learning from defects reporting & error disclosure · 2016. 4. 19. · patient safety reporting...
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울산의대 서울아산병원
응급의학과/의생명정보학과
이 재 호
오류로부터 학습
Learning from Defects
Reporting & Error Disclosure
2016.04.15 한국의료질향상학회 연수교육
학습목표
• 체계적인 사건보고 시스템 정립
• 오류로부터 학습
• 잠재적인 위해사건의 발생 예방
• 사건보고 시스템 정립 및 장애물 감소 전략
• Learning from defects (LFD) 도구 소개
• 근본원인 해결을 위한 LFD 도구 사용방법
• 효과적인 Error Disclosure 사례 공유
Medical Nemesis?
영국(2009-2912): “Never Events”
http://www.bbc.co.uk/news/health-22366147
Patient Safety Reporting System (PSRS)
Adverse Event Reporting System
Reporting, Monitoring, Analyzing, Planning
• Blame: No way to Success
• System Failure: not compatible to tort system
• Learning from Errors
• Report, Disclosure: Confidential, Feedback
• Root Cause Analysis & Action Plan
• Measure of Success: Prevention, Cost?
Aviation Safety Reporting System
• FAA가 재정 지원, NASA가 운영
• 예방에 초점
• 항공 안전사건 보고 자료 수집, 분석 및 대응
– 자발적으로 보고
– near miss를 포함
– 사고의 분석과 반응이 개선의 핵심
http://asrs.arc.nasa.gov/overview/summary.html
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Aviation Safety Reporting System
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Aviation Safety Reporting System
Keming HJ. Quality, Safety, and Reliability in Healthcare Delivery, Northeast Regional Patient
Safety & Quality Improvement Conference, Rhode Island Hospital
환자안전사건보고체계:
Focus Group Interview
질문 소속병원 지역병원 기타 (지역병원)
환자안전사건보고체계 9/9 3/5 무응답 5
보고자의 기밀성 보장 9/9 4/5 무응답 5
근본원인분석 10/10 2/5 기타1 무응답4
개선활동 10/10 3/5 기타1 무응답4
의료사고, 소송 사례 분석 10/10 1/5 기타1 무응답4
사고 예방을 위한 FMEA 시행 4/10 0/4 기타1 무응답5
질문 소속병원 지역병원
n(중복응답) n(중복응답) 기타
환자안전사건 보고체계 구분 자발적보고 9 자발적 4
의무적보고 3 의무적 3
자발적 보고체계 사건유형 근접오류 9 근접오류 2 무응답7
적신호 3 없다 1
위해사건 2
모든 사건 1
의무적 보고체계 사건유형 적신호 6 적신호 2 무응답7
위해사건 6 없다 1
오류발생 1
민원 및 소송 1
환자안전사건보고체계:
Focus Group Interview
전문가 의견: 보고체계 원칙과 기밀성 보장
- 기밀성 유지: 경영진은 “그 사람이 누구냐”하고 묻기도 함. 경영진의 인식의 변화 필요
- 기밀성 보장; QI실에서 무기명처리가 중요
- 처벌 및 비난; 오류가 많은 부서에 대해 디센티브를 주겠다 한 적도 있음.
- 시스템의 문제보다는 개인의 문제로 보는 경향이 있어서 비난 또는 처벌은 남아있다
전문가 의견: 보고체계 활성화
- 보고 후 조치(피드백) 등 변화
- near miss의 경우 인센티브가 효과가 있다. 예)3,000원/건
- 전산시스템으로 보고체계 활성화에 기여함
- 적신호는 빠른 보고를 위해 유선/문서 보고 함. near miss는 전산화 보고가 도움됨
환자안전사건보고체계:
Focus Group Interview
전문가 의견: 근원원인분석 및 개선활동 미시행 이유
※근본원인 미시행 이유
- 시스템적인 접근이 아닌 당사자한테만 책임을 물고 끝내려고 함.
- 분석에 더 많은 시간과 노력이 필요하고 더 많은 부서가 참여해야 하기 때문에 못한다.
- 방법을 못해서 못 할 수도 있지만 알아도 여건이 안되서 못하는 경우도 많다.
-expert가 없어서 expert analysis는 잘 안된다.
※개선활동을 시행하지않는 이유
- 인력과 시간이 많이 투입되어야 하니깐
- RCA가 급하고 일어난 사건도 해결 못하는데 ‘무슨 예방이냐’ 라고 생각한다
- JCI한 병원은 하고 있으나 나머지 병원은 RCA하기도 급급하다 예) OO병원 1건/년
환자안전사건보고체계:
Focus Group Interview
전문가 의견: 근접 오류가 잘 보고되지 않는 경우의 이유
- 보고를 해도 변화가 없는 등 피드백, 개선이 없으면 보고를 잘 안 하게 된다.
예) 전에는 목표가 오류건수 줄이기였으나 나중에는 near miss 보고건수 늘리기
였다. 그러나 보고를 하여도 피드백이 없어서 보고를 안 하기도 한다.
