General Principles

1
building
THE FOUNDATIONS
for patient SAFETY
collaboration
communication
education
Overview and IOM Reports
2
How the Focus on Quality Patient Safety Came to
Attention

• Presidential Actions
• Quality of Healthcare In America Project
• Institute of Medicine Reports
• Media Attention
• Business Groups
• Responses
• Federal/State/JCAHO

3
Presidential Actions

• 1997- President establishes Advisory Commission
  on Consumer Protection and Quality in the Health
  Care Industry
• 1998- President establishes Quality Interagency
  Coordination Task Force (QuIC)
• 1998- Vice President launches National Forum for
  Health Care Quality Measurement and Reporting

4
Quality of Healthcare in America Project

• Initiated by IOM in June, 1998
• Focus Quality of care
• Policy framework To improve quality foster
  accountability
• Produce reports
• Aligning financial incentives to reward quality
  care the critical role of information
  technology as tool for measuring understanding
  quality

5
Institute of Medicine Reports
IOM

• 1999 IOM Report-To Err is Human. Building a Safer
  Healthcare System
• 2001 IOM Report-Crossing the Quality Chasm
• 2001 IOM Report-Envisioning the National Health
  Care Quality Report

IOM
IOM
6
Overview
Congress
President
Establishes
Mandates
Advisory Commission on Consumer Protection and
Quality in the Healthcare Industry
Changed AHCPR to AHRQ Mandated AHRQ to develop
national report on quality
Creates
Quality of Healthcare in America Project
Contracts
AHRQ requested IOM to draft strategies for
national report IOM Report Envisioning the
National Health Care Quality Report
Output
Output
IOM Report To Err is Human
IOM Report Crossing the Quality Chasm
Output
7
Institute of Medicine

• Medical arm of the National Academy of Sciences
• The report is from a subgroup called the
  Committee on Quality of Care in Medicine
• No regulatory authority
• Three areas of study
• Misuse of Medicine (errors) - the 1999 report
• Overuse of Medicine
• Underuse of Medicine

8
Institute of Medicine Report1999 Report To Err
is Human

• Definitions
• Data/Studies
• Approach
• Conclusions
• Recommendations

9
IOM To Err is Human Definitions

• Adverse Event
• Injury caused by medical management rather than
  underlying disease/condition of patient
• Error
• 1) Planning Use of a wrong plan to achieve
  desired aim
• 2) Execution Failure of a planned action to be
  completed as intended
• Not all, but a sizeable of AE are result of
  Error
• 
  Source IOM Report

10
IOM To Err is Human Data/Studies

• 44,000 - 98,000 deaths/year
• 8th leading cause of death, ahead of car crashes,
  breast cancer AIDS
• 17 - 29 billion in lost income, disability and
  health care costs
• Adverse events occur in 2.9 - 3.7 of
  hospitalizations
• Preventable injuries in hospitals affect 3-4 of
  patients

Error rate is equivalent to two 747s crashing
every week
11
IOM To Err is Human Data/Studies

• New York (1984 data)
• 3.7 hospitalized patients have adverse events
• 13.6 of adverse events led to death
• Colorado/Utah(1992 data)
• 2.9 hospitalized patients have adverse events
• 8.8 of adverse events led to death

(Lucian Leape et al)
12
IOM To Err is Human Data/Studies
Colorado/Utah
New York
Extrapolation

• United States
• 33.6 million admissions to US hospitals in 1997
• 44,000 - 98,000 Americans die as result of
  adverse events

13
IOM To Err is Human Approach

• Establish a national focus on patient safety
• Identify and learn from errors through mandatory
  and voluntary reporting systems
• Raise standards and expectation for improvements
  with multiple agencies, professionals, and
  consumers
• Implement safe practices at the delivery level
  and build safety culture

14
IOM To Err is Human Conclusions

• Majority of problems are systems problems not the
  fault of individuals with problems wired into
  systems
• Only 2-5 errors are related to individuals
• System issues -- shifting employees around would
  not result in an improved error rate
• Human factor research shows that errors are
  inevitable

15
IOM To Err is Human Conclusions

• Harm occurs to one patient at at time making
  accidents less visible
• No agency or organization w/primary
  responsibility for safety
• Dont know the real picture or baseline
• Dont have current data

