Wrong Tissue in Block.

OBJECTIVES: Maintaining specimen identity during surgical pathology tissue processing is critical. Epic Beaker Laboratory Information System requires sequential scanning of specimen label and grossed blocks (block confirmation) to ensure specimen identity. We report our institution's experience with wrong tissue in block (WTIB) grossing errors before and after adopting block confirmation. METHODS: During the first 18 months of Beaker implementation, block confirmation was not required. We then mandated block confirmation for a 3-month period. To ensure compliance, we then built a "hard stop" feature that prevents scanning any unconfirmed blocks onto a packing list. We reviewed WTIB incidents pre- and postimplementation of these solutions. RESULTS: Before using block confirmation, we had WTIB incidents involving 17 (0.043%) of 38,848 cases. When we mandated block confirmation use, we had WTIB involving 2 (0.043%) of 4,646 cases. After implementing the hard stop feature, we had WTIB incidents involving 2 (0.005%) of 42,411 cases. Overall, there was an 88.4% (0.043% vs 0.005%; P < .001) reduction in WTIB incidents using block confirmation with a hard stop. CONCLUSIONS: Beaker is a customizable platform that can be tailored to a laboratory's workflow. By using barcoding, implementing custom-built features, and improving workflow protocols, we significantly reduced WTIB errors.

Clinical and Financial Implications of Second-Opinion Surgical Pathology Review.

OBJECTIVES: Second-opinion pathology review identifies clinically significant diagnostic discrepancies for some patients. Discrepancy rates and laboratory-specific costs in a single health care system for patients referred from regional affiliates to a comprehensive cancer center ("main campus") have not been reported. METHODS: Main campus second-opinion pathology cases for 740 patients from eight affiliated hospitals during 2016 to 2018 were reviewed. Chart review was performed to identify changes in care due to pathology review. To assess costs of pathology interpretation, reimbursement rates for consultation Current Procedural Terminology billing codes were compared with codes that would have been used had the cases originated at the main campus. RESULTS: Diagnostic discrepancies were identified in 104 (14.1%) patients, 30 (4.1%) of which resulted in a change in care. In aggregate, reimbursement for affiliate cases was 65.6% of the reimbursement for the same cases had they originated at the main campus. High-volume organ systems with low relative consultation reimbursement included gynecologic, breast, and thoracic. CONCLUSIONS: Preventable diagnostic errors are reduced by pathology review for patients referred within a single health care system. Although the resulting changes in care potentially lead to overall cost savings, the financial value of referral pathology review could be improved.

In-laboratory breast specimen radiography reduces tissue block utilization and improves turnaround time of pathologic examination.

BACKGROUND: This study was performed to determine whether in-laboratory specimen radiography reduces turnaround time or block utilization in surgical pathology. METHODS: Specimens processed during a 48-day trial of an in-lab cabinet radiography device (Faxitron) were compared to a control group of specimens imaged in the mammography suite during a prior 1-year period, and to a second group of specimens not undergoing imaging of any type. RESULTS: Cases imaged in the mammography suite had longer turnaround time than cases not requiring imaging (by 1.15 days for core biopsies, and 1.73 days for mastectomies; p < 0.0001). In contrast, cases imaged in-lab had turnaround time that was no longer than unimaged cases (p > 0.05 for core biopsies, lumpectomies and mastectomies). Mastectomies imaged in-lab required submission of fewer blocks than controls not undergoing any imaging (mean reduction of 10.6 blocks). CONCLUSIONS: Availability of in-lab radiography resulted in clinically meaningful improvements in turnaround time and economically meaningful reductions in block utilization.

Validation of a digital pathology system including remote review during the COVID-19 pandemic.

