Session 135
Quality, Safety, Information Technology and the Computerized Patient Record
System
Section 1: The Vulnerability of Computerized Provided Order Entry: Overview
But I will tell you who we are.
I'm pleased to be joined today by Shirley Lesieur, far end, and Nancy Smestad, they're
both Pharmacist Consultants and they work in the Office of Health IT and Patient Safety.
I'm Donna Kyle, the Chief of Pharmacy at the Michael E. Debakey Medical Center in
Houston. We'll refer to it as MEDVAMC throughout the presentation, but I put Houston
up there just in case you didn't know who Michael E. Debakey was.
So having said that, our objectives in this course this afternoon is to discuss the role of
the electronic medical record in enhancing medication safety, patient safety, and quality.
To describe the purpose of information technology in reducing medication errors. And to
discuss the role of OHI IT Patient Safety Office in the responsibilities and reporting
structure of this.
So again here I am, I'm going to start the presentation. And I want to talk to you just a
little bit about the vulnerability of the computerized provider order entry system. We
think of our system as being 99 percent accurate, and certainly we have come so far, as
described by Philip Longman in The Best Care Anywhere in the VA. But there are still
opportunities for misadventures, so we'll spend just a few moments talking about that
today.
The purpose of my portion of the presentation is to examine the potential error in a
computerized system. We'll review about three examples of near misses that actually
happened at the VA Medical Center in Houston. And then we'll look at considering
future development needs before I return and give the stage to Nancy and Shirley.
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So when I think about the VA's transformation and the image that has transformed itself,
I really go back to the days of when we went from inpatient care for every procedure that
we did to transitioning to outpatient care. Now I have to tell you I've been in the system
so long, I remember telautograph machines. You probably look at me and think what is
that? Well that was the first way we got a copy of the doctor's orders from the floor.
And at that time, of course there was a paper record located in the cavern in the basement
in a huge file room and it was very hard to retrieve. But once we started moving to our
computerized packages we did start that image transformation and that came not only
with the outpatient prescription package, but also the inpatient packages, unit dose, IV,
etc. And then finally by the time we moved along the line to the Computerized Patient
Record System we really began the transformation that has made us the standout that we
are in the healthcare system. The only problem I have with that is you know as
pharmacists, how many are pharmacists, yeah, we're still working in that old system that's
not neat and pretty like CPRS, and that does cause us a lot of problems, and part of what
I'll show you today, the near misses that we saw in Houston really relate to that and I'd be
willing to bet as you have finished orders over the years you can probably say I've seen
that same thing too in my site. I hope it's not just unique to Houston. But the VA
influence has grown over the years and millions of healthcare dollars are now spent by
other groups to try and pattern themselves after our healthcare model. Greater
automation, as we've heard from our senior leaders, is associated with reductions in
hospital cost, hospital mortality, and complications. If you think about it though, first Dr.
Petzel put out the Transformation Into the 21st Century as Secretary Shinseki has laid it
out. We also heard Peter Levin talk about how we're going to break down sections and
tackle this project and move it forward. But the thing that really caught my eye was
when the associate of Mr. Baker spoke and at the end of her presentation she listed three
things that still required a lot of care. I remember lab was first, I don't remember what
the second one is, do you? But the third one, the third one that's most important and dear
to our hearts is the Pharmacy Re-Engineering project, because until we're working in a
similar environment as what the physicians and providers are seeing in CPRS, we are at a
huge disadvantage, and I do believe you would agree with that.
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So now we want to try to move forward with this influence and we see that it's going to
move just beyond the Computerized Patient Record System, and also include this larger,
more global healthcare network. So we want to be prepared to be a part of that system as
best we can. But if you look at what David Lebowitz wrote in the Archives of Internal
Medicine in May of 2009, he said “Healthcare information technology can be a cloud
around a silver lining.” And he was referring to the study that was done at the VA
Medical Center in Houston, which we will talk about, of how there could still be
misadventures within the computerized provider order entry system.
So we know that CPOE, as we'll call it, does resolve errors, right? Sure. And the
electronic health record paired with that should also result in a safer and more effective
manner of delivering patient care.
But now we're going to talk a little bit about the vulnerabilities. And you might look and
say how can that be? Well let's take a look and see. We at the VA in Houston have the
great opportunity to live next door to the VHA Health Services Research and
Development organization that's like right across the street from us. Dr. Laura Peterson
expressed at one of our executive council meetings that the plan was to look at how the
computer has helped us in so many ways. And I went up to Laura and I said but there is
another aspect of that care that has not been researched nor reported in the literature, and
that was the misadventures. So we suggested to the group, and it was led by Dr. Hardeep
Singh, who did the research, that they might want to examine near misses in our
computerized system so that we wouldn't live an environment of thinking there is no
opportunity for an error to occur. So in 2008 they actually reviewed 559,992 orders, and
we will give the results of what they found shortly. But the data was collected, our
pharmacists helped collect that data, and it was reported through the MEDMARX
proprietary system. That system allowed us to look at near misses. Unfortunately we
don't have the opportunity to use that system anymore, so it's not quite as easy to do as it
was in the past. But for the period of time in the study done in 2008, published in 2009,
we did have that available to us.
