yes Yes

~ VllI. SerologY specimen specimen

A. C. F. Tests Histoplasmosis Col. blood and pal. blood pol. blood teol. blood <'I - - Yes t't refer. & Refer ~ refer refer

B. Skin tests Histoplasmosis - - - - - - :Ves

F.P. - Pl .. 11 primary specimen; M.P. - Mailed prim ary specimen; R. C. - Reference check specimen.

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- 121 -

LABORATORY HAZARDS IN HEALTH LABORATORIES

by

Dr. G. Briggs Phillips Research Scientist

Center for Safety Education New York Uriiversi~

New York, U.S.A.

1. INTRODUCTION

Although microbiologists have been aware for many years of the hazards attending their profession, systematic study, evaluation and correction of these hazards is a developnent which has received accelerated attention only during the last ten to fifteen years. It is characteristic that as general disease decreases, the relative importance of specific causes of disease increases. The laboratory is the I! cause I! of many ill­nesses among public health laboratory workers in the sense that it is in the laboratory that many workers become infected with the micro-organisms with which they work. The purpose of this paper is to discuss some overall aspects of the problems, and several approaches to its control.

2. THE mOBIEM

Hazards in the infectious disease laboratory fall into two prin­Cipal categories: (1) those that cause physical injuries, cuts, burns, explosions and fires, and (2) those that cause laboratory-acqnired ill", nesses. This paper cbals with the second category.

Necessarily one nrost ask, "Is laboratory-acquired infectious disease a problem in the public health laboratory?" The degree of affirma­tion determines the degree to which an infection-prevention programme is needed. However, one finds that all too often directors of laboratories do not keep adequate records of accidents and illnesses. Thus from memory the director may attest that there has been only one tuberculosis infection in the tuberoulosis laboratory durin6 the past five years. But when we realize that only three people work in this laboratory, we know that the "infection rate" is almost 7 per oont or more than 37 infections for each million man-hours worked! Furthermore, there is often a tendency to assume that an illness in a laboratory worker has been acquired elsewhere. With­out medical, microbiological and immunological investigation, the true source of many illnesses is never aclmowledged. Thus lacking adequate investigation and statistics it is difficult to measure the extent of the problem. Nonetheless, it is evident that in many infectious disease lab­oratories, occupationa1Jy incurred infections create serious moral, morale and economic problems.

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So far it has not been possible to ascertain the world-wide fre- .... quency of laboratory illnesses, but several local surveys of interest have been conducted. In the United Sta'..es Sulkin and Pike collected information on 1342 laboratory infections in which the fatality rate was 3%. One hundred sixty-seven of these infections occurred in public health lab-oratories. -This study, thI'ough a committee of the iunerican Public Health Association, has been expanded and now includes 2262 infections. D.D. Reid, in London, studied the frequency of tuberculosis among workers in 345 medical laboratories and found the incidence of pulmonary tuberculosis to be from 2 to 9 times greater than would be expected from the normal population in his country. During a recent tour of 111 medical and public health lab-oratories in 18 countries the author 1-TaS told of a total of 358 laboratory infe~tions. Most laboratories where human pathogens were handled had had laboratory-acquired illnesses. Few laboratories could claim an infectiqn- -~

free record. Regardless of the past record, ma.'1Y laboratory directors, particularly directors of laboratories with public health functions, were genuinely concerned about the ability of their laboratories and staffs to function satisfactorily in the event of sudden and/or large-scale outbreaks of infectious disease in the population. It was especially noted that th3 sudden necessity to handle infectious agents coe.ld create havoc when individual immunity among the staff and correct procedural techniques had not been established. It is an appropriate aim of a public health laboratory to be able to function efficientIy and at full strength during times of epi<ilmics or national emergencies.

But the concern need not be entire~r about those agents we tend to classify as-highly infectious such as tubercle banilli, psittaCOSis, brucella, etc., because mismanagement (or ;.;rong manipulation) of low grade pathogens or even so-called non-pathogens can lead to trouble. The problem of staphylococci infections in hospitals can servo as an example as well as the fact that thero ho.ve been at least recorded eleven fatal infections with Serratia marcescclns, a common_, red pigmented soil ::,rganism.

Yet another aspact of t.he prcblem is that the same faulty pro­cedures or accidents "hich '~'-luse h1JlT'arl infection can be responsible for cross-contamination of cult1l."'C and c:::'oss-infection of animals. These two factors may challenge the va~idity of laboratory diagnostic or experimental results.

3. AP3COil.GlffiS TO TIE FROBIEN

What approaches can be used in controlling laboratory hazards? Most approaches are obvious and, of those to be mentioned, SC!IIB are inter­related. Some can be applied in any laboratory because no expenditure of funds is required. Others require the expenditure of money and, therefore, may not be always possible. For convenience the approaches or methods for controlling laboratory-acquired infectious diseases ~~e listed as (1) vac­cination, (2) use of correct techniques ~nd procodures, (3) use of safety equipnent, (4) building facilities, and (5) management aspects. Under managenent aspects arc included a number of important functions such as programming, regulatin~, reporting, traini:ng and selection. -"

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3.1 Vaccination

Vaccination of laboratory p;rsonnel is certainly recommended when a satisfactory immunogenic preparation is available. Good immunity is conferred after vaccination against smallpox, tetanus, yellow fever, botulism, cholera, diphtheria, and typhoid. Other vaccines such as those for pSittacosis, Q fever, tularemia and anthrax have or are being tried exp;ri1nentally with varying degrees of success. But immunogenic prepara­tions have not been as yet develop;d for a number of human diseases which have been known to occur in laboratory workers; illTlong these are dysentery, blastomycosis, brucellosis, coccidioidomycosis, glanders, histoplasmosis, infectious hepatitis, leptospiroses, Rift Valley fever and toxoplasmosis. We generally evaluate the efficiency of vaccines for laboratory workers on the basis of their effectiveness in preventing disease in the general population. Two possible pitfalls to this line of thinking should be men­tionech The first is that the public health worker may be exposed in the laboratory to infectious micro-organisms at a much higher dose level than would be exp;cted from normal putlic exposure. Secondly, this exposure may be by a route different from that normally exp;cted, e. g., respirator,)" infection with tularemia or anthrax organism.

The next three control methods, use of correct techniques, use of safety equipnont and prop;rly designed laboratories, rest on the same two pillar stones. One states that almost any manipulation with infectiOUS

. cultures will result in the release of a measurable quantity of micro­organisms frcm the environment of the pipette, test tube or flask to the workers 1 environment. This has been the subject of much laboratory investi­gation and is relatively easy to demonstrate. The second urt<ilrlying principle is that through the use of sp;cial techniques, equipnent and facilities, accurate and scientific control of environment is possible which will reduce or eliminate laboratory-acquired infections.

3.2 Techniques and procedures

Hany procedural rules for laboratory safety are obvious; same are not. Avoid mouth pipctting of infectious or toxic fluids. Use only needle locking syringes. Sterilize all contaminated discard material. FrequentJ;v disinfect hands and working surfaces. Do not smoke, eat or drink in tho laboratory. These rules certainly are well known and should be observed.

Other procedural rules may be less well understood and require more explanation. (1) Do not blow out the last drop from the pipette. (2) Do not mix dilutions by blowing air through the pip;tte into the culture. 0) Wear gloves when handling infectious fluids in a syringe. (4) Use an alc ohol soake d pIe dget when remOving a syringe and nee dIe from a rubber stoppered vaccine bottle. There arc a number of others having to do with procedures such as centrifuging, grinding tissue, lyophilizing, etc.

Information on such rules and the reasons for their recommended use exist, although at the present sufficient communication channels ma;y be lacking. Rules or procedures pointed toward the elimination of air­borne contamination arc the most difficult to institute and enforce. Once

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the fundamental concepts of how aerosols may be produced by ordinary lab­oratory techniques are understood, the laboratory supervisor should attempt to design safety into new procedures and tests which are developed the idea being to eliminate or to modify those steps or manipulations which are the most hazardous.

3.3 Safety eguipnent

The most important single piece of safety equipoont in the infectious disease laboratory is the ventilated work cabinet. The basic requirelOOnts for such a cabirot are: (1) sufficient inward air flow (at least 50 linear feet per minute) or operation at a negative pressure, (2) filtration of exhaust air, and C)) means of sterilizing both the exhaust filter and tho interior of the cabinet.

Other tyres of safety equipnent have been developed because of the difficulty 'in safe~ carrying out certain procedures such as blending and centrifuging. Sane have been resigned to facilitate carrying out certain operations in ventilated work cabinets. Much equipnent is com­mercially available and source information can be made available. A partial list of safety equipment would include inoculating loop incinera­tors, pipet tor devices, safety centrifuge cups, safety blendor bowls and filter masks. The latter are mentioned because of tho .roll-known inefficiency of the common hospital gauze mask in filtering out airborne particles. Filter masks with high filtering efficiencies suitable for laboratory or animal room work are now available. However, since the ventilated cabinet externalizes an entire working area instead of the worker, it is genera~ tho first type of safety eqUipment which should be provided.

3.4 Building facilities

Construction criteria for laboratories which augment and improve safety have been develop;d and are available. Hore and more, as the demands upon the microbiologist increase, certain building design features cease to be mere advantages and become necessities. iunong these may be mentioned (1) building ventilation (2) control of direction of air movement, (3) biological filtration of air, (4) separation of areas of different risk levels, (5) use of germicidal gases and radiations and (6) separation and improvement of animal holding facilities. Hodern building criteria for laboratories do much to reduce infectious risks and to prevent laboratory infections.

3.5 Management aspects

The last method of controlling 'laboratory' hazards, the manage­ment approach of programming, regulating, reporting, training and select­ing, is perhaps the most important, although it is interrelated and over­laps with the other approa::hes mentioned. The management approach also attempts to include control of the "human factor" in the application of the other principles.

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Any programme of loss-prevention is based on the dual premises that (1) the loss (in this case laboratory-acquired illness) is the result of a series of events which result in an accident and, (2) accidents are largely preventable by controlling these events. Translated to terms of our own problem it simpJ.;r means this:

1.

2.

Accidents or wrong techniques create conditions for infection. Remember that the techniques may not be recognized as being wrong because, fram the biological point of view, they may not havo been "safety tested".

If the accident was preceded by any predisposing human or physical factors, these must be corrected in order to prevont the accident which causes the infection.

The following are a few suggestions for the management approach to the control of laboratory hazards. These are, of course, pOinted toward the real focal point of public health laboratory - the laboratory workers. People have emotions, people have personal needs, people are motivated in one direction or another. Therefore, we must use the management approach with a certain understanding of these "human factors".

1.

2.

3.

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6.

7.

Establish written safety regulations that are read and uncbrstood by all.

Train each new employee until it is certain that he understands the rules and why.

Follow a schedule of retraining old employees.

Keep tho safety needs in mind when screening and selecting new employees.

Inasmuch as possible, design safety into techniques and procedures as they are developed.

Establish responsibility for safety. Each supervisor should be responsible for the safety of his people, but each employee should have a personal responsibility safety should be a part of every job.

Establish a formal system for reporting aCCidents, lost­tiloo injuries and infections and insist on prcmpt reporting.

8. Invostigate each illness and each accident to deter­mine what should be done to prevent recurrence.

9. Encourage suggestions for eliminating laboratory hazards from workers at all levels.

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CONCLUSION

It is understandable that not all public health laboratories would need to employ all of the suggestions made in this paper. These suggestions are mere~ a composite of the approaches used to control laboratory hazards in a large number of laboratories. While it is obvious that the needs of public health laboratories in various parts of the world will vary a great deal, it is also apparent that a better interchange of infonnation will be beneficial to all.

Modern-d<\V public health and medical practices should be supported by laboratory services which are just as modern. Control of the laboratory infectious risks through vaccination, the use of correct techniques, the use of safety apparatus, the resign of laboratories and by eertain manage­ment functions contributes to overall control of laboratory environment and thus to the ability of the infectious dissase laboratory to perfonn its proper function efficiont~ and without interruption.

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INTERNATIONAL AND BILATERAL COLIABORATION IN RJBLIC HEALTH L.ABallTORY ACTIVITJES

by

Dr. R. Sansonnens Chief Medical Officer

Health Laboratory Services WHO Headquarters, Geneva

THE ROIE OF WHO IN FROMOTING AND ASSISTING NATIONAL PUBLIC HEALTH LABORATORY SERVICES

The am of the vlorld Health Organization, as set out in its Con­stitution, is to raise the standard of health of all peoples of the world to the highest possible level - health being defined as complete physical, mental and social well-being and not merely the absence of siclmess or infirmity. In working towards this end it is necessary to develop all activities related to the health of the individual and of the community in a well-balanced manner.

In a national health service, a well-organized laboratory ser­vice which undertake s both clinical and public health laboratory work is essential. Such a service can provide a great deal of the scientific information that is needed to orientate not only curative and preventive work but also the activities developed in many of the specific disciplines contained in a national health service. It is perhaps unnecessary to mention the great importance of laboratory work in improving epidemiological research in the control of infectious diseases, and in prOviding diagnostic facilities in the stuqy of degenerative diseases, comparative pathology, environmental factors and occupational health.

One of the roles of WHO in strengthening national health services is to promote, stimulate and assist the development of laboratory services. At the same time, the Organization fulfills its task as a directing and co-ordinating agency by organizing an international network of reference and co-operating laboratories which provide facilities to national health services, and by establishing international standards of different kinds.

The assistance that is available from MlO may be outlined as follows:

1.1 Information

With the collaboration of governmental services, non-governmental organizations in official relationship with WHO and members of the Expert Advisory Panels, and with the help of specialists in the many laboratory disciplines, information is collected on the organization, functioning and equipment of laboratories, on laboratory methods, on the training of laboratory techniCians, and on laboratory research of international interest. This information is analyzed and annotated. Some of it is

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published in the Bulletin of the World Health Organization or in the WHO International Digest of Health Legislation; some is distributed in mimeo­graIiled form to interested laboratories and to technical consultants work­ing in the different field projects of the Organizatio~ and some may serve as the basis of working paJErs for Expert Committees, Study Groups and Scientific Research Groups on subjects on which the opinion and advice of highly qualified sp3cialists are desired.

After they have been approved by the Director-General, the reports of Expert Camnittees and Study Groups are printed in the Technical Report Series, which are distribut~d to governments, organizations, libraries, etc. and also put on sale. Papers on scientific subjects and articles dealing with technical subjects are published in the WHO Bulletin if they contain information that is new or of value. Thus a wide and speedy distribution is ensured of general information and technical data that are of interest to laboratories and facilitate contact between laboratory workers. Thanks to the close relations that exist between i.JHO and a large number of laboratories and institutes, it is relatively easy to obtain, and to provide a government service or any other body with, the information it wishes to have.

1.2 Technical services

In order to facilitate production and control of biological pro­ducts and pharmaceutical preparations as well as obtain comparable results of laboratory tests, WHO provides the faciliws mentioned below:

L2.1 Pharmaceutical preparations

(i) Specifications for checking the quality of pharmaceutical pre-parations to ensure that products are placed on the market possess a fixed and satisfactory therapeutic action and have no harmful secondary effects; these specifications do not, however, insist on such purity of the prepara­tions as to make them unduly cost~ to produce. Once adopted, these specifications are included in the International Pharmacopoeia or are distributed separately.

(ii) Selection of international non-proprietary names for pharma-ceutical preparations in order to obviate the confusion resulting from the use of different non-proprietary naIllls for the sarre medicinal substances.

(iii) The establishment in Stockholm of a Centre for huthentic Chemical Substances, which distributes these substances, free of charge and on request for analytical purposes, to national administrations and laboratories and institutes working on a non-profit making basis. Eight such substances (see Appendix 16) are nOW available, and it is proposed to include seven­teen others in the list.

1.2.2 Biological standardization

With the object of ensuring world uniformity in the potency of preparations which are used in the prophylaxis, therapy or diagnosis of human and animal disease and cannot be adequately characterized by chemical

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and physical rooans, the following services, 'Which had already been started by the Health Ccrrunittee of the league of Nations, are being continued and expanded by WHO:

(i) The International Laboratories for Biological Standards at the Statens Seruminstitut, Copenhagen, and the National Institute for Medical Research, London, are custodians of all International Biological Standards and International Biological Reference Preparations recommended by the WHO Expert Committee on Biological Standardization. These two laboratories distribute samples of the preparations, free of charge, to national lab­oratories responsible for the official control of biological products in all countries, and through them, or in special circumstances directly, to the firms engaged in the production of biological preparations.

(ii) Countries that do not possess the laboratory facilities necessary to enable them to unoortake all the tests of biological products required by 1irHO may seek the collaboration of, and send their products to, other countries that do not have such facilities.

1.2.3 Methodology and diagnostic reference services

In order to help increase the production of vaccines of the h~h­est possible quality, the uniform use of reference standards and prepara­tions, and the preparation, control and use of antigens and diagnostic sera, "lv1IO stimulates and encourages the use of methods tested and recom­mended by exr:erts on the subject, which are then communicated to such national and other laboratories as make a request from them.

DiagnOSis poses important problems of nomenclature and classi­fication, the diversity of which constitutes a serious handicap to the suc­cess of canparative studies of geographical pathology and of epidemiological surveys. With the aim of promoting unifOrmity and consistency throughout the world in the identification and nomenclature of cells, micro-organisms and pathological tissues, WHO has officially established a number of International Reference Centres, thus strengthening the efforts of certain national and international scientific associations in this direction. For example, centres study and red blood cells, identify micro-organisms and pathological tissues according to internationally accepted classifications, standardize antigens and sera for the diagnosis of the treponematoses, and identi~ the snail vectors of bilharziasis. (The names and addresses of these centres are given in Appendix 17.) Sane of the centres work in close collaboration with a retwork of corresponding national centres designated by the governmants at the request of HHO. For example, there are about fifty national reference centres for SaJrnonella-Shigella and Escherichia coli, and 58 for influenza. The expansion of national centres for blood-grouping is under way, and there are plans for an international centre for phage typing, one for arthropod-borne viruses and one for animal tumours. All the centres have been set up in institutes or lab­oratories where the specialists rank among the first in their particular field. Generally, the functions of the international reference centres are the following:

(a)

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to collect, identify, and classify material submitted to them;

(b) to suPPJ¥ antigens, diagnostic sera, and reference preparations;

(c) to check the quality of antigens and diagnostic sera submitted for contro~

(d) to carry out research in the fields concerned; and

(e) to accept for training WHO fellows, or students recom­mended by WHO.

There are also a great many laboratories, some supported, some not, which collaborate with WHO in diagnostic reference work for polio­myelitis virus and the ~cobacteria, the production of antigens and sera for viruses and the rickettsiae, and the testing of insecticides and mol­luscicides.

1.3 Education and training facilities

The greatest problem encountered in assisting in the organization of laboratory services is the training of personnel. Needs differ, of course, from one country to another, but usual~ assistance comprises the provision of:

1.3.1 Visiting professors

At the request of governments and institutions, WHO may provide the services of a visiting professor, either to strengthen or develop cer­tain disciplines or to carry responsibility while a national of the country is being trained.

1.3.2 Fellowships to professors and staff of institutions

for post-graduate training for observation of techniques and methods

Each WHO Regional Office discusses needs with the ,governments of the countries in its region and agrees on the purposes of 8Qd the number of fellowships to be made available for each country. The proposed programme for all countries of the region is discussed at the Regional Canmittee meeting. Apart from providing funds, vlEO I s task is to organize the most useful prograrrme for each fellow. In most countries there is a selection committee in which WHO may partiCipate without vote. It is the government in each case that proposes the candidates, who will have a specific aSSignment on their return home, but WHOIS final approval is needed.

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For post-graduate training, the length of the fellowship should be such that the candidate receives adequate training of a type that will enable him to carry out his future responsibilities. There is no point in his being trained in very advanced techniques in an institute with facilities that Will not be available to him in his CAin country. At the sane time, however, he should have the opportunity to visit same leading institutions in order to enlarge his views and concepts in preparation for future devel­opnents.

Training courses

WHO organizes yearly, at regional or inter-regional level, training courses on diagnostic methodology. Each course lasts about four weeks and is given free of charge to some twenty laboratory workers. The courses are especiaD.y designed for laboratory speCialists of more or less the same experience, to give them practical training in new techniques or to improve their technical mow-ledge in a field of particular interest for national problems and international collaboration. Fellowships are awarded to enable people to attend these group training activities.

1.3.4 Training of laboratory technicians

In addition to providing fellowships for laboratory technicians to be trained by apprenticeship or in schools in the Regions, WHO is ready to advise and assist governments in establishing training courses for laborator,1 technicians by providing teaching staff and, to a limited extent, equipnent. Such courses may also be part of a project dealing with the organization or strengthening of a national laboratory service. Curricula and the distribution of theoretical and practical work, as well as in-service training, should be carefully plarmed and should take into account the trainee's standard of general education, the needs of the country, and the necessity to make the trainee's chosen profession an attractive one.

1.3.5 Educational meetings

WHO also organizes certain educational meetings to which specialJ¥ qualified persons are invited, in order to give them an oppor­tunity to exchange opinions and experiences. A report of the proceedings may be issued, and recommendations made.

1.4 Organization of laboratories

In addition to the above -mentioned services, WHO may be requested to provide technical assistance in the organization of laboratories. This organization, which is in fact of the greatest importance, may be of several kinds:

(a) organization of laboratories in campaigns against cOOllllunicable diseases such as tuberculosis, malaria, venereal diseases and treponematoses;

(b)

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organization of laboratories as an integral part of rural health demonstration centres;

(c) organization of clinical laboratories in teaching institutions;

(d) organization of vacc:ire and serum production depart­ments or specialized research work;

(e) organization or strengthening of a national laboratory service.

Requests far assistance in the organization of laboratories are discussed by the Regional Offices with the countries concerned. After final approval by the World Health Assembly, the goverIlIlEnt interested and the appropriate WHO Regional Office jointly sign a plan of op;lration in which are defined, ~ alia, the objectives for which WHO assistance is required, the plan of action, the target date for completion, and the commitments of WHO and of the government. The "planop" also contains the prOvision that the government should provide facilities for future evaluation of the project and give an assuranoe that it will continue the programme, within the scop;l of its available resources, after WHO assistance has ceased.

The assistance given by tho Organization usually consists of the provision of certain personnel and a limited amount of material.

Agreements are normally made for a period of frcm one to two years. This period can be extended if the government has fulfilled its commitments and can make out a case for the continuation of \\THO assistance until the country can itself carry on the progranme in op;lration.

A project is thus valid if the programme planned is within the financial possibilities of the country. The main object of villO assistance is to help in the organization of an official activity or service, and to train national p;lrsonnel.

1.5 Medical research

In pursuance of Resolution WHAll. 351 of the Eleventh World Health Assembly, carried in June 1958, a programme of intensified medical research was planned by WHO to start in 1960. The Twelfth vlorld Health Assembly, in its Resolution \-JHAl2.172, approved this project on the grounds "that the plan presented constitutes a logical continuation and extension of established \-JHO activities" and "that more extensive and intensive inter­national co-operation among the research workers of the world is required to prevent, control and cure disease ll • The il.ssembly recognized that

\rna Official Records No. 87, page 388

2wH0 Official Records No. 95, pages 443-444

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"there is a world-wide shortage of qualified scientists and that the general research potential of the world needs to be increased", and that "WHO has an important role to pI<\)" in increasing this potential and in fostering international collaboration among the scientists of the world by stimulating, co-ordinating, promoting and supporting research".

In consequence of this, there has already been a considerable increase in the number of research projects undertaken by the Organization within the framework of its normal activity. Further programmes are in course of preparation and WHO is extending its co-ordinating role in the field of research, in collaboration with many research workers and in closer contact with national and international scientific associations.

Well-trained and highly qualified IEople are esscntial in this field, and it is to be hoped that the laboratory services in the countries in process of devolopnent will, by degrees, be able to provide the tYIES of workers indispensable to intensified medical research.

1.6 Summary

The present activities of WHO in promoting, stimulating and assist­ing national public health laboratory services are as follows:

(a) diffusion to governments and institutions of useful selected information and of eXIXlrt opinions and recommendations on alJ. questions related to laboratory organization and work;

(b) prOvision of advice and information when requested;

(c) organization of advisory and educational meetings in order to provide spacialized tenching and technical staff with the opportunity to discuss common problems and exchange eXIErience;

(d) provision of advisory IErsonnel and (a limited amount of) equipment for the organization of a national laboratory service or of special laboratory activities;

(e) establishment of technical services and reference centres to facilitate world uniformity in diagnosis and in the production and control of biological products, pharma­ceutical preparations, antigens and sera;

(f) assistance to projects for the training of all kinds of teaching and technical laboratory personnel,;

(g) co-ordination in each country of the assistance available frem bilateral and international agenCies; and

promotion of assistance to and co-ordination of medical research.

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2. THE UTILIZATION OF RESOURCES AVAILABIE FROM BILA'lERAL AND INTERNATIONAL AGENClES FOR rEVELOPING NATIONAL RJBLIC

HEALTH LABORATORY mOORAMMES

The external assistance available to countries to develop their national health service in general or any of its component parts, such as a laboratory service, is as follows:

2.1

(a) that provided by the United Nations and its Sp3cialized Agencies, and

(b) that provided by one country to another (bilateral assi,stance) or by a group of countries which ma,y not be bound by agreements of mutual assistance (multi­lateral assistance).

Sources of financing of WHO and joint international health programmes

The activities of the World Health Organization are financed by the contributions of its Member Governments and by funds from other organiza­tions as well as VOluntary contributions. The main resources of WHO are as follows:

2.1.1

(a) WHO Regular Budget (b) The Malaria Eradication Sp3cial Account (c) Voluntary Fund for Health Prcmotion (d) Expanded Programme of Technical Assistance (e) UNICEF (f) United Nations S}:flcial Fund (g) Other extra-budgetary funds

The WHO Regular Budget

The Regular Budget of WHO is made up of money voted each year by its Member Governments. The scale of assessment of WHO is based on that of the United Nations, taking into account the difference in membership and the establishment of minima and maxima including provision that no country should be required to pay more p3r capita than the f€r capita payment of the highest contributor.

2.1.2 The Malaria Eradication Sp3cial Account (MESA)

The Malaria Eradication Sp3cial Account was established by the Eighth World Health Assemb~l in Mexico in 1955 in a resolution in which governments and indivichlals were asked to subscribe towards the total eradication of malaria. The Organization encourages governments to devote more of their national budgets to eradication and tries to p3rsuade the governments of countries which do not suffer fro~ malaria to subscribe to the Account for the benefit of those which do.

lResolution \1HA8.30, Handbook of Resolutions and DeCisions, 5th ed, p. 25.

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2. L 3 Voluntary Fund for Health Promotion

This Fund was established by the Thirteenth World Health AssemblYl in Geneva in 1960 to include the following sub-accounts to be credited with voluntary contributions received, the value of contributions in kind and interest earned on investments of money in the Fund:

2.1.4

(a) (b) (c) (d) (e)

General Account for Undesignated Contributions Special Account for Smallpox Eradication Special Account for Medical Research Special Account for Ccmmunity Water SupplY any other special accounts which may be placed in

the Fund by the Executive Board or the Health Assembly.

Expanded Programme of Technical Assistance

The Technical Assistance Programme was established by the United Nations in 1949. Funds are derived from voluntary contributions pledged and paid by governments to the Special Account for the United Nations Expanded Programme of Technical Assistance and are made available to the organizations which will carry out the projects. WHO is responsible for the health aspects of general economic developnent programmes undertaken.

2.1.5 UNICEF

The United Nations Children's Fund was formed just after the war to grant aid to many of those countries which had suffered. It is not a technical agency and its'purpose is primarily that of fund-raising to make available supplies and equip!lllnt in countries wrore there is a scarcity and to give certain other material assistance. UNICEF does not give WHO actual money to spend but collaborates with the Organization, e. g., by providing supplies for some of its field progranmes, mainly those dealing with maternal and child health, control of communicable diseases and nutrition. They assisted to a very great extent in the Yaws Programme and provision of insecticides for many WHO malaria projects. All UNICEF-assisted activities require the technical approval of WHO iv-hether or not WHO is directly concerned in their operation.

2.1.6 United Nations Special Fund

This Fund provides assistance to important projects with an eco­nomic aim and \~1I0 in acting as the EJ(6cutive Agency of this Special Fund is charged with the responsibility for implementation of approved S:r:ecial Fund projects in the field of health.

~esolution WHA3.24, Off. Rec. WId Hlth Org. 102, 7.8

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2.1.7 Other extra-budgetarY funds

These concern public health activities administered by the Pan American Sanitary Bureau and financed by the Member States of the Pa.'1. American Health Organization, as well as those provided by agencies such as the Organization of American States and the Institute of Nutrition of Central .America and Panama.

2. 2 Chronology of WHO programme

The planning, developnent and implementation of the WHO programme for a single year extend over a :r:eriod of three years which are referred to administrativeJ,y as the planning year, the approving year, and the operat­ing year.

lntnediately after the conclusion of the meetings of the World Health AssembJ,y and of the Executive Board session which follows it, the Director-General issues instructions to the regional directors regarding the preparation of programme proposals for the second succeeding year. The instructions indicate the tentative allocations of funds to each region. The

0

Regional Directors plan programmes in consultation with the government and, where appropriate, in collaboration with any other interested bilateral and multilateral agencies, on the basis of requests received from the governments. The projects accepted by the regional directors are anaJ,yzed and converted into acceptable budgetary terins for submission to the respective Regional Committees. After that, the proposed programme and budget estimates of each region are submitted to the Director-General together with the comments and recommendations of the Regional Ccmmittees. After revision, the annual proposed programme and too budget estimates of WHO as a whole are submitted for examination to the Standing Committee on Administration and Finance and the Executive Board. They are then sub­mitted to the World Health Assembly for review and approval, together with the COlllllents and recommendations of the Executive Board.

The developnent of the three years budget cycle of WHO may be summarized as follows:

Planning Year

( up to August/Se ptember ( ( ( August/September ( ( September/October ( (0 October/December ( (

Preliminary regional planning with governments

Submission to Regional Committees

Submission to the Director-General

Revision, consolidation and production of proposed programme an d budget estimates

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Approving ( Year (

( ( Hay (

O}:Elrating ( Year (

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Consideration by the Standing Committee on Administration and Finance and the EJrocutive Board and submission to the i-lorld Health Assembly with the recommendations of the Board

Revision and approval by the World He alth J..s sembly

Implerren tation

This explains why, apart from emergencies and unforeseen con­tingencies for which the "Executive Board Special Fund" of us $10 0 000 has been established, it is not possible to obtain assistance from the WHO Regular Budget for the year in vlhich the request is made, or for the year follOWing it •

2.3 Chronology of tho programmes of Technical Assistance and UNICEF

The programme planning procedure of those two agencies mqy be sum­marized as follows:

2.3.1 Expanded Programme of Technical Assistance

( March or April Country targets and agency sub-totals ( established by TAB (Technical ~ssistance { Board) (

The ( May/June Regional planning with governments planning (

and ( July/ August Co-ordination of country programmes; approving ( submission of country programme to TJU3

year ( by government ( ( October/December Review by TAB; review and approval by ( TAC (Technical i,ssistance Committee) ( and the General .h.ssembly of the United ( Nations

Operating ( Implementation year (

This shows that the budget cycle under the Expanded Programme of Technical Assistance beginS the year preceding the operating year. Priority in assistance is given to continuing projects.

- 138 -

2.3.2 UNICEF

The cycle far programming and allocation in UNICEF differs from that of WHO and Technical Assistance. Allocations for any year for supplies and equipnent and for within-country training stipends are made by the UNICEF Executive Board on two occasions in that year. In projects jointly assisted by UNICEF and 1:JHO, allocations are made by the UNICEF Executive Board upon receipt of approval by WHO of the technical aspects of projects requested by governments.

Owing to these differences between the budget cycles of WHO, UNICEF and Teclmical Assistance it is sometimes possible to include in the WHO programme additional projects, financed or supported by contributions from the other agencies, for implementation earlier than would be possible under the \·JHO Regular Budget (e.g., under the TAB Contingency Fund).

2.4 Co-ordination between WHO and bilateral and multilateral assistance

As the directing and co-ordinating authorit,y in the field of inter­national health, WHO endeavours to obtain the collaboration of all the groups responsible for bilateral and multilateral assistance - for example, ICA (International Cooperation Administration) - which have their own programme~ This can be at two levels:

(i) C:ropcration at government level by t.h3 creation of a national committee for co-ordination of technical assistance in the health fie lds comprising:

The Minister of Health of the comtry The -V-ffiO Area Representative The medical director of the agenqy providing the

bilateral or multilateral assistance Representatives of other international agencies

su::h as UNICEF or UNESCO

(ii) Co-operation at regional or inter-regional level by means of meetings between WHO and the bilateral agency, designed to bring about mutual understanding and a common policy.

2.5 Utilization of resources

In order to achieve the optimum use of available resources, the following conditions should be observed:

(i) There should be a national plan of development based strictly on the financial possibilities of the country concerned.

(u) There should be ccmplete co-ordination in the planning and implementation of the progrrnrumes of the different agencies. Duplication and differences in principle should •

t,_..Ji:

- 139 -

be avoided, and the governments should do everything wi thin their power to facilitate co-ordination of prof,'I'ammes.

(iii) A system should be evolved whereby a project can be evaluated during the course of its operation, so that any deficiencies observed can be remedied. It is important to follow up the progress of the project after outside assistance has come to an end; ani above all, everyone concerned should be able to use the experience thus gained in other projects. It is essential that for planning, implementation and evaluation there should be close collaboration between WHO and any agencies providing bilateral or multilateral assistance.

Utilization of resources so far as laboratory projects are con­cerned takes the follOwing forms:

(a) provision of consultants to assist in the technical and administrative planning of a laboratory service, in the construction of laboratory buildings, in the training of laboratory personnel, etc. Usually such consultants are engaged for psriods of from one to three months.

(b) prOvision of laboratory advisers for the implementation of long-term projects. The organization of a laboratory service in a develop­ing country will take at least five years and should be followed by evaluation to determine whether the assistance should be continued or not. A unified laboratory system combining both clinical and public health lab­oratory activities presents great advantages from the points of view of efficiency, economy, training and supervision of personnel and standardiza­tion of equipnent and methods. The preliminary planning should take into account the present state and future needs of the health service, the number of laboratories already established, the number, type and quality of personnel, the equipnent available, and the national finanCial resources. The first step is to organize too national central laboratory for diagnosis and for training laboratory personnel. University graduate staff may at first need training abroad. At the same time the personnel working in the small hospital lci:lOratories should receive revisionary training. Progressive development of the other functions of a central laboratory will folloW, such as the production of the most important vaccines and the control of pharmaceutical preparations - locally produced or imported. For such a project a senior laboratory adviser, assisted by a chief laboratory technician, may be needed; later short-term consultants could be recruited to assist in the implementation of new functions, preferably after the local staff has been trained abroad.

(c) provision of visiting professors to assist in the training of the scientific staff in post-graduate courses in a Faculty of Medicine or Science. If such schools do not exist in the country, fellowships should be given for undergraduate and postgraduate training abroad. It is essential that postgraduate training should be of such length as to

- 140 -

permit candidates to undertake their duties competently on their return. The ftrst period of training should not be in institutes where too student would be trained in the use of very exrensive apparatus, which most probably would not be available in his own country. The assistance of WHO to developed countries or to research workers from any country generally consists of fellowships for postgraduate training in specialized research. For that the programme should be carefully planned.

(d) provision of laboratory equipnent. If expensive or very complicated apparatus is being provided, it is essential to ascertain first whether the available laboratory rersonnel will be able to use it. It is also important to provire the necessary spare parts for any major apparatus.

2.6 Sunmary

The efficienqy and effectiveness of laboratories depend not only upon the quality of their technical personnel, facilities, etc., but equally upon their organization as a Public Health Laboratory Service fully integrated into the National Health Service.

