health it implementation , usability and safety workgroup
DESCRIPTION
Health IT Implementation , Usability and Safety Workgroup. October 10, 2014. David Bates, chair Larry Wolf, co-chair. Membership. 1. Ex Officio Members. Meeting Schedule. Agenda. CEHRT Regulation Briefing Usability Presentations MedStar Health Raj Ratwani and Terry Fairbanks - PowerPoint PPT PresentationTRANSCRIPT
October 10, 2014
Health IT Implementation, Usability and Safety Workgroup
David Bates, chairLarry Wolf, co-chair
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Membership
Name Organization
David W. Bates (Chair) Brigham and Women's Hospital
Larry Wolf (Co-Chair) Kindred Healthcare
Joan Ash Oregon Health & Science University
TBD Vendor representative
Janey Barnes User-View Inc.
John Berneike St. Mark's Family Medicine
Bernadette Capili New York University
Michelle Dougherty American Health Information Management Association
Paul Egerman Software Entrepreneur
Terry Fairbanks Emergency Physician
Tejal Gandhi National Patient Safety Foundation
George Hernandez ICLOPS
Robert Jarrin Qualcomm Incorporated
Mike Lardieri North Shore-LIJ Health System
Bennett Lauber The Usability People LLC
Alisa Ray CCHIT
Steven Stack American Medical Association
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Ex Officio Members
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Name OrganizationSvetlana Lowry Ex Officio, NISTMegan Sawchuk Ex Officio, Centers for Disease Control and PreventionJeanie Scott Ex Officio, Department of Veterans AffairsJon White Ex Officio, AHRQ/HHSEllen Makar ONC staff lead
Meeting Schedule
Meetings Task
Monday, September 22, 2014 2:00 PM-4:00 PM Eastern Time
• Review charge• Work to date=- background / history• Preliminary goals discussion of deliverable
Friday, October 10, 2014 1:00 PM-3:00 PM Eastern Time
• Presentation of usability research MedStar and NIST
Friday, October 24, 2014 1:00 PM-3:00 PM Eastern Time
• ECRI and TJC results of adverse event database analysis• Usability Testing • Implementation Science (field reports)• Certification – Alicia MortonFriday, November 7, 2014
1:00 PM-3:00 PM Eastern Time
Tuesday, November 25, 2014 2:00 PM-4:00 PM Eastern Time
• Possibly cancel
Friday, December 5, 201410:00 AM-12:00 PM Eastern Time
• Possibly cancel
Friday, December 12, 2014 1:00 PM-3:00 PM Eastern Time
• Post-implementation Usability & Safety, Risk Mgt & Shared Responsibility
• Safety Center Report Out • Realignment of timeline/ goals for 2015
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Agenda
• CEHRT Regulation Briefing• Usability Presentations
– MedStar Health• Raj Ratwani and Terry Fairbanks
– NIST• Lana Lowry
• Public Comment
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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
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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
Safety- enhanced Design
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).
http://www.gpo.gov/fdsys/pkg/FR-2014-09-11/pdf/2014-21633.pdf
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.
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).
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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
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Human Factors Perspective on Advancing EHR Usability & Safety
Rollin (Terry) Fairbanks, MD, MSCenter Director
National Center for Human Factors in Healthcare, MedStar Health
Emergency Physician, MedStar Washington Hospital Center
Associate Professor of Emergency Medicine, Georgetown University
Raj Ratwani, PhDScientific Director
National Center for Human Factors in Healthcare, MedStar Health
Assistant Professor of Emergency Medicine, Georgetown University
www.MedicalHumanFactors.net
1: User Interface Design
Displays and ControlsScreen DesignClicks & Drags
Colors & Navigation
The Two Bins of Usability
2: Cognitive Task Support
“Workflow Design”Smart Data VisualizationSupport Cognitive Work
Functionality
Photo credit to Bob Wears, MD, PhD
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Anatomically orientedIs this the best way?
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Bin 2 - Basic
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Bin 2 - Advanced
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nextgen
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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
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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
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Vendor DemographicsVendor Demographic Summary
Vendor Est. Revenue Est. Employees Est. Usability Team Size
Vendor 1 $1 billion+ 6000+ 15ppl
Vendor 2 $1 billion+ 6000+ 30+
Vendor 2 $1 billion+ 6000+ NA
Vendor 4 $100 million+ 2200 30+
Vendor 5 $100 million+ 650 NA
Vendor 6 $100 million+ 2000 30+
Vendor 7 $40 million 500 1-5
Vendor 8 $20 million 250 1-5
Vendor 9 $20 million 150 NA
Vendor 10 $10 million 60 NA
Vendor 11 $300,000 10 NA
Range $300,00 - $1 billion+ 10-6000+ 0-30+
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EHR Vendor UCD Processes
• Focused on customer requests• Responding to user feedback is UCD• No formalized method for incorporating and
testing user needs throughout design and development
No True UCD
• Understand UCD and its importance• Striving to implement UCD processes• UCD is not fully integrated yet
Basic UCD
• Rigorous UCD processes in place• Efficient testing methods• Extensive infrastructure
Well Developed UCD
Challenges:• General process • Leadership
Challenges:• Resources• Participant access• Use case development
Challenges:• Detailed work flow analysis• Safety data
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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
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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
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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
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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
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Discussion
Raj Ratwani, [email protected]
Rollin J (Terry) Fairbanks, MD [email protected]
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Next Meeting: Friday, October 24, 2014 1:00 PM-3:00 PM Eastern Time
