슬라이드 1

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1 2012년 9월 24일서울의대의료관리학교실김윤 1

2 Optimal achievement of therapeutic benefit Quality Improvement and Avoidance of risk and minimization of harm. Patient Safety 2

4 미국 매년의료과오로약 44,000~98,000 명사망 교통사고, 유방암, AIDS 로인한사망자수보다많음. 의료과오로인한의료비지출 : 9~15 조 / 년 우리나라 의료과오 : 4,500~10,000 명사망추정 ( 교통사고사망자수수준 ) 의료사고 : 10,000~27,000 명사망추정 ( 사고사망자수수준 ) 의료사고및의료과오에대한체계적인연구결과나예방대책없음. 4

Chemical Manufacturing 1 10 100 1,000 10,000 100,000 1,000,000 10,000,000 사망률

5 100,000 DANGEROUS (>1/1000) Health Care REGULATED Driving ULTRA-SAFE (<1/100K) 10,000 연간총사망자수 1, Bungee Jumping Mountain Climbing Chartered Flights Chemical Manufacturing ,000 10, ,000 1,000,000 10,000,000 사망률 Scheduled Airlines European Railroads Nuclear Power Note: both dimensions are logarithmic scales

6 Q1) 환자에게 Cefa 계열항생제를투여한이후쇼크증상을보였다. 투약전피부반응검사는음성이었으며, 유사약물에대한과민반응병력도없었다. Q2) 혈액형 A 형인환자에게 B 형혈액이수혈되기직전환자보호자가이를발견하고담당간호사에게수혈준비를중단시켰다.

7 Adverse event [ 의료사고, 위해사건 ] An injury caused by medical management rather than the underlying condition of the patient cf> Patient safety: Free from accidental injury Medical error [ 의료과오 ] The failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning) cf> Preventable Adverse Event: An adverse event resulting from an error Near misses [ 근접오류 ] a close call, near hit, incident, or good catch Ex> A detected retained sponge after an unresolved count A prepped wrong limb for surgery Cf> 의료분쟁, 의료소송 : 비의학적, 법적측면에서정의 7

8 Injury resulting from a use of drug Adverse Drug Event (ADE) Medication Error Potential ADE [Near Miss] 7 Preventable ADE (28~56%) Failure in the process of medication management - wrong drug, dose, route, patient, frequency Errors that have the capacity to cause injury, but fail to do so, either by chance or because they are intercepted E.g> Penicillin was given to a patient despite a known allergy to penicillin, but did not react 8

9 Adverse event 환자안전문제의크기 과거 최근입원 외래, 노인요양원 의료과오의유형 Act of commission: 기존연구들 Act of omission: 최근연구 - 환자에게필요한약물을처방하지않은경우 - 미국 : 필요한서비스의 55% 만받고있음 (McGlynn 등, 2003) Medical error (incl. Near miss) 9

10 12 입원환자 100 명당의료사고발생률 Harvard Medical Practice Study Utah Colorado Study Australian Healthcare Study UK Pilot Study Danish Pilot Study 10

11 약물부작용발생률 - 입원환자 100 명당 호주 (1995) 미국 (1995) 스위스 (2004) 국내연구 (2005) 11

12 Harvard Medical Practice Study(1984) Adverse events 의의무기록 1,133 건검토결과 70%: 예방가능 6%: potentially preventable 24%: 예방불가능 UT & CO Study(1992) surgical errors 의 54%: 예방가능 12

13 6 개월된아이가급성백혈병으로소아과병동에입원 소아과전공의가오후 3 시에 vincristine 5mg IV 라는투약 order 를작성 하여병동약국에팩스로보냄 ( 계산착오 ). 담당교수가 order 를검토하면서오류발견하지못하였음. 약사가오류를발견하여병동간호사및의사와연락을시도하였으나 실패하였음. 의사와상의가필요한 문제처방 으로분류하여둠. 13

