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Quality improvement around the world

Accreditation and the quality movement in France

A Giraud

BackgroundAs in many industrialised countries, the healthcare quality movement began in Francebecause of rising health expenditure and thenecessity to contain costs1 but, recently, thepublic has become more aware of issuesrelating to quality. Serious public health prob-lems such as the contaminated blood scandalof 1984, when blood that was stronglysuspected of being contaminated by HIV wasknowingly transfused to haemophiliac patients,and greater visibility of routine medical prac-

tice through regular publications in the laypress2 has led to a crisis of public confidence inthe ethics of the medical and political worldsand a strong demand for accountability andgreater transparency. Important reforms in theorganisation of health care and public healthhave therefore been undertaken, of whichaccreditation is one. Its objectives reflect thishistorical backgroundnamely, to assess thequality and safety of health care, to assess a healthcare organisations ability to ensure continuousimprovement in the quality of overall patient care,to formulate explicit recommendations, to involve

professionals at all stages of the quality initiatives,to provide external recognition of the quality of carein health care organisations,to improve public con-

fidence.3Accreditation was enacted in France as part

of the 1996 health care reform by ordonnance, agovernment decision that is taken without con-sulting Parliament. Governments in Franceunder the Fifth Republic use ordonnances whenthey feel there is an urgent need for reform thatcould be delayed by parliamentary discussions.Many healthcare reforms have been enacted byordonnance and, in 1996, it was felt that themagnitude of the deficit of the national healthinsurance fund and the public health situationwas suYciently serious. The ordonnance of 24April 1996 reforming public and private hospi-talisation stipulates that in order to ensure con-

tinuous quality and safety improvement of healthcare, all public and private health care organisa-tions must submit to an external evaluation proce-dure named accreditation (Article 7105).Accreditation applies to public and privatehospitals and healthcare networks but does notinclude general practice. However, in time thefields of application for accreditation are likelyto be extended.4

Accreditation is new in France so we are notyet able to describe the implementation of theprogramme, the uses that will be made of thefindings of the accreditation surveys, and thechanges it will eventually bring about in the

management of French hospitals and the qual-ity of healthcare services. We will thereforelimit ourselves to the description of theaccreditation policy in France, evaluate itssimilarities and diVerences with other accredi-tation programmes, and try to estimate itschances of success.

The policyThe instruments of accreditation in Franceconsist of an agency, a manual, and surveyors.

THE ACCREDITATION AGENCY

In order to implement accreditation the 1996ordonnance created what it defined as an inde-pendent and professional organisation, anational agency for accreditation and evalua-tion in health care, the Agence Nationale pourlAccrditation et lEvaluation en Sant

(ANAES). The mission of the new agency isto help develop quality assurance of medical prac-tice, in public and private hospitals as well as in

private practice,and to implement the accreditationprocedure so that it manages both qualityassurance and accreditation.5 ANAES consistsof a Board, a Scientific Council, and anAccreditation College and is headed by a Gen-eral Director. Its members are appointed by theMinister of Health and it is financed one thirdby the Department of Health, one third by theNational Health Insurance fund, and theremainder by the survey fees of the hospitals. Anotable feature of ANAES is the importance ofprofessional representation: the health profes-

sions comprise at least three quarters of theboard and more than half are medical doctors.The present Chairman of the Board is aprofessor of neurology and the General Direc-tor of the agency is a professor of public health.Members of the Scientific Council are expertsin the areas of quality assurance and accredita-tion, and/or belong to medical or otherscientific societies. The Council is presidedover by a professor of intensive care and isresponsible for the scientific quality of allguidelines and other documents produced bythe Agency. In particular, it supervised produc-tion of the accreditation manual. The

Key messages+ Accreditation in France is a government

sponsored initiative.+ In France accreditation is compulsory,

patient centred, and orientated to con-tinuous quality improvement.

Quality in Health Care 2001;10:111116 111

Hpital Jean Verdier,Assistance

Publique-Hpitaux deParis, 93140 Bondy,FranceA Giraud, head of publichealth medical information

Correspondence to:Dr A [email protected]

Accepted 27 March 2001

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importance of professional representation isintended to guarantee the Agencys independ-ence and credibility.

