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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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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
But we also have…
But we also have increased engineering challenges…
…All of which increase the
risk of systems failure
Healthcare should be…
Crossing the Quality Chasm: A New Health System for the 21st Century (IOM, 2001)
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
Reason, J., Human Error (Cambridge Univ. Press 1990)
Perrow, C., Normal Accidents (Princeton Univ. Press 1999)
Goal Conflicts and Double Binds
Modified from Reason, 1991
Organizations, Institutions, Policies, Procedures Regulations
Errors and Expertise
Modified from Woods, et al., 1994
Before the Accident
After the Accident
Modified from Richard I. Cook, MD (1997)
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)
“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
Development of interventions for managing hyperbilirubinemia should consider other types of evidence that performance improvement experts find compelling:
This systems approach has dramatically improved safety in the field of anesthesia.
Leape et al, JAMA, p. 506
“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