The next phase in patient safety education: Towards a standardized, tools-based pathology patient safety curriculum: A call to action from the Association of Pathology Chairs' Residency Program Directors Section Training Residents in Patient Safety Workgroup.

Patient safety education is a mandated Common Program Requirement of the Accreditation Council for Graduate Medical Education and for the Royal College of Physicians and Surgeons of Canada in all medical residency and fellowship programs. Although many hospitals and healthcare environments have general patient safety education tools for trainees, few to none focus on the unique training milieu of pathologists, including a mix of highly automated and manual error-prone processes, frequent multiplicity of events, and lack of direct patient relationships for error disclosure. We established a national Association of Pathology Chairs-Program Directors Section Workgroup focused on patient safety education for pathology trainees entitled Training Residents in Patient Safety (TRIPS). TRIPS included diverse representatives from across the United States, as well as representatives from pathology organizations including the American Board of Pathology, the American Society for Clinical Pathology, the United States and Canadian Academy of Pathology, the College of American Pathologists, and the Society to Improve Diagnosis in Medicine. Objectives of the workgroup included developing a standardized patient safety curriculum, designing teaching and assessment tools, and refining them with pilot sites. Here we report the establishment of TRIPS as well as data from national needs assessment of Program Directors across the country, who confirmed the need for a standardized patient safety curriculum.

Erroneous Patient Tissue Contaminants in 1574 Surgical Pathology Slides: Impact on Diagnostic Error and a Novel Framework for Floater Management.

CONTEXT.­: Tissue contaminants on histology slides represent a serious risk of diagnostic error. Despite their pervasive presence, published peer-reviewed criteria defining contaminants are lacking. The absence of a standardized diagnostic workup algorithm for contaminants contributes to variation in management, including investigation and reporting by pathologists. OBJECTIVE.­: To study the frequency and type of tissue contaminants on microscopic slides using standardized criteria. Using these data, we propose a taxonomy and algorithm for pathologists on "floater" management, including identification, workup, and reporting, with an eye on patient safety. DESIGN.­: A retrospective study arm of 1574 histologic glass slides as well as a prospective study arm of 50 slide contamination events was performed. Using these data we propose a structured classification taxonomy and guidelines for the workup and resolution of tissue contamination events. RESULTS.­: In the retrospective arm of the study, we identified reasonably sized benign tissue contaminants on 52 of 1574 slides (3.3%). We found size to be an important parameter for evaluation, among other visual features including location on the slide, folding, ink, and tissue of origin. The prospective arm of the study suggested that overall, pathologists tend to use similar features when determining management of potentially actionable contaminants. We also report successfully used case-based ancillary testing strategies, including fluorescence in situ hybridization analysis of chromosomes and DNA fingerprinting. CONCLUSIONS.­: Tissue contamination events are underreported and represent a patient safety risk. Use of a reproducible classification taxonomy and a standardized algorithm for contaminant workup, management, and reporting may aid pathologists in understanding and reducing risk.

Diagnostic quality model (DQM): an integrated framework for the assessment of diagnostic quality when using AI/ML.

BACKGROUND: Laboratory medicine has reached the era where promises of artificial intelligence and machine learning (AI/ML) seem palpable. Currently, the primary responsibility for risk-benefit assessment in clinical practice resides with the medical director. Unfortunately, there is no tool or concept that enables diagnostic quality assessment for the various potential AI/ML applications. Specifically, we noted that an operational definition of laboratory diagnostic quality - for the specific purpose of assessing AI/ML improvements - is currently missing. METHODS: A session at the 3rd Strategic Conference of the European Federation of Laboratory Medicine in 2022 on "AI in the Laboratory of the Future" prompted an expert roundtable discussion. Here we present a conceptual diagnostic quality framework for the specific purpose of assessing AI/ML implementations. RESULTS: The presented framework is termed diagnostic quality model (DQM) and distinguishes AI/ML improvements at the test, procedure, laboratory, or healthcare ecosystem level. The operational definition illustrates the nested relationship among these levels. The model can help to define relevant objectives for implementation and how levels come together to form coherent diagnostics. The affected levels are referred to as scope and we provide a rubric to quantify AI/ML improvements while complying with existing, mandated regulatory standards. We present 4 relevant clinical scenarios including multi-modal diagnostics and compare the model to existing quality management systems. CONCLUSIONS: A diagnostic quality model is essential to navigate the complexities of clinical AI/ML implementations. The presented diagnostic quality framework can help to specify and communicate the key implications of AI/ML solutions in laboratory diagnostics.

