山东省独立医学实验室执业现状调查及监管对策研究

Investigation and Supervision Countermeasures Study on the Present Situation of Independent Clinical Laboratory Practice in Shandong Province

目的全面了解山东省独立医学实验室的执业现状和监管存在的问题,明确对独立医学实验室的卫生监督要点,探索合理、高效的执法监督模式。方法以问卷调查和实地调研相结合,对山东省济南市、青岛市、烟台市、济宁市、聊城市、莱芜市6个地市的部分独立医学实验室和从事医学检验监督工作的卫生监督执法人员进行调查与分析。结果(1)参与本次调查的独立医学实验室在注册资金、房屋面积、专业设置、人员和设备配置等方面基本符合《独立医学实验室基本标准(试行)》,但在检验报告的发放、标本的运输与管理、生物安全等方面还存有监管漏洞,有待进一步完善;(2)从事医学检验监督工作的卫生监督执法人员对独立医学实验室基本能做到日常监督全覆盖,但对其执业的规范标准、监督风险点等方面仍存在一定的认识局限。结论可以从独立医学实验室和监督执法人员两个层面采取宣传、培训等形式提升监管认知,加强监督管理。

Objective In order to fully understand the status quo and existing problems of Independent Clinical Laboratory(ICL)in Shandong Province,clearly define the main points of supervision of ICL,and explore a reasonable and efficient law enforcement supervision mode.Methods Some ICL and law enforcement officials engaged in medical inspection in six cities of Shandong Province,including Jinan,Qingdao,Yantai,Jining,Liaocheng and Laiwu were investigated and analyzed through the combination of questionnaire survey and field research.Results(1)The research shows that the ICL involved in this research basically meet the"Basic Standards for Independent Clinical Laboratories(Trial)"in terms of registration funds,housing area,professional settings,personnel and equipment configuration.However,there are still regulatory loopholes in the issuance of inspection reports,the transportation and management of specimens and bio-safety,which need to be further improved.(2)Health supervision and law enforcement personnel engaged in medical inspection and supervision can basically cover the daily supervision of ICL,but there are still some limitations in understanding the standards and monitoring risk points of their practice.Conclusion The level of supervision and administration of ICL can be improved by publicity,training and other forms from two aspects,including ICL and law enforcement officials.