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Safety By Design: Ten Lessons

From Human Factors Research

By Grena G. Porto, RN,

Senior Director,
Clinical Consulting
VHA, Inc., Berwyn, PA
We cannot change the human
condition, but we can change
the conditions under which
humans work.
- James Reason1
Loss prevention has always been an
important and even dominant
component of the healthcare risk
managers role. Healthcare risk
managers have traditionally been
concerned with the prevention of
patient injury through the examination
and modification of patient care
processes. With the emergence of
medical error and patient safety as issues
of national concern, loss prevention
activities have taken on even greater
importance. Regulators, accreditation
bodies, payors and the public all
demand that healthcare providers
implement measures to prevent patient
injury, and each of these groups has
different but highly effective means of
holding providers accountable for
providing care more safely. As a result,
healthcare risk managers are under ever

greater pressure to implement effective

loss prevention strategies that
measurably increase safety and
reduce injury.
While this challenge is daunting, it also
provides healthcare risk managers with
an even stronger mandate for enacting
loss prevention programs. Along with
this comes the opportunity to try
different approaches. The emergence of
patient safety as a scientific discipline
presents healthcare risk managers with
a new arsenal of tools and tactics based
on knowledge developed by other
industries that have embraced safety.

The emergence of patient safety as a

scientific discipline presents healthcare
risk managers with a new arsenal of
tools and tactics.
Human factors is an academic discipline
that focuses on the interaction between
humans and devices, processes or
technology. More broadly, the term
refers to the role of humans in the
evolution of error. The application
of principles of human factors in the
design of technology is called human
factors engineering. The related fields
of ergonomics, the design of devices to
maximize safety and efficiency, and
human performance, the study of
cognition, attention, memory,
perception, communication and




other aspects of mental functioning,

also contribute to the body of
knowledge called human factors.
As healthcare organizations create
cultures of safety that focus less on the
performance failures of individuals and
more on system causes of errors, the
study of human factors becomes an
increasingly important source of
potential solutions to patient safety
problems. Much of what is known
about human factors has been learned
through decades of application, study
and validity testing in other fields, such
as aviation and nuclear power. This
article will summarize ten lessons
learned from the study of human factors
that healthcare risk managers can apply
to the patient care systems design to
reduce error and improve safety.

Errors of omission can be reduced

dramatically by designing work to
reduce reliance on memory. For
example, the probability that a person
will forget a step in a process when all
of the necessary items are imbedded in
that process is just 0.3%.5 Thus, by
making sure that all items necessary to
perform a procedure are included in a
pre-packaged procedure tray, the
probability that an item or step in that
process will be unintentionally omitted
is reduced by 70%.
A number of strategies can be employed
to reduce reliance on memory. Many of
these are already widely used in
healthcare, though often they are not
used as frequently or as effectively as
they could be. Such strategies include:
Checklists. Checklists are especially

Lessons from
Human Factors
Nolan2 describes three principles for
the design of safe care: 1) designing
the system to prevent errors, 2) making
errors visible so they can be intercepted,
and 3) developing mitigation strategies
to reduce the impact of errors. These
principles can be further expanded to a
list of ten strategies that can be applied
to the design of patient care processes
to reduce error.

1. Reduce reliance on memory.

Short-term memory is generally weak in
humans.3 The probability that a person
will make an error of omission in the
absence of a reminder is about 1%.4
While this number may seem small,
when it is applied to the number of
tasks that a healthcare worker must
perform each day, and the number of
steps in those tasks, the incidence of
memory lapses as a cause of errors
becomes more significant and
less tolerable.

helpful when there are a number of

steps and they must be performed in
a particular sequence. They have
long been used with great success in
aviation to help pilots avoid
omitting a critical step in complex
pre-flight preparations. Similarly,
checklists are used in healthcare as
well. Many hospitals employ
checklists to ensure that all
necessary steps have been taken
prior to taking a patient to surgery.
Other possible applications might be
during hand-offs at change of shift,
or to ensure a thorough and accurate
admitting history and physical exam.
Any process that involves more than
a few steps, or in which the
sequence of steps is crucial, is a
candidate for a checklist.
Protocols. While there is no

shortage of written protocols in

healthcare, they are not as effective
as they could be in helping
healthcare workers to avoid errors.
This is because they are often
written primarily to demonstrate
compliance with a standard or
requirement, or to document the
organizations philosophy about a
particular issue. They often reside


in cumbersome binders that go largely

ignored between accreditation
surveys. In order to be helpful to
the front-line healthcare worker in
avoiding errors, protocols must be
clear and concise, and must provide
step-by-step instructions, preferably
in a numbered or bulleted format
that is easy to follow and devoid of
long text.

