Learning Objectives for this Presentation:
By the end of the presentation participants will be able to develop a program for managing cold chain failure and for assisting the provider site to develop procedures for safe vaccine storage.


Background:
When cold chain failure is discovered at a provider site, the Quality Assurance (QA) staff and the provider staff must work together to resolve issues with serious and long-ranging consequences regarding vaccine viability and possible recall and re-immunization of affected children. In addition, Quality Assurance staff may be dealing with cold chain failure at multiple sites and must keep track of where each site is in the process of resolution.


Setting:
Pennsylvania is the fifth most populous state, with more than 1,500 private providers enrolled in the Vaccines for Children program.


Population:
Provider personnel at sites where cold chain failure has been discovered, either as a result of a QA site survey or by the provider site itself; also, patients who have received non-viable vaccine may have to be recalled and re-immunized.


Project Description:
The Pennsylvania Vaccines for Children program has developed standardized documentation of cold chain failure procedures to ensure that 1) The specific timeframe of the cold chain failure is documented accurately; 2) Vaccine viability is assessed; 3) An informed decision is made regarding recalling and re-immunizing children who received the affected vaccines; and 4) Circumstances leading to the cold chain failure are explored so that remedial action can be taken; and 5) The QA supervisor can track all cold chain failures from discovery to conclusion.


Results/Lessons Learned:
A systematic approach for addressing cold chain failure assures that all decisions are made on the best possible evidence, resulting in improved compliance for re-immunization.