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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 Date2/19/2018Designated Fed Officer Position Title*Director, Division of Laboratory Systems
Date Of Renewal Charter2/19/2020Designated 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 SuffixM.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
Committee Type*ContinuingDesignated Federal Officer Email*rsalerno@cdc.gov
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) provides the Department of Health and Human Services (HHS) scientific and technical advice and guidance. The advice and guidance pertain to general issues related to improvement in clinical laboratory quality and laboratory medicine. In addition, the Committee provides advice and guidance on specific questions related to possible revision of the CLIA standards. For example, the Committee has recommended that CDC convene a cross-agency coordinating group to assess the impact of CIDTs on public health surveillance. The Committee has also provided recommendations on laboratory interoperability, such as requesting that HHS encourage the development and evaluation of team-based care innovations that include CLIA covered specialties (and engage patients) in reducing diagnostic error and creating a process for standards utilization field studies across a wide range of clinical laboratories. Other CLIAC discussions and recommendations provide guidance and support for policy and research projects, such as a recent recommendation related to interoperability, and the laboratory workforce shortage. 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?*CLIA is among the most complex and challenging regulations that HHS has ever implemented. The intention of the CLIA statute is to ensure the quality and reliability of medical tests performed by clinical laboratories throughout the Nation, and the statute mandated a significant increase in Federal regulatory oversight. All of those involved in implementing the statute recognized the potential for unintended consequences that could possibly hinder rather than improve patient care, especially in light of the fact that laboratory testing is a dynamic science, with new tests and technology evolving continually. 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. Ms. Susan Sheridan was listed on the fiscal year 2017 report. She retired from CLIAC on 07/20/2017 and did not serve on the Committee during fiscal year 2018.The following CLIAC members Dr. Marc Couturier, Dr. Jordan Laser, Dr. Thomas Lorey, Dr. Katherine Perez, and Dr. Thomas Williams had term beginning dates of 7/1/2017. They were inadvertently left off the FY17 ACR but included in the FY18 ACR. The first meeting that these members attended was in November 2017 (FY18) and their costs are accounted for in FY18.
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 LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionNoAction CommentOn February 6, 2018, two letters were sent to the Secretary of HHS to express the Committee’s recommendations from the November 1-2, 2017 meeting. The first letter provided HHS with background information on CLIAC discussions on culture-independent diagnostic tests (CIDTs) and stated the Committee's recommendation that CDC urgently convene a cross-agency coordinating group to assess the impact of CIDTs on public health surveillance, and to recommend impactful solutions that are brought to the attention of agency and government leaders. The second letter provided HHS with background information on laboratory interoperability. The letter stated the Committee’s recommendation to encourage the development and evaluation of team-based care innovations that include CLIA covered specialties (and engage patients) in reducing diagnostic error and to create a process for standards utilization field studies across a wide range of clinical laboratories (varying size and complexity). In addition to the HHS letter on CIDTS, CDC co-sponsored the “2018 Forum on Culture-Independent Diagnostics: Charting a Path for Public Health” with the Pew Charitable Trusts, the Association of Public Health Laboratories (APHL), the Council of State and Territorial Epidemiologists (CSTE), and The Ohio State University. This forum was held on May 8-9, 2018 at The Pew Charitable Trusts’ Washington, DC office.
On July 24, 2018, two letters were sent to the Secretary of HHS to express the Committee’s recommendations from the April 10-11, 2018 meeting. The first letter provided HHS with background information on past CLIAC discussions on laboratory interoperability and stated the Committee’s recommendations on implementing guidelines for in vitro diagnostic devices and laboratory information systems and the development of a report to determine the landscape of laboratory interoperability. The second letter provided HHS with background information on CLIAC discussions on the laboratory workforce. The letter stated the Committee’s recommendation to CDC, CMS, and FDA to prioritize approaches to address the 20-year shortfall of trained laboratory professionals, include laboratory science professions in the science, technology, engineering, and mathematics programming addressing resources needed to address the laboratory workforce shortage, and supporting the funding of a study of the opportunity costs of the two decades of reduction in the laboratory workforce.
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*120Access 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 nine recommendations for fiscal year 18: 1) a recommendation pertaining to the development and evaluation of team-based care innovations and to create a process for standards utilization field studies; 2) a recommendation addressing culture-independent diagnostic tests (CIDTs); 3) a recommendation to create implement guidelines for in vitro diagnostic devices and laboratory information systems; 4) a recommendation to generate a laboratory interoperability report; 5) a recommendation to address the shortfall of trained laboratory professionals; 6) a recommendation to HHS to address training skills needed for laboratory professionals; 7) a recommendation to fund a study of the opportunity costs of the two decades of reduction in the laboratory workforce; 8) a recommendation to form a next-generation sequencing workgroup; and 9) a recommendation to form a workgroup to address non-traditional testing models.Access Agency WebsiteYes
% of Recs Fully Implemented*78.00%Access Committee WebsiteYes
% of Recs Fully Implemented Comment88 completed recommendations and 5 recommendations have no action/completed.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*22.00%Access PublicationsNo
% of Recs Partially Implemented CommentThere are 27 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_Recommendations_Web_10012018.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* Est Payments to Non-Fed Members Next FY* 
Payments to Federal Members* Est. Payments to Fed Members Next FY* 
Payments to Federal Staff* Estimated Payments to Federal Staff* 
Payments to Consultants* Est. Payments to Consultants Next FY* 
Travel Reimb. For Non-Federal Members* Est Travel Reimb Non-Fed Members nextFY* 
Travel Reimb. For Federal Members* Est Travel Reimb For Fed Members* 
Travel Reimb. For Federal Staff* Est. Travel Reimb to Fed Staff Next FY* 
Travel Reimb. For Consultants* Est Travel Reimb to Consultants Next FY* 
Other Costs Est. Other Costs Next FY* 
Total Costs$0.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)* Est. Fed Staff Support Next FY* 
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