ABSTRACT
CONTEXT.: The diagnostic workup of lymphoma continues to evolve rapidly as experience and discovery led to the addition of new clinicopathologic entities and techniques to differentiate them. The optimal clinically effective, efficient, and cost-effective approach to diagnosis that is safe for patients can be elusive, in both community-based and academic practice. Studies suggest that there is variation in practice in both settings. OBJECTIVE.: To develop an evidence-based guideline for the preanalytic phase of testing, focusing on specimen requirements for the diagnostic evaluation of lymphoma. DESIGN.: The American Society for Clinical Pathology, the College of American Pathologists, and the American Society of Hematology convened a panel of experts in the laboratory workup of lymphoma to develop evidence-based recommendations. The panel conducted a systematic review of literature to address key questions. Using the Grading of Recommendations Assessment, Development, and Evaluation approach, recommendations were derived based on the available evidence, strength of that evidence, and key judgements as defined in the Grading of Recommendations Assessment, Development, and Evaluation Evidence to Decision framework. RESULTS.: Thirteen guideline statements were established to optimize specimen selection, ancillary diagnostic testing, and appropriate follow-up for safe and accurate diagnosis of indolent and aggressive lymphoma. CONCLUSIONS.: Primary diagnosis and classification of lymphoma can be achieved with a variety of specimens. Application of the recommendations can guide decisions on specimen suitability, diagnostic capabilities, and correct use of ancillary testing. Disease prevalence in patient populations, availability of ancillary testing, and diagnostic goals should be incorporated into algorithms tailored to each practice environment.
Subject(s)
Evidence-Based Medicine , Lymphoma , Pathologists , Pathology, Clinical , Adult , Humans , American Medical Association , Education , Hematology/education , Laboratories , Lymphoma/classification , Lymphoma/diagnosis , Lymphoma/pathology , Pathologists/education , Pathology, Clinical/education , United States , Systematic Reviews as TopicABSTRACT
OBJECTIVES: The diagnostic workup of lymphoma continues to evolve rapidly as experience and discovery lead to the addition of new clinicopathologic entities and techniques to differentiate them. The optimal clinically effective, efficient, and cost-effective approach to diagnosis that is safe for patients can be elusive, in both community-based and academic practice. Studies suggest that there is variation in practice in both settings. THE AIM OF THIS REVIEW IS TO: develop an evidence-based guideline for the preanalytic phase of testing, focusing on specimen requirements for the diagnostic evaluation of lymphoma. METHODS: The American Society for Clinical Pathology, the College of American Pathologists, and the American Society of Hematology convened a panel of experts in the laboratory workup of lymphoma to develop evidence-based recommendations. The panel conducted a systematic review of the literature to address key questions. Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, recommendations were derived based on the available evidence, the strength of that evidence, and key judgments as defined in the GRADE Evidence to Decision framework. RESULTS: Thirteen guideline statements were established to optimize specimen selection, ancillary diagnostic testing, and appropriate follow-up for safe and accurate diagnosis of indolent and aggressive lymphoma. CONCLUSIONS: Primary diagnosis and classification of lymphoma can be achieved with a variety of specimens. Application of the recommendations can guide decisions about specimen suitability, diagnostic capabilities, and correct utilization of ancillary testing. Disease prevalence in patient populations, availability of ancillary testing, and diagnostic goals should be incorporated into algorithms tailored to each practice environment.
Subject(s)
Lymphoma , Pathology, Clinical , Humans , Cost-Benefit Analysis , Evidence-Based Practice , Lymphoma/diagnosis , Lymphoma/pathology , Pathology, Clinical/standards , Specimen Handling , United States , Systematic Reviews as TopicABSTRACT
OBJECTIVES: To determine whether different laboratory developed test (LDT) risk stratification proposals would assign differing levels of risk to selected LDTs as a measure of the validity of those proposals, and whether there would be differing interrater agreement rates as a measure of the reliability of those proposals. METHODS: A total of 4 reviewers applied 6 proposals for risk stratification of 4 LDTs. Interrater agreement was calculated as a measure of the reliability of the proposals. Also, a consensus risk categorization and concordance rate for each LDT was developed as a measure of the validity of the proposals. RESULTS: Interrater agreement rates (reliability) ranged from 38% to 100%, and concordance rates (validity) ranged from 20% to 100%. CONCLUSIONS: A spectrum of reliability and validity was observed depending on the policy used and the LDT categorized. Before implementation or legislation of risk-stratification methods, large evaluations of reliability and validity should be conducted on any proposed method.
