To view a list of CLSI documents helpful for COVID-19 testing click here.
To view a list of CLSI documents helpful for COVID-19 testing click here.

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CLSI standards and guidelines are developed for use by the global laboratory community. Purchase clinical laboratory standards documents from our shop.

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Join CLSI as a member or volunteer and experience how CLSI brings greater accuracy, efficiency, and safety to the laboratories of members around the world.

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CLSI's collaborative approach ensures balanced representation from the global laboratory community to yield unbiased consensus standards for global use.

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Through our Partnerships program, CLSI provides international outreach services and hands-on support to laboratories in resource-constrained countries, helping them achieve sustainable quality with systems to better diagnose and treat patients with infectious diseases.

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CLSI's quarterly Committees Week Meetings bring volunteers together to focus on document development in a consensus-based setting. View upcoming meetings.

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The Clinical & Laboratory Standards Institute (CLSI) is a not-for-profit membership organization dedicated to fostering excellence in laboratory medicine.

CLSI's Expert Panels

Expert panel volunteers support the development of CLSI products by providing technical expertise in specialty areas. Their project ideas are transformed into proposals for documents and other products that generate valuable guidance to the medical laboratory community. Members review the status of projects in progress, determine actions to be taken on existing projects, and complete an environmental scan to identify possible new projects. Reviewing and commenting on Proposed Draft documents in the Panel's specialty area is another important responsibility of volunteer participants.

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Expert Panel on Automation and Informatics (AUTO)

  • Riccardo L Benedetti / Member / Roche Diagnostics International Ltd, Switzerland
  • Serafina Brea, MBEE, MLS(ASCP)cm / Member / Centers for Medicare & Medicaid Services, United States
  • Ed Heierman III, PhD / Vice-Chairholder / Abbott, United States
  • Monika Kamalska, BS, MA, MB(ASCP)cm / Member / Memorial Sloan Kettering Cancer Center, United States
  • Elizabeth Kenimer Leibach, EdD, MS, MLS(ASCP)cm, SBBcm / Chairholder / Rutgers University, United States
  • William Marquardt, C(ASCP), MBA / Member / McKesson Laboratory Solutions, United States
  • Michael McConnell, MLT, BSc / Member / London Health Sciences Centre, Canada
  • Lydia Mikhail, MBA, MEL, TS(ABB) / Member / Orange County Health Care Agency - Public Health Lab, United States
  • Christine Nack / Advisor / Roche Diagnostics, Switzerland
  • Sandeep Naik, IVDD / Member / BD, United States
  • Manjula Gama Ralalage, MBBS, MSc / Advisor / Centers for Disease Control and Prevention, United States
  • Eban Tomlinson / Advisor / Semaphore Solutions, Canada
  • Cynthia D. Ward, MS, MBA / Member / Centers for Disease Control and Prevention, United States
  • Wenming Xiao, PhD / Member / CDRH, US Food and Drug Administration, United States
  • Robert Young, CGMBS, MS / Member / Lab Insights, LLC, United States

Expert Panel on Clinical Chemistry and Toxicology (CHEM)

  • David Alter, MD / Member / Emory University, United States
  • Lorin M. Bachmann, PhD, DABCC, MT(ASCP) / Chairholder / Virginia Commonwealth University Health System, United States
  • Ronald Booth, PhD, FCACB, FACC / Member / The Ottawa Hospital, Canada
  • Johanna Camara, PhD / Member / National Institute of Standards and Technology, United States
  • Saswati Das, MD, MBBS / Advisor / Ram Manohar Lohia Hospital , India
  • Theodore J. DiMagno, PhD / Member / Ortho Clinical Diagnostics, Inc., United States
  • Mark Herlan / Member / Roche Diagnostics GmbH , Germany
  • Kamisha Johnson-Davis, PhD, DABCC, FACB / Vice-Chairholder / University of Utah, United States
  • Juliane Lessard, PhD / Member / FDA Center for Devices and Radiological Health, United States
  • Marianela Perez-Torres, MT, PhD / Member / US Food and Drug Administration, United States
  • Gerardo Ramos, MS, PhD, MLS(ASCP), F-ABFT / Member / UT Health San Antonio, United States
  • Daniel Schwanzar / Member / Phadia GmBh, Germany
  • Richard Y. Wang, DO / Member / Centers for Disease Control and Prevention, United States
  • Carl E. Wolf, PhD, MS, F-ABFT / Member / VCU Health, United States
  • Sedef Yenice, PhD / Advisor / Group Florence Nightingale Hospitals, Turkey

