1. MARCH/APRIL2014
29
In any process, there are risks—things can go
wrong. It may sound like a word cluster, but among
the many possible process failures there are
“knowns” and “unknowns.” Unless you thoroughly
examine a process top­to­bottom, you really don’t
know what you don’t know. It’s those “unknown
unknowns” that are risks lying in wait—and that is the
type of hazard we must especially aim to root out in
home and specialty infusion pharmacy practice.
Much of the risk management and quality assurance
(QA) focus in health care is on taking heed of past mis­
steps and ensuring that processes are in place to pre­
vent them from reoccurring. When a harmful error
happens, we perform a root cause analysis (RCA) to
see where the system broke down and then refine pro­
cedures. Although recognizing and learning from mis­
takes is beneficial in many ways, it’s still a reactive
operation. What if we could complement that with the
ability to identify potential failures—failures we may
not have even thought of—before they occur?
There is a method for proactive hazard identification.
Failure Mode and Effects Analysis (FMEA), is a systematic
technique of mapping a process in order to identify where
and how potential failures can happen. The process also
considers the likelihood and detectability of a breakdown,
along with the severity of the consequences, so users
have a blueprint for preemptively addressing and resolv­
ing issues that surface (see Exhibit 1).
A Brief History
Like so many other QA tools, FMEA was born in one
industry and has been applied to a variety of sectors.
Created in the 1940s by the U.S. military, FMEA proce­
dures were published as a military standard by the
Department of Defense in 1949. In the 1960s, FMEA
was further developed by the aerospace industry—
probably due to the close linkage between military and
defense contractors building aircraft.
Later, FMEA was adopted by the National
Aeronautic and Space Administration (NASA) and used
on the Apollo program and several subsequent mis­
sions. In the 1970s, Ford Motor Company began using
FMEA in response to widespread problems it was
experiencing with its Pinto—maybe not as proactively
as the company would have liked—and by the 1980s it
was widely used throughout the automotive industry.
In the early­2000s, as patient safety initiatives were
reaching a crescendo, the Veterans’ Administration (VA)
brought FMEA to health care. The VA’s National Center
for Patient Safety (NCPS) led the development of
Healthcare Failure Mode and Effects Analysis (HFMEA™),
Delving into the Unknown Unknowns
—Using Failure Mode and Effects Analysis (FMEA) to Root Out Risk in Home and
Specialty Infusion Pharmacy
By Jeannie Counce and Matthew Grissinger, R.Ph., FISMP, FASCP

2. 30
MARCH/APRIL2014
Exhibit 1
Overview of Failure Mode and Effects Analysis (FMEA)
Process
• Step 1. Assemble a team. Bring together a group that represents all facets of the process you are examining.
Diversity is key because you want to capture a variety of perspectives.
• Step 2. Select a topic. It’s important to define the scope of the project from the beginning. FMEAs can be time­
intensive, especially for novices to the process—so be careful not to take on too much at one time.
• Step 3. Map out the process. Start by creating a detailed diagram (a process flow diagram) of the tasks
involved in executing the process or bringing a new product into an existing process. For example, the ware­
house process for preparing a delivery begins with “delivery ticket to warehouse printer” and ends with “bag
moves to checking table.” See below for how to apply Steps 4­7 to one of the sub­processes.
• Step 4. Ask, “What could go wrong?” Identify how and where each step or sub­process can fail to accomplish
its intended purpose (failure modes). List all possibilities regardless of how unlikely or insignificant the conse­
quences appear.
• Step 5. Find the risk priority number (RPN) for each failure. For each failure mode, determine the likelihood
of making an error, as well as the potential consequences of the failures, and whether it’s evident. How often
could this failure mode occur? What would happen as a result? How detectable is this failure? Assign numerical
values to each (likelihood, severity, detectability) and place them in a matrix. Multiply across the matrix to get
a risk priority number (RPN).
• Step 6. Prioritize and plan your attack. Beginning with the highest­scoring RPNs, identify any preexisting
processes that could help eliminate or detect the error before it reaches the patient. Evaluate each process for
its effectiveness based upon what was learned in previous steps.
• Step 7. Take action. Develop actions (process changes) to prevent the error, detect it before it reaches the
patient, or minimize its consequences. Monitor the new process to ensure the system works as anticipated.
Rating scale: 1=low; 10=high
Sub­Process Description Failure Modes Severity
(1­10)
Probability
(1­10)
Detectability
(1­10)
RPN
Score
Process Change
Enterals loaded onto cart
and labels attached to each
case. Quantity check marked
on delivery ticket (DT).
Not enough
labels
3 3 2 18
Wrong item
pulled
9 7 3 189 Checker initials each label on
cases of enterals signifying
review of name, product, and
exp. date.
