VACCINE STORAGE BEST PRACTICES. Richard Galati VFC Immunization Initiative Consultant St. Clair County Health Department

Transcription

1 VACCINE STORAGE BEST PRACTICES Richard Galati VFC Immunization Initiative Consultant St. Clair County Health Department

2 INTRODUCTION Information presented in this course provides an overview of the approved vaccine storage and handling best practices & represents the Standards of Care for immunization for all providers, regardless of whether or not they are VFC providers Vaccine storage unit and thermometer recommendations are based on recent scientific studies Proper vaccine storage and handling is important to protect vaccine quality and potency to ensure vaccine effectiveness and patient safety All personnel who handle or administer vaccines need to be knowledgeable about the contents of the CDC developed Vaccine Storage and Handling Toolkit. Vaccine management, including proper storage and handling procedures, is the basis on which good immunization practices are built.

3 LEARNING OBJECTIVES Identify potential consequences of vaccine mishandling & inappropriate storage practices Define and explain the vaccine cold chain Describe proper vaccine storage equipment use and temperature monitoring Identify vaccine storage and handling best practices Explain the responsibilities of the primary & back-up vaccine coordinators Review vaccine inventory management practices Locate resources related to current immunization practices

4 WHY IS PROPER VACCINE STORAGE AND HANDLING SO IMPORTANT?

5 OFFICE OF INSPECTOR GENERAL (OIG) VULNERABILITIES IN VACCINE MANAGEMENT REPORT June 2012 Involved a study conducted in April & May 2011 involving 45 VFC providers from 5 states to evaluate vaccine vulnerabilities in vaccine management 76% of providers had vaccine exposed to inappropriate temperatures for at least 5 cumulative hours during a 2-week period 29% had expired vaccines stored together with non-expired vaccines 84% of providers had thermometers not reading accurately or thermometers that were not up-to-date in calibration 25% recorded a temperature outside of the recommended temperature range and took no action 31% did not have a written vaccine management plan

6 CONSEQUENCES OF VACCINE STORAGE & HANDLING ERRORS Vaccines are temperature sensitive & mishandling increases the risk that recipients will not be protected because of reduced potency Vaccine storage and handling errors can cost thousands of dollars in wasted vaccine and revaccination Staff time in determining affected patients who need to be recalled because they received compromised vaccine Diminished patient confidence in provider when repeat vaccinations are required

7 Components of a Vaccine Management Plan Designation & responsibilities of a Primary & Alternate/Back-up Vaccine Coordinator Procedure for vaccine storage unit temperature monitoring Managing vaccine inventory (checking vaccine expiration dates & removing expired items from usable stock Vaccine storage equipment maintenance Procedures for responding to vaccine storage & handling problems Procedures for vaccine relocation in the event of a power failure Vaccine receiving, ordering, accountability, wastage, transfers, & borrowing procedures Ensure adequately trained vaccination personnel Plan reviewed & updated annually or when staff changes Plan should be consistent with the procedures as outlined in CDC s Vaccine Storage and Handling Toolkit (November 2012)

8 ELEMENTS OF AN EMERGENCY RESPONSE PLAN Corrective action procedures for managing potentially compromised vaccines when vaccine storage problems occur Plan for short-term & long-term power outages Emergency contact information for Primary & Alternate Vaccine Coordinators Identification of alternate vaccine storage facilities Protocol for packing vaccines for transport Availability of appropriate packing materials to transport or temporarily store vaccine Up-to-date list of vaccine manufacturer phone # s Plan should be consistent with the emergency procedures detailed in CDC s Vaccine Storage & Handling Toolkit

9 VACCINE EQUIPMENT

10 RECOMMENDED TYPES OF VACCINE STORAGE UNITS Stand-alone refrigerator Stand-alone freezer Combination refrigerator/freezer- using only the refrigerator compartment for vaccine storage Pharmaceutical/medical/laboratory grade refrigerator Pharmaceutical/medical/laboratory grade freezer Compact (under counter) refrigerator Compact (under counter) freezer

11 STAND-ALONE UNITS

12 YES or NO

13 YES AND NO Household combination refrigerator/freezer: Refrigerator YES Freezer - NO

14 IS THIS DORM REFRIGERATOR ACCEPTABLE?

15 NO! Dormitory-style unit

16 VACCINE STORAGE UNIT CHECKLIST Have enough room to store the year s largest inventory Able to maintain vaccine storage unit temperature within the recommended temperature range Sufficient room to place water bottles in the refrigerator and frozen coolant packs in freezer to stabilize the temperatures and minimize temperature excursions that can impact vaccine potency Dedicated only to the storage of vaccines - No food or beverages Place the unit in a well-ventilated room with space around the sides (at least 4-6 inches from the wall to allow air circulation) and top Only the primary or alternate vaccine coordinator should adjust the temperature of the vaccine storage unit Be frost-free or automatic defrost cycle

