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I have a clinic that is joint commission accredited and they are doing the Precision Dx multi panel drug testing on urine.  I am just now being told and I am working on a policy, training and so forth however, my question is do these type of point of care kits due to being waived need to have external QC.  The information I am seeing doesn't mention however, I want to make sure with others that are more knowledgeable than me.  Thank you for any help guidance or assistance....

 I am working on revising our written procedure for all of our POCT we have. Our current written procedure has everything in from the package insert (Intended Use, Principle, QC, Storage & Stability, QC, Specimen Storage, Interpretation of Results, Limitations, Precautions, etc). Is that needed for Pennsylvania? I looked up on PA DOH and it states:  Must have written procedures for all tests performed (supplemental package inserts are acceptable).  Does that m...