To be of greatest benefit to a country, too assistance from various agencies and organizations should be used to support a well plaIlIlfld programme based upon national reeds and material resources. Assistance is limited, and is intended to help governments to develop activities which they will continue when outside assistance has ceased.

WHO Regional Offices play an essential role in planning and co­ordinating international assistance on all aspects of public health. Any country wishing to request assistance to develop health programmes will find the Regional Directors and their area representatives always ready to advise them.

3. THE ROIE OF NATIONAL PUBLIC HEALTH lJI.BORATORY SERVICES TIJ INTERNATIONAL HEALTH

It has already been stated that a tedmically well';'organized lab­oratory service, integrated with the national health service, is indis­rensable to the developnent and efficient working of all public health activities. From the point of view of international health, the role of national laboratory services is particularl,y important in the following spheres:

).1 Epidemiology and tre control of cOOlJ1lunicable diseases

3.1.1 Quarantinable diseases

It is recognized that, of the six diseases subject to the Inter­national Sanitary Regulations, smallpox alone represents a world problem, by reason of the ever increasing volume and sreed of international traffio •. Often the cases imported into a country are atypical and all the more difficult to diagnose clinically because the disease has disappeared from

'-­--

- 141 -

so many places and doctors are unfamiliar with it. It is, therefore, essential that national laboratories should be in a position to diagnose the disease quickly and with certainty in order to reduce the number of contacts to a minimum and obviate the considerablo expense that may arise from an uncertain clinical diagnosis. The other quarantinable diseases -plague, cholera, yellow fever, typhus, and relapsing fever - no longer have their former international importance. In the areas where these diseases are found their epidemiological significance has been extensive~ studied. They may, however, still spread outside these areas. In some of these areas the phYSicians are well acquainted with the clinical picture of these diseases, and local laboratories can undertake the necessary examinations. But in countries where they are less frequently found, laboratory workers are not always experienced in their diagnosis, and they should know to which specialized laboratories in neighbouring countries they can apply for assistance.

3.1. 2 Rapidly transmitted communicable diseases

In gemral these are the virus diseases, the best example of wh:'..crc is influenza. In influenza the relatively short period of post-infectious immunity and the appearance of new mutants make it difficult to prevent the clevelopnent of epidemics. An etiological diagnosis of influenza can only be made in woll-equipped laboratories capable at least of isolating the virus, which can afterwards be identified in a reference centre. In this way, it is possible to follow the developnent of an epidemiC, and should the virus prove to bo particularly viru1ent a vaccine can be produced from the strain in question soon enough to protect the inhabitants of the areas farthest amy from the axis of infection.

3.1.3 Food-poisoning outbreaks

A great many of these are caused by Salmonella infections, which are often spread from one country to another through exported and imported foodstuffs, in particular powdered eggs and tinned meats and fish. By quickly tracking down the infection, and by the use of phage typing, it is possible to stop the distribution of the contaminated material and even, sometimes, to trace its epidemiological origin. The matter can then be drawn to the attention of the health authorities of the country concerned.

3.2 Control of biological and pharmaceutical products

There is a wide commercial distribution throughout the world of biological and pharmaceutical products, and it is essential that their therapeutic value and their actual potency correSpOnd with what is shown on their labels. It is the role of national lrooratories to verify that products of this kind manufactured in a country or imported into it are up to the standard indicated and can be administerod to people without danger. The use of International Biological Standards and Reference Preparations, as well as of the specifications established and recommended by WHO for checking the quality of Fharmaceutical preparations, has made possible uniformity in the methods of control and safety in the utilization of imported and locally mude products. In addition, it protects

- l.42 -

international commerce in biological and pharmaceutical preparations by giving to the manufacturers an assurance that their products canp~ with established criteria.

3.3 Research in human pathology

Studies undertaken in various countries have shown that the incidence of certain diseases that are clinically identical varies con­siderably from one country to another and from one population grrup to another, and that certain races show a greater tendency than others to be attacked by a particular disease. These observations open new perspective, for research into hereditary, ccnstitutional, conununicable and degenerative diseases. All too countries in process of being developed should, little by little, be able to participate in such research, and, by a study of their own problems, be in a position to contribute to the better understand­ing of those of the world as a whole. They must be helped through inter­national collaboration, which means the transfer of technical knowledge already acquired in the more developed countries, technical assistance in its different forms, and facilities for an extensive exchange of research workers.

It is by means of international collaboration and co-ordination of effort that all countries can contribute efficiently and fruitfully to progress in all fields of health.

,. ~,

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ii(-

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I •

- 143/144 -

WORLD HEALTH ORGANIZATION CENTRE FOR JJJTHENTIC CHElVIICAL SUBSTlillCES

APFENDIX 16

The authentic chemical substances nOW available at the Cer~re are listed below together with the unit and size. Most packages contain sufficient material for about twenty assays. All shipnents are made by surface mail except when airmail is requested.

Size

Chloramphenicol Dig i toxoside Ergometrine maleate Nelarsen

5 capsules of 2 capsules of

300 milligrams 10 milligrams 10 milligrams

1 gram Oestrone 30 milligrams

65 milligrams 30 milligrams

Progesterone Tubocurarine Vitamin A Acetate (this is an oily

approximately 8.6 milligrams of Vitamin A Acetate)

solution of 5 capsules of (0.344 micrograms of Vitamin A Acetate is equivalent to 1 International Unit - W1d H1th Org. tech. Rep. Sere 1950, 20 34)

rencies. made for

Each package costs US$4.00 or the equivalent amount in other cur­The shipment by surface mail will be made free. A charge will be

the despatch whenever airmail is requested.

Please send your orders and make cheques PIVab1e 1 to:

Contre for Authentic Chemical Substances Apotekens Kontrollaboratorium Lindhagensgatan 128 Stockholm Sweden

lIt is not intended to make arw charge for tho substances to national administrations or laboratories and institutes working on a non-profit basis, and a charge for despatch will only be made when airmail is requested.

( .it

- 145 -

APFEND:lA 1.7

WHO DlTERNATIONAL CENTRES AND REFERENCE LABORATORJES AND WHO/FAO REFERENCE CENTRES

1. International Centre s for Biological Standards and Reference ITeparations

1.1 International Laboratory for Biological Standards Statens Seruminstitut Amager Boulevard 80 COj:enhagen S Denmark (present ~ting director: Dr. P. Krag)

1.2 International Laboratory for Biological Standards National Institute for Medical Research The Ridgeway Mill Hill London, N.W.7 United Kingdom (present acting director: Dr. D. G. Evans)

2. Centre for Authentic Chemical Substances

2.1 Apotekens Kontrollaboratorium Lindhagensgatan 128 Stocki1oJJn Sweden (present acting director: Dr. N. Diclding)

3. International Blood Group Reference Laboratory

3.1 Lister Institute Chelsea Bridge Road. London, S.W.l United Kingdom (present school director: Dr. A. E. Mourant)

4. International SaJmoneUa and Escherichia Centre

4.1 Statens Seruminsti tut Amager Boulevard 80 Copenhagen S Denmark (present acting director: Dr. F. Kauffmann)

- 146 -

5. International Shigella Centres

5.1 International Shigella Centre : Central Public Health Laboratory Colindale Avenue London, N.W. 9 United Kingdm (pre sent acting director: Dr. S. T. Cowan)

5.2 InternaiiionaJ. Shigella Centre Conununicable Disease Centre '* ' AUanta 22 U. S. A. (present aciiing director: Dr. W. H. Ewing)

6. Internaiiional Enteric Fhage Typing Centre ..-

6.1 Ceniiral Public Health Laboratory Golinda1e Avenue London, N.U.9 United Kingdom (present aciiing direciior: Dr. E. S. Anderson)

7. Serological Reference Genues

7.1 International Treponematosis Laboratory Genue -.., School of Microbiology Johns Hopkins University 725 Noriih \-T olie Sueeii Bal timore 5, Maryland

" u. s. A. -(present acting director: Dr. T. B. Turner)

7.2 Serological Reference Centre for Treponematoses Staiiens Seruminstitu~ Amager Boulevard 80 Co~nh!!;gen S Denmark (present acting director: Dr. H. A. Nielsen)

7.3 Venereal Disease Research Laboratory Canrnunicable Disease Centre P.O. Box 185 Chamblee, Ge orgia U. S. A. (presenii acting direr-tor: !lir. Ad. Harris)

~,

-pi'

I "

"

..

- 147 -

B. Reference Centre for Testing RepositoEY Fenicillins

9.

8.-1 Food and Drug Administration Antibiotics Division Washington 25, D.C. U. S. A. (present acting director: Dr. William W. Wright)

Gonococcus Centre

9.1 Statens Seruminstitut Amager Boulevard BO Copmhagen S Denmark (present acting director: Dr. Alice Reyn)

10. International Influenza Centre s

10.1. World Influenza Centre National Institute for Medical Research The Ridgewa;v M:i.1l Hill-London, N.W. 7 United IUngdom (present acting director: Dr. C. H. Andrews)

10.2 International Influenza Centre for the Americas Communicable Disease Centre Atlanta 22, Georgia U. S. A. (pre sent acting director: Dr. R. Q. Robinson)

ll. Polionvelitis Centres

ll.l The Poliomyelitis Research Foundation South African Institute for Medical Research Hospital Street Johannesburg Union of South Africa (present acting director: Dr. J. H. S. Gear)

ll.2 Section of Epidemiology and Preventive Medicine Yale University School of Medicine 333 Cedar Street New Haven ll, Con. U. S. A. (present acting director: Dr. J. R. Paul)

u.:3 Insti tut Pasteur 25 rue du Dr Roux Paris XV Franee

- 148 -

(present acting d:lrector: Dr. P. Lepine)

U.4 Virus Research Laboratory The Hebrew University Hadassah Medical School P. O. Box 1172 Jerusalem Israel (present acting director: Dr. H. Bernkopf)

u.5 Department of Bacteriology University of Malaya Singapore Malqa (present acting d:lrector: Dr. Lee Liang Hin)

11.6 The National Institute of Health Kamiosaki-Chojamaru Shinagawa-Ku Tokyo Japan (present acting director: Dr. S. Koj:iJn.a)

1.2. Snail Identification Centres

12.1 Malaria and Bilharzia Research Laboratory P. O. Box 8105 Causewa;v Salisbury South Rhodesia (present acting director: Mr. H. V.de Vill.iers C:UU-ke)

12.2 Laboratoil'e de Malacologie Museum National d'Histoire Naturelle 55 rue de Buffon Paris V -_. France (present acting director: Dr. G. Ranson)

12.:3 Danmarks Akvarium Gharlottenlund Copmh~n Denmark (present acting director: Dr. O. Mandahl.-Barth)

... I

• ,.,. ,

...

, it·

- 149 -

13. International Referenoe Centres for the Histopathological of Tumours

1.3.1 International Reference Centre for Lung Tumours Institute for General and Experimental Path_logy of the University Oslo Norwa;y-(preseRt acting director: Dr. L. Kreyberg)

1.3.2 International Reference Centre fer Soft Tissue Tumours Armed Forces Institute of Pathology Washington 25, D.C. U. S. A. (pre sent acting director: Dr. D. J. Winslow)

U.3 International Reference Centre for Mammary Tumours Bland-Sutton Institute of Pathology Middlesex Hospital London W.l United Kingdom (present acting director: Dr. R. W. Scarff)

WHo/FAO Leptospirosis Reference Laboratories

14.1 Laboratory of the Queensland Department of Health and Home .Affairs Brisbane, Queens:i..and Australia (present acting director: Dr. A. Fryberg)

14. 2 Istitute Superiore di Sanita Viale Regina Elena 299 Rome Ita4r (present acting director: Dr. B. Babudieri)

14.3 Department of Viral and Riokettsial Diseases National Institute of Health Kamiosaki-Choj amaru Shinagawa-Ku Tokyo Japan (present acting director: Dr. M. Kitaoka)

- 1S0 -

14.4 Institute for Tropical Hygiene and Geographical Pathology Royal Tropical Institute Mauri tskade 57 A Amsterdam Netherlands (present acting direetor: Dr. J. c. Wolff)

l.4.5 The WellGome Laboratories of Tropieal Medicim The Welleome Building, Euston Road London, N.W.1 United Kingdan (present acting direetor: Dr. L. H. Turner)

14.6 Division of Veterinary Medicine Walter Reed Arrrr:r Institute of ResearGh Walter Reed Anr!y Medical Centre Washington 12, D.C. U. S. A. (present acting director: Dr. A. D. Alexander)

15. WHO,IFAO Brueellosis Centres

15.1 Division of Brueellosis and Tuberculosis Department of Zoonoses Ministry of Agriculture and AniInal Husbandry Buenos Aires Argentina

15.2 Commonwealth Serum Laboratories Parkville N.2., Victoria Australia

15.3 State Veterinary Serum Laboratory B~t'lWsve j 27 Co~nhagen Denmark

15.4 Centre de Recherches sur la Fi9vre ondulante Insti tut Bouisson-Bertrand Montpellier France ~nt acting dire"tor: Dr. 1. Carrere)

..

..

..

- 151 -

15.5 Veteri~ Microbiological Institute Botanikos

15.6

Athens Greece (present acting director: Dr. C. Melanides)

Indian Veterinary Resear~h Institute Mukteswar-Kumaun Uttar Pradesh India

15.7 Centre for the Stu~ of Brucellosis Institute of Hygiene and Microbiology Vial.e G.B. Morgagni 48 Flo:rence Italy (present acting director: Dr. G. Mazzetti)

15.8 National Institute of Animal Health Kodaira-machi, Kitatama-gun ~ Japan (present aoting dire.tor: Dr. M. Kobayashi)

15.9 Medical Research Institute General. Hospital Mexico, D.F. Mexico (present acting director: Dr. l'I. Ruiz Castaneda)

15.10 Institut Pasteur Tunis Tunisia

15.11 Institute of Veterinary Bacteriology and Serology Fendik Istanbul Turkey (present acting director: Dr. R. Durusan)

- 152 -

'15.12 Onderstepoort Veterinary Laboratory Onderste poort Union of South Afrioa

15.13 Ministry of Agriculture, Fisheries and Food Central Veterinary Laboratory New Haw \-Teybridge Surrey United Kingdom (present acting direotor: Dr. A. vT. Stablcforth)

15.14 Department of Medicine University of Minnesota Minneapolis, Minn. U. S. A. (present acting director: Dr. 1\-. 1'1. Spink)

15.15 Brucellosis Centre state Laboratory of Hygiene Rijeka Yugoslavia (present acting director: Dr. V. Rukavina)

... '"'

~,

-

0745

0815

0915

1015

1230

1330

1430

1530

1615

1730

1845

- 153/154 -

SCb~DUIE OF FIELD VISITS 9 De cember 1960

wave Bay View Hotel

.ANNEX III

l~rive Rizal Provincial Hospital at Pasig to visit Regional Public Health Laboratory for Regional Health Office No. III.

Leave Pasig for Alabang.

J~ive in Alabang. Visit to installation of Department of Health Laboratories for vaccine and serum production, BCG laborator,r, etc.

Luncheon offered by the Director of the Bureau of Rosearch and Laboratories and his staff.

Leave Alabang for Manila.

Arrive North General Hospital to visit hospital clinical laboratory.

Visit laboratory facilities of Bureau of Research and Laboratories at Plasma Building.

Visit Public Health Laboratory of the Manila Health Department at Quiricada Street.

Merienda Party offered by the Chief of Public Health Laboratory of the Manila Health Department and his staff.

Return to Bay View Hotel.

It

.- 155/156 -

ANNEX IV

SUMMJillY OF INTERIM EV hLUATION OF THE SEMINiIR

Two questionnaires including various questions on the organiza­tional and administrative aspects and the immediate effect of the project were used in the interim of the seminar (see Appendix 18 and Append:i.x 19). The participants, sixteen in number, and the observers, three in number, were requested to put a tick opposite each statement in whichever column would best express their considered opinion. There were three columns for each statement which indicate whether the seminar was considered good, fair or unsatisfactory in terms of its arrangements and in respect of its effect. In addition, the respondents were asked to give their frank opinions, suggestions and comments, since the forms were to be unsigned.

The questions on the administrative and organizational aspects of the seminar received 162 replies, of which 78.4% indicated that the meeting arrangements were "goodl1 , 16.0% "fairtl and 5.6% tlunsatisfactorytl (see Appendix 18).

The questions on the immediate effect of the meeting collected 152 replies, of which 63.8% considered the effect of the seminar "goodtl , 34. 9% 1! fair II and 1.3% "unsatisfactory" (see App:mdix 19).

From the above results of analysis and from the comments and sug­gestions made by the respondents (see ilppendix 20), it is apparent that the seminar was well arranged and was proceeding satisfactorily.

..

....

1 •

2.

3.

4.

- 157/158 -

APFENDIX 18

SUMMiillY OF INDIVIDUAL INTERTI1 APPRAISAL OF THE ilDMTInSTRATIVE ASFECTS OF THE SEMINlill

Reception on your arrival in Manila was:

satisfactory __ ~11~_

The accommodation is:

good 14

Payment of per diem is:

efficient 10

adequate

fair

satis­fact,ory

1 -----

o

5

inadequate 2

unsatisfactory ____ O __

unsatisfactory ____ O __

On the whole the information bulletins were:

pertinent and helpf'ul 17

of some value o

of no value °

5. Working papers were received in:

6.

7.

8.

9.

10.

Total

ample time for study 13

insufficient time for 1 study

no time for study

On the whole the library and reference facilities are:

poor adequate 16 inadequate ---° Length of the working day is:

too heavy just right 12 too short ----2

Time spent in presentation of topic is:

just right 11 too short 6 ----'- too heavy

Time spent in discussions is:

just right 14 too short 3 ---'-- too heavy

Free time e.vailable for r:srsonal matters and rest is:

just right 9 too short too heavy 8 ---

127 26

fur Cent 16.0

3

1

3

°

o

° TOTAL

9 162

5.6 100.0

-

, /

/ ...

- 159/160 -

SUHMARY OF INDIVIDUAL INTERIM APPRJaSAL OF 'IHE IMMEDIATE EFFECT OF THE SEMINAR

What is your opinion regarding the effectiveness of the following:

Very Effective

1. Presentation of topic

2. Discussion groups

3. Plenary discussions of group topics

4. Do you feel that the

6

8

5

objectives of the Very much seminar are being attained in the discussions you have had so far 13

5. In the discussions, do you feel that everyone has the opportunity and is able to express his views with freedom? 15 ------

6. Do the discussion guides assist the group in pinpointing the concepts and problem areas where exchange of views and group thinking are most required? 14

7. Considering the composition of the seminar group, do you feel that too specialties are adequate~ represented in your group? 13

8. Despite your familarity with too subjects, does your participation in the topic discussions with your col­leagues afford you a learning expo rie nce

9. Do you think that the discus­sions in your group meetings will find application in your

14

home country situation? 9

Total 97

Fer Cent 63.8

Fair~ Effective

10

9

12

To some extent

3

2

3

4

3

7

53

34.9

APJENDIX 19

Not Effective

1

o

o

Too LittJe

o

o

o

o

o

1

TOTAL

2 152

1.3 100,0

•

•

"

A

, ..

1.

- 161 -

COMMENTS .AND SUGGESTIONS ON THE SEMINIlR (Interim)

Arrival

APIENDIX 20

( a) Somebody should be wait ing at airport. What was the use of tlFersonal Data Formtl to notice the arriving time?

(b) Everyone in the "WHO Headquarters was very accommodating.

(c) Reception by hotel porter not satisfactory. It is sug­gested that an administrative staff suitably identified by a badge of office should be at airport.

(d) The only difficulty was at the airport where it took rather long to pass through usual formalities especially in collecting luggage. This is an airport problem.

2. Acc OOlIllodation

(a) It is surprising to find so many cockroaches which are ap-parently resistant to DDT.

(b) The hotel accommodations ccmpare very well with those in other cities of its size.

( c) Good but costly.

3. Finances

(a) Satisfactory but I would rather have US$16 because US$16 x 3 = 1'48.

(b) The cashier was very acccmmodating in even giving full pay­ments for the whole period.

(c) Just adequate.

(d) Satisfactory but if we have a little more it is better. So we would not have to eat at a little coffee shop with doormen and other labounnen who look at us with one eye. We would like to have per diem for those days we came before the meetings. (Days suggested by WHO's papers.)

(e) Insufficient.

- 162 -

Pre-Seminar Information

However, it is suggested that working papers should first be re­viewed by the seminar staff to look into possible chances of misleading participants. This can plrhaps be obviated by the preparation of working paplrs on any single subject by only one authority.

s. Reference Libr~

(a) We have more than enough considering the very l:iJnited time available for library work.

dule.

6.

(b) Adequate but could not be used because of the tight sche-

In what ways may the seminar staff and the administration of WPRO be of further assistance to you?

(a) To send out to our resplctive countries further information which would assist us in seeing whether what came out of the seminar has been made use of.

(b) Stimulate our government to improve our system of labora­tories in order to use effectively our resources.

(c) Technicnl advice later on. WPRO can help in giving infor­mation bulletins.

(d) Having made personal contact, future relationships should be simplified.

(e) More literature (even mimeographed).

(f)

(g)

Excellent, thank you.

Nothing to be added: all eminent.

(h) Dissemination of any news and technical information that may be available in the future.

(i) By allowing participants to communicate with the seminar staff and the WffiO on the progress of possible implementation of our recom­mendations. Last but not least, the WPRO is requested to provide all participants with the final editions of the seminar proceedings and recom­mendations.

(j) Strong recommendation to our country's administrator to apply the conclusions carried out.

(k) By grDnting fellowships to visit laboratories in more developld countries.

•

-

•

•

.,

....

•

•

- 163/1.64 -

7. Additional comments and suggestions

(a) Such like seminars should be organized at regular intervals.

(b) Expand Information Bullet:in No. 3 into a booklet lithe conduct of a WHO regional seminar". Although there was an outline given and more detail subsequently in the introduction, those members who being newcomers require some re-orientation by the very nature of their occupa­tion, may miss out on spoken instruction even in what to other lTBmbers is elementary. This applies particularly to the chairman, also information regarding typing assistance.

(c) It is recommendable to have a discussion after tte full and detailed introductions of their own countries.

(d) WPRO should encourage participating governments to convoke a follow-up seminar or conference on the subject by their own health workers involved in the effective implementation of a laborato~ service for the whole country.

(e) Better to fill in this sort of paper later, s~ in the next week, or question tWice, in early days and later, in order to obtain more accurate impressions and comments.

(f) We are strangers in a strange city. '-Ie would appreciate assistance in seeing the sights and how to spend our leisure hours fruitfully. This applies especially in the days waiting for the seminar (early arrivals) and after (late oopartures).

(g) "Social" asp:;cts seem to have been left out.

(h) The guide seems to be vague and sometimes overlaps. This can be remedied in the introduction or presentation. The vagueness is probably due to language problem.

(i) Too much of tho representatives are on the top echelon; there seems to be no one who runs an organization at a lower level •

i ~.

....

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SUMMARY CF FINAL EVALUATION CF THE: SEMINAR

Following the end of the seminar, two questionnaires were dis­tributed for completion by the participants (sixteen in number) and the observers (three in number), in order to assess more accurately than the interim evaluation the organizational and administrative aspects and the immediate effect of the seminar, as the impression and the judgment of the respondents were supposed to be more accurate at the end than in the interim.

There were three columns for each question which indicate whether the seminar was considered good, fair or unsatisfactory in terms of its arrangements and in respect of its effect (Appendix 21 and Appendix 22). The respondents were requested to check the appropriate statements and to give their frank criticisms, suggestions and comments, as the forms were to be unsigned.

The questions reflecting the organization and administration of the seminar received 190 replies, of which 69.0% indicated that the seminar arrangements were Itgoodlt , 26.8% II fair lt and 4.2% "unsatisfactory (see Appendix 21)

The questions reflecting the immediate effect of the project col­lected 169 replies, of which 48.5% considered the effect of the meeting "good", 48.5% "fair" and 3.0% "unsatisfactory" (see Appendix 22).

From the above results of analysis and from the suggestions and comments made by the participants and observers (see Appendix 23), it may be inferred that on the whole the seminar was very successful in its organization and administration, and successful in its immediate achieve­ments.

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APFENDIlC 21

SUMMARY OF INDIVIDUAL FINAL APFRAISAL OF TIE ADMINISTRATIVE ASFECTS OF THE SEMINAR

The total length of the seminar was:

Satisfactory 15 Too short 2 Too long

The schedule of the seminar was:

Satisfactory 7 Too crowded 11 Too loose

The working hours of the meeting were:

Satisfactory 11 Too short 0 Too long

The leadership of the meeting was:

Excellent 10 Satisfactory 8 Poor

Documentation to cover the subject matter was:

Excellent 6 Satisfactory 12 Poor

Library and reference facilities were:

Adequate 16 Limited 1 Poor

1

0

7

0

0

0 ---Opportunities to become acquainted with participants, observers and staff were:

Ample 16 Not enough 2 None at all o The amount of free time available for personal matters and rest was:

More than Adequate 10 Not enough 7 enough o

Physical arrangements such as meeting place, etc., were

Unsatis-Good 13 Adequate 3 factory 0

Accommodation and service were:

Good 10 Adequate 5 Poor 0

The amount of entertainment furnished was:

Just right 17 Not enough 0 Too heavy 0

Total 131 51 8

Per Cent 69.0 26.8 4.2

T 0 T A L

190

100.0

/

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SUMHARY OF INDIVIDUAL FINAL APffiAISAL OF TIlE :G1MBDIATE EFFECT OF THE SEMINAR

APFENDIX 22

1. Were you interested in this seminar?

Very much To some extent 2 -.::.--

Very little __ 0_

2. Did you learn any new things or acquire any new ideas?

3.

A great many

10 Some 7 N one at all _....;O~

Did you have enough opportunity to express your own ideas at the meeting?

Ample 13 Not enough 4 None at all 0 ---"--

4. Did you have enough opportunity to exchange lmowledge and experience with participants, observers and staff outside the seminar?

Ample 10 Not enough 6 None at all _-=1:...-

5. To What extent do you think the seminar fulfilled its purpose as defined in the objectives?

Beyond 2 Completely 14 Incompletely 1 expectations

If the answer is "Incanp1eteJy" give further details:

6. In addition, each of you came with specific objectives and expecta­tions. To what extent do you feel these have been attained?

8.

Beyond expectations If the an swer

3 Completely 12 Inc anple te ly_-=2,--

is "IncompleteJy" give further details:

The following are your impressions of the discussions of the topics:

(a) Introductory session

Excellent 5 Good 11 Mediocre 0

(b) Group discussions

Excellent 1 Good 10 Mediocre 0

(c) Plenary meetings

Excellent 4 Good 12 Mediocre 0

The seminar has been to you:

Of consid- 13 Of some value 4 Of little 0 erable value value

If tlB answer is "Of little value" state why:

T o T A L

Total 82 82 5 169

:Fer Cent 48.5 48.5 3.0 100.0

....

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•

, .'-0

2.

- 171 -

COMMENTS AND SUGGESTIONS ON THE SEMINAR (End of the Seminar)

APFENDIx: 23

Looking back on the seminar programme are there any revisions that you think might have made the experience of greater value to you?

(a) The agenda and topics of discussion in detail should have been informed of much earlier so as to be able to understand and study more completely as a whole. The discussions then could have been more comprehensive with wirer view of each individual participant.

(b) More opportunity to exchange information and experience with participants and observers outside actual seminar working hours.

(c) The topics for discussions cauld have been more condensed.

(d) Discussion guides were presented too briefly to be comprehended. by delegates. This led to a lot of red herrings in the discus­sions. It is believed that with more concise and clear guides discussions would take less time and reach more definite conclusions in a short time.

(e) The difficulty and problem enc ountered by each country are more or less similar. We could make the conclusion of sentence but would not get any ideal resolution method.

(f) Only at the home base. Reports on previous seminars written by participants should be circulated to others for future seminars.

(g) If the seminar discussion had been spread over 14 days instead of 10 dqys, I believe the work would have been more pleasant and less exhausting and toxic.

(h) The seminar programme was very comprehensive. Hence, it was of maximum value to us. It could not have been raised otherwise than by limiting subject matter to available time. More of the type of Alabang experiences needed for participants to observe.

(i) The idea of central control by the national lcboratory was ac­cepted. Also the idea of regional and combined laboratory, etc.

What est for future seminars (administrativel

(a) More charts, maps, pamphlets, tables should be offered by the participating country to make clear the existing institutions.

(b) The most of the technical part are served for the microbiological one. I would like to suggest more aspects of sanitaryenviron­mental and sane things concerning industrial hygiene also for the control of hypertension, cardiovascular disease to be added.

- 172 -

More secretarial service.

Limitation of subject matter Language difficulties should chairmen and rapporteurs.

according to time available. be considered in the selection of

(e) Technically -- discussions on more reliable techniques and sim­plification of some more complicated method always with the view of the isolated regions where access to better equipnent and well trained technicians are not always available.

(f) After each main topic, one whole afternoon should have been left to allow the chairmen and rapporteurs of their groups to consolidate the discussions. The provision of a stenographer for each group would have exr.cdited this work.

(g) AdVice to participants -- booklet on conduct of a seminar and request that above bE; followed.

(h) We would like to ooe more details in the administration of a public health laboratory.

(i) Should be more detail in technique and on the basis of scientific field and practical methods.

(j) I would suggest that Topic III (Country Report) must be discussed at first on the seminar.

(k) Some time should be alloted for partiCipants to effectively stueV the topics to bo discussed.

(1) More thorough briefing of chairmen and rapporteurs in advance by consultants -- to enable them to prepare some advance answers to stimulate discussion.

(m) More time for presentations of group minutes/ summary of dis­cussion. Hare time for deliberations on submitted recommenda­tions; Hore consi stency in pre sentation and organization of introductory sessions.

(n) The time for joint discussion should be longer. Introduction should not be very brief and topics explained clearly as often more time is spent on interpretation of meaning of questions than the answer. ClBrks should be more.

(0) At adequate time during the course to have a full day off to prepare for the documents for discussions rendered by the seminar participants for the convenience of the secretarial staff. This time it was very congested.

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(p) Much tillle could have been saved if a stenographer were present at all sessions to make notes. Rapporteurs not being acquainted with shorthand found difficulty in making complete notes and had to rely" on memory resulting in some instances incomplete reporting, necessitating revision.

3. Have the conclusions reached in this seminar find application in the planning and implementation of programmes in your country? If so, would you wish to mention probable areas and how, including possible difficulties?

(a) Changes would involve more or less all aspects of laboratory function.

(b) Yes, but budgetary proV1s~ons will take time (a few years within the limit of prefectural laboratories).

(c) The putting up of desired qualifications is very much needed to at least prevent too much politics in the picking of workers • Technical sUfCrvision either by law or voluntary is essential.

( d) Not certain.

(e) Yes, the follOwing would need to be carried out but with dif­ficulties:

(1) Organization of a national integrated health laboratory service.

(2) Organization and utilization of a national advisory council on health laboratory.

(3) Establishment of reference laboratories will take time. (4) Improvement in many other service s.

(f) Yes, but only with an effective leadership from a national level.

(g) Yes, most of all is applicable.

(h) Yes, in reorganization of laboratory service.

(i) Yes, within the framework of existing conditions. The subjects have brought home the necessity for standardization in all aspects of laboratory work.

(j) It will emphasize the need for the more co-operation between various laboratories. Also the necessity for attempting to obtain scme type of standardization in laboratory techniques.

(k) Applicability must be difficult but a few reference strong recommendations to government.

(1) Epidemiology Difficulties:

- 174 -

to suggest good co-operation between services and ministries to encourage new graduates of medical school to be interested in laboratory services

(m) Difficult to apply where a laboratory service has found a groove and where social legislation imposes· a given pattern. Never­theless, most useful experience wren, as not infrequently happens, the deficiencies of an accepted service are making themselves felt.

(n) Yes, as for possible difficulties only time will tell.

(0) Yes, where assistance would be available from high level lab­oratories and with the understanding of the problems faced by the isolated ones.

(p) Yes, particuJarJ.y with the organization of our present laboratory services. Where an opportunity so arises, the findings and recom­mendations of the seminar should be o.f much value. Most important p3rhaps is the stimulation of ministries of health to react to these recommendations whenever feasible.

(q) Yes, integration and co-ordination of laboratories. Difficulties: administrative, political problems.

(r) More concentrated control by national level laboratory will be suggested, may :iiJ.c1ude re':"organization, too. Pilot laborator:iss of each level (I, II, III, IV) would be e stablisheci. SUp3rvision over private laboratory should be enforced. (More canplete legisla:tion, execution of the regulation and maans for developing inc1ud:ing. )

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WORLO HEALTH ORGANISATION MONDIALE DE LA SANT~ ORGANIZATION

REGIONAL OFFICE FOR THE WESTERN PACIFIC

BUREAU R~GIONAL DU PACIFIQUE OCCIDENTAL

P. O. Box 2932. MANILA

SUUNAR ON PUBLIC H::;ALTH LABORATORY S~VICES

WmjmI/IB/l 12 August 1960

}~la, Philippines 5-16 December 1960

CRIDINAL: EHlLISH

INFORl-fATION BULI.w""'TlN NO. 1

1. Genaral Statement

The "Jestern Pacii'ic Regional Office of the World Health Organization is sponsoring a "rorking seminar on public-health laboratory services which .r.Ul take place at its headClllarters in i1anila from 5 to 16 December 1960.

2. <l:ljectives

These objectives are"

2.1 To determine the role of, as ,~ll as the needs and problems connected "I':ri th, public health laboratory services and exchange information on h01, countries in the Region are dealing ldth them.

2. 2 To formulate guiding principles in the planning, organization and operation of public-health laboratory services ,Mch countries in the Region may' consider in meeting their needs and problems in the field.

2.3 To explore means at' utilizing existing resources, co-ordil'.la~ p:tblic-health laboratory activities and effectively trajn1ng personnel.

2.4 To promote effective utilization of available assistance from bilateral and international agencies.

3. Organization

_ Three internationally mOlln ,-rorkers in the public-health laboratory' field .1.11 serve as cOn.B\:'ltants. They will comprise the seminar staff. The consultants are~

Dr. C. H. Yen Commissioner of Health Taiwan Provincial Government Vufeng Hsiang Taichung, Tairan Republic of China

Seminar Director

Dr. Ralph B. Hogan Hedical Director Chief, Laboratory Branch Communicable Disease Center P. O. Box 185 Chamblee, Georgia U. S. A.

Dr. R. Sansonnens Chief Neclical Officer Health Laboratory Services Section ~10 Headruarters Geneva

VIR/Hu/IS/l Page 2

The : HO Operational Officer f'or the seminar is Dr. A. A. Angara, Regional Public-Health Administrator.

Fif'teen countries in the ~estern P.acific Region have nominated seventeen participants lhose names are listed as an appendix to this bulletin.

Cbservers have been invited !'rom the follov1.ng organizations: (a) South P.acific Commission, (b) United States 406th l'iedical General Laboratory, and (c) UIlited States Navy Lm..'i.liary Medical Research Unit (NAivlRU-2). ljHO Head­quarters has also informed that Dr. G. Briggs thillips, Research SCientist, Center for Safety Education, New York University, "d.ll attend as observer. The South-East Asia Regional Office of the \'J orld Health Organization in New Delhi has inc1.icated its interest and ,d.ll send a representative.

Participants have been es~ecially selected by their respective governments !'ran among those uho have sane particular interest or responsibility in the laboratory field such as senior public-health or hospital laboratory 'I-1orkers, senior public-bealth administrators, or senior medical officers engaged in the control of camnunicable diseases. Because of this means of selection, it is antiCipated that the seminar discussions lrl.ll be enriched by the experience and knoFledge of the partiCipants and ensure a productive working out of the problems to be discussed.