Expert Panel on Evaluation Protocols (EP)

  • Valeria L. Alcon, PhD / Member / Health Canada, Canada
  • Mario Arias / Advisor, Colombia
  • J. Rex Astles, PhD, DABCC, FAACC / Member / Centers for Disease Control and Prevention, United States
  • Jeffrey R. Budd, PhD / Member / Consulting Biostatistician, United States
  • Karl De Vore, BA, SSBB / Advisor / Bio-Rad Laboratories, Inc., United States
  • A. Paul Durham, MA / Member / APD Consulting, United States
  • Brett Holmquist, PhD, ASCP, DABCC, FAACC / Member / LabCorp - Endocrine Sciences, United States
  • Jesper V. Johansen, PhD / Member / Radiometer Medical ApS, Denmark
  • Mark D. Kellogg, PhD, MT(ASCP), DABCC, FAACC / Vice-Chairholder / Boston Children's Hospital, United States
  • Marina V. Kondratovich, PhD / Advisor / FDA Center for Devices and Radiological Health, United States
  • Paula Ladwig, MS, MT(ASCP) / Chairholder / Mayo Clinic, United States
  • Edward Ki Yun Leung, PhD, DABCC, FAACB / Member / Children's Hospital Los Angeles, United States
  • Stephen Lovell, BS, PhD / Member / FDA Ctr. for Devices/Rad. Health (CDRH), United States
  • Kristen Meier, PhD / Advisor / Illumina Inc., United States
  • James H. Nichols, PhD, DABCC, FAACB / Vice-Chairholder / Vanderbilt University School of Medicine, United States
  • Carine Nyalendo, PhD, DEPD, CSPQ / Advisor / Chu Sainte-Justin, Canada
  • Ronnie Pedersen, PhD / Member / Becton, Dickinson and Company, United States
  • Donna Roberts, MS, MT(ASCP) / Advisor / Baylor Scott and White Health, United States
  • Scott A. Ruetten, PhD / Member / Abbott, United States
  • Jeffrey E. Vaks, PhD / Member / Roche Molecular Diagnostics, United States
  • Gerald Zavorsky / Advisor, United States

Expert Panel on Hematology and Immunology and Ligand Assay (HILA)

  • Richard J. Baltaro, MD, PhD, FCAP / Advisor / East Carolina University, United States
  • Richard J. Baltaro, MD, PhD, FCAP / Advisor / East Carolina University, United States
  • Donna D. Castellone, MS, MASCP, MT(ASCP), SH / Chairholder / NewYork-Presbyterian Hospital, United States
  • Kathleen M. Curran, BSMT / Chairholder / New York State Dept. of Health, United States
  • Trivikram Dasu, PhD, D(ABMLI) / Member / Amazon, United States
  • Francois Depasse, PharmD, MSc / Advisor / Diagnostica Stago, France
  • Mary J. Doyle, PhD, MS, MT(ASCP) / Member / Instrumentation Laboratory, United States
  • Jody Frinack / Member, United States
  • Latifa Hassan Gaddah, MD / Member / Security Forces Hospital, Saudi Arabia
  • Jana Gausman, MT(ASCP) / Member / OU Medicine, United States
  • Ian A. Giles, MD / Advisor / Sysmex America, Inc., United States
  • Jan Hoogendijk / Member / Roche Diagnostics, Switzerland
  • Paula Keating, PhD, BSc / Member / Canterbury Health Laboratories, New Zealand
  • Lorraine Liu, BSc, RT / Advisor / Lower Mainland Laboratoris, Canada
  • Matthew Morrow / Member, United States
  • Karen A. Moser, MD / Vice-Chairholder / ARUP Laboratories, United States
  • Yutaka Nagai, PhD / Member / Nihon Kohden Corporation, Japan
  • Vinit Patil / Member, United States
  • Elizabeth Stafford, PhD / Member / FDA Center for Devices and Radiological Health, United States
  • Elizabeth M. Van Cott, MD / Advisor / Massachusetts General Hospital, United States

