환자안전과의료의질질향상향상::: · james jt.a new, evidence-based estimate of patient...

환자안전과환자안전과환자안전과환자안전과 의료의의료의의료의의료의 질질질질 향상향상향상향상::::

근거기반근거기반근거기반근거기반 보건의료의보건의료의보건의료의보건의료의 핵심가치핵심가치핵심가치핵심가치

2016.06.03.

한국보건의료연구원원장 임태환

1

Causes of death, US, 2013

2Makary MA, Daniel M. BMJ 2016;353:i2139 doi: 10.1136/bmj.i2139 (Published 3 May 2016)

3Makary MA, Daniel M. BMJ 2016;353:i2139 doi: 10.1136/bmj.i2139 (Published 3 May 2016)

보건의료의 질: Quality of Care, WHO

바탕, 본질, 품질

EffectiveEffective

EfficientEfficient

AccessibleAccessible

Patient-centeredPatient-centered

EquitableEquitable

SafeSafe

6WHO. Quality of care, A process for making strategic choices in health systems 2006. Available at http://www.who.int/management/quality/assurance/QualityCare_B.Def.pdf

It is important to emphasize that, in the field of quality, the context in which the evidence is being used is very important: “Systems Thinking”

보건의료의 질(Quality)

Priorities of the National Quality Strategy

1. Patient Safety1. Patient Safety

2. Person-and Family-Centered Care2. Person-and Family-Centered Care

3. Care Coordination3. Care Coordination

4. Effective Prevention and Treatment4. Effective Prevention and Treatment

5. Healthy Living5. Healthy Living

7

6. Care Affordability6. Care Affordability

2015 National Healthcare Quality and Disparities Report, AHRQ

환자 안전(Safety)

편안한, 온전한

• Microscopic: Absence of preventable

harm to a patient during the process of health care

• Macroscopic: A discipline in the health

care sector that applies safety science methods toward the goal of achieving a trustworthy system of health care delivery

8What exactly is patients safety? (Emanuel L. et al. AHRQ, 2008)

환자 안전(Safety): Definition

• Freedom from accidental injury” (1)

• Key property of safety: emerging from the proper interaction of components of healthcare system, thereby leading the way to a defined focus for patient safety, namely systems(2)

Goal: Avoidance, prevention, and amelioration of adverse outcomes or injuries stemming from the process of care(3)

• An attribute of healthcare systems: minimizes the incidence and impact of , maximizes recovery from, adverse events.(4)

9

1 IOM, 2,3NPSF, 3AHRQ

Landmark reports related to patient’s safety

1. Incidence and types of adverse events and negligent care in Utah and Colorado

� 15,000 nonpsychiatirc discharge in Utah and Colorado in 1992

– Adverse events, in 2.9% of hospitalized pts. in each states– 32.6% and 27.4%of them, due to negligence,

respectively in Utah and Colorado– 6.6% of adverse events, led to death (8.8% of negligent events)

10Thomas EJ et al. Med Care 2000 38(3):261-71.

3 Landmark Studies


2. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I

� 30,121 randomly selected records from 51 randomly selected acute care hospitals in New York State in 1984

– Adverse events occurred in 3.7% of hospitalized pts, – 27.6% of them, due to negligence– 13.6%, led to death

11Brennan TA, Leape LL, Laird NM, et al NEJM; 1991: 324: 370-376

3 Landmark Studies


3. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study II

– Drug complications: 19%– Wound infections: 14%– Technical complications: 13%– Up to 50% of complications were associated with operation– Surgical complications, less likely by negligence (17%)– Non-surgical complications, more likely by negligence (37%)

12Leape LL, Brennan TA, Laird NM, et al NEJM 1991; 324: 377-384

3 Landmark Studies


• 44,000 ~ 98,000 Americans die in hospital each year from medical errors (IOM, 1999)

• More than 400,000 per year: the true number of premature deaths associated with preventable harm, USA( James JT, 2013)

• 7.5 per 100 hospital admissions, 36% of which were preventable and 21% of which were fatal, Canada (Baker GR, 2004)

James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013 Sep;9(3):122-8.