Mixed cases on
stack
9 7 3 189 Checker initials each label on
cases of enterals signifying
review of name, product, and
exp. date.
Expired
product
9 4 8 288 Checker initials each label on
cases of enterals signifying
review of name, product, and
exp. date.
Pull wrong
quantity (or
none)
3 6 5 90
Fail to mark on
DT
1 5 3 15
Mix up of mul­
tiple patients
(i.e. 2+ orders
on cart)
9 5 3 135 Checker initials each label on
cases of enterals signifying
review of name, product, and
exp. date.

3. Why should it be?
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The National Home Infusion Association (NHIA) is committed to extending association membership privileges to entities that
provide health care services and products in a legal and ethical manner, including compliance with all applicable laws, rules and
regulations. NHIA certifies that
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______________________________________________________
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______________________________________________________
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4. 32
MARCH/APRIL2014
which modified FMEA to better fit the health care deliv­
ery model. In particular, the VA addressed the way in
which severity of incidents is rated since outcomes such
as patient injury and death skew the scale upwards.
Today’s pharmacy practice can also benefit from
FMEA. It fits well with the growing number of QA and
patient safety standards, asserts William E. Fassett, R.
Ph., Ph.D., a Professor in the Department of
Pharmacotherapy, College of Pharmacy at Washington
State University. “I believe that tools like RCA and FMEA
should be—and are—increasingly part of pharmacy
school curricula,” he says. “State boards of pharmacy
are paying more attention to and requiring QA. My own
state requires an ongoing quality assurance and perfor­
mance improvement program for infusion pharmacies.
In California’s jurisprudence exam, one element tests
knowledge of QA activities, such as RCA and FMEA.”
The benefit of FMEA is that it’s forward looking, he con­
tinues. “It’s a prelude to risk. You use it when you are antic­
ipating changes to your system, bringing on new programs,
or considering activities of high risk.” Examples, according
to Fassett, include choosing a new infusion pump, adding a
new drug therapy, or adopting new software.
Because it’s process oriented, FMEA can apply to
almost any operational process, according to Fassett.
“It’s a good risk management technique, even for non­
clinical activities, such as bringing on a new business
line. You can do a lot of advanced troubleshooting.”
FMEA also allows providers to spend the most time
on the things that can go horribly wrong, adds Fassett.
“For infusion providers who are working with scarce
resources, FMEA allows you to better allocate those
resources by prioritizing needed actions,” he explains.
“In the real world, that means not addressing every
single thing that could possibly go wrong, but reducing
real risks of harm.”
Why It Works
Errors result from process break down, so process map­
ping is a really helpful tool. Since the first step to FMEA
is a thorough enumeration of the steps involved in any
given system, it is almost immediately enlightening.
Often, a seemingly simple process can involve as
many as 50 sub­steps. Displaying them visually allows
for a better understanding of the existing system,
which sets the stage for rooting
out risks and tweaking the system
to address them.
It also creates appreciation
among the many players participating in the process.
“FMEA raises awareness of the people doing the
steps,” explains Barbara Prosser, R.PH., an industry vet­
eran who applied QA activities to a national infusion
provider’s pharmacy operation for 16 years before
recently becoming a consultant. “Participants can see
what others on the team do, which forces everyone to
think beyond the obvious.”
Like any brainstorming activity, a diverse team,
including pharmacy technicians and warehouse per­
sonnel, allows you to see multiple perspectives. “You
have to pull in the right people and empower them to
speak out,” advises Prosser. “It reduces workload and
provides a more diverse insight into the process you’re
examining.” See p. 35 for more helpful tips.
Variety also pays off in the next FMEA step: identify­
ing all possible failure modes. When you ask, “What
could go wrong?” the observations naturally vary
depending on the respondent. There are no bad
answers, explains Samuel Wachsman, R.Ph., M.B.A.,
Manager of Pharmacy and Customer Service for
Horizon Healthcare Services in Lancaster, Pennsylvania.
“Be exhaustive, even if it borders on silly,” he recom­
mends. “That’s where the discoveries come from.”
Even if your current process contains safety features,
performing an FMEA can reveal that they may not work
the way you intended. Wachsman saw this first hand
when his team examined the process it was using to fill
PCA pumps for hospice patients. “As patients progress,
we need to increase the concentration of the drug,” he
explains. Recognizing that a change in dosing can
increase the risk of medication errors, they would
always send a new pump, programmed for the new reg­
imen, with the delivery. “The pharmacist would repro­
gram the pump, someone else would check it, and we’d
put a sticker on the medication cassette instructing the
nurse to use the new pump,” recalls Wachsman.
