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NPSF Professional Learning Series presents:
The New IOM Report on Health IT and
Patient Safety
May 31, 2012
David C Classen MD, MS
CMIO
Pascal Metrics
Associate Professor of Medicine
University of Utah School of Medicine
Jeff Brown MEd
Senior Cognitive Scientist
Applied Research Associates

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Disclosure
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Learning Objectives
• List major findings of the New IOM Report on HIT and
Patient Safety
• Explain the implications of recommendations for vendors
• State implications of recommendations for healthcare
organizations
• Name two approaches to proactive identification of
systemic conditions for patient harm
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NPSF Professional Learning Series
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NPSF Professional Learning Series presents:
The New IOM Report on Health IT and
Patient Safety
May 31, 2012
David C Classen MD, MS
CMIO
Pascal Metrics
Associate Professor of Medicine
University of Utah School of Medicine
Jeff Brown MEd
Senior Cognitive Scientist
Applied Research Associates

Health IT and Patient Safety:
Building Safer Systems for Better Care
May 31, 2012

Committee membership
GAIL L. WARDEN (Chair)
Henry Ford Health System
JAMES P. BAGIAN
University of Michigan
RICHARD BARON*
Greenhouse Internists, PC
DAVID W. BATES
Brigham and Women’s Hospital
DEDRA CANTRELL
Emory Healthcare
DAVID C. CLASSEN
University of Utah
RICHARD I. COOK
University of Chicago
DON E. DETMER
American College of Surgeons and
University of Virginia School of Medicine
MEGHAN DIERKS
Harvard University and
Beth Israel Deaconess Medical Center
TERHILDA GARRIDO
Kaiser Permanente
ASHISH JHA
Harvard University
MICHAEL LESK
Rutgers University
ARTHUR A. LEVIN
Center for Medical Consumers
JOHN R. LUMPKIN
Robert Wood Johnson Foundation
VIMLA PATEL
New York Academy of Medicine and
Columbia University
PHILIP SCHNEIDER
University of Arizona
CHRISTINE SINSKY
Medical Associates Clinic and Health Plans
PAUL C. TANG
Palo Alto Medical Foundation and
Stanford University
*Resigned from committee March 2011
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Charge to the committee
• Summarize existing knowledge of the effects of health IT
on patient safety
• Make recommendations to HHS regarding specific actions
federal agencies should take to maximize the safety of
health IT–assisted care
• Make recommendations concerning how private actors can
promote the safety of health IT–assisted care, and how the
federal government can assist private actors in this regard
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Committee process
• 12 month study
• 3 in-person meetings
• 2 public workshops
• Data gathering from the public and vendors
• Extensive literature review
• 9 external reviewers
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Key findings
• Health IT can improve patient safety in some areas such as
medication safety; however, there are significant gaps in the
literature regarding how health IT impacts patient safety
overall
• Safer implementation and use begins with viewing health IT
as part of a larger sociotechnical system
• All stakeholders need to work together to improve patient
safety
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Current state of health IT
Magnitude of harm and impact of health IT on patient safety is
not well known because:
•Heterogeneous nature of health IT products
•Diverse impact on different clinical environments and workflow
•Legal barriers and vendor contracts
•Inadequate and limited evidence in the literature
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The New Game: Harm Documentation
Department of Health and
Human Services
OFFICE OF
INSPECTOR GENERAL
15,000 Medicare
beneficiaries per
month
experience
adverse events
contributing to
death
State with Safety
Program Flat-line
Improvement
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US Government Study
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Study Goal
• Objectives
o Capture incidence of patient harm
o Assess preventability of adverse events
o Estimate costs to Medicare
• Congressional Mandates
o Deficit Reduction Act of 2005 – “hospital-acquired conditions”
o Tax Relief and Health Care Act of 2006
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Sample for National Incidence Study
October
2008
999,645
780
• Sample month
• Medicare beneficiaries
discharged from acute
care hospitals
• Sample Medicare
beneficiaries
661
• Hospitals represented
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Incidence Rates – of all beneficiaries
13.5%
• Adverse Events
(NQF, HAC, F– I Level)
0.6%
• NQF Serious Reportable Events
1.0%
13.5%
• Medicare Hospital-Acquired
Conditions
• Temporary Harm Events (E
Level)
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Is safety improving in the US?
Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ.
Temporal trends in rates of patient harm resulting from medical care. New England
Journal of Medicine. 2010 Nov; 363(22):2124-2134.
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Results-Demographics
• Hospital descriptors
▫ AHA size: 2 Small; 3 Medium; 5 Large
▫ 8 Urban vs 2 Rural
▫ 10 hospitals--3 Teaching vs 7 Non-teaching
• 2341 patient records from 5 year period
• 588 harms detected
▫ 25 / 100 admissions
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Adverse Events by Category
Harm Category
Infectious
Surgical/ Obstetrical
Hematologic
Renal/Fluids/Endocrine
Respiratory
Cardiovascular
Gastrointestinal
Neurologic
Other categories
0 20 40 60 80 100 120
Number of harms
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Trends in All Harms Over Time: External
Slope: 0.98 (95% CI 0.93, 1.04 p = 0.47)
Landrigan et al., New Engl J Med 2010; 363: 2124-34
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Safety as a system property
• Safety is a characteristic of a sociotechnical system
• System-level failures occur almost always because of
unforeseen combinations of component failures
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Features of safer health IT
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Patient engagement tools
• Health IT can lead to safer care by
– Enabling patients and families to participate in their
care
– Helping patients and families become more
knowledgeable about conditions and treatments
– Improving communication among health care
providers, patients, and families
– Facilitating shared decision making
• However, patient use of health IT adds a layer of
complexity to the sociotechnical system
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Recommendations: Summary
Current market forces are not adequately addressing the
potential risks associated with use of health IT
All stakeholders must coordinate efforts to identify and
understand patient safety risks associated with health IT by:
•Facilitating the free flow of information
•Creating a reporting and investigating system for health IT–
related deaths, serious injuries, or unsafe conditions
•Researching and developing standards and criteria for safe
design, implementation, and use of health IT
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Recommendation 1
The Secretary of Health and Human Services (HHS) should
publish an action and surveillance plan within 12 months that
includes a schedule for working with the private sector to
assess the impact of health IT on patient safety and
minimizing the risk of its implementation and use. The plan
should specify:
a. The Agency for Healthcare Research and Quality
(AHRQ) and the National Library of Medicine (NLM)
should expand their funding of research, training, and
education of safe practices as appropriate, including
measures specifically related to the design,
implementation, usability, and safe use of health IT by all
users, including patients.
(continued on next slide)
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Recommendation 1 (continued)
b. The Office of the National Coordinator for Health IT (ONC)
should expand its funding of processes that promote safety
that should be followed in the development of health IT
products, including standardized testing procedures to be
used by manufacturers and health care organizations to
assess the safety of health IT products.
c. ONC and AHRQ should work with health IT vendors and
health care organizations to promote post-deployment safety
testing of EHRs for high prevalence, high impact EHRrelated
patient safety risks.
d. Health care accrediting organizations should adopt
criteria relating to EHR safety.
e. AHRQ should fund the development of new methods for
measuring the impact of health IT on safety using data
from EHRs.
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One Focus Area: NQF Safe Practices
Culture
Consent and
Disclosure
Consent & Disclosure
Workforce
Information Transfer
and Clear Communication
Medication Management
Healthcare-Associated
Infections
Condition- &
Site-Specific Practices
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Information Transfer
and Clear Communication
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-Excerpt-
CPOE may be adopted
with a stage approach
once integrated information
systems are in place to
support safety and effective
CPOE systems…
The CPOE system is tested
against The Leapfrog Group
Inpatient CPOE Testing
Standards…developed to
provide organizations that are
implementing CPOE with
appropriate decision support
about…
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Recommendation 2
The Secretary of HHS should ensure insofar as possible that
health IT vendors support the free exchange of information
about health IT experiences and issues and not prohibit
sharing of such information, including details (e.g.,
screenshots) relating to patient safety.
Recommendation 3
ONC should work with the private and public sectors to make
comparative user experiences across vendors publicly
available.
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Recommendation 4
The Secretary of HHS should fund a new Health IT Safety
Council to evaluate criteria for assessing and monitoring the
safe use of health IT and the use of health IT to enhance
safety. This council should operate within an existing
voluntary consensus standards organization.
