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Although rapid prescreening (RPS) has been shown to be an effective quality control procedure for detecting false-negative conventional Papanicolaou (Pap) tests, RPS has not been widely implemented in he United States. In our laboratory, cytotechnologists performed RPS in 3,567 liquid-based Pap tests: 1,911 SurePath (BD Diagnostics-TriPath, Burlington, NC) preparations that were manually screened and 1,656 ThinPrep Pap tests (Hologic, Bedford, MA) hat were imaged using the ThinPrep Imaging System (Hologic). We compared the sensitivity of RPS, 10% rescreening (R-10%), and routine screening (RS). In contrast with previously published findings, we found hat RS + RPS did not improve screening sensitivity compared with RS + R-10%. These results support the ollowing hypotheses: (1) Higher baseline RS sensitivity as a result of Pap test diagnoses standardization mplemented for quality improvement purposes decreases the performance impact of RPS. (2) R-10% and RPS quality assurance methods detect diagnostic ailures caused by different types of cognitive errors. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To determine if the implementation of Lean methods resulted in improved Pap test quality and diagnostic accuracy in 5 clinician practices. MATERIALS AND METHODS: We performed a 1-year case-control study that included 5,384 control (preintervention) and 5,442 case (postintervention) women who had a Pap test procured by 1 of 5 clinicians. Using Lean methods, the clinicians increased their focus of Pap test procurement by creating a 'one-by-one' workflow and recorded process completion using a Lean checklist. We compared the case and control Pap test quality and accuracy measures using the proportion of Pap tests lacking a transformation zone component, proportion of unsatisfactory Pap tests, frequency of newly detected cervical intraepithelial neoplasia following a previous benign Pap test, and proportion of Pap tests with a diagnosis of atypical squamous cells of unknown significance. RESULTS: After the intervention, there was a statistically significant decrease in the mean proportion of Pap tests lacking a transformation zone component, p =.011. Two of 5 clinicians showed a statistically significant decrease in their unsatisfactory Pap test frequency, although the overall Pap test unsatisfactory frequency for the case group was not statistically significant lower, p =.087. The case group showed a 114% increase in newly detected cervical intraepithelial neoplasia following a previous benign Pap test, p =.004. There was no statistically significant difference for the proportion of Pap tests with a diagnosis of atypical squamous cells of unknown significance, p =.908. CONCLUSIONS: Disseminating Lean methods across a group of clinicians resulted in improved Pap test quality and diagnostic accuracy. [ABSTRACT FROM AUTHOR]

Papanicolaou screening is feasible anywhere that screening for cervical cancer, the leading cause of cancer-related death among women in developing countries, is appropriate. After documenting that the Vietnam War had contributed to the problem of cervical cancer in Vietnam, we participated in a grassroots effort to establish a nationwide cervical cancer prevention program in that country and performed root cause analyses of program deficiencies.We found that real-world obstacles to successful cervical cancer prevention in developing countries involve people far more than technology and that such obstacles can be appropriately managed through a systems approach focused on programmatic quality rather than through ideological commitments to technology. A focus on quality satisfies public health goals, whereas a focus on technology is compatible with market forces. [ABSTRACT FROM AUTHOR]

OBJECTIVE. The prevalence of thyroid nodularity in children has been estimated to be 1.8%. The reported prevalence of specific diseases which comprise these nodules is conflicting as evidenced by a reported range of malignancy of 2 to 50% in solitary nodules. In order to better classify pediatric (< 18 years old) thyroid disease and evaluate the utility of fine needle aspiration biopsy (FNAB) in this patient population, we retrospectively reviewed 66 FNABs from 64 thyroid nodules and 2 perithyroid lymph nodes from 57 patients. METHODOLOGY. Patients: The study was composed of 8 males and 49 females who ranged in age from 1 to 18 years old (mean = 13.1). Design: Surgical and/or clinical follow-up was obtained in all patients. The 66 FNAB diagnoses were initially classified into specific diseases. However, for the purpose of this review, the cases were classified as: 3 insufficient, 51 benign, 8 suspicious, and 4 malignant. RESULTS. There were no 'false positives' and one 'false negative' (a papillary carcinoma was misdiagnosed as a benign nodule). Overall, 10 patients (18%) had malignant thyroid lesions, including 8 papillary carcinomas and 2 follicular carcinomas. Benign diagnoses included benign nodule, cyst, lymphocytic thyroiditis, granulomatous thyroiditis, hyperplasia, and abscess. CONCLUSIONS. The prevalence of malignancy in pediatric patients with thyroid nodules was 18%. We conclude that, because of its high diagnostic accuracy and minimal invasiveness, FNAB is useful in the management of pediatric thyroid nodules. [ABSTRACT FROM AUTHOR]

