1. 18 WWW.PSQH.COM JULY/AUGUST 2015
caregiver’s day-to-day experience, where
culture, processes, and technology interact
to produce—or inhibit—patient safety at
the unit level.
As noted, we reduced the sociotechnical
domains to three—culture, process, and
technology—each of which acts indepen-
dently, interdependently, and intradepen-
dently. Domains are composed of sub-
domains focused on defining unit-level
clinical safety and accurately representing
those things that affect the unit’s clinical
safety dynamics—the primary driver of
our development of this sociotechnical
model (Table 1).
The simplified framework consists
of three domains and 13 sub-domains
focused on elucidating patient safety at
the front line of care from those most
intimately affected by the technology.
Application
To assess the utility of our model, we
applied it to quantitative and qualita-
tive data collected from more than 290
frontlinecaregiversineightdistinctclin-
ical units in three nonprofit hospitals of
more than 200 beds in three geographic
regions in the United States. The quan-
titative data was collected in 2013 using
a validated culture survey instrument
based on the University of Texas’ Safety
Attitudes Questionnaire (SAQ) (Sexton
et al., 2006). Response rates exceeded
60%. Discipline-specific qualitative data
were collected using generally accepted,
anthropological, field-based research
methods (Jordan, 2013) at each facility
in 2013 and 2014. Loosely structured
ethnographic interviews were guided by
those things done routinely by doctors,
nurses, techs, aides, and others—of
which technology is just one piece in a
very complex, dynamic, and risk-filled
system. The complexity of these frame-
works makes their practical application
difficult. It also is challenging to use
the models to teach frontline staff how
the dynamics of their daily work can
profoundly impact unit-level patient
safety—e.g., burnout, resiliency, leader-
ship, teamwork, process improvement
and learning, communication practices,
and, yes, HIT. Our experience has been
affirmed in conversations with chief
medical officers and chief medical infor-
mation officers in organizations attempt-
ing to apply these models. As a result of
these experiences, we decided to develop
a simplified sociotechnical model to
elucidate the general state of patient
safety on the unit, where technology is
just one component to consider.
A New Model
Our simplified sociotechnical model is
based on data collected from frontline
caregivers, who are the most intensive,
frequent,andimportantusersofelectronic
health records. Our unit-level approach
uncovered situations and dynamics that
canonlybegleanedfromdirectinteraction
with these caregivers and is informed
by years of clinical practice, consulting,
EHR implementation, informatics, and
patient safety experience. A simplified
sociotechnical model emerged, based on
frontlinequantitativeandqualitativedata,
resulting in a practical, patient safety–
focused model reflective of the frontline
Concern for the safety of health informa-
tion technology (HIT) is long-standing,
and recent reports have catapulted HIT
safety to prominence. The Institute of
Medicine (IOM) (2012) notes:
Although definitive evidence is hard to
produce,thecommitteebelievespooruser-
interface design, poor workflow, and
complex data interfaces are threats to
patient safety. Similarly, lack of system
interoperability is a barrier to improv-
ing clinical decisions and patient safe-
ty, as it can limit data available for clinical
decision making (p. 4).
Because safety is an “emergent prop-
erty of a larger system,” the IOM (2012)
proposed using a structured assessment
of HIT implementation and operational
risk, i.e., a sociotechnical system. However,
the five-domain sociotechnical model
(people, process, technology, organiza-
tion, and external environment) proposed
by the IOM (2012) and others (Harrison,
Koppel, & Bar-Lev, 2007; Sittig & Singh,
2010) is limited in two critical ways:
1. It focuses exclusively on HIT, which
is only one component required to
achieve a safe and reliable system of
patient care in a complex sociotech-
nical environment
2. The complexity of the five-domain
model makes it difficult to apply and
teach to frontline caregivers
Based on our experience, current
sociotechnical frameworks (IOM, 2012;
Harrison et al., 2007; Sittig & Singh,
2010) do not accurately reflect the daily
dynamics of frontline patient care—
A Simplified Sociotechnical Model
Uncovers Health IT Safety Risks
By Michael S. Woods, MD, MMM; and Stanley L. Pestotnik, MS, RPh
HEALTH IT
SAFETY

2. JULY/AUGUST 2015 WWW.PSQH.COM 19
the data collected in the SAQ and included questions regard-
ing senior and unit leadership, teamwork, communication,
processes, and technology use and functionality (consistent
with the sub-domains of the simplified framework).
Qualitative data (verbatim comments) were reviewed by one
of the authors (MSW), and de-identified and modified to retain
each comment’s meaning. Common themes across groups were
identified by triangulation—validating qualitative data themes
by reaching the same conclusion from two or more separate
data streams collected from different units and/or disciplines
and reviewed by the authors for concurrence. Themes were
then examined in the context of the three-domain model, and
domain interactions were identified. Multiple issues were asso-
ciated with more than one domain/sub-domain, reinforcing
the complex interactions of the environment.
Findings
The initial goal of our exercise was to use our simplified model
to assess patient safety within the eight units and the model’s
utility, simplicity, and power. The model functioned well,
and uncovered patient safety strengths and opportunities in
each unit. We were surprised, however, by how powerful the
simplified model was at elucidating a number of significant
HIT safety issues at the front line of care, despite the fact that
we were not focused solely on HIT safety.
