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CLIA Proficiency Testing

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Regulatory Requirements for<br />

Laboratories<br />

42 CFR part 493, Subpart H - requirements<br />

for laboratory participation in PT for<br />

nonwaived testing<br />

• For each regulated analyte or specialty without<br />

analytes, laboratories must:<br />

• Enroll in an approved PT program<br />

• Analyze 5 challenges per event<br />

• Obtain 80% for satisfactory score (most analytes)<br />

• Perform satisfactorily on 2 out of 3 testing events<br />

6

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