Patient Safety Reporting Systems PSRS

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Patient Safety Reporting Systems (PSRS)

• Institute of Medicine,
• Jan 23, 2003, Irvine, CA
• Paul Barach, MD, MPH
• Department of Anesthesia
• University of Chicago
• pbarach_at_airway.uchicago.edu

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Case Study 1 Bristol Royal Infirmary 1990-2002

• First concerns to CEO 1990
• First public concern 1995
• First published report 1996
• Public Inquiry 2000
• Kennedy report 2001
• Government response 2002

Hugh Ross, Edinburgh 3/2002
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Case Study 2 The Report of the Manitoba
Pediatric Cardiac Surgery InquestAn Inquiry
into twelve deaths at the Winnipeg Health
Sciences Center

• They (findings of the report) point to the
  conclusion that serious organizational and
  personnel problems experienced by the Health
  Sciences Centers Pediatric Cardiac Surgery
  Program during 1993 and throughout 1994 may have
  contributed the deaths of these 12 children

http//www.pediatriccardiacinquest.mb.ca/pdf/pcir_
intro.pdf
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Case Study 3 Wrong Sided Procedure

• 45 year old WF, CRF, HTN, DM, CHF for AV access
  in left upper arm
• Monday morning
• Overbooked surgery
• ambulatory clinic
• IV placed in left arm
• Patient in Block room
• Right sided shoulder prepped
• Patient and resident confirm that right arm to be
  operated on

• Patient late and VIP
• 3 Medical students in clinic
• No arm marked
• Sedated by resident

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Case Study 3Wrong Sided Procedures-How common ?

• Australia Incident Monitoring System-5 blocks of
  139 events
• Singelton et al., Anesthesia and Intensive Care
  1993
• Closed Claims Database 2000 4723 claims
• 39 wrong sites
• 36 GA 3 regional and MAC
• JCAHO150 events since 1995
• 26 wrong part 13 wrong patient 11 wrong
  procedure
• Informal survey---many events 100s of near
  misses

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Medical Mistakes 8 Killer
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Drivers of PSRS

• Reduce patient harm, hazards
• Reduce liability and legal exposure
• Public accountability
• Pressmedical and lay (i.e., US World and News
  Consumer Reports)
• Federal and State regulatory bodies
• Internet
• Comprehensive informatics systems
• Fundersfederal and private
• Competition? Marketplace?
• Management and boards accountability

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The First Law of Improvement (Paul
Batalden/Deming)

• Every system is perfectly
• designed to achieve exactly
• the results it gets

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The Link between Micro-systems and Patient Safety

• The system changes that are required to improve
  patient safety need to occur where patients and
  providers meet on the front lines of health care
  a.k.a., the micro-system

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Overview of PSRS

• The need for Standardized definitions what are
  we reporting?
• Ownership (Federal State Organizational
  Professional Disease based)
• Mandatory vs. Voluntary
• Anonymous vs. Confidential/de-identification
• Narrative and threshold
• Ease of reporting
• Safety Culture Leadership support
• Feedback
• Regulatory status
• Sphere Modes of dissemination-local vs. national
• Immunity
• Central role of RCA in organizational learning

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Terminology is Everything

• Code words for medical error
• Are we talking about the same thing?
• From adverse events to hospital acquired
  infections
• Preventability
• Prophylaxis
• Australian Council Data Definitions taskforce

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Heinreichs Ratio

• 1 Major injury
• 29 Minor injuries
• 300 No-injury accidents

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29
300
1. Heinreich HW Industrial Accident Prevention,
NY And London 1941
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Iceberg Model of Accidents and Errors
Misadventure Death\severe harm
No Harm Event No harm done but potential for harm
may be present
Near Miss Unwanted consequences were prevented
because of recovery
From Hal Kaplan with permission
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Definitions Accident and Injuries

• Accidents God, fatalism, punishment, luck,
  chance, the evil eye.
• Accident encompasses a large and fuzzy set of
  events of which a small proportion are injurious.
• Other terms Errors near misses
  non-consequential events incidents events
  critical incidents accidents etc.
• MPSMS Adverse events THAT are made more likely
  by healthcare delivery