Subject(s)
Clinical Laboratory Techniques/standards , Humans , Reproducibility of Results , Risk AssessmentABSTRACT
BACKGROUND: Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests-now commonly referred to as laboratory-developed tests (LDTs)-are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. CONTENT: This review provides an overview of federal statutes and regulations related to IVDs and clinical laboratory operations, with a focus on those potentially applicable to LDTs and proposed regulatory efforts. Sources reviewed include the Code of Federal Regulations, the Federal Register, congressional hearings, guidance and policy documents, position statements, published literature, and websites. SUMMARY: Federal statutes regarding IVDs were passed without substantive evidence of congressional consideration toward the concept of LDTs. The FDA has clear oversight authority over IVD reagents introduced into interstate commerce. A 16-year delay in publicly asserting FDA authority over LDTs, the pursuit of a draft guidance approach toward oversight, and establishment of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) applicable to LDTs contributed to community uncertainty toward LDT oversight. Future regulatory and/or legislative efforts may be required to resolve this uncertainty.
Subject(s)
Clinical Laboratory Services/legislation & jurisprudence , Clinical Laboratory Techniques , Laboratories/legislation & jurisprudence , Medical Device Legislation , Genetic Testing/legislation & jurisprudence , Humans , United States , United States Food and Drug AdministrationABSTRACT
With the changing landscape of medicine in general, and pathology in particular, a greater emphasis is being placed on laboratory management as a means of controlling spiraling medical costs and improving health-care efficiency. To meet this challenge, pathology residency programs have begun to incorporate formal laboratory management training into their curricula, using institutional curricula and/or online laboratory management courses offered by professional organizations. At the University of Utah, and its affiliated national reference laboratory, ARUP Laboratories, Inc, interested residents are able to supplement the departmental lecture-based and online laboratory management curriculum by participating in assistant medical directorship programs in one of several pathology subspecialty disciplines. The goals of many of the assistant medical directorship positions include the development of laboratory management skills and competencies. A survey of current and recent assistant medical directorship participants revealed that the assistant medical directorship program serves as an excellent means of improving laboratory management skills, as well as improving performance as a fellow and practicing pathologist.
ABSTRACT
OBJECTIVES: To determine the optimal workflow combination of flow cytometry (FC) and immunohistochemistry tests for efficient and cost-effective evaluation of plasma cell (PC) neoplasms (PCNs) in bone marrow (BM) specimens. METHODS: Various workflow combinations of immunohistochemistry and FC for 4,031 BM specimens worked up for PCNs were compared. Turnaround time (TAT), immunohistochemistry usage, technical charges, and addendum/amendment rates were compared between periods to determine the optimal workflow combination. RESULTS: Five distinct workflow periods were identified, with varying combinations of full or limited FC panels for assessing PC clonality and CD138/κ/λ immunohistochemistry for PC quantification. Replacement of full FC with limited FC was associated with significant reductions in TAT and number of immunostains performed per case. Elimination of immunohistochemistry on cases determined to be polyclonal by FC also resulted in significant reductions in immunohistochemistry usage and significant cost savings. CONCLUSIONS: Assessment of PC clonality using a limited FC panel followed by reflex CD138 immunohistochemistry on cases that are monoclonal by FC provides an optimal and cost-effective workflow for evaluating PCNs in BM samples.
Subject(s)
Bone Marrow/pathology , Lymphoma, B-Cell/pathology , Neoplasms, Plasma Cell/diagnosis , Bone Marrow/immunology , Flow Cytometry/methods , Humans , Immunohistochemistry/methods , Immunophenotyping/methods , Lymphoma, B-Cell/immunology , Syndecan-1/immunology , WorkflowABSTRACT
CONTEXT: Competency gaps in leadership and laboratory management skills continue to exist between what training programs deliver and what recent graduates and future employers expect. A number of recent surveys substantiate this. Interest in delivering content in these areas is challenged by time constraints, the presence of knowledgeable faculty role models, and the necessary importance placed on diagnostic skills development, which overshadows any priority trainees have toward developing these skills. OBJECTIVE: To describe the problem, the near-future horizon, the current solutions, and the recommendations for improving resident training in laboratory management. DATA SOURCES: The demands of new health care delivery models and the value being placed on these skills by the Pathology Milestones and Next Accreditation System initiative of the Accreditation Council for Graduate Medical Education for training programs emphasizes their importance. This initiative includes 6 milestone competencies in laboratory management. Organizations like the American Society for Clinical Pathology, the American Pathology Foundation, the College of American Pathologists, and the Association of Pathology Chairs Program Directors Section recognize these competencies and are working to create new tools for training programs to deploy. CONCLUSIONS: It is our recommendation that (1) every training program develop a formal educational strategy for management training, (2) greater opportunity and visibility be afforded for peer-reviewed publications on management topics in mainstream pathology literature, and (3) pathology milestones-oriented tools be developed to assist program directors and their trainees in developing this necessary knowledge and skills.
