Recently, the Shenzhen cell quality testing platform serving the Shenzhen Comprehensive Cell Bank and Shenzhen (Beike) Regional Cell Preparation Center received the 2015 “Inter-Laboratory Quality Assessment Certificate” issued by the Clinical Laboratory Center of the Ministry of Health. All quality assessment items were qualified. This shows that the quality inspection technology and capabilities of the Shenzhen cell quality testing platform constructed and operated by Beike Biotech have reached the domestic first-class level, which will play a positive role in further standardizing the quality of cell testing and can effectively ensure the quality of cells and the safety of clinical cell storage and clinical applications.
External quality assessment (EQA) is a process in which multiple laboratories analyze the same specimen and an external independent agency collects and feeds back the results reported by the laboratory to evaluate laboratory operations. Determine the laboratory’s calibration and testing capabilities and monitor its continued capabilities through inter-laboratory comparisons. The role of EQA is to use inter-laboratory comparisons to determine laboratory capabilities. In fact, it refers to a verification activity that assesses, supervises and confirms the laboratory’s capabilities in order to ensure that the laboratory maintains a high testing level.
In order to standardize clinical laboratory interlaboratory quality evaluation activities and integrate with internationally accepted interlaboratory quality evaluation forms, the Clinical Laboratory Center of the Ministry of Health has issued certificates to units participating in interlaboratory quality evaluation activities every year since 2003 after the completion of all interlaboratory quality evaluation plans, and listed qualified projects in the certificates.
The Shenzhen cell quality testing platform operated by Beike Biotech participated in the interlaboratory quality assessment this time, including blood screening enzyme immunoassay, blood screening nucleic acid testing, blood type testing and complete blood cell count testing. Blood screening enzyme immunoassay tests include hepatitis B virus surface antigen, hepatitis B virus core antibody, hepatitis C virus antibody, HIV antibody, and Treponema pallidum antibody. Blood screening enzyme immunoassay and blood type testing are conducted three times a year, and the full score for each test is 100 points. Blood screening nucleic acid testing items include hepatitis B virus (HBV-DNA) and hepatitis C virus (HCV-RNA). Blood screening nucleic acid and complete blood cell count tests are conducted twice a year, and the full score for each test is 100 points.
Beike Biotechnology has always adhered to the management policy and business philosophy of “quality first”, and has always carried out quality control of test results in strict accordance with ISO9001 and AABB standards in all aspects and high standards to maintain the good operation of the quality management system. It actively participates in the interlaboratory quality assessment program of the Ministry of Health Clinical Inspection Center, and consciously regards participating in interlaboratory quality assessment activities as an opportunity to improve and assess the testing capabilities of the cell quality testing platform. It also integrates the interlaboratory quality assessment activities into the quality control throughout the year to fully ensure the quality and safety of cells.
So far, Beike Biotechnology has participated in 4 interlaboratory quality assessment activities organized by the Clinical Laboratory Testing Center of the Ministry of Health since 2011, and all have obtained qualified “Interlaboratory Quality Assessment Certificates”; in the future, the Shenzhen Cell Quality Testing Platform will continue to participate in interlaboratory quality assessment projects to provide customers with safer cells stored and clinical-grade cells prepared.
