1. HIT Policy Committee Certification Adoption Workgroup Review of February 25 th HIT Safety Hearing Paul Egerman, Chair Marc Probst, Co-Chair March 17, 2010

2. 22 Agenda The Certification/Adoption Workgroup Summary of Hearing Preliminary Recommendations Open Questions Next Steps Appendix- Specific Preliminary Recommendations

3. 33 Certification/Adoption Workgroup Chairs: Paul Egerman Marc Probst - Intermountain Healthcare Members: Rick Chapman - Kindred Healthcare Adam Clark - Lance Armstrong Foundation Charles Kennedy - Wellpoint Scott White - SEIU Training & Employment Fund Latanya Sweeney - Carnegie Mellon University Steve Downs - Robert Wood Johnson Foundation Joseph Heyman - American Medical Association Teri Takai – State Chief Information Officer, CA Micki Tripathi - Massachusetts eHealth Collaborative George Hripcsak - Columbia University Paul Tang - Palo Alto Medical Foundation Carl Dvorak- Epic Joan Ash- Oregon Health and Science University ONC Lead: Jonathan Ishee

4. 4 HIT Patient Safety Hearing- Presenters Panel 1: Identifying the Issues –Ross Koppel, University of Pennsylvania –David Classen, University of Utah –Alan Morris, Intermountain Healthcare Panel 2: Stakeholders –Dave deBronkart, ePatientDave –Justin Starren, Marshfield Clinic –Jean Scott, Veterans Health Administration –Michael Stearns, e-MDs –Shelley Looby, Cerner –Carl Dvorak, Epic Panel 3: Possible Approaches –Jeff Shuren, Food and Drug Administration/HHS –William Munier, Agency for Healthcare Research & Quality –James Walker, Geisinger –Edward Shortliffe, American Medical Informatics Association

5. 5 Summary of HIT Patient Safety Hearing Anecdotes and Experience-Very Little Data Continued Confidence in HIT Area for Concern

6. 6 Four Areas to be Addressed Technology Issues (Software bugs) Complex Interactions of People and Technology Training and Implementation Interoperability

7. 7 Preliminary Recommendations - Goal Establish a patient-centered approach to safety that is consistent with the National Coordinator’s vision of a learning health and healthcare system. –The emphasis should be on preventing unsafe conditions that might lead to injuries. We suggest focusing attention on “hazards” and "near-misses“. –In support of this goal, a national, transparent, information system is needed with the following components: Reporting and Monitoring Evaluation and analysis Dissemination of information----learning –To achieve this goal, a culture of improvement needs to be created by each healthcare entity.

8. 8 Preliminary Recommendations Patient Engagement Training and Implementation Establish National Database—PSO—Stage 2 MU Clinician “Feedback Button” Certification to include Vendor Customer Alerts Best Practices

9. 9 Open Questions Should we recommend a special HIT Patient Safety Oversight function or an NTSB-like entity that investigates serious patient safety concerns? Should whistleblower protection be expanded/changed as part of this process? Is there a role for accreditation organizations (e.g., Joint Commission)?

10. 10 Open Questions - Continued Are special considerations needed for small physician groups or rural hospitals or safety-net institutions? Do we want to make a recommendation about the timing of Stages 2 and 3? The impact of FDA regulation is an important area for discussion. Do we have any recommendations for the ONC concerning the FDA?

11. 11 Next Steps Solicit Feedback from Presenters Solicit Feedback from Policy Committee and Public Conference Calls on March 25, and March 29 Final Presentation on April 21, 2010.

12. Appendix

13. 13 Specific Preliminary Recommendations 1.Patient engagement plays a major role in identifying errors and preventing problems. For example, in ambulatory settings, when it is possible for patients to observe data as it is entered, potential errors can be avoided. Through a PHR, patients obtain the ability to review some of the data in their EHR, and, as a result, PHRs should continue to be encouraged. Access by family members to inpatient medication lists should also be encouraged (assuming patient authorization is received). Mechanisms that make it easier for patients to report inaccurate or questionable data need to be encouraged as “best practices.” Examples include (a) the use of a “feedback button” that makes it easier for a patient to question/correct a medication that is shown in a patient portal, (b) a PHR system that includes a communication link back to the provider for patient corrections, and (c) secure communications that permit patients to report data omissions.

14. 14 Specific Preliminary Recommendations 2. The implementation and training process has a significant impact on patient safety. –Training programs should include information about reporting Patient Safety incidents and unsafe conditions. –We recommend that the Regional Extension Centers provide patient safety reporting training.

15. 15 Specific Preliminary Recommendations 3. A national database and reporting system needs to be established by ONC to create the information needed for the learning process. –The national HIT reporting system needs to have the following components: To be patient-centered, all "incidents" or "potential hazards" need to be confidentially reported by the provider directly to a national patient safety organization (PSO). Patients should also be able to make reports. The PSO must be able evaluate data received from these reports and provide findings that will assist other providers. As a result, standardized formats for data collection and reporting, such as those used by AHRQ, are needed. Data from the PSO should be used to influence future certification criteria. –We recommend that Stage 2 of Meaningful Use include a requirement that each Hospital and EP report potential hazards and incidents to the national PSO. Copies of those reports should be sent to any vendors that might be involved. –While data from a PSO is necessary, by itself, it is not a complete response to all HIT Patient Safety concerns. There may be areas that PSO data does not cover. Continued attention to Patient Safety, along with additional research, will be needed.

16. 16 Specific Preliminary Recommendations 4. We recommend Certification criteria be created that will make it easier for clinician-users to immediately report any problems/concerns with information that appears on screens (a “feedback button”). –This feedback button could also be used by clinician-users to request corrections to data.

17. 17 Specific Preliminary Recommendations 5. The Stage 2 certification criteria should include vendor development and communications processes. –Reflecting some of the concepts of the FDA's Quality System Regulation (QSR) program, certification should require vendors to have a process that records patient safety problems and communicates alerts to their customers.

18. 18 Specific Preliminary Recommendations 6. We recommend that ONC work with the Regional Extension Centers and with organizations like American Medical Informatics Association (AMIA) to create a set of best safety practices for selecting, installing, using, and maintaining HIT, and disseminate those best practices to providers. –As part of this process, utilization of Jim Walker’s Hazard Evaluation tool and Dave Classen’s flight simulator should be examined as best-practice candidates.

19. 19 Additional Information Additional Information and Materials from the February 25 th Hearing May be Found at: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1 473&&PageID=17117&mode=2&in_hi_userid=11673& cached=true