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Section 2: The Vulnerability of Computerized Provided Order Entry: CPRS
Ordering Selections
So here are some of the places where ordering can go awry. It can be in the drug that's
selected by the provider. More often it's in the strength selected by the provider, and
we'll take a look at some examples of that. It could be the route, I think I have one
example to bring that out. Possibly the frequency, less often the indications, but it's the
last one on the page that really gives us fits. That comments field. It's very important.
Free text. The provider can give us those extra instructions that we need but I think you
and I know what they do in that field instead.
So let's look at a few examples, and this is the first. And this one is a little confusing, so
bear with me here. The provider has selected warfarin, the strength that was selected was
10 mg, but down in the comments field it says take a different strength on a couple of
days of the week. Now you might say the provider would have done us a better service if
he had entered it as a complex order. Well we'll talk about why that doesn't happen
sometimes. But even though I made a little bit of a transition down at the bottom
incorrectly, the way the order would have come out looking was take 10 mg so many
days a week and then a different strength on a different day. I would imagine that you've
probably seen these in your facility too.
If you look at this view in CPRS, and it is a little bit harder to see, this is a slightly
different order, the provider has again selected one drug, one strength, but then again
down in the comments section as you look you'll see in the text part it says take this on
Tuesday/Thursday, take a different strength on Saturday and Sunday. And I think he
even wrote thanks. Thanks. Which was very helpful, but you know we're not usually
seeing this order. We do usually keep two screens open and you can look back and forth,
but more frequently we're finishing that order in the old VistA system as well you know
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So when that order comes across for a pharmacist to process, this is what they first see.
Again, very familiar to you. This is just the first screen where they're selecting the
warfarin order.
And then if you move to the next screen you'll see the dose that was selected at our
particular institution was warfarin 2 mg. We were going to give two tablets to meet that
dose. But this is only one screen that we see.
So if you move to the second screen in finishing that order, again, 3 mg Tues, Thurs, Sat,
4 mg something else. So again you have to be very careful. And if your pharmacist is
having any difficulty with the speed at which the system works in processing orders, this
certainly is an opportunity for misadventure.
On this particular order, this one's clever, the provider selected lidocaine 2 percent UroJet jelly, and somewhere right down below in about the second or third line you'll see that
it says NA.
So when this order was transposed into being finished by the pharmacist it was to give
the lidocaine 2 percent Uro-Jet jelly nasally. Now it's probably not what the provider
wanted, but again they chose a route because they couldn't finish the order without the
route, so that was what the pharmacist saw when they went to finish that particular order.
And again you can see how that came out in the screen. Nasal was the route, and I don't
believe that's what the provider intended.
And the last little order I want to glance at quickly is a furosemide order because this is
one of the orders that does cause problems in our facility. The providers may not know
how to select the drug and the diluent and to get it in at the rate they wanted.
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So this one is given at a rate of 999 mils per hour, but I only want you to give 500
milligrams, we're going to throw in some Lasix and some albumen. So once again it's a
little bit complicated for the pharmacist to follow.
These are just three peculiar examples that we've seen.
But in a four-month study that Dr. Singh did there were actually 552 examples of where
errors of this were found out of those 55,000 orders that were processed.
Again, here's the one with sodium chloride. And the rate, you'll see down there the
infusion rate is 999 mils per hour, but only give 500 mils if you would.
So why do these things happen? Why are these errors happening? Well certainly it could
be because the provider can't find the right strength of the drug. And that often is the
case. They'll choose any strength and then put a comment in as to what they really want
the patient to have. And say thank you. Maybe the route was not found and that can be
problematic for the provider. Or in many cases it may be that the provider does not know
how to enter a complex order or put different strengths on different days. And that goes
back to part of the education that the providers get. In our particular facility when new
providers come in or the fellows and residents come in they're given about a four-hour
training block on all the computer things they'll be doing, and I think the pharmacy part is
about the last 15 minutes, and oh by the way we don't get to give it. So somebody else is
training them on tips, and as you may know they often learn from one another during
their transition period, so there really is a lack of computer training for them to make
them the providers we would like them to be. Now in one of the sessions I heard earlier
in the week though, seems like CPRS version 28 is going to help us again with some of
these things, and we're really looking forward to that, being able to distinguish different
IV bags and which additives you would like in it. Being able to separate some
administration times, and that should also be very helpful to us. But again that's version
28 of CPRS, and you know where we're still working, right? And I think sometimes the
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providers have difficulty because they're working so fast. The speed at which they enter
the orders can be a bit of a problem.
Now what is the patient safety risk in these cases? Well the pharmacist may miss the
additional directions that are included in the comments field. As we saw where there are
several screens to go through and the last change was on the last screen, that does offer
risk. And then when there is a problem that has to be corrected, oftentimes the
pharmacist cannot reach the provider for clarification, so that is another delay that I'm
sure you've experienced, either by using pager systems or sending a note back to the
provider. And many times the result is that the medication administration is delayed until
the provider is located and is able to resolve the problem. We've had a peculiar problem
in Houston recently. Anybody here from Lebanon, PA? Well we've been seeing in our
VistA side where we've had as much as a minute or two delay in processing orders. We
can't figure out if it's because of the new Reflection Attachmate system, but when you're
trying to get through many orders, and I hate to tell you how many prescriptions I have in
the queue on Friday, but many orders the delay when you're waiting for that screen to
move forward causes a real problem, and in their haste there could be another opportunity
for a near miss.
