Journal of Pathology and Translational Medicine

Original Article

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

1,674 View
110 Download
1 Web of Science
1 Crossref

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

Citations to this article as recorded by

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

Review

Good Laboratory Standards for Clinical Next-Generation Sequencing Cancer Panel Tests: Jihun Kim, Woong-Yang Park, Nayoung K. D. Kim, Se Jin Jang, Sung-Min Chun, Chang-Ohk Sung, Jene Choi, Young-Hyeh Ko, Yoon-La Choi, Hyo Sup Shim, Jae-Kyung Won; J Pathol Transl Med. 2017;51(3):191-204. Published online May 10, 2017; DOI: https://doi.org/10.4132/jptm.2017.03.14

22,948 View
1,056 Download
30 Web of Science
31 Crossref

Abstract PDF

Next-generation sequencing (NGS) has recently emerged as an essential component of personalized cancer medicine due to its high throughput and low per-base cost. However, no sufficient guidelines for implementing NGS as a clinical molecular pathology test are established in Korea. To ensure clinical grade quality without inhibiting adoption of NGS, a taskforce team assembled by the Korean Society of Pathologists developed laboratory guidelines for NGS cancer panel testing procedures and requirements for clinical implementation of NGS. This consensus standard proposal consists of two parts: laboratory guidelines and requirements for clinical NGS laboratories. The laboratory guidelines part addressed several important issues across multistep NGS cancer panel tests including choice of gene panel and platform, sample handling, nucleic acid management, sample identity tracking, library preparation, sequencing, analysis and reporting. Requirements for clinical NGS tests were summarized in terms of documentation, validation, quality management, and other required written policies. Together with appropriate pathologist training and international laboratory standards, these laboratory standards would help molecular pathology laboratories to successfully implement NGS cancer panel tests in clinic. In this way, the oncology community would be able to help patients to benefit more from personalized cancer medicine.

