 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  Medical failure is a public health problem (4 th to 8 th largest cause of preventable death)  Medical failure is a systems problem

 What’s Driving Patient Safety? Progress, Complexity and Change...

 The Patient Safety Paradox We have…  New Technological “Miracles” Pushing Health Care Forward  New Opportunities to Customize Care But we also have…

 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 Healthcare should be…  Systems-Based  Patient-Centered  Evidence-Based Crossing the Quality Chasm: A New Health System for the 21 st Century (IOM, 2001)

 What Does it Mean to Be Patient-Centered?

 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

 What is Systems Thinking? Where Does it 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 Analysis Teach About HealthCare ?

 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)

Swiss Cheese Model Modified from Reason, 1991 Triggers DEFENSES Accident Incomplete Procedures Mixed Messages Production Pressures Responsibility Shifting Inadequate Training Attention Distractions Deferred Maintenance LATENT FAILURES Goal Conflicts and Double Binds The World Regulatory Narrowness Clumsy Technology

 Sharp and Blunt Ends Errors and Expertise Monitored Process Organizations, Institutions, Policies, Procedures Regulations Resources and Constraints Practitioner Knowledge Focus of Attention Goals Modified from Woods, et al., 1994

Modified from Richard I. Cook, MD (1997) Hindsight Bias

 How Do We Apply Safety Science to Optimizing the Prevention of Kernicterus?

 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 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 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 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 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

 Evidence-Based Medicine Meets Patient Safety The Problems are…

 EBM Meets Patient Safety The 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: (2002) Shojania, K. et al., Safe but sound, patient-safety meets evidence-based medicine, JAMA, 288: (2002)

 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 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 “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