Laboratory Medicine Department

| Basic Overview |--------------

The Department of Laboratory Medicine of Huashan Hospital, Fudan University, was founded in 1950. Through generations of effort, inheritance and innovation, it has become a new highland for coordinated development of clinical laboratory diagnostics in medicine, education and research, integrating hematology and body-fluid, biochemistry, immunology, microbiology and molecular testing, with one department serving multiple campuses. It is one of the earliest hospital laboratories in Shanghai and China to implement whole-process quality-control management.

The department is the reference laboratory for clinical biochemistry and clinical laboratory medicine of the Shanghai Clinical Laboratory Center, and an important part of the National Health Commission clinical pharmacology base. In 1995 it became Shanghai’s first Ministry of Education doctoral training site in Clinical Laboratory Diagnostics; in 2005 its glycated hemoglobin testing received NGSP Level I laboratory accreditation; in January 2006 it became the first hospital laboratory in mainland China accredited by the College of American Pathologists; in 2006 it was approved as one of the first National Health Commission standardized-training bases for laboratory specialists; in 2011 it was approved as one of the first National Clinical Key Specialties; in 2012 it passed laboratory accreditation by the China National Accreditation Service for Conformity Assessment; in 2019 it received Shanghai Municipal Health Commission Clinical Key Specialty (Tengfei Program) status; in 2020 it was named an advanced collective in Shanghai’s fight against COVID-19; in 2021 it established mainland China’s first cerebrospinal-fluid testing center in a tertiary hospital and received Fudan University’s Outstanding Medical Team title; in 2022 it received the “Most Beautiful Service Window” award for the fifth China International Import Expo from Shanghai’s health system; in 2023 it received the collective award of the seventh Fudan University Youth May Fourth Medal. In 2024 it received the global Univants of Healthcare Excellence award (the only recipient in China). In the Fudan ranking, its specialty reputation and overall ranking have remained among the national top ten for nine consecutive years. It is currently a deputy-chair institution of the Laboratory Medicine Branch of the Chinese Medical Association and a vice-president institution of the Laboratory Physicians Branch of the Shanghai Medical Doctor Association.

| Academic Leader |--------------

Guan Ming, Research Professor and doctoral supervisor, is director of the Laboratory Department and Central Laboratory of Huashan Hospital, Fudan University, chief scientist of the National Key R&D Program, member of the Eighth National Health Standards Committee, deputy chair and secretary-general of the Laboratory Medicine Branch of the Chinese Medical Association, deputy chair of the Cancer Gene Diagnosis Committee of the Chinese Anti-Cancer Association, deputy chair of the Genetic Diagnosis Branch of the Chinese Society of Genetics, former chair of the Laboratory Medicine Specialty Branch of the Shanghai Medical Association, chair of the Clinical Laboratory Committee of the Shanghai Industry–Medicine Integration Strategic Advisory Committee, and vice-president of the Shanghai Medical Doctor Association Laboratory Physicians Branch. He is deputy editor-in-chief of Clinica Chimica Acta, the Chinese Journal of Laboratory Medicine, the International Journal of Laboratory Medicine and Laboratory Medicine. He has received the Shanghai Leading Talent, Shanghai Outstanding Academic Leader and National Medical Doctor—Outstanding Conduct awards. As first person responsible, he has undertaken one National Key R&D Program and eight National Natural Science Foundation projects; as first or corresponding author he has published more than 120 SCI papers in Cell Discovery, ACS Nano, J Hematol Oncol, Clinical Cancer Research and other international journals; he holds 13 granted national invention patents, two successfully commercialized, including one converted into a Class III medical-device certificate, and won one second prize of the Shanghai Medical Science and Technology Award as first recipient. He has served as chief reviewer, editor or deputy editor of 13 monographs, including Molecular Diagnostic Technology and Clinical Applications and Cerebrospinal Fluid Testing and Clinical Neurology, and has led drafting of three national industry standards/guidelines. His main research focuses are clinical molecular-biology testing and mechanisms of tumor metastasis and invasion.

| Clinical Features and Services |--------------

The department uses homogeneous management across campuses and operates at the main Huashan Hospital, Hongqiao, Baoshan and Pudong campuses and the Jiangsu Road branch. More than 600 tests are available. Key priorities include smart-laboratory construction, distinctive testing platforms and integration of clinical research and innovation, focusing on rapid testing for major infectious diseases, pathogen drug-resistance mechanisms, cerebrospinal-fluid biomarker screening and meningeal metastasis, supporting diagnosis and treatment of central-nervous-system and infectious diseases.

