Surgical Site Infections (SSI) Surveillance with Case Studies (Part I)

Surgical Site Infections (SSI) Surveillance with Case Studies (Part I)


>>First of all, I just want
to introduce myself. I’m Janet Brooks and my subject matter
expertise right now is SSI and I probably feel like I know everyone of you in the room
from different questions that I’ve answered.
NSH
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My mailbox, now people just say,
“Send it to Janet,” you know. So I feel like I know all of
you quite well at this point. I know where you are and how you feel. I had over 20 years experience in the trenches
as an infection preventionist at large and small hospitals so I know the
trials and tribulations with — especially as we change our definitions. I want to welcome everybody here
in the room and those of you that are listening via web
streaming today, all of those, probably thousands that are on there right now. I haven’t heard a number yet from
Courtney of how many are logging in but I’m sure there’s a lot of people listening. Let’s go ahead and get started. So our objectives today is to look at
our methodology for collecting our data and identify — we’re going to
focus on our SSI changes for 2014. I do go over filling in denominator data,
that’s your procedures; and your numerator data which is your surgical site infections. So especially for the newer IPs
this can be helpful for everybody. And then how to apply these
definitions to some case studies. And I’ve sort of thrown case studies throughout
the whole presentation this year rather than having a giant chunk at the end. I’m trying to present a piece of information
and then see how you can apply that. So I know that Kathy Bridson asked early on,
but I’m just curious again, how many of you — is it really maybe less than a year that
you’ve been as a younger IP or a new, as an infection preventionist, are
less than a year working with SSIs? Okay, good. I just want to kind of get a
feel for that because I do go over the basics and then some advanced issues. Well, this is my, you know, the go-to spot. This is the — we’re on the NHSN website and
this is your surgical site infection section. And over here on the right you can quick-link
rather than dragging down to the bottom of the page get to your trainings, your
protocols, your data collection forms, a whole section on CMS reporting materials. The bottom are supporting materials and I’m
going to be going over that in a minute. You can quick-link to your analysis resources. And I have to thank Maggie for her presentation. I mean, perfect timing in terms of really
hitting a lot of the SSI questions that I get as well that she gets around what’s
going on with risk adjustment and what we’re collecting right
now, some of this new data. And then we have our Frequently Asked Questions. And I think it was mentioned
early-on, I’m not sure by whom, but we’ve just finished updating all our FAQs to reflect the new definitions
and the new protocols. And there were quite a bit
of changes for SSI in ’14. And I think probably within the next
week the FAQs that I get, you know, for SSI Protocol will be up there. And we’ve actually moved this time
up into this protocol section here where you go grab the most or actual protocol. So you’re going to find your FAQs up there. Before you had scroll all
the way down to the bottom and we weren’t sure it was
jumping out enough for everybody. So this is the data collection forms
and again I’m highlighting things that I get asked questions about. What I want to show you is for
every data collection form — these are all the up-to-date forms. This is from the SSI section of the website. There is a Table of Instructions
that goes piece by piece for every element you’re
supposed to be entering on a form. There is a Table of Instruction that tells
you what that piece of information wants. So it’s got some good details in it. Those details are often found in the protocol
but it’s just good to know there are IPs that aren’t — don’t realize we have a
Table of Instruction for every single form. So here’s your actual Numerator SSI
Form and here’s your Denominator Form and here’s your Table of Instructions. Now for CMS supporting materials, I don’t
personally have to go to that a lot but I want to let you know that these are the ones that
are all geared specifically for SSI information. And the one that I like is this one
right here because I feel like, wow, am I sure I know when they
did their last update? Am I sure I know what’s coming in the future
and what we’re supposed to be reporting? And as you look at this, this was
just updated in December of 2013. So this has all your most
up-to-date reporting of requirements. And this is just not SSI. It’s that really nice page that they put out
that has all your deadlines, when it started, you know, when your due dates
are for reporting as well. So that’s the one that I find helpful,
and I always keep track of the date to make sure I have the most recent one. I’m not putting in a lot of details about
CMS reporting because we’ve been doing it for a while with COLOs and HYSTs. But for the IQRP Program it
is still COLOs and HYSTs. Nothing was added in 2014. But we do now have these new
PPS exempt cancer hospitals. It’s a handful of them. I think it might be more. Last time I heard 11/13. And they did start in January of ’14
reporting COLO and HYSTs as well. This is the section — if you
could see how many times I hit this in a day it would probably be shocking. This is the Supporting Material
Section down towards the bottom of the SSI section of the NHSN website. So what I use constantly — let’s see
if I have my little arrows in here. No, I didn’t. Yes. This is basically what those
of us that have been around a while, and you can tell I’ve been around a
while, called the famous Chapter 17. All of your HAI definitions, okay? We know that even though
it’s called the [inaudible], surveillance definitions for different types. Even though it’s not — it is a chapter
if you printed it out hard copy. I look at that constantly and because of
SSI organ spaces you have to get really, really familiar with this chapter. And you’ll know why in case
this has eluded you once we get into talking about organ space infections. My other favorite is, whoops, go back,
is this ICD-9 CM procedure code mapping to NHSN operative procedure categories. Again, I get daily emails from
the users, and I love you all. I’m not trying to sound negative at all. Don’t take this wrong. But I get emails where they’ll send me saying
my patient had blumty-blump procedure done. Is this an NHSN operative procedure? Is this an OTH Other procedure for
you poor folks in Pennsylvania? And you know who you are. You know that OTH Other category. And I basically have to turn it back around
because I never want to give an answer if I’m worried it’s not the correct one. And I say, because a lot of our procedure
codes are based on ICD-9 codes, I’m saying, will you do me a favor and send me
back the ICD-9 code for that case? And then I also tell them, but,
remember, we have this amazing resource where we have mapped all of the ICD-9
codes that could possibly be a procedure or operative codes into this guide. And here’s what it looks like. Now I just am curious, and I’ll
— how many of you use this? No judgment. Okay. Well, I’m glad I’m pointing it out. See, because what you’ll see here, and
I’ll try to highlight it, it comes out and you’ll see there’s white
columns and gray columns. So look over here. I’m going to put — this one right
here is a 4571 and it tells you. So if all you had was this list that said this
was a 4571, I’m like, was that a small bowel? Is that a COLO? What does that fit into? It tells you. That is in our NHSN COLO category. Then you go over here and
you see, oh, I had a 4281. Is that an NHSN operative procedure? And that’s a big old no. It’s nothing. It is not — you cannot report an
SSI to something that was a 4281. And then you go over here and you see a 45.8. And that means it’s an invalid code. And if you look in an ICD-9 — how many of
your guys — I’m asking too many questions. I’ll [inaudible]. How many of you guys have ICD-9
CM Code Books in your office? Well, we’re talking about
ICD-10s in a little bit. I highly recommend you put
that into your budget. As an IP, and this has nothing
to do with what I’m doing now, I couldn’t live without my ICD-9 Code Book
to able to look up and see what is this code? What is this procedure? I mean, it’s used daily. So I highly recommend you have that
because otherwise you have no ability to look that up on your own. So, anyways, if you look up this code,
45.8, that is showing it’s an invalid code and when I look that up in my ICD-9 code
it usually means it’s one they retired, just not used anymore. So you shouldn’t even be finding it. And then — oh, I’m sorry. Invalid means — sorry. I’ve got — the NU is No Longer in Use. It was an ICD-9 valid operative
procedure code and it’s out of use. And this 45.8 is just an invalid code. It would not be any kind of NHSN operative
procedure, so that’s really, really helpful. And it’s all separated out by pages in an Excel
document for you all to use as a resource. We also have at the top, have the
Training Section of the website. And right now there isn’t as much on it,
and we’re going to be updating the LECTORIS for new IPs, or those of you who haven’t
done it, to train to the new definitions and that’s actively being worked on now. And then once this webinar is ready — it takes,
you know, a few weeks, but you’ll then be able to find this webinar on the
training website as well. Now your monthly reporting plan is
really the roadmap of what you are — data you are sending to NHSN every month,
your in-plan procedures that you’re following. So for most of you, if you’re
an inpatient acute-care setting, you’re all going to have your COLOs and your
HYSTs in there, and then some of you are in states that have very specific other
procedures they want you to follow. It might be a handful more, and those will be
in your monthly surveillance reporting plan. And then those of you, I’m sorry, in California
— how many Californians do we have here? Oh, quite a few. Hi. I moved here from Napa,
California so I feel your pain. Have a very large selection
as well as Pennsylvania. You know, almost every operative procedure
in Pennsylvania and in California with 29 or something — a lot, so
they’ve got a lot in their plan. But the plan, by something being
in-plan and checked off, that drives and activates all the business rules
that live behind an application. So that’s what makes it a
active in-plan surveillance. And you must have one, you know. It’s a month-to-month. So you have to have COLOs in every
month that you’re following those. So this is what your monthly reporting plan, if
you had a look at this, this would be ICU-West and it’s telling — you can tell that
they’re following CLABSYs, COUTIES, and they’re just following
for inpatient hysterectomies. Now active surveillance, you know, you’ve got
your procedures being done but how are you going to find the surgical site infections? So you have to have a surveillance
method that’s very active and on-going. So you want to, first of all, determine which
patients need to be monitored so you know, you need to know who’s having — I’m going to
focus on COLO-HYST because we’re all kind of, most of us, in the same boat for those two — which patients are having those procedures
every month, and that’s important. And there’s lots of methods and these
are all pulled out from our beginning of our SSI protocol where we touch
on post-discharge surveillance. You can review your admission logs. Those are very important. And your re-admission logs. Some people actually can have a code in the logs
they run that say this is a re-admit of a person who was here in the last 30 days. So that can be a flag for you to let me check
this patient and see if they had a procedure. Everybody has different reporting
systems that have flags to give them a warning this may
be a patient that is suspicious. You’re going to look at your — if you — the last facility I was in my admission
logs always had their diagnosis. So, I mean, if I saw the word
like abscess, if I saw the word — any kind of infection, I was going to look
up that patient just to make sure I was — if they’d had a procedure the
month before, did I need to follow that to look for a surgical site infection. Your ED Logs are really helpful
if you can get that even if the patient isn’t readmitted
to your facility. If you can get your ED Logs with their
diagnosis or some sort of summaries, you can maybe find some of your superficial
SSIs where they come in and are treated but then are not readmitted to your facility. Also you can be reviewing, obviously,
all your lab reports for any sort of wound cultures that are being sent. And then you can — other diagnostic tests that
you find helpful, and reviewing nurses’ notes and physicians’ notes on key, on the patients. And then, also, what can be good, if you have
— and I know it can be really difficult, but if you have certain targeted high-risk
surgical wards you can try to get involved on maybe the weekly multi-disciplinary
rounds so you can then, in actual real time, be hearing about which patients
are struggling with wound healing or might be catching early some
possible surgical site infections. That being said, at this point we don’t
have, because we do get asked this, we do not have an actual set, mandatory, validated method that we say how
you are doing your surveillance or your post-discharge surveillance. That is still fairly — it’s customized
and is done, especially the post-discharge, differently in different facilities and we’re
