1. William B Munier, MD, MBA, Director Center for Quality Improvement and Patient Safety Agency for Healthcare Research and Quality AHRQ Annual Conference 11 September 2012 Toward Aggregation of National Data from Patient Safety Organizations Program Update

2. 2 Program Update PSO Program PSO Program – OIG report – Legal challenges – Affordable Care Act – Current status Common Formats Common Formats

3. 3 PSOs & Common Formats Patient Safety Organizations (PSOs) provide a major resource for improving quality & safety Patient Safety Organizations (PSOs) provide a major resource for improving quality & safety – Legally-protected privilege & confidentiality – Expert knowledge – Aggregated data that speeds learning Common definitions and formats (Common Formats) provide the opportunity to harmonize measurement throughout the US & reduce reporting burden Common definitions and formats (Common Formats) provide the opportunity to harmonize measurement throughout the US & reduce reporting burden

4. 4 Patient Safety Today Despite 12 years of focus after “To Err is Human,” there is substantial evidence that patient safety is still a major problem: Despite 12 years of focus after “To Err is Human,” there is substantial evidence that patient safety is still a major problem: – Events keep occurring at alarmingly high rates – Measurement is labor-intensive & inconsistent Evidence can be found in 10 recent reports from the Office of the Inspector General on adverse events in hospitals Evidence can be found in 10 recent reports from the Office of the Inspector General on adverse events in hospitals The need for PSOs has never been greater! The need for PSOs has never been greater!

5. 5 Nov 2010 and Jan 2012 OIG Reports on Adverse Events OIG reported that 13.5% of hospitalized Medicare beneficiaries experienced serious adverse events; an additional 13.5% experienced temporary harm events OIG reported that 13.5% of hospitalized Medicare beneficiaries experienced serious adverse events; an additional 13.5% experienced temporary harm events Hospital staff did not report 86% of events to the hospital’s internal incident reporting systems Hospital staff did not report 86% of events to the hospital’s internal incident reporting systems There was inconsistent identification of adverse events & confusion among front line staff regarding what events they needed to report to the hospital There was inconsistent identification of adverse events & confusion among front line staff regarding what events they needed to report to the hospital AHRQ & CMS should create & promote a list of patient safety events addressing “the full range of harm;” AHRQ Common Formats can be the basis AHRQ & CMS should create & promote a list of patient safety events addressing “the full range of harm;” AHRQ Common Formats can be the basis

6. 6 Follow-up with CMS In August, AHRQ & CMS hosted a Webinar on the Common Formats for all CMS surveyors across the country In August, AHRQ & CMS hosted a Webinar on the Common Formats for all CMS surveyors across the country CMS plans to add information on the Common Formats to their Web site to assist surveyors & others to understand what the Formats are & how they contribute to improving patient safety CMS plans to add information on the Common Formats to their Web site to assist surveyors & others to understand what the Formats are & how they contribute to improving patient safety While CMS surveyors can check on use of the Formats, they are not permitted to view PSO patient safety work product, or PSWP While CMS surveyors can check on use of the Formats, they are not permitted to view PSO patient safety work product, or PSWP

7. 7 PSO Trial Court Decisions Several lawsuits have been filed challenging the protections offered by the Patient Safety Act Several lawsuits have been filed challenging the protections offered by the Patient Safety Act Most significant to date: IL Dept of Financial and Professional Regulation v. Walgreens (IL 4/7/11) Most significant to date: IL Dept of Financial and Professional Regulation v. Walgreens (IL 4/7/11) – In an opinion filed May 29, 2012, an Illinois appellate court upheld a lower court’s decision that patient safety work product is privileged under the Patient Safety Act & therefore is not discoverable

8. 8 PSO Trial Court Decisions Other decisions have included: Other decisions have included: – “A state law that conflicts with a Federal law is without effect” – Providers must establish that reports are prepared solely for reporting to a patient safety organization & not for another purpose Lessons learned include the importance of: Lessons learned include the importance of: – Documentation of PSES, policies, & procedures – Documentation of particulars, including dates, regarding each case, reporting into PSES, & reporting to PSO

9. 9 The Affordable Care Act: A National Driver for PSOs The ACA contained two provisions that give PSOs new roles & responsibilities: 1. Readmissions: AHRQ is to make available a program for eligible hospitals to improve their readmission rates through the use of Patient Safety Organizations 2. Health Insurance Exchanges: Qualified Health Plans (QHPs) operating through the new Health Insurance Exchanges (HIEs) can only contract with hospitals > 50 beds if they have a patient safety evaluation system (PSES) – which means a PSO – as of January 1, 2015

10. 10 PSO Program Coming of Age! 76 PSOs currently listed 76 PSOs currently listed 30 states & DC represented 30 states & DC represented 40 PSOs delisted since inception 40 PSOs delisted since inception 12 data-use agreements signed with the Privacy Protection Center (PPC) 12 data-use agreements signed with the Privacy Protection Center (PPC) Data expected during 2012 to PPC & the Network of Patient Safety Databases Data expected during 2012 to PPC & the Network of Patient Safety Databases

11. 11 PSO Profile Data Count of PSOs by Type of Business (A PSO may choose more than one type)

12. 12 PSO Profile Data Count of PSOs by Type of Event Reports Solicited

13. 13 Types of Providers Total providers working with PSOs = 2,004 Total providers working with PSOs = 2,004 – 1,605 Hospital – 20 Long-Term Care – 379 Other Other types of providers include freestanding clinics, ambulance/EMS services, ambulatory surgery centers, home health care

14. 14 Hospitals Working With PSOs Count of Hospitals by Census Region (Note: there are 4 hospitals in the territories or Other region) 337 606 208 450 Size of Area Large Metro 619 (39%) Medium Metro 303 (19%) Small Metro 290 (18%) Micropolitan 207 (13%) Noncore 186 (11%)

15. 15 Hospitals Working With PSOs Count of Hospitals by Number of Licensed Beds (Note: PSOs did not submit bed size for 171 hospitals.)

