Standard Operating Procedure

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Title: Monitoring vaccine storage temperatures at fixed storage locations

Code : TAN-EVM-SOP-E2-01 Version number: 1

Effective date: 01 July 2017

The United Republic of TanzaniaMinistry of Health, Community Development, Gender, Elderly and Children

Standard Operating Procedure

Monitoring vaccine storage temperatures at fixed storage locations

TANZANIA

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Approvals Name Date Signature

Authorized by:

Reviewed by:

Revised by:

Original author:

Version history

No Date Description of change Reason for change

1 Original

2

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Distribution

Distribute this SOP to the following:

Facility type Position(s)

Central Vaccine Store Logisticians, Vaccine storekeepers

Regional Vaccine Stores Immunization and vaccine officers, Vaccine storekeepers

District Vaccine Stores Immunization and vaccine officers, Vaccine storekeepers

Health facilities Health workers

Table of content

Distribution ..................................................................................................................................... 3

Policy and objectives ............................................................................................................................. 4

1.1 Policy ..................................................................................................................................... 4

1.2 Objectives ................................................................................................................................ 4

Responsibility ..................................................................................................................................... 4

Associated materials and equipment ...................................................................................................... 4

Procedure ..................................................................................................................................... 4

1.3 Training ................................................................................................................................... 5

1.4 Positioning of temperature monitoring devices ............................................................................ 5

1.4.1 Freezer rooms ................................................................................................................ 5

1.4.2 Cold rooms .................................................................................................................... 5

1.4.3 Vaccine freezers.............................................................................................................. 5

1.4.4 Vaccine refrigerators ...................................................................................................... 6

1.5 Correct reading of a temperature monitoring devices ................................................................... 6

1.6 Temperature recording process .................................................................................................. 6

1.7 How to maintain the temperature monitoring charts and reports .................................................... 6

1.8 What to do if temperatures are out of recommended range............................................................ 7

1.8.1 Cold rooms and vaccine refrigerators ........................................................................................ 7

1.8.2 Freezer rooms and vaccine freezers ........................................................................................... 8

1.9 Daily tasks ............................................................................................................................... 8

1.9.1 Freezer rooms at Central Vaccine Store ..................................................................................... 8

1.9.2 Cold rooms at Central, Regional and District Vaccine Stores ................................................... 8

1.9.3 Vaccine freezers at Regional and District Vaccine Stores .......................................................... 8

1.9.4 Vaccine refrigerators: District Vaccine Stores ......................................................................... 10

1.9.5 Vaccine refrigerators at health facilities .................................................................................. 10

1.10 Weekly tasks .......................................................................................................................... 10

1.11 Monthly tasks ........................................................................................................................ 10

1.12 End of year tasks .................................................................................................................... 10

Related documents and SOPs .............................................................................................................. 10

Annex 1 – Daily Refrigerator Temperature Monitoring Chart ............................................................. 11

Annex 2 – Daily Freezer Temperature Monitoring Chart .................................................................... 12

Annex 3 – Temperature excursion response protocol ............................................................................ 13

Annex 4: Temperature excursion diagnosis .......................................................................................... 14

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Policy and objectives

1.1 Policy

Personnel who are responsible for looking after vaccines should know how to operate and interpret various temperature monitoring devices that are used in their workplaces. They should also know how to keep daily temperature records and how to carry out periodic temperature reviews.

Personnel are responsible for their actions and must know how to react effectively to problems as soon as they arise.

1.2 Objectives

This document explains the daily, weekly and monthly procedures for monitoring vaccine storage temperatures at fixed storage locations throughout the vaccine supply chain in Tanzania. The objective is to use the temperature records for: -

a. Verification of vaccine storage within recommended temperature ranges of +2°C to +8°C in cold rooms and vaccine refrigerators and -25°C to -15°C in the freezers and freezer rooms.

b. Detection of temperature alarm conditions, which may have caused vaccine damage, and to take appropriate action.

c. Assessment of cold chain equipment performance over time during vaccine handling and take appropriate action.