going to be talking, you know, about that. But it is, again, something that you want to
be doing and have a part of your surveillance. There was a misconception in the beginning that
CMS would never get any SSIs that are found by post-discharge surveillance,
and that’s not true. That’s the AR Model. But the 30-day surveillance where
they use the age in the ASA Code, they’re finding the ones no matter how
they’re found, whether it’s admission, re-admission to your facility, post-discharge. So you want to develop some sort of tools
to have a consistent way that you feel like you’re capturing your
post-discharge surveillance. Now if you find a patient whose
found via post-discharge — you know, they come into the ER and then that’s
how they maybe first culture the wound is in the ER, but then they readmit the patient. That would be a readmit to your facility. You kind of go to the deepest level,
the most complicated that had occurred, like this became bad enough
this patient was readmitted for care of this surgical site infection. And also, again, you can get a connection to
reviewing all of your post-op clinic records. And there are also — I mean, the ultimate, and
there are facilities that have the person power to do this, is, if you think about it, especially if you’re not a hospital that’s
doing every single one, it could be difficult. But if you’re only doing COLOs and HYSTs you
really have to think about the fact if I need — these are both 30-day procedures. You don’t have to go out 90 days. And have some sort of method that you can review
that chart, fully review each chart, at 30 days. So this is just a little glance at our — on
the left you’ll see this is the denominator for collection form that’s
used for every procedure. Now remember, when you sign up to do COLOs
and HYSTs, you’re saying, I’m doing every COLO and HYST, every procedure
that meets that criteria. And then on the right is your actual
infection, your SSI Surveillance Form. So we’re going to go over some key terms. And this is a new slide this next one. It’s not in your packet. This was my little bit of armor that I put on. My friends were joking, saying, “You
should come on with a bulletproof vest and say don’t kill the messenger.” But I know that we have thrown a lot of changes for SSI surveillance at you
all in 2013 and in 2014. There’s only two more coming
in ’15 which you have to wait to the very end of the presentation to get that. But then we’re done. Then it’s level. Don’t quote me on that. But, anyway, these changes that have occurred
in 2013 and 2014, definition of primary closure and all the things that we’ve done this year,
did not happen in a little group of people at NHSN saying, “Let’s, you know,
let’s change up our definitions.” There was a year and a half — you know HICPAC
Guidelines, you know HICPAC Working Groups. There was a year and a half, HICPAC/SSI Working
Group, that was very multi-disciplinary — surgeons, IPs, A or N Representatives,
CDC, NHSN, infection preventionists — and it went on for over a year and a half
to really look at trying to harmonize, and you’re hearing that word a lot, but to try
harmonize our definitions with the definitions that are really being out there and applied
by other surgical professional organizations like the Society of Thoracic
Surgeons and the definitions they use for their complex cardiac cases; like
the Society of Orthopedic Surgeons and how do they really look at joint infections;
like the Musculoskeletal Infection Society where we got our new PJI definitions. These are the people that asked for this. This came at a surgeon level of can we harmonize
so that when we look at NHSN data we really feel like this makes more sense and is more valid. And, historically, when you looked at NHSN
data in the past, before these changes, and compared it to any of
these other surgical societies, we were reporting much lower
numbers than they were. So that’s why some of this came — this why all,
really, all the changes came about were driven by a really, really well-thought
group of very sharp people that were trying to get this harmonization. So, present on admission. This was gone over a lot last year because we
have a new present-on-admission definition, and Kathy reviewed it again today. POA does not apply to HAIs. If you look at the POA definition,
it’s like it does — has to occur in the first two
days; it has to do this and that. It doesn’t work with SSIs
because they’re procedure-based. Everything’s procedure-based. Think of Maggie saying you got to be
driven by the date of the procedure. And they all have these long
30-day surveillance periods. So the whole POA definition just doesn’t
even work for surgical site infections. And it says that in black and white now. I mean, it’s kind of what we knew was
true but we didn’t have it in writing. And then when we had the POA definition we
realized it doesn’t apply to like lab ID, to VAE, and it doesn’t apply
to surgical site infections. They’re procedure-based. So once a procedure starts, the clock sort of starts ticking again is
the way I like to think of it. And the HAI definition doesn’t work because
that’s the one that bounces off of the POA and says oh, if everything happens on
day three it’s an HAI after admission. Well, again, these are procedure-based
with long surveillance periods. And the HAI definition is what
introduces the whole gap-day rule, and we don’t apply this tight little gap-day to
a person who has a 30-day surveillance period. Things can brew, and they can start
as superficial and move to deep, so we don’t have that gap-day
rule which shows up in HAIs. And that’s why we, again, very clearly, if
you go into Chapter Two, our HAI Chapter, you’ll see it says this doesn’t
apply to surgical site infections. So this was a big change this year. Last year the big change was the
definition of a primary closure. If you think about before 2013, man, that
incision had to be just closed up tight as could be and not a wick
or a drain coming out. And then we had a new definition
which was very much based on the American College of
Surgeons’ definitions. It’s very, very tightly based on
Misquip’s [assumed spelling] definition of operative procedures, primary
procedure versus an open procedure. But what we did in 2014 is,
again, it’s all those procedures in Table I, which we’re familiar with. It, you know, tells you what they are or,
and all the OTH categories for Pennsylvania, and it takes place in an OR where at least one
incision is made into a skin or mucous membrane, and also that’s your laparoscopic procedures, or
an incision left open during a prior procedure. This is to cover for — now that you remove
the incision method from your definition, it means you may have a patient who goes
to the OR and they leave the incision open and then they return two days later to close it. Well, that still is a procedure but
they’re cutting through the fascia or something to start that procedure. So you still want to include them. And then it takes place — this is the same
as it has been for the last couple of years — in an operating room which is
defined as a patient care area that meets the FGI or the AIA criteria. And that’s the same; that did
not change from last year. So, again, just to be clear, as of 2014
the incisional closure is no longer a part of a definition of an NHSN operative procedure. So all otherwise eligible, meaning an
incision was made and it took place in an OR, will be entered into your denominator data. And if you think about that it’s the
same as thinking of here’s my denominator and you base your surveillance
and you’re writing up a surgical site infections
on your denominator. So if it’s in your denominator and
they have developed an infection in that surveillance period
you will attribute it. We’ll get into that more. So, these are some of the FAQs that I went
ahead and just put them in right at the get-go. So why are both primary closures as well as
non-primary closures now being collected as part of the denominator data that’s being
sent to NHSN for surgical site procedures that are followed in our
facilities’ surveillance plan? Well, both non-primary closures are common now and the previous definition did not have any
representation of this surgical practice. Therefore, it’s important to collect data on
these procedures and the related infections to really gain a comprehensive
picture of the surgical risk factors in order to guide prevention needs. So now you’re going to have an ability —
now what Maggie said was really important. Right now none of these open procedures,
other than primaries they call it, field the check box, are going to
be impacting your SIRS that you run. They’re not being sent to CMS. We don’t have any baseline
data to look at these. They’re there for you to look at. And it can be very helpful for a surgeons
to be able to see, especially those that — the COLOs and where, you know, not a majority
by any means, but some are left open — that you’ll be able to actually
give them information. Okay, here’s how many SSIs you
had that met this criteria. But you had this many based on this procedure. You have that internally now. But we’re not sharing that data with CMS and
it’s not affecting your SIR at this point because we’re not going to re-baseline. We haven’t re-baselined. So everything, as Maggie said, is
based on 2006 through 2008 data. Our primary closure definition did
not change from last year, same. And you’ll remember, last year in
the manual we actually gave you — because sometimes you don’t know what
something is unless you know what it isn’t. So we also last year in the NA, and this is
just, you know, cut and pasted from your manual, we also gave you the non-primary
closure definition of incision. And that is right here. Wordy just because I’m just — it’s a placeholder to remind
you this is your definition from the SSI protocol, okay,
for a non-primary closure. It was also in there last year. Didn’t change at all. We just weren’t applying it. So what we — non-primary closure
basically means your open procedures. So when you — and we’ll get to that
in terms of when you fill this is. So if a patient — this is my next most
frequently asked question lately — if a patient underwent an NHSN operative
procedure with a non-primary closure — so it was left completely open — and subsequently this patient
develops a surgical site infection from that operative procedure, must we
include this in the SSI in the numerator? And, yes, that procedure is in your denominator
data and if the patient develops an SSI that meets criteria within the
surveillance period, which is — it will be entered into your — oh, I
said denominator again — numerator. Correction, that should say numerator data — and it will be linked to that
procedure that is already sitting there in your denominator data
marked as an open procedure. Every procedure, when it goes
over, is going to have a field that says was this a primary
closure or an other than primary? So it is linked to a known open procedure. And this was just a reminder note that that — the SIRS are not going to be
impacted by this collection. We’re just getting this baseline
data and then we’ll be able to actually look at it and see if it matters. Does it matter? Is there a huge difference between the
procedures that are left open and closed? But we won’t know that until we get
that at least years two’s data from you. All right. Mea culpa. A lot of changes. So, this has been corrected. If you go back to you facilities
and print out key terms and tables of instructions for your denominator. What happened? The SSI protocol itself has the
correct non-primary closure definition, but that same definition also lived in key terms
and it lived in the little Table of Instructions to fill out your denominator form and we did not
— remember that there was this little sentence in here about oh, if it’s a
non-primary closure it is not an SSI. So that is incorrect. That is not true. That’s 2013’s statement. It’s been corrected. But if you by any chance — how
many of you work off of a hard copy of a manual versus really going to the site? Probably, yeah, at least half. So if you printed off a hard copy of your
Table of Instructions and your key terms, just go and print those off again so that you
have the correct non-primary closure definition. The one in the — most people use the protocol. The protocol is correct, but
I just want to point this out. Now this is a list — and actually, it’s like I can tell you this is sort
of — I have to thank our users. I tell you that sometimes you all show us
things or have put together little things that are very helpful that we like to share. This was a list that someone put together. I tweaked it with the IP a little bit. But she put this together for a training
for her OR staff of trying to think of all the examples she could have. What would be a non-primary closure? What it may include, what
it may be described as. And then what a primary closure may include. And so I thought this was just a
really helpful listing of things. And I highlighted the one,
and it’s very unusual, but you’ll see on the left
side here I highlighted this. It doesn’t happen very often but we get enough. I’ve gotten a couple of questions so we decided
we want to make sure we are clear on this and also is stated in the protocol. There are some cases where
they actually do the procedure. They know they’re going to go
right back in in a day or two. So if you look at the patient from the outside
it looks like they closed up the patient. But, actually, in fact, it’s just a
very temporary closure at the skin. The fascia is completely open, the muscle
is open, because they’re going to just kind of unzip that patient in a day
