Department Overview

The Clinical Laboratory of Zhongshan Hospital, affiliated with Fudan University, was founded in the 1940s. Guided by the principle of "everything for the patient," the department has consistently pursued the developmental goals of being accurate, fast, high-quality, and innovative. It has formulated a quality policy focused on continuously improving test quality, accelerating testing speed, enhancing service attitudes, and employing innovative technologies. The laboratory has developed a streamlined, intelligent, and systematic management model. For seven consecutive years, from 2014 to 2020, Zhongshan Laboratory has ranked among the top five best clinical laboratories in China in comprehensive reputation rankings for hospital laboratories. In 2018, due to its advanced management model, unique work methods and experiences, and continuous team innovations, it received the prestigious "Mayor's Quality Award" in Shanghai. In 2021, Zhongshan Laboratory became one of the core units of the National Medical Laboratory Clinical Medical Research Center. As the leader of the Fudan Zhongshan Medical Alliance Clinical Laboratory, it has become a regional, centralized testing center, helping to improve the quality of primary-level testing and healthcare resources.

The Clinical Laboratory currently consists of seven sub-disciplines: Clinical Basic Laboratory, Clinical Biochemistry and Immunology, Clinical Molecular Diagnostics, Clinical Mass Spectrometry, Clinical Microbiology, Clinical Hematology, and Emergency Testing. With a total area of over 2,500 square meters, it houses more than 300 advanced automated testing instruments. Additionally, it has adopted high-end technologies such as next-generation sequencing, circulating tumor cells, liquid chromatography-tandem mass spectrometry, and multicolor flow cytometry.

Quality Management

Zhongshan Laboratory performs over 600 different tests, serving more than 800,000 patients annually. With an annual workload exceeding 75 million tests, it stands as one of the largest clinical laboratories in Shanghai and nationally. In response to the growing workload and increasing turnaround times, the laboratory places the utmost importance on maintaining quality and implements comprehensive quality management to ensure that "all aspects are covered, the entire process is controlled, and everyone is involved." They have compiled over 1,400 quality documents to ensure rigorous quality control and adherence to international standards.

Key Milestones

- In 2009, Zhongshan Laboratory became the first medical laboratory in Shanghai to pass the ISO 15189 Medical Laboratory Quality and Competence Accreditation.

- In 2010, it achieved level I laboratory certification in the National Glycohemoglobin Standardization Program (NGSP) for glycated hemoglobin (HbA1c) testing.

- In 2010, it was included in the first group of National Clinical Key Specialties Construction Projects.

- In 2015, it became the lead unit for the Pathology Discipline Group of Important Weak Subjects Construction in Shanghai.

- In 2015, it became the pilot unit for high-throughput gene sequencing technology for national cancer diagnosis and treatment projects.

- In 2016, it joined the NGSP as the only secondary reference laboratory (SRL) in China.

- In 2017, it became the leading unit for the Clinical Key Specialties Expansion Program in Shanghai.

- In 2020, it became the lead unit for the Fudan Zhongshan Medical Alliance Clinical Laboratory.

- In 2021, it was designated as one of the first core units of the National Medical Laboratory Clinical Medical Research Center.

-In 2022，it achieved STCSM Clinical Testing MS Technology Service Platform

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Efficiency and Service

While ensuring testing quality, Zhongshan Laboratory is committed to reducing reporting times. Since 2007, they have continually improved and reduced reporting times for outpatient routine biochemical reports from 4 hours to 2 hours for 94 tests and from 6 hours to 4 hours for 56 routine immunology tests. This has significantly reduced patient report waiting times and improved overall clinical efficiency, laying the foundation for the "one-day medical express" service in Shanghai and the surrounding areas. In the construction of the hospital's Chest Pain Center, the laboratory expedited sensitive cTnT reporting to 20 minutes, surpassing international guidelines. These initiatives have greatly benefited patients by providing timely clinical diagnosis and treatment.

Service and Communication

To enhance the quality of laboratory services for both clinicians and patients and to facilitate effective two-way communication, Zhongshan Laboratory conducts quarterly patient satisfaction surveys and biannual surveys among hospital medical staff. These surveys provide valuable feedback on laboratory services, which the department uses to identify opportunities for continuous improvement. They communicate feedback and improvements through clinical meetings.

Zhongshan Laboratory has received numerous awards and honors for excellent service. These include recognitions for exceptional window services, and Dr. Wei Guo, the director of the laboratory, received the "March 8th Red Flag" award in Shanghai. Dr. Beili Wang, the deputy director, was also honored with the "March 8th Red Flag" award from the hospital. Furthermore, Dr. Meixiu Gu, the head of the Clinical Basic Laboratory, received the "Shanghai User Satisfaction Service Star" award from the Shanghai Quality Association, the Shanghai General Union of Trade Unions, and the Shanghai Women's Federation, among others.

