Adverse Events

Recognizing, Reporting, Analyzing

By Tom Inglesby
INDUSTRY FOCUS

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CLARITY
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 In the February 2012 issue of
Annals of Intensive Care (Spring-
erOpen Journal), Mait Garrouste-
Orgeas,Franois Philippart, et al.
summarized the state of patient
safety as it related to adverse in-
cidents thusly:
Errors are caused by combi-
nations of human factors and
system factors, and informa-
tion must be obtained on how
people make errors in the
ICU environment. Preventive
strategies are more likely to
be effective if they rely on a
system-based approach, in
which organizational flaws are
remedied, rather than a human-
based approach of encouraging
people not to make errors. The
development of a safety culture
in the ICU is crucial to effective
prevention and should occur
before the evaluation of safety
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programs, which are more
likely to be effective when they
involve bundles of measures.
While we must continue to
emphasize to all members of the
care team that they are the front
line to preventing errors, taking a
systems or holistic approach will
greatly assist in making adverse
events rarer. Aiding in the implemen-
tation of the latter are many compa-
nies that provide incident reporting,
analysis, and review systems.
Clarity Group, Inc., in Chicago
is a healthcare resource company
that specializes in three areas. We
are one of the very first Patient
Safety Organizations (PSO) listed
with the Agency for Healthcare
Research and Quality, explains
CEO Anna Hajek. We have three
main areas of our organization, all
of which wrap around the integrated
management of risk, quality, and
safety for healthcare providers.
She continues, Our Health-
care SafetyZone Portal is a fully
integrated product that allows
data collection, data follow-up
and collaboration, and then data
analysis. Many of our customers
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use our Portal product for adverse
event reporting across their organi-
zations and are also clients of our
Clarity PSO. In that organization,
we do much deeper analytics on
comparative databases and other
patient safety activities. So were on
the front end, data collection, and
were also on the analytical side.
Hospitals should be open to chang-
ing policies and procedures when
shown their current versions are not
providing the necessary conditions for
patient safety. Hajek says, You will
find, in doing thorough data analysis,
emerging issues that will definitely
have an impact on how you do train-
ing in the organization and also on
existing policies and procedures.
Our clients tell us that, because the
data they get are good and accurate,
and increases reporting across their
organization, they have the ability to
make changes much quicker and in a
much more targeted way than in the
past. Our PSO is doing data analysis
from multiple providers, comparing
As software becomes more integrated
and complex, many facilities
are opting out of hosting applications
on their own computers.
data and benchmarking, so we can
do what we call deep dives into areas
that look like they are outliers and get
into true causes of whats happening.
This can lead us to put forth some
pretty specific recommendations on
what needs to be done from a policy,
procedure, and training standpoint.
As software becomes more inte-
grated and complex, many facilities
are opting out of hosting the applica-
tions on their own computers. It is
a real service to your clients if you
have a software as a service (SaaS)
product, claims Hajek. Our Portal
product is software as a service,
and we have a private cloud network
that we work in, so it has very tight
security. We work with very highly
rated organizations for hosting
data; they have HIPAA compliance
and protect the data from cyber-
attacks. When were privileged to
get data from our clients, its our
responsibility to keep that patient
data safe. We do it as best we
can, taking into account what is
the state of the art.
The ubiquity of the tablet and
smartphone, on and off the unit,
has led companies to focus devel-
opment efforts on mobile comput-
ing. We call our system mobile
friendly, comments Hajek. You
have to encourage reporting by
giving people as many options as
you can to get them to make that
report. Smartphones and tablets
are all necessary accessories
today, and people can use those
devices to enter data, just like they
can if theyre sitting at a computer.
She adds, Healthcare providers
today are working toward achieving
the Triple Aim of healthcare, which
is to provide excellent quality with
good outcomes, at a lower cost,
and with greater patient satisfac-
tion. You want all of your services
working together in an integrated
fashion so that you can achieve
that. Patient care is now in many
different healthcare settings, so
you have to have an understand-
ing of whats happening with that
patient everywhere, not just when
in the hospital, which traditionally
has always been where adverse
event reporting has taken place.
What you are seeing is that all
these other areas are creating a
much broader healthcare market,
and you have healthcare systems
 that are getting quite broad in
terms of the resources that they
have in place; you have to be able
to follow the patients progress
everywhere, and thats where our
products are focused.
Historically, healthcare providers
have been focused on incident
reporting relative to deaths and
significant adverse
outcomes. Hous-
ton, Texasbased
CRG Medical
developed the
KBCore platform
that allows orga-
nizations to iden-