or two and finish the procedure. So, in fact, this — because,
when you read the definition, it says they must be closed
at all tissue levels. And people sometimes wonder, what
does that mean, all tissue levels? This would encompass where, yes,
the skin looks closed but, in fact, the fascia and muscle layers are open. And they really do this when
they’re going to take them right, usually back to surgery in
a pretty immediate manner. But I just wanted to, you know, show you that. Let me see if there’s anything else different. Of course, you know, and I’ve got some slides that will show you some more
examples that may be helpful. You may not like them but they may be helpful. So, my son is a graphic designer so I
have to thank him for doing this for me.>>Aw.>>Aw, I know. So — because, you know, it’s hard for
us to grab things from the internet. Sometimes there’s not — we’re not
supposed to get them from there. And so I said to him, “I
want one nice and tight, one that has some little
closures, one that’s wide open.” Then he calls me up. He goes, “Mom, would you
like staples or sutures?”>>[Laughter] So I said, “I
think I’ll go with staples. I think they’re stronger.” So, of course, this is a primary closure. This is now a primary closure. Now you probably have packing in
here and everything, you know, and you might even have a
little wound vac placed in here. But this would be open. Or you have a wound vac here and a
wound vac here but they’ve closed this. And this is a other than primary. This is an open. And this again could be completely
filled with — let me go in here. He did not draw these. I said, “Hey, [inaudible],
could you do a moon vac?” He’s like [inaudible]. So these are representative of —
you can see this was never closed in any skin edges and is just completely packed. That’s going to be — because some folks have
asked, “Well, if they pack the whole thing or if they put a wound vac
in, does that mean it’s now like what you consider closed
because look at — .” And I said, “No, no, no. That they never brought any of these skin edges
together and they’ve put that whole wound vac in there, so both of these would be considered
fully open, not closed at the level.” So when you go into — now this is cut from
your actual application when you enter, okay? So when you get here to wound closure technique
it’s a dropdown and it’s going to say primary. And then it doesn’t say open. I’m just warning you. Then it says other than primary. So that’s your selection right there, okay? So in the past what procedures
were you sending to us? Only procedures. Until this year the only thing
that should have been going into your denominator data was
your primarily closed incisions. That is what, when you sent us
your COLOs, you sent us your HYSTs, we were taking that all of
those were closed primarily. Now we put out a guidance in a newsletter
and if you guys didn’t, you know, look back in November, after we sent in the
NHSN Newsletter a summary of what was coming. We’ve been telling you this for what every
[inaudible] we told you what was coming. But we told you it was coming and there was a, and we’ll call it an uproar,
there was an outcry, an outcry. They’re like yikes, there’s no way
that we can have something in place to capture wound culture and
be ready for this in 2014. What can we do? Help. So we put our heads together. We really do care. We try to listen. And we said, what can we do? What’s a workaround? So we went to our actual people up there with
the brains that build these applications. Well, we have rules around when
fields have to get entered, and fields get entered way ahead
to prepare for what’s coming. And this field had been built
into the application. We couldn’t remove the field
of incisional closure. We couldn’t remove the diabetes field. They were built into the 2014 application. Because I’ve been getting emails that said that
newsletter said this isn’t coming until 2015. And it said, we said, “No.” We said, “In 2015 you really
have to have the answer right and we’re giving you the workaround for 2014.” And what it said up here in the intro paragraph
of this, it said, “All SSI fields are built into the NHSN application for release.” That was us and maybe we should
have wordsmithed it to let you know. I mean, we couldn’t take these fields out. So the workaround that we said was, “Report these denominators the same
way you were determining in ’13.” Because in ’13 what you sent us was only
supposed to be your closed procedures. So how were you determining what
your primary closures were in 2013? So I’ll give you three sort of examples. A facility I work pretty closely
with, because I used to work there for a long time, a big university. Well, as soon as this definition changed of what
was a primary closure and it was much more open, they built a field into their OR record. They educated the OR, the
whole team, and actually — because they didn’t know how are we going
to know what’s open and closed to send NHSN? So they, a way long time ago, had built
in a field that said, in the OR record, that said this is an incision
that has a primary closure. And they educated them. When the definition changed they said okay, new definition of primary closure,
and they educated the staff. I’ve also spoken to hospitals that
said we can’t open up every record. We don’t have the person power to do that. So we have started looking at the ones we — we have a flag of like — we
look at every Class 3 and 4. I mean, one Class 3 and 4. Because they’re the ones
that were probably left open. And we try to pull out the
ones that left open that way. And then, honestly, there were other
people that said well, here’s what we do. We send all our COLOs over. We send all our HYSTs over to you. And then, if during the surveillance
period we find an SSI and it was — we were like, oh, wait. They didn’t close this one. We pull that out then and
we don’t attribute that SSI. Was that meeting the definition? Not really but it was the method they were
using because you had to have something in place to decide what you were sending us in 2013. So that’s what we mean by the workaround. What were you doing in ’13? And use that same method to
fill in those two fields. So if, in fact, in 2013, you don’t think
there were a lot of people doing this. But if you were sending all your COLOs and
only pulling them out, the denominator, when you found an SSI attributive of one and
not sending us the SSI and not sending us that procedure, what you would be doing in 2014, if you’re doing that same
thing, that’s all you can do. You’re not going to pull that denominator
out when you find that open procedure. You’re going to pull that record
out and change that record, because you’ve now discovered that’s a
record where that was an open procedure. Okay? So what we’d like you doing in 2014,
the fields are there, is working on a method that you will be able to more easily capture
the closure method for your operative procedures because people have been — they’re surprised. I’m like I tried to send my January procedures
and they’re saying they’re incomplete because I don’t have incisional
closure method on there, okay? So. All right. Let’s do a case. Get your little clickers ready. So a patient is admitted
with a ruptured diverticulum and a COLO procedure is performed
in the In-patient OR. The case is entered as a Wound Class III. They obtained a specimen in the OR
which returns positive for E. coli. The surgeon staples closed the incision at
four locations with packing placed in-between. Is this procedure primarily closed for 2014? Let’s get your voting started. Well, you guys are fast on this. And I’m going to give you 10 more seconds. You’ll all get this right after
that lovely graphic of my son’s. Yes, 90% of you said yes. It was closed to the skin at four
locations and packed in-between. The rationale, the skin was
closed at some point. Okay, what I should have said or I’m just
going to say something as I’m saying that. We’re going to assume in my
presentations that they closed the fascia. I didn’t — and every single case something — did I remember to say closed
at all tissue levels? But, anyway. So fascia was closed in that case and
the skin was closed at four points. Thus, and this is straight
out of the definition, “If any portion of incision is closed
at the level of the skin by any manner, a designation of a primary closure
should apply to that surgery.” If you are reporting COLOs in
your monthly reporting plan, should this case be entered
into your denominator data? So start your voting. Get your little clickers out. I can give you 10 seconds. Very good. Yes, because this was a [inaudible]. Excellent. You guys are sharp. The real — oh, I thought I
had a rationale in that case. Well, I guess I didn’t. So the rationale in that is that, remember, in your denominator data you are
putting in open and closed procedures. So this is the next one. A patient is admitted with an acute abdomen. They’re taken to the OR for an appendectomy
for a suspected ruptured appendix. Wound Class is III. The surgeon does not close the incision, leaves it open with a wound vac
to heal by secondary intention. Is this procedure primarily closed for 2014? Set your clickers. Yes, no? All right, 10 seconds. Correct. It was left completely
open with a wound vac. Kind of like that picture I showed. It wouldn’t have been quite that
big an incision for an appy. It would have been a bad
appy if it looked like that. This incision was left completely open. A non-primary closure is defined as
a closure that is other than primary and includes surgeries where the superficial
layers are left completely open during the original surgery so they can’t be
classified as a primary closure. So if you’re filing appy in your monthly
reporting plan should this procedure be in your denominator data? Yes. No, it was a contaminated case. Let’s see if everyone’s got this. All right, 10 seconds. Oh, good. This one I was a little nervous. Yes. And this was in some ways — it drove
a little bit our decision to like we want to just — you tell us all your COLOs
that are happening in your inpatient OR because I cannot — there were a
lot, a lot of times that I heard, “Well, we don’t send in NHSN our COLOs
where it was like contaminated. We don’t send — I think we’re not supposed to
send any just in Wound Class III’s and IV’s.” And I’m like where is that in the definition? There’s no — it never said you have
to have such and such wound class to be an NHSN operative procedure. It was never driven by wound class. And neither was the reporting of an SSI
ever driven by, oh, don’t send us your SSIs if it was a Wound Class III or IV, because
that’s what the SIRS are taking in. Not so much the one that goes to CMS but ours. If you look at that for COLO and HYST your wound
class is definitely taken into account on both of those so that is — I
just want to clear up that — it’s really cleared up this year
because we’re saying send them all. But, you know, in the past we’ve
really heard people were holding back. And then how can you say we have a
level playing field when we’re looking at our data in terms of comparative data? So, good job on that. Wound class — I keep telling you
my rationale before I go to it — is not a part of the NHSN
Operative Procedure definition, and a high wound class is not an exclusion
for reporting in your denominator data. All procedures that meet the NHSN definition
of an operative procedure should be reported if they’re part of your facility’s
reporting plan. So let’s take the same case,
so if you have to look back, and that patient was now
readmitted two weeks later. That person who had the ruptured appendix and
had the open, the other than primary closure and a wound vac place, are
readmitted two weeks later. They were in for a week. So it’s now it’s about post-op day 21. They have a fever, acute abdominal pain, and
CT evidence of two intra-abdominal abscesses. And they do a CT-guided drainage
of 100 cc’s of purulent drainage. The drainage is culture positive
for E coli and B frage and the patient meets criteria
for a GI IAB organ/space SSI. Because this was a contaminated case this
infection should not be reported to NHSN as attributable to the appy procedure. Is that true or false? All right. The voting is open. You guys are nice and fast. That break must have given you caffeine. I heard that you all drank 60
gallons of coffee yesterday. Had anybody told you that [laughter]? You didn’t hear that. I was just — I was somewhat of
a contributor to that, but, wow. I sort of did the math. I’m like, is that half a gallon a
person if there’s 300 people here? It just shows how much coffee we have to drink
to do our jobs and get through this much. All right, so. Very good. False. I had sort of told you that. But this really, I think, I don’t know if
how many of you — I saw some head nodding. I think this has been happening
in the past, you know. People just thought, yeah, I
don’t have to tell them that. It was a contaminated procedure
and they got an SSI but, you know, NHSN doesn’t want to know that. And that, that was sort of some
urban myth that occurred we think. So as of 2014 incisional
closure is no longer a part — am I beating you over the head with this? — is no longer a part of the NHSN
Operative Procedure definition. So all otherwise eligible procedures
are included, and this is a biggy, any subsequent infections that
meet criteria should be reported and linked to that open procedure. Again, it won’t be used in certain analysis
and it show up in your analysis for a while because this is our baseline year and then, as
I think, Maggie has said, we’re going to be able to — we’re looking at stuff that’s
