The clinical hematology laboratory is one of the main departments of the Shanghai clinical laboratory. It was established in May 2009. It covers an area of nearly 600 square meters. To this day, the department counts five professionals and technicians holding a bachelors degree or above. Among them, there are two chief technicians, one deputy chief technician, one technician in charge, and one inspector. They all possess a large range of experience in the relevant field. Up to now, the department has purchased various advanced equipment including: nearly 20 automated blood analyzers (Beckman Coulter, Sysmex, Abbott, ABX, Nippon Photonics and Mindray), urine dry chemical analyzers (Roche, Siemens, Bayer, Kyoto, East, Di Rui, You Lite, Matt and other brands), almost 20 units of automatic coagulation analyzers (Sysmex), one automatic push piece dyeing machine (Sysmex SP1000i), one fully automated blood cells analyzer, one morphometric analysis system (CELLAVISION DM 120), one confocal laser microscope (Leica SP8), one flow cytometer (Beckman Coulter), one hemorheology analyzer (Germany), etc.
The department is responsible for the quality management and service work of clinical blood and liquid tests in clinical laboratories of various medical institutions in Shanghai, as well as blood, urine, coagulation and other routine testing and quality management. It is also responsible for the testing and clinical evaluation of relevant instruments and reagents, acting as third party, as well as the continuing education, various research works, etc. The department is also responsible for the accuracy of testing, must participate in the laboratory quality assessment activities of the WHO department of clinical medicine and the CAP center for blood, urine, blood coagulation, cell morphology, blood parasites, reticulocyte counting, etc. The department has, moreover, achieved excellent results in these tasks.
In recent years, the clinical hematology laboratory has been gradually carrying out the construction of clinical blood and liquid cytology library and standardization laboratory of blood cell counts, actively carrying out quality control research and various development works in order to better perform quality control tasks in Shanghai regional institutions.
The department’s specific responsibilities include:
1. To carry out various tasks according to the national and international clinical laboratory management standards, the actual situation in Shanghai and experts’ advice to develop "Shanghai medical laboratory quality management requirements" (appendix A: special requirements for blood and body fluids).
2. To carry out evaluation activities of blood fluid projects’ quality in clinical laboratories in Shanghai and in other provinces and municipalities. Up to now, nearly 20 items have passed the ISO 17043 proficiency test.
3. To design the Shanghai area hematology regional quality control plan. To choose the relevant quality control or evaluation tool. To carry out clinical quality controls in Shanghai. To analyze and evaluate data reports sent monthly by various hospitals. In addition, the department’s projects mainly includes: blood cell counting, chemical analysis of dry urine, urinary tangible components, coagulation analysis, D dimer, fibrin degradation products, blood rheology analysis, urinary HCG, thrombus elasticity map, etc.
4. To conduct site inspections of the clinical laboratories in hospitals according to the annual quality requirements for a comprehensive evaluation.
5. To perform a flight check of the blood fluid projects in clinical laboratories.
6. To carry out standardization works, including the establishment and application of reference methods to provide mutual protection for mutual recognition of results among laboratories.
7. To carry out routine laboratory testing in accordance with the standards and requirements of the ISO17025 quality management system for the accreditation of testing and calibration of laboratories.
8. To carry out testing system evaluation: since 2000, having been commissioned by the Shanghai food and drug administration, the department is responsible for the testing of domestic in vitro diagnostic products (IVDs), acting as third party. In addition, according to the American clinical laboratory standards institution (CLSI), since 2003, the lab takes care of the in vitro diagnostic products for clinical evaluation. To provide scientific basis for selecting IVD products in clinical laboratories.
9. To carry out annual national level continuing education trainings on blood and body fluid related content. To conduct regular team leaders trainings in Shanghai hospitals at all levels and secondary network management trainings, testing physicians, etc.
10. To conduct scientific research on blood and body fluid related content.