A key feature is the Accreditation Collegewhich is responsible for examining the surveyreports, attributing accreditation, definingrecommendations for improvement for everyhospital, and publishing an annual report. Itis composed of 11 members and a similarnumber of deputy members. Members are

hospital managers, hospital doctors, pharma-cists or allied health professionals, and twomedical doctors with recognised expertise inquality assurance and/or accreditation. All areexperienced professionals who have been inpractice for at least 15 years. They areappointed by the Minister of Health on theproposal of the Scientific Council of theANAES, after approval by the Board.

THE ACCREDITATION MANUAL

Two specialties (psychiatry and cancer) havedeveloped their own accreditation manuals,but there is only one oYcial manual that isapplicable to all healthcare organisations. The

manual was compiled during 1998 by ANAESwith the help and contribution of 150 profes-sionals, 57 of whom were medical doctors. Theworking groups included nine patients repre-sentatives. The actual writing was preceded bya literature search on the topic of accreditation,foreign experiences, and various manuals com-piled privately in France, in particular theaccreditation manual of the National Federa-tion of Cancer Hospitals.6 Foreign manualswere also examined, including those of the Joint Commission for the Accreditation ofHealthcare Organisation, the Canadian Coun-cil on Health Facilities Accreditation, the Aus-tralian Council on Health Care Standards, theKings Fund, and CASPE Research. A first

version of the manual was tested in 12hospitals, amended, and tested again before itwas ready for oYcial use in February 1999.The whole procedure was supervised by theScientific Council of ANAES.7 An English ver-sion of the manual is available online on theAgencys website (http://anaes.fr).

The manual is divided into three sections(box 1) and each section is subdivided intochapters. Every set of standards begins with thedefinition of a general policy concerning theobjective of the standardfor instance, on theorganisation of patient records (DPA):

DPA standard 1: The healthcare organ-isation formulates and implements a pa-

tient record policy for all its activitysectorsand ends with the evaluation of the level ofquality achieved:

DPA standard 7: The patient record isthe subject of a strategy of assessment andcontinuous improvement.

The standards concern management proc-esses and procedures. Outcome standards areexpected to be introduced at a later stage. Thepurpose of the manual is for all professionals inthe hospitals to implement continuous qualityimprovement (CQI) by means of an explicitquality management system, and for clinicians

to use practice guidelines and protocols. Itresponds to the main principles of CQIthatis, involving everyone in the organisation, beingconcerned with all the internal organisationalprocesses, and focusing on external needs (inthis instance, those of the patient).8

A management system concerned with all theorganisational processes

In France the hospitals are divided intospecialised departments or firms (services),each led by a medical chef de service who exer-cises complete power on its medical policies.Every service tends to pursue its own interests

with no real consideration for the hospital as awhole. Departments compete for their fairshare of the hospitals global budget, and theculture is more one of competing interests thanof constructive solidarity.9 A further rift is theone which often exists between clinicians andmanagers whose culture, objectives, and lan-guage often diVer. The hospital has thereforebeen compared to a mosaic of decentraliseddecision centres.10 The accreditation manualtakes the radically diVerent approach thatquality is the product of the cooperation ofeveryone in all the management processes. It isnot divided by departments but by processes:implementing patients rights and information,

managing patient records, organising patientcare, managing human resources, the infor-mation system, quality and risk prevention, etc.The chapter on organisation of patient care(OPC) follows the patients route through thehospital from access, admission, assessment ofthe patients condition and needs, coordinationof care, discharge, to quality assessment of thepatients care. It prescribes organisationalprocesses that can ensure continuity of care byinvolving all concerned professionals:

OPC standard 6: Patient care is coordi-nated within the various clinical activitysectors.

I Patients and patient care+ Patient rights and information (DIP)+ Patient records (DPA)+ Organisation of patient care (OPC)

II Management and organisation in theservice of the patient+ Management of the healthcare organis-

ation and its activity sectors (MEA)+ Management of human resources (GRH)+ Management of logistics (GFL)+ Management of the information system

(GSI)

III Quality and prevention+ Quality management and risk prevention

(QPR)+ Specific prevention programmes and

transfusion safety (VST)+ Monitoring, prevention and control of

the risk of infection (SPI)

Box 1 Structure and contents of the accreditationmanual (from the English version).