Citations

Citations to this article as recorded by

Validation and Clinical Application of ONCOaccuPanel for Targeted Next-Generation Sequencing of Solid Tumors
Moonsik Kim, Changseon Lee, Juyeon Hong, Juhee Kim, Ji Yun Jeong, Nora Jee-Young Park, Ji-Eun Kim, Ji Young Park
Cancer Research and Treatment.2023; 55(2): 429. CrossRef
Establishing molecular pathology curriculum for pathology trainees and continued medical education: a collaborative work from the Molecular Pathology Study Group of the Korean Society of Pathologists
Jiwon Koh, Ha Young Park, Jeong Mo Bae, Jun Kang, Uiju Cho, Seung Eun Lee, Haeyoun Kang, Min Eui Hong, Jae Kyung Won, Youn-La Choi, Wan-Seop Kim, Ahwon Lee
Journal of Pathology and Translational Medicine.2023; 57(5): 265. CrossRef
Clinical applications of next-generation sequencing in the diagnosis of genetic disorders in Korea: a narrative review
Jihoon G. Yoon, Man Jin Kim, Yong Jin Kwon, Jong-Hee Chae
Journal of the Korean Medical Association.2023; 66(10): 613. CrossRef
Obtaining spatially resolved tumor purity maps using deep multiple instance learning in a pan-cancer study
Mustafa Umit Oner, Jianbin Chen, Egor Revkov, Anne James, Seow Ye Heng, Arife Neslihan Kaya, Jacob Josiah Santiago Alvarez, Angela Takano, Xin Min Cheng, Tony Kiat Hon Lim, Daniel Shao Weng Tan, Weiwei Zhai, Anders Jacobsen Skanderup, Wing-Kin Sung, Hwee
Patterns.2022; 3(2): 100399. CrossRef
Update on Molecular Diagnosis in Extranodal NK/T-Cell Lymphoma and Its Role in the Era of Personalized Medicine
Ka-Hei (Murphy) Sun, Yin-Ting (Heylie) Wong, Ka-Man (Carmen) Cheung, Carmen (Michelle) Yuen, Yun-Tat (Ted) Chan, Wing-Yan (Jennifer) Lai, Chun (David) Chao, Wing-Sum (Katie) Fan, Yuen-Kiu (Karen) Chow, Man-Fai Law, Ho-Chi (Tommy) Tam
Diagnostics.2022; 12(2): 409. CrossRef
Defining Novel DNA Virus-Tumor Associations and Genomic Correlates Using Prospective Clinical Tumor/Normal Matched Sequencing Data
Chad M. Vanderbilt, Anita S. Bowman, Sumit Middha, Kseniya Petrova-Drus, Yi-Wei Tang, Xin Chen, Youxiang Wang, Jason Chang, Natasha Rekhtman, Klaus J. Busam, Sounak Gupta, Meera Hameed, Maria E. Arcila, Marc Ladanyi, Michael F. Berger, Snjezana Dogan, Ahm
The Journal of Molecular Diagnostics.2022; 24(5): 515. CrossRef
Performance Evaluation of Three DNA Sample Tracking Tools in a Whole Exome Sequencing Workflow
Gertjan Wils, Céline Helsmoortel, Pieter-Jan Volders, Inge Vereecke, Mauro Milazzo, Jo Vandesompele, Frauke Coppieters, Kim De Leeneer, Steve Lefever
Molecular Diagnosis & Therapy.2022; 26(4): 411. CrossRef
Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development
Timothé Ménard, Alaina Barros, Christopher Ganter
Therapeutic Innovation & Regulatory Science.2021; 55(5): 1066. CrossRef
Fast Healthcare Interoperability Resources (FHIR)–Based Quality Information Exchange for Clinical Next-Generation Sequencing Genomic Testing: Implementation Study
Donghyeong Seong, Sungwon Jung, Sungchul Bae, Jongsuk Chung, Dae-Soon Son, Byoung-Kee Yi
Journal of Medical Internet Research.2021; 23(4): e26261. CrossRef
Status of Next-Generation Sequencing-Based Genetic Diagnosis in Hematologic Malignancies in Korea (2017-2018)
JinJu Kim, Ja Young Lee, Jungwon Huh, Myung-Hyun Nam, Myungshin Kim, Young-Uk Cho, Sun-Young Kong, Seung-Tae Lee, In-Suk Kim
Laboratory Medicine Online.2021; 11(1): 25. CrossRef
MSI-Testung
Josef Rüschoff, Gustavo Baretton, Hendrik Bläker, Wolfgang Dietmaier, Manfred Dietel, Arndt Hartmann, Lars-Christian Horn, Korinna Jöhrens, Thomas Kirchner, Ruth Knüchel, Doris Mayr, Sabine Merkelbach-Bruse, Hans-Ulrich Schildhaus, Peter Schirmacher, Mark
Der Pathologe.2021; 42(4): 414. CrossRef
Molecular biomarker testing for non–small cell lung cancer: consensus statement of the Korean Cardiopulmonary Pathology Study Group
Sunhee Chang, Hyo Sup Shim, Tae Jung Kim, Yoon-La Choi, Wan Seop Kim, Dong Hoon Shin, Lucia Kim, Heae Surng Park, Geon Kook Lee, Chang Hun Lee
Journal of Pathology and Translational Medicine.2021; 55(3): 181. CrossRef
MSI testing
Josef Rüschoff, Gustavo Baretton, Hendrik Bläker, Wolfgang Dietmaier, Manfred Dietel, Arndt Hartmann, Lars-Christian Horn, Korinna Jöhrens, Thomas Kirchner, Ruth Knüchel, Doris Mayr, Sabine Merkelbach-Bruse, Hans-Ulrich Schildhaus, Peter Schirmacher, Mark
Der Pathologe.2021; 42(S1): 110. CrossRef
16S rDNA microbiome composition pattern analysis as a diagnostic biomarker for biliary tract cancer
Huisong Lee, Hyeon Kook Lee, Seog Ki Min, Won Hee Lee
World Journal of Surgical Oncology.2020;[Epub] CrossRef
Risk Stratification Using a Novel Genetic Classifier IncludingPLEKHS1Promoter Mutations for Differentiated Thyroid Cancer with Distant Metastasis
Chan Kwon Jung, Seung-Hyun Jung, Sora Jeon, Young Mun Jeong, Yourha Kim, Sohee Lee, Ja-Seong Bae, Yeun-Jun Chung
