The Pathology Workforce and Clinical Licensure

Abstract

There has been a recent recognition of the need to prepare PhD-trained scientists for increasingly diverse careers in academia, industry, and health care. The PhD Data Task Force was formed to better understand the current state of PhD scientists in the clinical laboratory workforce and collect up-to-date information on the training and certification of these laboratorians. In this report, we summarize the findings of the PhD Data Task Force and discuss the relevance of the data collected to the future supply of and demand for PhD clinical laboratory scientists. It is clear that there are multiple career opportunities for PhD scientists in academic medical centers, commercial clinical laboratories, biotechnology and pharmaceutical companies, and the federal government. Certified PhD scientists have and will continue to form an important resource for our technologically advancing field, bringing training in scientific methods, and technologies needed for modern laboratory medicine. The data gathered by the PhD Data Task Force will be of great interest to current and future PhD candidates and graduate PhD scientists as they make decisions regarding future career directions.

Diplomate in Medical Laboratory Immunology Certification Examination: A New Chapter for Medical Laboratory Immunology

“…A detailed account of the discipline of clinical laboratory immunology and the critical role that Ph.D. trained directors play in clinical laboratories has been reported previously ( 28 , 35 ). Briefly, clinical immunology laboratories perform testing that supports the clinical services covering immune-deficiency diseases, infectious diseases, autoimmunity, hematologic malignancies, allergy, and transplantation.…”

“…The CLIA program is implemented by the Division of Clinical Laboratory Improvement and Quality that operates under the aegis of the Quality, Safety and Oversight Group that exists within the Center for Clinical Standards and Quality at CMS ( 31 ). The CAP is one of seven approved accreditation organizations with deeming authority under the CLIA program, and it is widely considered one of the most rigorous accreditation programs for clinical laboratories ( 33 , 35 , 36 ). Broadly speaking, and from a practical standpoint of the laboratory, CLIA and CAP rules emphasize a rigorous and stringent process relating to method validation and assay performance characteristics for the tests performed in clinical laboratories, as well as for the credential requirements (certification and/or licensure) of the personnel directing, supervising, and performing the testing ( 35 ).…”

“…The CAP is one of seven approved accreditation organizations with deeming authority under the CLIA program, and it is widely considered one of the most rigorous accreditation programs for clinical laboratories ( 33 , 35 , 36 ). Broadly speaking, and from a practical standpoint of the laboratory, CLIA and CAP rules emphasize a rigorous and stringent process relating to method validation and assay performance characteristics for the tests performed in clinical laboratories, as well as for the credential requirements (certification and/or licensure) of the personnel directing, supervising, and performing the testing ( 35 ). The test method validation must include detailed documentation listing the intended use of the test, the type of analyte (measurand), and requirements for performance characteristics (accuracy or validity: sensitivity and specificity or method comparison, precision, limit of detection, analytical measuring range, linearity, reference intervals, analytical specificity, and analytical sensitivity) ( 37–41 ).…”

“…In clinical medicine, board certification is the gold standard used to document a practitioner’s qualifications in a specific discipline. The U.S. Department of Health and Human Services and the 13 states that require licensure (California, Florida, Georgia, Hawaii, Louisiana, Montana, Nevada, New York, North Dakota, Rhode Island, Tennessee, West Virginia, and New Jersey) mandate that nonphysician clinical laboratory directors possessing a Ph.D. degree be board certified and/or possess credentials demonstrating appropriate competency to serve as a clinical laboratory director ( 28 , 35 ). For many years, the ABMLI certification examination provided that documentation for doctoral-level immunologists ( 58 ).…”

“…For many years, the ABMLI certification examination provided that documentation for doctoral-level immunologists ( 58 ). The ABMLI examination was discontinued in 2017, but the need to certify doctoral-level immunologists continues because board certification provides an important avenue for Ph.D. immunologists to direct clinical laboratories ( 28 , 35 ). Unfortunately, training in immunology in general, and specifically cellular immunology (including but not limited to evaluation of subsets within CD4 and CD8 T cell and B cell populations, as well as cellular immune function), is not a major component of many Accreditation Council of Graduate Medical Education –accredited pathology residency programs.…”