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Is it warm in here? CLIA requires that acceptable temperature (and humidity, if indicated) ranges for each testing and storage area be established based upon testing performed and/or materials stored in that area. Temperature (and humidity) must be monitored and recorded each day the facility is open. Calibrated devices must be used for this purpose and corrective action must be taken if a reading falls outside of acceptable limits. Action must be documented. Don’t forget to go back and take another reading to ensure that desirable temperature (or humidity) has been attained.A client using a battery-powered thermometer-hygrometer recently reported a sudden elevation in lab ambient temperature. Changing the batteries brought the readings back into acceptable range. Lessons to be learned: 1) Use a calibrated device for each testing or storage area. 2) When in doubt, check calibration. 3) Change batteries before discarding an “inaccurate” battery-powered thermometer or hygrometer. |
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