Pennsylvania Patient Safety Reporting System

1. PA - PSRS Pennsylvania Patient Safety Reporting System Alan B.K. Rabinowitz Administrator, Patient Safety Authority 2006 National Health Policy Conference February 7, 2006

2. Objectives • Background on Pennsylvania’s mandatory reporting statute • The PA-PSRS System • Sharing Data • Lessons Learned • Assessment after 18 months

3. Pennsylvania: Background for State Action • Escalating Medical Malpractice Insurance Premiums • Alleged Physician Exodus • Threatened Closure of Hospital-based Clinical Services • IOM Report (1999): “To Err Is Human” • Public Expectations

5. Slide courtesy of:

6. From Mark Twain 1864 “It would be a good thing for the world at large, however unprofessional it might be, if medical men were required by law to write out in full the ingredients named in their prescriptions. Let them adhere to the Latin, or Fejee, if they choose, but discard abbreviations, and form their letters as if they had been to school one day in their lives, so as to avoid the possibility of mistakes on that account.” Mark Twain San Francisco Morning Call October 1, 1864

7. Act 13: Medical Care Availability and Reduction of Error Act of 2002 • To reduce and eliminate medical errors by identifying problems and implementing solutions that promote patient safety • Establishes the Patient Safety Authority • Promulgates facility-based reporting requirements • Mandates written patient notification and designation of patient safety officers, plans and committees • Administrative provisions, including patient safety CME requirements and self-reporting • Medical malpractice-related and tort reform provisions

8. PA Patient Safety Authority • Independent agency under an 11-member Board • Non-regulatory • Dedicated funding stream outside of the General Fund • Collects, analyzes and evaluates trends of serious events and incidents • Makes recommendations for improvements in healthcare practices • Advises facilities on matters related to patient safety • Issues an Annual Report

9. PA - Reporting Components Types of Events Who Reports Other Considerations Acute Care Hospitals Ambulatory Surgical Facilities Birthing Centers Near-Misses (“Incidents”) Adverse Events(“Serious Events”) [Infrastructure Failures] ------ Incidents and Serious Events to PSA Serious Events and IFs to DOH Mandatory No Individual Identifying Data Confidentiality Provisions Non-discoverable Whistleblower Protections Facility assessment

10. Report Intake

11. Anonymous Reports of Serious Events • Only applies to Serious Events • Must be submitted by a healthcare worker • Event must first be reported through facility’s reporting process • Verification and possible review by Authority • Referral to Department of Health for failure to report • Whistleblower protection

12. Roadblocks • Complex IT project • Pennsylvania’s population distribution • 420 facilities • Legislative expectations and media scrutiny • Time Sensitivity • Perceived “Solution” to Med/Mal crisis • Public confusion between learning and accountability

13. System Development • Five-year $10.5 million contract • Data collection and analysis

14. System Design • Web-based • Based on UHC Patient Safety Net • User-friendly • Real-time feedback • Internal analytical tools • Data export capacity • Interface development • No additional user costs

15. Pennsylvania Patient Safety Reporting System (PA-PSRS) Report Intake: • 21 Core Questions • Patient Age / Gender • Location • Event type • Level of harm, contributing factors and root causes • Several narrative fields • Recommendation to prevent future occurrence • Additional Event Detail Questions • 15 Major categories, 233 sub categories • 250 Specific Event Types

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

17. PA-PSRS Report Output: • Real time feedback to facilities • Patient Safety Advisories • Annual Report Related Activities: • Education and Outreach • Research • Promotion of Culture of Safety and Full and Open Disclosure

19. Use of Color-Coded Wristbands Creates Unnecessary Risk (Supplementary) Unanticipated Care after Discharge from ASF’s The Beers Criteria: Medication Screening in the Elderly Hidden sources of Latex in Healthcare Products Use of X-Rays for Incorrect Needle Counts Patient Identification Issues Falls Associated with Wheelchairs Medication Errors Linked to Name Confusion When Patients Speak-Collaboration in Patient Safety Anesthesia Awareness Dangerous Abbreviations in Surgery Problems Related to Informed Consent Focus on High Alert Medications Bed Exit Alarms to Reduce Falls Confusion between Insulin and Tuberculin Syringes (Supplementary) The Role of Empowerment in Patient Safety Risk of Unnecessary Gallbladder Surgery Changing Catheters Over a Wire (Supplementary) Abbreviations: A Shortcut to Medication Errors Lost Surgical Specimens Recent Advisory Topics

20. 70,000 Reports in 6 Months 95% Reports = Events without harm 35% of Facilities Implemented New Procedures in Response to PA-PSRS Falls and Medication Errors = Largest Number of Reports Procedure Complications = Largest Number of Reports with Harm 59% of Events with Harm Involve Elderly (cf: 41% of Inpatient Hospitalization = Elderly) Annual Report for 2004 (Issued May 2005)

21. Statistics PA-PSRS n = 243,474 (as of 01/07/06)

22. Patient Identification High Alert Medications Drugs Associated with Falls Informed Consent is No Excuse Syringe Confusion Unlabeled Bowls in Surgery Abbreviations Errors Related to IT Hospital Acquired Infections Wristband Confusion Stress Management Patient Safety Lessons

23. Supplementary Advisory

24. Colors Used in Wristbands (Dec 2005 Survey)

25. Mandatory reporting vs. conventional wisdom Volume indicates good “buy in” Help-Desk queries and facility feedback = user satisfaction Value of near-miss reporting Encourages communication and empowerment Application of Patient Safety Advisories /shared learning Promotes internal QI and patient safety initiatives Everything You Need to Know You Learned from Your Grandmother Logistics Adequate funding Aesop’s Fable: The Tortoise and the Hare PSA: Assessment

26. PA-PSRS: Ongoing Goals Promote Education and Training • Root Cause Analysis: Targeted to Patient Safety Officers • Patient Safety Concepts: Culture of safety, legal principles, best practices, national initiatives: Targeted to executives, CMOs and physician champions • Promote Culture Change: Targeted to Trustees Encourage Research • Develop Protocols Governing Access to Data Facilitate Data Sharing • Partner with other Data Collection and Research Entities

27. Comments About PA-PSRS “I think we’re going to see in the Pennsylvania model a way to use mandatory reporting in a positive way that will make a difference.” Lucian Leape, MD Harvard University “Pennsylvania [has implemented] new patient safety initiatives that are seen as among the most progressive in the nation.” Philadelphia Inquirer June 1, 2004 Recipient of 2004 Healthcare IT Innovator Award from Healthcare Informatics magazine (September 2004 issue) Published by McGraw-Hill Companies

28. Comments About PA-PSRS “Pennsylvania’s health care providers and patients are fortunate to have their safeguards championed by the Patient Safety Authority....By implementing the Pennsylvania Patient Safety Reporting System, the Authority has begun to assist health care systems in successfully identifying and correcting their shortcomings....Patients and health care providers are benefiting from the efforts of this pioneering group.” William W. Lander, MD Past President Pennsylvania Medical Society

29. Culture of Safety The ultimate success of the PA-PSRS system is not in the number of reports we receive, but in how facilities and individual providers use the information within those reports to improve patient care.

30. PA Patient Safety Authority www.psa.state.pa.us