17 VACCINE STORAGE UNIT CHECKLIST - Continued - Use a safety-lock plug or plug guard to reduce the chance of the unit being accidentally unplugged Post a DO NOT UNPLUG sign/sticker at the wall outlet or on the plug to alert individuals to not unplug the unit Label the circuit breaker to alert individuals to not turn off the power to the storage unit Institute at least a monthly refrigerator/freezer maintenance schedule

18 VACCINE STORAGE PRACTICES Ensure appropriate placement of vaccines Never store vaccines on the door shelves, on the floor, in crisper bins, or underneath the cold air vent Temperature/air flow in these areas may not be stable & may expose vaccine to inappropriate storage temperatures Do not store vaccines in direct contact with the surface of any glass shelf Keep vaccine 2-3 inches from storage unit walls Store vaccine with space between boxes/vials to allow cold air circulation Store vaccine vials inside their original packaging and in clearly labeled uncovered plastic baskets/trays with slotted sides (mesh) to allow cold air circulation around vaccine

19 LOADING VACCINES

20 THERMOMETERS

21 RECOMMENDED THERMOMETERS Provide continuous monitoring information with an active display of the current temperature, as well as minimum and maximum temperatures Use only calibrated thermometers with a Certificate of Traceability and Calibration Testing (traceable to NIST or ASTM standards) This is a VFC requirement Thermometer accuracy (+/- 1 degrees F or 0.5 degrees C) should be verified on the certificate Use of digital thermometers with a probe in a biosafe glycol-filled bottle placed inside of the unit that can be monitored outside of the storage unit. Use of digital vaccine data logger with a glycol encased probe Have an alarm to alert staff when the temperature is out-of-range Have a low battery indicator

22 THERMOMETERS NOT RECOMMENDED FOR USE Fluid-filled biosafe liquid thermometers Bimetal stem thermometers Food thermometers Household mercury thermometers Temperature chart recorders Infrared thermometers Thermometers that are not calibrated

23 THERMOMETER PLACEMENT WITHIN THE UNIT

24 REVIEW OF THERMOMETER DO S & DON TS Do use a NIST or ASTM traceable certified thermometer. It is VFC requirement to use a NIST or ASTM certified thermometer Don t use thermometers that are not calibrated Do have your thermometer re-calibrated every year or according to manufacturer recommendations. It is a VFC requirement & a best practice to have your thermometer recalibrated Do test your thermometer periodically to make sure it is functioning properly Do maintain temperature log sheets for a least 3 years

25 REVIEW OF TEMPERATURE MONITORING Temperature monitoring is a critical part of good storage and handling practices & ensuring vaccine potency VFC providers are required to monitor and record temperature readings twice each work day Each vaccine storage unit must have a working calibrated thermometer Thermometers should be placed in a central location of the storage unit, in close proximity to the stored vaccines Thermometers should not be placed on the door shelves, near or against walls, close to cold air vents, or on the floor of the unit Thermometers must be re-calibrated annually or according to manufacturer recommendations Recommend having a calibrated back-up thermometer for each vaccine storage unit in the event something happens to the primary thermometer or when the primary thermometer is sent in for calibration

26 SUMMARY OF VACCINE STORAGE EQUIPMENT & THERMOMETER RECOMMENDATIONS Stand-alone refrigerators and stand-alone freezers offer the most consistent storage temperatures Dormitory-style refrigerator/freezers should not be used for vaccine storage Continuous temperature monitoring provides valuable data to assure vaccine viability A thermometer probe encased in a glycol-filled bottle will most closely approximate vaccine vial temperature Thermometers attached to refrigerator walls or hanging in the air will not compare to vaccine vial temperature

27 SUMMARY OF VACCINE STORAGE EQUIPMENT & THERMOMETER RECOMMENDATIONS Storage temperatures may vary depending on location of vaccine vials and type of storage unit used Water bottles stored in a refrigerator help to reduce temperature fluctuations Vaccine packaging and plastic trays provide an additional thermal buffer

28 VACCINE COORDINATORS

29 RESPONSIBILITIES OF PRIMARY & ALTERNATE VACCINE COORDINATORS Ordering and accounting for vaccines in accordance with vaccine management plan Overseeing proper receipt and storage of vaccine shipments Positioning/organizing vaccines in the storage units in an appropriate manner Monitoring the refrigerator and freezer temperatures at a minimum of twice a day (1 st thing in morning and prior to office closing) Recording the temperatures on a log sheet and maintain temperature log sheets for at least 3 years Implement standard procedures in the event storage temperatures in the refrigerator or freezer are outside of the recommended range Maintaining storage and handling equipment and records (keep storage unit(s) clean Rotating vaccine stock so that vaccines closer to their expiration date will be used first. Remove expired vaccine from storage unit Ensure office staff are adequately trained and provide ongoing education for staff. Maintain a log sheet with staff member trained, type and date of training

