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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.

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.

Patient safety and quality improvement initiatives are integral parts of every cytopathology laboratory. The need to re-visit 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. This interview with Dr. Yael Heher, Dr. Adam Seegmiller, and Dr. Paul VanderLaan explores recent developments that have shaped their perspectives in patient safety, test utilization, and lab quality. The practical strategies presented provide tools for enhanced patient safety and improved outcomes in a new era of ancillary/molecular testing and standardized reporting in the cytopathology laboratory.

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.

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.

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.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.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.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.

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.

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.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.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.To improve the value of care provided, pathology departments should conduct internal reviews and consider transitioning specimen types to gross-only when safe.

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.

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.

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.

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.

Pathologists and pathology laboratory personnel provide care for patients within increasingly complex healthcare delivery systems. Systems and infrastructure are imperfect, as are humans, and thus all types of diagnostic error are inevitable. Understanding root causes and systemic vulnerabilities is at the core of root cause analysis (RCA), as is improving patient safety. This chapter describes root cause analysis as a standardized tool for managing patient safety events within pathology and laboratory medicine. Specific techniques are covered including how to assemble an RCA team, using fishbone diagrams, cause maps, and process maps, as well as disseminating the results of a successful RCA. Benefits of successful RCA include improved safety culture, risk reduction for patient safety events, and workforce engagement.

Despite our best efforts to mitigate pathology error, harmful pathology error will inevitably occur. Disclosure of error to patients is encouraged and even mandated by regulatory bodies and advocacy groups. Many pathologists are interested in participating in disclosure of serious error but are ill-equipped to do so. Error disclosure by pathologists requires not only a better understanding of how errors occur in pathology, but the relationship between pathologists and treating clinicians in reducing error, and barriers pathologists’ face when disclosing error. This chapter examines the current state of error disclosure as it pertains to pathology and provides a practical guide for who, when, and how to disclose serious pathology error to patients. The authors discuss the rationale and principles behind effective disclosure. Related topics including the management of adverse events, barriers to disclosure, and additional resources for the implementation of disclosure programs in pathology are explored.

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.

Harmful error is an infrequent but serious challenge in the pathology laboratory. Regulatory bodies and advocacy groups have mandated and encouraged disclosure of error to patients. Many pathologists are interested in participating in disclosure of harmful error but are ill-equipped to do so. This review of the literature with recommendations examines the current state of the patient safety movement and error disclosure as it pertains to pathology and provides a practical and explicit guide for pathologists for who, when, and how to disclose harmful pathology error to patients. The authors provide a definition of harmful pathology error, and the rationale and principles behind effective disclosure are discussed. The changing culture of medicine and its effect on pathology is examined including the trend towards increasing transparency and patient engagement. Related topics are addressed including the management of expected adverse events, barriers to disclosure, and additional resources for the implementation of disclosure programs in pathology.

Objectives: Despite sweeping medical advances in other fields, histology processes have by and large remained constant over the past 175 years. Patient label identification errors are a known liability in the laboratory and can be devastating, resulting in incorrect diagnoses and inappropriate treatment. The objective of this study was to identify vulnerable steps in the histology workflow and reduce the frequency of labeling errors (LEs). Methods: In this 36-month study period, a numerical step key (SK) was developed to capture LEs. The two most prevalent root causes were targeted for Lean workflow redesign: manual slide printing and microtome cutting. The numbers and rates of LEs before and after interventions were compared to evaluate the effectiveness of interventions. Results: Following the adoption of a barcode-enabled laboratory information system, the error rate decreased from a baseline of 1.03% (794 errors in 76,958 cases) to 0.28% (107 errors in 37,880 cases). After the implementation of an innovative ice tool box, allowing single-piece workflow for histology microtome cutting, the rate came down to 0.22% (119 errors in 54,342 cases). Conclusions: The study pointed out the importance of tracking and understanding LEs by using a simple numerical SK and quantified the effectiveness of two customized Lean interventions. Overall, a 78.64% reduction in LEs and a 35.28% reduction in time spent on rework have been observed since the study began.

Background The pneumatic tube delivery system (PTDS) has been an integral part of blood bank (BB) operations at our institution ever since its implementation in the early 2000s. Its reliable performance is essential for rapid and accurate delivery of blood products, impacting patient safety and product integrity. However, malfunctioning operational events are not uncommon given PTDS complexity and hospital-wide utilization. In 2018, 33 of 285 (12%) blood products were wasted due to PTDS events at our institution. Here we review the root cause analysis (RCA) of a patient safety event involving delayed transfusions and a wasted blood product causing temporary harm to two patients. Methods Two patients, both hospitalized on the same floor, simultaneously experienced significant delays in red blood cell (RBC) transfusions. One patient with active bleeding experienced a 2-hour delay and another patient with anemia experienced a 50-minute delay before appropriate transfusion occurred. The two patients did not receive their transfusions until their nurses physically retrieved RBC units from the BB. An incident report was filed by a floor nurse, which prompted a RCA involving the laboratory quality and patient safety team, the BB, the hospital maintenance department overseeing the PTDS, and the information systems service controlling programming of the PTDS. Results Operational challenges surrounding the PTDS were central to the multiple root causes identified (see Table). RBC units sent to the floor from the BB were electronically directed to another floor or returned to the BB, which resulted in a waste of one RBC unit. Despite multiple potential contributing factors identified, deeper investigation did not uncover evidence for any specific root cause and the electronic tube transaction history showed normal PTDS operations during the time of the incident, with all transactions appearing as successfully completed within expected timeframes. Neither of the patients involved in this safety event experienced permanent harm. The findings of this investigation were reviewed at our departmental Pathology Morbidity and Mortality conference together with stakeholders from hospital maintenance. Conclusion The root causes for PTDS technical malfunctioning leading to this safety event remain uncertain despite a collaborative RCA. This multidisciplinary retrospective RCA process, however, provided an opportunity for greater awareness of the complex mechanism of the PTDS, promoted awareness of the roles of the various stakeholders involved, and fostered interdepartmental collaboration to prevent future patient safety incidents using quality improvement principles. Table Disclosures No relevant conflicts of interest to declare.

Molecular testing to identify targetable driver mutations is the standard of care for patients with advanced-stage non-small cell lung cancer. Recent guideline recommendations by the College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) established a benchmark turnaround time (TAT) target of 10 working days for results to be available to the treating oncologist and ≤ 3 days for specimens to arrive at a commercial testing laboratory if testing is not performed in-house.To provide insights regarding the pre-testing, post-testing, and testing intervals that constitute the overall TAT target, we performed a detailed workflow analysis. A total of 157 lung cancer specimens were sent out for molecular testing at a commercial vendor from a single academic medical center during the calendar year 2015.Overall, 128 specimens (81.5%) met the recommended 10-working day TAT, with a median total TAT of 9 weekdays (mean ± standard deviation, 9.17 ± 4.15 days). The pre-testing interval was ≤ 3 days for 146 specimens (93.0%), and the post-testing reporting interval was 1 day for 116 cases (73.9%). The TAT variance was not related to intrinsic specimen characteristics.Overall, the findings indicated that the CAP/IASLC/AMP TAT guideline recommendations are feasible for most lung cancer specimens when a streamlined system is in place.