Administrative Policies and Procedures

Transcription

1 Administrative Policies and Procedures Originating Venue: Medication Management Policy No.: MM 2716 Title: Handling and Storage of Vaccines Cross Reference: Date Issued: 10/15, 7/16 Date Reviewed: 7/16 Date: Revised: 7/16 Attachment: None Page 1 of 2 Policy: All refrigerators and freezers with vaccine storage will be appropriately monitored for temperature excursions according to CDC best practice guidelines. Purpose: To provide appropriate guidelines for the storage and handling of vaccines. Failure to store and handle vaccines properly can reduce vaccine potency resulting in inadequate immune responses in patients and poor protection against disease. Storage and handling errors can also result in significant financial loss if the vaccine cannot be used. Procedure: Vaccine Storage and Handling 1. Dormitory-style refrigerators are not used to store vaccine. 2. Vaccines are stored at the recommended temperature immediately upon arrival. 3. Refrigerated vaccines are maintained at a temperature range of 36 F to 46 F at all times. 4. Vaccines that require freezing will be maintained at a temperature of -58F to + 5 F 5. A temperature log that has the ability to identify out of range conditions is used to document refrigerator and freezer temperatures. 6. If a temperature is noted to be out of range, immediate investigation and response will occur. If vaccine is felt to have been out of adequate temperature control, the vaccine will be immediately sequestered and determination regarding the disposition of the vaccine will be investigated. 7. eratures of the refrigerator and freezer is monitored and documented at the beginning of each work day. The current temperature is monitored and documented twice daily, preferably at the beginning and end of the work day. 8. A calibrated thermometer with a certificate of traceability and calibration is kept in the refrigerator. A backup calibrated thermometer is available on premises. 9. Recalibration of the thermometer is done in accordance with manufacturer recommendation. 10. Signage is posted next to electrical outlines and circuit breakers (e.g., Do Not Unplug and Do Not Stop Power) to maintain a consistent power source. 11. Vaccines are stored in bins or baskets (uncovered) with slotted sides or opening. 12. Bins are arranged in the refrigerator so that air flow around the vaccine is promoted. 13. Bins are clearly labeled with the name of the vaccine. Bins are to contain only one type of vaccine. 14. Vaccines are never stored in the refrigerator door.

2 Title: Handling and Storage of Vaccines Policy No.: MM 2716 Page 2 of Water bottles can be stored in the refrigerator door to help maintain a constant temperature. Care is taken to prevent too much water storage such that the ability for the refrigerator door to close is not compromised and the seals are maintained. Water bottles should be labeled Do Not Drink. 16. Food and drink (other than water for temperature control purposes) is not to be stored in the same refrigerator as vaccine. 17. Vaccines (opened and unopened) are stored in their original box with the lid in place. 18. Vaccines are prepared for administration at the time of their use. 19. Only the diluent supplied by the vaccine manufacturer is used to reconstitute a vaccine 20. Vaccine stock is rotated weekly so the vaccine and diluent with the shortest expiration date can be used first. During this process, assessment for expired vaccine occurs. 21. Expired vaccine is disposed of in accordance with hazardous waste regulation unless specific arrangements have been made to return it to the manufacturer. 22. Vials are dated as soon as they are opened unless they are single dose and will be disposed of immediately upon single use. 23. Multi-dose vials are disposed of on the date of the manufacturers expiration date, or dated for 28 day expiration upon entering the vial. 24. Unused reconstituted vaccine is disposed of in accordance with manufacturer recommendation. 25. During mobile vaccination clinics such as the Flu Vaccine the vaccine will be maintained in the same fashion as when originally shipped from pharmacy supplier. Care will be taken to protect from freezing, or from opening the cooler excessively. Vaccine will be drawn and used immediately. 26. A temperature excursion outside the recommended range will be immediately reported to the supervisor. All vaccines will be moved to another appropriate location and bagged and labeled Do Not Use, until their stability has been determined by each manufacturer. Store in Refrigerator Between 36 F and 46 F (2 C and 8 C) MMR HepA HepB HepA-HepB Hib Hib-HepB Human papillomavirus (HPV2 and HPV4 ) Influenza (LAIV, IIV, RIV ) IPV Meningococcal-containing (Hib-MenCY, MCV4, MPSV4) Pneumococcal (PCV13 and PPSV23) Rotavirus (RV1 and RV5) Diphtheria toxoid-, Tetanus toxoid-, and Pertussis-containing (DT, DTaP, DTaP-HepB-IPV, DTaP-IPV, DTaP-IPV/Hib, Tdap, Td, TT) Store in Freezer Between -58 F and +5 F (-50 C and -15 C) VAR HZV MMRV MMR Date Policy to be reviewed: 7/18