So here are the final results of the study that we did. If you wish to look at the whole
study it is in the archives in Internal Medicine, May of 2009. Almost one percent of the
orders in the study period did have a bit of inconsistent communication. And out of this
one percent, 20 percent of those errors could have resulted in moderate to severe harm to
the patient. And there were certain drug categories that were more likely to cause
problems and at the top was cardiovascular drugs, followed by analgesics, antibiotics,
and anticoagulation items were actually several on down the list, but I'm sure each of you
know as I do that those offer the greatest risk in terms of the patient once they are
transitioning from an inpatient back home.
So from my perspective the things that we need to do is continue to improve the study
methods that we use in looking at how dosages are entered. We also need to use the
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comments field. We're not suggesting that anybody get rid of it, but make sure it's just
used for clarification and if there is an educational opportunity to train on a better way to
enter the order that should also be done. But most importantly I think we have to
continue the reengineering project and we have to push as pharmacists to get that done.
If it's on the list of those people who we've heard, our senior leaders this week, we just
need to reinforce that that's exactly what we need to do, and I think that would be very
important.
Section 3: Describe the Purpose of Information Technology in Reducing
Medication Errors: Managing Medication Errors
The section that I'm going to talk about this afternoon is describing the purpose of
information technology in reducing medication errors and how we can go about that, and
increasing patient safety in the long run, which is exactly what we're all here for.
Part of the purpose of what we're looking at today when we're looking at establishing a
medication safety team and the components of the individuals that you're going to have
involved in your medication safety team is it's going to involve a vast array of disciplines.
More disciplines than probably we thought of two to five years ago, because it may be
really important to ensure that you incorporate individual representatives from aspects
such as biomedical engineering, they can have a vast impact on our medication safety
team when we're looking at things. You might want to incorporate your education
service within your team as a component of the disciplines. You probably want to
incorporate IT, laboratory, dietary, other exemplary services that you might not have
considered incorporating before to analyze your medication errors and hopefully reduce
medication errors and increase patient safety. Now part of the component that you're
going to want to look at is addressing your policies and procedures and how are all of
these different disciplines going to weigh into the evaluation of your current policies,
procedures, guidelines, and establishment of new practice standards within your facility.
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One of the important components of your team that you're going to establish is to ensure
that you have an open, receptive environment. Now a component of this is to ensure that
you have end-users represented on your team. We can't just have managerial staff on this
team. We really need those of us that are working with the software on a daily basis,
utilizing it in patient care areas, and what are they seeing, what's occurring, and what can
they bring to the table? It's very important that this environment is an open-ended
environment, and one of the avenues that we want to look at is starting with their ability
to bring to us near misses because if we can look at near misses, there is the possibility if
we can address and correct things when they're just a near miss, that hopefully it won't
end up being an adverse event that could cause harm to a patient. The other thing is
working with senior leadership within your facility to ensure that they recognize the
importance of this team and allocate resources on a monthly basis and time allotment for
your individuals to get together.
We want to make sure that as a team component we focus on the system and process
solution, so when we're looking at the system we want to look at how is the system
functioning and how can we make the system better? In other words, we don't want to be
looking at who, but how is the process deficient and how are our guidelines, how can we
reform our guidelines, our procedures, and possibly even our software set-up in order to
ensure that we reduce medication errors? By having end-users involved and the different
disciplines involved, you'll be able to ensure that you have all of these avenues addressed
and that they're able to bring to the table the necessary ideas that will hopefully help you
in enhancing any future direction that you want to go relative to your policies, your
guidelines, etc.
We want to encourage medication error reporting and this is really extremely important
that you have an environment whereby people feel that they can report the errors,
whether there is near misses or in whatever fashion that they need to to ensure that we
can hopefully resolve those from a system standpoint. And then we want to analyze our
medication errors in order to improve patient safety and ultimately improve medication
safety as well.
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One of the quotes that I like to use is “the problem is never how to get new innovative
thoughts into your mind, it's how to get the old ones out”. And we know part of my
component of this presentation is to address some of the new technologies that are going
to be out there that are really going to challenge us and challenge our abilities to
incorporate those and to embrace the new technological advances that we are going to see
within the next two to five years.
The definition of a just culture which we've all seen is basically it is defined as a
blameless system, and it's a non-punitive environment and an open-ended environment.
There are three behaviors that are a component of the just culture. Human error is one of
the components and of course this is just error that occurs just due to an accidental
situation. I mean somebody forgets to, they scan the patient's wristband, they've scanned
the bag, they hang the IV and walk away and forgot to open it and start the IV piggyback
infusing. That's just accidental, they got called away, they got interrupted, and we know
that that happens on a daily basis. And that's just a component of a human error, it's just
accidental. There's at-risk behavior, which again is just a component of an accidental
component whereby something happens, a dose is mislabeled, something in that arena.
It's not really something that was intentional. And of course then there's the component
which is reckless behavior, which we hope that none of us ever see, which is an
intentional component where somebody intentionally caused an error and caused harm to
a patient, and we hope that none of us ever experience anything like that.
