A preliminary diagnosis service provides prospective blinded dual-review of all general surgical pathology cases in an academic practice

Quality assurance of diagnostic accuracy in surgical pathology is an important part of a pathologist's total quality management program. At our academic institution, the quality of diagnostic accuracy is monitored via dual-review of every general surgical pathology case, which accounts for nearly 20,000 cases per year. This comprehensive dual-review is achieved by operating a preliminary diagnosis service, staffed by a senior or board eligible resident. Analysis of a portion of our dual-review data (6300 cases) demonstrates an overall diagnostic concordance rate of 95.4% and a clinical major discrepancy rate of 0.29% between the preliminary diagnosis and staff pathologist diagnosis, comparable to other published rates. The incorporation of a preliminary diagnosis service into our academic surgical pathology practice has proven to be beneficial with regard to quality assurance and resident education. Other academic institutions may similarly benefit from the addition of such a service.     

Specimen Identification Errors in Breast Biopsies: Age Matters. Report of Two Near‐Miss Events and Review of the Literature

The consequences of patient identification errors due to specimen mislabeling can be deleterious. We describe two near‐miss events involving mislabeled breast specimens from two patients who sought treatment at our institution. In both cases, microscopic review of the slides identified inconsistencies between the histologic findings and patient age, unveiling specimen identification errors. By correlating the clinical information with the microscopic findings, we identified mistakes that had occurred at the time of specimen accessioning at the original laboratories. In both cases, thanks to a timely reassignment of the specimens, the patients suffered no harm. These cases highlight the importance of routine clinical and pathologic correlation as a critical component of quality assurance and patient safety. A review of possible specimen identification errors in the anatomic pathology setting is presented.     

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 (ADASP) herein provides guidelines for QA and QI in surgical and autopsy pathology.     

Why on earth do surgeons need quality assurance?

The article discusses the ways in which surgeons should respond to the growing external and internal pressures for ensuring the quality and appropriateness of surgical treatment. Quality Assurance is defined. Its development in the USA is described and it is debated whether or not a similar system should be introduced into the United Kingdom. The reasons for initiating a system of quality assurance into one health district and the experience so far gained is reported. The problems of quality assurance and some of the solutions are discussed.     

Monitoring diagnostic accuracy and complications. A report from the Children's Oncology Group Hodgkin lymphoma study

Background/Purpose

Cancer studies mandate quality assurance programs for clinical trials. Surgeons consistently play 2 roles early in the management of Hodgkin lymphoma in children and adolescents: obtaining a specimen for pathologic diagnosis and placing a central venous catheter to assist with therapy delivery. A surgical quality assurance program was embedded as part of the of the Hodgkin lymphoma study (AHODOOO31) to assess diagnostic accuracy and complications.

Methods

Surgical checklists and operative and pathology reports were reviewed concurrently. Diagnostic technique, success rate, location of biopsy, combined procedures under one anesthetic, and complications are reported.

Results

One hundred eighty-five cases were reviewed, with 169 having complete data. Diagnostic techniques included open biopsy (n = 148), computed tomography-guided core biopsy (n = 5), thoracoscopic/laparoscopic biopsy (n = 10) and fine-needle aspirations (n = 4). No staging laparotomies were performed. Biopsy sites included cervical (133), mediastinal (18), axillary (7), and others (11). Diagnostic accuracy was 145 of 148 (98.5%) for the open biopsy; 4 of 5, core biopsy (80%); 6 of 10 (60%), thoracoscopic/laparoscopic biopsy; and 1 of 4, fine-needle aspiration (25%). Eighteen had mediastinal disease only, 9 of whom had a thoracoscopic biopsy with a 55% diagnostic accuracy. Inadequate sample was the only reason for a lack of diagnosis. A second open operation was required in these cases for diagnosis. At biopsy, frozen section confirmed a malignancy in 68. In 38 of these 68 children, a central line was placed during the same anesthetic. The most common complication was inadequate sampling. Three wound infections were reported.

Conclusions

With an appropriate surgical approach to obtain an adequate tissue specimen, diagnostic accuracy is high and surgical complications are low in children with Hodgkin lymphoma. Diagnostic technique should ensure adequate tissue sampling especially when not using an open procedure. When possible, central line insertion should be performed under the same anesthetic. Fine-needle aspiration was not used enough to assess its role in the diagnosis of children with Hodgkin lymphoma.     