Expert Panel on Microbiology (MICRO)

  • Kevin Alby, PhD, D(ABMM) / Member / University of North Carolina, United States
  • Esther Babady, PhD, D(ABMM) / Member / Memorial Sloan Kettering Cancer Center, United States
  • Ana Maria Cardenas, PhD, D(ABMM) / Advisor / Becton Dickinson, United States
  • Karissa Culbreath, PhD, D(ABMM) / Member / University of New Mexico Department of Pathology, United States
  • German Esparza, MSc / Advisor / Proasecal SAS Colombia, Colombia
  • Marcelo F. Galas / Member / Pan American Health Organization, United States
  • Andre Hsiung, MS(ASCP) / Advisor / Hardy Diagnostics, United States
  • Nicole Hubbard, MD / Advisor / College of American Pathologists, United States
  • Shawn R. Lockhart, PhD, D(ABMM), F(AAM) / Member / Centers for Disease Control and Prevention, United States
  • Brian V. Lubbers, DVM, PhD / Member / Kansas State University, United States
  • Margie Morgan, PhD, D(ABMM) / Member / Cedars-Sinai Medical Center, United States
  • Mark G. Papich, DVM, MS / Advisor / College of Veterinary Medicine, North Carolina State University, United States
  • Jean B. Patel, PhD, D(ABMM) / Chairholder / Beckman Coulter, United States
  • Sandra S. Richter, MD, D(ABMM), FIDSA / Member / bioMerieux, United States
  • Audrey N. Schuetz, MD, MPH, D(ABMM) / Vice-Chairholder / Mayo Clinic, United States
  • Susan Sharp, PhD, D(ABMM), F(AAM) / Member / Copan Diagnostics, Inc., United States
  • Ribhi M. Shawar, PhD, D(ABMM), F(AAM) / Member / FDA Center for Devices and Radiological Health, United States
  • Richard B. Thomson Jr., PhD, D(ABMM), FAAM / Advisor / Evanston Hospital, NorthShore University HealthSystem, United States

Expert Panel on Molecular Diagnostics (MOL)

  • Bin Chen, PhD, FACMG / Member / Centers for Disease Control and Prevention, United States
  • Sanchita Das, MD, D(ABMM) / Member / National Institutes of Health, Department of Laboratory Medicine, United States
  • Sherry A. Dunbar, PhD, MBA / Vice-Chairholder / Luminex Corporation, United States
  • Birgit Funke, PhD, FACMG / Advisor / Sema4, United States
  • Peera Hemarajata, MD, PhD, D(ABMM), PHM, CLS, M(ASCP)CM / Member / Los Angeles County Public Health Laboratories, United States
  • Julie Woolworth Hirschhorn, PhD, TS(ABB) / Member / Medical University of South Carolina, United States
  • Renee M. Howell, PhD, MT(ASCP) / Advisor / Siemens Healthineers, United States
  • Cynthia L. Jackson, PhD / Member / Rhode Island Hospital, United States
  • Daniel Jones, MD, PhD / Advisor / Ohio State University, United States
  • Ronald M. Przygodzki, MD / Advisor / US Department of Veterans Affairs, United States
  • Ryan F. Relich, PhD / Member / Indiana University Health Care, United States
  • Ted E. Schutzbank, PhD, D(ABMM) / Chairholder / Agena Bioscience, United States
  • Yi-Wei Tang, MD, PhD / Member / Cepheid, United States
  • Zivana Tezak, PhD / Member / FDA Center for Devices and Radiological Health, United States
  • Nadeem A. Tusneem, MA / Member / Q2 Solutions - EA Genomics, United States
  • Shalini Verma, MD / Member / Siemens Healthcare Diagnostics Inc., United States
  • Barbara Zehnbauer, PhD, FACB, FACMG / Advisor / Emory University Hospital, United States
  • Gang Zheng, MD, PhD / Advisor / Mayo Clinic, United States

