Many medications require tight management of their storage temperatures, as excursions either above or below the required range may result in adulteration, leading to therapeutic failure or waste. According to the 2016 State of Pharmacy Automation survey, 83% of facilities have automated their temperature monitoring, with more than half opting for wireless systems.1 It is our hope that sharing stories of how organizations have implemented automated temperature monitoring may inspire the remaining facilities to do so. Because temperature-sensitive medications often require storage outside of the pharmacy, precise, continuous temperature monitoring is necessary to maintain confidence that the medication remains viable. In addition, automated temperature monitoring ensures that data is readily available, easing regulatory compliance.
Cone Health is an integrated, not-for-profit health care network located in the Piedmont of North Carolina. A large, comprehensive health network, Cone Health has more than 100 locations, including six hospitals representing 1254 acute care beds. In addition, Cone Health operates three ambulatory care centers, three outpatient surgery centers, four urgent care centers, a retirement community, more than 100 physician practice sites, and multiple centers of excellence. These locations are supported by 11,000 employees, 1300 physicians, and 1200 volunteers.
The flagship hospital, Moses H. Cone Memorial Hospital, is a 536-bed teaching facility and referral center, which includes a pediatric emergency department, level II trauma center, and centers of excellence in orthopedics, neurosciences, stroke, and heart and vascular care. Committed to education, Moses Cone and other hospitals in the Cone Health Network provide physician residency training, as well as PGY1 pharmacy residency training in acute care and ambulatory care, PGY2 training in cardiology, oncology, infectious disease, and ambulatory care, and a combined MS/PGY1/PGY2 health-system pharmacy administration residency program. Cone Health is the only health system in the nation to offer an ASHP-accredited PGY2 pharmacy residency in neonatology. The Moses Cone hospital pharmacy operates a robust distribution model with unit-based cabinets supported by carousel technology and inventory management software, as well as an EMR system.
Challenges in a Manual Process
Prior to implementing wireless temperature monitoring (WTM) and standardizing monitoring policies, Cone Health utilized various workflows to accomplish temperature documentation and continuous monitoring. The primary approach consisted of health system employees manually documenting temperatures in a daily paper log. Depending on the area, this documentation was completed by nursing staff, pharmacy staff, or a mixture of both. Policy required that temperatures be logged once daily for typical refrigerators, while refrigerators storing state-supplied CDC Vaccines for Children had their temperatures logged twice daily. Corrective actions for any out-of-range temperatures were also documented on the log sheet in a separate, designated section.
Additionally, several medication refrigerators were connected to the hospital’s automated dispensing cabinets (ADCs) via software modules. Select modules continuously logged temperature readings via built-in sensors, which sent alerts to the server whenever a temperature was out of range. These alerts were addressed at the server level, and documentation of corrective action was completed at this time as well.
Both temperature monitoring approaches presented challenges. The central problem with using a manual documentation process is the human element; staff may forget to check or document temperatures. Temperature logs were occasionally incomplete, missing temperature documentation, corrective action documentation, or both. An additional concern was covering areas of the health system that did not have a reliable 24/7 service—for example, for those areas that were closed on weekends and holidays.
Remote temperature monitoring via the software modules was also inconsistent. Pharmacy was the only department routinely using the Web-based server, and the department did not have adequate staffing and standardized workflows established to routinely search for out-of-range temperature alerts. Also missing were standardized pharmacy and nursing procedures to perform the corrective action(s) needed when out-of-range temperatures were identified.
Gaining Buy-In and Choosing a System
Administration support to implement WTM was easily obtained. In fact, due to findings of a recent accreditation survey, hospital administration had mandated that a viable alternative to our system be established. A thorough assessment was performed for each facility within Cone Health, with a member of the pharmacy staff walking the floors to identify possible probe locations. The total number of temperature monitoring probes required to bring all refrigerated medication storage locations under surveillance was presented to system-wide pharmacy leadership.
Pharmacy personnel were ultimately responsible for selecting a temperature monitoring system. The initial plan was to purchase medical-grade refrigerators for use in the pharmacy concurrent with implementation of the WTM system and then replace non-medical grade refrigerators in other patient care areas over time. Potential vendors were researched, then pursued more in-depth via phone interviews and trade show meetings. Evaluating ease of use, cost, peer recommendations, configurability, notification structure, and customer support, pharmacy closely examined the top three choices. At this point in the process, IT, nursing, organizational accreditation services, and facilities management were also involved to help identify any incompatibilities with selection and/or implementation, and determined the WTM system that best fit the needs of the health system.
Teamwork and communication were crucial throughout the implementation process. While pharmacy served as the lead, nursing assisted in fielding initial alarm calls, IT supported the wireless network, facilities management provided mechanical support for refrigeration, communications initiated the alarm algorithm, and organizational accreditation services helped ensure regulatory requirements were met. All departments worked together to develop the implementation algorithm and a new policy and procedure (P&P).
Partnership with the vendor played an important role in staff training and system setup and deployment. Pharmacy worked in tandem with the vendor to take the lead in the physical implementation of the temperature monitoring probes, individually deploying them to each of the designated refrigerator locations.
The Moses Cone Hospital piloted the initial WTM system deployment. Once proof of concept was confirmed, a total of 61 probes were quickly deployed throughout the Moses Cone campus.