The document also describes the emergency actions to take in the event of a breakdown in the continuous temperature monitoring equipment.

Contingency action(s) to be taken in the event of cold chain equipment failure is described in: TAN-EVM-SOP-E3-01: Responding to emergencies in fixed storage locations

Responsibility

Logisticians, Vaccine storekeepers, Immunization officers and Health workers are responsible for recording and temperatures monitoring in the cold chain equipment at fixed storage locations throughout the vaccine supply chain.

Associated materials and equipment

The table below shows the recommended temperature monitoring devices for fixed storage locations in vaccine supply chain.

Cold chain equipment Recommended Temperature monitoring devices

Freezer rooms at central vaccine store • Remote temperature monitoring devices• Temperature alarm system with auto-dialer • Built-in thermometer

Vaccine freezers at Regional and District Vaccine Stores

• Remote temperature monitoring devices• Temperature alarm system with auto-dialer• Alcohol stem thermometer

Cold rooms at Central, Regional and District Vaccine stores

• Remote temperature monitoring devices• Temperature alarm system with auto-dialer• 30-days electronic continuous temperature monitoring system

Vaccine refrigerators at Regional and District vaccine stores and health facilities

• Remote temperature monitoring devices• 30-day electronic refrigerator temperature logger• Electronic freeze indicator• Thermometer

Procedure

1.3 Training

Responsibility:

National Immunization officers

ØDevelop and disseminate training guide to the regional and district levels

ØConduct training of trainers at regional and district levels

Regional and District Immunization Officers

ØConduct training to healthcare workers on proper reading, recording and interpretation of all temperature monitoring devices used in the immunization supply chain.

ØConduct training healthcare workers on appropriate actions to be taken when there are temperature deviation or alarms to avoid vaccines damage.

1.4 Positioning of temperature monitoring devices

Responsibility: National logisticians and technicians, Regional/District Immunization officer, Vaccine storekeepers and vaccinators.

1.4.1 Freezer rooms

The sensors of the temperature monitoring devices must be fixed by the National Cold chain technicians and should not be moved.

1.4.2 Cold rooms

The sensor of the temperature monitoring devices in cold rooms at all level must be fixed by the National Cold chain technicians and should not be moved.

A minimum of four 30-days electronic temperature monitoring devices (Fridge Tags) should be conspicuously placed in the cold room shelves.

Temperature mapping study must be conducted to determine the coldest places in the room to avoid unnecessary freezing of vaccines. A 30-days electronic temperature monitoring devices should be placed in the coldest part of the cold rooms.

For a typical cold room with up to 40m³:

a. Place two devices on the shelf, which is closest to the evaporator air stream from each of the refrigeration units.

b. Place two more devices on the shelves in the centre of the cold room, one on the middle shelf and one on the bottom shelf.

1.4.3 Vaccine freezers

Place one thermometer on top of the vaccine where it can easily be read.

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1.4.4 Vaccine refrigerators

Place the temperature monitoring devices (30-day refrigerator temperature logger, thermometer or freeze indicator) on top of the vaccine where the devices can easily be read.

For Remote Temperature Monitoring (RTM) devices, fix sensors at the appropriate position depending on the type of refrigerators. It is advised to place RTM devices on the wall at the position where health workers can easily read.

1.5 Correct reading of a temperature monitoring devices

Responsibility: Logistician, Regional Immunization officer, District Immunization officer, Vaccine storekeepers or health workers

For a 30-days temperature monitoring devices, just read the number displayed on the device and record to the nearest number. For example, 3.2°C should be recorded as 3°C and 4.6°C should be recorded as 5°C.

In case there is no a 30-days temperature monitoring devices read the temperature from the RTM devices as displayed on the RTM screen. Recording should be done as per the instruction given above.

In the absence of both 30-days temperature monitoring and RTM devices, thermometer can be used to record temperature reading. Reading must be done by looking the thermometer with your eyes at right angles to the instrument. If you read the thermometer at an acute angle, the temperature you observe on the scale will be incorrect.