tify information on
near misses. CEO
Douglas Dotan
explains, These
are situations that
occur that didnt
necessarily lead to
INDUSTRY FOCUS
a bad outcome or
a death but could
be improved upon
if the information
is collected and
analyzed. While
incident reporting
is part of the overall issue with
hospitals, our real focus for KBCore
and the Purple Button mobile app
is to allow hospitals to learn from
situations and near misses so they
can actually reduce the number of
mandated incidents they have to
report. Whether a surgical proce-
dure or just routine patient care,
things dont always go perfectly,
and thats understandable. Its rare
that an information system allows
you to share information on near
misses to avoid a bad outcome in
the future.
Hospitals are moving toward
broader networks. Theyve
acquired physician practices, and
theyre looking at health manage-
ment strategies to reduce cost
and improve quality. One of the
advantages of KBCore is that it
allows disparate organizations
and provider groups to share
communications, explains Dotan.
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Youre going to have a lot of diverse
cultures, through various acquisi-
tions, and the KBCore suite and
the Purple Button mobile app allows
one common platform to communi-
cate issues.
Readmissions are an example
of the fiscal imperatives facing
facilities today. The whole idea is
to determine why a readmission
happened, and you need to assess
what steps were taken or werent
taken, adds Anngail Smith, opera-
tions and risk analyst. We have a
section on contributing factors that
helps people figure out why events
occur, and readmissions are one
of them. Once youve collected
narrative data, you want to code
it. When you code it, you can figure
out whether it was a delay in diag-
nosis, a failure to diagnose, or an
untimely discharge. There are a
number of factors, and we have
those factors listed so that you
can roll up various factors such
as readmissions from different
locationsa surgical floor, a medi-
cal floor, or other areas.
Jim Fasone, chief strategy offi-
cer, notes, Since hospitals are not
allowed reimbursement for readmis-
sion, there is a lot of money at stake
when they have errors. Our system
allows a reduction in adverse patient
outcomes, and by reducing these,
hospitals will actually save money
while moving toward high reliability
and zero harm.
Dotan agrees. Our system,
our whole focus, is on intervening
factors. The problem is they have to
take time to document something
that doesnt cause
harm, so why report
it? One of the
things that we did
was we automated
the process. We
made the power of
the Purple Button
into an app in the
pocket of the clini-
cian. That imme-
diately takes away
the complaint, I
have to leave the
patients bedside
and go to the
computer to docu-
ment something
that didnt cause
any harm. It can be
documented now
as an unsafe condi-
tion, or a near miss, or an incident,
and in 60 seconds you can move
on and continue to treat patients.
He explains, The Purple Button
revolution puts the power of qual-
ity, safer patient outcomes, and
risk management in your pocket.
I think its going to change the
way we collect and share knowl-
edge, and it will reduce patient
harm. Most of our effort, instead
of being on root cause analysis
of failed events, will be on how
to analyze the things we do well.
We call this positive deviance.
Negative deviance causes harm;
deviance is positive if it fixes
something or prevents a situation
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fromgetting worse. Identification
of positive deviance allows the
facility the opportunity to fix the
problem, making things better
and safer for patients and staff.
Incident reporting is only part of
the approach to preventing adverse
 events. Reporting an adverse
event, incorporating more analyti-
cal modules, such as a peer review
or a root cause analysis to better
understand the adverse event
management sidethose are
the traditional methods. Thats
how weve done it in the past, and
those approaches will remain criti-
cal to preventing adverse events,
but the exciting thing this year for
us is proactive, real-time surveil-
lance, says Mike Etzinger, vice
president of marketing for RL Solu-
While users of technology dont
always appreciate disruption,
the healthcare industry is constantly
under pressure to make serious
changes.
INDUSTRY FOCUS
tions in Toronto. The idea is to
get ahead of the event rather than
just doing a great job of manag-
ing the event once it occurs. Look
for those triggers or indicators, in
advance, which might prevent an
adverse event from happening.
According to Catherine Lathem,
vice president for product manage-
ment, Risk Register is one
component of it, a new module
that we just released in Febru-
ary of 2015, which helps to log,
assess, and prioritize potential
risks as well as track initiatives
to minimize those risks. The
second part would be our risk
surveillance component that takes
real-time feeds from our lab, ADT,
pharmacy, surgery, and medical
records modules and looks for
indicators that would identify,
for example, potential sepsis or
readmission, based on a particu-
lar surgery. Its really bringing
the critical data to the forefront,
because risk managers today just
have so much information to weed
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through. What were trying to do is to
find that critical clinical and adminis-
trative data that might provide a risk
manager, quality director, or some-
one in patient safety a broader view
of whats going on in the hospital in
a real-time environment.
She continues, We filter that infor-
