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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 neonatal screening laboratories, especially the quality control of key links, to reduce missed inspections. Methods: Newborn infants were sacrificed at 72 h after birth to prepare dry blood filter paper. The contents of TSH and Phe in the blood samples were detected by ELISA, FEIA and BIA, “Congenital hypothyroidism ” or “phenylketonuria ” as the key words, search, “China Medical Network” related literature; reference to ISO15189 laboratory quality certification system and “newborn disease screening technical specifications ”And other information, the development of quality manuals, procedures documents, responsibilities system, standard operating procedures, quality technical record sheet. Results: The quality manual, 36 kinds of program files, 68 kinds of responsibilities and systems, 9 kinds of standard operating procedures and 78 kinds of quality technical record sheets were formulated and implemented step by step. At the same time, we strengthened the experimental research and formulated the scientific biological reference Interval, analyzed the screening data over the past 11 years, summed up the experience, lack of search to continuous improvement. Conclusion: Neonatal disease screening is a systematic project. Laboratory quality control is the key. To control laboratory quality, laboratories must formulate quality control strategies and targets and take various approaches, methods and measures to ensure quality The realization of goals.