T/ZCHSP 003-2023 Active

Scope: This document specifies the basic requirements, construction requirements, personnel, equipment and material requirements, organizational management, job division and key operation requirements, quality control, information reporting, safety management, and daily maintenance for emergency nucleic acid testing laboratories. This document applies to fixed sites and mobile laboratories conducting emergency nucleic acid testing. Main technical content: This standard specifies the basic requirements, construction and layout, personnel management, equipment and materials, quality control, information reporting, safety management, and daily maintenance for emergency nucleic acid testing laboratories, applicable to fixed sites and mobile laboratories conducting emergency nucleic acid testing. (1) Clarifies the basic requirements, including the management methods that emergency nucleic acid testing laboratories should comply with. (2) Specifies the laboratory construction requirements, including the layout of the laboratory foundation, hardware requirements, and special requirements for mobile laboratories. (3) Clarifies the personnel management requirements, including the qualification requirements for laboratory testing personnel and auxiliary personnel, and personnel ratio requirements. (4) Specifies the equipment and material requirements, including equipment configuration, calibration requirements, and material configuration and management requirements. (5) Specifies the organizational management requirements, including the three-level management structure of the laboratory, grouping requirements, and related responsibilities. (6) Specifies the job division and key operation requirements, including the job setting of each zone, the requirements for the construction of operating procedures, and file requirements. (7) Specifies the quality control requirements, including performance verification, the formulation of preventive measures, and quality evaluation. (8)