13Baker GR , The Canadian Adverse Events Study, JAMC 2004; 170 (11):1678-86

Mortality of preventable harm

Preventable harm 30.7

14

Mortality of preventable harm

Preventable harm 125.4

15

17

At least, 44,000 people, and perhaps as many as 98,000 people, die in hospital each year as a result of medical errors that could have been prevented

To Err is Human: Building a Safer Health System

1. Leadership and knowledge– Center for Patient Safety

2. Identifying and Learning from Errors3. Setting Performance Standards and

Expectations for Safety4. Implementing Safety Systems in Health

Care Organizations

18

Recommendations

Kohn LT, Corrigan JM, and Donaldson MS, Editors: Committee on Quality on Health Care in America, IOM

WHO: World Alliance for Patient Safety

19

Action Areas

Action area 1. Global patient safety challenge

Action area 2. Patient and consumer involvement

Action area 3. Developing a patient safety taxonomy

Action area 4. Research in the field of patient safety

Action area 5. Solutions to reduce the risk of health care and improve its safety

Action area 6. Reporting and learning to improve patient safety

20

• Speak up if you have questions or concerns: it’s your right to know

• Pay attention to the care you are receiving

• Educate yourself about your diagnosis, test, and treatment

• Ask a trusted family member or friend to be your advocate

• Know what medications you take and why you take them

• Use a health-care provider that rigorously evaluates itself

against safety standards

• Participate in all decisions about your care

The Speak Up campaign

Action area 2. Patient and consumer involvement

Why do people make the errors?

• Shift in patient safety paradigm

Paradigmshift

21

Patient safety

• Focused on the system of care delivery that

– Prevent errors

– Learns from the errors that do occurs

– Build on a culture of safety that involves health

care professionals, organizations, and patients

22

� The conscientious use of current best evidence in making decisions about the care of individual patients or the delivery of health services

Service Delivery

Best research evidence

Clinical Expertise

Evidence-based healthcare

23

근거기반 보건의료과 환자안전 향상

Paul Glasziou P. BMJ Qual Saf 20112011;20:i13-i17

SafePatient Care

Do right things right

24

근거기반 보건의료와 환자안전 향상

Doing the right thing

Clinical knowledge

Evidence–practice gap

What to do

EBM

Doing thing right

Dissemination

Knowing-doing gap

How to

QA

Do the right things

Do the things right

25

Do right things right!

국내외 의료기술평가기관과 역할

AHRQ(USA)

AHRQ invests in research and evidence to make health care safer and improve quality

NICE(UK)

Improving health and social care through evidence-based guidance

CADTH(Canada)

CADTH is an independent organization responsible for providing health care decision-makers with objective evidence to help make informed decisions about the optimal use of health technologies

MSACPBAC

(Australia)

MSAC, PBAC assesses the effectiveness of technologies in terms of safety, effectiveness, and cost effectiveness

NECA(Korea)

NECA provides scientific evidence to contribute to the efficient use of medical resources and promote of public health

28

HTA기관 환자안전 연구 해외사례: 미국

• AHRQ Quality and Patient Safety

• AHRQ PSNet(Patient Safety Network)

29

미국 환자안전지표(Patient Safety Indicator, PSI)

PSI 02. 저사망률DRG의사망률Death Rate in Low-Mortality DRGs

PSI 11. 수술후호흡곤란비율Postoperative Respiratory Failure Rate

PSI 03. 욕창발생률Pressure Ulcer Rate

PSI 12. 수술중폐색전증/심부정맥혈전증비율Perioperative Pulmonary Embolism or Deep Vein Thrombosis Rate

PSI 04. 심각한치료가능합병증으로인한수술입원환자의사망률Death Rate among Surgical Inpatients with Serious Treatable Complications

PSI 13. 수술후패혈증발생비율Postoperative Sepsis Rate

PSI 05. 수술물품잔류/회수되지않은장비파편의수Retained Surgical Item or UnretrievedDevice Fragment Count

PSI 14. 수술후열개창발생비율Postoperative Wound Dehiscence Rate

PSI 06. 의인성기흉비율Iatrogenic Pneumothorax Rate

PSI 15. 사고천자또는열상비율Accidental Puncture or Laceration Rate

PSI 07. 중심정맥도관관련혈류감염률Central Venous Catheter-Related Blood Stream Infection Rate

PSI 16. 수혈부작용수Transfusion Reaction Count

PSI 08. 수술후고관절골절발생비율Postoperative Hip Fracture Rate

PSI 17. 출생아분만중손상비율Birth Trauma Rate - Injury to Neonate

PSI 09. 수술중출혈또는혈종비율Perioperative Hemorrhage or Hematoma Rate

PSI 18. 산과적외상비율-기구사용질식분만Obstetric Trauma Rate –Vaginal Delivery With Instrument

PSI 10. 수술후생리및대사장애비율Postoperative Physiologic and Metabolic Derangement Rate

PSI 19. 산과적외상비율-기구없이시행한질식분만Obstetric Trauma Rate –Vaginal Delivery Without Instrument 30