1.6 Temperature recording process

Responsibility: Logisticians, Regional Immunization officer, District Immunization officer, Vaccine storekeepers, health workers.

Record the current temperature reading as displayed in the devices (twice a day) in the temperature-monitoring chart. First reading must be done before 10 am in the morning and the second reading immediately after official working hours.

Record the maximum temperature reading and duration as displayed in the device after pressing the read button, first time. Then record the minimum temperature reading and duration after pressing the read button, the second time.

You should only record temperature after reading.

1.7 How to maintain the temperature monitoring charts and reports

Responsibility: Logisticians, Regional Immunization officer, District Immunization officer, Vaccine storekeepers and health workers.

Every freezer room, cold room, vaccine freezer and vaccine refrigerator must have a currently updated temperature monitoring chart on which the following records are captured:-

ØRecords of daily temperature readings (twice a day).

ØRecords of daily maximum and minimum temperatures.

ØRecords of the number and types of alarms observed daily.

ØRecords of type and numbers of vaccine doses affected in case of temperature excursion(s)

ØActions taken by responsible person in case of temperature excursions (alarms)

File the charts and replace them with a new one on every first day of the month. This chart must be reviewed and signed by the facility supervisor monthly and archived for at least three (3) years. Annex 1 shows a monthly recording chart. Annex 2 shows a monthly temperature review reporting form.

1.8 What to do if temperatures are out of recommended range

Responsibility: Logisticians, Regional Immunization officer, District Immunization officer, Vaccine storekeepers, and health workers.

1.8.1 Cold rooms and vaccine refrigerators

a. Temperature between +2°C and +8°C: Situation normal, no action necessary.

b. Temperature between 0°C and +2°C: Monitor the situation carefully. If the temperature has NOT returned to between +2°C and +8°C by the time of the next inspection:

• Electric and gas refrigerators: Adjust thermostat. Continue to monitor the temperature carefully to make sure it does not drop below 0°C. If the thermostat is not adjustable, call the higher-level official. (DIVO, RIVO or Cold chain technician)

c. Temperature at or below 0°C: VACCINE AT RISK.

• Electric and gas refrigerators, including solar: Adjust thermostat. Continue to monitor the temperature carefully to make sure it doesn’t drop below 0°C. If the thermostat is not adjustable, call the higher-level official. (DIVO, RIVO or Cold chain technician)

• If a freeze indicator shows ALARM (ý) or a 30-day electronic temperature monitoring device shows a “freeze alarm”, the temperature has dropped below -0.5°C for more than 60 minutes. The health worker must suspect vaccine freezing in all freeze-sensitive vaccines. The health workers are advised to remove all freeze-sensitive vaccines and put them into a vaccine carrier and mark them “DO NOT USE”. Thereafter, s/he must call the DIVO to come and perform a Shake Test to establish if any has been frozen.

• Vaccines, which are physically frozen, and those vials which failed the Shake Test must be discarded immediately, recorded and reported to higher level.

d. Temperature between +8°C and +10°C: Monitor the situation carefully. If the temperature has NOT returned to between +2°C and +8°C by the time of the next inspection:

• Electric refrigerators, including solar: Check that the refrigeration unit is working. If there has been a temporary power failure, continue to monitor carefully after the power comes back to make sure the temperature returns to +2°C and +8°C. If it does not, adjust the thermostat.

• Gas refrigerators: Check the gas cylinder and replace if necessary. If gas is OK, adjust the thermostat. Also, inspect the hose pipe and regulator connection for any gas leakage.

e. Temperature above +10°C: VACCINE AT RISK. Check VVMs for colour changes to establish whether vaccine has been damaged or shelf life shortened. Transfer vaccines to an alternative cold chain equipment like cold box, refrigerator as stipulated in the agreed contingency plan. Remove all temperature-damaged vaccines and write a report to higher level. In addition, send a vaccine request to higher stores for replenishment.

