Recording refrigerator temperatures twice a day with paper logs was long the standard practice for monitoring vaccine and patient nutrition storage. Yet that system has significant drawbacks. Not only is it a challenging process to monitor, but it also takes staff away from direct patient care responsibilities, and actions taken by staff in response to out-of-range temperatures often go undocumented. Most important, paper log recording makes it difficult to respond to out-of-range temperatures in a timely fashion to prevent drug loss, particularly with off-site clinics that are closed at night and on weekends.
At Mercy Health System, we averaged two to three drug loss events per year due to out-of-range temperatures from refrigerator malfunction or power failure, at a cost of $3,000 to $15,000 per incident. Notably, these are the only times we were aware that the temperature went out of range. The question we were unable to answer was: How many times did refrigerator temperatures go out of range when a clinic was closed, only to return to normal by the time the clinic reopened? With three acute care hospitals and 38 clinics in northern Illinois and southern Wisconsin, we were looking for a method that would provide 24/7 monitoring of refrigerator temperatures throughout our health system and enable us to respond in real time to prevent potential drug loss and to insure product integrity.
Starting the Process
In 2009 we convened an interdisciplinary team—comprising pharmacy, facilities, IT, risk management, clinic directors, communications, and nutrition—with the objective of establishing an integrated system-wide process to ensure the safe and proper storage of all refrigerated medications and patient nutrition. After evaluating several available technologies and workflows, the team chose to pilot the use of independent battery operated continuous monitoring devices. This process provided 24/7 continuous monitoring; a vast improvement over the manual log system, but ultimately, that approach was not the solution to our problem, for a number of reasons.
First, the system required us to perform manual downloads, offering little labor saving compared with the paper logs. We also found that when the device sounded an alarm for out-of-range temperatures, it was a challenge for staff to consistently respond, both because the alarms were too frequent and because no particular staff members were assigned the responsibility of addressing the alarms. Once the alarm was silenced, the staff was instructed to place a work order with the facilities department to check the refrigerator and sensor, but we found over time that it was often unknown whether facilities responded, and if so, what action was taken. Moreover, there was no alert when the sensor batteries wore out, thus we often assumed the device was recording temperatures, when in actuality the battery was dead and no monitoring was occurring.
Dissatisfied with this system, in 2010 the team considered more advanced wireless systems, with priorities including robust hardware and software, and utility of the system design. The team identified five key features to consider when selecting a wireless system:
After reviewing the available sensor systems, Mercy invited several vendors to present their products to the team. Ultimately, after a comprehensive search, Mercy chose to use a single vendor for the entire system. The monitoring system uses an automated and synchronized Internet protocol (IP)-based technology enabling secure remote system monitoring over an organization’s existing Wi-Fi or wired Ethernet network. The software platform allows for continuous monitoring, recording, and reporting of data from various IP-based refrigerator temperature monitoring devices.
The team initially piloted the product within sections of the main hospital, while the rest of the system continued using paper monitoring. It took approximately one year to test and develop the policies and procedures (P&Ps). Once the test was deemed successful, a pro forma was submitted and approved to expand the technology throughout the entire health system. The team deployed the project in phases. The first phase included the installation of sensors in refrigerators throughout the main hospital. The hospital switchboard staff would receive email and pager alerts from sensor locations where refrigerator temperatures were out of range. The switchboard monitored the sensor alerts 24/7 and contacted the facilities department as needed. They would then document the alert, the responding staff member, the action taken, and the time when the temperature returned to its proper range.
One Size Does Not Fit All
As we deployed the system to our other hospitals and clinics, we learned that what was successful at the main facility did not necessarily apply to our other locations. One of our primary challenges was to systemize a process that allowed for continuous monitoring of off-site clinic and hospital locations that did not have 24/7 on-site facilities, with the monitoring handled by a call center able to adapt to the increase in monitoring and alert response workloads.