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can avoid errors such as

administering drugs or nutrients
into the wrong tube or instilling a
feeding into a drainage tube. Colormatching can also eliminate the rework and waste that occurs when a
worker inadvertently opens a sterile
or clean item, which must later be
removed from the patient, discarded
and replaced.

Standardization. Standardization

initially gained acceptance in

healthcare as a cost management
strategy, but it is also an effective
strategy for reducing error. By
limiting the number of different
ways that a healthcare worker is
permitted to do a particular task, the
chances that the worker will make a
mistake in performing that task are
reduced. There are many untapped
opportunities for using
standardization to reduce errors in
healthcare. Supplies and devices are
obvious choices for standardization,
but other areas, such as techniques
and processes, can be also be
standardized. Even interactions
with patients and between
healthcare workers can be
standardized through the use of
outlines or scripting, so that the
necessary information is consistently
and accurately transmitted.

Color-matching. Color-matching
items that are used together can
eliminate the need for the
healthcare worker to remember
which items go together, and can
prevent him or her from mistakenly
using the wrong items together.
Color-matching is different than
color coding in that the user does
not have to remember what a
particular color means. With colormatching, the user need only match
the colors on items in order to avoid
error. One effective use of colormatching is in IV, TPN or drainage
tubing, so that nurses can easily
identify which tubes are which and

Much of what is known about human

factors has been learned through decades
of application, study and validity testing
in other fields, such as aviation and
nuclear power.

Pre-packaging. By pre-packaging all

items necessary for a particular task
into one kit, the need for the
healthcare worker to remember all
the required items, or to interrupt
the task while a needed item is
obtained, is eliminated. Prepackaging not only reduces the
possibility of an overlooked step in
the process, but also reduces the
chance of an error that may result
following an interruption in the
procedure. Examples of prepackaging include IV kits and
procedure trays, which contain all
the items a worker would need for
that particular procedure. Like
color-matching, pre-packaging can
save time and eliminate re-work,
thereby saving money as well.

Automated reminders. Organizations

that have electronic medical records,
or computerized physician order entry
systems, have the ability to create
automated reminders to help
workers remember key information.
Automated reminders are also a
feature of personal digital assistants
(PDAs) that increasingly are used in
patient care. The advantage of



automated reminders is that once

they are installed, they work
consistently and reliably until
disabled, without any extra effort on
the part of the healthcare worker.

2. Reduce reliance on vigilance.

Humans become easily distracted and
are generally not good at repetitive
tasks that require concentration over
long periods times. These human
vulnerabilities make it difficult both to
avoid an error and to recognize an error
once it has been made. The probability
of making an error of commission, such
as misreading a label, is 0.3%, while the
probability of failing to detect an error
upon inspection, such as noticing that
the name on the ID bracelet does not
match the name on the medication
container, is 10%.6 Both of these
processes - getting it right the first time
and noticing when it is wrong - require
the vigilance of the individual, a skill at
which humans are generally unreliable.
Strategies to reduce reliance on
vigilance include:

Bar-coding. By eliminating the

need for a healthcare worker to
inspect a name bracelet or a label,
bar-coding can markedly reduce
errors caused by lack of vigilance.
Although bar-coding is commonly
employed in retail and
manufacturing, only 2.5% of
hospitals surveyed by the Institute
for Safe Medication Practices
(ISMP) use bar-coding anywhere in
the organization, and less than 1%
had implemented bar-coding
throughout the hospital.7 One
reason for the low utilization of barcoding by hospitals is the lack of
universal bar-coding standards.
Nevertheless, bar-coding offers
exciting opportunities to avoid
errors related to patient
identification prior to medication

administration, transfusions and

procedures. Bar-coding offers the
additional benefit of automatically
capturing treatment information,
thereby enhancing the quality of
the documentation of patient care.

Constraints. Processes and devices

can be designed so that certain
serious errors cannot occur, even if
the healthcare worker is distracted.
An example of a device constraint
is the free-flow protection feature of
IV pumps. Removal of
concentrated solutions of potassium
chloride from patient care areas is
an example of a procedural
constraint. Procedural constraints
are relatively simple and
inexpensive to implement and can
be used widely throughout an
organization to reduce the
opportunity for error.

