新生儿疾病筛查实验室质量控制策略和方法

Strategies and methods of quality control of newborn diseases-screening in laboratory

目的:加强新生儿疾病筛查实验室全面质量管理,尤其是重点环节的质量控制,减少漏检。方法:新生儿出生后72 h,采足跟血制成干血滤纸片,用ELISA法、FEIA法和BIA法、荧光法检测血片中TSH和Phe含量,筛查新生儿CH和PKU;以"先天性甲状腺功能减低症"或"苯丙酮尿症"等为关键词,检索《中国医知网》相关文献;参照ISO15189实验室质量认证体系和《新生儿疾病筛查技术规范》等资料,制定质量手册、程序文件、职责制度、标准操作规程、质量技术记录表。结果:制定了质量手册、36种程序文件、68种职责和制度、9种标准操作规程和78种质量技术记录表,并分步实施和落实;同时,加强实验研究,制定了科学的生物参考区间,分析了11年来的筛查资料,总结经验、查找不足,以持续改进。结论:新生儿疾病筛查是一项系统工程,实验室质量控制是关键,要做好实验室质量控制,实验室必须制定质量控制策略、目标,采取多种途径、方法和措施,以保障质量目标的实现。

Objective： To strengthen the total quality management of newborn diseases -screening in laboratory, particularly the key link＇s quality control, and reduce the omission - screening. Methods ： To take a drop of plantar heel blood of newborns 72 hours after delivery, and put onto a filter paper and dried. To test blood levees of TSH and PHE with ELISA, FEIA, BIA and fluorescence method, and screen newborn CH and PKU; Taking ＂ Congenital Hypothyroidism＂ and ＂ Phenylalanine＂ and so on as the key words, to search the related records in ＂ Chinese hospital knowledge database＂ ; Referring to the ISO15189 laboratory qualification system and ＂ Newborn Diseases - Screening Technology standard＂ and so on, to formulate quality handbook, the program file, the responsibility system, standard practice rule, quality and technology data table. Results ： The quality handbooks, 36 kinds of program files, 68 responsibilities and systems, 9 standard practice rules and 78 quality and technology data tables had been formulated, and implemented and carried out step by step. At the same time, the experimental study had been strengthened, the biological reference interval had been formulated, screening materials for past 11 years had been analyzed. Conclusion： Newborn disease screening is a systems engineering. Laboratory quality control is key. Quality control strategy and goal must be formulated in the laboratory. Many kinds of ways, the method and the measure should be adopted to guarantee the realization of the quality objectives.