Bill Klaproth (Host): Welcome to the ASHRM Podcast,
made possible by the American Society for Healthcare Risk management to support
efforts to advance safe and trusted healthcare through enterprise risk
management, you can visit ASHRM.org, that's ashrm.Org/membership, to learn more
and to become an ASHRM member. I'm Bill Klaproth. On this podcast, we're
talking about FMEA. What is it? When is it utilized and what is the process?
Today, we're talking with Geri Schimmel, patient safety and risk professional
consultant; and Anne Huben-Kearney, a risk and patient safety consultant. Geri
and Anne, welcome.

Geri Schimmel: Thanks, Bill. It's nice to be here.

Anne Huben-Kearney: I agree completely. This is
exciting. Thank you.

Host: Well, thank you both. Looking forward to
talking about this. Geri, let's start with you. So, what is an FMEA? And why is
it essential in the risk patient safety professional's toolkit?

Geri Schimmel: Bill, an FMEA is a failure mode and
effects analysis. And for the sake of some context for our discussion here, I'd
like to put a definition to it. So, it is a systematic approach to identifying
risks associated with a new process, product, practice, policy, et cetera, or a
change to an existing process. And you want to do this before implementation.
It's essential in the risk professional's toolkit because it is proactive.
Unfortunately, as risk managers, we spend our time doing root cause analyses,
RCAs, out of necessity. That's when an event has already occurred and,
unfortunately, very possibly harmed a patient. So, the more FMEAs we can do
before there's any intervention needed with the patient, or it has reached the
patient and we have solved the system problem with a better process in place,
the better off everyone is because we have created a safer environment, both
for patients, their families, and ourselves as risk professionals. So, I hope
that answers the question.

Host: Yeah. Anne, any thoughts on that? You want to
add to that?

Anne Huben-Kearney: No, I think the point that Geri's
raising is excellent, that, you know, we need to put more of our energy, time
and resources into those FMEAs to prevent harm. And that's exactly what Geri
said. And it's to help patients, staff, the organization and definitely, you
know, the employees as risk professionals.

Host: And Geri, since we're talking about FMEAs, it
sounds like maybe some healthcare institutions don't do this, and it sounds
like it's a practice that should be incorporated more often. Is that right?

Geri Schimmel: I think that they are done. Certainly
if you are an accredited organization under Joint Commission, you are required
to do at least one a year. However, what we're trying to do is to shift the
balance of time. So instead of risk professionals needing to followup on
incident reports and on doing root cause analyses, we want folks to be able to
be spending more of that time in the proactive world instead of the reactive
world. The proactive world is both failure mode effects analysis, FMEA, and
apparent cause analysis, ACA, so you can think of an ACA as sort of a baby
little piece. It's looking at one step that may be in a larger FMEA.

Anne Huben-Kearney: I think what you're also saying
is that when you're doing those FMEAs, you're really identifying those
unintended consequences with a new or a change in a process. You don't know
that sometimes until you're into it, you've already implemented the process or
the policy. We had one with a blood draw. Lab changed the policy on when they
were going to do the blood-- not when, but how, that they had to have a nurse
sign off. But blood draws were done at change of shift. Nurses were busy giving
report, medicating patients, taking care of things, and it was done without the
involvement of the nursing department. So, labs weren't getting done on time
because they're waiting for the nurse, which backed up everything else for that
day, for that particular patient. Either discharge, you know, pre-op or
whatever. So, that was an unintended consequence for a policy that they thought
they were doing the right thing to reduce labeling errors on the blood
specimens.

