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CLIA Final Rule Highlights

CLIA changes became effective April 24, 2003 and include the following:

* Procedures must include the date(s) of initial approval prior to use, any changes, and discontinuance;
* Laboratories must demonstrate accuracy, precision, and reportable range for FDA-approved test systems as they are brought on line rather than relying solely on manufacturers' data;
* Reference ranges must be verified for the patient population served;
* Manufacturer's instructions or CLIA regulations must be followed, whichever is more stringent for the specific test system;
* Quality control must monitor accuracy and precision of the "complete" analytical process, including environmental conditions and system operators;
* Methods with extraction phase (like rapid Group A Strep detection) must have at least one QC material that detects errors in that phase;
* Molecular amplification procedures must have at least one QC material capable of detecting inhibition when reaction inhibition is a source for false negative results;
* Quality control duties must be rotated among all personnel who perform each test;
* Published quality control ranges may be used, but must be verified by the laboratory;
* Quality control must be performed for each batch, lot, and shipment when prepared/opened;
* Quality control must be performed on susceptibility testing materials before or concurrent with initial use and each day of testing
* Quality control must be performed daily on acid-fast stains;
* Quality control may be performed daily on syphilis serology, unless manufacturer requires QC with each batch within the day;
* Quality control may be performed on automated hematology once daily unless manufacturer requires more frequent QC.

The full text of the CLIA Final Rule was published in the Federal Register on 1-24-03. For help interpreting or implementing CLIA or any other regulations affecting your laboratory, contact KnappˇFrazer Consulting.
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