The responses to this under the just culture is a proactive learning experience and
ensuring that we provide education and system solutions to incorporate all of this and
hopefully to ensure that there aren't the components of human error, accidental errors,
any type of at-risk behavior. And then what type of roles do we all play? Well you
know, there's many type of different roles that individuals play, and you know there are
many types of leaders that have been identified over the years that are basically the
leaders in medication management. But over time when you look at the evolution of
technology I really believe that there are many different types of disciplines that delve
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into that leadership. You are going to need the expertise of biomedical engineering.
You're going to need the expertise that IT may provide you. You're going to need the
expertise that education service, that maybe dietary, that possibly laboratory service can
provide you relative to the new technology that's going to be available to us in the future.
And it's important to recognize that all of those components are leaders within medication
management.
Medication error reporting. Again when we're looking at this it should be a non-punitive
environment, don't place any blame, and we want to look at the process. Now there are
many things that sometimes we're all well aware of that within our software we may have
to live with. We could do things that could correct scenarios for providers. We can
create templates, we can create quick order templates that will assist them so hopefully
we can minimize the possibility of errors. But as we all know, whether it's our VistA
software or whether it would be software that would be a COTS product software, there
may be certain limitations within the software itself that we would still have to live with
and have to ensure that we recognize those and incorporate those as a part of our practice.
And then possibly might have to change our processes relative to ensure that we provide
the safest environment possible.
Now I want to look at some examples here and I'm going to give you some examples that
has basically come across our desk at our office, and I think that these will be some
things that will give you some insight into information technology patient safety. We're
going to look at three avenues; medication errors in outpatient ambulatory care,
medication errors in inpatient unit dose therapy and intravenous therapy, and then
medication errors in the emergency department.
The first avenue that I'm going to present to you today is an outpatient ambulatory error
that basically was reported to our office and it dealt with prescription statuses. What
occurred was we had a report to our office whereby outpatient medications hold status
was confusing to the patients and the providers. This is exactly the way it was presented
to our office. When we delved into it what we found is that a veteran was discharged
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from a particular medical center and upon discharge all the medication reconciliation was
done and he was provided with a list of his medications upon discharge, he and his wife,
and all of this was gone over with them one-on-one on a one-on-one basis. In doing so
the pharmacy also had a policy whereby they would communicate with the veteran and
found that the veteran had sufficient supply of three of his current medications on hand,
the directions had not changed, so the outpatient pharmacy put those three prescriptions,
the three new discharge prescriptions, on hold. Well when the veteran got home, the
veteran and his wife were looking at the medication list that they received from the
pharmacy and it said furosemide status hold. So the veteran and his wife interpreted this
that they were not to take the medication. There were two other prescriptions on the list,
his potassium and his trazodone, that were also in a status of hold. And for outpatient
pharmacy this status reflected a park status, whereby we're parking the prescription until
the patient calls in and states that they need the refill on this medication but they have
sufficient supply, the directions are the same, the dose is the same at home. So
consequently three days later when the home health nurse did her first visit at the patient's
home she found that the patient was experiencing pitting edema of his extremities, and in
conversation with the patient and his wife found that he hadn't been taking his furosemide
for about three or four days. So she was very nervous because she also interpreted when
she read this hold status she interpreted that the patient wasn't to take the medication. So
initially she called the patient's provider and the provider looked at it in CPRS and they
also misinterpreted that the patient wasn't to take the medication, but actually the patient
was to take the medication, he was supposed to be on the furosemide. They contacted the
pharmacy for an explanation of their process and received the explanation of their
process that this is basically a park status, and then she was given a verbal order as far as
furosemide for the next two to three days that the patient should take before he went back
on his normal dose of furosemide. In essence she was able to alleviate the situation
without the patient having being admitted to the hospital, however you can see that
within the software this could be confusing not only to the veteran, the veteran's
caregiver, but also to other healthcare professionals.
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So one of the things, and I'll just show you the CPRS screen a little bit here where you
can see where I have an arrow where the status is designed as H for that particular
prescription. One of the things that we've done through our office is that we worked with
Pharmacy Benefits Management and other workgroups and there's a new service request
out there to hopefully get a status of park that would be a new software enhancement to
the pharmacy outpatient software package in order to hopefully alleviate this in the
future.
Another medication error that was reported to our office was an error relative to inpatient
pharmacy, and as you'll notice with this, this was an electronically entered prescription on
an inpatient for NPH insulin 20 units to be administered twice a day. As you can see,
when the order was signed by the provider and came across into the inpatient medication
software package, in number 12 which is the dispense drug, you'll notice that the units
per dose entered, it came across correctly as a units per dose of one, which is what we all
know is correct. However when you look down one of the things that was reported to us
is your pharmacy is able to select number 12 and they can actually enter a units per dose
of zero and the software will accept it.
