How to Determine Complexity Designation
Through clinical laboratory tests, healthcare providers can diagnose specific diseases or conditions, monitor patient health, and make decisions for patient care. The tests themselves undergo evaluation that includes ratings for the complexity of performing the test in the lab, and knowing a test’s complexity helps lab personnel know which accreditation standards apply.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require labs to be certified by the Centers for Medicare & Medicaid Services (CMS). CMS also enforces regulatory compliance and approves private accreditation organizations such as Accreditation Commission for Health Care (ACHC) to perform surveys.
Two additional federal agencies are responsible for complexity determination: the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). Safe and accurate testing requires knowledge of the FDA’s complexity designation for any test your facility is using. Ratings are based on criteria such as knowledge, training, reagents and materials, operational steps, quality control, equipment maintenance, and interpretation and judgment.
The FDA assigns three complexity designations, starting with the lesser regulated, called waived, and moving to moderate and high. Moderate- and high-complexity testing may also be called “non-waived” testing. Determining a test’s complexity allows testing personnel to know which accreditation standards apply.
The complexity designation of a test system/analyte may be verified online in the FDA database through the link below. Enter the Manufacturer and/or Analyte name and click the “Search” button. A list of tests will appear. Select the appropriate test from the list to learn the designated complexity and specialty.
