Department of Laboratory Medicine

【Overview】 The Department of Laboratory Medicine of Guangdong Provincial Hospital of Chinese Medicine is a comprehensive medical laboratory integrating medical care, education, research and services. It includes the Department of Laboratory Medicine and the Department of Blood Transfusion of the main hospital on Dade Road, the Departments of Laboratory Medicine of Ersha Island Hospital, Fangcun Hospital, University Town Hospital, Zhuhai Hospital and Guizhou Hospital, the Clinical Laboratory Standardization Team, and the Laboratory Units of Xiatang, Tianhe and Shijing Outpatient Clinics. The Department of Laboratory Medicine was one of the earliest hospital laboratory departments in China to introduce the ISO quality management system. In 2004, the Department of Laboratory Medicine of Ersha Island Hospital became the first hospital laboratory department in China to obtain accreditation as an ISO/IEC 17025 testing laboratory. In 2005, it became the second department in China, after the Department of Clinical Laboratory of the General Hospital of the Chinese People's Liberation Army, and the first comprehensive laboratory department to obtain ISO 15189 medical laboratory accreditation. In 2013, the Medical Calibration Laboratory of the Department of Laboratory Medicine became one of the first laboratories in China to obtain accreditation to both ISO 15195 for medical reference laboratories and ISO/IEC 17025 for calibration laboratories. In 2016, the Medical Calibration Laboratory was included in the service list of the Joint Committee for Traceability in Laboratory Medicine (JCTLM), marking the formal entry of the Medical Calibration Laboratory of the Department of Laboratory Medicine of Guangdong Provincial Hospital of Chinese Medicine into the ranks of world-class calibration laboratories. It is capable of assigning values to reference materials for international clinical laboratory testing programs and contributing to the standardization and international mutual recognition of laboratory results. Beginning in 2009, the Department of Laboratory Medicine, as one of 7 institutions nationwide and representing South China, participated in the research project “Establishment of Reference Intervals for Important Routine Clinical Laboratory Tests in the Chinese Population” of the Ministry of Health. The project was also funded by a major project grant under the national “12th Five-Year Plan”. In the same year, the Department of Laboratory Medicine was named one of the “Top Ten Outstanding Laboratory Departments of the Year in Chinese Laboratory Medicine” by Science Times. In 2012, it was designated a “Key Clinical Specialty of Guangdong Province”. In 2013, it was selected by the Guangdong Clinical Laboratory Center as a “Pilot Base for Clinical Laboratory Quality Evaluation in Guangdong Province”. In 2019, it was designated a “High-Level Key Clinical Specialty of Guangdong Province”; in the same year, it was selected as a “Base for Advanced Study and Training in Laboratory Medicine” by the Capacity Building and Continuing Education Center of the National Health Commission, and was selected by the National Office for Ageing as the Guangdong regional center of the medical consortium for geriatric chronic diseases (laboratory medicine). In 2022, the Medical Laboratory Technology major for which it is responsible at Guangzhou University of Chinese Medicine was awarded the title of “National First-Class Undergraduate Major Development Site”; in the same year, the course Clinical Microbiology Testing Technology was awarded a “First-Class Course of Guangdong Province”; in 2023, the course Clinical Biochemistry Testing Technology was awarded a “First-Class Course of Guangdong Province”. At present, the Department of Laboratory Medicine has 181 employees, including 19 doctoral degree holders and 74 master's degree holders; 16 with senior professional titles and 43 with associate senior professional titles; 3 doctoral supervisors and 12 master's supervisors; and 1 outstanding teacher of Xinnan Fang. It is a high-quality service team with a well-established organizational structure and a rational talent composition. It has established 8 subspecialties—clinical hematology testing, clinical fluid testing, clinical biochemistry testing, clinical immunology testing, clinical microbiology testing, clinical molecular biology testing, clinical emergency testing and clinical transfusion testing—and 1 clinical laboratory standardization research platform.