Patient-facing communication for cytopathologists: A framework for disclosing diagnostic error.

Medical errors are a major source of harm to patients. Regulatory bodies mandate and patient safety experts advocate the disclosure of medical errors to patients to promote transparency and to create accountability for improving health care processes. Although pathologists regularly report errors-either to pathology or clinical colleagues or via internal safety reporting systems-few pathologists directly disclose those errors to patients. Yet many pathologists are interested in participating in the direct disclosure of medical errors to patients and may even be mandated to do so. When surveyed on why they do not directly disclose errors to patients, pathologists commonly cite a lack of confidence and a lack of training. Another barrier cited is the lack of a preexisting relationship between the pathologist and the patient. With respect to this last barrier, cytopathologists have a distinct advantage over surgical or clinical pathologists, as many cytopathologists regularly interact with and develop a rapport with patients when they are performing fine-needle aspiration (FNA) procedures. To improve the safety culture in pathology, direct error disclosure practices must be developed, supported, and strengthened. It is critical for cytopathologists to be comfortable with disclosing errors to patients. Being comfortable with disclosing an error, however, requires training, practice, and advance reflection. Using a practical, case-based format centered around FNA examples, this article addresses how to disclose a medical error to a patient. It provides a framework, heuristic principles, and structured conversation systems and talking points to guide the inexperienced pathologist to find his or her voice in a challenging disclosure conversation.

Pathology trainees rarely report safety incidents: A review of 13,722 safety reports and a call to action.

Reporting and understanding patient safety incidents is a cornerstone of improving patient care quality and safety. The Accreditation Council for Graduate Medical Education specifically mandates that physician trainee education include participation in the recognition, reporting, and root cause analysis of patient safety incidents. Studies on safety event reporting, however, have consistently shown that attending physicians submit few safety reports, and trainees submit even fewer. We undertook a study to assess the rate at which pathology trainees report patient safety events relative to the rates at which trainees in other medical specialties do. We performed a retrospective analysis of 13,722 safety reports submitted to our medium-sized Academic Medical Center's incident reporting system. We then analyzed those reported by trainees (residents and fellows), and then further drilled down on the subset of trainee-reported safety events reported by pathology trainees. Despite accounting for over 5% of all types of trainees at the enterprise level, pathology trainees accounted for only 0.5% of all trainee safety reports. Our findings represent a call to action for pathology training programs to engage their residents and fellows in quality and safety initiatives, to understand and remove barriers to safety event reporting for vulnerable populations such as trainees, and to empower trainees to confidently report safety risks as valued frontline care providers.

Towards high reliability in national pathology education: Evaluating the United States and Canadian Academy of Pathology educational product.

The United States and Canadian Academy of Pathology (USCAP) leadership undertook a high level, global review of educational product outcomes data using high reliability organization (HRO) principles: preoccupation with failure; reluctance to simplify; sensitivity to operations; commitment to resilience; and deference to expertise. HRO principles have long been applied to fields such as aviation, nuclear power, and more recently to healthcare, yet they are rarely applied to the field that underpins these-and many other-complex systems: education. While errors in education are less calamitous than in air travel or healthcare delivery, USCAP's educational products impact over 15,000 learners a year, and thus have important implications for the future practice of pathology. Here we report USCAP's experiences using HRO principles to evaluate our keystone educational product, the "USCAP Short Course." Following this novel method of data review, USCAP leadership was able to better understand diverse learner needs based on practice venue, training level, and course topic. Unexpected lessons included the identification of specifically challenging educational topics, such as molecular pathology, and a need to focus more resources on emerging fields such as quality and patient safety. The results allow USCAP to assess educational product performance using HRO tools, and provide strong data-driven decision support for future national pathology education strategy.

