Vaccine Storage and Handling Update. Why all the Storage and Handling Updates?

Transcription

1 Vaccine Storage and Handling Update April 22, 2013 Terri Adams RN, BSN Vaccines for Children Coordinator MDCH, Division of Immunizations Why all the Storage and Handling Updates? Office of Inspector General (OIG) released a report entitled: Vulnerabilities in Vaccine Management, June 2012 Explores vaccine storage & handling, inventory management and eligibility in the Vaccines for Children (VFC) program Storage and Handling concerns: Improper temperatures, unapproved storage units, expired vaccine stored alongside non-expired vaccine Posted on the OIG website at: 1

2 Vaccine Management is Important Vaccines prevent some serious, sometimes fatal diseases Vaccines that are not properly stored and handled can result in: Failure to protect children & adults Monies lost to replacing vaccine & possible revaccination, office resources----losses are Costly! Embarrassment to providers & staff Loss of patients trust in your clinical judgment Potential liability to providers The vaccine we gave you last week was not stored properly and may not protect you from disease. To make sure you are protected, we need to give you another dose. 2

3 Vaccine Management is Essential What is the bottom line? Key Points on Storage Equipment and Vaccine Management Vaccine Equipment Necessities Vaccine Storage units must: Be in good working order Less than 10 years old Have enough room to store the year s largest inventory Have enough room to store water bottles or frozen packs Be able to maintain required temperatures year round Be dedicated to vaccine storage No food or beverages should be stored in unit 3

4 Storage Unit Grade (Know the GRADE that is best for vaccine storage) Pharmacy Grade or Purpose-Built Refrigerator or Freezer Units Recommended as best option for vaccine storage Intended to store medications/other biologics Nearly all the internal space in the unit can be used! Good temperature recovery when unit is opened to get vaccines Self sealing doors to prevent door being ajar Household Units or Commercial Units Intended for food storage Only 30% of space is acceptable for vaccine storage Exposure to freezing temperatures have occurred in combination units Household or commercial refrigerator-only and freezeronly units will have more usable space than a combination unit Best Practice Best Practice is to have two pharmaceutical grade or purposebuilt stand-alone units to store vaccines Stand-alone means self-contained units that only refrigerate or freeze and are suitable for vaccine storage Stand-alone frost-free freezer is preferred Can vary in size, from compact to large stand-alone Size needed depends on amount of vaccine inventory 8 Examples of Stand-Alone Units 4

5 Are You Using a Dorm Style Unit? Dormitory-style units can NEVER be used to store vaccine under any circumstances Dorm style is a small combination refrigerator/freezer unit with one exterior door and a small interior freezer How about Household Combination Units? If a household combination unit is being used, the first thing to do is: Use only the refrigerator compartment of a combination unit to store refrigerated vaccines Purchase a separate stand-alone frost free freezer to store frozen vaccine Why? Studies have found that that the freezer portion cannot hold proper temperatures Next step, begin to plan moving towards the best practice goal Example of a Household Combination Unit 5

6 Temperature Monitoring is Key! FACT: Your Storage Unit is Only as Good as the Temperature Monitoring System Inside It Thermometer Necessities Thermometers must: Be calibrated Have a Certificate of Traceability and Calibration Testing Certificate must not be expired Be in good working order Examples of Temperature Monitoring Devices Maintain refrigerator temperature at 35 F (2 C) to 46 F (8 C) Best safety margin temperature is 40 F (5 C) Maintain freezer temperature at 58 F ( 50 C) to +5 F ( 15 C) Best safety margin temperature is 0 F ( 18 C) 6

7 Best Practice What is the Goal for Thermometers? Have a external mounted digital data logger with a detachable probe that is in a glycol-filled bottle Meeting CDC s current standards such as: Minimum/maximum temperature readings High/low alarms, low battery indicator Why? Glycol-encased probes provide a more accurate temperature Provides continuous monitoring of the storage unit Allows downloading of temperatures without removing probe from unit Examples of a Digital Data loggers Ensure Digital Data Logger meets current CDC guidelines Further information at Temperature Monitoring Basics Each storage unit should have its own thermometer Staff must understand how to use thermometer and warning lights or indicators Place thermometer in center of the unit near the vaccines Monitor & document temperatures in refrigerator & freezer unit twice a day In the a.m. when clinic opens & minutes before leaving for the day Record minimum/maximum temps every morning If using a digital data logger, download stored temperatures to your computer weekly for review Download sooner if data logger alarms 7

8 Have an Emergency Response Plan Keep Vaccine in Original Boxes Have a Backup Vaccine Coordinator Ensure Vaccine Efficacy and Help Prevent Vaccine Errors Label Each Box Remove Expired Vaccine Assign a Vaccine Coordinator Store Vaccine in Center of Unit Have a Vaccine Management Plan Know Your Resources Vaccine Storage Practices Ensure all vaccines are delivered during office hours Store only vaccines in storage units Keep vaccines in their original boxes with lids in place Do Not store vaccines in plastic bags or sealed containers Separate & clearly label each box By age: childhood, adolescent, adult By purchase type: Private or VFC If diluents are packaged: With vaccine; then store together in refrigerator VFC DTaP Ages: 6 weeks through 6 years Use for: Any dose in the series Route: Intramuscular (IM) injection Example of a vaccine label Separate from vaccine; then store at room temperature or in refrigerator Consider installing alarms and back-up generators 8

9 Don t Let Vaccines Expire! Monitor vaccine and diluent expiration dates Check vaccine expiration dates weekly Rotate stock frequently move to the front & use what will expire first Verify expiration of vaccine inventory by visually inspecting the vaccine box Never use expired vaccine or diluent! Expired vaccines and diluents should be removed immediately from the storage unit! If expiration date is marked with only a month/year: The vaccine or diluent is good up to the last day of the month indicated on the vial Remember: Call your local health department: Before buying new vaccine storage equipment Ask questions regarding vaccine storage and handling Request free staff training in your office Know your vaccine management resources: CDC Storage and Handling Toolkit MDCH handouts and resources 9