[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):197-202.[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(04):197-202.[doi:10.3969/j.issn.1671-7414.2024.04.036]
点击复制

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()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第39卷
期数:
2024年04期
页码:
197-202
栏目:
质量控制·实验室管理
出版日期:
2024-07-15

文章信息/Info

Title:
Design and Effect Evaluation of in Vitro Diagnostic Reagents for Beijing Hospital Based on Performance Management of the Whole Process Closed-loop Management
文章编号:
1671-7414（2024）04-197-06
作者:
宋景晨a; 郭芷萱b; 窦婧婧a; 刘 蕾c; 吴锁薇a; 李传保b
（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，北京 100730）
Author(s):
SONG Jingchena; GUO Zhixuanb; DOU Jingjinga; LIU Leic; WU Suoweia; LI Chuanbaob
（a. Department of Medical；b. Department of Clinical Laboratory；c. Department of Pharmacy，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; 闭环管理; 绩效管理; 效果评估
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2024.04.036
文献标志码:
A
摘要:
目的 构建体外诊断试剂（in vitro diagnostic reagents，IVD reagent）全流程闭环管理方案并实施，优化IVD管理工作。方法 基于北京医院IVD 管理现状，设计IVD 全流程闭环管理方案，包括IVD 申请、IVD 遴选、IVD 申购、IVD 采购、IVD 领取、IVD 入出库和IVD 使用等环节。选择关键指标建立评估框架，运用访谈法、查阅相关信息系统的方法收集和统计方案实施前（2020 年）和实施后（2023 年）的管理数据、采购数据和检测数据，对流程管理、质量管理和成本管理进行评估。结果 优化了管理流程，IVD 申购时间平均缩短了约60%，IVD 采购无需人工处理，实时拆分订单并发送至对应的供应商，IVD 领取时间平均缩短了约75%；IVD 和检测质量管理满意，供货商资质完善度达到100%，室间质评得到满分，无IVD 相关不良事件；成本管理有效，IVD 采购成本降低了约15%，分别建立了人免疫缺陷病毒抗体测定、丙型肝炎抗体测定、梅毒螺旋体抗体测定和乙型肝炎表面抗原定量测定四个项目的IVD 成本精细化管理模型，IVD 损耗的平均值为0.07% ～ 1.21%，标准差为0.07% ～ 0.66%。结论 IVD 全流程闭环管理方案切实可行，提高了IVD 管理工作效率，保证了IVD 质量和检测质量，降低了IVD 成本，细化了成本管理工作。
Abstract:
Objective To establish in vitro diagnostic (IVD) reagents closed-loop management scheme for the whole process and implement, and optimize the IVD management. Methods Based on the status quo of IVD management in Beijing Hospital, the closed-loop management scheme of the whole IVD process was designed, such as IVD application, IVD selection, IVD subscription, IVD purchase, IVD receipt, IVD inbound and outbound, and IVD use. Key indicators were selected to establish an evaluation framework. Management data, procurement data and testing data before (2020) and after (2023) implementation of the program were collected and counted by means of interviews and consulting relevant information systems, and then process management, quality management and cost management were evaluated. Results The management process was optimized, the IVD purchase time was shortened by about 60% on average, the IVD purchase did not need manual processing, the order was split in real time and sent to the corresponding supplier, and the IVD collection time was shortened by about 75% on average. IVD and test quality management were satisfactory, supplier qualification perfection reached 100%, full marks were obtained in the inter-room quality assessment, and no IVD-related adverse events were observed. The cost management was effective, and the IVD procurement cost was reduced by about 15%. IVD cost fine management models were established for four items, namely, human immunodeficiency virus antibody assay, hepatitis C antibody assay, treponemal antibody assay and hepatitis B surface antigen quantitative assay. The average value of IVD loss was 0.07% ～ 1.21%, and the standard deviation was 0.07% ～ 0.66%. Conclusion The IVD whole process closed-loop management scheme is feasible, which can improve the efficiency of IVD management, ensure the quality of IVD and detection, reduce the cost of IVD, and refine the cost management work.

