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Massachusetts Department of Public Health Training Module

Massachusetts Department of Public Health Training Module. Vaccine Management, Storage, and Handling. Presented by: Bob Morrison Vaccine Manager Massachusetts Department of Public Health November 16, 2010. 1. Learning Objectives. Summarize principles of vaccine management

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Massachusetts Department of Public Health Training Module

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  1. Massachusetts Department of Public HealthTraining Module Vaccine Management, Storage, and Handling Presented by: Bob Morrison Vaccine Manager Massachusetts Department of Public Health November 16, 2010 1

  2. Learning Objectives • Summarize principles of vaccine management • Describe current vaccine storage and handling recommendations • Describe preventative measures to maintain refrigerator and freezer temperatures • List steps to protect vaccine in the event of a power outage or emergency 2 LA DPH

  3. Vaccine Management 3

  4. Importance of Vaccine Protection • Vaccines are fragile-keep at recommended temperatures at all times to maintain potency • Mishandled vaccines increase the risk that recipients will not be protected • Vaccines are expensive • Vaccine Restitution Policy, effective 1/1/11 4 LA DPH

  5. Vaccine Management Guidelines • Develop and maintain detailed written protocols and emergency plan • See www.mass.gov/dph/imm for sample templates • Assign responsibilities to one person • Designate a back-up person • Provide staff training on vaccine management • Obtain proper equipment and materials LA DPH 5

  6. Vaccine Manager Responsibilities • Order vaccine and oversee inventory • Receive vaccine and refrigerate/freeze immediately • Provide proper storage and handling • Handle damaged, wasted and expired vaccine • Respond when vaccine is out of required temperature range • Contact MDPH Vaccine Unit to determine if vaccine has been damaged (617-983-6828) LA DPH 6

  7. Vaccine Inventory Management Limit access to authorized personnel Order vaccines regularly, do not stockpile Organize vaccine with shortest shelf life in front Conduct and log vaccine inventory monthly Rotate vaccines and monitor expiration dates 7 LA DPH

  8. Vaccine Inventory Management • Separate by lot numbers and formulations • Keep vaccines in original packaging to protect from light • Never use expired vaccine or diluent • Report vaccine usage if required • Return unused, expired vaccine and diluent if required 8 LA DPH

  9. Receiving Vaccine • Examine shipment immediately upon arrival • Report problems to MDPH within two hours • Check contents against packing slip • Check vaccine expiration dates • Examine contents for damage • Check temperature monitor • Immediately place in appropriate storage • Keep a shipping box on hand to use when returning any damaged or expired vaccine 9

  10. 10 CDC

  11. 3 Components of the Cold Chain • Proper transport and storage equipment • Trained personnel • Current vaccine management policies and procedures 11 LA DPH

  12. Maintain the Cold Chain Transport vaccine from refrigerator to clinic site in cooler with cold packs (not frozen packs) and thermometer Refrigerate cold packs for at least 24 hours before use in transport Keep vaccine on cold packs, but provide a barrier to protect from direct contact with cold pack 12

  13. Vaccinator Responsibilities at Station • Maintain the cold chain at vaccinator station • Injectable vaccine: max 30 minutes at room temperature • Intranasal vaccine: kept at 2 - 8° C (35 - 46°F) • Any vaccine drawn up must be used by end of clinic or be disposed of • Protect from exposure to light • Label opened unused vials with date and your initials 13

  14. Vaccine Storage and Handling 14 CDC

  15. General Vaccine Storage Requirements Have unit large enough to store your maximum vaccine inventory Dedicate unit to vaccines/medications only Monitor refrigerator/freezer temps for at least 3 days prior to storing vaccine Maintain required temperature range year-round Make arrangements for vaccine storage, monitoring temperatures and receipt of vaccine during vacations or other lengthy absences 15

  16. Vaccine Storage Units • CDC recommends separate refrigerator and freezer units for vaccine storage • For combination units, make sure there are separate doors and controls for refrigerator and freezer • It is recommended that units used to store vaccines be less than 10 years old • Have a certified calibrated thermometer inside both the refrigerator and freezer in a central area 16 LA DPH

  17. Maintain Proper Temperatures HANDLE WITH CARE! Maintain refrigerator temps between 2°-8°C or 35°-46°F Maintain freezer temps at -15 °C or 5°F or colder Protect from light 17

  18. Vaccine Storage & Handling Tips Do not store vaccine on unit doors Do not store biologics with food or drink Place thermometer and vaccine in central area of the unit Organize and label vaccine in baskets that allow air circulation Refer to package insert for specific guidelines regarding the storage and handling of different formulations 7/13/2014 18 LA DPH

  19. Acceptable Vaccine Storage 19 CDC

  20. Unacceptable Vaccine Storage CDC 20

  21. Unacceptable Vaccine Storage 21

  22. Certified Calibrated Thermometers 22

  23. Monitor Temperatures • Record temperatures twice daily • First thing in the morning • End of the work day • Temperature logs must be retained for at least 3 years • Monitor for out-of-range temperatures • Place temperature logs on front of unit • Submit temperature logs as required 23 LA DPH

  24. Out of Range Temperatures • All out of range temperatures require immediate reporting to MDPH Vaccine Unit 617-983-6828 or 617-983-6800 (24 x 7) 1-888-658-2850 • Actions and results of these actions must be documented on the temperature logs LA DPH 24

