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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

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Health it implementation usability and safety workgroup

Health IT Implementation, Usability and Safety Workgroup

October 10, 2014

David Bates, chair

Larry Wolf, co-chair





Agenda
Agenda

  • CEHRT Regulation Briefing

  • Usability Presentations

    • MedStar Health

      • Raj Ratwani and Terry Fairbanks

    • NIST

      • Lana Lowry

  • Public Comment


Onc certification authority
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


Safety enhanced design
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


Ucd in cehrt regulation
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


Human factors perspective on advancing ehr usability safety

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


The Two Bins of Usability Safety

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


Anatomically oriented Safety

Is this the best way?




nextgen Safety


Focus areas
Focus Areas Safety

  • 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


Vendor user centered design ucd
Vendor User Centered Design (UCD) Safety

  • 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



Ehr vendor ucd processes
EHR Vendor UCD Processes Safety

  • Challenges:

  • General process

  • Leadership

  • Challenges:

  • Resources

  • Participant access

  • Use case development

  • Challenges:

  • Detailed work flow analysis

  • Safety data


Analysis of safety enhanced design sed reports
Analysis of Safety Enhanced Design (SED) Reports Safety

  • 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


Perspectives on certification
Perspectives on Certification Safety

  • 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


Our perspective on ucd certification
Our Perspective on UCD Certification Safety

  • 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


Safety monitoring and analysis to inform ucd
Safety Monitoring and Analysis to Inform UCD Safety

  • 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


Discussion
Discussion Safety

Raj Ratwani, PhD

[email protected]

Rollin J (Terry) Fairbanks, MD MS

[email protected]

www.MedicalHumanFactors.net


Next meeting friday october 24 2014 1 00 pm 3 00 pm eastern time

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


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