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Hello Everyone, For Point of Care test kits that are CLIA Waived, our policy has always been to run external controls on every new lot, every shipment of the same lot, and monthly. We are CAP accredited. In the instructions for use (IFU) package insert most of our kits do not state that monthly quality control is required. Have you removed the monthly quality control requirement from your policy? or do you still choose to perform monthly QC?
BD Veritor System for Rapid Detection of Group A Strep, for example: BDVeritorQC.JPG
Our facility continues to perform QC minimally once per month. It validates the integrity of the kit that has been sitting at RT, and develops a routine- less opportunity to forget.
I have my departments run QC on the kits when they open them and again monthly on any open kits. Exactly for the same reason that Autilia stated. It validates the integrity of the kit that has been sitting at room temperature.
We use 3 kits: UA HCG, UA Dipstick and QuickStrep. The HCG and Dipstick IFU's both include monthly QC while the QuickStrep IFU doesn't mention monthly. For the reasons cited in previous comments and to remain consistent, all kits on the floors must be QC'ed monthly.
Hello! I'll take a unique stance here. :) If the manufacturer doesn't mandate it, we don't implement it. We have a strong and well-supported POC team (thanks to my health system), and I prefer to invest that cost in the quality oversight of the program as a whole. Best, Mary
We don't implement lot to lot QC testing unless it's a manufacturers requirement. We do require monthly QC ran on some instrumentation due to performing QC is an annual competency requirement. This gives operators a chance to meet the requirement.
I'm with Mary on this one, if it isn't required by the manufacturer, we don't do it. I've done away with monthly QC on a few of our waived tests where it was not required.
We only run QC monthly on waived kits/tests that are required by the manufacturer's IFU. Most of the POC testing have built-in QC monitors....Urine Preg, Strep, Mono, Flu, RSV and SARS. The internal QC is recorded along with the patient results - which covers the recording of QC each day of patient testing.
For the reasons cited in previous comments and to remain consistent, all kits on the floors must be QC'ed monthly.