4. Documentation

Participants have been recruested to prepare country reports on the public­health and hospital laboratory establisluoonts in their countries. These papers will be consolidated by one of the seminar staff members into one worlciJ'lg paper. other papers will deal with the follol'ling subjects' (a) planning, organization and administration of a national public-health laboratory service, (b) technical requirements for public-health laboratory services; and (3) international. collaboration. Dr. thillips has ldndly accepted the invitation to prepare another 'forking paper entitled "Laboratory Hazards in Health Laboratories".

Tba working papers will not be read before the seminar group, instead they Nill serve as background materials for the topics to be discussed.

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VPii..1 HiIl mil Page 3

In addition, pre-seminar visits ,;ill be mac1.e by each of the consultants to a group of countries to provide them first-hand information on laboratory establislunents and to observe actual working conditions, needs and requirements. Participants, therefore, are recmested to contact their health ministries for confirmation of the visiting dates of the consultants in their own countries so that a fuller orientation on the local scene is received through their assistance.

During the seminar, a room "d.ll be reserved at the WHO Building 1-1hich Hill displ~ literature, books, pamphlets and other materials on public-health laboratory activities.

5. Seminar Operation

English 1dll be the working language of the seminar.

The seminar participants ldll be divided into t1oJO Horking groups and it is intended that they should be given the t:ime and opportunity to wrk as such.

The order of business <;ill be along the following lines~

(a) Each topic for discussion ,,;ill be summarized by a panel at ~ plenary meeting.

(b) The participants l;ill break into tvlO 1-lOrking groups to discuss the topic and 1!'ill use a discussion guide previousl;r prepared by the seminar staff.

(c) The groups will submit their reports in the plenary session and disoussion by the entire seminar group will follow.

Negotiations are runT being undertaken vlith the Fhilippine Government for ..........., field visits to institutes, laboratories, etc. 1hioh ,,;ill be of interest to the

seminar participants and v;ill relate to the topics discussed.

Films will also be shown in the course of the topic presentation and discussion.

6. Accommocation and other Arrangements

The seminar staff, participants and observers ,dll be accommodated in the same hotel which is just a few minutes walking distance from the Conferenoe Roan of the ",'HD Building.

Arrangements will be made for meeting and transporting staff and partiCipants upon their arrival at the Manila International Airport. The pqment of per diems and other entitlements will be handled by the Administration of the Western ~acific Regional Office.

Itineraries of travel and other details rill be arranged through individual cOlllllUllications ,dth the seminar staff and participants.

Australia

China

SElUNA.."'t ,N PUBLIC HEALTE LABORAl'ORY S;;;RVICES Hanila, "hilippines ··.5 - 16 December 19):,

List of ryarticipants

Dr. Eric John De Salis Medical Officer In-Charge CommonHealth Health Laborator,y Institute of AnatODtY' Canberra , A. C. T., Australia

Dr. Kong-fuei Tsung Director of Taichung Health Laboratory No. 100 San-min Road Taichung, Tailvan Republic of China

Feder~tion of Mal~

Japan

Dr. R. Bhag1,an Singh Acting Senior Bacteriologist Institute far Medical Research Kuala lumpur Federation of Mal~a

Dr. ;:illiam Gillespie MacIntosh Acting Pathologist Pathological Laboratory Box lJl Suva, Fiji

Dr. l'Jasuo Takabe Chief Communicable Diseases Control Section Pt:blic Health BlCreau Ministr,y of Health and ielfare Kasumigaseki, Chiyoda-lru Tokyo, Japan

Dr. len Yanagisa.va Vice-Director National Institute of Health Ministr,y of Health and 'elfare Kasumdgaseki, Chiyoda-ku Tokyo, Japan

Korea

Rev Zealand

North Borne 0

Philipnines

Ryukyu Islands

- 2

Dr. 11 Chyu Chief, Department of Parasitology National Institute of Health 28 Sam Chung-dong Seoul, Korea

Dr. Harold Trevor Knights Bpi .-'emiologist National Health Instit-ute 52-62 Riddiford Street -'ellington, S.l NevI Zealand

Dr. Cecil Herbert James l'lec1ical Jfficer-in-Charge ~ueen Elizabeth Hospital Jesselton, North Borneo

Dr. Gabino V. Balbin Regional Health Director Regional Health Office No. 1 DeDartment of Health Dagupan City

Dr. Trinidad P. Pesigan Acting Director Bureau of Research and Laboratories Department of Health Manila

Dr. Jl'Iinoru Hara Director of Koza Health Department USCJ\R Public Health and ; ~elfare Department AID 331, San Francisco California

Dr. DinshaF Tavaria Nedical :'fficer-in-Charge Central Laborator,y Nedical Department Kt'ching, Sarawak

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S:iJJ.gapore

3

Vir. L:iJn Ch:iJJ. Kuan City Analyst Ci~ Analyst's Department City Hall Singapore 6

Terri tOry of Papua and New Gu:iJJ.ea

Vietnam.

Western Samoa

Dr. J. J. Saave Assistant Director Department of Public Health Territory of Papua and New Guinea

Dr. Do-chi-Nang Pasteur Institute Saigon, Vietnam.

f~. Peter Rasmussen Bacteriologist Health Department Apia, '·estern Samoa

. .-,

WORLD HEALTH ORGANISATION MONDIALE DE LA SANT~ ORGANIZATION

REGIONAL OFFICE FOR THE WESTERN PACIFIC

BUREAU R~GIONAL DU PACIFIQUE OCCIDENTAL

P. O. Box. 2932, MANILA

SEMINAR ON PUBLIC HEALI'H LABCRATCRY Sl!:RVlCES

wm/Hu/1 :3 October 1960

Manila, lliilipp:ines 5-16 December 1960 ffilGlNAL: EWLISH

1. 2.

A REVlEW 00 THE PUBLIC HEAL'll! LABCRAT<RY tERVICES :m COUNTRJES AND 'lERRrrffilES CF THE WES'lERN PACIFIC REGION

1 C. H. Yen, M.D., D. P.H.

CClf.lENTS

INTR<DOOTICN •• • • • • • • • • • • • • . . . . . . . • • 1 1 1 2 2

PUBLIC HE.Al['H IABCRATffiY Sl!:RVlCES • • • • • • • • • • • • • • • 2.1 Policy and legislati va provisions •••• • • • • • • • • • 2.2 Planning, organizaticm and administration •••••••••

2. 2.1 Essential hospital laboratory service • • • • • • • • 2.2.2 Essentia.J.l;r research centres with hospital

2.3 2.4 2.$ 2.6 2.7

laborator.r service . . . • . • . • . . • . Dist:inct central public health laboratory :integrated within hOSpital laboratory- ••• Distinct central plblic health and local

• •

. . . . . 2

. . . 3

laboratory service s • • • • • • • • • • • • • • • •• 3 2.2.$ Dietinct central plblic health laboratory-

service with regiOnal. laboratories • • • • • • • •• 4 2.2.6 Distinct plblic health laboratory service

without a central laboratory- • • • • • • • • • • •• 4 2.2.7 Distinct public health laboratory- with advisory

canmittees for laboratory service • • • • • • •• $ Functions of laboratories at different levels • • • • • •• $ Distribution of laboratory service s • • • • • • • • •• 6 Services rendered and population coverage • • • • • • • •• 6 System of collecting spec:iJ1lens • • • • • • • • • • • •• 7 Registration of specillJms, records and report,e and filing . • • . • • . . . • . . . . . . . • • .. 7

IProvincial Health Administration, Taiwan, Republic of China

.3.

4.

5.

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2.8 Budget........................... LABORATORY E&RSONN&L • • • • • • • • • • • • • • • • • • • .. .. • • 3.1

3.2 3.3

Classification and number of various categories, training and- min:imum qu.alifications for laboratory p:lrsonn:ll • • • • 3.1;1 Medical staff • • • • •••• 3.1.2 Scientist staff • • • • • • • • • • • • • • • .3.1.3 Technological staff • • • • • • • • • • • • • • • • System of technical sUp:lrvision and promotion • • • • Refresher and post-graduate courses for laboratory Jersonnel • • • • • • • • • • • • • • • • • • •

3.4 Renumeration and security of tenure • • • • • • • • • • • • 3.5 Full-time or part-time service •••• • • • • • • • • Hl.OBIEMS AND m.EDS IN THE DEVE LOOONl' OF A PUBLIC HEALTH LABCRATCRY :ERVICE :rn A COUNTRY •••••••••••• . . . . C~NTS • • • • • • • • • • • • • • • • • • . . . . . . . . . . .

Lack of an organized service • • • • • • • • • • • • • • • The lack of a central sUp:lrvision • • • • • • • • • • • • • The lack of a national advisory council (or canmittee) on the health laboratory service •••• • • • • • • • • • The need to strengthen training programme • • . . Response to changing needs ••• • • • • • • • • • • • • •

7 8 •

8 8 8 8 9

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10

II 11 II 12

12 12 12

•

1. INTRmUCTICIi

1<IFR/HrL/l page 1

Thi.s paISr is a consolidated information on public health laboratory services in countries of the Western Pacific Region. It is based on individual country reports of seminar participants received betwen August and September 1960 !ran the follmd.ng countries and territories: Australia, China, Fiji, Japan, Korea, Malafa, New Zealand, North Borneo, Fhilippines, Ryukyu Islands, Sarawak, Singapore, Vietnam and \'1estern Samoa.

The situations existing in these countries and territories vary ~ndousJ;r in such aspects as geographical and climicatic conditions,; cultural, educational and econanic develoIJllent; availability of health facilities and health pers0DD91, population size and distribution; and means of camnunications. The influences exeJ"l;ed by- these factors in the developnent of public health laboratory services axoe obviouS and arr:r attempt to generalize on them would not onJ;r be difficult but also contusing.

The World Health Organization Regional Office for the Western Pacific has, therefore, prepared an outline of topics sent to participating countries as guidelina in the writing of count..ty reportis. It is of interest to note that when the fourteen country reports wre received, they' differed greatJ;r in the detail of information furnished varying !ran a very brief n~ by- sane to extended reports by- other countries, thus making canparative stud;y sCJDeWhat difficult. However, all reports were illuminating and informative and they- are treated here in line with the guideline used for the preparation of the country reports.

2. PUBLIC HEALTH LABCRATORY SERVICES

2.1 Poligy and legislative provisions

All the countries concerned provide curative and preventive medical services which V&ry'in extent. Laboratory services are uniformJ;r governmental institu­tions functioning either as an independent entity or as a division in an existing clinic, hospital or health department. In a number of cOlmtries, there are both non-profit as well as profit-making private laboratories. Private 110-oratories deal chief'l\r with chemical an~sis and clinical diagnostic tests. There appears to be more private laboratories in the better developed countries.

All countries have the appropriate legislation or authority providing for the organization of laboratory services and specifying their functions, sc~ of work, staffing pattern and budget. Regulations also provide for a SY'stem of fees for individual laboratory services. Sane countries require the registration of private laboratories and specii'y' minimum requirements inCluding qualifications of the laboratory chief and standard equipnent. The health authority is vested with the right to inspect laboratories. There does not seem to be ~ specifica­ticn as regards qualificaticns for technicians. Many countries did not report

" on how private laboratories are regulated by- the appropriate governmental authcr­ity. Ch the whole, even when there is a regulatory authority, it appears that mal\Y' heaJ.th departments do not actuall;y' have the ISrsonnel to perfonn the function.

WlR/HlL/l page 2

Legislations and regulations on disease control and control of food, drug, water, milk, beverage, meat, narcotics and dangerous drugs exist in all the countries. They specify reporting of certain epidemic diseases, the safety standards for food, drug, water, milk, meat, etc. Rmalties are imposed on violation of these laws, regulations, and ordinances.

Most countries state that laboratory fees are minimal and are charged fran patients, physicians, hospitals and food or drug manufacturers. Tests and examinations for articles and specimens of public health importance are invariably free of charge, e.g., exanination of sputa for acid fast baciUi, sera for venereal diseases, blood for malaria and filariasis, specimens for cholera, ~ plague, smallpox, enteric fevers and leprosy are absolutely' free of charge. No fees are charged on laboratory examinations made in the course of a survey. North Borneo stated that all public health tests are free of charge.

2.2 Planning. organization and administration

The organization of public health laboratory services differ fran country to country in the ioTe stern Pacific Region. Their type s can be grouped roug~ into the following categories.

2.2.1 Essential hospital laboratory service

North Borneo and Western Samoa have no separate public health laboratory services. They maintain hospital laboratory services which are also utilized for conducting tests for essentially public health requirements. Their rout~ clinical laboratory examinations also assist in focussing attention to conditions of public health importance as in the laboratory diagnosis of infectious diseases.

North Borneo has a sepa::ate laboratory for malaria control, a water lab­oratory in the publiC vrorks department, and veterinary and soil tes.-ing lab­oratories in the agriculture department. other specimens of public health importance are referred to nearby countries.

2.2.2 Essentiall.y research centres "lith hospital laboratory service

In Vietnam there is no full-fledged public health laboratory but there are three highly developed research centres (i.e., the three Pasteur Institutes) which examine specimens referred by the health department and prepare vaccines, sera and other standard reagents for the country. The health department also utilizes clinical laboratories of provinCial hospitals for the examination of specimens of public health importance. The responSibility of operating and/or co-ordinating public health laboratory services does not seem to be located at the public health department.

The Pasteur Institute s are autonanous finanCially and in technical operation. They assist concerned ministries in the following mannert

(a) for the I"Wlistr;y of Health

i. serve as reference laboratories for mare complicated medical analysis}

WHi/HlL/l page :3

11. suppl¥ vacciDas, sera and azrl:.igens pt'epared in Vietnam or imported fran Paris.

(b) for the Ministr,r at' Agriculture

i. serve as reference laboratories for the study of infectious diseases of animals;

ii. suppl¥ veterinary vaccines and sera.

(c) for the Ministry at' Econcmty'

i. control purity and detection of imitations of all kinds of pt'oducts, particular~ foodstuffs;

ii. examine agricultural and mining products, etc.

The Ministry of Health maintains a laboratory for rharmaceuliical pt'oducts, a nutrition laboratory and a laboratory in cvnnection with its malaria eradica­tion progranme.

2.2.3 Distinct central public health laboratory integrated within hospit.1l laborator,y

This group is exemplified by Fiji and Sarawak i-lith sane differences between them. Both have a distinct public h-.:alth laboratory 'l-rhich is a section of the public health department. In Fiji, the central laboratory is located in a hospital which operates as an independent section of the medical department. Its small branch laboratory at LauJ.oka, however, is only for routine clinical work. There is also a small laboratory for the tuberculosis hospit:ll. and a laboratory at the central leprosy hospital. In Sarawak, there is no separate public health ].Qboratory service, but there is a central laboratory of the medical and health department in Kuching. In these countries the need seem to be more on the clinical rather than on the public health aspects of disease control. It has seemed mare economical on their part to combine the clinical and public health laboratories. There also seems to be a dsfinite assigmnent of responsibilit;r of laboratory ser-w'ices under the medical (and health) depar\illent.

2.2.4 Distinct central publiC health and local laboratory services

This type of organization is seen in Japan, China and the Ryuk;,yu Islands. Although differing in size, extent and stage of developnent, they- are similar in having a distinct public health laboratory service in addition to the hospital laboratory service. In Ryul!;yu, there are one central public health laboratory, !> health centre laboratories and 10 hospital laboratories. Although there is

v.Tm/mL/l page 4

some overlapping in the activities of the health centres and the hospital lab­oratories, the main public health laboratory work is done at the health centre laboratories. RyukyIl derives the services of reference laboratories from Japan. In the province of Taii-ran, China, there are a central public,health laboratory (the Provincial Hygiene Laboratory) with 22 health centre laboratories (county or municipal), 18 hospital laboratories and 472 health station laboratory rooms. At the provincial level there are six reference laboratories in six institutions for sera and vaccines, venereal diseases, tuberculosis, sanitation, leprosy and malaria. A joint laboratory 1lhere a regional public health laboratory was integrated to a provinCial hospital laboratory "Tas established only recent~.

Japan has public health laboratories that are among the most extensive~ developed in the 1:Iestern Pacific Region. At the national level the central public health laboratory services are carried out by an aggregate of five national (reference) laboratories, nane~, the Institute of Health, the Institute of ,,-...... Public Health, the Institute of Leprosy, the Institute of Hygienic Laboratory and the Institute of Nutrition. At the local level, there are 51 (prefectural. ). and municipal.) local health laboratories, and 790 health centre laboratories.

2.2.5 Distinct central. public heal.th laboratory service with regional laboratories

This group includes Korea, I'1ala,ya and thefuilipP:Lres. These countries provide distinct public health laboratory and hospital laboratory services. But the difference lies in the fact that full-type public health laboratories men­tioned in paragraph 2.2.4, page 4 of the other working paper for the Seminar (Wm/HiLI2) entitled lfPJ..anning, Organization and Administration of a National Public Health Laboratory Service" have a number of regional or branch laboratories aside fran the central (national.) laboratory.

In Korea the central public heal.th laboratory is the National. Institute of Health. It has a chemical laboratory and serves as a reference laboratory. The National Institute of Veterinary Medicine serves also as reference laboratory. The country has 10 regional health, 76 health centre and 100 hospital laboratories.

In l'Iala,ya, there is a national laboratory with 2 branch (regional) lab­oratories and 5 laboratories for clinical pathology. Local public health lab­oratory services are perforlOOd in the district hospitals.

In the fuilippines, there is a national (central) public health laboratory, five regional public health laboratories and a number of provincial. and city public health laboratories attached to provincial or city health offices. One regional public health laboratory is attached operati~ to a provincial. hospital.

2.2.6 Distinct public health laboratory service without a central laboratory

This type is found in Australia and Singapore.

Wffi/lHL/l pageS

There are fourteen public health laboratories in Australia. All are under the control of canmonwealth agencies. There are national reference lab­oratories for saJlnonella, typhOid, shigella, mycology', virus, and parasitology'. Each state has a diagnostic laboratory at its capital.

In Singapore, at the central government level, there are departments of pathology and chemistry under the Ministry of Health. The former provides lab­oratory services for government hospitals, clinics and general practitioners but is housed, together with the univerSity's pathology' department, in the premises of the gemral hospital. The latter has a separate chemical laboratory rendering an island-w.1.de service and S}:2cializes in criminal investigation, examination of hazardous materials and dutiable articles. There is no conSOlidated sillgle oentral health laboratory. At the city level, there are separate laboratories for bacteriology, the analyst's laboratory, pl.ag,;e prevention and anti-mosquito work. These laboratories perform the main publio health laboratory services. Clinical laboratorie s are frequent~ attached to the hc.spi tals.

2.2.7 Distinct public health laboratory with advisory camnittees for laboratory service

This is exemplified in the National Institute of Health of New ~aland. The Institute serves as a national reference centre for infeotions with salmonella, toxoplSf!!N!, viruses (e.g., influenza, smallpo~ etc.), staPlYloooooi, and far the typing of enteric }ilages; it also produces anti-ty}iloid and smallpox vacciD3s. At lomr levels, public health laboratories are attached to small. and large hospitals and perform clinioal pathology and public health mioro-biology and pathOlOgy'. Sanitary laboratory services such as water and milk examinations are performed by four main centres under a Department of Scientific and Industrial Research. There is an advisory cOllllllittee en laboratory services for the hospital services and for private laboratories. The. cClJlll1ttees are of interest as there is no mention of one in arv other country. Whether or not these cCIIIIlittees also give advises to the national reference laboratories is not apparent.

2.3 Functions of laboratories at different levels

At the national level many countries have a national institute of health or its equivalent (e.g., research institute, oentral laboratory). These institutes o:f'ten serve in one or more capacities as reference laboratories. Their functions cover such fields as microbiology, serology, chemistry, biochemistry, pathology, forensic mediciD3, food and drug oontrol, sanitary an~sis, bioJil7sios, allergology, JiIysiology, nutrition and in oonnection with the control or special diseases. While functions of laboratories vary trom country to oountry they all essential~ pt'ovide services connected with preventive and curative medioine, perhaps with more emphasis in the fo:rmer. Another usual funotien is research. In a few countries or territories suoh as North Borneo, Sarawak and Western Samoa, the hOSpital laboratory serves as the central laboratory and pat"forms to a certain extent essential public health laboratory services. When meded they avail of the reference laboratories of other countries.

wm/mL/l page 6

At the regional and provincial levels there usually operate distinCt public health laboratories in regional or provincial health departments or they mq be canbined with the hospital laboratory service. The functions of the public health laboratory are mainJ;v directed towards the fields of prewntive medic~ and sanitation, including foods and drugs, water and milk control. When the ptillic health laboratory is independently operating, clinical pathology is included in its seop! of activities. When canbined with the hospital lab­oratory, the public health laborator,r is managed under the hospital administra­tion.

At the country or city lewl, the public health laboratory is usua.J.J.y a part of the appropriate health service. Its functions are similar but lesser in scope than the provincial health laboratOries.

At the township and village levels, laboratory servioe is usually CCll­

ducted in a room or section of the bealth centre and health station. Its activities are mainJ;v confined to clinical microscOW. These snall units also serve as collecting centres for spec:imens in the control of diseases such as wmreal disease, tuberculosis, etc., for referrals to the proper agencies.

The hospital laboratory very frequently is the site where regional, provincial, county and city public health laboratories are located. To a certain extent, an integrated hOSpital am public health laboratory has the advantage of pooling or saving on facilities and technical personml.

Where other agencies such as public works, agriculture, veterinary medicine and industry have special laboratories, efforts should be taken to co­ordinate their activities ~dth the public health laboratory.

2.4 Distribution of laborata;r services

National public health laboratories are usually located at their capitals; the same is true of reference laboratories. Regional, provincial, county and city or other local laboratories are frequently distributed in prOldJnity to and along similar lines as the public health service of their corresponding level. Suffice it to ~ that public health laboratOries are usually strategically located in terms of the population to be served.

It was uniformly stated in the country reports that laboratory services are available to general pt'actitiomrs and to private hospitals. It was not pOSSible, hOV2ver, to gauge the extent of utilization raade by physiCians and institutions. One gathers the impression that in scme countries, the utiliza­tion of the laboratory by public health and private parties is not great.

2.5 Services rendered and population coverage

The services rendered by the public health laboratory have been presented above and in another papar. l It is difficult to generalize on the population

...... -

coverage by the different ty'Jes of laboratory services. There seems to be a ~

lwm/HiL/2 entitled "Planning, Organization and Administration of a National Public Health Service"

r i

I ~ ,

-'"

'y

wm/HIL/l page 7

m1nimum number of 5 000 to 50 000 people at the health station (village) Jevel and 50 000 to 800 000 in countries 01:' cities served by health laboratories. The potential of the population served at the provincial and national levels will coincide with the respective population of each. Estimates such as these are obviously rough since the population that could be covered wouJ.d depend on the accessibility of c amnunications by roads, trains, boats and air services.

2.6 System of collecting s:pec:in2ns

Most countries indicated that individual spec:imens are usual,ly collected at the clinics and hospitals and by practitioners and hane visitors who deliver them to the laboratorY. Non-personal spec:!JDens (e. g., water, milk, etc.) are collected by health insI=flctors and delivered to the Jaboratory'. Food products and drugs are submitted either directly by the manufacturers or obtained on the spot during inspec"jions by the health inspector.

Postal services for the delivery' of sane specimens to laboratories are indicated in the country reports from China, Korea, MalB\Y'a and New Zealand. In Japan, the law prohibits the sending or pathologic material by mail unless dOne by a government office, the bacteriology institute or by a physiCian or veterinarian. As collection and packing of specimens greatly influence resul.ts of examinations, there is need for laboratories to provide appropriate containers with 1nstructions on hcm the sI=flc:i.men should be taken, handled and sent.

2.7 Registration of specimens, records and reports and fil:ing

In most countries there is a registry' for specimens received by the lab­oratory noting thereon the kind, when received, serial number and results obtained. The findings are sent. back to the orig:inator of the request with copies to the health department on items required 17</ Jawor regulation. Lab­oratories I=flriodically canpile their reports loilich are somet:iDl:!s published with the annual reports. In Korea, records are by law kept for at least three years.

2.8 Budget

The individual country reports prOl/ided infat'Illation on the budgetar,y position and eXpenditures covering the past five years. As expected budgetary outlB\Y's differed between countries. It is impossible to compare the .figures as the expenditures, per se, are of no significance unl.ess their proportion +.0 the total health budget is mown. Fran the statements made in the reports, most countries expressed the need and desirability of increasing budgetary provisions for laboratories.

wm/mL/l page 8

LABORATORY FERSONNEL

3.1 Classification and number of various categories, tra.:Uring and minimum qualifications for laboratory personnel

Countries use different nomenclatures and the categories of personnel employed vary even between laboratories in the same country. In general, howver, the technical staff may be classified into the follo.ling categories:

3.1.1 Medical staff

These are rredical graduates who have had one or more years of practical. exrerience in the laboratory field. In some instances the rredical staff may have a diploma in public health, microbiological sciences or pathology. The mare senior of them are generally chosen to serve as chief of either tre central, reference, regirnal and provincial ]a boratories. More junior perscrmel serve as chiefs of departrrents or divisions of the bigger laboratories. In other countries the situation is less favourable in that they do not have enough medicaJJy qualified personnel and use is made of others in the technical categories. In all functions, hOl~ver, tissue pathology is ahJaYs done by a rredical staff member.

3.1.2 Scientist staff

The scientist staff are science graduates with specialization in the fields of microbiology, chemistry, veterinary mediCine, pharmacy, etc. who after gradua­tion have had tV-TO or more years experience in their specialty in a laboratory. They fill laboratory positions of biochemist, chemist, bacteriologist, para­sitologist, etc. In same reference laboratories, there are positions provided for Ji1.armacists, dentists and sanitary engineers.

3.1.3 TechnologiCal staff

It is evident from the country reports that this category constitutes the largest group of laboratory workers. They are generalJy kno.n as technologists or technicians. In some countries as in China, a four-year college course is given in medical technology. They receive a bachelor of science degree and are desig­nated as technologists in contra-distinction to the technicians who have not had the requisite baccalaureate attainment. Certificate courses in medical technology, ranging from two to three years after senior high school, are offered in scme countries. In Japan and Vietnam, there is a two-year course given at a training school for laboratory technicians. In New Zealand, a three to five-year course for the certificate of proficiency in hospital laboratory is offered depending upon the student I s academic standing at the time of admission. Aside fran the diplana and certificate courses, most countries offer refresher and in-service training courses for junior technicians to raise their perfonnance standards.

, ~

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3. 2 System of technical supervision and promotion

wm/mL/l page 9

Most of the country reports stated that the conduct of laboratorJ services is the responsibility of the director or chief of the laboratory. He in turn is responsible to the medical or hospital administrator under whon the laboratory is established. There aprears to be no technical supervision from a technical bo~ outside the laboratory. There is also no mention of a provision for direct sUp3r­vision. There seems to be a need for regular supervision of laboratories by a c<Jllpetent technical group. This function can best be done by the central public health laboratory staff.

In New Zealand, there are two advisory camnittees, viz., one for hOSpital laboratories and one for private laboratories.

Pronotion in terms of appointments or salaries of heaJ.tIl workers :in all countries are based on two factors, 'Vil'le, availability of post and ability. Every country has a system of grading posit:ions and individual pranot:ions are in accordance with civil service regulations.

3.3 Refresher and post-graduate courses for laboratOl]' personnel

These have been partJ;y discussed under 3.1 above but further example s might be added.

In China, refresher courses are given fran tima to tima by the provincial hygiene laboratories, Malaria Research Institute, Institute of Environmental Sanitation, Venereal Diseases Centre and tre Tuberculosis Control Centre. Post­graduate courses are given at the Institute of Medical Technology and Institute of Pathology at the National Tai,Jall UniverSity.

In Fiji, refre6her courses are given at the central laboratory.

In Japan, short and long term courses are given at the National Institute of Public Health.

In Mal1Va, in-se:..'Vice training takes three years and is conducted at the Institute of ¥Jedical Research. Written, practical and oral examinations are required to pass the course.

3.4 RenUlll3ration and security of tel1UI'S

Since public health laboratory workers are government employees, they are governed by the civil service laws. The scale of Jl2\Y' :including adjustment allowances, pranotions and tenure of office are all stipulated in the law or regulation. Except for cause" there is always a security of tenure with oppor­tunities for pranotion. Their positions invaria~ are pensionable and the retirement age ranges fran 55 to 60 years. The p~ scale varies with the country.

Wffi/HIL/l page 10

Fran the available data given by the reports, the pay scale would seem to range as follows:

A Central Laborato;r

Chief of the laboratory

Department heads, medical staff, senior scientists

Scientists

Senior technicians

Intermediate technicians

Junior technicians

In lowest paying country

US$

800 - 10OO/year

650 - 700/year

600 - 6S0/year

550 -

400 -

300 -

In highest paying countEr

US$

5000 - BOOO/year

3500 - SOOO/year

3000 - 3500/year

2000 - 3000/year

2200 - 2400/year

950 - 2000/year

In the 10;'lest pa;ying countries, employees may receive food rations, housing allmi'ance and lltechnical allm.lance ll, so that the actual canpensation may be greater than 'What the figures above would show. In certain countries the lab­oratory workers receive an extra allowance for risk of exposure to infectious materials.

It would have been helpful to compare salary scales received by laboratory workers with those employed in the hospital or medical institutions and with other governmental agencies. Unfortunate~, no data along this l.:ire was received. As there was no information about incone tax and cost of living in each reporting country, it would be difficult to canpare and interpret figures received fran the participating countries. On the 'Whole, hOI-rever, the cotmtry reports revealed the difficulty of recruiting health workers principally because of the low salary offered.

Full-time cr part-time service

The country reports confirm the fact that all laboratory workers serve on a full-t:iJlB basis. Exceptions are chiefs oi' laboratories or senior experts, especi~ vrhen full-time officers are difficult to recruit. If, for instance, certain types of experts fran a research institute or professors in a university are few, they are recruited with the understanding that they would be able to concurrent~ work in the public health laboratory as well as in their other activities. Sometimes, in order to co-ordinate the laboratory uark of a hospital and health service, the post of head of the laboratory is assigned to the administrator oi' the hospital or health service. \vhile it is agreed that laboratory ,.orkers must serve full. t:iJlB in the laboratory, arrangements to avail of the part-time services of cC4lsultants in specific subjects would also seem

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desirable. ~.

J

4. mOBIEMS AND NE:EDS IN THE DEVELOImNT OF A PUBLIC HEALTH LABORATORY SERVICE IN A COUNTRY

WPR/HiL/I page 11

The following is a summary of the problems and needs of public health laboratories as indicated in the country reports:

a) Shortage of well-trained laboratory personnel;

b) Lack of public appreciation of the work of laboratories and their utilization Qy the general publiC, phy~icians and even health workers;

c) Lack of virologists and specialists in tissue pathology;

d) Very low pay for laboratory workers;

e) Need for giving more emphasis on the statistical approach rather than on clinical pathology;

f) Lack of proper technical supervision of laboratories;

g) DifficulW of getting medicalJy qualified personnel to engage in health laboratory work;

h) Need for more laboratory aspects of environmental sanitation and nutrition;

i) Need for more intra-country programmes;

Need for strengthening inter-departmental co-ordination in the laboratory field;

k) Need for more budgetary allotment and facilities for the lab­oratory service; and

1) Need for more international collaboration in laboratory technology.

5. COMMENTS

In reviewing the reports from various countries, the following points of importance become apparent.

5.1 Lack of an organized service

Usual~, there are central and reference laboratories as well as regional, provincial, health centre and hospital laboratories. Although these laboratories are responsible to their immediate agency heads, there is no provision for a centralized supervisory authority nor of a central planning and co-ordinating

Hill/HiL/l page 12

authority or direction of the laboratory services. Hany laboratories at different levels in the country function independently of each other. They are not organized into a system of servicing which is desirable on a national basis so that I"rell co-ordinated public health laboratory services can oporate efficiently throughout the country.

5. 2I'he lack of a central surervision

In most countries the conduct of services in a laboratory is guided and supervised by its mm director. The director in turn is responsible to the health officer or hospital superintendent. Too often the health officer or hospital administrator is too occupied with his duties or is unfamiliar with the techno­logical aspects of laboratory work. It would be advantageous for raising or maintaining the quality of services if local health laboratories were placed under the technical supervision of a central unit at the national level.

5.3 The lack of a national adv~so council or committee on the health laboratory service

Ex"ept for Nelv Zealand, no country report has mentioned the existence of an advisoryboqy on laboratory services at the national or local level. Such body seems desirable to assist the national health administration in determining policy and in recommending overall planning of laboratory services. Standard procedures and legislations could also be recommended by this boqy.

5.4 The need to strengthen training programme

Although most countries offer courses leading to diploma certificates or provide in-service training courses under government sponsorship, there is observed a lack of uniformity in the requirements for admission and the curriculum content

.. -(:-

of the courses given. Every country should endeavour to provide intra-country ~ training programmes in order that its laboratory service may have enhanced standards.

5.5 Response to changing needs

From the country reports, it is noted that disease prevalence and major health problems have been undergOing changes during tho past decades. Hany coun- ~ tries have reported the successful control or even eradication of m2ny diseases such as smallpox, cholera and plague and the steady decline in the incidence of diseases like malaria, diphtheria, pertusis, enteric fevers, tuberculosis, etc. On the other hand, an increase in the incidence of other diseases is being observed, e.g., poliomyelitis, encephalitis and other virus infections. I,Hth the changes in the health picture, laboratory services should be geared to cope with new problems. Laboratories must be equipped to meet new needs and provi-sions taken for the training of more workers in tho field of virology. In better developed countries, cardiovascular disease, cancel' and mental disorders constitute the major health problems. Their laboratories should be mobilized to assist in the unravelling and tackling of the problems they pose. Physiological, biophysical, epidemiological and statistical methodologies arc being added to the laboratory disciplines. In developing countries, however, sanitation, water,food /" and drug control and the contrel of infectious diseases will for a long time remain the principal fields in which laboratory assistance "Hill be required.

l F~

•

WORLD HEALTH ORGANIZATION

ORGANISATION MONDIALE DE LA SANT~

REGIONAL OFFICE FOR THE WESTERN PACIFIC

BUREAU R'GIONAL DU PACIFIQUE OCCIDENTAL P. O. Box 2931, MANILA

wm/mI/2 SEMINAR C!l RlBLIC HEALTH IABCRATCRY SERVICES 10 October 1960

Manila, Fhilipp:ine s 5-1.6 December 1960

<RID-INAL: EHlLISH

3.

PIANNING, CRGANIZATIOO AND ADMINISTRATIOO CF A NATIOOAL HEALTH LABCRATORY SERVICE

by

1 C. H. Yen, M.D., D. P.H.

CemENTS

mTRCDOOTION' • • • • • • • • • • • • • • • • •. •. .. • • • • ... • • sccm .AND FUNCTION • • • • • • • • • • • • • • • • • • • • • • • • 2.1 lTincipaJ. functions of a public health laboratory· • • •

2. 1.1 Service • • • • • • • • • • • • • • • • • •. • • • • • 2.1.2 Re search • • • • • • • • • • • • • • • •. • •. • • • • 2.1 • .3 Teaching and training • • • • • • • • • • • •. • • • •

2.2 lTinoipa1 tyres of laboratories • • • • • • • • • • • • • • 2.2.1 The olinical laboratory (ward laboratory) •••••• 2. 2. 2 The hospital laboratory • • • • • • • • • • • • • • • 2.2.3 The publio health laboratory (basic 1iyp3) •••••• 2.2.4 The public health laboratory (full ty:pe) •••••• 2.2.5 The reference (sp3cialized or research) laboratory. • 2.2.6 The central (national) laboratory •••••••••• 2.2.7 Regional or district laboratory • • • • • • • • • • • 2.2.8 The joint laboratory • • • • • • • • • • • • • • •• 2 •. 2.9 'lhe mobile laboratory. • • • • • • • • • • • • • • •

PI.A.NN'nll • • , " • • • • • • • • • • • • • • • • • • • • • • • • • 3.1 Factors influenoing the planning of a national

health laboratory service ••••• . • • • • • • • • • • • 3.1.1 Existing health facilities am p3rsonne1 •••••• 3.1. 2 GeograJidcal, popu1aUon am cClJllllWli.cation status • • 3.1..3 Eoonanio support •.•• • • • • • • • • • • • • • • •

1Tovincia1 Health Administration, Taiwan, Republic of China

1 2 2 2 2 .3 .3 .3 3 4 4 4 5 5 5 .5 6

6 6 6 6

4.

