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Need some wisdom on an age old subject. AmnioTest vs pH paper
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.
I have 1 OB department utilizing the Accutest pH paper and another one who utilizes the AmnioTest. As far as my knowledge goes, AmnioTest is a moderately complex test whereas the pH paper is CLIA waived. I have not been successful in convincing the OB department who utilizes the AmnioTest to switch over to pH paper due to competency issues because of its moderate complex category. I'm not sure why AmnioTest is not considered an "all qualitative color comparison pH" but my OB who uses the pH paper results out patient results as only a positive or negative, but my OB who uses the AmnioTest results out patient results as a specific pH number. This way of resulting came about before I came into the POCC role. Does anyone else result out the pH paper as a positive/negative and not an actual pH number?
The pH paper procedure is to dip the paper strip into a collected sample to inoculate it : waived. The amnio test procedure has the swap being inserted into the vagina to inoculate it : non-waived = you can not have a CNA doing this. To my knowledge the L&D physicians do not collect a sample to inoculate the pH paper. I would not consider this a waived test.
I remember when ProLab Amniotest came out. The sales person sold it to us as a waived test. We call it Nitrazine paper in a stick. Then I found out it was a non-waived test. I called the company. They told me that they never applied for a waived status because it cost money. At the time everyone liked the paper in a stick and they did not want to go back to the piece of nitrazine paper that is awkward to use. We have to run QC using pH 4, and pH7 buffer solution. each day we have a patient. The TJC inspectors made sure we have a record of QC the day we tested a patient. WE now have Amniotest which the doctors like and they use it judiciously.
Pet, is the daily QC a paper form? Does the charting include lot #, exp date, and result? Is it a Nurse Enter/edit test? Or interfaced (Statstrip - QML- EMR)?
Our OB Triage department uses the AmnioTest swab in an algorithm with microscopy and ROM+. I've found some of our CLIA waiver/PPM clinics using the AmnioTest swabs as well which we then confiscate. Results are entered as Enter/Edit using the result interpretation verbiage from the package insert.
The amnio test procedure has the swap being inserted into the vagina to inoculate it : non-waived = you can not have a CNA doing this.
To my knowledge the L&D physicians do not collect a sample to inoculate the pH paper. I would not consider this a waived test.
Then I found out it was a non-waived test. I called the company. They told me that they never applied for a waived status because it cost money. At the time everyone liked the paper in a stick and they did not want to go back to the piece of nitrazine paper that is awkward to use.
We have to run QC using pH 4, and pH7 buffer solution. each day we have a patient.
The TJC inspectors made sure we have a record of QC the day we tested a patient.
WE now have Amniotest which the doctors like and they use it judiciously.
Our OB Triage department uses the AmnioTest swab in an algorithm with microscopy and ROM+.
I've found some of our CLIA waiver/PPM clinics using the AmnioTest swabs as well which we then confiscate.
Results are entered as Enter/Edit using the result interpretation verbiage from the package insert.