16. 16 Provider Profile Data Count of Hospitals by Ownership (Note: PSOs did not submit ownership information for 383 hospitals.)

17. 17 Common Formats Only patient safety reporting scheme designed to meet three goals: Only patient safety reporting scheme designed to meet three goals: – Provide information on harms from all causes – Support local quality/safety improvement – Allow the end user – to collect information once & supply it to whoever needs it (harmonization) Designed to serve IOM goals for national patient safety measurement Designed to serve IOM goals for national patient safety measurement

18. 18 Modular Focus Hospital Version 1.2 Blood & Blood Products Blood & Blood Products Device & Medical or Surgical Supply, Including HIT Device & Medical or Surgical Supply, Including HIT Fall Fall Healthcare-Associated Infection Healthcare-Associated Infection Medication & Other Substances Medication & Other Substances Perinatal Perinatal Pressure Ulcer Pressure Ulcer Surgery & Anesthesia Surgery & Anesthesia Venous thromboembolism Venous thromboembolism All others via generic forms All others via generic forms

19. 19 Harmonization Issues Current Medicare HACs & PSIs – administrative data Current Medicare HACs & PSIs – administrative data Partnership for Patients HACs Partnership for Patients HACs CDC’s NHSN CDC’s NHSN FDA’s MedSun FDA’s MedSun NQF Serious Reportable Events (SREs) NQF Serious Reportable Events (SREs) State reporting system requirements State reporting system requirements Event reporting vs. surveillance Event reporting vs. surveillance EHRs & ONC’s meaningful use EHRs & ONC’s meaningful use

20. 20 National Drivers for Adoption of the Common Formats Institute of Medicine Report on Health IT and Patient Safety, November 2011 – recommends use of the Common Formats, as well as PSOs, for reporting IT-related adverse events Institute of Medicine Report on Health IT and Patient Safety, November 2011 – recommends use of the Common Formats, as well as PSOs, for reporting IT-related adverse events Office of the Inspector General (HHS) – 2011 and 2012 reports on adverse events in hospitals recommend surveyors/accreditors evaluate hospitals regarding their use of the Common Formats Office of the Inspector General (HHS) – 2011 and 2012 reports on adverse events in hospitals recommend surveyors/accreditors evaluate hospitals regarding their use of the Common Formats CMS – is working with AHRQ to align CMS programs, including survey & certification, with the Common Formats CMS – is working with AHRQ to align CMS programs, including survey & certification, with the Common Formats FDA – has been working for nearly two years with AHRQ to align its device-reporting system, MedSun, with Common Formats. FDA – has been working for nearly two years with AHRQ to align its device-reporting system, MedSun, with Common Formats. Office of the National Coordinator for HIT – requested challenge award proposals for adverse event reporting using Common Formats & PSOs; plan to integrate Common Formats in stage 3 Meaningful Use criteria Office of the National Coordinator for HIT – requested challenge award proposals for adverse event reporting using Common Formats & PSOs; plan to integrate Common Formats in stage 3 Meaningful Use criteria

21. 21 Expansion of Settings/Formats Readmissions Common Format for hospitals Readmissions Common Format for hospitals – Dr. Brian Jack (Project RED) providing advice – Beta version pilot test at the VA now completed – Open for comment at the NQF until September 20th Nursing home Common Formats Nursing home Common Formats – Beta version available now Ambulatory Common Formats Ambulatory Common Formats – Scheduled for development soon

22. 22 Event Reporting vs. Surveillance The Common Formats are currently designed as a concurrent event-reporting system The Common Formats are currently designed as a concurrent event-reporting system – Contain information in the EHR & more – Do not include denominators The Formats are being adapted to be used as a retrospective surveillance system – Safer Care The Formats are being adapted to be used as a retrospective surveillance system – Safer Care – Will include denominators; will generate rates – Will not address near misses & unsafe conditions

23. 23 The Future Definition of patient safety events (Common Formats) ultimately needs to support operational systems at three levels: Definition of patient safety events (Common Formats) ultimately needs to support operational systems at three levels: 1. Adverse event reporting (not part of medical record) 2. Surveillance (derived from medical records) 3. Use of electronic health records (recording of data directly into EHRs) Clinical & electronic definitions must be consistent throughout all levels, & be interoperable where appropriate Clinical & electronic definitions must be consistent throughout all levels, & be interoperable where appropriate

24. 24 Why Work With a PSO? Why Use Common Formats? Gain privilege against discovery & lawsuits Gain privilege against discovery & lawsuits Join an increasing group using standard measures; share experience (selectively) Join an increasing group using standard measures; share experience (selectively) Decrease measurement burden – over time! Decrease measurement burden – over time! Gain from a growing community of experts who are sharing their experience based on aggregate data representing large numbers of patients Gain from a growing community of experts who are sharing their experience based on aggregate data representing large numbers of patients Improve patient care! Improve patient care!