William B Munier, MD, MBA, Director Center for Quality Improvement and Patient Safety Agency for Healthcare Research and Quality AHRQ Annual Conference 10 September 2012 AHRQ’s Work in Quality Measurement for Patient Safety Common Formats

2 The Measurement Issue Highlighted by the Partnership for Patients Highlighted by the Partnership for Patients – No way to know precisely how many patient safety events have occurred or are occurring in the US – No way to measure actual performance nationally – Sampling & extrapolation only way to establish a baseline & subsequently establish national trends Without measurement, it is virtually impossible to know if progress is being made Without measurement, it is virtually impossible to know if progress is being made

3 Common Formats Authorized by Patient Safety Act in 2005 PSOs Authorized by Patient Safety Act in 2005 PSOs Developed with a Federal work group comprising major health agencies ( e.g., CDC, CMS, FDA, DOD, VA ) Developed with a Federal work group comprising major health agencies ( e.g., CDC, CMS, FDA, DOD, VA ) Incorporates input from public, industry Incorporates input from public, industry Reviewed by an NQF expert panel, which provides advice to AHRQ Reviewed by an NQF expert panel, which provides advice to AHRQ Promulgated as “guidance” announced in the Federal Register Promulgated as “guidance” announced in the Federal Register Approved by OMB (process & Formats) Approved by OMB (process & Formats)

4 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

5 Common Formats Common Formats are site-specific (e.g., hospital) Common Formats are site-specific (e.g., hospital) They apply to all patient safety concerns: They 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

6 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

7 Event Type Patient Information Level of Harm Hospital Common Formats For all events, CFs assess general information.

8 Hospital Common Formats If the event is covered by an Event-Specific Format, additional information will be requested. Medication Event Type Patient Information Level of Harm

9 Hospital Common Formats If the event involves more than one type of adverse action, e.g., a malfunctioning device that administers too much drug, then more than one event-specific Format will be invoked. MedicationDevice Event Type Patient Information Level of Harm

10 Hospital Common Formats Narratives are collected on all adverse events. While they are not useful at a national level, they are invaluable at the local level. MedicationDevice Narrative Event Type Patient Information Level of Harm

11 Hospital Common Formats MedicationDevice Narrative User Defined Customization Each institution, vendor, or PSO can add an unlimited number of additional questions of its own choosing. Event Type Patient Information Level of Harm

12 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/CMS meaningful use EHRs & ONC/CMS meaningful use

13 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

14 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

15 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

16 Common Formats on the Web To view sample reports, event descriptions, user guide, and programming instructions for electronic implementation visit: