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- 2024 CAP Pathology Advancement Award
The College of American Pathologists (CAP) established the Pathology Advancement Award in 2013 to recognize a person or team who demonstrates components of foresight, resolve, and untiring commitment to both evolutionary and revolutionary undertakings that advance the positioning of the pathologist in the house of medicine and the delivery of safer patient care. It recognizes efforts that are neither easy nor obvious, and the recipient will often be a change agent.
The College of American Pathologists presents the following members of the CAP’s Microbiology Committee with the 2024 CAP Pathology Advancement Award: Romney M. Humphries, PhD, D(ABMM), Isabella Martin, MD, FCAP, Carol A. Rauch, MD, PhD, FCAP, Rosemary She, MD, FCAP, Patricia J. Simner, PhD, D(ABMM), and Kaede Ota Sullivan, MD, MBA, FRCPC, FAAP, D(ABMM). The award recognizes the team’s outstanding and transformative work ensuring the use of current breakpoints for antimicrobial susceptibility testing (AST).
The team worked diligently over the past decade to tackle this seemingly insurmountable yet critical patient safety issue. Their efforts heightened awareness of a significant problem, created important tools for laboratories, and resulted in changes to FDA opinion and policy.
For years, the Microbiology Committee has been concerned about laboratories using outdated interpretative criteria (breakpoints) for antimicrobial susceptibility tests with FDA-cleared devices. Breakpoints define pathogen susceptibility to antibiotics and are regularly updated by standard-setting organizations. However, the FDA did not adopt these updates promptly, preventing AST device manufacturers from obtaining clearance with updated standards. Without FDA-recognized breakpoints, laboratories had to use outdated devices or perform off-label validation, risking use of ineffective antibiotics in patient treatment.
To gauge the extent of this patient safety issue, the team worked with committee leadership to survey laboratories who subscribed to bacteriology PT surveys about breakpoints. Shockingly, only 30–62% of laboratories used up-to-date breakpoints for various organism/antimicrobial combinations, some of which were nine years out of date.
The Microbiology Committee raised concerns to the Council on Scientific Affairs and the Council on Government and Professional Affairs, leading to a meeting with the FDA in 2020. With the FDA unable to act due to the COVID-19 pandemic, the committee then made changes to the 2021 LAP Microbiology Checklist, requiring laboratories to document breakpoints currently in use and mandating the use of up-to-date breakpoints by January 1, 2024. This three-year timeline gave laboratories time to validate off-label breakpoints and pressured device manufacturers to update their breakpoints.
The team demonstrated impressive foresight and resolve in tackling this important patient safety issue, exemplifying the CAP mission of serving patients and pathologists and advocating excellence in medicine.
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Romney M. Humphries, PhD, D(ABMM)
Dr. Humphries is the division director of laboratory medicine and a professor of pathology, microbiology, and immunology at Vanderbilt University Medical Center in Nashville, Tennessee.
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Isabella Martin, MD, FCAP
Dr. Martin is an assistant professor of pathology and laboratory medicine at the Geisel School of Medicine at Dartmouth College and the medical director of microbiology at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.
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Carol A. Rauch, MD, PhD, FCAP
Dr. Rauch is an adjunct associate professor of pathology, microbiology, and immunology at Vanderbilt University School of Medicine in Nashville, Tennessee.
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Rosemary She, MD, FCAP
Dr. She is a professor in the department of pathology at City of Hope in Duarte, California.
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Patricia (Trish) J. Simner, PhD, D(ABMM)
Dr. Simner is a professor of pathology and infectious diseases and director of bacteriology, division of medical microbiology at Johns Hopkins University School of Medicine in Baltimore.
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Kaede Ota Sullivan, MD, MBA, FRCPC, FAAP, D(ABMM)
Dr. Sullivan is a professor of pathology and laboratory medicine at Temple University’s Lewis Katz School of Medicine in Philadelphia.
