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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.

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HHS - 826 - Clinical Laboratory Improvement Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameClinical Laboratory Improvement Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2022Committee Number826
Original Establishment Date2/28/1992Committee StatusChartered
Actual Termination Date Committee URLhttps://www.cdc.gov/cliac/
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*24
Current Charter Date2/19/2022Designated Fed Officer Position Title*Director, Division of Laboratory Systems
Date Of Renewal Charter2/19/2024Designated Federal Officer PrefixDr.
Projected Termination Date Designated Federal Officer First Name*Reynolds
Exempt From Renewal*NoDesignated Federal Officer Middle NameMathewson
Specific Termination Authority42 U.S.C. 217aDesignated Federal Officer Last Name*Salerno
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPh.D.
Specific Establishment Authority*42 U.S.C. 217aDesignated Federal Officer Phone*(404) 498-6516
Effective Date Of Authority*2/28/1992Designated Federal Officer Fax*404) 498-6365
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*rsalerno@cdc.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Clinical Laboratory Improvement Advisory Committee (CLIAC), hosted by the Centers for Disease Control and Prevention (CDC) in collaboration with the Centers for Medicare & Medicaid Services (CMS), and the Food and Drug Administration (FDA), provides scientific and technical advice to the Department of Health and Human Services (HHS). CLIAC provides timely and relevant advice and recommendations for refining and revising the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and addressing new clinical laboratory testing quality issues to meet the changing needs of a dynamic health care system. Its role and functions are in the CLIA regulations (42 CFR part 493.2001) to meet the CLIA statutory requirement for consultation with private organizations and public agencies [42 USC 263a section 353 (q)]. Laboratory certificate fees support CLIAC through an interagency agreement between CMS and CDC, not through congressional appropriation.

As of September 30, 2022, CLIAC has provided a total of 167 recommendations, which include five recommendations in the fiscal year 2022. Recent recommendations have addressed laboratory data exchange and harmonization, next generation sequencing, the laboratory workforce, and the remote selection, interpretation, and reporting of patient results.

In the fiscal year 2023, CDC, CMS, and FDA will continue to convene meetings of the CLIA Regulations Assessment Workgroup. This workgroup was recommended by CLIAC in 2019 to provide input to CLIAC for deliberation on how CLIA might specifically be updated based on the findings in the April 2019 reports by the Personnel Regulations, Non-Traditional Workflow Models, and Next Generation Sequencing (NGS) workgroups. The workgroup is charged with providing advice to CLIAC for consideration in making recommendations to the Department of Health and Human Services (HHS) on revising the CLIA regulations. The workgroup began meeting in April 2022 and provided an update during the April 13-14, 2022 CLIAC meeting. The CLIA Regulations Assessment Workgroup is scheduled to present its first workgroup report during the November 9-10, 2023 CLIAC meeting. Future resulting CLIAC recommendations will guide CDC and CMS in starting the regulatory revision process.

Also, in the fiscal year 2023, CDC, CMS, and FDA will work together to assemble three new workgroups. The CLIA Certificate of Waiver and Certificate of Provider-performed Microscopy Workgroup is charged with providing input to CLIAC for consideration in making recommendations to the HHS on the potential need for expanding regulatory oversight of CLIA Certificate of Waiver sites. The workgroup will also provide input to CLIAC on the potential need for expanded regulatory oversight of Certificate for Provider-performed Microscopy Procedures sites. The Next Generation Sequencing (NGS) Workgroup was recommended by CLIAC in 2021 to define the scope of practice and the requisite CLIA qualifications for personnel performing bioinformatic data analysis and interpretation to produce test results that inform clinical decision-making. The workgroup is charged with providing input to CLIAC for deliberation on how CLIA might specifically be updated, considering the CDC NGS request for information summary report, the April 2019 reports by the Personnel Regulations, Non-Traditional Workflow Models, and NGS workgroups, and the November 2021 CLIAC recommendation on personnel performing bioinformatic data analysis and interpretation. The focus of the workgroup is to define the scope of practice and the requisite CLIA qualifications for personnel performing NGS bioinformatic data analysis and interpretation to produce test results that inform clinical decision-making. The Biosafety of Laboratory Instrumentation Workgroup will be convened as a result of discussions during the CDC Town Hall Meeting on Laboratory Biosafety held on June 24, 2022. The workgroup will bring together diagnostic instrument manufacturers, clinical and public health laboratory professionals, federal partners, and industrial hygienists to provide input to CLIAC on solutions that will provide a safe working environment for the nation’s clinical and public health laboratories.

