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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameClinical Laboratory Improvement Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number826
Original Establishment Date2/28/1992Committee StatusChartered
Actual Termination Date Committee URLhttps://wwwn.cdc.gov/cliac/
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*Unlimited
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 151 recommendations, which include 29 recommendations in fiscal year 2019. Recent recommendations have addressed laboratory interoperability and the advancement of standards to ensure accurate transmission of laboratory information in electronic health systems; the implementation of innovative laboratory technologies and practices, including next generation sequencing and non-traditional workflow models; the increasing emergence of antibiotic resistance; the role of the laboratory in the opioid crisis; and the need to update the CLIA personnel regulations.
CLIAC recommended that HHS thoroughly update CLIA regulations to address issues related to new biomarker testing and other new technologies and that HHS should form a new CLIAC workgroup with the charge of advising on how CLIA might specifically be updated. CDC, CMS, and FDA, will be working together to assemble the workgroup to provide input to CLIAC regarding the revision of the CLIA regulations. 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; chemistry; hematology; pathology (including histopathology and cytology) and genetics (including biochemical, molecular and cytogenetics); representatives of medical technology, public health, clinical practice; and consumers. 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 25 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 260,000 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 12 recent 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. Dr. Elizabeth Palavecino term ending date corrected to 10/08/2018. She did not participate on the Committee during fiscal year 2019.
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 response to CLIAC recommendations made during the September 1-2, 2010 meeting, the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance Proposed Rule was published in the Federal Register on February 4, 2019.
https://www.federalregister.gov/documents/2019/02/04/2018-28363/clinical-laboratory-improvement-amendments-of-1988-clia-proficiency-testing-regulations-related-to. CDC and CMS are analyzing all public comments and will draft the final rule for publication.

The Nontraditional Testing Workflow Model Workgroup, recommended by CLIAC in April 2018, was formed and met December 6, 2018. The workgroup provided input to CLIAC during the April 10-11, 2019 CLIAC meeting regarding the need for optimal oversight by CLIA and best methods for such oversight in nontraditional testing workflow models in which the testing process workflow is separated and performed by more than one physical location or facility. CLIAC deliberated and provided three recommendations to HHS.

The Next Generation Sequencing Workgroup, recommended by CLIAC in April 2018, was formed and met on January 16-17, 2019. The workgroup provided input to CLIAC during the CLIAC during the April 10-11, 2019 CLIAC meeting regarding quality of next generation sequencing based testing in clinical laboratory settings quality of next generation sequencing based testing in clinical laboratory settings including the identification of challenges in applying the existing regulatory framework; strategies to address the identified gaps and challenges; and strategies for assuring workforce competency. CLIAC deliberated and provided eight recommendations to HHS.


The CLIA Personnel Workgroup, recommended during the November 7-8, 2019 CLIC meeting, was formed and met on February 26-27, 2019. The workgroup provided input to CLIAC during the CLIAC during the April 10-11, 2019 CLIAC meeting regarding revising the CLIA personnel regulations. CLIAC deliberated and provided 12 recommendations to HHS.

CLIAC sent three letters to HHS in February 2019 to express the Committee’s recommendations to HHS from the November 7-8, 2019 meeting. The first letter provided information on presentations given on current issues surrounding diagnostic errors and the laboratory’s contribution to decision-making and stated the Committee’s two recommendations: 1) Laboratory medicine should have an active role in the workings of the Federal Interagency Workgroup on Improving Diagnostic Safety and Quality and healthcare centers be required to have independent multidisciplinary diagnostic improvement program that includes laboratory professionals as co-equal stakeholders; and 2) the Federal Interagency Workgroup on Improving Diagnostic Safety and Quality develop and/or centralize, approaches to monitor diagnostic error, best practices and research priorities for reducing diagnostic error, information-management processes related to decision support for improving diagnostic performance, incentivizing diagnostic performance improvement and the develop resources for improving diagnostic performance analogous to those developed for antibiotic stewardship. The second letter provided information on how clinical laboratory data can add support and value to the opioid response and ways in which the CDC, CMS, and FDA can improve clinical laboratory engagement in response activities. The letter stated the Committee’s recommendation that that the CDC, CMS, and FDA convene a blue-ribbon panel on laboratory engagement in controlling the opioid crisis. The third letter provided information on Committee discussions on given on current issues surrounding antimicrobial resistance and stated the Committee’s recommendation that CMS require that clinical laboratories convert to contemporary antimicrobial resistance breakpoints in accordance with manufacturer’s instructions and that the FDA update existing guidance to prioritize manufacturers’ timely integration of updated antimicrobial susceptibility breakpoints.