- 환자안전사고의 예방을 중요하게 생각하지 않음, 주관부서에서 안전문화인식
에 대한 교육, 행사가 미진하므로 귀찮아 한다.
- 동기부여 부족, 번거로워서(필요성 인식 부족), incentive 없음, 보고자체가 귀
찮다, 나에게 이로움이 없어서, 보고에 대한 피드백이 없어서
- 지역병원; 보고를 하면 비난을 받을 것이라는 생각이 팽배함, 자기 업무도 바쁜
데 보고까지 하기 귀찮아 함
- 부서내의 문제는 부서에서 해결해야 된다는 생각 (부서 밖으로 나가면 안 된다)
환자안전사건보고체계:
Focus Group Interview
Requirements for PSRS (Leape, 2002)
• 비처벌성 (Non-punitive)
• 기밀성 (Confidential)
• 독립성 (Independent)
• 전문가분석 (Expert analysis)
• 적시성 (Timely)
• 시스템 지향성 (Systems-oriented)
• 반응성 (Responsive)
분류 세부항목 분포(%) 기타
보고방식 전산보고서 42
수기보고서 58
보고형태 통합 보고 20 3개 기관: 통합형태
분리 보고 80 12개 기관: 투약 & 낙상 별도,
그 외는 통합보고서 형태
공통항목
- 등록번호, 연령, 성별, 진료과, 발생 일시, 발생 진료과, 사건내용 기술,
문제 원인 기술: 90% 이상 포함
- 환자명, 입원실, 위해 정도, 문제 결과, 사건 이후 중재활동: 80% 포함
Patient Safety Reporting System (PSRS)
Patient Safety Reporting System (PSRS)
환자안전보고서의 법적 보호(익명성 보장)
근거에 기반한 환자안전보고서 양식 개발
보고서 검토 후 문제 유형 분류, 적재적소 의사결정
보고 후 과정의 진행, 직원 & 부서 피드백, 선순환 구조
근본원인분석 후 다학제간 문제 해결, 구성원 학습
국가 차원의 환자안전사건 경향 파악, 재발 방지
Patient Safety Reporting System (PSRS)
AHRQ Common Formats: PSOs
일반적인 양식
Healthcare Event Reporting Form(HERF)
Patient Information Form(PIF)
Summary Of Initial Report(SIR)
사건 특이적 양식
Device or Medical/Surgical Supply
Blood or Blood Product
Fall
Healthcare-Associated Infection
Medication or Other Substance
Perinatal
Pressure Ulcer
Surgery or Anesthesia
AHRQ Common Formats: PSOs
AHRQ Common Formats: PSOs
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AHRQ Common Formats: PSOs
22
AHRQ Common Formats: PSOs
https://pso.ahrq.gov/sites/default/files/npsdbrief_pso.pdf
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AHRQ Common Formats: PSOs
https://https://pso.ahrq.gov/sites/default/files/wysiwyg/npsd_data_brief_0715.pdf
24
AHRQ Common Formats: PSOs
https://https://pso.ahrq.gov/sites/default/files/wysiwyg/npsd_data_brief_0715.pdf
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AHRQ Common Formats: PSOs
https://https://pso.ahrq.gov/sites/default/files/wysiwyg/npsd_data_brief_0715.pdf
27
Learning from Defects
Comprehensive Unit-based Safety Program
(CUSP)
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30 http://www.ahrq.gov/professionals/quality-patient-safety/cusp/cusp-success/whatiscusp.html
Learning from Defects (LFD)
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• A structured approach to improve safety and teamwork culture as
part of quality improvement initiatives
• A lighter version of a root cause analysis (RCA) that allows
frontline caregivers to address adverse clinical events and identify
system failures by providing a structured approach to identify what
happened, determine why it happened, implement interventions
to reduce the probability that a similar event will recur, and evaluate
whether the interventions were effective.
American Journal of Medical Quality. 2009 May;24(3):192–5.
Learning from Defects (LFD)
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• What is a defect?
Any clinical or operational event or situation that
you would not want to have happen again
Incidents that caused patient harm or put patients at risk
for significant harm
• Purpose of tool
To provide a structured approach to help staff and
administrators identify the types of systems that
contributed to the defect and to follow up to ensure
safety improvements are achieved
Learning from Defects (LFD)
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• Who should use this tool? Health care providers
• All staff involved in the delivery of care related to a
defect should be present when this defect is evaluate
• Physician, nurse, administrator, and other selected
professionals
• Medication defect: pharmacy staff
• Equipment defect: clinical engineering staff
LFD: 4 Basic Questions
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1. What happened?
2. Why did it happen?
3. How will you reduce the risk of the defect?
4. How will you know the risk is reduced?
LFD: How to use this tool
• Complete the form for at least one defect per month
• Investigate all of the following defects:
– Adverse event reporting systems
– Sentinel events
– Claims data
– Infection rates
– Complications
– Where is the next patient going to be harmed?
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LFD: What happened?
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• Provide a clear, thorough, and objective explanation
of what happened
• Select a Defect
LFD: What happened?
38 American Journal of Medical Quality. 2009 May;24(3):192–5.
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LFD: Why did it happen?