Objective: To determine the effectiveness of using glacial acetic acid (GAA) to convert unsatisfactory bloody ThinPrep (TP) cervical smear test to satisfactory, and identify associated missed diagnoses and high-risk HPV (hrHPV) genotypes., Methods: In a retrospective descriptive cross-sectional analysis, all TP tests performed in Mississippi, USA, 2012-2016, were evaluated for unsatisfactory results owing to blood. Tests that were converted to satisfactory by GAA treatment, and corresponding anomalies and HPV genotypes were identified., Results: Among 106 384 TP tests, there were 1460 (1.37%) unsatisfactory results, of which 1442 (98.77%) were converted to satisfactory after GAA treatment. Laboratory preprocessing with GAA increased costs minimally. Precancerous lesions were detected in 166 (11.51%) of 1442 GAA-treated samples, of which 12 (7.2%) were high-grade lesions, 110 (66.3%) were atypical squamous cells of undetermined significance, and 63 (57.3%) tested positive for hrHPV. Of 60 genotyped samples, 39 (65%) had non-HPV16 and non-HPV18. Including mixed infections, 48 (80%) contained less-common hrHPV types, reflecting an unexpected distribution in bloody specimens., Conclusions: GAA pretreatment of bloody TP tests would reduce the incidence of unsatisfactory results and missed high-grade lesions, and prevent the cost of repeat tests and delayed treatment. Clinicians without access to GAA should consider HPV testing., (© 2018 International Federation of Gynecology and Obstetrics.)

Context: Additional reviews of diagnostic surgical and cytology cases have been shown to detect diagnostic discrepancies., Objective: To develop, through a systematic review of the literature, recommendations for the review of pathology cases to detect or prevent interpretive diagnostic errors., Design: The College of American Pathologists Pathology and Laboratory Quality Center in association with the Association of Directors of Anatomic and Surgical Pathology convened an expert panel to develop an evidence-based guideline to help define the role of case reviews in surgical pathology and cytology. A literature search was conducted to gather data on the review of cases in surgical pathology and cytology., Results: The panel drafted 5 recommendations, with strong agreement from open comment period participants ranging from 87% to 93%. The recommendations are: (1) anatomic pathologists should develop procedures for the review of selected pathology cases to detect disagreements and potential interpretive errors; (2) anatomic pathologists should perform case reviews in a timely manner to avoid having a negative impact on patient care; (3) anatomic pathologists should have documented case review procedures that are relevant to their practice setting; (4) anatomic pathologists should continuously monitor and document the results of case reviews; and (5) if pathology case reviews show poor agreement within a defined case type, anatomic pathologists should take steps to improve agreement., Conclusions: Evidence exists that case reviews detect errors; therefore, the expert panel recommends that anatomic pathologists develop procedures for the review of pathology cases to detect disagreements and potential interpretive errors, in order to improve the quality of patient care.

Background: The majority of errors in laboratory medicine testing are thought to occur in the pre- and postanalytic testing phases, and a large proportion of these errors are secondary to failed handoffs. Because most laboratory tests originate in ambulatory primary care, understanding the gaps in handoff processes within and between laboratories and practices is imperative for patient safety. Therefore, the purpose of this study was to understand, based on information from primary care practice personnel, the perceived gaps in laboratory processes as a precursor to initiating process improvement activities., Design: A survey was used to assess perceptions of clinicians, staff, and management personnel of gaps in handoffs between primary care practices and laboratories working in 21 Colorado primary care practices. Data were analyzed to determine statistically significant associations between categorical variables. In addition, qualitative analysis of responses to open-ended survey questions was conducted., Results: Primary care practices consistently reported challenges and a desire/need to improve their efforts to systematically track laboratory test status, confirm receipt of laboratory results, and report results to patients. Automated tracking systems existed in roughly 61% of practices, and all but one of those had electronic health record-based tracking systems in place. One fourth of these electronic health record-enabled practices expressed sufficient mistrust in these systems to warrant the concurrent operation of an article-based tracking system as backup. Practices also reported 12 different procedures used to notify patients of test results, varying by test result type., Conclusion: The results highlight the lack of standardization and definition of roles in handoffs in primary care laboratory practices for test ordering, monitoring, and receiving and reporting test results. Results also identify high-priority gaps in processes and the perceptions by practice personnel that practice improvement in these areas is needed. Commonalities in these areas warrant the development and support of tools for use in primary care settings., (© Copyright 2014 by the American Board of Family Medicine.)