“We thought we were setting up a series of great pre­
cautions, but when we went through the
FMEA, we realized that the new pump
might not be seen by the nurse.”
During FMEA, his team recognized
that the pump could be on the bot­
tom of the supply­stocked delivery bag,
or the patient could disregard it when
unpacking the bag in preparation for the
nursing visit.

5. Attaching the higher­dose medication cassette to
the pump with the previous programming would be a
serious error. So, the Horizon team decided to attach
the new cassette to the new pump prior to delivery—
and continue using the alert sticker.
As mentioned earlier, ranking each failure mode pro­
vides insight into how to proceed. “Our team used the
Institute for Healthcare Improvement FMEA tool as a
guideline, which uses a 10­point scoring scale to rate
the severity, likelihood, and detectability and multi­
plies them together to get a risk priority number
(RPN),” explains Krista Decker, R.Ph., MSQA,
Medication Safety Officer at Johns Hopkins Home Care
Group (JHHCG).
“The issues almost sort themselves out once you
start thinking through the rankings,” observes
Wachsman. “But when you see the RPNs it becomes
very clear where the risks lie.”
“The nature of the RPN system allows you to identi­
fy the areas within your process that have the greatest
impact on patients,” adds Decker, whose team used
FMEA to evaluate its medication pump programming
process. “It also points to process failures that are the
most difficult to detect.”
The idea is to make likely failures either less likely or
more detectable. In other industries, more emphasis
might be placed on lessening the severity of a failure
mode, but in health care the potential for patient harm
is always severe.
It’s important, however, to distinguish between
detecting and preventing errors when you are looking
for process improvements. For example, implement­
ing an independent double check doesn’t prevent
errors; it prevents harm by making the error
detectable. A better process change, such as default
measurement settings on an automatic compounder,
would prevent an error in the first place. “Error proof­
ing is the preferred action for any performance
improvement initiative,” says Decker.
Because it’s consensus driven and involves a diversi­
ty of team members, FMEA is a great way to get buy­
in, regardless of the organization’s size, according to
Prosser. “When everyone is involved in talking about
processes, they have a lot more ownership in the
changes and are more ready to embrace them,” she
observes. “FMEA provides a great framework for cre­
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6. 34
MARCH/APRIL2014
ating policy and training programs.”
“Changes aren’t just rules created by management,
so employees see the value in them,” echoes
Wachsman. “They understand the actions that come
out of it so much better because they often come up
with them themselves.”
In that way, FMEA also creates accountability in a non­
threatening way, adds Wachsman, who once used it to
help improve warehouse processes. “I knew that depart­
ment could do better, but I didn’t want to make it per­
sonal,” he recalls. “FMEA was very effective because it
focused on the procedures and not the people.”
What Could Go Wrong?
Most people fail because they pick their topic of study
incorrectly. If not managed from conception, FMEA
can quickly become cumbersome and overwhelming.
“It’s important to define the scope of the project for
it to be meaningful,” advises Wachsman, who despite
“finding great things,” admits he bit off more than he
could chew with his PCA FMEA. “It turned into a big,
hairy beast with 150 process steps from physician
order to hook up in the home. From that we learned to
break projects into smaller pieces.”
In addition, the process is only as good as the people
involved. The more seasoned team members can see
failure modes both hypothetically and from personal
experience. A capable project manager can keep the
group on task and divvy up smaller assignments.
“Even then, it’s still impossible to anticipate everything,”
contends Prosser, who applied FMEA to a chemotherapy
program. She notes that FMEA is most effective when it’s
part of a larger quality assurance program.
“A check system can be very effective, but if the ini­
tial prescription is entered into the computer incor­
rectly, the error would reoccur when the prescription
is refilled,” she continues. “You have to be able to go
back, find the kinks, and tweak your processes based
on events—it all leads back to ‘Plan Do Check Act.’”
Decker agrees, emphasizing that you want to ensure
that actions taken actually reduce risk. “Once our action
plan was developed, the final step was to have the team
reassign RPNs to the failure modes to assess if improve­
ments were actually made to the process,” she recalls.
“Wherever we can error proof the process, or make
errors more detectable, the overall RPN goes down.”
The downside to FMEA is that doing all the steps—
and doing them well—takes time. “It can get tedious,”
observes Wachsman, who notes the process becomes
easier with practice. “Don’t try to do it all in one big
session—you want to be fresh.”
JHHCG’s infusion pump FMEA project took approxi­
mately three months to complete, according to Decker.
Exhibit 2
New Drug Safety-Related FMEA Questions
Source: Institute for Safe Medication Practices
Drug Characteristics Probing Questions
Drug names Does the drug name (brand or generic) look or sound like another drug
name?
Dosage form/strength/units Do these overlap with another product with a similar drug name?