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Injuries are not Accidents

• Distinct patterns
• Systems issues
• Risk groups-vulnerable populations
• Profiles of harmed patients
• Near misses precede many/all of these events
• The focus on the human actors tends to detract
  from an examination of the full range of factors
  that contribute to injuries

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Public Health Model for Disease Control

• Define the problemepidemiology, surveillance
  systems
• Agent-host-environment-vector model (Haddon)
• Identify causal factorsrisk factorsanalytic epi
  studiessocial, genetic, environmental
• Develop interventions
• Evaluate the interventions
• Injury In America (1980s)

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Injury Surveillance Systems

• Systematic collection of data
• Trend analysis
• Sentinel events
• Near misses
• Reporting systems

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System for classifying injuries

• ICD codes
• Clinical nature of injury and area of body
• E-codes
• External cause of injury
• Abbreviated Injury Score (AIS)
• Injury severity score (ISS)
• Degrees of injury severity
• Revised trauma score
• Glasgow coma scale

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Injury Epi Basic tools

• Deaths (n)
• Deaths/100,000 population
• Deaths/10,000 veh or bvkm
• Deaths/1000 crashes
• Case fatality (Deaths/100 injured)
• PYL, QPYL, Days hosp, Cost hosp lost income
• AIS, ISS scores
• Prevalence, C-C, Cohort, Time Series

• Measures of Risk
• Severity of outcome Independent of exposure
• Measures of burden Cost of preventable loss
• Standard codes for measuring severity by
  observable injuries, organ by organ
• Tools

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Injury Basic Tools W5H epidemiology

• WHO? Age, Sex, SES
• WHICH/WHAT? Crash type One vehicle, Two
  Vehicle, Driver pedestrian, motorcycle,
  Heavy-Light, Train, Hit fixed object
• WHEN? Day, Night, Weekend
• WHERE? Urban, Interuraban, Type of road
• HOW? Speed, BAC, Substance abuse, Fatigue, Hot
  spots, Black spots
• Key interactions Youth, Night, Alcohol, Heavy
  Vehicles, One Vehicle Crashes

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SRS for Non-Medical Domains

• Aviation
• Aviation safety reporting system (ASRS)
• Aviation safety airways program (ASAP)
• Air Altitude Awareness Program
• Canadian aviation safety reporting system (CASRS)
  
• British Airways safety information system
  (BASIS)Air safety report (ASR)Confidential
  human factors reporting program (CHFRP)Special
  event search and master analysis (SESMA)
• Human factors failure analysis classification
  system (HFACS)
• Israeli air force near miss reporting system
• NASA
• Safety reporting system
• Petrochemical processing, steel production
• Prevention and recovery information system for
  monitoring and analysis (PRISMA)
• Nuclear (nuclear power and radiopharmaceutical
  industries)
• Licensing event reports (LER)Human performance
  information systems (HPIS)Human factors
  information system (HFIS)
• Nuclear Regulatory Commission allegations systems
  process (NRCAS)
• Diagnostic misadministration reports regulatory
  information distribution system (RIDS)

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Aviation Safety Reporting System (ASRS)

• The main themes of the aviation safety reporting
  system are that it is
• Designed and accepted by all parties
• Voluntary-30,000 reports/year over 500,000
  1974-2002
• Confidential
• Non-punitiveno pilot has ever been
  penalized
• Objective
• Accepts reports from all comers
• Independent analysis (Battelle/NASA) of
  regulatory system (FAA)
• Gives feedback to all stakeholders
• Provides oversight
• Encourages full narrative, sometimes up to
  20 pages
• All products are peer reviewed before
  publication.