Geri Schimmel: Which is exactly to the point, Anne,
that indeed here they changed a policy and a process, but they didn't
necessarily create a better mouse trap. The new process in and of itself had
defect. And so really, you need to put this all also in the context of that
PDCA, plan, do, check, act process, so that when you create a new process or
you are evaluating a process, you go back and say, "Okay, we put an action
plan into place. Is that action plan working?" And Anne will talk more
about that when she talks about the steps. One of the things you made me think
of is that I sometimes, and for some, it's the thinking outside of the box of
what you would use an FMEA for, but to me, sometimes these are best suited for
the things that you say, "This is an accident waiting to happen," the
things with the frontline staff and some of those things are very limited, so
they could meet the limited criteria of an ACA. But some of them, when you
actually start to look at the processes as Anne's example just was, they
involve other departments, they are more complicated. You really need to map
out the whole thing to determine who the players are that are involved that
need to come to the table for the discussion.

Host: Well, we love examples, so thank you both for
sharing that. We appreciate it. So, Anne, when could an FMEA be utilized?

Anne Huben-Kearney: Well, I think, you know, as Geri
said, you're creating a new service, you know, a new clinical department. Say,
you know, with the pandemic when you were implementing telehealth, you know,
and getting the physician office practices, you're changing a system, you're
changing your electronic health record. You want to improve a process or a
system. An example, you know, again to help, is a patient fall program, but not
doing the whole patient, and we'll talk about that when we get to scope, but
what piece of the patient fall program and dividing it into bite-sized pieces.
You're looking at high-risk meds and not all the high-risk meds administration,
but a particular high-risk med. And then again, as Geri said, the whole
process. You're starting a Coumadin clinic. You're moving patients. You're now
deciding to do C-sections in the OR versus the OB department. You're looking at
meds for your say long-term care or inpatients through a J-tube or a G-tube,
but just that particular process. And even in an emergency response, you know,
Geri and I were talking about an example that we have emergency response plans.
You're moving patients, say for example, from a freestanding geri psych unit,
either to another facility or even in case of an emergency, flooding, whatever
it might be. You have the policy on paper, but are all the participants, to go
back to Geri's point, involved in who is there on the night shift moving those
patients, what is the emergency response? Just literally going through the
steps that Geri talked about. So, there really is just about anything that you
can think of quite honestly. Even the bite size, but I like that point that
you're talking about, Geri, that piece could be an FMEA, because it's something
that's bothering the nurses. It's an accident waiting to happen or the staff is
telling you, you know, this doesn't flow right, or the workarounds, why are you
doing workarounds? Is something in this system is not working effectively?

Geri Schimmel: There's no one that knows the work
better than the people doing the work. I watched an example this morning. The
ER has a policy where the pharmacist comes and does the med rec. The patient
thought the idea was brilliant. The patient had a written list of their
medications. Couple hours later up on the unit, nurse comes in with the meds,
very astute patient. Patient said, "Is this this in this dose? It's a different
color. Is it this in this dose?" The doses were all wrong. So, where did
that process is it helpful to have the extra person of the pharmacist coming in
in the ER? Or should the nurses taking care of the patients be doing the med
rec? I don't have an answer, but what I'm saying is it was just an illuminating
example this morning of what seems like a great idea and a new process being
put into place fell apart.

Anne Huben-Kearney: That's perfect. There's your FMEA
right there.

Host: All right. So, let's talk about this, the
implementation of this, Anne? Can you provide us with an overview of the FMEA
process? You were talking about scope earlier. Can you tell us how does that
work?

Anne Huben-Kearney: Well, I'm going to give an
overview as you noted. And Geri and I talked recommending a systematic
approach. So, there is a degree of subjectivity because you're going to be
involving people, you're going to do a flow chart and everybody's got a
different perspective. But we're going to caution you not to underestimate the
potential failure modes or the effects. I mean, as Geri said, it might be a
simple thing, but it might be more complex. And then, you want to start with a
clear beginning, what is the first step, and a clear end. I gave the example of
medication administration with high risk meds. You're not going to take on all
the whole medication administration process. It is multiple complex, et cetera.
But as I gave the example, just breaking it down as meds administered via a
J-tube or a G-tube or, as I said, a high risk medication. For the patient falls
FMEA, you may want to just do the patient assessment and do an FMEA on that and
the tools and the process and the education and differentiation on your
assessment scales. And then, another on the patient fall prevention strategies.