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OPC standard 7: Continuity of care isensured.

OPC standard 8: Health professionalsinvolved in operating theatres, other inter-vention sectors and clinical activity sec-tors work together in formulating theiroperational procedures.

At this stage, only two standards addressquality of care:

OPC standard 14: Clinical and ancillary

medical activity sectors use diagnostic andtherapeutic protocols.

OPC standard 15: Clinical and ancillarymedical activity sectors assess profes-sional practices and their results.

Assessment of professional practice is to beachieved through the definition and use of per-formance indicators (OPC 15b) and sentinelevents (OPC 15c). It is the task of every hospi-tal to define its own.

The quality management and risk preven-tion section (QPR) focuses on the cross-cuttingprevention of the major risks (transfusion(VST), infection (SPI)) at the hospital level:

QPR standard 1: The healthcare organ-

isation initiates, leads and maintains aquality policy based on quality manage-ment and risk prevention.

VST standard 1: The authorities andprofessionals concerned are involved indrawing up and implementing the organi-sations policy concerning specific preven-tion programmes, including transfusionsafety.

SPI standard 1: The healthcare organis-ation establishes and operates a coordi-nated infection control policy amongpatients and professionals.

THE SURVEYORS

All are experienced and active healthcare

professionals who have been trained in accredi-tation procedures by ANAES. Training is bothinitial and ongoing. Surveyors are part timeand cannot spend more than one third of theirworking time on accreditation. In order toensure consistency of the accreditation surveys,surveyors must follow the principles of theaccreditation survey listed in an accreditationsurveyors charter planned to evolve asexperience of the procedure is acquired. Obvi-ously, surveyors can have no professional ties orinterests of any kind with the organisation theysurvey.

The procedure

Initially, accreditation was a private and volun-tary procedure but, as its objectives evolvetowards public regulation, it is tending tobecome compulsory.11 In France the voluntary/compulsory issue was resolved as follows. The1996 ordonnance instituted a 5 year period(19962001) during which hospitals can applyto enrol for accreditation. This is the volun-tary aspect of the procedure. However, if atthe end of this 5 year period any hospital hasnot yet volunteered, it will be compulsorilyenrolled by the local hospital authority so thatno hospital, public or private, can escape a pro-cedure that is, in fact, compulsory.

The procedure itself consists of self-assessment followed by the survey visit and areport, the purpose of which is to assess thecompliance of the hospital with the standardsdefined in the accreditation manual. Self-assessment is considered to be the most impor-tant part of the process and a special guide waswritten by ANAES to help hospitals with it.Self-assessment is intended as a preparation forthe survey visit during which the whole organ-

isation assesses (or discovers) its baseline stateof compliance with the standards contained inthe manual. At the end of the self-assessmentthe hospital sends to ANAES a report in whichit estimates its degree of compliance with themanual standards and defines what improve-ment measures it has undertaken where neces-sary. The actual accreditation survey followsthe self-assessment by less than 3 months.Depending on the size of the surveyed organis-ation, the survey team is composed of at leastthree professionals including a doctor, a mem-ber of the allied health professions, and a man-ager. The survey visit lasts a varying number ofdays. The surveyed organisation must be able

to answer the question What do you do inorder to comply with ... the concernedstandard? The hospital must then be able toproduce the documents proving that they havethe corresponding policy. Where any deficien-cies have been noted during the self-assessment, the organisation must be able todemonstrate what improvement measures theyhave undertaken to correct them. Surveyorscan also interview professionals and patients toverify the answers they have received.

After the survey visit is completed thesurveyors write an expert report in which theycompare their own conclusions with thosemade by the hospital itself after the self-assessment. This is sent to the Accreditation

College which examines both reports and thenwrites an accreditation report in which itattributes an accreditation level, with orwithout reservations, and eventually decides onrecommendations for improvement. The Col-lege also considers the methods used forself-assessment and for the survey visit. A sum-mary of the accreditation report is made avail-able to the public. At the time of writing about200 hospitals are in the process of self-assessment and 10 have been accredited. Allcompleted survey reports are accessible on theANAES website.

