汉铭医院医院病安管理系统－以用药安全为例.pps

1、1,漢銘醫院醫院病安管理系統以用藥安全為例,中國醫藥大學 醫務管理學系暨碩士班 郝宏恕 博士 Steven Hao, Ph.D., MBA.,2006.06.29,2,學歷： 國立交通大學運輸管理系 美國紐約州立大學 管理學院 財務管理碩士(MBA) 管理系統博士(Ph.D.) 經歷： 美國華盛頓大學醫務管理研究所博士級講師(1991-1994) John Deere Health Care Inc. HMO 醫管顧問(1993-1994) 長庚大學 醫務管理學系所 副教授 (1994-1997) 中國醫藥大學 醫務管理學系所 主任兼所長(1997-2001) 中國醫藥大學 學術研究發展委員會

2、 委員兼執行秘書(1999-2002) 中國醫藥大學 校務發展委員會 副主任委員兼執行秘書(2001-2002) 台灣醫務管理學會 教育研究委員會召集委員(2000-2006) 台灣醫務管理學會 常務理事(2003-2006),簡歷,3,大綱,前言 醫院風險/病患安全管理系統 用藥安全 結語,4,醫院風險病患安全管理系統,5,系統思維與病安,舊思維（無效） Name Blame Shame 新思維（系統） CQI Human Factors Engineering Social Engineering,6,品質改善與病患安全之關係,7,系統思維新挑戰,Systems are composed

3、of multiple, interconnected components: people, machines, processes, data. The goal of a system is to maximize the output of the system. Optimize the performance of each of its components in order to maximize the systems output. The output of a system has multiple dimensions. Safety, effectiveness,

4、patient-centeredness, timeliness, efficiency, and equity. The system must optimize the level of each dimension. Optimization is a value judgment by those who design the system, who manage the system, and who use the output of the system. Most systems are open systems Complex systems are at risk of p

5、roducing unintended consequences.,8,執行病安四個主要障礙,Donald M. Berwick Most clinicians remain blind to care-associated deaths, injuries, and near misses, because of difficulties in recognizing, tracking, and summarizing these events. A lack of appreciation of the true incidence and nature of patient injur

6、ies leads to ”unscientific theories,” which result in “counterproductive responses to the problem.” There is a lack of a business case for safety, to justify and offset the large investments that may be necessary to make care safe. Patient safety represents a difficult and complex problem.,9,建立醫院全面病

7、人安全管理系統,病人安全醫院文化,病人安全組織架構,員工作業 安全指引,醫療不良事件 通報系統,病人安全指標,教育訓練,研究,10,病患安全文化問卷,Safety attitudes questionnaire- 60 items /schools/med/imed/patient_safety/surveyandtools.htm Stanford instrument- 30 items Items published in (Singer et al. 2003) Modified Stanford instrument-32 items Lia

8、ne.Ginsburgmail.atkinson.yorku.ca Hospital survey on patient safety culture- 79 items /qual/hosculture,11,病患安全文化目標,Shared values and beliefs about safety within the organization Always anticipating precarious events Informed employees and medical staff Blame-free environment recogn

9、izing human infallibility Culture of continuous improvement Empowering families to participate in care of patients Informed and activated patients Culture of reporting “Just” culture,Physician team work Learning culture,12,病人安全組織架構,病患安全委員會,醫療組,行政組,放射品質暨病安小組,病理檢驗品質暨病安小組,護理品質暨病安小組,醫管品質暨病安小組,內科品質暨病安小組,

10、感染品質暨病安小組,急診品質暨病安小組,外科品質暨病安小組,藥事品質暨病安小組,精神品質暨病安小組,院長,風險管理部,護理組,醫事組,住院給藥病安小組,儀器設施病安小組,13,美國NPSF2003調查結果,Topics Ranked by physician Survey %Very Interested Proven medication safety practices 67.2 Legal,tort,and malpractices issues 57.0 Non-punitive environments and systems 55.9 for reporting error Saf

11、ety practices (eg, standardization and 55.1 simplification of key processes) Ethical issues 53.9 Patient safety in hospital-based settings 53.5 Models for error reduction 52.8,前言,14,Topics Ranked by Nursing Survey %Very Interested Proven medication safety practices 75.8 Designing jobs for safety (eg

12、, work hours, 75.7 work loads,staffing ratios) Ethical issues 72.1 Non-punitive environments and systems 69.1 for reporting error Models for constructively dealing with 68.7 unsafe practices,美國NPSF2003調查結果,前言,15,Topics Ranked by Nursing Survey %Very Interested Safety practices (eg, standardization a