based on 2006 through 2008 procedures. So they’re a little bit apple and
oranges at this point with the changes. But what’s beautiful is once we’ve all
stabilized and we re-baseline, it will be all, it will be, I think, some
really good comparable data. So, this is new duration of operative procedure. You can probably guess why we had to have
a new duration of an operative procedure because what was our old duration
was incision start, incision stop. Well, we’ve just removed incision as necessary. These procedures are not necessarily closed. So we had to have a new definition
for your duration time. You don’t have to put in the procedure
start time in the application. You never have. You have to figure it out in your head. And how many times have I counted
on my fingers 1, 10, doing — you have to figure out how many
hours long the procedure was. But the procedure start time is
when the procedure has begun. Now for a patient that’s going in
and having an incision it’s beginning when they make the incision. They’ve begun that procedure. But if it’s someone who arrives with an open
wound, and maybe it was just closed to the level of the fascia, it’s when they
start and cut into the fascia or start the closure of that procedure. So, again, it’s the procedure start time. And the procedure finish
time is — this was all taken from the American Association
of Clinical Anesthesia. Clinical directives is right out of
their guidelines, all these times. And they’re ones that AORN,
when we were looking at this, very much assured us is a
— so you can blame AORN. They assured us that this is a very common
time that is captured in most OR records. Sometimes it might be called Procedure Stop
Time; it might be called Procedure Finish Time. You might have a different word
for it but if you work with your — which you’ve probably already
started doing that — your OR liaisons to capture the time
that most closely reflects this. The most common question I’ve been getting
is, does this match anesthesia stop time? And the answer is no, because anesthesia stop
time, when we did some investigating and looked at the definition — if you have a really
complicated case, some of your cardiac cases and others, they don’t have
an anesthesia stop time. You see them in the elevators. They’re bagging the patient
all the way up to the ICU. That anesthesia stop time doesn’t finish
until they sign off on that patient who goes from the OR to the ICU directly. You’d have these extreme extended stop times. So it isn’t the same as your
anesthesia stop time. Now we did not give a work-around
for height and weight. I’ve never seen — I mean every OR — I
mean every hospital I’ve ever worked for, they wanted to know the patient’s
height and weight. It’s also often needed to
use for dosing of patients. You have to know their BMI;
you have to know their weight for dosing of different medications. The height has to be entered
in feet and inches or meters. Either one that you enter it will transpose
and fill in the other one automatically. We have a little glitch that
they’re fixing right now. What we wanted to do is to automatically
— if you put in 68 inches it will be happy and it will convert it to five
feet eight inches for example. But sometimes that doesn’t work. So if you get an error message
just try in your head to switch it. We’re working on fixing it. It’s been reported. But just put it in as feet and inches. And there was a little problem
with meters for a bit. I mean this was a new field that if you
put in an odd number for a meter like 1.63 which would be the equivalent
— I’m making this up. I don’t know. It’s a half an inch of something, you
know, like that’s five foot 10-1/2. Those odd numbers for some reason
were giving you an error report. Again, if you enter your meters and you get a
little error, try bumping it up an even number. But we’re working on fixing that as we speak. So, hopefully, we’ll step getting
these error messages with the height. The weight is the most recent record — weight
recorded in the medical record in pounds or kilograms and it then converts
and does the other one for you or otherwise closest to the procedure. We, you know, if they didn’t — the last
one they got was at the pre-op check. That used that. We didn’t mean you had to like absolutely
put the patient on the scale before or after. We’re not being ridiculously
picky about the weight so that’s what we’re saying the most
recent or closest to the procedure that you can find in the medical record. So, and I don’t know if Dawn will be upset
that I’m saying this because we really, really don’t think this should be happening. But there have been a couple of cases where
a patient arrives, has never been seen at that facility ever, ever, ever, has a
procedure done and then maybe, I don’t know, they sign out AMA or something and
there is literally is not a height and weight on that patient. There’s no other medical record to look at. They didn’t capture anything in the OR. And you can’t send that record over. You’ll keep getting an error message
because something has to be in that field. You guys have to promise me you won’t abuse
this because it should be extremely rare that this would occur because you have
access to the entire medical record. And if they didn’t capture it at
that sting I want you to look back when they were there before for something
and try to find the height and weight. I want you to look in the OR. I want you to look at all available records to
find this because this is an important field. This is what’s going to give us
when we readjust, think about this. this is what’s going to give us our obesity. Think of the risk factor
for obesity with our SSIs. But it will give you an error message and if you absolutely can’t find it
you have to put in like one pound. And if you have to put, or you have
to put that they are one foot tall, and that will tell the Maggie folks that
this was not available and the problem for you all it’s just not going to
show up in your risk adjusted data. So work hard with your IT Departments. Work hard with your nursing staff. This we never expected we’d need any
kind of workaround and we didn’t give it to get these fields available for you all. And just let people know what good data
it’s going to give us in the future for risk of SSIs based on obesity. Diabetes — so this is also a new field. It isn’t new because those of you — how
many of you have been reporting C-sections? Yeah, probably the Pennsylvania
folks [laughter]. Those Pennsylvania folks, yeah. So, okay, so again, don’t
shoot the messenger here. This — remember the HICPAC Working
Group I was telling you about. This was the very, very last
field that everyone argued over. I mean, really, it was — this was a
toughie for the HICPAC Working Group. And this is the definition that they
came up with and it is based on treatment that a patient is actually receiving
treatment for their diabetes, not just they’re controlling
it by diet alone, okay? So the definition. It would exclude a person,
though, who receives just a — especially cardiac procedures and
a lot of different skip measures. You have to control their glucose
right around the time of the OR. So you might see a patient who got a dose
or two to control some hyper or hypoglycemia around the time of their OR procedure. We’re not talking about that. These are people that are
being treated with this. So we’ve had some issues with people saying,
you know, I don’t have a way to find this and we don’t — many people
have found ways to find it but at this point we did develop a
diabetes workaround for you for 2014. Again, the field is there. It already had been built in the application. If at this time you don’t have an
ability to capture this field just send over all your procedures
that will default to No. That they’re not diabetic, okay? So we did offer a workaround. It’s a very easy workaround. Now in yellow you’ll see what
I put here at the bottom. We have gotten a lot of feedback from our
users that they would like this to be based on an ICD-9 or what will be
ICD-10 diagnosis code of diabetes. And I think probably, I would
guess a lot of you may be doing that already even though we didn’t — because then everyone was asking
me, “Where’s my code list? Tell me my list.” I said, “We didn’t make a list because
we didn’t make this code based. But we’ve heard your concerns and we
are actively in discussion about this.” And it’s the time to do it because right now — well ICD-9s go away in October 1st
so we’re going to be needing to look at what the ICD-10 codes look like. And they may be very well suited to this but
at this point it is not a code-based system. Now the rationale isn’t — you
know, I’ve been trying for all these to give you the rationale behind why we ask for
this which does have an added burden, you know. I know that as years of being an IP. But, obviously, the diabetes and obesity which
will be determined, and I’ll show you this. What’s really neat because someone said to
me, “Well, you know, BMI’s what’s important. You should be determining the BMI.” Well, the person hadn’t gone into
the application yet because as soon as you do you see — and it was
new; they didn’t know it yet. As soon as you put it the height and the
weight, boom, the BMI automatically fills in. So I can pretend I’m a patient and check my
BMI, you know, as I’m trying to lose weight. Oh, let me see if I’ve lost. Is my BMI any better? I can just go into our application
and figure it out myself. So, anyway, so that was to capture our obesity. And it automatically calculates the BMI for you and it will give us much better
risk-adjusted data in the future. And probably, you know, again, we’re
re-baselining everything in 2015 when things have stabilized and
so urinalysis, you know, at the — the analysis that you do for risk
factors should be available after that. Now that’s all. That covered all the big changes. Our definition of an NHSN inpatient
did not change, or an outpatient. If they are a inpatient it means
that their day of admission, their day of discharge, are
two different calendar days. If they are an outpatient it
means their day of admission and their day of discharge is the same day. And so what I will say, and
that’s the same day, you know. So the way I’m going to — what I do want
to address for this is that I get a lot of questions, and again, it’s that definition — NHSN definitions don’t go by people’s
billing code definitions, okay? It’s just a whole different definition. And CMS bases their definition
of like you are supposed to be sending your inpatient procedures
to us based on our definition. So if you have an acute care OR, it’s your main OR where you have inpatients
having their hysterectomies and you have outpatients having their
hysterectomies if it isn’t being happening in an outpatient surgery center,
and you have hysterectomy cases that they send home the exact same day. They come in at 8:00, they have their
hysterectomy in your OR at 10:00, and they’re home at 7:00 that night, that
should not go into your denominator data. It was done in your OR but it does not meet
our definition of an inpatient HYST procedure. But if they come into your inpatient acute
care OR and they come in one day and spend and leave the next calendar day, that is
considered an inpatient HYST procedure. Whether for some billing purposes that was
called a outpatient or a observation patient, you know, whatever, it still meets
our definition of an inpatient. Operating room hasn’t changed one bit. I’m not going to linger. This is a long presentation but these are
— most of your C-section rooms, hopefully, are coded as meet the standards
for an operating room. Many, many cardiac cath labs will meet and
that’s where you’ll see maybe an inpatient that gets sent to cardiac cath
lab to have a pacer insertion and pacemakers are an NHSN operative procedure. A little reminder that when
you do make a decision to follow a procedure category
you’re following all of the NHSN procedure ICD-9
Codes that fall in that category. You can’t say, “Well, I’m just
going to follow 6831s and 6839s.” You need to follow that whole grouping
that meets our definition based on ICD-9 CM Codes of abdominal hysterectomy. So this would be a — shows for [inaudible]. Okay, I’m going to show you,
even though I have a little, what I call my errata slide
at the end with our errors. And this will also be in the NHSN application. There’s a reporting instruction
which we’re going to get to. But I want to show it to you here. There’s a reporting instruction
that we now are reporting all APPYs. We don’t want you to look up every appy in
Delvin [assumed spelling] and see did they do — was it incidental or did they just do this? Was it a rupture? It’s just an added burden. If comes across coded as an appy, send it to us in your denominator data as
an appy if you follow those. There is a parentheses in
this Table I currently, if you look at it, that says, “Not incidental.” We didn’t realize it was in there. You know, we put the reporting instruction
in but it says, and that that is not — should be — just cross that off. It should just say that we — it shouldn’t say, “Not incidental APPYs,” because
we changed that in 2014. We’ll get to that. That’s table one. So, we’re going to move on now to how to
complete a denominator for procedure form. Now for many of you, this is,
you know, this is old hat. You — collection period is a month. You complete a denominator for procedure form for every operative procedure meeting
the NHSN operative procedure definition that was done during that period
in your monthly reporting plan. And you try to get that data submitted within
a month of the end of the reporting period. For example, if your monthly
reporting plan indicates that you monitor COLO [phonic] procedures in
January and 43 COLOs were done that month, then you should enter 43 separate COLO
procedures into NHSN by the end of February. You don’t want to — do not want to wait. We get panic calls to the end — or the day
before like, CMS submission deadline for this because you’re going to have, you know,
a real problem on your hands if you — it takes a while to enter that many. And so, you want to make sure you
get them in, in a timely manner. And Maggie is going to take the last
half hour, like after lunch of the — the two hours we have and
she’s going to be addressing — because you’re going to see what — when’s
she going to talk about how to import data for using like, CSV files or CDA — so
Maggie’s handling that portion of it, which — so that’ll — we’ll end with giving
you details on importing procedures. So the first part, as it is for all of ours, is
that you have your basic patient information. Anything with an asterisk is a required field, your patient ID, your gender,
your date of birth. Now remember with patient ID,
you want to use the ID that lives with the patient admission to admission. Many facilities you get the — the patient
ID number and then you might have a — what you call an encounter number or a — it
really links it to that particular admission, but use the one that lives admission
to admission or you’ll have problems with being able to have your information like. You know, because the procedure — you — you just have to use that
permanent number as your patient ID. And then again, your NHSN procedure — your date of your procedure and your NHSN
operative procedure code and that complete list of the — of the NHSN operative
procedure codes is, you know, obviously found in the SSI
section of the manual. And when we say, “with code”
that means not the ICD9 code, this is like — this is a COLO, this is a hiss. That’s the code number that has to go in there. The ICD9 is — see that next to it — we
don’t require the ICD9 code to be entered. Some of you may be choosing that,
but it’s not a required field. So if you do enter an ICD9 CM code first, the
NHSN will automatically auto fill and know that that code, like for instance, is
an abdominal aortic aneurism repair, and so it auto fills it for
you if you’re doing that. Then you get into the next
section on a denominator form, which is your actual procedure details. So first of all, you know what the definition of
an inpatient or outpatient is, we just did it. You’ll note that on every form, that’s required. So for most of you [inaudible] —
some of you may be following some of your outpatient surgery centers. Most of the time, you all will be
entering that this was not an outpatient. You’re going to use your new
duration, it’s — this didn’t change. The field is still just a duration field, but you’re going to use your new procedure
start time, procedure finish time definitions. Now in Chapter Nine, which is the SSI
protocol, still sometimes say chapters, but it is Chapter Nine if you print it out. It is — there are a lot of
reporting instructions and I — we’ve reformatted and I hope
people found it helpful. We reformatted the SSI section and kind of,
it flows I think a little more easily read and we have, you know, a whole section
that is a little extra helpful. You can almost think of them as FAQ’s
reporting instructions for your denominator data for this — when you’re entering in
procedures and you have like a question, if you’re not sure what you’re supposed to do. Look there because a lot of times
when I’m answering questions, I’m — I say to people, “Oh, that’s in your
denominator reporting instruction. Here it is.” And I’ll cut and paste it, that’s reporting
instruction number four or something. So get familiar with those. And every year, we sometimes add a new
one that we realize might be helpful that people have been asking
a lot of questions about. It’s just kind of like the extra
stuff around denominator reporting. And then, we also have the same
thing for when you’re thinking about your numerator, your
surgical site infection. We have a lot of details on
reporting instructions for that too. So here’s the only two real– the big denominator reporting instructions
was again, the incidental APPYs. We use to say we only want an — we don’t
want any incidentals, we just want your like, APPYs that had to do with like a real —
like maybe appendicitis case and we just — the burden was just — especially with
so many people running off of line list, of here’s these operative procedures
that happened, here’s the APPYs. For them to open up every one and determine,
you know, should it, shouldn’t it — it just didn’t really make sense. And then for XLAPs it was the same thing. We had a reporting instruction that
if a person had an XLAP that — then led to any other NHSN operative
procedure being done in that area — like we open you up, what’s going on in there. That’s what XLAP is for, you know? And then they did something
else, you weren’t supposed to know, so you tell us they had an XLAP. Even though your coders may have definitely
coded an XLAP, again it would make you have to almost look up every XLAP and
see if something else happened. Now that being said, someone did point
out and I confirmed it, there is — there are coding rules — I am
absolutely not a coding expert. And your coders you hope are the subject matter
experts for your — for — as your coders. There is when you — when you all go out and
get your ICD10 books, don’t waste money on ICD9 at this point — there is — well, there was at
least in ICD9 a reporting instruction that said, “If they do an XLAP and it leaves to them
going in and doing surgery on the colon area, don’t report — don’t put an XLAP in.” Well, that was a coding rule, you know? It wasn’t, you know, an NHSN rule or anything. So hopefully your coders — those aren’t
coming across anyway, but in that — so I just want to let you know
that at this point if you’re coders and if you’re basing your coding off of
line lists that either come from your OR and they said they did an XLAP
or that comes from your coders — go ahead and just report it as an XLAP. Some operative procedures
have more than one incision. For example CABG, some CEA’s,
fusions, refusions, PVBY — they can have more than one incision. So an example would be a CABG, they might
have an incision on the donor vessels made for the leg and then they
also have the chest incision. And like a fusion with an
anterior and a posterior report. You complete one denominator for procedure. You’re not putting in two denominators — one for the leg part of the
CABG and one for the CABG. That’s one operative procedure with
a duration time being from the start to the procedure to the procedure finish time. But if procedures and more than one
NHSN operative procedure category done through the same incision and I
get asked — asked this a lot — during the same trip to the OR, you want
to then create a record for each procedure that you are monitoring in
your monthly reporting plan and use the total duration for the whole thing. Okay? So, I’m going to give you two examples. You could have a person that
had an — absolutely had — they were planning to do a CABG and
they were planning to do a card. They knew they were going to do a CABG and they
were going to replace a valve at the same time. Okay? It’s going to make that
a little longer procedure, yes. If you are from a hospital that’s following
cards and following CABG’s, you are going to put down the entire time that
that took on each of those. So your card is going to say that this was
a five-hour procedure and your CABG is going to say that this was a five-hour procedure. All right, so you’re going
to have both of those. The other question that I got — I’m giving you
all my little thinking of these things I get — is I had someone the other
day asked and said a person — they went in and they were
planning to do a HYST, but when they got in there they realized
they had to do a COLO procedure as well. You know, so it was like, surprise. So, am I supposed to put that COLO in because
they didn’t think they were going to do a COLO? I’m like, “Yeah, you absolutely
— if that COLO is coded and [inaudible] came across,
you want to put that COLO in.” It was a surprise, but you do put in the COLO. Because the thing is, they weren’t —
you know — it was something like, “Well, what if I wasn’t following HYST in my
plan, do I — but I am following COLO?” I was like, “Yup, the COLO
goes in your denominator data.” This is an exception here and we have had
this happen, where they send a patient down and for some reason, they don’t — the coding
— they were sending them down to have a CBGC, remember that’s when just a chest. Usually it’s when they’re doing
internal mammary, so you were going to — they thought the patient was just
going to come out with a chest incision and that got coded somehow, probably based
on how it was entered into the OR data. During the procedure they realized they
were going to need to use a leg vein and so, they actually did a CBGB on the patient
because they harvested a leg vein. So a CBGC — it really became, you
know, also a CBGB and when that happens, you don’t send it over, obviously
as two procedures. You just send it over as the CBGB
because that tells you there’s the chest and the leg incision. Okay? So basically, and that happens sometimes. So this is our 24-hour rule I sometimes call it. So if a patient goes to the OR more than once
during the same admission and another procedure of the same or different NHSN
operative procedure categories perform through the same incision within 24 hours
of the end of the original procedure, you only report one denominator for
procedure form, for the original procedure. Okay, so we have an example for you here
and then you’re going to combine the — at the time from the second onto the first. So a patient has a COLO and it
was performed on Tuesday morning, and it had duration of three
hours and 10 minutes. Tuesday evening the patient returns to
the OR where the COLO incision was opened to repair a bleeding vessel — that’s an
OTH other — I just happened to know that. The duration of the second procedure
was one hour and 10 minutes. You only report the COLO with a combined
now of four hours and 20 minutes. That OTH other procedure is not
going to be in your denominator data. And the concept here is that that second
procedure is really only being done because that original procedure
usually has some sort of complication that needed immediate attention and
so it’s almost treated as an extension of the original one where they’re
so close together in time like that. If that same thing happened
and it’s beyond 24-hour period, you’re going to still have a COLO
procedure in your denominator data and if you follow the OTH category you’d
have an OTH in your denominator data that — that represented that repair
of a bleeding vessel. Now this — we’re going to clean up the
language around this because I kind — I haven’t had a lot, but a couple questions. If you look in the NH — the SSI
protocol, under our definition of a primary and nonprimary closure, there
is this little note here. Where’d my mouse go, come on
[inaudible], where’d it go? Anyway, and it — this note
reflects what to do when you — this note completely reflects what — how
you’re supposed to sign the incisional closure when someone goes right back
to the OR within 24 hours. What — like if they went to the OR and
they left the incision open due to swelling, and then they return to the OR eight —
18 hours later to close that incision, so that second procedures not even
going to be in your denominator data. We want assigning the incisional
closure type for the one that is in our denominator data, that first procedure. Okay? So that’s what this
instruction was applying to. Okay? Let’s try a case now and
see if we can apply some of these. So a patient has a COLO and a HYST through a
single incision during a single trip to the OR and both of these procedures are in your
monthly reporting plan, which would be true for a lot of us here who do COLO and HYST. The incision is at — starts at 8:23
and the procedure finish time is 11:33. They did note in the OR record that
the HYST part of the procedure — because they’ll sometimes, you’ll see
that of when they transfer the team and you now have a different
team doing the HYST part of it. You may have a different team, depending
on the expertise — began at 10:00. Which statement is true? Only the COLO should be reported because it’s
really higher on our priority list of risk of infection, which we’re going to be getting
to, but it’s something you are very familiar with — that list, which on has the
highest risk of developing an SSI. COLO is higher than HYST. Number two — two separate procedures should of
reported a COLO with a duration time of one hour and 37 minutes and a HYST with a duration
time of one hour and 33, or two separate — also two separate procedures should be
reported — one for COLO and one for HYST, but each should have a duration
time of three hours and 10 minutes. Which — which do you think is true? One, two or three? Votes are coming in. All right, 10 more seconds. Very good. It’s two. Remember, you don’t split the time
when you have two procedures like that doing between this — number three
is a correct answer. It’s going to be two separate procedures,
but each will have the entire duration. We’ll be getting to a couple examples of when do you ever split the
duration of an operative procedure. We’ll be getting to that. And I’m not going to — that’s just
basically the — this is your actual — I cut this from our denominator
for reporting instructions. This is in there as a very specific
