Ellen Flink, MBA NYS Department of Health December 5, 2005

1. Adverse Event ReportingThe New York Experience2nd Annual Betsy Lehman Center Patient Safety Symposium Reporting, Disclosure and Accountability Ellen Flink, MBA NYS Department of Health December 5, 2005 NEW YORK STATE DEPARTMENT OF HEALTH

2. How NY got started • Response to the medical malpractice crisis of the 80’s • First incident reporting system effective October 1985 • Statutorily based in Laws of 1986 • NYPORTS development part of the regulatory reform effort of 1995

3. Three iterations • Beginning in 1985 with HIRS-a paper driven system • Continuing with PETS in 1993-based on algorithm of treatment and harm • Re-worked and overhauled into NYPORTS-implemented in 1998 • Ongoing refinements and updates NEW YORK STATE DEPARTMENT OF HEALTH

4. Are we where we hoped to be?Where we are now….. • Reporting rates have stabilized • Robust secure web based system • Shift from individual to systems approach • Focus on quality • Embrace “culture of safety” • Data analysis and dissemination of lessons learned for improvement

5. NYPORTS Cases by Year 2000-2004

6. Reporting of Individual NYPORTS Codes: 2002 - 2004 401- PE 402- DVT 604- AMI 751- Falls 801- Procedure related injury 803-Hemorrhage or hematoma 808- Post-op wound infection

7. Shifting the perspective from bad apples to bad systems is not entirely intuitive. Armies, airlines, power plants learned this lesson long ago and made the required changes.- Wachter and Shojania

8. Institute of Medicine To Err is Human: Building a Safer Health System Preventable medical errors 44,000 to 98,000 Americans die each year Eighth leading cause of death in the United States Cost as much as $29 billion annually IOM conclusion: the majority of these problems aresystemic, not the fault of individual providers November 1999

9. Culture of Safety • We must do more to create a collaborative culture in health care; one in which providers at all levels feel free to report and learn from their mistakes, act in concert, and voice their concerns while there is still time to do something about them. This culture will require substantial new training, inservice coaching, and patience…..

10. Data Analysis and Dissemination • NYPORTS Statewide Council • Regional Forums • Professional Organization Meetings • NYPORTS News and Alert • NYPORTS Bulletin Board • NYPORTS Educational Videoconferences • Annual reports • Patient Safety Conference • New York Patient Safety Award Program

11. Current System Refinements • Significant system enhancements effective June 2005 • Retirement of 15 “occurrence” codes • Converted to “Microsoft.Net” technology • Improved ‘canned’ and custom reports functionality • Implemented RCA Evaluation Tool • New Process Measures Project • Developing new clinical specialty panels • Changes were made based on user survey and ‘wish list’

12. Lessons Learned • Information must be meaningful and useful to end users • Obtain “buy in” by involving stakeholders in the development process • Confidentiality protections are important • Web based system allows facilities to access data and produce reports • Ongoing training and educational support • System design must allow for meaningful changes/improvements • Clear definitions of reporting criteria reduces variability • Analysis and dissemination of data is a key to improvement

13. Other Challenges • Completeness of reporting • Resources to support system • Quality and accuracy of RCAs • Clinical analyses of data • Ongoing Education and Training • Quality improvement monitoring and evaluation • Evolution of NYPORTS - CQI

14. Are we safer? • Opportunities for improvement • Facilities can measure effectiveness of system changes over time • Sharing data on multiple levels can lead to system wide change • Since there is no way to assure complete reporting, we can’t measure whether changes in reporting rates are due to improved care.

15. Patient Safety Improvement • Systems thinking • Human Factors Engineering • Keep the safety of patients at the center of all safety decisions • Culture change

16. Patient Safety • Partially charted territory • Human Factors Engineering: FMEA & beyond • Counting reports IS NOT the objective, identifying vulnerabilities IS • Analysis, action and feedback are key • Prevention NOT Punishment • Cultural change takes time • Safety is the foundation upon which Quality is built - VA National Center for Patient Safety

17. Bottom Line • We don’t know what we don’t know!

18. Impact of 2005 Patient Safety Legislation • Patient Safety Center in DOH • State Legislation in 2000 requires the establishment of a voluntary “near miss” reporting system • DOH’s Patient Safety Center will consider becoming a PSO • Too early to make a determination

19. The only real mistake is the one from which we learn nothing. -John Powell