In recent years it has launched more than 100 frontier projects, including Shanghai’s first and other restricted-category new technologies: pathogen-microorganism metagenomic testing, immunocytochemical staining of cerebrospinal fluid, rapid on-site cytological evaluation (ROSE), vitreous cytology, BRCA1/2 mutation testing, mass-spectrometric hormone and drug-concentration testing, and a new four-item coagulation panel. Five signature services have been established: cerebrospinal-fluid, thrombosis and hemostasis, mass-spectrometry, flow-cytometry and metagenomic high-throughput sequencing testing. Laboratory big data and artificial intelligence (AI) are used to build a smart laboratory quality-management practice base. “Building a smart integrated management solution and optimizing services through multi-campus coordination” won an excellent case award in the East China region of the 2023 national hospital competition for the Eighth Improving Medical Services Action. The department is nationally renowned for exfoliative cytology of cerebrospinal fluid and other body fluids and vitreous cytology. It also develops in-house tests for myeloproliferative neoplasms and cerebrospinal-fluid liquid biopsy, providing genetic diagnosis and supporting personalized medicine.

| Teaching |--------------

In 1984, Professor Ni Zanming, former director, helped establish the Medical Laboratory Medicine Department at the former Shanghai Medical University, with key teachers from the department providing instruction. A master’s admissions site for Clinical Diagnostics and Clinical Laboratory Diagnostics was also established. In 1995 it became Shanghai’s first Ministry of Education doctoral admissions site in Clinical Laboratory Diagnostics. It has received Fudan University’s Outstanding Teaching Team award and now has three doctoral and four master’s supervisors. Professor Guan Ming heads the National Health Commission standardized-training base for laboratory specialists; he was named Huashan Hospital Outstanding Teaching Director in 2023 and an outstanding mentor in Shanghai’s 2022 and 2023 “Rising Stars of Medicine” young medical-talent program.

Each year the department holds national and provincial continuing-education courses, the Huashan Laboratory Innovation Forum and Journal Club research lectures, and periodically invites academicians, outstanding young scholars and Changjiang Distinguished Professors to lecture to young staff. It teaches the Experimental Diagnostics demonstration course for Fudan University medical students and the MBBS English class, and trains visiting physicians and interns. Since the 1950s it has trained visiting and intern students from throughout China, with mature management and extensive experience. In 2006 it passed the rigorous review for the Ministry of Health/Chinese Medical Doctor Association specialist-training pilot base; in 2014 it became one of Shanghai’s first National Health Commission specialist physician—laboratory physician training bases. It accepts 30–40 visiting trainees annually and regularly holds trainee physician forums for mutual learning and teaching enhancement.

| Research |--------------

As a National and Shanghai Clinical Key Specialty, the team focuses on rapid testing for major infectious diseases and pathogen resistance, cerebrospinal-fluid biomarker screening and meningeal metastasis, and discovery of novel tumor markers with integrated diagnosis and treatment. During the past five years it led applications for two National Key R&D Programs (2019 and 2022), 11 National Natural Science Foundation projects and more than 20 projects from the Ministry of Education, National Health Commission, Shanghai Municipal Science and Technology Commission and Health Commission. More than 150 papers were published as first or corresponding author in overseas SCI journals including Cell Discov, EBioMedicine, Chem. Eng. J and Theranostics, together with over 100 papers in Chinese journals.

Members have received the National Natural Science Foundation Excellent Young Scientists Fund, Shanghai Leading Talent, Shanghai Outstanding Academic Leader, Shanghai Health Commission Silver Snake Award, Shanghai Top Ten Young Medical Managers, Shanghai Pujiang Talent Program, Shanghai Health Commission Young Talent Program, Shanghai Young Science and Technology Talent “Yangfan Program,” Shanghai “Rising Stars of Medicine,” Shanghai Outstanding Invention Gold and Silver Awards, Fudan Top Ten Young Medical Staff, Top Ten Medical Workers and Top Ten Medical Technologists. They have also won two second prizes and one third prize of the Shanghai Medical Science and Technology Award.

The department emphasizes development of its scientific and technical talent team, continually improves talent training, stimulates enthusiasm and creativity, and strengthens academic and research competitiveness. Guided and supported by innovation, it promotes scientific advances, translation of results and clinical–basic collaboration, and actively hosts academicians’ and young laboratory physicians’ lectures and clinical new-technology seminars, providing high-quality research guidance and training.

| Supporting Border Areas and Overseas Missions, Demonstrating Red Cross and Huashan Spirit |--------------

Team members actively join the Huashan Hospital National Emergency Medical Rescue Team and overseas medical teams. Four groups of key staff supported earthquake relief in Wenchuan, Sichuan, in 2008, performing battlefield laboratory testing and water-purification tasks at the Sino-German field hospital. From 2017–2019, three groups went to Gwadar Port, Pakistan, to help build the Gwadar Port Red Cross Bo’ai Medical Emergency Center and undertake overseas laboratory testing. From 2020–2022, staff went to Wuhan, Beijing, Xinjiang and Sichuan to perform COVID-19 nucleic-acid testing. Under the policy of normalizing epidemic prevention and control, the department, one of Shanghai’s four public nucleic-acid laboratories, undertook emergency Shanghai COVID-19 screening, testing for the Lingang makeshift hospital, the Jing’an District mass screening, CIIE support testing and other tasks, helping strengthen the citywide epidemic-control barrier and demonstrating the professional strengths and Huashan Red Cross spirit.