Ocular pH Implementation Supply Questions

Hi Ken,
Your post is timely for me because it’s been awhile that we had any doc/provider asking for pH paper in “the eye kit” but just got one today in an urgent care.
What I know is limited about 2 or 3 levels of QC but my understanding is that you follow your state regulations unless the manufacturer requires it. Texas requires only 2 levels so we leave out middle QC.
Our program is fairly large so unless we do it at the testing site to train or troubleshoot, here, a POCC does not take perform routine QC.
You are asking two questions I was going to ask so hope someone chimes in.
I actually got in to check and see about past posts on the because I was pretty sure the info has been posted in the past.

Hi Ken,
My facility uses pH paper in the ED (ocular) and strips in the GI areas. POCC performs QC to ensure completion. I use 3 levels of pH buffer, 4,7 and 10. The pH paper range is 0-12 and the strips are 0-14. Both are ordered from MicroEssentials company. They also have buffer solution. The state of Maryland requires QC to be performed weekly. I just use the Thermo Scientific buffer solution from the main lab.
Not sure what the reason of choice is for the paper and the strips as both were here before me. 
The paper and strips are only used by the Providers (I hope) so competency is not too bad.
Good luck with your new project, Ken!

Our system uses MicroEssential pH paper 1-12 and 2 controls for pH, Fisher Chemical Buffer Solution 4 and 7. We chose these levels due to the pH levels for determining action and treatment. Do follow Peggy's advice and know what your State requires. The Buffer Solution is bought by the bottle and delivered to POC. We aliquot and label accordingly and send via courier to our locations with a paper QC log. Our locations for eye pH are Emergency Departments and Urgent Cares. These pH tests are ordered in the patient's EMR and enter/edit resulted by the Provider.

Erika

Hi all,
I did want to come back and note that my Urgent Cares went forward with doing a POC Request to use pH paper in the eye kits.
I appreciated all the info posted to Ken!
I did get answers to my 2 questions I tried asking FDA source. A fantastic CLIA employee for my state (reported 'did some digging' with FDA) found what I needed (questions: using the FDA waived testing list, no pH paper I was checking for use was listed by brand; is all pH paper included as 'various' (on the FDA list), and is eye fluid included in the description 'body fluid' as a waived test). Per their 'dig in', I have been assured that FDA does consider all pH paper as waived testing; and FDA/CMS includes the precious eye fluid in 'body fluid' definition. I'm proceeding to add the testing to all the Urgent Care CLIAs.
We are also going with MicroEssential pH paper wide range. 
Peggy

CLIA Listing of Waived tests 2017.pdf

1650-160 Spec Sheet #934 pHizatest.doc.pdf

Hello all,
Our POC just had a meeting with Labor and Delivery regarding the use of the Amniotest Nitrazine swabs.............a moderately complex classified test. We would like to switch them to pH paper. I had the same questions about the CLIA waived status of pH paper as I ran into the same issue as Peggy in that the paper is not listed by brand on the CLIA site. Very frustrating.
I am hoping the attached PDF files may be viewed by anyone reading this post as I got some information from MicroEssential as well. We are going to get the pHizatest for quick detection of rupture vs. non rupture with amniotic fluid. It's WAIVED! Yay!
Thanks, Peggy for revisiting this topic as it's hot on our list as well.
Erica

Hi everyone,
Just wondering what reference ranges are you all using? Did you have to do a study to determine the range within your population? I've read in an article that normal tears range from 6.5-7.6 with a mean of 7.0.

Crisane