We are a hospital based Donor Center and up until now, have had our monthly Q.C. testing for platelet apheresis product pH performed on equipment in the chemistry department. Last year a software update to the patient testing equipment resulted in not being able to result a pH when the value was close to the minimum 6.2 required. So, we reverted to the old pH meter method. At this time, this equipment is being taken out of service in the Chemistry department, as it is only used for us.

We can move the equipment to the Blood Bank and QC our own products, and keep control material available, but for less than 20 tests per month, I am wondering if it is possible to use pH strips of some sort to do this testing.

Are any of the donor centers on this forum using pH strips? If so, which strips and may I get a copy of your procedure?

Does anyone use an I-Stat to do this Q.C. testing?

Thanks

I used to work in a hospital based Donor Center and we did all our pH testing with pH strips. We just QC'd them each day of use using Urinalysis QC shared by that department. It's been 3 years but I doubt much has changed.

Thanks for the response. I just heard from my local FDA contact and was told that the FDA did not allow use of pH strips...I have asked for documentation.

In the meantime, we have decided to "appropriate" the old pH meter from chemistry and test in the BB.

In the FDA Guidance for Industry for Collection of Platelets by Automated Methods, Page 8 of the PDF version states "we recommend that a pH meter or gas analyzer be routinely used rather than pH (nitrazine) paper."

http://www.fda.gov/cber/gdlns/plateletauto.htm

And yes, we all know that these guidance documents are "nonbiding recommendations" and not the law...

Thanks for the reference, I did not remember that there was information on pH testing methodology in that guidance.

We use a very simple pH meter called the IQ 125. It's cheap and easy to use.

Hey J, we also use a very old meter that is only being kept for us. We only do about 50 pHs on it a month, but the upkeep is very minimal as well as the QC material lasting for over a year. This is for monthly QC only. We use the BAC-T for our bacteria detection. (collection facility)