Final Rule on the Requirements for Laboratory Director Personnel Qualifications and Quality Control Requirements

Laboratory Director Requirements - Background Information

QC Requirements and Background Information

Regulatory Extensions for Lab Director and QC Requirements

On January 24, the Federal Register published the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention's (CDC) final rule on the requirements for laboratory director personnel qualifications and certain quality control (QC) provisions under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The final rule requires that all new directors of high complexity laboratories who have a doctorate degree, also need to be board certified. The rule "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. The Lab Director rule is effective February 24, 2003.

The final rule also consolidates and reorganizes the requirements for patient test management, QC, and quality assurance; and changes the consensus required for grading proficiency testing challenges. The ASM provided comments regarding the proposed QC requirements on September 25, 1996 and December 7, 1998; the CMS/CDC response to the ASM comments is provided on pp. 3659-3661 of the final rule. Changes to the microbiology QC requirements, which affect the subspecialties of microbiology, including bacteriology, mycobacteriology, and mycology can be found in a table, on p. 3693 of the final rule. Per Tom Merrick, MD, ASM member and member of the CAP Commission on Laboratory Accreditation, the CAP Laboratory Accreditation Program will work as quickly as possible to get these changes into the Microbiology Checklist. In the meantime, CAP inspectors will be following the QC requirements as currently written, until CMS reviews and approves the new Checklist. The QC provisions of the final rule are effective April 24, 2003.

August 29, 2003 - ASM Responds to CMS/CDC Request Regarding Quality Controls for Antigen Tests
PSAB's Committee on Professional Affairs responded to a request from the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) regarding ASM’s position on the current CLIA regulations that require quality control testing of microbial antigen detection tests that include an extraction step in their procedures.

April 11, 2003 - ASM Comments on QC/Laboratory Director Guidelines
PSAB's Committee on Professional Affairs submitted comments to the Centers for Medicare and Medicaid Services (CMS) on its draft copy of the revised Interpretive Guidelines, Appendix C of the State Operations Manual, which applies to the CLIA regulations on quality control and laboratory director requirements that were published in the Federal Register on January 24, 2003.