[1]宋景晨a,李传保b,盖媛媛a,等.北京医院临床检验体外诊断试剂的遴选与优化管理实践[J].现代检验医学杂志,2024,39(03):194-198.[doi:10.3969/j.issn.1671-7414.2024.003.033]
　SONG Jingchena,LI Chuanbaob,GAI Yuanyuana,et al.Selection and Optimization Management of in Vitro Diagnostic Reagents for Clinical Examination in Beijing Hospital[J].Journal of Modern Laboratory Medicine,2024,39(03):194-198.[doi:10.3969/j.issn.1671-7414.2024.003.033]
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北京医院临床检验体外诊断试剂的遴选与优化管理实践()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第39卷
期数:
2024年03期
页码:
194-198
栏目:
质量控制·实验室管理
出版日期:
2024-05-15

文章信息/Info

Title:
Selection and Optimization Management of in Vitro Diagnostic Reagents for Clinical Examination in Beijing Hospital
文章编号:
1671-7414（2024）03-194-05
作者:
宋景晨a; 李传保b; 盖媛媛a; 吴锁薇a; 刘 蕾c; 李旭颖d; 郭芷萱b; 姚德明*
（北京医院/ 国家老年医学中心，中国医学科学院老年医学研究院 a. 医务处；b. 检验科；c. 药学部；d. 财务处，北京 100730）
Author(s):
SONG Jingchena;  LI Chuanbaob;  GAI Yuanyuana;  WU Suoweia;  LIU Leic;  LI Xuyingd;  GUO Zhixuanb;  YAO Deming*
（a.Department of Medical ; b. Department of Clinical Laboratory; c. Department of Pharmacy; d. Department of Finance , Beijing Hospital/National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China）
关键词:
体外诊断试剂; 试剂遴选; 试剂管理优化
分类号:
R466
DOI:
10.3969/j.issn.1671-7414.2024.003.033
文献标志码:
A
摘要:
目的 形成临床检验体外诊断试剂（in vitro diagnostic reagents，IVD）遴选与优化的管理方案和管理数据库，优化IVD 管理工作。方法 对政策背景和北京医院临床检验IVD 的管理现状进行分析，基于临床需求，制定已开展和新申请检验项目IVD 的遴选与优化管理方案，通过梳理项目、公开招标、创新报价方式、现场评审等步骤，对全院IVD进行遴选和优化，形成北京医院IVD管理数据库和资质数据库，并从合规性、工作效率和成本管控方面进行效果评估。结果 按照制定的IVD 遴选与优化管理方案完成全院1 737 项IVD 的遴选和优化工作，管理方案的实施提高了工作效率，平均一次会议评审的内容增加10 倍以上，加快了新申请IVD 准入频率；降低了IVD 成本，全院采购金额平均降幅约15%，重点IVD 产品遴选后较遴选前价格降低，且差异具有统计学意义（t=2.493, P=0.034）。结论 IVD 遴选与优化的管理方案切实可行，可以达到“保合规，提效率，降成本”的目标。
Abstract:
Objective To form the in vitro diagnostic reagents (IVD) selection and optimization management plan and management database, and optimize the IVD management work. Methods Through the analysis of the policy background and the current management status of the IVD clinical laboratory in Beijing Hospital, the selection and optimization management plan for existing and newly applied laboratory IVD was formulated based on clinical needs. The IVD of the whole hospital was selected and optimized by combing projects, open bidding, innovative quotation methods, on-site review and other steps. The IVD management database and qualification database of Beijing Hospital was formed, and the effect from the aspects of compliance, work efficiency and cost control was evaluated. Results The selection and optimization of 1 737 IVDs in the whole hospital were completed according to the formulated IVD selection and optimization management plan. The implementation of management plan improved the work efficiency. The content of review in an average meeting was increased by more than 10 times, and the frequency of new applications for IVD access was accelerated, while the IVD cost was reduced, and the average purchase amount of the whole hospital was reduced by about 15%. The prices of key IVD products were lower after selection than before selection, and the difference was significant (t=2.493, P=0.034). Conclusion The management scheme of IVD selection and optimization was feasible, and it could achieve the goal of ensuring compliance, improving efficiency and reducing costs.

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相似文献/References:

[1]宋景晨a,郭芷萱b,窦婧婧a,等.北京医院体外诊断试剂基于绩效管理的全流程闭环管理设计和效果评估[J].现代检验医学杂志,2024,39(04):197.[doi:10.3969/j.issn.1671-7414.2024.04.036]
　SONG Jingchena,GUO Zhixuanb,DOU Jingjinga,et al.Design and Effect Evaluation of in Vitro Diagnostic Reagents for Beijing Hospital Based on Performance Management of the Whole Process Closed-loop Management[J].Journal of Modern Laboratory Medicine,2024,39(03):197.[doi:10.3969/j.issn.1671-7414.2024.04.036]

备注/Memo

备注/Memo:
基金项目：2022~2023 年度北京医院院级科研课题（BJ-2021-226）。
作者简介：宋景晨（1989-），女，硕士研究生，助理研究员，主要从事医院管理和实验室管理研究，E-mail：songjc513@126.com。
* 通讯作者：姚德明，男，研究员（副院长），主要从事医院管理研究。
更新日期/Last Update: 2024-05-15