Vaginal pH testing
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What is everyone using for vaginal pH testing? Our providers want to use the Amniotest swabs, but because it is moderately complex, I am hesitant to go that route. Are there any good waived tests out there, or most places just using pH paper?
Thank you!
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Hi Cindy,
Sadly, also due to CLIA complexity and CLIAs held, we are just using pH paper in a few fam meds and all the Women's and ObGyn clinics.
How are you performing PT on the pH paper?
We got rid of pH testing on L/D about a year ago. They have the ROM test in the lab.
It took some work, but now the L/D areas were fine. ROM is far more sensitive and specific and is not impacted by urine that may be in the field. Also, L/D educators eliminated all of the manual direct demonstration comps for the pH Swab.
( I am calling it a pH swab because I always get the name of the pH swab confused with one of the ROM tests-but the swab I am talking about is non-waived.)
We would not allow the ROM kit tests out of the lab due to expense and comps.
I agree with Diana on the availability of other more specific tests. For AmnioTest, you might consider emailing CMS for clarification. My recollection is that there was a vaginal pH swab that had been approved around the transition of moving CLIA test complexity designation from CDC's purview to that of the FDA. You might check to see if CMS has provided guidance to their surveyors on review of swabs for visual pH determinations that is in alignment with visual pH test strips.
LabExcellence@cms.hhs.gov
Megan
We actually purchase the CAP survey for pH testing. Comes 2x a year with 3 samples.
I previously just made up unknowns for this purpose.
CAP has told me the only pH PT they offer for our vaginal pH test using the pH paper is the AFL survey. The range on this survey is wider than the paper we are using (Microessential Lab Hydrion S/R 0.0-6.0 pH paper). For our test I need the increments to be 0.5. I am now creating unknowns but was hoping for an alternative.
Ours just want to know Ruptured or NOT. The AFL survey is working okay for us.
Is vaginal pH testing with paper considered waived testing?
Sent via Groupsite Mobile.
83986QW All qualitative color comparison pH testing - body fluids (other than blood) Various pH detection (acid-base balance) in body fluids such as semen, amniotic fluid, and gastric aspirates
Hope this helps, Mary
Peggy
We use pH paper as a procedure, not a test.
While we are on the subject of pH paper, does anyone have a package insert other than a letter on the Nitrazine or Nitratest pH paper. (Bristol-meyers)
Thanks
Bonnie
I have contacted the Bristol-Meyers company before about a package insert and all they would give me is an SDS sheet. We also tried to use pH paper (Nitrazene) as a procedure instead of a test and got crucified by joint commission in December, so I wouldn't recommend that route........
This is procedure we use with Nitrazine paper
Do you happen to have the JCAHO standard that was referenced in procedure vs test?
They cited WT.03.01.01- "Staff and licensed independent practitioners who perform waived testing have been trained for each test that they are authorized to perform. The training for each waived test is documented." Our thought process with classifying it as a procedure instead of a test was that we would not need to have traing/competencies or do a validation. We use nitratest paper for vaginal pH and eye pH and it is largely used by residents which are a nightmare to keep up with.