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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

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.

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.

Because your blood counts will generate "patient Data" they fall under CLIA. Proficiency testing, competency assessment, training, and operator qualifications all apply. You can meet the requirements by having a qualified laboratorian general supervisor, oversee all of the instrument maintenance, calibration, linearity and QC review. The laboratory Director will need to follow some of these things as in traditional patient-based lab. Who will be your "CLIA assessor" for this activity, AABB, CAP, Other? If you are going to be AABB accredited then AABB will assess your operation against the CLIA regulations. The laboratory Director can be responsible for ordering the CBCs. However if this research is clinical, the physicians sending their patients should complete the orders. All of this should be specificed into your research protocol and IRB submission.

Indeed! Keep up the good work! Scott