Clinical Immunology Department, as one of the SCCL major departments, was formally established in May 1999. It is a comprehensively sophisticated laboratory with multiple functions, which includes regional quality management of clinical laboratory, training, assessment of diagnostic reagent, formulation of quality requirements and technical specifications, development of quality control materials, expansion of external quality assessment (EQA) items, continuous education of professional technicians and testing services. Now, the department is equipped with automatic analyzers like Siemens DADE BNP, Abbott I 1000, Roche Cobas e411, Beckman Coulter ACCESS 2, BD FACSCanto II, Siemens DADE VIVA, and so on. The department has passed ISO17025 and ISO17043. In addition, it passes and excels in the annual EQA scheme and proficiency testing activity organized by the National Center for Clinical Laboratory for many years. The self-established reference method was used in trueness verification scheme of small molecule hormones to provide assurance for the mutual recognition of inter-laboratory results. The quality standard of leukemia/lymphoma immunophenotyping test has been preliminary established and the EQA of the test was proceed with self-produced quality control materials.
The commitments include:
1. To establish quality requirements in Shanghai, according to the national and international quality management criteria, the real situation in Shanghai area and the suggestions from professionals.
2. To evaluate and determine of the suitable quality control materials, organize the internal quality control (IQC) work, analyze and assess the data feedback from IQC participants.
3. To be responsible for the unannounced inspection of the performance of hospital labs which belong to Grade 2 Level A and above, twice per year.
4. To organize EQA for the whole clinical laboratories in Shanghai, twice per year.
5. To do on-spot inspection for clinical labs which belong to Grade 2 Level A and above. To make the comprehensive evaluation by annual quality requirements.
6. To hold continuing education classes at national level each year, and training for supervisors of clinical immunology at each hospital and for Second Level Network Management as well.
7. To carry out standardization work, including the establishment of the reference method and application.
8. To do scientific research with regard to the clinical immunology, including quality control materials development, national standard material program, and other research projects funded by the Science and Technology Commission of Shanghai Municipality and by Shanghai Municipal Health Bureau.
9. To perform examination on resident doctors of laboratory medicine in terms of requirements by Shanghai Municipal Health Bureau since 2005.
10. To provide test service under the guidance of ISO/IEC 17025:2005 general requirements for the competence of testing and calibration laboratories.
11. To provide PTP service, according to ISO17043.