Recommendation 5
All health IT vendors should be required to publicly register
and list their products with ONC, initially beginning with EHRs
certified for the meaningful use program.
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Recommendation 6
The Secretary of HHS should specify the quality and risk
management process requirements that health IT vendors
must adopt, with a particular focus on human factors, safety
culture, and usability.
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Recommendation 7
The Secretary of HHS should establish a mechanism for both
vendors and users to report health IT–related deaths, serious
injuries, or unsafe conditions.
a. Reporting of health IT–related adverse events should be
mandatory for vendors.
b. Reporting of health IT–related adverse events by users
should be voluntary, confidential, and nonpunitive.
c. Efforts to encourage reporting should be developed, such
as removing the perceptual, cultural, contractual, legal, and
logistical barriers to reporting.
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The Patient Safety and Quality Improvement
Act of 2005
▫ Creates “Patient Safety Organizations” (PSOs)
▫ Establishes “Network of Patient Safety Databases”
(NPSD)
▫ Authorizes establishment of “Common Formats”
for reporting patient safety events
▫ Requires reporting of findings annually in AHRQ’s
National Health Quality / Disparities Reports
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Recommendation 7-8
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Recommendation 8
The Secretary of HHS should recommend that Congress
establish an independent federal entity for investigating
patient safety deaths, serious injuries, or potentially unsafe
conditions associated with health IT. This entity should also
monitor and analyze data and publicly report results of these
activities.
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Recommendation 9
a. The Secretary of HHS should monitor and publicly report
on the progress of health IT safety annually beginning in
2012. If progress toward safety and reliability is not
sufficient as determined by the Secretary, the Secretary
should direct the FDA to exercise all available authority to
regulate EHRs, health information exchanges, and PHRs.
b. The Secretary should immediately direct the FDA to
begin developing the necessary framework for regulation.
Such a framework should be in place if and when the
Secretary decides the state of health IT safety requires
FDA regulation as stipulated in Recommendation 9a
above.
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Recommendation 10
HHS, in collaboration with other research groups, should
support cross-disciplinary research toward the use of health
IT as part of a learning health care system. Products of this
research should be used to inform the design, testing, and
use of health IT. Specific areas of research include:
a. User-centered design and human factors applied to health
IT,
b. Safe implementation and use of health IT by all users,
c. Sociotechnical systems associated with health IT, and
d. Impact of policy decisions on health IT use in clinical
practice.
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Human Factors
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A Definition
A multi-disciplinary/multi-specialty field
of research and practice concerned with
optimizing human-system performance,
especially in high-risk, high-consequence
settings and domains.
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It’s not about information
technology, buttons or dials…
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Sociotechnical Systems
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“When technical systems have more variety than a
single individual can comprehend, one of the few
ways humans can match this variety is by
networks and teams of divergent individuals…”
Weick K., (2001). Making Sense of the Organization. Chapter 14, page 333.
Blackwell Publisher, Ltd.
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Sociotechnical Systems Are
Never ‘Out of the Woods’
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Declining D
Revenue,
Competition…
Why did that happen?
Loss of resilience.
C
New facility planned
Cost cutting
Focus on efficiency
Normalized
risk; unsafe
behavior
B
Time pressure,
> interruption,
unworkable
procedure,
inadequate #
scanners..
Heightened
A
potential for an
adverse event
Clinical Space
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Issues of Context
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What’s the Payoff?
• Lesser risk of harm
• Lesser risk of failed implementation
• Information technology that supports rather
than hinders the user
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• Health information technologies are an interactive element, among many, that together
shape the behavior of complex socio-technical systems.
• We need clinically-situated research to understand cognitive
requirements in advance of proposing ‘solutions’—how do the
elements of the cognitive system interact to affect and effect
outcomes?
• Implementation strategies should include robust processes for
identifying workarounds—markers of an unintended impact on
frontline clinical processes.
• Healthcare organizations need persistent surveillance systems that
are sensitive to side-effects of change in technologies, policies,
processes, purchasing, tasks...
• Usability science and user research are insufficient to understand the
requirements for information technologies in domains and professions
where there is high consequence for failure.
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Mature Sciences can be
applied towards Design
Everyday
Decisions
• Usability Science
• User Research
Life or
Death
Decisions
• Cognitive
Systems
Engineering
methods
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Submit A Question
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