Background Digital pathology (DP) using whole slide imaging is a recently emerging game changer technology that can fundamentally change the way of working in pathology. The Digital Pathology Study Group (DPSG) of the Korean Society of Pathologists (KSP) published a consensus report on the recommendations for pathologic practice using DP. Accordingly, the need for the development and implementation of a quality assurance program (QAP) for DP has been raised.
Methods To provide a standard baseline reference for internal and external QAP for DP, the members of the Committee of Quality Assurance of the KSP developed a checklist for the Redbook and a QAP trial for DP based on the prior DPSG consensus report. Four leading institutes participated in the QAP trial in the first year, and we gathered feedback from these institutes afterwards.
Results The newly developed checklists of QAP for DP contain 39 items (216 score): eight items for quality control of DP systems; three for DP personnel; nine for hardware and software requirements for DP systems; 15 for validation, operation, and management of DP systems; and four for data security and personal information protection. Most participants in the QAP trial replied that continuous education on unfamiliar terminology and more practical experience is demanding.
Conclusions The QAP for DP is essential for the safe implementation of DP in pathologic practice. Each laboratory should prepare an institutional QAP according to this checklist, and consecutive revision of the checklist with feedback from the QAP trial for DP needs to follow.
Background The Continuous Quality Improvement program for cytopathology in 2020 was completed during the coronavirus pandemic. In this study, we report the result of the quality improvement program.
Methods Data related to cytopathology practice from each institute were collected and processed at the web-based portal. The proficiency test was conducted using glass slides and whole-slide images (WSIs). Evaluation of the adequacy of gynecology (GYN) slides from each institution and submission of case glass slides and WSIs for the next quality improvement program were performed.
Results A total of 214 institutions participated in the annual cytopathology survey in 2020. The number of entire cytopathology specimens was 8,220,650, a reduction of 19.0% from the 10,111,755 specimens evaluated in 2019. Notably, the number of respiratory cytopathology specimens, including sputum and bronchial washing/ brushing significantly decreased by 86.9% from 2019, which could be attributed to the global pandemic of coronavirus disease. The ratio of cases with atypical squamous cells to squamous intraepithelial lesions was 4.10. All participating institutions passed the proficiency test and the evaluation of adequacy of GYN slides.
Conclusions Through the Continuous Quality Improvement program, the effect of coronavirus disease 2019 pandemic, manifesting with a reduction in the number of cytologic examinations, especially in respiratory-related specimen has been identified. The Continuous Quality Improvement Program of the Korean Society for Cytopathology can serve as the gold standard to evaluate the current status of cytopathology practice in Korea.
Digital pathology (DP) using whole slide imaging (WSI) is becoming a fundamental issue in pathology with recent advances and the rapid development of associated technologies. However, the available evidence on its diagnostic uses and practical advice for pathologists on implementing DP remains insufficient, particularly in light of the exponential growth of this industry. To inform DP implementation in Korea, we developed relevant and timely recommendations. We first performed a literature review of DP guidelines, recommendations, and position papers from major countries, as well as a review of relevant studies validating WSI. Based on that information, we prepared a draft. After several revisions, we released this draft to the public and the members of the Korean Society of Pathologists through our homepage and held an open forum for interested parties. Through that process, this final manuscript has been prepared. This recommendation contains an overview describing the background, objectives, scope of application, and basic terminology; guidelines and considerations for the hardware and software used in DP systems and the validation required for DP implementation; conclusions; and references and appendices, including literature on DP from major countries and WSI validation studies.