Remote digital pathology allows healthcare systems to maintain pathology operations during public health emergencies. Existing Clinical Laboratory Improvement Amendments regulations require pathologists to electronically verify patient reports from a certified facility. During the 2019 pandemic of COVID-19 disease, caused by the SAR-CoV-2 virus, this requirement potentially exposes pathologists, their colleagues, and household members to the risk of becoming infected. Relaxation of government enforcement of this regulation allows pathologists to review and report pathology specimens from a remote, non-CLIA certified facility. The availability of digital pathology systems can facilitate remote microscopic diagnosis, although formal comprehensive (case-based) validation of remote digital diagnosis has not been reported. All glass slides representing routine clinical signout workload in surgical pathology subspecialties at Memorial Sloan Kettering Cancer Center were scanned on an Aperio GT450 at ×40 equivalent resolution (0.26 µm/pixel). Twelve pathologists from nine surgical pathology subspecialties remotely reviewed and reported complete pathology cases using a digital pathology system from a non-CLIA certified facility through a secure connection. Whole slide images were integrated to and launched within the laboratory information system to a custom vendor-agnostic, whole slide image viewer. Remote signouts utilized consumer-grade computers and monitors (monitor size, 13.3-42 in.; resolution, 1280 × 800-3840 × 2160 pixels) connecting to an institution clinical workstation via secure virtual private network. Pathologists subsequently reviewed all corresponding glass slides using a light microscope within the CLIA-certified department. Intraobserver concordance metrics included reporting elements of top-line diagnosis, margin status, lymphovascular and/or perineural invasion, pathology stage, and ancillary testing. The median whole slide image file size was 1.3 GB; scan time/slide averaged 90 s; and scanned tissue area averaged 612 mm2. Signout sessions included a total of 108 cases, comprised of 254 individual parts and 1196 slides. Major diagnostic equivalency was 100% between digital and glass slide diagnoses; and overall concordance was 98.8% (251/254). This study reports validation of primary diagnostic review and reporting of complete pathology cases from a remote site during a public health emergency. Our experience shows high (100%) intraobserver digital to glass slide major diagnostic concordance when reporting from a remote site. This randomized, prospective study successfully validated remote use of a digital pathology system including operational feasibility supporting remote review and reporting of pathology specimens, and evaluation of remote access performance and usability for remote signout.

Data-Driven Development of an Institutional "Gross-Only" Policy for the Examination of Select Surgical Pathology Specimens.

OBJECTIVES: To determine diagnostic, workflow, and economic implications of instituting a gross-only policy at our institution. METHODS: Retrospective (2017) key word searches were performed to identify "gross-only" cases for which microscopic evaluation could potentially be omitted, but was performed, and those who underwent gross evaluation per surgeon request. Cases were evaluated for type(s), part(s), block volume, turnaround time, demographics, and diagnosis. Laboratory costs and reimbursement were evaluated. RESULTS: In total, 448 potential gross-only cases with 472 specimens consisted of atherosclerotic plaques (33.5%), bariatric stomach/bowel (32.6%), hernia (15.7%), heart valves (12.7%), and other (5.9%). Four (2.6%) bariatric surgery cases had Helicobacter pylori infection; these were the only cases with "significant" histologic findings. Cost analysis revealed that converting all potential gross-only specimens to gross only would result in overall losses based on average reimbursements, most influenced by bariatric specimens (Current Procedural Terminology code 88307), comprising 65.2% of estimated loss. CONCLUSIONS: Establishing a gross-only policy should be guided by established recommendations but institutionally individualized and data driven. It was reasonable for us to establish a gross-only policy for most evaluated specimens, while excluding bariatric stomach specimens in which microscopic pathology could be missed, given the lack of H pylori screening at our institution.

Bar Coding and Tracking in Pathology.

Bar coding and specimen tracking are intricately linked to pathology workflow and efficiency. In the pathology laboratory, bar coding facilitates many laboratory practices, including specimen tracking, automation, and quality management. Data obtained from bar coding can be used to identify, locate, standardize, and audit specimens to achieve maximal laboratory efficiency and patient safety. Variables that need to be considered when implementing and maintaining a bar coding and tracking system include assets to be labeled, bar code symbologies, hardware, software, workflow, and laboratory and information technology infrastructure as well as interoperability with the laboratory information system. This article addresses these issues, primarily focusing on surgical pathology.