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Dynamic Complex System

• Highly coupled---?complex (Aposolakis Perrow)
• Acknowledge error as source of learning (Van Der
  Scaaf)
• Modelling Monitoring Alertness
• Contingency planning (Toyota model)
• Rich and safe reporting systems (ASRS)
• Extensive use of simulation
• Constantly monitoring migrations (Rasmussen
  Almaberti)

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Mistakes are a fact of life. Its the response
to the error that counts

• - Nikki Giovanni

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Benefits of Near Misses

• 3-100 times more common than adverse events
• Fewer barriers to data collection
• Focus on recovery
• Hindsight bias is reduced
• Great track record
• No or very limited legal liability
• Rich literature supports learning from near
  misses

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Barrier Analysis

• In terms of individuals, organizations, and
  society
• Legal
• Cultural
• Regulatory
• Financial
• Educational
• HIPPA
• Technological (see PBG)
• Lack of good models and evidence of impact(NASHP)

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Reporting is a Delicate Balancing Act
Voluntary Reporting
Discipline
Open Communication
Professional Accountability
From Hal Kaplan with permission
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Factors Determine Quantity/ Quality of Incident
Reports

• Indemnity
• Confidentiality
• Separate
• Feedback
• Ease

Feeling of Trust
Motivation
James Reason ,1990
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Common Conflicts in PSRS

• Sacrificing accountability for information
  --Negotiating moral hazards in choosing between
  good of society compared with needs of
  individuals
• Near miss data compared with accident data-- Near
  miss data plentiful, minimizes hindsight bias,
  proactive, less costly, no indemnity
• A change in focus from errors and adverse events
  to recovery processes-- Recovery equals
  resilience emphasis on successful recovery,
  which offers learning opportunity
• Trade offs between large aggregate national
  databases and regional systems-- National offers
  longer denominators, capture of rare events
  regional offers potentially more specific
  feedback and local effectiveness
• Finding right mix of barriers and incentives
  Supporting needs of all stakeholders ecological
  model
• Safety has up front, direct costs payback is
  indirect --Spending "hard" money to save larger
  sums and reduce quality waste
• Safety and respect for reporters as well as
  patients-- A just culture that acknowledges
  pervasiveness of hindsight bias and balances
  accountability needs of society
• The need for continuous timely feedback that
  reporters find relevant changing bureaucratic
  culture-- Critical to sustain effort of ongoing
  reporting

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Business Case for PSRS

• Ethical imperativeJust do the right thing
  Vision Zero
• Align the interest of the healthcare professions
  with the systems needs (Alcoa Model)
  Transparency for patients, care givers,
  management (Weick) Professionalism (ABIM 6
  competencies)
• Organizational imperative/Safety
  culture-Microsystems (Mohr)
• Educational imperative-ACGME, AAMC, AAP
• Technological imperative

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Safety Culture

• Organizational cultures-shaped by shared
  practices, and by process of collective learning
  (Weick)
• High Reliability Organizations (HROs)--Roberts
• Essential elements
• Reporting Culture
• Informed Culture
• Just Culture
• Flexible Culture
• Learning Culture
• 
  Jim Reason, 1990

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How Different Organizational Cultures Handle
Safety Information
Adapted from Westrum (1992, 2000)
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Patient Empowerment

• Educate patients and their families about
  medications and procedures
• Make them into your extra eyes to monitor the
  system
• Encourage them to ask questions
• Encourage them to take responsibility for their
  care
• Make them aware of vulnerable populations
• Communicate, communicate, communicate

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Accountability

• Acknowledge error and injury
• Learn to apologize
• Disclose to patient and family
• Provide restorative and remedial care
• Care does not stop with the adverse event, it
  just begins

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General Principles for PSRS

• Creating a safe environment for safety
• The value of storytelling and narrative analysis
• Portfolio of systems with information sharing
• Independent data analysis
• Confidentiality
• Should be integrated into the microsystem
• Focus on near misses
• Feedback is critical cornerstone for sustained
  reporting and learning
• Legal Scope Immunity Waiver FOIA
• National guidelines with local reporting
• Regulatory and political support
• All reporting is voluntary

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The illiterate of the future are not those who
cannot read or write, but those who cannot learn,
unlearn, and relearn.
Alvin Toffler, Future Shock
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THANK YOU