Precision Dx multi panel urine drug testing point of care
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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.
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Hi Melva, we recently worked up a policy/practice for a multi panel drug test on urine for one clinic. We also have WT with Joint Commission. The product the requesting MD suggested/preferred does not include external QC in the IFU; however, we did add routine use and on the QC log included a section to track the number of times the QC product is brought to room temp for use (limited by QC IFU). The QC product is also used for operator competency.
If your manufacturer's instructions for use do not mention external QC, then it is not required. However, it is good laboratory practice. In our procedure, we require external QC per new lot/shipment, and we also use external QC for operator competency as Peggy stated. It also is a check on shipping and storage of the kits.
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