14 병동에서처방원본이약국에도착함. 오후교대근무약사가문제처방전임을인식하지못하고약을조제함. 전산화된용량점검시스템이있었으나, 이상용량임을발견하지못하였음. 병동간호사가 order에의문을갖고당직전공의에게문의함. 당직전공의가용량을다시계산하였으나, 전화통화를하면서용량이잘못전달됨. 간호사가오후 5시 20분경에치사량을 1분에걸쳐정맥투여. 간호사가환자상태를관찰 ( 맥박수가 110에서 74로낮아짐 ). 간호사가당직의사를호출하였고, 당직의사는진찰후 환자상태양호 로기록. 환자의엄마가아이스크림을먹이려할때, 구토, 호흡곤란발생. 5시 45 분경심폐소생술을시행하였으나, 환자는사망하였음. 14

15 여러분이병원장이라면, 어떠한조치를취하시겠습니까? 15

16 사람의잘못 OR 시스템의문제? 16

17 의사의용량계산오류 해결책 (1) 전공의용량오류발견실패 해결책 (2) 약사담당간호사연락실패 해결책 (3) 업무인계약사의용량오류인지실패 해결책 (4)

18 시스템에있는하나의구멍만으로는결함을유발하지않음 시스템의결함은 Swiss Cheese 조각의구멍들이나란히정렬되었을때 ( 즉, 프로세스의여러부분에결함이있을때 ) 발생 18

19 사람의잘못 OR 시스템의문제? 겉보기에실수를저지르는것은사람이지만, 실수의배후에는잘못된시스템이존재함. 의료과오의 90% 이상은시스템의문제 사람은실수를한다 전제하에시스템설계 사람이실수하기어렵게시스템을설계 실수를저지른사람을비난 / 문책하는것은의료사고를줄이는데거의효과없음. 19

20 Are the lines crooked or straight? Optillusions.com 20

21 Error is the inevitable downside of having a brain!

22 3 pivot points Designing systems to prevent error Counteract humans cognitive weakness: O2 & NO2 Designing procedures to make errors visible Designing procedures to reduce the effect of errors when they are not detected or intercepted 22

23 Medical Gas Wall Outlet and Line A B 23

24 24

25 Existing Design New Design

26 서울대병원수혈사고사례 (1995) 입원환자수혈사고발생 담당검사가간호부 사건사고보고서 를뒤져과거의수혈사고를모두기소 사건사고보고서 사라짐 Kill the messenger 26

27 알지못하는문제를 해결할수는없다. You can t manage what you can t measure 27

28 28

29 의료소송시스템은 가정 : 소송의가능성 ( 위협 ) 때문에의사들이환자를안전하게진료 징벌중심, 개인중심, 발생한의료손상에초점 환자안전을향상시키려는접근방법은 가정 : 의료과오는시스템의문제에기인 징벌최소화, 시스템중심, 협력적인전략중심 두문화간의갈등 E.g.: 의료사고에대한보고의무의법제화 29

30 비난 / 문책의문화 (Culture of Blame) 에서 누가했는가? 안전의문화 (Culture of Safety) 로 무엇이잘못됐는가? 왜, 일어났는가? 변화의장애요인 오류의존재를인정 바뀌는것에대한저항 징계, 보복, 당혹스러움에대한두려움 변화에드는비용부담 30

31 모든인간에게는건망증이있기때문에, 인간의기억에의존하는시스템은 반드시실패를경험할수밖에없다 (Leape, 1997) 31

32 Harvard Medical Practice Study 3.7% rate of adverse events On average, there are sentinel events per hospital per year. 의료사고 : 확률의문제 진료환자 : 입원환자 20명 *20주/ 년 =400명 의료사고 : 400명 *3.7% = 15건 의료과오 : 400명 *3.7%*27.6% = 4건 의료사고, 의료진개인의책임으로돌릴것인가? 32

33 여러분이담당한환자에서의료사고가 발생했다면어떻게해야할까요? 환자에게언제어떻게설명해야할지 재발방지위해병원시스템에어떤문제가있었는지 분석하고, 개선책을제시할수있습니까? 33

34 설명과사과 (Disclosure & apology) 정확한설명 : 무슨일이일어났는가? uncertainty itself is painful silence is easily interpreted as lack of respect & compassion. 의료진의사과 : 정말미안합니다 often technically correct, it may not convey the deep sense of sorrow and regret 비슷한사고가재발하지않도록하는대책시행 재정적도움이나보상 34