13、nd 67.2 simplification of key processes) Patient safety in hospital-based settings 66.4 Information-based strategies to improve patient 65.7 safety ( eg, practices guidelines and standards) Models for error reduction 64.7 Methods for making safety a system-wide 62.1 objective ( eg, a culture of safe

14、ty),前言,美國NPSF2003調查結果,16,前言,JCAHO在2001年修改評鑑標準，其指出醫療組織每年至少要有一次在高風險的服務流程中執行風險評估 風險評估的方法中失效模式及效應分析是JCAHO支持醫界運用的分析評估方法。,17,前言,醫院服務系統兩大特質 複雜性(complex) 適應性(adaptive)投機取巧,18,HFMEA,HFMEA可應用於高風險流程如下： Prevention of wrong site procedure/surgery. Prevention of adverse drug events.,19,HFMEA,Healthcare FMEA A pro

15、spective and systematic method of identifying and preventing product and process problems before they occur“ VA National Center for Patient Safety (NCPS),20,Primary: Prevent adverse events before they occur Secondary: JCAHO Leadership Standard: LD 5.2 Responsible for ongoing, proactive program for i

16、dentifying patient safety risks and reducing medical/health care errors,為何要執行HFMEA ?,自2003年起JCAHO已列為正式的標準，每一所醫院皆須使用HFMEA以改善高風險流程。,21,FMEA (Failure Modes and Effects Analysis),FMEA並不是什麼新技巧，它的歷史約有50年以上，最早出現於航太工業，尤其是和美國 NASA有著絕大的關係。這些年來，因為汽車使用的普及，涉及到人身安全，所以汽車產業極為重視此一技法，遂普遍的活用在汽車產業上，而逐漸為人知曉。基本上企管學界將FMEA

17、定位為一種結合理論知識與實務經驗的不良預測技術。 按部就班、抽絲剝繭、巨細靡遺的科學手法,22,失效模式與效應分析（FMEA）,FMEA可說是一種預防性可靠度分析法，為確認、分析和記錄系統內可能存在的失效模式，主要在探討系統內潛在失效原因及發生時對系統、次系統所造成的影響，並針對系統潛在問題提出適當的預防措施或改進方案。 FMEA技術起源於西元1950年代，首先由格魯曼（Grumman）飛機公司將FMEA的觀念運用在飛機主操控系統的失效分析 。 廣泛的運用在太空、航空、國防、汽車、機械、電子、造船、醫療服務等產業 。,23,失效模式與效應分析（FMEA）,FMEA之作業程序 選擇一個或多個高風

18、險流程或次流程，進行風險評估。 召集小組。 繪製圖表。 小組討論流程或次流程可能/潛在的失效模式。 找出失效原因，瞭解發生頻率及嚴重度。 辨識最高的危險。 採取行動以減輕系統存在的最高危險性：可能需重新設計流程。 成果評估：改善措施實施後，定期評估。,24,HFMEA vs FMEA,JCAHO 2001 recommended HCOs conduct proactive risk management. VA NCPS 2001 designed HFMEA. HFMEA combines FMEA and FDA HACCP together with VAs RCA. American

19、 Society for Healthcare Risk Management 2002 sent HFMEA instructional CD and worksheets to every hospital CEO in the US.,25,HFMEA,繪製圖表-系統圖,26,HFMEA,繪製圖表-HFMEA分析表,27,HFMEA,繪製圖表-HFMEA分析表（嚴重等級）,28,HFMEA,繪製圖表-HFMEA分析表（機率等級）,29,HFMEA,繪製圖表-HFMEA分析表（危險評量）,30,HFMEA Process,Step 1 - Define the Topic Step 2 -

20、 Assemble the Team Step 3 - Graphically Describe the Process Step 4 - Conduct the Hazard Analysis Step 5 - Identify Actions and Outcome Measures,31,HFMEA Process,STEP 1 - Define the Topic The topic to be reviewed should a high-risk or high-vulnerability area, to merit the investment of time and reso

21、urce by the HFMEA team.,32,HFMEA Process,STEP 2 - Assemble the Team Assemble the Team Multidisciplinary team with Subject Matter Expert (s) plus advisor,33,HFMEA Process,P1,P3,P2,1 2 3 4 5,Sub-Processes: A. xxx B. xxx C. xxx,Sub-Processes: A. xxx B. xxx C. xxx D. xxx,Sub-Processes: A. xxx B. xxx C.