  25. Emergency Plan for loss of power • Develop an emergency plan • Share the emergency plan • Post the emergency plan • Update and practice your plan annually 25 LA DPH

  26. Power Failure • If you lose power for extended period, follow your emergency plan: • pack vaccine • transport to prearranged site • notify MDPH Vaccine Unit • When power returns: • do not adjust the temperature control in unit • allow unit to return to proper temperature range • return vaccine to unit LA DPH 26

  27. Temperature Adjustment 27

  28. Temperature Adjustment • Never adjust the refrigerator temperature control with vaccine in unit • Consult with MDPH Vaccine Unit • Remove vaccine to another refrigerator/freezer • Adjust temperature of unit • Wait until you have 3 successive readings one hour apart within range before returning vaccine to the unit 28 LA DPH

  29. Safeguard Power Supply • Use a plug guard or safety-lock plug • Place “Do Not Unplug” sign on storage unit, outlet and “Do Not Disconnect” on circuit breakers • Consider installing a temperature alarm • Do not use extension cords 29 LA DPH

  30. Safeguard Power Supply 30 CA DPH

  31. Safeguard Power Supply 31 CA DPH

  32. The Effect of “Thermotrauma” on Vaccines Live vaccine: Tolerates freezing (Call MDPH Vaccine Management Unit if this occurs: 617-983-6828) Deteriorates rapidly after removal from refrigeration Inactivated vaccine: Damaged by freezing Tolerates short time out of refrigeration 32

  33. Vaccine Shelf Life • Multi-dose vials of vaccine contain a bacteriostatic agent. • After opening, can be used until the date of expiration as specified by the manufacturer and package insert, unless visibly contaminated. • Date and initial multi-dose vials after opening and use first. • In the event the refrigerator/freezer temperatures are out-of-range, this is important in determining the viability of the remaining doses in the vial. • Always check the package insert for shelf life guidelines when opening multi-dose vials. • Single-dose vials do not contain a bacteriostatic agent. • Once opened, they must either be used or discarded at the end of the day.

  34. Storing Diluents • Diluents packaged separately from their corresponding vaccines can be stored at room temperature or in the refrigerator. • Diluents packaged with their vaccines should be stored in the refrigerator. • Once vaccines are reconstituted with a diluent, their shelf life is limited. 34

  35. Take-Home Messages Colder is NOT better for inactivated vaccines It is estimated that >$100 million worth of vaccine is exposed to freezing temperatures each year in the United States Out of range temperature readings require IMMEDIATE action Remove expired vaccine from refrigerator Report vaccine usage to MDPH Vaccine Unit: 617-983-6828 35

  36. Vaccine Storage & Handling Questions MDPH Vaccine Management Unit (617) 983-6828 MDPH Immunization/Epidemiology Division (888) 658-2850 (617) 983-6800 (24x7) Always consult with MDPH Immunization Program before removing improperly stored vaccine from the storage unit If the temperature of the vaccine goes out of range, either too high or too low, call the MDPH Vaccine Management Unit immediately! 36

  37. Please take a look at the other training modules! Vaccine and Medication Preparation and Administration Planning a Clinic/EDS/POD All-Staff Briefing & Just-In-Time Training Available at: http://sph.bu.edu/otlt/alliance/training_publichealthnursing.php 7/13/2014 37

  38. Online Resources MDPH Guidelines for Compliance with Federal and State Vaccine Administration Requirementshttp://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/guidelines_vaccine_compliance.pdf MDPH General Protocols for Vaccine Storage, Administration, Standing Orders, and Mass Immunization Clinics, Sept 2009http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/mso_protocols_general.pdf MMWR: General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices (ACIP), December 2006 http://www.cdc.gov/mmwr/pdf/rr/rr5515.pdf MDPH Vaccine Management Guidelines for Vaccine Providerhttp://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/vaccine_management_checklist.pdf 38

  39. Online Resources MDPH Immunization Programhttp://www.mass.gov/dph/imm Immunization Action Coalitionwww.immunize.org Epidemiology and Prevention of Vaccine-Preventable Diseases, The Pink Book: Course Textbook (11th Edition), May2009http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm#download World Health Organizationhttp://www.who.int/en 39

  40. Online Resources MDPH Sample Vaccine Management-Standards Operating Procedures (SOP)http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/vaccine_management_sop_sample.pdf Emergency Response Worksheet for vaccine storagehttp://immunize.org/catg.d/p3051.pdf Pediatrics “Standards for Child and Adolescent Immunization Practices” National Vaccine Advisory Committee, Pediatrics 2003: 112: 958-963http://www.pediatrics.org/cgi/content/full/112/4/958 40

  41. Online Resources • CDC: Vaccine Storage and Handling Toolkit http://www2a.cdc.gov/vaccines/ed/shtoolkit/default.htm • CDC: Vaccine Management Business Improvement Project (VMBIP); New Centralized Vaccine Ordering and Storage Requirementshttp://www.cdc.gov/vaccines/programs/vmbip/default.htm • MDPH: Vaccine Management Business Improvement Plan: Basic Guidelineshttp://mass.gov/EOHHS2/docs/dph/cdc/immunization/vmbip_basic_gu idelines.pdf • Los Angeles County Immunization Program, Vaccine Storage and Handling presentationhttp://www.lapublichealth.org/ip/trainconf/Vaccine%20Storage%20Handling.pdf 41

  42. QUESTIONS? Thank You ! 42

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