Implementing wireless temperature monitoring was a learning experience; we found that installing the sensors in the refrigerators was simply the first step. The key to a properly functioning system is the development of comprehensive P&Ps. We also learned that those procedures couldn’t ensure that the technology is used correctly without designating the team members accountable for the procedures. As we deployed the temperature monitoring across our health system, our policies went through many variations, finally resulting in our current robust P&P. Our policies define when the alerts are generated, who receives those alerts, and the process for notifying the responsible parties off hours, particularly in the clinics. We learned that when accountability goes undefined, and a refrigerator malfunctions during off hours, the systems fail.
To resolve these issues, we turned to our nurse health line, which is essentially a 24-hour call center, and they helped us develop a process for the identification of and response to alerts. The call center monitors alerts in ways similar to the hospital switchboard staff process, but from a multi-site perspective. Responding to temperature alerts generated when clinics were closed created a challenge for the team, but was ultimately resolved by use of a staff call tree. Off-hour alerts are sent to the call center staff, who then reach out to the assigned parties on the call list, usually the clinic director or nursing staff. If no response is received to the initial call, they will continue through the call list in order, making a call every 15 minutes. If there is still no response after two cycles through the call list, they contact the administrator on call. Given the significant vaccine inventory in many of the clinics, a malfunctioning refrigerator left unaddressed can lead to considerable financial losses. The clinic directors are responsible for assuring proper response to the alert, including safe transport of the vaccine to an alternative refrigerator storage location if necessary.
Once the temperature-monitoring system was in place system-wide, it became evident that we needed additional oversight to assure timely response to alerts and to maintain the integrity of the monitoring system, including documentation of actions taken by staff in response to alerts. The call center staff took on that oversight responsibility, which included the creation of two reports sent weekly to all department leadership. One report lists unresolved sensor alert notifications that lack documentation of action taken by staff. We follow up on these cases to determine the action taken before listing them as closed. The second report, often referred to as the “sensor ignore list,” is a listing of sensor devices that are placed on temporary inactive status by clinic staff due to a malfunctioning sensor or refrigerator, from which the medications have been removed while awaiting repair of the defective unit. That unit remains on the ignore list, meaning alerts from that sensor are disregarded, until the clinic notifies us that the repair is complete. There is a small risk with this approach that if staff fail to inform the call center when a device has been repaired, valid alerts might be disregarded. As a result, we emphasize the importance of strong communication between the clinic staff and the call center.
Better Safety, Better Compliance, No Drug Loss
Today, we have 24/7 monitoring in more than 278 refrigeration units throughout our system, allowing us to react in real time to out-of-range temperatures, improving medication safety as well as compliance with TJC and Vaccines for Children (VFC) guidelines. In addition, our staff is now free to use the time spent manually monitoring temperatures on other tasks. (Keep in mind that VFC still requires paper logs in addition to continuous monitoring for its vaccines.) We have achieved 100% compliance to required documentation, including actions taken, and 100% of our sensors are functional and reporting, with back-up procedures in place should a sensor malfunction. Perhaps most important, since implementing wireless temperature monitoring system-wide, we have had no drug loss due to temperature changes. We have had a clinic refrigerator malfunction on a weekend, but because of our system and procedures, the clinic director was notified in a timely fashion and we were able to relocate and save the vaccines.
Given the value of wireless temperature monitoring and the success driven by our procedures, we are now applying this technology to other temperature-monitoring needs. For example, we have placed sensors in the surgical suite warmers to monitor the warming of IV solutions prior to administration. The parameters and the temperature ranges are different, but the alerts and our process for responding to them are the same, underscoring the strength of our model. We will continue to consider new applications and ways to improve our process. Yet with the right tools, procedures, and a committed team, we have implemented a wireless temperature monitoring protocol across our diverse health system that has allowed us to free staff for more patient-focused tasks, as well as react in real time to temperature warnings, preventing drug loss and enhancing medication safety and patient care.
Don R. Janczak, MS, PharmD, BCPS, CPHQ, is the director of pharmacy at the Mercy Health System in Janesville, Wisconsin. He is also an instructor in advanced pharmacology and therapeutics at the University of Wisconsin–Milwaukee College of Nursing. Don received his pharmacy degree from the University of Illinois–Chicago.
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