So, I think the saying is not boiling the ocean. You want to
have a clear starting point. We're going to talk about medications through a
J-tube or a G-tube. And then, you're going to say, and the end is when the
medication is administrated to the right patient at the right time and the
right dose. Using your example, Geri, medication reconciliation in the ER. You
know, I think there's so many, but very finite is my point. And then once
you've done that, and I think you've heard us allude to it, but how important
it is to have a cross-functional team. You want them to have the knowledge and
the skills and what their roles are in relation to that scope of the FMEA. You
know, you're going to look at transporting meds from the nursing unit from the
pharmacy to the nursing unit. You want to make sure that the couriers who are
transporting the meds aren't part of the team. And I think we want to consider,
if you're related to this system, you may also want to include the patient or
their family. Say you're changing an aspect of patient registration. Why not
have the patients and like your example, Geri, with the loved one, an astute
individual, going through that medication reconciliation process. Think about
when the patient or say a member of the patient family council should be
involved. You've heard us talk about frontline staff. Critical, absolutely
critical. But we want to make sure that you don't forget IT, because so many of
the issues and, Geri, your medication reconciliation might be an issue with the
system, the EHR system, not talking from the ER to the nursing unit. Where's IT
with that integration?

Geri Schimmel: Correct. And very often, to your point
with IT, IT does what's needed or federally required or et cetera within their IT
system, but they don't necessarily know how it is impacting the staff in the
overall scheme of the process of something getting done.

Anne Huben-Kearney: We also have a couple of
questions. Minimize the number of supervisory or management level staff. They're
absolutely vital. They're going to help with the implementation, but you don't
want the frontline staff feeling intimidated. You want to know about the
potential workarounds that they're going to anticipate or that they know of and
also representatives in other shifts. You know, being nurses, we know that what
happens on the first shift may not be the same on the second shift, including
the resources available. So, make sure that you're looking at the big picture.

The next one is flow charting. And I think we've talked
about that, that you want to brainstorm, you want to look at the perspectives
of every department involved. And it's not a blame game, it's really focusing
on trying to fix the problem. So, what's that first step in the scope and then literally
flow chart. We like sticky notes and move them around as you need to.

Geri Schimmel: Great answer, Anne. You know, it's my
favorite.

Anne Huben-Kearney: I've been sending it for you,
Geri. But like specimen labeling in a physician office, what are the steps?
Where are the supplies located? What time are the specimens get picked up?
Where do they get picked up, et cetera? And the key that we found out that if
this team cannot agree on the steps of the process, it is an unreliable process
and a much bigger problem. So then, it should be a PI project rather than an
FMEA because they cannot agree on the steps. Clearly, they're not clearly
understood. Geri, you mind to add anything to that about the flow charting?

Geri Schimmel: No, I would've added the last point
that you made. It's very important that everyone agree. It's often
uncomfortable when you see that as opposed to a process lining up, people have
different approaches to the same process.

Anne Huben-Kearney: Right. The path diverges. Then,
the fun part comes in after you've done the steps, you're going to identify the
potential failure modes for each step. And again, the sticky notes, you're
moving them around. What other things that could go wrong? And it could be
related to knowledge, it could be related to equipment, it could be related to
time, it could be related to the environment. Just move those around. And then,
you're going to identify the frequency, severity and ease of detection for each
one of those failures. You're asking the question that already, for each of the
failure modes, what could fail at this step, whether it's serious or
insignificant, then you're going to say, how frequently could that happen?
Because you're looking at the cause, why and how could this failure happen? How
frequently that could happen? What is the severity, what's the likelihood of
that failure mode? And again, as Geri talked about, you know, the near misses,
what's the risk of that, you know, hitting the patient? And then if it does,
what's the severity of that?