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1.8.2 Freezer rooms and vaccine freezers

a. Temperature between -25°C and -15°C: Situation normal, no action necessary.

b. Temperature below -25°C: Adjust thermostat. Check that the temperature is within the normal range at the time of the next inspection.

c. Temperature above -15°C: If there has been a temporary power failure, no further action is necessary. A temporary rise to -10°C is permissible following an extended power cut. Check that the refrigeration unit is working, monitor the situation closely and take appropriate action if conditions are not normal at the time of the next inspection.

d. Temperature above -10°C: VACCINE AT RISK. Take immediate action to implement the agreed contingency plan, and make a report.

1.9 Daily tasks

1.9.1 Freezer rooms at Central Vaccine Store

Responsibility: Logisticians, Vaccine storekeepers

a. Read the temperatures shown on the external digital thermometers or remote temperature devices, twice daily, 7 days a week. Take readings daily in the morning before 10 am and in the evening before closure of business. Check that the temperature readings are between -15°C to -25°C.

b. Check that the temperature readings on the electronic continuous temperature monitoring devices have been between -15°C to -25°C throughout the previous 24 hours.

c. For each freezer room, record the results of the twice daily readings on the temperature monitoring chart.

1.9.2 Cold rooms at Central, Regional and District Vaccine Stores

Responsibility: Logisticians, Regional Immunization officer, District Immunization Officer and Vaccine storekeepers.

Read the temperatures shown on the 30-day electronic temperature monitoring devices twice daily, 7 days a week. Take readings every morning before 10 am and in the evening before closure of business. Check that the readings are between +2°C to +8°C.

a. Check that the readings on the chart recorder or electronic continuous temperature monitoring system have been between +2°C to +8°C throughout the previous 24 hours.

b. Check the status of the electronic freeze indicator(s).

c. For each cold room, record the results on the temperature chart.

1.9.3 Vaccine freezers at Regional and District Vaccine Stores

Responsibility: Regional immunization Officers, District Immunization officer and Vaccine storekeepers;

Read the temperature on the thermometer stored with the vaccine twice daily, 7 days a week. Take readings daily in morning before 10 am and in the evening before closure of business. Check that the readings are between -15°C to -25°C.

Check that the readings on the thermometer or electronic continuous temperature monitoring system have been between -15°C to -25°C throughout the previous 24 hours. For each vaccine freezer, record the results on the temperature chart.

1.9.4 Vaccine refrigerators: District Vaccine Stores

Responsibility: District Immunization officer and Vaccine storekeepers;

Read the temperatures shown on the 30-day temperature monitoring devices, remote temperature monitoring devices or thermometer of stored vaccine twice daily, 7 days a week. Take readings daily before 10 am and in the evening before closure of business. Check that temperature readings are between +2°C to +8°C by: -

a. Checking that the readings on the 30-day temperature monitoring device have been between +2°C to +8°C.

b. Check the status of the 30-day temperature monitoring devices for freeze alarm.

c. For each vaccine refrigerator, record the results on the temperature chart.

1.9.5 Vaccine refrigerators at health facilities

Responsibility: Health workers

a. Either, check that the readings on the 30-day temperature monitoring devices have been between +2°C to +8°C throughout the previous 24 hours.

b. Take first reading in the morning before start of work and in the evening before closing of the business. Check that the readings are between +2°C to +8°C. Check the status of the 30-day temperature monitoring devices for freeze alarm

c. For each vaccine refrigerator, record the results on the temperature chart.

1.10 Weekly tasks

Responsibility: Regional/District Immunization officer, Vaccine storekeepers or vaccinator.

a. Stores with remote temperature monitoring devices

• Download weekly temperature charts from remote monitoring devices connected to the cold chain equipment.

• Check whether there have been any excursions outside the acceptable temperature ranges.

• Mark these on the chart and discuss with your supervisor any action that needs to be taken.

b. Stores with FridgeTags

• Download weekly temperature data for all cold chain equipment from the device. Check whether there is any excursion outside recommended ranges. Discuss with your supervisor any necessary actions that need to be taken.