Background: Clinical management of thyroid neoplasms is based on light microscopic diagnosis, but its accuracy and precision are poorly defined., Objective: To assess inter- and intraobserver variability of preoperative cytopathologic and postoperative histopathologic thyroid diagnoses., Design: Samples were collected in a prospective, multicenter trial validating a gene expression classifier between June 2009 and December 2010., Setting: 14 academic and 35 community clinical sites., Patients: 653 patients with 776 surgically resected thyroid nodules of 1 cm or greater., Measurements: Intraobserver concordance among 2 or more central histopathologists who independently read histopathology slides was calculated. Interobserver concordance between the diagnoses made by the central histopathologists and those made by local pathologists were calculated. Intra- and interobserver concordance for cytopathology was similarly calculated by comparing diagnoses made by local pathologists with those made by a central panel of 3 cytopathologists., Results: Concordance on the histopathologic distinction between benign and malignant diagnoses was 91% comparing local with central histopathologists and 90% comparing 2 central histopathologists. Using the 6-category Bethesda System, 64.0% of diagnoses made by local and central cytopathologists and 74.7% of intraobserver diagnoses were concordant. Central cytopathologists made fewer indeterminate diagnoses than local pathologists (41.2% vs. 55.0%)., Limitations: Many local pathologists did not use the Bethesda System, so their reports were translated to allow comparison. The study required histopathology, and the study population and specimens did not encompass all newly evaluated patients with a thyroid nodule., Conclusion: Substantial inter- and intraobserver variability exists in the cytopathologic and histopathologic evaluation of thyroid nodules, confirming an inherent limitation of visual microscopic diagnosis., Primary Funding Source: Veracyte.

The media, medical legal, and safety science perspectives of a laboratory medical error differ and assign variable levels of responsibility on individuals and systems. We examine how the media identifies, communicates, and interprets information related to anatomic pathology breast diagnostic errors compared to groups using a safety science Lean-based quality improvement perspective. The media approach focuses on the outcome of error from the patient perspective and some errors have catastrophic consequences. The medical safety science perspective does not ignore the importance of patient outcome, but focuses on causes including the active events and latent factors that contribute to the error. Lean improvement methods deconstruct work into individual steps consisting of tasks, communications, and flow in order to understand the affect of system design on current state levels of quality. In the Lean model, system redesign to reduce errors depends on front-line staff knowledge and engagement to change the components of active work to develop best practices. In addition, Lean improvement methods require organizational and environmental alignment with the front-line change in order to improve the latent conditions affecting components such as regulation, education, and safety culture. Although we examine instances of laboratory error for a specific test in surgical pathology, the same model of change applies to all areas of the laboratory., (Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To prospectively evaluate a new non invasive device that combines fluorescence and reflectance spectroscopy in a population in women at risk for cervical dysplasia., Methods: A total of 1607 women were evaluated with multimodal hyperspectroscopy (MHS), a painless test with extremely high spectral resolution. Subjects who were referred to colposcopy based on abnormal screening tests or other referral criteria underwent the MHS test and also had a sample taken for additional cytology and presence of high risk human papilloma virus (HPV) prior to undergoing biopsy., Results: Sensitivity of MHS for cervical intraepithelial neoplasia (CIN) 2+ was 91.3% (252/276). Specificity, or the potential reduction in referrals to colposcopy and biopsy, was 38.9% (222/570) for women with normal or benign histology and 30.3% (182/601) for women with CIN1 histology. Two year follow-up data, collected for a subgroup of 804 women, revealed 67 interval CIN2+ that originally were diagnosed at enrollment as normal or CIN1. MHS identified 60 of these (89.6%) as positive for CIN2+ prior to their discovery during the two year follow-up period., Conclusions: MHS provides an immediate result at the point of care. Recently, the limitations of cytology have become more obvious and as a consequence greater emphasis is being placed on HPV testing for cervical cancer screening, creating a need for an inexpensive, convenient and accurate test to reduce false positive referrals to colposcopy and increase the yield of CIN2+ at biopsy. MHS appears to have many of the attributes necessary for such an application., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Context: Growing evidence has demonstrated a high frequency of quality gaps in laboratory medicine, with recent studies estimating that 15% to 54% of primary care medical errors reported by primary care physicians and staff are related to the testing process. However, there is lack of evidence-based performance metrics in the preanalytic and postanalytic phases of the testing pathway for primary care practices., Objective: To use results of the literature review to assist in the development of quality indicators that could improve preanalytic and postanalytic processes in primary care-based laboratory medicine., Data Sources: Literature in Ovid/MEDLINE from 2001 through 2011 was searched as a primary source of information. Ninety-five peer-reviewed and non-peer-reviewed publications were retrieved following title and abstract review and 10 articles were reviewed in their entirety by the authors. A systematic review of the literature was conducted regarding the connections between clinical laboratories and primary care offices and the resulting errors. Root causes of errors were categorized into 7 major themes: process failures, delays, communication gaps, errors in judgment and cognition, influence of minorities/language, practice culture, and lack of patient centeredness. Selected articles were evaluated for evidence quality using the Systematic Evidence Review and Evaluation Methods for Quality Improvement grading scale developed by the Centers for Disease Control and Prevention., Conclusions: The focused literature review documented 7 key error themes in the laboratory medicine/primary care testing process. Performance metrics related to these themes are proposed that deserve future study for evidence-based improvement.

