Presentation Transcript

1. Vaccine Storage and Handling

   Joni Reynolds Colorado Department of Public Health & Environment, Immunization Program
2. Presentation Outline Introduction Cold Chain Storage and Handling Plans Personnel Storage Equipment Storage Practices Temperature Monitoring Handling inappropriate storage conditions Inventory Management Shipments Preparation and Disposal
3. Objectives At the end of this presentation, the participant will: Identify steps in the vaccine cold chain List the required elements of an acceptable vaccine storage and handling plan Identify acceptable vaccine storage units and thermometers Identify correct temperature ranges for inactivated and live virus vaccines
4. Introduction Storing vaccines improperly is a costly mistake! Reduces vaccine potency Inadequate immune responses in recipients Inadequate protection against disease Loss of millions of dollars worth of vaccine
5. Introduction Vaccine failures 2° reduced vaccine potency lead to: Large recalls for revaccination Expense Potential liability Decreased patient confidence Embarrassment Vaccine Storage and Handling Mistakes are AVOIDABLE!
6. The Cold Chain
7. Cold Chain Vaccine Potency Excessive heat or cold damages vaccine Once potency is lost, it can never be regained Vaccine becomes ineffective Cold chain must be correctly maintained
8. Cold Chain Visual inspection of vaccines is an unreliable method of assuring potency Viable vaccine that has been stored properly Non-viable vaccine that has been frozen
9. Cold Chain Out of range temperatures require immediate action Refrigerator temps often kept too cold One study: site-visits found 15% of refrigeration units had temps 34°F or lower When vaccine integrity is questionable, contact: State immunization program Manufacturer of vaccines in question Mishandled doses should not be counted as valid doses and must be repeated Unless serologic testing indicates adequate response
10. Cold Chain Appropriate temperature ranges: Refrigerator: 35°- 46°F (2°- 8°C) Optimal is 40°F (5°C) Freezer: 5°F (-15°C) or Colder Varicella, MMR, Zoster, Ice Packs Hepatitis A, B, DTaP, DT, Tdap, Hib, IPV, Pneumo, Rota, Mening., inactivated influenza, LAIV, HPV, Yellow Fever, Water Bottles
11. Storage and Handling Plans Routine Plan should include: Designation of primary vaccine coordinator and at least one back-up staff Proper vaccine storage/handling information Vaccine shipping (receiving/transport) information Procedures for vaccine relocation in the event of an emergency situation Documentation that plan has been reviewed or updated annually or since staff change Inventory control procedures Procedures for responding to vaccine wastage

12. Vaccine Personnel

13. Vaccine Personnel Each office should designate: One assigned primary staff member responsible for ensuring proper vaccine management One designated back-up staff member Training should be provided for both the primary and backup coordinators
14. Vaccine Personnel Other staff Should be familiar with site’s policies and procedures for S&H Training All staff handling vaccines should receive training on policies and protocols Policies and procedures should be reviewed annually to update all staff

15. Vaccine Storage Equipment

16. Storage Units Refrigerators without freezers and stand-alone freezers tend to better maintain required temps Household refrigerator with freezer-type storage units are acceptable, provided they have separate compartments and separate external doors
17. Vaccine Refrigerators/Freezers Dormitory-Style Units Single-door combined refrigerator-freezer should not be used Freezer compartment cannot maintain required temp for varicella and zoster vaccines May only be used for small quantities of inactivated vaccines May not be used for long- term (overnight) vaccine storage Must not be overcrowded and temps must be monitored closely for unacceptable fluctuations
18. Vaccine Refrigerators/Freezers Placement in clinic Must have good air circulation around the unit Place in well-ventilated room
19. Vaccine Refrigerators/Freezers Temperature Adjustments Should only be made by the primary or back-up vaccine coordinator Make only slight adjustments and re-assess every 30 minutes until temp stabilizes Temps in newly installed or repaired units may take 2-7 days to stabilize Allow one week before utilizing new units for vaccine storage
20. Vaccine Refrigerators/Freezers Maintaining stable temperatures Store containers of water in refrigerator doors and ice packs in freezers Limit frequency that doors are opened Routinely check that doors are closed tightly
21. Vaccine Refrigerators/Freezers Vegetable bins should not be used Do not store vaccine in very bottom of unit Vegetable bin drawer pulled
22. Thermometers Certified and Calibrated – recommended by the CDC, NIP for all vaccine storage units Calibrated = given a temperature scale at time of manufacturing Certified = A second calibration done against a reference standard from appropriate agency Avoid using cheap thermometers. VFC enrolled providers are now required to use certified/calibrated thermometers, currently available through the VFC program. Periodic recertification and recalibration required
23. Certified Calibrated Thermometers
24. Certified Calibrated Thermometers
25. Thermometer Placement Center of compartment Away from coils, walls, floor, and fan Middle shelf
26. Protect Power Supply Avoid outlets with built-in circuit switches (red reset buttons) Avoid outlets that can be activated by wall switch
27. Protect Power Supply Use a safety-lock plug or outlet cover to prevent inadvertently unplugging Post warning sign at plug and on unit Label fuses and circuit breakers Consider installing temperature alarms