The impact of second opinion surgical pathology on the practice of head and neck surgery: a decade experience at a large referral hospital

BACKGROUND: A second review of histopathologic diagnoses is a quality assurance practice that helps expose diagnostic errors and guide management of patients being referred from outside hospitals. Identification of anatomic regions and specimen types that are prone to diagnostic error will be helpful in guiding policy decisions regarding mandatory second opinion surgical pathology. METHODS: All available outside pathology reports were retrieved for patients referred to The Johns Hopkins Hospital Department of Otolaryngology-Head and Neck Surgery between January 1, 1990, and January 1, 2000. The outside diagnosis was compared with diagnosis rendered at the referral hospital. A discrepant diagnosis was regarded as any change resulting in a significant modification in therapy or prognosis. RESULTS: Of the 814 cases reviewed, the second opinion surgical pathology diagnosis resulted in 54 (7%) changed diagnoses. Of the changed diagnosis, 13 (24%) involved a change from a benign to a malignant diagnosis; 8 (15%) involved a change from a malignant to a benign diagnosis; and 33 (61%) involved a change in tumor classification. Follow-up information supported the second opinion diagnosis in 41 of 43 cases (95%). CONCLUSIONS: In a consequential number of cases, second opinion surgical pathology results in major therapeutic and prognostic modifications for patients sent to large referral hospitals for head and neck oncologic surgery.     

Development of a functional, internet-accessible department of surgery outcomes database

The need for surgical outcomes data is increasing due to pressure from insurance companies, patients, and the need for surgeons to keep their own "report card". Current data management systems are limited by inability to stratify outcomes based on patients, surgeons, and differences in surgical technique. Surgeons along with research and informatics personnel from an academic, hospital-based Department of Surgery and a state university's Department of Information Technology formed a partnership to develop a dynamic, internet-based, clinical data warehouse. A five-component model was used: data dictionary development, web application creation, participating center education and management, statistics applications, and data interpretation. A data dictionary was developed from a list of data elements to address needs of research, quality assurance, industry, and centers of excellence. A user-friendly web interface was developed with menu-driven check boxes, multiple electronic data entry points, direct downloads from hospital billing information, and web-based patient portals. Data were collected on a Health Insurance Portability and Accountability Act-compliant server with a secure firewall. Protected health information was de-identified. Data management strategies included automated auditing, on-site training, a trouble-shooting hotline, and Institutional Review Board oversight. Real-time, daily, monthly, and quarterly data reports were generated. Fifty-eight publications and 109 abstracts have been generated from the database during its development and implementation. Seven national academic departments now use the database to track patient outcomes. The development of a robust surgical outcomes database requires a combination of clinical, informatics, and research expertise. Benefits of surgeon involvement in outcomes research include: tracking individual performance, patient safety, surgical research, legal defense, and the ability to provide accurate information to patient and payers.     

Molecular Pathology Informatics

Molecular informatics (MI) is an evolving discipline that will support the dynamic landscape of molecular pathology and personalized medicine. MI provides a fertile ground for development of clinical solutions to bridge the gap between clinical informatics and bioinformatics. Rapid adoption of next generation sequencing (NGS) in the clinical arena has triggered major endeavors in MI that are expected to bring a paradigm shift in the practice of pathology. This brief review presents a broad overview of various aspects of MI, particularly in the context of NGS based testing.     

Audits,errors and the misplace of clinical indicators: revisiting the Quality in Australian Health Care Study

Publication of the Quality in Australian Health Care Study in 1995 represented a defining moment for Australian health care providers. The high incidence and cost of preventable adverse events underscored a need for defined process, error recognition and audit cycle. Despite this, surgical audit has continued to emphasize clinical indicators relevant to technical performance. The greatest burden of preventable error can be traced to deficiencies in the process by which management expectations are supported. Recognizing this, the focus of clinical audit must be expanded. In particular, outcome assessment should be routine rather than sporadic, and should broadly encompass safety, effectiveness and efficiency. Devolving this responsibility to paraclinical groups is in itself insufficient. Quality and safety cannot be adequately addressed unless surgeons actively participate in audit cycle. Failure to meet this challenge in a transparent and timely manner potentially undermines the future of professional autonomy.     

Quality improvement in laparoscopic radical prostatectomy for pT2 prostate cancer: impact of video documentation review on positive surgical margin

PURPOSE: We correlated intraoperative video documentation and pathology findings to understand the mechanisms by which positive surgical margins occur and improve the surgical technique. MATERIALS AND METHODS: Between January 2003 and May 2004, 240 consecutive patients underwent laparoscopic radical prostatectomy, of whom 180 had pT2 prostate cancer and represent the population of this study. After the first 90 patients (group 1) we started a quality assurance study, analyzing intraoperative video recordings and correlating them with pathology findings in patients with a positive margin. The cancer characteristics and positive margin rate were compared between the first 90 patients and the subsequent 90 after the study was initiated (group 2). RESULTS: Of the 12 cases of positive surgical margins studied the video review helped identify 8 with a technical error. In all 4 cases in which a technical error could not be identified the positive margin site was at the distal apex. The most frequent identifiable mechanism by which positive margins occurred was a capsular tear during neurovascular bundle dissection. The 2 groups were comparable in regard to preoperative cancer characteristics and total tumor volume. In patients who underwent bilateral nerve sparing the positive margin rate was 10.6% in group 1 and 5.4% in group 2 (p = 0.18). All positive margins in group 2 involved the prostatic apex. CONCLUSIONS: Quality assurance efforts through pathological and intraoperative documentation review can help decrease the positive margin rate, particularly in organ confined disease. However, eradicating positive margins at the distal prostatic apex remains a challenge.     

