Checklist template

Vaccine cold chain for pharmacies

A ready-to-use checklist with 108 items in 6 sections, covering Units, Monitoring, Excursion response, Receiving, Transport, Records. Use it as-is in InspectLoop, or adapt it to your own standards in minutes.

  • 6 Sections
  • 108 Items
  • 90 Yes / No checks
  • 5 Scored ratings
  • 115 Points

Use this template How audits work

1. Units 19 items

  1. Vaccines are stored in a purpose-built or pharmaceutical-grade refrigerator Yes / No 1 pt
  2. No vaccine is stored in a dormitory-style unit with a freezer compartment inside the refrigerator Yes / No 1 pt
  3. Frozen vaccines are kept in a separate stand-alone freezer Yes / No 1 pt
  4. The vaccine refrigerator holds no food or drinks Yes / No 1 pt
  5. Vaccines are stored in the middle of the unit, away from the walls, the floor of the unit and the cooling vent Yes / No 1 pt
  6. No vaccine is stored in the door shelves or in the vegetable drawers Yes / No 1 pt
  7. Vaccines are kept in their original boxes Yes / No 1 pt
  8. Each vaccine has its own labeled bin or shelf position Yes / No 1 pt
  9. Look-alike vaccines (pediatric and adult strengths, similar brand names) are separated and flagged Yes / No 1 pt
  10. Stock with the earliest expiry date is placed at the front Yes / No 1 pt
  11. Air can circulate around the boxes; the unit is not packed full Yes / No 1 pt
  12. Water bottles are placed in unused door or bottom space of a household-style unit to steady the temperature Yes / No 1 pt
  13. The unit is plugged directly into a wall outlet, not a power strip or extension cord Yes / No 1 pt
  14. A "Do not unplug" label is on the plug or the outlet Yes / No 1 pt
  15. The circuit breaker for the unit is labeled Yes / No 1 pt
  16. The door seals are clean and close fully Yes / No 1 pt
  17. The unit stands clear of the wall by the distance the manufacturer states Yes / No 1 pt
  18. Diluents are stored as their package insert states, next to their vaccine where refrigerated Yes / No 1 pt
  19. Suitability and organization of vaccine storage units Rating
    • Purpose-built, organized and uncrowded 5 pts
    • Suitable unit but crowded or disorganized 3 pts
    • Unsuitable unit 1 pt

2. Monitoring 20 items

  1. Each unit has a digital data logger with a buffered probe Yes / No 1 pt
  2. The probe is placed in the center of the unit among the vaccines Yes / No 1 pt
  3. The data logger's calibration certificate is current Yes / No 1 pt
  4. Expiry date of the data logger calibration certificate Date
  5. The logger display is readable from outside the unit without opening the door Yes / No 1 pt
  6. Refrigerator temperature at the time of the visit (°F or °C) Number
  7. Freezer temperature at the time of the visit (°F or °C) Number
  8. The refrigerator reading is between 36°F and 46°F (2°C and 8°C) Yes / No 1 pt
  9. The freezer reading is between -58°F and +5°F (-50°C and -15°C) Yes / No 1 pt
  10. Minimum and maximum temperatures are read at the start of each business day Yes / No 1 pt
  11. Minimum and maximum temperatures are recorded with the time and the reader's initials Yes / No 1 pt
  12. The minimum and maximum memory is reset after each reading Yes / No 1 pt
  13. The temperature log has no missing business day in the last 30 days Yes / No 1 pt
  14. Business days with no temperature entry in the last 30 days Number
  15. The logger records at an interval of 30 minutes or less Yes / No 1 pt
  16. Logger data is downloaded and reviewed at the frequency set by company policy Yes / No 1 pt
  17. The logger alarm is set to the limits of the acceptable range Yes / No 1 pt
  18. Out-of-range alarms are sent by text, phone or email to a named person when the pharmacy is closed Yes / No 1 pt
  19. A backup data logger is available on site Yes / No 1 pt
  20. Temperature monitoring practice Rating
    • Daily minimum and maximum recorded and logger data reviewed 5 pts
    • Daily log complete but logger data not reviewed 3 pts
    • Gaps in the log 1 pt

3. Excursion response 19 items

  1. A written excursion procedure is posted on or beside the unit Yes / No 1 pt
  2. The procedure tells employees to label affected vaccines "Do not use" and keep them at the correct temperature Yes / No 1 pt
  3. The procedure tells employees not to discard vaccines before the manufacturer has been consulted Yes / No 1 pt
  4. Manufacturer phone numbers for stability questions are listed with the procedure Yes / No 1 pt
  5. Employees asked could describe what to do on finding an out-of-range reading Yes / No 1 pt
  6. Temperature excursions recorded in the last 12 months Number
  7. Date of the most recent excursion Date
  8. Each excursion record states the highest or lowest temperature reached Yes / No 1 pt
  9. Each excursion record states how long the temperature was out of range Yes / No 1 pt
  10. Each excursion record states the manufacturer's decision for every affected product Yes / No 1 pt
  11. Affected vaccines were kept separate until the decision was received Yes / No 1 pt
  12. No dose from an unresolved excursion was administered Yes / No 1 pt
  13. Patients who received a dose later found to be compromised were contacted, per company policy Yes / No 1 pt
  14. The emergency plan names a backup location to move vaccines to in a power failure Yes / No 1 pt
  15. The backup location has agreed to receive the vaccines, with a contact name on the plan Yes / No 1 pt
  16. The plan states at what point in a power failure vaccines are moved Yes / No 1 pt
  17. The unit door is kept closed during a power failure until the move is decided Yes / No 1 pt
  18. The cause of the last excursion (door left open, power loss, unit failure) was corrected Yes / No 1 pt
  19. Handling of the last excursion Rating
    • Quarantined, manufacturer consulted and recorded 5 pts
    • Handled but not fully recorded 3 pts
    • Not handled or no record 1 pt