Dosing range/schedule Are dosing parameters complex?
Drug’s indication(s) Is the drug’s indication similar to another product with a similar drug name?
Storage location Would it be stored near, or could it be mistaken for, another similarly
packaged product?
Appearance of drug name on
computer screens
Would a similarly spelled drug name be listed in close proximity to the
intended product on prescriber, wholesaler, or pharmacy computer order
entry screens?
Appearance/design of
manufacturer container label
Does the trade dress, color, size, or shape of the label make it look similar
to another product?
Expression of dosage strength Does the package label clearly express the strength or concentration in
each tablet, capsule, or container?
Quality/placement of barcode Will your barcode system read the barcode on the manufacturer’s label?

7. MARCH/APRIL2014
35
“We had a kickoff meeting and regularly scheduled
team meetings every two weeks,” she recalls.
There are ways to abbreviate the process, especially
for a new drug where a pre­set list of questions can do
the trick (see Exhibit 2), or when responding to an
industry­wide issue, such as a sentinel event alert. But,
don’t go too far in the other direction. A detailed
process map opens your eyes and brings out the less
detectable failures.
Formal FMEAs were once an accreditation require­
ment, but have recently been reclassified as one of the
many tools that can be used as part of proactive risk
management assessments. “I don’t think people will
do FMEA as much now that it’s not a requirement,”
observes Prosser. “I think that they do it instinctively
on some level already—but it’s worth it to use the tool
to formalize that thought process.”
“It’s an extremely useful tool,” asserts Decker, who
learned FMEA as part of Lean Sigma Green Belt train­
ing. “By proactively dedicating a FMEA team, an orga­
nization can increase patient satisfaction, improve
overall quality and reliability of products and services,
eliminate waste, and reduce costs.”
“The process definitely has value,” concludes
Wachsman. “I urge every provider to try it and see if they
don’t discover something. If you could prevent an error,
why wouldn’t you? Don’t your patients deserve that?”
Jeannie Counce is the Editor-in-Chief of INFUSION. She can
be reached at: (406) 522-7222 or Jeannie.Counce@NHIA.org
Matthew Grissinger, R.Ph., FISMP, FASCP, is the Director of
Error Reporting Programs for the Institute for Safe Medication
Practices in Horsham, Pennsylvania. He also teaches a med-
ication safety certificate program at Temple University that
uses FMEA along with other risk management tools. Matt can
be reached at: (215) 947-7797 or mgrissinger@ismp.org
Tips for Successfully Conducting Failure Mode and Effects
Analysis
• Start with the right people. “Involve all the people who actually do the process,” counsels Wachsman. “Use
front­line people.”
• Get a fresh perspective. Be sure to include someone who isn’t totally familiar with the process. Preferably,
someone who is analytical and somewhat familiar with what the organization does.
• Be candid. “Don’t rely on the policies and procedures manual for the process steps,” says Wachsman. “These
things evolve over time. With a staff that has longevity, the actual process might not look at all like what’s in
the manual or what the manager thinks people are doing.”
• Rank with consistency. Ranking is subjective. Yet, you want to be consistent in assessing likelihood, severity, and
detectability of failures, or the final RPNs that prioritize process changes won’t point you in the right direction.
“Ensure that you have a multidisciplinary FMEA team so you get viewpoints from several levels,” Decker advises.
• Break up the work. FMEA can be a lengthy process. Some steps, such as the work flow diagram and “what
could go wrong?” can be done with the full team, and lead person could manage the rest. Spread the work out
over several sessions so participants are fresh.
• Don’t sweat the small stuff. When mapping out the workflow don’t worry about presentation. “There’s a ten­
dency to want to use fancy flowcharts and layout programs,” recalls Wachsman, “but don’t invest the time on
this step. Spend your time on the brainstorming part; that’s where the meat is.”
• Don’t overlook the obvious. “It’s possible to miss an important step because it appears to be a no­brainer,”
explains Prosser. “For example, don’t focus on preventing errors in pulling supplies from a bin without think­
ing about how the wrong supplies could be in the bin in the first place.”
• Simple is effective. Process changes don’t have to be elaborate to work, notes Wachsman, whose warehouse
team used to write patients’ last names on the bag of supplies that was to be delivered. “Since some patients
have the same last name, we decided to print out a full address label and stick it on the bag.”
FMEA Resources
American Society for Quality
http://asq.org/learn­about­quality/process­analysis­
tools/overview/fmea.html
Institute for Healthcare Improvement
http://app.ihi.org/Workspace/tools/fmea/
Veterans’ Administration National Center for Patient
Safety
www.patientsafety.va.gov/docs/hfmea/HFMEAIntro.pdf