Patient Safety Organization: Why You Can’t Afford NOT to Participate!

1. Patient Safety Organization: Why You Can’t Afford NOT to Participate! Steve Love, president/CEO, Dallas-Fort Worth Hospital Council Kristin Jenkins, president, DFWHC Education and Research Foundation Starr West, senior director, policy analysis, Texas Hospital Association Oct. 8, 2009

2. Today’s Presentation • Educate on the purposes and functions of a PSO. • Introduce the opportunity to join a statewide PSO created as a partnership of the Texas Hospital Association and the Dallas Fort Worth Hospital Council Education and Research Foundation.

3. Value to Participating in a PSO • Obtain federal protections for sharing of patient safety information outside your organization. • Benchmark your events with like hospitals. • Standardize and automate your incident reporting system. • Get assistance with preventing medical errors. • As a “charter” member help select executive director and vendor, establish bylaws and policies and procedures.

4. PSO Orientation

5. The Patient Safety and Quality Improvement Act of 2005 • Creates “Patient Safety Organizations” (PSOs). • Establishes “Network of Patient Safety Databases.” • Authorizes establishment of “Common Formats” for reporting patient safety events. • Requires reporting of findings annually in AHRQ’s National Health Quality/Disparities Reports. • Amends AHRQ’s enabling legislation. • AHRQ will administer program. • Office of Civil Rights will handle enforcement. • Program is voluntary. • Aims to improve safety by addressing: • Fear of malpractice litigation. • Inadequate protection by state laws. • Inability to aggregate data on a large scale for improvement analysis and information sharing in a protected environment .

6. PSO Protections Rather than a patchwork of state-by-state protections, there now will be national uniform confidentiality and privilege protections for clinicians and entities performing quality and safety activities.

7. PSO Rulemaking • Final rule published in the Nov. 2, 2008, Federal Register; effective Jan. 19, 2009. • Entities seeking certification and listing as a PSO must complete a “Certification for Initial Listing” form.

8. Final Rule Highlights • All PSOs • Expands on types of entity excluded from becoming PSOs. • Adds requirement that PSOs must notify affected providers of improper disclosure of “patient safety work product” and/or security breaches. • Component PSOs • Eliminates proposal for separate IT system from parent organization. • Eliminates general restriction on shared staff with parent for most PSOs. • Establishes new restrictions for component PSO whose parent is excluded from listing (e.g., no shared staff with parent). • Patient Safety Work Product • Permits a provider and PSO to establish a functional reporting system. • Provides protection when information is documented as collected within a “patient safety evaluation system” for reporting to a PSO. • Allows provider to document that information is being removed voluntarily from PSES and no longer is PSWP; provider then can use for other purposes.

9. Who Can Be a PSO? • Eligible organizations: • Any public or private entity / component • Any for-profit or not-for-profit / component • Ineligible organizations: • Health insurance issuers or their components • Accrediting and licensing bodies • Entities that regulate providers, including their agents (e.g., QIOs) • Mandatory public reporting systems

10. Some of the First PSOs • California Hospital Patient Safety Organization • ECRI Institute PSO • Florida Patient Safety Corporation • Institute for Safe Medication Practices • Kentucky Institute for Patient Safety and Quality • Quantros Patient Safety Center • University Healthsystem Consortium • PSOs currently exist in 26 states and the District of Columbia

11. PSOs: Patient Safety Work Product • PSWP is any data: • Developed by a provider and reported to a PSO • That identifies or constitutes deliberations of or the fact of reporting pursuant to a patient safety evaluation system, or • Developed by a PSO for the conduct of patient safety activities • Protected when information is documented as collected within a “patient safety evaluation system” for reporting to a PSO • Original provider records (e.g., medical record, billing information) are not PSWP • Non-identifiable PSWP is not confidential or privileged

12. How Does the Patient Safety Evaluation System Fit with QI Activities?

13. Reporting Patient Safety Events • Statutory and regulatory reporting requirements • The Network of Patient Safety Databases (NPSD) • Common Formats for patient safety event reporting

14. Reporting Requirements • PSO participation is voluntary, but for participating PSOs and providers: • PSOs are required to collect information that allows comparison of “similar events among similar providers.” • “Common Formats” have been made available by AHRQ, acting for the Secretary of HHS, to assist PSOs to meet this requirement. • At recertification, PSOs will be required to state how they meet the requirement.

