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

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

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

3. The Reporting Issue • 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 • 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. Partnership for Patients (PfP) • Nationwide campaign in US to reduce harm to patients over three years: 2011-2013 • Goals are to reduce: • Preventable hospital-acquired conditions by 40% • Hospital readmissions by 20% • 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. PfP Measurement Challenge • Without measurement, there is no way to know if progress is being made • 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 • ICD-11 & AHRQ Common Formats could both be part of the solution in the future

6. Nov 2010 and Jan 2012OIG 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 • Hospital staff did not report 86% of events to the hospital’s internal incident reporting systems • 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

7. Problems Identified by OIG • 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 • 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. AHRQ Common Formats • 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

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

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

11. Event Reporting vs. Surveillance • 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 • Will include denominators; will generate rates • Will not address near misses & unsafe conditions

12. ICD–11 and the Common Formats • 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

13. The Future • Definition of patient safety events (ICD-11 & Common Formats) ultimately needs to support operational systems at three levels: • Adverse event reporting (not part of medical record) • Surveillance (derived from medical records) • Use of electronic health records (recording of data directly into EHRs) • Clinical & electronic definitions must be consistent throughout all levels, & be interoperable where appropriate

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