Internal QC Documentation requirements

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Our hospital practices were originally Joint Commission accredited just like our main facility so I made sure that the practice labs followed the JC regulations.   For JCAHO, we made sure that the internal QC was always documented along with each rapid test result (flu, strep, HCG, etc.) just like we do in the main lab. Since then the decision was made to not have the practices accredited by JC so now I only have the CLIA regulations to follow.  I still have the personnel document the internal QC because CLIA requires that manufacturer's instructions be followed and the package inserts state that the internal QC must be acceptable for the test to be valid.  Is that an accurate interpretation?  For those of you with CLIA only practices, do you require internal QC documentation for each test performed?

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Since you use Joint Commission as your accrediting agency, you should check out chapter QSA for these requirements.  However, CLIA does require you document every
internal QC as well.


We don't use Joint Commission any longer at the practices, they are only CLIA certified.  Do you have a reference in CLIA documents for the requirement to document internal QC?

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Susan LaFevers
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