22、xxx D. xxx,Sub-Processes: A. xxx,Sub-Processes: A. xxx,P4,P5,STEP 3 - Graphically Describe the Process,34,HFMEA Process Step 4: Conduct Hazard Analysis:(a) List potential failure modes for each step,3A 3B 3C 3D,Failure Mode: 1. xxx 2. xxx,Failure Mode: 1. xxx 2. xxx,Failure Mode: 1. xxx,Failure Mode

23、: 1. xxx 2. xxx 3. xxx 4. xxx,Use worksheet,(b) Determine Severity & Probability (c) Use the Decision Tree (d) List all Failure Mode Causes,35,HFMEA Process,STEP 5 - Actions and Outcome Measures Decide to “Eliminate,” “Control,” or “Accept” the failure mode cause. Describe an action for each failure

24、 mode cause that will eliminate or control it. Identify outcome measures that will be used to analyze and test the re-designed process. Identify a single, responsible individual by title to complete the recommended action. Indicate whether top management has concurred with the recommended actions.,3

25、6,執行步驟,37,執行步驟,38,Hazard Analysis,Severity Rating : Catastrophic - death or major permanent loss of function (sentinel event) Major - permanent lessening of bodily functioning, disfigurement, required major surgery, increased length of stay or level of care for more than 2 patients Moderate - increa

26、sed length of stay or level of care for more than one patient Minor - No injury, nor increased length of stay or level of care,39,Hazard Analysis,Probability Rating : Frequent - Likely to occur immediately or within a short period (may happen several times in one year) Occasional - Probably will occ

27、ur (may happen several times in 1 to 2 years) Uncommon - Possible to occur (may happen sometime in 2 to 5 years) Remote - Unlikely to occur (may happen sometime in 5 to 30 years),40,HFMEA Decision Tree,Hazard needs controlled? HAZ 8?,Single Point Weakness? Failure will result in system failure (Crit

28、icality),Does Effective Control Measure already exist ?,Hazard so obvious/apparent that control measure not needed? (Detectability),Proceed with HFMEA Step 5,STOP,YES,YES,YES,NO,NO,NO,NO,YES,41,Definitions :,Single point weakness: If the step in the process is so critical that is failure will result

29、 in system failure or in an adverse event then you have identified a single point weakness. Effective Control Measure: A barrier that eliminates or substantially reduces the likelihood of a hazardous event occurring,42,PSA Testing (攝護腺特異性抗原),Step 1: Define the Topic: Lab Safety (PSA testing) Step 2:

30、 Assemble the Team Leader: Patient Safety Manager Members: Techniciansetc. Subject Matter Experts “On-Call”:,43,Step 3: Graphically Describe the Process,Sub-Processes: A. Order written B. Entered in HIS C. Received in Lab,Sub-Processes: A. Review order B. Centrifuge Specimen C. Verify Calibration D.

31、 Run QC E. Run Sample F. Report Result G. Enter in HIS,Sub-Processes: A. ID Patient B. Select proper tube/equip C. Draw blood D. Label,Sub-Processes: A. Report Received,Sub-Processes: A. Results Filed,Focus,44,Step 4: Conduct Hazard Analysis:(a) List potential failure modes for each step,Review orde

32、r,Verify Calibra.,Centri. Specimen,3A 3B 3C 3D 3E 3F 3G,Failure Mode: 1. Wrong test ordered 2. Order not received,Failure Mode: 1. Instrument not Calibra. 2. Bad calibra. stored,Failure Mode: 1. QC result not accep.,Failure Mode: 1. Mech. error,Run QC,Run sample,Failure Mode: 1. Equip. broken 2. Wro

33、ng speed 3. Specimen not clotted 4. No power 5. Wrong test tube,Report result,Run sample,Failure Mode: 1. Not entered,Failure Mode: 1. Computer crash 2. Result entered for wrong Pt 3. Result not entered 4. Result misread by tech.,Use worksheet,腦力激盪法、 收集法 .,45,Step 4: Conduct Hazard Analysis:,Catastr

34、ophic Major Moderate Minor,Determine Severity and Probability of potential failure modes, record on worksheet,Frequent Occasional Uncommon Remote,46,Step 4: Conduct Hazard Analysis:(b) Determine Severity and Probability of potential failure modes, record on worksheetHazard Scoring Matrix,Determine H

35、azard Score and Enter on Worksheet,47,Step 4: Conduct Hazard Analysis:(c) Complete Decision Tree,Hazard needs controlled? HAZ 8?,Single Point Weakness? Failure will result in system failure (Criticality),Does Effective Control Measure already exist ?,Hazard so obvious/apparent that control measure not needed? (Detectability),Proceed with HFMEA Step 5,STOP,YES,YES,YES,NO,NO,NO,NO,YES,48,Step 5：Actions & Outcomes,severity,probability,Hazard Score,SP Weakness?,Existing ECM?,Detectable?,Proceed?,Moderate,Management concurrence,Person Responsible,Lab Supervisor,Facilities Engineering,Su