For Officer – Secretary:
Joseph Passarelli, BA
Current Secretary, CLSI
Senior Director, Scientific Relations, Roche Diagnostics
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.
For Director (Professions Constituency):
Gary W. Procop, MD, MS
Incoming CEO, American Board of Pathology
Gary W. Procop, MD, MS is the incoming Chief Executive Officer of the American Board of Pathology, effective January 1, 2022. He spent most of his career at the Cleveland Clinic where he held several leadership positions. He remains a Consulting Staff at Cleveland Clinic, and a Professor of Pathology at the Cleveland Clinic Lerner College of Medicine.
Dr. Procop completed a Bachelor of Science at Eastern Michigan University, followed by an M.D. and M.S. at Marshall University School of Medicine. Residency training in Anatomic and Clinical Pathology training was completed at Duke University Medical Center, followed by a Clinical Microbiology Fellowship at the Mayo Clinic. He is a diplomat of the American Board of Pathology in Anatomic and Clinical Pathology, and Medical Microbiology. He is a Fellow of the American Academy of Microbiology, the College of American Pathologists, the American Society for Clinical Pathology, the Infectious Diseases Society of America, and the Royal Society of Tropical Medicine and Hygiene.
He has given more than 691 scientific presentations, and has 234 published manuscripts, 51 chapters, and has three books to his credit. He is a Member of the Board of Directors and the Chair of the Antifungal Subcommittee of the Clinical & Laboratory Standards Institute. He is also a Member of the Board of Directors of the American Board of Medical Specialties, and has held leadership positions in several other national Pathology and Microbiology organizations.
Major recognitions include the ASM BD Award for Research in Clinical Microbiology, the CAP Distinguished Patient Care Award, the Cleveland Clinic John Beach Hazard Teaching Award, the ASCP Mastership Designation, Case Western Reserve University School of Medicine Scholarship in Teaching Award, and the Belinda Yen-Lieberman, PhD, and James M. Lieberman, MD, Endowed Chair in Clinical Microbiology. His primary interests are developing and promoting best practices in laboratory testing, the practical applications of molecular diagnostic methods for the diagnosis and treatment of infections; infectious disease pathology; mycology and parasitology. He is currently working on a Masters of Education in Health Professions through Johns Hopkins University.
For Director (Industry Constituency):
Susan Sharp, PhD, D(ABMM), F(AAM)
Scientific Director, Copan Diagnostics
Susan E. Sharp, Ph.D. is the Scientific Director for Copan Diagnostics and an Assistant Professor in the Department of Pathology at Florida International University. She is a past-president of the American Society for Microbiology, a current member of the CLSI Microbiology Expert Panel and of the CLSI AST-Subcommittee, as well as several CLSI ad hoc working groups. She completed her B.S. degree in Medical Technology and her M.S. degree in Medical Microbiology with a minor in Biochemistry from the University of Nebraska Medical Center. She completed her Ph.D. in Veterinary Microbiology and Parasitology at Texas A&M University and post-doctoral training at Hartford Hospital. She is a Diplomat of the American Board of Microbiology and a Fellow in the American Academy of Microbiology. She is a past member of the Board of Scientific Counselors for the Office of Infectious Diseases at the Centers for Disease Control and Prevention and a past member of the Microbiology Resource Committee for the College of American Pathologists. She has given over 180 scientific presentations and authored over 80 published manuscripts and 13 book chapters. As a clinical microbiology director for over 30 years, her interests were in cost-effective, clinically-relevant diagnostic microbiology and setting standards and guidelines for the practice of clinical microbiology. As the Scientific Director for Copan Diagnostics, her primary goals are to further the knowledge and acceptance of gold standard and novel specimen collection devices, and to develop studies and work with investigators to advance the field of automation, interpretive algorithms, and artificial intelligence in diagnostic microbiology.
For Director (Government Constituency):
Collette Fitzgerald, PhD
Deputy Director for Science, Division of Laboratory Systems, Epidemiology and Laboratory Services, Centers for Disease Control and Prevention
Dr. Collette Fitzgerald is the Deputy Director for Science in the Division of Laboratory Systems (DLS) at CDC.
She began her career in microbiology 29 years ago, across the pond, at the Health Protection Agency in London, where she gained a love for the laboratory and public health.
For the past 23 years, she has worked at the Center for Disease Control and Prevention, in Atlanta, GA. Eighteen of those years were spent working in the Enteric Diseases Laboratory Branch in the Division of Foodborne, Waterborne and Environmental Diseases, where she most recently served as Chief of the National Enteric Reference and Outbreak Laboratory Team (NERO). Dr Fitzgerald’s strong leadership led NERO to enhance laboratory quality and safety, embrace whole genome sequencing (WGS) and Quality Management Systems (QMS). In 2016, NERO became the first laboratory at CDC to have a next generation sequencing test validated for use under CLIA for identification of enteric pathogens.
In Jan 2017, Dr. Fitzgerald joined DLS at CDC, where she now leads the Science and Evaluation Offices in the Office of the Director, in support of the DLS mission to improve public health, patient outcomes, and health equity by advancing clinical and public health laboratory quality and safety, data and biorepository science, and workforce competency. Dr. Fitzgerald is currently CDC’S ex-officio on the Clinical Laboratory Improvement Advisory Committee (CLIAC), and has been a Clinical and Laboratory Standards Institute (CLSI) Consensus Council committee member since Nov 2019.
Dr. Fitzgerald earned her PhD in Molecular Microbiology from the University of Lancaster, UK, and a Bachelor of Science in Biochemistry with Chemistry from the University of Southampton, UK.