参考文献/References:

[1] 中华人民共和国中央人民政府. 中共中央国务院印发《“ 健康中国2030” 规划纲要》[EB/OL]. (2016-10-25)[2024-2-24]. https://www.gov.cn/zhengce/2016-10/25/content_5124174.htm?eqid=d3b8bd10000095130000000664590b75. Central Government of the People’s Republic of China. The CPC central committee and the state council issued the outline of healthy China 2030[EB/OL].(2016-10-25)[2024-2-24]. https://www.gov.cn/zhengce/2016-10/25/content_5124174.htm?eqid=d3b8bd10000095130000000664590b75.
[2] 中华人民共和国中央人民政府. 北京推出医耗联动综合改革 [EB/OL]. (2018-12-28)[2023-6-18].https://www.gov.cn/xinwen/2018-12/28/content_5352881.htm. Central Government of the People’s Republic of China. Beijing has launched a comprehensive reform of medical and consumption linkage [EB/OL]. (2018-12-28)[2023-6-18].https://www.gov.cn/xinwen/2018-12/28/content_5352881.htm.
[3] 国务院办公厅. 国务院办公厅关于推动公立医院高质量发展的意见 [EB/OL].(2021-05-14)[2023-6-18]. https://www.gov.cn/zhengce/content/2021-06/04/content_5615473.htm. General Office of the State Council. Opinions of the General Office of the State Council on Promoting highquality development of public hospitals [EB/OL].(2021-05-14)[2023-6-18]. https://www.gov.cn/zhengce/content/2021-06/04/content_5615473.htm.
[4] 马颖奇, 韩斌斌, 陈淑慧. 基于代销和定额的临床诊断试剂管理探索[J]. 中国卫生经济, 2022, 41(7): 88-91. MA Yingqi, HAN Binbin, CHEN Shuhui. Exploration on management of clinical diagnostic reagents based on consignment and quota[J]. Chinese Health Economics, 2022, 41(7): 88-91.
[5] 国家卫生健康委员会, 国家中医药管理局. 国卫财务函[2022]72 号: 关于在全国范围内持续开展“公立医疗机构经济管理年”活动的通知[EB/OL].(2022-04-28)[2024-04-15]. http://www.nhc.gov.cn/caiwusi/s7785t/202204/fadb461999e24386abad54c8c9ec8d08.shtml. National Health Commission, State Administration of Traditional Chinese Medicine. Countries Financial Letter[2022]No.72: Notice on continuing to carry out the “Year of economic management of public medical institutions” nationwide[EB/OL].(2022-04-28)[2023-6-18]. http://www.nhc.gov.cn/caiwusi/s7785t/202204/fadb461999e24386abad54c8c9ec8d08.shtml.
[6] 李龙飞, 徐婷, 张舒, 等. SPD 模式下体外诊断试剂的精细化管理[J]. 医疗装备, 2023, 36(6): 49-52. LI Longfei, XU Ting, ZHANG Shu, et al. Refined management of in vitro diagnostic reagents under SPD mode[J]. Chinese Journal of Medical Device, 2023, 36(6): 49-52.
[7] 邱新颖, 陈大洋, 熊丹, 等. 基于ISO15189 开发临床实验室试剂管理系统[J]. 临床检验杂志, 2022,40(1): 64-66. QIU Xinying, CHEN Dayang, XIONG Dan, et al. Development of reagent management system for clinical laboratory based on ISO15189[J]. Chinese Journal of Clinical Laboratory Science, 2022, 40(1): 64-66.
[8] 黄艳美, 汤国平, 周庆利. 基于SPD 的医院体外诊断试剂精细化管理实践[J]. 中国医疗器械杂志,2022, 46(2): 230-232. HUANG Yanmei, TANG Guoping, ZHOU Qingli. Practice of refined management of in vitro diagnostic reagents based on SPD in hospital[J]. Chinese Journal of Medical Lnstrumentation, 2022, 46(2): 230-232.
[9] 许慧彬, 黄靖, 邓鑫, 等. 基于深度访谈法的医院医务人员健康教育激励机制研究- 以福建省人民医院为例[J]. 中医药管理杂志, 2023, 31(9): 119-122. XU Huibin, HUANG Jing, DENG Xin, et al. Research on incentive mechanism of health education for hospital medical staff based on in-depth interview method-a case study of Fujian Provincial People’s Hospital[J]. Chinese Journal of Management in Chinese Medicine, 2023, 31(9): 119-122.
[10] 程夏倩, 华婷, 施骏, 等. 儿童医院体外诊断试剂的规范化及信息化管理与应用[J]. 中国药业, 2021,30(13): 5-8. CHENG Xiaqian, HUA Ting, SHI Jun, et al. Normalized and informationalized management and application of the in vitro diagnostic reagents in a children’s hospital [J]. China Pharmaceuticals, 2021, 30(13): 5-8.