Forced functions. A forced

function is similar to a constraint in
that it is a design feature that
automatically guides the user of the
device or process. However, unlike
a constraint, a forced function
actually requires the user to employ
the device or process correctly, or
not at all. An example of a forced
function is a plug or connector that
fits only when applied in the correct
manner. Forced functions are
common in medical devices, but are
more difficult to design into

Natural mapping. The term

natural mapping refers to designs
that make sense intuitively or
respond to widely accepted
conventions. For example, turning
a knob clockwise corresponds with
increasing volume or intensity.
Therefore, a device that required
turning a dial counterclockwise to
increase volume or intensity would
be likely to create confusion in the


user. At a minimum, the user would

have to be extremely vigilant to
avoid an error. Likewise, pressing
the upper of two buttons or pressing
a switch up corresponds to upward
motion and any other design would
likely lead to error. Similarly red is
the universally accepted color of
danger, so that warning lights
should be red rather than blue or
green. Also, information is
generally read and processed from
left to right, so that this is how work
should be designed. By designing
devices and processes that conform
to these conventions, users of the
devices or processes do not have to
be highly vigilant to perform well,
and mistakes can be avoided.
Devices and processes that do not
conform to these norms should be

3. Simplify tasks and processes.

Complexity increases the probability of
error.8 A number of factors contribute
to the complexity of a task or process,
including the number of steps, the
number of choices to be made, the
timing of the choices, and the duration
of the task. The effect of the number
of steps in a process on the probability
of error is summarized in the
following table:9

No. of Steps

Base Error Rate









Thus, simply by reducing the number of

steps in a process, the probability of
error can be substantially reduced.
Flowcharting the processes and visually
inspecting work areas can be useful
tools for analyzing processes to identify
and eliminate unnecessary
redundancies, complexities and extra
steps. However, strategic redundancies,
such as double checks at critical points,
should be preserved.
Likewise, the number of choices should
be limited to reduce error. For instance,
in a neonatal intensive care unit, only
pediatric sizes of endotracheal tubes and
pediatric concentrations of drugs should
be available. Other choices are usually
not necessary and may lead to error. In
addition, the choices should be timed
so that adequate time can be devoted
to properly make the decision. For
example, the choice about which size
of catheter to be used should not occur
once the procedure has begun - the
process should be structured so that one
task does not interfere with another one.

4. Reduce handoffs.
The higher the number of people
involved in a task or process, the greater
the likelihood of error. This is largely
due to communication failures that
occur during handoffs. Thus, reducing
the number of handoffs can be an
effective way of reducing the probability
of error. One example of how this can
be achieved is by scheduling work so
that workers do not have to be relieved
for breaks at critical times. Another
strategy to reduce handoffs is crosstraining and expanded responsibilities,
so that work does not have to be
handed off from one task specialist
to another quite so often.

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5. Reduce the need for calculation.

The probability of making a simple
arithmetic error, even after self
checking but without using a separate
sheet of paper, is 3%.10 It is not unusual
for healthcare workers to perform
mental calculations dozens of times per
day. Counting the number of sponges
used, the number of beats per minute,
the number of drops per second, the
number of pills given, and even the
number of patients seen all require
calculation, and in most cases, the
healthcare worker does these
calculations mentally. Thus,
calculation errors in healthcare are
commonplace. Yet such errors can be
easily avoided by employing the
following strategies:

Calculators. Every patient care area

should have calculators, and their
use should be taught and mandated.
Even simple calculations should be
performed on calculators.

Preprinted charts. Charts that

show commonly-used values,
calculations and conversions,
similar to those available to
calculate a 15% tip, should be
provided to all patient care workers.

Double blind checks. When a

calculation must be done manually,
it should be double checked on a
separate piece of paper by another
individual who did not see the
original calculation.

Automation and artificial

intelligence. As information
technology evolves, automatic
calculations of dosages and other
calculations will be commonplace
and will eliminate the need for
healthcare workers to perform
calculations, even with a calculator.

6. Provide for reversibility

or automatic correction.
Since not all errors can be avoided,
work must be designed so that errors
can be promptly detected and corrected.
An example of this is the second
reading of emergency room x-rays
by a radiologist after the emergency
department physician has read it.
These over-reads provide the
opportunity to identify any missed
findings and intervene before harm
occurs. This same principle can be
applied to other critical processes,
such identification of surgical sites
or identification of a patients allergy

7. Plan for recovery when

prevention fails.
Since some incidence of error is
inevitable, planning and rehearsing the
response to error is a critical part of
work design. When a serious error
occurs, stress levels are high and clear
thinking is difficult. Thus, planning
and practicing the response to these
situations in advance is critical.
Cardiac arrest drills and infant
abduction drills are examples of
planning for and practicing recovery.
Training and drills involving error
scenarios such as transfusion errors and
wrong site surgery can also be
conducted. The drill should include
not only the clinical aspects of
managing the error but the handling of
the disclosure to the patient and/or
family as well.