Development of an intraoperative pathology consultation service at a free-standing ambulatory surgical center: clinical and economic impact for patients undergoing breast cancer surgery.

BACKGROUND: Second surgeries represent a significant detriment to breast cancer patients. We examined the impact an intraoperative pathology consultation service had on multiple facets of breast cancer surgery. METHODS: We compared the 8 months before the establishment of a pathology laboratory, when intraoperative pathology consultation was not available, with the 8 months subsequent, when it was performed routinely. RESULTS: The average number of surgeries per patient decreased from 1.5 to 1.23, and the number of patients requiring one surgery increased from 59% to 80%. Re-excisions decreased from 26% to 9%. Frozen section allowed 93% of node-positive patients to avoid a second surgery for axillary lymph node dissection. A cost analysis showed savings between $400 and $600 per breast cancer patient, even when accounting for fewer axillary lymph node dissections based on the American College of Surgeons Oncology Group Z0011 data. CONCLUSIONS: Incorporation of routine intraoperative margin/sentinel lymph node assessment at an outpatient breast surgery center is feasible, and results in significant clinical benefit to the patient. Use of frozen section decreased both the time and cost required to treat patients.

[Pathology laboratories staff workload evaluation in Turkey: a survey study]. / Türkiye'de Patoloji Laboratuvarlarinda Personel Is Yükü Degerlendirmesi: Bir Anket Çalismasi

OBJECTIVE: The workload affects the quality of the pathology report. The aim of this study was to investigate the territorial distribution and productivity of pathology laboratories around Turkey and to estimate the staff workload. MATERIAL AND METHOD: A survey questioning the workload was sent to all Ministry of Health and university hospitals. Staff workload was questioned according to the hospital classification and educational activity to evaluate the productivity. Data were entered using SPSS 16.0 statistical software package program and the distribution criteria, t-test and one-way anova were used in the analysis to evaluate the differences between the averages. RESULTS: An average of 2.8 pathologists worked at the pathology laboratories. A total of 5.500 biopsies and 3.750 cytology specimens were received and 20.000 blocks prepared per year. Pathologists evaluated 1.935 biopsies and 1.400 cytology specimens on average and this is equivalent to 2.718 biopsies per year. Gynecology and general surgery department materials constituted 57 percent of all biopsies. Each technician prepared 6.200 blocks, 11.500 slides and 1.000 immunohistochemistry preparations on average. An average of 3.4 paraffin blocks was prepared for each biopsy. The efficiency was low in 17% of teaching hospitals and 77.8% of non-teaching hospitals. In contrast 62.5% of teaching hospitals had work overload. The majority (70.5%) of the respondents mentioned staff shortage. CONCLUSION: There is no pathologist shortage in Turkey and the problem is workload distribution. Pathology residents' overwork would be reduced by using pathology assistants. There is no shortage of technicians or secretaries, but uneven distribution. Pathology staff planning must be tailored taking into account the features of each hospital. Standard planning for all hospitals is not suitable.

Current experience and attitudes to biomedical scientist cut-up: results of an online survey of UK consultant histopathologists.

AIMS: To assess the current utilisation of biomedical scientist (BMS) surgical specimen cut-up in the UK and attitudes of consultant histopathologists to the practice. METHODS: Email invitations were sent to all UK consultant histopathologists to participate in an online survey (SurveyMonkey) assessing attitudes to and utilisation of BMS surgical specimen cut-up. RESULTS: 463 individual replies were received (35% response rate) from 1320 invitations to participate, covering 181 UK histopathology departments. A majority of the respondents were either fully in favour of BMS cut-up (52.7%), or in favour but with some reservation (46.2%). Only five respondents (1.1%) were completely opposed to BMS cut-up. 267 (57.7%) respondents reported that their BMS staff loaded biopsies only. 148 (32%) reported BMS cut-up of more complex benign specimens, and 83 (17.9%) reported BMS handling of orientated skin specimens. Only 39 (8.4%) reported that BMS staff in their departments currently cut-up larger cancer resections. CONCLUSIONS: This survey is representative of current BMS cut-up practice in the UK. The majority of UK consultant histopathologists replying to this survey support BMS cut-up to some degree, but utilisation of BMS cut-up is rather limited and patchy at present. Cost, staffing constraints, perceived quality issues and individual consultant preferences are cited as reasons for limited uptake currently. Recognised benefits of promoting BMS cut-up include better use of consultant time, enhanced team working, BMS job satisfaction and career progression, and better adherence to standard operating procedures.

