Implementation of the New National Standard "Quality Assurance Specifications for Human Body Monitoring"

Journalists learned today that the State Administration for Market Regulation has approved the release of the National Standard for Quality Assurance in Human Biomonitoring. The standard was drafted by the National Health Commission and will officially be implemented starting March 1st. After the revision of the "Quality Assurance Standard for Human Biomonitoring", there are four main changes. First, expanding the scope of application. Ethical review and requirements for the management of human genetic resources have been included in the standard system, and comprehensive regulations have been made for on-site investigations, including organizational implementation, questionnaires, physical examinations, etc. Second, optimizing the requirements for biomaterial collection. Updated principles for determining the monitored population, added quality control requirements for key processes such as biosafety, sample blank, sample packaging, sample receipt, and sample storage, and adjusted and optimized the collection methods for blood and urine samples, while deleting relevant content on the collection of samples such as fat, feces, exhaled breath, and other tissues. Third, enhancing laboratory analysis requirements. Blank test requirements have been added to the laboratory testing process, and significant changes and refinements have been made to the evaluation content and requirements of core quality control indicators such as determination and quantitation limits, precision, calibration curve construction, accuracy evaluation, and parallel sample analysis. Fourth, strengthening data management. Normative requirements have been put forward for the detection of biomarkers, as well as the collection, verification, and processing of biomonitoring data. The implementation of the new standard will further improve the quality assurance system for human biomonitoring, effectively enhance the standardization and accuracy of human biomonitoring work in China, provide solid technical support for the protection of occupational health, assessment of health risks from environmental pollution, and emergency response in public health, and play an active role in safeguarding public health.