Managing Cold Chain Failure

1. Pennsylvania Vaccines for Children Program Managing Cold Chain Failure Authors: Deborah Budney, RN; Mary Knowlton, MEd; Donna Singley, RN; Harryl Allen, BA

2. The Cold Chain Maintaining vaccine at recommended storage temperatures … Manufacturer Distributor Provider … from the manufacturer to the patient

3. Essential Components of Cold Chain Maintenance Equipment Management Protocols Trained Staff Emergency Plan

4. Cold Chain Failure in 2005 Number of VFC private provider sites enrolled as of December 31, 2005 Number of QA site visits in 2005 Number of cold chain failures that required remediation (Thirteen sites are proceeding with or have completed recall and reimmunization. One provider refused and one facility is pending) 1,431 532 15

5. Collaboration Provider QA Personnel Department of Health Consultant Vaccine Manufacturers

6. Review Objectively the Circumstances Leading to Failure • Temperature logs • Temperature reassessment during visit • Vaccine shipment dates • Inventory on hand • Equipment • Staff

7. Vaccine Cold Chain Protocols Provider QA Personnel

8. Suspected Cold Chain Failure Providers will follow protocols establishedin PA VFC Provider Alert • Providers advised to inventory all vaccines; place in appropriate storage; not use until viability has been determined • Contact the appropriate manufacturers • Depending on circumstances of failure a QA site visit may be conducted

9. Confirmed Cold Chain Failure Provider, QA supervisor, PA Department of Health will follow established protocols to: • Delineate and document the extent of the cold chain failure • Identify patients who received affected vaccine • Initiate a plan for recall and re-immunization

10. Delineating and Documenting Cold Chain Failure • Document specific times when temperatures were out of range • Document temperatures to which affected vaccines were exposed • Examine three years of temperature logs • Take inventory of vaccines on hand and plot against temperature logs

11. Establishing a Plan for Reimmunization • Identify patients who received affected vaccine • Initiate a plan for recall and re-immunization • Contact identified patients and/or guardians with • Purpose of recall • Need for revaccination • Information about available clinics and times for revaccination

12. Ensuring that Provider Maintains the Cold Chain in the Future • Research circumstances that led to cold chain failure • Suspend vaccine orders until safe storage is assured • Develop a written corrective action plan • Schedule follow-up site visits to confirm compliance

13. Tracking Cold Chain Failures to Resolution • Maintain a log of all pending cold chain failure remediation • Contact providers frequently to check on progress toward resolution

14. Lessons Learned A systematic approach for addressing cold chain failure • Assures that all decisions are made on the best possible evidence • Results in improved provider compliance for reimmunization • Aids in managing multiple incidents

15. In Conclusion … How can we best prevent breaks in the cold chain? • Utilize mailings to providers (i.e., quarterly newsletter, Kid Vac News) to address correct vaccine storage and handling practices • Provide educational resources during AFIX reviews • Visit as many facilities as possible to assess storage and handling practices