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Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations

Code of Federal Regulations (CFR): The Code of Federal Regulations is a codification (arrangement) of the general and permanent final rules published in the Federal Register by the executive departments and agencies of the Federal Government.

Federal Register (FR): The Federal Register is the official daily publication for notices, proposed rules, and final rules published by federal agencies and organizations, as well as executive orders and other presidential documents.

  • Notice: Announcements of public meetings, hearings, investigations, grants and funding, environmental impact statements, information collections, statements of organization and functions, delegations and other announcements of public interest.
  • Proposed Rules: Proposed rules announce and explain federal agencies’ plans to solve problems and accomplish goals through proposed regulations and provide the opportunity for interested persons to submit comments to be considered in drafting the final regulation.
  • Final Rules: Final rules are the regulations published in the Code of Federal Regulations and enforced by the federal agencies.

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 Displaying rows: 1 to 20 of 126 Next >>
DateSort IndicatorReferenceSort IndicatorRegulation #Sort IndicatorPublication TitleSort Indicator
05/23/201479 FR 29774CMS-3291-N 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

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.  PDF
05/12/201479 FR 27106CMS-3267-F, RIN 0938-AR49 Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II

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.  PDF
05/02/201479 FR 25435CMS-1443-FC 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

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.   PDF
02/06/201479 FR 7290CMS-2319-F CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports

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.  PDF
10/01/201342 CFR 493  Code of Federal Regulations Title 42 Part 493 Laboratory Requirements  

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).  PDF
09/27/201378 FR 59704CMS-3111-N Medicare, Medicaid, and CLIA Programs: Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington

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.  PDF
09/23/201378 FR 58386CMS-1443-P 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

Proposed rule includes changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing referral.  PDF
02/22/201378 FR 12323CMS-3279-N Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of COLA as a CLIA Accreditation Organization

Announces the continued approval of COLA as an accreditation organization for laboratories under CLIA until February 22, 2019.  PDF
12/04/2012 P.L. 112-202 Taking Essential Steps for Testing Act of 2012

The TEST Act gives CMS discretion when addressing PT referral by a laboratory.  PDF
10/01/201242 CFR 493  Code of Federal Regulations Title 42 Part 493 Laboratory Requirements  

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).  PDF
09/14/201277 FR 56846FDA-2012-N-0937 Agency Information Collection Activities; Proposed Collection; Comment Request; CLIA 1988 Waiver Applications

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.  PDF
05/25/201277 FR 31359CMS-3257-N Deeming Notice for the Joint Commission as an Accrediting Organization Under the Clinical laboratory Improvement Amendments of 1988

Notice announces the continued approval of the Joint Commission as an accrediting organization for clinical laboratories under CLIA until May 25, 2018.  PDF
04/18/201277 FR 23265CMS–668B, CMS–1557, CMS–10399 Agency Information Collection Activities: Submission for OMB Review; Comment Request

Announces OMB review of Form CMS–668B, used by laboratories to express satisfaction with the survey process and to make recommendations for improvement.   PDF
02/07/201277 FR 6124CMS–668B, CMS–1557 Agency Information Collection Activities: Proposed Collection; Comment Request

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.  PDF
01/30/201277 FR 4563CMS-29, CMS–209 Agency Information Collection Activities: Submission for OMB Review; Comment Request

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.  PDF
11/29/201176 FR 73648CMS–29, CMS–209 Agency Information Collection Activities: Proposed Collection; Comment Request

CMS–209 form recording the personnel data of all technical staff to support their compliance with personnel qualifications requirements of CLIA.  PDF
10/20/201176 FR 65197  Statement of Organization, Functions, and Delegations of Authority

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.  PDF
10/01/201142 CFR 493  Code of Federal Regulations Title 42 Part 493 Laboratory Requirements  

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).  PDF
09/14/201176 FR 56712 CMS–2319–P AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS; Centers for Disease Control and Prevention (CDC), HHS; Office for Civil Rights (OCR), HHS.

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.  PDF
05/20/201176 FR 29249CMS-10232, CMS-10251, CMS-R-185, CMS-R-211 Agency Information Collection Activities: Submission for OMB Review; Comment Request

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.   PDF
 
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