example telling you what to do. Because of bleeding during surgery, a
drain was placed in that abdominal incision and the incision was in loosely closed. Does this incision meet criteria
for a primary closure in 2014? One yes, or two no. Just to give me a little more information
about that incision where they did two things, they had to leave in a drain
and loosely close it. All right? 10 seconds, people are voting very fast. I make this too easy. All right. Yes, that is a primary closed wound
because it closed at any tissue level and wick strains coming out are allowed. You can have wicks and drains and some packing, as long as it’s closed at
some level at the skin. Now we’re going to get into a little
bit about bilateral procedure. So procedures that are for bilaterally
— we’re not talking about two procedures and one incision, but where you have
kind of a left and a right side. For example, your kpros is
a perfect example of that. Some hips I’m even even seeing being
done at the same time as bilaterals. In those cases, you actually
do do two separate denominator for procedure forms are completed
for a bilateral hip. So, to document the duration of the procedure, you’re going to indicate the procedure
start time to the procedure finish time for each distinct procedure
separately if they told you that or ultimately take the total time and divide it. Now some people, they really very
clearly note in the opnote — we finish this and now we’re
moving onto the next knee. And then you could really know in
case one knee was more complicated, but a lot of times what you really have — and
in terms of burden as well, you have one time. Like we did a bilateral knees
and it took us four hours. So then you’re going to just split it in
half and give each knee a two-hour procedure. So let’s do a case [inaudible]. So case four, a patient has a
bilateral knee prosthesis — a kpro — implanted during a single trip to the OR. The left kpro procedure start time
was at 8:30 a.m. and there was no note of a procedure finish time for this knee. Then they did a right kpro and the
procedure finish time for that was at 11:30 a.m. Which statement is correct? One kpro procedure should be reported
with a combined duration of three hours. Two separate kpro procedures should be reported,
each with a duration of one hour and 30 minutes or two separate kpros should be entered and each should have a duration
of three hours and zero minutes. Which one is true, is correct? And — you guys are voting really fast. You’re ready to go to lunch, aren’t you? Watching that clock there. All right, 10 seconds because
you’re — so many — And that is correct. This was a bilateral. Number two — you’re going to take that and
split the time since they didn’t note it. Bilateral procedures you split the time
if they didn’t note it between the two. Another common one if you think about that, if they do a bilateral breast procedures
is the other one that jumps to mind — the hips, knees and breasts are the
most common where you would apply this. So I want to let you know that there’s new
and updated reporting instructions for use — again, in page 915 is where you’re
going to find your actual SSI. Nine means it’s Chapter Nine — 9-15 is where you’ll find your actual event
reporting instructions for when you — if you have a question about
how to report infections, there’s additional reporting instructions. And your denominator reporting instructions
start on page 19 of your SSI protocol. Now let’s go next to your
denominator for reporting, see if we can get through
denominator before the lunch break. This is just again, your wound class is
going to go in next, it’s a required field. We removed unknown as a choice, so if it comes
across as unknown, you’re going to want to talk to the team, educate them, hopefully
get them to enter one because if — it’s going to come across as an incomplete
record, so you’re going to have to get that data and educate your — I — it
should be extremely rare, wound class is very important
part of an operative procedure. And we get a lot of questions
and — about wound class. Can you please tell me what
this wound class should be? Tell me if I should call
this the IP [inaudible]. What should I call this wound class? What should I call that? We have really stopped giving wound class
recommendations, that’s not our role in NHSN. It should be applied by someone who is the
field and involved in that specific case. So there — we’re going to
talk a little bit about — more about this, but you’ll note here at
the bottom of this one, clean wound class. There are a set of procedures and they’re right
there — APPYs, billys, procedures [inaudible], COLOs, rectal, small bowel and vaginal HYST. You will never be able to enter those when you’re entering your
denominator data as a clean procedure. That’s really the only time at this
point that we really want an IP, we’ll have to maybe put in something different. If you’re still having problems with your
OR, calling any of these clean procedures — you’re not going to be able to
because clean is not an option on your dropdown menu in the application. It just starts as a clean contaminate it,
so that’s where you’ll work again with your OR liaisons, your OR education
team to make sure that they know — this group based on really
outside expertise and experts in this said these should
never, ever be called clean. Aside from that, they’re —
we really have removed any — the sense of saying that we’re going to tell
you this has to be clean contaminated, whatever. So, that’s, you know, why we don’t
like to assign wound classes. In last year under wound class, we had
had an asterisk next to the work “genital” and that asterisk had said that that actually —
the word genital should — this was last year — should — and you’ll see if you look back — what also means the male and
female reproduction tracts, which are quite different
than your genital tract. And that was something NHSN had put in —
that was our own thing we put in last year and we realized we aren’t happy with it. We took it out, it is in part — we really have
the wound class exactly how it’s written now by the — the group that developed these. We didn’t develop wound classes, so we removed
that because that would imply that an ovary is, you know, is always a contaminated
class and that’s just not true or a procedure on the testes is contaminated. Well, that is not true and we
got a lot of pushback about that. And then you’ve got your contaminated,
dirty infected — these did not change. They’re cut exactly from the guidelines. I went over this, but these are the procedures
that can never be coded as a clean wound class. So based on this, you really could have a
clean c-section, it’s not your genital tract. It connects to, but we got
a lot of questions like, “We have a lot of really planned
elective non-ruptured c-section patients.” I mean, they’re kind of clean as a
whistle when they go in, they — you know. Do I have to call that clean contaminated?” And we have historic — there has
been historically that we have — that’s been said yes, but we now have a
saying, “You know, you can have c-sections that are elective, plan, no ruptured, no
connection to the — to the genital tract there, you know, that would — could meet criteria.” So again, what we’re really putting
it to is it really needs to based on the findings of that particular case. We’re not involved there. We don’t know what happened in that OR
and let them assign the wound class. And if you feel like there’s some really
gross errors going on, then you need to work with your liaisons and your OR to correct those. General anesthesia hasn’t — hasn’t
changed at all — our definition there. I’m going to breeze by the things that have
been the same for years, so for timing, but it’s all here if you need it. ASA score, again, they’re — I think
a while ago, but we took it out. There was an unknown, we have no more unknown
— you’re going to need to know the ASA score and this is set by the American Society of Anesthesiologist classifications
and we updated ours a little. There had been one update, so I mean,
it’s very subtle, but the ASA scores that are written in the manual are up to date. This was the new wording, it was a little
different — tweaked nothing substantive, but there is an ASA score of six that
you guys might find in your records. How many of you have ever
seen a six come across? Go have a seat. Yeah, I’ve got about 10 hands up. What six is, is the ASA score
that’s usually assigned on a brain dead patient when
they’re harvesting organs. And so, we do not want those —
you don’t want a — you’re — those procedures are not going
to go into your denominator data. A procedure done on a brain dead ASA six
patient shouldn’t go in your denominator data because if you think about it — there’s absolutely zero risk that
patient’s going to get an SSI. I mean, that — bluntly put
that’s true, you know, so. Okay, emergency procedure — select if
the emergency — and these again, all — a lot of these things you’re seeing pasted
here, I’ve — from the table of instructions. So if you forget this, look at your table of
instructions for your denominator procedure. So an emergency means that
they really did not allow for your standard immediate pre-op
preparation that you do on those cases. What’s your normal pre-op prep
that should be done for a patient with that procedure that’s being done? They couldn’t get their vital signs stable or they couldn’t do the correct antiseptic
skin prep or for colon procedures, they were not able to even do a colon prep. That’s an emergency procedure. If they were there long enough that
they got everything done perfectly, well that probably won’t get
coded as an emergency procedure because you know how long a
bowel prep takes, you now? It takes while. So, now trauma it seems like it shouldn’t
be a difficult field to fill out, but I do get questions about this. Trauma — yes, no. They said, “Well, what kind of trauma? How long ago?” And like, someone had trauma in their knee a
year ago and now they’re back and we’re fixing that trauma, you know, we’re tweaking it a bit. I’m like, “No, no, no. We mean the patient who is on the table right
then has sustained a trauma that you are in an immediate nature needing to repair.” So a patient who has a fall and
breaks her hip, blunt trauma — that’s blunt, I get that one a lot — has a broken hip, now needs
an Hpro procedure to be done. That is considered that was due to a trauma. Now they might not have gotten that patient
to the OR the day the trauma happened, but that is being done due to
a fractured hip that occurred. It — you know, but not one that occurred
a year ago, and now has to have a revision, so hopefully that’ll help with that. Scope — this is if the entire NHSN
procedure was performed using a laparoscopic or robotic assist. And so, that’s when you say scope
yes as one of the risk factors. No if the extended — if it
was extended for hands assist, there are some huge extensions they do now
and they take lab [inaudible] and they open it up like to three inches long and put in
these wound protectors and hand assist — so you have the surgeon actually
putting their hand completely into the colon and pulling things out. Well, that’s — now that would
be a scope no because you have like a three inch — you
actually have an incision. It’s not — no longer just
a laparoscopic procedure. If a scope was used for an entire HYST or
VAG HYST, but they then just remove the — the uterus through the vagina,
that’s still a scope procedure. You know, the fact that they
had to actually remove it — it’s not — make it not a scope procedure. The diabetes field — we
went over that definition and you were given the workaround for that. So that’s the diabetes — it’s now new,
it’s just that before it was only there for c-section patients and now
it’s for all procedures that are in your denominator reporting plan. Height, weight we covered — just to remind you, these are all these new wonderful
risk factors we’ll be able to have risk adjustment for very soon. And this is a picture of what it looks like or
if you haven’t actually visually seen it yet, you can see how the height is in. It automatically figured out the meters. The weight is in, it automatically
fills in kilograms or pounds, depending what you put in it. And there’s that wonderful little
BMI that it calculates for you. Closure technique — I’d already
shown you a picture of that. It’s going to either say primary or
other than primary on your dropdown. And if you’re — if you tend to fill out
a form and then hand it off for someone, this is what it’s going to look like. We already discussed that definition. Surgeon code — this is not a mandatory field. It’s certainly helpful and I highly recommend it so you can give surgeon specific
information back. So that’s where you can use that,
still not asterisk, not required, but a question I get a lot
particularly for reconstructive cases or breast procedures if you follow those. They’ll have a team, a primary physician
who does the, like bilateral mastectomies and then a plastic surgeon who
comes in and does the implants. So you have a team and they said,
“Who should we attribute this SSI to?” Well, this is not a required field of ours and
we don’t really dictate how you want to do that, but we say, “It’s usually the person who’s
primary in the case or who has the most — the longest part or more complex part
of the procedure, but if you have a team that works a lot together, you can
just set up a surgeon code team.” So your code that says 300,
well that’s Dr. X and Dr. Y who always do these two cases together. And then you’re not pointing your
finger at any particular surgeon. Now, I’m going to stop. This is a perfect place to stop.