Objectives: This is the first systematic review of the effectiveness of barcoding practices for reducing patient specimen and laboratory testing identification errors., Design and Methods: The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used., Results: A total of 17 observational studies reporting on barcoding systems are included in the body of evidence; 10 for patient specimens and 7 for point-of-care testing. All 17 studies favored barcoding, with meta-analysis mean odds ratios for barcoding systems of 4.39 (95% CI: 3.05-6.32) and for point-of-care testing of 5.93 (95% CI: 5.28-6.67)., Conclusions: Barcoding is effective for reducing patient specimen and laboratory testing identification errors in diverse hospital settings and is recommended as an evidence-based "best practice." The overall strength of evidence rating is high and the effect size rating is substantial. Unpublished studies made an important contribution comprising almost half of the body of evidence., (Copyright © 2012 The Canadian Society of Clinical Chemists. All rights reserved.)

Second pathologist peer review is used in many surgical laboratory quality-assurance programs to detect error. Directed peer review is 1 method of second review and involves the selection of specific case types, such as cases from a particular site of anatomic origin. The benefits of using the directed peer review method are unique and directed peer review detects both errors in diagnostic accuracy and precision and this detection may be used to improve practice. We utilize the Lean quality improvement A3 method of problem solving to investigate these issues. The A3 method defines surgical pathology diagnostic error and describes the current state in surgical pathology, performs root cause analysis, hypothesizes an ideal state, and provides opportunities for improvement in error reduction. Published data indicate that directed peer review practices may be used to prevent active cognitive errors that lead to patient harm. Pathologists also may use directed peer review data to target latent factors that contribute to error and improve diagnostic precision.

Few reports have documented the effectiveness of Lean quality improvement in changing anatomic pathology patient safety. We used Lean methods of education; hoshin kanri goal setting and culture change; kaizen events; observation of work activities, hand-offs, and pathways; A3-problem solving, metric development, and measurement; and frontline work redesign in the accessioning and gross examination areas of an anatomic pathology laboratory. We compared the pre- and post-Lean implementation proportion of near-miss events and changes made in specific work processes. In the implementation phase, we documented 29 individual A3-root cause analyses. The pre- and postimplementation proportions of process- and operator-dependent near-miss events were 5.5 and 1.8 (P < .002) and 0.6 and 0.6, respectively. We conclude that through culture change and implementation of specific work process changes, Lean implementation may improve pathology patient safety.

Unlabelled: In 1996, we documented that the burden of cervical cancer in Vietnam was associated with troop movements during the Vietnam War. Subsequently, establishment of Papanicolaou screening in southern Vietnam was associated with reductions in cervical cancer incidence from 29.2/100,000 in 1998 to 16/100,000 in 2003. This is one of the first English-language reports of a real-world cervical cancer prevention effort associated with a decisive impact on health outcomes in a contemporary developing country., Lessons Learned: if our ideological commitment is to improve health outcomes as rapidly as possible among as many people as possible, then Papanicolaou screening (with or without HPV or visual screening) must be implemented without further delay in any setting where cervical screening is appropriate but unavailable; consideration must be given to HPV vaccination after, rather than before, full coverage of target demographic groups by screening services has been achieved and/or the possibility has been excluded that HPV vaccination may be ineffective for cancer prevention. Competing ideological commitments engender imprudent yet commercially useful alternative strategies prone to decelerate global reductions in mortality by suppressing the more-rapid uptake of less-expensive open-source technology in favor of the less-rapid uptake of more-expensive proprietary technologies with uncertain real-world advantages and unfavorable real-world operational limitations. Global cervical cancer prevention efforts will become more effective if global health leaders, including the Bill & Melinda Gates Foundation, embrace an ideological commitment to improving health outcomes as rapidly as possible among as many people as possible and assimilate the policy implications of that commitment., (Copyright © 2011 Wiley-Liss, Inc.)

