Health IT Implementation , Usability and Safety Workgroup

1. Health IT Implementation, Usability and Safety Workgroup September 22, 2014 David Bates, chair Larry Wolf, co-chair

2. Agenda • Introduction of chairs • Workgroup member introductions • Discussion of the three areas of focus • Implementation • Usability • Safety • Workplan • Public Comment

3. HITPC Workgroups and Chairs HIT Strategy and Innovation Chair: David Lansky Co-chair: Jennifer Covich Advanced Health Models and Meaningful Use Chair: Paul Tang Co-chair: Joe Kimura Health Information Technology Policy Committee Chair: Karen DeSalvo Vice Chair: Paul Tang HIT Implementation, Usability & Safety Chair: David Bates Co-chair: Larry Wolf Interoperability & Health Information Exchange Chair: Micky Tripathi Co-chair: Chris Lehmann Privacy and Security Chair: Deven McGraw Co-chair: Stanley Crosley Consumer Perspective and Engagement Chair: Christine Bechtel Co-chair: Neil Calman

4. Member Responsibilities • Workgroup members are expected to be actively engaged in their workgroup • Membership of the workgroups will be reviewed on a quarterly basis to ensure active participation • Members missing more than 5 meetings will be removed from membership (unless extenuating circumstances) • Differing opinions are welcome and encouraged but should be done in a respectful manner • Participants should be prompt and do their best to minimize personal interruptions (e.g., mute phones) • All meeting materials are due at least 24 hours in advance of workgroup meetings • Members are expected to review materials in advance of the meeting and be actively engaged in the discussion

5. Membership

6. Health IT Implementation, Usability and Safety (IUS) Charge • The Health IT Implementation, Usability and Safety Workgroup will provide input and make recommendations on policy issues and opportunities for improving how health IT is designed, certified, implemented and used to minimize safety risks and leverage data to support improvements in patient care and health outcomes.   • The Workgroup will consider existing work including the IOM report on health IT and patient safety, the FDASIA report on health IT safety and innovation, the National Quality Strategy and the ONC Safety Plan. • An important charge of the group is to be reflective of the summary of experience in the field thus far, creating a forum for public discourse and learning. Examples of issues to be considered include but are not limited to: • lessons from implementation experiences • transparency on usability and safety • improvements to the certification program • safety reporting • analysis of aggregate data for lessons learned

7. FACA milestones JASON Task Force Kick-off Interoperability Governance Subgroup (estimates) HITPC comments on MU3 NPRM HITSC comments on Certification NPRM Joint HITPC/HITSC JASON/Governance Final Recs Federal HIT Strategic Plan Posted for Comment FACA Final Interoperability Roadmap Recs FACA Final HIT Strategic Plan Comments Interoperability Roadmap Posted for Comment Milestone

8. High-level Workplan

9. Meeting Schedule

10. Implementation • Implementations are done variably • Some of worst issues relating to safety with HIT have been associated with poor implementations • A number of studies have been done to suggest best practices (Ash, Koppel) • SAFER guidelines • But these best practices are not necessarily used

11. University of Pittsburgh Pediatrics Study • Studied children transported in for special care • Mortality rate increased from 2.8% to 6.3% (OR=3.3) after introduction of a commercial CPOE application • Study design was before-after • Other changes were made at same time as CPOE was implemented • Overall mortality wasn’t reported Han, Pediatrics 2005

12. Introduction of CPOE • CPOE was introduced very rapidly—over 6 days! • After implementation, order entry wasn’t allowed until the patient had actually entered hospital and been logged into system • After CPOE implementation, all drugs including vasoactive agents were moved to central pharmacy • Pharmacy couldn’t process medication orders until after they were activated • Many order sets weren’t available initially • Result was substantial delays in care delivery

13. Comments on Han Study • Study was very weak methodologically • Nonetheless, increase in mortality rate was very large and of obvious concern • Introducing substantial delays in this group could easily have caused • Organization broke many of the rules for implementation • Essential for other organizations to handle sociotechnical aspects better Phibbs et al, Pediatrics 2005

14. Other Pediatric Mortality Studies • University of Washington PICU study: • Montefiore Study—NICU and PICU • Mortality 3.16% before, 2.41% after Del Beccaro et al, Pediatrics, 2006 Keene et al, Pediatr Cri Care Med, 2007

15. Implementation • Implementations involve many issues besides safety • Can have short and long-term effects on efficiency • Implementation has not been directly addressed by meaningful use • We will explore area and discuss approaches

16. Usability • Usability in HIT software is quite variable • Have been many complaints about the issue from the broad community in U.S. • Is evidence for example that decision support is more effective when human factors principles are followed • In one study users were 4.75 times as likely to accept the alert when display was high quality • Affects both safety and efficiency

17. Science of Human Factors Usability can now be reliably assessed Often divided into: • Semantics: often equated to terms such as 'ease of use' or 'user-friendliness', without formal definition of the properties of the construct • Features: here, usability is equated to the presence or absence of certain features in the user interface such as windows, icons, menus or pointing devices • Operations: where the term is defined in terms of performance and affective levels manifest by users for certain task and environmental scenarios Dylan, 2001

18. Usability • Has not been directly addressed by meaningful use • Has been hard to access independent comparisons • This group will need to delve into the issue, understand current situations, make suggestions about what strategies ONC might pursue to improve situation

19. Safety • Literature suggests that HIT clearly appears to improve safety overall • Many studies which strongly support the benefits1,2 • However, literature also provides multiple anecdotes that health IT creates new safety risks • Magnitude of harm and impact of health IT on patient safety is uncertain: • Heterogeneous nature of health IT • Diverse clinical environments, workflow • Limited evidence in the literature • FDA has authority to regulate HIT but has not done so except in limited ways—authority limited to HIT that meets the definition of a “medical device”

20. Examples of Problems Associated with HIT • “Flight simulator” of CPOE across 63 hospital EHRs detected only 53% of potentially fatal medication orders 1 • Clear problem of providers writing electronic orders on the wrong patient because they don’t realize what record they are in 2 • A sensor attached to an asthma rescue inhaler records the location where the rescue medication is used but not the time. When the information is uploaded to a computer the time of the upload, not the time of the medication use, is recorded.  • The decision support in part of a clinical system stops working because of an “upgrade,” but no one notices for 6 months • When even serious safety-related issues with software occur, no central place to report them to, and they do not generally get aggregated at a national level 3

21. Possible Contributions • Recommendations about changes in certification process • Recommendations about changes in meaningful use • Recommendations to ONC to address gaps in other ways, e.g. through dissemination of best practices • Could also address recommendations to HIT Safety Center

22. Conclusions • Clearly implementation, usability and safety are inter-related • Need to sort out what contributions we can make in each area that will be most useful to ONC • Opportunities for improvement in each

23. Next Meeting: Friday, October 10, 2014 1:00 PM-3:00 PM Eastern Time