A CONTINUOUS PROCESS

This is an important feature of the process.Hospitals are being made to understand thataccreditation is not a one time procedure andthat it is not obtained once and for all. On thecontrary, it is presented as a means of ensuringa continuous improvement process within thehospitals, showing changes from the baselinequality estimated by self-assessment before thesurvey visit and the progress as surveys arerepeated at least every 5 years, thus ensuringthe continuity of the improvement in quality.Compliance with the standards will be as-sessed by the College of Accreditation on thebasis of the survey report. No one will fail, at

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least this first time, but for hospitals withrecommendations the next accreditation levelwill depend on their implementation of therecommendations. Survey visits will normallybe repeated every 5 years but, for hospitalswith reservations, a survey visit focused ondeficient areas may take place at an earlier dateas decided by the College. A cyclical process isthus being installed, instituting a systematicand prospective risk prevention policy in hos-

pital management which constitutes a funda-mental departure from the retrospective crisismanagement of quality problems that has pre-vailed up until now in the healthcare system inFrance.

THE CENTRAL IMPORTANCE OF THE PATIENT

An important objective of the current Frenchhealth policy is to refocus health care on itsultimate objectthat is, the patientratherthan the process of care per se. Explicit concernfor the welfare of patients has been the object ofmany legal texts in recent years. In particular,in 1988 an important law defined the condi-tions of the protection of patients in medical

research.

12

A Charter of the rights of the hospi-talised patient was issued in 1995.13 Symboli-cally, the 1996 ordonnances first title isPatients rights. It contains a whole array ofmeasures aimed at providing greater attentionto the rights and needs of patients, and ensur-ing a greater participation of the patient in thelife of the hospital; the patients Charter mustbe made public and included in the infor-mation booklet that every patient is given onadmission. Professionals must recieve specifictraining in patients rights and confidentiality.Access for deprived populations and immi-grants must be organised specifically.14 Repre-sentatives of patients now sit on every hospitalboard and on hospital committees such as the

infection committee (Comit de Lutte contreles Infections Nosocomiales, CLIN). Everyhospital must organise a commission de concilia-tion where conflicts between patients and thehospital may tentatively be solved amicablybefore reaching the legal stage. Furthermore,although not an explicit reference of themanual, the assessment of patient satisfactionis an important issue in the accreditationprocedure. The ordonnance requires that everyhospital should proceed to regularly assess their

patients satisfaction. The results of theseassessments will count for accreditation.15

Patients rights and information are the subjectof the first chapter in the manual (DIP) and

management of patients complaints is thesubject of a specific standard (DIP standard 8).

THE INVOLVEMENT OF ALL PROFESSIONALS

Healthcare policy in France is characterised bythe strong influence of the State and the weakbargaining power of a divided medical profes-sion.16 Most major reforms, such as nationalhealth insurance, were introduced unilaterallyby the government against the opposition ofthe medical profession. Although the accredita-tion policy was introduced in the sameauthoritative fashion, and despite the fact thatthe process is decidedly public and government

owned, an essential point is the involvement ofprofessionals. We have described theimportance of professional involvement in thecomposition of ANAES. A similar multiprofes-sional involvement is expected at the hospitallevel. This can sometimes prove more diYcultwhere doctors are concerned; indeed, doctorshave often been the missing link in healthcarequality assurance systems because their defini-tion of quality in medicine diVers from the one

adopted by regulators and managers. For doc-tors, improvement in medical quality consistsin the accomplishment of medical progressthrough clinical research. The majority havenot participated up to now in the managerialculture of audit and accreditation. In France, aselsewhere, quality assurance as medical audit isviewed by many as an intrusion and a waste oftime. The diYculty is enhanced in France bythe fact that the concepts used are all of Anglo-Saxon origin and do not always find easy trans-lation into French and acceptance in theFrench culture.17 The fact that conceptsrelating to quality assurance and managementare not integrated in the medical curriculum

contributes to doctors disinterest. One reasonwhy the structures of ANAES include so manyprofessionals, apart from their necessary tech-nical contribution, is the importance of obtain-ing professional legitimacy and credibility.However, at the local level it often remains dif-ficult to obtain medical participation in meet-ings, and the very time consuming work for theself-assessment prior to the survey visit ismostly carried out by nursing and managementpersonnel.

