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研究生:郭盈君
研究生(外文):YING CHUN KUO
論文名稱:醫療檢驗機構品質管理指標與能力試驗相關之研究
論文名稱(外文):The Association between Quality Management Measures and Proficiency of Accredited Items in Medical Diagnostic Institutes
指導教授:許光宏許光宏引用關係
學位類別:碩士
校院名稱:長庚大學
系所名稱:企業管理研究所
學門:商業及管理學門
學類:企業管理學類
論文種類:學術論文
論文出版年:2007
畢業學年度:95
語文別:中文
中文關鍵詞:醫療檢驗品質品質指標能力試驗分級管理
外文關鍵詞:Medical Diagnostic QualityQuality IndicatorsLaboratory ProficiencyClassification Management
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由於醫療成本提高和醫療市場日益競爭下,醫療品質的議題越來越受重視,過去對於醫療品質的探討大多是有關於醫生診斷方面的品質、病人對於服務的滿意度等等,比較少探討有關檢驗的品質,但要對疾病做出正確的醫療診斷,必須要有正確快速有品質的檢驗數據供醫護人員參考,所以檢驗的品質管理是值得探討的。
本研究的研究目的為以下三點: 1. 了解研究地區醫療檢驗機構品質的分布狀況, 2. 探討影響醫療檢驗品質的因素,3. 醫療檢驗品質構面和能力試驗的相關性,4. 醫療檢驗分級管理制度之雛議。
研究對象包括醫學中心的臨床病理科、醫院的檢驗科以及私人的檢驗所,共65家:35所檢驗所、23所地區醫院、6所區域醫院和1所醫學中心,能力試驗部份,分為三類:生化類、尿液類和免疫類。
根據訪查表調查和能力試驗問卷資料分析,
1. 不同層級之品質構面分數為醫學中心和地區醫院的十大品質構面都優於區域醫院和檢驗所。
2. 與品質構面分數相關之因素有管理階層、品質系統及管理程序、人員素質、儀器設備、試劑及庫存管理、內部品管、外部品管、檢體處理、檢驗報告、文件保存及紀錄、持續性品質改善、工作環境與安全。
3. 研究結果發現內部品管和總項次能力試驗合格率呈現正相關,外部品管和總項次能力試驗合格率呈現正相關,人員素質構面和免疫能力試驗合格率間呈現正相關。
4. 分級管理雛議:水平整合以聯合採購、信託中心等方式,垂直整合做雙向轉檢,以品質為準分包業務。
結論:以分級制度建立檢驗機構之聯盟關係,如整合性醫療系統,以提升品質,專業分工為主要目標,成為未來發展之輔。
The medical quality is gaining more attentions due to implementing global budget and rising trend of medical cost and competitiveness. A growing body of research was focused on the quality of diagnoses, treatments, and patient satisfactions in the past. Few were interested in quality of medical technology and laboratory tests, which are some what more radical and crucial for the subsequent diagnosis and treatment in current health care industry. The accuracy and efficiency of a laboratory diagnosis system are even important than what we expected in the medical settings. Therefore, this study aims to investigate issues as to solve puzzle of the field: 1) to describe the distribution of quality indicators among medical diagnostic institutes; 2) to examine the factors associated with quality of medical diagnostic institutes; 3) to inspect the association between quality indicators and laboratory proficiency levels; 4) to develop a preliminary model for stratification management of medical diagnostic industry under an integrated delivery system.
The data was collected from a specific administrative area, which included one medical center, 6 regional hospitals, 23 district hospitals, and 35 medical diagnostic institutes. The proficiency items were classified as biochemistry, urine, and immune tests.
According to the interview and inspection by nominated specialties, the study has come to major conclusions as follows: 1) the constructs of quality were found to be positively correlated with levels of institutes within an integrated delivery system; 2) The most important factor related to quality indicators was levels of institute, the quality constructs such as management levels, system and procedure controls, human resources, instruments, warehouse management, internal quality control, external quality control, specimen handling, reports, documentations, continuous quality improvement, and work environments and safety were found to be differentiated; 3) the overall proficiency level was found to be associated with both internal and external quality control, however proficiency of immune tests was related to quality of professional personnel; 4) a preliminary model for stratification management was suggested using joint procurement and escort center for colleting cases as horizontal alliance and using bidirectional referrals with quality dissemination as vertical alliance.
An innovative stratification management herewith alliance among medical laboratory diagnostic institutes is suggested from this study, where an integrated delivery system will be more efficiency, quality oriented, and professional specific in the future.