Catheter-associated Urinary Tract Infection (CAUTI) with Case Studies (Part I).

Catheter-associated Urinary Tract Infection (CAUTI) with Case Studies (Part I).


[ Silence ]>>Good morning everyone and
welcome to our third and final day of the 2014 NHSN Training Course. We want to acknowledge again, all of you here who have given your undivided
attention and great participation. Everyone in the room as well as
everyone watching the live web-stream, we do appreciate your participation. I have multiple updates that I’ll give
throughout the day but I have a couple of important things that you’ll
need to know first thing. We wanted to remind you that the
evaluation forms are in the back on the back table outside of this room. I was told that if you are getting CE’s,
well, when you apply for that you’ll be able to do the evaluation on the computer so you
don’t necessarily have to complete it today. But if you aren’t going to be
applying for CE’s then we ask that you do complete the evaluation form today,
and leave it on the table before you have to go. We really appreciate your feedback and
your input and it is important to us, so we do ask that you complete that
if you are able to give your input. With regards to feedback and input we wanted
to let you know, we know some of the people in the front have a hard
time with the bright lights. We can’t unfortunately dim the lights any more than we already have because
of the live web-streams. So we apologize if they’re a little
bright or hot on the tops of your heads. We also know that the round tables
haven’t been ideal for you in the room. Again, hoping that you’ve been able
to see the presentations with all of the drop-down slide viewing but I know
it’s difficult if you have to have your back or have to turn around to face the front. Just so you know, the reason we chose to
do it this way was because we really wanted to maximize the amount of people we could get in
a room and get here to this in-person training so that you’d be able to actually
be in the room if you wanted to. So many people enroll and register to try to get
on the random list that we felt that we should, you know, try to do this so that we
could maximize to the 300 or over, but we will evaluate for next year to see if there’s any way we can fix
that or get a bigger room. Let’s see, I wanted to remind you that the team
outside the door is in the back to help you with your transport to the airport. So, they can help you with all of that but they
need you to sign up on a sheet and let them know when your flight is so that
they can group people together and make sure everybody gets
to the airport on time. And if you are leaving early, which we
want you to stay today as late as possible to hear all the important information being
presented today, but if you do need to leave and you know that it’s going to be ahead of
schedule, please let them know now or as early as possible so that they can make sure
to set you up front aside to get you out early for the transportation. We ask that — oh, yes this is very important. So, you have met many of the individuals
who answer the NHSN mailbox for you. There is a group of user support
team that you were not able to meet because they were not presenters and they’ve
actually been working behind the scenes to continue to answer the mailbox of questions
that come in over the course of this training and are always the front line
individuals that help you. So there’s a group of those. The individuals, the infection preventionists,
a lot of the data analysts, data analyst methods and analytics team, you’ve met here, so
now you know that there’s not hundreds of people behind the scenes
available to answer your questions and when we give the training we always know
that there’s going to be a hike in the mailbox because of all the important
information that was presented. So over the next few weeks the
mailbox is going to double. Over the next two weeks we’re actually down
one IP because she’ll be away for two weeks, so we ask that you give us a little
bit of leeway and understanding if it takes a little bit longer to
answer questions in the next few weeks and give us your support with that, just
to make sure that we catch everybody back up with all the information
that’s been presented. So we just wanted to bring that
to your attention because I know when you ask questions it’s very important and you need those answers
because you need to do your job. We do recognize that too, so we will do the
best that we can to keep up with the questions that already have begun to
come in in these past two days from viewers watching the live web-streaming. And a reminder for these
presentations, they’ve all been taped. They will be archived and posted. We expect them to be up by mid to late April
and this way for your reviewing pleasure, and anyone that you want to pass the information
on to — individuals who couldn’t come, people who weren’t able to get
onto the live web-streaming. They will be broken up into
sections and sessions by topic so that individuals can watch them when
it fits into schedules and do it even in a little more piecemeal
than three days in a row. Because I know it’s a lot
of information to take in. There’s something you might want to watch
again, it’ll be available for you to watch. So I think with those, I will have
Kathy come up and talk about CAUTI, and we’ll give some more
announcements right before lunch. Thank you. [ Applause ]>>Good morning. Well, today we’re going to talk
about catheter-associated UTI’s, and we’re going to try to have a little bit of
fun today so, since you’ve had two long days. Hopefully you’ll enjoy this
morning’s presentation. So, I’m am going to have to cover a little
bit of information that I’ve already covered, such as HAI definitions, POA’s, because we
have people tuning in for the web-streams that may have not listened to
the [inaudible] definition. So if you want to tune out in those situations
you can, and hopefully you’ll tune back in when it’s something new for you,
but just a little bit of a warning. So, today we’re going to go over
the CAUTI, definitions and key terms that are utilized in CAUTI surveillance. We’re going to talk about how to collect
the urinary catheter and patient data. We’re going to again identify the data
collection forms and then we’re going to apply the definitions to
some patient case studies. So, same general overview
that we’ve done in the past. And we’re going to cover the epidemiology,
the definitions, and the changes for 2014. Talk about denominator collection
and I’ll provide you some resources, we’ll do case studies, and then lastly I
do want to give you an update on, you know, what’s going on with the CAUTI definitions. You probably have heard that we
are reviewing those definitions. We’ve actually been reviewing them since the end
of 2012 and hope to have some changes for 2015. I might not be able to give you a
lot of specifics because I’ve learned that don’t give specifics until it’s
actually totally done because as sure as you know what it’s going to change. So — but I can tell you what, you know,
what is being done and then for those of you that are coming to APIC I’ll also be going
a presentation there and maybe I’ll be able to give a little bit more
details at that time, so. So again, we’re not going to go over in-depth
today requirements for the Centers for Medicare and Medicaid Services Inpatient Quality
Reporting Program or the Oncology, the Cancer Exempt Hospitals Reporting. All that information’s available
on our website or through the QIO’s and I’ve provided you those resources here. Also, we will not be going through step by
step data entry and Maggie’s been covering all of the data analysis for us very
well, so we don’t have to do that. So, CAUTI’s, who cares about CAUTI’s? Right? Who cares? Urinary tract infection is tied, believe
it or not, you probably know this, with pneumonia as the second most common
type of health care associated infection, and it’s really only second
to SSI’s in overall incidents. And we know that the majority of them
are associated with indwelling catheters. I don’t know if you’re aware but a
little over 5% of ICU CAUTI’s result in bloodstream infections and in
non-ICU CAUTI’s that is up to about 7.4. So, interestingly enough, higher
secondary BSI rate outside of the ICU. 13,000 people die every year for UTI’s,
so you know, it does cause some morbidity and mortality, and interestingly, up to
1/3 of asymptomatic bacteriuria is treated with antimicrobials even though this is, you
know, in conflict with published guidelines and results in a lot of unnecessary
antibiotic usage, C. difficile infections, adverse reactions. And so, that’s one of the main reasons that
ASB was removed back in 2009 from our criteria. So, it’s important for us to shine a light, sort
of, on CAUTI and what we can do to prevent that and how we can treat it and
identify it correctly. And a lot of people are saying now that, you
know, CAUTI’s may be a proxy measure for the overall general quality
of care for patients. So, you know, that’s another reason that we might be concerned
about what happens in this area. So again, we just want to make sure that
all of our data that we enter is good data. And so, things to consider
for CAUTI surveillance. So, nice thing is that unlike SSI
surveillance, all CAUTI’s are going to require a positive urine culture. So you can start with your laboratory
as your basis for case finding. So hopefully you’re all able to
get a routinely generated report of your positive urine cultures
and that’s your starting point. But I do want to point out that
it’s really important for you to know your laboratory’s urine
culture reporting policies. Specifically, what are the ranges of
colony-forming units that they’re reporting? Some facilities don’t report down to
10 to the third, which is, you know, part of the definition for UTI’s. Some of them don’t quantify yeasts, and so your
facility’s not able to meet all the criterias that are currently written since we include
yeast as a pathogen for CAUTI’s at this time. Sometimes positive urine cultures are reported
for the unit on which they were collected and not necessarily on the
unit that the patient is on. So you may need to check to make
sure that you’re attributing that CAUTI to the right location. It seems to happen a lot with
patients that are discharged. Sometimes the discharge location — or
location for the culture is not accurate. So just — you need to consider
the transfer rules and how the laboratory report
might be affecting that. And finally, you know, just to take into account
that you need to account for positive cultures from the Emergency Department because those
could really represent CAUTI’s from patients that had recently been discharged
and might be — should be attributed to that
discharging location. So again, what are you going to look at first
and where is it going to be on the record? Those are, you know, things
that you need to think about. You’re going to be looking for your urine
culture results and your laboratory results. And then probably what you want to look
for — unless you’re in Pennsylvania, most facilities — not a lot of
facilities are doing surveillance for non-catheter associated UTI’s,
so you know, you’re going to look — maybe the next thing you look at is whether or not they had a urinary catheter
in place in the time period. You know, and you’re going to be
looking for nursing documentation and graphic sheets for those
types of information. This is a sample worksheet that, you know, that
we put out for your use for data collection. You guys — some facilities create their
own data collection sheet, which is fine, just as long as it collects all of
the information you need for NHSN, but this one is available
on the website for your use. And then, you know, the old spiel about making
sure that we’re all doing things the same way. I went over this pretty well with CLABSI. You know, we need to all be
consistently applying the definitions. Standardizing your chart review will
help you to be consistent over time. So if you get into a routine
of how you collect data and how you identify cases,
that will really help. Maintain the focus on the criteria
and don’t deviate from that. CAUTI is one of those areas sometimes where
people feel that maybe they’re not capturing all of the patients that they
clinically believe have a UTI. We hear this a lot with patients that are on
ventilators or spinal cord injury patients, maybe because, you know, they’re not
able to communicate, for whatever reason, suprapubic tenderness or CVA pain. Surprisingly, though, honestly only —
well, 80% of our patients that are reported as CAUTI’s have fever as their only symptom. That may be surprising to you or it may not be. So, if you think about it that way,
the spinal cord injury patients or the ventilated patients
are maybe not that different. I mean, most patients when we identify
it it’s through the use of a fever. You know, the other thing to think about
with that, I always tell people is that just because a patient is ventilated doesn’t
mean they can’t communicate pain. Especially with these sedation vacations
and depending on the level of sedation, patients can exhibit signs of pain if
their physical assessments are done. So, I don’t — I always hate for people to
just say, “Well they’re on a ventilator, we can’t tell whether or not
they have an suprapublic pain. So that’s not always the case. So again, think about surveillance definitions