DiscussionDoes accreditation in France respond to thedefinition given by the ExPeRT project of anexternal quality mechanism: a regional or

(potentially) national process voluntarily enteredby service provider organisations for the improve-ment of organisation and delivery of health servicesassessed against explicit, published standards by

peer group teams moderated by a non-partisanauthority involving (but impartial to) users,

providers, purchasers, and government18? InFrance accreditation is a national processwhich healthcare providers enter with the viewof improving the management and delivery ofhealthcare services in their organisation byhaving them assessed by peer group teamsagainst explicit published standards and mod-erated by an authority that involves govern-ment (in France the main purchaser), provid-

ers and, to a lesser degree, users. This process,however, is not voluntary but is made compul-sory by law. Is the moderating authoritynon-partisan and is it equally impartial to gov-ernment, providers, and users? How doesaccreditation take its place in the quality move-ment in France? Does it have a chance of suc-ceeding in improving the organisation anddelivery of healthcare services in France?

The answer to these questions probably liesin the answer to the question: Who wants toinfluence whom to achieve what?19 The historyof healthcare quality assurance in developedcountries can be roughly divided into three

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periods.20 The first took place in the USAaround 1917 when, following the initiative of EA Codman, surgeons decided that they wouldnot operate in hospitals that did not providethem with a minimum standard of quality intheir working conditions. Eventually this initia-tive developed into accreditation. It is impor-tant to point out that this first period of qualityassurance was (a) the result of a professionalinitiative, private and voluntary, and (b) mainly

structure orientatedthat is, aimed at ensuringdoctors with satisfactory working conditions.At that time the question of the quality ofmedical procedures was not an issue. It was noteven a concept. Quality was what we (doctors)do,21 and the purpose of accreditation was toprovide doctors with an appropriate environ-ment to do it. In other words, doctors wantedto influence providers (hospitals) to obtain sat-isfactory working conditions.

When the economic crisis of the 1970sattracted the attention of Western governmentsto the increasing costs of health care, econo-mists, epidemiologists, managers, and regula-tors (that is, the external users of health

care

22

) started examining medical practices.

23

With no evidence that health indicatorsimproved in parallel with health expenditures,and comforted by the extent of unexplainedvariation that had started to be documented indoctors practices,23 they developed a rhetoricfor introducing so called professionally ledquality assurance of medical practice. But thequality argument was promptly viewed bythe medical profession for what it wasnamely, a method for rationalising medicalprescriptions through utilisation review, con-sensus conferences, and practice guidelines.The focus had shifted from structure to processand, whereas the first period of qualityassurance was induced by and for the medical

profession (the original users of healthcare24), the second one was initiated outsidethe medical profession and, one could say,against it: todays quality assurance questionsdoctors decisions and practices. So it is notsurprising that it never gained professionallegitimacy in the eyes of the doctorsasopposed to other health professionals such asnursesand that the biggest diYculty inimplementing quality assurance of medicalpractices in most industrial countries except,perhaps, the Netherlands has been the doctorsconstant indiVerence at best and, more often,the outright opposition to it. During thissecond period of quality assurance purchasers

and regulators wanted to influence providers(doctors) to achieve better quality care for lessmoney. However, in France, as in many otherwestern countries, they largely failed becausethey did not succeed in getting the medicalprofession to feel concerned. Will accreditationsucceed where quality assurance failed?

Accreditation, although authoritatively in-troduced in France by law, is characterised byan explicit involvement of the medical profes-sion, both in the structures of the programmeand in its implementation which consists ofpeer review. It is mainly concerned withmanagement, but management that includes

both the organisation of healthcare deliverythat mainly concerns managers, and the moreprofessional aspects of medical practicesuchas making informed decisions about patientswith the help of evidence based practiceguidelineswhich essentially concerns doc-tors. In the UK these two aspects of medicalmanagement have been united in the new con-cept of clinical governance.25 Undoubtedly,accreditation will considerably improve pro-

spective risk management in French hospitalsand therefore will hopefully reduce the hazardsof hospitalisation. But will the medical profes-sion follow? Will its participation in accredita-tion go beyond a formal involvement instructures and surveys? Will they engage at thelocal level in new behaviours that would resultin an improvement in the quality of medicalcare and of patient satisfaction? Such behav-iour would, for instance, involve a systematicreview of the quality of patient records, asystematic assessment of the organisation ofevery patient stay, and an explicit policy forpatient information in every service. In an idealworld doctors would want to influence them-

selves or each other in order to improve thequality of everyday practices as well as theirparticipation in medical research and publica-tions. Does accreditation contain the necessaryincentives?

