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20-Jul-2017 03:27

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It lists the following condition: "Plasma and platelet components prepared from Whole Blood collections or collected during apheresis procedures from these donors should NOT be distributed for transfusion."We asked for a clarification concerning donors who are on topical versus injectable and long-time platelet donors who are not "seeking" phlebotomy to reduce their red cell mass.The response from the FDA was: "The alternative procedure approval requires you collect ONLY red blood cells from any donor who provides the information that they are on prescription testosterone.If the Product QC Lab is performing any additional testing that is subject to CLIA, then the facility must have someone who meets the TC requirements to perform competency assessments.CMS: For moderate complexity testing, the facility must have personnel who meet the TC qualifications.In the example provided in the question, if the donor donated on Monday the 7th, they would then be eligible to donate again on Monday the 14th. Question 4: How long should the deferral period be for a donor of Apheresis Platelets if the collection is intended to be a single unit with a target yield of 5.0 (using a historical platelet count), yet during processing the collection is split into 2 products based on acceptable volume and platelet count?

The personnel who meet the TC qualifications are eligible to perform competency assessments; they do not have to be identified as the TC.

We advise individual blood centers to consult with their medical directors and come up with decisions they would like to make concerning these scenarios. And so for all other questions that need clarification, a phone call back to FDA should help.



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