// JSON Document *Objects in descending order by date* Add new entries to bottom of document var data = [ { "date": "08/05/1988", "ref": "53 FR 29590", "reg": "HSQ-146-P", "title": "Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs", "abs": "Proposed laboratory regulations under CLIA'67, provided new uniform PT requirements, added new specialty of clinical cytogenetics, recodified the regulations at part 74 and part 405 subpart M into a new part 493. ", "code": "FR", "keywords": "", PDF: "https://archives.federalregister.gov/issue_slice/1988/8/5/29584-29632.pdf#page=7" }, { "date": "09/09/1988", "ref": "", "reg": "H.R. 100-899", "title": "Clinical Laboratory Improvement Amendments of 1988", "abs": "Mr. Dingell, from the Committee on Energy & Commerce - report and additional views (NOT AVAILABLE ELECTRONICALLY) ", "code": "CFR", "keywords": "", "PDF": "" }, { "date": "09/29/1988", "ref": "", "reg": "S.R. 100-561", "title": "Medical Testing Improvement Act of 1988", "abs": "Mr. Kennedy, from the Committee on Labor & Human Resources – report (NOT AVAILABLE ELECTRONICALLY) ", "code": "CFR", "keywords": "", "PDF": "" }, { "date": "10/31/1988", "ref": "", "reg": "P.L. 100-578", "title": "CLIA '88", "abs": "'The Law (100-578)' ", "code": "CFR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf" }, { "date": "03/14/1990", "ref": "55 FR 9538", "reg": "HSQ-146-F", "title": "Medicare, Medicaid and CLIA Programs; Revisions of the Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratory Improvement Act of 1967 Programs", "abs": "Revised laboratory regulations under CLIA'67 ", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1990/3/14/9534-9610.pdf#page=5" }, { "date": "05/21/1990", "ref": "55 FR 20896", "reg": "HSQ-176-P", "title": "Medicare, Medicaid and CLIA Programs: Regulations Implementing the Clinical Laboratory Improvements of 1988 (CLIA '88)", "abs": "Proposed quality standards (PT, PTM, QC, QA) and administrative processes for CLIA'88. ", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1990/5/21/20892-20959.pdf#page=5" }, { "date": "08/03/1990", "ref": "55 FR 31758", "reg": "HSQ-177-P", "title": "Clinical Laboratory Improvement Act Programs; Fee Collection", "abs": "Proposed fee collection program for issuance of certificates under CLIA'88 ", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1990/8/3/31738-31773.pdf#page=21" }, { "date": "08/20/1990", "ref": "55 FR 31758", "reg": "HSQ-146-CN", "title": "Medicare, Medicaid and CLIA Programs; Revisions of the Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs; correction", "abs": "Typographical corrections (NOT AVAILABLE ELECTRONICALLY) ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "04/02/1991", "ref": "56 FR 13430", "reg": "HSQ-179-P", "title": "Medicare and Laboratory Certification Programs; Enforcement Procedures for Laboratories", "abs": "Proposed enforcement procedures (sanctions) for noncompliance with CLIA'88 regulations", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1991/4/2/13424-13445.pdf#page=7" }, { "date": "02/28/1992", "ref": "57 FR 7002", "reg": "HSQ-176-FC", "title": "Medicare, Medicaid and CLIA Programs; Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)", "abs": "CLIA'88 administrative processes and quality standards", "code": "FR", "keywords": "", "PDF": "https://www.federalregister.gov/documents/2000/03/17/00-6580/clia-program-cytology-proficiency-testing" }, { "date": "02/28/1992", "ref": "57 FR 7188", "reg": "HSQ-177-FC", "title": "Clinical Laboratory Improvement Act Program; Fee Collection", "abs": "CLIA'88 fee collection program (NOT AVAILABLE ELECTRONICALLY) ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "02/28/1992", "ref": "57 FR 7218", "reg": "HSQ-179-F", "title": "Medicare Program, Medicare and Laboratory Certification Program; Enforcement Procedures for Laboratories", "abs": "CLIA'88 enforcement procedures (NOT AVAILABLE ELECTRONICALLY)", "code": "FR", "keywords": "", "PDF": "" }, { "date": "02/28/1992", "ref": "57 FR 7245", "reg": " ", "title": "Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity", "abs": "Test List #1 (NOT AVAILABLE ELECTRONICALLY)", "code": "FR", "keywords": "", "PDF": "" }, { "date": "07/08/1992", "ref": "57 FR 30362", "reg": " ", "title": "Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity", "abs": "Test List #2 (NOT AVAILABLE ELECTRONICALLY)", "code": "FR", "keywords": "", "PDF": "" }, { "date": "07/31/1992", "ref": "57 FR 33992", "reg": "HSQ-181-F", "title": "Clinical Laboratories Improvement Program; Granting and Withdrawal of Deeming Authority to Private Nonprofit Accreditation Organizations and or CLIA Exemptions Under State Laboratory Programs", "abs": "CLIA'88 administrative processes and requirements for granting CLIA exemption and deemed status", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1992/7/31/33988-34021.pdf#page=5" }, { "date": "08/11/1992", "ref": "57 FR 35760", "reg": "HSQ-176-CN", "title": "Medicare Program; Medicare and Laboratory Certification Program; Enforcement Procedures for Laboratories", "abs": "Typographical corrections, clarification of PT phase-in", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1992/8/11/35758-35763.pdf#page=3" }, { "date": "08/28/1992", "ref": "57 FR 39211", "reg": "", "title": "Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity", "abs": "Test List #3 Includes list of waived test", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1992/8/28/39206-39233.pdf#page=6" }, { "date": "09/02/1992", "ref": "57 FR 40239", "reg": "", "title": "Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity, Notice", "abs": "Test List #4 Changed certain microbiology procedures to high complexity (NOT AVAILABLE ELECTRONICALLY)", "code": "FR", "keywords": "", "PDF": "" }, { "date": "10/01/1992", "ref": "57 FR 45392", "reg": "", "title": "Deletion of text from previously published notice", "abs": "Notice deleting the language in Test List #4 which changed certain microbiology procedures to high complexity", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1992/10/1/45391-45393.pdf#page=2" }, { "date": "01/19/1993", "ref": "58 FR 5215", "reg": "HSQ-202-FC", "title": "Medicare, Medicaid and CLIA Programs; Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Clinical Laboratory Improvement Act Program Fee Collection", "abs": "Added physician-performed microscopy (PPM), continued to delay implementation of CLIA to workplace drug testing, added 'hemoglobin by single analyte instruments...' to waived test list, quantified limited public health testing, deleted parentage testing, gynecologic slides may not be counted as one-half slide, other corrections and clarifications (NOT AVAILABLE ELECTRONICALLY) ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "01/19/1993", "ref": "58 FR 5212", "reg": "HSQ-206-F", "title": "Medicare, Medicaid and CLIA Programs; CLIA Program Fee Collection; Correction", "abs": "Technical correction restoring 493.602-493.634 (user fees) which were incorrectly removed in the 2/28/92 publication (NOT AVAILABLE ELECTRONICALLY) ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "07/22/1993", "ref": "58 FR 39154", "reg": "HSQ-202-CN", "title": "Medicare, Medicaid and CLIA Programs; Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988", "abs": "Notice correcting typographical errors, gynecologic slides may count as one-half slide, grandfathered personnel qualifications reprinted", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1993/7/22/39152-39156.pdf#page=3" }, { "date": "07/26/1993", "ref": "58 FR 39860", "reg": "", "title": "Compiled List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity", "abs": "Compilation of Test Lists #1-#4 with new additional tests and a list of waived test systems, categorization process and submission information provided", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1993/7/26/39857-40017.pdf#page=4" }, { "date": "10/06/1993", "ref": "58 FR 52115", "reg": "HSQ-209-N", "title": "Medicare, Medicaid and CLIA Programs: CLIA '88 Exemption of Laboratories Licensed by the State of Washington", "abs": "Grants exemption from CLIA requirement to laboratories located within the State of Washington with a valid Washington medical test site license. Effective 10/6/93 through 10/6/94", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1993/10/6/52110-52116.pdf#page=6" }, { "date": "12/23/1993", "ref": "58 FR 68148", "reg": "HSQ-211-N", "title": "Approval of the Commission on Office Laboratory Accreditation (COLA)", "abs": "Announces approval of COLA as an accrediting organization for clinical laboratories under the CLIA program. Effective 12/23/93 through 11/1/97", "code": "FR", "keywords": "", "PDF": "https://archives.federalregister.gov/issue_slice/1993/12/23/68145-68153.pdf#page=4" }, { "date": "01/06/1994", "ref": "59 FR 682", "reg": "HSQ-210-FC", "title": "Medicare, Medicaid and CLIA Programs; Personnel Requirements for Cytotechnologists", "abs": "Extended certain dates by which individuals must gain the necessary experience, education, certification to qualify as a cytotechnologist ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-1994-01-06/html/94-58.htm" }, { "date": "10/20/1994", "ref": "59 FR 52968", "reg": "HSQ-220-N", "title": "CLIA Program; Approval of the American Society for Histocompatibility and Immunogenetics (ASHI) for the Specialty of Histocompatibility", "abs": "Announces approval of ASHI as an accrediting organization for clinical laboratories (histocompatibility only) under the CLIA program. Effective 10/20/94 through 10/20/2000 ", "code": "FR", "keywords": "", "PDF": "http://www.gpo.gov/fdsys/pkg/FR-1994-10-20/html/94-25987.htm" }, { "date": "12/06/1994", "ref": "59 FR 62606", "reg": "HSQ-217-FC", "title": "Medicare, Medicaid and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements and Personnel Requirements for