And here's a screen capture when the pharmacy accepted this particular order where the
pharmacy edits the units per dose as you can see to zero. Well it appears correctly in the
pharmacy profile and the units per dose are going to be zero, however when the nurse
tries to scan this NPH insulin order then what happens is she's going to get an error
message back that she shouldn't administer this particular medication because there's no
dispense units associated with it. So she can't dispense the insulin. Well is it a true
medication error? Yes. What happens is it's a delay in the administration of the
medication because the nurse had to – what occurred within this scenario is the nurse had
to call pharmacy and notify pharmacy and then pharmacy had to search and edit number
12 dispense to the units per dose to one so then she could document it and administer it
via BCMA.
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With this one we've already, this has gone through the different committees and it's been
analyzed by the Pharmacy Legacy Enhancements Workgroup and there's going to be a
patch in the near future to correct this scenario.
Medication errors IVs. Medication errors in IV therapy are three times more likely to
result in harm or patient death. Basically this is because the process is so involved. It
involves segments starting with procurement of the IV therapy medications, preparation,
accurate labeling, the availability of the medication, the delivery of the medication to the
nursing unit, the administration site, the product, patient identity, and then the final
administration of the product. As I mentioned earlier a nurse can go ahead and scan the
patient's wristband, scan the IV piggyback, hang the IV piggyback and forget to open it to
start the infusion.
Medication errors in the emergency department. There are different methodologies
whereby medication errors are occurring in the emergency department. This has been
analyzed by Joint Commission and one of the requests that they have is that the
medications that are transcribed in the emergency department are reviewed by a
pharmacist prior to removal from an automated dispensing cabinet and subsequent
administration to a patient. The other entity that they look at is medication reconciliation
in the emergency department. This becomes very critical. One of the things that some of
the literature has reported recently is that many facilities are staffing the emergency
department with a pharmacist to do the medication reconciliation when the patient arrives
in the emergency department and then that pharmacist also reviews any of the medication
orders that are transcribed by the provider and then finishes those orders prior to the
removal of the medications from the automated dispensing cabinet in order to reduce the
likelihood of medication errors in the emergency department. Now there was just an
article that was reported I believe it was in May in the American Society of Health
Systems Pharmacists, where there was a facility in Minneapolis that is actually utilizing
pharmacy technicians and staffing their emergency room, this is a pilot project by the
state of Minnesota, to staff their emergency room with a pharmacy technician who will
do the medication reconciliation that's then reviewed by a designed pharmacist and then
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signed off on and then the provider is ensured that they will have the correct information
prior to electronically transcribing the medication orders for the patients in the emergency
room. They also have a pharmacist that reviews all medication orders in the emergency
room prior to dispensing from their automated dispensing cabinet. I believe the article
was in the May journal of ASHP if you haven't seen that one.
Section 4: Describe the Purpose of Information Technology I Reducing
Medication Errors: Report of an Event / Role in IT Patient Safety / Goals
What I'd like to address next is a report of an event that came to our office, and this was
started in an emergency department and actually it involved a Methadone Treatment
Clinic patient. It was reported to us from the National Center for Patient Safety and our
office was asked to get involved with this one. What was reported is the patient arrived,
a Methadone Treatment Clinic patient arrived in the emergency department of a facility
and the patient was on 70 mg of methadone a day. The provider in the emergency
department completed the medication reconciliation as he was supposed to. Now he
reviewed the patient's cover sheet on CPRS, there was no notice on there that the patient
was a Methadone Treatment Clinic patient, and did the medication reconciliation,
methadone did not show up as a part of the medications that the patient was currently on.
So the provider, the emergency room provider, prescribed an opiate for this particular
patient and of course he wasn't supposed to get one. One of the things that we discovered
then when we delved into this, National Center for Patient Safety, our office, IT Patient
Safety, and Pharmacy Benefits Management Office, worked collaboratively on this
scenario and delved into exactly what transpired and we found out that currently there's
no methodology within CPRS to accurately display that a patient happens to be in say an
opioid treatment clinic patient. There also wasn't a methodology within their processes
or their medication management guidelines as to how they're going to document that
information in CPRS. Now what the facility was doing is the Methadone Treatment
Clinic has a COTS product, a Commercial Off The Shelf product that they utilize for
their entry of all of the information relative to patients that are enrolled in their
Methadone Treatment Clinic. It also is involved in the dispensing and then subsequently
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sometimes the doses are administered in the methadone clinic as well. There's no
interface between this COTS product and CPRS. What we did was there was a notice
that was sent out and we really embrace everyone here who was involved in responding
to our questions and to adhering to what we asked you to do, and sites have been able to
go ahead and put some notification and some form on the cover sheet of the CPRS chart,
as well as they've been asked to either enter the methadone as an outpatient prescription,
non-VA meds, or a clinic medication, so that these would be able to trigger the drug-drug
interactions as well as they would be a component of the medication reconciliation. And
we did just review a new service request that is going to look at an interface between
VistA and the COTS product software that's utilized for the Methadone Treatment
Clinics and that is working its way through as well.
Medication use quality. We want to make sure that we have a safe environment, it's free
of harm, errors are preventable if at all possible, our medication use process is effective,
it's patient-centered, it's efficient, it's equitable, and it is timely.
Now what's our role in information technology patient safety? Well an Informatics
Pharmacist is becoming critical with the advances in technology in this age of
technological advances that occur so rapidly. What we're involved in is analyzing the
issues that occur relative to the software that's out there and how can the changes in the
software, how can we recommend changes to the software in order to ensure that we
increase the safety of our software, ultimately increase the safety to the employees and
ultimately to the patient.
