1. Laura M. Lee, R.N. Clinical Center, NIH The Epidemiology of Clinical Errors in a Research Hospital: Mining Occurrence Reporting Data for Mining Occurrence Reporting Data for “Low Hanging Fruit”

2. Bona BenjaminSteve Bergstrom Ginnie DaineCharles Daniels Clare HastingsDavid Henderson Mary Sparks 250 bed hospital at NIH250 bed hospital at NIH Mission is clinical research; primary product is scienceMission is clinical research; primary product is science All patients are volunteersAll patients are volunteers Over 1100 protocols (Phase I or II clinical trials, natural history)Over 1100 protocols (Phase I or II clinical trials, natural history) “High risk; high reward”“High risk; high reward” The Clinical Center The Team

3. First implemented in 1980 First implemented in 1980 Part of Medical Information System Part of Medical Information System Exceeded regulatory requirements Exceeded regulatory requirements User feedback – uniformly negative User feedback – uniformly negative  Inflexible architecture  Limited data entry options  “Black hole” - no feedback  Limited use as an improvement tool Electronic Occurrence Reporting: 1980 - 1997

4. In 1998 reengineered entire system based on stakeholder requirements In 1998 reengineered entire system based on stakeholder requirements  Non-punitive environment  Web-based  Logical, user-friendly data entry  Automatic notification of “content experts”  Users ability to view occurrence reports and follow-up information  Flexible architecture that allows for customizable data collection  Customization of reports (e.g., unit, Institute, protocol) Occurrence Reporting: Present

5. Occurrence Reporting System

6. Number of Occurrences System redesign Education and increase attention to patient safety Regular feedback provided to users Occurrence Reporting Trends

7. Treatment Related Code Blue Code Blue Protocol/Consent Protocol/Consent Clinical Care Clinical Care Allergy Allergy Contact difficulty Contact difficulty Transfers Transfers Specimen collection Specimen collection Restraints Restraints Vascular Access Device Vascular Access Device Types of Occurrences

8. Medication Events Number of Occurrences Other issues Wrong dose Omission Not documented Wrong time Wrong drug Wrong rate Pyxis issues Expired drug Wrong form Wrong patient Delay in admin Allergy Wrong quant

9. Treatment-Related Occurrences Clinical Care Specimen collection Other events Vascular access Difficulty with transfer Blood and blood products Code Blue Restraints Delay in service Transfer to ICU Difficult contacting MD Allergy Wrong pt info Consent Number of Occurrences

10. Total reports classified as errors38% Did not reach patient24% Reached patient but no change in patient status36% Resulted in increased monitoring37% Temporary change in status2% Prolonged LOS or harm<1% Near-death event<1% Death---- Errors adversely affecting patient outcomes3% Errors adversely affecting clinical research<1% Impact on Patient Care and Clinical Research

11. So we know that bad things happen… We now have lots of data about “untoward events” that occur in our clinical research environment We now have lots of data about “untoward events” that occur in our clinical research environment Needed a process / methodology for: Needed a process / methodology for:  Managing the data  Identifying clusters of events  Driving process improvement  Continuously monitoring the events

12. Medication Clusters Fent/Mida mix- ups      9  Look alike meds      45 Ongoing Delay in starting PCA       20  Cyclosporine levels      8  Peds dosing errors     7  Rituximab rates    4  Meds at bedside       12  Omitted resp therapy rx      6  Omissions r/t roller clamps     5 Ongoing Sterile product labels      65 Ongoing ORS Data Staff education Communication Patient Education Information Systems DocumentationDevice ChangePolicy ChangePractice Change Process Redesign Continuous Monitoring Cluster

13. Care Delivery and Device Clusters Device Related  Butterfly needle failure     28 ORS Data Staff education Communication Patient Education Information Systems DocumentationDevice ChangePolicy ChangePractice Change Process Redesign Continuous Monitoring Cluster Care Delivery      Management of tracheotomy patients Ongoing   17

14. Implementation of a non-punitive, interactive Occurrence Reporting System dramatically increased reporting of clinical care events in a clinical research institution; Implementation of a non-punitive, interactive Occurrence Reporting System dramatically increased reporting of clinical care events in a clinical research institution; The ORS database facilitates epidemiological identification of clusters of adverse events; The ORS database facilitates epidemiological identification of clusters of adverse events; Data from the ORS can be used to drive clinical performance improvement activities and increase patient safety in our environment; Data from the ORS can be used to drive clinical performance improvement activities and increase patient safety in our environment; U The ORS is a reliable mechanism for monitoring the efficacy of improvement interventions. Conclusions