Pathology-related cases in the Norwegian System of Patient Injury Compensation in the period 2010-2015. / Patologirelaterte saker i pasientskadeordningen i perioden 2010 ­ 15.

BACKGROUND: The Norwegian System of Patient Injury Compensation (NPE) processes compensation claims from patients who complain about malpractice in the health services. A wrong diagnosis in pathology may cause serious injury to the patient, but the incidence of compensation claims is unknown, because pathology is not specified as a separate category in NPE's statistics. Knowledge about errors is required to assess quality-enhancing measures. We have therefore searched through the NPE records to identify cases whose background stems from errors committed in pathology departments and laboratories. MATERIAL AND METHOD: We have searched through the NPE records for cases related to pathology for the years 2010 ­ 2015. RESULTS: During this period the NPE processed a total of 26 600 cases, of which 93 were related to pathology. The compensation claim was upheld in 66 cases, resulting in total compensation payments amounting to NOK 63 million. False-negative results in the form of undetected diagnoses were the most frequent grounds for compensation claims (63 cases), with an undetected malignant melanoma (n = 23) or atypia in cell samples from the cervix uteri (n = 16) as the major groups. Sixteen cases involved non-diagnostic issues such as mix-up of samples (n = 8), contamination of samples (n = 4) or delayed responses (n = 4). INTERPRETATION: The number of compensation claims caused by errors in pathology diagnostics is low in relative terms. The errors may, however, be of a serious nature, especially if malignant conditions are overlooked or samples mixed up.

How Do We Make Clinical Molecular Testing for Cancer Standard of Care for Pathology Departments?

Understanding of the genetic basis and molecular pathogenesis of cancer has evolved substantially over the past century. The advent of high-throughput gene sequencing methods has unraveled hundreds of recurrent somatic genetic alterations in various malignancies, either causative or harboring major prognostic and/or predictive implications. Knowledge of these specific changes has dramatically altered diagnostic and therapeutic approaches to cancer, enabling personalized molecular therapies. This article shares approaches to adopting and fine-tuning the practice of molecular diagnostics as an essential component of diagnostic pathology in a tertiary care cancer hospital and proposes methods by which genetic testing in cancer can become standard of care in pathology departments across the nation.

Physician level reporting of surgical and pathology performance indicators: a regional study to assess feasibility and impact on quality.

BACKGROUND: There is increased awareness that, to minimize variation in clinician practice and improve quality, performance reporting should be implemented at the provider level. This optimizes physician engagement and creates a sense of professional responsibility for quality and performance measurement at the individual and organizational levels. METHODS: Individual provider level reporting was implemented within a provincial health region involving 56 clinicians (general surgeons, surgical oncologists, urologists and pathologists). The 2 surgical pathology indicators chosen were colorectal cancer (CRC) lymph node retrieval rate and pT2 prostate cancer margin positivity rate. Surgical resections for all prostate and colorectal cancer performed between Jan. 1, 2011, and Mar. 30, 2012, were included. We used a pre- and postsurvey design to obtain physician perceptions and focus groups with program leadership to determine organizational impact. RESULTS: Survey results showed that respondents felt the data provided in the reports were valid (67%), consistent with expectations (70%), maintained confidentiality (80%) and were not used in a punitive manner (77%). During the study period the pT2 prostate margin positivity rate decreased from 57.1% to 27.5%. For the CRC lymph node retrieval rate indicator, high baseline performance was maintained. CONCLUSION: We developed a robust process for providing physicians with confidential, individualized surgical and pathology quality indicator reports. Our results reinforce the importance of individual physician feedback as a strategy for improving and sustaining quality in surgical and diagnostic oncology.

Efficacy of an incident-reporting system in cellular pathology: a practical experience.

BACKGROUND AND AIMS: Incident reporting (IR) refers to systematic documentation of adverse incidents to facilitate their appropriate investigation and institution of corrective or remedial actions, and provide data to identify risk trends for recurrent problems. Minimisation of errors and reduction in process variation is recognised as an important goal of quality management and is an essential part of continuous quality improvement. Published data on the role IR plays in cellular pathology remains scanty. METHODS: In this study, the authors collected and analysed all incidents and adverse events reported in their department over a 2-year period. RESULTS: 584 incidents were reported (0.5% of all cases processed). The majority (59%) occurred in the pre-analytical phase of the laboratory process with 23% in the analytical and 18% in the post-analytical phases. Booking-in and specimen labelling-related incidents were the largest single group (56% of all incidents), prompting further root cause analysis, but no other obvious patterns or trends were identified, and most incidents were followed by corrective actions on an individual basis. Most incidents (79%) posed potential harm, as opposed to causing actual harm to the service or patients. Only 78 cases (14%) posed a major risk to patients, such as specimen loss or mix-up, whereas 27% were associated with moderate risk and 59% with minor or insignificant risk. CONCLUSION: Major risk incidents are relatively rare in the cellular pathology laboratory. IR should be included as an important component of a risk management strategy and clinical governance framework.

Improving the interaction between the ophthalmology and histopathology departments.

PURPOSE: The purpose of this study was to improve communication between the ophthalmology and histopathology departments at Royal Hallamshire Hospital, Sheffield, by effectively changing the structure and completion of the histopathology request form through the process of a successful audit. This aimed to ensure that comprehensive information was made available to the histopathologist. METHODS: An audit was performed by review of 710 histopathology request forms, completed by the ophthalmology department, over a 1-year period, between July 2005 and June 2006 inclusive. Results were used to re-model the ophthalmic histopathology request form. New forms were circulated and all forms completed over a 3-month period, between January 2008 and March 2008, were reviewed, thus closing the audit loop. RESULTS: On the basis of audit results of 710 histopathology request forms, a new histopathology request form was created, which was easier to complete. Review of the 224 new histopathology request forms showed improved percentages of completion of important sections of the form. CONCLUSIONS: Through the audit process we have created a new ophthalmic histopathology request form that is more user-friendly for the ophthalmologist and more consistently provides the necessary information for the ophthalmic histopathologist. This has improved efficiency and effectiveness of communication between the specialities, which should contribute to minimise the chances of medical error and improved turnaround times for the planning and delivery of patient care.

[Accreditation in pathology. Systematic presentation and documentation of activities in pathology]. / Akkreditierung in der Pathologie. Systematische Darstellung und Dokumentation der Tätigkeiten in der Pathologie.

In the last ten years, almost 60 departments of surgical pathology were accredited in Germany according to DIN EN ISO/IEC 17020. Accreditation in pathology was accompanied by the adoption of a highly dynamic process, which requires staff to be more aware of quality and to introduce a quality-oriented system. The accreditation body in turn needed to consider all the duties, responsibilities and processes in surgical pathology and was supported in this regard by the Sector Committee of Pathology and Neuropathology of the DGA German Association for Accreditation. In this review we illustrate the various problems associated with accreditation in surgical pathology by answering eight questions that have arisen over many years of activity. These include the registration and appropriate presentation of the scope of accreditation, the terminology, as well as the extent and depth of documentation. A department of pathology applying for accreditation is required to document the entire step-wise process leading to a surgical pathological diagnosis.

Diagnostic accuracy of community pathologists in the interpretation of colorectal polyps.

BACKGROUND AND AIMS: Management of patients with endoscopically removed colorectal polyps is generally dependent on pathological evaluation. The aim of this study was to assess the accuracy and clinical impact of pathologic interpretation of colorectal polyps by community pathologists. METHODS: Two expert gastrointestinal pathologists reviewed the slides of 300 colorectal polyps initially examined by 14 general pathologists. Polyps had been detected by a fecal occult blood test colorectal cancer screening program in Haut-Rhin, a French administrative district. RESULTS: Villous histology was overread in 24.8% of cases and high-grade dysplasia in 22.0%. The diagnosis of serrated adenoma was confirmed in 15.7% of cases. The diagnosis of T1 carcinoma was overestimated in seven cases (17.9%) and missed in four. In the screening program, the proportion of correct diagnoses of community pathologists was estimated at 45.3% of polyps, of misclassification without clinical impact at 27.5%, and of misclassification with a theoretical impact on management at 27.2%, leading to over-surveillance in 20.3% of polyps and to unnecessary surgical resection in three individuals. Overall, 37.5% of the pathology reports of malignant polyps were complete, presenting all criteria necessary for therapeutic decision-making. CONCLUSION: Community pathologists exhibited moderate accuracy for interpreting colorectal polyps, with an impact on patient management for around one out of five individuals. Our results confirm the intrinsic poor reliability of the pathologic interpretation of villous histology and high-grade dysplasia and suggest that these advanced pathologic features should be abandoned for clinical use. They illustrate the need for a clarification of the nomenclature of serrated polyps.