4. Receiving 16 items

  1. Vaccine deliveries are opened as soon as they arrive Yes / No 1 pt
  2. Front store employees who accept deliveries know to hand vaccine boxes to the pharmacy at once Yes / No 1 pt
  3. The temperature monitor or indicator in the shipping box is checked on arrival Yes / No 1 pt
  4. The time in transit is compared with the limit printed on the shipping box or the packing slip Yes / No 1 pt
  5. The contents are checked against the packing slip Yes / No 1 pt
  6. Expiry dates are checked at receiving Yes / No 1 pt
  7. Lot numbers and expiry dates are entered in the inventory record Yes / No 1 pt
  8. Vaccines are placed in the unit before any other task is started Yes / No 1 pt
  9. A shipment with a triggered indicator is labeled "Do not use" and stored at the correct temperature while the supplier is called Yes / No 1 pt
  10. Frozen vaccines are moved to the freezer first Yes / No 1 pt
  11. Deliveries are scheduled for days when the pharmacy is open Yes / No 1 pt
  12. Diluents shipped with the vaccine are received and matched to it Yes / No 1 pt
  13. Publicly funded vaccine stock is identified separately from privately purchased stock Yes / No 1 pt
  14. Vaccine shipments received in the last 30 days Number
  15. Receiving records show the name of the person who unpacked each shipment Yes / No 1 pt
  16. Receiving of vaccine shipments Rating
    • Checked and stored immediately 5 pts
    • Stored promptly but indicators not checked 3 pts
    • Boxes left unopened at room temperature 1 pt

5. Transport 16 items

  1. Vaccines for off-site clinics travel in a qualified cooler or a portable vaccine refrigerator Yes / No 1 pt
  2. Conditioned frozen water bottles or phase-change packs are used, not loose ice or frozen gel packs touching the boxes Yes / No 1 pt
  3. An insulating layer separates the coolant from the vaccine boxes Yes / No 1 pt
  4. A data logger with a buffered probe travels inside the cooler with the vaccines Yes / No 1 pt
  5. The temperature inside the cooler is recorded on departure Yes / No 1 pt
  6. The temperature inside the cooler is recorded on arrival Yes / No 1 pt
  7. The temperature is recorded at least hourly during the clinic Yes / No 1 pt
  8. The cooler travels in the passenger area of the vehicle, not in the trunk Yes / No 1 pt
  9. Only the doses expected to be used at the clinic are taken off site Yes / No 1 pt
  10. The cooler is kept closed between patients Yes / No 1 pt
  11. Doses are drawn up only when the patient is ready Yes / No 1 pt
  12. Unused doses returned from a clinic are marked to be used first, if they stayed in range Yes / No 1 pt
  13. Total time out of the storage unit stays within the cooler's qualified duration Yes / No 1 pt
  14. Frozen vaccines are not transported except in an emergency, with the manufacturer's guidance Yes / No 1 pt
  15. Transfers of vaccine between stores use the same packing method Yes / No 1 pt
  16. Off-site clinics held in the last 12 months Number

6. Records 18 items

  1. Temperature logs are kept for the period required by local regulation or the vaccine program Yes / No 1 pt
  2. Logger data files are saved where they can be retrieved, not only on the device Yes / No 1 pt
  3. The storage and handling procedure was reviewed in the last 12 months Yes / No 1 pt
  4. The procedure names a primary vaccine coordinator Yes / No 1 pt
  5. The procedure names a backup vaccine coordinator Yes / No 1 pt
  6. Both coordinators completed storage and handling training in the last 12 months Yes / No 1 pt
  7. Every employee who receives or stores vaccines is trained before doing so Yes / No 1 pt
  8. A physical count of vaccine stock is done monthly Yes / No 1 pt
  9. Expired vaccines are removed from the unit on the day they expire Yes / No 1 pt
  10. Expired vaccine doses found in the units during the visit Number
  11. Multi-dose vials are marked with the date first opened Yes / No 1 pt
  12. Unit maintenance (coil cleaning, door seal check, defrost where manual) is recorded Yes / No 1 pt
  13. Date of the last maintenance of the vaccine refrigerator Date
  14. Vaccine doses wasted in the last 12 months Number
  15. Corrective actions from the previous review have been completed Yes / No 1 pt
  16. Name of the primary vaccine coordinator Short text
  17. Overall control of the vaccine cold chain Rating
    • Units in range, logger data reviewed and every excursion resolved 5 pts
    • In range with gaps in the log or the excursion records 3 pts
    • Out of range, or doses used after an unresolved excursion 1 pt
  18. Corrective actions required Comments

About this template

This checklist is part of the InspectLoop template library. Yes / No checks score 1 point when met; ratings score the points shown for each option. The overall score is the percentage of points earned, with N/A answers excluded. In InspectLoop you can add photos, assign corrective actions, require sign-off and compare results across sites.

Categories

Related templates

← All templates

Brand standards

At every site, every time

Start Free Contact us