Implementation of a percutaneous core needle biopsy training program: results from the University of Michigan-Komfo Anokye Teaching Hospital breast cancer research partnership.

PURPOSE: To describe a training program in percutaneous core needle biopsy implemented in conjunction with a breast cancer research collaboration between the University of Michigan (UM) and the Komfo Anokye Teaching Hospital (KATH), Kumasi, Ghana. METHODS: In July 2007 a Ghana-based training program for performance of core needle biopsy was jointly coordinated by the UM and KATH principal investigators (L.N. and B.A.). This course required less than 1 week for implementation. RESULTS: Following the training course (July 2007 through August 2008), 82 core needle biopsies of breast masses were performed at KATH. Of these, 56 had tissue specimens available for review at UM for comparison with KATH primary pathology reports. Forty-six of the 56 UM-reviewed cases (82%) had a KATH diagnosis of breast cancer; UM pathology review was in agreement with the cancer diagnosis in all 46 cases (100%). Ten of the 56 UM-reviewed cases (18%) had a KATH diagnosis of benign fibroadenoma/fibrocystic breast tissue; UM review was concordant in all ten cases (100% concordance for benign lesions). For the remaining 26 procedures we were unable to retrieve either the KATH pathology report or tissue blocks for UM review. DISCUSSION: The design and implementation of appropriate diagnostic biopsy programs is important for delivery of high-quality, efficient breast cancer care in developing nations. This study demonstrates a successful 1-week training program in percutaneous core needle biopsy for a multidisciplinary group of physicians. Further work is needed for similar programs to accurately identify and classify breast cancer internationally.

Experience with voice recognition in surgical pathology at a large academic multi-institutional center.

There are few reports of institutional use of voice recognition technology in clinical practice. We describe our experience with voice recognition-integrated synoptic-like dictation, associating templates with key spoken phrases, that we have used in gross examination of common specimens and as a major component of our workflow since 2001. The primary application is VoiceOver Enterprise (Voicebrook, Lake Success, NY), which uses Dragon NaturallySpeaking Medical Edition (Nuance Communications, Burlington, MA) as its speech engine. This integrates with the anatomic pathology laboratory information system (APLIS) and other applications, such as Microsoft Office (Microsoft, Redmond, WA). The largest user group, pathology assistants, mainly dictates biopsy reports, numbering approximately 210,000 specimens since 2001. The technology has been useful in our anatomic pathology workflow and provided a good return on investment, including marked improvements in turnaround time, results standardization, error reduction, and cost savings. The most helpful features of the software are templating, the seamless integration with APLIS, and the voice command creation tools.

Re-establishing a surgical pathology service in Kumasi, Ghana: case report and discussion of barriers and key elements of a successful collaboration between low- and high-resource countries.

At Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana, a breakdown of technical equipment and lack of pathologists resulted in closure of the surgical pathology laboratory in 2004. At an international meeting in January 2005, 1 USA and 1 Norwegian pathologist were asked if their departments could help with the pathology problem at KATH. This article describes the proposals, the barriers encountered, and the key elements of the final successful collaboration between a low-resource and a high-resource country. The proposal to the USA hospital focused on receiving specimens for diagnosis. A detailed proposal was not developed, as several key operational barriers were identified early on, including legal issues, technical capacity issues, and staff capacity issues. The proposal to the University Hospital of North Norway (UNN) resulted in development of a 5-year plan to reestablish surgical pathology at KATH. Two KATH technicians came to UNN and trained in the histopathology laboratory for 3 months. On their return, they started producing slides at KATH. Since April 2006, weekly shipments of hematoxylin and eosin (H & E) stained slides have been sent to UNN by courier service. When needed, paraffin blocks are sent on request. In March 2006, 2 young Ghanaian physicians were received as trainees at the UNN to do full resident work and training with the aim of being approved as specialists in pathology in Ghana by 2010. Full surgical pathology service and training of new pathologists on site are expected to be reestablished at KATH by 2010.