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Background The Korean Society for Cytopathology has conducted the Continuous Quality Improvement program for cytopathology laboratories in Korea since 1995. In 2018 as part of the program, an annual survey of cytologic data was administered to determine the current status of cytopathology practices in Korea. Methods: A questionnaire was administered to 211 cytopathology laboratories. Individual laboratories submitted their annual statistics regarding cytopathology practices, diagnoses of gynecologic samples, inadequacy rates, and gynecologic cytology-histology correlation review (CHCR) data for 2018. In addition, proficiency tests and sample adequacy assessments were conducted using five consequent gynecologic slides. Results: Over 10 million cytologic exams were performed in 2018, and this number has almost tripled since this survey was first conducted in 2004 (compounded annual growth rate of 7.2%). The number of non-gynecologic samples has increased gradually over time and comprised 24% of all exams. The overall unsatisfactory rate was 0.14%. The ratio of the cases with atypical squamous cells to squamous intraepithelial lesions accounted for up to 4.24. The major discrepancy rate of the CHCR in gynecologic samples was 0.52%. In the proficiency test, the major discrepancy rate was approximately 1%. In the sample adequacy assessment, a discrepancy was observed in 0.1% of cases. Conclusions: This study represents the current status of cytopathology practices in Korea, illustrating the importance of the Continuous Quality Improvement program for increasing the accuracy and credibility of cytopathologic exams as well as developing national cancer exam guidelines and government projects on the prevention and treatment of cancer.
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Background Since 1995, the Korean Society for Cytopathology has overseen the Continuous Quality Improvement program for cytopathology laboratories. The Committee of Quality Improvement has carried out an annual survey of cytology data for each laboratory and set standards for proficiency tests. Methods: Evaluations were conducted four times per year from 2008 to 2018 and comprised statistics regarding cytology diagnoses of previous years, proficiency tests using cytology slides provided by the committee, assessment of adequacy of gynecology (GYN) cytology slides, and submission of cytology slides for proficiency tests. Results: A total of 206 institutes participated in 2017, and the results were as follows. The number of cytology tests increased from year to year. The ratio of liquid-based cytology in GYN gradually decreased, as most of the GYN cytology had been performed at commercial laboratories. The distribution of GYN diagnoses demonstrated nearly 3.0% as atypical squamous cells. The rate for squamous cell carcinoma was less than 0.02%. The atypical squamous cell/squamous intraepithelial lesion ratio was about 3:1 and showed an upward trend. The major discordant rate of cytology-histology in GYN cytology was less than 1%. The proficiency test maintained a major discordant rate less than 2%. The rate of inappropriate specimens for GYN cytology slides gradually decreased. Conclusions: The Continuous Quality Improvement program should be included in quality assurance programs. Moreover, these data can contribute to development of national cancer examination guidelines and facilitate cancer prevention and treatment.
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Background Limited data are available on the current status of cytology practices in Korea. This nationwide study presents Korean cytology statistics from 2015.
Methods A nationwide survey was conducted in 2016 as a part of the mandatory quality-control program by the Korean Society for Cytopathology. The questionnaire was sent to 208 medical institutions performing cytopathologic examinations in Korea. Individual institutions were asked to submit their annual cytology statistical reports and gynecologic cytology-histology correlation data for 2015.
Results Responses were obtained from 206 medical institutions including 83 university hospitals, 87 general hospitals, and 36 commercial laboratories. A total of 8,284,952 cytologic examinations were performed in 2015, primarily in commercial laboratories (74.9%). The most common cytology specimens were gynecologic samples (81.3%). Conventional smears and liquid-based cytology were performed in 6,190,526 (74.7%) and 2,094,426 (25.3%) cases, respectively. The overall diagnostic concordance rate between cytologic and histologic diagnoses of uterine cervical samples was 70.5%. Discordant cases were classified into three categories: category A (minimal clinical impact, 17.4%), category B (moderate clinical impact, 10.2%), and category C (major clinical impact, 1.9%). The ratio of atypical squamous cells of undetermined significance to squamous intraepithelial lesion was 1.6 in university hospitals, 2.9 in general hospitals, and 4.9 in commercial laboratories.
Conclusions This survey reveals the current status and trend of cytology practices in Korea. The results of this study can serve as basic data for the establishment of nationwide cytopathology policies and quality improvement guidelines in Korean medical institutions.