16
IOM To Err is Human Conclusions

• Punitive response not effective to prevent
  recurrence
• Need to manage mistakes differently
• Aviation/nuclear power models may help

17
IOM To Err is Human Recommendations

• Leadership and Knowledge
• Create a Center for Patient Safety
• Identifying Learning from Errors
• Nationwide Mandatory Reporting System
• Voluntary Reporting Efforts
• Protection of Sources

18
IOM To Err is Human Recommendations

• Setting Performance Standards Expectations
• Focus on Patient Safety
• Licensing Bodies and Professional Societies
• FDA Activities
• Implementing Safety Systems in Healthcare
  Organizations
• Specific Programs
• Improve Medication Delivery

19
IOM To Err is Human Leadership Role

• Provide Leadership
• Make patient safety a corporate priority
• Make patient safety everyones responsibility
• Make clear assignments and set expectations
• Provide human and financial resources
• Develop effective mechanisms for
  identifying/dealing with unsafe practitioners

20
IOM To Err is Human Leadership Role

• Respect Human Limits
• Design jobs for safety
• Simplify processes and systems
• Standardize processes
• Promote Effective Teams
• Train teams
• Involve patients

21
IOM To Err is Human Leadership Role

• Anticipate the Unexpected
• Improve access to information
• Create a Learning Environment
• Encourage recognition and reporting
• Ensure no reprisals for reporting
• Develop a culture of openness and communication
• Implement feedback and learning from mistakes

22
Key Learnings

• This report made huge impact on health care,
  media, and spurred policy makers.
• The patient safety movement has taken off
  nationally and internationally.
• New collaboratives and alliances have been
  created on patient safety.
• Legislation has been sparked at federal and state
  level.
• Errors will remain a target for media and
  consumer groups.

23
IOM 2001 ReportCrossing the Quality Chasm
Problems

• Widespread defects in current health care system
  with variation in care delivered
• Misalignment of financial system
• Huge growth in knowledge and advances in
  technology
• Gaps in safe and appropriate care
• Structure does not make best use of resources

24
IOM Crossing the Quality ChasmAgenda

• All health care constituencies commit to a
  national statement of purpose for the health care
  system as a whole and to a shared agenda of six
  aims for improvement.
• Clinicians and patients and organizations support
  care delivery, adopt a new set of principles to
  guide redesign.

25
IOM Crossing the Quality ChasmAgenda

• All health care constituencies commit to a
  national statement of purpose for the health care
  system as a whole and to a shared agenda of six
  aims for improvement.
• Clinicians and patients and organizations support
  care delivery, adopt a new set of principles to
  guide redesign.

26
IOM Crossing the Quality ChasmAgenda

• DHHS identify priority conditions for initial
  efforts resource allocation change process.
• Organizations design/implement more effective
  support processes.
• All stakeholders create an environment that
  fosters and rewards improvement.

27
IOM Crossing the Quality Chasm Six Aims

• Patient-Centered
• Effective
• Timely
• Equitable
• Safe
• Efficient

28
IOM Crossing the Quality ChasmNew Rules for Care

• Care based on continuous healing relationships
• Customization based on patient needs/values
• Patient as the source of control
• Shared knowledge- free flow of information
• Evidence based decision making

29
IOM Crossing the Quality ChasmNew Rules for Care

• Safety as a system priority
• Need for transparency
• Anticipation of needs
• Continuous decrease of waste
• Cooperation among clinicians

30
IOM Crossing the Quality ChasmRecommendations

• Reduce the burden of illness, injury, and
  disability and improve health and functioning of
  people of US.
• Pursue six major aims.
• Congress should authorize funds for processes for
  the six aims
• Redesign health care according to ten new rules
  for care.

31
IOM Crossing the Quality ChasmRecommendations

• AHRQ to identify at least 15 conditions for
  study, work with NQF and stakeholders to improve
  quality in each condition.
• Congress should establish Innovation Fund for
  projects to improve quality care.
• AHRQ and others should convene workshops on new
  approaches.
• DHHS should establish program to make scientific
  evidence useful and accessible to clinicians.