Cytologists", "abs": "Extended dates by which individuals must enroll in cytology PT, doctorates must be board certified to be a high complexity lab director, extended QC phase-in. Announced ASCP as approved certifying organization for cytotechnologists. ", "code": "FR", "keywords": "", "PDF": "http://www.gpo.gov/fdsys/pkg/FR-1994-12-06/html/94-29914.htm" }, { "date": "12/23/1994", "ref": "59 FR 66314", "reg": "HSQ-221-N", "title": "Medicare, Medicaid and CLIA Programs; Clinical Laboratory Amendments of 1988 Continuance of Exemption of Laboratories Licensed by the State of Washington", "abs": "Announces that laboratories licensed by the State of Washington and located within the State continue to be exempt from the CLIA requirements until 10/6/96 ", "code": "FR", "keywords": "", "PDF": "http://www.gpo.gov/fdsys/pkg/FR-1994-12-23/html/94-31513.htm" }, { "date": "01/03/1995", "ref": "60 FR 130", "reg": "HSQ-224-N", "title": "CLIA Program: Approval of the Joint Commission on Accreditation of Healthcare Organizations as an Accrediting Organization", "abs": "Announces approval of JCAHO as an accrediting organization for clinical laboratories under the CLIA program. Effective 1/3/95 through 1/3/97 ", "code": "FR", "keywords": "", "PDF": "https://www.federalregister.gov/documents/1995/01/03/94-32203/clia-program-approval-of-the-joint-commission-on-accreditation-of-healthcare-organizations-as-an" }, { "date": "02/09/1995", "ref": "60 FR 7774", "reg": "HSQ-223-N", "title": "CLIA Program; Approval of the College of American Pathologists", "abs": "Announces approval of CAP as an accrediting organization for clinical laboratories under the CLIA program. Effective 2/9/95 through 12/31/98 (NOT AVAILABLE ELECTRONICALLY) ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "04/24/1995", "ref": "60 FR 20035", "reg": "HSQ-216-FC", "title": "CLIA Program; Categorization of Tests and Personnel Modifications", "abs": "Revises regulations to allow mid-level practitioners and dentists to perform tests in the renamed subcategory of moderate complexity, provider-performed microscopy procedures. Adds 3 tests in PPM. Expands general supervisor and high complexity testing personnel provisions. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1995-04-24/pdf/95-9953.pdf" }, { "date": "05/15/1995", "ref": "60 FR 25944", "reg": "", "title": "Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity", "abs": "Announces approximately 2900 additional test systems, assays, and examinations that have been categorized since the publication of the compiled test list. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1995-05-15/pdf/95-11653.pdf" }, { "date": "07/21/1995", "ref": "60 FR 37660", "reg": "HSQ-228-N", "title": "CLIA Program; Approval of the American Association of Blood Banks", "abs": "Announces approval of AABB as an accrediting organization for clinical laboratories under the CLIA program. (Specialties/subspecialties of immunohematology, hematology, diagnostic immunology, histocompatibility, routine chemistry & toxicology only) (NOT AVAILABLE ELECTRONICALLY) ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "07/21/1995", "ref": "60 FR 37657", "reg": "HSQ-229-N", "title": "CLIA Program; Approval of the American Osteopathic Association as an Accrediting Organization", "abs": "Announces approval of AOA as an accrediting organization for clinical laboratories under the CLIA program. Effective 7/21/95 through 7/21/97 (NOT AVAILABLE ELECTRONICALLY) ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "08/28/1995", "ref": "60 FR 44503", "reg": "HSQ-230-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories in the State of New York", "abs": "Grants exemption from CLIA requirements applicable to valid permit-holding laboratories located within the State of New York including New York City effective until 6/30/01 (NOT AVAILABLE ELECTRONICALLY) ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "09/13/1995", "ref": "60 FR 47534", "reg": "HSQ-225-P", "title": "Public Health Service; CLIA Program; Categorization of Waived Tests", "abs": "Proposes criteria that would be used to determine whether to categorize tests as waived from certain CLIA requirements. Also, proposes revisions to requirements labs performing waived tests must meet. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1995-09-13/pdf/95-22378.pdf" }, { "date": "09/15/1995", "ref": "60 FR 47982", "reg": "HSQ-222-P", "title": "CLIA Program; Categorization and Certification Requirements for a New Subcategory of Moderate Complexity Testing", "abs": "Proposes to create a new subcategory of high quality moderate complexity procedures called accurate and precise technology (APT) tests. (NOT AVAILABLE ELECTRONICALLY) ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "11/30/1995", "ref": "60 FR 61509", "reg": "HSQ-233-P", "title": "CLIA Programs; Cytology Proficiency Testing", "abs": "In accordance with a court order, proposes to require that cytology PT be conducted at a pace corresponding to the maximum workload rate for individuals examining cytology slides. In addition, solicits comments on the use of computer facsimile representations of cytology specimens, as an alternative to glass slide PT. (NOT AVAILABLE ELECTRONICALLY)", "code": "FR", "keywords": "", "PDF": "" }, { "date": "06/13/1996", "ref": "61 FR 30072", "reg": "HSQ-231-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories in the State of Oregon", "abs": "Grants exemption from CLIA requirements applicable only to laboratories located within the State of Oregon that possess a valid State license. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1996-06-13/pdf/96-14969.pdf" }, { "date": "07/08/1996", "ref": "61 FR 35736", "reg": "", "title": "Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity; Notice of Additional Waived Laboratory Test Systems, Assays, and Examinations; and Notice of Announcement of Boards Approved by HHS", "abs": "Announces the addition of test systems to the waived category, and announces approximately 2400 additional test systems, assays, and examinations categorized between 3/15/95 and 6/7/96. In addition, announces HHS approval of the American Board of Histocompatibility and Immunogenetics and the American Board of Medical Genetics for qualifying individuals as laboratory directors and clinical consultants. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1996-07-08/pdf/96-17097.pdf" }, { "date": "10/01/1996", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 1996 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-1996-title42-vol3/pdf/CFR-1996-title42-vol3-part493.pdf " }, { "date": "02/05/1997", "ref": "62 FR 5433", "reg": "HSQ-244-N", "title": "CLIA Program; Clinical Laboratory Improvement Amendments of 1988 - Denial of Exemption of Laboratories in the Commonwealth of Puerto Rico", "abs": "Announces that a request from the Commonwealth of Puerto Rico for exemption from CLIA requirements has been denied. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1997-02-05/pdf/97-2761.pdf" }, { "date": "04/11/1997", "ref": "62 FR 17832", "reg": "", "title": "Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity", "abs": "Announces the addition of approximately 1300 test systems, assays, and examinations that have been categorized between 6/7/96 and 12/31/96. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1997-04-11/pdf/97-9350.pdf" }, { "date": "05/12/1997", "ref": "62 FR 25855", "reg": "HSQ-237-FC", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Requirements--Extension of Certain Effective Dates for Clinical Laboratory Requirements under CLIA", "abs": "Extended date of the QC phase-in and the date by which an individual with a doctoral degree must possess board certification to quality as a high complexity laboratory director to 7/31/98. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1997-05-12/pdf/97-12271.pdf" }, { "date": "05/19/1997", "ref": "62 FR 27262", "reg": "HSQ-242-N", "title": "Approval of the Commission on Office Laboratory Accreditation for Immunohematology", "abs": "Announces the approval of the addition of the full specialty of Immunohematology to the specialties/subspecialties previously approved for COLAs deemed status. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1997-05-19/pdf/97-12959.pdf" }, { "date": "07/01/1997", "ref": "62 FR 35513", "reg": "HSQ-243-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Continuance of Exemption of Laboratories Licensed by the State of Washington", "abs": "Announces that laboratories licensed by the State of Washington and located within the State continue to be exempt from CLIA requirements until 4/20/01. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1997-07-01/pdf/97-17193.pdf" }, { "date": "08/29/1997", "ref": "62 FR 45815", "reg": "HSQ-219-GNC", "title": "CLIA Program; Fee Schedule Revision", "abs": "Updates certificate fees for laboratories under CLIA. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1997-08-29/pdf/97-23084.pdf" }, { "date": "10/01/1997", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 1997 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-1997-title42-vol3/pdf/CFR-1997-title42-vol3-part493.pdf" }, { "date": "04/09/1998", "ref": "63 FR 17429", "reg": "HCFA-2246-N", "title": "Medicare,Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Continuance of Approval as an Accrediting Organization: Joint Commission on the Accreditation of Healthcare Organizations (JCAHO); American Association of Blood Ban", "abs": "Announces the continued approval of accrediting organizations for clinical laboratories under the CLIA program. JCAHO effective 4/9/98 through 6/30/99 AABB effective 4/9/98 through 7/21/01 AOA effective 4/9/98 through 7/21/01 ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1998-04-09/pdf/98-9263.pdf" }, { "date": "05/14/1998", "ref": "63 FR 26722", "reg": "HCFA-2239-F", "title": "CLIA Program; Simplifying CLIA Regulations Relating to Accreditation, Exemption of Laboratories Under a State Licensure Program, Proficiency Testing, and Inspection", "abs": "Responds to selected comments received on a final CLIA rule (2/28/92) in the areas of proficiency testing and inspections for clinical laboratories. This rule accommodates, when possible, the Administration’s regulatory reform initiative by reducing duplicative material, emphasizing outcome-oriented results and simplifying regulations. The rule also streamlines regulations in the areas of State exemption, and granting deemed status of laboratories accredited by an approved accreditation organization. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1998-05-14/pdf/98-12752.pdf" }, { "date": "06/15/1998", "ref": "63 FR 32699", "reg": "HCFA-2239-F", "title": "CLIA Program; Simplifying CLIA Regulations Relating to Accreditation, Exemption of Laboratories Under a State Licensure Program, Proficiency Testing, and Inspection", "abs": "Typographical corrections for HCFA-2239 published 5/14/98 ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1998-06-15/pdf/X98-20615.pdf" }, { "date": "10/01/1998", "ref": "63 FR 32699", "reg": "HCFA-2239-F", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 1998 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-1998-title42-vol3/pdf/CFR-1998-title42-vol3-part493.pdf" }, { "date": "10/14/1998", "ref": "63 FR 55031", "reg": "HCFA-2024-FC", "title": "Medicare, Medicaid, and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements Under CLIA ", "abs": "Extended date of the QC phase-in and the date by which an individual with a doctoral degree must possess board certification to quality as a high complexity laboratory director to 12/31/00. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1998-10-14/pdf/98-27523.pdf" }, { "date": "09/23/1999", "ref": "64 FR 51590", "reg": "", "title": "Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity", "abs": "Announces the addition of approximately 5700 test systems, assays, and examinations that have been categorized between 9/1/97 and 9/3/99. Also announces transfer of the test categorization responsibility to the FDA on or about 1/31/00. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1999-09-23/pdf/99-24638.pdf" }, { "date": "10/01/1999", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 1999 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-1999-title42-vol3/pdf/CFR-1999-title42-vol3-part493.pdf" }, { "date": "12/30/1999", "ref": "64 FR 73561", "reg": "", "title": "CLIA Program; Transfer of Clinical Laboratory Complexity Categorization Responsibility", "abs": "Announces the transfer of responsibility for the categorization of commercially marketed in vitro diagnostic (IVD) tests under CLIA’88 from ob to the FDA. An interagency agreement on the scope and nature of the transfer of this CLIA function was signed on February 27, 1999. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-1999-12-30/pdf/99-33941.pdf" }, { "date": "03/17/2000", "ref": "65 FR 14510", "reg": "HCFA-2233-N", "title": "CLIA Program; Cytology Proficiency Testing", "abs": "Announces the withdrawal of a proposed rule on cytology proficiency testing published November 30, 1995 (60 FR 61509) and contains a supplementary statement of rationale, in accordance with the appeals court ruling. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2000-03-17/pdf/00-6580.pdf" }, { "date": "05/02/2000", "ref": "65 FR 25492", "reg": "HCFA-2177-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Removal of Exemption of Laboratories in the State of Oregon", "abs": "Removes the CLIA’88 exemption previously granted to laboratories within the State of Oregon. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2000-05-02/pdf/00-10882.pdf" }, { "date": "05/03/2000", "ref": "65 FR 25295", "reg": "HCFA-2177-N", "title": "Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity", "abs": "Announces the addition of approximately 1,130 test systems, assays and examinations that have been categorized between 9/4/99 and 1/31/00. Announces 46 test systems, assays and examinations determined as waived between 9/4/99 and 2/28/00. ", "code": "FR", "keywords": "", "PDF": "" }, { "date": "05/04/2000", "ref": "65 FR 25928", "reg": "", "title": "Genetic Testing Under the Clinical Laboratory Improvement Amendments(CLIA)", "abs": "Notice that HHS will be preparing an NPRM to revise the CLIA regulations applicable to laboratories performing human genetic testing. Comments are being solicited before issuing the NPRM. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2000-05-04/pdf/00-11093.pdf#page=1" }, { "date": "10/01/2000", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2000 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2000-title42-vol3/pdf/CFR-2000-title42-vol3-part493.pdf" }, { "date": "10/31/2000", "ref": "65 FR 64966", "reg": "HCFA-2118-N", "title": "Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of COLA as a CLIA Accreditation Organization", "abs": "Announces the continued approval of COLA as an accreditation organization for laboratories under CLIA from 10/31/00 to 12/31/02. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2000-10-31/pdf/00-27956.pdf" }, { "date": "11/24/2000", "ref": "65 FR 70575", "reg": "HCFA-2118-CN", "title": " Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of COLA as a CLIA Accreditation Organization; Correction", "abs": "Corrects a technical error that appeared in 65 FR 64966. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2000-11-24/pdf/00-29992.pdf" }, { "date": "12/29/2000", "ref": "65 FR 82941", "reg": "HCFA-2024-FC2", "title": "Medicare, Medicaid, and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements Under CLIA", "abs": "Extended date of the QC phase-in and the date by which an individual with a doctoral degree must possess board certification to qualify as a high complexity laboratory director to 12/31/02 ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2000-12-29/pdf/00-33288.pdf" }, { "date": "03/05/2001", "ref": "66 FR 13328", "reg": "HCFA-2068-N", "title": "Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of the American Society for Histocompatibility and Immunogenetics as a CLIA Accreditation Organization", "abs": "Announces the continued approval of ASHI as an accreditation organization for clinical laboratories under the CLIA program. Effective for the period 3/5/01 through 10/31/06 ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2001-03-05/pdf/01-4928.pdf" }, { "date": "09/12/2001", "ref": "66 FR 47493", "reg": "CMS-2119-N", "title": "Continuance of the Approval of the College of American Pathologists as a CLIA Accreditation Organization.", "abs": "Notice announcing the continuance of the approval of the College of American Pathologists (CAP) as an accreditation organization for laboratories under CLIA ‘88. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2001-09-12/pdf/01-22822.pdf" }, { "date": "10/01/2001", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2001 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2001-title42-vol3/pdf/CFR-2001-title42-vol3-part493.pdf" }, { "date": "12/28/2001", "ref": "66 FR 67163", "reg": "CMS-2094-P", "title": "Medicare, Medicaid, and CLIA Programs; Qualification Requirements for Directors of Laboratories Performing High Complexity Testing", "abs": "This proposed rule would revise and expand the qualification requirements by which an individual with a doctoral degree may qualify to serve as a director of a laboratory that performs high complexity testing. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2001-12-28/pdf/01-31722.pdf" }, { "date": "03/22/2002", "ref": "67 FR 13341", "reg": "CMS-2138-N", "title": "Medicare, Medicaid, and CLIA Programs; Continuance of Approval of the American Osteopathic Association (AOA) as an CLIA Accreditation Organization", "abs": "Notice announcing the continued approval of the American Osteopathic Association as an accreditation organization for laboratories under CLIA ‘88 until March 24, 2008. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2002-03-22/pdf/02-6953.pdf" }, { "date": "10/01/2002", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2002 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2002-title42-vol3/pdf/CFR-2002-title42-vol3-part493.pdf" }, { "date": "10/25/2002", "ref": "67 FR 65585", "reg": "CMS-2159-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Continuance of Approval of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) as an Accrediting Organization", "abs": "Notice announcing the continued approval of the Joint Commission on Accreditation of Healthcare Organizations as an accreditation organization for clinical laboratories under CLIA ‘88 until October 25, 2005. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2002-10-25/pdf/02-25947.pdf" }, { "date": "01/24/2003", "ref": "68 FR 3639", "reg": "CMS-2226-F", "title": "Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule", "abs": "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. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2003-01-24/pdf/03-1230.pdf" }, { "date": "08/22/2003", "ref": "68 FR 50722", "reg": "CMS-2226-CN", "title": "Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Correction", "abs": "This document corrects technical errors that appeared in the final rule published in the Federal Register on January 24, 2003, entitled “Medicare, Medicaid and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications.” This document is a supplement to the January 24, 2003 final rule. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2003-08-22/pdf/03-21549.pdf" }, { "date": "10/01/2003", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2003 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.ecfr.gov/current/title-38/chapter-I/part-17/subject-group-ECFR6728fb2fa92f88d/section-17.3500" }, { "date": "11/13/2003", "ref": "68 FR 64350", "reg": "", "title": "Food and Drug Administration; Delegation of Authority", "abs": "Notice that the Commissioner, FDA, has been given the authority to implement CLIA’s complexity categorization provisions, including developing regulations and guidance for CLIA complexity categorization. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2003-11-13/pdf/03-28435.pdf" }, { "date": "04/27/2004", "ref": "69 FR 22849", "reg": "", "title": "Food and Drug Administration; Delegation of Authority for CLIA Test Categorization", "abs": "Clarification of delegation of authority to the FDA for interpreting the CLIA provisions related to complexity categorization; holding public workshops and meetings on CLIA complexity categorization; and, developing and issuing implementing rules and guidance for CLIA complexity categorization. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2012-09-14/pdf/2012-22660.pdf" }, { "date": "10/01/2004", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2004 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2004-title42-vol3/pdf/CFR-2004-title42-vol3-part493.pdf" }, { "date": "12/30/2004", "ref": "69 FR 78426", "reg": "CMS-2490-N", "title": "Medicare, Medicaid and CLIA Program; Continued Approval of the American Association of Blood Banks for Deeming Authority", "abs": "This notice announces the re-approval of the American Association of Blood Banks (AABB) as an accrediting organization for clinical laboratories under CLIA ’88 until July 21, 2007. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2004-12-30/pdf/04-28152.pdf" }, { "date": "03/25/2005", "ref": "70 FR 15327", "reg": "CMS-221-N", "title": "Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of the American Society for Histocompatibility and Immunogenetics as a CLIA Accreditation Organization", "abs": "Notice announcing the continued approval of the American Society for Histocompatibility and Immunogenetics (ASHI) as an accreditation organization for clinical laboratories under CLIA ‘88 until March 25, 2011. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2005-03-25/pdf/05-5595.pdf" }, { "date": "04/29/2005", "ref": "70 FR 22317", "reg": "CMS-2207-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988; Continuance of Exemption of Laboratories Licensed by the State of Washington", "abs": "Notice announcing the laboratories located in the State of Washington that possess a valid license under the Medical Test Site Licensure Law, Chapter 70.42 of the Revised Code of Washington (RCW), continue to be exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) until April 30, 2007. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2005-04-29/pdf/05-8286.pdf" }, { "date": "09/07/2005", "ref": "70 FR 53231", "reg": "FDA 2001D-004", "title": "Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications; Availability", "abs": "FDA notice announcing the availability of the draft guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications” to recommend an approach for determining whether a laboratory test may be performed by laboratories with a certificate of waiver under CLIA. This draft guidance replaces the previous draft guidance entitled “Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver,” March 1, 2001. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2005-09-07/pdf/05-17732.pdf" }, { "date": "10/01/2005", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2005 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2005-title42-vol3/pdf/CFR-2005-title42-vol3-part493.pdf" }, { "date": "10/01/2006", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2006 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2006-title42-vol4/pdf/CFR-2006-title42-vol4-part493.pdf" }, { "date": "02/03/2007", "ref": "72 FR 8171", "reg": "CMS-2221-N", "title": "Medicare, Medicaid and CLIA Programs; Approval of COLA (Formerly the Commission on Office Laboratory Accreditation) as a CLIA Accreditation Organization", "abs": "Notice announcing the continued approval of COLA as an accreditation organization for clinical laboratories under CLIA‘88 until February 25, 2013. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2007-02-23/pdf/E7-3025.pdf" }, { "date": "02/23/2007", "ref": "72 FR 8173", "reg": "CMS-2218-N", "title": "Medicare, Medicaid and CLIA Programs; Approval of the Joint Commission (Formerly the Joint Commission on the Accreditation of Healthcare Organizations)as a CLIA Accreditation Organization", "abs": "Notice announcing the continued approval of The Joint Commission as an accreditation organization for clinical laboratories under CLIA ’88 until February 23, 2012. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2007-02-23/pdf/E7-3030.pdf" }, { "date": "09/28/2007", "ref": "72 FR 55219", "reg": "CMS-2267-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington", "abs": "Notice announcing that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site Licensure Law, Chapter 70.42 of the Revised Code of Washington, continue to be exempt from the requirements of the CLIA until September 28, 2013. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2007-09-28/pdf/E7-18731.pdf" }, { "date": "10/01/2007", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2007 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2007-title42-vol4/pdf/CFR-2007-title42-vol4-part493.pdf" }, { "date": "01/30/2008", "ref": "73 FR 5574", "reg": "FDA-2008-D-0031", "title": "Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices", "abs": "FDA notice announcing the availability of the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The FDA is issuing this guidance to recommend approaches for determining whether a laboratory test may be performed by laboratories with a CLIA Certificate of Waiver. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2008-01-30/pdf/E8-1557.pdf" }, { "date": "05/07/2008", "ref": "73 FR 25752", "reg": "FDA-2008-D-0228", "title": "Guidance for Industry and Food and Drug Administration Staff; Administrative Procedures for CLIA Categorization; Availability", "abs": "FDA notice announcing the availability of the guidance entitled “Administrative Procedures for CLIA Categorization.” The guidance describes FDA's current practices concerning the administrative aspects of categorizing commercially available in vitro diagnostic tests under CLIA. The guidance discusses what manufacturers should submit to help expedite CLIA categorization by FDA. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2008-05-07/pdf/E8-10178.pdf" }, { "date": "05/23/2008", "ref": "73 FR 30109", "reg": "CMS–2224–N", "title": "Medicare, Medicaid, and CLIA Programs; Continuing Approval of AABB (Formerly the American Association of Blood Banks as a CLIA Accreditation Organization", "abs": "Notice announcing the continued approval of the American Association of Blood Banks (AABB) as an accrediting organization for clinical laboratories under CLIA ’88 until May 23, 2014. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2008-05-23/pdf/E8-10769.pdf" }, { "date": "10/01/2008", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2008 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2008-title42-vol4/pdf/CFR-2008-title42-vol4-part493.pdf" }, { "date": "12/19/2008", "ref": "73 FR 77702", "reg": "CMS-2295-N", "title": "Deeming Notice for American Society for Histocompatibility and Immunogenetics (ASHI) as an Accrediting Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "This notice approves and grants The American Society for Histocompatibility and Immunogenetics (ASHI) deeming authority as an accrediting organization for clinical laboratories under CLIA for the subspecialty of General Immunology. This notice is effective from December 19, 2008 until March 25, 2011. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2008-12-19/pdf/E8-29659.pdf" }, { "date": "12/22/2008", "ref": "73 FR 78368", "reg": "CMS-2283-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories in the State of New York", "abs": "This notice announces that laboratories located within the State of New York that possess a valid permit under Article Five of Title V of the Public Health Law of the State of New York and its implementing regulations at 10 N.Y. Comp. Codes R. & Regs., Title V, Part 58., continue to be exempt from the CLIA requirements until December 12, 2014. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2008-12-22/pdf/E8-30452.pdf" }, { "date": "01/16/2009", "ref": "74 FR 3264", "reg": "CMS-2252-P", "title": "Medicare, Medicaid, and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Program; Cytology Proficiency Testing (PT)", "abs": "This proposed rule would amend the CLIA regulations for cytology proficiency testing (PT), to reflect changes in cytology laboratory operations and practices. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2009-01-16/pdf/E9-804.pdf" }, { "date": "03/27/2009", "ref": "74 FR 13443", "reg": "CMS-2282-N", "title": "Medicare, Medicaid, and CLIA Programs; Approval of the American Osteopathic Association as a CLIA Accreditation Organization", "abs": "Notice announcing the continued approval of the American Osteopathic Association (AOA) as an accreditation organization for clinical laboratories under CLIA until March 27, 2015. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2009-03-27/pdf/E9-5473.pdf" }, { "date": "03/27/2009", "ref": "74 FR 13436", "reg": "CMS-2284-N", "title": "Deeming Notice for the College of American Pathologists (CAP) as an Accrediting Organization Under the Clinical laboratory Improvement Amendments of 1988", "abs": "Notice announcing the continued approval of the College of American Pathologists (CAP) as an accreditation organization for clinical laboratories under CLIA until March 27, 2015. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2009-03-27/pdf/E9-6903.pdf" }, { "date": "10/01/2009", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2009 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2009-title42-vol5/pdf/CFR-2009-title42-vol5-part493.pdf" }, { "date": "02/01/2010", "ref": "75 FR 6206", "reg": "FDA-2009-N-0489", "title": "Agency Information Collection Activities; Submission for OMB Review; Comment Request; Recommendations for CLIA Waiver Applications", "abs": "The FDA announces that a guidance document has been submitted to the OMB for review. This guidance document describes recommendations for device manufacturers on submitting an application for a device seeking waived complexity status under CLIA. The Secretary has delegated to FDA the authority to determine whether particular tests (waived tests) are “simple” and have “an insignificant risk of an erroneous result” under CLIA. “69 FR 22849” ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2010-02-08/pdf/2010-2598.pdf" }, { "date": "05/04/2010", "ref": "75 FR 23781", "reg": "FDA-2010-N-0199", "title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the CLIA Categorization", "abs": "This notice solicits comments on administrative procedures for CLIA test categorization. The document describes procedures FDA will use to assign the complexity category to a device. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2010-05-04/pdf/2010-10358.pdf" }, { "date": "08/06/2010", "ref": "75 FR 47601", "reg": "FDA-2010-N-0199", "title": "Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization", "abs": "A guidance document describing the procedures FDA will use to assign the complexity category to a device. Administrative Procedures for the CLIA Categorization-(OMB Control Number 0910-0607; Extension) ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2010-08-06/pdf/2010-19358.pdf" }, { "date": "08/11/2010", "ref": "75 FR 48698", "reg": "CMS-2363-N", "title": "Medicare, Medicaid and CLIA Programs; COLA (Formerly the Commission on Office Laboratory Accreditation) Voluntary Withdrawal From the Specialty of Pathology", "abs": "This notice announces COLA's voluntary withdrawal from the specialty of Pathology. COLA is an approved accreditation organization for clinical laboratories under (CLIA). ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2010-08-11/pdf/2010-19675.pdf" }, { "date": "10/01/2010", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2010 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2009-title42-vol5/pdf/CFR-2010-title42-vol5-part493.pdf" }, { "date": "11/24/2010", "ref": "75 FR 72826", "reg": "CMS-116 CMS-417", "title": "Agency Information Collection Activities: Submission for OMB Review; Comment Request", "abs": "Revision of a currently approved CLIA Application Form CMS-116. The application must be completed by entities performing clinical laboratory testing of human specimens for diagnosis, treatment or general assessment of health. The application information is vital to the certification process. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2010-11-26/pdf/2010-29718.pdf" }, { "date": "03/01/2011", "ref": "76 FR 11248", "reg": "CMS-R-185, CMS-10303, CMS-10379", "title": "Agency Information Collection Activities: Proposed Collection; Comment Request", "abs": "Extension of currently approved collection of information activities to determine comparability/equivalency of the standards, policies and processes of accreditation organizations and CLIA exempt State licensure programs to those of the CLIA program. The information collection activities fulfill certain statutory reporting requirements; Granting or Withdrawing “Deeming Authority” to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regulations. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2011-03-01/pdf/2011-4552.pdf" }, { "date": "04/22/2011", "ref": "76 FR 22711", "reg": "CMS-2372-N", "title": "Announcement of the Re-Approval of the American Society of Histocompatibility and Immunogenetics (ASHI) as an Accreditation Organization Under the CLIA.", "abs": "Notice announcing the continued approval of the American Society for Histocompatibility and Immunogenetics (ASHI) as an accreditation organization for clinical laboratories under CLIA program for General Immunology, Histocompatibility, and ABO/Rh typing until April 22, 2016. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2011-04-22/pdf/2011-8948.pdf" }, { "date": "05/20/2011", "ref": "76 FR 29249", "reg": "CMS-10232, CMS-10251, CMS-R-185, CMS-R-211", "title": "Agency Information Collection Activities: Submission for OMB Review; Comment Request", "abs": "Extension of currently approved collection of information activities to determine comparability/equivalency of the standards, policies and processes of accreditation organizations and CLIA exempt State licensure programs to those of the CLIA program. The information collection activities fulfill certain statutory reporting requirements; Granting or Withdrawing “Deeming Authority” to Private Nonprofit Accreditation Organizations and of State Exemption Under State Laboratory Programs and Supporting Regulations. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2011-05-20/pdf/2011-12383.pdf" }, { "date": "09/14/2011", "ref": "76 FR 56712", "reg": "CMS–2319–P", "title": "AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS; Centers for Disease Control and Prevention (ob), HHS; Office for Civil Rights (OCR), HHS.", "abs": "This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and also amend the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2011-09-14/pdf/2011-23525.pdf" }, { "date": "10/01/2011", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2011 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-part493.pdf" }, { "date": "10/20/2011", "ref": "76 FR 65197", "reg": "", "title": "Statement of Organization, Functions, and Delegations of Authority", "abs": "Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS). Oversees the planning, policy, coordination and implementation of the survey, certification and enforcement programs for all Medicare and Medicaid providers and suppliers, and for laboratories under the auspices of CLIA. Develops requirements of participation for providers and plans in the Medicare, Medicaid, and CLIA programs. Revises requirements based on statutory change and input from other components. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2011-10-20/pdf/2011-27169.pdf" }, { "date": "11/29/2011", "ref": "76 FR 73648", "reg": "CMS–29, CMS–209", "title": "Agency Information Collection Activities: Proposed Collection; Comment Request", "abs": "CMS–209 form recording the personnel data of all technical staff to support their compliance with personnel qualifications requirements of CLIA. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2011-11-29/pdf/2011-30729.pdf" }, { "date": "01/30/2012", "ref": "77 FR 4563", "reg": "CMS–29, CMS–209", "title": "Agency Information Collection Activities: Submission for OMB Review; Comment Request", "abs": "CMS–209 form The laboratory will complete the CMS–209 by recording the personnel data needed to support their compliance with the personnel requirements of CLIA. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2012-01-30/pdf/2012-1945.pdf" }, { "date": "02/07/2012", "ref": "77 FR 6124", "reg": "CMS–668B, CMS–1557", "title": "Agency Information Collection Activities: Proposed Collection; Comment Request", "abs": "Form CMS–668B The laboratory completes this form to express its satisfaction with the survey process and to make recommendations for improvement. Surveyors furnish this form to all laboratories that receive either an onsite survey or the Alternate Quality Assessment Survey (i.e., paper survey of quality indicators). CMS Central Office performs an overview evaluation of the completed forms. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2012-02-07/pdf/2012-2774.pdf" }, { "date": "04/18/2012", "ref": "77 FR 23265", "reg": "CMS–668B, CMS–1557, CMS–10399", "title": "Agency Information Collection Activities: Submission for OMB Review; Comment Request", "abs": "Announces OMB review of Form CMS–668B, used by laboratories to express satisfaction with the survey process and to make recommendations for improvement. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2012-04-18/pdf/2012-9259.pdf" }, { "date": "05/25/2012", "ref": "77 FR 31359", "reg": "CMS-3257-N", "title": "Deeming Notice for the Joint Commission as an Accrediting Organization Under the Clinical laboratory Improvement Amendments of 1988", "abs": "Notice announces the continued approval of the Joint Commission as an accrediting organization for clinical laboratories under CLIA until May 25, 2018. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2012-05-25/pdf/2012-12639.pdf" }, { "date": "09/14/2012", "ref": "77 FR 56846", "reg": "FDA-2012-N-0937", "title": "Agency Information Collection Activities; Proposed Collection; Comment Request; CLIA 1988 Waiver Applications", "abs": "A call for the collection of data from Manufacturers of in-vitro diagnostic devices to estimate the total operating and maintenance cost associated with the CLIA Waiver application process. ", "code": "FR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2012-09-14/pdf/2012-22660.pdf" }, { "date": "10/01/2012", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2012 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/CFR-2012-title42-vol5/pdf/CFR-2012-title42-vol5-part493.pdf" }, { "date": "12/04/2012", "ref": "", "reg": "P.L. 112-202", "title": "Taking Essential Steps for Testing Act of 2012", "abs": "The TEST Act gives CMS discretion when addressing PT referral by a laboratory. ", "code": "CFR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/PLAW-112publ202/pdf/PLAW-112publ202.pdf" }, { "date": "02/22/2013", "ref": "78 FR 12323", "reg": "CMS-3279-N", "title": "Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of COLA as a CLIA Accreditation Organization", "abs": "Announces the continued approval of COLA as an accreditation organization for laboratories under CLIA until February 22, 2019. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2013-02-22/pdf/2013-03927.pdf#page=1" }, { "date": "09/23/2013", "ref": "78 FR 58386", "reg": "CMS-1443-P", "title": "Medicare Prog; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics and to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral; Prop", "abs": "Proposed rule includes changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing referral. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2013-09-23/pdf/2013-22821.pdf#page=2" }, { "date": "09/27/2013", "ref": "78 FR 59704", "reg": "CMS-3111-N", "title": "Medicare, Medicaid, and CLIA Programs: Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington ", "abs": "Announces that laboratories licensed by the State of Washington and located within the State continue to be exempt from the CLIA requirements until September 27, 2019. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/CFR-2013-title42-vol5/pdf/CFR-2013-title42-vol5-part493.pdf" }, { "date": "10/01/2013", "ref": "42 CFR 493", "reg": "", "title": "Code of Federal Regulations Title 42 Part 493 Laboratory Requirements", "abs": "This document contains the codified CLIA regulations as of October 1, 2013 and includes the FRN documents denoted with -F, -FC or -CN (listed below). ", "code": "CFR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/CFR-2013-title42-vol5/pdf/CFR-2013-title42-vol5-part493.pdf" }, { "date": "02/06/2014", "ref": "79 FR 7290", "reg": "CMS-2319-F", "title": "CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports", "abs": "This final rule amends CLIA'88 regulations to specify that, upon the request of a patient (or the patient’s personal representative), laboratories subject to CLIA may provide the patient, the patient’s personal representative, or a person designated by the patient, as applicable, with copies of completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2014-02-06/pdf/2014-02280.pdf#page=2" }, { "date": "05/02/2014", "ref": "79 FR 25435", "reg": "CMS-1443-FC", "title": "Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to CLIA of 1988 Enforcement Actions for PT Referral", "abs": "ACTION: Final rule with comment period This final rule with comment period implements changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing (PT) referrals. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2014-05-02/pdf/2014-09908.pdf" }, { "date": "05/12/2014", "ref": "79 FR 27106", "reg": "CMS-3267-F", "title": "Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II", "abs": "This final rule makes a number of clarifications and changes pertaining to CMS regulations governing proficiency testing referrals under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These changes are intended to prevent confusion on the part of laboratories, reduce the risk of noncompliance, and establish policies under which certain proficiency testing (PT) referrals by laboratories may not generally be subject to revocation of a CLIA certificate, or a two-year prohibition on laboratory ownership or operation that may be applied to an owner and an operator when a CLIA certificate is revoked. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2014-05-12/pdf/2014-10687.pdf" }, { "date": "05/23/2014", "ref": "79 FR 29774", "reg": "CMS-3291-N", "title": " Announcement of the Re-Approval of AABB (Formerly Known as the American Association of Blood Banks) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "This notice announces the application of AABB for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant AABB deeming authority for a period of 6 years. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program. This notice is effective from May 23, 2014 to May 25, 2020. ", "code": "FR", "keywords": "", "PDF": "http://www.gpo.gov/fdsys/pkg/FR-2014-05-23/pdf/2014-11918.pdf#page=1" }, { "date": "11/07/2014", "ref": "79 FR 66348", "reg": "CMS-3271-P", "title": "Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing", "abs": "This proposed rule would amend the CLIA regulations to clarify that the waived test categorization applies only to non- automated fecal occult blood tests and it proposed to remove the hemoglobin by copper sulfate method from the list of waived tests if commenters confirm that the method is no longer used. ", "code": "FR", "keywords": "", "PDF": "http://www.gpo.gov/fdsys/pkg/FR-2014-11-07/pdf/2014-26559.pdf" }, { "date": "03/27/2015", "ref": "80 FR 16395", "reg": "CMS–3313–N", "title": "Announcement of the Re-Approval of the College of American Pathologists (CAP) as an Accreditation Organization Under the Clinical Laboratory", "abs": "This notice announces the approval of the College of American Pathologists (CAP) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. CMS has determined that the CAP meets or exceeds the applicable CLIA requirements and grants CAP deeming authority for a period of 6 years. ", "code": "FR", "keywords": "", "PDF": "http://www.gpo.gov/fdsys/pkg/FR-2015-03-27/pdf/2015-07111.pdf" }, { "date": "03/27/2015", "ref": "80 FR 16408", "reg": "CMS–3314–N", "title": "Medicare, Medicaid, and CLIA Programs; Announcement of the Re-Approval of the American Osteopathic Association/Healthcare Facilities", "abs": "This notice announces the approval of the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. CMS has determined that AOA/HFAP meets or exceeds the applicable CLIA requirements and has granted AOA/HFAP deeming authority for a period of 6 years. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2015-03-27/pdf/2015-07115.pdf" }, { "date": "03/27/2015", "ref": "80 FR 16410", "reg": "CMS–3308–N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988", "abs": "This notice announces that laboratories located in and licensed by the State of New York that possess a valid permit under New York State Public Health Law Article 5, Title V, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 6 years. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2015-03-27/pdf/2015-07113.pdf" }, { "date": "04/01/2016", "ref": "81 FR 18858", "reg": "FDA-2008-D-0031", "title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications", "abs": "The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. This notice solicits comments on collections of information associated with Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications. Submit either electronic or written comments on the collection of information by May 31, 2016. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2016-04-01/pdf/2016-07365.pdf" }, { "date": "04/22/2016", "ref": "81 FR 23706", "reg": "CMS-3330-N", "title": "Announcement of the Re-Approval of the American Society of Histocompatibility and Immunogenetics (ASHI) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "Notice announcing the re-approval of the American Society of Histocompatibility and Immunogenetics (ASHI) as an accreditation organization for clinical laboratories under CLIA until April 21, 2022. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2016-04-22/pdf/2016-09301.pdf" }, { "date": "04/27/2016", "ref": "81 FR 24820", "reg": "FDA-2013-N-0514", "title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization", "abs": "The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. This notice solicits comments on requests for Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic tests when a premarket review is not needed. Submit either electronic or written comments on the collection of information by June 27, 2016. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2016-04-27/pdf/2016-09769.pdf" }, { "date": "10/20/2017", "ref": "82 FR 48770L", "reg": "CMS-3271-F", "title": "Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing", "abs": "This Final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to nonautomated fecal occult blood (FOB) tests. This change would exclude the more complex automated FOB analyzers from the list of waived tests in the CLIA regulations. DATES: These regulations are effective December 19, 2017. ", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2017-10-20/pdf/2017-22813.pdf" }, { "date": "01/09/2018", "ref": "83 FR 1004", "reg": "CMS-3326-NC", "title": " Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)", "abs": "This request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA). The Centers for Medicare & Medicaid Services (CMS) is seeking comments from the laboratory community on the following topics:

The Centers for Medicare & Medicaid Services (CMS) intends to consider public comments (including information such as evidence, research, and trends) received in response to this request for information when we draft proposals, in consultation, as appropriate, with the Centers for Disease Control and Prevention (ob), to update the existing CLIA regulations through future rulemaking. We are also soliciting public comment on other areas of CLIA which should be reviewed and potentially updated.", "code": "FR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2018-01-09/pdf/2017-27887.pdf" //verfied }, { "date": "03/23/2018", "ref": "83 FR 12799", "reg": "CMS-3352-N", "title": "Medicare Program; Announcement of the Approval of the American Association for Laboratory Accreditation (A2LA) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "This notice announces the approval of the application of the American Association for Laboratory Accreditation (A2LA) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the A2LA meets or exceeds the applicable CLIA requirements. We are announcing the approval and granting the A2LA deeming authority for a period of 4 years. DATES: This notice is applicable from March 23, 2018 to March 23, 2022. ", "code": "CFR", "keywords": "", "PDF": "https://www.gpo.gov/fdsys/pkg/FR-2018-03-23/pdf/2018-05892.pdf" }, { "date": "12/31/2018", "ref": "83 FR 67723", "reg": "CMS-3356-NC", "title": "Medicare Program; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees", "abs": "This notice with comment period announces the increase of fees for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The CLIA statute requires CMS to impose user fees to cover the general costs of administering the CLIA program. COMMENTS: Comments must be received no later than 5 p.m. on March 1, 2019 to ensure consideration.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2018-12-31/pdf/2018-28359.pdf" }, { "date": "02/04/2019", "ref": "84 FR 1536", "reg": "CMS-3355-P", "title": "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance", "abs": "This proposed rule would update proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes and to revise microbiology requirements and grading criteria. This proposed rule would also make additional technical changes to PT referral regulations to more closely align them with the CLIA statute. COMMENTS: Submit either electronic or written comments no later than 5 p.m. on June 4, 2019.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2019-02-04/pdf/2018-28363.pdf" }, { "date": "02/22/2019", "ref": "84 FR 5688", "reg": "CMS-3373-N", "title": "Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "This notice announces the re-approval of COLA as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program until February 22, 2025.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2019-02-22/pdf/2019-03169.pdf" }, { "date": "03/29/2019", "ref": "84 FR 11980", "reg": "CMS-3375-N", "title": "Announcement of the Approval of the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (AAHHS/HFAP) (Formerly Known as the American Osteopathic Association/Healthcare Facilities Accreditation Program) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "This notice announces the re-approval of AAHHS/HFAP as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program until March 29, 2023.", "code": "F", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2019-03-29/pdf/2019-06291.pdf" }, { "date": "09/30/2019", "ref": "84 FR 51591", "reg": "CMS-3383-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington", "abs": "This notice announces that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site law, Chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 4 years until October 2, 2023.", "code": "F", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2019-09-30/pdf/2019-21062.pdf" }, { "date": "12/13/2019", "ref": "84 FR 68172", "reg": "", "title": "Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee (CLIAC)", "abs": "The Centers for Disease Control and Prevention (ob) is seeking nominations for membership on CLIAC. CLIAC, consisting of 20 members including the Chair, represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer representative. In addition, the Committee includes three ex officio members (or designees), including the Director, ob; the Administrator, Centers for Medicare and Medicaid Services (CMS); and the Commissioner, Food and Drug Administration (FDA). A nonvoting representative from the Advanced Medical Technology Association (AdvaMed) serves as the industry liaison. The Designated Federal Officer or their designee and the Executive Secretary are present at all meetings to ensure meetings are within applicable statutory, regulatory and HHS General Administration manual directives.

Nominations for membership on CLIAC must be received no later than March 1, 2020. Packages received after this time will not be considered for the current membership cycle.

All nominations should be mailed to:

CLIAC Secretary,
Senior Advisor for Clinical Laboratories,
Division of Laboratory Systems,
Center for Surveillance,
Epidemiology and Laboratory Services,
Office of Public Health Scientific Services,
Centers for Disease Control and Prevention,
1600 Clifton Road NE,
Mailstop V24–3,
Atlanta, Georgia 30329–4027

Or

E-mailed to: CLIAC@cdc.gov

Or
faxed to: (404) 471–2706.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2019-12-13/pdf/2019-26921.pdf" }, { "date": "05/26/2020", "ref": "85 FR 31509", "reg": "CMS–3398–N", "title": "Announcement of the Re-Approval of AABB (Formerly Known as the American Association of Blood Banks) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "This notice announces the re-approval of AABB as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. The approval announced in this notice is effective until May 27, 2024.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2020-05-26/pdf/2020-11235.pdf" }, { "date": "07/06/2020", "ref": "85 FR 40290", "reg": "ob–2020–0051", "title": "Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health Laboratories", "abs": "Centers for Disease Control and Prevention (ob), Department of Health and Human Services (HHS).

ACTION: Notice.

SUMMARY: This notice extends the date of the comment period to September 14, 2020, for receipt of written and electronic comments in response to the Request for Information Concerning Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health Laboratories (85 FR 29456), published by the Centers for Disease Control and Prevention.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2020-07-06/pdf/2020-14417.pdf" }, { "date": "07/27/2020", "ref": "85 FR 45221", "reg": "CMS-116", "title": "Agency Information Collection Activities: Proposed Collection; Comment Request", "abs": "SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to revise the Clinical Laboratory Improvement Amendments (CLIA) Application Form.

The laboratory must submit an application that describes the characteristics of the laboratory and examinations and procedures performed by the laboratory. The application must be completed by entities performing laboratory’s testing specimens for diagnostic or treatment purposes. This information is vital to the certification process. In this revision, the majority of changes were minor changes to the form and accompanying instructions to facilitate the completion and data entry of the form. We anticipate that the changes will not increase the time to complete the form. Form Number: CMS–116 (OMB control number: 0938–0581);

DATES: Comments must be received by September 28, 2020.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2020-07-27/pdf/2020-16243.pdf" }, { "date": "03/30/2021", "ref": "86 FR 16599", "reg": "CMS-3411-N", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories in the State of New York", "abs": "SUMMARY: This notice announces that laboratories located in and licensed by the State of New York that possess a valid permit under the New York State Public Health Law are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 6 years, from March 26, 2021 to March 26, 2027.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2021-03-30/pdf/2021-06499.pdf" }, { "date": "01/19/2022", "ref": "87 FR 2736", "reg": "42 CFR Part 493
ڰѳ–3355–R䱷
RIN0938–AT55", "title": "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance; Extension of Timeline for Publication of Final Rule", "abs": "
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS); Centers for Disease Control and Prevention (ob), HHS.
ACTION: Extension of timeline for publication of final rule.
SUMMARY: The Social Security Act (the Act) specifies that a Medicare final rule must be published no later than 3 years after the publication date of the proposed rule or interim final rule, as applicable, except under exceptional circumstances. In accordance with the Act, this document announces an extension of the timeline for publication of the final rule and includes a brief explanation of the justification for the variation.
DATES: As of January 18, 2022, the timeline for publication of the final rule to finalize the provisions of the proposed rule published on February 4, 2019 (84 FR 1536), is extended until February 4, 2023.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2022-01-19/pdf/2022-00932.pdf" }, { "date": "03/07/2022", "ref": "FR 87 12711", "reg": "CMS–3425–N", "title": "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance; Extension of Timeline for Publication of Final Rule", "abs": "
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS); Centers for Disease Control and Prevention (ob), HHS.
ACTION: Notice.
SUMMARY: This notice announces the re-approval of COLA as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. The approval announced in this notice is effective until March 7, 2024.
DATES: This notice is effective from March 7, 2022 to March 7, 2024.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2022-03-07/pdf/2022-04770.pdf" }, { "date": "03/22/2022", "ref": "FR 87 16190", "reg": "CMS-3422-N", "title": "Announcement of the Re-Approval of the American Association for Laboratory Accreditation (A2LA) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS); Centers for Disease Control and Prevention (ob), HHS.
ACTION: Notice.
SUMMARY: This notice announces the re-approval of A2LA as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. The approval announced in this notice is effective until March 22, 2028.
DATES: This notice is effective from March 23, 2022, until March 22, 2028.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2022-03-22/pdf/2022-06023.pdf" }, { "date": "4/15/2022", "ref": "FR 87 22534", "reg": "CMS–3423–N", "title": "Announcement of the Re-Approval of the American Society of Histocompatibility and Immunogenetics (ASHI) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS); Centers for Disease Control and Prevention (ob), HHS.