Thyroid.2020; 30(11): 1589. CrossRef
Biomarker testing for advanced lung cancer by next-generation sequencing; a valid method to achieve a comprehensive glimpse at mutational landscape
Anurag Mehta, Smreti Vasudevan, Sanjeev Kumar Sharma, Manoj Panigrahi, Moushumi Suryavanshi, Mumtaz Saifi, Ullas Batra
Applied Cancer Research.2020;[Epub] CrossRef
Application Areas of Traditional Molecular Genetic Methods and NGS in relation to Hereditary Urological Cancer Diagnosis
Dmitry S. Mikhaylenko, Alexander S. Tanas, Dmitry V. Zaletaev, Marina V. Nemtsova
Journal of Oncology.2020; 2020: 1. CrossRef
Assembling and Validating Bioinformatic Pipelines for Next-Generation Sequencing Clinical Assays
Jeffrey A SoRelle, Megan Wachsmann, Brandi L. Cantarel
Archives of Pathology & Laboratory Medicine.2020; 144(9): 1118. CrossRef
Standard operating procedure for somatic variant refinement of sequencing data with paired tumor and normal samples
Erica K. Barnell, Peter Ronning, Katie M. Campbell, Kilannin Krysiak, Benjamin J. Ainscough, Lana M. Sheta, Shahil P. Pema, Alina D. Schmidt, Megan Richters, Kelsy C. Cotto, Arpad M. Danos, Cody Ramirez, Zachary L. Skidmore, Nicholas C. Spies, Jasreet Hun
Genetics in Medicine.2019; 21(4): 972. CrossRef
A DNA pool of FLT3-ITD positive DNA samples can be used efficiently for analytical evaluation of NGS-based FLT3-ITD quantitation - Testing several different ITD sequences and rates, simultaneously
Zoltán A. Mezei, Dávid Tornai, Róza Földesi, László Madar, Andrea Sümegi, Mária Papp, Péter Antal-Szalmás
Journal of Biotechnology.2019; 303: 25. CrossRef
Pharmacogenomic Testing: Clinical Evidence and Implementation Challenges
Hippman, Nislow
Journal of Personalized Medicine.2019; 9(3): 40. CrossRef
Cancer Panel Assay for Precision Oncology Clinic: Results from a 1-Year Study
Dohee Kwon, Binnari Kim, Hyeong Chan Shin, Eun Ji Kim, Sang Yun Ha, Kee-Taek Jang, Seung Tae Kim, Jeeyun Lee, Won Ki Kang, Joon Oh Park, Kyoung-Mee Kim
Translational Oncology.2019; 12(11): 1488. CrossRef
Analytical Evaluation of an NGS Testing Method for Routine Molecular Diagnostics on Melanoma Formalin-Fixed, Paraffin-Embedded Tumor-Derived DNA
Mancini, Simi, Salvianti, Castiglione, Sonnati, Pinzani
Diagnostics.2019; 9(3): 117. CrossRef
Benchmark Database for Process Optimization and Quality Control of Clinical Cancer Panel Sequencing
Donghyeong Seong, Jongsuk Chung, Ki-Wook Lee, Sook-Young Kim, Byung-Suk Kim, Jung-Keun Song, Sungwon Jung, Taeseob Lee, Donghyun Park, Byoung-Kee Yi, Woong-Yang Park, Dae-Soon Son
Biotechnology and Bioprocess Engineering.2019; 24(5): 793. CrossRef
Use of the Ion PGM and the GeneReader NGS Systems in Daily Routine Practice for Advanced Lung Adenocarcinoma Patients: A Practical Point of View Reporting a Comparative Study and Assessment of 90 Patients
Simon Heeke, Véronique Hofman, Elodie Long-Mira, Virginie Lespinet, Salomé Lalvée, Olivier Bordone, Camille Ribeyre, Virginie Tanga, Jonathan Benzaquen, Sylvie Leroy, Charlotte Cohen, Jérôme Mouroux, Charles Marquette, Marius Ilié, Paul Hofman
Cancers.2018; 10(4): 88. CrossRef
Use of the Ion AmpliSeq Cancer Hotspot Panel in clinical molecular pathology laboratories for analysis of solid tumours: With emphasis on validation with relevant single molecular pathology tests and the Oncomine Focus Assay
Ahwon Lee, Sung-Hak Lee, Chan Kwon Jung, Gyungsin Park, Kyo Young Lee, Hyun Joo Choi, Ki Ouk Min, Tae Jung Kim, Eun Jung Lee, Youn Soo Lee
Pathology - Research and Practice.2018; 214(5): 713. CrossRef
Recent Advancement of the Molecular Diagnosis in Pediatric Brain Tumor
Jeong-Mo Bae, Jae-Kyung Won, Sung-Hye Park
Journal of Korean Neurosurgical Society.2018; 61(3): 376. CrossRef
The long tail of molecular alterations in non-small cell lung cancer: a single-institution experience of next-generation sequencing in clinical molecular diagnostics
Caterina Fumagalli, Davide Vacirca, Alessandra Rappa, Antonio Passaro, Juliana Guarize, Paola Rafaniello Raviele, Filippo de Marinis, Lorenzo Spaggiari, Chiara Casadio, Giuseppe Viale, Massimo Barberis, Elena Guerini-Rocco
Journal of Clinical Pathology.2018; 71(9): 767. CrossRef
Clinical laboratory utilization management and improved healthcare performance
Christopher Naugler, Deirdre L. Church
Critical Reviews in Clinical Laboratory Sciences.2018; 55(8): 535. CrossRef
Development of HLA-A, -B and -DR Typing Method Using Next-Generation Sequencing
Dong Hee Seo, Jeong Min Lee, Mi Ok Park, Hyun Ju Lee, Seo Yoon Moon, Mijin Oh, So Young Kim, Sang-Heon Lee, Ki-Eun Hyeong, Hae-Jin Hu, Dae-Yeon Cho
The Korean Journal of Blood Transfusion.2018; 29(3): 310. CrossRef
Value-based genomics
Jun Gong, Kathy Pan, Marwan Fakih, Sumanta Pal, Ravi Salgia
Oncotarget.2018; 9(21): 15792. CrossRef

