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Health IT Implementation , Usability and Safety Workgroup. September 22, 2014. David Bates, chair Larry Wolf, co-chair. Agenda. Introduction of chairs Workgroup member introductions Discussion of the three areas of focus Implementation Usability Safety Workplan Public Comment.

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Health it implementation usability and safety workgroup

Health IT Implementation, Usability and Safety Workgroup

September 22, 2014

David Bates, chair

Larry Wolf, co-chair


  • Introduction of chairs

  • Workgroup member introductions

  • Discussion of the three areas of focus

    • Implementation

    • Usability

    • Safety

  • Workplan

  • Public Comment

Hitpc workgroups and chairs
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

Member responsibilities
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

Health it implementation usability and safety ius charge
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

Faca milestones
FACA milestones

JASON Task Force


Interoperability Governance Subgroup


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


High level workplan
High-level Workplan


  • 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

University of pittsburgh pediatrics study
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

Introduction of cpoe
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

Comments on han study
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

Other pediatric mortality studies
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


  • 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


  • 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

Science of human factors
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


  • 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


  • 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”

Examples of problems associated with hit
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

Possible contributions
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


  • 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

Next meeting friday october 10 2014 1 00 pm 3 00 pm eastern time

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