The College of American Pathologists (CAP) is a member-based physician organization founded in 1946 comprising approximately 18,000 board-certified pathologists. It serves patients, pathologists, and the public by fostering and advocating best practices in pathology and laboratory medicine.It is the world's largest association composed exclusively of pathologists certified by the American Board of Pathology, and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high-quality and cost-effective medical care. The CAP currently inspects and accredits medical laboratories under authority from the Centers for Medicare & Medicaid Services (CMS). Their standards have been called "the toughest and most exacting in the medical business." The CAP provides resources and guidance to laboratories seeking accreditation in programs for biorepositories, genomics, ISO 15189, and more. In November 2008, Piedmont Medical Laboratory of Winchester, Virginia became the first laboratory in the United States to be officially accredited under ISO 15189.The CAP provides accreditation and proficiency testing to medical laboratories through its laboratory quality solutions programs. Early versions of proficiency testing—known as surveys—which laboratories use to help test and ensure accuracy, were first initiated in 1949. Laboratories first began receiving CAP accreditation in 1964, and the organization was later given authority to accredit medical laboratories as a result of the Clinical Laboratory Improvement Amendments (CLIA) of 1988.The CAP publishes checklists containing requirements pertaining to the performance of laboratory tests. The All Common Checklist (COM) contains a core set of requirements that apply to all areas performing laboratory tests and procedures.Some requirements exist in both the COM checklist and in a discipline-specific checklist, but with a different checklist note that has a more specific requirement. In these situations, the discipline-specific requirement takes precedence over the COM requirement.The COM checklist also describes the requirements for analytical validation/verification of the method performance specifications (i.e.accuracy, precision, reportable range) that laboratories must perform for each test, method, or instrumentsystem before use in patient testing. CAP has also created programs that look at the frequency of errors throughout laboratory testing, including Q-Probes and Q-Tracks. CAP's Q-Probes studies aim to describe errors at different stages of testing; pre-analytic, analytic, and post-analytic. In order to reduce the frequency of errors occurring at the different stages of testing, performance measures have been put in place in order to improve patient safety. CAP has created a database to record the error rates seen from more than 130 inter-laboratory studies.The CAP opened a Washington, DC, office in 1970 and advocating for pathology in a legal and policy-oriented capacity remains a core mission of the organization, both through direct action and programs that connect pathologists to legislators.The CAP Foundation is the philanthropic arm of the organization and is classified as a 501(c)(3) charitable entity. Its flagship program, See, Test & Treat, partners with hospitals and clinicians to provide free cancer and HPV screening, as well as educational events, to underserved communities. The program served over 900 women in 2017.
Validation is a cornerstone of reliability and trust in diagnostics, yet discipline-specific assumptions and unspoken contextual differences often lead to miscommunication, misalignment, and avoidable delays. As AI/ML becomes more integrated into healthcare, there is a growing necessity to re-examine how the term validation is used and understood. We highlight inconsistencies in the use of the term validation through an analysis of 94 themes across five domains, including Communication Science (n = 12), AI/ML (n = 26), Clinical and Laboratory Practice (n = 19), Regulatory Science (n = 22), and Business (n = 15). We emphasize how persistent reliance on domain-specific implied definitions impedes interdisciplinary alignment. Rather than advocating for a single definition, we derived five consensus proposals that collectively advocate for more specific and context-aware additions to the term validation to support clarity, reliability, and compliance across disciplines. Our goal is to support clearer communication and provide useful strategies that inform the development, regulation, and use of digital health technologies.
