1. Health IT Hazard Manager: Design & Demo James M. Walker, MD, FACP; Principal Investigator, Geisinger Health System Andrea Hassol, MSPH; Project Director, Abt Associates September 19, 2011 HIT Hazard Manager

2. Hazard Control Hazard analysis is accident analysis before the accident happens. Nancy Leveson

3. HIT Hazard Manager version 1.0 Beta Test 1.Background and Purpose 2.Hazard Manager Demo 3.Beta Test Sites and Procedures 4.Preliminary Findings 5.Next Steps

4. Health It Hazard Manager Development and Alpha-Test: Geisinger Health System Beta Test Website Implementation: ECRI Patient Safety Organization; Abt Associates Beta Test Evaluation: Abt Associates; Geisinger Health System

5. No Adverse Effect ”Un-Forced” HIT-use Error Error in HIT design or implementation Interaction between HIT and other healthcare systems. Care Process Compromise? Identifiable Patient Harm? Patient Harm No Adverse Effect ”Forced” HIT- use Error HIT-Related Hazard Hazard Identified? Hazard Resolved ? HIT-related Hazard Near Miss Yes No Yes No The Contribution of HIT-related Hazards to Patient Harm

6. Error in HIT design or implementation HIT-Related Hazard Interaction between HIT and other healthcare systems. Hazard Control ”Un-Forced” HIT-use Error Care Process Compromise? Identifiable Patient Harm? Patient Harm No Adverse Effect Near Miss “ Hazard Identified? “ Hazard Resolved? “ Hit-related Hazard “ ”Forced” HIT- use Error “ No Adverse Effect Yes No Yes No Hazard Control

7. No Adverse Effect “ ”Un-Forced” HIT-use Error ”Forced” ” HIT- use Error Hazard Identified? Hazard Resolved? HIT-related Hazard Care Process Compromise? Identifiable Patient Harm? Patient Harm No Adverse Effect Near Miss Error in HIT design or implementation Interaction between HIT and other healthcare systems. Safety incident reports HIT-Related Hazard Yes No Yes Feeding Back Incident Reports into Hazard Control

8. Health It Hazard Manager Levels of Access (Security) 1. Health Care Organization: can enter, view and manage its own hazards; view hazards entered by other HCOs using the same software product (deidentified as to HCO) 2. Software Vendor: can view its customers hazards (deidentified as to HCO) 3. Policymakers, Researchers, Regulators: can view all hazards (deidentified as to HCO and vendor)

9. Health It Hazard Manager Ontology of Hazards Discovery: when, how and who discovered the hazard; stage of discovery Causation: usability, data quality, software design, hardware, clinical decision support, implementation, user factors, other organizational factors Impact: risk and impact of care process compromise; seriousness of patient harm Corrective Action: interim and definitive fix, urgency

17. Percent of Hazards with Specified AttributeAll HazardsMy Organization’s Hazards Faulty Recommendation3/13 (23%)0/4 (0%) Missing Recommendation1/13 (8%)0/4 (0%) Clinical Content Inadequate1/13 (8%)0/4 (0%) Decision-Engine Logic Inadequate1/13 (8%)0/4 (0%) Inappropriate Level of Automation0/13 (0%)0/4 (0%) Other (specify)1/13 (8%)0/4 (0%)

18. Health It Hazard Manager Beta Test – version 1.0 7 test sites: integrated delivery systems, large and small hospitals, urban and rural –Usability –Usefulness –Ontology of hazard attributes –Automated Reports –Inter-rater Reliability 4 vendors

19. Beta Test Preliminary Findings An individual’s role determines what hazards they become aware of: -IT Implementation teams learn about potential hazards during testing -IT Production teams learn about hazards that may compromise care processes -Patient Safety teams learn about care process compromises that reach patients (with or without harm) Hospitals have separate IT issues and patient incident reporting systems - are not explicitly designed for hazard identification - but can help teams identify hazards

20. Beta Test Preliminary Findings Failures to control hazards are often labeled “User Error”. The Hazard Manager supports more hazard control and less “blame the user”. “Harm” is often limited to physical injury. The Hazard Manager raises awareness about psychological, financial and reputational harm. Each causation category includes an “other specify” option to elicit additional user insights; the ontology will evolve over time to capture additional attributes of Health IT hazards.

21. Project Schedule Beta Test data collection complete, October, 2011 Data analysis, November - December 2011 All sites project meeting, December 2011 Final Report, May 2012 Software revised, May 2012

22. Questions? Comments? For more information: andrea_hassol@abtassoc.com