Subject(s)
Pathology/education , Clinical Competence , Curriculum , Humans , Internship and Residency , Laboratories/organization & administration , Leadership , Pathology/organization & administration , Societies, Medical , United StatesABSTRACT
"High complexity" clinical laboratories are approved under the Clinical Laboratory Improvement Amendments to develop, validate, and offer a laboratory-developed test (LDT) for clinical use. The Food and Drug Administration considers LDTs to be medical devices under their regulatory jurisdiction, and that at least certain LDTs should be subject to greater regulatory scrutiny. This review describes the current regulatory framework for LDTs and suggests ways in which to appropriately enhance this framework.
Subject(s)
Clinical Laboratory Techniques , Medical Laboratory Science/legislation & jurisprudence , Quality Assurance, Health Care/legislation & jurisprudence , United States Food and Drug Administration , Humans , Pathology/legislation & jurisprudence , United StatesSubject(s)
Consensus , Curriculum , Laboratories/organization & administration , Pathology/education , HumansABSTRACT
Through the combined efforts of the American Pathology Foundation (APF), the American Society for Clinical Pathology (ASCP), and the Program Directors Section (PRODS) of the Association of Pathology Chairs (APC), a needs assessment was performed via a survey on the PRODS listserv, workshops at the APC/PRODS annual meetings in 2009 and 2010, and a Work Group of representatives of APF, ASCP, and PRODS. Residency program needs and resource constraints common to training pathology residents in practice and laboratory management were identified. In addition, a consensus curriculum for management training was created to serve as a resource for residency training program directors and others. The curriculum was converted into a "wiki" design tool for use by program directors, residents, and faculty.
Subject(s)
Consensus , Curriculum , Laboratories/organization & administration , Pathology/education , Humans , Internship and Residency , Pathology/organization & administrationSubject(s)
Cytomegalovirus Infections/etiology , Gastrointestinal Hemorrhage/virology , Heart Transplantation/adverse effects , Immunosuppressive Agents/adverse effects , Jejunal Neoplasms/virology , Lymphoma, Large B-Cell, Diffuse/virology , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Antiviral Agents/therapeutic use , Biopsy , Capsule Endoscopy , Cytomegalovirus Infections/drug therapy , Cytomegalovirus Infections/pathology , Fatal Outcome , Female , Gastrointestinal Hemorrhage/drug therapy , Gastrointestinal Hemorrhage/pathology , Humans , Jejunal Neoplasms/drug therapy , Jejunal Neoplasms/pathology , Lymphoma, Large B-Cell, Diffuse/drug therapy , Lymphoma, Large B-Cell, Diffuse/pathology , Middle Aged , Treatment OutcomeABSTRACT
Compensation for pathologist and clinical laboratory services generally depends upon standardized procedural coding systems, the coverage determinations of individual insurance companies, fee schedules that assign reimbursement rates for those services, and contractual compensation arrangements. Procedural coding relies primarily on the American Medical Association's Current Procedural Terminology (CPT) nomenclature. Disease conditions, signs, and symptoms are coded using the International Classification of Diseases, Ninth Revision, Clinical Modification. The single largest health insurance "company" in the United States is the Center for Medicare and Medicaid Services (CMS), and most private insurance companies look to CMS as a model for health services compensation. CMS uses a Physician Fee Schedule and a separate Clinical Laboratory Fee Schedule, whose designs and annual updates differ.
Subject(s)
Fees and Charges , Insurance Claim Reporting/economics , Insurance, Health, Reimbursement , Pathology, Clinical/economics , Practice Management, Medical/economics , Practice Management, Medical/organization & administration , Centers for Medicare and Medicaid Services, U.S. , Humans , Medicaid , Medicare , United StatesABSTRACT
Successful and ethical management of a clinical laboratory requires vigilant focus on proper business conduct. A comprehensive risk management program must encompass government standards as provided for financial and marketing practices, including fraud and abuse, antitrust, antikickback, privacy, and security. The program also must incorporate the appropriate reaction to medical malpractice litigation along with considerations of expert testimony.
