LabNotes - Volume 13, No.2, Spring 2003

Related Industry Website: CLIA

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) is a regulation specifying that all laboratories must meet certain conditions to perform testing on human specimens.

The original Clinical Laboratory Improvement Act was established in 1967 to regulate laboratories engaged in interstate commerce. In 1988, with the passage of CLIA '88, the definition of the laboratory was broadened to include laboratories located in physicians' offices or other small healthcare facilities. With CLIA '88 the level of regulation was determined by the complexity of the tests performed rather than the performance site. Physician office laboratories, dialysis units, health fairs and nursing homes are all covered, along with other previously exempt laboratories.

At the same time, advancements in technology and information processing greatly increased the number and complexity of tests that could be performed in the smaller laboratory.

www.cms.hhs.gov/CLIA

What's New with CLIA?

• Printed in the January 24, 2003 Federal Register is the final rule for The Centers for Medicare & Medicaid Services CMS-2226F, which completes the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
• This final rule documents the following:
  1. Provides one set of quality control (QC) standards for nonwaived testing.
  2. Reduces QC frequency in most of the subspecialty and specialty areas, and merges moderate and high complexity QC requirements to simplify compliance.
  3. Removes the prospective FDA review of manufacturers' QC instructions for compliance with CLIA that was to occur after the end of the QC phase-in period on January 1, 2003.
  4. Eliminates redundancy, clarifies, simplifies and uses plain language where possible.
  5. Reorganizes the existing requirements to parallel the flow of a patient specimen through the laboratory, facilitating the prevention of errors. Studies indicate that most laboratory errors occur in the pre-analytical (specimen collection and handling) phase of testing. Thus, all CLIA requirements applicable to this phase of testing are in one place in logical order, and CLIA anticipates that this will help the laboratory decrease errors.
  6. Retroactively "grandfathers" individuals with a doctoral degree without board certification who have served or are currently serving as a director of a laboratory performing high complexity testing and requires board certification for all future doctoral-degreed directors of high complexity testing. This provision became effective on February 24, 2003.
  7. Requires that moderate complexity laboratories validate a test once before use to ensure the test works accurately before patients are tested.
• The final rule applies to laboratory testing in all settings, including commercial, hospital and physician office laboratories.
• Of the 176,000 laboratories certified under CLIA, the new rules will have the greatest impact on the 38,000 labs that are authorized to perform high or moderate complexity testing.
• The CMS-2226F regulation will not include requirements for labs that perform only waived testing.
• The effective date for all requirements of CMS-2226F was April 24, 2003.

For further information, contact the Centers for Medicare and Medicaid Services (CMS) at (877)267.2323.

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