Now one of the things that as an Informatics Pharmacist we're going to be involved in is
automated dispensing. You know initially automated dispensing started with outpatient
automated dispensing that we had and then we rolled into inpatient automated dispensing
and then ultimately automated dispensing cabinets that are on the nursing units, and now
of course we're into the technology of smart pumps. Well your Informatics Pharmacist
becomes critical in this and it doesn't make any difference whether you're talking about
the Department of Veterans Affairs or you're talking about the private sector. Those
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databases all have to be maintained and there has to be a symbiotic relationship between
the databases that are created for the different automated dispensing equipment that's out
there and the drug file or the pharmacy software file that you're using for your drug file,
because it has to be a symbiotic relationship and your informatics pharmacist is the
individual that's going to be able to maintain all of that. One of the things that with the
automated dispensing cabinets that are placed on the nursing units, there was just an
article that was released in ASHP and it was in the July 15th edition of ASHP. If you
haven't taken a look at that it's a two-page article on the common errors that are still
occurring with automated dispensing cabinets and actually this article talked about, it
brought to home from the end-user standpoint, we're talking about the end-users on the
nursing units, not just nurses but other end-users that access the automated dispensing
cabinets and the types of scenarios that are still occurring there. One of the things that
they talked about is the environment whereby these automated dispensing cabinets are
located. Now it doesn't really make any difference, in the article you'll read that it doesn't
make any difference whether you're utilizing those automated dispensing cabinets for
first doses, for PRNs, for controlled substances, or for the entire doses of medications that
the patient is going to receive that day. One of the big factors that the end-users are still
complaining about is that the automated dispensing cabinets are not in an environment
that's conducive to safety. Many times if you go and you look at the inspection of where
these are located, they're located in a high traffic environment, and that's what this article
addresses. This of course is causing the end-users a lot of disconcern. Now you know as
well as I do that five or ten years ago we talked about this, we talked about automated
dispensing cabinets in nursing units being located in high traffic areas, and that this could
cause errors and ultimately those errors could reach the patient. But in this article they
talk about they're still located in high traffic areas, they state that those automated
dispensing cabinets need to be moved to an area where the staff, the end-users, whether
it's pharmacy using them, nursing using them, respiratory therapy having access to them,
whoever has access to them that it's in an area where it's quiet. Now they even addressed
the idea that they used bar code technology, and we're not just talking about bar code
technology to stock the automated dispensing cabinets, but bar code technology to
remove the items from the drawers, from the bins of the automated dispensing cabinet.
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When they discussed this with the end-users they still said that if these are in high traffic
areas there's still the possibility of errors when they remove them, even if they use the bar
code technology. Now the other avenue that they addressed in this is that the end-users
are still saying they have no place to put the drugs once they remove them from the
automated dispensing cabinets, and this causes errors when they get back to the patient's
room and possibly give wrong medication to the patient because many times they'll
remove five different patients' medications at a time. That was July 15th of ASHP in case
you want to take a check on it.
Medication errors in IT patient safety. The institute of safe medical practice report
entitled To Err is Human suggested there were between 44,000 and 98,000 people that
die each year as a result of medical misadventures. They also stated that the cost of
adverse drug events and medication errors can be upwards of $5.6 billion annually. Now
when you're looking at your medication safety team one of the things that I find is really
important to bring to that team is the ISMP report, the Institute of Safe Medication
Practices, and review that report and all of the contents within that report with your team.
It's really a good source of information. And then of course to review your National
Patient Safety goals as they change.
The Institute of Medicine reports on medication errors. Medication use, four out of five
adults use medications such as OTCs, prescription medications, dietary, and/or herbal
medications. One-third of these adults take five or more different medications, and you
all know as well as I do that most of these patients don't tell you everything that they are
taking when you ask them for a list of their medications. Again, medications harm about
1.5 billion people per year. In hospitals there are at least 400,000 preventable adverse
drug events per year, which approximate one medication error per patient per day.
The goals for all of us are to deliver safe patient care, improve end-user confidence in the
software and automated dispensing systems, reduce noncompliance at the point of care,
develop and implement best practice, and share these with others.
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Section 5: Discuss the IT Patient Safety Office’s Roles, Responsibilities and
Reporting Structure
My role is to discuss IT Patient Safety Office's role, responsibilities, and our reporting
structure.
I'm going to review our place in the organization, our mission, and a little bit of our
history.
Here is the organizational structure. IT Patient Safety is a component of the Healthcare
Information Office at VA Central Office, and it also encompasses other services such as
the Library Service, 508 compliance, and the Bar Code Resource Office. This particular
chart is available on the OI leadership Internet site.
IT Patient Safety's mission. We were established to provide leadership and direction for
safe and effective IT systems that support the delivery of healthcare. Actively promote a
culture safety within healthcare IT systems by collaborating with VHA program offices,
VA medical facilities, and public and private healthcare organizations.