But one thing as well, when you're looking at all the
potential failure modes is to make sure that you look at the ERM environment,
the whole domains, clinical and patient safety, strategy, you know, that new
clinical service, financial, what are the implications of cost saving or cost,
you know, reduction, human capital, human capital. Do you have the resources to
do it? Legal and regulatory. Geri mentioned already about the drug commission;
technology, which I think and we think is becoming more and more of an issue.
And then obviously, the hazard. We mentioned the emergency response. So, you're
rating the severity, one, perhaps no harm. Ten is the most severe, patient
death, permanent patient harm as a result of the failure, the likelihood of occurrence.
One is highly unlikely like it's never happened before, it's a fluke or 10
being it's inevitable. It's going to happen. It happens regularly, and that's
where the staff and the workarounds are really, really important. And then, the
last is likelihood of detection, high detectability. You know, you know it's
going to happen. Low detectability is really scary. It's unexpected. It doesn't
happen that often. It's again, how you as a group determine the ratings. Not
just an individual, but the group. Geri, you want to add something to that?

Geri Schimmel: When we're talking about scale and
harm scale, I think it's very important to bring up the fact that it's,
essential. That everyone across the organization is using the same rating scale
and approaching that rating scale in the same way. We're not here to say you
should use this scale or that scale or the other. There are many of them out
there, but it is essential that everyone on the team working on the project
knows, just the same as the scope. Here's the scope very clearly of what we're
going to do, here's what we're not going to address, and here's the methodology
that we are going to use, then the scale to rate our problem or issue or
whatever you'd like to call it, so that everyone is working in the same
direction moving forward. If I think something is a 10 and Anne turns around
and says, "Well, Geri, really in the organization, I think this is a
two," then we're not going to have consensus or leadership buy-in on how
the work is going to proceed as the team looking at the issue, if we can't come
to consensus.

Anne Huben-Kearney: And the reason why we're talking
about this is because based on that rating scale and again, whatever you use,
you're going to determine the risk priority index. As I mentioned earlier,
you're not going to boil the ocean. What are the most important things to start
out with? So, you're going to multiply the severity times the likelihood of
occurrence times the likelihood of detection. And I want to just give you a
real life example. We've all been driving along, well, most of us, and there's
a flat tire while we're driving. It's high severity, can't drive with a flat
tire. So, we'll give that a 10. Low level of occurrence, I'm hoping two, you
know, it should be fairly low. And then, easily detected, maybe not so easily
detected because it's losing air and you're driving along. So, I'll give that a
three. So, the 10, the severity, times the likelihood of occurrence, two, times
the likelihood of detection, three, equals 60. And that's how you determine
your risk priority index. And you do that for each of the potential failures.
And then, you determine what are your priorities.

And based on that is your action plan. You're not going to
do everything. You're not going to do the low-lying fruit, you're going to do
what is most important, what's the most critical to this particular process.
Now, make sure your frontline staff are involved in developing the action plan
for the FMEA, but also the monitoring metrics. They are indeed part of the
solution. So once you implement those actions and you want to know what, when
and who is responsible. And Geri and I will reiterate, please don't make it the
professional responsible. It should be the department that is most intricately
involved with it with whatever the issue might be. The lab, IT, if it's an EHR
system, whatever it might be, but below that level, not the risk professional.
And then, you're going to monitor the effectiveness of the actions. FMEAs are
ineffective and inefficient if the actions are not implemented property. But
how are you going to know that? You're going to know because you're going to
monitor the actions. Geri, you have a thought on that?

Geri Schimmel: Yeah, I think it's very important and
that when the action plan and the measures are determined, that the measures
actually have timeframes associated with them. We're going to measure once a
week for two months, then we're going to go to every third month. And because
that feedback, although it is not the risk professional who is doing the
monitoring, that feedback and those measures are something that should go to
whether it then becomes a committee or the risk professional who's following it
up, and that way they can determine when it's ready to potentially roll out
across an entire system.