Expert Panel on Newborn Screening (NBS)

  • Sucheta Bhatt, MD / Member / Illumina, Inc., United States
  • Candice Brannen, PhD / Member / Baebies, Inc., United States
  • Paula V. Caposino, MA, PhD / Member / FDA Center for Devices and Radiological Health, United States
  • Rachel Carling / Advisor / Viapath, Guys and St Thomas, United Kingdom
  • Andy De Souza, PhD / Member / University of Alberta Hospital, Canada
  • Taraka Donti / Member, United States
  • Debra Freedenberg, MD, PhD, FFACMG / Advisor / Texas Department of State Health Services, United States
  • Uttam Garg, PhD, DABCC / Advisor / The Children's Mercy Hospital, United States
  • Amy Gaviglio, MS, LCGC / Chairholder / G2S Corporation, United States
  • Dietrich Matern, MD, PhD, FACMG / Member / Mayo Clinic, United States
  • Joanne Mei, PhD / Advisor / Centers for Disease Control and Prevention, United States
  • Joseph Orsini, PhD / Member / New York State Department of Health, United States
  • Vamsee Pamula, PhD / Advisor / Baebies, Inc., United States
  • Scott M. Shone, PhD, HCLD(ABB) / Member / North Carolina State Laboratory of Public Health, United States
  • Marci K. Sontag, PhD, MS / Member / CI International, United States
  • Bradford L. Therrell Jr., MS, PhD / Advisor / University of Texas Health Science Center at San Antonio, United States
  • Jon Washburn / Member / Baebies, Inc. , United States
  • Dianne R. Webster, PhD, FFSi, RCPA, FHGSA / Member / Auckland District Health Board, New Zealand
  • Ronald J. Whitley, PhD, DABCC, FACB / Vice-Chairholder / University of Kentucky Medical Center, United States
  • Raquel Yahyaoui, MD, PhD / Advisor / Malaga Regional University Hospital, Spain

Expert Panel on Point-of-Care Testing (POCT)

  • Yung W. Chan, MT(ASCP) / Member / FDA Center for Devices and Radiological Health, United States
  • Yu Chen, MD, MSc, PhD, FAACB, FCACB, DABCC / Member / Horizon Health Network, Canada
  • Uyen B. Chu, PhD / Member / Madigan Army Medical Center, United States
  • Kathleen David, MT(ASCP) / Advisor / TriCore Reference Laboratories, United States
  • Diane Davis, MT(ASCP)SH / Member / Instrumentation Laboratory, United States
  • Gayle R. Deobald / Member / Mayo Clinic, United States
  • Francois Depasse, PharmD, MSc / Advisor / Diagnostica Stago, France
  • Corinne R. Fantz, PhD, DABCC / Member / Roche Diagnostics, United States
  • Roberta E. Hoenig, BS, MT / Member / Northwell Health, United States
  • Ellis Jacobs, PhD, DABCC, FAACC / Advisor / EJ Clinical Consulting, LLC, United States
  • Michael Loeffelholz, PhD, D(ABMM) / Member / Cepheid, United States
  • Peggy A. Mann, MS, MT(ASCP) / Chairholder / The University of Texas Medical Branch, United States
  • Derrick Mendel, MBA, MLS(ASCP)cm / Advisor / COLA, United States
  • Jeanne Mumford, MT(ASCP) / Vice-Chairholder / John Hopkins Hospital, United States
  • Ann E. Snyder, MT(ASCP) / Member / Centers for Medicare & Medicaid Services, United States
  • Heather Stang, MS, MT / Member / Centers for Disease Control and Prevention, United States
  • Christiane Wright / Advisor, United States
  • Lou Ann Wyer, MS, MT(ASCP), CQA(ASQ) / Advisor, United States
  • Marcia L. Zucker, PhD, FAACC / Advisor / ZIVD LLC, United States

