Never Events (Including Retained Foreign Objects) The Surgeons Point of View J.H. Pat Patton, Jr., MD, FACS Henry Ford Hospital, Detroit, MI 1
Disclosures None 2
Learning Objectives Examine the occurrence, effects, types, factors and mitigating strategies for surgical Never Events Describe the science of safety and a systems approach to patient safety methodology Consider the ongoing risk of Human Factors failure 3
Agenda Surgical Never Events What are Never Events How often do they occur How do Never Events effect patient care What are the risk factors for Never Events to occur What tools have been used to mitigate Never Events What is the safety science behind the mitigation strategies Why do Never Events still occur 4
The Never Event 5
Never Events Defined by National Quality Forum (NQF) in 2002, revised 2011 29 Events, 7 Categories Surgical Product or Device Patient Protection Care Management Environmental Radiologic Criminal 6
Surgical/Procedural Never Events 1. Surgery or other invasive procedure performed on the wrong body part 2. Surgery or other invasive procedure performed on the wrong patient 3. Wrong surgical or other invasive procedure performed on a patient 4. Unintended retention of a foreign object in a patient after surgery or other procedure 5. Intraoperative or immediately postoperative/postprocedure death in an American Society of Anesthesiologists Class I patient 7
Surgical/Procedural Never Events Rates 4000 events each year in the US Retained Foreign Objects (RFO) 1 : 10,000 procedures Wrong Site/Side 1 : 100,000 procedures Over half of these may occur outside the OR 8
Never Events: Effects Effects 71% of events reported to the Joint Commission over a 12 year period were fatal Mortality rates for RFO estimated 4.5% Harm to Patient, Provider, Institution Malpractice payments $1.3 billion (1990-2010) Non-payment by CMS since 2007 (est. $22 million/year) 9
Never Events: Risk Factors Several surgeons or teams Multiple procedures during one operation Time pressures Emergent operation Abnormal anatomy Morbid obesity Cases involving lateralization/level 10
Retained Foreign Objects (RFO) Retained Surgical Items (RSI) 1:10,000 procedures Occur increasingly outside of the OR Textile/non-textile related Small miscellaneous items, unretrieved device fragments (UDFs) Technology alone is not the answer 11
1. Incorrect count 2. Unexpected intra-op event 3. >1 Surgical team 4. Count not performed 5. >1 Sub-Procedure 6. Duration of procedure 7. Blood loss >500cc 12
So What s the problem and why does it still happen so often? 13
The Evolution of Healthcare Safety Culture Historical Constructs Focus on individual performance and individual patient outcomes Errors, mistakes, and near misses rarely disclosed or admitted to Hierarchical and Authority Issues Difference in communication styles 14
The Individual or the System Most medical errors are made by well intentioned, well educated, well trained human beings who have become accustomed to small glitches, routine foul-ups, and a culture that suppresses doing anything much about them in the name of overriding goals 15
Systems Approach to Errors There are two objectives of safe system design: Make it difficult for providers to make mistakes Permit the detection and correction of errors before harm occurs Anticipate defects and provide defense 16
Risk Reduction Strategies Incorporate into Processes and Systems Avoid reliance on memory Standardization Checklists Forcing Functions Eliminate look-alikes Create redundancy 17
Risk Reduction Tools Universal Protocol Checklists Crew Resource Management/Team Training Technology: EMR, RFID, Bar-code scanners 18
Why haven t these things worked? 19
Challenges to Safe System Design Human Factors Knowledge Base Workarounds Lack of Situational Awareness/Emotional Intelligence Oversight/Supervision Resources Constraints/Efficiency Demands 20
Human Factors Taxonomy 21
Why Errors Still Occur Human Cognitive Error (combined with a lack of redundancy/accountability) Communication (lack of standardization) Audience Content Occasion Purpose Constraints: Time, Workload, Technology, Resources 22
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Needed Improvements Transparency Reporting (Knowledge) Learning from mistakes (Skills) Accountability/Compliance Process and Outcomes Behavioral Expectations Speak up, Safety Attitude, Situational Awareness/Emotional Intelligence Communication More effective, more frequent, standardized 24
Journey to Improving Reliability 10-6 10-5 10-4 10-3 10-2 Behavior Accountability Behavior Expectations Communication Knowledge & Skills Reinforce & Build Accountability Integrated With Process Design CQI Root Cause Analysis Evidence-Based Best Practices Technology Enablers Intuitive Work Environment Resource Allocation Optimized Outcomes 10-1 From ACPE s High Reliability course, Craig Clapper - HPI 25