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BACKGROUND Molecular tools for tissue profiling generally require collection of fresh frozen tissues (FFT) as sources of high-quality DNA and RNA. Nowadays, researchers carry out large-scale, multi-center studies and they request inter-institutional minimal intrinsic bias, some fundamental similarities, and the same standardized and validated procedures. METHODS This study reports standardized quality control procedure for fresh frozen tissue of the National Biobank of Korea. RESULTS The main procedures for quality control for FFT are as follows: records related to sample collection such as labeling of samples, transport temperature, lag time from excision of tissue to freezing, and sample size were reviewed for all fresh frozen samples. The stability of RNA and DNA in fresh frozen tissue was evaluated for 3% of collected samples and purity was assessed (ratio of the absorbance at 260 and 280 nm) as was integrity (agarose gel electrophoresis). Stained hematoxylin and eosin sections were reviewed by a pathologist to confirm the diagnosis and to assess how representative the frozen sample was. CONCLUSIONS We introduced that the quality-control criteria for fresh frozen tissue of the NBK. We expect that this study contributes to standardization of collection, storage, and quality control of fresh frozen tissue.
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In Korea, the quality control(QC) program forcytopathology was introduced in 1995. The program consists of a checklist for the cytolopathology departments, analysis data on all the participating institutions' QC data, including the annual data on cytologic examinations, the distribution of the gynecological cytologic diagnoses, as based on The Bethesda System 2001, and the data on cytologic-histolgical correlation of the gynecological field, and an evaluation for diagnostic accuracy. The diagnostic accuracy program has been performed 3 times per year with using gynecological, body fluid and fine needle aspiration cytologic slides. We report here on the institutional QC data and the evaluation for diagnostic accuracy since 2004, and also on the new strategy for quality control and assurance in the cytologic field. The diagnostic accuracy results of both the participating institutions and the QC committee were as follows; Category 0 and A: about 94%, Category B: 4~5%, Category C: less than 2%. As a whole, the cytologic daignostic accuracy is relatively satisfactory. In 2008, on site evaluation for pathology and cytology laboratories, as based on the "Quality Assurance Program for Pathology Services" is now going on, and a new method using virtual slides or image files for determining the diagnostic accuracy will be performed in November 2008.
A retrospective quality assurance study of intraoperative consultation (frozen section) was carried out to assess the accuracy and to determine the reasons of discordance. Of 14,977 surgical pathology cases accessioned over a 6-month period in Asan Medical Center, frozen sections were done on 1,270 (8.5%) patients and 2,392 frozen sections (1.88 frozen sections/case) were performed. Discordance was noted in 106 cases (4.4%) and diagnosis was deferred in 26 cases (1.1%).
All deferred cases were reviewed with the result of 53.8% justified and 46.2% unjustified. The discordant cases were divided into three categories as to their clinical significances: category A (no affect on patient care) 61.3%, B (minimal affect) 9.4%, and C (major affect) 29.2%. Of 31 category C cases, 7 cases were false positive and 24 cases were false negative. Misinterpretation (70.8%) was the leading cause of discordance, followed by sampling error (15.1%), failure to identify lesion (8.5%), and technical problem (5.7%). More than one-third (35.8%) of all discordances were of central nervous system cases. Total central nervous system cases were 403 (16.8%) with a significantly higher disordance rate (9.8%) and deferral rate (2.5%) in comparison to the other cases with 3.4% discordance rate and 0.8% deferral rate. There were 43 colorectal cancer cases of intraoperative consultation for adequacy of resectional margins. The surgical margins were between 0.4 cm and 28 cm (mean: 6.7 cm) away from the tumor and there was no tumor-positive case. The study indicates surgical pathology should 1) promote interpretative skills in cases involving minute fragments of neurosurgical cases, 2) defer the diagnosis and ask for more tissue on inadequate or inappropriate specimens and 3) give only gross opinions without unnecessary frozen section procedures in the event of simple, clear-cut cases.
