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- 2024 CAP Laboratory Improvement Programs Service Award
In 2006, the College of American Pathologists (CAP) established the Laboratory Improvement Programs Service Award to recognize an individual serving within the ranks of the Council on Scientific Affairs (CSA) who has demonstrated exceptional service.
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Jonathan R. Genzen, MD, PhD, MBA, FCAP
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Amy B. Karger, MD, PhD, FCAP, DABCC
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David B. Sacks, MB, ChB, FRCPath, FCAP
The College of American Pathologists honors Dr. Jonathan Genzen, chair of the Clinical Chemistry Committee, Dr. David Sacks, member, Clinical Chemistry Committee, and Dr. Amy Karger, member, Accuracy-Based Programs Committee, with the CAP Laboratory Improvement Programs Service Award for their outstanding contributions raising awareness of the updated equations for eGFR and the standardization of hemoglobin A1C (HbA1c) testing.
For many years, eGFR calculations included race-based adjustment factors, affecting patient eligibility for organ transplants, medications, and treatment options. In September 2021, the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) introduced two new equations for eGFR that exclude race adjustments: one based on creatinine, the other on both creatinine and cystatin C. The National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease recommended implementing the 2021 CKD-EPI creatinine equation and encouraged increased use of cystatin C to address racial and ethnic disparities.
Dr. Karger is director of the Central Laboratory for the CKD-EPI research group and co-author on the New England Journal of Medicine article introducing the two new race-free CKD-EPI equations and was an invited expert panelist/discussant for the NKF/ASN Task Force. Due to her expertise, she helped the CAP chemistry cluster committees produce public statements and guidelines. Dr. Genzen continues to provide awareness of the new eGFR equations to clinical laboratories by working with the Clinical Chemistry Committee to collect and publish data on adoption of the new equation, as well as working with the Checklist Committee on a checklist requirement for eGFR calculations.
Dr. Sacks’ continual interactions with the National Glycohemoglobin Standardization Program (NGSP) and manufacturers of HbA1c assays, coupled with the lowering of acceptable PT performance limits in the GH5/GH2 Programs for laboratories, have led to assay improvements.
During the comment period for the CLIA proposed rule on HbA1c proficiency testing, the awardees were in agreement with their fellow CSA and clinical colleagues not to increase the acceptance limits from ± 6% to ± 10%. When the final rule was released, the CMS set the acceptance limit at ± 8%. With guidance from CSA leadership, Drs. Sacks and Genzen led the discussion with the Council on Accreditation and the Continuous Compliance Committee to ensure CAP-accredited laboratories are still able to recognize the previously achieved ± 6% acceptance limits through creation of a checklist requirement and providing laboratories with dual grading performance evaluation reports to meet both CMS and CAP requirements. Improvements for the measurement of HbA1c would not be possible without their efforts.
Dr. Sacks is a senior investigator and chief of clinical chemistry at the National Institutes of Health in Bethesda, Maryland.
Dr. Genzen is a professor of pathology at the University of Utah and chief medical officer and senior director of government affairs at ARUP Laboratories in Salt Lake City.
Dr. Karger is a professor in the department of laboratory medicine and pathology at the University of Minnesota in Minneapolis.