Temperature tracking and review
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Ok CAP labs, how are you interpreting these checklist items and what are you doing for temperature review? Our whole lab needs to review processes and I need to make sure my off sites match that process. Some of us are reviewing temp reports monthly, some not. We use a continuous monitoring system so I think there is different interpretations of what is required.
COM.04200 Instrument/Equipment Record Review
The laboratory director or designee reviews and assesses instrument and equipment maintenance and function check records at least monthly. DO YOU CONSIDER FRIDGES/FREEZERS EQUIPMENT AND YOU REVIEW TEMPS EACH MONTH?
COM.30750 TEMPERATURE CHECKS (this is paraphrased)
The laboratory monitors and records temperatures using a calibrated thermometer as defined in written procedure. NOTE: Temperature-dependent storage devices and temperature-dependent environments where reagents, supplies, and patient/client specimens are stored within a specified temperature range must be checked daily. Use of a continuous monitoring device or a minimum/maximum thermometer satisfies the requirement for daily temperature recording, including during laboratory closures (eg, weekends, holidays), as long as the monitoring data is evaluated on the next business day prior to use. If an automated (including remote) temperature monitoring system is used instead of manual temperature monitoring, laboratory personnel must have ongoing immediate access to the temperature data so that appropriate corrective action can be taken if a temperature is outside of the acceptable range. System records must demonstrate daily functionality of the automated system in accordance with manufacturer's instructions. This does not require routine daily review of the system records. CONFUSED ABOUT CONTINUOUS MONITORING(WE USE SMARTSENSE) - "MONITORING DATA IS EVALUATED ON THE NEXT BUSINESS DAY", "SYSTEM RECORDS MUST DEMONSTRATE DAILY FUNCTIONALITY BUT DOES NOT REQUIRE DAILY REVIEW"? HOW DO YOU DEMONSTRATE DAILY FUNCTIONALITY IF YOU DON'T REVIEW DAILY?? SHOULD WE HAVE SOMEONE BE LOOKING AT ALARMS/ERRORS DAILY FOR CORRECT FOLLOW UP?
GEN.41042 FRIDGE/FREEZER TEMPS
The laboratory monitors and records refrigerator/freezer temperatures using a calibrated thermometer daily. System records must demonstrate daily functionality of the automated system. THIS ESSENTIALLY RESTATES COM.30750.
COM.04200 Instrument/Equipment Record Review
The laboratory director or designee reviews and assesses instrument and equipment maintenance and function check records at least monthly. DO YOU CONSIDER FRIDGES/FREEZERS EQUIPMENT AND YOU REVIEW TEMPS EACH MONTH?
COM.30750 TEMPERATURE CHECKS (this is paraphrased)
The laboratory monitors and records temperatures using a calibrated thermometer as defined in written procedure. NOTE: Temperature-dependent storage devices and temperature-dependent environments where reagents, supplies, and patient/client specimens are stored within a specified temperature range must be checked daily. Use of a continuous monitoring device or a minimum/maximum thermometer satisfies the requirement for daily temperature recording, including during laboratory closures (eg, weekends, holidays), as long as the monitoring data is evaluated on the next business day prior to use. If an automated (including remote) temperature monitoring system is used instead of manual temperature monitoring, laboratory personnel must have ongoing immediate access to the temperature data so that appropriate corrective action can be taken if a temperature is outside of the acceptable range. System records must demonstrate daily functionality of the automated system in accordance with manufacturer's instructions. This does not require routine daily review of the system records. CONFUSED ABOUT CONTINUOUS MONITORING(WE USE SMARTSENSE) - "MONITORING DATA IS EVALUATED ON THE NEXT BUSINESS DAY", "SYSTEM RECORDS MUST DEMONSTRATE DAILY FUNCTIONALITY BUT DOES NOT REQUIRE DAILY REVIEW"? HOW DO YOU DEMONSTRATE DAILY FUNCTIONALITY IF YOU DON'T REVIEW DAILY?? SHOULD WE HAVE SOMEONE BE LOOKING AT ALARMS/ERRORS DAILY FOR CORRECT FOLLOW UP?
GEN.41042 FRIDGE/FREEZER TEMPS
The laboratory monitors and records refrigerator/freezer temperatures using a calibrated thermometer daily. System records must demonstrate daily functionality of the automated system. THIS ESSENTIALLY RESTATES COM.30750.
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We use SmartSense as well. Our lab documents the daily functionality of the system in an electronic qc program, a manual log would work as well. We log into the system daily to ensure it is working. Each department has alarms set up to notify the department of out-of-range temperatures so corrective action can be accomplished and documented. Additionally, a text and/or email is sent to the department supervisor if the incident has not been resolved after a defined period of time.
A monthly review by the supervisor is accomplished by running the monthly report for the assets and ensuring that the appropriate corrective action was accomplished. This is documented with our monthly Quality Assurance that is reviewed by our laboratory medical director.
Hope this helps,
Tim
Our CE department takes care of any and all maintenance records.
We monitor any cold storage or room temperature areas that contain POC reagents and equipment. Some of our refrigerators are monitored by the pharmacy dept. If there is an issue with pharm equipment, they have a protocol they follow for alerting the unit with the issue, and POC follows up with immediate issues and monthly review. For areas not monitored by the pharm dept, we have min/max thermometers to monitor temps and humidity. Nursing staff performs daily checks and manually logs the
information. If there is an issue, they contact us. At the end of the month, they send us their log sheets and we
review/sign off.
CONFUSED ABOUT CONTINUOUS MONITORING (WE USE SMARTSENSE) - "MONITORING DATA IS EVALUATED ON THE NEXT BUSINESS DAY", "SYSTEM RECORDS MUST DEMONSTRATE DAILY FUNCTIONALITY BUT DOES NOT REQUIRE DAILY REVIEW"? HOW DO YOU DEMONSTRATE DAILY FUNCTIONALITY IF YOU DON'T REVIEW DAILY?? SHOULD WE HAVE SOMEONE BE LOOKING AT ALARMS/ERRORS DAILY FOR CORRECT FOLLOW UP?
Pharmacy - continuous monitoring 24/7 - we are notified if there is an issue. For weekends when POC is closed,
we review any issues that Pharm alerts us to. If there is an alert and reagents have expired during that time, they are discarded. For i-STAT cartridges, they are dated and used before room temp expiration. We've never had an inspector question this practice.
I hope this helps you!