5.

6. 7.

- 2 -

Essential steps in planning •••••• '.' •••••••• 3.2.1 The survey • • • • • • • • • • • • • • • • • • • • • 3.2.2 Preparation of laboratory staff •••• •• 3.2.3 Preparation of facilities. • • •••••••• 3.2.4 Choice of a system of service • • • • • • • •••

ffiGAlfIZATIOO' • • • • • • • • • • • • • • • • • • • • • • • • 4.1 Is it desirable to have an integrated national

public he alth laboratory service? • • • • • • • • • • • 4.2 A national advisory council (board) on

the laboratory service • • • • • • • • • . . . . . . . 4.3 Staffing . . . . • . . • • . . . • . . . • . . . . • . •

4.3.1 Categories of the staff. • • • • • • • • • • • • 4. 3. 2 Qualification and training of the staff • • • • • • •

ADM~'ISTRAT ION. • • • • • • • • • • • • • • • • • • 5.1 Legislation.........................

5.1.1 Public laboratories • • ••••••••••• 5.1.2 Private laboratories •••••••••••••••• 5.1.3 Quality control • • • • • • • • • • • • • • 5.1.4 Biological standards and reagents •••••••••• Maintenance of standard strains and diagnostic reagents • • Relationship with laboratories of other governmental agencies • • • • • • • • • • • • • • •

5.4 Standard laboratory procedures and methods • • • • • • • 5.5 Scientific meetings and publications •••••• . . . 5.6 SUp3rvision of public health laboratory services •••••• nrIERNATIONAL COLLABCRATION • ••• • • • • • • • • • • • • • S~y •••••••••••••••••••••••• . . . . • •

.ANNEX 1 - A SYSTEM OF CENTRALLY DIRECTED NATIONAL PUBLIC HEALTH LABORATORY SERVICE

ANNEX 2 - A SYSTEM OF COMPIETE DECENTRALIZED NATIONAL RJBLIC HEALTH LABORATORY SERVICE

ANNEX 3 - A SYSTEH OF DUALLY DIRECTED NATIONAL RJBLIC HEALTH LABORATORY SERVICE

~

7 7 7 7 7 8

8

9 9 9

10 10 10 10 11 11 11 11

11 12 12 12 13 13

,-.

1. INTRCIlUCTION

vTFR/HIL/2 page 1

Tlle iJnportance of the role pl~d by the public health laboratory in a national health service can hardly be over-emphasized. In earlier da;y"s, public health laboratories were established to deal specifically with the detection of the spread and control of infectious diseases. A brief account of the historical evolution of public health laboratories is given in the first report of the WHO Expert COIlIII1ittee on Health Laboratory Methodsl and need not be repeated here. But it is worthwhile to note that in recent years there has been a rapid and constant expansion in the activities of public health laboratories due to the :increasing demand made by health officers, clinicians, sanitary engineers, etc. TodBiv', in IIl8tW oountries, the public health laboratory does not only' deal with the problems of detection on the mode of spread, diagnosis, control and prevention of diseases and in the prognosis and treatm,mt of patients but also with the determination and control of enviramnental factat's detrmental to man. Thus, the public health laboratory serves in the fields of preventive and curative medic:iJle, in the sanitary- control of water supp:q, of sewerage and waste disposal, of vector control, of air pollution, of industrial hazards, and in the fields of milk, food and drug control. In addition to the above, toxicology (forensic medicine), radiation hygiene and nutritional investigations are in SCllle countries also included in the activities of the public health laboratory. As problems confronting health workers are still numerous, new labat'atory methods to tackle them are being devised and will in the future result in further activities of the public health laboratory.

With the increasing fields of activities of the public health laboratory, there has developed a variety' of terms to designate the different types of lab­orator,r, e.g., clinical laboratory, medical laboratory, hospital laboratory, hygieniC laboratory, sanitary laboratory, pathological laboratory, plblic health labat'atory, health laboratory, etc. Although by usage the functions and scope of activities of each of these types are well }mown, there seems to be a general lack of precise definition for each. Just where does the scope and :f'unctions of one end and the other begin? Does one type merge with another? Where are the duplications and the overlappings?

In the seccnd report of the WHO Expert Cotmnittee on Health Laboratory Methods2 mention was made of the I1definition and }ilUosoJilYI1 of the hospital laboratory. It was pointed out that hospital bacteriology farms part of the hOSpital service but in several countries most of the bacteriological work for hospitals are undertaken by the public health laboratory and, converse~, same of the laboratory aspects of public health are undertaken by the hospital lab­oratory.

lwld Hlth Drg. Techn. Rep. Ser. 1957, 128

?wld Hlth Drs. Techn. Rep. Sere 1959, 161

wm/HlI/2 page 2

To elaborate on the definition of these laboratories must be difficult and perhap:s not important. Yet for the sake of having a clear term of refe:r;ence in our minds when 'We consider the topic of this working paper, it is necessary to denote what is meant by a llpublic health laboratoryll and a llnational publio health laboratory service". Without getting too much involved in terminology and definition, we shall consider the public health laboratory as a unit of public health service employing laboratory methods to study, determine and identify the causative and contributory factors or agents (animate or inanimate) related to the health and disease of man including the host response to such factors or agents.

Thus, the public health laboratory, in a narrower sense, mq limit its functions to fields dealing with the protection of the health of the community against infections, epidemics and occupational disease While, in a broader sense, its fun.ction ma;v cover the services for the restoration and preservation of the health of an individual. In this paper the tem "public health laboratoryll is used in the latter or broader sense and its functions would include those fields covered by one or more of the types of laboratory mentioned above. The llnational public health laboratory service", on the other hand, would mean an organized system of services canposed of individual public health laboratories in a country or territory.

2. SCOlE AND FUNCTION

Although not easy to define, the scope of the public health laboratory is related to its assigned functions.

2.1 Principal functions of a public health laboratory

2.1.1 Service

The public health laboratory is intended to assist and guide the health officer and the clinician in the maintenance and pranotion of public health services and medical care. It is important to stress that laboratory findings ro should. not be interpreted separatel3r but must be considered by the health officer and the clinician in the light of other findings. As the laboratory assists practising Jilysicians in arriving at an accurate diagnOSis, they must in turn acquaint themselves with the services offered and when to avail of them so that they can better utilize the laboratory.

2.1.2 Research

It is extreme~ important to conduct research in a public health lab­oratory if on:q- part~ to stimulate incentive for work and attract into the service qualified personnal.. Research would be futile unless carried out by liell-trained and canpetent personnel in a suitab~ equipped laboratory. One of the principal objectives of a 1.aboratory is to devel.op new tests, techniques and methods as well as to improve existing ones. Even in a less equipped lab­oratory, sage kind of research activity, us-uaJ.q on the more practical aspeots, is to be e~ouraged.

2.1.3 Teaching and training

WlR/HiL/2 page 3

Laboratories should be utilized whenever possible for the teaching of undergraduate medical and para-medical personnel and the training of technicians. The laboratory is the logical place where students and trainees can gain practical ext:erience. The fully develop;ld public health laboratory should not onJ;y conduct training and teaching but must be able to render supervision to maintain the quality and standard of service of peripheral health laboratories.

2.2 PrinCipal tyPEls of laboratories

HeaJ.th laboratories vary in type and size depending upon the level of the health service with mich they are connected •

. "'" 2.2.1 The clinical laboratory (ward laboratory) r /I

This is usually connected with the DID service of a hospitaJ., cliniC, ward, or at a local health station and centre. Its main activities are:

(a) clinical microscop,y - stained smears for diJiltheria, gonorrhea, etc. urine sediment, stool examination for parasites and ova, sputum specimen for tubercle baCilli, etc.,

(b) routine urine examinations, (c) blood counts and smears (darkfield for spirochatos, etc.), (d) examination of exudates, (e) blood grouping, and (f) detenn1nation of icterus index.

2.2.2 The hospital laboratory

/"'. This is an integral part of the hospital. Sometimes part of its activ-

:-

ities are carried out in a public health laboratory or vice versa. Its main activities are:

(a)

(b) (0) (d) (e) (f) (g) (h) (i) (j) (k)

(1)

histopathology - microscopic examination of tissues - diagnostiC cytology,

histochemistry, chemical pathology, bacteriology, paraSitology, ~ology, virology (including rickettsia), serology, hematology, biophysiCS - (including isotot:e determination), clinical physiology - (including electrocardiography and

basal metabolism determination), and allergology - (laboratory tests for allergy).

WHI./HiL/2 page 4

2.2 • .3 The public health laboratory (basic tYJ?8)

This is usually a part of the city or county health service and mao?" or D18iY' not be integrated with hospital laboratories in the S8lle area. Its main activities are:

(a) bacteriology, (b ) parasitology, (c) mycology, (d) virology, (e) serology, (r) histopathology, (g) chemical pathology, (h) sanitation chemist17 (including milk and water examination),

and (i) food. and drug control.

2.2.4 The public health laboratory Crull tne)

This is usu~ provided by' the provincial. or state health department. It lllS\V or IIUV not be integrated with the hospital laboratOl7 in the same area. Activ­ities or this type consist of':

(a) (b) (c) (d) (e) (f') (g) (h) (i)

(j) (k) (1) (m) (n) (0) (p) (q) (r)

bacteriology, parasitology, mycology, virology, serology, histopathology, hematology, chemical pathology, sanitation cheD'ist17 (milk, water, se-werage, waste, air

pollution, isotope contamination), entanology, pt'oduction of diagnostic sera and antigens, maintenance of' stock cultures and biological standards, Jilarm.aceutical anal1"sis and standardization, food ana.l;y"sis and exanination, drug anaJ.ysis and control, industrial. hygiem (physiology -- f'atigue test), toxicology, and epidemiology - epidemiological and statistical studies on

epidemics, cardiovascular diseases, cancer, mental. diseases, etc.

2.2.5 The ref'erence (speciali:zed or research) laboratory

This is usualJ.y an independent unit established at the pt'ovincial or national level or as part of a university activity. Its main activities are lllnited to one or two f'unctions such as:

wm/Hu/2 page 5

(a) inStitute for biological standards -- to standardize biologicals and to maintain standard diagnOstic sera, antigens" ho:nnones,

(b)

(c)

(d)

vitamins, and other test reagents, .

and/or institute production of biologicals (e.g., vaccine, sera, etc.),

institute for food and drug control, and

institute of nutrition.

2.2.6 The central (national) laboratory

This is alwqs established at the national level. GeneraJ.ly, there is only one such laboratory in a country-. Its main activities are s:ilnilar to the full-type public health laboratory but its activities are more extensive and it is better equipped. Very- often, the central laboratory may be an aggregate of lII8niV reference laboratOries, e. g., the National Institute of Health in Bethesda, Maryland, U.S.A.

2.2.7 Regional or district laborato;r

This is s:imilar to the full-type public health laboratory-, but it mq _rve more than one province or district which has no county or city public he~ laboratory. Sometimes it is a branch of the central labo't'atory.

2.2.8 The joint laboratory

There is a tendency in certain countries to integrate partially or cem­plete~ the hospital laboratory service to the public health laborat017. Such arrangement has the advantage of better utilization of technical personnel, savings on operational expenses and equipnent. In developing countries with limited resources and shortage of trained personnel, a joint laboratory far the hOSpital and public health servioe maov be the one of choice.

2.2.9 The mobile laborato;r

In certain countries where peripheral health laboratory- units are not established, it mq be necessary to have a mobile laboratory- for servicing rural areas. This shouJ.d nomaJ.ly be considered as a temporary or emergency measure as during an epidemic. The equipnent has to be fair~ simple and the number and ldnds of tests perfomed may be quite limited. The mobile unit can also be utilized to collect s~cimens far exanination at the base laboratory. It is alliqs better, homver, to have a permanent type of laboratory.

wm/mL/2 page 6

3. PLANNING

There is no standard pattern far a national health laboratory servioe that oan fit all countries. The pattern for each country is naturally dependent on many factars. Yet points of practical importance have to be observed insofar as planning of the servioe is concerned. These points are:

3.1 Factars influencing the planning of a national health laboratory service

The type at' service for each country vary according to its health problems. In sane countries the problem mSiY' be concerned with the prevalence of epidemic diseases such as cholera, smallpox, and plague; in others the disease ma;y be polianyelitis, encephalitis, etc., while in still others, it may be malaria and filariasis. One oountryls health needs ma;y deal with microbiological investiga­tions and water sanitation while in others they may be concerned with veotor oontrol.

3.1.1 Existing health facilities and personnel

Availability of both qualified health personnel and the physical facil­ities of health organizations (govel'!lll2ntal and private) influence the pl.aJming of a national public health laboratory service. A laboratory is best established within ar in oonneotion wi.th an existing health unit. The laboratory must be run by technioally qualified and canpetent personnel. The availability of personnel affects the planning of staffing and the type of laboratory to be established. Also, the traditional attitude at' physicians and health 'i'Torkers toward a lab­oratory servioe should be determined. Too at'ten in sane countries, the utilization of laboratory service by practising physicians is very limited.

3.1. 2 Ge ographical. population and communication status

Population distribution, size of country, geographical condition and means at' canrnunication certainly influence the decision on the location of the central laboratory and the extent of its peripheral units.

3.1..3 Econanic support

No public health laboratory service can be set up unless it has a suf­fiCient budgetary support. It is a general principle not to depend entirely m the incans of the labaratory far its maintenance. There is also the danger that by charging fees me loses the oppartunity of obtaining ar receiving materials and specimens which IllBiV be of major public health importance. In sane countries the public health laboratory offers an entirely free service while in othezs charges are levied selectively, e. g •• on examinations not con­sidered of public health importance.

3.2 Essential. steps in planning

3.2.1 The survey

WH!./HiL/2 page 7

As a first step1 it is desirable to make an accurate survey of the major heal.th problems1 econanic situation1 availability of health facilities am personnel1 size of the territory1 distribution of population am condition of camnunications.

3.2.2 Preparation of laborato;r staff

Maqy countries lack well-trained laboratory workers. A poor laboratory service is worse than none at all as inaccuracy or error in the findings can do more harm than good. To safeguard against this deficiency \<hich may arise from inadequately trained staff1 it is important to start training laboratory workers at an early stage of the programme. Highly-quaJ.ified personnel oan sanetimes be drawn fran the university departments and research centres although in sane countries, it is not always possible to do so. It mq be stated that men an organized publiC health laboratory is not yet developed in a country, it is important to train the key persamel either in the country or abroad.

3.2.3 Preparation of facilities

In most countries certain types of laboratory invariably exist. 'l'here­fore 1 in planning an organized national public health laboratory service, exist­ing facilities should be utilized as much as possible. New units might be added depending on the survey result1 the country's need and the means avail­able to support it. In developing countries with meager facilities, there invariab~ is also a lack of trained personnel as well as funds. In these cases, however, the scheme can be modest at the beginning to prOVide the simpler type

I'" of laboratory which will be the basis for future expansion.

3.2.4 Choice of a ~stem of service

Based on the survey, the type of service including facilities and health personnel will depend upon the budgetary provision. It is desirable that the laboratory must be established as part of an existing health agency. For example, cUn1cal laboratories should be simple units which should meet the needs of a health station, centre or clinic while the hospital laboratories should be able to meet the more canplex demands of the hospital. services.

It is possible to reduce the number of public health laboratories because a basic type of public health laboratory can be made to service several health units in an area. One public health laboratory for each city or county health department should suffice when the size and population of the area are not too large and mere the means of communication is satisfactory. Provincial health departmezrlis should have the full-type public health laboratory as in most coun­tries this is the level of administration where such type is convenient. At the national. leve11 one central labO'l"ato:y is usu.~ sufficient although branch laboratories m~ be set up. Whenever possible1 it is desirable to either org~ze a unit or develop close working relationship between the laboratories

Wffi/EHL/2 page 8

of the public health and hospital services. Reference laboratories are usuaJ.ly found in well-developed countries. For developing countries, it may be necessary in certain conditions to avail of the reference laboratories of other countries. The co-ordination, direction and administration of the public health laboratories raise the question of an organized national public laboratory service. This subject deserves careful consideration and is discussed below.

4. ffiGANIZATION

Having reviewed the types of health laboratories gener~ located at different levels of government, it will be noted that in general they function independently of each ather. Some countries have approved private laboratories but in general public health laboratories are govermnent operated.

4.1 Is it desirable to have an integrated natiCllal public health laboratory service?

Except in few countries, many laboratories at the local, provincial and national levels receive no direction or supervision fran a central authoritu.

Under central direction, public health laboratories can maintain unifomity :in poliCies and procedures and ensure the quality of service. Such a system also permits1be interflow of personnel am facilitates exchange of infomation between units. One disadvantage, however, is that an operating unit under central directiCll ma;y not feel free to take the initiative or to fully respond to the needs and requirements of the health agency which it nomally serves. On the ather hand, a laboratory that is staffed and directed by' the county health department (see ilnnex II) mq suffer fran. quality of service. From the national viewpoint, absence of central direction for public health laboratories may be responsible for the lack of uniformity in the procedures for the technical services and difficulty in collecting infonnation and interpreting results. Norms.1J.y, the central laboratory provides public health ltboratories with standard stock cultures, strains and other reagents.

In view of the above, one ma:y consider the need for a dual control of laboratories as illustrated in Annex III. The public health laboratory should be established at various levels under the public health service. The type mq range fran the snall and simple like the clinical. laboratory at the rural health unit level, through the basic type public health laboratory at the citu or county health department level, the full-type public health laboratory at the state or provincial. health department level, and the central public health laboratory at the national level. Budgetary provisions and employment of personnel and general direction of work should be the responsibility of the health officer at the approp1'iate level. It is thought, however, that the recruitment of the director of laboratory, although norma1.ly the responsibility of the health officer, should be made only upon the recanmendation of the central.

"

laboratory authority. The central. laboratory should, in addition, be responsible .-for the technical. guidance of the public health laboratories at lower levels.

• .1 .,.

c.

Wffi/HiL/2 page 9

In addition to the three schemes shown in Annexes I, II and III, there can, of course, be many other schemes and it ")ould be the responsibility of individual gove:rnJi1ents to choose, modify and evolve one to fit the country1s conditions.

4.2 A national advisory council (board) on the laboratory service

Few countries have a council (board) that serves as an advisory body to the minister of health (or his equivalent). This body can advise and assist the minister in determining policies on laboratory activities, recommending standard pt'ocedures and suggesting necessary legislation. Membership of the council may be camposed of public health administrators, directors of central and reference laboratories, SCientists, epidemiologists and }ilysicians.

Actual overall direction of t!Y3 national public health laboratory service could be exeouted by an office of the minister of health or by the central lab­oratory or such other organizations delegated by the minister.

4. 3 Staffing

4. 3.1 Categories of the staff

The number and kind of staff employed in a laboratory vary greatly in a country or !rom country to country and depend on the type and volume of work. Generally speaJdng, laboratory staff falls into four main categories, viz., adm:illistrative, medical, scientific and technological. In the central, provincial and county or city public health laboratory, the administrative staff is headed by a director of laboratory and ma:y receive assistance fram sections personnel on the compilation of reports, statistics and library. The director should be a medically qualified person with adequate experience in public health laboratory work. In developing countries, however, this may not be possible and a qualified non-medical workBr or scientist ma:y temporarily be utilized until a medical man can be enlisted.

In smaller laboratories the administrative staff should be at a rru.n:unum and dispensed with in the smallest unit as with the rural health station clinical laboratory. Medical staff, aside !ram serving in such position as laboratory chief, may also be needed in various departments of larger laboratories, e. g., in pathology. other specialized departments of laboratories may be headed by the scientific staff, e.g., microbiologists, chemists, veterinarians, pharmacists or science graduates, with the required specialized training in their respective fields. The technological staff composed of laboratory technologists (junior college) and technicians constitute the important service personnel in any lab­oratory. However, in no laboratory should a non-medical staff be called upon to serve consultative~ in a medical capacity. Even in the smallest unit, suoh as the rural health station clinical laboratory, findings should be confirmed by medical personnel, preferab~ from the health station.

Wffi/HIL/2 page 10

4.3.2 Qualification and training of the staff ,

The medical staff usually are nedic-al. graduates who have had one or more years of experience in practical laboratory work. Hhen such staff is to be selected for a key pOSition, it is desirable to include in his training elements of statistics and general administration.

The scientific staff is composed of coll.ege graduates in science majoring in subjects such as microbiology, chemistry, veterinary medicine, Jilarmacy, etc. who after graduation have had at least two or more years of practical laboratory­experieIXle. In some countries spilcial post-graduate courses which are open to non-medical graduates are given leading to a diploma in bacteriology, parasitology and tropical hygiene.

The technological staff have varied levels of qualification. At the higher level, the worker may have had two to three at' more years of college dealing with laboratory- work for 1mich a school certificate ma;'/' be given; these are the technologists or senior technicians. They are not; frequent~ found in developing countries. Lower Jevel technicians may have had on~ an elementary school education and first entered the laboratory as helpers but who grad~ learned various laboratory- techniques through apprenticeship. The medium category­of techniciam are those who, after passing through apprenticeship, haw under­gone a short-tenn training course in laboratory- wat'k.

Technicians constitute the majority of workers in most laboratories; they pilrfonn da;v-to-day routine 1aboratory duties which require reliability of pil;rformance.

In view of their importance, there is a med for each country to provide ref:resher, certificate at' diploma courses for the training of technologists and technicians.

5. ADMINISTRATION

5.1 Legislation

Laws ani regulations are needed to pranote the developnent and improve the standards of public health laboratory services.

5.1.1 Public laboratories

Health laboratories in countries differ in organization and administra­tion as may be provided by law or regulation with reference to functions, scope of work, staff:ing pattern, scale of pay, source of financial support, authority for action, etc. Very few countries have a law or regulation which defines or stipulates qualifications and academic requirements of laboratory workers especia~ of the technological category. ..... j

-' -

t

~.1.2 Private laboratories

WHI./HU/2 page II

Private' laboratories are generally required by law to be registered but there frequentl¥ are no provisions for the min:ilJlum qualifications of their staff.

~.1.3 Quality control

Most oountries have minlJDum requirements for the safety of foods, drugs, oosmetios, milk and water. UsualJ.y, there are laws and regulations condemning unfit articles which ma;v invoke severe penalties for violaticns.

5.1.4 Biological standards and reagents

In most countries, there are national standards and requirements far biologicals such as vaccires, sera, toxins, etc. Although the standards are s:lJnilar for cosmetics, there should be more unifomity of acceptable standards throughout the world.

~. 2 Maintenanoe of standard strains and diagnostio reagents

Almost every laboratory keeps stock cultures and strains of virus for diagnootic work and other tests. It also keeps antisera and prepares reagents. But too often, mutation and other changes ocour in the subculture of bacteria or in the sub-passage of virus. MaIv oountries have national institutes responsible for maintaining standard cultures and strains which help in maintaining unifo:mdty in laboratory tests and making results obtained oanparable. It is :ilJlportant, too, that there should be a world standard centre for this purpose. Through the auspices of the World Health Organization, there are such centres, and each Member Country should utilim them as much as possible.

Relationship with laboratories of other governmental agencies

National agricultural and industrial agencies ma;v also have laboratories whose relatiGJlship with health laboratories cannot be overlooked. For instance, in IIl8l\Y' countries tbere are veterinary laboratories under the agricultural m:1nistry. Beoause of the :ilJlportanoe of zoonoses and an:ilJlal intermediate hosts to publio health, there should be co-Operation and co-ordination of activities between them, particularly through exchange of relevant information in animal

disease control programzoos such as rabies, bovine tuberculosis, psitacosis, etc. The co-operation of industrial agenCies (e.g., those related to the processing and manufacturing of food products and drugs) which ma;,v have laboratories whose activities are of direct concern to the public should also be cultivated.

. Public health laboratories should collaborate ltrith special governmental ar private research institutes and university departments as they can be of assist­ance in the training of the laboratory workers and serve as reference laboratories.

wm/mL/2 page 12

5.4 Standard laboratory procedures and ~thods

Procedures and methods for the collection, treatment and testing of speciJnens, the isolation, identification and the storage of bacterial cultures and virus strains, the determination of toxin and anti-toxin, the preparation of reagents and the reading and interpretation of tests are usually adopted individually through general usage and bear the nane of the original investigator, sometimes with modifications. In the performance.. of tests, it is ilIlportant to denote distinctly the nane of the method indicating also the modification, if arry. Most coun~ries compile their own "Standard Laboratory Methods" or adopt one fran other countries. They are usually derived fran sane internationally !mown publication sum as Wadsworth I s Standard MethOds or Bergy's Determinative Bacteriology, etc., which in turn draws information from publications by" investi­gators. The international scientific societies from tillle to time publish the approved ~thods. But many newer methods are being evolved and the laboratory has to depand constantly on newly developed techniques which are published by" laboratolY workers. As a rule it is deSirable, hOloiever, for a national central laboratory to compile a laboratory manual far use in the country.

~.5 Scientific ~etings and publications

It is extremely important that laboratory "l-Iorkers should organize SOCieties, hold scientific meetings and publish technical journals. It is through journals and ot.her literature that free exchange of infonnation and ilIlprovement of mw methods can be developed. International societies and meetings of this nature are even more ilIlportant and significant. As a general prinCiple, it is only after a method advocated by" one original. worker is confirmed by" others that it can be adopted for general use.

In developing countries where original laboratory research is usual.J;r lacking, it is desirable to hold regular discussion meetings ani seminars on current literature. Free access to literature and information through a good library service is essential to the publiC health laboratory workers.

5.6 SUp3rvision of public health laboratory services

~ laboratories are without the benefit of receiving a periodic check of the quality of their performance. The diverSity of techniques involved in the keeping of stock cultures and standard strains, preparation of antisera and other reagents, and in the performance and reading of laboratory tests render standard techniques and procedures subject to deviatiOns and errors. Their detection is as ilIlportant as the rerformanoe of the test itself. It is, there­fore, desirable to have a competent technical group to check over the oonduct of services in laboratories. This responsibility should normalJ.y be assUJll8d by" the central publio health laboratory.

6. lNI'ERNATIONAL COLLABCRATION

WIR/lHL/2 page 13

Close international collaboration in the field of public health laboratory service is extremely important. There should be an exchange of information of eJq2rience, stock materials and :p'lrsonnel between countries. This exchange can best be mediated by the World Health Organization.

(a)

7. SUMMARY

For the successful pranotiM of publiC health services and medical care in any country, it is necessary to have an organized public health lab­orat~ service.

(b) The public health laboratory may vary from the simple to the highly speCialized type and should be a part of the operating units of the national public health service. Their number and distribution can follow the general distribution of the public health services, viz., at the central, prOvincial, county or municipal and local (rural village) levels.

(c) Regional or branch public health laboratories may be established to serve more than one county and city.

(d) A joint laboratory combining the functions of a public health and hospital laboratory in a local area is desirable.

(e) A mobile laboratory is necessary only when the territory is still under­develo:p'ld and must be considered as a temporary measure.

(f) It is important for a specialized laboratory to serve as a reference lab­oratory for its speCialty.

(g) It is desirable to co-ordinate activities of the public health laboratory with those of veterinary and industrial agencies as well as with university departments, research institutions and private laboratories.

(h) The publiC health laboratory of a country needs integration under a system with a central authority which should direct and supervise technical operations and maintain standards. The general administration of each unit should be independently controlled by the appropriate public health laboratory depart..nent or unit to "rhich it mSiY" be attached.

(i) It seems desirable to have a national adviSOry body (council or board) on laboratory services which can advise the minister of health on poliCies, standards and legislations required.

Public health laboratories have three main functiOns, viz., service, research and training.

1.VPR/PHL/2 page 14

(k) Staffing problems still p3rsist in many countries. More attention should be paid by governments to the training and preparation of highly qualified laboratory workers as vell as laboratory technicians.

(1) legislation is needed to ensure satisfactory developnent and operation of public health laboratory services. Many countries lack regulations providing for minimum qualifications of laboratory worlrers.

(m) It is deSirable to lreep at a minimum the imposition of laboratory fees so that specimens of public health importance ma;r not be missed.

(n) International collaboration in the field of public health laboratory services is important; this can be promoted through mediation of the World Health Organization.

.-l

,- ...

-" ~

... - J:

ANNEX I

Seheme I

A system of centralJ;r directed national public health laboratory service:

--_._-------(i~dYis or!) Nationcl Council of Health .

I Laboratories

Clinical Laboratory

Provincial Health

Department

.1

v 1. ~rsonne~ recruitment

2. Administrative Direction and Budget Provision

National Health Administration

123

! ! ~ Central

Laboratory

1 2[ 11

Full . T:-fTlEl Pt:blic health

Laborat;ory

I

,-1-+ .- 2--7

-3-4

Reference Laboratory

Basic Type Public Health Laborator.v

l All by the National Government

throrgh the eentral laboratory

except reference laboratories , . Technical Service Direction r

1"""\

{

A system of complete

(Advisory) National Council on Health Lab.

Village or Township ealth Centr

IClini~al

Lab.

1, __ --'

