Amniotest Swabs
Our OB providers would like to implement this test. I see it is moderately complex. The OB providers are under a CLIA certificate of compliance with the lab (not a PPM certificate). I am getting ready to do the risk analysis for writing an IQCP. My question is since CLIA requires 2 levels of QC each day of patient testing, and the manufacturer clearly states in their insert that QC is NOT required, do I have to first follow the CLIA regs for a while and then write the IQCP or since it is a new test can I write the IQCP based on the validation data only. Thanks.
Malinda Feinauer MT(ASCP), | Laboratory Technical Specialist - POCT
SSM Health Dean Medical Group
Laboratory
1313 Fish Hatchery Rd
Madison, WI 53715
Phone 608.252.8246 | TL 5438246 | Fax 608.283.7376
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This test does not qualify for IQCP, because there is no control, electronic that is performed daily. You need to do QC Daily.
If you look on CAP to see the eligibility, AmnioTest doesn't meet the requirements for an IQCP. Just perform QC every day of patient testing and you're covered.
Better yet is skip the Amniotest and use Nitrazine paper. It is waived and does not require 2 level daily QC.
We did perform IQCP following CAP Eligibility Determination for IQCP Option flowchart.
Our state does allow IQCP, it is non-waived, it is not undfer Anatomic Path or Cytopath, it does have internal control process, and manufacturer allows for less external qc than default CLIA/CAP qc frequency.
As for trying to develop/use an IQCP initially vs running daily qc initially, that is really up to your lab.
The CAP IQCP eligibility does not require electronic qc, it can be electronic or procedural or built in controls.
Have you/they considered immunoassay testing? Much better accuracy