BACKGROUND:Many clinical guidelines include laboratory measurements, which require accuracy across laboratories. This study aimed to determine whether testosterone measurements by a small subset of labs using commutable specimens could be used as a surrogate marker of accuracy across widely used testing platforms. It also assessed the frequency of categorization errors that might occur near the male hypogonadal threshold and whether performance on traditional surveys predicted performance using commutable specimens. METHODS:Three presumed commutable samples were created using human serum; Sample A was provided in a routine mailing of a traditional (non-commutable) proficiency testing survey (reference value 234 ng/dL, n = 1431 laboratories), Samples B and C were part of a routine mailing of an accuracy-based survey (reference values 277 ng/dL and 196 ng/dL, n = 118 and 138 laboratories). RESULTS:The overall mean bias from the reference method value was less than 2% for all 3 samples, but individual peer (method) group biases ranged -16% to +15%. Five percent of reported values for Sample A were above the hypogonadal threshold (264 ng/dL), falsely indicating "healthy state" (peer group miscategorization ranged 29% to 0%). Conversely, 44% of results for Sample B were below the hypogonadal threshold, falsely indicating hypogonadism (peer group miscategorization ranged 100% to 0%). Comparison of results between non-commutable and commutable specimens indicated that bias was different in direction and magnitude for 3 of 6 method groups. CONCLUSIONS:Assessing performance using commutable specimens reported by smaller numbers of users may serve as a reasonable approximation for performance of method groups in general.
Precise inter-laboratory quantitation of BCR::ABL1 RNA is critical for effective chronic myeloid leukemia (CML) disease management. Although standardized reporting on the International Scale (IS) was specifically developed to improve inter-laboratory reproducibility in BCR::ABL1 quantitation, the clinical impact of this reporting system has not been comprehensively assessed. We analyzed 15 years of BCR::ABL1 results (2009-2023) reported by over 200 clinical laboratories (6 annual samples; >5500 results) in a College of American Pathologists proficiency testing program. Inter-laboratory precision was evaluated by standard deviations (SD) for high, intermediate, and low-transcript samples. Early rapid IS adoption over 7 years (8% of labs in 2009; 86% by 2015) was correlated with a progressive decrease in inter-lab SDs of reported BCR::ABL1 results (high-sample r = -0.73, p = 0.004; intermediate-sample r = -0.71, p = 0.022; low-sample r = -0.84, p = 0.002). IS implementation exceeded 99% by 2019, as inter-lab SD's reached their nadir value (~0.2). No other assessed variable correlated with time-dependent improvement in inter-lab reproducibility, including reference gene selection (ABL1 versus others), RQ-PCR reagent selection, assay type (FDA-approved, commercial, or laboratory-developed), or practice setting. IS-based reporting is thus likely the principal driver of enhanced inter-laboratory precision in BCR::ABL1 quantitation, validating the real-world clinical relevance of adopting robust standardization in clinical molecular diagnostics.
This study evaluated the current landscape of pathology education in Liaison Committee on Medical Education (LCME)–accredited U.S. medical schools, focusing on curricular structure, faculty leadership, and gaps in student exposure. Trends influencing pathology's visibility and role within undergraduate medical education were assessed. A cross-sectional, descriptive review of all LCME-accredited allopathic medical schools was conducted using publicly available data collected between January 25 and April 14, 2025. School websites and the Visiting Student Learning Opportunities (VSLO) platform were reviewed for accreditation year, class size, pathology faculty numbers (MD, DO, or PhD with primary appointments), presence of pathology departments and residency programs, Pathology Interest Groups, pre-clinical and clinical electives, post-sophomore fellowships, and affiliated hospitals. Because data were derived from publicly available institutional sources, findings reflect institutional visibility and accessibility of pathology education rather than definitive availability or quality of instruction. A total of 159 LCME-accredited medical schools were analyzed, with a mean class size of 143 students and an average of 39.6 pathology faculty per institution. Pathologists held major institutional leadership roles at 58 schools (36.5
Hypoglycemia is a common complication in people with type 2 diabetes mellitus (T2DM) treated with basal insulin, yet its true prevalence in real-world primary care remains underexplored. This study used blinded continuous glucose monitoring (CGM) to assess glycemic patterns in patients with T2DM on basal insulin-supported oral therapy (BOT) with insulin glargine 100 U/mL (Gla-100) in Spain. GPDetect was a prospective, multicenter, observational study in adults with T2DM treated with Gla-100 for ≥ 6 months in primary care. Participants underwent 14 days of blinded CGM (FreeStyle Libre® Pro iQ®). The primary objective of the present study was to estimate the proportion of patients with T2DM treated with Gla-100 whose TBR (glucose < 70 mg/dL) exceeded the internationally recommended threshold of 4