Prioritizing Patient Safety and Minimizing Waste: Institutional Review of Cases and a Proposed Process for Designing a Surgical Pathology Gross-Only Examination Policy.

OBJECTIVES: Gross-only examination policies vary widely across pathology departments. Several studies-particularly a College of American Pathologists' Q-Probes study-have looked at the variations in gross-only policies, and even more studies have addressed the (in)appropriateness of certain specimen types for gross-only examination. Few, if any, studies have tackled the important task of how to revise and safely implement a new gross-only examination protocol, especially in collaboration with clinical colleagues. METHODS: We reviewed the grossing protocols from three anatomic pathology centers to identify common gross-only specimen types. We compiled an inclusive list of any specimen types that appeared on one or more centers' lists. We performed a retrospective review of the gross and microscopic diagnoses for those specimen types to determine if any diagnoses of significance would have been missed had that specimen been processed as a gross-only. RESULTS: We reviewed 940 cases among 13 specimen types. For 7 specimen types, the gross diagnoses provided equivalent information to the microscopic diagnoses. For 6 specimen types, microscopic diagnoses provided clinically meaningful information beyond what was captured in the gross diagnoses. CONCLUSIONS: To improve the value of care provided, pathology departments should conduct internal reviews and consider transitioning specimen types to gross-only when safe.

The value of monitoring amended reports in cytopathology quality programs: A biennial review.

BACKGROUND: Quality and safety are the foundation of the practice of cytopathology. Review of key performance indicator (KPI) data can shine a light on laboratory vulnerabilities and potential areas for targeted improvement. The rate and content of amendment reports is a frequently monitored KPI in anatomic pathology, but few have studied its value in cytopathology. The goal of this study was to examine the frequency, classification, and outcome of amendments for a large cytopathology laboratory. METHODS: All amendment reports issued for cases during a 2-year period from July 2019 to June 2021 were included in the study. Amendments were classified into three error type root causes: Specimen Identification Error, General Report Defects, and Diagnostic Error. RESULTS: A total of 202 amendment reports were issued equating to a rate of 0.275%. A total of 83 (41.1%) were gynecologic cases and 119 (58.9%) were nongynecologic cases. Within the gynecologic cases, 13 (15.7%) cases were due to Specimen Identification Error, 13 (15.7%) cases were due to Diagnostic Error, and 57 (68.7%) cases were due to General Report Defects. Within the nongynecologic cases, 15 (12.6%) cases were due to Specimen Identification Error, 30 (25.2%) cases were due to General Report Defects, and 74 (62.2%) cases were due to Diagnostic Error with 32 of these due to true diagnostic change. Discovery methods included following re-review after additional clinical information was provided, reinterpretation after additional ancillary testing was performed, or conference review. There was no correlation with years in practice. CONCLUSIONS: Studying amendment reports is an underrecognized and valuable quality assurance tool. Amendments can help provide information about types of errors, monitor laboratory processes, and help guide quality improvement endeavors.

All in for patient safety: a team approach to quality improvement in our laboratories.

Patient safety and quality improvement initiatives are integral parts of every cytopathology laboratory. The need to revisit our approaches to patient safety are essential in light of the expanding test menu, ancillary studies, comprehensive diagnostic reports, and emergence of new technologies for augmenting cytologic diagnosis. Our interview with Drs. Yael Heher, Adam Seegmiller, and Paul VanderLaan explores recent developments that have shaped their perspectives in patient safety, test usage, and laboratory quality. The practical strategies presented provide tools for enhanced patient safety and improved outcomes in a new era of ancillary and molecular testing and standardized reporting in the cytopathology laboratory.

