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

2. 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 hospitals annual operating budget 70% of Medical Errors are Preventable Potentially Preventable Unpreventable Preventable Medical Errors are a Leading Cause of Death *IOM Report 1999

3. * HHS Secretary Mike Leavitt, 2005 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

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

15. Med Error (13.305) Serious Injury (9.650) Adverse Event (10.960) Incident (9.941) Medical Device (11.220) Pharmacy DHQ Security RM FDA DPH Clin Eng 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 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 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 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 P-AME VISITOR INJURY ACCIDENT, THEFT, VANDA;OSM PI Office Safety Reporting Flow: P-AME Form (Blue) AME form (White) Security Report Incident/Occurrence Report Patient Fall Incident Report User Facility Report An orphan - Employee Accident Report

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

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

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 Risk Assessment Best Practices Adverse Event Analysis Recognition Teamwork Process Improvement Patient Involvement Sept 2001 Sept 2002 Sept 2003 Sept 2004

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