A system for sharing routine surgical pathology specimens across institutions: the Shared Pathology Informatics Network.

This report presents an overview for pathologists of the development and potential applications of a novel Web enabled system allowing indexing and retrieval of pathology specimens across multiple institutions. The system was developed through the National Cancer Institute's Shared Pathology Informatics Network program with the goal of creating a prototype system to find existing pathology specimens derived from routine surgical and autopsy procedures ("paraffin blocks") that may be relevant to cancer research. To reach this goal, a number of challenges needed to be met. A central aspect was the development of an informatics system that supported Web-based searching while retaining local control of data. Additional aspects included the development of an eXtensible Markup Language schema, representation of tissue specimen annotation, methods for deidentifying pathology reports, tools for autocoding critical data from these reports using the Unified Medical Language System, and hierarchies of confidentiality and consent that met or exceeded federal requirements. The prototype system supported Web-based querying of millions of pathology reports from 6 participating institutions across the country in a matter of seconds to minutes and the ability of bona fide researchers to identify and potentially to request specific paraffin blocks from the participating institutions. With the addition of associated clinical and outcome information, this system could vastly expand the pool of annotated tissues available for cancer research as well as other diseases.

Institutional pathology consultation.

Sun Yat-Sen Cancer Center is the only cancer center in Taiwan. The hospital maintains a policy, and the division of oncology makes a concerted effort to obtain and review pertinent pathologic specimens in all patients who had pathologic diagnosis performed at other institution before rendering therapy. A 1-year retrospective study was undertaken to assess the frequency of discordant diagnosis of our second-opinion pathology slide review and determine its impact on patient care. Discrepancies were classified into four basic categories: A) no diagnostic disagreement; B) no diagnostic disagreement but pertinent information not included, such as tumor size, lymphovascular invasion, perineural invasion, histologic grading, margin status, extracapsular spread in metastatic lymph nodes; and C) major diagnostic disagreement, which was defined as follows; 1) change from benign to malignant, 2) change from malignant to benign, 3) a different type of neoplasm, and 4) change in N and M classification in TMN staging framework. Of 715 cases, a total of 673 (94%) showed no discrepancy. However, 35 of 673 (5.2%) cases failed to offer pertinent information (category B). Major disagreement was found in 42 16%) cases (category C). This study illustrated the fact that second pathology slide review prior to therapy can identify a small group of cases that result in a major change in their therapeutic plan. Admittedly, the review of pathology slides involves additional time and effort for both consulting and referring institutions. It can ensure quality medical care and limit medicolegal liability. As the Association of Directors of Anatomic and Surgical Pathology recommended, second pathology review should be standard practice. It is necessary that our major Pathology Association and Societies adopt a strong position on this matter to influence government or insurance company to pay for this service rendered by pathologists.

Diagnostic telepathology: long-term experience of a single institution.

OBJECTIVES: The paper reviews the development of the application of telepathology in a department of surgical pathology between 1991 and 2003. The goal of the efforts during this time was to give up the concept of programming a single application, available only between two fixed workstations with sophisticated devices and special software, and to find the virtual "largest common denominator" for implementing as many different applications as possible with the same basic system. METHODS: A new telepathology system was designed as a client-server system with a relational database at its centre. The clients interact together by transferring the questions (texts and images) to a record (case) in the database on the server and by transferring the answers to the same record on the database. RESULTS: The new "open" telepathology system iPath (http://telepath.patho.unibas.ch) has been very well accepted by many groups around the world. The main application fields are: consultations between pathologists and medical institutions without a pathologist (e.g. for frozen section diagnoses or for surgical diagnoses in hospitals in South Asia or Africa), tumour boards, field studies and distance education (http://teleteach.patho.unibas.ch). CONCLUSIONS: Having observed that with iPath we have succeeded in satisfying all our telepathology needs, we are inclined to put the emphasis on the nature of the tasks being performed, as opposed to the methods or technical means for performing a given task. The three organisation models proposed by Weinstein et al. (2001) can be reduced to only two models: the model of discussion groups and the model of expert groups (virtual institutes).

