1. 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 Patient Safety Reporting and ICD-11 AHRQ’s Common Formats

2. 2 Agenda Introduction Introduction Common Formats Common Formats Relationship to ICD-11 and the Patient Safety Technical Advisory Group Relationship to ICD-11 and the Patient Safety Technical Advisory Group The Future The Future

3. 3 The Reporting Issue There are no universally-accepted definitions for reporting of patient safety events, either as: There are no universally-accepted definitions for reporting of patient safety events, either as: – A theoretical taxonomy, or – An operational patient safety reporting system ICD-11 can serve as a guiding taxonomy ICD-11 can serve as a guiding taxonomy It will need to have functional value for reporting systems if it is to be used, just as ICD diagnosis codes have functional value for classifying discharge diagnoses in the US; they are used for payment & other purposes It will need to have functional value for reporting systems if it is to be used, just as ICD diagnosis codes have functional value for classifying discharge diagnoses in the US; they are used for payment & other purposes

4. 4 Partnership for Patients (PfP) Nationwide campaign in US to reduce harm to patients over three years: 2011-2013 Nationwide campaign in US to reduce harm to patients over three years: 2011-2013 Goals are to reduce: Goals are to reduce: – Preventable hospital-acquired conditions by 40% – Hospital readmissions by 20% Measurement challenge that faced PfP: Measurement challenge that faced PfP: – 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

5. 5 PfP Measurement Challenge Without measurement, there is no way to know if progress is being made Without measurement, there is no way to know if progress is being made Existing systems & research studies were used to: Existing systems & research studies were used to: – Estimate incidence & determine goals – Develop a plan to track performance based on measurement of representative populations & extrapolation to the entire US While that approach allows PfP to track progress, what is needed is a universally-accepted way to measure patient safety events – defined clinically & electronically While that approach allows PfP to track progress, what is needed is a universally-accepted way to measure patient safety events – defined clinically & electronically ICD-11 & AHRQ Common Formats could both be part of the solution in the future ICD-11 & AHRQ Common Formats could both be part of the solution in the future

6. 6 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 Medicare “hospital acquired conditions” & AHRQ “PSIs” rarely occurred Medicare “hospital acquired conditions” & AHRQ “PSIs” rarely occurred In those states that require hospitals to report certain types of adverse events, serious underreporting occurs: only 1 in 12 events (found by OIG) were reported In those states that require hospitals to report certain types of adverse events, serious underreporting occurs: only 1 in 12 events (found by OIG) were reported

7. 7 Problems Identified by OIG Inconsistent identification of adverse events Inconsistent identification of adverse events – Variation within hospitals – Variation across hospitals – Variation among states that have external reporting requirements Confusion among front line staff regarding what events they need to report to the hospital Confusion among front line staff regarding what events they need to report to the hospital OIG identified the Common Formats as providing a systematic method for collection of all types of adverse events and recommended that AHRQ and CMS promote more widespread use of the Formats OIG identified the Common Formats as providing a systematic method for collection of all types of adverse events and recommended that AHRQ and CMS promote more widespread use of the Formats

8. 8 AHRQ 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) Developed through consensus among government health experts/agencies; feedback from the private sector; & vetting through a National Quality Forum (NQF) expert panel Developed through consensus among government health experts/agencies; feedback from the private sector; & vetting through a National Quality Forum (NQF) expert panel

9. 9 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

10. 10 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

11. 11 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

12. 12 ICD–11 and the Common Formats The objective of both efforts is to define patient safety events to guide patient safety reporting The objective of both efforts is to define patient safety events to guide patient safety reporting – WHO’s ICD–11 is part of the long-standing, universally- accepted classification of diagnoses; it is a natural home for a conceptually sound taxonomy for patient safety events – AHRQ’s Common Formats are designed for use at the local level with operational definitions that are specific enough to support software systems There should be a direct relationship between ICD-11 & the Common Formats; supporting that link, AHRQ serves on the WHO Patient Safety Technical Advisory Group There should be a direct relationship between ICD-11 & the Common Formats; supporting that link, AHRQ serves on the WHO Patient Safety Technical Advisory Group

13. 13 The Future Definition of patient safety events (ICD-11 & Common Formats) ultimately needs to support operational systems at three levels: Definition of patient safety events (ICD-11 & 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

14. 14 Common Formats on the Web To view sample reports, event descriptions, user guide, and programming instructions for electronic implementation visit: https://www.psoppc.org/web/patientsafety