For quality assurance purposes, the authors correlated aspiration cytology and subsequent tissue findings and examined the reasons for discrepancies. In three months from Jan. to Mar. 1996, 1,383 aspirations were performed, of which 285 (20.6%) had subsequent tissue diagnoses within two months. The aspiration sites were thyroid (483), lymph node (LN) (290), breast (250), soft tissue (154), liver (89), lung (49), salivary gland (26), pancreas (22), gallbladder (3), bone (3), joint (2), adrenal gland (2), scrotum (2), mediastinum (2), omentum (2), oral cavity (1), chest wall (1), and intraabdominal (1) and pelvic cavities (1). A total of 68 discrepancies were identified, and biopsies and smears from these cases were reviewed monthly. In 27 cases (40%), the discrepancy was attributed to sampling error. In five cases (9%), aspiration gave superior results with better sampling and preservation than biopsy. Thirty six cases (53% of discrepant cases) were errors in cytologic diagnosis. We categorized these discrepancies into "A", "B", and "C" ("A": minor disagreement with no affect on patient care, "B": minimal affect on patient care, "C": major affect on patient care), which were 9 (13%), 14 (21%) and 13 (19%) cases, respectively. In thirteen cases of category "C", there were eleven false negative and two false positive diagnoses.
Eleven false negative cases included thyroid (3), lymph node (2), breast (2), bone (1), salivary gland (1), lung (1), and liver (1). Three cases of thyroid were papillary carcinomas diagnosed as nodular hyperplasia (1), occasional pleomorphic cells (1), and cystic change (1). Two breast cases of invasive ductal carcinomas were diagnosed as ductal hyperplasia. A malignant lymphoma was diagnosed as reactive hyperplasia and a metastatic carcinoma of LN was diagnosed as tuberculosis. Other cases were malignant tumors of bone, salivary gland, lung, and liver those were misinterpreted as benign lesion or normal. Of two false positive cases, one was nodular hyperplasia of thyroid diagnosed as papillary carcinoma and the other was normal islet cell of pancreas diagnosed as islet cell tumor. A continuous monitoring of laboratory performance is an essential component of the quality control and assurance, and the review of discrepant cases provides useful information for improvement of diagnosis.
Jeong Wook Seo, Yoon Sung Lee, Je Geun Chi, Ghee Young Choe, Soong Deok Lee, Chong Jai Kim, In Ae Park, Woo Ho Kim, Ja June Jang, Chul Woo Kim, Seong Hoe Park, Jung Bin Lee, Hyun Soon Lee, Yong Il Kim, Eui Keun Ham, Sang Kook Lee
This study outlines the current status of the autopsy practice and the medical records for autopsies at the Department of Pathology, Seoul National University Hospital.
Total number of autopsy cases from 1954 to 1995 was 3,131.
Adults aged over 17 were 371 cases and children were 2,515 cases. The demographic data in 245 cases was not available.
The number of adult autopsies and its proportion among total number of autopsies during 10-year periods decreased from 144 cases (40%) during the 10-year-period from 1956 to 52 cases (3%) during the 10-year-period from 1986. The number of children cases during the same period groups increased slightly from 210 cases (58%) to 393 cases (25%). But the number of fetal cases increased rapidly from 7 cases (2%) to 1,146 cases (72%). Among fetal autopsies the proportion of fetuses died earlier than 24 weeks of gestation increased and this figure exceeds that of fetuses that died later than 24 weeks of gestation from 1992. Forty percent of the cases were submitted from the clinical departments of the Seoul National University Hospital but the remainders were referred from 73 hospitals. Final autopsy diagnoses were analysed according to the Korean Standard Classification of Disease (KCD)-3 coding system and by searching key words for all cases. Common diagnoses as coded among cases from 1990 were P9, P0, P2, Q2 and Q0. Common diseases by key words for adult cases were liver disease, tuberculosis and pneumonia.
Common diseases for children cases were pneumonia, hyaline membrane disease, meningitis and tuberculosis. Through this study we could show the importance of autopsy services for fetuses. We could also establish a regular registration system for autopsies at general hospitals.