At this stage of the procedure it is not knownwhat the public authorities intend to do withthe results of accreditation in France. If theoYcial theory is that accreditation is mainlydestined to encourage quality monitoringsystems in hospitals, a common fear is thatunsatisfactory scores would encourage authori-ties to close down hospitals in these times ofrestructuring of the healthcare system (Francesupposedly has about 60 000 hospital beds inexcess) so that, if the process today is largely

professionally driven, the continuity of profes-sional participation may depend on the natureof the utilisation of its results by government. Itwill also depend on the evolution of the contentof the standards: will they remain stronglymanagement orientated, in which case thedoctors may not feel really involved (only twostandards explicitly concern quality of caretoday), or will they evolve to include visitatielike procedures, thereby explicitly including thequality of medical practices in the evaluation ofperformance?18 Given the political system inFrance, the main users of accreditation arelikely to be, firstly, the government and,secondly, if all goes well, the users. Whither the

provider?

I thank Professor Philippe Loirat, Chairman of the ScientificCouncil of ANAES,andProfessor Ellie Scrivens forreading andcommenting on the manuscript.

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des patients inclus dans les protocoles de recherche mdi-cale, called loi Huriet after the name of its author.

13 Circular no. 22, Ministry of Health, Paris, 6 May 1995.14 Forcioli P. Les droits du patient dans laccrditation. La

Presse Md 7 October 2000.15 Ordonnance no. 96-346 du 24 avril 1996 portant rforme

de lhospitalisation publique et prive. Article 710-1-1.Journal OYciel 25 avril 1996, 6324.

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17 Giraud A. Medical audit in France: historical perspective.BMJ 1992;304:4268.

18 Shaw C. External quality mechanisms for health care: sum-mary of the ExPeRT project on visitatie, accreditation,EFQM and ISO assessment in European Union countries.Int J Qual Health Care 2000;12:16975.

19 Klazinga N. Re-engineering trust: the adoption and adapta-tion of four models for external quality assurance of healthcare services in western European health care systems. Int JQual Health Care 2000;12:1839.

20 Giraud A. Les trois priodes de lvaluation mdicale. In:Giraud A, ed. La Nouvelle valuation mdicale. Paris:Economica, 2000.

21 Brennan TA, Berwick DM. New rules. San Francisco:

Jossey-Bass, 1996.22 Schyve PM. The evolution of external quality evaluation:

observations from the Joint Commission on accreditationof health care organizations. Int J Qual Health Care2000;12:2558.

23 Fuchs V. The new technology assessment. N Engl J Med1990;323:6737.

24 Wennberg J, Gittelsohn A. Variations in medical care amongsmall areas. Sci Am 1982;246:12034.

25 Donaldson LJ, Muir Gray JA.Clinical governance: a qualityduty for health organisations. Quality in Health Care 1998;7(Suppl):S3744.

1st Asia Pacific Forum on Quality Improvement in Health Care

Three day conference

Wednesday 19 to Friday 21 September 2001

Sydney, Australia

We are delighted to announce this forthcoming conference in Sydney. Authors are invited to

submit papers (call for papers closes on Friday 6 April), and delegate enquiries are welcome.The themes of the Forum are:

x Improving patient safetyx Leadership for improvementx Consumers driving changex Building capacity for change: measurement, education and human resourcesx The context: incentives and barriers for changex Improving health systemsx The evidence and scientific basis for quality improvement.

Presented to you by the BMJ Publishing Group (London, UK) and Institute for HealthcareImprovement (Boston, USA), with the support of the the Commonwealth Department ofHealth and Aged Care (Australia), Safety and Quality Council (Australia), NSW Health(Australia), and Ministry of Health (New Zealand).

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