[11] 涂伟丽, 钱英. 高质量发展背景下公立医院体外诊断试剂的管理与改进[J]. 中国医疗设备, 2023,38(3): 119-123. TU Weili, QIAN Ying. Management and improvement of in vitro diagnostic reagents in public hospitals under the background of high-quality development[J]. China Medical Devices, 2023, 38(3): 119-123.
[12] 辛建雪, 周伟, 方沅湘, 等. 新医改背景下基于北京协和医院体外诊断试剂精细化管理模式探索与实践[J]. 中国卫生产业, 2021, 18(29): 180-183. XIN Jianxue, ZHOU Wei, FANG Yuanxiang, et al. Exploration and practice of the refined management model of in vitro diagnostic reagents based on Peking Union Medical College Hospital under the background of the new medical reform[J]. China Health Industry, 2021, 18(29): 180-183.
[13] 郁卓群, 陈爽. 医院体外诊断试剂SPD 供应链管理解决方案实践[J]. 中国医疗设备, 2022, 37(10): 114-118. YU Zhuoqun, CHEN Shuang. Practice of hospital IVD-SPD supply chain management solution[J]. China Medical Devices, 2022, 37(10): 114-118.
[14] 王静怡, 田爽. 国产医疗器械体外诊断试剂采购的资质审核管理[J]. 医疗装备, 2021, 34(9): 60-62. WANG Jingyi, TIAN Shuang. Management of procurement qualification auditing of domestic in-vitro diagnostic reagents[J]. Chinese Journal of Medical Device, 2021, 34(9): 60-62.
[15] 孙晶晶, 郭蕾, 蔡军, 等. 体外诊断试剂院内管理的风险分析与控制[J]. 中国医学装备, 2021, 18(5):140-143. SUN Jingjing, GUO Lei, CAI Jun, et al. Risk analysis and control of in-hospital management of in vitro diagnostic reagents[J]. China Medical Equipment, 2021, 18(5): 140-143.
[16] 陆锦贵. 浅谈供应链管理模式的IVD 试剂质量监管[J]. 现代医院管理, 2021, 19(2): 26-29. LU Jingui. Discussion on quality supervision of IVD reagent in supply chain management mode[J]. Modern Hospital Management, 2021, 19(2): 26-29.
[17] 贾昱晞, 周伟, 方沅湘, 等. 基于供应商绩效评价体系的体外诊断试剂精细化管理[J]. 中国卫生产业,2021, 18(15): 190-193, 198. JIA Yuxi, ZHOU Wei, FANG Yuanxiang, et al. Refined management of in vitro diagnostic reagents based on supplier performance evaluation system[J]. China Health Industry, 2021, 18(15): 190-193, 198.
[18] 曹群, 周伟, 方沅湘, 等. 医改背景下医院试剂供应商动态分级管理策略研究[J]. 中国医院, 2020,24(12): 77-78. CAO Qun, ZHOU Wei, FANG Yuanxiang, et al. Research on the dynamic hierarchical management strategy of hospital reagent suppliers under the background of medical reform[J]. Chinese Hospitals, 2020, 24(12): 77-78.
[19] 周伟, 贾昱晞. 医院试剂管理体系建设及质量控制[J]. 中国医疗管理科学, 2021, 11(6): 47-50. ZHOU Wei, JIA Yuxi. Hospital reagent management system construction and quality control [J]. China Medical Administration Sciences, 2021, 11(6): 47-50.
[20] 徐晓辉, 高朦, 张伟, 等. 全周期可追溯试剂管理系统的设计与应用[J]. 中国数字医学, 2020, 15(6): 50-52. XU Xiaohui, GAO Meng, ZHANG Wei, et al. Design and application of the full-cycle traceable reagent management system[J]. China Digital Medicine, 2020, 15(6): 50-52.
[21] 刘斌, 顾伟, 成月佳, 等. 基于多货主的体外诊断试剂二级库管理模式的探索[J]. 中国医疗设备, 2022,37(5): 119-123. LIU Bin, GU Wei, CHENG Yuejia, et al. Exploration of the management mode of the secondary storeroom of in vitro diagnostic reagents based on multi-consignor[J]. China Medical Devices, 2022, 37(5): 119-123.

相似文献/References:

[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.[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(04):194.[doi:10.3969/j.issn.1671-7414.2024.003.033]

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、实验室管理相关工作和研究，E-mail：songjc513@126.com。
通讯作者：李传保（1979-），男，研究员，主要从事临床血液、体液学检验，个体化用药研究和实验室管理工作。
更新日期/Last Update: 2024-07-15