【Specialty Features】 1. Clinical Laboratory Standardization Research International reference methods have been established for 25 items; 14 items have entered the international JCTLM service list; and 3 independently developed clinical laboratory standard methods have been recommended by JCTLM as internationally recognized reference methods. In cooperation with the National Institute of Metrology, China, the Department has conducted multiple standardization research projects and independently developed 9 national certified reference materials. For 10 consecutive years, it has provided value-assignment services for accuracy-verification samples for liver-function and renal-function testing to the Guangdong Clinical Laboratory Center and Chongqing Clinical Laboratory Center, and has repeatedly provided value-assignment services for calibrators to domestic and overseas manufacturers. 2. Clinical Laboratory Quality Management Using ISO15189, ISO/IEC 17025 and ISO15195 accreditation as platforms, the Department of Laboratory Medicine has trained a group of laboratory quality-control experts covering all professional groups. These include 1 assessor of the Joint Committee for Traceability in Laboratory Medicine, 1 member of the National Clinical Metrology Technical Committee, 6 chief assessors and lead assessors and 10 assessors of the China National Accreditation Service for Conformity Assessment (CNAS), and 3 experts of the expert group of the Guangdong Clinical Laboratory Quality Control Center. In recent years, our center has compiled more than 10 professional books on clinical laboratory standardization and laboratory quality management, providing abundant learning resources for medical laboratory professionals. The books edited as chief editor, Guide to Writing Quality System Documents for Medical Laboratories and Examples of Quality System Documents for Medical Laboratories, were published in their 1st and 2nd editions in 2006 and 2015, respectively. These two books are regarded as essential reference books for preparing medical laboratories in China for ISO15189 accreditation. 3. Research on the Classification of Pathogenic Microorganisms and Reference Strains In the identification of clinical microbiological species, the Department has successively named Guangzhou Francisella, the new genus Allofrancisella, the new genus Pseudofrancisella, the new genus Cysteiniphilum and the new genus Fastidiosibacter, among others, totaling 1 new family, 5 new genera and 8 new species. It was the first clinical biology laboratory in China to discover and validly name new bacterial species and obtain international recognition, and was invited to participate in compiling several chapters of Bergey's Manual of Systematics of Archaea and Bacteria. Regarding standard strains, nearly 20 strains have successively been standardized and deposited in international culture collections including the American Type Culture Collection (ATCC), the National Collection of Type Cultures (NCTC) in the United Kingdom and the China General Microbiological Culture Collection Center (CGMCC). 4. Laboratory Testing and Micro-Dialectical Diagnosis in Traditional Chinese Medicine As one of the members of the national key laboratory jointly built by the central and provincial governments for dampness syndrome in traditional Chinese medicine, the Department conducts research on “Establishment and Clinical Application of Early-Warning Laboratory Diagnostic Indicators for Dampness Syndrome”. A preliminary model system of early-warning laboratory diagnostic indicators for dampness syndrome in traditional Chinese medicine has been established, enabling evaluation of its warning value and its role in monitoring outcomes after intervention. Modern medical technologies are used to support research on dampness syndrome in traditional Chinese medicine at the microscopic level and to support studies of the mechanisms underlying the occurrence and progression of dampness-syndrome-related diseases.

【Scientific Research Achievements】 From 2017 to the present, the Department of Laboratory Medicine has undertaken 8 national-level projects and 34 provincial- and ministerial-level projects, with total research funding exceeding 10 million yuan; participated, as a principal completing institution, in the development and publication of 12 health-industry standards and was responsible for developing 9 national metrology technical specifications; received 1 first prize for scientific and technological progress at the provincial level as a principal completing contributor; obtained more than 10 national patents, 3 of which have been transferred; published more than 60 SCI papers, including 12 with an IF greater than 5; and served as chief editor of 15 academic monographs and textbooks.