Expert Panel on Preexamination Processes (PRE)

  • Aparna Jha Ahuja, MD / Vice-Chairholder / T2 Biosystems
  • Denise R. Cervelli, BA, BS, MT(ASCP) / Member / Siemens Healthineers, United States
  • Lakshmi Chandramohan, PhD, D(ABMM), MB(ASCP), NYSCQ / Member / Neogenomics Laboratories, United States
  • Loralee Coe, MT(ASCP), MPA / Member / Laboratory Corporation of America, United States
  • Judith Dixon, MS, MT(ASCP), BS / Member / COLA, United States
  • Donald Dunbar, PBT(ASCP) / Member / Greiner Bio-One, United States
  • Leonard K. Dunikoski Jr., PhD, DABCC / Advisor / BD, United States
  • Daniel Hesselgesser, MT(ASCP) / Member / Centers for Medicare & Medicaid Services/CLIA Program, United States
  • Sharon Johnson / Member / Mayo Clinic, United States
  • Anne-Marie Martel, MT / Advisor / Ordre professionnel des technologistes medicaux du Quebec, Canada
  • Nehal Mehta, MS / Member / IQLS - Integrated Quality Laboratory Services, France
  • Estelle Ninnemann / Chairholder / ACL Laboratories , United States
  • Eric Nyirenda, BSc, ASQ-CMQ/OE, CSSBB, CQA / Advisor / Nchanga North General Hospital, Ministry of Health, Zambia, Zambia
  • Ghazaleh Pourmahram, PhD, MICR / Advisor / Self Employed - Scientific Consultant and Advisor, Barbados
  • George F. Souza, BS / Advisor / Massachusetts General Hospital, United States
  • Sheryl Thiessen, BSMT, MA, RT(CSMLS), MT(ASCP) / Member / BC's Agency for Pathology and Laboratory Medicine, Canada
  • Elizabeth A. Wagar, MD / Member / University of Texas, MD Anderson Cancer Center, United States

Expert Panel on Quality Management Systems (QMS)

  • Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE / Member / Laboratories Made Better! P.C., United States
  • Julie Coffey, MLT, ART, CMQ/OE(ASQ), CQA / Member / Institute for Quality Management in Healthcare, Canada
  • Maura Daniels, BS, MT(ASCP) / Member / Sysmex America, United States
  • Genie Davis, BS / Advisor / Arkansas Department of Health, United States
  • Jennifer Dawson, DLM(ASCP)SLS, QIHC, QLC/LSSBB/CPHQ/MHA / Advisor / Human Longevity, Inc., United States
  • Lorie Erikson, MS, MT(ASCP), CQA(ASQ) / Member / FDA Center for Devices and Radiological Health, United States
  • James Fuller, PhD, CQA(ASQ), DABCC / Advisor / Ligonier Lab Services, United States
  • Sheri L. Hearn, BS, MPH / Member / Oregon State Public Health Laboratory, United States
  • Karen Heaton, MLT(CMLTA) / Member / Alberta Precision Laboratories, Canada
  • Sue Hetzel, MT(ASCP)SBB, CMQ/OE(ASQ) / Advisor / Aurora Health Care/ACL Laboratories, United States
  • Austinlal Martin Jose / Advisor, United Arab Emirates
  • Debra Kuehl, MS, M(ASCP) / Vice-Chairholder / Centers for Disease Control and Prevention, United States
  • Laura McClannan, MT(ASCP)SBB, CQA(ASQ) / Chairholder / Oklahoma Blood Institute, United States
  • E. Jayne Scoggin, BA, CT, CG, MB(ASCP), CQA(ASQ) / Advisor / ResearchDX, United States
  • Daniel J. Scungio, MT(ASCP), SLS, CQA(ASQ) / Member / Sentara Healthcare, United States
  • Jean Tenuta, BA, MS, MBA, MLS(ASCP)CM, DLM(ASCP), SLS(ASCP) / Member / Becton, Dickinson and Company, United States

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