Annual Report 2017

Kimihiko Kawamura, Motoi Miyakoshi, Masahiro Uchikawa, Susumu Wakai, Koji Ono, Hiroshi Yamakawa, Ryuzaburo Otake, Yoji Hashimoto, Yasuo Shibuki, Hiroki Kakishima, Tomohiro Nakatani, Michi Shohji, Tsutomu Watanabe, Rie Matsuo, Kazuya Tokita, Chiaki Ikeda, Susumu Asikawa, Yukie Nakajima, Sachiko Kobayashi, Yuko Adegawa, Satoe Miyaki, Kumiko Nagasaki, Noriko Takahashi, Mizuho Fujima, Tomoe Ito, Kyoko Orihara, Kaori Ueki, Fumie Watanabe, Akino Kino, Takako Takada, Kyoko Osanai, Ruriko Machida, Asuka Matsunaga, Hiroshi Chigira, Go Sato, Sakiko Yoshimura, Yu Aruga, Saori Kobayashi, Kaori Yamaguchi, Ryoko Uegaki, Kensyo Kashiwaya, Saori Nakabayashi, Shingo Nakajima, Hideya Matsubayashi, Saeko Shirahama, Akiko Takayanagi, Mei Fukuhara, Kumi Nakatani, Momoko Kito, Moemi Kasane, Kazuhiro Yoshida, Kenta Takehara, Madoka Kondo, Yota Ikegami, Megumi Hasegawa, Takaki Kobayashi, Kana Katsuragi, Aisa Mizoguchi, Hitomi Tsuchiya, Mai Okayama, Haruki Sasaki, Mayu Takeno, Sakura Ishida, Yuri Kurosawa, Misato Tsubokura, Hitomi Nakamura, Megumi Masuda, Yoshiko Shibata, Naomi Fujiki, Ritsuko Toyama, Chieko Nozawa, Kozaburo Endo, Shigeru Tamura, Mikako Kobayashi

Routine activities/research activities

 Operations at the Clinical Laboratories are organized into five sections: Clinical laboratories (CL) (urinalysis, hematology, biochemistry, immunology, bacteriology and gene testing), blood sampling, transfusion and cell therapy testing, pathological examination, and physiological examination. The department received initial accreditation under ISO 15189, the international standard related to requirements for quality and competence in medical laboratories, in September 2012, and has maintained this accreditation, completing a four-year cycle of surveillance visits and reassessment for renewal.

1) The CL Section retooled biochemistry, immunology and urinalysis instruments, as well as CL and specimen dispensing transport systems, in January 2016, and has been providing quick and accurate testing results to examination.

 As for the hematologic tests, we introduced a flow cytometer with eight-color analysis capabilities to streamline the specimen treatment in cell surface marker tests, contributing to the improvement of diagnostic accuracy for hematopoietic malignancies.

 As for bacteriology testing, the use of mass spectroscopy for bacterial identification has reduced the number of days needed for the results to be reported, contributing to the appropriate use of antibiotics.

 As for the gene testing, we have begun compre-

 hensive gene testing using a next-generation sequencer (NGS) in collaboration with Sysmex at the Sysmex Cancer Innovation Laboratory (SCI-Lab), and the successful accumulation of results has led to the application of Advanced Medical Care B from the Ministry of Health, Labour and Welfare in April 2018.

2) In the Blood Sampling Section, in response to an increase in the number of sampled patients, we have added two booths in the central blood-drawing room, increasing the total to nine booths, to reduce waiting time.

3) In the Transfusion and Cell Therapy Testing Section, the reporting system of the number of hematopoietic stem cells has established to shorten the hospitalization periods of patients and donors; It is composed of a sequential analysis of a simple and inexpensive blood test using a multi-parameter automated hematology analyzer to determine the timing for sampling peripheral blood stem cells, and a quickly report the number of harvested cells using a flow cytometry.

4) In the Pathological Examination Section, the number of automated immunostainers was increased to cope with the ever-increasing need for screening of patients for molecular target drugs.

5) In the Physiological Examination Section, the installation of additional cardiac ultrasonography equipment has reduced the number of days patients spend on the waiting list, facilitating prompt response to requests for tests and evaluation of cardiac toxicity from anticancer drugs in relation to clinical trials.

 The number of clinical laboratory test orders has been increasing steadily in most of sections. In 2017, the total number of clinical tests performed was 6,281,973, up 5% from the previous year (Table 1). The Clinical Laboratories is also moving forward with collaborations in clinical trials, translational research, and biobank projects.

Research results

 The Clinical Laboratories is conducting basic and clinical studies concerning factors affecting the accuracy of laboratory tests.

