The quality control program should make use of whatever tools are available to monitor the method system and ensure reliable test results.
The Centers for Medicare and Medicaid Services (CMS) dictates quality control requirements for laboratories operating in the United States through the Clinical Laboratory Improvement Amendments (CLIA). CLIA requires both intralaboratory (or internal) QC and external quality assessment (QA) measures. Intralaboratory QC is the QC that is performed by the laboratory itself. The external QA required by CLIA is a proficiency testing program.
Interlaboratory (between laboratories) quality control may also be an option for some method systems. Laboratories using the same instrumentation and same QC lot numbers periodically compare QC results (peer comparisons) to determine target values, QC limits, and data consistency.
