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8 "Quality assurance"
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Diagnostic proficiency test using digital cytopathology and comparative assessment of whole slide images of cytologic samples for quality assurance program in Korea
Yosep Chong, Soon Auck Hong, Hoon Kyu Oh, Soo Jin Jung, Bo-Sung Kim, Ji Yun Jeong, Ho-Chang Lee, Gyungyub Gong
J Pathol Transl Med. 2023;57(5):251-264.   Published online August 24, 2023
DOI: https://doi.org/10.4132/jptm.2023.07.17
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AbstractAbstract PDFSupplementary Material
Background
The Korean Society for Cytopathology introduced a digital proficiency test (PT) in 2021. However, many doubtful opinions remain on whether digitally scanned images can satisfactorily present subtle differences in the nuclear features and chromatin patterns of cytological samples.
Methods
We prepared 30 whole-slide images (WSIs) from the conventional PT archive by a selection process for digital PT. Digital and conventional PT were performed in parallel for volunteer institutes, and the results were compared using feedback. To assess the quality of cytological assessment WSIs, 12 slides were collected and scanned using five different scanners, with four cytopathologists evaluating image quality through a questionnaire.
Results
Among the 215 institutes, 108 and 107 participated in glass and digital PT, respectively. No significant difference was noted in category C (major discordance), although the number of discordant cases was slightly higher in the digital PT group. Leica, 3DHistech Pannoramic 250 Flash, and Hamamatsu NanoZoomer 360 systems showed comparable results in terms of image quality, feature presentation, and error rates for most cytological samples. Overall satisfaction was observed with the general convenience and image quality of digital PT.
Conclusions
As three-dimensional clusters are common and nuclear/chromatin features are critical for cytological interpretation, careful selection of scanners and optimal conditions are mandatory for the successful establishment of digital quality assurance programs in cytology.
Development of quality assurance program for digital pathology by the Korean Society of Pathologists
Yosep Chong, Jeong Mo Bae, Dong Wook Kang, Gwangil Kim, Hye Seung Han
J Pathol Transl Med. 2022;56(6):370-382.   Published online November 15, 2022
DOI: https://doi.org/10.4132/jptm.2022.09.30
  • 1,721 View
  • 110 Download
  • 1 Web of Science
  • 1 Crossref
AbstractAbstract PDFSupplementary Material
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.

Citations

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  • Diagnostic proficiency test using digital cytopathology and comparative assessment of whole slide images of cytologic samples for quality assurance program in Korea
    Yosep Chong, Soon Auck Hong, Hoon Kyu Oh, Soo Jin Jung, Bo-Sung Kim, Ji Yun Jeong, Ho-Chang Lee, Gyungyub Gong
    Journal of Pathology and Translational Medicine.2023; 57(5): 251.     CrossRef
Quality Assurance of Intraoperative Consultation Review Analysis of 2,392 frozen sections.
Dong Hae Chung, Jae Hee Suh, On Ja Kim
Korean J Pathol. 1997;31(4):332-341.
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  • 46 Download
AbstractAbstract PDF
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.
Cytologic and Histologic Correlation for Quality Assurance in Aspiration Cytology.
Ho Jung Lee, Young Mee Cho, So Young Park, Joo ryung Huh, On Ja Kim, Gyung Yub Gong
Korean J Pathol. 1997;31(11):1214-1221.
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AbstractAbstract
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.
The Current Practice of the Autopsy Services and the Autopsy Records at the Seoul National University Hospital.
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
Korean J Pathol. 1998;32(6):453-459.
  • 1,660 View
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AbstractAbstract
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.
Image Standardization and Determination of Gray Level Threshold in the Assessment of the Myocardial Fibrosis by the Computerized Image Analysis.
Nam Young Lee, Young Sik Park, Jin Haeng Chung, Jeong Wook Seo
Korean J Pathol. 1998;32(7):494-503.
  • 1,424 View
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AbstractAbstract
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 of Frozen Section Diagnosis An analysis of 5,273 consecutive cases .
Sang Yong Song, Geunghwan Ahn
Korean J Pathol. 1999;33(12):1182-1190.
  • 1,725 View
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AbstractAbstract PDF
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.
Second Opinion Diagnostic Discrepancy in Surgical Pathology: Asan Medical Center Experience.
Young Min Kim, Kyung Ja Cho, Sun Young Jun, Mi Sun Choe, Shin Kwang Khang, Jae Y Ro
Korean J Pathol. 2003;37(5):301-306.
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AbstractAbstract PDF
BACKGROUND
Review of the outside pathology material is an important practice that provides useful information on patient managements and improves the diagnostic quality in surgical pathology. We report our experience with the frequency and types of diagnostic discrepancies in patients referred to the Asan Medical Center for treatment or a second opinion.
METHODS
All referral pathology diagnoses (867 surgical cases) made from October 2001 to July 2002 at Asan Medical Center were compared with outside pathology diagnoses.
RESULTS
Of the 867 surgical cases reviewed, 231 (26.7%) cases had a diagnostic discrepancy, which included 49 (5.7%) major and 182 (21.0%) minor discrepancies. The contents of the major discrepancies were a change in the diagnosis (34 cases), a change in the type of malignancy including small cell carcinoma and non-small cell carcinoma of the lung (10), a diagnosis of a metastasis as the primary lesion (4), and errors in interpreting the invasiveness (1). The causes or reasons for the major discrepancy were a difference in interpretation (81.6%), the availability of special studies (10.2%), a failure to identify the lesions (4.1%), and a lack of clinical information (4.1%).
CONCLUSIONS
The major discrepancy rate (5.7%) was comparable to that of the other reports from western countries. Among the major discrepancies, a change in diagnosis was most commonly observed and difference in interpretation was the most common reason. A routine review of all the patients pathology material is recommended for all referral patients for an improvement in the pathologic diagnoses and to provide better medical care.

J Pathol Transl Med : Journal of Pathology and Translational Medicine