【Specialty Influence】 The Department of Laboratory Medicine conducts scientific research cooperation with the Institute for Reference Materials and Measurements of the European Union and the Wadsworth Center of the New York State Department of Health in the United States. It also has several in-depth collaborations with the National Clinical Research Center for Laboratory Medicine and the National Institute of Metrology, China, and can conduct multicenter, large-sample clinical trials and promote the application of scientific research achievements. As the sponsoring institution, the Department has 4 professional committees: the Laboratory Medicine Professional Committee of the Guangdong Society of Integrated Traditional and Western Medicine; the Blood Transfusion Professional Committee of the Guangdong Society of Integrated Traditional and Western Medicine; the Laboratory Medicine Professional Committee of the Guangdong Society of Chinese Medicine; and the Laboratory Medicine Professional Committee of the Guangdong Urogenital Association. In addition, several experts from the Department have been invited to serve concurrently in well-known domestic academic organizations, including committee members of the Laboratory Medicine Branch of the Chinese Medical Association; deputy director committee members of the Laboratory Medicine Branch of the China Association of Chinese Medicine; standing committee members of the Laboratory Physicians Branch of the Chinese Medical Doctor Association; standing committee members of the Clinical Laboratory Management Professional Committee of the Chinese Hospital Association; deputy chairpersons of the Laboratory Medicine Expert Committee of the Capacity Building and Continuing Education Center of the National Health Commission; members of the Medical Professional Committee and the Calibration Professional Committee of the Laboratory Specialized Committee of the China National Accreditation Service for Conformity Assessment; and members of the National Clinical Metrology Technical Committee.

【Expert Profiles】 Academic Leader of the Specialty: Zhuang Junhua, research fellow, chief technician and doctoral supervisor. He currently serves as honorary chairperson of the Laboratory Medicine Branch of the China Association of Chinese Medicine; deputy chairperson of the Experimental Medicine Professional Committee of the National Health Industry Enterprise Management Association; chief assessor for medical laboratory accreditation of the China National Accreditation Service for Conformity Assessment; honorary chairperson of the Laboratory Medicine Professional Committee of the Guangdong Society of Integrated Traditional and Western Medicine; honorary chairperson of the Laboratory Medicine Professional Committee of the Guangdong Society of Chinese Medicine; consultant to the Laboratory Medicine Branch of the Guangdong Medical Association; first-term academic consultant to the Laboratory and In Vitro Diagnostics Branch of the Guangdong Medical Consumables Management Association; expert of the expert group of the Guangdong Clinical Laboratory Quality Control Center; expert for medical-device review in Guangdong Province; expert of the medical appraisal expert database of the Guangdong Medical Association; and consultant to the editorial board of the journal Laboratory Medicine. Academic and Departmental Leader; Director of the Department: Huang Xianzhang, PhD, professor, chief technician, doctoral supervisor, person in charge of the Medical Laboratory Technology major at Guangzhou University of Chinese Medicine, and outstanding teacher of Xinnan Fang. He is a committee member of the Laboratory Medicine Branch of the Chinese Medical Association; standing committee member of the Laboratory Physicians Branch of the Chinese Medical Doctor Association; standing committee member of the Clinical Laboratory Professional Committee of the Chinese Hospital Association; deputy chairperson of the Laboratory Medicine Expert Committee of the Capacity Building and Continuing Education Center of the National Health Commission; and member of the National Clinical Metrology Technical Committee. He is also a member of the Medical Professional Committee of CNAS, a member of the CNAS Calibration Professional Committee, and a CNAS chief assessor.

【Talent Structure】 Academic Leader: Zhuang Junhua Academic and Departmental Leader; Director of the Department: Huang Xianzhang Department Directors: Ke Peifeng, Wu Xinzhong, Lin Haibiao, Xu Ning, Chen Cha, Yang Yongqiang, Wu Xiaobin Department Secretary: Wan Zemin Responsible Positions: Chen Lin, He Wenjun, He Min, Qu Pinghua, Liang Zheng, Han Guang, Wang Yi, Li Song