Anne Huben-Kearney: That's really good. I like that,
Geri, because if it's not effective at any point along the way, you have the
opportunity to get interested and analyze why. Is there an unforeseen failure,
something totally, totally unexpected or maybe one of those dreaded
workarounds? Again, having the team involved with the action plan hopefully
will reduce those workarounds. Or maybe there's another change taking place in
the organization that's affecting your particular FMEA. So, that's really good
to have that going on concurrently rather than waiting for the end. So, that's
my part, a very brief overview of the steps involved.

Host: I love it. Well, I tried to keep notes for our
listeners, Anne. So to recap, you mentioned make sure you have a clear first
step and a clear end. Focus on a cross-functional team, include the patient and
family, if that makes sense. You said don't forget about IT. You said make sure
the frontline is up to speed, but don't overwhelm. You talked about staying
focused on the big picture. You talked about flow charting this in your sticky
notes example, which was great, and focus on fixing the problem. Then, you
talked about the failure modes. Identify failure for each step, identify the
frequency, the severity, you talked about ease of detection. You gave us that
great flat tire example in the index. You said, make sure the frontline staff
is involved and also pay attention to monitoring. And then lastly, you have to
monitor for the effectiveness of the actions as well. So, thank you for that
great process. We appreciate that.

So Geri, this is all great stuff. Let me ask you this. Are
there any additional resources or upcoming educational sessions available where
people can continue to educate themselves on this?

Geri Schimmel: Absolutely. First and foremost, I'd
like to send everyone to the ASHRM Failure Mode and Effects Playbook, which
came out last September, so not everybody may be familiar with it. It's fairly
new publication. And that will go through all of what we've been talking, but
in great detail. Additionally, at the ASHRM Annual Pre-conference, which is
September 29th and 30th, we will be doing another session of the patient's
safety certificate program. And we talk about failure modes, we talk about root
cause analysis, and we talk about apparent cause analysis in the two-day
course. And then, on Sunday, October 1st, we are actually doing a pre-conference
workshop, specifically on FMEA. So, multiple opportunities for people to join
in and get more information and have some time for actual hands-on practice
with the tools.

Host: Love it. Well, Geri and Anne, thank you so much
for your time today. We appreciate it. One last question for each of you as we
wrap up talking about FMEA. Anne, can you share any final thoughts you have
with us?

Anne Huben-Kearney: One thing is just to remind
everyone it is worth the time. We know it is a time-consuming process to do it
right. Brainstorming the steps takes time, and having the input from everyone
takes time. But it is worth it. You're going to reduce the need for an RCA,
root cause analysis. But most importantly, you're going to identify and reduce
risks for your patients, for your staff and for the organization.

Host: Well said. And Geri, how about you? Final
thoughts?

Geri Schimmel: Remember, it is an essential tool in
the risk professional's toolkit, and we'd like you to think about FMEA tagged
differently. Maybe you'll help everybody consider. So, focus on proactive risk
management, make it efficient and effective, educate, implement and sustain
change, and act and engage collaboratively.

Host: Absolutely. Well, Anne and Geri, thank you so
much for your time today. We appreciate it.

Anne Huben-Kearney: You're welcome. Thank you.

Geri Schimmel: Thanks everyone. We're glad you joined
us.

Host: And once again, that's Geri Schimmel and Anne
Huben-Kearney. And you can learn more if you go to the ASHRM website, ashrm.org.
And look up publications and look for the failure mode and effects analysis,
FMEA playbook. The ASHRM Podcast was made possible by the American Society for
Healthcare Risk Management to support efforts to advance safe and trusted
healthcare through enterprise risk management. You can visit
ashrm.org/membership to learn more and to become an ASHRM. And if you found
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full podcast library for topics of interest to you. I'm Bill Klaproth. Thanks
for listening.