青海省民族医疗机构检验室建设情况调研  

Research on the Laboratory Construction of Ethnic Medical Institutions in Qinghai

作　　者：石春兰 刘学良 陈鹏 年永琪 马应凤 牛贵姗 俞雅琼 韩天楚 刘海青 SHI Chunlan;LIU Xueliang;CHEN Peng;NIAN Yongqi;MA Yingfeng;NIU Guishan;YU Yaqiong;HAN Tianchu;LIU Haiqing(Qinghai Provincial Drug Review and Verification Center,Xining,Qinghai,China 810007;Qinghai Provincial Tibetan Hospital,Xining,Qinghai,China 810000)

机构地区：[1]青海省药品审评核查中心,青海西宁810007 [2]青海省藏医院,青海西宁810000

出　　处：《中国药业》2024年第18期6-9,共4页China Pharmaceuticals

基　　金：青海省科技计划项目[2023-ZJ-604]。

摘　　要：目的 了解青海省民族医疗机构(简称医疗机构)检验室的建设情况。方法 以青海省31家有备案品种的医疗机构检验室为研究对象,采用实地调研法对其建设情况、管理人员及检验人员情况、检验检测设备配备情况、检测检验能力情况开展调查。参照《青海省医疗机构制剂质量提升三年行动方案》中实验室验收标准评判各检验室的检验检测能力。结果 12家(38.71%)医疗机构检验室总面积小于标准要求(200 m2)。从事制剂配制的共651人,其中管理人员34人(5.22%),检验人员76人(11.67%)。除2家(6.45%)医疗机构委托省内药品生产企业或制剂室配制外,其余29家(93.55%)检验室拥有检验检测设备总数718台(套),总价值4 835.3万元(按固定资产价值500元以上计算)。仅4家(12.90%)省级或市(州)级医疗机构检验室能正常开展制剂检验,14家(45.16%)检验室能正常开展原药材检验;均未对毒性成分和外源性有害物质进行限量控制。存在的问题有检验人员专业能力不足、检验检测设备配备不齐全、检验室建设布局不合理、制剂质量标准不完善。结论 青海省医疗机构检验室的检验检测能力总体较低且发展不平衡,应采取切实措施提升检验检测的技术支撑能力。建议建立准入、淘汰机制,加强监管,整合资源,走集约化发展道路,优化人员配备,加强人员业务培训,固本强基,推进中藏药标准化研究。Objective To understand the construction of laboratories in ethnic medical institutions(referred to as the medical institutions)in Qinghai.Methods The laboratories of 31 medical institutions having filing varieties in Qinghai were taken as the research objects,a field survey was adopted to investigate the laboratory construction,managers and inspectors,inspection and testing equipment,testing and inspection abilities.The testing and inspection abilities in laboratories were evaluated based on the laboratory acceptance criteria of the Three-Year Action Plan for Improving the Quality of Preparations in Medical Institutions in Qinghai.Results Twelve medical institutions(38.71%)had a total laboratory area less than the standard(200 m2).There were 651 personnel engaged in formulation preparation,including 34 managers(5.22%)and 76 inspectors(11.67%).Except for two medical institutions(6.45%)that entrusting the pharmaceutical manufacturing enterprises or preparation rooms in the province to prepare,the remaining 29 medical institutions(93.55%)had 718 inspection and testing equipments in the laboratories,with a total value of CNY 48 million 353 thousand(calculated based on a fixed asset value of CNY 500 or more).The laboratories of only four provincial-or municipal(autonomous prefecture)-level medical institutions(12.90%)could carry out the preparation testing normally,and 14 laboratories(45.16%)could carry out the testing for original medicinal herbs normally,all laboratories did not carry out the limit control on the toxic ingredients and exogenous harmful substances.There were some problems such as insufficient professional ability of inspectors,incomplete inspection and testing equipment,irrational layout of laboratory construction and imperfect quality standards for formulations.Conclusion The overall testing and inspection abilities of the laboratories in medical institutions in Qinghai are relatively low and the development is unbalanced.Practical measures should be taken to improve the technical support ability f

关 键 词：医疗机构制剂 制剂检验 检验能力 检验室 

分 类 号：R95[医药卫生—药学]