Context: Methods to improve surgical pathology patient safety include measuring the frequency of error in specific steps of the surgical pathology testing process, root cause analysis of active and latent components, and implementation of quality improvement initiatives., Objective: To determine the frequency and cause of near-miss events in the specimen accessioning, setup, and biopsy-only gross examination testing steps of anatomic pathology., Design: We used an observational checklist method to identify near-miss events. We performed root cause analysis to determine latent factors contributing to near-miss events. We conducted observations for 45 hours during 5 days, involving the accessioning and processing of 335 specimens., Results: We detected a total of 2310 process-dependent and 266 operator-dependent near-miss events, resulting in a near-miss-event frequency of 5.5 per specimen. Root cause analysis showed that all process and operator near-miss events were associated with multiple system latent factors, including lack of standardized protocols, appropriate knowledge transfer, and focus on safety culture., Conclusion: We conclude that the increased focus on surgical pathology near-miss events will reveal latent factors that may be targeted for improvement.

The process of cytologic-histologic correlation is highly valuable to the fields of both cytopathology and surgical pathology, because correlation provides a wealth of data that may be used to improve diagnostic testing and screening processes. In this study, overall improvement appeared to be driven largely by improvement in preanalytic Papanicolaou (Pap) test sampling, because longer institutional participation also was associated with improved sampling sensitivity. The authors hypothesized that Pap test sampling may have improved secondary to the introduction of liquid-based technology, which was implemented in many laboratories during the study time frame. Through the performance of continuous data tracking and retrospective root cause analysis to identify factors that may have influenced any observed changes in performance indicators, institutions may learn which initiatives are successful or unsuccessful. The future of correlation lies in the standardization of methods, the development of more formal and rigorous root cause analysis processes to determine system components underlying correlation discrepancies, and the active use of correlation data to redesign testing and screening processes for quality and patient safety improvement., (Copyright © 2011 American Cancer Society.)

Introduction: In the USA, most anatomical pathology residency training is based on an apprenticeship model in which residents learn directly by watching more senior personnel and then performing the examination. The level and the effect of the standardisation of resident trainee gross tissue examination practices have not been extensively evaluated., Methods: In this apprenticeship-based training programme, a retrospective report review was performed to measure the level of standardisation of gross description (for 11 mandatory descriptors) and tissue submission (for four mandatory sections) practices for uterine specimens removed for benign conditions (n=78). Practices were examined for significant relationships with error, turnaround time (TAT), resource utilisation and postgraduate year of resident (n=25) training., Results: Residents provided mandatory descriptors from 23.1% to 93.6% of the time and submitted mandatory sections from 82.1% to 96.2% of the time. Cases submitted by less experienced residents had a longer TAT and were associated with more errors, measured by the necessity to submit additional tissues. Less experienced residents used greater resources (submitting 9.5 tissue cassettes per case) compared with more experienced residents (7.3 cassettes per case), and a statistically significant correlation was found between the number of cassettes submitted and TAT., Conclusions: In this training programme, the model of apprenticeship training leads to less than optimal standardisation of gross examination practices, inefficiency, active errors and a high frequency of latent conditions leading to error.

Improving the quality of oncologic pathology diagnosis is immensely important as the overwhelming majority of the approximately 1.6 million patients who will be diagnosed with cancer in 2010 have their diagnoses established through the pathologic interpretation of a tissue sample. Millions more patients have tissue samples obtained to rule out cancer and do not have cancer. The majority of studies on the quality of oncologic pathology diagnoses have focused on patient safety and have documented a variety of causes of error that occur in the clinical and pathology laboratory testing phases of diagnostic testing. The reported frequency of a diagnostic error made by oncologic pathology depends on several factors, such as definitions and detection methods, and ranges from 1% to 15%. The large majority of diagnostic errors do not result in severe harm, although mild to moderate harm in the form of additional testing or diagnostic delays occurs in up to 50% of errors. Clinical practitioners play an essential role in error reduction through several avenues such as effective test ordering, providing accurate and pertinent clinical information, procuring high-quality specimens, providing timely follow-up on test results, effectively communicating on potentially discrepant diagnoses, and advocating second opinions on the pathology diagnosis in specific situations.