Guidelines for HER2 testing in breast cancer: a national consensus of the Spanish Society of Pathology (SEAP) and the Spanish Society of Medical Oncology (SEOM).

Identifying breast cancers with HER2 overexpression or amplification is critical as these usually imply the use of HER2-targeted therapies. DNA (amplification) and protein (overexpression) HER2 abnormalities usually occur simultaneously and both in situ hybridisation and immunohistochemistry may be accurate methods for the evaluation of these abnormalities. However, recent studies, including those conducted by the Association for Quality Assurance of the Spanish Society of Pathology, as well as the experience of a number of HER2 testing National Reference Centres have suggested the existence of serious reproducibility issues with both techniques. To address this issue, a joint committee from the Spanish Society of Pathology (SEAP) and the Spanish Society of Medical Oncology (SEOM) was established to review the HER2 testing guidelines. Consensus recommendations are based not only on the panellists' experience, but also on previous consensus guidelines from several countries, including the USA, the UK and Canada. These guidelines include the minimal requirements that pathology departments should fulfil in order to guarantee proper HER2 testing in breast cancer. Pathology laboratories not fulfilling these standards should make an effort to meet them and, until then, are highly encouraged to submit to reference laboratories breast cancer samples for which HER2 determination has clinical implications for the patients.

Deficiencies in pathological reporting of colorectal cancer in Victoria.

BACKGROUND: Colorectal cancer (CRC) pathological reporting deficiencies have been shown to be common, with deviations from the suggested minimum dataset. Information from both surgeon and pathologist is necessary for a complete report. These deficiencies have been shown to be correctable with the use of synoptic reporting. We carried out an audit on a random sample of CRC pathological reports from the first 6 months of 2004 in Victoria, Australia, with the aim of documenting current CRC pathological reporting deficiencies. METHODS: A random sample of pathological reports for CRC was obtained from the Cancer Council of Victoria. One hundred and sixteen of these reports were reviewed by a team of surgical and pathology trainees. Presence or absence of the various fields of the 1999 National Health and Medical Research Council minimum dataset for CRC reporting was recorded. RESULTS: There were deviations from the minimal dataset. Most notable was the absence of the information on the apical node, the presence of distant metastasis and perineural invasion. CONCLUSIONS: The opportunity exists for improvement in the pathological reporting of CRC in Victoria through the uniform introduction of synoptic reporting.

Recommendations for quality assurance and improvement in surgical and autopsy pathology.

Current regulations require that departments of pathology have a structured and active program of quality assurance (QA) and quality improvement (QI), with the goals of enhancing patient safety, minimizing error, ensuring timely delivery of reports, and monitoring physician competence. Types of potential error may evolve over time and, as regulations become progressively more stringent, QA/QI programs need to be constantly updated. The Association of Directors of Anatomic and Surgical Pathology herein provides guidelines for QA and QI in surgical and autopsy pathology.

The national head and neck histopathology external quality assurance scheme: evolution, design, and analysis of 11 circulations from 1999 to 2005.

The background and design of a specialised head and neck histopathology external quality assurance (assessment) scheme with optional oral and ENT arms is described. Participation (submission of response forms) exceeded 85% in eight of 11 slide circulations. In 60% of the 168 circulated cases, up to 33% (and in occasional cases, up to 56%) of respondents gave incomplete or wrong responses owing to a lack of awareness of specific diagnostic entities or to the misinterpretation of specific histological features. In all, there were 118 wrong responses, of which 58% could be considered "potentially serious". The scheme incorporates several design features which optimise the educational value. The stringent marking of cases, and the flagging of performances showing "a meaningful deviation in standard" based on the decision of peer members rather than a rigid numerical formula, encourages high standards.

[The data-processing tool: an aid to implementation of quality assurance in a department of pathology. The example of Pap smears]. / Aide à la mise en place d'un système d'assurance qualité en anatomie et cytologie pathologiques: l'outil informatique. Application à la cytologie cervico-utérine.

Modern laboratory management software must be able to produce pathological reports for all specimens referred for diagnostic analysis, and must also be able to ensure improved quality for each step of the diagnostic process. Indices of diagnostic quality useful for staff members should be made available. The management software should enable user-friendly analysis and comparison in order to choose what kind of changes should to be applied for appropriate implementation of Quality Assurance procedures. This methodology is especially useful for Papsmears.

Ductal carcinoma in situ (DCIS) in Karachi.