Eight key HIT safety findings (and their associated socio-
technical intersections with culture and process) emerged from
application of the simplified sociotechnological model:
1. Quantitative culture data, regardless of score, is insuf-
ficient to determine a clinical unit’s safety when HIT is
involved. Do not assume that because it has high culture
Simplified Sociotechnical Domains
Domain name Sub-domains
Culture • Patients & Families
• Leadership
• Teamwork
• Psychological Safety
• Burnout/Resilience
Process • Structured Communication
• Reliable Processes & Policy
• Process Improvement
• Organizational Learning
Technology • Usability
• Usefulness
• Workflow
• Safety
Table 1. The Simplified Sociotechnological Framework.
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3. 20 WWW.PSQH.COM JULY/AUGUST 2015
scores, a unit is able to use HIT
safely, or that the HIT itself is safe.
2. HIMSS Stage levels are not reflec-
tive of a clinical unit’s safety. All
units in the sample were HIMSS
Stage Five or higher, yet frontline
staff clearly articulated multiple,
proximate, and actionable safety
issues within the HIT system.
3. Top-down,centralizedHITdecision-
making reduces unit (and system)
safety by reducing the ability to
quickly act on HIT-related safety
issues identified by frontline care-
givers. Miller and Gardner (1997)
noted this was an ineffective
management strategy for HIT safety
oversight, saying, “We recommend
local oversight of clinical software
systems whenever possible …” This is
akin to an HIT rapid response team
(RRT)—a concept we developed
from our findings.
4. Frontline, unit-specific usability
challenges create cascading ineffi-
ciencies. This is where inefficiency
creates subsequent inefficiencies that
compound upon an individual during
a fixed period of time. Cognitive
stress caused by poorly functioning
HIT hinders work, exacerbates the
potential for frontline burnout, and
increases safety risk (Boralv et al.,
1994). We have, in exploratory work,
found a strong correlation between
HIT usability and a composite burn-
out score (exhaustion and lack of
accomplishment) with an R2 = 0.66.
5. Insufficient provider training exac-
erbates cascading inefficiencies. This
compoundsonnurseswhomphysicians
often rely on to complete orders in the
CPOE system, leads to overtime costs,
and contributes to burnout.
6. Culturalcomponents,suchasdisrup-
tive behavior, profoundly affect
the culture, process, and technol-
ogy domains. Frontline staff must be
comfortable reporting any safety or
quality concern to anyone at any time.
This only evolves in environments
driven by principles of civility, where
leadership sets the tone and enforces
the rules of non-negotiable mutual
respect (Woods, 2010).
7. HIT safety issues identified at the
unit level often represent industri-
alized HIT risk. Industrialization is a
word we have coined to describe the
extent of penetration of an HIT issue
within an organization using an HIT
system. For example, an issue with
an inaccurate order set that affects
only the pediatric oncology ward
has a low degree of industrialization,
affecting only a small and limited
group. A medication reconciliation
form completed on all patients in
the emergency department that has
an error in the underlying structure
and is a potential safety risk has a
high degree of industrialization, as
it would affect every patient being
admitted to the organization from
the emergency department. The
front line in each unit identified
such HIT issues, including incorrect/
inaccurate protocols, problems with
auto-population, inaccurate medi-
cation mapping, and many others
that create significant, real, ongoing
patient risks that are identified by
unit-level assessment and replicated
across the organization.
8. Inadequate due diligence prior to
go-live results in early derailment
of HIT implementation. Basic
hardware-software incompatibilities
lead to profound unit-level workflow
disruption when simple functional-
ity, such as being able to log on or
load HIT care modules, is lacking.
Conclusions
A simplified sociotechnical framework
of culture, process, and technology that
incorporates qualitative and quantitative
HEALTH IT
SAFETY
data in an integrated safety analysis
provides an accurate and comprehensive
picture of clinical safety, inclusive of
HIT, at the front line of care. Periodic
sociotechnical reassessment enables the
integrated implementation of safety
improvement across all three domains.
A local HIT RRT can be empowered by
leadership to aggressively address HIT
safety and usability issues as an important
component of the safety effort, as most of
theissuesidentifiedbythefrontlineinthis
analysis were proximate and actionable
and affected multiple other units.
We believe the approach presented,
crafted from direct, on-the-ground,
frontline experience, has generally
advanced the practical application of
sociotechnical assessment for patient
safety, has powerful face and content
validity, and redefines expectations for
practical sociotechnical assessments
related to uncovering patient safety-
related opportunities. The findings from
this simplified assessment enable solu-
tions to be intelligently crafted, inten-
tionally directed, and comprehensively
integrated into all domains that impact
clinical safety, not just HIT.
A copy of the original peer-reviewed
research for this article may be down-
loaded at www.sociotechnologix.com. ❙
Michael Woods is a board-certified surgeon who
has written about and consulted on patient safety for
over 15 years. He is a principal of Sociotechnologix,
LLC, and the clinical advisor to SafeHIT, its software
to identify HIT safety, usability, and workflow issues.
He may be contacted at mike@sociotechnologix.com.
Stanley Pestotnik is a clinical pharmacist, bioinfor-
maticist, and patient safety advocate, and is credited
with co-founding one of the pioneering real-time clini-
cal decision support software systems, TheraDoc, Inc.
He has served as an advisor to the U.S. Department of
Health and Human Services’Office of the National Coor-
dinator Clinical Decision Support Expert Panel. Pestot-
nik may be contacted at stan.pestotnik@comcast.net.
Frontline staff must be comfortable
reporting any safety or quality concern
to anyone at any time.

4. JULY/AUGUST 2015 WWW.PSQH.COM 21
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