Innovation

With support from national and regional projects such as National Clinical Key Specialties Construction Projects, Shanghai Important Weak Subjects Construction Projects, and Shanghai Clinical Key Specialties Expansion Programs, Zhongshan Laboratory actively develops new methods and projects of great clinical significance. These include introducing advanced testing systems and platforms like next-generation sequencing, digital PCR, circulating tumor cells, liquid chromatography-tandem mass spectrometry, and multicolor flow cytometry. The laboratory has also developed and implemented new projects urgently needed by clinical departments, such as circulating tumor cell testing (the first medical unit in Shanghai to perform this test for clinical purposes), next-generation gene sequencing for colorectal and lung cancer personalized medication targeting genes (the first pilot unit in China for high-throughput gene sequencing technology in the field of cancer diagnosis and treatment), and digital PCR testing, among others.

Innovative research conducted by the laboratory in the field of liver cancer circulating tumor cell detection has led to the publication of three consecutive papers in Clinical Cancer Research (Impact Factor 10.107). Their work includes the development of a "Human Plasma 7

 Small RNA Detection Reagent Kit" approved by the China Food and Drug Administration, as well as participation in a series of projects on personalized diagnosis and treatment strategies for liver cancer based on liquid biopsy and omics technology platforms, which received the Shanghai Medical Association's first prize for science and technology.

In 2019, Professor Wei Guo, the director of the laboratory, gave a keynote academic presentation at the American Clinical Mass Spectrometry (MSACL) annual meeting as the first Chinese representative. She introduced the development of clinical mass spectrometry application promotion in China. To date, Zhongshan Laboratory has been involved in the development of 16 national industry standards (with three as the lead author) and 25 clinical guidelines (with 18 as the lead author). In 2017 and 2018, as the leading unit, they authored the first domestic "Liquid Chromatography-Mass Spectrometry Clinical Application Guidelines" and the "Expert Consensus on Liquid Biopsy in Clinical Oncology and Medical Laboratory Practice," filling a void in the field of clinical testing using new technologies.

Discipline Development

Back in the 1990s, Zhongshan Laboratory actively promoted consistency in testing and contributed to improving the quality of laboratory tests in the industry. They organized a project in 2003, working with over 30 hospitals in Shanghai, for the "ALT Testing Result Consistency Project" in the Shanghai area, which earned them the Shanghai Medical Science and Technology Award (second prize). In 2011, with support from the National Clinical Key Specialties Construction Project, Zhongshan Laboratory, as the lead unit, initiated the "Consistency of Routine Biochemical Test Results" project. This project helped most of the clinical laboratories achieve inter-laboratory CV<5% for routine clinical biochemical tests, significantly improving the consistency of test results.

Starting in 2009, Zhongshan Laboratory participated in the US NGSP Laboratory Certification Program. For six consecutive years, it has maintained Level I laboratory certification in the NGSP, ensuring that their testing meets international standards. Since 2011, they have spearheaded the promotion of the Shanghai Glycated Hemoglobin Consistency Program (SHGHP). Nearly a hundred laboratories from various levels and locations have joined, gradually expanding their influence across Shanghai and beyond. In 2016, Zhongshan Laboratory became the only NGSP network secondary reference laboratory (SRL) in China, having assisted 44 hospitals and companies in passing NGSP testing certification.

In 2019, Zhongshan Laboratory, in collaboration with the Chinese Medical Association Diabetes Branch, the Chinese Physician Association Laboratory Physician Branch, and the National Medical Laboratory Clinical Medical Research Center, launched the Chinese Glycated Hemoglobin Consistency Program (CGSP). As the leader, the program spans 141 medical laboratories in 30 provincial-level administrative regions. With SHGHP and CGSP working together, over 10 million specialized test results will receive effective quality assurance each year, delivering significant clinical and social benefits. The "Chinese Type 2 Diabetes Prevention and Treatment Guidelines (2020)" adopted HbA1c≥6.5% as a supplementary diagnostic criterion for diabetes, affirming the quality of glycated hemoglobin testing through CGSP and providing benefits to more diabetic patients.

In 2011, Zhongshan Laboratory participated in the Ministry of Science and Technology's "12th Five-Year Plan" National Science and Technology Support Program for "Establishing the Reference Intervals and Related Technical Support System for Common Clinical Laboratory Tests in the Chinese Population." They were responsible for recruiting the reference population in the East China region and conducting testing research. The project systematically established reference intervals for commonly used tests in the Chinese population for the first time, ending the longstanding practice of referencing foreign reference intervals in China. They have since established reference intervals for over 50 commonly used clinical tests and released 13 health industry standards. The achievements earned them the first prize in science and technology from the Liaoning Province in 2017. Zhongshan Laboratory has also been the primary or contributing author for 15 laboratory-related health industry standards, including standards for venous blood specimen collection, blood cell analysis, and reference intervals for the Chinese population, providing important references for the standardized application of laboratory tests in clinical medicine.