Not long after implementation, it became clear that Moses Cone was experiencing a high number of temperature excursions. Alarms sounded excessively, indicating a high frequency of temperature excursions. Despite attempts to regulate the temperatures, the data revealed the refrigerators consistently were either too cold or too warm. To address this, the probe placement was assessed, but after repeated testing, it was confirmed that probe placement was not the problem. Team members noted that the medical-grade refrigerators in the pharmacy were not experiencing these temperature excursions. The problem soon became obvious: The non-medical grade refrigerators were less likely to maintain consistent temperatures. The immediate purchase and deployment of pharmaceutical-grade refrigerators was necessary for all hospital areas.
The realization that significant additional capital outlay would be required was not a welcomed finding. However, data provided by the WTM system made it easy to illustrate to administration the severity and frequency of temperature excursions. The data clearly warranted replacement of the non-pharmaceutical grade refrigerators. Luckily, not all refrigerator units at the Moses Cone Campus needed to be replaced, but for those units requiring replacement, the quote was significant. Prices for the various campuses were obtained and medical-grade refrigerators were ordered and installed.
With the new refrigerators and temperature-monitoring system in place, a new method for handling alerts was required. Because the WTM system first went live within the pharmacy prior to going live throughout the rest of the hospital, pharmacy personnel managed alerts. Designated pharmacy staff was trained to troubleshoot issues and given access to the cloud server to document corrective actions. Eventually, all medication refrigerators in patient care areas were phased onto the WTM system. Key pharmacy personnel monitored refrigerator activity in these areas and assisted with adjusting refrigerator temperatures and temperature probe locations to ensure the capture of accurate and consistent data. However, it became apparent that expansive training would be required of all frontline users to address temperature alerts throughout the hospital.
Key stakeholders from pharmacy, organizational accreditation, IT, and facilities management convened to develop a workable plan for addressing alerts (see FIGURE). This group identified a need to consolidate notifications and training to a select, core group of employees. The hospital’s central calling team, known as the Service Response Center (SRC), was assigned ownership of addressing WTM alarms. The team currently addresses similar issues throughout the health system, so it seemed a logical candidate to address WTM excursions as well.
Presently, all notification alarms are routed to this team. Our notification algorithm directs them to contact the specific problem area(s) in the event of an alert. The SRC team completes all corrective action documentation within the server after resolution is completed; if the alert cannot be resolved rapidly (eg, inoperable refrigerator due to mechanical failure), SRC contacts facilities management to initiate an appropriate resolution. The department where the refrigerator is located is contacted to validate whether the product(s) is still viable and if a move to an alternate storage location is needed while the repairs and/or replacement is completed. Consolidating all training and alerts to the SRC team standardized the process for addressing alerts outside of the pharmacy.
The health system-wide P&P was updated to include the new WTM technology and workflow (see P&P on page 22). Currently, the only required system maintenance is annual probe replacement and recertification, which the vendor provides. During our first recertification process, only pharmacy medication refrigerators were active on the system. Pharmacy personnel were responsible for replacing the probes and returning the used ones to the vendor. Moving forward, facilities management has agreed to handle probe replacement on an annual basis. If the sensors begin to malfunction, a supply of sensors is available, and the vendor will replace faulty sensors as needed.
Benefits of WTM
Immediate benefits were realized with WTM implementation. The system standardized data collection, alarm notification, and resolution documentation. The Cone Health System now has a standard algorithm to follow when managing temperature excursions. The burden of managing the complex system of refrigerated medication storage locations is streamlined, and responsibilities are shared among a collaborative group. Web-based access to data and reports allows for immediate data recall, which simplifies regulatory compliance. Most importantly, we have peace of mind knowing that medications are stored at the proper temperature and will be effective for patients.
WTM implementation allowed us to leverage technology to simplify the management of a complex process. Collaboration among departments, proper planning, and effective communication were essential elements of the project. Ultimately, the implementation of system-wide, automated temperature monitoring ensures that every refrigerated medication in the Cone Health system is adequately monitored, thus guaranteeing medication viability at the time of administration.
James Mundy, PharmD, is the assistant director of pharmacy—operations at The Moses H. Cone Memorial Hospital in Greensboro, North Carolina, a 536-bed community teaching hospital and flagship hospital for the Cone Health Network. Previously, he was the assistant director of pharmacy—sterile products, manufacturing, and perioperative services at The Moses H. Cone Memorial Hospital. Jim received his PharmD from Campbell University.
Robert P. Granko, PharmD, MBA, is the director of pharmacy at The Moses H. Cone Memorial Hospital. He is also the director for the Cone Health Network Health-System Pharmacy Administration/MS PGY2 Residency Program and maintains an academic appointment at the University of North Carolina Eshelman School of Pharmacy. Bob received his BS in pharmacy from Long Island University School of Pharmacy, his Doctor of Pharmacy from the University of North Carolina School of Pharmacy, and his Masters in Business Administration from Pfeiffer University School of Graduate Studies.
Michael Hayes, PharmD, MBA, is the clinical pharmacy manager at the Annie Penn Hospital, a 115-bed rural community located in Reidsville, North Carolina, part of the Cone Health Network. He received his PharmD from the University of Nebraska Medical Center College of Pharmacy and his MBA from East Carolina University.
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