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Sue Arata

BACTERIAL TESTING FOR SD PLATELETS

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So...I have been seeing articles pertaining to new FDA regulations that will require bacterial testing on single donor platelets prior to transfusing. I would like to know if anyone is doing this in transfusion service areas of hospitals ( rather than in donor centers with initial testing)? If you are doing it in a hospital setting of transfusion services, what are you using for testing? From what I have surmised, this testing will be required prior to transfusion in addition to the initial testing. Does anyone have more information?

Thank you for your input.

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the way the guidance is written, the testing would only have to be done on days 4 and 5.  If the product was in your hands at the start of either day, you would be required to do the testing, if you transfused.

If you get it from you supplier on those days AND you transfuse it the same day, you do not have to because your supplier will have done it.  If you use it the next day, testing is up to you.

This is from a guidance which I do not believe has been formalized yet (could be wrong).

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5 hours ago, David Saikin said:

This is from a guidance which I do not believe has been formalized yet (could be wrong).

It is still in draft, and has changed (significantly) a couple of times.  It is rumored to be finalized next month.

This will create significant changes for all of us, I suspect we'll get a year to implement, same as the new Babesia testing requirement.  Our testing vendor isn't ready to offer it to clients yet.

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19 minutes ago, David Saikin said:

We've been getting Babesia neg units for about 3 yrs now.  

Same here, but it has been an investigational test until now.  FDA has mandated it for 13 states.  They gave us a year (I'm in Mass, we're a high risk state) to begin testing.

I suspect we will also get a year to implement whatever the new platelet guidance requires.

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Just to state the obvious, if you are using pathogen reduced platelets, no testing is needed.  That has been our choice due to (1) it's a superior method for preventing viral, bacterial, parasite transmission and (2) the logistics of testing 20-30 platelets per day are formidable and not without significant expense for materials, labor, QC, proficiency and competency.  If your supplier provides the option of pathogen reduced, I would go that direction despite the increased expense.

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The only test I know of is PGD (Pan Genera Detection) test by Verax.  We have not completed our validation yet because the logistics of implementing the test are extensive because I work in a children's hospital and we split our apheresis platelets into really small syringe aliquots for our NICU and CVICU so we use our platelets for the full 5 days.  The test takes about a 1.5 mL of platelets per test per 24 hours.  We have not implemented PAS platelets yet due to the fact that our primary vendor doesn't collect them yet and I have to build and validate them in our computer system (I am the only one who can build in our computer system and I am the manager and technical specialist as well).  I hope to build them into our next computer upgrade next year.  So the only plus I see from using the PGD is the potential to extend the expiration date of the apheresis platelets to 7 days but I haven't even looked at what that validation is going to require.  Verax is very good at providing all the information you need, however.

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With regard to PI with platelets, it is true you do not need to test the PI products but Babesia testing still needs to be done for RBCs collected in the 13 states of interest.

Regarding test strategies, some hospitals,eg Johns Hopkins, has opted to do secondary bacterial testing on day 4 rather than the PGD test.  Attached is a recent study covering the cost effectiveness of the approaches believed to be acceptable by the FDA.  However, as noted the Guidance is not Final. This paper is a good starting point though. 

platelets Cost effectiveness methods bacteria testing Transfusion 0419.pdf

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