And now for a little history. Our progress through time. In 2002 the program was started
and it was staffed basically through collateral duty. There was just a couple of us and our
major focus at that time was to react to reported incidents. I think CPRS version 25 or 26
had just come out with all kinds of problems. And we concentrated on notification to the
field. We developed relationships with the National Center for Patient Safety, Pharmacy
Benefits Management, and the VHA clinical community. In 2005 the office was
formalized and the first full-time Director of OI Patient Safety program was hired, and
that's Jeannie Scott and she is our Director. Staffing of the office became a priority and it
was staffed to provide needed expertise and support and to establish policies and
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procedures. And here we are in 2010, we're still one of the youngest program offices in
the system, and we currently have a full-time staff of 14 FTE. And our program
continues to evolve.
Now I'm going to talk a little bit about the culture of safety, what it is, and VHA's
commitment to the culture of safety. Well what is it? And the definition I'm giving is a
little bit from here and a little bit from there. It's basically a collection of values and
benefits that are shared and held across the organization. VHA has demonstrated its
commitment to patient safety by allocating resources with the establishment of the
National Center for Patient Safety and OHI IT Patient Safety Office, as well as
encouraging the development of clinical software incorporate best practices and clinical
decision support, thus promoting safe patient care. They also try and go for non-punitive
mechanisms to report errors and near misses as available through NCPS and IT issues can
be flagged as potential patient safety issues within Remedy. Reporting is encouraged and
educational opportunity to spread the word is seized at conferences such as VeHU, and
just out of curiosity I'd like to know how many of you have access to Remedy directly?
Wow, not many of you. I assume the rest of you are reporting through your IT offices. If
you do report through your IT and you consider an issue with software to be a patient
safety issue, please take the couple of extra minutes to tell them that you think it's a
patient safety issue and ask them to flag the Remedy issue as a potential patient safety
issue. There will be a few extra questions that you're going to have to answer, but the
more reports we get, the better our software is going to be.
Developing a culture of safety in the Veterans Health Administration. Dr. James Bagian,
VHA Chief Patient Safety Officer, co-authored the article describing the journey towards
a safe culture within VHA. If you refer to this slide when you get back home you'll
notice I've included the web address for the entire article. And his VHA data sources
were VHA documents, Congressional testimony, he also used medical literature, general
press, and personal communications. Basically what he discussed was VHA leadership
has taken steps to promote a culture of safety by making public commitments to
improving patient safety, allocating resources towards establishment of special centers,
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enhancing employee education on patient safety, and providing incentives to promote
patient safety.
Now I'm going to go over the role of IT patient safety. Our role presently focuses on the
electronic health record, supporting the provision of a safe clinical environment for
patient care. Before I continue with how we do that I want to mention that I went to a
couple of sessions today and it seems that we're going to be moving somewhat away from
the electronic health record into healthcare system program, and we are definitely going
to be involved in the ground layers of that. Our office was asked to attend, all of us, and
told that we were going to be part of this movement. So there are good things to come
and it's only by your reports that we know what we have to focus on when we attend and
work with these other groups.
One of the things that our office does is an analysis of retrospective reviews of reported
software issues which may have potential patient safety consequences, and we use a
formal assessment tool which evaluates the severity, the frequency, and the detectability
to determine its potential impact on patient care. We characterize the risk as low,
moderate, or high, and issues are brought to our attention from various sources, a
principal one being Remedy tickets. But we also get direct reports from National Center
for Patient Safety, from the Pharmacy Benefits Management Office, and from VHA
management.
Collaboration coordination. Our office actively participates with other offices within
VHA as well as with OI&T to provide guidance documents such as NCPS advisories and
alerts, or PBM notices. We work in partnership with various workgroups during the
development of corrective patches, pharmacy legacy quarterly enhancement workgroup,
which includes a lot of user level members, is one of the main groups that we work with,
and we develop corrective patches to software enhancement projects as well as providing
a risk assessment for all submitted new service requests. Now as I say that you're
probably saying well we're not seeing very many patches coming out, and part of our
current problem is that we have to wait for pharmacy reengineering increments three and
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four to come out because the routines that they need to use and work on for the patches to
correct the problems that everyone has reported to us are all tied up with those
increments. So once you see increments three and four come out in rapid fire after that
you're going to start seeing quite a few patches coming out that are going to be
addressing patient safety issues.
Communications. We actively participate as presenters at national conferences such as
VeHU, the pharmacy informatics, national patient safety officer, patient safety manager
conferences, and others. Our office has contacts at all levels of the organization and we
provide resources such as human factors engineering expertise as needed. We also
communicate adverse events up the chain to the OHI and VHA leadership as appropriate.
Moving forward. Our role is a dynamic one and it's changing considerably. We have
currently started a steering oversight board which was established in 2010, and they're
going to be in an advisory capacity and their membership includes Patient Care Services,
Chief of Nursing Office, Chief Business Office, the Deputy Under Secretary for Health
for Operations and Management, National Center for Patient Safety, VISN Clinical
Managers, facility Patient Safety Coordinators, and OHI and VA IT staff. So you can see
it's a large group of people getting together to try and give us some ideas and to work
towards what needs to be done so that we can promote safety within our organization.
The goal is to promote best practices by including formal usability testing, user-centered
design process, and providing expertise in usability engineering as feasible. It's also to
support the role of end-users as a central player in the development process. Usability
needs to be a primary driver of efficient, effective, and safe electronic health records.
