Health IT Implementation , Usability and Safety Workgroup

1. Health IT Implementation, Usability and Safety Workgroup October 10, 2014 David Bates, chair Larry Wolf, co-chair

2. Membership 1

3. Ex Officio Members

4. Meeting Schedule

5. Agenda • CEHRT Regulation Briefing • Usability Presentations • MedStar Health • Raj Ratwani and Terry Fairbanks • NIST • Lana Lowry • Public Comment

6. ONC Certification Authority • Stage 2 – 2014 Edition EHR Certification Criteria on “user-centered design” and “quality management systems.” • Increased transparency based on information available through certification. See ONC’s CHPL site. • ONC Authorized Certifying Body (ACB) can conduct surveillance in live environments. • ACB’s are “health oversight agencies” under HIPAA • See ONC FAQ #45

7. Safety- enhanced Design Current: Safety-enhanced design. User-centered design processes must be applied to each capability an EHR technology includes that is specified in the following certification criteria: § 170.314(a)(1), (2), (6) through (8), and (16) and (b)(3) and (4). • We proposed a ‘‘safety-enhanced design’’ (SED) certification criterion for the Proposed Voluntary Edition that was unchanged as compared to the 2014 Edition certification criterion. We did, however, solicit public comment regarding whether we should modify the certification criterion. Specifically, we requested comment regarding whether: • The scope of SED should be expanded to include additional • certification criteria • Formative usability tests should be explicitly required, or used as substitutes for summative testing • There are explicit usability tests that should be required in addition to summative testing • There should be a minimum number of test subjects explicitly required for usability testing New: Safety-enhanced design. User centered design processes must be applied to each capability an EHR technology includes that is specified in the following certification criteria: § 170.314(a)(1), (2), (6) through (8), (16) and (18) through (20) and (b)(3), (4), and (9). Response: We will, however, consider all the thoughtful comments we received regarding expanding the scope and testing of the SED certification criterion in relation to future rulemaking activity concerning a SED certification criterion. http://www.gpo.gov/fdsys/pkg/FR-2014-09-11/pdf/2014-21633.pdf

8. UCD in CEHRT Regulation Safety-enhanced design. User centered design processes must be applied to each capability an EHR technology includes that is specified in the following certification criteria: § 170.314(a)(1), (2), (6) through (8), and (16) and (b)(3) and (4). • § 170.314(a)(1) (CPOE); § 170.314(a)(2) (Drug/drug, drug-allergy interaction checks) • § 170.314(a)(6) (Medication list); • § 170.314(a)(7) (Medication allergy list) • § 170.314(a)(8) (Clinical decision support) • § 170.314(a)(16) (Electronic medication administration record) • § 170.314(b)(3) (Electronic prescribing) • § 170.314(b)(4) (Clinical information reconciliation). • Fact Sheet: http://www.healthit.gov/sites/default/files/2014-r2-ehr-certification-final-rule-onc-factsheet.pdf • Table of 2014 certification criteria: http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf • Quick Guide: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/CEHRT2014_FinalRule_QuickGuide.pdf

9. Human Factors Perspective on Advancing EHR Usability & Safety Raj Ratwani, PhD Scientific Director National Center for Human Factors in Healthcare, MedStar Health Assistant Professor of Emergency Medicine, Georgetown University Rollin (Terry) Fairbanks, MD, MS Center Director National Center for Human Factors in Healthcare, MedStar Health Emergency Physician, MedStar Washington Hospital Center Associate Professor of Emergency Medicine, Georgetown University

10. The Two Bins of Usability 2: Cognitive Task Support “Workflow Design” Smart Data Visualization Support Cognitive Work Functionality 1: User Interface Design Displays and Controls Screen Design Clicks & Drags Colors & Navigation Photo credit to Bob Wears, MD, PhD

11. Anatomically oriented Is this the best way?

12. Bin 2 - Basic

13. Bin 2 - Advanced

17. nextgen

19. Focus Areas • User centered design (UCD) and implementation (ONC/SHARPC project) • 11 in depth vendor visits • Analysis of SED reports • Our perspective on certification • Analysis of health IT related patient safety event data

20. Vendor User Centered Design (UCD) • Objective: • Understand vendor UCD processes and challenges • UCD: any formalized process for incorporating user needs throughout design, development and implementation • Method: • Onsite meetings primarily with: • Usability experts • Business Analysts • Product Managers

21. Vendor Demographics

22. EHR Vendor UCD Processes • Challenges: • General process • Leadership • Challenges: • Resources • Participant access • Use case development • Challenges: • Detailed work flow analysis • Safety data

23. Analysis of Safety Enhanced Design (SED) Reports • Tremendous variability • As few as 3 participants (some with 20) • Violates usability standards & creates double standard • Diverse range of participant expertise • Some with no clinical expertise (eliminates bin 2) • Diverse experience levels • Variability in amount of training on the system • Revisit guidelines to the authorized certification bodies (ACBs) • Not all the SED reports are public

24. Perspectives on Certification • Implementation processes: • Variability in implementation processes across vendors/providers • Few guidelines (SAFER guides are a start) • Customization: what is actually being certified? • Most vendors expressed concern over the investments required to meet summative testing requirements

25. Our Perspective on UCD Certification • Give vendors the option to either: • Attest to a UCD process and provide summative testing results OR • Attest to a UCD process and provide evidence of the UCD process being employed • Several advantages: • Byproducts of the UCD process would serve to meet the cert requirement • Vendors can expend “usability resources” as desired based on need

26. Safety Monitoring and Analysis to Inform UCD • Use machine learning (NLP) to analyze HIT related safety events • Example:Inpt dialysis nurse entered order in XXXX for Aranesp 100 mcg IV push q7d on incorrect pt. A pharmacist verified order but this order was never reviewed by floor nurse.  Inpt dialysis nurse realized she entered order on incorrect patient.. moments after signing the electronic order and immediately removed the task on eMAR but did not discontinue order in MedConnect. The inpt dialysis nurse removed Aranesp dose from the Dialysis Pyxis (non a profiled device) for the correct patient and administered the correct dose. • Input as a “Medication” event in a database of 30,000+ events . Flagged as HIT related with NLP. • Analyze these events in the context of UCD practices to provide insights on how to improve UCD • Which events would have been mitigated by formative testing? • By personas? etc

27. Discussion Raj Ratwani, PhD Raj.Ratwani@MedicalHFE.org Rollin J (Terry) Fairbanks, MD MS Terry.Fairbanks@MedicalHFE.org www.MedicalHumanFactors.net

28. Next Meeting: Friday, October 24, 2014 1:00 PM-3:00 PM Eastern Time