Managing temperatures in the hospital laboratory setting is a process that requires forethought and vigilance in order to positively affect operations. Proper refrigeration of reagents, microbiological materials, blood products, urine, etc, is essential to maintaining the integrity and stability of these elements. To facilitate this, a perpetual process for monitoring and maintaining temperatures in laboratory refrigeration devices is necessary.
Margaret Mary Health (MMH)—a not-for-profit critical access hospital—provides emergency services, maternity care, outpatient rehabilitation, home health, oncology, and hospice services for the community in Batesville, Indiana. In providing these services, the MMH laboratory works closely with its providers to improve patient care by ensuring blood, urine, tissue samples, and reagents are stored and processed with the highest safety and quality standards. Integral to these activities is acquiring, optimizing, and maintaining medical-grade refrigeration devices.
Importance of Monitoring
The foremost priority in maintaining quality standards for laboratory refrigeration devices (including the blood bank) is implementing an automated and self-documenting temperature monitoring system in order to properly maintain consistent temperatures within specified ranges. Sustaining the integrity of blood products is highly dependent on this concept, and regulatory bodies mandate many of the actions that enable this. However, simply having a robust monitoring system is not enough; the devices themselves must be properly operated and maintained in order to maximize their utility.
Within the blood bank and throughout other temperature-dependent disciplines of the lab and the greater hospital, MMH employs a 24/7 temperature monitoring system for refrigerators and freezers, as well as room temperature and humidity levels where applicable. This system wirelessly transmits real-time data to onsite and/or remote computers, including advanced alert functions to notify the proper personnel in the event of an emergency. Furthermore, color-coded temperature viewing and paperless reporting for trend analysis, corrective actions taken, and historical data are available to specified users.
Proactive Device Control
When approaching the management of temperature-sensitive products, our lab adopted Lean and 5S principles, and labeled all products so they could be visually identified quickly.
Furthermore, our monitoring system allows for simplified inventory control of all temperature control devices within the facility by displaying the name of the device, its specific location, the current temperature and date/time stamp of the last temperature reading, the specific temperature range for that device, and the sensor ID number. If a device’s temperature ventures out of its specified range, an alarm pop-up will flash on the computer screen of the individual department responsible for that device and its contents. The pop-up indicates the name of the device, the severity of the alert, the time that the alert occured, the outermost value, and the specific temperature at the time of the alert.
A feature that has proven beneficial for both internal protocols, as well as external regulatory mandates, is that the system allows for online documentation of corrective actions and houses this data for the necessary legacy. Temperature excursions can be the result of both human and technological errors. A door may be mistakenly left ajar, in which case remedial actions are fairly straightforward; however, a technological breakdown may require more significant remediation. If, for example, the system identifies a problem with one of the device sensors, an email is automatically sent to our plant operations department (POD), as would be the case for all battery and communication-loss alerts. Rapid response to such indications is vital to the integrity of medical-grade refrigeration devices, as the key to maximizing their life span is found in proper operation and proactive maintenance. This includes reviewing historical data for possible trends indicating malfunction. Most refrigeration devices do not fail all at once; rather, smaller breakdowns will slowly accumulate until the device becomes untenable. Therefore, the best method for maintaining well-functioning equipment is to discover variances as they begin to happen and respond aggressively with repairs.
Refrigerator Cleaning and Maintenance
Given that several laboratory practitioners rely on refrigerators and freezers for product and specimen storage, we utilize a team approach for overall device cleaning and non-mechanical maintenance (the POD manages scheduled maintenance and any unforeseen mechanical issues). A section leader manages the coordination of preventative maintenance, but every one of our 30 staff members share responsibility for maintaining time-dated and organized units. We also have a team comprising 11 lab assistants who are responsible for cleaning the devices. This lab-based team wipes down the exterior and interior of each laboratory refrigeration device as needed to remove residue and keep all surfaces clean. General surface cleaning, including wiping down handles, occurs multiple times a day using a bleach cleaner. An obvious benefit of having a laboratory team (as opposed to housekeeping) perform basic, scheduled cleaning is their understanding of proper safety protocols for and knowledge of the products and reagents being stored. Certain refrigerated products need to be handled in specific ways, so when, for example, a blood bank refrigerator’s interior needs to be cleaned, the section leader for the blood bank will perform this task. She cleans one shelf or area at a time in order to minimize the temperature change impact of removing those products from the device. These cleanings are always performed during down periods—ie, on weekends, nights, and during expected lulls in workflow—to avoid interruptions to testing.
In the event a refrigerator malfunctions and needs to be taken out of service for repair, its contents are transferred to another refrigerator that is monitored and maintained under the same standards. Laboratory personnel are responsible for the transfer and organization of the contents, and their knowledge of the sensitivity of those contents helps make this process safe and expedient. The POD arranges any mechanical repairs or replacements, either internally or through the manufacturer, and the lab and POD teams work closely to communicate the progress of the repair and the date and time the device will be placed back in service.
When cleaning certain refrigerators or freezers, personal protective equipment (PPE)—including gloves, a lab coat, and goggles—may be necessary, depending on the nature of the cleaning. For refrigeration devices that store blood products, reagents, and biohazardous materials, we clean all surfaces with a health care–specific, bleach-based germicidal cleaner. The towels used for cleaning can be disposed of via regular trash if no biohazard fluid can be extracted through squeezing. If the towel is saturated, then it must be disposed of in biohazard containers. Likewise, in the case of a biohazard spill, appropriate, facility-wide policies and procedures (P&Ps) would be enacted. In the unlikely event that a spill occurs, all staff would be protected by their PPE and would follow specific SOPs for clean-up, depending on the extent of the spill. If a person is exposed to a biohazard substance during cleaning or transfer, we also follow the exposure control P&Ps (in addition to the spill clean-up P&Ps).
Keep in mind that regulatory agencies are highly likely to inspect your refrigeration devices; thus, it is important to ensure that they are organized, well maintained, and clean. It is quite common for inspectors to request temperature records, as well as P&Ps, so it is prudent to periodically review temperature records to ensure they clearly communicate compliance, and likewise ensure that temperature-related P&Ps include a detailed plan for downtime events and precise steps for addressing any deviations from established temperature ranges. Having this information well organized and easily accessible will contribute to a smooth inspection experience.
Given the versatility of modern, medical-grade refrigeration devices, there are certain features that can positively affect maintenance as well as regulatory compliance. These include rollout baskets or shelves for easy product access and organization, glass doors for clear visibility of the interior without having to open the device, stainless steel handles and parts for durability and ease of cleaning, an external visual monitor and alarm, and digital temperature chart recorders. Customizing the interior of each device with a combination of shelving types based on the products being stored will help maximize utility.
Ultimately, in order to establish an effective, facility-wide temperature maintenance program, a team approach is necessary. Therefore, the key departments that rely on refrigeration, such as lab, pharmacy, nutrition services, radiology, and nursing services, must work closely with facility operations or engineering staff to develop and implement a system-wide plan for temperature continuity and conformity to regulations, as well as compliance with each department’s governing agencies.
Annette Gillman, MT(ASCP), is the laboratory manager at Margaret Mary Health in Batesville, Indiana. She received her bachelor of science degree from Marian University in Indianapolis and is a member of CLMA. Annette’s professional interests include customer service, teamwork, Lean initiatives, leadership, and continual process improvement.
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