Implementation of the new national standard "Human Biological Monitoring Quality Assurance Specifications"

Reporters learned today (the 28th) that the State Administration for Market Regulation (National Standardization Administration) has approved and issued the national standard 《Quality Assurance Specification for Human Biomonitoring》。 The standard was drafted by the National Disease Control and Prevention Administration and will officially take effect on March 1. After revision, the 《Quality Assurance Specification for Human Biomonitoring》 mainly features four changes. First, it expands the scope of application. It incorporates ethical review and requirements for the management of human genetic resources into the standard framework, and provides comprehensive regulation for field investigations, including implementation procedures and stages such as questionnaire surveys and physical examinations. Second, it optimizes requirements for biological sample collection. It updates the principles for determining the monitored population, adds quality control requirements for key steps such as biosafety, sampling blanks, sample aliquoting, sample reception, and sample archiving, and adjusts and optimizes the collection methods for blood samples and urine samples, while deleting related content on the collection of samples such as fat, feces, exhaled air, and other tissues. Third, it raises laboratory analysis requirements. At the laboratory measurement stage, it newly adds requirements for blank tests, and makes systematic changes and refinements to the evaluation content and requirements for core quality-control indicators, including the determination principles for the method limit of detection and limit of quantification, precision, calibration curve drawing, accuracy assessment, and parallel-sample analysis. Fourth, it strengthens data management. For the first time, it puts forward normative requirements for the detection of effect biomarkers and for the collection, verification, and processing of biomonitoring data. With the implementation of the new standard, it will better improve the quality assurance system for human biomonitoring, strongly enhance the standardization and accuracy of China’s human biomonitoring work, and provide solid technical support for tasks such as protecting the health of occupational populations in China, assessing health risks from environmental pollution, and public health emergency response and handling, thereby playing a positive role in safeguarding public health. (CCTV News)