8. Provide adequate training.

Constantly evolving technologies and
medical advances, together with high
turnover in staff, make training both
more critically needed and more
difficult to deliver than ever before.
The relationship between the lack of
training and incidence of error is an
obvious one, and yet one that has not
been embraced by the healthcare

community. Training and education

budgets are typically among the first to
be cut, and little or no accommodation
is made for formal training programs
during the normal workday for
healthcare workers. The phrase see
one, do one, teach one, has become
the mantra of medical education.
Adequate training is a planned activity
that is provided at appropriate intervals
and for appropriate duration, with
ample opportunity for observation and
practice. It is provided at a time when
other work duties do not interfere with
the trainees concentration and it is
considered a part of the trainees job,
rather than an unnecessary perk.
Adequate training provides
opportunities to learn that are free of
risk to either the patient or the trainee,
such as simulation training. Effective
training does not rely too heavily on
self-learning by the trainee and includes
appropriate amounts of guidance by a
qualified instructor. Moreover, it is
structured to meet the trainees needs
rather than those of the organization,
and its success is measured by the
trainees level of understanding rather
than the trainers amount of effort.

9. Manage fatigue.
As shift workers, healthcare workers are
particularly vulnerable to fatigue. This
problem is made worse by workforce
shortages, mandatory overtime and
double shifts. The effects of fatigue on
performance are similar to those of
alcohol. After 17-19 hours of
wakefulness, a normal day for many
shift workers, response times are up to
50% slower and accuracy is significantly
worse than when a person is intoxicated
with a blood alcohol level of 0.05%.11


A number of strategies can be employed

to manage fatigue. The use of
mandatory overtime and double shifts
should be eliminated. When such
measures cannot be avoided, the work
of fatigued employees should be
structured to compensate for their
shortcomings in performance. This may
mean reassigning tedious work or work
which requires a high degree of
concentration for accuracy. In addition,
frequent short breaks and adequate meal
breaks, together with scheduled naps,
can help minimize fatigue among shift
workers. Also, managers and
supervisors must be trained to recognize
the signs of fatigue and to encourage
workers to report when they are too
fatigued to perform safely.

10. Provide adequate

informational resources.
Accurate and readily accessible
information can help prevent errors. In
one case, unclear reference materials
contributed to a fatal medication error
which culminated in the criminal
prosecution of the nurses involved.12 As
with training and education, however,
the purchase of textbooks and resources
is often targeted early in budget cuts.
To guide the provision of safe patient
care, all patient care areas should have
easily accessible, high quality and up
to date reference materials, such as
computerized PDRs, textbooks and
web-based resources. Maintenance of
these reference materials through a
process of regular review and
replacement must be made a job
responsibility of the areas manager.
In addition, all staff must be made
aware of the existence and availability
of these resources and must be
encouraged to make use of them.

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10. Nolan, 2000.

Healthcare risk managers have long

played an important role in the design
and re-design of patient care processes
to help prevent error. This activity has
taken on even greater importance as a
result of increased public attention to
medical error. Healthcare organizations
are under great pressure to reduce
medical errors and provide safe patient
care. The field of human factors
provides healthcare risk managers with
many new strategies that can be applied
to the design of systems for patient care
to help reduce error. By becoming
familiar with and applying these
strategies, risk managers can help ensure
the success of patient safety efforts
within healthcare organizations.

11. Williamson, A.M., Feyer, A.M.

Moderate sleep deprivation
produces impairments in cognitive
and motor performance equivalent
to legally prescribed levels of
alcohol intoxication.
Occupational and Environmental
Medicine. 2000. 57:649-55.

1. Reason, J. Human error: models

and management. BMJ. 2000.
2. Nolan, T.J. System changes to
improve patient safety. BMJ.
2000. 320:771-73.
3. Norman, D.A. To Err is Human.
New York, NY: Basic Books Inc.,
4. Nolan, 2000.
5. Nolan, 2000.
6. Nolan, 2000.
7. Institute for Safe Medication
Practices. ISMP Alert. Vol. 6, No.
15, 7/25/01.
8. Leape, L.L. Error in medicine.
JAMA. 1994. 272:1851-57
9. Nolan, 2000.

12. Error, Negligence, Crime: The

Denver Nurses Trial. Enhancing
Patient Safety and Reducing Errors
in Health Care. Annenberg Center
for Health Sciences. Rancho
Mirage, CA. November 8-10,