Effects of clinical service reorganisation on cellular pathology workload.

AIMS: To assess changes in volume and complexity of cellular pathology workload after clinical service reorganisation and alterations in pathology reporting practices, and to identify objective measures of change applicable to all cellular pathology departments. The ear, nose, and throat (ENT), head and neck (HN) specialty was chosen for assessment. METHODS: Cellular pathology workload from the ENT-HN surgical specialty was assessed numerically and the complexity in examination of cancer resection specimens was evaluated. Medical and technical time inputs in the reporting of ENT-HN cancer resections were measured prospectively, and the histological and cytological workload arising from the management of such cases was obtained. RESULTS: The 88.83% increase in ENT-HN specimens contrasted with a 13.53% increase in total surgical workload. Substantial increases in work complexity were found when measured as blocks/slides for each case and number of histochemical/immunohistochemical requests. On average, examination of one ENT-HN cancer case consumed 55% of one pathologist's work session and over one 10th of a technician's working week. On average, each cancer generated 3.3 histological and 1.06 cytological specimens. CONCLUSIONS: Evidence is provided of the increase in cellular pathology workload and in its complexity. This study lists objective measures of complexity applicable to all pathology subspecialties. Given the workforce crisis and expanding clinical needs, realistic workload calculations should include measurement of complexity and not just volumes.

Proactive management of histopathology workloads: analysis of the UK Royal College of Pathologists' recommendations on specimens of limited or no clinical value on the workload of a teaching hospital gastrointestinal pathology service.

AIMS: To investigate the effect on the workload of a gastrointestinal pathology service of implementing the recommendations of the Royal College of Pathologists' (RCPath) working party on specimens of limited or no clinical value (LONCV). METHODS: All endoscopic gastrointestinal pathology reports for the first three months of 2001 at a large teaching hospital were reviewed against the RCPath recommendations. Specimens in the category of LONCV were recorded and the final histopathology diagnosis noted. RESULTS: The biopsies in the LONCV category were 30% of oesophageal, 61% of gastric, 0.5% of duodenal, and 7% of colorectal origin. CONCLUSIONS: Implementing the RCPath recommendations would reduce the number of requests for the examination of gastrointestinal endoscopic specimens by 3500 specimens each year in this department. None of the specimens in the LONCV category showed an abnormality that could not have been detected by a more efficient and less invasive method. In the UK, where there is a severe shortage of trained histopathologists, the implementation of these recommendations would ensure that these scarce resources are not misused.

Is microscopic assessment of macroscopically normal hysterectomy specimens necessary?

AIM: To determine whether microscopic examination of macroscopically normal hysterectomy specimens yields findings that could alter subsequent clinical management. METHODS: All pathology reports on hysterectomy specimens submitted to the department of histopathology at the Northern General Hospital from January 1997 to December 1998 were reviewed. Cases were included for further assessment if the hysterectomy specimen was regarded as macroscopically normal by a consultant pathologist and if the patient had no history of, or suspicion of, neoplastic disease. The subsequent microscopic findings from these cases were assessed to determine whether any lesions of clinical importance were identified. RESULTS: Eight hundred and fifty four specimens were reviewed, of which 139 were suitable for inclusion. Only one of the 139 cases harboured a microscopic abnormality that necessitated specific clinical follow up; this was a focus of cervical intraepithelial neoplasia 2 (CIN 2). On follow up of that patient, no further neoplastic disease was identified. CONCLUSION: Microscopic assessment of macroscopically normal hysterectomy specimens does not contribute to patient management and is unnecessary in an era of manpower shortage and cost containment.