QC Range Verification QSA.02.07.01
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Hi All,
Working on TJC accreditation and trying to figure out how to be compliant with this requirement. At our facility the end user units order their own supplies and thus we have lots of different QC lots going at any given time. We currently do lot-to-lot comparisons for most devices (epoc, HMS and Hemochron), but were never able to achieve that with ABL. The requirement is:
The laboratory determines through repetitive testing the statistical parameters for each lot number of control material, including mean, standard deviation, and coefficient of variation. The parameters are documented.
It also says that we have to determine our own QC ranges - which we can't do with POC devices - so just documenting in our QA policy that we use manufactuer ranges and why.
Does anyone have any ideas on how to verify QC ranges if you don't order the supplies? To me this means that the calculations need to be done prior to using the lot, we do get these numbers with monthly LJ review - does a retrospective review count?
Thanks for reading!
Working on TJC accreditation and trying to figure out how to be compliant with this requirement. At our facility the end user units order their own supplies and thus we have lots of different QC lots going at any given time. We currently do lot-to-lot comparisons for most devices (epoc, HMS and Hemochron), but were never able to achieve that with ABL. The requirement is:
The laboratory determines through repetitive testing the statistical parameters for each lot number of control material, including mean, standard deviation, and coefficient of variation. The parameters are documented.
It also says that we have to determine our own QC ranges - which we can't do with POC devices - so just documenting in our QA policy that we use manufactuer ranges and why.
Does anyone have any ideas on how to verify QC ranges if you don't order the supplies? To me this means that the calculations need to be done prior to using the lot, we do get these numbers with monthly LJ review - does a retrospective review count?
Thanks for reading!
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I believe your lab director can determine if they want to use the manufacturer's ranges.
If not, maybe it is a good idea to talk to your lab director to centralize the ordering to ensure that the quality of the controls or reagents are acceptable.
This is a common citation/deficiency.