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CLIA Regulations and the Donor world

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I'm currently looking for anyone who maybe able to give me some feedback about CLIA regulations and the donor world. 

To explain I'm working for a research company that is setting up a laboratory with a Certificate of Compliance to perform CBC's on donors prior to the collection of MNC's. All my experience is clinical and I have never worked in the donor world before. I'm wondering how some of the CLIA regulations apply. For example having a physician order for the CBC. I have reached out to our state CLIA inspector multiple times with no response, which is frustrating enough and I'm looking for some guidance. 



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Your medical director can be the orderer of the CBC required, as a standard procedure for your collections. 

I never really worried about the CLIA regs for donors.  My CLIA folks never looked at my donor stuff because I was FDA licensed and AABB accredited.  Most of my CLIA inspectors were not Lab trained (nurses usually).  Now the FDA uses mostly non-lab personnel also but they are rigorous in their scrutiny of donor operations.

They always seemed to care about temperatures being documented???  But hey - obviously you need to QA/QC your collections from the device, donor testing,  to the final product, including competencies of everyone involved.  As an inspector I tended to look at the Quality documentation. 

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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.

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