mation based on what you want to
see because the feeds are so data-
rich. We work with the management
team at the facility to really under-
stand what, specifically, they are
looking for.
The parameters are set upon
implementation. They would deter-
mine if they want to know readmis-
sions based within seven days, or
based on 30 days, or readmission
with a potential surgical site infec-
tion, Lathem notes. They would
set all those parameters. Then they
would be alerted through an email
alert or a pager alert, or it would be
loaded onto a dashboard. We feel
that the dashboard alleviates some
alert fatigue.
We start off with what were call-
ing our tile wall, or our info center.
You have icons on a wall, similar to
all of our products, and they would
tell you a raw number. Then, when
you click on that, it would bring up
either the report, or the file list, or
the patient record, whatever is the
pertinent information associated
with that tile.
Etzinger adds, Weve gone with
a consumer approach to the data
entry experience. If you look at
RL6, it has the interface that you
would see on a smartphone, so
its something thats familiar
to the user and allows them to
get in and get out as quickly as
possible with minimal training.
He adds, While voluntary inci-
dent reporting after an incident
will always be a critical compo-
nent to any risk management
initiative, risk surveillance serves
to augment voluntary reporting by
automatically surfacing informa-
tion that might prevent an incident
from happening in the first place.
Two buzzwords in the technology
domain are cloud and mobile.
Adverse event reporting can take
advantage of both as providers
of the technology increase their
offerings through cloud comput-
ing, with SaaS and data storage
in off-site server farms and smart-
phone and tablet applications for
mobile access.
Riskonnect, based in Kennesaw,
Georgia, covers both areas. Kelly
Barton, vice president for opera-
tions, provides some background.
Riskonnect was founded at a time
before software as a service was
even a term. Cloud computing was
barely mentioned. iPhones did not
exist. The founders and senior
management had a vision of what
SaaS could do. Weve brought that
to fruition and really disrupted lega-
cy technology providers in the risk
management space. Our business
started selling a risk management
work platform, built on the idea of
platform as a service. You can see
how that vision is now in complete
play throughout the industry.
Brian Stromberg, healthcare
sales executive with Riskonnect in
Mt. Airy, Maryland, admits, There
is legacy software out there that
can do patient safety. It might do a
little claims management. It might
do quality. But theres not one plat-
form that is fully integrated, that
allows mass customization of its
fields, its workflows, its approvals,
and really integrates everything.
The Riskonnect Healthcare Work
Platform allows hospitals to not
only do patient safety and claims
management, it also integrates
with our policy and procedures, root
cause analysis, peer review, and
return-to-work functionality. Every-
thing is fully integrated. The idea
is to automate the entire process,
reduce the number of clicks, and
leverage the data across different
functions in the hospital.
While users of technology dont
always appreciate disruption, the
healthcare industry is constantly
under pressure to make serious
changes. Take the influence of
mobile technology, tablets, and
smartphones. As Barton says, it
was only a few years ago that the
iPhone came on the market; today
the device, and its competitors,
can be seen everywhere. We take
mobile tech for granted, and that
can be a mistake when searching
for an event reporting solution.
they are actually just allowing some-
one to access a URL on their mobile
device. Its not a true app designed
for a mobile device. Hospitals want
to move to more mobile devices so
they can encourage and increase their
reporting of adverse events, especially
when it comes to physicians, who in
general are very low reporters. Making
an incident report very easy to fill out
on a mobile device will lend itself to
increasing physician reporting.
Stromberg continues, We make it
very easy for a physician, nurse, or
pharmacy tech to click on an icon and
quickly walk through a very short form
that allows them to submit data on
a particular adverse event, whether
its an actual event, a near miss, or
an unsafe condition. We take it a
little bit further. Not only do we send
out alerts and notifications, once an
events entered, but we also can fully
automate the workflow process. Once
departments manager to review,
validate the data, and possibly
enter some more information.
Nurse and pharmacy managers,
for example, can use the mobile
app to access real-time dashboards.
They can follow certain events
and be updated on their mobile
device any time theres a change or
someone comments on a particular
event, says Stromberg. Another
big advantage is that our solution
allows you to involve subject matter
experts immediately, all via a mobile
device. Youre constantly in commu-
nication and aware of whats going
on in your facility.
Barton comments, We can
predict that the pace of healthcare
is going to increase. Its going to
be faster, and its going to be more
globalized. That will increase risk.
But at the same time, those who
invest in the latest, greatest, most

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According to Stromberg, Some that event is submitted, a task will innovative technology will be better
vendors say they can do mobile, but automatically be assigned to that prepared for those risks.

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