United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2003_register executive 2010-09-23 article Part III Rules and Regulations D09002ee1c81861c9 D09002ee1c81862be United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Centers for Medicare & Medicaid Services originator org United States Government Agency or Subagency United States Centers for Disease Control and Prevention originator org United States Government Agency or Subagency This final rule revises and responds to comments on certain laboratory requirements issued pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. 100-578. Specifically, this final rule sets forth requirements for certain quality control (QC) provisions and personnel qualifications; consolidates and reorganizes the requirements for patient test management, QC, and quality assurance; and changes the consensus required for grading proficiency testing challenges. To ensure a smooth transition to the new provisions for directors of high complexity testing who are not board certified (but who have doctoral degrees), we will not be holding facilities out of compliance with the provisions of the rule concerning directors who are not board certified until the effective date of this new rule, to the extent the facilities are otherwise in compliance with the requirements for laboratory directors. 68 FR 3641 https://www.govinfo.gov/app/details/FR-2003-01-24/03-1230 03-1230 fr24ja03-23 RIN 0938-AK24 4120-01-P CMS-2226-F https://www.govinfo.gov/app/details/FR-2003-01-24/03-1230 https://www.govinfo.gov/content/pkg/FR-2003-01-24/html/03-1230.htm https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/03-1230.pdf 74 p. 3641 3714 68 FR 3641 Title 42 Part 493 42 CFR Part 493 RIN 0938-AK24 Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Federal Register Vol. 68, Issue RULE 03-1230 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Centers for Disease Control and Prevention 2003-04-24 CMS-2226-F 4120-01-P 03-1230 Final rule.

This final rule revises and responds to comments on certain laboratory requirements issued pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. 100-578. Specifically, this final rule sets forth requirements for certain quality control (QC) provisions and personnel qualifications; consolidates and reorganizes the requirements for patient test management, QC, and quality assurance; and changes the consensus required for grading proficiency testing challenges. To ensure a smooth transition to the new provisions for directors of high complexity testing who are not board certified (but who have doctoral degrees), we will not be holding facilities out of compliance with the provisions of the rule concerning directors who are not board certified until the effective date of this new rule, to the extent the facilities are otherwise in compliance with the requirements for laboratory directors.

This final rule is effective on April 24, 2003, except Sec. 493.1443(b)(3) is effective on February 24, 2003. Rhonda S. Whalen (CDC), (770) 488- 8155, Judith A. Yost (CMS), (410) 786-3531. Standards and certification: Laboratory requirements Medicare, Medicaid, and CLIA programs; quality systems and certain personnel qualifications, http://cms.hhs.gov/clia/dirc/con.asp http://www.abms.org/statistics.asp http://www.access.gpo/nara/index.html http://www.acgame.org/adspublic/reports/ http://www.cms.hhs.gov/clia/dirc/con.asp http://www.opm.gov/feddata/retire/rs-projections.pdf Vol. 68, no. 16 Office of the Federal Register, National Archives and Records Administration 2003-01-24 continuing daily deposited born digital 440 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2003-01-24 P0b002ee1809e5967 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr24ja03 https://www.govinfo.gov/app/details/FR-2003-01-24 https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/FR-2003-01-24.pdf https://www.govinfo.gov/content/pkg/FR-2003-01-24/xml/FR-2003-01-24.xml fdlp 3371 3801 DGPO 2010-09-23 2024-06-07 FR-2003-01-24 machine generated eng FR FR-2003-01-24 68 16