ANNEX 2

Scheme II

~~~~~public health laboratory service

FTovincial Health

Laboratory

National Health

3

Central Laborator;y-

[ ~

~

.-, .' ,

" ,

1 I

Full-type Public-Health

Laboratory

~~--~----~~r--------~/

" "

Reference Laboratory

..-" /

lB· .

I asJ.c T-ype P.R.

Lab.

1. 2.

Personnel R0crui~~ent Administrative Direction and

Budget Provision Technical Service Direction

I All decentralized and public '. health laboratories are ), responsible to resp3ctive J health administrators.

ANNEX 3 Scheme III

A system of dually directed national public health laboratory serviye

j ~!~~~i~-6o~~ij ---.... ~ on Health Labs.

.. -

\ Na tional Heal th \ -:--

MNini''''7= 3 -:

_. __ .. ] Refurence

Laboratory

Clinical Laboratory

\ 1 1

1

.---~.,.

~ 1 f ------...,'

/

/

Central Laboratory ~

3

~'\\ / Provincial \ I Heal til }._ 2 _ Full-type \ Department; - P .H. Lab.

" .? .... / '10'--.. ,,' •. _ --' , r--_ .... I

V

/

,; ,;

/

/ o·

City or County Health Department

3

\ Basic type P.H. Lab.

l~ Personnel Recruitment Joint appointment

Responsibility of the health administration

2. Administrative Direction and Budget Provision

3. Technical Service Direction Responsibility of the Central Laboratory

I

WORLD HEALTH ORGANIZATION

ORGANISATION MONDIALE DE LA SANTII

REGIONAL OFFICE FOR THE WESTERN PACIFIC

8UREAU Ri!GIONAL DU PACIFIQUE OCCIDENTAL

P. O. Box 2932. MANILA WlR/IHL/:3 fEMINAR ON RlBLIC HEALTH

IABCRATCRY SERVICES 17 October ].960

Manila, Philippines 5-1.6 December 1960

CRIDIHA.L: ENlLISH

1.

TECHNICAL REQU:mElo£NTS FCR PUBLIC HEAI:l'H IABCRATCRlES

1 Dr. RalIh B. Hogan

CONTENTS

TIlBS CF PUBLIC HEAL'lH LABCRATCRlES • • • • • • • • • • • • • • • • 1.1 The small clinic laboratory (Level No.1) ••••••••• 1.2 Local hOSpital (county) and public health

laboratory (lavel No.2) • • • • • • • • • • • • • • • • •• 1. 3 Regional publio health laboratory (Level No.3) •••••• 1.4 National reference laboratory (Level No.4) •••••••• MINlMUM SBlCE REQUnu::MEN'l'S •• • • • • • • • • • • • • • • • • • • STAP"F • • • • .. • .. • • • • • • • • • . . . . . . . . . . . . • • • 3.1 Frofessional qualifications •••••••••••••••• I.A.B~TatY S£RVICES • • • • • • • • • • •• • • • • • • • • • 4.1 Bacteriological examinations • • • • • • • • • • • • • • • • 4.2 Sanitary ba.oteriology, milk, water, sewage ••••••••• 4.3 Parasitological examinations • • • • • • • • • • • • • • • •

4.3.1 Level No. 1 laboratory ••••••••••••••• 4.3. 2 Level No. 2 laboratory • • • • • • • • • • • • • • • 4.3.3 Level No. 3 laboratory •••••••••••••• • 4.3.4 Level No. 4 laboratory • • . • •••••••••••

4.4 ~ological examinations • • • • • • • • • • • • • • • • • • 4. 4.1 Level No. 1 laboratory • • • • • • • • • • • • 4. 4. 2 level No. 2 laboratory • • • • • • • • • • • • • • • 4. 4. 3 level No. 3 laboratory • • • • • • • • • • • • • • • 4.4.4 Level No. 4 laboratory ••••••••••• • •

1 1

1 1 2 2 2 :3 :3 3 4 4 4 5 5 5 6 6 6 6 6

~dical Director, Chief, Laboratory Branch, Camnunicable Disease Center, " -r Atlanta 22, Georgia, U.S.A.

6.

4.$ 4.6

- 2 -

Virology' • • • • • • • • • • • • • • • • . •.• • • • • • • • Production of biologicals • . . . • • • . . · .... • • • 4.6.1 Diagnostic reagents ••••••••••••••••• 4. 6. 2 Biologicals . . . . . . . . • . • . . • . .. • . • . .

COLIECTlCU, ":L'R.AmPCRT, AND REGISTRATlOO CF LABCRATCRY SlECIMENS •• $.1 Colleotion of specimens • • • • • • • • • • • • • • • • .• • • $. 2 Transportation of specimens • • • • • • • • • • • • .• • • • • $ • .3 Reports and registration • • • • • • • • • • • • .• • • • • • $.4 $.$

Records • • • • • • • • • • • • • • • • • • Inventar,r control • • • • • • • • • • • •

• • · . . . . ... .. . • • • • 5.5.1 Laboratory supplies ••• • • • • • • • • • • • • • • 5.5.2 Biologicals • • • • • • • • • • • • • · . . • • •

GElERAL SERVICES • • • • • • 6.1 Media preparation • • •

. . . . . . • • . . . · . . • • • • . . . . • • • • . . . · .. . • • •

6.2

6 • .3

6. J,e 1 Space required and ls;vout • • • • • • • • • .• • • • • 6.1.2 Fersonnel . • • . • • • • • . . • • • . • • • • • . • 6.1 • .3 EquiprEnt • . . . • • • • • • • • • . . • . . . • • • 6.1.4 Basic materials needed •••••••••••••••• 6.1.5 Water •••••• . . . . . . . . . . · . · . • • Preparation of scientific glassware • • • • • • • • • • • • • 6.2.1 Space required and ls;vout • • • • • • • • • • .• • • • 6. 2. 2 Ferson.ne 1 • • • • . • • • • • • • • • • • • • • • • • 6. 2 • .3 General procedures • • • • • • • • • • • • • • • • • • Care, handling, and breeding of laboratory animals • • • • •

AN1£X 1 L

CAlE, HANDLJ:tI} AND BREEDOO CF LABCRATCRY ANIMAIS • • • • • Location of an:imal quarters • • • • • • • • • • • • • • • • • 1.1 Size of units or roams • • • • • • • • • • • • • • • •

2.

6. 7.

8.

102 L.3

Construction. . . • • • • • • • • . . • • • • • • . • • Heating, cooling, ventilation, and lighting • • • • •

Cages • • • • • • • • • • • • • • • • . . · . . • • • 2.1 C age material . . • . • . . . • . • . . • . • . • • • 2.2 Cage design and space requirements for

experimental an1mal.s • • • • • • • • • • • • • • • Sanitation - cages and quarters • • • • • • • • • • • • • • • Organizational structure and management • • • • • • • • • • • 4.1 Central laboratories • • • • • • • • • • • • • • • • • 4. 2 Branoh and local laboratories • • • • • • • • • • • • 4.3 Servioe facilities • • • • • • • • • • • • •••••• Care and handling • • • • • • • • • • • • • • • • • • • • •• 5.1. Nutrition...................... 5.2 Hamling and restraining techniques • • · . · . . S.:3 Litter or bedding ••••••• • • • • • • • • • • • Diseases and parasites • • • • • • • • • • • • • • • • • • • Laboratory animal breeding • • • • • • • • • • • • • • • 7.1 Selection of strain or breed •••••••••••• 7.2 Breeding system for randan bred anilIlals • • • • • • • 7 • .3 Miscellaneous breeding infarmation • • • • • ••• Cage design and space requirements for breeding laboratory a.n:im.als • • • • • • • • • • • • • • • • • • • • •

7 9 9

10 10 10 10 11 11 12 12 12 12 12 12 13 13 14 14 14 14 J5 J5 16

19 19 19 19 19 19 19

20 20 21 21 21 21 21 21 22 2.3 23 24 24 24 24

- 3 -

.ANNEX 2 - BIBLIOORAIHY 00 AN:rnAL CARE AND BREEDOO ••••••••• • • 27

ANlEX 3 - SIECJFICATlOOS USED BY THE COMMUNICABIE DISEASE CEN'mR Fat THE MANUFACTURE CF ANll'IAL FEEDS .• • • • • • • • • • • • 32

ANl&X 4 - HiEPARATION CF SClENTIFIC GIASSWARE •••••••• . . . . . 34 1. Handling of used glassware and related

items in laboratories •• • • • • • • • • • • • . . . . 34 2. CleanIDg • • , • • • • • • • • • . • .. .. .. .. .. .. .. .. .. .. .. • 34 3. Inspection and preparation • • • • • • • • • • • • • • 35 4. Sterilization... .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 35 5. Space and equipnent required for the preparation

of scientific glassware and related items • • • • • • • • • 35 6. Fersarmel .. • . . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . 36

ANlEX 5 - POSSIBIE AMERICAN SOURCES CF EQUIOONT AND MATERIALS • • . . . 37 ..-. ANNEX 6 - FQSSIBIE Al£RICAN SOURCES OF EQUIR£NT AND MMERIALS •

F CR MI!:D IA. HiE PARAT ION • • • • • • • • • • • • • • • • • • 38 1. Eq'Ui pnent ... .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. 38 2. &teri~s.... .. .. .. .. .. • .. .. .. .. .. .. .. .. .. .. .. .. .. • .. .. .. 38

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1. TYlES CF RJBLIC HEALTH lABCRATCRlES

WHI./mI/3 page 1

In discussing the technical requ:irenents for public health labaratoriss, SCIlla arbitrary classifioation of publio health laboratories is neoessary. Gen­erally spea.king, :tour types of laboratories rendering health servioes are recog­nizable throughout the world: the small clinic laboratory, the local hospital (county) am public health laboratory (CClnbined), the regional public health laboratory (associated with state hospital or nsd:1.cal school), and tba national re:terence laboratory. While:tour general types o:t laboratories are described, each indivichud laboratory will represent sane degree of transition between types, dependent large~ on needs and conditions lo~ •

1.1 The snall clinic laborato17 (level No. 1)

This is essentia.J.:q' a rural health unit. The staff us~ oonsists o:t "....., a }ilysician, nurse, clerk, and a laboratory technician. The JilYsician mq be a

part-time employee who holds various types of clln.l.cs at specified times. All or }:Qrl of the staff might travel fran place to place to provide outpatient service to various areas. Only limited laboratory equipnent am supplies are available (a microscope, lamp, a few simple stains, collecting equipoent, etc.). At this level, major em:P;lasis is placed on clinical diagnosis and relati'V'9~ few specimens are referred to better equipped laboratories. Usua.J.:q' ~ :tresh prilJ1ar,r spec:iJlens are examined.

j"

1.2 local hospital (county) and public health laboratory (level NO.2)

Fresh primary spec:iJllens are received from both patients attending the outpatient clinics and those in the hospital. In sane instances, mailed prlmar,y specimBns ma;r be received fran practi"ing Mrsicians. AdditicoaJ. laboratory equipnent such as centrifuges, incubators, autoclaves, etc. and simple media and other reagents are available at this level. A large~ better trained staff is available lID.) C3Il provide in-service training for new employees.

1.3 Re ional blic health laborato level No. ) be associated with state hospital or nsdical school)

Although essentiaJ..J;r a bona fide public health laboratnry, it is freq­uent:q- aSSOCiated with a large hOfipi tal caring for both in- and out-patients. In addition to supp1y1ng the services offered at the second level, the laboratory is probably the first level to pt'ovide a reference diagnostic service. It is well equipped and has a well trained staff. In addition to the usual equipnent fer microbiology, laboratories at this level should be capable o:t determination at least "f the baseline of radioactivity- of its water supplies. M:imJoal equipnent required is a Geiger Muller counter, preferab~ with autanatic sample changer. It ms;r provide tra:ining for technicians. OccasionaJ.l¥ sane inves­tigative workconcernad with control progrBll1lll9s ma;r be conducted. In a number of smaller countries, this might constitute the top level of laboratories.

WPR/mI/3 page 2

1.4 National reference laboratory (Level No.4)

Although in some instanoes this laboratory may be associated with a large hospital or medical sohool, its primary function is a reference oentre. It may receive mailed primary speoimens from physioians in a given area, but. gene~ these speoimens should be sent to Level No.3., As a nat.ional laboratory, it would receive check speoimens from lower l,evels for final. identification or oon­firmation. Immuno-diagnostic work is primarily concerned with epidemiological studies on prevalence. A certain amount of research am eValuation of diagnostic procedures is expected at this level (see 4.1, last paragraph). Refresher training is offered at this level am evaluations of the lower level laboratories are comucted.

In view of the nuclear power age into which we are enter~, laboratories at this level should be capable of analyzing eamples for iDiividual. nucleotides. In addition to radioisotope equ:1.pment available in the regional laboratory, a single channel analyzer is required, and a multichannel amJ.yzer is preferred.

2. MINIMUM SPACE REQUIREMENTS

The minimum space requirements for these laboratories depend on the type of laboratory. The laboratoty associated with a hospital requires a min1Jnum of 4.5 square feet per bed to provide the laboratoty facilities for the hospital. Additioml space should be made available if public health services are performed for out-¢1ent clinics, private }Xlysicians, or the health department. Hospitals of less than one huIJired beds usually perform laboratory services in one-roan laborat~B.. Larger laboratories require separate rooms for dish-washing, prepara&1.QD8, bacteriology, clinical chemistry, radiology, etc. Analysis of fourteen state laboratories (U.S.) reveals noor space varying from 1.260 to 40 OOO;aquare feet. This represents a variation of 135 square feet per laborat017 employee to more than 650 square feet. Most public health laboratories in ~ United States are not associated with hospitals. Space is, therefore, given as sq~e ,:feet per person. Those laboratori~s with less than 200 square feet Per peI'llOll are obviously crowded, do not allow sufficient; working space for adequate st~e space. The minimum desirable space is, therefore, something in excess of 200 square feet, the optimum depending largely on the type of labOratory and the kiIxI. of procedures undertaken. Large rooms accommodating a number of workers generaJ..ly require less noor space per individuaJ.. Where small rooms for -individual workers are required" the optimum noor space required is increased.

3. STAFF

The staff is composed of professional, technical and administrative (clerical am diener) personnel. The optimum ratio of profeSSional. to technical personnel will vazy with the size of the laboratoty and the degree of specializa­tion of laboratory procedures carried out. Analysis of fourteen state laboratories (U.S.) with staffs varying from 4 to 140 reveals roughtly one41alf of the personnel as profeSSional; the other one-half technical am administrative. In the central laboratories (and some regional laboratories) where greater profeSSional training is required to perform more exacting techniques am to undertake researoh, a higher proportion of profeSSional personnel is needed.

3.1 Professional qualifications

WPR/HiL/3 page 3

The qualifications or the scientific and technical staff required will depend on the ~e or laboratory and to some extent on the personnel available. At the lowest level, the clinic laboratory, the single technician should have academic training through the college level and a minimum of one year1s practical training and experience.

It is generally felt, particularly thro~hout Europe, that the director of a central laboratory (Levels No.3 and No.4) should hold a medical qualifica­ti.on. In the United States, approximately one-haJ£ or the state laboratories are headed by a Ph.D. The qualifications, particularly of the professional staff, are subject to considerable variation of opinion and represent an excellent subject for discussion. (Note: Position descriptions from several laboratories will be available for reference and discussion.)

4. LABORATORY SERVICES

4.1 BaCteriological examinations

The prjmary' level laboratory (the clinic laboratory) should be equipped with a microscope and lamp, laboratory centrifuge, and s:im.ple biological stains, and should be able to examine sputum as well as gastric washings, and should also be able to examine pharyngeal swabs and urethral smears. With these materials the laboratory personnel nuq be able to make presumptive identification or the organisms causing tuberculosiS, pneumonias of bacterial origin, and gonorrhea. They would not be equipped to do al\Y' culture work, biochemical tests, serology, pathogenicity tests, or histopathology. Only limited clinical pathology such as In'inaJysis and blood counts would ordinarily be undertaken. Presumably specimens collected at this level would be sent on to the next level for further work if the collecting laboratory could not process them because of lack of competency and/or

r. equipnent or facilities. "". ... /

A second level laboratory should be equipped with autoclaves, a media kitchen, and other equipment necessary for general bacteriological diagnostic work. It would receive spec:lJnens from the lower level laboratories or ph;ysicians, by mail or cOln'ier, and would collect fresh pr:imary spec:iJDens as well from patients on the premises. This laboratory should be able to do isolation and preliminary identification work, including serology and biochemistry, on a wide variety of bacterial pathogens, including the organisms causing tuberculosis, bacterial pneumonias, meningococcus meningitis, diphtheria, various salmonelloses and enteric fevers, brucellosis, and tularemia, but perhaps excluding cultln'ing of such organisms as the leptospiras. It should also be able to cultln'e and identify staph;ylococci and streptOCOCCi, and perhaps to "group" the latter. Isolates from this laboratory, after preliminary identification, might be sent to the third level laboratory which serves as a reference laboratory and which is better able to characterize JIIIU\Y of the organisms for epidemiological purposes.

The third level laboratory, equivalent to a state or provincial laboratory, serves as a reference laboratory for the lower levels and may completely process all routine specimens, although much of its work would probably be composed of

7 'l isolates referred by the second level laboratory. This laborato17 should be a fully-equipped bacteriological diagnostic laboratory with a staff competent to

WPR/HiL/3 page 4

identif,f and characterize all but a relatively few difficult or "research-type­isolates, which would be referred to a national level reference laboratory- for identification or confirmation. (Maztr of the isolates received fram the second level laboratory- presumably would be sent for confirmation of work alrea~ done at that level.) It might also engage in such activities as phage typing of typhoid or stapl:'\,Ylococcal isolates, since these activities would ordinarily not be done at lower levels. Personnel of the third or state level laboratory­presumably would do a l:iJnited amount of research on public health probleJIIB in areas of concern to them.

A national laboratory-, which has as its pr1mar,y function to act as a reference centre, represents the highest level of laboratory campetenq-. This is a well-equipped and well-staffed laboratory that is able to undertake evaluation programmes for lower level laboratories as well as to carry out final identifications or difficult or controversial isolates referred from lower levels. It would also be engaged in an active research programme concerned with publlc health problems in microbiology, radiology, and related disciplines, and should be the highest level of applied laboratory sclences in its particular country.

4.2 Sanitary- bacteriology, milk, water, sewage

U3vel No. I laboratories, primarily clinical in nature, would probabJ.¥ not be concerned at all with sanitary bacteriology, since equipment and personnel would not be available. level No.2 laboratories might well handle the bulk of local sanitary- bacteriology involving public eating establishments since this is essentia.l.ly a local problem. Milk and watel' bacteriology ~ including laboratory­work on outbreaks of food poisoning, could probably best be done in a centralized laboratory- such as a level No. 3 laboratory-, unless the transportation network were such that rapid transport of the pr:ilnary specimens could not be accomplished. If this were the case, the work would of necessity have to be done at the nerl lower level or not done at all. The national reference laboratory would not be expected to be involved in routine milk and uater analyses, but probabJ.¥ would be concerned with food poisoning outbreaks and the setting of staJxlards on inter­state carriers. In aztr case, standard techniques recanmended by the state or national laboratory should be used to achieve uniformity in testing and to main­tain adequate sanitary- standards.

4.3 Parasitological examinations

4.3.1 Level No. I laboratory

(a) PcrforJllB direct wet moum examinations of feces for trophozoites and cysts of protozoa, eggs, larvae and adults of bel.m.int.hs; or urine for eggs of sC::u.St.OSOMeS (primarily S. hematobium); of sputum for eggs of Paragonimus westermanI; of blood for· OO:'.:..:'F ~';.crafilaria (primarily Wuchereria 'bancrofti and W. malayi); and of rectal biopsies ana asp:trates (if collected by sigmoidoscopy) for schistosome eggs and Entamoeba histolytica.

(b) Stains and examines thin and thick blood films for malaria and filariasis.

....

{

4 • .3.2 Level No. 2 laboratory

(a) On specimens collected frem in- and out-patients, examines wet mounts and stained blood films as at Level No. 1

WPR/HIL/.3 page 5

(b) On certain cases performs concentration techniques on feces (formalin-ether procedure) for intestinal protozoa and helminths and on blood (Knott I s or saponin procedure' for micro­fUariae.

( c ) Ii' mailed primary specimens are received from practising ~sicians at this level, examines the direct wet mounts of specimens suitably preserved (formalin, etc.); stained blood film~ (promptly delivered)' stained feces and rectal aspirates (preserved in PVA-fixative~; concentrations or feces (preserved in formalin) and blood (in anticoagulant).

4.3.3 Level No. .3 laboratory

(a) Performs the same examinations as of Level No.2 on spec:illlens from in- and out-patients and on mailed primary specimens received from pnysicians.

(b) Ii' therapy control programmes for intestinnl nematodes are conducted at this level, performs egg counts (Beaver I s or stoll l s procedures) on either fresh or formalin preserved feces.

(c) Ii' this level serves as a reference centre for Level No.2 and other divisions of the government, examines stained blood films, fecal specimens in PVA-fixative or stained fecal smears and rectal aspirates and concentrations of feces and blood. On occaSion, might perform direct examination of feces, urine, and sputum; and egg counts on feces.

4.3.4 Level No.4 laboratory

(a) As pr:iJllarily a reference laboratory, examines wet mounts of certain materials, stained blood films, fecal smears and rectal aspirates, and concentrations of feces and blood from patients examined at a lower level. On occaSion, check egg counts performed at Level No.3.

(b ) Identifies unusual arthropods, snails, etc. referred.

(c) For investigative purposes (prevalence studies, control evaluations, etc.) may perform al\Y of the above examinations on primary specimens.

(d) For investigative purposes and methodology evaluations, performs as needs indicate, the following immuno-diagnostic tests:

Complement fixation test for SChistosomiasis, paragonomiasis, echinococcosis, leishmaniasis, and filariasis;

WPR/PHL/3 page 6

Hemagglutination test for echinococcosis;

Bentonite flocculation test for trichinosis; perhaps the Methylene blue dye or fluorescence inhibition test for toxoplasmosis; and the Intradermal test for schistosomiasis.

4.4 ~cological examinations

4.4.1 level No. 1 laboratory

(a) Collects clinical specimens !'rom suspected cases of riDgworm, piedra, ehrmoblastOll\Vcosis, rhinosprodiosis and pulmonary infections.

~b) Examines skin, hair and soil spec:imen for evidence of ring­worm infection with use of lQ(; KCH mounts.

(c) Examines hair under ultra-violet light for evidence of tinea.

(d) Runs grams and acid-fast stains on sputum and pus for evidence of infection with Candida albicans or systematic fungi.

(e) Inoculates media with clinical spec:imen. Refers them to level No.2.

4.4.2 level No. 2 laboratory

(a) Carries out all activities performed at level No.1. In addition, tentatively identifies cultures. Refers unknowns to next higher level.

(b) Collects tissue specimen for histologiC study and refers them to Level No.3.

4.4.3 level No.3 laboratory

(a) Performs all services handled by levels No.1 and No.2. In addition, identifies all fungus cultures. Refers problem cultures to level No.4.

(b) Carries out histological work.

(c) Carries out an:ima1 pathogenicity tests.

(d) Performs biochemical tests when needed for the identifica­tion of pathogeniC fungi.

4.4.4 level No. 4 laborat~

(a) Serves as reference laboratory to lower levels.

(b) Carries out complement-fixation and other serological tests for histoplasmosis.

(c) Carries out skin test surveys and other epidemiological work.

•

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WPR/PHL/3 page 7

(d) Trains personnel for staffing of laboratories of the 10lfel' levels.

(e) Develops and runs a research programme.

4.5 V:irologr

Diagnostic procedures and laboratory activities pertinent; to viral diseases are determined on the basis of the current limitations experienced in this field. These restrictions necessarily guide the role which a particular laboratory mq be expected to plq within its area of responsibility and consist of factors involving budget, pt"ocurement of tra.:lned personnel, reagent;s, and special. medical problems. Thus, smaller laboratory units (levels I and 2) represent the immediate focal point of contact with clinicians aM epidemiologists in the field. The:ir activities are ooncerned mainly with collection of speoimens appropriate to the clinical problem, furnishing intol'llBtion on the types of examination available, assisting in the dissemination of information pertaining to incidence of infection and contributing assistance for collection of speoimens in the field and pertinent epidemiologic data. The actual amount of diagnostic laboratory studies available at this level ma;y be limited to scme of the more i'requentJ,y required serological. tests (level No.2) generalJ,y using canplement f:ixation techniques which oould be co-ordinated with Venereal Disease serology, and such presumptive diagnostic pro­cedures which must be perfo:naed rapidly, aM for which oomplicated equipnent or a:ceptional canpetence is not required. The examination of 8U8P8cted rabid animals by d:irect smears 1118.7 be included in this category. In azv event, emphasis is pl.aced on providing storage fac1l1ties, refrigerants far shipnent, shipping con­tainers, information on sample preservation, loCIU. area far oollection of informa­tion, and to act as an iJ:rtemediary for collection of additional. specimens and 8a111Pling as required by labaratories of a higher echelon.

The regional laboratory (level No.3) is intermediate in £unction between the local and central laboratories aM the first level where definitive laboratOl'7 facilities for the diagnosis of diseases of virus etiology can be rational.ly established. At this level, serology of a broader spectrum of virus diseases ma;y be made available. The oomplement f:ixation tests are limited only by the type of antigens obtainable but should include the arthropod transmitted ence{ilalitides appropriate to the area, mumps, herpes, Influenza A and B, the group specific antigen for Adenoviruses, the psittacosis-IDV group, the poliovirus antigens, possibJ,y the rickettsial. antigens ani the variola-vaccinia group. The number and t;ypes should be determined by the endemiCity of the infectious agents in al\1 specifiC area.

Isolation and identification of viruses will be limited by the avail­ability of host systems. These should include embryonated eggs far isolation of influenza and pox viruses, a mouse colol\1 to provide suckling and mature mice, am a l:iJnited nmnber of guinea pigs and rabbits. Hemagglutination may be used as an accessory procedure for detecting and typing several groups of viruses and the canpleted study of rabies intection can be perfomed readi J,y by mouse inoculation.

If at all, the use of cell cultures should be limited to con\;inuous passage lines which can be established and carried with minimum difficulty. HeLa and/ar human amnion lines may be carried in commerc1aJ.J,y available reagente aM seed cultures are readily obtainable in the event of laboratory failure. These

.~ lines otfer the widest supplementary aid in detecting and vping of enterov:iruses most frequen\;J,y involved in epidemic diseases, the adenoviruses, herpes, variola­vaccinia group, measles, etc.

WPR/HlL/.3 page 8

Additional functions of regional laboratories should include service as an intemediary between local ani central laboratories in shipment am storage of specimens, integration am dissemination of information of local health problems, and training and evaluation of local laboratory personnel.

The director of the regional laboratory should have a broad background in microbiology in addition to his ability related to other duties associated with his laboratory. A well-trained serologist and a virologist should be part of his staff, augmented by competent and appropriate numbers of technical assistants.

The central laboratory mould be equipped to offer as complete reference service as possible to regional and local laboratories in the field of virus isolation and identification. It should be able to duplicate &lid extem sero­logical procedures offered by the lower echelon laboratories. It should be capable of preparing a limited nWli>er of reagents required for diagnostiC &lid special studies in sufficient quantities to supply starxiardized control. biologicals to its satellite stations. As an extension of this activity, the central laboratory should provide evaluation am training services and be prepared to evaluate com­mercially avallable reagents, acting in addition to advisory capacity to local manufacturers of biologicals to assist in such improvements ani changes as are deemed necessary.

The central laboratory should serve as a repository for stock proto-type strains of viral and rickettsial types am a reservoir for seed cultures of a number of cell lines. Information of professional progress including novel test procedures, recovery and standardization of new infectious agents, confirmation of etiologic relationships, and other information of a similar nature should be harvested by the central. laboratory arxi transmitted to regional am local laboratories as soon as adequate confirmation and staDiardization for routine use can be establiBhed.

A part of central laboratory function should be the maintenance of facilities for breeding starxiard strains of an:iJnaJ.s for diagnostic purposes to assure adequate supplies to the associated laboratories.

The functions of the central laboratory are summarized as follows:

1. Serology

Complement fixation am neutralization to determine diagnostic antibod;v levels for all viruses and rickettsiae to which these pro­cedures are applicable.

2. Isolation

(a) In primary am continuous passage cell lines.

(b) In embryonated eggs: influenza, herpes, and pox viruses.

(c) Suckling and adult mice: Coxsackie, psittacosis, rabies and ARBOR viruses.

(d) Ot;her animals: as required, e.g., guinea pigs for rickettsia.

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4.6

3. Evaluation and reference

(a) Specimens 8Ubmitted far extension o:f studies.

(b) Evaluation for technical competence.

(c) Evaluation o:r commercial reagents.

(d) Standardization o:f new procedures.

4. Inf'ormation am training

WPR/PHL/3 page 9

(a) Distribution of inf'ormation o:f pro:fessional. progress.

(b) Training facilities in basic and new~ developed tech­niques,

5. Reagents -- preparation, storage and distribution o:f

(a) Antigens nat available commerci~.

(b) Antisera :for diagnosis am controls :for complement :fixation, neutralization and hemagglutination-inhibition tests, nat commerc~ available.

(c) Seed stocks o:f prototype viruses and cell lines.

6. Experimental aniEJ.s

(a) Supply centre.

(b) Animal husban<:b:7.

7. Methodology research

In a central laboratory I the department dealing with problems o:f viral and rickettsial diseases should be a :functionally separate unit :from other clinical laboratory activities. Personnel sta:f:fing should be established on this principle. A director with extensive academio and practical training in virology is highly desirable to supervise diagnostio activities am to iBiicate am direct fruitful areas of investigation. Assisting, as heads o:f unit activities, should be individuals with specialty experience in the appropriate :field segments. Technical assistants should possess higher technical skills than those assigned to lower echelon . laboratories • Because o:f the technical requirements in viral diagnostic procedures as well as the time consumed in carr,ying them out I sta:rfing should be sauewhat greater than the minimal requirements :far routine demands in order to provide for unanticipated circumstances.

Production o:r biOlogicalS

4.6.1 Diagnostic reagents

I:f these are not available ccmnercially I they must obvious~ be produced in the laboratory. Fran the staBipoint o:f econc:mtY' am standardization the advantages are all on the side o:r production in the central laboratory with

WPR/FHL/3 page 10

distribution to local laboratories. The cost of production, testing and stan- ... dardization of a large lot is frequently no greater than a small one. In addition to the economy irr/olved, all laboratories within the governmental jurisdiction utilize the same standardized mat.erials and thus more unifo::"lll results are obtained. To assure adequate quality and standa..""'<iization, it is recommended that the reagent be subjected to a dou,;)le chec]{. Tho reagElnt should be checked by the unit producing the reagents to determine that i~,:, meets its :Iquality specifications." Those reagents meeting these established criteria shotild be further checked by the specialty unit engaged in diagnosis and/o;:' resea!'ch in that area. No reagent should be released that is r.et acceptable to both uni~s.

4.6.2 Biologicals

Official laboratories have produced biologicals -- vaccines, taxoids, anti­toxins, skin test antigeruJ, etc. -- fo!' the cl.i./l~MSis, prop~laxis am therapy of infectious diseaRes, sometmes as the only agency from which these are available and. sometimes to supplement those available from cCnB'lerciE.l sources. In the United states, most state laboratories have discontinued production of such biologicals and l;ith fe~; exceptions rely on commercial sources as most efficient. A central laboratory aSSt"!"les the obligat:ton of establishing standards and licensing production by cOl1'.mercial companies. On the other hand, the Stat,e Serum Institute in Denmark produces all biologicals for the co~trJ. In some instances, production of certain (or all) biologicals IIl2;Y be necessm.TJ. Ooviously, these should be produced only in those laboratories .There fu.U competency is available.

5. COLIECTIO!J, TRANSFCRT, AND REJISTRATION O::!' IA30RI\.TORY SPED!MEl!S

5.1 Collection of specimens

Specimens, unless properly colleoted, serv-c no useful purpose. Manuals on Collection and shi~ment of biological specimens prepared by several lab­oratories will be available fo:' reforent;e and discussion. The individual specimen and its container muat be identified beyond question. A legible copy, listing speoimens , giving origin (physician's name, hospital), patient's name, number, type (serum, water sample, stool, th:'oat washW.g, etc.), date obtained, disease suspected, and tests desired should be included with the material sent to the laboratorr. The original a.."li fj..rst cx:-bon should b3 sent directly to the laboratory involved. A "i;,hird copy should be retained u!r~il the results of the laboratory findings 2re returned.

Packaging of specmens must ensu::e their ~=rival at the laboratory in such condition that a labo:oatory test c.:'.n be perfo:"r.l8d. Trite though it may seem, leaking or crushed specimons a:-3 u.s1l..1.lJ.y uselesD. Rei'rigeration or some other preservation is sometir.:es necess~r. The <'J.::.ount and type of preservation depend a gre~t deal on the time (distance) H takes to get the specimen to the laborato!",V, as "!-,ell as te::tpe:":l.ture condi·;;i.ons E':l rotri.e; and the nature of the specimen to lie tes-c,ed.

5.2 Transportation of spedmsns

Transportation should be by the ro~ost re.pid method possible. It is dif­ficult to generalize on best r.lethods without. kno-.-1ing local conditions; however, messenger service has been found s.:.t.iE'i'acJc,ory ;;'ntr;::.city and air mail interCity where distances are 500 kilo.'!!etres or more. Arrange:r.ents can be made for scheduled transport (hl13, train, mail) fer dt~-:.;a.nces leas than 500 ki1ometres.

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5 • .3 Report.s and registration

WPR/HiL/3 page 11

A register or log book is usually used to note the receipt of specimens in the laborator,y. This register lists the pertinent information concerning the specimen and notes the results and disposition. The registrar frequently is responsible for seeing that the laborator,y results are sent to the requesting Ji1ysician, sanitarian, health officer, etc. This"t\vpe of register does require transcription of data and hence is time consuming and costly.

A report. system based on carbon copies, or mechanical copying devices, limits transcription errors, reduces personnel costs, and can provide copies for filing and quick reference. This type of system merits consideration. Each specimen should be assigned a number, running consecutivelJr, a8 it is received and this should be noted on the specimen receipt (returned to the sender if this is deemed practical), the specimen and its container, and the laborat01'7 report.. This has been foum desirable for tracing shlpments, laborato%7 results, requests tor additional information, and reports of activities.

5.4 Records

Records of laboratory activities should be kept uncomplicated. There is a tendency to gather more information than is needed or is ever used. Here again local conditions are the deciding tactor. The type of record kept depends on what use is to be made of it. Various types of report forms will be available for review and discussion.

What information is needed fran records? How can recorda and filing systems be established so that this information is readily available? A good records system freltuentlJr provides the basis for future planning. Information I1I8iY be needed as to what diseases are prevalent in order to establish proper measures for co.rd;rol and prevention. Information may be needed as to what water systems was :regul.1rrlJr contaminated. It ~ be desirable to know what tests are most frequentlJr requested and by whom. How III&JV t1Phoid carriers are present in a locality and who' are they? How III&JV cases of venereal diseases and where are they concentratedJ

One filing system has already been mentioned, i.e., the registration of specimens. This gives a reference by number to individual specimens. A cross index by name and laboratory fiming may also be desirable. Files may also be necessary for regional activities, water and milk supplies, sewage disposal systems, transport systems serving food, etc. A simple tabulation of daily results ma;y prov:ide the information necessary or rapid compilation of results can be done by machinery. Elcamples of summa.ry sheets and record forms will be available tor reYiew and discussion. An example is the IBM punch card system where eighty it~ of information can be cross indexed on a single card. There are also several. simpler punch card devices which can give the same information but require .t'r<XIl 5 to 200 times as III&JV manhours of effort. for sorting and counting.

trnitam size report. forms are helpful in &l\Y filing system. Different color report forms aid in routing information to the proper individual or office. Some information needed for permanent recorda may be microfilmed and cross indexed. These may be duplicated ani stored in a number of places and of course take up very little space. They have the advantage of being inexpensive and resistant to almost everything but fire •

WPR/PHL/3 page 12

Codes are useful in indexing files and preparing tabulations. The World Health Organization has established codes far death reports and several other types of reports. If coding is contemplated, WO codes should be considered rather than establishing new code numbers.

5.5 Inventory control

(Sample inventory systems will be available for review and discussion.)

5.5.1 Laboratory SUpplies

Regardless of the capability of the staff, a laboratory can be only as productive as the availability of supplies. Running out of supplies can therefore be expensive in terms of time and accomplishment. An inventory control system based on accurate records of supplies placed in and withdrawn from stock is essential to avoid unexpected depletion of critical supplies. An accurate inventory control permits planning to purchase once or twice yearly in large lots thus taking advantage of appreciable disoounts.

5.5.2 Biologicals

Accurate records as to available stock are essential to avoid depletion of items and to plan for proper production schedules.

6. GENERAL SERVICES

6.1 MQdia preparation

The approach to media preparation will depend upon the size of the lab­oratory and the amount of media required. In the small laboratory undertaking limited culture activities, the media may well be prepared by the laboratory assistant under the general supervision of the bacteriologist. In these lab­oratories where several bacteriologists require media, centralization of media preparations in a central media kitchen is usually more efficient.

6.1.1 Space required and layout

In the preparation of IOOdia for a bacteriological laboratory, the space required and the equipment layout would be determined by the demand on the work unit. In considering minirm.un requirements, preparation could be accomplished in an area of apprOximately 120 square feet. This area allows ample space for a weighing and m:ixing station, work tables and sterilizing equipment. Layout should be such to facilitate operations with a minimum of movement from one work station to another. Weighing stations should be located where air currents are at a minimum. Sterilizing equipment (autoclave) must be located or shielded to minimize heat transfer to other work stations. Dispensing and packaging stations should be centrally located to facilitate hanUing. It would be desirable to have a separate room for dispensing sterile media. This room should be cleaned frequently with decontaminating solution to minimize the possibility of contamination. In an area of this size, two trained technicians should be able to produce approximately ten to twelve litres of completed media per eight-hour work day.

