Temperature and Humidity Monitoring
12 Trials of Lab Quality – Tips for clinical laboratory professionals in implementing quality initiatives – By Jennifer Dawson, December 14, 2015
“Have you ever encountered a temperature log that seemed forgotten, with the last readings entered months before? What about a recorded temperature that is outside of the acceptable range with no corrective action to be found? Temperature records are not kept just for CAP compliance, though this is a requirement. The intent of monitoring temperature is to ensure that reagents, supplies, equipment, kits and specimens are stored at appropriate, validated temperatures to ensure integrity of testing for the patient.
In order to ensure proper temperatures are maintained, all items to be stored in a refrigerator, freezer or room must first be evaluated for proper storage temperature. This fundamental step is often overlooked. Do not assume that refrigerated means 2 to 8 degrees Celsius or frozen means -10 to -30 degrees Celsius. Manufacturers establish temperature specifications based on their own stability studies, and laboratories are obligated to follow these requirements.
Just as temperature monitoring is often ignored or done poorly, humidity monitoring is often overlooked. When humidity is found to be outside of acceptable ranges, often, no corrective action is implemented as potential solutions are seemingly too costly or complex. Has your laboratory performed a thorough evaluation of manufacturer and best practice stability specifications of temperature and humidity requirements for all reagents, kits, equipment and specimens? If not, your laboratory may have a serious compliance and patient safety risks lurking. “