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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.


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 Year2020Committee 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 Date2/19/2020Designated Fed Officer Position Title*Director, Division of Laboratory Systems
Date Of Renewal Charter2/19/2022Designated Federal Officer PrefixDr.
Projected Termination Date Designated Federal Officer First Name*Reynolds
Exempt From Renewal*NoDesignated Federal Officer Middle NameMathewson
Specific Termination AuthorityDesignated 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 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) and provides timely and relevant advice and recommendations for refining and revising the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and addressing new issues of clinical laboratory testing quality 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)]. CLIAC is supported by laboratory certificate fees through an interagency agreement between CMS and CDC, not through congressional appropriation.

To date, CLIAC has provided a total of 156 recommendations, which include five recommendations in fiscal year 2020. Recent recommendations have addressed the laboratory workforce and remote selection, interpretation, and reporting of patient results.

In fiscal year 2021, CDC, CMS, and FDA will continue to work together to assemble a workgroup recommended by CLIAC in fiscal year 2019, to provide input to CLIAC regarding the revision of the CLIA regulations to address issues related to new biomarker testing and other new technologies. Future resulting CLIAC recommendations will guide CDC and CMS in starting the regulatory revision process. Other CLIAC discussions and recommendations provide guidance and support for policy and research projects, such as a recent recommendation related to improving diagnosis. The Committee also provides a liaison to the CDC Office of Infectious Diseases Board of Scientific Counselors 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) and genetic testing (including cytogenetics); representatives 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 development of new devices/technology.
How frequent & relevant are cmte mtgs?*The Committee meets approximately two times 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 disease diagnosis, prevention, and control to improve the health and safety of Americans. Approximately 14 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 5-10% per year and the scope of testing is becoming increasingly complex. Over the past 28 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 270,000 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 that include 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 personnel that have not been updated since 1992. CDC, CMS, and FDA will be 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 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 health care system.
Why close or partially close meetings?N/A
Recommendation RemarksNo formal reports are required in the charter; the committee provides advice and recommendations through various means other than formal reports.
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 fiscal year 2020, CDC and CMS analyzed all public comments received from the published Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance Proposed Rule. This proposed rule was in response to CLIAC recommendations made on proficiency testing.

During the November 15, 2019 Federal Interagency Workgroup on Improving Diagnostic Safety and Quality, two CDC representatives participated – one from the Division of Laboratory Systems and one from the Division of Healthcare Quality Promotion. This was a direct result from CLIAC recommendations related to improving diagnosis and the laboratory’s contribution to decision-making.

On July 7, 2020 CDC published a Request for Information on personnel who perform bioinformatics activities in clinical and public health laboratories, storage and retention of next generation sequencing (NGS) data files, and maintenance of sequence analysis software. https://www.federalregister.gov/documents/2020/07/06/2020-14417/request-for-information-concerning-personnel-and-the-retention-of-next-generation-sequencing-data-in. CDC will analyze the 16 public comments and prepare a summary report for CLIAC. The publication of this request for information is a direct result from CLIAC recommendations related to CDC creating a survey of laboratories performing NGS to collect data on the role of bioinformaticians and to define the specific use cases for long-term storage of NGS data,

The Genetic Testing Reference Material (GeT-RM) program has initiated a new reference material project for hereditary cancer as a result from a CLIAC recommendation on expanding the CDC GeT-RM program regarding scope and type.

During the November 6-7, 2019 CLIAC meeting, an extended public comment session on Emerging Technologies and the Clinical Laboratory. Information provided via public comments was used by CLIAC to inform their deliberations and recommendations to HHS and will help focus a the CLIAC recommendation for a new workgroup charged with providing input to CLIAC in advising how CLIA might specifically be updated to address new technologies.

During the November 6-7, 2019 CLIAC meeting, a recommendation was made related to remote selection, interpretation, and reporting of patient results, during the COVID-19 pandemic CMS will allow laboratories to utilize temporary testing sites for remote review and reporting of laboratory data/slides/images as long as specific criteria are met as published in the CMS Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency memo.

In response to another CLIAC recommendation made during the November 6-7, 2019 related to CDC exploring how virtual reality and simulation-based training can be used to achieve competency-based outcomes, CDC launched a three-year pilot project to:
• Develop the first-ever CDC VR Laboratory training course
• Investigate if laboratory learners gain skills in addition to gaining knowledge when experiencing CDC VR training courses
• Identify criteria for training goals and topics that would benefit most from incorporating VR technology to CDC distance-based learning
Additional details about these efforts can be found at https://www.cdc.gov/labtraining/vr.html.
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*156Access Contact Designated Fed. Officer*No
Number Of Recommendations CommentRecommendations address potential rulemaking to revise the CLIA regulations; the development of criteria for the approval of waived tests; good laboratory practices in waived testing sites and for genetic testing; and other recommendations for voluntary laboratory practice standards. Recommendations generally provide guidance to assure quality laboratory testing and support for policies, studies, and evaluation activities. There were five recommendations for fiscal year 2020. Due to the COVID-19 pandemic, there was only one CLIAC meeting in fiscal year 2020.
During the November 6-7, 2019 meeting, there were five recommendations.
• Four recommendations on the laboratory workforce: (1) CDC/HHS create a strategy to communicate broadly to the clinical laboratory community the Health Resources & Services Administration (HRSA) Health Careers and Opportunity Program (HCOP) resources currently available; (2) our agency partners collaborate with relevant organizations (e.g. accrediting organizations, manufacturers, professional societies, and academic institutions for higher education bodies) to increase awareness of freely available CDC laboratory training resources; (3) CDC create an online library of clinical laboratory educational resources for use by organizations for their own post-baccalaureate training of clinical laboratory professionals; and (4) CDC explore how virtual reality and simulation-based training can be used to achieve competency-based outcomes.
• One recommendation related to remote selection, interpretation, and reporting of patient results: the CLIA Program consider that, when laboratory professionals are providing patient care through selection, interpretation, and reporting of patient results by accessing data remotely in a secure environment, they shall be deemed as performing those services at the primary site that houses the CLIA Certificate.
Access Agency WebsiteYes
% of Recs Fully Implemented*83.97%Access Committee WebsiteYes
% of Recs Fully Implemented Comment130 completed recommendations and 1 recommendation has no action/completed.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*16.03%Access PublicationsNo
% of Recs Partially Implemented CommentThere are 25 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 mission to promote health and quality of life by preventing and controlling disease, injury, and disability.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$9,000.00Est Payments to Non-Fed Members Next FY*$20,000.00
Payments to Federal Members*$3,930.00Est. Payments to Fed Members Next FY*$7,860.00
Payments to Federal Staff*$237,035.00Estimated Payments to Federal Staff*$239,406.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$23,244.00Est Travel Reimb Non-Fed Members nextFY*$72,031.00
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*$1,757.00Est Travel Reimb to Consultants Next FY*$106,247.00
Other Costs$3,251.00Est. Other Costs Next FY*$20,752.00
Total Costs$278,217.00Est. Total Next FY*$466,296.00
Federal Staff Support (FTE)*1.45Est. Fed Staff Support Next FY*1.45
Cost RemarksEst Cost Remarks
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-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