6.1.2 Personnel

WPR/HiL/3 page l.3

Personnel responsible far supervising operations in media preparation should be required to have technical. training and experience in the chemical and biological fields. A knowledge of chemical. formulation and growth requirements of miero--ornanisms would be invaluable. Non-supervisory personnel should have an educational background which would allow them to grasp basic concepts or sterility, preparation, ani operation of necessary equipment. Training programmes should be conducted to familiarize personnel with changes and new developments in media preparation.

6.1.3 Equipment

(a) Essential

(1) A trip balance graduated in 0.1 grams for measuring desired ingredients.

(2) Cylinders graduated in cubic centimetres ar millilitres for measuring liquid volumes.

(3) A filter device for sterilizing materials which cannot be subjected to heat. A Seitz type filter has proven satisfactory if prepared ani used properly.

(4) A steriliz~ unit (autoclave) operating under apprarlmately 15 pounds pressure at 120 degrees centigrade.

(5) A heat source such as a Bunsen ~ Burner or small cook stove to boil media requiring heat to dissolve ingredients.

(6) A hand or automatic pipetting device of the Cormall or Brewer type far dispensing accurate amounts of prepared material into test tubes and other containers.

(7) Preparation manuals supplied by caupanies manufacturing standardized dehydrated media and other media supplies. These manuals are excellent reference books for the preparation of ~ types of media.

(8) pH adjustment equipllEnt such as pH test paper or a Beckman type metre.

(9) Glassware such as test tubes, petri plates, n.asks, beakers, pipettes ani such material essential to the operation or biological. laborataries.

(10) Wark tables and cabinets as required for adequate working space ani storage.

(b) Desired

(1) An electrloally operated automatic pipetting device which is accurate ani has the capability of delivering 1 to 30 ml. per stroke at speeds ranging from 10 to 150 strokes per m1nu\;e.

WPR/PHL/3 page 14

(2) Electrical automatic cycling control for autoclave operation.

(3) Constant temperature water baths for holding materials at temperature levels desirable for pouring agar plates.

(4) Electrical pH metre for highly accurate adjustment.

6.1.4 Basic materials needed

(a) Standardized dehydrated culture media or other necessary media ingre-dients which are pertinent to the operation.

(b) Inhibitory compounds, dyes and color indicators.

(c) Varied assortment of chemicals as needed for preparation procedures.

(d) Cotton for stopper material and paper supplies for packaging.

-(e) Distilled and/or demineralized water.

6.1.5 Water

For general microbiological purposes, the quali~ of water is seldom critical. Either distilled or dellIlneralized water should be satisfactory in most parts of the world. Some chemical analytical procedures of course required triple distilled water. Water does become a problem. when a laboratory urnertakes to use tissue cultures in diagnosis or research. For tissue culture only the very purest water possible is good enough. In some places with heavy irrlustrial or other water pollution, the triple distilled water must be filtered through charcoal before all chemical substances toxic to sensitive growing tissues are removed. A device which is said to produce high quality pyrogen-free water at very low cost was recently marketed by American Sales Corporation. It operates by blowing steam through porcelain baffles.

6.2 Preparation of scientific glassware

Except for the very small laboratory -- the clinic laboratory -- where the single technician usually washes his own limited glassware, prOviSion of a separate kitchen for washing am sterilization is strongly recommemed. A separate room for waShing, drying am sterilizing not only removes the clutter from the laboratory but contributes to better working conditions in the laboratory through reducing traffic and elilnina.ting the heat produced by washing, drying and sterilizing. Glassware used for research and clinical purposes must be chemically clean and in marw instances sterile.

6.2.1 Space required and layout

Space requirements are determined by we am scope of operations. In con­sidering minimum requirements as to type of operation, the following space allot­ments should be adequate.

(a) Handwashing - approximately 100 square feet per person. The area should be equipped with separate sinks for washing and rinsing and a source of a:fPropriate processing water such as tap, demineralized, or distilled, and possibly boiled tap water, and a drying oven.

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WPR/ffiL/.3 page 15

(b) Machine Washing - apprax:imately 150 square feet per person. The area should be equipped with washing machine (Turb.omatic type), dryer, sink and a work table for sorting gla~sware. Appropriat: processing water should be available for varl.OUS cycles of washing machine.

6.2.2 Personnel

The supervisor should be required to have thorough. knowledge of standard concepts and systems of sterilization ani be familiar with equipment ani materials employed. Non-supervisory - with proper training can be recruited from cOllDl1On labour pool.

6.2.3 General procedures

(a) Handling of used glassware and related items - Items being returned for washing should be separated as to size, submer~ed in water or mUd de contaminant (O-Syl or Liquor Cresoles 'ZJ,) in appropriate closed containers and sterilized.

(b) Cleaning

(1) Handwasbing - caps, plugs, labels, media and foreign matter should be removed prior to cleaning in solution of mUd handwashing-type detergent (Tetrax). A recommended procedure for washing is to boil the items in detergent. solution for 5-10 minutes and rinse 6-8 times in running tap water. Final. rinse in distilled, demineralized water or boiled water is sometimes necessary. Especially careful rinsing procedure is a must for glassware used in tissue cw. ture laboratories.

(2) Machine Washing (Turbomtic type) _ It is not necessary to remove media and foreign materials, but caps, plugs am labels should be removed prior to washing. Glassware is placed on appropriate washer racks (headers) and cycled for pre"'Wa~ wash, and rinse with tap and demineralized water.

Detergent - nSoil-A-W~tI (1 part to 1000 parts water) With pH of 12-0 - 12.5 for best results.

Temperature levels - Wash solution - 8So C Rinse solution- 700 C

(3) Acid Cleaning - Potassium dichromate solution used in cleaning special items and periodic cleansing of various tJpes of glassware such as pipettes, funnels, etc. Complete removal of aoid is essential. '

(0) Inspection and Preparation - Check for cleanliness and imper­fections. Glassware to be sterilized is capped, stoppered or plugged with cotton and covered with paper or aluminum fOU prior to steriliZation. GLassware not requiring sterilization is placed in cartons or containers to preserve cleanliness.

WPR/HIL/3 page 16

(d) Sterilization

(1) Electric sterilizer (hot air) 180°C

Thin wall items require 60 minutes. Thick wall items and items enclosed in containers (pipette and petri dish cans) require 120 minutes _ sterility control.

(2) Steam sterilizer 1210 C

Loosely packed items require 15 minutes. Closely packed items require 30 minutes.

(e) Storage - Place in dust-free room.

6.3 Care, handling, and bree~ of laboratory animals

If adequate quality of laboratory animals were available from commercial sources, little advantage if ~ would be obtained by breeding animals by the laboratory. Elcperience has demonstrated, however, that good quality animals, free of disease, are se1dam if ever consistently available from commercial producers, or shipping conditions result in delivery of animals in poor condition. Animals properly bred and reared in a scientific enviromnent result in animals of more standardized reactivity, freedom from disease, and better livability.

Quarters for experimental animals should be readily accessible to the lab­oratories. Several small rooms are ~eferable to one large room for housing experimentally infected animals or animals used for disease diagnosis.

Masonry am metal are generally preferred over other construction materials. other materials !1la3' be used but special attention must be given to rodent proofing of the animal quarters. All outside doors and win:iows should be provided with screens.

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A temperature range of 700 -80~ is generally satisfactory for laboratory i"'" animals ~ Air ooniitioners and ventilating fans !1la3' be used for cooling and ventilating. Central. heating without recirculation is preferred. If other methods of heating are used, control of room temperature is difficult.

Animal quarters should be provided with adequate lighting, not only for the convenience of those who work in the animal quarters, but for the physio­logical well being of the animals as well.

There are maI\Y' factors which should be considered in the deSign and con­struction of laboratory a.rUJna.l cages. Factors which determ1.ne the size of cage needed are:

Species to be housed; Length of holding period, and NumbEr of animals to be housed per cage.

In designing cages for laboratory animals, the following guides should be used:

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Should be simple in construction; As cClllfortable as possible far animals; Should be eas~ cleaned; Design cages far more than one species when possible; Feed and water to be added without opening the cage; Should be escape proof and for certain speCies should have

wire or perforated fioors.

WPft/PRL,/3 page 17

Cages ma;y be constructed of stainless steel, galvanized steel, plastic, fiberglass, and wood with wire. Oenerall.7 stainles steel is preferred due to the long life and ease of cleaning of cages consliructed of this material. The other materials mentioned deteriorate when exposed to the action of urine and/or auto­claving.

It has been stated that good sanitation is only second in importance to good nutrition in animal coloIV' management. AnimaJ. house sanitation includes wild rodent and insect control, frequent decontamination of fioors, sterilization and cleaning of cages and watering and feeding devices, and control of traffic in the animal quarterS.

The director of laboratory animal activities in a large central laboratory should be an individual. with professional. training in animal husbandry or veteri­nal7 science. Animal caretakers in smal.l.er laboratories should be trained at the central laboratory.

Fao1lit.l8s should be provided for sliorage of feed and clean sterile cages, sterilization or chemical decontamination of cages, et.c., incineration of animals and refuse, and cage washing (machine or manual).

Generally it. is more sat.isfact.ory t.o feed manufactured diets in pellet. form t.han laborat.ory prepared diet.s from the standpoint of uniformit,y of mixing of nutrients, and the fact that. pelleted feeds can be fed in hoppers to prevent fecal contaminat.ion. Manufactured feeds should be packed in multiple wall paper bags.

Diets composed ot natural. teedstuffs and containing the toiloring per-centages of nutrients are generally adequate:

Mice rats, and hamsters - 17-25% protein (at. least a part from &riiiii:h sources 11' possIble). 4-11% tat., 40-55% carbol\Ydr&t.e (NFE) and not more than 8% fiber.

Guinea ~s and rabbits - l5-2a& protein, 3-6% fat, 4o-5a& carb~:te (NFE), ana 12-2a& tiber. Far the guilBa pig, Vitamin nCD must be furnished in the torm of green veget.ables or be incarporated in the peileted diet so that there is .300 mg. of Vitamin "C. per powxl of feed.

Monkeys - Far the monkey the same percentages of nutrients preViously given for mice are adequat.e except for Vit.amin "cn -200 mg. per pound of teed is required.

There are two general principles to be observed in restraining and handling animal S. These are

1. Restrain the animal so t.hat the animal does not injure the handler,

WPRjmL/.3 page 18

2. The hamler does not injure the animals.

(Techniques illustrated by slides).

Litter and bedding are necessary for some species, and there are several satisfactory materiale which may be used. Among these are dry sawdust or shavings (soft wood), rice husks, am ground corn cobs.

Some of the more troublesome diseases am parasitec of laboratory animals are Salmonellosis in rodents and pri.rna.tes; infantile diarrhoea in young mice; tuberculosis in prillla.tes; snuffle am coccidiosis in rabbits, am ear mange or canker in rabbits. The best method of disease control is prevention. Prevention consists of applying the sanitation measures previously mentioned, isolation of new anilIla.ls before introduction to the laboratory colonies, adequate ventilation of quarters, use of properly designed cages, and the use of adequate diets. Chemotherapy is generally of little value.

The selection of a strain or breed of a species of laboratory animal should be based primarily on the intended use of the animals, i.e., select a recognized strain or breed which is most susceptible to the agents to be studied.

Random bred animals are satisfactory for most routine laboratory investi­gations and diagnostic procedures. Inbreeding should be attempted only by those who are thoroughly familiar with genetics.

The most effiCient breeding system for mice, rats and guinea pigs is the family system. A family consists of 5 to 15 females and a male, with the females remaining with the male at all times. Variations of this system are employed. in the breeding of rabbits and hamsters. A family of rabbits consists of 11 females and a male housed separately, the female being transported to the male's cage for mating. A family of hamsters consists of 5 or 6 females and a male. The females are isolated as soon as obviously pregnant and are not returned to the family cage until the young are weaned.

The general reoonmendations made previously for the design am construction of cages and quarters for housing experimental animals apply for breeding animals also.

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ANNElC 1

CARE, HANDLING AND BREEDING OF LABORATORY .ANIMALS

This appendix is not inteMed to be a complete manual on laboratory animal care, but only outlines some of the basic procedures foUailed in laboratory animal care, handlin~, am breeding. See bibliography for more complete references on this subject (Annex 2).

1. Location of animal quarters

Laboratory animal space should be provided near research and diagnostic laboratories, either within the same building or in a nearby building. Animals should not be kept in the laboratory, aM the experimental animal quarters should be isolated from the animal. breeding quarters.

1.1 Size of units or roams

The rooms should be small in size so that infected animals can be isolated to prevent cross infections with other animals infected with different agents. If this is not pOSSible, separate the animals within the roan.

1.2 Construction

Buildings housing laboratory animals ideally should be constructed of masonry or metal because of ease of rodent proofing and long life. If these materials are not available, then every effort must be made to prevent enliry of wild rodents into the animal quarters. The outside walls and ceilings of these buildings should be insulated. If' commercial insulating materials are not avail­able,us~r.lor~.llj· av.:,i:!n.blCl, materials such as thatChing which is used for tooting in maQ1 tropical areas.

All HindOl'1S and doors should be screened to prevent entry of flies and mosquitoes and to allow opening of windows for ventilation.

1.3 Heating, cooling, ventilation, and lighting

A temperature range of 70 - 800F is desirable for all laboratory animals. The temperature should be as constant as is possible to maintain.

Ventilating fans can be used not only to cool but to change the air within the animal rooms. A water sprinkler system installed on the roof of the animal building is very effective in lowering the room temperature.

Heating - Central heating, thermostatically controlled is the most desirable method of heating animal quarters. If this heating method is not feasible and roCIU heaters (stoves) must be used, be sure to provide adequate ventilation.

Lighting - Provide adequate lighting. Fluorescent lighting is the lighting method of choice but ordinary inoandescent lamps are satisfactory. Provide at least eight hours of light per ~.

2. Cages

Cages properly designed and constructed are equally as imporliant as good animal quarters.

2.1 Cage material

Stainless steel is the best material for most animal cages due to its wearing qualities and ease of cleaning.

WPR/PHL/3 Annex 1 page 20

Ot,her materials used for cages are aluminum, fiberglass, plastics, gal­vanized iron, and wood.

2.2 Cage design and space requirements for experimental animals

Whenever feasible cages should be designed to house more than one speCies. Cages should be designed to allow feeding and watering from outside the cage, and should be easilY cleaned.

Mouse - Allow 8-10 square inches of noor space per weanling animal and 15 square---riiches of noor space per adult animal. A simple shoe box: type of cage 5-6 inches in depth is very satisfactory for mice. This type of cage usually has a feeder built into the cage cover (wire mesh or sJ.otted metal) and the water is supplied by a bottle with a drinking tube which protrudes through the cage cover.

Guinea Pi~ - 0.5-1.0 square feet of cage floor space is recommended per animal. Oages wl.th wire floors and dropping pans are generally recommended for experimental animals and cages with solid floors with litter are generally used for breeding animals.

Hamster - 15-20 square inches of cage noor space per weanling animal and 30-40 square inches per adult animal. Cages for hamsters must be constructed of metal to prevent the animals from gnawing out of the cages ~ A shoe box type cage is very satisfactory for the hamster, but should be at least lon deep, or have a heavy cover to prevent the hamsters from escaping.

Rabbit - Allow 2-3 square feet of cage noor space per adult rabbit and a minimum inside cage height of 16". Wire floored cages should be used for housing rabbits, and they should be caged individually to prevent fight 'g.

Monkey - 8-12 cubic feet should be allowed per monkey. Experimentally infected monkeys should be housed one per cage. Door latches should be located out of reach of the monkeys' fingers to prevent escape.

3. Sanitation - cages and quarters

Cages used for experimentally infected animal s should be sterilized or decgntam1nated before re-use. Sterilization by autoclav1ng for )0 minutes at 250 F is recoIlUllended, rut chemical decontamination can be used.

Floors should be cleaned and disinfected regularly. Cage dropping pans should be cleaned of dirty litter at least twice weekly to prevent fly breeding, and pans should be sprayed with a decontaminant before adding new litter. Dirty litter should be collected in metal cans with covers for transporting to the incineration facilities.

Watering and feeding devices should not be interchanged between cages, and they should be cleaned and sterilized frequently.

Wild rodents and' insects must be controlled by routine spraying and use of poison bait stations.

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WPR/HlL/.3 .Annex 1 page 2i

Traffic control - Only authorized staff members should be permitted in the an:iJnal quarters. There should be no traffic between the infected animal quarters am the animal breeding quarters. AniJIIal caretakers should be required to change clothing am shoes before entering the animal quarters, and should bathe am change back to street clothes before leavi~ at the end of the da;y. Personnel should be instructed nat to smoke or eat until they have thoroughly washed their hands. These precautions are necessary to prevent the animal care­takers from contracting and spreading diseases be~ studied in the an:iJIIals.

4. Organizational structur~ and management

4.1 Central laboratories

.. It is recommended that the responsibility for all laboratory animal activ-ities be placed in the hands of an individual with professional training in animal. husbandry or vet.erinary science. The director of laboratory animal activities should be responsible for the selection, assignment, an:!. training of laboratory

,..... an:iJllal caretakers, and the assignment of experimental animal space.

Branch and local laboratories

The Laboratory Director should deSignate a professional staff member to be responsible for laboratory animal activities. The staff member responsible should follow procedures recommerxled by the central laboratory animal activit.ies director, and the animal caretakers should be trained at the central laboratory.

4.3 Service facilities

Feed am litter storage facilities should be provided near the animal quarters. These facUities should be rodent proof.

sterilization facilities should be provided for sterilizing animal cages and related equipment. Ideally this would be accomplished by autoclaving. How­ever, chemical sterilization can be used.

Incineration facilities should be provided. for disposing of dead animals and animal refuse.

Locker - Shcwer facilities should be provided for the animal caretakers.

Cage storage space should be provided for storage of clean cages, cage racks and related equipment.

Cage washing space should be provided for washing cages and related. equip­ment after it has been sterilized. This can best be accomplished by the use of a niachine, but can be done manually when plemy of labour is available.

5. Care and handling

5.1 Nutrition

Manufactured laboratory an1mal diets in pellet form should be used if available in preference to laboratory prepared diets. Manufactured. feeds should

"- be packaged in mult:1ple wall heavy paper bags to faCilitate handling and storage and prevent contamination from outside sources.

WPR/mr./3 Armex I page 22

Mice, rats and hamsters have essentially the same nutritional requirements. Basicany a diet consistLlfi Of the following percentages of nutrients is adequate:

Protein 17% Min. Fat 7% Min. N.F .E. 45% Min. Fiber 5% Max.

The !uinea Pit-and rabbit are herbivorous animals and require a high per­oentage of iber in heir diets.

Protein 2C1.t> Min. Fat 5% Min. N.r.E. 4lI% Min. Fiber 18% Max. Vitamin "CII fortified - to contain 500 mg. Vitamin "C" per pound

of feed (guinea pig only)

Monkey

Protein 2(Jf, Min. Fat 5% Min. N.F.E. 52% Min. Fiber 5% Max. 200 mg. Vitamin "C" per found of feed.

5.2 Handling and restraining techniques

Mice may be lifted and carried by the base of the tail, but never on the termina:reiil.

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Hamsters may be handled by placing one hand on either side of the animal and forming a cup. Another method which may be used is to grasp the loose fold of skin directly behind the neck with thumb and forefinger and restraining the left rear foot by grasping between the third and fourth fingers of same hand. )~. Another hand method is to place the hand over the animal's back (palm downward) grasping the animal with thumb and forefinger on either side of head and below the ears. This is the least desirable method since a great deal of pressure is exerted on either side of the head.

Guinea pigs r&sent being held tightly ani try to free themselves while being restrained. When lifting a guinea pig, the hand (palm down) should be placed over the back grasping the anmal by the neck directly in front of the shoulders with the th1.lll1b and forefinger. Place the other hand under the rump of the animal to support the 'Weicht of its body.

Rabbits should never be carried by their ears. To lift a rabbit, grasp ~~~of~~b~~~~~and~the~~ under the animal's hind quarters to support its weight.

Monkeys - In restraining a monkey, the animal's arms should be drawn behind its baCk and held with one hand. Gloves with gauntlets are recolllllended for restraining monkeys. Nets may be used for catching monkeys in large stocl cages. Every precaution should be taken on the part of the caretaker to prevent being bitten by the monkey.

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Litter or bedding

WPR/!m./' Annex 1 page 23

There are several. types of be~ or litter that are satisfactory for laboratory ammaJ.s. Amo~ them are wood shavings J sawdust, rice husks, aDd ground corn cobs. Cane fiber and similar material.s are not recallllellded sinoe these are eaten aM the fiber particles may irritate or puncture the intestinal tract.

6. Diseases and parasites

Salmonellosis is one of the most troublesome diseases of laboratory animal s. S. typhjJnurium and S. enteriditis are largely responsible for Salmonellosis in laboratory rodents. However, other Salmonella types also are isolated from rodents and primates with diarrhoea. Symptoms are loss of colliition, rough hair coat, diarrhoea, an:!. death.

Prevention is effected by strict sanitation, isolation of DEJIf anjmals before introduction into the laboratory colol\V', rodent control to prevent access by wild rodents to feedstuffs, litter and colol\V' animals.

Chemotherapeutic measures are ineffective. If an outbreak occurs, destroy all animals in the unit and sterilize or decontaminate all cages an:!. related equip­ment before introducing DEJIf stock.

InfantUe diarrhoea is an important an:!. costly disease in certain strains of mice. It occurs most frequently in first litter mice 2 to 15 da;ys of age. There is evidence that the cause is one CD:' more viruses. Symptans range from slightly loose stools to a foul smelling profuse yellowish diarrhoea. Hortal.ity ma;y be 100 percent in those auimaJ.s affected with the acute form of the disease. There is no known effective treatment.

Rabbit snuffles in chronic form are characterized by sneezing, nasal. dis­charge, matted fur on forepaws (fran wip~ nose), slow loss of con:l.ition, am eventual death. Cause is believed to be Brucella bronchiseptium and Pasteurella lepisepticum, the latter being the more pathogeniC.

Prevention or control - (l,viously infected animals should be discarded, am naSal swab cultures should be performed on the remaining animals. Discard all positive animals and check remaining aniJDal.s by periodiC nasal. swab cultures.

Chemotherapy - There is no success.t'ul chemotherapeutic treatment. Preven­tion consists of providing plenty of space, draft-free ventilaliion, and good nutrition. .

Coccidia infections occur in the rabbit and guinea pig, but are a much more serious problem in the rabbit. There are two forms of Coccidia which cause disease in the rabbit, the intestinal (E. perforans) and the hepatiC (E. stiedae).

Symptoms (Rabbit) - The severe hepatiC form (E. stiedae) causes enlarge­ment of the liver, loss of con:l.ition and distention of the abdomen. In the severe intestinal. type (E. perf'orans~, the young rabbits show a ravenous appetite, become emaciated, and scour badly.

Control measures consist of providing adequate floor space, ventilation, nutrition, an:!. strict sanitation. To reduce fatal.ities, Sulphadimidine may be added to dr1nlcing water or feed in the amount of one percent.

Synq>toms (Guinea pigs) - Eimeria carviae is responsible for coccidiosis in guinea pigs and is host specific. The symptoms are loss of appetite, list­lessness arxl diarrhoea.

Control is best accomplished b.Y strict sanitation, adequate ventilation, adequate cage space, arxl good nutrition.

Ear mange is prevalent in maqy rabbit colonies. The corxlition is caused b.Y two species of mites - Psoroptes camnunes arxl Chorioptes cuniculi.

Symptoms are scratching of ears, shaking of head arxl wry neck (middle ear involvement). When the ears are examined, encrusted areas will be cbserved in the outer ear.

Treatment consists of applying mineral oil or vegetable oil until 8Gab. are loosened. Remove scabs with cotton tipped swabs or forceps, continue treatment three or four weeks arxl check animals each week thereafter. All hutches or cages arxl related eqlrlpment housing affected animals should be thoroughly disinfected.

7. Laboratory animal. breeding

7.1 Selection of strain or breed

The selection of strains or breeds of laboratory animals should be based on the following consideration - The strain or breed most susceptible to the diseases or paraSites which are to be studied, or are likely to be encountered in diagnostic procedures.

Methods of breeding used are inbreeding, random breeding, am crossbreeUir.g. Random bred animals are satisfactor,y for most routine laborator,y investigations arxl diagnostic procedures. Inbred animals are required only in special fields of research such as tumor investigations.

7.2 Breeding system for rarxlom bred animals

The fa.mily system is the most widely used. This system consists of fa.mily (cage) units of one male and one or more females. The females may be left with the male at all times or may be removed to isolation cages for littering. The system whereby the females remain with the male at all times is recommerxled for mice, rats am guinea pigs unless exact date of birth is required.

Inbreeding should not be attempted unless supervised by a geneticist.

7.3 Miscellaneous breeding information

Mice - At the Camnunicable Disease Center the family system is practiced. A f8lllily consists of five females and a male, and the females litter in the family cage. Mice are generally bred when 6-8 weeks of age. The complete estrus cycle occurs about ever,y five da;rs. The gestation period is completed in 19-21 dqs. Mice are normally weaned at about three weeks of age at which time they should weigh 8-12 grams.

Complete cage pedigree am production records should be maintained. The useful breeding life ranges from 8-12 months, deperxling on strain, adequacy of diet, arxl colol\Y management.

-..

WPR/PHL/3 Allnax 1 page 25

Hamsters (Syrian am Albino) are bred when six weeks of age. At the Cc:mmunica.ble Disease Center J the family system of breeding is practiced. A family consists of five females and a male. Pregnant females are isolated for littering. When the young are weaned at three weeks of age, the female is returned to the family unit. The complete estrus cycle occurs every four days. The gestation period is completed in sixteen ~s. Hamsters have a useful breeding life of approximately one year. Identical records are maintained for hamsters and mice.

Guinea Pigs are bred when 3-4 months of age. At the Communicable Disease Center the family system of breeding is practiced. A family unit consists of five females and a male. The females remain in the unit at all times. The average gestation period is sixty-eight days. The complete estrus cycle occurs every 16 days. The young are weaned at 2-3 weeks of age. The breeding span is approximate­ly two years for sows am one year for boars.

Rabbits are bred when 4-8 months of age depeming on the breed am stage of development. At the Communicable Disease Center we have observed that maturity ~s not necessarily coincide with age. A colony of the New Zealam White breed is maintained at the Communicable Disease Center and the family system of breeding is practiced. A family consists of eleven fCI"JUes and a male. All family members are caged separately. Females are placed in the cage of the male for breeding. The female ovulates approximately ten hours after copulation, and the festation period ranges from 28-36 days. The useful breeding life is approximately two years. The young are weaned at eight weeks of age. Individual pedigrees should be main­tained within the breeding colol\V.

R. Cage design am space requirements for breeding laboratory animals

The same general recommendation.CJ as to deSign, materials, etc. given prev­iously for experimental animal cages apply here also.

Mice require 30-40 inches of cage floor space per breeding animal. A shoe box type cage 5-611 deep with a perforated metal or wire cover is generally used. The feeder is either built into the cover or is inserted through a hole in the cover. Water is supplied by use of a bottle and drinking tube. Cages constructed of stainless steel are preferred, but maI\Y breeders now use plastiC and fiberglass­plastic cages. Cages constructed of the latter two materials cannot be autoclaved without deterioration. Cages constructed of wood with wire covers can be used satisfactorily.

Rabbits require 7-8 square feet of cage floor space per breeding female and young. Cages should be at least sixteen inches high inside. Cages constructed of stainless steel with perforated noors are preferred but cheaper materials can be used. Nest boxes should be provided for females a few days before kindling date.

Guinea Pigs require approximately one square foot of_ cage floor area' per breeding ani::al.. Bo;'·h Dol 'Ld ~'rd perforated iloo:'s are' U'led for breeding. Litter is placed on the cage floor when solid floors are used.

WHt/PHL/3 Annex 1 page 26

Hamsters require .30--40 square inches of cage floor space per breeding animal. A shoe box type cage is satisfactory. The pregnant females should be removed from the breeding cage am placed in an isolation cage for littering. The isolation or littering cage should have a minimUIII of 150 square inches of floor space.

ANNEl( 2

BIBLIOORAHIY ON ANJMAL CARE AND BREEDIHl

General

Aroot, H.J. and Benda, C. (1931) In: Jaffe, R., ed., Anatomie un:i Patho~ie der Spontanerkrankungen der IG.einen laboratoriumstiere, IGiiiiliChen, Neers einClien, Ratte, Maus (AnatOl1\Y and pathology of spontaneous disease of the small laboratory animals), Berlin, J. Springer (Also translation by Nell Comrq, Vols. I and. III at Kettering Laboratory, College of Medicine, CinCinnati, <hio).

Asdell, S.A. (1946) Patterns of mammalian reproduction, Ithaca, New York, Canstock PUblishing Compa~.

Becker, E.R. (1934) Coccidia and coccidiosis of domesticated game and laborato17 animals and of man, Allies, Iowa, Collegiate Press, Inc.

Brumley, O.V. (1931) A textbook of the diseases of the smaIl.domestic animals, 2nd ed., Philadelphia, Lea alit Febiger.

Carworlh Farms, Inc., Quarterly Letters, New City, Rockland Country, New York.

Dukes, H.H. (1937) The WSiOlOgy of domestic animals, 4th rev. ed., Ithaca, New York, Comstock PUDli ing Co., mc.

bling, H.E. (1934) A manual of external paraSites, Springfield, Ill., C.C. ThaD8.S Publishing Co.

Farris, E.J. (1944) AnatolllY' and physiology laboratory guide. 4th rev. ed., Philadelphia, J.B. Uppincott Co.

FarriS, E.J., et al (1945)An:iJnal coloI:\,V maintenance. Ann. N.Y. Acad. Sci. 46, Art. I

FarriS, E.J. (1950) ed., The care and breeding of laboratory animals, New York, John Wiley & Sons, Inc.

Fox, H. (1924) Disease in captive wild mammals and birds; incidence, description, comparison, PhiladelPhia, J.B. Lippincott Co.

Great Britain, Ministry of Agriculture am Fisheries (1930) Diseases of animals, ;: Report of Proceedings, London, H.M. Stationery Office.

Gruneberg, H. (1947) Animal genetics and mediCine, New York, London, Paul B. Hoeber, Inc.

Hegner, R., Root, F.M. and Augustine, D.L. (1929) Animal parasitolog,r, New York, The Century Co.

Journal of the Animal Technicia."lS Association (1950) Nottingham, Animal Technicians Association.

Laboratory Animals Bureau Technical notes and bulletins published by Medical Research laboratories.

WPR/HIL/3 Annex: 2 page 28

leahy, J.R. and Barro, p. (1951) Restrain of animals, Department of Anatomy, New York State Veterinary Gollege, Cornell univerSity.

~nard, L.A. (1951) Animal nutrition, New York, McGraw-Hill Book Go.

Morrison, F.B. (1951) ~Fe::.:e::..;d~s:r=and::;...::f~eT:e=· ~~~~;:.;;~::::-:~:......:th:=.e..:s:.t::.:'=ld::e:::nt:::.....;a::nd=-.:s.:t.=.oclanan==, 21st ed. unabridged.

Merck and Go., Inc. (1952) fharmacological activity am. clinical use of sulfa­nilamide, sulfathiazole, alii SUtlapyridiiii in veterinary Medicine, rev., Ramlay, NeW Jersey.

ractical

Nutrition News Bulletin (1944), St. Louis, Ralston Purina GanpaIV.

Parish, H.J. (1950) Notes on canmunicable diseases of laboratory animals, Edin­burgh, L. and S. LiVirigstone, Ltd.

Ralston Purina Compaqr (1942) The care am. feeding of laboratory animals, St. Louis, Ralston Purina Go., Research Laboratories.

Sisson, S. (1936) In: Grossman, J.D., ed., The anatomy of the domestic an1Inals, Philadelphia, W.B. Saunders Co.

United States Department of Agriculture (1942) Keepin{! livestock healt~ Yearbook of Agriculture, Washington, United states Government Print:rng O!rice; House DocUlllent No. 527.

Whitney, L.F. (1950) Canplete book of home pet care, New York, Doubleday and Co. Ine.

Worden, A.N. am Lane-Petter, WIn. (1957), ed. Care ani management of laboratory animals, rev. ed., Chicago, The Animal Gare Pam!.

Cat

Bigelow, R.P. (1935) Dire~tions for the dissection of the cat, rev. ed. New York, Macmillan Co.

Davison, A. (1937) Mammalian anatom;y with special reference to the cat, 6th ed. fhiladelphia, BtakiBton.

Gates, G.S. (1928) The modern cat. Her mincl and manners. An introduction to comparative psycholo€l,'New York, Macmillan Co.

.-- I

WPR/FHL/3 Annex 2 page 29

I>" Horsburgh, D.B. and Heath, J.P. (1939) Atlas of cat anatCIIIY, California, Stanford

t

University Press.

Kirk, Hamilton (1951) Index of treatment in srnall--an:imal practice, 2d. ed. Baltimore, Williams and Wilkins Co.

Reighard, J.E. and Jennings; H.S. (19.35) Anatomy of the cat, .3rd and enI. ed. New York, H. Holt and Co.

Saunders, C.G. (1920) Rabbit and cat diseases, Chicago, American Veterinary PubliShing Co., (VeterInarY Medicine Series No. 1.3).

Poultry

Biester, H.E. and Schwarte, L.H. ed (1948) Diseases of poultr,y, 2d. ed. Ames, Iowa, The Iowa State College Press.

Chamberlain, F. (1943) Atlas of ann anatomy, Lansing, Michigan, Hallenbeck Printing Co.

Levi, W. M. (1951) The pigeon, Columbia, S.C., R.L. Br,yan Co.

Winter, A.R. and Funk, E.M. (1951) Poultr,y science and practice, Fhiladelphia, J.B. Lippincott.

Dog

Bradley, O.C. (1912) Guide to the dissection of the dog, New York, Longmans Green and Co., Inc.

Bradley, O.C. (1948) Topographical anat~ of the dog, 5th ed. London, Oliver and Boyd.

Gaines Dog Research Center (1951) The ~osium held in Conjunction with ennels, Kankakee, Ill.

newer knowledge about dogs. In: A veterinary the Dedication of the New Gaines ResearCh

Johnson, H.M. (1913) Audition and habit form~tion in the dog, Boston, Henr,y Holt and CompaZV.

McC~, C.M.·(1943) Nutrition of the dog, Ithaca, New York, Comstock Publishing Co., Inc.

Morris, M.L. (1949 and 1950) !'rescription bulletin service (dog diet). Bulletins 1-17 inclusive, contents and index,.!.. Copyright, Hill Packing Co.

stockard, C.R. (1941) The genetic and endocrine basis for differences in form and behavior as elucidated by studies of contrasted pure-line dog breeds and their hybrids, Amer. Anat. Mem. 19.

WPR/ffiL/3 Annex 2 page )0

United States, National Institutes of Health, Surgery study Section (1949) Care of the dog used in medical research, Washington, United States Governmen~ Printing Office.

Whitney, L.F., and Whitney, G.D. (1953) The distemper complex, Orange, Conn., Practical Science Publishing Co.

Frog

Dickerson, M.C. (1906) The frog book; North American toads and fr~, with a study of the habits and llle histories of those of the Northeaste:'!'ntes, NeW fork, DoUbled8£" ana co., me.

Primates

Bast, T.A. (1933) In: Hartman, C.G. am straus, W.L., Jr. ed., The &nato! of ,......., the Rhesus monkey (Macaca malatta), Baltimore, Williams and WilkiriB o.

Forbes, H.O. (1894) A handbook of the primates, London, George Allen and Unwin, Ltd. 2 vols.

Hartmann, R. (1901.) Arthropoid apes, New York, Appleton-Century-Crofts, Inc.

Schultz, A.H. (1930) Notes on the growth of anthropoid apes, with especial reference to deciduous dentition. Report of the Laboratory and Museum of Comparative Pathology or the Zoological Society of Philadelphia.

Stiles, C.E. and Hasell, A. (1929) Key catalogue of paraSites reported for primates (monkeys and lemurs) with their possible public health importance. U.S. Publ. Hlth Ser. Hyg. Lab. Bull. 152, 409.

Mouse

Dingle, H.H. (1956) Infectious diseases of mice, In: Snell, G.D. et. aI, ed., Biology of the laboratory mouse. New York, Dover Publications, Inc.

Gruneberg, H. (1943) The ranetics or the mouse, Cambridge, University Press, (New York - Macmillan 0.)

Keeler, C.E. The laboratory mouse: its origin, heredity and culture, Harvard University Press.

Rabbit

Benoit, R. and J:Qceord, A. (1948) Le1apin: elevage - races - maladies, (The rabbit: rearing-breeding-diseasos), Lausanne, Libi'arie Pay-ot, p. 202,"lU figs. (Vet. Bull. ~:j758, 1951).

Bensley, B.A. (1938) Practical anatorrry of the rabbit, 6th ed. rev. Philadelphia, P. Blakiston's Son & Co., Inc.

WPR/PHLI.3 Annex 2 page 31

~ Crabb, E.D. (1946) Principles of functional anat~ of the rabbit, St. Louis, J.S. Swift Co., Inc.