31

Adverse Events after Hospital DischargeAdverse Events after Hospital Discharge

Alert FatigueAlert Fatigue

ChecklistsChecklists

Computerized Provider Order EntryComputerized Provider Order Entry

Detection of Safety HazardsDetection of Safety Hazards

Diagnostic Errors

Disruptive and Unprofessional BehaviorDisruptive and Unprofessional Behavior

Error Disclosure

AHRQ PSNet: Patient Safety Primers (1)

32

Handoffs and Signouts

Healthcare-Associated InfectionsHealthcare-Associated Infections

High ReliabilityHigh Reliability

Human Factors EngineeringHuman Factors Engineering

Improving Communication Between Clinicians

Medication ErrorsMedication Errors

Medication ReconciliationMedication Reconciliation

Missed Nursing CareMissed Nursing Care


33

Never Events

Nursing and Patient SafetyNursing and Patient Safety

Organizational Leadership

Patient Safety in Ambulatory CarePatient Safety in Ambulatory Care

Physician Work Hours and Patient SafetyPhysician Work Hours and Patient Safety

Radiation SafetyRadiation Safety

Rapid Response systemsRapid Response systems

The Role of the Patient in SafetyThe Role of the Patient in Safety


Root Cause AnalysisRoot Cause Analysis

Safety Culture

Simulation TrainingSimulation Training

Support for Clinicians Involved in Errors & Adverse Effects (Second Victims)

Systems ApproachSystems Approach

Teamwork TrainingTeamwork Training

Triggers and Trigger ToolsTriggers and Trigger Tools

Voluntary Patient Safety Event Reporting


Wrong-Site, Wrong-Procedure & Wrong-Patient Surgery (WSPEs)Wrong-Site, Wrong-Procedure & Wrong-Patient Surgery (WSPEs)34

Priorities of The National Quality Strategy

35

Priority 1. Patient Safety: Making care safer by reducing harm caused in the delivery of care

AHRQ. 2015 National Healthcare Quality and Disparities Report.

HTA기관 환자안전 연구 해외사례: 영국

• NHS NICE • Standards and Indicators

36

VTE 위험군 스크리닝 프로그램• Each year over 25,000 people in England die from venous

thromboembolism (VTE) contracted in hospital

37House of Commons Health Committee (2005) The prevention of venous thromboembolism in hospitalised patients. London: The Stationery Office.


38

NICErecommendation

VTE 위험군 스크리닝 프로그램


Assessment on and within24 hours of admission andWhenever clinical situation changes

NICE Guidance (CG92)

39

VTE 위험군 스크리닝 프로그램

40NICE guidance

• Steady increase in the proportion of adult admissions risk assessed for VTE from 47% in July 2010

• Overall, all the NHS regions achieved the 95% goal in Q2 2015-2016

41

Recommendation: 1.1.1 Assess all patients on admission to identify those who are at increased risk of VTE.

Audit standard: Patients assessed on admission for VTE risk

42

Recommendation: 1.1.1 Assess all patients on admission to identify those who are at increased risk of VTE.

Audit standard: Proportion of patients who were assessed on admission to identify those who are at increased risk of VTE.

43

Recommendation: 1.4.1Offer pharmacological VTE prophylaxis to general medical patients assessed to be at increased risk of VTE

Audit standard: Proportion of patients appropriately prescribed LMWH (patients has VTE risk factors and no bleeding risks)

44

Recommendation: 1.5.9Offer VTE prophylaxis to patients undergoing gynaecological, thoracic or urological surgery who are assessed to be at increased risk of VTE

Pridgeon S.Allchorne. (2014) Venous thromboembolism (VTE) prophylaxis and urological pelvic cancer surgery: A UK national audit, BJU International, Vol 115, Issue 2, pp 223-22

Audit standard: Proportion of pelvic cancer centers that reported using both LMWH and anti-DVT stockings during the inpatient period after radical cystectomy