Factors affecting the number of lymph nodes retrieved in colorectal cancer specimens

Background Staging of colorectal cancer is dependent on the number of lymph nodes in a surgical specimen that are positive for metastatic cancer. It is generally recommended that a minimum of 12 lymph nodes be examined to ensure adequate staging. It is unclear which factors specifically contribute to variation in the number of lymph nodes retrieved from surgical specimens. This study aims to understand the factors affecting the number of lymph nodes identified in surgical colorectal cancer specimens. Methods A total of 264 retrospectively collected cases of colorectal cancer surgically treated at the University Health Network in Toronto from 2004 to 2006 were analyzed. We used univariate analyses of variance (ANOVA), and univariate and multivariable linear and logistic regression analyses to study variation in the lymph node number associated with a variety of explanatory variables. Results The average number of lymph nodes retrieved per case was 18.1, with 70 (26.5%) cases containing fewer than 12. Variation in the lymph node number was greatest between different pathology assistants (p = < 0.001). The mean number of nodes retrieved by different pathology assistants ranged from 12.6 to 29.7. On average, surgery for recurrent cancer removed 6.0 (95% CI 1.2 to 10.9, p = 0.02) fewer lymph nodes than for primary cancer. Each additional year of patient age was associated with retrieval of 0.1 (95% CI 0.04 to 0.2, p = 0.005) fewer nodes, and rectal cancer specimens had 2.7 (95% CI 0.04 to 5.4, p = 0.05) fewer lymph nodes than colon cancer specimens. Conclusion Most of the variation in the number of lymph nodes identified in surgical specimens from colorectal cancer operations was accounted for by differences between pathology assistants. Presented at the SAGES Scientific Session April 18–22, 2007 Las Vegas, Nevada     

Pathology Gross Photography: The Beginning of Digital Pathology

The underutilized practice of photographing anatomic pathology specimens from surgical pathology and autopsies is an invaluable benefit to patients, clinicians, pathologists, and students. Photographic documentation of clinical specimens is essential for the effective practice of pathology. When considering what specimens to photograph, all grossly evident pathology, absent yet expected pathologic features, and gross-only specimens should be thoroughly documented. Specimen preparation prior to photography includes proper lighting and background, wiping surfaces of blood, removing material such as tubes or bandages, orienting the specimen in a logical fashion, framing the specimen to fill the screen, positioning of probes, and using the right-sized scale.     

Pathology of the Aorta

The aorta is a distinctive surgical pathology specimen removed most frequently for aneurysm or dissection. Genetic syndromes, inflammatory processes and acquired diseases of aging result in aortic pathology; these are presented in terms of pathology, differential diagnosis and classification schemes. The pathologic context of a variety of commonly encountered histopathologies is described.     

Are prostate needle biopsies predictive of the laterality of significant cancer and positive surgical margins?

OBJECTIVE

To determine whether data obtained from preoperative prostate needle biopsy can predict the laterality of significant cancer and positive surgical margins on final‐specimen pathology after laparoscopic radical prostatectomy (LRP).

PATIENTS AND METHODS

Data from 490 patients undergoing LRP by one surgeon were reviewed retrospectively. The demographic characteristics, intraoperative data and pathological results were analysed. Univariate and multivariate analyses were used to determine which factors before and during LRP influenced the positive surgical margin status.

RESULTS

There was only minor agreement between the laterality of positive needle biopsies and laterality of any cancer and significant cancer on final‐specimen pathology (κ = 0.135 and 0.151, respectively). This was irrespective of the number of needle cores obtained or final‐specimen Gleason grade. Similarly, the laterality of dominant cancer on needle biopsy had only a minor agreement with the location of positive surgical margins (κ = 0.050) and fair agreement with the location of extracapsular extension on final‐specimen pathology (κ = 0.235).

CONCLUSIONS

Preoperative needle biopsy data have only a minor correlation with the laterality of significant cancer and positive surgical margins at final pathology of LRP specimens. Recognition of this fact, and the frequent bilaterality of significant cancer, with its potential for contralateral positive surgical margins even when the biopsies are positive only unilaterally, is an important consideration when planning nerve‐sparing, and potentially for focal therapy.     

Visualizing surgical quality data with treemaps

Background

Treemaps are space-constrained visualizations for displaying hierarchical data structures using nested rectangles. The visualization allows large amounts of data to be examined in one display. The objective of this research was to examine the effects of using treemap visualizations to help surgeons assess surgical quality data from the American College of Surgeons created the National Surgical Quality Improvement Program database in a quick and timely manner.

