Download the entire issue - American Association for Clinical ...

What are the three most important
elements of safe process design?
The first is accounting for human factors.
It is important to recognize that processes
which rely on perfect human performance
are incapable of high reliability. The second
is standardization with limited discretionary
variability (See “Examples,” below).
Furthermore, reasons for appropriate variation
should be captured and fed into the
process design. The third is organizational
culture. It is essential to have a positive reporting
culture that exposes misses and
near misses, because no process or procedure
is failure-proof. Successful reporting
cultures also identify key vulnerabilities.
How do attitudes about safety in the
laboratory affect process design?
All processes that rely on vigilance and hard
work are incapable of performing at a high
level of reliability. If leadership and/or the
front line worker do not understand the
limitations of human performance, then
high levels of reliability will not be possible.
Also, a positive reporting culture is essential.
Punishment for human error will impede
process improvement and make the
organization less safe and less reliable.
14 CliniCal laboratory news July 2011
PATIENT SAFETY FOCUS
TAkING AIM AT REDuCING LAB ERRORS
Designing Processes for Patient Safety
The Key is Finding the Vulnerabilities and Fixing Them
richard gitomer, Md, Mba, is chief quality
officer for emory university Hospital
Midtown and is a general internist by
training. He has led numerous improvement
projects related to access, efficiency,
and innovation in the ambulatory setting
and care of patients with chronic conditions.
dr. gitomer is a recognized leader
in process improvement through his collaborations
with the institute for Healthcare
improvement and the association of
american Medical Colleges.
this inteRview was ConDuCteD By CoRinne Fantz, phD.
Clinical laboratories routinely monitor
key processes. Is it not enough to know
what errors occur and why they occur?
Measurement alone does not result in improvement,
but it is essential for identifying
areas that need improvement and for monitoring
improvement. There is a saying, “You
don’t fatten the chicken by weighing it.” (See
Figure, above).
What opportunities and challenges do
new technology bring to old processes?
New technologies increase the capability of
systems. For example, autoverification in
the lab is faster and more reproducible than
manual verification of results. But technology
comes with some inherent risks. For
those technologies that still require human
intervention, the interface between humans
and the technology remains the most
vulnerable point. These vulnerabilities
include incorrect human operation, due
either to human error or errors that result
from interacting with the new technology.
All systems will fail at some point. With
older technology, we know those failure
modes and have designed processes to limit
their impact. We do not have the same understanding
of new technologies. So, until
lab examples of standardization
with limited variability
® standardized procedures across all sites
® standardized phlebotomy trays
® one type of point- of-care glucometer in the health system
® automation that limits the care providers choice of tube types
® selection of a primary referral laboratory
® use of templates for interpretative reports
Prothrombin Time
90% Turn around Time
measurement is important to quality improvement, but by itself
will not significantly improve quality.
those vulnerabilities are fully understood,
there will be safety and reliability shortfalls.
Communication errors are a major
contributor of preventable harm to
patients. How can laboratory staff make
change-of-shift hand-offs safer?
Handoffs, like all processes, benefit from
standardization, which increases the likelihood
that key information will not be
missed. Standardization also creates an
opportunity to measure and improve the
process. The standard process should include
a template, or checklist (See “Checklist,”
opposite), which highlights key information
that should be exchanged.
While every laboratory has a process
for communicating critical values,
could you elaborate on a few design
elements that make one process safer
than another?
Communicating critical lab values is a process
that is heavily reliant on humans with
all their inherent vulnerabilities. In addition,
creating a first-level communication
process that includes all the eventualities
and exceptions necessary to respond to
every situation would result in a process
so complex that the staff would be unable
to execute it in a reliable fashion. Using a
reliable approach to design as described by
Roger Resar, performance levels in the high
90 percentages can be achieved with a series
of simple processes (See “Designing a
Process,” opposite).
The first step is to create a standardized
process that effectively communicates at
least 80% of the critical lab values on the
first attempt. For all the failures, there is a
second process that ensures appropriate
communication. This second process usually
is more resource-intensive, but it is able
to handle the complexities not addressed in
the first process. The benefit of this strategy
is more effective use of resources. The risk is
that failure of the initial standard process to
function at an 80% level of reliability or better
can overwhelm the redundant process.
By design, the redundant process is more
resource-intensive but has limited capacity.
As a physician consumer of laboratory
services, could you provide an example
of a laboratory process that directly
impacts the safety of your patients?
I am a general internist who sees ambulatory
patients. Reliable communication of critical
lab results directly impacts the safety of
my patients. By definition, these patients are
mostly healthy, so the incidence of critical
lab values is very low. Being an infrequent
event makes the likelihood that any process
designed to remedy the notification barriers
has a greater likelihood of failing. Therefore,
in my case, because receiving prompt and
accurate notification of critical lab results is
a rare event, it has a higher failure rate than
a process that occurs regularly.
Positive patient identification is essential
to ensuring patient safety. Do errors
in patient identification always mean
the process is bad?
Process failure is expected for all processes.
Since identifying patients is a process carried
out by humans, it will fail at some
measurable rate. Based on the specifications
of the clinical team, these error rates
could be well below the needs of the users