Audit standard: Proportion of pelvic cancer centers that reported using anti-DVT stockings during the inpatient period after radical prostatectomy

Audit standard: Proportion of pelvic cancer centers that reported using LMWH during the inpatient period after radical prostatectomy

환자안전을 위한 공공기관 연계체계

PatientSafety

의료기관인증평가원

보건복지부

한국보건의료연구원

한국의약품안전관리원 한국의료분쟁조정중재원

46

국내 환자안전 지표

• 의료기관인증평가 환자안전지표(시범)

47

조사항목

1 환자 확인 관련 지표를 관리한다

2 의사소통 관련 지표를 관리한다

3 수술, 침습적 시술 관련 지표를 관리한다

4 낙상 관련 지표를 관리한다

5 손위생 수행 관련 지표를 관리한다

6 욕창 관련 지표를 관리한다

7 카테터 관련 혈류감염 지표를 관리한다

8 카테터 관련 요로감염 지표를 관리한다

9 인공호흡기 관련 폐렴 지표를 관리한다

의료질평가지원금 산정을 위한 기준

• 의료 질과 환자안전 영역

48

평가지표 가중치

• 의료기관 인증 여부

상• 입원환자당 의사수

• 입원환자당 간호사수

• 성인, 소아 중환자실 병상당 의사수

중

• 성인, 소아 중환자실 병상당 간호사수

• 환자안전 전담인력 구성 여부

• 의사당 일평균 외래환자 진찰 횟수

• 수술의 예방적 항생제 사용

• 항생제 처방률

• 주사제 처방률

• 의료기관 입원환자 병문안 관리체계

• 음압격리병상 설치 여부 등 30개

환자안전법 환자안전지표 17(안)

관련기준 환자안전지표 관련기준 환자안전지표

1 환자확인율 13 손 위생 수행률

3구두처방 후 24시간 이내의사 처방 완수율

14중심정맥관 관련혈류감염발생률

3 전과( 科)기록 작성률 14요로카테터 관련요로감염 발생률

5수술 절개직전 Time out 시행률

14인공호흡기 관련폐렴 발생률

7낙상 발생 보고율[1,000재원일당 ]

16조제오류 보고율

8욕창 발생 보고율[1,000재원일당 ]

16투약오류 보고율

10 마취전 환자 평가비율 17 30분 이내 수혈시작 비율

11 심폐소생술 교육 이수율19 소방안전 교육 시행률

12 수술 부위 감염발생률

49지영건(2015). 환자안전기준 및 환자안전지표에 관한 연구

adverse drug events

nosocomial infections

venous thromboemboli

decubitus ulcers

falls

surgical complications

diagnostic errors

Most common causes of iatrogenic harm

Ashish Jha. Toward a Safer Health Care System. JAMA, 2016 50

Patient safety research

Better Knowledge for Safer Care

51

Patient safety research priorities

Korea(NECA, 2015)*

의사소통 및 연계 결여

환자안전 문화 결여 및문책적 과정

부적절한 안전 지표 개발

의료관련 감염

약물 부작용 및 투약 오류

잠재된 조직적 결함52

* 환자안전체계 구축 기반연구(김수경, 이상일, 2015)

· 전문가 (20인) 대상 델파이 설문조사

· 빈도, 위해 규모, 보건의료 체계에 대한 영향, 해결방안 실행성 및 지속가능성, 시급성 평가


Korea(NECA, 2015)


환자안전 문화 결여 및 문책과정

적절한 안전 지표 개발

의료관련 감염


잠재된 조직적 결함

53

주요 환자안전연구: 의료관련 감염

• 진단 및 치료재료 재사용 원칙에 관한 연구(2009)

• 의료관련 감염병 및 항생제 내성 극복을 위한 국가 보건의료 관리 체계

개선 방안 거시연구(2011)

• 환자안전 강화를 위한 주사제 안전사용 관리방안 연구(2016)

54

진단 및 치료재료 재사용 원칙에 관한 연구

• 국외(미국, 독일 등 총 23개국) 현황 조사

• FDA와 GAO 보고서 고찰

• 일회용 의료기기 재사용의 안전성, 유효성에 대한 의료기술평가

• 사례연구(전기생리학적 카테터)

• 법적, 사회적, 윤리적 고찰

금지 권고하지 않음질적 관리하에서

허용공식적 입장 없음

프랑스(권고성격), 스페인, 오스트리아, 포르투갈, 캐나다(마니토바, 노스웨스트준주)