32
IOM Crossing the Quality ChasmRecommendations

• National commitment to build information
  infrastructure to support health care delivery.
• Purchasers should remove barriers to payment
  method that impede quality improvement.
• Develop research agenda to study alignment of
  payment methods with quality improvement goals.
• Summit of leaders to address strategies for
  clinical education for 21st century.
• AHRQ to fund research to study system changes and
  achievement of six aims.

33
IOM Crossing the Quality ChasmRedesign
Imperatives
New Process

• Redesign care processes
• Effective use of information technologies
• Knowledge and skills management

34
IOM Crossing the Quality ChasmRedesign
Imperatives
New Process

• Development of effective teams
• Coordination of care across patient conditions,
  services, and settings over time.
• Use of performance and outcome measurement for
  continuous quality improvement and accountability.

35
Key Learnings

• Little new information.
• Less influential that 1999 report.
• Little action taken by government on funding
  recommendations.
• Creates six new criteria to assess care.
• Validates issues, especially misalignment of
  payment methods and quality.

36
Institute of Medicine Report 2001Envisioning the
National Health Care Quality Report

• Data Set Framework
• Measures
• Data Sources
• The Report

37
IOM Envisioning the National Health Care Quality
Report Recommendations

• Framework to address two dimensions components
  of health care quality and consumer perspective.
• AHRQ to apply uniform criteria for measures
• AHRQ to have advisory body to assess improvements
  of report.

38
IOM Envisioning the National Health Care Quality
Report Recommendations

• AHRQ to set long term goal for approach to assess
  and measure quality of care for national data
  set.
• AHRQ to consider combining individual measures
  into summary measures and make available to
  public.
• Data sources should be assessed by criteria.

39
IOM Envisioning the National Health Care Quality
Report Recommendations

• AHRQ to draw on public and private data sources.
• Data should be nationally representative and
  reportable at state level.
• Report should be in several versions for
  different audiences.

40
Key Learnings

• IOM was asked by AHRQ to plan for national
  quality report on health care.
• In 1999 legislation Congress mandated a report be
  developed and published annually starting in 2003
  by AHRQ.
• The report is part of overall national quality
  focus.
• There is no one agency with oversight for quality
  of care or patient safety. The report may bridge
  gaps.
• There is much work still to be done in creating a
  report.

41
Legislative Response Federal

• Kennedy-Frist-Jeffords Patients Safety Act of
  2001
• Snowe-Graham (S824) Medication Errors Reduction
  Act of 2001
• Schumer (S705) Health Information Technology and
  Quality Improvement Act of 2001
• Specter (S24) Health Care Assurance Act of 2001

42
Legislative Response State

• CS/SB 1558 Omnibus health care bill adopted by
  2001 Florida legislature (section 63).
• Primarily in response to Florida Commission on
  Excellence in Health Care recommendations.
• Mainly regulatory changes little funding.

43
Legislative Response StateKey Elements

• AHCA to post on web quarterly summaries and trend
  analysis of adverse incident reports.
• Civil immunity for RM providing info required by
  law.
• Civil penalties to anyone who prevents RM from
  reporting incidents.
• Two hour course mandated on safety.

44
Legislative Response StateKey Elements

• Hospitals and ASC to evaluate systems for
  wrong-site surgery, wrong patient, wrong
  procedure, and unnecessary procedure.
• Commission of the above incidents as grounds for
  disciplinary action.
• Leaving a foreign body in patient as grounds for
  disciplinary action.
• DOH and AHCA to review reporting requirements to
  eliminate duplication.

45
Joint Commission

• Implemented new patient safety standards July 1,
  200.1
• Created a focus on errors via sentinel event
  standards with learnings aggregated and
  published.
• Drafted standards on staffing effectiveness with
  measures related to human resources and clinical
  services.
• Has utilized a framework for quality improvement
  with dimensions that parallel IOM report.

46
References/Resources

• Institute of Medicine, To Err is Human. Building
  a Safer Health System.(2000). National Academy
  Press. Washington, DC.
• Institute of Medicine, Crossing the Quality
  Chasm. (2001). National Academy Press.
  Washington, DC.

47
References/Resources

• Institute of Medicine, Envisioning the National
  Health Care Quality Report. (2001). National
  Academy Press. Washington, DC.
• FHA 2001 Legislative Summary (May 2001)
  www.fha.org
• FHA Patient Safety www.fha.org/quality.html