Written Procedure Requirements
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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 mean I can pull out parts that we use frequently, like QC timing, and then say refer to package insert for more detailed specifics and have my labs put the package insert in their lab binders with the short version written procedure with the lab directors signature?
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