영국, 헝가리, 캐나다(뉴브런즈윅, 온타리오, 알버타, 브리티시콜롬비아), 이탈리아, 스위스

독일, 미국, 호주, 덴마크, 스웨덴, 벨기에, 노르웨이, 네덜란드, 캐나다(퀘벡)

싱가포르, 일본, 대만, 그리스, 뉴질랜드, 폴란드, 핀란드

의료기기 종류 근거요약

생검용 forceps실험실연구에서 수행된모든 연구에서 재처리된이후에 안전하지 않았음

55


Korea(NECA, 2015)




의료관련 감염



56

주요 환자안전연구: 부작용 및 투약오류

• 눈미백수술(2010) 등 신의료기술의 안전성 및 유용성 평가연구 약 670건

• 진단방사선 피폭선량 관리 체계 방안 구축(2014) 및 방사선 노출 저감을

위한 영상진단 가이드라인 개발(2015)

• 서화문신 실태파악 기획연구(2014) 및 안전관리를 위한 기반연구(2015)

• 치아우식증에서 아말감의 안전성 및 유효성(2014)

• 수술의 질 향상 프로그램 개발을 위한 담낭절제술 합병증 발생위험도

예측모델 개발(2016)

• 만성 B형간염 항바이러스제 장기사용과 합병증 위험도 연구(2016) 등

57


Korea(NECA, 2015)




의료관련 감염



58

주요 환자안전연구: 적절한 안전 지표 개발

• 성형수술(시술)이용자 안전을

위한 가이드라인 및 기준연구

(2015)

• 환자안전 확보를 위한 한국형 프

로토콜 개발 및 평가(2012)

– 병원 한 곳의 의무기록조사를

통한 위해사건 발굴

– 위해사건의 인과성 및 예방가능성

에 대한 전문가 합의

• 의료기기 안전문제 우선순위

설정 연구(2014)

59


Korea(NECA, 2015)




의료관련 감염



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그 외 주요 환자안전연구

• 잠재된 조직적 결함

– 보건의료기술 안전의제 선정과 의사 결정 방안 연구(2013)

– 보건의료 안전관리체계 분석 연구(2014)

• 환자안전 의사소통 및 연계 결여

– 이용자 및 종사자의 병원안전 인식도 조사연구(NECA, 2015)

• 환자 안전문화 결여 및 문책과정

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� Big data improve healthcare

- Artificial Intelligence

- Collective Wisdom

� Precision medicine– Translation of

personalized medicine to clinical practice

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ALPHAGO vs. LEE SEDOL

•보건의료환경 변화

Patient Safety in the Era of Precision Medicine


• Genetic risk profile에 대한 정보제공이healthful behavior 동기에 미치는 영향

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• Ethical issues on incidental findings

65Krier JB1, Green RC. Management of incidental findings in clinical genomic sequencing.Curr Protoc Hum Genet. 2013;Chapter 9:Unit9.23.

�Clinical utility�Patient preferences…�Privacy�Commercialization


I. Patient Safety Culture

1. “To Err is human”2. Sorry Works3. Trustworthy

• "If you're not failing every

now and again, it's a sign

you're not doing anything

very innovative."

- Woody Allen

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1. Valid Measures2. Blameless Voluntary Reporting System3. Surveillance Bias

• What information will be reported to improve patient safety?

– Any adverse event, near miss– Excluding natural course of a disease,

criminal activity, gross negligence, professional misconduct

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Julianne M. Morath

II. Systems Thinking

• How will the information be reported, and to whom?– Flexible, several options(phone line, PW protected Web-

based form, paper form, ‘whoops’ board, ‘good catch’ log)

– Ubiquitous and user-friendly form, mostly text

• How will the analytical process identify the problems in the system, and what expertise will be needed?– Cornerstone of reporting system– How will the voluntary reporting system align with

internal and external existing reporting systems?

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What happened?

Has it happened before?

Could it happen again?

What caused it to happen?

Who should be told?

Blameless Voluntary Reporting System

II. Systems Thinking

III. Evidence-based & Patient-Centered Health Care: Consensus and Collaboration

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Patient Patient Patient Patient

CenteredCenteredCenteredCentered

환자안전과의료의질질향상향상::: · james jt.a new, evidence-based estimate of patient...

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