{"abstract":"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.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Centers for Disease Control and Prevention","name":"Centers for Disease Control and Prevention","id":44,"url":"https://www.federalregister.gov/agencies/centers-for-disease-control-and-prevention","json_url":"https://www.federalregister.gov/api/v1/agencies/44","parent_id":221,"slug":"centers-for-disease-control-and-prevention"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2003/01/24/03-1230.html","cfr_references":[{"chapter":null,"citation_url":null,"part":493,"title":42}],"citation":"68 FR 3641","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This final rule is effective on April 24, 2003, except Sec. 493.1443(b)(3) is effective on February 24, 2003.","disposition_notes":null,"docket_ids":["CMS-2226-F"],"dockets":[],"document_number":"03-1230","effective_on":"2003-04-24","end_page":3714,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/01/24/03-1230.xml","html_url":"https://www.federalregister.gov/documents/2003/01/24/03-1230/medicare-medicaid-and-clia-programs-laboratory-requirements-relating-to-quality-systems-and-certain","images":{"ER24JA03.000":{"large":"https://img.federalregister.gov/ER24JA03.000/ER24JA03.000_large.png","medium":"https://img.federalregister.gov/ER24JA03.000/ER24JA03.000_medium.png","original_size":"https://img.federalregister.gov/ER24JA03.000/ER24JA03.000_original_size.png"}},"images_metadata":{"ER24JA03.000":{"large":{"identifier":"ER24JA03.000","content_type":"image/png","size":2340,"width":390,"sha":"c7e8c01d7ed9c2a8128da6697b3cc57a","url":"https://img.federalregister.gov/ER24JA03.000/ER24JA03.000_large.png","height":56},"medium":{"identifier":"ER24JA03.000","content_type":"image/png","size":841,"width":181,"sha":"d7e4614bc7af560c39204c683c9be149","url":"https://img.federalregister.gov/ER24JA03.000/ER24JA03.000_medium.png","height":26},"original_size":{"identifier":"ER24JA03.000","content_type":"image/png","size":703,"width":167,"sha":"c31a3e1b4eadf3a063992da84bd91a14","url":"https://img.federalregister.gov/ER24JA03.000/ER24JA03.000_original_size.png","height":24}}},"json_url":"https://www.federalregister.gov/api/v1/documents/03-1230?publication_date=2003-01-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-01-24/03-1230/mods.xml","not_received_for_publication":null,"page_length":74,"page_views":{"count":9432,"last_updated":"2026-07-25 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/03-1230.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-01-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/01/24/03-1230.txt","regulation_id_number_info":{"0938-AK24":{"issue":"200304","html_url":"https://www.federalregister.gov/regulations/0938-AK24/laboratory-requirements-relating-to-quality-systems-and-certain-personnel-qualifications-cms-2226-cn","title":"Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications (CMS-2226-CN)","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200304&RIN=0938-AK24&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0938-AK24"],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":3641,"subtype":null,"title":"Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications","toc_doc":"Medicare, Medicaid, and CLIA programs; quality systems and certain personnel qualifications","toc_subject":"Standards and certification:","topics":["Grant programs-health","Health facilities","Incorporation by reference","Laboratories","Medicaid","Medicare","Reporting and recordkeeping requirements"],"type":"Rule","volume":68}