Clinical Laboratory Testing: Keeping Up With CLIA (2023 Update)-Clinical Laboratory Testing (2023 Update)

Clinical Laboratory Testing (2023 Update)

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The role of the clinical laboratory in the healthcare system is crucial in providing objective scientific data for diagnosis and treatment. With the advancements in medical technology, laboratory testing has become more sophisticated and easier to perform in patient care settings. The Clinical Laboratory Improvement Amendments (CLIA) were established in 1988 to regulate laboratory testing in response to inaccurate results reported for cervical cancer tests. The Centers for Medicare & Medicaid Services (CMS) is responsible for regulating clinical laboratories under CLIA, regardless of whether they serve Medicare or Medicaid patients. CLIA regulations are categorized based on the complexity of the test, with waived tests being the least complex and high complexity tests requiring more stringent requirements. Most physician office laboratories perform waived tests, which are considered safe enough to be performed without routine regulatory oversight. However, waived tests still need to be done in accordance with manufacturer's instructions and medical practices must apply for a CMS certificate of waiver. While waived tests are exempt from direct CLIA supervision, medical practices should always operate under the assumption that they will be inspected. For moderate and high complexity testing, CLIA regulations set qualifications for testing personnel, quality control, inspections, and accreditation requirements. Laboratories performing nonwaived tests are required to undergo on-site survey inspections at least every two years by various agencies. Medical practices with waived status have low administrative costs, while those with nonwaived status can have significantly higher costs. Common laboratory tests ordered in medical practices include comprehensive metabolic panel, lipid panel, complete blood count, thyroid stimulating hormone test, hemoglobin A1c test, liver function panel, erythrocyte sedimentation rate, C-reactive protein test, follicle stimulating hormone test, and prothrombin time test. It is important for medical practice staff to be familiar with CLIA regulations and understand the limitations and requirements of each test. Proper documentation, quality assurance, and staff training are essential in ensuring accurate and reliable laboratory results.

Keywords

clinical laboratory

healthcare system

laboratory testing

CLIA regulations

waived tests

high complexity tests

CMS certificate of waiver

on-site survey inspections

comprehensive metabolic panel

staff training