目 錄
指導教授推薦書…………………………………………………… i
口試委員會審定書………………………………………………… ii
授權書……………………………………………………………… iii
誌謝………………………………………………………………… vi
中文摘要…………………………………………………………… v
英文摘要…………………………………………………………… vi
第一章 緒論……………………………………………………… 1
1.1研究背景與動機……………………………… 1
1.2研究目的.................................................................................... 3
第二章 文獻探討................................................................................ 4
2.1醫院評鑑制度............................................................................ 4
2.2 ISO醫學實驗室認證................................................................. 7
2.3 TAF之CNLA認證................................................................... 8
2.4醫療品質之定義與演進........................................................... 10
2.5分級醫療與整合性醫療照護系統........................................... 11
第三章 研究材料與方法................................................................... 14
3.1名詞解釋................................................................................... 14
3.2研究對象................................................................................... 16
3.3研究流程................................................................................... 16
3.4研究工具................................................................................... 19
3.5資料處理與分析方法............................................................... 22
第四章 研究結果............................................................................... 24
4.1研究變項描述性統計............................................................... 24
4.2問卷信度分析........................................................................... 25
4.3醫療檢驗品質分析................................................................... 26
4.4醫療檢驗機構集群分析........................................................... 27
4.5醫療檢驗機構能力試驗........................................................... 32
4.6品質構面與能力試驗之相關................................................... 35
第五章 討論....................................................................................... 49
5.1檢驗機構品質構面................................................................... 49
5.2檢驗機構能力試驗................................................................... 53
5.3品質構面與能力試驗之相關................................................... 55
5.4醫療檢驗機構分級管理........................................................... 57
5.5建立檢驗整合系統................................................................... 62
5.6研究限制................................................................................... 65
第六章 結論與建議........................................................................... 66
6.1結論........................................................................................... 66
6.2建議........................................................................................... 67
6.3未來研究建議........................................................................... 68
參考文獻............................................................................................... 70
附錄....................................................................................................... 75
參考文獻
英文參考文獻
1. Brook, R.H.,McGlynn, E.A.(1996). "Part 2:Measuring Quality of Care. "NEJM;335(13):966-970.
2. Beaulieu, N.D.,Epstein, A.M.(2002). "National Committee on Quality Assurance Health-Plan Accreditation:Predictors, Correlates of performance, and Market Impact. "Medical Care;40(4):325-337.
3. Berte, L. M. (2005). "A Simple Model for Quality Management System Implementation in Health Care Organizations and Service."ASQ World Conference on quality and Improvemt Proceedings ; 59: 105-110.
4. Bremond, J. and M. Plebani (2001). "IVD industry role for quality and accreditation in medical laboratories." Clinica Chimica Acta 309(2): 167-171.
5. Campbell, S.M.,Braspenning, J.,Hutchinson, M.,Marshall, M.(2002). "Research Methods Used in Developing and Applying Quality Indicators in Primary Care. " Quality and Safety in Health Care;11:358-364.
6. D Burnett, et al.(2002). "Clinical pathology accreditation:standards for the medical laboratory." Jounrnal of clinical pathology 55(10): 729-733.
7. Dautzenberg, Y. E. M. (2005). "Twsting a European set of indicator for the evaluation of the management of primary care practice." Family Practice 23: 137-147.
8. Donabedian, A.(1980). "Methods for Deriving Criteria for Assessing the Quality of Medical Care. " Medical Care Review;37(7):653-98.
9. Donabedian, A.(1988). "The Quality of Care-How Can It Be Assessed ?" JAMA;260(12):1743-1748.
10. Donabedian, A.(1996). "The Effectiveness of Quality Assurance. " International Journal for Quality in Health Care;8(4):401-7.
11. Kazandian, V. A. et al.(1993). "Relating Outcomes to Process of Care-The Maryland Hospital Association’s Quality Indicator Project(QI Project). " The Joint Commission Journal on Quality Improvement;19:530-538.
12. Kenny, D. (2001). "ISO and CEN documents on quality in medical laboratories." Clinica Chimica Acta 309(2): 121-125.
13. L.Sjoblem, F. G. (1996). "Quality improvement drivers in the electronics industry." Jounrnal of Management and Accounting Research 8: 55-86.
14. Nadzan, D.M.,Turpin, R.,Handold, L.S & White, R.E.(1993). "Data-driven performance improvement in health care: the Joint Commission’s Indicator Measurement System(IMSystem). " Joint Commission Journal on Quality Improvement;19(11):492-500.
15. O’Malley, C.(1997). "Quality Measurement for Health System:Accreditation and Report Cards. " Am J Health-Sys Pharm;54:1528-1535.
16. Scrivens , E(. 1998). "Policy Issues in Accreditation. " International Journal for Quality in Health Care;10(1):1-5.110
17. Shahangian, S. (1998). "Proficiency Testing in Laboratory Medicine." Archives of Pathology&Laboratory Medicine 122(1): 15-30.
18. Siebe Slagter, J. G. L. (2001). "Accreditation of medical laboratories in the Netherland." Clinica Chimica Acta 309(2): 155-161.

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