In the clinical laboratory setting, it can be easy to forget about proper temperature monitoring, despite the fact that such monitoring is an integral part of a clinical laboratory’s daily operations. The mechanisms and procedures designed to enable proper monitoring and maintenance of temperatures, both in the general laboratory environment, as well as in specialized areas and within engineering controls, tend to work behind the scenes, and rarely is their presence thought about unless a breakdown occurs. The vast majority of medical laboratories are required by their institutions and by regulatory bodies to maintain and monitor proper temperatures in the entire laboratory environment. These requirements are largely driven by the need to ensure the integrity of testing systems and reagents, and to protect inherently valuable samples and products.
Furthermore, the total laboratory environment must be monitored continuously. To handle this task, the lab must select the right components, know their advantages and limitations, ensure their accuracy to regulatory requirements, and maintain required records. Enabling these factors may require the implementation of new programs and systems or the augmentation of existing monitoring technology.
Effects of Temperature Fluctuation
Among the range of environmental parameters that must be accounted for are air pressure and flow, humidity, and, most important, temperature. Accurate and precise temperature recording over time is essential for many analytical measurements. Because most in vitro testing systems are biological in nature, the heightened sensitivity inherent to these practices requires stable and reliable temperature control conditions. The physical properties of certain products can change depending on temperature, and aspects such as the stability of reagents or the viscosity of aqueous liquids will vary if temperature ranges are not maintained.
Proper Calibration of Equipment
The process of recording and documenting temperatures and other elements in the lab is essential to both internal protocols and external regulatory mandates. Therefore, it is prudent to employ devices that provide a constant recording graph or computer data recording system with minimum/maximum thermometer capabilities in order to alert designated laboratory personnel to any temperature variances.
Likewise, all temperature measuring devices must go through calibration verification against a current National Institute of Standards and Technology (NIST) traceable thermometer or equivalent certified instrument when implemented and at least once a year thereafter. A proper calibration record should contain: a unique thermometer identifier, the temperature readings from both the certified thermometer and the test thermometer, criteria of acceptance, the results of the calibration, the date performed, an identifier for the person who performed the testing, and a comments section for any additional information. Any thermometers or recording devices that fail calibration should be removed from service.
Current Benefits and Future Capabilities
The latest wireless monitoring systems and medical-grade refrigeration devices have become quite sophisticated in the last decade, and are now capable of replacing manual monitoring and documentation processes, and providing robust system integrity. In addition, diagnostic, remediation, and repairs can be done quickly, in light of the random and unpredictable nature of technology failures.
Looking forward, refinements in the basic software of temperature monitoring and management systems will allow for the preprogramming of tolerances for short term fluctuations caused by the opening and closing of doors that would not otherwise affect the integrity of the contents. The probes in use today are so sensitive that alarm fatigue is a real possibility and can dull staff reaction to bona fide problems. Therefore, vigilance over these systems and preparation for emergencies remains vital. Given the increasing dependence placed on electronic devices for almost every activity in the lab, a thoughtful understanding of what effects a downtime scenario would have and what back-up mechanisms would need to be in place is invaluable. For today’s medical laboratory practice, current temperature monitoring an refrigeration systems are robust, cost-effective, and secure in both surveillance and documentation to provide peace of mind about product and testing integrity.
David McCormick is the managing editor of MedicalLab Management magazine. He can be reached at firstname.lastname@example.org
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