Invest in a robust temperature monitoring reporting system. At Virginia Mason Medical Center (VMMC), we review the probe follow-up report that details each instance a probe goes out of range—as well as any corrective actions taken—on a weekly basis. Moreover, our current temperature monitoring system provides the enhanced capability of compelling staff to respond to out-of-range alerts within a specified time period. When an alert occurs, it is first transmitted by either pager or e-mail to the first responder; if that person does not take immediate action, they receive another alert 15 minutes later. If no response is forthcoming, the system then contacts the first responder’s manager. Needless to say, this system is very effective at prompting immediate action. After pharmacy responds to the alert, the action taken to rectify the situation is recorded in the system.
The expired tasks report—which specifies all tasks that were not addressed through all three levels of alerts—is reviewed monthly; however, because the probe follow-up report is so thorough, the expired tasks report is typically quite sparse.
Automated temperature monitoring simplifies regulatory reporting tasks. In the event of a TJC audit, the record provided by the probe follow-up report establishes compliance, because each event and its remedy is logged. As recent TJC audits have focused closely on the responses to out-of-range alerts, implementing a temperature monitoring system with mature reporting capabilities is a worthwhile investment.
Automated reporting also simplifies regulatory compliance with state vaccine programs and investigational drug services. Our pediatric department receives state supplied vaccines, and we are required to demonstrate control over their storage environment. To maintain compliance with the program, the vaccines are stored in specific refrigerators. On a monthly basis, we email a PDF of the graph demonstrating the actual temperature for that unit to the program administrator. Likewise, for investigational drugs, we can easily supply graphical data demonstrating temperature control for investigational drug storage, be it refrigerators, freezers, or ambient temperature in the storage room.
Establish a clear chain of command for managing the temperature monitoring systems. When our current temperature monitoring system was implemented, it was assumed that pharmacy would be responsible for the system and we used this to our advantage. At that time, many of our refrigerators were non-medical grade, so each alert from one of these residential units was another reason to justify to administration the cost of purchasing medical grade refrigerators. This pursuit worked well; now all of our refrigerators are medical grade and perform at a much higher level than our old residential units.
While it may seem self-evident that pharmacy should assume responsibility for managing the temperature monitoring system, in hindsight, this was an error on our part. Rather than addressing each alert proactively, pharmacy’s involvement should be limited to instances where a unit has been out of range for a length of time. If a staff member has propped a door open on a unit, it is more efficient for a maintenance or engineering employee to follow up on that alarm than it is for a pharmacist to visit the unit to investigate. Of course, pharmacy should certainly be involved anytime an alert indicates that product stability may have been affected.
Recalibrate probes regularly. At VMMC, we currently monitor 108 temperature probes and we expect to add more in the near future. Each probe is recalibrated annually to ensure it is operating within acceptable limits. By performing this maintenance on 10 probes each month, pharmacy can avoid recalibrating all 108 probes at once.
For the recalibration process, we use a highly accurate professional digital thermometer to verify temperatures; if the refrigerator temperature and the probe temperature do not match, we recalibrate the probe to the correct specification. Be sure to test the temperature in the probe’s exact location to ensure analogous readings.
Although pharmacy staff currently conducts all recalibrations, in the future we would like to transition this responsibility to the biomedical engineering team, as they have expertise in this area.
Create a specific, succinct temperature monitoring policy and procedure (P&P). VMMC is in the process of revamping its temperature monitoring P&P, as our previous iteration grew so lengthy that staff members did not read it. We are rewriting the new P&P to be concise, yet specific to refrigerators in all areas.
William Eidsmoe, BS, RPh, serves as the manager of pharmacy informatics and investigational drug service at Virginia Mason Medical Center in Seattle, Washington. He received a BS in chemistry from the University of Puget Sound and a BS in pharmacy from the University of Washington.
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