1

Craigie, E.H. (1948) Bensley's practical anat8i't of the rabbit. An elemenWo laboratory textbook in mammalian anatOll\Y, ed., Toronto, University oroDto Press. LOiiion, Mord University Press. pp. XII-.391 (Vet. Bull. 21:.3360, 1951)

Lund, E.E. (1949) Considerations in the practical coDtrol of intestinal. cocci­diosis of domestic rabbits, N.!. Acad. sci. 52, Art. 4.

and their control, 3d ed. ustries.

Rat

Greene, E.C. (1955) AnatCllG" of the rat. Trans. Amer. Fhil •. Soc. (new series) 27 New York, Hainer Publishing Co. -

Greemnan, If.H. and Duhring, F.L. (19.31) Breed~ and care of the albino rat for research purposes, 2nd ed., Philadelphia, Star Press.

Griffith, J.Q. and FarriS, E.J. ed., (1942) The rat in laboratory investigation, Philadelphia, J.B. Lippincott Co.

Hunt, H.R. (1924) A laboratory manual of the anatcmy of the rat, New York, Macmillan Co.

Long, J.A. and Evans, H.M. (1922) The oestrous cycle in the rat am it;s associated phenomena, Berkeley, California University California Press.

>1 Main, R.J. (19.39) The care of a small rat colon;y, St. Louis, C.V. Mosby Co.

Nicholas, J.S. (1935) The normal stages in the development of the rat (Dnbryo­logical drawings ani photographs) New Haven, Conn., Osborn Zoological Laboratory , Yale University.

Wiesner, B.P. and Sheard, N.M. (1933) Maternal behaviour in the rat, Edinburgh, Oliver ani Boyd.

ANNEX: 3

S~IFICATIONS USED BY THE CCHroNICABLE DISEASE CENl'ER FOR THE MANUFACTURE OF ANIMAL FEEDS

1. Guinea pig diet, size of pellets 3/811 diametre by 1" long. Guaranteed analysis: Protein - 20)\ minimum; Fat - 5%; Fiber - 18% maximum; N.F .E. - 44% minimum.

Vitamins and minerals - A - 4000 I. U/lb.; B-12 - 150 micrograms/ib.; D - 600 I. U/lb.; K - 25 mg/lb; Alphatocopherol - 75 mg/lb.; Choline - 500 mg/lb. Calcium (available) - 0.6% of diet; Phosphorus (available) 0.5% of diet; Folic Acid - 3 mg/lb.; Niacin - 10 mg/lb.; Pantothenic ACid - 10 mg/lb; Riboflavin - 4 mg/lb.; Thiamine -4 mg/lb.

FeeC: shall be fortified to contain a minimum of 1000 mgs. of vitamin C per pound of feed prior to pelleting ani 500 mgs. 40 days after date of manufacture; moisture content not more than 12%.

2. Rabbit pellets, same formula as Item 1, except vitamin C not required •

.3. Mouse diet (for breeding mice). Pellet size 3/8-3/41l dia­metre ana not more than 1" long. All particles should be finely ground and mixed adequately so that the feed does not contain aqy large grain particles. Protein - 17% minimum; Fat ... 7% minimum; N.F .E. - 45 minimum; Fiber - 5% maximum; Ash - 5.5% maximum; Moisture content not more than 12%.

Vitamina - A - 4000 I. U/lb.; D - 600 U.S.P. units/lb.; Alphatocopherol - 25 mg/lb.; K - 2 mg/lb.; Thiamine - 6 mg/lb.; Riboflavin - 6 mg/lb.; kiacin - 10 mgjlb.; Pantothenic Acid -.30 mg/lb.; Choline - 700 mg/lb • .; Fyridaxide - 2 • .3 mg/lb.; Inositol - 0.5 mg/lb.; Folic Acid - 5 mg/lb.; B-12 - 50 micrograms/lb.; Biotin - 150 micrograms/lb.

4. Nonkey diet .. pellet size same as Item 3. All particles shall be finely ground am mixed adequately so that the feed does not contain any large grain particles. Protein - 20%; Fat - 5% minimum; N.F.E. - 52% minimum; Fiber - 4% maximum.

Vitamins - Contents may be 20% less than breeding diet, Item 3. Feed shall be fortified to contain a minimum of 200 milligrams of vitamin C per pound of feed 40 days after date of manufacture.

Minerals - Same as breeding diet, Item 3. Moisture content not more than 12%.

5. Dog pellets: Protein - 24% minimum (half or m~re must be an:iJna.1 protein),; Fat - 5% minimum; N.F .E. - 45% minimum; Fiber - 5% max:i.mum. Moisture not more than 12%.

WPR/PHL/.3 Annex .3 page jj

Vitamins and minerals - A - .3000 I. U/lb.,; D - 400 U.S.P. Ullits/ib.,; Alphatocopherol - 25 mg/lb. minimum,; Thiamine -0.6 mg/lb. minimum; Riboflavin - 1.0 mg/lb. ; Niacin - 15 mg/lb. minimwn,; Choline - 500 mg/lb. minimum,; B-U - 15 micrograms/lb. minimum,; Pyr~·.do:x:i.ne - 1.5 mg/lb.,; Calcium fhosp:~G~ __ "..lS ratio - 1.2:1.0,; Available calcium - 0.6% of diet; Available phosphorus - 0.5% of diet,; Pantothenic acid -10 mg/lb.

General specifications

1. Vendor must guarantee a constant formula for all feeds, both as to percentages and amount of nutrients and ingredients.

2. All feeds are to be packaged in paper containers consisting of a minimum of three l~ers of heavy paper •

.3. The following certification must be made on the analysis tag of each bag of feed: "10 antibiotics or estrogens have been added to this feed." Consignee may analyze the feed at aqy time for estrogenic activity or antibiotics. If the estrogenic activity exceed five parts per billion or if antibiotics are present, all feed of this type and. shipment will be rejected.

4. Pelleted feeds containing moldy grains, numerous large grain particles, weevils, or bags containing more than 2% dust or meal will be rejected.

5. All torn or broken bags will be rejected.

6. Vendor will'stamp date of manufacture on analysis tag of each bag of feed.

7. All feeds must be delivered to the government within ten days after manufacture.

ANNE[ 4

FREPARATION OF SCIENl'IFIC GLASSWARE

Glassware used for research and clinical purposes must be chemical~ cleaned and in lII9.IV instances sterile.

1. Handling of used glassware and related items in laboratories

1.1 Items being returned to wash room should be placed in containers that can be Closed. These items should be separated as to size, i.e., medium and large pieces and test tubes should be disassembled and kept separated fram all other types of glassware. Water or a solution of water and mild decontaminant, such as a ~ solution of O-syl or Liquor Cresolis, should be put in the containers and all items submerged before sterilizing. If sterilizing facilities are available, used items should be sterilized in the laboratories before being returned to the wash roan. otherwise,· sterilization should be accomplished in the wash room prior to hamling.

1.2 All caps, plugs and labels should be removed and, if glassware contains aIV media, agar, or foreign lIIB.tter, this should also be removed if items are to be washed by hand. If glassware is to be machine washed, removal of media, agar, etc. iB not necessary.

2. Cleaning

2.1 If glassware is to be washed by hand, it should be placed in a solution of mild handwashing type detergent, such as Tetrox, and boiled for, to 10 minutes. The glassware should then be rinsed from 6 to 18 times in running tap water (or change water after each r:i.rl~e). The final rinse should be with distilled or aemineralized water if available. If especia~ treated waters are not available, rinsing could be accomplished with previous~ boiled water.

.......

2.2 If glassware is to.be I!13.chine washed, it should be placed on approp­riate washer racks (headers) according to the type of glassware. This machine (approximately 5' x 4' x 41) has different headers for various types of glassware. The complete cycle (8 minutes) includes pre-wash (2 minutes), wash (3 minutes), ,.... tap water rinse (2 minutes), and demineralized water rinse (1 minute). The deter-gent used as the cleaning solution in this machine ~~oil-A-Wayll - approximately one part detergent to 1000 parts water) should have a pH 12.0 to 12.5 for best results. Temperature levels of 850C for wash solution and 70°C for rinsing waters should be maintained for satisfactory cleaning.

2.3 Potassium dichromate (crystal ferm) solution can be utilized satis­factor~ for special processing of glassware. Acid bath mixtures are .prepared as follows:

24 grams of sodium or potassium dichromate 200 cubic centimetres of tap water 160 cubic centimetres of concentrated sulfuric acid

Extreme caution should be exercised in handling and mixing these ingredients. Acid resistant gloves and aprons should be worn. This solution is used in cleaning special. items that cannot be hand or machine ~'lashed and also is used in cleaning glassware for special use,. In some instance3 it is necessary to periodic~ clean various types of glassware, such as pipettes, dispensing funnels, etc. It is absolutely necessary that glassware be repeatedly rinsed to ensure complete removal. of acid.' An automatic pipette washer is effective in removing acid from treated pipettes.

3. Inspection and preparation

WPR/HiL/3 Annex 4 page 35

After washing by ham or machine, the glassware is dried and then inspected by holding before a bright light to check for cleanliness or imperfections (etching and cracks). Glassware requiring sterilization can be prepared in various w~s, i.e., capped, stoppered (rubber or cork), plugged with cotton and gauze, am capped with paper or aluminum foil. Paper covers should be tied securely with string. Syringes should be wrapped unassembled but with mated plunger and barrel in the same package, using muslim, paper, or aluminum foil. Item capacity should be ciearly indicated on the wrapper. Syringes, 3cc ani smaller, can be placed in test tubes and plugged with cotton. Tubing of small syringes eliminates the necessity of marking and wrapping, and reduces cost of preparation. After washing, inoculating needles are inspected for damaged points am the openings tested by forcing water through with a syringe. If sharpening is required, inspection should be made for burrs inside of bevel. Large quantities of needles can be processed in canmon containers such as petri dishes. When needles are prepared separately in test tubes, gauze, cotton, or glass inserts should be used to protect the point. Items not requiring sterilization should be placed in cartons or containers to keep as clean as possible until ready for use.

4. sterilization

Any item that has been prepared with caps, stoppers and rubbgr tubi~~ am any other material that will not withstand temperatures up to 180 C (356°F), must be sterilized with steam. If sterilized with stgam (autoclave), loosely packed items should be exposed to temperatures of 121 C (250'7), for a period of fifteen minutes. Closely packed items require thirty minutes. If sterilized in an e!ectric sterilizer (hot air), thin-walled items should be exposed to 1800 C (356 F) for a period of sixty minutes. Thick-walled ~tems and those packed in containers such as pipette and petri dish cans require a sterilization period of 120 minutes. Empty containers, such as flasks, bottles, etc., should be placed in autoclaves hOrizontally, never up-right, unless they contain a liquid. If items have caps or stoppers, they should be placed on loosely until after sterilization. If items are not used immediately, caps and stoppers should be tightened to avoid possible contamination. Items requiring storage should be placed in a dust-free roOIll.

5. Space am equipment required for the preparation of SCientific glassware ana related items

5.1 The minimum amount of space required for hand washing would be approx­imately 100 square feet per person. lhis area should be equipped with separate sinks for washing and rinsing and a source of appropriate processing water. An electric hot plate or some heating apparatus can be used for boiling purposes if boiled water is required. Containers (preferably stainless steel) should be available for soaking, boiling am rinsing. Carts or some type of carriage should be available for transporting glassware from the wash area to an area for inspection am preparation.

5.2 The minimum amount of space required for machine washing should be approx:iJDa.tely 150 square feet per person. This area should be equipped with a sink, washing machine, and a work table for sorting glassware. Wire baskets

'-- or some type of container would be necessary to contain, transport and <i"y the

WPR/PHL/.3 Annex 4 page 36

glassware after removal from the washing machine racks (headers). A steam heated cabinet or an electric dryer should be available for dr,ying the glassware as soon as possible to prevent dust from accumulating on the wet glassware. Glassware should be inspected and packaged in an area separate from the washing.

6. Personnel

Personnel responsible for supe~s~ng glassware preparation should have a thorough knowledge of standard concepts and s,ystems of sterilization and be familiar with various types of necessary equipment and materials emplqyed in pro­cessing glassware. Non-supervisory personnel can be recruited from a cammon labour pool and with proper training can be utilized in most phases of the opel'ation.

-< •

,.

1

ANNEll 5

POSSIBLE AMERICAN SOtmcES OF EQUIPMENl' AND MATERIALS

1. Turbomatic Washer ~ Better Built Machine Compa1'\Y', New York, N.Y. Approximate cost - ~5000. Headers for various types of glassware - approximatelJ ~50 each.

2. Electric Hot Air Sterilizer - Precision Scientific Compaqy, Chicago, lllionois. Catalog number 1256. Approximate cost, *,1.500 •

.3. Temperature recorder (used with electric hot air sterilizer) - The Electrie Auto-Lite Compa~, Toledo, Ohio. Approximate cost, ~5.

4. Water Demineralizer - Barnstead still and Demineralizer Com~, Lanesville Terrace, Boston .31, Massachusetts. Model number MM5. Approximate cost - $8000 (produces 1500 gallons per hour - smaller capacity apparatus can be purchased).

5. still for single distilled water - Consolidated Machine Corporation, Boston 14, Massachusetts. Model N.P.S • .30, approximate cost,$lOOO. (Produces ,30 gallons per hour).

6. Autoclave (steam sterilizer), Type 21. American sterilizer Compaqy, Erie 1, Pennsylvania. Approximate cost, $1500.

7. Acid Vats - a~ of such constructed with acid-resistant materials (stainless steel, etc.).

8. Technicon-automatic Pipette Washer - Technicon Compaqy, New York, New York. Approximate coat, $75.

9. Machine Washing Detergent - Brand name, "Soil-A-Way" - Economics Laboratory, Inc., St. Paul 1, Minnesota. Approximate cost - 18 cents per pown.

10. A mild ham. washing detergent - brand name, "Tetrox" - Economics I"'. Laboratory, Inc., St. Paul 1, Minnesota. Approximate cost - 2 cents per pound.

11. Decontaminant. - Brand name:

a. "O-Byl" - Lahn & Fink Products Corporation, Bloomfield, New Jersey.

b. "Liquor Cresoles Saponatusll , U.S.P. XIII NF - Baird & McGuire, Inc., Holbrook, Massachusetts.

12. Glassware

a. Corning Glass Works, Corning, New York.

b. Kimble Laboratory CD..assware, <Mens-illinois, Toledo 1, Chio.

A reference for sterilization procedures - "A Textbook of Sterilizationn,

by Weeden B. Underwood, obtainable from American sterilizer Compaqy.

ANNEX 6

POSSll3LE AMERICAN SOURCES OF EQUIPMENT AND MATERIALS FOR MEDIA PREPARATION

1. Equipment

a. Harvard Trip Balance, Model 3450, double beam, maximum capacity two kilos. Cost - $25. Will Corporation, Rochester 3, New York.

b. Steam Autoclave, various sizes, obtainable from American sterilizer Company, Erie , Pennsylvania •

c. Glassware - all standard types available from:

(1) Fisher Scientific Comparv, Chicago, Illinois. (2) A.S. Aloe Company, St. Louis, Mo.

d. Brewer-Automatic Pipettor, electrically operated model 40. Approxi­mate cost - $180. Will Corporation, Rochester 3, New York.

e. Cornwall Pipettor, hand operated. Cost approximately $8.00 plus $2.50 far a two-way valve far continuous pipetting. Will Corporation.

f. Seitz Filter Unit, 2 litr.e capacity. Cost - approximately $175. Republic Seitz Filter Corporation, 17 Stone Street, Newark 4, New Jersey. (Filter material obtainable in sized pads or sheets).

g. Beckman pH Meter, Model G. ApprOXimate cost - $450. Corporation. (pH test paper also obtainable from this source. up. Complete set - *'1.5).

2. Materials

Will Cost - $2 and

a. standardized dehydrated culture media and other supplies.

(1) Difco Laboratories, Inc., Detroit 1, MiChigan. (2) Baltimore Biological Laboratories, 1640 Gorsuch

Avenue, Baltimore 18, Maryland.

(Preparation manuals are available from both companies and are valuable aids in preparation of media.)

b. D,yes and Color Indica~ors

(1) (2)

(3)

Difco Laboratories, Inc., Detroit 1, MiChigan. National Aniline DiviSion, Allied Chemical am Dye

Corporation, 40 Rector street, New York, N.Y. Fisher Scien~ific Company, Chicago, Illinois.

c. Chemicals

(1) J. T. Baker Chemical Company, Phillipsburg, N.J. (2) Nutritional Biochemical Corporation, Cleveland 28, Ohio. (3) Fisher Scientific Co~any, Chicago, Illinois.

"'" .

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J

WORLD HEALTH ORGANIZATION

ORGANISATION MONDIALE DE LA SANT~

REGIONAL OFFICE FOR THE WESTERN PACIFIC

BUREAU R~GIONAL DU PACIFIQUE OCCIDENTAL

P. O. Box. 2932. MANILA

SEMINAR Cfi RlBLlC HEALTH LABCRATCRY SERVICES

wm/HlI/4 24 October 1960

Manila, H1i11.ppines 5-16 December 1960

CRID:mAL: Ell} LlSH

1.

LABCRATCRY HAZARDS IN HEALTH LABCRATCRlES

by'

G. Briggs Hdllipsl.

CON~NTS

INl'RCIH£TIctJ • • • . . . . . . . . . . . . . . . • • • • • • 1

THE mOBIEM • • • • . . • • • • • • . . . . • • • • • • • • • • • l.

APIROADHES TO THE !ROBIEM . . . . . . . . . . . . . . . . . . . . . . 2

Vaccination • • • • • • • • • • • • • • • • • • • • • • • • • • • 2

).2 Techniques and procedures • • • • • • • • • • • • • • • • • • •• 3

3.' Safet;y' equipnent . • . • • • • • • • • • • • • • • • • • • • •• 3

3.4 Building facilities . . . • . • • . . . . • . . . . . . • . . .• 4

3.5 Management aspects · . . . . . . . . . • • • • • • • • • •

C (KHDS ION • • • • • • • • • • • • • • • • • • • • • • • • • . . • • •

~aearch Scientist, Center for Safet,y Education, New York Universit,y

4

5

Wffi/HII/4 r~ pagel

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1. INI'RCDUCTION

Although miorobiologists have been aware for man;,v years of the hazards attending their profession, systematio study, eValuation and correction of these hazards is a developEnt which has received accelerated attention only during the last ten to fifteen years. It is characteristic that as general disease decreases, the relative importance of specific causes of disease increases. The laboratory is the "cause" of many illnesses among public health laboratory workers in the sense that it is in the laboratory that man.v workers became infected with the micro-organisms with which they work. The purpose of this paper is to disouss sane overall aspects of the problems, and several approaches to its control.

2. THE ffiOBIEM

Hazards in the infectious disease laboratory fall into two principal categories: (1) those that cause physical injuries, cuts, burns, explosions and fires, and (2) those that cause laboratory-acquired illnesses. This paper deals with the second category.

Necessarily one must ask, "ls laboratory-acquired infectious disease a problem in the publio health laboratory?1I The degree of affirmation detemines the degree to which an infecticn-prevention programma is needed. HOlI8ver, one finds that all too often direotors of laboratories do not keep adequate recat'ds of accidents and illnesses. Thus fran memory the director mq attest that there has been only one tuberculosis infection in the tuberculosis laboratory during the past five years. But when we rea.l.:i!ze that ~ three people work :in this laboratory, we Imow that the lIinfection rate" is almost 7 per cent or more than 37 intections for each million man-hours workedJ Furthermore, there is often a tendency to asSUIIIB that an illness in a laboratory worker has been acquired elsewhere. Without medioal, miorobiologioal and :lJnmunologioal investigation, the true source of ~ illnesses is never acknowledged. Thus lacking adequate :investigation and statistics it is difficult to measure the extent of the problem. Nonetheless, it is evident that in many infectious disease laboratories, occupatione.l.q incurred infections create serious moral, morals and econanic problems.

So far it has not been possible to ascertain the world..owide frequenc;y of laboratory illnesses, but several local surveys of interest have been conduCted. In the United States Sulkin and Pike collscted information on 1342 laboratory infections in "'hich the fatality rate was.3%. One hundred sixty-seven of these infections occurred in public health laboratories. This stud,y', through a. caumittee of the American Public' Health Association, has been expanded and now includes 2262 infections. D. D. Reid, in London, studied the frequency of tuberculosis among workers in 345 medical laboratorie s and found the incidence of pulmonary tuberculosis to be fran 2 to 9 times greater than would be expected fran the normal popu:La.tion in his country. During a recent tour of JJJ. medical and public health laboratories in 18 countries the author was told of a total of 358 laboratory infections. Most laboratories whe19 human pathogens were handled had had laboratory-acquired illnesses. Few laboratories could claim an infection-free record. Regard1ess of the past record, ~ laboratory directors, particularly directors of laboratories with public health !'unctions, were genuinely concerned about the ability of their laboratories and staffs to function satisfac~ in

WlR/HIL/4 page 2

the event of sudden and/or large-soale outbreaks of infectious disease in the popuJ.a.tion. It was esr.ecially noted that the sudden neoessity to handle infeotious agents couJ.d create havoc when individual immunity among the staff and correot procedural techniques had not been established. It is an appropriate aim of a public health laboratory to be able to function efficiently and at full strength during tilnes of epidemics or national emergencies.

But the concern need not be entirely about those agents we tend to classU"y' as highly infectious such as tubercle bacilli, pSittacOSis, bruoella, etc., because mismanagement (or wrong manipul.ation) of low grade pathogens or even so-called non-pathogens can lead to trouble. The problem of staphylococci infections in hospitals can serve as an example as well as the fact that there have been at least reoorded eleven fatal infections uith Serratia marcescens, a oommon, red pigmented soil organism.

Yet another asr.ect of the problem is that the same fauJ.ty procedures or acCidents Which cause human infection can be responsible far cross-eontam1nation of culture and cross-infection of animals. These two factors may challenge the validity of laboratory diagnostic or exparimental resuJ.ts.

3. APlROACHES TO THE mOBIEM

What approaches can be used in controlling laboratory hazards? Most approaobes are obvious and, of those to be mentioned, sane are interrelated. Sare can be applied in arty laboratory because no eJq:enditure of funds is required. others require the eJq:enditure of money and therefore ma.v not be alwqs possible. For convenience the approaches or methods for controlling laboratory-aequired infectious diseases are listed as (1) vacCination, (2) use of correct techniques and procedures, (3) use of safety equipnent, (4) building facilities, and (5) management aspects. Under management aspects are included a number of :l.mporliant functions such as prograrruning, regulating, reporting, training and seleotion.

3.1 Vaccination

Vacoination of laboratory r.ersonnel is certainly recCl1ll1J3nded when a satis­factory immunogenic preparation is available. Good :iJrmrunity is conferred a1'ter vacoination against smallpox, tetanus, yellow fever, botulism, cholera, diphtheria, and t;n:noid. Other vaccires such as those for psittacosis, Q fever, tularemia and anthrax have or are being tried experoontally with varying degrees of success. But immunogenic preparations have not been as yet developed for a number of human diseases which have been mown to oocur in laboratory workers. Among these are dysentery, blast~cosis, brucellosis, coccidioidOll\Vcosis, glanders, hist4'lplasmosis, infectious hepatitis, leptospiroses, Rift Valley fever and toxoplasmosiS. We generally evaluate the efficiency of vacc:ines for laboratoI7 workers on the basis of their effectiveness in preventing disease in the general population. Two possible pitfalls to this line of th:i.nk:Ulg shouJ.d be nentioned. The first is that the public health worker ma;v be exposed in the laboratory to infectious micro­organisms at a much higher dDae Jsvel than would be expected frem nonnaJ. public exposure. Seconcl.J.y, this exposure mL\V be by a route different frem that n~ expeoted, e. g., respira.tory infection with tularemia or anthrax organism.

Wm./IHL/4 page 3

The next three control methods, use of correct techniques, use of safety equipnent and proparl;y' designed laboratories, rest on the same two pillar stones. ~ states that almost arty manipulation with :infectious cultures will result in the release. or a measurable quantity of micro-organisms fran the environment of the pip'tte, test tube or f'lask to the workers' environment. This has been the sub­ject of much laboratory :investigation and is relativel;y' easy to c1emonlrt,rate. The second under~ principle is that through the use of special techniques, equip­ment and facilitieS, accurate and scientific control of environment is possible which will reduce or eliminate laborator,y-acqu1red infections.

3.2 Technigues and procedures

Man;r procedural rules for laboratory safety are obvious; sane are not. Avoid mouth pip'tting of infectious or toxic fluids. Use onl;y' needle locking

~. syringes. Sterilize all contaminated discard material. Frequentl;y' disinfect hands and work:i.ng surfaces. Do not smoke, eat or drink in the laborato1'9'. These rules certainl;y' are wll mown and should be observed.

other pr:-ocedural rules ma;v be less well understood and require more explana­tion. (1) Do not blow out the l.ast drop fran the pip'tte. (2) Do not mix dil.utions by" b10wing air through the pipette into the cuJ.ture. (3) Wear gloves when handling infectious fluids in a syringe. (4) Use an alcohol soaked pledget when removing a syringe and needle fran a rubber stopp'red vaccine bottle. There are a number of others having to do with procedures such as centrifuging, grinding tissue, ~Jililizing, etc.

Tnfonnation on such rules and the reasons for their recc:mnended use exist, although at the present sufficient ccmmnmication ch~1s ma;v be lacking. Rules or procedures pointed tCMard the el:lJnination of airborne contamination are the most difficu1t to institute and enforce. <:me the fundanental concepts of how aerosols mq be produced by" ord:l.nary l.aboratory techniques are understood, the laboratory supervisor should attempt to design safety into new pl'ooe<iures and tests which are dew loped the idea being to e1.im1nate or to mod:i.1'y those steps or manipiLatiCllS which are the most hazardous.

3 • .3 Safety eguipnent

The most ilIlportant single piece of safety equipnent in the infectious disease laboratory is the ventilated work cabinet. The basic requ:Lrements for such a cabinet are: (1) sufficient imJard air now (at least 50 linear feet per minute) or operation at a; negative pre.,sure, (2) filtration of exhaust air, and (3) means of sterili zing both the 8Jlhaust filter and the interior or the cabinet.

other types of safety equipnent have been deve10ped because of the difficulty in safe~ carrying out certain procedures such as blending and centrifuging. Sane haw been designed to facilitate carrying out certain operations in ventilated work cabinets. Much equipnent is caomerciaJ..l;y' available and source inf<mnation can be made available. A partial list of safety equipnent would include inoculating loop incinerators, pipettor devices, safety centrifuge cups, safety blendor bowls and filter masks. The atter are mentioned because of the wll-mam :U!efficiency of the ccmnon hospital gauze mask in filtering out airborne partioles. Filter

WlR/HIL/4 page 4

masks with high filtering efficiencies suitable for laborato~ or animal roam work are now available. However, since the ventilated cabinet externalizes an entire working area instead of the worker, it is generaJ.J.y the first type of safety equip­ment which should be provided.

3.4 Building facilities

Constl"l',ction criteria for laboratories which augxoont and improve safety have been developed and are available. More and more, as the demands up<m the micro­biologist increase, certain building design features cease to be JIlSre advantages and becane necessities. Among these ma:.r be mentioned (1) bujlding ventilation (:::) control of direction of air movement, (3) biological filtration of air, (4~ separation of areas of different risk levels, (,5) use of germicidal gases and radiations and (6) separation and improvement of animal holding facilities. Modern

.... ,

b1!ildi n(,; criteria for laboratories do much to reduce infectious risks and to _. pre-vent laboratory infections.

305 Management as~cts

The last method of controlling laboratory hazards, the management approach of programming, regulating, reporting, training and selecting, is perhaps the most :1Jnportant, although it is interrelated and overlaps with the other approaches mentioned. The management approach also attempts to include control of the "human factor'!. in the application of the other principles.

A:try program.e of loss-prevention is based on the dual premise that (1) the loss (in this case laboratory-acquired illness) is the resuJ.t of a series of ewots which result in an accident and, (2) accidents are Jarge:q preventable by oontrolling these events. Translated to tems of our O\m problem it sjmp:q means this:

1. Mcidents or wrong techniques create conditions for infection. Remember that the techniques ma:.r not be recognized as be:ing wrong because, from the biological point of view, they ma;y- not have been II safety tested".

2. If the accident was preceded by az:w predisposing human or phy'sicalfactors, these must be corrected in order to prevent the accident which causes the infection.

The following are a few suggestions for the management approach to the control of laboratory hazards. These are, of course, pointed toward the real. focal point of public health laboratory - the laboratory workers. People have emotions, people have personal needs, people are motivated in one direction or another. Therefore, we must use the management approach with a certain under­standing of these 'human factors II •

1. Establish written safety regulations that are read and under­stood by all.

2. Train each new employee until it is certain that he understands the ru:Le s and wh7.

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WlR/lHL/4 , ... pageS

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3. Follow a soheduJa of retraining old emPJ.oyees.

4. Keep the safety needs :in m:illd when soreening and seleoting new employees.

5. Inasmuch as pt'5sible, design safety :into teohniques and procedures as they are develoJ:ed.

6. Establish responsibility for safety. Each suJ:ervisor should be responsible for the safety of his peopJs, but each employee should have a personal responsibility - sai'ety should be a part of every job.

7. Establish a fonnal system f~ reporting accidents, lost-time injuries and infeotions and insist on pranpt reporting.

8. Investigate each illness and each acoident to dete:mdm what should be done to prevent recurrence.

9. Encourage suggestio;:1S for el:imina.ting laboratory hazards £ran workers at all levels.

4. COOCill3ION

It is understandable that not all public health laboratories would need to employ all of the suggestions made :Ill. this paper. These suggestions are mere~ a oanposite of the approaches used to oontrol laboratory hazards in a large number or laboratories. While it is obvious that the meds of public health laboratories in various parts of the world will vary a great deal, it is also apparent that a. better interchange of :illi'ormation will be bemficial to all.

Modem-da;y publio health and medical practices should be supported by laboratory services which are just as modern. Control of the laboratory infeotious risks through vaccillation, the use of oorreot techniques, the use of safety apparatus, the design of laboratories and by certain management fUllCtions oontributes to O'l8rall oontrol of laboratory environment and thus to the ability of the infectiOUS disease laboratory to perform its proper function efficient~ and with­out interruption.

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WORLD HEALTH ORGANISATION MONDIALE DE LA SANT~ ORGAN I ZATION

REGIONAL OFFICE FOR THE WESTERN PACIFIC

BUREAU R~GIONAl DU PACIFIQUE OCCIDENTAL

P. O. Box 2'32. MANILA

wm/mL/, fEMINAR ON PUBLIC HEALTH IABCRATCRY SERVICES .3 November 1960

Manila, Ehilippines 5-16 December 1960

CRlGINAL: EIDLLSH

1.

INTERNATIONAL AND BIIA'IERAL COLIABCRATION IN PUBLIC HEALTH IABCRATCRY ACTIVTrJES

1 Dr. R. Sansonnsns

CemENTS

THE ROIE. CF WHO IN IRCMarING AND ASSISTING NATIONAL RlBLIC HEAIll'H IABCRATCRY S&RVICES • • • • • • • • • • • • • • • • • •

Irl£omation •• • . • . . . • . . . . • • • • • • • • Technical services . . . . . . . . . . . • . . . . • •

• • • · . . 1. 2.1 Eharmaceutioal preparations • • .. • • • • • • 1. 2. 2 Biological standardization • • • • • • • • • • 1.2.3 Methodology and diagnostic reference services • • •

1.3 Eduoation and training facilities ••••••••••••• 1 • .3.1 Visiting professors ••••. ~ .••••••••••• 1..3.2 Fellowships to professors and staff of

1.4 1.$ 1.6

institutions • • • • • • • • • • • • • • • • • • 1. 3 • .3 Training c curse s . . • • • • • • . • • • . • • • • • 1.3.4 Training of laboratory technicians • • • • • • • 1.3.5 Educational meetings • • • • • • • • • • • Organization of laboratories • • • • • • • • • • • • • Medical research •• . • • . . . . . • • . • • . SUlIID.a:t"Y" • • • • • • • • • • • . . . . . . . . .

lehief Medical Officer, Health Laboratory Servioes, WHO Headquarters

1 1 2 2 2 .3 4 4

4 4 4 5 5 6 6

2. THE Ul'ILIZATION OF RESOURCES AVAILABIE FRCM BILA'mRAL AND IN'lERNA'fIONAL AGENCIES FOR DEVELOPIllJ NATIONAL FUBLIC HEALTH IAB CliAT CR. Y FR ()}R.A.M:MES • • " • • • • • " • • • • • • • • • • 2.1 Sources of financing of VillO and joint international

health programmes .."........... • . • • 2.1.1 The WHO Regular Budget • • • • • • • . • • • • 2.1.2 The Malaria E.radication Sp3cial Account (MESA) ••• 2.1.3 Voluntary Fund for Health Promotion • • • • • • • • • 2.1.4 Expanded Programme of Technical Assistance ••• 2. ;1.,5 UNICEF ••••• • • • • • • • • • • • • • • • • 2.1.6 United Nations Special Fund • • • • • • • • • • 2.1,7 other extra-budgetary funds •• • •

2.2 Chronology of WHO programme •••••••••••••••• 2.:3 Chronology of the programmes of Technical Assistance

an.d UNICEF •••••••• • • • • • • • • • • • • •• •• 2.3.1 Expanded Programne of Technical Assistance ••••• 2.3, 2 UNI~ ••• • • • • • • • • • • • • • • • • " • " •

2.4 Co,..ord:i.na.tion between WHO and bilateral and multilateral

2.5 2.6

assistance Utilization Summary • •

. • of . .

. . . . . . resources . . . . . . • .

· · · . . • •

· · • . · • • • • • • • • • • . • • • · · •

3. THE ROIE CF NATIONAL RJBLIC HEALTH LABCRATCRY SERVICES IN INTERNATIONALHEAEr.H. " •• " .•.• " " " " •• " .• " " · . 3.1 Epidemiology and the control of communicabl.e diseases ••••

3.1.1 Quarantinable diseases • • • • • • • • • • • • 3.1.2 RapidJ:y transmitted communicable diseases • • • • 3.1." 3 F .)od-poisoning outbreaks • • • • • • • • • • • Control of biological and pharmaceutical products • · . . Research in human pathology • • • • • • • • • • • • • • • • •

ANlEX - 'WHO INTERNATIONAL CENTRES AND REFERENCE LABORATClUES AND , WHO/FAO REFERENCE CENTRES • • • • • • • • • • • • • • • • · . .

7

7 8 8 8 8 8 9 9 9

10 10 11

11 11 13

13 13 13 14 14 14 J5

16

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I. THE ROlE CF WHO IN mCMOl'nD AND ASSISTOO NATIONAL RJBLIC HEALTH IABCRATCRY S&RVlCES

wm/FHL/5 page 1

The a.:i.m of the World Health Organization, as set out :in its Constitution, is to raise the standard of health of all p30ples of the world to the highest possible level - health being defined as canplete physical, mental and social well-being and not merely the absence of sickness or infirmity. In working towards this end it is necessary to develop all activities related to the health of the individual and of the ccrnmunity :in a well-balanced manner.

In a national health service, a 1191l-organized laboratory- service which undertakes both clinical w.:l public health laboratory- work is essential. Such a service can provide a great deal of the scientific information that is needed to orientate not only curative and preventive work but also the activities devel­oped in mat:W of the specific discip1:ines contained in a national health service. It is p3rhaps urmecessary to mention the great importance of laboratory work in improving epidemiological research in the control of infectious diseases, and in providing diagnostic facilities :in the study of degenarative diseases, oanparative pathology, environmental factors and occupational health.

One of the roles of WHO in strengthening national health services is to pranote, st:imu1m:.e and assist the developnent of laboratory- services. At the same t:iJne, the Organization fulfills its task as a directing and co-ordinating agency by organizing an international nework of reference and co-op3rating laboratories which provide facilities to national health services, and by estab­lishing international standards of different kinds.

The assistance that is available from WHO ma;r be outlined as follows:

1.1 Information

With the collaboration of governmental services, non-governmental organiza­tions in official relationship with WHO and members of the E~rt Advisory- Panels, and with the help of specialists in the many laboratory disoip1:ines, infcmnation is collected on the organization, functioning and equipnent of laboratories, on laboratory methods, on the training laboratory- techniCians, and on laboratory research of :international :interest. This information is analyzed and annotated. Same of it is published in the Bullet:in of the World Health Organization or in the WHO International Digest of Health legislation; sane is distributed in mimeographed fom to :interested laboratories and to technical consultants working in the different field projects of the Organization; and sane may' serve as the basis of working pap3rs for Expert Committees, Study Groups and Scientifio Research Groups on subjects on which the opinion and advice of highly qualified speCialists are desired.

Arter they have been approved by the Director-General, the reports of Expert Committees and Study' Groups are pt'inted in the Technioal Report Series, lihich are distributed to governments, organizations, libraries, etc. and also put on sale. Papers on scientific subjects and articles dealing with technical subjects are published :in the miD Bulletin if they contain information that is new or of value. Thus a wide and sp3edy distribution is ensured of general

wm/mL/5 page 2

information and technical data that are of interest to laboratories and facil­itate contact between laboratory workers. 'rhanks to the close relations that exist between WHO and a large number of laboratories and institutes, it is relatively easy to obtain, and to provide a government service or a.rw other body with, the information it l-rishes to have.

1. 2 Technical services

In order to facilitate production and control of biological products and pharmaceutical preparations as well as obtain comparable results of lab­oratory tests, WHO provides the facilities mentioned below:

1.2.1 Pharmaceutical preparations

(i) Specifications for checking the quality of IiJ,armaceutical prepara­tions to ensure that products placed on the market possess a fixed and satisfactory therapeutic action and have no harmful secondary effects; these s}:.Scifications do not, hen-rever, insist on such purity Of the preparations as to make them undul;y costly to produce. Once adopted, these s}:.Scifications are included in the International Pharmacopoeia or are distributed separately.

(ii) Selection of international non-proprietary narres for pharmaceutical preparations in order to obviate the confusion resulting fran the use of dif­ferent non-proprietary naIJeS for the same IlEdicinal substances.

(iii) The establishment in Stockholm of a Centre for Authentic Chemical Substances, which distributes these substances, free of charge and on request for anaJytical purposes, to national administrations and laboratories and institutes working on a non-profit making basis. :::ight such substances (see annex) are now available, and it is proposed to include seventeen others in the list.

1.2.2 Biological standardization

With the object of ensuring world uniformity in the potency of prepara-tions 1'1hich are used in the proIiJ,ylaxis, therapy or diagnosis of human and animal -, disease and cannot be adequately characterized by chemical and physical means, the following services, uhich had already been started by the Health Committee of the league of Nations, are being continued and expanded by WHO:

(i) The International Laboratorie s for Biological Standards at the Statens Seruminstitut, Copenhagen, and the National Institute for r-ledical Research, London, are custodians of all International Biological Standards and Interna­tional Biological Reference Preparations recommended by the WHO Expert COIIIIlittee on Biological Standardization (see annex). These two laboratories distribute samples of the preparations, free of charge, to national laboratories responsible for the official control of biological products in all countries, and through them, or in special circumstances directly, to the firms engaged in the production of biological preparations.

wm/HII/~ page ;3

