Waived Laboratory Practices in Ambulatory Care
July 19, 2017 | Healthcare Risk, Quality, & Safety Guidance
The Clinical Laboratory Improvement Amendments of 1988, as further amended by the Taking Essential Steps for Testing Act of 2012, collectively referred to as CLIA, established quality standards to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the testing is performed. CLIA covers all non-research-laboratory testing performed on human specimens for the purpose of diagnosis, prevention, or treatment of any disease or impairment or the assessment of the health of human beings. A laboratory with a CLIA waiver (42 USC § 265a) performs tests that involve simple laboratory examinations and procedures that have an insignificant risk of erroneous results that employ methodologies that are "so simple and accurate as to render the likelihood of erroneous results by the user negligible or . . . that pose no unreasonable risk of harm to the patient if performed incorrectly" (42 USC § 263a).
CLIA applies to all clinical laboratories, regardless of whether they accept Medicare or Medicaid. Exceptions exist in Washington, which has a CLIA-approved state statute, and in New York, which has a partial exemption. Risk managers in those states should consult the appropriate...