learning from defects reporting & error disclosure · 2016. 4. 19. · patient safety reporting...

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

6

Aviation Safety Reporting System

7

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

21

AHRQ Common Formats: PSOs

22

AHRQ Common Formats: PSOs

https://pso.ahrq.gov/sites/default/files/npsdbrief_pso.pdf

23

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

25

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)

28

30 http://www.ahrq.gov/professionals/quality-patient-safety/cusp/cusp-success/whatiscusp.html

Learning from Defects (LFD)

32

• 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)

33

• 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)

34

• 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

35

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?

36

LFD: What happened?

37

• 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.

39

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

40

LFD: Why did it happen?

http://www.ahrq.gov/professionals/education/curriculum-tools/cusptoolkit/toolkit/learndefects.html

41

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

48

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

54

• 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