省级新生儿疾病筛查质量保证体系的建立与完善

The establishment and development of provincial system for newborn screening quality assurance

山东省逐渐建立完善了新生儿疾病筛查质量保证体系。依托现有的省、市、县 (区 )三级妇幼保健网络建立了县 (区 )级新生儿标本的采集、递送网络、市级新生儿疾病筛查的实验、诊断治疗网络以及省级新生儿疾病筛查质量控制和管理网络。各级卫生行政部门制定和颁发了各项管理规定和规范性文件 ,起到了政策决策、监督管理和督促落实的宏观调控作用。全面质量控制手段不仅包括标本采集、递送过程中的质量控制 ,还包括实验室分析、患者随访、治疗的质量控制以及各种信息资料的上报、结果评价等内容。各类人员均经过严格的培训考核上岗。标本的采集、保存、递送严格按照制定的标准并进行相关的登记记录。实验分析的质量控制通过方法选择、仪器设备的质量控制 ,建立实验标准操作手册和实验记录 ,以及分析过程中的室内质量控制和定期的室间质量评价活动来完成。诊断治疗的质量控制通过及时有效地召回复查可疑病人 ,给予患儿正确及时的诊断和恰当的治疗 ,保证患儿的定期随访并建立规范完整的病例档案来完成。建立了省级信息资料的及时汇总评价 ,成为质量保证体系不可缺少的部分和内容。

The newborn disease screening quality assurance system was established and perfected gradually in Shandong Province. The collection and delivery network of newborn sample at the county and district level, the experiment, diagnosis and treatment network of newborn disease screening at city level and newborn disease screening quality control and management network at province level were established on the basis of the existing maternity and child health care network at the province, city and county levels. The health administration at all levels set down and issued various management regulations and standard documents, which played the macroscopic regulation and control role of policy determination, monitoring management and supervising. The overall quality control measures not only included the course of specimen collection and delivery, but also included lab analysis, follow up, treatment and the report, outcome evaluation of the information data. Everyone can be on duty after being trained and examined strictly. The collection, preservation and delivery of the specimens should be done according to the established standard with the relevant registration and record. The quality control of the lab analysis could be achieved by methods selection, the quality control of the apparatus and devices, setting up the experimental standard instrument manual and experimental record, analysis and evaluation of the quality control. The quality control of the diagnosis and treatment could be achieved by the suspicious patients callback in time with the correct and timely diagnosis and appropriate treatment, periodical follow up and setting up the standard case files. The timely collection and evaluation on the information data at province level had become the essential part and content of the quality guarantee system. The effective measures, which could carry out the various quality assurance methods, had been set up during the course of the perfection and development of the quality assurance system.