The computerized image analysis is a useful tool for the quantitative assessment of histopathologic findings. In contrast to the usual microscopic examination by pathologists, the computerization should be accompanied with the standardization process of the image. We developed an algorithm to standardize images and to determine the optimal gray level threshold, using a myocardial fibrosis model.
Sirius red staining was more convenient for the image analysis than Masson's trichrome staining because of a better contrast with the surrounding structures. To get an optimal measurement, light intensity was standardized at each of the fibrosis, myocardium and background. In this study, the most promising method to determine the degree of fibrosis was that of revising the background without tissue to a gray level of 200, obtaining a green component of the color image, revising the myocardial fiber to 163, and defining a partial ratio as fibrosis index when the gray level threshold was 120. These threshold levels and parameters were determined after drawing the binarization index curves according to the change of the gray level threshold and by the morphological examination of the actual binarization figures overlaid to the original color image.
Through these processes we could get a consistent result on the myocardial fibrosis and we expect a similar principle applies when we analyze color images in the histopathologic quantitation by computerized image analysis.
Quality assurance analysis of frozen section diagnosis is very important for the pathologists to improve the diagnostic ability and the quality of medical service. We analysed 5,273 consecutive cases of frozen section diagnosis which were done in Samsung Medical Center during 10 months from June 1, 1998 to March 31. 1999 with special reference to the discordance between frozen section diagnosis and final diagnosis.
The concordance rate was 97.65%, discordance rate 1.34%, and deferred diagnosis (type 1) rate 1.01%. Category A (discordant diagnosis without any effect on the patients) was 53 cases (1.01%), category B (discordant diagnosis with minimal but no serious effect on the patients) was 10 cases (0.19%), and category C (discordant diagnosis with serious effect on the patients) was 8 cases (0.15%). Type 2 (discordant diagnosis by extra-pathologist problem) was 22 cases (0.42%) and type 3 (discordant diagnosis by pathologist problem) was 49 cases (0.93%). The most frequent causes of type 2 and 3 discordant diagnosis were presence of new lesions on deeper sections and the misinterpretation of lesions. Discordant diagnosis was noted in lymphoreticular system, central nervous system, thyroid, gastric resection margin, breast, female genital organs, intestine, hepatobiliary system, upper aerodigestive tract, urinary tract, lung, and soft tissue in descending order of frequency. Frozen section diagnosis was deferred in central nervous system, lymphoreticular system, gastric resection margin, female genital organs, thyroid, intestine, upper aerodigestive tract, lung, and soft tissue in descending order of frequency. The most important cause of discordant diagnosis was a misinterpretation of the lesions. Based on our results, a continuous and careful follow-up of quality assurance analysis of frozen section diagnosis and a share of experience of problematic cases are mandatory for the pathologists to improve the quality of medical services.
Although the success of the Papanicolaou test as a screening tool of cervical cancer is evident, there still exists 2-5% of discrepancy rate by both human and machine. To improve the qualilty of cervico-vaginal cytology, the authors compared cervicovaginal smear with cervical biopsy diagnoses, and analysed the causes of discrepancies. Among 30,922 cervicovaginal smears from June 1996 to April 1997 at our hospital, there were 271 cases of cervicovaginal smear with subsequent cervical punch or LEEP cone biopsies within several months. The biopsies and smears from a total of 98 discordant cases were reviewed. The discrepancy was attributed to sampling errors in 43 cases(43.9%), and to cytologic diagnosis in 49 cases(50.0%).
Among these, 43 cases were interpretative errors(categories A;19, B;16 and C;8), whereas six cases were screening errors(categories B;2 and C;4). Among cervical biopsy cases, errors were present in four. As for 10% random rescreening, cytote chnologists reviewed 3,196 of 30,922 smears during the same period. There were 43 cases of screening error(categories A;27, B;16).
Cytologic/histologic correlation was superior to 10% random rescreening of negative cases. The most effective method for quality improvement in cervicovaginal cytology was to implement both quality control(rescreening) and quality assurance(cytologic/histologic correlation) programs.