Legal Status
Clinical Laboratory Improvement Program
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 authorized Federal regulatory standards for all clinical laboratory testing performed on humans in the U.S., except clinical trials and basic research.The CLIA program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans to provide information for the diagnosis, prevention, or treatment of disease or impairment, and for the assessment of health. An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. The Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA program. Other Health and Human Services agencies' articles may also appear in these search results.
Showing 1-20 of 544 results since 1994. View 524 more results.
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Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations
This proposed rule would update the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2019. It also...
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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance document provides an overview of the mechanisms...
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Medicare Program; Announcement of the Reapproval of the Joint Commission as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
This notice announces the application of the Joint Commission for reapproval 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 Joint Commission meets or exceeds the applicable CLIA...
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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...
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback”
The Food and Drug Administration (FDA, we, or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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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
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...
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Consolidated Cruise Ship Security Regulations
The Coast Guard is issuing a final rule to eliminate outdated regulations that imposed unnecessary screening requirements on cruise ships and cruise ship terminals. This final rule replaces these outdated regulations with simpler, consolidated regulations that provide efficient and clear requirements for the screening of baggage, personal items,...
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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...
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Clinical Laboratory Improvement Advisory Committee (CLIAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. The public is also welcome to view the meeting by...
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Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be...
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Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information...
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Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of November 29, 2017. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Recommendations for Dual 510(k) and Clinical Laboratory...
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Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of November 29, 2017. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Select Updates for Recommendations for Clinical Laboratory...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback”
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information,...
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Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
This request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been updated since 1992. We are also seeking public comment regarding the flexibility to impose...
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Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information...
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Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.'' FDA is issuing this draft guidance document to update and clarify the policy for a manufacturer's application of an assay that was previously cleared...
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The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``The Least Burdensome Provisions: Concept and Principles'' FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while...
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Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts...
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National Health and Nutrition Examination Survey (NHANES) Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals to Use Serum, Plasma, and Urine Samples
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the availability of stored sera, plasma, and urine samples obtained from participants in the National Health and Nutrition Examination Survey (NHANES) for use and the fee schedule for such use. The National Health and Nutrition...
Showing 1-20 of 544 results since 1994. View 524 more results.
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