Reevaluation of the US Pathologist Workforce Size.

Importance: There is currently no national organization that publishes its data that serves as the authoritative source of the pathologist workforce in the US. Accurate physician numbers are needed to plan for future health care service requirements. Objective: To assess the accuracy of current pathologist workforce estimates in the US by examining why divergency appears in different published resources. Design, Setting, and Participants: This study examined the American Board of Pathology classification for pathologist primary specialty and subspecialties and analyzed previously published reports from the following data sources: the Association of American Medical Colleges (AAMC), the Accreditation Council for Graduate Medical Education (ACGME), a 2013 College of American Pathologists (CAP) report, a commercially available version of the American Medical Assoication (AMA) Physician Masterfile, and an unpublished data summary from June 10, 2019. Main Outcomes and Measures: Number of physicians classified as pathologists. Results: The most recent AAMC data from 2017 (published in 2018) reported 12 839 physicians practicing "anatomic/clinical pathology," which is a subset of the whole. In comparison, the current AMA Physician Masterfile, which is not available publicly, listed 21 292 active pathologists in June 2019. The AMA Physician Masterfile includes all pathologists in 15 subspecialized training areas as identified by the ACGME. By contrast, AAMC's data, which derive from the AMA Physician Masterfile data, only count physicians primarily associated with 3 general categories of pathologists and 1 subspecialty category (ie, chemical pathology). Thus, the AAMC pathology workforce estimate does not include those whose principal work is in 11 subspecialty areas, such as blood banking or transfusion medicine, cytopathology, hematopathology, or microbiology. An additional discrepancy relates to the ACGME residency (specialties) and fellowship (subspecialties) training programs in which pathologists with training in dermatopathology appear as dermatologists and pathologists with training in molecular genetic pathology appear as medical geneticists. Conclusions and Relevance: This analysis found that most sources reported only select categories of the pathologist workforce rather than the complete workforce. The discordant nature of reporting may pertain to other medical specialties that have undergone increased subspecialization during the past 2 decades (eg, surgery and medicine). Reconsideration of the methods for determining the pathologist workforce and for all workforces in medicine appears to be needed.

Initial Diagnostic Workup of Acute Leukemia: Guideline From the College of American Pathologists and the American Society of Hematology.

CONTEXT: - A complete diagnosis of acute leukemia requires knowledge of clinical information combined with morphologic evaluation, immunophenotyping and karyotype analysis, and often, molecular genetic testing. Although many aspects of the workup for acute leukemia are well accepted, few guidelines have addressed the different aspects of the diagnostic evaluation of samples from patients suspected to have acute leukemia. OBJECTIVE: - To develop a guideline for treating physicians and pathologists involved in the diagnostic and prognostic evaluation of new acute leukemia samples, including acute lymphoblastic leukemia, acute myeloid leukemia, and acute leukemias of ambiguous lineage. DESIGN: - The College of American Pathologists and the American Society of Hematology convened a panel of experts in hematology and hematopathology to develop recommendations. A systematic evidence review was conducted to address 6 key questions. Recommendations were derived from strength of evidence, feedback received during the public comment period, and expert panel consensus. RESULTS: - Twenty-seven guideline statements were established, which ranged from recommendations on what clinical and laboratory information should be available as part of the diagnostic and prognostic evaluation of acute leukemia samples to what types of testing should be performed routinely, with recommendations on where such testing should be performed and how the results should be reported. CONCLUSIONS: - The guideline provides a framework for the multiple steps, including laboratory testing, in the evaluation of acute leukemia samples. Some aspects of the guideline, especially molecular genetic testing in acute leukemia, are rapidly changing with new supportive literature, which will require on-going updates for the guideline to remain relevant.

Principles of analytic validation of immunohistochemical assays: Guideline from the College of American Pathologists Pathology and Laboratory Quality Center.

CONTEXT: Laboratories must validate all assays before they can be used to test patient specimens, but currently there are no evidence-based guidelines regarding validation of immunohistochemical assays. OBJECTIVE: To develop recommendations for initial analytic validation and revalidation of immunohistochemical assays. DESIGN: The College of American Pathologists Pathology and Laboratory Quality Center convened a panel of pathologists and histotechnologists with expertise in immunohistochemistry to develop validation recommendations. A systematic evidence review was conducted to address key questions. Electronic searches identified 1463 publications, of which 126 met inclusion criteria and were extracted. Individual publications were graded for quality, and the key question findings for strength of evidence. Recommendations were derived from strength of evidence, open comment feedback, and expert panel consensus. RESULTS: Fourteen guideline statements were established to help pathology laboratories comply with validation and revalidation requirements for immunohistochemical assays. CONCLUSIONS: Laboratories must document successful analytic validation of all immunohistochemical tests before applying to patient specimens. The parameters for cases included in validation sets, including number, expression levels, fixative and processing methods, should take into account intended use and should be sufficient to ensure that the test accurately measures the analyte of interest in specimens tested in that laboratory. Recommendations are also provided for confirming assay performance when there are changes in test methods, reagents, or equipment.

Consensus statement on effective communication of urgent diagnoses and significant, unexpected diagnoses in surgical pathology and cytopathology from the College of American Pathologists and Association of Directors of Anatomic and Surgical Pathology.

CONTEXT: Recognizing the difficulty in applying the concept of critical values to anatomic pathology diagnoses, the College of American Pathologists and the Association of Directors of Anatomic and Surgical Pathology have chosen to reevaluate the concept of critical diagnoses. OBJECTIVE: To promote effective communication of urgent and significant, unexpected diagnoses in surgical pathology and cytology. DESIGN: A comprehensive literature search was conducted and reviewed by an expert panel. RESULTS: A policy of effective communication of important results in surgical pathology and cytology is desirable to enhance patient safety and to address multiple regulatory requirements. CONCLUSIONS: Each institution should create its own policy regarding urgent diagnoses and significant, unexpected diagnoses in anatomic pathology. This policy should be separate from critical results or panic-value policies in clinical pathology, with the expectation of a different time frame for communication. Urgent diagnosis is defined as a medical condition that, in most cases, should be addressed as soon as possible. Significant, unexpected diagnosis is defined as a medical condition that is clinically unusual or unforeseen and should be addressed at some point in the patient's course. Further details of this statement are provided.