(ii) Countr:ies that do not possess the laboratory facilities necessary to enable them to undertake aJl the tests of biological products required by WHO ma,v seek the coD.aboration of, and send their products to, other countries that do not have such facilities.

1.2.;3 !fethodology and diagnostic reference services

In order to help increase the production of vaccines of the highest possible quality, the uniform use of reference standards and preparations, and the preparation, control and use of antigena and diagnostic sera, WHO st:iJnulates and encourages the use of methods tested and recanmended by experts on the subject, which are then canmunicated to such national and other laboratories as make a request for them.

Diagnosis poses important problems of nanenclature and classifioation, the diversity of which constitutes a serious handicap to the success of canparative studies of geogrcphical pathology and of epidemiological SUTveY-S. With the a:im of promoting uniformity and consistency throughout the world in the identification and nomenclature of cells, micro-organisms and pathological. tissues, WHO has officially established a number of International Reference Centres, thus strengthening the efforts of cert:rln national and international scientific associations in this direction. For exanple, centres study" and red blood cells, identif,r micro-organisms and pathological tissues according to internationaJJy accepted classifications, standardize antigens and sera for the diagnosis of the treponematoses, and identif,r the snail vectors of bilharziasis. (The names and addresses of these centres are given in an annex). Sema of the centres work in close collaboration with a network of corresponding national centres deSignated by the governments at the request of WHO. For example, there are about 50 national reference centres for SaJmonella..Shigella and Escherichia ooli. and 58 for influenza. The expansion of national centres for blood-grouping is under wq, and there are plans for an international centre for phage typ:J.ng, one for arthropod-borne viruses am one for animal tumours. All the centres have been set up in institutes or laboratories where the specialists rank among the first in their particular field. GeneraJJy, the functions of the internati(UaJ. reference oentres are the following:

(a) to collect, identif,r, and classify material subnitted to them;

(b) to supply antigens, diagnostic sera, and reference preparations;

(c) to check the quality of antigens and diagnostic sera submitted for control;

(d) to carry out research in the fields concerned; and

(e) to accept for training WHO fell~Ts, or students recamnended by.WHO.

There are also a great !IlaI\Y laboratories, sOllle supported, some not, which oollaborate with WHO in diagnostiC reference work for polianyelitis virus and the 1IW'C0bacteria, the production of antigens and sera for viruses and the rickettsiae, and the testing of insecticides and molluscicides.

wm/HiL/.5 page 4

1.3 Education and training facilities

The greatest problem encountered in assisting in the organization of lab­oratory services is the training of personnel. Needs differ, of course, from one country to another, but usual~ assistance comprises the provision of:

1. 3.1 Visiting professors

At the request of goverrunents and institutions, WHO may provide the services of a visiting professor, either to strengthen or develop certain disciplines or to carry responsibility while a national of the country is being trained.

1. 3. 2 Fellowships to professors and staff of institutions

for post-graduate training

for observation of techniques and methods

Each WHO Regional Office discusses needs with the governments of the countries in its region and agrees on the purposes of and the number of fellow­ships to be made available for each country. The proposed prograJlll1J3 for all countries of the region is discussed at the Regional Committee rooeting. Apart frm prOviding funds, WHO's task is to organize the most useful progratme for each fellow. In most countries there is a selection committee in which WHO may participate without vote. It is the governroont in each case that proposes the oandidates, 'Who will have a specific assignment on their return hane, but WHO's final approval is needed.

For post-graduate training, the length of the fellowship should be such that the candidate receives adequate training of a type that ,rill enable him to carry out his future responsibilities. There is no point in his being trained

...

:r:

in very advanced techniques in an institute with facilities that will not be r.. available to him in his own country. At the same tiIOO, however, he should have the opportunity to visit some leading institutions in order to enlarge his views and concepts in preparation for future developnents.

1.3.3 Training courses

WHO organizes yearl¥, at regional or inter-regional level, training courses on diagnostic methodology. Each course lasts about four weeks and is given free of charge to some 20 laboratory workers. The courses are special1y designed for laboratory speCialists of more or less the same experience, to give them practical training in new techniques or to improve their technical knowledge in a field of particular interest for national problems and international collaboration. Fellowships are avTarded to enable people to attend these group training activities.

1.).4 Training of laborato;y technicians

In addition to providing fellowships for laboratory technicians to be trained by apprenticeship or in schools in the Regions, -v.ffiO is ready to advise and assist governroonts in establishing training courses for laboratory technicians by pt'oviding teaching staff and, to a J.:imited extent, equipnent. Such courses

...

Wffi/lHL/5 page .5

lIIBiY" also be part of a project dealing with the organization or strengthening of a national laboratory service. Curricula and the distribution of theoretical and practical work, as 'lIe1l as in-service training, should be carefulJy pl.am1ed and should ta.lre into account the trainee I s standard of general education, the needs of the country, and the necessity to make the trainee IS chosen profession an attractive one.

1.3.5 Educationalmeetings

WHOalso organizes certain educational meetings to which specially qualii'ied persons are invited, in order to give them an opportunity to exchange opinions and experiences. A report of the proceedings ma;r be issued, and recanmendations made.

1.4 Organization of laboratories

In addition to the above"'iJlentioned services, WHO ma;r be requested to provide technical assistance in the organization of laboratories. This organiza­tion, which is in fact of the greatest :ill1portance, ma;r be of several kinds:

(a) organization of laboratories in campaigns against caTlllunicable diseases such as tuberculOSiS, malaria, venereal diseases and treponematoses;

(b) organization of laboratories as an integral part of rural health demonstration centres;

(c) organization of clinical laboratories in teaching institutions;

(d) organization of vaccine and serum production departments or speCialized research work;

(e) organization or strengthening of a national laboratory servioe.

Requests for assistance in the organization of laboratories are discussed by the Regional Offices with the countries concerned. After final approval. by the World Health Assembq, the government interested and the appropriate 'WHO Regional Oi'fice sign jointly a plan of operation in which are defined, inter a]ja, the objectives for which WHO assistance is required, the plan of action, the target date for canpletion, and the commitments of WHO and of the government. The "planop" also contains the provision that the government should provide facilities for future evaluation of the project and give an assurance that it will continue the programme, within the scope of :'.-1-,-:; available resources, after WHO assistance has ceased.

The assistance given by the Organization usually consists of the provi­sion of certain personnel and a limited amount of material.

Agreellrilnts are normally made for a period of fran one to two years. This period can be extended if the government has fulfilled its commiwnts and can make out a case for the continuation of WHO assistance until the country can itself carry on the programme in operation.

WlR/mL/5 page 6

A project is thus valid if the programme planned is within the financial possibilities of the country. The main object of WHO assistance is to help in the organizati~ of an official activity or service, and to train national J2rsonne1.

1.5 Medical research

In pursuance of Resolution WHAll.351 of the Eleventh World Health Assembly, carried in June 1958, a programme of intensifieJ medical research was pJ.anned by WHO to s~art in 1960. The Twelfth World Health Assembly, in its Resolution WHA12.17 , approved this project on the grounds "that the plan presented constitutes a logical continuation and extension of established WHO activities" and "that more extensive and intensive international co-oJ2ration among the research workers of the world is required to prevent, control and cure disease ll • The Assembly recognized that IIthere is a world-wide shortage of qualified scientists and that the general research potential of the world needs to be increasedll , and that 'WHO has an important role to play in increasing this potential and in fostering inter­national collaboration among the scientists of the world by stimulating, co­ordinating, prcmoting and supporting research. II

In consequence of this, there has already been a considerable increase in the number of research projects undertaken by the Organization within the frame­work of its normal activity. Further progranunes are in course of preparation and WHO is extending its co-ordinating role in the field of research, in collaboration with many research workers and in closer contact with national and international scientific associations.

Well-trained and highly qualified J20ple are essential in this field, and it is to be hOJ2d that the laboratory services in the countries in process of developnent will, by degrees, be able to provide the "tyJ::.es of workers indispensable to intensified medical research.

1. 6 SUIllIIlal'l

The present activities of WHO in promoting, stimulzing and assisting national public health laboratory services are as foll<Ms:

(a) diffusion to governments and institutions of useful selected informa­tion and of expert opinions and recanmendations on all questions related to 1ab­orat~ organization and work;

(b) provision of advice and information when requested;

(c) organization of advisory and educational meetings in order to provide sJ2cialized teaching and technical staff with the opportunity to discuss canmon problems and exchange experience;

lwHo Official Records No. 87, page 388

4N.H0 Official Records No. 95, pages 443-444

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(d) provision of adviSory rersonnel and (a Jimited amount of) equipnent for the organization of a national laboratory service or of special J.aborat~ activities;

(e) establishment of technical services and reference centres to facil­itate world uniformity in diagnosis and in the production and centrol of biological products, pharmaceutical preparations, antigens and sera;

(f) assistance to projects for the training of all kinds of teaching and technical laboratory rersonnel;

(g) co-ordination in each country of the assistance available £ran bilateral and international agencies; and

(h) pranotion of assistance to and co-ordination of medical research •

2. THE UTILIZATION CF RESOURCES AVAIIABIE FROM BIIATERAL AND INTERNATIONAL AGENClES FOR IEVELOPING NATIONAL RJBLIC

HEALTH IABCRATCRY lROORAMMES

The external. assistance availabls to countries to develop their national. health service in general or az:w of its canponent parts, such as a laborat~ service, is as follows:

(a) that provided by UN and its srecialized agences, and

(b) that provided by one country to another (bilateral assistance) or by a group of countries which may not be bound by agreements of mutual assistance (multilateral assistance).

2.1 Sources of financing of WHO and joint international health programmes

The activities of the Worl.d Health Organization are financed by the con­tributions of its Member Governments and by funds fran other organizations as well as voluntary contributions. The main resources of WHO are as follows:

(1) WHO Regular Budget (2) The Malaria Eradication Special Account (3) Voluntary Fund for Health Pranotion (4) Expanded Programme of TeChnical Assistance (5) UNICEF (6) United Nations Special Fund (7) other extra-budgetary funds

wm/:mL/5 page 8

2.1.1 The WHO Regular Budget

The Regular Budget of WHO is made up of money voted each year by its Member Governments. The scale of assessment of WHO is based on that of the United Nations, taking into account the difference in membership and the estab­lishment of minima and ma.xima including provision that no country should be required to pay more per capita than the per capita pa,yment of the highest contributor.

2. L 2 The Malaria Eradicatior. S~cial Account (mSA)

The Malaria Er~dication Special Account was established by the Eighth World Health Assemb~ in Mexico in 1955 in a resolution in which governments and individuals were asked to subscribe towards the total eradication of malaria. The Organization encourages governments to devote more of their national budgets to eradication and tries to persuade the governments of coun­tries which do not suffer from malaria to subscribe to the Account for the benefit of those which do.

2.1.3 Voluntary Fund for Health Promotion

This Fund Was established by the Thirteenth World Health Assemb~4 in Geneva in 1960 to include the following sub-accounts to be credited with voluntary contributions received, the value of contributions in kind and interest earned on investments of money in the Fund:

(a) General Account for Undesignated Contributions (b) Special Account for Smallpox Eradication (c) Special Account for Medical Research (d) Special Account for Community Water Supp~ (e) any other special accounts which may be placed in the Fund

by the Executive Board or the Health Assembly.

2.1.4 Expanded Programme of Technical Assistance

The Technical Assistance Programme was established by the United Nations in 1949. Funds are derived fram voluntary contributions pledged and paid by governments to the Special Account for the United Nations Expanded Progranrne of Technical Assistance and are made available to the organizations which will carry out the projects. WHO is responsible for the health aSplcts of general economic development programmes undertaken.

2.1.5 tJt:lICEF

The United Nations Children I s Fund was fonned just after the war to grant aid to many of those countries which had suffered. It is not a technical agency and its purpose is primari~ that of fund-raising to make available

~solution WHA.8. 30" Handbook of Resolutions and DeCisions, 5th ed., p. 25

4nesolution HHA3.24, Off. Rec. WId Hlth Org. 102, 7.8

.r

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supplies and equipnent in countries where there is a scarcity and to give certain other material assistance. UNICEF does not give WHO actual money to spend but collaborates with the Organization, e. g., by providing supplies for SOlll:! of its field programmes, mainly those dealing with maternal and child health, control of camnunicable diseases, and nutrition. They assisted to a very great extent in the Yaws Programme and provision of insecticides for mmv WHO malaria projects. All UNICEF-assisted activities require the technical approval of WHO whether or not WHO is direct~ concerned in their operation.

2.L6 United Nations Special Fund

This Fund provides assistance to important projects with an economic aim and WHO in acting as the Executive Agency of this Special Fund is charged with the responsibility for implementation of approved Special Fund projects in the field of health.

, 2.1.7 Other extra-budgetary funds

These concern public health activities administered by the Pan American Sanitary- Bureau and fina.n:led by the Member States of the Pan American Health Organization, as well as those provided by agencies such as the Organization of American States and the Institute of Nutrition ar Central America and Panama.

2.2 Chronology of WHO pt'ogramme

The planning, developlEnt and implsnentation of the WHO prograJllll8 for a single year extend over a period of three years which are referred to adminis­trativeJ¥ as the planning year, the approving year, and the operating year.

ImmediateJ¥ after the conclusion of the neetings of the World Health Assembly and of the Executive Board session which follows it, the Director­General issues instructions to the regional directors regarding the preparation of prograIIIIIE proposals for the second succeeding year. The instructions indicate the tentative allocations of funds to each region. The Regional Directat"s plan programmes in consultation with the governments and, 'Where appropriate, in collaboration with any other interested bilateral and multilateral. agencies, on the basis of requests received from the governments. The projects accepted by the regional directors are anaqzed and converted into acceptable budgetary terms fat" submission to the respective Regional Canmi ttees. After that, the proposed programme and budget estimates of each region are submitted to the Directat"­General together with the comments and recommendations of the Regional Camn1ttees. After revision, the annual proposed programme and budget estimates of WHO as a whole are submitted for examination to the Standjng Comrni ttee on Administration and Finance and the Executive Board. They are then submitted to the World Health Assembly for review and approval, together with the comments and recamnendations of the Executive Board.

The developnent of the three years budget cycle of WHO ma;v be SUJI1lIIaI'ized as follows:

WHl./mL/5 page 10

Planning Year

Approving Year

(up to August/September ( ( (A ugust/Se pt.ember ( (Sept.ember/CCtober ( (CCtober/becember (

(January ( ( (

~ (May (

Operating ( Year (

Preliminary regional plann:ing with governments

Submission to Regional Committees

Submission to the Director-General

Revision, consolidation and production of proposed programme and budget estimates

Consideration by the Standing Committee on .Administration and Finance and the Executive Board and submission to the World Health Assemb]y 'With the recan­mendations of the Board

Revision and approval by the World Health Assemb]y

Implementation

This explains why, apart fran emergenCies and unforeseen contingencies for which the "Executive Board Special Fund" of US$lOO 000 has been established, it is not possible to obtain assistance fran the WHO Regular Budget for the year in which the request is made, or for the year following it.

2 • .3 Chronology of the programmes of 'l'echnical Assistance and UNICEF

The programme planning procedure of these two agencies mIV be sWllllarized as follows: ,.,....

2. }.l Expanded Programne of Technical Assistance

(March or April ( ( ( (I-1a;v / June

The planning ( and (Ju]y/August

approving ( year (

Operating year

( ~ CCtober/becember

(

( (

Country targets and agency sub-totals established by TAB (Technical Assistance Board)

Regional planning with governments

Co-ordination of country programmes; submission of country programme to TAB by government.

Review by TAB; review and approval by TAC (Technical Assistance Committee) and the General Assemb]y of the United Nations

Implene ntation

WlR/mI/5 page 11

This shows that the budget cycle under the Expanded Programma of Technical Assistance begins the year preceding the o~rating year. Priority in assistance is given to continuing projects.

2.3.2 UNICEF

The cycle far programming and allocation in UHlCEF differs from that of WHO and Technical Assistance. Allocations far any year for supplies and equip­ment and for within-country training stipends are made by the UNICEF Executive Board on two occasions in that year. In projects jointJ;r assisted by UNICEF and WHO, allocations are made by the UNICEF Executive Board upon receipt of approval by WHO of the technical aspects of projects requested by govermnents.

Oidng to these differences between the budget cycles of WHO, UNICEF and Technical Assistance it is sometimes possible to include in the WHO programme additional projects, financed ar supported by contributions fran the other agencies, for implementation earlier than would be possible under the WHO Regular Budget (e.g., under the TAB Contingency Fund).

2.4 Co-ordination between WHO and bilateral and multilateral assistance

As the directing and co-ord:inating authority in the field of international health, WHO endeavours to obtain the collaboration of all the groups responsible for bilateral and multilateral assistance - for example, lCA (International Co­operation Administration) - 'tJhich have their own programme. This can be at two levels:

(i) Co-operation at govermnent level by the creation of a national camnittee far co-ord:ination of technical assistance in the health fields com­prising:

The Minister of Health of the country The WHO Area Representative The medical director of the agency providing the bilateral or

multilateral assistance Representatives of other international agenCies such as UNICEF

or UlESCO

(ii) Co-operation at regional ar inter-regional level by neans of neetings between WHO and the bilateral agency, designed to bring about mutual understanding am a cammon policy.

2.5 Utilization of resources

In order to achieve the optimum use of available resources, the following conditions should be observed:

(i) There should be a national plan of developnent based strictl;r on the financial possibilities of the country concerned.

wm/mL/5 page 12

(ii) There should be complete co-ordination in the planning and implementation of the programmes of the different agencies. Duplication and differences in princip~ should be avoided, and the governments should do everything within their power to facilitate co-ordination of programmes.

(iii) A system should be evolved whereby a project can be evaluated during the course of its op9ration, so that aQy deficiencies observed can be remedied. It is important to follow up the progress of the project after outside assistance has come to an end; and above all, everyone concerned should be able to use the eXp9rience thus gained in other projects. It is essential that for planning, imp~mentation and evaluation there should be close collaboration between WHO and aQy agencies providing bilateral or multilateral assistance. -Utilization of resources so far as laboratory projects are concerned takes J.

the following forms:

(a) prOvision of consultants to assist in the technical and administrative planning of a laboratory service, in the construction of laboratory buildings, in the training of laboratory personnel, etc. UsualJy such consultants are engaged for periods of from one to three months.

(b) proviSion of laboratory advisers for the implementation of long-term projects. The organization of a laboratory service in a developing country will take at ~ast five years and should be followed by evaluation to determine whether the assistance should be continued or not. A unified laboratory system combining both clinical and public health laboratory activities presents great advantages from the points of view of efficiency, economy, training and supervision of personnel, and standardization of equipnent and methods. The preliminary planning should take into account the present state and future needs of the health service, the number of laboratories alre~ established, the number, type and quality of p9rsonnel, the equipnent availab~, and the national financial resources. The first step is to organize the national central laboratory for diagnosis and for training laboratory p9rsonnel. University graduate staff may at first need training abroad. At the same time the personnel working in the small hospital laboratories should receive revisionary training. Progressive developnent of the other functions of a central laboratory will follow, such as the production of the most important vaccines and the control of pharmaceutical preparations - locally produced or imported. For such a project a senior laboratory adviser, assisted by a chief laboratory technician, may be needed; later short-term consultants could be recruited to assist in the imp~mentation of new functions, preferabJy after the local staff has been trained abroad.

(c) provision of visiting professors to assist in the training of the scientific staff in post-graduate courses in a Faculty of Medicine or Science. If such schools do not exist in the country, fellowships should be given for undergraduate and pos1;graduate training abroad. It is essential that post­graduate training should be of such ~ngth as to permit candidate s to undertake their duties competentJy on their return. The first period of training should

J

wm/HIL/5 page 13

nat, be in institutes where the student wotlld be trained in the use of very expensive apparatus, which most probBbly "rould not be available in his own country. The assistance of \-IRO to developed comttries or to research workers from ~ CO\ID.try generally consists of fellowships for postgraduate training in speciali2Bd research. For that the programme should be carefully planned.

(d) prOvision of laboratory equipnent. If expensive or very canplicated apparatus is being prOVided, it is essential to ascertain first "mether the available laboratory personnel will be able to use it. It is also important to provide the necessary spare parts for ~ major apparatus.

2.6 Summary

The efficiencr,r and effectiveness of laboratories depend not only upon the quality of their technical personnel, facilities, etc., but equally upon their organization as a l1.l.blic Health Laboratory Service fully integrated into the National Health Service.

To be of gree.test benefit to a country, the assistance frOlll various agencies and organizations should be used to support a 'Well planned prograrrJne baaed upon national needB and material resources. Assistance is limited, and is intended to help governments to develop activities which they will continue when outside assistance has ceased.

WHO Regional Offices play an essential role in planning and co-ordinating international assistance on all aspects of public health. ll:n::r country wishing to request assistance to develop health programmes will find the Regional Directors and their area representatives al,-rays ready to advise them.

3. THE ROrE CF NATIONAL RJBLIC HEALTH LABORATCRY S&RVICES IN IN'mRNATIONAL HEALTH

It has already been stated that a technically "Well-organized laboratory service, integrated with the national health servioe, is indispensable to the

~ developoont and efficient working of all public health activities. Fran the point of view of international health, the role of national laboratory services is particularly important in the following spheres:

3.1 EpidemiOlogy and the control of communicable diseases

3.1.1 Quarantinable disease s

It is recC€llized that, of the six diseases subject to the International Sanitary Regulations, smallpox alone represents a world problem, by' reason of the ever increasing volllll2 and speed of international traffic. Oi'ten the cases :IlIlported into a comtry are typical and all the more difficult to diagnose clinically because tb8 disease has disappeared frOlll so m~ places and doctors are unfamiliar with it. It is therefore essential that national laboratories

wm/HiL/5 page 14

should be in a position to diagnose the disease quickly and 'l-r.l th certainty in order to reduce the number of contacts to a m:i.ni.mum and obviate the considerable expense that may arise fran an uncertain clinical diagnosis. The other quarantinable diseases - plague, cholera, yellow fever, typhus, and relapsing fever - no longer have their former international :iInportance. In the areas where these diseases are found their epidemiological Significance has been extensively studied. They may, ho.ever, still spread outside these areas. In sane of these areas the physicians are well acquainted with the clinical picture of these diseases, and local laboratories can undertake the necessary examinations. But in countries where they are less frequently found, laboratory workers are not al.layS experienced in their diagnosiS, and they should know to which specialized laboratories in neighbouring countries they can a~ for )' assistance.

3.1.2 Rapidl.y transmitted communicable diseases

In general these are the virus diseases, the best example of which is influenza. In influenza the relatively short period of post-infectious

immunity and the appearance of new mutants make it difficult to prevent the developnent of epidemics. An etiological diagnosis of influenza can only be made in well-equipped laboratories capable at least of isolating the virus, which can afterwards be identified in a reference centre. In this way, it is possible to follo"r the developnent of an epidemiC, and should the virus prove to be particularly virulent a vaccine can be produced fran the strain in question soon enough to pt'otect the :ilJhabitants of the areas farthest away fran the axis of infection.

3.1.3 Food-poisoning outbreaks

A great matij'" of these are caused by Salmonella infections, 'l-lhich are often spread from one country to another through exported and :iInported food-stuffs, in particular pDVldered eggs and tinned meats and fish. By quickly '-, tracking down the infection, and by the use of phage typing, it is possible to stop the distribution of the contaminated material and even, sanetimes, to trace its epidemiological origin. The matter can then be drawn to the attention of the health authorities of the country concerned.

3.2 Control or biological and pharmaceutical products

There is a wide commercial distribution throughout the world of biological and }:harmaceutical products, and it is essential that their therap:lUtic value and their actual potency correspond 'l-r.l th what is shown on their labels. It is the role of national laboratorie s to verify that products of this kind manufactured in a country or :iInported into it are up to the standard indicated and can be administered to people without danger. The use of International Biological Standards and Reference Preparations, as well as of the specifica­tions established am recamnended by WHO far checking the quality of }:harma­ceutical preparations, has made possible uniformity in the methods of control and safety in the utilization of :iInported and locally made products. In addition, it protects international. commerce in biological and }:harmaceutical preparations by giving to the manufacturers an assurance that their products eanply with established criteria.

..

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3.3 Research in human pathology

vJm/HiLIS page 15

Studies undertaken in various countries have shown that the incidence of certain diseases that are clinically identical varies considerably from one country to another and from one population group to another, and that certain races show a greater tendency than others to be attacked by a particular disease. These observations open new perspectives for research into hereditary, constitutional, camnunicable and degenerative diseases. All the countries in process of being developed should, little by little, be able to participate in such research, and, by a study of their own problems, be in a position to con­tribute to the better understanding of those of the world as a whole. They must be helped through international collaboration, which means the transfer of technical knowledge already acquired in the more developed countries, technical assistance in its different forms, and facilities for an extenstve exchange of re search workers.

It is by means of international collaboration and co-ordination of effort that all countries can contribute effiCiently and fruitfully to progress in all fields of health.

WPR/HiL/5 .Annex page 16

WHO INTERNATIONAL CEN'l'RES AND REFERENCE IJU3ORATCRlES' AND WHO/FAO REFERENCE CENTRES

1. International Centre s for Biological Standards and Reference P.reparaUons

1.1

1.2

International Laboratory for Biological Standards Statens Seruminstitut Amager Boulevard 80 Cor:enhagen S Denmark (present actmg director: Dr. P. Krag)

International Laboratory for Biological Standards National Institute for Medical Research The Ridgeway Mill Hill London, N.W.7 United Kingdcm (present acting director: Dr. D. G. Evans)

2. Centre fat' Authentic Chemical Substances

2.1 Apotekens Kontrollaboratarium Lindhagensgatan 128 Stockholm Sweden (present acting director: Dr. N. Didding)

3. International Blood Group Reference Laboratory

3.1 Lister Institute Cbe lsea Bridge Road London, S.W.l United Kingdom (present school director: Dr. A. E. Mourant)

4. International Salmonella and Escherichia Centre

4.1 Statens Seruminstitut Amager BouleVard 80 C or:enhagen S Denmark (present acting director: Dr. F. Kauffmann)

..

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5.

6.

International Shigella Centres

5.1 International Shigella Centre Central Public Health Laboratory Colindale Avenue

5.2

London, N.W. 9 United Kingdan (present acting director: Dr. S. T. Cowan)

International Shigella Centre COlIIIl1unicable Disease Centre A tlan ta 22 U. S. A. (present acting director: Dr. W. H. Ewing)

International Enteric fuage Typing Centre

6.1 Central Public Health Laboratory Colindale Avenue London. N.W. 9 United Kingdom (present acting director: Dr. E. S. 1l.nderson)

7. Serological Reference Centres

7.1 International Treponematosis Laboratory Centre School of Microbiology Johns Hopkins University 725 North \.J olfe Street Baltmore 5, Maryland U. S. A. (present acting director: Dr. T. B. Turner)

Serological Reference Centre for Treponematoses Statens Seruminstitu~ .Amager Boulevard 80 Copenhagen S Derunark (present acting director: Dr. H. A. Nielsen)

7.3 Venereal Disease Research Laboratory Canmunicable Disease Centre P.O. Box 185 Chamblee, Ge orgia U. S. A. (present acting director: I>1r. Ad. Harris)

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w:m/mL/5 Annex page 18

8. Reference Centre for Testing Repository Fenicillins

8.1 Food and Drug Administration Antibiotics Division Washington 25, D.C. U. S. A. (present acting director: Dr. Hilliam W. Wright)

9. Gonococcus Centre

9.1 Statens Seruminstitut Amager Boulevard 80 COp3nhagen S Denmark (present acting director: Dr. Alice Reyn)

10. International Influenza Centres

10.1 World Influenza Centre National Institute for Medical Research The Ridgewa;v Mill Hill-London, N.\-T.7 United Kingdom (present acting director: Dr. C. H. Andrews)

10.2 International Influenza Centre for the Americas Communicable Disease Centre Atlanta 22, Georgia U. S. A. (present acting director: Dr. R. Q. Robinson)

11. Poliosyelitis Centres

11.1 The Poliomyelitis Research Foundation South African Institute for Hedical Research Hospital Street Johannesburg Union of South Africa (present acting director: Dr. J. H. S. Gear)

11.2 Section of Epidemiology and Preventive MediCine Yale University School of l"ledicine 333 Cedar Street New Haven 11, Con. U. S. A. (present acting director: Dr. J. R. Paul)

11.3 Institut Pasteur 25 rue du Dr Raux Paris XV --France (present acting director: Dr. P. Lepine)

11.4 Virus Research Laborator,r The Hebrew Universi~ Hadassah Medical School P.O. Box 1172 Jerusalem Israel (present acting director: Dr. H. Bernkopf)

11.5 Department of Bacteriology Universi~ of Malaya Singapore Mala;ya. (present acting director: Dr. Lee Liang Hin)

11.6 The National Institute of Health Kamiosaki-Chojamaru Shinagawa-Ku Tokyo Japan (present acting director: Dr. S. Koj:ilna)

12. Snail Identification Centres

12.1 MaJ.aria and Bilharzia Research Laborator,r P. O. Box 8105 Causewa;r Salisbury South Rhodesia

wm/mI/5 .Annex

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(present acting director: Mr. H. V. de Villiers Clarke)

12.2 Laboratoire de Malacologie Museum National d'Histoire Naturelle 55 rue de Buffon Paris V --France (present acting director: Dr. G. Ranson)

12 • .3 Danmarks Akvarium Char10ttenlund Copenhagen Denmark (present acting director: Dr. G. Mandah1-Barth)

wm/mL/5 .Annex page 20

13. International Reference Centres for the Histopathological of Tumours

13.1 International Reference Centre for Lung Tumours Institute for General and Exper:iJnental Pathology of the University Oslo Norwa;r (present acting director: Dr. L. Kreyberg)

13.2 International Reference Centre fer Soft Tissue Tumours Armed Forces Institute of Pathology WaShington 25, D.C. u. S. A. (present acting director: Dr. D. J. Winslow)

13.3 International Reference Centre for Marmnary Tumours Bland-Sutton Institute of Pathology Middlesex Hospital London W.1 United Kingdcm (present acting director: Dr. R. W. Scarff)

14. WHO,/FAO Leptospirosis Reference Laboratories

14.1 Laboratory of the Queensland Department of Health and Home Affairs Brisbane, Queensland Australia (present acting director: Dr. A. Fryberg)

14. 2 Istitute Superiore di Sanita Viale Regina Elena 299 Rome Italy (present acting director: Dr. B. Babudieri)

14.3 Department of Viral and Rickettsial Diseases National Institute of Health Kamiosaki-Chojamaru Shinagawa-Ku Tokyo Japan (present acting director: Dr. M. Kitaoka)

.........

>W ,

WlR/HIL/5 Annex

I'EC8 21·

14.4 Insti tute for Tropical Hygiene and Geographical Pathology Royal Tropical Institute

14.5

Mauritskade 57 A Amsterdam Netherlands (present acting director: Dr. J. C. Wolff)

The Wellcane Laboratories of Tropical Medicine The Wellcame Building, Euston Road London, N.vl.l United Kingdan (present acting director: Dr. L. H. Turner)

14.6 Division of Veterinary Medicine Walter Reed Army Institute of Research Walter Reed Arr.rry Medical Centre Washington 12, D.C. U. S. A. (present acting director: Dr. A. D. Alexander)

15. WHO;!AO Brucellosis Centres

15.1 Division of Brucellosis and Tuberculosis Department of Zoonoses

15.2

15.3

15.4

Ministry of Agriculture am. An:iJnal Husbandry Buenos Aires Argentina

Commonwealth Serum Laboratories Parkville N.2., Victoria Australia

State Veterinary Serum Laboratozy :B~owsvej 27 Copenhagen Denmark

Centre de Recherches sur la Fievre ondulante Insti tut Bouisson-Bertrand Montpellier France fJnsen"acting director: Dr. 1. Carrere)

WFR/mL/5 Annex page 22

15.5 Veterina~ Microbiological Institute Botanikos Athens Greece (present acting director: Dr. C. Me1anides)

15.6 Indian Veterinary Resear~h Institute Hukteswar-Kurnaun Uttar Pradesh India

15.7 Centre for the Stuqy of Brucellosis Institute of Hygiene and I1icrobio1ogy Viale G.B. Morgagni 48 Florence Italy (present acting director: Dr. G. Mazzetti)

15.8 National Institute of Animal Health Kodaira-machi, Kitatama-gun ~ Japan (present acting director: Dr. M. Kobayashi)

15.9 Medical Research Institute General Hospital MexiCO, D.F. Mexico (present acting director:

15.10 Institut Pasteur Tunis Tunisia

Dr. M. Ruiz Castaneda)

15.11 InstituiB of Veterinary Bacteriology and Serology Rmdik Istanbul Turkey (present acting director: Dr. R. Durusan)

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15.12 Onderstepoort Veterin~ Laborator,y Onderstepoort Union of South Africa

15.13 Ministr,y of Agriculture, Fisheries and Food Central Veterinar,r Laborator,y New Haw Heybridge Surrey United Kingdom ( pre sent acting dire ctor~ Dr. A. v!. Stab1eforth)

15.14 Department of Medicine University of Minnesota Minneapolis, Minn. U. S. A. (present acting director: Dr. K. ,\-T. Spink)

15.15 Brucellosis Centre State Laborator,y of Hygiene Rijoka Yugoslavia (present acting director~ Dr. V. Rukavina)

VTIR/HII/5 Annex

page 23

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WORLD HEALTH ORGAI ORGANIZATION L

WORlD HEALTH ORGANIZATION

CENTRE FOR AUTHENTIC CHEMICAL SUBSTANCES

The authentic chemical substances now available at the Centre are listed below together with the unit and size. Most packages contain sufficient material for about 20 assays. All Shipments are made by surface mail except when airmail is requested.

Chloramphenicol Digitoxoside Ergometrine maleate Me lar sen Oestrone Progesterone Tubocurarine Vitamin A Acetate (this is an oily solution of

of Vitamin A Acetate)

Size

300 milligrams 5 capsules of 10 milligrams 2 capsules of 10 milligrams

1 gram 30 milligrams 65 milligrams 30 milligrams

5 capsules of apprOximately 8.6 milligrams (0.344 micrograms of Vitamin A Acetate is equivalent to 1 International Unit -WId Hlth Org. techn. Rep. Ser:. .!.!&.Q., ~, 34)

El!.ch package costs uS$ 4.00 or the equivalent amount in other currencies. The shipment by surface mail will be made free. A charge will be made for the despatch whenever airmail is requested.

• Please send your orders and make cheques payable to:

•

Centre for Authentic Chemical Substances Apotekens Kontrollaboratorium Lindhagensgatan 128 Stockholm Sweden

It is not intended to make any charge for the substances to national administrations or lat )ratories and institutes working on a non-profit baSiS, and a charge for despatch will only be made when airmail is requested.