Other CLIAC discussions and recommendations provide guidance and support for policy and research projects, such as emerging technologies in clinical and public health laboratories, laboratory data exchange and harmonization, the laboratory workforce, the laboratory's role in addressing health disparities, and the expansion of point-of-care testing. The Committee also provides a liaison to the CDC Board of Scientific Counselors, Deputy Director for Infectious Diseases to share the clinical laboratory perspective with that CDC Board and bring relevant information back to CLIAC.
How is membership balanced?*The Committee consists of 20 members who are knowledgeable in the fields of microbiology (including bacteriology, mycobacteriology, mycology, parasitology, and virology); immunology (including histocompatibility); chemistry; hematology; pathology (including histopathology and cytology); genetic testing (including cytogenetics); representatives from the fields of medical technology, bioinformatics, public health, and clinical practice; and consumer representatives. This representation is accompanied by an equal emphasis on diversity, and qualified females and minorities are represented. The Committee also consists of three non-voting ex officio members and a non-voting liaison representative from the Advanced Medical Technology Association, which plays an important role in interacting and coordinating activities relating to the development of new devices/technology.
How frequent & relevant are cmte mtgs?*The Committee meets at least once per year. The Committee continues to play a critical role in recommending changes to CLIA program policy, standards, and guidelines by providing direction on the policy and procedures used in the development of and modifications to the CLIA regulations, the identification and prioritization of significant research data gaps, and continued evaluation of the procedures used in the implementation and administration of the program.
Why advice can't be obtained elsewhere?*Clinical laboratories are the backbone of the healthcare system and provide the foundation for accurate and timely diagnosis, prevention, and control of disease to improve the health and safety of Americans. Approximately 15.76 billion laboratory tests are performed in the U.S. each year with at least one out of three patient encounters involving the ordering of one or more clinical laboratory tests; the volume of U.S. clinical laboratory testing is increasing at an average of 6-10% per year and the scope of testing is becoming increasingly complex. Over the past 30 years since the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the number of FDA-cleared or approved tests has increased by more than 400% resulting in a need to ensure that the nation's over 320,000 CLIA-certified laboratories can accurately and reliably conduct testing and report results. CLIAC is the only Federal advisory committee that provides scientific and technical advice and guidance related to laboratory testing quality and practices to HHS and its agencies, including CDC, CMS, and FDA.

CLIAC's advice, recommendations, and guidance are crucial, and CLIAC has made recommendations for HHS to update CLIA regulations for laboratory testing and personnel that have not been updated since 1992. CDC, CMS, and FDA are working together to act on these recommendations to revise the CLIA regulations; future CLIAC recommendations will provide additional guidance to HHS regarding both regulatory and non-regulatory actions needed for ensuring quality and safe laboratory practices. The Committee is essential for providing HHS with timely and relevant advice and recommendations for refining and revising the CLIA regulations and addressing issues of clinical laboratory testing quality to meet the changing needs of a dynamic healthcare system.
Why close or partially close meetings?During fiscal year 2022, all CLIAC meetings were open to the public.
Recommendation RemarksNo formal reports are required in the charter; the Committee provides advice and recommendations through various means other than formal reports. Monique Spruill, CMS ex officio resigned on 5/15/2022 and Gregg Brandush, CMS ex officio was appointed on 5/16/2022. Committee member Ewa King resigned on 5/23/2022.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*No
Outcome Trust In GovernmentNoAction Reallocate ResourcesNo
Outcome Major Policy ChangesNoAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchNoAction Proposed LegislationYes
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionNoAction CommentIn the fiscal year 2022, in response 23 personnel recommendations made over the span of several meetings including May 1993, November 2018, and April 2019, CMS and CDC published the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories Proposed Rule in the Federal Register on July 26, 2022 (https://www.federalregister.gov/documents/2022/07/26/2022-15300/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and). This proposed rule received 20,554 public comments. CDC and CMS will work in the fiscal year 2023 to address the comments and prepare the final rule for publication.

In the fiscal year 2022, in response 20 proficiency testing (PT) recommendations made during the September 1-2, 2010 CLIAC meeting, CMS and CDC published the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance in the Federal Register on July 11, 2022 (https://www.federalregister.gov/documents/2022/07/11/2022-14513/clinical-laboratory-improvement-amendments-of-1988-clia-proficiency-testing-regulations-related-to). This final rule implements revised regulations that CMS and CDC proposed in 2019 to update CLIA PT regulations. The final rule includes:
-The addition and deletion of analytes and microbiology tests that require PT, as well as updates to the criteria for acceptable performance and administrative processes for CLIA PT programs.
-An update to align the CLIA regulations with the statute (42 U.S.C. 263a (i)(4)), which does not exclude waived tests from the ban on improper PT referral.