15. Patient Safety Event Data • Collection of standardized information is essential to allow: • “Reporting for learning” on a large scale, one of the primary objectives of the legislation • Comparisons • Trending • Aggregation will occur at several levels • Provider (e.g., hospital) • PSO • NPSD

16. Network of Patient Safety Databases • Provides benchmarks and baselines for measurement. • Disseminates results, best practices. • Conducts analyses for the National Healthcare Quality Reports. • Develops a Web-based evidence-based management resource to support research. • Provides technical assistance as needed.

17. Common Formats

18. Data Flows: Providers, PSOs and PSWP Provider Provider Provider AHRQ National Quality Reports PSO User: PSO PPC NPSD PSO User: Provider PSO User: Researchers Other Qualified Sources

19. Common Formats • PSOs will collect, aggregate and analyze information on quality and safety of care. • Statute authorizes collection of this information in a standardized manner. • Common Formats • Common Formats apply at the “point of care,” which is essential for assuring collection of the specified information at the time it is available.

20. Why Common Formats? • Standardize the patient safety event information collected. • Common language and definitions • Common style/format for data elements • Facilitate shared learning. • Allow for trend and pattern comparisons – local, regional and national.

21. How Were Common Formats Created? • AHRQ built an inventory of 66 current patient safety event reporting systems • Reporting forms, data elements and definitions • Public and private systems included • Inventory findings: • Variability across different systems • Different representation of same patient safety events, e.g., surgical adverse event • Variability in recording common elements: • Location, facility, etc.

22. Common Format Development • Developed initial common formats with federal agencies with reporting systems (CDC, FDA, DoD, IHS, NIH, VA). • Federal subject matter experts • Iterative process • Conducted two pilot tests in hospitals. • Published notice of availability of Common Formats, Version 0.1 Beta, in Federal Register on Aug. 29.

23. Design Goals • Be as short and simple as possible • Functional • Flexible • Usable with existing workflows • Comprehensive in capturing all event types • Use existing definitions and data elements to the extent consistent with conceptual requirements

24. Design Goals • Construct in modules • Those concerns that apply to all events being reported, e.g., who, what, when, where • Those concerns that pertain to specific types of events, e.g., falls, medication errors • Specify requirements adequately to support software system development • Put processes in place to enhance and expand

25. Common Formats Scope • Common Formats apply to all patient safety concerns: • Incidents – patient safety events that reached the patient, whether or not there was harm • Near misses (or close calls) – patient safety events that did not reach the patient • Unsafe conditions – any circumstance that increases the probability of a patient safety event

26. Components of Initial Common Format Event Reporting Currently available event-specific forms include: • Anesthesia • Blood, Tissue, Organ Transplantation or Gene Therapy • Device & Medical or Surgical Supply • Fall • Health Care-Associated Infection • Medication and Other Substances • Perinatal • Pressure Ulcer • Surgical and Other Invasive Procedure (except Perinatal) AHRQ intends to develop additional event-specific Common Formats over time.

27. Common Formats - Future Steps • Expanded and enhanced versions based on user feedback • Expansion to other settings • Expansion to other topic areas of patient safety events • Complete remaining phases of quality cycle (e.g., root cause analysis) • Annual updates and revisions (2010 & beyond)

28. PSO Technical Assistance • PSO Privacy Protection Center • Technical assistance for PSOs • Two major areas of activity • De-identification of Patient Safety Work Product • Technical assistance with use of the Common Formats • PPC contract awarded to the Iowa Foundation for Medical Care

29. Measuring ROI • Benchmark your events with like hospitals. How much are quality/patient safety issues costing your hospital? How much can you save by improving? • What would it cost to standardize and automate your incident reporting system? How much do you save through the PSO? • What cost savings have been achieved by avoiding potential medical errors associated with procedures, medications, equipment, etc? How much do you save by reducing length-of-stay?

30. Next Steps • Letter of Intent by Nov. 1 • www.tha.org/pso • For more information, contact: • Kristen Jenkins @ kjenkins@dwfhc.org or 469/648-5016 • Starr West @ swest@tha.org or 512/465-1042

31. Your questions?