Safety Event Reporting

1. Safety Event Reporting George E. Ritter, Jr., MD Senior VP and Chief Medical Officer SafeCare Systems george.ritter@safecaresystems.com

2. 70% of Medical Errors are Preventable Potentially Preventable Unpreventable Medical Errors are a Leading Cause of Death Preventable The Patient Safety Crisis • 44,000 to 98,000 deaths per year • $37.6B in costs per year* • Preventable mistakes cost $17 to $29 billion per year* • Medical errors consume 10-15% of a hospital’s annual operating budget *IOM Report 1999

3. Patient Safety –“Is one of the top priorities for healthcare”* • Patient Safety & Quality Improvement Act of 2005 • National Database ($58 million/5 years) • Vendor Certification and Technical Assistance • JCAHO Accreditation Mandates • Leapfrog and other Employer & Payer-driven safety initiatives • State Medical Error Reporting Laws in 27 states * HHSSecretary Mike Leavitt, 2005

4. Clinical care is a chain of processes that together improve a patient’s health. Each step can be associated with: variation, failure, and errors.

7. Sound Reasoning Effective Practices Reliable Systems

8. “This, then, is the basic meaning of a ‘learning organization’ - an organization that is continually expanding it’s capacity to create its future.” Peter M. Senge The Fifth Discipline

9. And the Lord said, ‘Behold, they are one people, and they have all one language; and this is only the beginning of what they will do . . . Come, let us go down, and there confuse their language, that they may not understand one another’s speech’. Genesis 11: 6–7

10. Adverse event/outcome • Unintended consequence • Unplanned clinical occurrence • Therapeutic misadventure • Peri-therapeutic accident • Iatrogenic complication/injury • Hospital-acquired complication • Near miss • Close call • Incident • Medical mishap • Unexpected occurrence • Untoward incident • Bad call • Sentinel event • Failure • Mistake • Lapse • Slip

13. Improvement is a process… External Event Performance Improvement Office Safety Event Report(s) or JCAHO Sentinel Event Alert Unit process data Internal Event Collaboration Manager or Team Leader or PI Coordinator evaluates event Nursing & Physician Peer Review Programs Risk Management Office Collaboration Collaboration flow diagram constructed with details and timeline of event multidisciplinary team formed Begin tests of change Plan data collection Plan ActDo Study event compared to “nominal” process redesign process deviations, flaws determined collect data subject process steps to FMEA Run Chart Control Chart Pareto Analysis RCA ask “why?” 3 times hold the gains yes no Does the process seem safe? brainstorm on ways to “fix” root causes report as required Feb 2005

15. Safety Reporting Flow: P-AME Form (Blue) Med Error (13.305) DHQ P-AME incorrect drug selection, dose, dosage form, quantity, route, concentration, rate illegible prescriptions failure to administer an ordered dose wrong dosage form, wrong drug preparation, wrong time, unauthorized drug improper dose, deteriorated drug, wrong route, wrong site, or wrong rate of adm monitoring error AME form (White) AME Pharmacy Security Report Incident (9.941) Security any event that deviates from the routine care of the patient. patient injury visitor injury property or equipment damage/loss medical equipment which appears to be broken, damaged malfunctioning VISITOR INJURY ACCIDENT, THEFT, VANDA;OSM User Facility Report Adverse Event (10.960) Patient Fall Incident Report Incident/Occurrence Report FDA infant abduction, infant discharged to the wrong family rape by another patient or staff hemolytic transfusion reaction surgery on the wrong patient or wrong body part suicide of a patient sentinel event RM DPH Serious Injury (9.650) “serious” events that are life threatening, result in death or require a patient to undergo significant additional diagnostic or treatment measures, or disrupt services, including: injury, fires, damage to the hospital structure, suicide of a patient, criminal, theft of narcotics, physical injury to a patient, medication errors, burns, slips or falls, biomedical device or other equipment failure, surgical errors involving the wrong patient, the wrong side of the body, the wrong organ or the retention of a foreign object, blood transfusion errors, poisonings, infectious disease outbreaks, allegations of abuse, any material death within 90 days of delivery or termination or pregnancy PI Office An orphan - Employee Accident Report Clin Eng Medical Device (11.220)

16. The Pathway to Reporting of Medical Errors and Near-Misses at Internet Reporting for all Interface with Staff Partner with Managers for near-miss reporting Redesign the Interface with managers The strategic campaign toward learning, safety, clinical quality, and patient confidence and loyalty. Fix the basics of incident reporting

17. Event Entry Report: Near Misses, Incidents, Adverse Events, High-Risk Occurrences, Medical Errors Safety Event Reporting - The Solution Employees Patients Visitors Anonymous Reporting Risk Module Web-enabled Event Reporting Workflow Management & Notification Client Event Database Decision Support & EIS Event Taxonomy National Comparative Database Client Best Practices Library linkages Evidence-Based Research & Universal Medical Taxonomies

19. Safety Reporting Successes: • Avoid reliance on memory: • Pre-Op Checklist reorganized to support verification of site, procedure with patient as well as identify anticoagulation status • Simplify • Communication procedures for stat anesthesia • Critical test results communication • Pharmacy preparation of IV and high risk meds • Changed surgical consent process after confusion • Standardize: • PCIS changes for Metoprolol dosing (mgs instead half tabs) • Enhanced standardized labeling of paralytic agents in critical care • CPOE changes for numerous drugs (Metoprolol) (mgs instead half tabs) • Standardized microinfuser pumps use

20. Use constraints and forcing functions: • Automatic stop orders for blood draws and indwelling catheters • Use protocols : • CPOE changes to prevent incorrect ordering of administration of vancomycin (5 mins. vs. 60-90 min) • Weight based heparin protocols • CVC insertion protocols • Preoperative Antibiotics protocol • Absorb errors (time lapses and redundancy): • “Time out” to verify site and procedure in OR performed in a consistent manner to reduce wrong site procedures

21. Top Leadership Priority Non-punitive Culture Patient Involvement Process Risk Assessment Sept 2001 Improvement Sept 2002 Best Practices Teamwork Sept 2004 Sept 2003 Adverse Event Recognition Analysis

22. No Excuses: • There is an ROI • There are compelling reasons to act now • Errors waste precious resources • Grasp the leadership challenge • We will all benefit from safe, effective, efficient healthcare • Fear of disclosure is an excuse

23. …hospitals are still dangerous places to be if you are sick. …We can't afford this kind of health care anymore. And we shouldn't pay for it. Karen Davis, PhD; President, The Commonwealth Fund