1. PSO Common Formats for Patient Safety Event Reporting AHRQ Annual Conference 2008 William B Munier, MD, MBA 7 September 2008

2. 2 The Patient Safety and Quality Improvement Act of 2005 Encourages formation of PSOs to improve the quality & safety of health care Encourages formation of PSOs to improve the quality & safety of health care AHRQ will administer rules for listing qualified PSOs AHRQ will administer rules for listing qualified PSOs HHS Office for Civil Rights will be responsible for enforcing confidentiality HHS Office for Civil Rights will be responsible for enforcing confidentiality

3. 3 Rather than a patchwork of state-by-state protections, there will now be national uniform protections; that is, confidentiality & privilege for clinicians & entities performing patient safety activities

4. 4 Common Formats PSOs will collect, aggregate, & analyze information on quality & safety of care PSOs will collect, aggregate, & analyze information on quality & safety of care Statute authorizes collection of this information in a standardized manner Statute authorizes collection of this information in a standardized manner Common Formats Common Formats – Allow aggregation of comparable data at local, PSO, & national level – Facilitate the exchange of information – Underlie the ability to compare & learn

5. 5 Common Formats can provide a common language for patient safety reporting across the nation

6. 6 Common Formats Planning for Common Formats was initiated by AHRQ in 2005 Planning for Common Formats was initiated by AHRQ in 2005 Secretary Leavitt authorized their development & deployment in 2006 Secretary Leavitt authorized their development & deployment in 2006 AHRQ began AHRQ began – Developing a conceptual framework – Compiling an inventory of reporting systems

7. WHO International Classification of Patient Safety (ICPS) Framework Contributing Factors* Event Types Actions taken Organization outcomes Patient impact/ outcomes Patient impact/ outcomes Event characteristics Patient characteristics Mitigating factors Recovery factors Preventative factors (+) Influences Lead to Framework class Have Event Modifiers Core framework class * Includes active factors & latent factors Lead to

8. 8 Design Goals Be as short & simple as possible Be as short & simple as possible Be driven by envisioned uses Be driven by envisioned uses Be dynamic; meet altered needs & circumstances Be dynamic; meet altered needs & circumstances Be modular Be modular Permit controlled expansion/revision Permit controlled expansion/revision Use existing definitions & data elements to the extent consistent with conceptual requirements Use existing definitions & data elements to the extent consistent with conceptual requirements

9. 9 Conceptual Framework Limit scope to safety: preventing harm to patients from the delivery of health care Limit scope to safety: preventing harm to patients from the delivery of health care Develop for specific delivery settings Develop for specific delivery settings Construct in modules 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 Specify requirements adequately to support software system development

10. Modularized Common Formats Associated inputs Administrables (medications, etc) Consumables Devices Research Mitigating actions Recovery Rescue Consequential Actions Internal External Immediate impacts Organizational Care processes Staff information Demographics Harm Staff information Demographics Harm Event-specific details About 24 types of events Patient information Demographics Harm 3 1 2 PSE Overview Identity Facility Time Location Reporter Narrative Link to forms PSE Overview Identity Facility Time Location Reporter Narrative Link to forms

11. Modularized Common Formats Final Assessment Form (FAF) Assessment of preventability Final narrative Encoding Event-specific forms Nine types of events, e.g., Fall HAI Medication Patient information Form (PIF) Demographics Harm Mitigating Actions Interventions 3 1 2 Healthcare Event Reporting Form (HERF) Identity Date, Time Location Reporter Narrative Link to other forms Healthcare Event Reporting Form (HERF) Identity Date, Time Location Reporter Narrative Link to other forms

12. 12 AHRQ Evidence Base of Reporting Systems 64 PSERS* >100 PSE reporting forms >1,000 Definitions of PSE terms >10,000 PSE reporting variables Supporting documentation (PSERS descriptions, PSE reporting forms, encoding schemes, patient safety reports, etc.) * Patient Safety Event Reporting System

13. 13 Inventory Findings Few systems collect information on the complete improvement cycle Few systems collect information on the complete improvement cycle Commonality found for some definitions Commonality found for some definitions Variability found for many Variability found for many – Clinical event, e.g., adverse drug reaction – Accident, e.g., fall – Demographic, e.g., provider type, facility type

14. 14 Common Format Development Developed initial common formats with Federal agencies with reporting systems (CDC, FDA, VA, DoD, NIH) Developed initial common formats with Federal agencies with reporting systems (CDC, FDA, VA, DoD, NIH) Conducted two pilot tests in hospitals Conducted two pilot tests in hospitals Contracted with the National Quality Forum (NQF) to receive coordinate feedback Contracted with the National Quality Forum (NQF) to receive coordinate feedback Published notice of availability of Common Formats, version 0.1 Beta, in Federal Register on August 29 th Published notice of availability of Common Formats, version 0.1 Beta, in Federal Register on August 29 th

15. Common Formats Development Cycle Draft event description Draft event report Specify data elements, etc Update meta-data registry Implement Common Formats Implement CF paper forms Solicit Feedback Analyze feedback Complete? Pilot data elements, etc Implementation Issue? Implementation Issue? No Yes

16. 16 Common Formats Development Cycle Formats will not be subject to Formats will not be subject to – Federal regulatory processes – NQF formal consensus process Formats will Formats will – Be updated annually as guidance – Have tight version control

17. 17 Your questions?