30 RESPONSIBILITIES OF PRIMARY & ALTERNATE VACCINE COORDINATOR - Continued Monitor vaccine expiration dates, on a regular basis, and ensure that expired vaccine is not administered to patients Place DO NOT UNPLUG and DO NOT SWITCH OFF POWER TO VACCINE STORAGE UNITS stickers or signs next to wall outlets providing power to the refrigerator/freezer and the circuit breaker panel. For circuit breakers the number of the circuit that is active for the unit(s) needs to be marked on the posted sign/sticker. Instruct maintenance and/or cleaning personnel not to unplug the refrigerator/freezer or switch the circuit breaker off. If power needs to be shutoff, the primary and/or back-up vaccine coordinator needs to be notified so that actions can be taken to safeguard the vaccines inside of the refrigerator and/or freezer Document dates of regular maintenance on the unit and dates of repairs/servicing

31 TRAINING OF OFFICE STAFF Staff who handle and administer vaccines should receive comprehensive vaccine storage & handling training Staff should have ready access to and knowledge of immunization guidelines and resources Conduct training during orientation, when vaccine recommendations are updated, and when new vaccines are stocked Training should be documented and a log of the training maintained Accountability checks should be in place to ensure policies and procedures are followed Complete the Skills Checklist for Immunization with staff Complete the Checklist for Safe Vaccine Storage and Handling sheet with staff and be able to check YES in all of the boxes

32 TEMPERATURE LOG BEST PRACTICES VFC providers are required to record refrigerator and freezer temperatures on a temp log twice a day and/or enter the temperatures in the I-CARE registry NEVER record a temperature outside of the recommended temperature range and NOT do anything Document out-of-range temperatures Post temperature log on each storage unit door Maintain temperature logs for a minimum of 3 years

33 VACCINE INVENTORY MANAGEMENT Limit access to the vaccine supply to only authorized personnel All staff who accept vaccine deliveries should be aware of the importance of maintaining the vaccine cold chain, and immediate steps to take upon receipt of the vaccine The primary or alternate vaccine coordinator should be notified immediately upon arrival of a vaccine shipment to ensure the vaccine is stored under appropriate conditions Institute a system, such as I-CARE, to maintain complete and accurate records on vaccine received, vaccines in stock, vaccine administered, wasted/expired. Tally sheets can also be used to track vaccine stock. Review expiration dates weekly and rotate vaccine stock so that those with the earliest expiration dates are in front, so they will be used first Immediately remove expired vaccine and diluents from the storage unit & mark DO NOT USE Order and stock enough vaccine to ensure there is an adequate supply to meet the needs of your patients. Do NOT over order vaccine because this practice can lead to vaccine waste if unused vaccine expires or if there is a vaccine storage unit failure or power outage.

34 VACCINE INVENTORY MANAGEMENT - Continued Diluents (used for reconstitution) Diluents are NOT interchangeable, unless specified by manufacturer NEVER use stock vials of sterile water or normal saline to reconstitute vaccines Mark the vaccine vial with the date and time it is reconstituted Do NOT pre-draw doses of vaccine before they are needed Diluents are shipped in equal quantities as the vaccines for reconstitution Some diluents do not require refrigeration and can be stored in the door or in a cabinet

35 VACCINE INVENTORY MANAGEMENT - CONTINUED - Vaccine Labeling Organize vaccine and diluent packages by type in trays/uncovered containers To avoid confusion, vaccine and diluent packages should be stored together by type and arranged in rows. Diluents should be stored next to their vaccines. Clearly label the tray/uncovered container with the name of the vaccine or diluent. Label the packages of vaccines and diluents from the same manufacturer so that they will be used together Trays/uncovered containers must NOT be stacked or placed so closely together that air circulation inside the storage unit is impeded Store all opened & unopened vaccine and diluent in its original packaging inside the storage unit so that the contents and expiration dates are easily identifiable Label the VFC vaccines to differentiate from private stock

36 WHAT SHOULD BE THE LESSONS LEARNED Vaccine management, including proper storage and handling procedures, is the basis on which good immunization practices are built Use the recommended equipment for vaccine storage & temperature monitoring Follow appropriate vaccine storage practices Ongoing education of immunization staff is vital to ensure proper storage and handling procedures are maintained Need for careful oversight by primary vaccine coordinator

37 RESOURCES CDC s Vaccine Storage & Handling Toolkit November handling-toolkit.pdf

38 RESOURCES - Continued - Immunization Action Coalition (IAC) website has a variety of vaccine storage & handling resources Vaccine storage and handling job aids and training videos - California Department of Public Health Epidemiology & Prevention of Vaccine-Preventable Diseases ( The Pink Book ) You Call the Shots: Vaccine Storage & Handling Module Immunization education & training for healthcare providers

39 QUESTIONS???????