35 의료과오와관련된의료진도도움이필요 정서적인지지 환자와환자가족에게적절한때에사과할수있어야 하지만현실은 의료계문화는자신의의료과오를동료에게조차드러내는것을꺼리게만듦 실수를저질렀다는부끄러움 실력없는의사로낙인찍힐것이라는두려움 언제어떻게환자에게알리고사과해야하는지모름 비슷한사고를예방하기위해취해야할조치는무엇인지모름 35

36 미국 Mayo clinic 내과레지던트를대상으로 1 년동안심각한의료과오를 저지른적이있는지를조사 (N=184) 1 년동안적어도 1 회이상 : 34% 지난 3 개월동안 1 회이상 : 14.7% 의료과오를경험하지않은군과경험군정신건강비교 Depersonalization (MBI-DP) : 6.62 vs Emotional exhaustion (MBI-EE) : vs Depression(%) : vs 의료사고를경험한의료진에대한지원시스템이없기때문에 pathological coping mechanisms lose their self confidence feel permanently wounded or unworthy 36

37 37

38 계획실행평가개선 가장널리사용되는 질향상접근법

39 계획단계 개선아이디어 구체적인실행계획작성 : 역할분담 실행단계 계획대로시행되지않은것기록 분석단계 잘한것 / 잘못한것 / 개선할것 개선단계 : 분석단계 분석단계에서얻은교훈반영 PDSA cycle 지속여부결정

40 1. 목표? Specific and measurable 2. 지표? Measures of improvement 3. 개선활동? Key changes 4. PDSA Cycle 반복 P D S A Plsek PE. Improving care through collaboration. Pediatrics. 1999;103(1 Suppl E):

41 Every system is perfectly designed to achieve exactly the results it gets. 투입 Complex System (Medical System) 산출 Paul Batalden, MD 41

42 42

43 43

44 Trial-and-Learning approach Rapid cycle of improvement 44

46 Make recommendations Provide tools to implement the recommendations

48 Evidence 8 hospitals in 8 cities Toronto, Canada New Delhi, India Amman, Jordan Auckland, New Zealand Manila, Philippines Ifakara, Tanzania London, England Seattle, WA

49 ...and was found to reduce the rate of postoperative complications and death by more than one-third! Haynes et al. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. New England Journal of Medicine 360: (2009)

50 Landmark Study National Strategy S afety Organization Safety Program 미국 (1991/1999) 호주 (1995) 영국 (2000) 뉴질랜드 (2003) 캐나다 (2004) 프랑스 (2007) 브라질 (2009) 독일 (2009) 스웨덴 (2009) 튀니지 (2010) 미국 (2000) Crossing the quality chasm 영국 (2001) Building a safer NHS for patients. 미국 : AHRQ, NQF, CMS, QIO, JC 등 영국 (2001) 캐나다 (2003) 호주 (2006) 뉴질랜드 (2010) 미국 Sentinel event policy ( 96) PS Standards ( 01) PS Goals ( 03) HAC payment policy ( 08) 영국 Incident reporting ( 01) PS standard ( 01) PS: Patient Safety,

Professionalism Medical education Credential physicians in certain procedures [Meta] Regulation Accreditation: JC Sentinel event Policy (1996) Patient-safety Standards

51 Professionalism Medical education Credential physicians in certain procedures [Meta] Regulation Accreditation: JC Sentinel event Policy (1996) Patient-safety Standards (2001) Patient-safety goals (2003) Market forces LeapFrog Group Computerized physician order entry ICU Intensivists Evidence-based hospital referral CMS payment adjustment for HAC

52 52

53 JCAHO. Sentinel Event Statistics as of: March 31, 2009

54 왜우리나라에서는 환자안전이정책의제가되지못할까? 환자안전 Landmark study 가아직없을까? 중요한환자안전문제는무엇일까? 지난 10 년간병원에서합병증 / 부작용은줄었을까? 만약 Yes 라면. 무엇때문에 의료기관인증평가 병원의자발적노력 똑똑한소비자

항균제 관리 필요성

항균제 관리 필요성 6. 3 vincristine 5mg IV order ( ). order... ..,. order.,. 5 20 1. ( 110 74 ).,. 5 45 : Quality of care is the degree to which health services for individuals and populations increase the likelihood of