| 04/25/2024 | 89 FR 31755 | [CMS–3449–N] | 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
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. PDF
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| 04/01/2024 | 89 FR 22406 | [CMS–3441–N] | Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington
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. PDF
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| 03/08/2024 | 89 FR 16773 | | Clinical Laboratory Improvement Advisory Committee; Notice of Charter Renewal
ACTION: Notice of charter renewal.
SUMMARY: The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Clinical Laboratory Improvement Advisory Committee (CLIAC). PDF
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| 03/06/2024 | 89 FR 15994 | [CMS–3448–N] | Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988
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. PDF
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| 02/01/2024 | 89 FR 6431 | 42 CFR Part 493
[CMS–3326–CN]
RIN 0938–AT47 | Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction
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. PDF
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| 12/28/2023 | 848 FR 89976 | 42 CFR Part 493
[CMS–3326–F]
RIN 0938–AT47 | Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories
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. PDF
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| 09/29/2023 | FR 88 67301 | [CMS–3383–N2] | Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington; Exemption Period Extension
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. PDF
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| 03/27/2023 | FR 88 18142 | [CMS–3436–N] | Announcement of the Approval of the Accreditation Commission for Health Care (ACHC) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
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. PDF
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| 11/17/2022 | FR 87 68912 | 42 CFR Part 493
[CMS–3355–F2]
RIN 0938–AT55 | Clinical Laboratory Improvement Amendments CLIA) Proficiency Testing Related to Analytes and Acceptable Performance; Correction
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. PDF
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| 7/26/2022 | FR 87 44896 | 42 CFR Part 493
[CMS–3326–P]
RIN 0938–AT47 | Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories
AGENCY: Centers for Medicare & Medicaid Services (CMS) and Centers for Disease Control and Prevention (CDC), 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. PDF
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