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Section 6: Discuss the IT Patient Safety Office’s Roles, Responsibilities, and
Reporting Structure: Allergy Order \Checks
I'm now going to review a case scenario. It's a pretty sad one. No allergy order checks.
In the beginning a review of identified allergy order check issues and some of the tools
available to reduce the risk. Problems related to the lack of an allergy order check were
first reported in NOIS, our old software problem tracking program, all the way back in
1998. And the problems were starting to be reported that order checks were not being
triggered appropriately. I just want to mention a couple basic ingredients here. The drug
ingredient file and the VA drug class are very important in our current system for
triggering allergy alerts, and some of the early patches released to correct deficiencies
were GMRA*4*17, which was designed to identify and correct free text entries. Because
the free text entries did not necessarily match anything and often had missing
information, it was not unusual to see reports of missing allergy drug order checks. A
subsequent CPRS patch eliminated the ability to enter free text allergies and
GMRA*4*20 was released in September of '06. This patch updated the free text utility
that was distributed earlier so that it could now be used to identify ingredient file-based
and drug class file-based allergies. In November of '05 NCPS issued an advisory that
alerted the field to the fact that VistA package allergy file may have allergy entries that
have been accidentally entered without a VA drug class when a drug class was
appropriate, resulting in the lack of an allergy order check. At that time the
recommendations were pretty much just asking the sites to be aware of the problem and
to be vigilant. They also reported that a patch was in development to address the issue.
CPRS version 25 bug. An additional issue was identified in July of 2007. A patient had
a documented allergy to iodine. The provider ordered a drug with iodine listed as an
ingredient. The expected alert did not trigger. Investigation at that time determined that
allergies entered through the CPRS GUI pulled data from the wrong file for a limited
number of items and subsequently the ingredient field and VA drug class were not
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populated. That was resolved with GMRA*4*21 and that included an update to all the
iodine entries and also provided a list of patients so that the data could be reviewed.
HDR. With the advent of the HDR it was important to standardize all the data files so
that they could be accurately shared across the system. Unfortunately many free text
allergy entries still existed in the individual databases. GMRA*4*29 provided additional
functionality and that was released in May of 2007. If the free text allergy reactant was
found in the conversion matrix, then the allergy entry was updated to the associated
reactant from the matrix. If the free text allergy reactant was not found in the matrix, or
if updating the reactant would cause a duplicate entry, the free text reactant was updated
to include the phrase free text after the reactant, and this served as a visual clue that the
allergy was a free text and would not be considered during order checking. Patient safety
alert AL0812 was issued in March of '08. Problems related to free text entries continued
to be reported to NCPS and an alert was issued reminding facilities that these entries
would not trigger alerts. The facilities at that time were instructed to run the allergy
clean-up utility and report results back to NCPS. Additionally they were instructed to
resolve any entries on the list and report back when the task was completed. This was
March of 2008.
Okay. Here we are in 2010. And we're still talking allergy order checks. Subsequent to
additional reports of incidents related to the lack of allergy drug order checks, NCPS
distributed AL1008. A review of safety reports and aggregated review log events entered
into the VHA patient safety information database shows similar situations have occurred.
A sampling of records at three VA medical centers revealed that thousands of allergies
and ADRs referred to as causative agents in CPRS and VistA, have been documented as
ingredients not drugs in the VA medical records. And you'll never guess what. Penicillin
was the most frequently identified reactant. It's just incredible to me that there would be
thousands of these still out in the system. This means these patients would not have drug
allergy order checks triggered to warn clinicians about potential serious allergic reactions
if a different drug is ordered within the same drug family. Additionally it was found that
there was great variation among sites as to which order checks are enabled. So on May
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12th of 2010 the CPRS clinical workgroup endorsed a recommendation to distribute
guidance advising sites to make the following three alerts mandatory and uneditable;
critical drug interactions, no allergy assessment, and allergy drug interaction. You
haven't seen it yet, but it's coming. And basically currently our office, NCPS, and Patient
Care Services is working on determining how best to enforce this new recommendation.
Long term there's a new service request with a business goal of incorporating a chemical
classification system into the current adverse reaction tracking package to provide
veterans an allergy documentation system that can provide alerts for allergies to drugs of
a similar chemical structure. Hopefully this will lead to fewer adverse reaction prompts
so that the providers won't be so upset when they get three notices that they have
acetaminophen and it's in the same class as codeine, or acetaminophen with codeine and
they keep getting all these extra prompts that they don't want to see. So this will lead to
fewer adverse reactions and will increase the usefulness of our documented allergy
information. The adverse reaction tracking, or allergy system, is also noncompliant with
the new CHI HITSP standards. Adapting CHI HITSP standards will make the sharing of
information with outside sources more accurate. Currently, our processes require a lot of
patience as we incrementally improve patient care. As we move forward we are striving
to include user-centered design to improve the user interface, thus ideally decreasing the
opportunities for misadventures and hopefully with the coming new healthcare
infrastructure, or structure, I'm not quite sure, it's all very new, we'll have much better
and much quicker resolutions to issues and maybe we won't even have any issues, wow,
talk about really wishful thinking, but things should improve and we should start seeing
software in the future moving through and updates coming through much more quickly.
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