In the fiscal year 2022, the CDC had several accomplishments related to eight next generation sequencing (NGS) recommendations made during the CLIAC meeting held April 10-11, 2019, including:
-CDC continued to convene the NGS Best Practices Forum in fiscal year 2022. The forum focused on encouraging professional societies and others to develop and/or update NGS guidelines and that CMS, CDC, and FDA create guidelines or best practices related to clinical and public-health NGS. The NGS Best Practices Forum will conclude in the fiscal year 2023.

-The CLIA Regulations Assessment workgroup was established to provide input to CLIAC for deliberation on how CLIA might specifically be updated. Throughout 2022 and 2023, the workgroup will have discussions focused on the total testing process, data as a specimen, histopathology, analytical testing specifications, and digital pathology. The topics of data processing and quality management issues will be included in the workgroup discussions. The workgroup will present its first report to CLIAC during the November 9-10, 2022 CLIAC meeting.

In the fiscal year 2022 in response to a CLIAC recommendation on health disparities made during the October 28-29, 2020 meeting, the CDC's Division of Laboratory Systems developed a journal article that has been accepted for publication in the Journal of Applied Laboratory Medicine entitled: Effective access to laboratory test results: A health equity issue that enhances diagnostic excellence. The article identifies gaps ranging from linguistic, cultural, and socioeconomic disparities to a lack of systematic approaches (e.g., implementation of specific support protocols, and policies) that affect limited English proficiency (LEP) patients’ access to patient portals. It also summarizes initiatives healthcare providers, laboratory professionals, and portal developers can use to address disparities that affect more than 26 million LEPs while improving their health equity.

In response to CLIAC recommendations on biosafety during April 2015 and April 2016, CDC’s Division of Laboratory Systems hosted a town hall on June 24, 2022 (https://www.cdc.gov/safelabs/biosafety-townhall.html), in collaboration with clinical and public health laboratory partners and instrument manufacturers. The purpose of this meeting was to provide an overview and discussion on laboratory biosafety when using laboratory instruments to test human and biologic specimens. The publication Clinical Laboratory Biosafety Gaps: Lessons Learned from Past Outbreaks Reveal a Path to a Safer Future discussed critical gaps in clinical laboratory biosafety, including issues related to the use and disinfection of laboratory instruments.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentImplementation of laws or regulatory requirementsNumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentN/AGrants Review CommentN/A
Number Of Recommendations*167Access Contact Designated Fed. Officer*No
Number Of Recommendations CommentRecommendations address general issues related to improvement in clinical laboratory quality and laboratory medicine practice. Recommendations generally provide guidance to assure quality laboratory testing and support for policies, studies, and evaluation activities. There were five recommendations for the fiscal year 2022.

During the November 3-4, 2021 meeting, there were three recommendations.
One recommendation related to laboratory data exchange and harmonization is to encourage collaboration with CDC, CMS, FDA, other HHS organizations (e.g., The Office of the National Coordinator for Health Information Technology or ONC), In vitro diagnostics (IVD) and electronic health record (HER) vendors, and professional organizations to leverage current standards and fund a phased approach by which specimens, actionable test results, and methods are coded for interoperability. EHR vendors, bioindustry suppliers, and non-profit and commercial laboratories must implement the standard(s) within a specified timeline. HHS should identify an appropriate mechanism for compliance.
Two recommendations on next generation sequencing: (1) CLIAC recommends that CDC, CMS, and FDA convene a workgroup to define the scope of practice and the requisite CLIA qualifications for personnel performing bioinformatic data analysis and interpretation to produce test results that inform clinical decision-making; and (2) CLIAC recommends that the CDC, CMS, and FDA create a workgroup to review real-world practices as they apply to NGS for the end-to-end processing of data, including the acquisition, analysis, and transmittal of data (including the Admission, Discharge, Transfer (ADT) message, orders, and results) between instruments and health records, including but not limited to electronic communication between the electronic health record (EHR), laboratory information system (LIS) or laboratory information management system (LIMS), and IVD vendors, as well as interoperability between institutions, quality management systems, including documentation, regarding data security, fidelity, transmission, curation, retention, and retrieval, and validation of software algorithms used to generate interpretations