Subject(s)
Guideline Adherence , Pathology, Clinical/organization & administration , Professional Practice/standards , Quality Assurance, Health Care , Risk Management/organization & administration , Ethics, Institutional , Humans , Malpractice , Professional MisconductABSTRACT
Several current forces have set anticipated future changes in health care in motion, or, at least, have set the stage for change. End-consumer demand increasingly drives the market; as a result, entire businesses are transforming or emerging anew to meet these demands. In general, consumers demand high quality at reasonable cost, to be delivered as fast as possible with minimal inconvenience. The health care consumer takes this expectation further, to include the desire for all helpful information regarding one's health to be made readily available for him/her to make the best decision and minimize morbidity, mortality, misdiagnosis, and inconvenience. This article addresses the impact upon the laboratory by considering four key interrelated dynamics that affect these trends: market, medicine, technology, and information systems.
Subject(s)
Clinical Laboratory Techniques/trends , Delivery of Health Care/trends , Medical Laboratory Science/trends , Pathology, Clinical/trends , Clinical Laboratory Techniques/economics , Delivery of Health Care/economics , Humans , Insurance, Health, Reimbursement , Medical Informatics , Medical Laboratory Science/economics , Pathology, Clinical/economicsABSTRACT
The business of medicine requires more than just the knowledge and skills necessary to provide quality patient care. A growing number of opportunities are available for physicians to learn how to better manage the business side of their practices. Today's clinical laboratories, particularly those in health care organizations under pressure to efficiently use limited resources, benefit from having management and leadership specifically trained for these roles.
Subject(s)
Commerce/education , Competency-Based Education/methods , Laboratories, Hospital/organization & administration , Pathology, Clinical/education , Pathology, Clinical/organization & administration , Efficiency, Organizational , Humans , Organization and Administration , WorkforceABSTRACT
CONTEXT: Laboratory data are essential to the medical care of fetuses, infants, children, and adolescents. However, the performance and interpretation of laboratory tests on specimens from these patients, which may constitute a significant component of the workload in general hospitals and integrated health care systems as well as specialized perinatal or pediatric centers, present unique challenges to the clinical pathologist and the laboratory. Therefore, pathology residents should receive training in pediatric laboratory medicine. OBJECTIVE: Children's Health Improvement through Laboratory Diagnostics, a group of pathologists and laboratory scientists with interest and expertise in pediatric laboratory medicine, convened a task force to develop a list of curriculum topics, key resources, and training experiences in pediatric laboratory medicine for trainees in anatomic and clinical pathology or straight clinical pathology residency programs and in pediatric pathology fellowship programs. DATA SOURCES: Based on the experiences of 11 training programs, we have compiled a comprehensive list of pediatric topics in the areas of clinical chemistry, endocrinology, hematology, urinalysis, coagulation medicine, transfusion medicine, immunology, microbiology and virology, biochemical genetics, cytogenetics and molecular diagnostics, point of care testing, and laboratory management. This report also includes recommendations for training experiences and a list of key texts and other resources in pediatric laboratory medicine. CONCLUSIONS: Clinical pathologists should be trained to meet the laboratory medicine needs of pediatric patients and to assist the clinicians caring for these patients with the selection and interpretation of laboratory studies. This review helps program directors tailor their curricula to more effectively provide this training.
Subject(s)
Curriculum , Internship and Residency , Pathology, Clinical/education , Pediatrics/education , Teaching , Child , Child Health Services , Child, Preschool , Humans , Medical Staff, HospitalABSTRACT
Clinical laboratories use reference laboratories for laboratory services that they, themselves, routinely are unable to provide, often for economic and/or competency-related reasons. Decisions on reference laboratory providers usually are based upon reputation, quality of service, depth of test menu, other value-added services, testing frequency and turnaround time, price, client services support, information technology support, and logistics. The referring laboratory also is faced with the challenge of how to manage physician ordering patterns and their requests for esoteric testing. This is particularly important and problematic in cases of questionable medical necessity, high cost, or both. This article attempts to address this dilemma and how best to manage the utilization of expensive esoteric tests, particularly in the face of little or no reimbursement for these services by payers and health plans.