The Centers for Medicare & Medicaid Services today issued new quality and personnel rules for laboratory services that are designed to enhance patient safety while making it easier for laboratories to understand and comply with these requirements. The changes are part of a broader effort across the Department of Health and Human Services to restore common sense to the regulatory process and promote higher-quality care.
The rules, which complete the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), apply to laboratory testing in all settings ‑ including commercial, hospital, and physician office laboratories. The requirements are tailored to the complexity of the testing.
Currently about 176,000 laboratories are 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.
“For the first time, CLIA requirements have been reorganized in a more logical fashion to parallel the flow of a patient specimen through the laboratory,” CMS Administrator Tom Scully said. “This reorganization should help laboratories understand and apply the requirements more easily, and reduce laboratory errors.”
The final rule reduces the frequency with which laboratories must perform quality control (QC) in most specialty and subspecialty areas and brings all non-waived testing under the same QC requirements. Personnel standards will continue to be based on test complexity.
As recommended by the Clinical Laboratory Improvement Advisory Committee (CLIAC), the rules now require laboratories to validate the accuracy of moderate as well as high complexity tests prior to the testing of patient specimens and the reporting of those results; however, requirements for routine QC will be more flexible. Guidelines will be available to laboratories to use to meet the federal requirements and will be posted on the CMS website.
The final rule also “grandfathers” certain non-board certified individuals with a doctoral degree who have served or are currently serving as a director of a laboratory performing high complexity testing, allowing them to continue directing high complexity laboratories despite their lack of board certification. All new directors of high-complexity laboratories who have a doctorate, rather than a medical degree, will need to be board certified.
The final rule will be published in the January 24 Federal Register. The grandfathering provision will become effective February 24. For all other requirements, the effective date will be April 24, to allow time to educate laboratories about the new rules.