Among the many daily duties within the clinical lab, temperature monitoring was historically one of the most tedious and error-prone activities performed by staff, regardless of their experience. It often required lab personnel to record equipment temperatures at multiple times throughout the day and/or night. One common method involved placing a thermometer inside an equipment chamber and then opening the chamber door to observe and record the temperature at specific intervals of time. This practice not only exposed samples and reagents to outside air, causing temperatures to fluctuate and rise, it was the exact opposite of what temperature monitoring is intended to do.
Over time, lab management and automated programs established better ways to maintain sample integrity and adhere to lab protocols so that the importance of temperature monitoring is never overlooked or at risk because of human errors.
Methods of temperature monitoring
Aside from the aforementioned thermometer, other options for temperature monitoring may have been considered more reliable, with some still in practice today.
Marigale Walsh, Director of Merchandising at MarketLab, said, “Traditional methods relied on thermometers, chart recorders and digital meter/data loggers. Thermometers were read at established intervals with manual documentation. Chart recorders have also been used in the past and are still very popular. Digital recorders with varying degrees of sophistication have also been in place and offer additional benefits and convenience, but also have some downfalls.”
The importance of temperature monitoring methods isn’t lost on Michael Hanssens, Director of Business Development at Rees Scientific, who pointed out some of the key features of successful automated temperature monitoring systems.
“It continuously logs temperature, humidity and other environmental factors in critical lab equipment. It protects valuable assets, efforts and products. Along with real-time monitoring, it provides automated daily printouts, alarm notification, audit trails and complete data encryption to help meet compliance.”
Monitoring lab temperatures today
In the same way that the temperature of the clinical lab industry changes over time, so have the options for temperature monitoring within the same labs. While tried-and-true, hands-on methods remain, other methods offer the confidence and accuracy provided by automated solutions.
Joe Arteaga, Director of Product Management – Controlled Temperature Technologies at Thermo Fisher Scientific, asserted that one of the most common and preferable methods of temperature monitoring today is “wireless monitoring solutions that offer 24/7/365 continuous monitoring and alarm notification, even during a power outage. These types of systems are scalable, so they can be designed to monitor one lab, or an entire enterprise with multiple locations and multiple brands of equipment. In clinical environments, a system that is also compatible with the FDA’s 21CFR Part 11 initiative is extremely important.”
Also referencing industry requirements is Mark Fauber, Product Manager – Continuous Monitoring at MesaLabs, who pointed out that, “Today, the most explicit requirements for temperature monitoring in a healthcare environment are published by the Centers for Disease Control (CDC) publication titled Vaccine Storage and Handling Kit dated January 2020. Monitoring systems meeting the requirements of the CDC’s publication are easily adapted for use in a wide variety of applications including the clinical laboratory.”
Fauber added, “The use of third-party automated monitoring systems is all but a requirement for laboratories, hospitals, blood banks and other testing and production industries today. These systems allow for real-time notification of out of specification (OOS) conditions and allow for the rescue of stored materials before they are lost. Automated monitoring systems also allow for thorough data gathering and investigation of non-conformances through access to historical data and reports that are saved in their databases.”
In addition to adhering to established protocols for temperature monitoring, close attention also needs to be paid to the condition and age of lab equipment and its capacity to carry out temperature-related procedures.
Colleen Holtkamp, Market Manager at Helmer Scientific, reminds lab professionals, “Temperature monitoring is critical for ensuring compliance and quality. The use of medical-grade cold storage designed for clinical applications is also essential. Equipment that is not medical-grade, such as dormitory and commercial-grade units, may not provide the temperature uniformity or performance required to safeguard stored products.”
She continued, “While automated central monitoring is common, many clinical labs still rely on chart recorders as part of their overall monitoring program. In addition, some labs require medical-grade units that offer local monitoring capabilities with features such as automatic alarm testing and the ability to download event logs and PDF temperature graphs. These features help ensure the integrity of stored products and improve efficiency by saving time that can be spent on more productive activities.”
Established standards and protocols
When looking to the generally accepted best practices for temperature monitoring, lab professionals have many existing standards and protocols in place that allow for industry compliance requirements to be met.
Thermo Fisher’s Arteaga asserts that, “In clinical environments, there are a few critical elements that need to be considered.” Among these is the use of independent sensors – a second confirmation that the temperature on the equipment’s display is accurate, and FDA 21CFR Part 11 compatibility, which addresses electronic signatures and records.” (Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application)
Helmer’s Holtkamp adds, “Capabilities such as automatic high and low temperature alarm testing help support regulatory compliance. For example, the College of American Pathologists (CAP) now requires a record of the temperature at which the alarm activated during an alarm test. Electronic records, such as a downloadable event log, provide an effective and efficient means of maintaining compliance.”
According to Rees Scientific’s Hanssens, there is a wide range of standards for compliance from the CDC, WHO and FDA. Some of the best practices include: “keep valuable assets at an ideal temperature 24 hours a day/7 days a week, accurately record temperatures daily, report out-of-range temperatures immediately, keep a diary of all events, ensure instant notification of alarms and keep results for at least three years or according to individual state requirements.”
Fauber of MesaLabs pointed out, “SOPs and compliance issues vary widely and thus it becomes difficult to truly assess ‘best practices’ for temperature monitoring between labs, hospitals and other industries. There are specific guidelines for the different areas, and even those may be interpreted differently by the management, state or other regulatory agencies.”
MarketLab’s Walsh said, “Everyone needs to be held accountable to ensure compliance with established protocols. While this sounds obvious, strict adherence to best practices is critical, but this needs to be consistently checked and monitored with a schedule developed by that particular lab. There must be a quality management program written into standard operating procedures.”
She continued, “Nothing can be taken for granted. Everything needs to be documented and addressed before there is a temperature monitoring breakdown or a procedure not followed. If not, there could be potential loss of irretrievable specimens and very expensive reagents.”
Looking to the future
As the clinical lab industry watches the horizon for new temperature monitoring products and technologies to come, some forecasts would have all eyes looking to the clouds.
Arteaga said, “Clinical labs are starting to adopt remote temperature monitoring that is cloud-based so that they can stay more connected to their equipment. If a unit alarms, personnel can now receive notifications through email/text so that they have time to take action to protect their samples.”
Concurring, Fauber added, “Cloud-based services, such as Software as a Service (SaaS) and Platform as a Service (PaaS), continue to grow at 20 percent plus annually and are now well accepted in the healthcare industry. Cloud-based monitoring systems provide a cost-efficient and highly reliant system easily adapted from a single site clinical lab to a large, geographically dispersed lab provider.”
He added, “Another trend in monitoring systems is the emergence of multi-purpose sensors, or universal transmitters, capable of monitoring multiple different parameters, in addition to temperature, with a simple change of probe type and programming. This flexibility helps to decrease the complexity, maintenance and cost of automated temperature monitoring systems by allowing for an existing sensor to be repurposed without the need to purchase a new one.”
Walsh summed up, “In many cases, temperature monitoring has moved to electronic-based systems. When standard maintenance and compliance are strictly enforced, the best offense is a good defense. And when maintained properly, the clinical lab can quickly address an issue before it becomes a problem.”