Case report: Successful simultaneous heart-kidney transplantation across a positive complement-dependent cytotoxic crossmatch.

Preformed donor-specific antibodies are associated with a higher risk of rejection and worse graft survival in organ transplantation. However, in heart transplantation, the risk and benefit balance between high mortality on the waiting list and graft survival may allow the acceptance of higher immunologic risk donors in broadly sensitized recipients. Transplanting donor-recipient pairs with a positive complement dependent cytotoxic (CDC) crossmatch carries the highest risk of hyperacute rejection and immediate graft loss and is usually avoided in kidney transplantation. Herein we report the first successful simultaneous heart-kidney transplant with a T- and B-cell CDC crossmatch positive donor using a combination of rituximab, intravenous immunoglobulin, plasmapheresis, bortezomib and rabbit anti-thymocyte globulin induction followed by eculizumab therapy for two months post-transplant. In the year following transplantation, both allografts maintained stable graft function (all echocardiographic left ventricular ejection fractions ≥ 65%, eGFR>60) and showed no histologic evidence of antibody-mediated rejection. In addition, the patient has not developed any severe infections including cytomegalovirus or BK virus infection. In conclusion, a multitarget immunosuppressive regimen can allow for combined heart/kidney transplantation across positive CDC crossmatches without evidence of antibody-mediated rejection or significant infection. Longer follow-up will be needed to further support this conclusion.

Something's Lost and Something's Gained: Seeing Reference Laboratory Quality from Both Sides, Now.

Growing regulatory burdens, payment model changes, and increased complexity in laboratory medicine have contributed to an increased reliance on reference laboratories. Although reference laboratories often offer rapid, low cost, high quality testing, outsourcing laboratory tests can create quality and patient safety vulnerabilities particularly in the pre-analytic and post-analytic phases of the test cycle. Disconnects in governance, policy, and information technology between the reference laboratory and the referring provider conspire to increase risk. Laboratory leaders seeking to reduce risk and improve quality must ensure clear and collaborative oversight, monitor meaningful quality metrics, and integrate feedback from ordering providers.

Frozen-Section Checklist Implementation Improves Quality and Patient Safety.

OBJECTIVES: An intraoperative consultation (IOC) checklist was developed and implemented aimed at standardizing slide labeling and monitoring metrics central to quality and safety in surgical pathology. DESIGN: Data were collected for all IOC cases over a 9-month period. Slide labeling defect rates and IOC turnaround time (TAT) were recorded and compared for the pre- and postimplementation periods. RESULTS: In total, 839 IOC cases were analyzed. Preintervention slide labeling showed that 85% of cases contained at least one defect (n = 565). Postintervention data revealed that 27% of cases contained at least one defect (n = 274). The improvement was statistically significant (P < .001). Mean TAT was 21.6 minutes preintervention vs 23.2 minutes postintervention, and the change was insignificant (P = .071). CONCLUSIONS: The implementation of a standardized IOC reduced slide labeling error. This improvement did not affect mean TAT and may have the increased quality of IOC TAT data reporting. Other metrics affecting patient safety and quality were monitored and standardized.

Pre-analytic error: A significant patient safety risk.

Ancillary testing in cytopathology has grown dramatically over the past decade, enhancing the clinical value of cytology specimens obtained via minimally invasive methods. However, a complex testing landscape brings with it new and emerging risks to patient safety. Recognition of complicated systems issues as well as shared responsibility in process ownership can help to minimize safety risks. Because pre-analytic factors account for the majority of errors in pathology, attention to operational steps (test ordering, specimen collection, specimen transport, specimen accessioning, and specimen processing) is critical for successful quality improvement programs. With increasing technical costs and complexity of many ancillary molecular tests, a growing trend toward send-out testing to centralized reference laboratories poses additional patient safety risks. Given these new realities in cytopathology ancillary testing, a collaborative, team-based approach with all process stakeholders is needed to improve pre-analytic processes, reduce error risk, and enhance patient safety.