28. Vaccine Storage Practices

29. Vaccine Storage Conditions Live Vaccines Very sensitive to heat Varicella and zoster vaccines must be in continuous frozen state 5°F or colder MMR usually stored in freezer but can be in refrigerator MMRV must be stored in freezer HPV, MMR, MMRV, rotavirus, varicella and zoster vaccines are light-sensitive Protect from light at all times Store in their boxes with the tops until needed
30. Vaccine Storage Conditions Inactivated Vaccines Sensitive to excessive heat and freezing Maintain at temps between 35°F to 46°F Colder is not better! Can tolerate short periods at room temperature Potency at such temperatures is adversely affected over time
31. Location and Positioning Store vaccines in middle of compartment Away from coils, walls, floor and cold air vent Do NOT store in doors of storage unit Never store in vegetable bins Keep refrigerated vaccine away from cold air venting in from freezer Usually this is top shelf Best to keep MMR on top shelf if placed in refrigerator Air vent from Freezer Diluent may be stored in refrigerator doors. Vaccines may not.
32. Storage of Non-Vaccine Products Food and Beverages Never store with vaccines Results in frequent storage unit opening, unstable temps, unnecessary light exposure Medications and other biologicals If possible store in separate unit If no choice, store in unit below vaccines

33. Temperature Monitoring

34. Check, Correct and Record Post temp log sheet on door of every storage unit Read thermometer in all compartments of every vaccinestorage unit Twice daily In morning upon arrival to clinic and evening upon clinic closure Regardless of type of thermometer, alarm or recorder
35. Check, Correct and Record Record temperatures on log every time a reading is taken Record the time the thermometers were read Person must initial log at time of readings If reading is missed, leave log space empty Do not guess what temperature was
36. Check, Correct and Record TAKE IMMEDIATE ACTION TO PROTECT VACCINES! Temps found out of range need immediate correction Document problem, how vaccines were protected, action(s) taken to correct problem, time problem identified and corrected Mechanical malfunctions and power outages must be documented on log sheet
37. Maintaining Temperature Logs Store completed logs for a minimum of 3 years Store continuous recording/graphic thermometer readings/paper with logs for 3 years

38. Handling Inappropriate Storage Conditions

39. Handling Inappropriate Storage Conduct inventory of affected vaccines Isolate affected vaccine vials and mark them as “DO NOT USE” Store affected vaccines under appropriate conditions until integrity determined Contact state immunization program for further guidance

40. Inventory Management

41. Inventory Management Expiration Dates Multi-dose vials may be used until date of expiration Meningococcal polysaccharide must be used within 35 days of reconstitution Single-dose vials without their protective caps must be used by end of clinic day Reconstituted lyophilized vaccines must be used within a specified time frame or discarded See package insert
42. Inventory Management Stock Rotation Place vaccine/diluent supplies according to expiration dates Weekly and upon receipt of new shipments Earliest expiration dates placed in front for earliest use Never administer expired vaccines Remove from storage unit and label “Expired” Contact state immunization program; Do not discard expired/wasted vaccines If expired vaccine is mistakenly administered, the physician in charge should be notified, the child should be recalled and revaccinated, and a VAERS report should be completed.
43. Inventory Management To minimize risk for waste, maintain a 30-60 day inventory supply Order vaccines monthly Do not over order vaccines Keep privately purchased stock separate or labeled clearly from VFC (state supplied) stock

44. Vaccine Shipments

45. Vaccine Shipments Receiving Vaccine Shipments Arrange deliveries only for when primary or backup person is on duty All staff must be aware of maintaining cold chain and to immediately notify assigned person(s) of vaccine arrival For VFC enrolled providers, notify state immunization program of changes in provider, primary contact, unexpected or different office closures, hours of operation, change of address
46. Vaccine Shipments Upon Receipt: Examine container and contents for signs of physical damage Shipment time should not have exceeded 48 hours Crosscheck contents with packing slip Check expiration dates Check lyophilized vaccine to ensure correct type and quantity of diluent was also sent
47. Vaccine Shipments Upon Receipt: Examine for heat or cold damage Check cold chain indicators Inactivated vaccines should be cold, not frozen MMR should be cold or frozen Dry ice should be present with varicella and zoster vaccines Immediately and appropriately store vaccines
48. Vaccine Shipments Concerns about shipment? Mark vaccine/diluent as “DO NOT USE” Store under proper conditions Apart from other vaccine supplies e.g., in brown bag with appropriate marking “DO NOT USE”. Immediately contact state immunization program for further guidance

49. Vaccine Preparation and Disposal

50. Vaccine Preparation Reconstitution = the mixing of lyophilized (freeze-dried) vaccine with a liquid (diluent) before it can be administered Reconstitute vaccine immediately before use Do not allow exposure to warm temps and light Use appropriate diluent – use only the diluent that comes with that vaccine Check for expiration dates on vaccine vial and diluent vial Lyophilized power + Diluent = Reconstituted Vaccine
51. Pre-filling Syringes The CDC, NIP strongly recommends providers do NOT pre-fill doses before they are needed because it increases risk for: WASTAGE! Administration errors Storage under inappropriate conditions Bacterial contamination and growth Reduced vaccine potency Quality control and patient safety issues Manufacturer-filled syringes are an alternative
52. Questions Name/Contact Info