• Discuss temperature records written on the temperature chart weekly with facility incharge and notify the DMO office if there is a risk of vaccine freezing.

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1.11 Monthly tasks

Responsibility: Logisticians, Regional/District Immunization officer, Vaccine storekeepers or Health workers.

a. Hold a meeting to review the past month’s temperature records.

b. Identify any systematic temperature trends, which may indicate cold chain equipment problems.

c. Discuss and agree any remedial action needed to avoid vaccine wastage.

d. Record results of the meeting on the monthly temperature review form and file the form in the monthly temperature record file. See Annex 1.

1.12 End of year tasks

Responsibility: Logisticians, Regional/District Immunization officer, Vaccine storekeepers or Health workers. Start new files for the monthly temperature review reports.

a. Store all the previous year’s temperature records for future reviews for up to three (3) years period.

b. Prepare an annual vaccine store temperature report based on the previous year’s records. See Annex 3.

Related documents and SOPs

• TAN-EVM-SOP-E2-02: Checking the accuracy of temperature monitoring devices.

• TAN-EVM-SOP-E3-01: Responding to emergencies in fixed storage locations.

• TAN-EVM-SOP-E8-01: When and how to conduct the Shake Test.

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Annex 3 – Temperature excursion response protocol

1HASEXCURSIONOCCURRED?

EXCURSIONRESPONSEWHATSHOULDIDOINTHEEVENTOFA

TEMPERATUREALARM?

FORALLEXCURSIONS:1) Recordtheexcursioninthemonthlytemperaturemonitoringchart2) Contactyoursupervisor3) Continuemonitoringtherefrigeratorandifthetemperatureisno

longerbetween2-8oCproceedwiththe“ongoingexcursion”protocol

2ISITSTILLONGOING?

FORFREEZEEXCURSIONS:1) Isolatefreeze-sensitivevaccines.2) Markfreeze-sensitivevaccinesas“DONOTUSE”Yoursupervisor

willdetermineifthosevaccinescanbeusedornot.3) Reportexcursiontoyoursupervisor.

FORHEATEXCURSIONS:1) CheckVVstatusofvaccines2) Disposeofvaccinesatstage3or4usingdtheappropriatemethod

asappliestoyourfacility3) Updatetheledgerbookasneeded.

IFYES:1) Moveallvaccinestoalternativestorage(coldbox/vaccinecarrier,

anothervaccinerefrigeratororanotherfacility)2) Contactyoursupervisor

CONTACTYOURSUPERVISORIF:a. Anexcursionhasoccurred

orisstillongoing.b. Theexcursioncauseisstill

unknownortoocomplexandatechnicianisneededtofixthefaultequipment.

c. Thegastopowertherefrigeratorhasrunout

d. Thesourceofelectricityisinconsistent,orunavailableforanextendedperiodoftime

e. Youhavetodisposeofthevaccinesbecauseofdamage

CONTACTDETAILSNameandPhoneNumberofHFIn-charge………………………………………….…………………………………..NameandPhoneNumberofDIVO………………………………………….…………………………………..VaccineRelocationSitesNameandPhoneNumber

1. …………………………………………………………………

2. …………………………………………………………………

3. …………………………………………………………………

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Annex 4: Temperature excursion diagnosis

EXCURSION DIAGNOSIS WHAT CAUSED THIS TEMPERATURE ALARM?

If yes, plug it back in.

If yes, switch to the standby cylinder and contact your supervisor to request more gas.

If yes, remove the obstruction or dust.

If yes, move the refrigerator farther away from the wall.

If yes, defrost the refrigerator.

If yes, level the refrigerator

If yes, contact your supervisor to call a technician to fix the plug.

If yes, contact your supervisor. Switch to an alternate power source.

CONTACT DETAILS

Name and Phone Number of HF In-charge

…………………………………………. …………………………………..

Name and Phone Number of DIVO

…………………………………………. …………………………………..

Vaccine Relocation Sites Name and Phone Number

1. ……………………………………… ………………………….......

2. ……………………………………… ………………………….......

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Standard Operating Procedure

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