The Clinical Laboratory Improvement Amendments

March 12, 2015 | Healthcare Risk, Quality, & Safety Guidance

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Laboratories are found in nearly every healthcare setting. As of November 2014, 249,094 laboratories in nearly 30 different settings were enrolled under CLIA. Almost half (48.9%) are based in POLs (CMS "Laboratories by Type"). The majority of POLs, whether owned by hospitals or the physicians themselves, perform only waived tests (61.4%) or PPM and waived tests (23.8%), as of November 2014 (CMS "Physician Office"). Specialist POLs, such as endocrinology, hematology, or medical oncology practices, may perform non-PPM moderate-complexity and/or high-complexity testing. Approximately 6% of CLIA-regulated laboratories are based in in skilled nursing facilities, with another 6% operated by home health agencies. Hospital-based laboratories, most of which perform all three types of tests (waived, moderate-complexity, and high-complexity), represent slightly less than 4% of all laboratories. (CMS "Laboratories by Type") For more details on where laboratories are commonly located, see Figure. Locations of CLIA–Enrolled Labs.

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Regardless of the setting, risk managers, compliance officers, and others must consider the issues discussed below to ensure CLIA compliance and, more importantly, to limit the risk of adverse patient outcomes.

The primary goal of CLIA is patient safety—in fact, the major revision to the statute in 1988 was prompted in part by the revelation of problems in both POLs and Pap smear testing. According to CMS, approximately 12.8 billion tests are performed each year in the United States (CMS...

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