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Using Specs to Verify CLIA Compliance

Using Instrument Specifications to Verify CLIA Compliance
Laboratories subject to the CLIA Quality System Regulations issued on April 24, 2003 must verify manufacturers’ performance specifications for accuracy, precision, reportable range, and reference ranges for each new unmodified, moderate complexity test performed before patients’ results can be reported.

How does an end user accurately interpret a manufacturer’s published instrument specifications, and effectively use them to validate the performance of a piece of equipment within the parameters specified by regulations such as CLIA?

The following links will help clarify commonly used terms and establish the relationship between terminology used by manufacturers when specifying instrument performance, and the terminology used by laboratory regulatory organizations such as CLIA.

Laboratory Definitions of Performance

Manufacturers Definitions of Performance

Relating Manufacturers and Laboratory Terminology