The Shanghai clinical microbiology center, established according to the secondary bio-safety requirements, has been excelling in the recent years, when it comes to comparing and verifying test results with those of the health ministry center and the CAP laboratories in the United States. The department possesses a number of the world's leading equipment, such as the Bruker MALDI-TOF-MS microbial identification mass spectrometer, the Vitek Compact-2, the MicroScan WalkAway-96 Plus, the BD Phonix 100 automated microbial identification and drug sensitivity assay system, the Bact/Alert 120 blood culture system, an intelligent anaerobic multifunctional system, a negative pressure room and so on. Besides, it also has a built-in international standard strain library, a biobank smart ultra-low temperature refrigerator storing over 500 international standard strains. The department has successfully obtained the ISO17025 and ISO17043 international quality management system certifications, has established a rapid detection system of clinical microorganisms, and is capable of quickly identifying microorganisms based on phenotypes and proteomics.
The department presently counts five full-time microbial professionals and technicians, among whom two have senior titles, two others belong to the intermediate level, and one has a junior title. Among them, two are ISO15189 evaluation experts and have a range of experience in the laboratory management and quality control field. To speed up the development of the laboratory, in recent years, the introduction and training of new talents have been significantly increased. Thus, one specialist from 211 national relevant institutions has been introduced to the center, internal master's degree trainings have increased, scientific research has been one of the main focuses, and the center has presided over and undertook various research projects at the provincial level 2, and has been granted four patents of invention from the state intellectual property office. In accordance with ISO17043 quality management system requirements, the department has carried out seven clinical microbiological quality evaluation (EQA) projects, and has been developing independent research and lab quality control category 2 for eight items. Among them, there are the "microbial mass spectrometry test", the "bacterial vaginosis sialidase (BV) determination", and other EQA projects. In order to better fulfill the national demands, in addition to meeting the quality control needs of medical laboratories in Shanghai, the department also pushes other provincial and municipal medical laboratories to participate in EQA activities, or in the microbial quality control assessments. The department has also participated in the compilation and publication of three books, and published various SCI periodicals in core journals. From 2006, the department has been holding, twice a year, hospital laboratory microbiological examination of quality control training sessions. It has presided over clinical microbiology technological testing related to eleven national continuing medical education projects, and has trained nearly 1,500 microbial inspection personnel.
The department’s specific responsibilities include:
1. Responsible for the organization of clinical microbiology EQA activities in Shanghai. The formal EQA projects mainly includes: aerobic bacteria identification, anaerobic bacteria identification, drug susceptibility testing, microbial mass spectrometry, D-fungal dextran testing, endotoxin testing, mycobacterium tuberculosis smear, bacterial vaginosis sialidase (BV) determination;
2. Responsible for organization of annual quality standards for clinical laboratory microbiology testing in Shanghai according to the national and international clinical laboratory management standards, clinical microbiology laboratory in Shanghai and the actual situation of quality control experts;
3. R&D, evaluation, introduction and preparation of relevant quality control products, organization of the city's EQA, analyze and evaluate the monthly EQA data reported by microbiology laboratories;
4. Undertake, twice a year on level two and above, the annual clinical laboratory microbiology flight testing;
5. Be responsible for the quality inspection of clinical laboratories in hospitals of grade A and above, according to the annual quality requirements for a comprehensive evaluation;
6. To carry out standardization work, be responsible for the management of the international standard strain library. Each month and for all levels of clinical microbiology labs, to provide standard strains and quality control tablets. Be responsible for the drug susceptibility testing and dyeing liquid quality controls, as well as provide support for the mutual recognition of results between laboratories;
7. Maintain and continuously improve the quality of inspections, make the labs run according to the ISO17025 quality management system for accreditation of testing and calibration of laboratories, to carry out aerobic bacteria, anaerobic bacteria, fungal identification and susceptibility testing and other bacteriological testing services;
8. To carry out evaluations of in vitro diagnostic products (IVD) and the performance of the large microbiological detection systems. In 2014, the domestic automated blood culture system performance evaluation was completed. In 2017, the department made a performance evaluation of the domestic microbial identification mass spectrometer. To participate in the collection and database construction of standard spectra of mass spectrometry. To undertake testing of domestic in vitro diagnostic products (IVDs) as third party. To conduct in vitro diagnostic products clinical evaluations. To provide scientific basis for selecting IVD products in clinical laboratories;
9. To organize annual clinical microbiology technology-related state-level continuing medical education trainings, to regularly hold team leaders trainings in hospitals of all levels of microbiology in Shanghai, and to hold secondary network management trainings, testing physicians, and so on;
10. Undertake/preside over the development of new technologies related to microbiology and the control research, as well as participating in the development of scientific research, including the projects funded by the Shanghai municipal health planning commission (gene chip technology to detect clinical common pathogenic fungi), the Shanghai science and technology commission and the Shanghai natural science foundation.