Human resource training and education

 Development and education of personnel are conducted according to the education and training protocol prescribed based on quality management system (QMS) as per ISO 15189. With respect to routine work, all personnel are assessed annually for their capabilities through self-assessment and assessment by assessors using the check sheet for the understanding of work. Newly recruited technologists are trained using the check sheet for initial understanding to ensure the acquisition of work skills. In addition, newly recruited technologists undergo four-week training in blood sampling to learn the basic knowledge and skills including patient reception for blood sampling, handling specimens, and interaction with patients. With regard to academic activities, we host monthly conferences. In addition, we held a workshop focusing on the quality and technical requirements of ISO 15189 four times a year, aiming to instill an understanding of QMS as per ISO 15189 among all personnel. As a rule, all workshop sessions are organized by the personnel of the Clinical Laboratories with an aim to improve their presentation skills. Each section sets its yearly goals for academic activities and conducts regular progress management as a means for systematically encouraging people to obtain certifications, contribute papers, and make presentations at academic conferences. Rehearsals are always performed before academic presentations to ensure the quality of presentations. With regard to student education, we maintain ongoing university internships, actively accept on-site practice trainees, and work to communicate the attraction of clinical testing operations.

Future prospects

 As an ISO 15189-accredited testing facility, we guarantee the quality and capabilities meeting international standard and also promote cooperation in clinical trials and clinical studies. We expand the central blood drawing room to improve the efficiency of work related to blood sampling. We pursue standardization of the quality control system in cancer genomic medicine. We construct a cooperation system for cancer immunotherapy, such as chimeric antigen receptor T cell therapy (CAR-T). We strengthen the organizational capacity for performing ultrasound examination, aiming to improve qualitative diagnosis of tumors. We promote the training and use of highly specialized clinical laboratory technologists. We promote academic and research activities and disseminate information in and out of the country.

Publications

1. Takahashi N, Tanosaki R, Sakai S, Kishino K, Kajiwara M, Ito T,Ikeda K, Haraguchi K,

 Watanabe N, Ueda Y, Matsumoto M, Takanashi M. Comparison of total uncleated cell counts of bone marrow grafts among transplant-

 collection centers in Japan. JJTC, 63: 120-125, 2017

2. Hashimoto M, Miyakoshi M, Nakatani T,

 Nakajima Y, Kobayashi S, Itou T, Hasuo S,

 Nakajima S, Hiraoka N. Study of ultrasound images of paragangliomas. JJMUT, 42: 24-35, 2017

3. Kito M, Munakata W, Ono K, Maeshima A,

 Matsushita H. The infiltration of classical

 Hodgkin lymphoma cells into pleural effusion; Int J Hematol, 107: 1-2, 2018

4. Aruga Y, Arakawa A, Ono K, Ogawa C,

 Matsushita H. Pseudo-Chediak–Higashi granules and Auer rods in mixed phenotype acute leukaemia, T/myeloid, not otherwise specified; BJ Hematol, 180: 175, 2018

5. Yoshimura S, Munakata W, Ikeda C, Matsushita H. Marked erythroblastosis in myelodysplastic syndrome induced by gastric hemorrhaging; Int J Hematol, 107: 387-389, 2018

List of papers published in January 2017 - March 2018

Journal

1. Makise N, Sekimizu M, Kubo T, Wakai S, Watanabe SI, Kato T, Kinoshita T, Hiraoka N, Fukayama M, Kawai A, Ichikawa H, Yoshida A. Extraskeletal osteosarcoma: MDM2 and H3K27me3 analysis of 19 cases suggest disease heterogeneity. Histopathology, 73:147-156, 2018

2. Yoshimura S, Munakata W, Ikeda C, Matsushita H. Marked erythroblastosis in myelodysplastic syndrome induced by gastric hemorrhaging. Int J Hematol, 107:387-389, 2018

3. Kito M, Munakata W, Ono K, Maeshima AM, Matsushita H. The infiltration of classical Hodgkin lymphoma cells into pleural effusion. Int J Hematol, 107:1-2, 2018

4. Aruga Y, Arakawa A, Ono K, Ogawa C, Matsushita H. Pseudo-Chediak-Higashi granules and Auer rods in mixed phenotype acute leukaemia, T/myeloid, not otherwise specified. Br J Haematol, 180:175, 2018

5. Makise N, Sekimizu M, Kubo T, Wakai S, Hiraoka N, Komiyama M, Fukayama M, Kawai A, Ichikawa H, Yoshida A. Clarifying the Distinction Between Malignant Peripheral Nerve Sheath Tumor and Dedifferentiated Liposarcoma: A Critical Reappraisal of the Diagnostic Utility of MDM2 and H3K27me3 Status. Am J Surg Pathol, 42:656-664, 2018

6. Yoshida A, Makise N, Wakai S, Kawai A, Hiraoka N. INSM1 expression and its diagnostic significance in extraskeletal myxoid chondrosarcoma. Mod Pathol, 31:744-752, 2018