药品检验实验室能力评价指标体系的构建研究

发布时间：2018-06-28 14:23

本文选题：药品检验实验室 + 能力　；参考：《沈阳药科大学》2017年博士论文

【摘要】：为构建适合我国国情的药品检验实验室能力评价工具,深入了解实验室的能力现状及存在的问题,并为加强能力建设从而提出有针对性的政策建议提供数据支撑,有必要将药品检验实验室的能力进行量性研究,构建一个科学合理的"药品检验实验室能力评价指标体系",建立相应的评价标准及评价方式,从而科学、有效、充分地评价药品检验实验室的综合能力。本研究通过文献综述和专家访谈法,总结归纳药品检验实验室能力的核心构成要素,初步构建实验室能力评价指标体系的基本框架;采取两轮德尔菲专家咨询对评价指标体系进行修改和完善;运用层次分析法确定各级指标权重,构建药品检验实验室能力评价综合模型,并对该模型进行信度和效度检验;利用建立的药品检验实验室能力评价指标体系和评价模型对青海省7个实验室进行实证性研究,并对调查及评价结果进行汇总分析。本研究构建的药品检验实验室能力评价指标体系,包括资源配置和技术能力2个一级指标,人力资源、仪器设备、基础设施、信息化建设、检验能力、检验工作量、能力验证和科研能力8个二级指标以及23个三级指标;建立的综合评价模型为Y=ΣW·Yi=(0.0800Y1+0.0441Y2+0.0243Y3+0.0655Y4+…+0.0319Y23)*10;选取青海省两级共 7个药品检验机构作为指标体系的实证研究对象,研究结果为:青海省各药品检验机构能力综合评分介于28.13-66.11分之间,省院得分明显高于州(市)级药品检验机构,州(市)级药品检验机构中,实验室B得分最高为39.38分,实验室D得分最低为28.13分;从8个二级指标的原始得分来看,能力验证和检验能力得分较高,信息化建设和检验工作量得分较低,成为导致综合能力较低的短板。本研究首次站在现代管理体系的平台上,构建了具有良好信、效度的药品检验实验室能力评价指标体系,评价结果可为实验室自身和监管者所用,为公正、客观、全面地评价药品检验实验室的能力提供了工具;通过应用构建的药品检验实验室能力评价指标体系,可以深入分析当前药品检验实验室能力的现状,并可依据评价的结果,调整资源配置方向,加强能力建设,全面提升综合能力。
[Abstract]:In order to build the ability evaluation tool suitable for the national conditions of our country, to understand the present situation and existing problems of the laboratory, and to provide the data support for the strengthening of the capacity building so as to put forward pertinent policy suggestions, it is necessary to carry out a quantitative study on the ability of the drug inspection laboratory and build a scientific and reasonable "medicine". It is scientific, effective, and fully appraising the comprehensive ability of the drug inspection laboratory. This study summarizes the core components of the power of the laboratory laboratory through literature review and expert interview. The basic framework of the index system; adopting two rounds of Delphy expert consultation to modify and perfect the evaluation index system; use the analytic hierarchy process to determine the weight of the indicators at all levels, construct the comprehensive model of the ability evaluation of the laboratory for drug inspection, and test the reliability and validity of the model, and use the established evaluation index of the ability of the drug inspection laboratory. The system and evaluation model have carried out an empirical study on 7 laboratories in Qinghai Province, and the results of the investigation and evaluation are summarized and analyzed. The evaluation index system of the capacity of the drug inspection laboratory is constructed, including the 2 first level indexes of the resource allocation and technical ability, the human resources, the equipment, the infrastructure, the information construction, the inspection ability and the inspection. The test workload, capacity verification and scientific research capacity 8 two level indicators and 23 three level indicators; the established comprehensive evaluation model is Y= Sigma W. Yi= (0.0800Y1+0.0441Y2+0.0243Y3+0.0655Y4+... +0.0319Y23) *10; selected 7 drug inspection institutions in Qinghai province two as the target system of the empirical research. The results are as follows: the comprehensive score of the drug inspection institutions in Qinghai is between the 28.13-66.11 points, the provincial hospital scores are obviously higher than the state (city) drug inspection institutions, and the state (city) level drug inspection institutions are the most successful in the laboratory. At 39.38 points, the lowest score of D in the laboratory is 28.13. From the original score of the 8 two level indicators, the ability to verify and test the ability is higher, the information construction and the test work score is low, which has become a short board which leads to the low comprehensive ability. This research has built a good letter and validity on the platform of modern management system for the first time. The evaluation index system of drug test laboratory capacity can be used by the laboratory and the supervisor. It provides a tool for the impartiality, objective and comprehensive evaluation of the ability of the drug inspection laboratory. Through the application and construction of the capability evaluation index system of the drug inspection laboratory, the ability of the current drug inspection laboratory can be deeply analyzed. Based on the evaluation results, we should adjust the direction of resource allocation, strengthen capacity building, and comprehensively enhance the comprehensive ability.
【学位授予单位】：沈阳药科大学
【学位级别】：博士
【学位授予年份】：2017
【分类号】：R95

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