During the April 13-14, 2022 CLIAC meeting there were two recommendations.
One recommendation was made that CDC raise the recognition of laboratory professionals in health care through its outreach, communication, training, and guidance (partnerships with the laboratory science community to increase interest in laboratory careers), work with partners to create and expand access to educational content and resources and identify other opportunities to reduce the burden on individual training programs (create and oversee programs for clinical laboratory sciences training programs) and conduct a workplace survey of laboratory professionals to support and guide critical recruitment and retention activities.
A second recommendation was made related to remote selection, interpretation, and reporting of patient results that augments the CLIAC 2019 recommendation that CMS and the U.S. Department of Health and Human Services permanently codify that a laboratory's CLIA certificate covers employees of that laboratory who are performing data analysis and interpretation of digital information under the quality oversight from a primary site when working remotely under the home laboratory’s CLIA certificate.
Access Agency WebsiteYes
% of Recs Fully Implemented*95.80%Access Committee WebsiteYes
% of Recs Fully Implemented Comment159 completed recommendations and 1 recommendation has no action/completed.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*4.20%Access PublicationsNo
% of Recs Partially Implemented CommentThere are 7 recommendations with partial implementation.Access OtherNo
Agency Feedback*YesAccess Commenthttps://www.cdc.gov/cliac/
Agency Feedback Comment*Yes, through agency updates provided at the beginning of each Committee meeting. A recommendations table with the date of the recommendation, category, the recommendation text, and current status is updated and can be found at https://www.cdc.gov/cliac/meeting.html.Narrative Description*The intention of the CLIA statute and its implementing regulations is to ensure the quality and reliability of medical tests performed by clinical laboratories throughout the nation. The Committee's advice and recommendations relative to the CLIA program are consistent with and supportive of CDC's vision of equitably protecting health, safety, and security.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$18,250.00Est Payments to Non-Fed Members Next FY*$20,000.00
Payments to Federal Members*$8,112.00Est. Payments to Fed Members Next FY*$8,112.00
Payments to Federal Staff*$229,069.00Estimated Payments to Federal Staff*$212,567.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$68,950.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$82,740.00
Other Costs$10,791.00Est. Other Costs Next FY*$28,002.00
Total Costs$266,222.00Est. Total Next FY*$420,371.00
Date Cost Last Modified10/28/2022 4:12 PMEst. Fed Staff Support Next FY*1.05
Federal Staff Support (FTE)*1.50Est Cost Remarks
Cost RemarksThe FY22 CLIAC parent committee and workgroup meetings were 100% virtual and did not require any travel costs.  
Hide Section - Interest Areas

Interest Areas

Category
Area
Computer Technology
Information Technology
Education
Training
Emergency
Emergency Preparedness and Management
Food and Drugs
Biotechnology
Medical Devices
Health
Health Care
Hospitals
Medical Education
Medical Practitioners
Public Health
Safety
Labor
Job Training
Occupational Safety and Health
Workforce and Occupations
Legislation
Administrative Procedure
Regulations
Medicine
Health and Health Research
Medicine and Dentistry
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-040328Clinical Laboratory Improvement Advisory Committee2021
 COM-038607Clinical Laboratory Improvement Advisory Committee2020
 COM-036480Clinical Laboratory Improvement Advisory Committee2019
 COM-034679Clinical Laboratory Improvement Advisory Committee2018
 COM-001966Clinical Laboratory Improvement Advisory Committee2017
 COM-002322Clinical Laboratory Improvement Advisory Committee2016
 COM-003816Clinical Laboratory Improvement Advisory Committee2015
 COM-004457Clinical Laboratory Improvement Advisory Committee2014
 COM-006197Clinical Laboratory Improvement Advisory Committee2013
 COM-006956Clinical Laboratory Improvement Advisory Committee2012
 COM-008387Clinical Laboratory Improvement Advisory Committee2011
 COM-008713Clinical Laboratory Improvement Advisory Committee2010
 COM-010118Clinical Laboratory Improvement Advisory Committee2009
 COM-011032Clinical Laboratory Improvement Advisory Committee2008
 COM-012105Clinical Laboratory Improvement Advisory Committee2007
 COM-012674Clinical Laboratory Improvement Advisory Committee2006
 COM-013797Clinical Laboratory Improvement Advisory Committee2005
 COM-014505Clinical Laboratory Improvement Advisory Committee2004
 COM-015871Clinical Laboratory Improvement Advisory Committee2003
 COM-016515Clinical Laboratory Improvement Advisory Committee2002
 COM-017579Clinical Laboratory Improvement Advisory Committee2001
 COM-018416Clinical Laboratory Improvement Advisory Committee2000
 COM-019733Clinical Laboratory Improvement Advisory Committee1999
 COM-020357Clinical Laboratory Improvement Advisory Committee1998
 COM-021613Clinical Laboratory Improvement Advisory Committee1997