Study design

A controlled human subjects experiment was conducted to assess the ability of individuals to make quick and accurate judgments on surgery data by visualizing a treemap, with data hierarchically displayed by surgeon group, surgeon, and patient. Participants were given 20 task questions to complete involving examining the treemap and comparing surgeons' patients based on outcomes (dead or alive) and length of stay days. The outcomes measured were error (incorrect or correct) and task completion time.

Results

120 participants completed 20 task questions for a total of 2400 responses. The main effects of layout and node size were found to be significant for absolute error, P < 0.0505 and P < 0.0185, respectively. The average judgment time to complete a task was 24 s with an accuracy rate of approximately 68%.

Conclusions

This study served as a proof of concept to determine if treemaps could be beneficial in assessing surgical data retrospectively by allowing surgeons and healthcare administrators to make quick visual judgments. The study found that factors about the layout design affect judgment performance. Future research is needed to examine whether implementing the treemap within a dashboard system will improve on judgment accuracy for surgical quality questions.     

Rare pathology of the breast: adenoma of the nipple

Adenoma of the nipple is a benign pathology which histologically interests the epithelium of the galactophorous ducts. This pathology looks like Paget's disease both macroscopically and microscopically, therefore an exact differential histologic diagnosis is needed with the breast's carcinoma to undertake the most timely surgical therapy.     

National survey of surgical morbidity and mortality conferences

BACKGROUND: Morbidity and mortality conferences historically have been a paramount meeting for education and quality assurance within surgical departments of teaching institutions. The purpose of this survey was to assess the present educational value and the quality assurance aspect of surgical mortality conferences. METHODS: Surveys were sent to every academic surgical training program director within the United States and Canada (n = 127) and queried the general format and an individual's experience and attitude toward their institutions conference. RESULTS: A total of 546 individuals from 34 institutions returned completed surveys. The survey findings showed that 74% of these surgical departments discussed all deaths and 50% discussed all complications. There was general agreement that surgical morbidity and mortality conferences are of good educational value and effective in reducing future error. The majority of respondents expressed that evidence-based literature should be the primary basis of discussion, with comprehensive presentations that focus on analysis of error. CONCLUSIONS: This survey showed that morbidity and mortality conferences are both educational and perceived by the respondents as effective in reducing future error.     

Tissue print micropeel: A new technique for mapping tumor invasion in prostate cancer

Because of widely adopted screening programs for early detection of prostate cancers, many patients who undergo radical prostatectomy have tumors that are not grossly evident, and the extent and distribution of the cancer in the gland can only be determined by a microscopic examination of the surgical specimen. Historically, one of the most important predictors of the quality of cancer control following surgical resection of a solid tumor is the absence of cancer at the surgical margins. Although the clinical significance of cancer at the margins of a radical prostatectomy specimen has been a source of controversy in recent years, surgical pathology assessment of radical prostatectomy margins remains an important part of prostate cancer clinical care. However, a comprehensive histopathologic review of every radical prostatectomy specimen is beyond the resources of most hospitals. Tissue print micropeel technologies, combined with appropriate markers, provide a new strategy that combines a relatively simple technique for sampling specimen margins with a method for obtaining molecular information about the cancer that can add to the macroscopic and microscopic anatomical findings. This new tissue printing approach for incorporating molecular markers into the assessment of radical prostatectomy margins is reviewed in this article.     

Rates of surgical site infection as a performance measure: Are we ready?

With the introduction of quality assurance in health care delivery, there has been a proliferation of research studies that compare patient outcomes for similar conditions among many health care delivery facilities. Since the 1990s, increasing interest has been placed in the incorporation of clinical adverse events as quality indicators in hospital quality assurance programs. Adverse post-operative events, and very especially surgical site infection (SSI) rates after specific procedures, gained popularity as hospital quality indicators in the 1980s. For a SSI rate to be considered a valid indicator of the quality of care, it is essential that a proper adjustment for patient case mix be performed, so that meaningful comparisons of SSI rates can be made among surgeons, institutions, or over time. So far, a significant impediment to developing meaningful hospital-acquired infection rates that can be used for intra- and inter-hospital comparisons has been the lack of an adequate means of adjusting for case mix. This paper discusses what we have learned in the last years regarding risk adjustment of SSI rates for provider performance assessment, and identifies areas in which significant improvement is still needed.     

Error in surgical pathology

A total of 272 surgical pathology claims reported to The Doctors Company from 1998 through 2003 were reviewed. They were analyzed and repetitive patterns involving both specimen type and category of diagnostic error were identified. These patterns were then compared with those uncovered in a prior review of 218 surgical pathology claims reported from 1995 through 1997 to identify trends and see if new patterns of diagnostic error had emerged.