Joseph Passarelli is Senior Director, Scientific Relations at Roche Diagnostics Corporation. In this role, he represents Roche as a scientific liaison to professional societies and standard- and guideline-setting organizations worldwide. He has worked both domestically and internationally in research and development for more than 35 years and has experience in discovery, research, development, laboratory management, technology transfer, regulatory submissions, and market commercialization. His scientific background includes developing immunoassays that use multiple technologies for homogenous laboratory-based testing platforms. He is recognized in the fields of drugs of abuse testing and therapeutic drug monitoring. Before assuming his current role, Mr. Passarelli was head of Roche Diagnostics Research and Development for these scientific disciplines. Mr. Passarelli has been active with CLSI for several years, having participated on the document development committees for the EP05, EP06, EP07, EP09, and EP17 revisions. In addition, he was a member of the Consensus Committee on Clinical Chemistry and Toxicology and the Consensus Council. In addition to his collaboration with CLSI, Mr. Passarelli is Corporate Representative to the International Federation of Clinical Chemistry and Laboratory Medicine’s Executive Board and member of the Harmonization Oversight Group of the International Consortium for Harmonization of Clinical Laboratory Results. He is interested in educating and promoting the value of standardization and harmonization through the use of recognized standards and guidelines and collaborates extensively with professional organizations worldwide. Mr. Passarelli is a member of the American Association for Clinical Chemistry (AACC) Industry Division and received the 2014 AACC Presidential Citation for his contributions to laboratory medicine and education.

Dr. Bachmann received her PhD in Molecular Medicine and completed a Clinical Chemistry Fellowship at the University of Virginia. She is a Diplomat of the American Board of Clinical Chemistry, an ASCP certified medical technologist and a Fellow of the American Association for Clinical Chemistry (AACC) Academy. She currently serves as Professor of Pathology, Co-Director of Clinical Chemistry, Co-Director of Point-of-Care Testing, and Director of the New Kent Emergency Department Laboratory within the Virginia Commonwealth University Health System.

Dr. Bachmann has served in many leadership positions, including Member of the AACC Board of Directors, Chair of the NIDDK/IFCC Laboratory Working Group for Standardization of Albumin in Urine, and Advisor for the International Standardization of 25-Hydroxyvitamin D Levels in National Health Surveys through the Office of Dietary Supplements (ODS), National Institutes of Health (NIH), and Centers for Disease Control (CDC). She currently serves on the AACC Finance and Nominating Committees and is a member of the College of American Pathology (CAP) Accuracy Based Programs Committee. Her research and clinical interests include development of laboratory practice guidelines, quality assurance, and standardization of clinical laboratory measurement procedures.

Dr. Bachmann has served as Document Development Committee Co-Chair for CLSI’s C57, Vice Chair for EP26, and as a Document Development Committee Member for C64, C62, and the revision of CLSI EP25. She is serving on the Document Development Committees for EP45 and EP21/EP46. Dr. Bachmann is currently the Chair of the CLSI Expert Panel on Clinical Chemistry and Toxicology and is a member of the CLSI Education Advisory Committee.

Barbara L. Zimmer, PhD is the Principal Scientist Emeritus for Microbiology at Beckman Coulter, Inc. She has worked in development of in vitro diagnostics (IVD) microbiology products for over 25 years in both the Product Development and Medical/Clinical/Scientific Affairs groups. Her expertise is developing tests for microbial identification, antimicrobial susceptibility testing, and detection of antimicrobial resistance. In addition, for 30 years, she served as a clinical faculty member for the University of California, Davis School of Medicine. Dr. Zimmer is a long time CLSI volunteer. She was a Voting Member for the Subcommittee for Antimicrobial Susceptibility Testing for 14 years, and currently serves as an Advisor to that Committee. She co-chairs the Methods Development and Standardization Working Group. She also served as a Voting Member of the Consensus Committee for Microbiology for three years. Outside of CLSI, she has been very active in the Susceptibility Testing Manufacturer’s Association (STMA), which represents the voice of that industry to both CLSI and other agencies. She has given many presentations locally and internationally on the use of CLSI documents in the Clinical Microbiology Laboratory. She has been a member of ISO TC 212 Working Group 4 and contributed to the development of ISO 20776-1 and -2 on antimicrobial susceptibility testing, and ISO 16782 on broth for susceptibility testing.

Dr. Zimmer received her PhD from the University of California, Davis, and her MS from the University of Kentucky. Her clinical experience includes work at several hospitals, including Mayo Clinic. She is also a member of the American Society for Microbiology.

Lea Carrington is the of Director of the Division of Immunology and Hematology Devices (DIHD) in the US Food and Drug Administration (FDA)’s Office of In Vitro Diagnostic Devices (OIVD). She has held this position since 2015. In this role, she participates in the scientific and regulatory review and approval of a variety of immunology and hematology in vitro diagnostic medical devices for assays and instrumentation in the areas of: allergy, autoimmune diseases, flow cytometry, neurological disorders, serum-based cancer biomarkers, automated differential cell counters, coagulometers and specialized hemostasis tests, fecal occult blood, genetic health risk assessment, companion diagnostics, and point-of-care devices. Immediately preceding the DIHD director position, she held a position as Chief of the Hematology Branch of DIHD (2009 to 2015) and was a lead scientific reviewer of hematology and coagulation devices (2004 to 2009) in the Hematology Branch.

Prior to joining FDA in 2003, Ms. Carrington gained over 20 years of extensive technical experience and regulatory application as the Chief Medical Technologist of the Special Coagulation laboratory at Walter Reed Army Institute of Research and the Department of Pathology laboratory at Walter Reed Army Medical Center. She performed a combination of clinical research and clinical laboratory testing in this specialty area, serving all branches of the armed forces. She earned an MS in Biomedical Development and Technology at Georgetown University and an MBA at Johns Hopkins University. She is an ASCP-certified technologist earning a BS degree in Medical Technology from Norfolk State University. Ms. Carrington has served on the CLSI Area Committee Expert Panel for Hematology and Immunology as well as two CLSI document development committees.

Vote Now