OBJECTIVE: To study the frequency of ductal carcinoma in situ (DCIS) in a large pathology series. DCIS is a proliferation of non-invasive, malignant epithelial cells within the ductolobular system of the breast. It is a heterogeneous entity with several morphologic variants that differ in gross appearance, growth pattern, cytologic features, mammography, and malignant potential. METHODS: The data of The Aga Khan University' Pathology Department, diagnosed on the basis of histopathology, during a 6-year period (1st January 1998 to 31st December 2003) was reviewed, all cases of DCIS studied, and data was analyzed with the help of analytical software SPSS. RESULTS: Thirty-eight cases of DCIS were reported to the Aga Khan University Pathology Department, during a 6-year period (1998 to 2003), comprising approximately 1% of all breast cancers reported to the unit in the same period. The mean age of the patients at diagnosis was 48.95 years (CI 95% 44.6; 53.3). Approximately half the cases occurred in the 45-54 year age group (figure 1). Two cases (5.3%) were recurrences with previous lumpectomy scars. Comedo necrosis was observed in five (13.2%) cases, whereas 33 (86.8%) cases were non-comedo type. The clinical presentation was a palpable mass (92.1%), nipple discharge (5.3%) or clinically occult lesions diagnosed on mammography (2.6%). Approximately half the patients presented with a grade 2 disease. Atypical ductal hyperplasia was observed in a third of the cases, predominantly associated with a grade 1 and 2 disease. The estrogen and, progesterone receptor status was studied in 12 (31.6%) cases. Estrogen positivity was observed in 11 (91.7%) cases and progesterone positivity in 7 (58.3%) cases. Microcalcification was observed in four (10.6%) cases. CONCLUSION: The cases reported in this study are the indolent grade 1 or 2 cases with a non-comedo pattern, and a positive estrogen and progesterone receptor status. If untreated, only 40% of these innocuous forms of DCIS become invasive over a time span of approximately 25-30 years. In Pakistan we are missing the more aggressive forms of DCIS which have a shorter transition to invasive carcinoma.

Validity of frozen section in the diagnosis of breast lumps: 5 years experience at the Aga Khan University Hospital.

OBJECTIVE: To determine the accuracy of frozen section in the diagnosis of breast lump. METHODS: Frozen section diagnosis given in consecutive breast biopsies performed in 5 years in our laboratory was evaluated against the final pathology report of permanent sections. RESULTS: The Aga Khan University Hospital Lab receives more than 400 cases per year for frozen section. Three hundred and nineteen consecutive frozen sections of breast lumps examined from 1999-2003 were considered for analysis. Age of patients ranged between 22 and 90 years (mean age 49 years). In 316 cases (99%) there was no difference between the frozen section diagnosis and the final diagnosis. Three cases (0.94%) were incorrect; 2 cases (0.62%) were false positive. One case was false negative (0.31%). In 7 cases (2.19%), frozen section diagnosis was deferred to permanent sections. Frozen section diagnostic accuracy was 99%. Sensitivity and specificity was 99.3% and 93% respectively. Positive predictive value and negative predictive values of frozen section were 96.6% and 99.3% respectively. CONCLUSION: High accuracy of the frozen-section diagnosis in the breast lumps was confirmed in our study

Upper gastrointestinal cancer pathology reporting: a regional audit to compare standards with minimum datasets.

AIMS: Accurate pathological (pTNM) staging of oesophageal and gastric cancer provides important prognostic information. The aim of this study was to compare the standard of pathology reporting of oesophageal and gastric cancer resections from a cancer network with standards set by the Royal College of Pathologists. METHODS: All reports for oesophageal and gastric cancer resections from the five hospitals in the cancer network in 2001 were collected. Individual items of information were compared with minimum datasets provided by the Royal College of Pathologists. Items were classified as "complete", "partially complete", or "absent". RESULTS: One hundred and ten reports were audited (54 oesophageal and 56 gastric). Fourteen gastric and 17 oesophagectomy reports were over 75% complete. Clinically important missing data occurred most frequently for the pM component of TNM staging (pMx omitted in 87 reports) and completeness of resection expressed as a bold statement (absent in 50 reports). Twelve reports could not be classified because the specimen contained no residual tumour after neoadjuvant treatment. CONCLUSION: The use of a standard proforma for reporting upper gastrointestinal cancers based on a minimum dataset provided by the Royal College of Pathologists is recommended, with modifications to allow for specimens with no tumour after neoadjuvant treatment.