Nitrazine paper QC solution
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Our midwife clinic would like to use nitrazine paper. What QC material are other locations using for this test?
Thank you!
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We use standard 5 and standard 7 as the weekly controls.
We use pH buffers 4.0, 7.0, 10.0. We put them in little squeeze bottles and label them and they QC the strips every 3 months and either document it in the Nova glucometer or on a log sheet.
What is the manufacturer for these pH buffers?
We’re using a swab that is coated with nitrazine called Amniotest. It’s individually wrapped but sensitive to light. This item together with different levels of buffer that can be used for QC is from ProLab. The QC is in a 5ml squeeze bottle. We run daily QC so no IQCP required.
In case you didn't know, Amniotest is moderate complexity. We ran it for a few years as waived, then were cited by CAP.
We have amniotest as well, but our midwives clinic only has a PPM CLIA certificate, so they can only have the nitrazine in that location.
For those running QC less than daily; does that require having an IQCP plan? I thought CLIA required daily QC...
It is a moderately complex test so the training will need to be initial, 6 mos then first full year. After which an annual competency.
IQCP will be required for any test system that is running LESS QC than what CLIA requires (daily).
I am struggling to explain reasoning to an OB provider that is adamant about using Amniotest rather than nitrazine pH paper for initial PROM screen. Due to cost of amnisure, our OB unit often "pre-screens" using pH paper before Amnisure. the pH paper is wavied been using it for years with no issues. OB provider says use it in their office (PPMP CLIA) and it is a waived test under 83986QW. I know that by specific review of manuf. it is not waived. see screens below. However i honestly don't understand why Amniotest is not an "all qualitative color comparison amniotic fluid" no response via Pro-lab 800 number for US on IFU. I have logged a chat to get email response on complexity, validation etc.
I fought this a couple of years ago - same provider and won but I am losing this round. Any input on the Amniotest is appreciated.