3 Temperature Log for Refrigerator Fahrenheit Month/Year VFC PIN or other ID # Page 1 of 3 DAYS Put an X in the row that corresponds to the refrigerator s temperature. Take if temp is out of range too warm (above 46ºF) or too cold (below 35ºF). Day of Month am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Danger! Temperatures above 46ºF are too warm! temps and room temp on the lines below and call your state or local health department immediately! 46 F 45 F 44 F 43 F 42 F 41 F Aim for 40º 40 F 39 F 38 F 37 F 36 F 35 F Danger! Temperatures below 35ºF are too cold! temps and room temp on the lines below and call your state or local health department immediately! temps (above 46ºF or below 35ºF) here: Item #P3037F (8/13)

4 Temperature Log for Refrigerator Fahrenheit Month/Year VFC PIN or other ID # Page 2 of 3 DAYS Put an X in the row that corresponds to the refrigerator s temperature. Take if temp is out of range too warm (above 46ºF) or too cold (below 35ºF). Day of Month am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Danger! Temperatures above 46ºF are too warm! temps and room temp on the lines below and call your state or local health department immediately! 46 F 45 F 44 F 43 F 42 F 41 F Aim for 40º 40 F 39 F 38 F 37 F 36 F 35 F Danger! Temperatures below 35ºF are too cold! temps and room temp on the lines below and call your state or local health department immediately! temps (above 46ºF or below 35ºF) here: Item #P3037F (8/13)

5 Temperature Log for Freezer Fahrenheit Month/Year VFC PIN or other ID # Page 1 of 3 DAYS Put an X in the row that corresponds to the freezer s temperature. Take if temp is out of range too warm (above 5ºF) or too cold (below -58ºF). Day of Month am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Danger! Temperatures above 5ºF are too warm! temps and room temp on the lines below and call your state or local health department immediately! 5 F 4 F 3 F 2 F 1 F 0 F -1 F -2 F -3 F -4 F -58 F to -5 F temps (above 5ºF or below -58ºF) here. Item #P3038F (9/13)

6 Temperature Log for Freezer Fahrenheit Month/Year VFC PIN or other ID # Page 2 of 3 DAYS Put an X in the row that corresponds to the freezer s temperature. Take if temp is out of range too warm (above 5ºF) or too cold (below -58ºF). Day of Month am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm am pm Danger! Temperatures above 5 F are too warm! temps and room temp on the lines below and call your state or local health department immediately! 5 F 4 F 3 F 2 F 1 F 0 F -1 F -2 F -3 F -4 F -58 F to -5 F temps (above 5ºF or below -58 F) here. Item #P3038F (9/13)

7 Date & Time of Event If multiple, related events occurred, see Description of Event below. Vaccine Storage Troubleshooting Record (check one) Refrigerator Freezer Use this form to document any unacceptable vaccine storage event, such as exposure of refrigerated vaccines to temperatures that are outside the manufacturers' recommended storage ranges. A fillable troubleshooting record (i.e., editable PDF or WORD document) can also be found at Storage Unit Temperature at the time the problem was discovered at the time the problem was discovered When recording temperatures, indicate F (Fahrenheit) or C (Celsius). Date: Temp when discovered: Temp when discovered: Name: Person Completing Report Time: Minimum temp: Maximum temp: Comment (optional): Title: Date: Description of Event (If multiple, related events occurred, list each date, time, and length of time out of storage.) General description (i.e., what happened?) Estimated length of time between event and last documented reading of storage temperature in acceptable range (35 o to 46 o F [2 to 8 C] for refrigerator; -58º to 5ºF [-50 to -15 C] for freezer) Inventory of affected vaccines, including (1) lot #s and (2) whether purchased with public (for example, VFC) or private funds (Use separate sheet if needed, but maintain the inventory with this troubleshooting record) At the time of the event, what else was in the storage unit? For example, were there water bottles in the refrigerator and/or frozen coolant packs in the freezer? Prior to this event, have there been any storage problems with this unit and/or with the affected vaccine? Include any other information you feel might be relevant to understanding the event. Action Taken (Document thoroughly. This information is critical to determining whether the vaccine might still be viable!) When were the affected vaccines placed in proper storage conditions? (Note: Do not discard the vaccine. Store exposed vaccine in proper conditions and label it do not use until after you can discuss with your state/ local health department and/or the manufacturer[s].) Who was contacted regarding the incident? (For example, supervisor, state/local health department, manufacturer list all.) IMPORTANT: What did you do to prevent a similar problem from occurring in the future? Results What happened to the vaccine? Was it able to be used? If not, was it returned to the distributor? (Note: For public-purchase vaccine, follow your state/local health department instructions for vaccine disposition.) Item #P3041 (8/13)