T/CSBT 004-2019 Active Group standards

T/CSBT 004-2019 Blood donation center blood testing laboratory quality monitoring indicators

Publish Date: 2019-04-12 Implement Date: 2019-04-12 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBT 004-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2019-04-12

Implement Date: 2019-04-12

Scope

Scope: This standard specifies the quality monitoring indicators required for process monitoring and quality improvement in blood donation stations, including the principles of establishing quality monitoring indicators, their significance, interpretation, data collection process, and calculation methods. This standard applies to the quality monitoring of blood testing processes in general blood donation stations (hereinafter referred to as "laboratories"), as well as inter-laboratory capability comparison and evaluation. Main technical content: Based on relevant regulations, standards, and guidelines for quality indicators, and referring to quality indicators in other industries at home and abroad, while taking into account the technical characteristics of blood donation station blood testing laboratories, the quality indicators for blood donation station laboratories are formulated, including: overall indicators, process indicators (before testing, during testing, and after testing), resource indicators (personnel, equipment, materials, methods, biosafety, information, and quality control). Each indicator specifies the data collection standards, calculation formulas, and significance. The three categories of indicators are independent of each other but also have certain correlations. They monitor the overall operation of the laboratory, provide data support for scientific and systematic analysis of the internal operation of the laboratory and the implementation of inter-laboratory capability comparison, and provide an effective tool for laboratory quality improvement.