On July 9, 2019, a letter was sent to the Secretary of HHS to express the Committee’s recommendations from the April 10-11, 2019 meeting. The letter provided information on the formation of the Next Generation Sequencing Workgroup and CLIAC deliberations how new technologies such as next generation sequencing fit into the current Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, the need for new or updated next generation sequencing guidelines, and the incorporation of interoperability and data usage standards for clinical, genomic, and next generation sequencing testing, the Committee voted to provide the following recommendations to HHS. The letter stated three recommendations: 1)
that HHS thoroughly update the CLIA regulations to address issues related to new biomarker testing and other new technologies; 2) that CMS, CDC, and FDA encourage professional societies and others (e.g. CLSI) to develop and/or update NGS guidelines; and 3) HHS support the incorporation of standards for interoperability and data usage in clinical genetic and genomic testing and NGS across the laboratory subspecialties.
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*149Access 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 29 recommendations for fiscal year 2019.
During the November 7-8, 2018 meeting, there were six recommendations.
• Two recommendations on antimicrobial resistance issues: (1) CMS should require that clinical laboratories convert to contemporary antimicrobial resistance breakpoints in accordance with manufacturer’s instructions; and (2) the FDA should update existing guidance to prioritize manufacturers’ timely integration of updated antimicrobial susceptibility breakpoints.
• One recommendation related to the clinical laboratory’s role in the opioid response: CDC, CMS, and FDA should convene a blue-ribbon panel to gather information on laboratory engagement in controlling the opioid crisis.
• One recommendation proposing the formation of a workgroup to advise the Committee on how to respond to the personnel questions asked by CMS at the November 2019 meeting.
• Two recommendations on current issues surrounding diagnostic errors and the laboratory’s contribution to decision-making: (1)Laboratory medicine should have an active role in the workings of the Federal Interagency Workgroup on Improving Diagnostic Safety and Quality, and healthcare centers should be required to have an independent multidisciplinary diagnostic improvement program that includes laboratory professionals as co-equal stakeholders; and (2) the Federal Interagency Workgroup on Improving Diagnostic Safety and Quality should develop and/or centralize, approaches to monitor diagnostic error.
During the April 10-11, 2019 meeting, there were 23 recommendations, including 12 on revising the CLIA personnel regulations, three for optimal oversight by CLIA and best methods for such oversight in nontraditional testing workflow models, and eight regarding quality of next generation sequencing (NGS) based testing in clinical laboratory settings. One of the eight NGS recommendations was to update the CLIA regulations to address issues related to new biomarker testing and other new technologies and another recommended creating a new CLIAC workgroup with the charge of advising on how CLIA might specifically be updated.
Access Agency WebsiteYes
% of Recs Fully Implemented*80.13%Access Committee WebsiteYes
% of Recs Fully Implemented Comment120 completed recommendations and 1 recommendations have no action/completed.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*19.87%Access PublicationsNo
% of Recs Partially Implemented CommentThere are 30 recommendations with partial implementation.Access OtherNo
Agency Feedback*YesAccess Commenthttps://www.cdc.gov/cliac/
Agency Feedback CommentYes, 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/docs/CLIAC_RecommendationsTable_10012019.pdf.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*$16,000.00Est Payments to Non-Fed Members Next FY*$20,000.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$225,868.00Estimated Payments to Federal Staff*$231,739.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$44,934.00Est Travel Reimb Non-Fed Members nextFY*$58,617.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$3,229.00Est. Travel Reimb to Fed Staff Next FY*$5,545.00
Travel Reimb. For Consultants*$43,947.00Est Travel Reimb to Consultants Next FY*$59,186.00
Other Costs$19,545.00Est. Other Costs Next FY*$24,080.00
Total Costs$353,523.00Est. Total Next FY*$399,167.00
Federal Staff Support (FTE)*1.45Est. Fed Staff Support Next FY*1.45
Hide Section - Custom Links

Custom Links

     Committee Level Reports               
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

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Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

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Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 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