1. PA - PSRS NGA Center for Best Practices Health Policy Advisors September 10, 2004 Medical Liability & Patient Safety: Pennsylvania’s Experience

2. PA - PSRS Background Institute Of Medicine Reports –“To Err is Human – Building a safer health system” (1999) –“Crossing the Quality Chasm” (2001) –“Patient Safety - Achieving a new standard for care” (2004) 44,000 - 98,000 preventable deaths (estimated) $29 Billion per year in additional costs

3. PA - PSRS “Little Progress Seen Since 1999 IOM Report On Medical Errors”… HealthGrades (2004)

4. PA - PSRS Why Do Errors Happen?

5. PA - PSRS Patient Safety Organization…

6. PA - PSRS Strategic / Policy Decisions Charter Statute Regulation Executive Order Funding General Funds Assessment / Fees Grant / Other Oversight Independent Agency/Board Existing Agency Licensure Board Goal Learning Regulatory Patient Safety Organization

7. PA - PSRS Reporting Components Acute Care Hospitals Long-Term Care Facilities Ambulatory Surgical Facilities Free Standing Clinics Pharmacies Physician’s Offices Other Licensed Entities Who Reports Mandatory vs. Voluntary Individual Identifying Data Data Sharing Confidentiality Provisions Other Considerations By Definition –Medical Errors –Near Misses –Adverse Events –Serious Events Pre-Defined List –NQF “Never Events” –JCAHO Sentinel Events Types of Events

8. PA - PSRS Pennsylvania’s Approach

9. PA - PSRS The Medical Care Availability and Reduction of Error (MCARE) Act of 2002 Establishes the Patient Safety Authority Goal: Reduce and eliminate medical errors by identifying problems and implementing solutions that promote patient safety Promulgate new reporting requirements for: Hospitals, Ambulatory Surgical Facilities (ASF’s) and Birth Centers

10. PA - PSRS Patient Safety Authority 11-member Board appointed by the Governor and General Assembly consisting of: –Physician General (Chair), Physician, Nurse, Pharmacist, Hospital employee, health care worker, non-health care worker, and 4 other PA residents Established as an independent entity Non-regulatory

11. PA - PSRS Funding Model Allows for up to $5 Million a year. Assessment of $105/unit based on: –For Hospitals: Licensed Beds –For ASFs: Licensed Operating Rooms –For Birth Centers: Licensed Birthing Rooms In 2004 and 2005 – assessed $2.5 million or 50% of authorized amount.

12. PA - PSRS Reportable Events Serious Event (“adverse event”) –Event that results in patient harm Incident (“near-miss”) –Event that could have injured a patient Infrastructure Failure –Event related to physical plant, facility systems and criminal activity

13. PA - PSRS PA - Reporting Components Acute Care Hospitals Long-Term Care Facilities Ambulatory Surgical Facilities Free Standing Clinics Pharmacies Physician’s Offices Other Licensed Entities Who Reports Mandatory vs. Voluntary No Individual Identifying Data Data Sharing Confidentiality Provisions Other Considerations By Definition –Medical Errors Near Misses –Adverse Events Serious Events Pre-Defined List –NQF “Never Events” –JCAHO Sentinel Events Types of Events

14. PA - PSRS Reporting System

15. PA - PSRS Report Intake

16. PA - PSRS Report Intake 21 Core Questions –Patient Age / Gender –Location –Event type –Level of harm, contributing factors and root causes –Recommendation to prevent future occurrence Additional Event Detail Questions –15 Major categories, 233 sub categories

17. PA - PSRS Patient Safety Authority - Clinical Analysis Analytics Triage Patient Safety Review Meeting Contact with Individual Facilities Public Advisories and Recommendations PSA Annual Report Program Outputs Incoming Reports

18. PA - PSRS Advisory Topics Dangerous Abbreviation in Surgery Falls Associated with Wheelchairs MRI Hidden Risks Hidden Sources of Latex Use Of Multidose Medication Vials And Latex Allergy Use of X-Rays for Incorrect Needle Counts Preventing Wrong-Site Surgery

19. PA - PSRS Analytical Tools

20. PA - PSRS Harm Score Trend PA-PSRS

21. Distribution of Events Slice 1Slice 2Slice 3Slice 4 9% 21% 28% 16% 11% 6% 9% 3% 6% PA-PSRS

22. Event Distribution PA-PSRS

23. Event Details by Location

24. PA - PSRS Culture of Learning The ultimate success of this reporting system will not be found solely in the data collected. Rather, improved patient safety will be the result of actions taken by individual facilities in response to what they learn through PA-PSRS.

25. PA - PSRS PA Patient Safety Authority www.psa.state.pa.us