Medical Device Link.

Originally Published IVD Technology April 2003

INDUSTRY NEWS

Richard Park

The Centers for Medicare & Medicaid Services (CMS; Baltimore) issued a final rule that established one set of quality control (QC) standards for all nonwaived testing. This rule completes the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and applies to lab testing in all settings, including commercial, hospital, and physician office laboratories. 

CMS reorganized the existing QC requirements to parallel the flow of a patient specimen through the laboratory, from specimen collection to test result reporting. The new rule introduces a number of different changes related to QC, such as in proficiency testing, required frequency of QC for certain types of testing, and laboratory director personnel standards. 

The final rule reduces the frequency with which laboratories must conduct QC in most specialty and subspecialty areas. The rule also merges moderate and high-complexity QC requirements to simplify compliance for laboratories. 

The rule grandfathers in certain non-board-certified individuals with doctoral degrees who are currently the heads of laboratories performing high-complexity testing, thereby allowing them to continue in their positions despite their lack of board certification. However, all new directors of high-complexity laboratories who have doctorates, rather than medical degrees, will need to be board certified.

In addition, the final rule eliminates the prospective FDA review of manufacturers’ QC instructions for compliance with CLIA. FDA was supposed to have performed this task after the end of the QC phase-in period, which ended on December 31, 2002, but CMS determined that this was unnecessary. At first, CMS considered allowing the provisions for FDA’s review process of manufacturers’ test system QC instructions to take effect at the completion of the phase-in period. However, implementing these provisions would have required additional FDA personnel, resulting in significant increases in program costs that would have needed to be recouped through higher fees imposed on laboratories. Since CMS already certifies compliance for all QC routinely, CMS officials concluded that FDA’s review of manufacturers’ QC instructions would be a duplicate and incomplete effort.

Industry analysts believe the new CLIA QC standards will have a significant effect on laboratories.

“The revised CLIA QC regulations will have a major effect on clinical labs performing moderate-complexity tests, as the bar has been raised for implementing new tests that have been cleared or approved by FDA,” says Linda Ivor, a clinical scientist at Gen-Probe Inc. (San Diego). “Under the final rule, labs must validate the performance of moderate-complexity tests the same as for high-complexity tests. CMS has also changed the minimum requirements for proficiency testing so that a score of 80% will pass, rather than 90%. This should reduce the number of ungradable challenges. While there are concerns that some provisions of the final rule remain unclear, CMS has indicated that its ‘Surveyor Guidelines’ will serve as a living document. As such, the guidelines can allow for changes in interpretations, while the rule remains static.”

Other analysts believe certain types of laboratories will find it especially difficult to comply with the new QC regulations.
“The greatest effect of the final CLIA QC rule will be on facilities using moderate-complexity tests, in particular physician office laboratories (POLs),” says Thomas M. Tsakeris, president of Devices and Diagnostics Consulting Group (Rockville, MD). “POLs will likely have the most difficulty in meeting the revised QC rules and, consequently, some may decide not to use moderately complex devices. The effect will be even greater on those POLs that only perform waived tests. The new QC rules will also further POLs’ incentives to insist that point-of-care device manufacturers obtain waiver status for new devices, which is exceedingly difficult.”

While the grandfathering provision became effective on February 24, the effective date for all other QC requirements is April 24, to give laboratories time to educate themselves about the new rule. The final rule can be accessed through the Federal Register Web site at http://www.access.gpo.gov/nara/index.html.  


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