The Clinical Laboratory Improvement Amendments (CLIA) outlined in the Code of Federal Regulations (refer 42 CFR 493) provides a complexity system for laboratory tests based on seven criteria. Laboratory tests are first divided into waived and nonwaived. Nonwaived tests are further divided into moderate and high complexity. The test complexity is assigned by the FDA. This is done during the pre-market approval process. If the laboratory develops its own test or if an approved test is modified in any way from the manufacturer's operating instructions, the complexity category defaults to high complexity per the CLIA regulations.
CLIA-waived tests are defined as test systems that are easy to use or operate, with low risk for an incorrect result and, that if testing errors do occur, the risk of patient harm is low. This category includes tests provided on a list published by CLIA, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Sites performing only waived testing must have a CLIA certificate of waiver and follow the manufacturer’s instructions. Other CLIA requirements do not apply to these sites, but state or accreditation agencies may impose more stringent regulations. A full list of tests waived by the FDA is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm
. Accessed May 1, 2020.
Laboratories or sites that perform nonwaived testing must have either a CLIA certificate of compliance or registration. They will be subject to inspection, compliance with CLIA standards, as well as applicable regulatory and state requirements.
POCT can be of any complexity level. However, waived and moderately complex testing methods comprise most POCT methods and instrumentation.