ACTION: Notice.
SUMMARY: This notice announces the re-approval of ASHI as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. The approval announced in this notice is effective until April 15, 2028.
DATES: This notice is effective from April 15, 2022 to April 15, 2028.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2022-04-15/pdf/2022-08153.pdf" }, { "date": "6/16/2022", "ref": "FR 87 36330", "reg": "FDA–2013–N–0514", "title": "Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments", "abs": "
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension an existing collection of information, and to allow 60 days for public comment in response to the notice. This guidance describes recommendations for device manufacturers submitting to FDA an application for determination that a cleared or approved device meets this CLIA standard (CLIA waiver application). The guidance recommends that CLIA waiver applications include a description of the features of the device that make it ‘‘simple’’; a report describing a hazard analysis that identifies potential sources of error, including a summary of the design and results of flex studies and conclusions drawn from the flex studies; a description of fail-safe and failure alert mechanisms and a description of the studies validating these mechanisms; a description of clinical tests that demonstrate the accuracy of the test in the hands of intended operators; and statistical analyses of clinical study results.This notice solicits comments on information collection associated with implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
DATES: Submit either electronic or written comments on the collection of information by August 15, 2022.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2022-06-16/pdf/2022-12929.pdf" }, { "date": "7/11/2022", "ref": "FR 87 41194", "reg": "42 CFR Part 493
ڰѳ–3355–F
RIN 0938–AT55", "title": "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance", "abs": "
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS; Centers for Disease Control and Prevention (ob), HHS.
ACTION: Final rule.
SUMMARY: This final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. This final rule also makes technical changes to PT referral regulations to better align them with the CLIA statute.
DATES: Effective August 10, 2022, except for the amendments to §§ 493.2 and 493.801 through 493.959 (amendatory instructions 2 and 5 through 21), which are effective July 11, 2024.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2022-07-11/pdf/2022-14513.pdf" }, { "date": "7/26/2022", "ref": "FR 87 44896", "reg": "42 CFR Part 493
ڰѳ–3326
RIN 0938–AT47", "title": "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories", "abs": "
AGENCY: Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (ob), Department of Health and Human Services (HHS).
ACTION: Proposed rule.
SUMMARY: This proposed rule would update the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarify the CLIA fee regulations. This proposed rule includes a proposal to provide sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are proposing to incorporate limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also proposing to distribute the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, we are proposing to clarify the methodology used to determine program compliance fees. This proposed rule would ensure the continuing quality and safety of laboratory testing for the public. This proposed rule would also amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate techlogical changes. In addition, this proposed rule would amend the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite state monitoring) to allow for the imposition of such sanctions on CoW laboratories.
DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 25, 2022.
ADDRESSES:You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the ‘‘Submit a comment’’ instructions.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2022-07-26/pdf/2022-15300.pdf" }, { "date": "11/17/2022", "ref": "FR 87 68912", "reg": "42 CFR Part 493
ڰѳ–3355–F2
RIN 0938–AT55", "title": "Clinical Laboratory Improvement Amendments CLIA) Proficiency Testing Related to Analytes and Acceptable Performance; Correction", "abs": "
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
ACTION: Final rule; correction.
SUMMARY: In the July 11, 2022 issue of the Federal Register, we published a final rule that updated proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. The effective date was August 10, 2022, except for the amendments in amendatory instructions 2 and 5 through 21, which are effective July 11, 2024. This document corrects one technical error identified in the July 11, 2022, final rule.
DATES: This document is effective July 11, 2024, and is applicable beginning August 10, 2022.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2022-11-17/pdf/2022-24990.pdf" }, { "date": "03/27/2023", "ref": "FR 88 18142", "reg": "[CMS–3436–N]", "title": "Announcement of the Approval of the Accreditation Commission for Health Care (ACHC) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
ACTION: Notice.
SUMMARY: This notice announces the approval of the application of the Accreditation Commission for Health Care (ACHC) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the ACHC meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant the ACHC deeming authority for a period of 6 years.
DATES: The approval announced in this notice is effective from March 27, 2023 to March 27, 2029.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2023-03-27/pdf/2023-06280.pdf" }, { "date": "09/29/2023", "ref": "FR 88 67301", "reg": "[CMS–3383–N2]", "title": "Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington; Exemption Period Extension", "abs": "
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
ACTION: Notice; exemption period extension.
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) announce the extension of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) exemption period for the State of Washington. The exemption period is extended for 6 months, that is until April 2, 2024.
DATES: The exemption granted by this notice is effective from October 2, 2023 to April 2, 2024.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2023-09-29/pdf/2023-21460.pdf" }, { "date": "12/28/2023", "ref": "848 FR 89976", "reg": "42 CFR Part 493
ڰѳ–3326–F
RIN 0938–AT47", "title": "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories", "abs": "
SUMMARY: This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. This final rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are finalizing the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also finalizing the distribution of the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, we are finalizing the clarification of the methodology used to determine program compliance fees. This final rule ensures the continuing quality and safety of laboratory testing for the public. This final rule also amends histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this final rule amends the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions on CoW laboratories.
DATES: These regulations are effective January 27, 2024, except for instruction 3, amending § 493.2; instructions 14 through 19, amending §§ 493.945, 493.1273, 493.1274, 493.1278, 493.1359, and 493.1405; instruction 20 removing § 493.1406; instructions 21 through 30, amending §§ 493.1407, 493.1411, 493.1417, 493.1423, 493.1443, 493.1445, 493.1449, 493.1451, 493.1455, and 493.1461; instruction 31 removing § 493.1462; and instructions 32 through 36, amending §§ 493.1463, 493.1469, 493.1483, 493.1483, 493.1489, and 493.1491, which are effective December 28, 2024.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2023-12-28/pdf/2023-28170.pdf" }, { "date": "02/01/2024", "ref": "89 FR 6431", "reg": "42 CFR Part 493
ڰѳ–3326–C
RIN 0938–AT47", "title": "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction", "abs": "
SUMMARY: This document corrects technical and typographical errors in the final rule that appeared in the December 28, 2023, Federal Register entitled, ‘‘Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories’’ (referred to hereafter as the ‘‘December 2023 final rule’’).
DATES: This correction is effective January 27, 2024.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2024-02-01/pdf/2024-01942.pdf" }, { "date": "03/06/2024", "ref": "89 FR 15994", "reg": "[CMS–3448–N]", "title": "Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "
SUMMARY: This notice announces the application of COLA for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology; Diagnostic Immunology, including Syphilis Serology, and General Immunology; Chemistry, including Routine Chemistry, Toxicology, and Endocrinology; Hematology, including routine hematology and coagulation; Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification; Pathology, including Histopathology, Oral Pathology, and Cytology. We have determined that COLA meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant COLA deeming authority for a period of 6 years.
DATES: Effective Date: This notice is effective from March 6, 2024, to March 6, 2030.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2024-03-06/pdf/2024-04674.pdf" }, { "date": "03/08/2024", "ref": "89 FR 16773", "reg": " ", "title": "Clinical Laboratory Improvement Advisory Committee; Notice of Charter Renewal", "abs": "
ACTION: Notice of charter renewal.
SUMMARY: The Centers for Disease Control and Prevention (ob), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Clinical Laboratory Improvement Advisory Committee (CLIAC).", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2024-03-08/pdf/2024-04962.pdf" }, { "date": "04/01/2024", "ref": "89 FR 22406", "reg": "[CMS–3441–N]", "title": "Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington", "abs": "
ACTION: Notice of charter renewal.
SUMMARY: This notice announces that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site law, chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 4 years.
DATES: The exemption granted by this notice is effective from April 1, 2024 to April 1, 2028.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2024-04-01/pdf/2024-06802.pdf" }, { "date": "04/25/2024", "ref": "89 FR 31755", "reg": "[CMS–3449–N]", "title": "Announcement of the Re-Approval of AABB (Association for the Advancement of Blood and Biotherapies) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988", "abs": "
ACTION: Notice
SUMMARY:This notice announces the application of the Association for the Advancement of Blood and Biotherapies (AABB) for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant AABB deeming authority for a period of 6 years.
DATES:The approval is effective from April 25, 2024, to April 25, 2030.", "code": "CFR", "keywords": "", "PDF": "https://www.govinfo.gov/content/pkg/FR-2024-04-25/pdf/2024-08809.pdf" } ]