• Review the list of factors that contributed to the incident
• Check off those that negatively and positively contributed
to the outcome of the incident
• Negative contributing factors are those that harmed or
increased the risk of harm for a patient
• Positive contributing factors limited the amount of harm
• Rate the most important contributing factors that
relate to the incident
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LFD: Why did it happen?
http://www.ahrq.gov/professionals/education/curriculum-tools/cusptoolkit/toolkit/learndefects.html
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LFD: Why did it happen?
http://www.hopkinsmedicine.org/armstrong_institute/_files/cusp_toolkit_new/learning-from-defects-tool.pdf
LFD: Why did it happen?
http://www.ahrq.gov/professionals/education/curriculum-tools/cusptoolkit/toolkit/learndefects.html
LFD: How will you reduce the risk of the
defect happening again?
Brainstorm possible interventions
Select intervention
LFD: How will you reduce the risk of the
defect happening again?
• Develop an intervention for each important contributing
factor identified
• Develop interventions to defend against the two to five
most important contributing factors
• Refer to the Strength of Interventions chart to rate
each interventions
• Make an action plan for two to five of the highest scoring
interventions
LFD: How will you reduce the risk of the
defect happening again?
Interventions To Reduce the Risk of th
e Defect
Ability To Mitigate the
Contributing Factor,
1 (Low to 5 (High)
Team’s Belief That the I
ntervention Will Be Impl
emented and Executed,
1 (Low) to 5 (High)
Strength of Interventions
LFD: How will you reduce the risk of the
defect happening again?
Strength of Interventions
Weaker Actions Intermediate Actions Stronger Actions
Double check Checklists or cognitive aid Architectural or physical pla
nt changes
Warnings and labels Increased staffing or reduce
d workload
Tangible involvement and ac
tion by leadership in support
of patient safety
New procedure, memorandu
m, or policy
Redundancy Simplify the process or rem
ove unnecessary steps
Training and education Enhance communication (e.
g., check-back, SBAR)
Standardize equipment and
process of care map
Additional study or analysis Software enhancement or m
odifications
New device usability testing
before purchasing
Eliminate look-alike and sou
nd- alike drugs
Engineering control of interl
ock (forcing functions)
Eliminate or reduce distracti
ons
LFD: How will you reduce the risk of the
defect happening again?
• Select 2-5 of the highest scoring interventions
• Develop an action plan to put them in place
Specific Interventions To Reduce the Risk
of the Defect
Who Will Lead
This Effort?
Follow-up
Date
• Remember the people side of the intervention
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LFD: How will you reduce the risk of the
defect happening again?
LFD: How will you know the risk is
reduced?
• Ask frontline staff involved whether the interventions
reduced the likelihood of recurrence of the defect
• After the interventions have been put in place, complete
the “Describe Defect” and “Interventions” sections and
have staff rate the interventions
Describe Defect:
Interventions Intervention Was Eff
ectively Carried Out,
1 (Low) to 5 (High)
Intervention Reduced
the Likelihood of Recu
rrence,
1 (Low) to 5 (High)
LFD: How will you know the risk is
reduced?
51 Jt Comm J Qual Patient Saf. 2006 Feb;32(2):102-8.
52 Jt Comm J Qual Patient Saf. 2010 Jun;36(6):252-60.
Error Disclosure
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• Providing information to a patient
and /or family about an adverse
event or serious error
Error Disclosure
56 http://www.ncbi.nlm.nih.gov/books/NBK2652/pdf/Bookshelf_NBK2652.pdf
Error Disclosure
• Legal obligation
• Ethical imperative
• Right thing to do
• Respect of patient autonomy
• Preserve patient-physician trust
• Policy
• Healing for care giver
• Improve safety
Error Disclosure
JAMA. 2003 Feb 26;289(8):1001-7
Error Disclosure
• Stating that error occurred
• What error was
• Why error occurred
• What changes will be made to prevent such
errors in future
• Giving apology
58
Clinton HR, Obama B. N Engl J Med 2006;354:2205-2208.
Results of Medical Error Disclosure Program at
the University of Michigan Health System
Error Disclosure
60 International Journal for Quality in Health Care 2010; Volume 22, Number 5: pp. 371–379
61
Mazor K, Roblin DW, Greene SM, Fouayzi H, Gallagher TH. Primary care physicians' willingness to disclose
oncology errors involving multiple providers to patients; 2015 Nov 3;:bmjqs–2015–004353.
62
Error Disclosure
Acad Pediatr. 2015 Aug 29. pii: S1876-2859(15)00219-3. doi: 10.1016/j.acap.2015.06.011. [Epub ahead of print]
63 http://www.patientsafetyinstitute.ca/en/toolsResources/disclosure/Pages/default.aspx
Error Disclosure Guideline
64 J Public Health Res. 2013 Dec 1; 2(3): e32.
Error Disclosure Training & Support
Summary: Learning from Errors
• Patient Safety Event Reporting
• Defect Analysis & Action Plan: Learn from Defect
• Error Disclosure
• Team approach, Communication, Support
• Culture of Safety
감사합니다