Original Article

Quality Control Program for Fresh Frozen Tissue and Its Results of Chonbuk National University Hospital National Biobank of Korea.: Shin Young Park, Hyun Ah Baek, Hyoung Jong Kwak, Sang Hyun Hong, Ho Sung Park, Kyu Yun Jang, Woo Sung Moon, Myoung Jae Kang, Dong Geun Lee, Myoung Ja Chung; Korean J Pathol. 2010;44(3):295-301.; DOI: https://doi.org/10.4132/KoreanJPathol.2010.44.3.295

3,934 View
42 Download
1 Crossref

Abstract PDF

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.

Citations

Citations to this article as recorded by

Influence of Cold Ischemia Time and Storage Period on DNA Quality and Biomarker Research in Biobanked Colorectal Cancer Tissues
Min Gyoung Pak, Mee Sook Roh
Kosin Medical Journal.2020; 35(1): 26. CrossRef

Review

Quality Control Program and Its Results of Korean Society for Cytopathologists.: Hye Kyung Lee, Sung Nam Kim, Shin Kwang Khang, Chang Suk Kang, Hye Kyoung Yoon; Korean J Cytopathol. 2008;19(2):65-71.; DOI: https://doi.org/10.3338/kjc.2008.19.2.65

2,358 View
21 Download
9 Crossref

Abstract PDF

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.

Citations

Citations to this article as recorded by

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
Usefulness of p16INK4a Immunocytochemical staining for the Differentiation between Atrophy and ASCUS in Diagnosis of Uterine Cervical Cancer
Hye Ryoung Shin, Taekil Eom, Wan-Su Choi
Biomedical Science Letters.2023; 29(3): 144. CrossRef
Current status of cytopathology practice in Korea: impact of the coronavirus pandemic on cytopathology practice
Soon Auck Hong, Haeyoen Jung, Sung Sun Kim, Min-Sun Jin, Jung-Soo Pyo, Ji Yun Jeong, Younghee Choi, Gyungyub Gong, Yosep Chong
Journal of Pathology and Translational Medicine.2022; 56(6): 361. CrossRef
Current status of cytopathology practices in Korea: annual report on the Continuous Quality Improvement program of the Korean Society for Cytopathology for 2018
Yosep Chong, Haeyoen Jung, Jung-Soo Pyo, Soon Won Hong, Hoon Kyu Oh
Journal of Pathology and Translational Medicine.2020; 54(4): 318. CrossRef
Continuous quality improvement program and its results of Korean Society for Cytopathology
Yoo-Duk Choi, Hoon-Kyu Oh, Su-Jin Kim, Kyung-Hee Kim, Yun-Kyung Lee, Bo-Sung Kim, Eun-Jeong Jang, Yoon-Jung Choi, Eun-Kyung Han, Dong-Hoon Kim, Younghee Choi, Chan-Kwon Jung, Sung-Nam Kim, Kyueng-Whan Min, Seok-Jin Yoon, Hun-Kyung Lee, Kyung Un Choi, Hye
Journal of Pathology and Translational Medicine.2020; 54(3): 246. CrossRef
Current Status of and Perspectives on Cervical Cancer Screening in Korea
Sung-Chul Lim, Chong Woo Yoo
Journal of Pathology and Translational Medicine.2019; 53(4): 210. CrossRef
Current Cytology Practices in Korea: A Nationwide Survey by the Korean Society for Cytopathology
Eun Ji Oh, Chan Kwon Jung, Dong-Hoon Kim, Han Kyeom Kim, Wan Seop Kim, So-Young Jin, Hye Kyoung Yoon
Journal of Pathology and Translational Medicine.2017; 51(6): 579. CrossRef
Comparison of Unsatisfactory Samples from Conventional Smear versus Liquid-Based Cytology in Uterine Cervical Cancer Screening Test
Hoiseon Jeong, Sung Ran Hong, Seoung-Wan Chae, So-Young Jin, Hye Kyoung Yoon, Juhie Lee, Eun Kyung Kim, Sook Tai Ha, Sung Nam Kim, Eun-Jung Park, Jong Jae Jung, Sun Hee Sung, Sung-chul Lim
Journal of Pathology and Translational Medicine.2017; 51(3): 314. CrossRef
The Usefulness of p16INK4aImmunocytochemical Staining in ASC-H Patients
Kwang Il Yim, Yeo-Ju Kang, Tae Eun Kim, Gyeongsin Park, Eun Sun Jung, Yeong-Jin Choi, Kyo-Young Lee, Chang Seok Kang, Ahwon Lee
The Korean Journal of Pathology.2011; 45(3): 290. CrossRef

First
Prev
Page of 1
Next
Last

Search