MAJ. JELAUN NEWSOME
School of Army Aviation Medicine
Fort Novosel, Alabama
As a young and energized newly graduated and board-certified physician, I was naturally the “ideal” candidate to take over the vaccine program for the health clinic to which I was assigned. It would be my responsibility to oversee the program, which included ordering, storing and administering the immunizations. Along with my new role, I also was assigned as a primary care provider, medical director and supervisor to other personnel within the clinic.
When assigned the role, I was assured the daily monitoring and maintenance of the vaccines were handled by others. I was acting as a supervisor and just there for higher-level questions, decisions, complications and risk mitigation. As such, I left the daily operations to others, including monitoring the vaccine status, ordering replacement vaccines and immunization administration. I was available for questions and the occasional adverse reaction to allergy shots. As this was an additional duty and I already had a lot on my plate, I had not given much thought to the logistics of vaccine cold-storage or what to do with potential vaccine compromise or contamination.
On this particular day, the last physical check of the refrigerator temperature was at 0530. At approximately 0700, a Soldier heard the alarm sounding from the refrigerator, and the temperature was noted to be 10 C. The vaccines should be kept at a maximum of 4 C. As the supervisor, I was immediately alerted and all vaccines in the refrigerator were labeled as "DO NOT USE." They were then placed in a separate container and moved into a working refrigerator located immediately next to the malfunctioning appliance.
Based on the timeline, I estimated the vaccine would have been out of temperature tolerance for approximately 1.5 hours. I immediately contacted Defense Logistics Agency Troop Support Medical (DLA-TSM) and completed a Potentially Compromised (PC) Temperature Sensitive Medical Product (TSMP) Event worksheet. The information needed to determine if the vaccines were still safely useable is extensive. It includes, but is not limited to, information about the refrigerator where the vaccine was stored, vaccine packaging, the particulars of the potential loss event and specific details on the vaccine inventory (vaccine name, national drug code number, manufacturer, lot number, expiration date, dose quantity and cost).
After a thorough investigation, we determined all the vaccines were still safely usable. DLA advised us to store one of the specific vaccines in the freezer rather than the refrigerator and mark on the material that it experienced a prior excursion. The potential loss was classified as a “Non-preventable loss” and “Refrigerator/freezer failure — unavoidable or unanticipated.” The estimated value of the compromised vaccines was approximately $2,000.
Lessons learned
While the refrigerator power failure was unanticipated and unavoidable, this was a close call. There were several issues that could have gone better. First, the clinic had a secondary alarm system that was supposed to telephonically alert a point of contact if the refrigerator failed and went out of temperature tolerance. This did not occur. The only reason the out-of-tolerance temperature was limited to 1.5 hours was due to an alert Soldier who heard the alarm. If this happened over a weekend, the effects would have been magnified. Upon taking the role as the supervisor, I should have tested the system. Second, the refrigerator should have been on a backup power supply similar to other vital medical equipment in the clinic.
However, several aspects of the situation went very well. The alert Soldier astutely heard the alarm and immediately moved the suspect vaccines to another refrigerator. We also did not dispose of the vaccines until getting further instructions from DLA. If we had disposed of them prematurely, we would have needlessly wasted vaccines and money. Additionally, we fortunately had a relatively small number of vaccines stored in that particular refrigerator at the time, as we had just finished an immunization drive. If that situation occurred when we had a full stock, the effects would have been compounded.
After this close call, I held an informal after-action review. I recommended the refrigerator have a backup power source. Additionally, the clinic should require testing of the automated telephonic alarm system annually — or at least when there is a changeover of key personnel. This will ensure the system is up to date. I also reinforced the concept of not discarding any vaccine that is perceived to be out of temperature tolerance until it is properly investigated. We were fortunate to not lose this relatively small number of vaccines. However, we must understand this situation could also happen with larger institutions with larger numbers of vaccines worth a significant amount of money.