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Beyond Reliance on Vigilance and Evidence-Based Medicine A Systems Perspective on Identifying Hyperbilirubinemia & Preventing Kernicterus FDA Expert Advisory Panel June 11, 2003. Martin J. Hatlie, JD, President Partnership for Patient Safety. The IOM Call to Action.

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Martin J. Hatlie, JD, President Partnership for Patient Safety


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martin j hatlie jd president partnership for patient safety

Beyond Reliance on Vigilance and Evidence-Based MedicineA Systems Perspectiveon Identifying Hyperbilirubinemia& Preventing KernicterusFDA Expert Advisory PanelJune 11, 2003

Martin J. Hatlie, JD, President

Partnership for Patient Safety

the iom call to action
The IOM Call to Action
  • Medical failure is a public health problem (4th to 8th largest cause of preventable death)
  • Medical failure is a systems problem
the patient safety paradox
ThePatient Safety Paradox

We have…

  • New Technological “Miracles” Pushing Health Care Forward
  • New Opportunities to Customize Care

But we also have…

the patient safety paradox5
The Patient Safety Paradox

But we also have increased engineering challenges…

  • Increased Process Complexity
  • Escalating Change
  • Information Overload
  • Increased Demands for Cost Effectiveness

…All of which increase the

risk of systems failure

guiding principles for health system reform
Guiding Principles for Health System Reform

Healthcare should be…

  • Systems-Based
  • Patient-Centered
  • Evidence-Based

Crossing the Quality Chasm: A New Health System for the 21st Century (IOM, 2001)

patient centeredness
Patient-Centeredness

First and Foremost, it means Safety…

“Despite the cost pressures, liability constraints, resistance to change and other seemingly insurmountable barriers, it is simply not acceptable for patients to be harmed by the same healthcare system that is supposed to offer healing and comfort. “First do no harm” is an often quoted term from Hippocrates. Everyone working in healthcare is familiar with it. At a very minimum, the healthcare system needs to offer that assurance and security to the public.”

To Err is Human: Building a Safer Health System (IOM, 2001), p.3

where does systems thinking come from
Where Does Systems Thinking Come From?
  • Health research (including EBM)
  • Engineering & design
  • Cognitive psychology
  • Human factors/Ergonomics
  • Sociology & organizational behavior
  • Lessons learned from other industries
  • Quality improvement
  • Complexity theory
what does systems thinking teach
What Does Systems Thinking Teach?
  • Complex, dynamic systems never run perfectly – they are prone to failure and degradation (“Accidents are normal”)
  • It is particularly hard to manager risk that is remote, emerging, or latent (“Not all failure is foreseeable”)
  • People who manage complex work are fallible, no matter how hard they try not to be

Reason, J., Human Error (Cambridge Univ. Press 1990)

Perrow, C., Normal Accidents (Princeton Univ. Press 1999)

slide13

Swiss Cheese Model

Goal Conflicts and Double Binds

LATENT

FAILURES

Inadequate Training

Deferred Maintenance

Incomplete Procedures

Mixed Messages

Attention Distractions

Clumsy Technology

ProductionPressures

Regulatory Narrowness

Responsibility Shifting

Triggers

The World

Accident

Organization

Individual

Profession

Team

Institution

Technical

DEFENSES

Modified from Reason, 1991

sharp and blunt ends
Sharp and Blunt Ends

Organizations, Institutions, Policies, Procedures Regulations

Resources and

Constraints

Practitioner

Knowledge

Goals

Focus ofAttention

Errors and Expertise

Monitored Process

Modified from Woods, et al., 1994

slide15

Hindsight Bias

Before the Accident

After the Accident

Modified from Richard I. Cook, MD (1997)

how do we apply safety science to optimizing the prevention of kernicterus17
How Do We Apply Safety Science to Optimizing the Prevention of Kernicterus?
  • Systems never run perfectly – they are prone to failure and degradation
    • Guidelines and protocols should NOT assume optimal system performance
how do we apply safety science to optimizing the prevention of kernicterus18
How Do We Apply Safety Science to Optimizing the Prevention of Kernicterus?
  • Reliance on vigilance and memory are insufficient to produce reliably good outcomes
    • Reliance on visual assessment of jaundice is NOT a systems approach
how do we apply safety science to optimizing the prevention of kernicterus19
How Do We Apply Safety Science to Optimizing the Prevention of Kernicterus?
  • Errors in complex systems are rarely due to a single “bad apple”
    • Physicians, nurses, parents, families, prenatal educators all have shared responsibility
    • Others?
how do we apply safety science to optimizing the prevention of kernicterus20
How Do We Apply Safety Science to Optimizing the Prevention of Kernicterus?
  • Where possible, simplification and standardization are important tools for managing risk in complex systems
    • Complicated protocols are more prone to failure
how do we apply safety science to optimizing the prevention of kernicterus21
How Do We Apply Safety Science to Optimizing the Prevention of Kernicterus?
  • Errors are inevitable, but prompt “recovery” can greatly reduce adverse events
    • Important tools = teamwork, communication, listening, respect for everyone’s role, alertness for latent failure, alertness for remote risks, redundancy, feedback, shared accountability and moving beyond blame
ebm meets patient safety the problems are
EBM Meets Patient SafetyThe Problems are…
  • EBM tends to focus on individual practice, not the systems in which clinicians work
  • Randomized controlled trials are difficult to conduct where adverse events are the outcome
  • Because adverse events are infrequent, they can be extraordinarily expensive to study in a RCT
  • EBM is slow, whereas risk emerges rapidly in healthcare

Leape, L., Berwick, D., Bates, D., What practices will most improve safety, evidence-based medicine meets patient safety, JAMA, 288: 501-7 (2002)

Shojania, K. et al., Safe but sound, patient-safety meets evidence-based medicine, JAMA, 288: 508-13 (2002)

ebm meets patient safety
EBM Meets Patient Safety

“Aviation safety was not built on evidence that certain practices reduced the frequency of crashes. Instead, it relied on the widespread implementation of hundreds of small changes in procedures, equipment, training and organization that aggregated to establish an incredibly strong safety culture and amazingly effective practices. These changes made sense; were usually based on sound principles, technical theory or experience; and addressed real- life problems, but few were subjected to controlled experiments.”

Leape, Berwick, Bates, JAMA, p. 505

ebm meets patient safety25
EBM Meets Patient Safety

Development of interventions for managing hyperbilirubinemia should consider other types of evidence that performance improvement experts find compelling:

  • Systems thinking and human factors principles
  • Inference from process to actual adverse events
  • Accepted practices in other industries
  • Common Sense (“the obvious right thing to do.”)

This systems approach has dramatically improved safety in the field of anesthesia.

Leape et al, JAMA, p. 506

optimizing patient safety
Optimizing Patient Safety

“Policymakers must consider the entire experience with safety practices, both in healthcare and other industries, when deciding which practices should be recommended for widespread use. Evidence from randomized trials is important information, but is neither sufficient nor necessary for acceptance of practice. For policymakers to wait for incontrovertible proof of effectiveness before recommending a practice would be a prescription for inaction and an abdication of responsibility…the prudent alternative is to make reasonable judgments based on the best available evidence combined with successful experiences in health care. While some errors in these judgments are inevitable…they will be far outweighed by the improvement in patient safety that will result.”

Leape, Berwick, Bates, JAMA, p. 507