versus clinical definitions and the fact that sometimes the two are not going to meet. You know, we’re looking — we’re using
the definitions for surveillance different than clinicians are using to make
determinations about what’s going on with a patient and what they should do. And our data elements are going to be limited. They’re going to be finite
and the clinicians are able to use everything that’s available to them. So, it’s okay if they don’t always match. We obviously try to make our criteria so that
they are as close to clinical definitions as possible, but we have a long way
to go, especially in CAUTI, I know. But we are definitely working on that now. Was that a laugh [laughter]. So, sometimes, you know, sometimes it’s
helpful to remind your staff about surveillance or to educate staff about
surveillance in clinical definitions. How many people here have had to have
this conversation in their — yeah. Yeah, yeah. Yep. And surprisingly, sometimes it’s infectious
disease physicians that you have to have that conversation with, which
is always surprising to me because I would have thought
they understood that. But we always want to make sure obviously
that we’re using the surveillance definitions as a determinant of what we report. And we’re always here at
[email protected], as Dawn told you, to receive your questions
and try to help you out. Oh! So, I want to make a disclaimer. I thought it would be fun if I
shared some of the funny emails that we get from users, because we get some. I didn’t include any identifiers
on these, so if it’s from you and you recognize it don’t
tell anybody [laughter]. And they will not know. So I’m going to share — as we go
along today I’m going to share a couple of funny emails that we have gotten. So, here’s one that I got from a user. She said, “I am looking at a patient that
presented to our facility on 2/15/13. A Foley was placed in the
ER on the admission date. During her stay she was afebrile
and symptom-free with one exception. A temp of 102 was documented at midnight. The nurse manager feels that this is possibly a
misdocumentation and would like some guidance. Do we still call this a CAUTI?” No, you can just discount that [inaudible]. Don’t worry about it. It’s probably a mistake. Yes, you have to still call this a CAUTI. All right, so we’re going to get into
the nuts and bolts of the definitions and we’re not really going to be talking about
non-catheter associated UTI’s here today. As you may or may not know, they
have their own criteria designated as the B criteria’s for SUTI. The A criterias are all catheter-associated, the
B criteria’s are all non catheter-associated. And I want to identify that ABUTI
can also be non-catheter associated or they can be catheter-associated. And if you are determining
whether or not an LCBI, BSI is secondary to a non-catheter
associated UTI, you have to make sure that you use non-catheter associated
definitions and you’ll see as we go along, if you don’t already know, why that’s important. So, there are basically two
specific types of UTI. Symptomatic UTI, or SUTI, or
an asymptomatic bacteremic UTI, or ABUTI, as we like to refer to it. I do want to point out sometimes people are
confused between asymptomatic bacteremic UTI and asymptomatic bacteriuria or
ASB, which we used to have in 2009. Asymptomatic bacteriuria just means
that there are organisms in the urine, but an asymptomatic bacteremic UTI is one
where there’s not only organisms in the urine but there’s also a matching
organism in the blood stream. So the patient has a blood stream infection
as a result or concurrently with the UTI. So that is the difference,
they’re not the same animal, and it’s important that you understand that. Both types of infections, both SUTI’s and
ABUTI’s, if they’re catheter-associated, need to be reported as part of any CMS,
CAUTI surveillance that you’re doing. That’s another thing that’s sometimes
people don’t quite understand. You can’t just report the SUTI’s,
you also have to report the ABUTI’s. So, you know, over the years as
I’ve presented this information, I’ve presented it in different ways
and sometimes it’s hard for people to understand the logic of why
the definitions are as they are. Sometimes they seem like they’re really
complicated, so I’ve tried to present it in different ways and this
time I thought I’d tell you — just present the logic behind
the SUTI definitions. And one of the important points is that the
symptoms of a true UTI are going to vary whether or not the patient has a Foley in place. If the patient has a catheter in place they’re
going to have urgency sometimes, you know. I mean, how many people have had a patient and
they said, “I’ve got to go to the bathroom.” And you say, “You’ve got a
catheter in, just relax.” You know, “You can go.” So, that foreign body causes urgency, it can
cause burning, a burning sensation sometimes. You shouldn’t be having frequency,
so we took those out of patients — you know, they used to be in the
criteria for patients that had Foleys and they didn’t make any sense to be in there. So that’s why we’ve taken
them out of the criteria for patients that are currently catheterized. Infants, we know exhibit different
symptomatology as well for infections and that’s why we provide some infant-specific
criteria, and those additional ones are apnea, bradycardia, lethargy, vomiting, or hypothermia. Because, you know, patients can have instability
in temps when they have an infection. So, these are sort of the two big concepts of
why we have some complexity to our UTI criteria. So this is sort of an overview
of the UTI definitions. So, we can see that I’ve
divided these by age groups. SUTI one and SUTI two are
for patients of any age. SUTI three and SUTI four are for infants. And then we have our ABUTI’s, which
again, are for patients of any age. Now, I told you yesterday that infants not only
can meet these but they can meet any of these. It’s just the patients that are over one
year of age that cannot meet three or four. Okay. Within each of these different
types of UTI’s we have catheter-associated or non-catheter associated UTI’s. Make sense? All right. So now we’re going to look at how the
colony-forming units are applied to these. So, for SUTI one and SUTI three
we’re dealing with patients that have at least 100,000 colony-forming units. And I have an asterisk here, you’ll
notice that it goes down to — they have to have no more than two
organisms in that urine culture. And that’s because we want to make sure that
this is not a contaminated urine culture. If there’s three or more organisms
the chances are pretty high that that’s been just a poorly
collected culture, we don’t want to use it to
say that somebody has a UTI. We don’t want to over-call these UTI’s. ABUTI also requires greater than 100,000. You’ll never have an ABUTI that has less
than 100,000, and that’s for a reason. You know, we — this patient is asymptomatic,
so we want to have a high degree of — as high a degree as we can of
confidence that this is truly a UTI and so that’s why we’re going to require
a high colony-forming unit count. You’ll notice, though, there’s two
stars there and that means that not — we don’t use organisms, we use uropathogens. So there cannot be more than two uropathogens and we provide you a list of
what those uropathogens are. It’s a pretty broad list, but there are a
few organisms that are not on that list. That list is included in
the NHSN CAUTI protocol. I’m trying to remember. I think we have it on our organism
list, too, that’s on the website where we have MBI and we have common commensals. People are nodding, so. So that leaves SUTI two and SUTI four. So you’ll notice that one of the infants,
the SUTI three, has 100,000 or more. One of the infants has greater
than 1,000 or less than 100,000. So we have adult and child, adult and child. Or, I say adult — any age
and child, any age and child. So this group here, SUTI two and four
have a lower colony-forming count, 1,000 or more, but less than 100,000. Again, no more than two organisms
in the culture. Because this is a smaller colony-forming
count, we are going to require some symptoms — I’m sorry, some supportive positive
UA to give more credence to the fact that this is truly a good culture
and indicative of an infection. So that’s why this criteria requires this lower
level colony count and a supportive positive UA, again, within a time period of no more than
a single gap day between adjacent elements. Okay. Is this a good way to present this? Does this make sense? Okay. Good. Thank you for the feedback. Okay, so when we’re looking at a symptoms really
the main question that you have to ask yourself, and I went over this a little bit, was the
catheter in place at the date of the event? If the answer is yes, then you’re going to have
a limited number of symptoms that you can use. You can only use suprapubic tenderness,
costovertebral angle pain or tenderness, or fever greater than 38 degrees Celsius. If it’s a baby you can additionally
use hypothermia, less than 36, apnea, bradycardia, lethargy, or vomiting. Okay? You’ll notice what we’ve taken
out of there when you look at the no. So there was no catheter in
place on the date of the event. You’ll see here I bolded. You now have dysuria, frequency,
or urgency that you can utilize. And then you have all that
you had for the yes answer. You have your suprapubic tenderness, CVA pain or
tenderness, fever, and then the infant criteria. So we simply remove these
three, dysuria, frequency, or urgency if the catheter is in place. As I said, when there’s more than two species
of microorganisms that’s routinely regarded as a contaminated culture and we
don’t want to use it for NHSN. We do get questions about culture
reports that come back as mixed flora, and generally mixed flora represents
more than two organisms, two species, so if you have mixed flora and you
have any additional organism recovered from the same culture that’s going
to have more than two organisms. So, for example, if you have to
report that maybe there’s a greater than 100,000 Pseudomonas
aeruginosa, and there’s mixed flora, clinically we probably would
believe that greater than 100,000, but unfortunately we have mixed flora
in there so we can’t utilize that. This is one of the issues that we’re kind of
talking about with the new definitions also. You know, can we say if there’s
a preponderant organism, can we say that that should be utilized? As it stands right now, in that situation
you would not use that culture report. If the organisms are the same
genus but two different species, they’re considered two different organisms. So if you had a Pseudomonas and aeruginosa — aeruginosa and a Pseudomonas stutzeri
[assumed spelling], that’s two organisms. If you add anything onto that you’re
not going to be able to use the culture. And kind of the flip side of
that, if you have an organism that has just simply the same organism but has
different susceptibility pattern such as MRSA or MSSA, those are considered just
one organism because, you know, we know that how the laboratory works those
up they may just pick different colonies from, you know, that — cultures or colonies
that represent the same organisms and there is some variation
and resistance within those. So, we don’t want to say that those
are different organisms all together. So those will be considered just one organism. Okay. Sometimes, obviously patients will
have a positive urine culture — excuse me — shortly after their catheter is removed. So, for those patients if
the event date, the UTI date, is on the day of device discontinuation or the
following calendar day, just like for CLABSI, these are going to be considered
device-associated. As long as the device had already
been in for greater than two days. And, for this criteria you are
able to utilize urgency, frequency, and dysuria because the catheter
has been taken out. So I’ve given you two examples. First one, the Foley is placed and
it’s there, it’s placed on day one. Day two it’s still there. Day three it’s in place for part
of the day and then only for part of the day and then it’s removed. The next day the patient meets UTI criteria,
this is going to be considered a CAUTI. Unlike here, where the Foley’s placed
on day one, it’s taken out on day two. It was there for part of the day, taken out. The next day they have no Foley
and they meet criteria on day four. That is going to be a health care
associated UTI, but it’s not going to be considered a catheter-associated UTI. Whether or not you clinically agree with that
or not, that’s the definitional interpretation. Okay. So let’s just go over
the criteria as a whole here. So these are the A criteria
for SUTI’s, symptomatic UTI’s. A, meaning that these are going
to be catheter-associated. On the first you’ll see its split,
the first half of this is for patients that have the catheter in
place on the day of event. The second half are for those that
had it in for greater than two days but had it removed the day of
or the day before the event. Okay? So for the first ones, it’s in
place, it’s been in place for greater than two days on the day of event. They can have fever, suprapubic
tenderness, CVA angle pain or tenderness, and they have to have a positive urine
culture of greater than 10 to the fifth, and no more than two species of microorganisms. And again, the gap day for
— single gap day does apply. If the catheter had been in place for greater
than two days and it was removed the day of or the day before the event, then we add in
dysuria, urgency, frequency, and then, again, fever, CVA, suprapubic/SP tenderness, and the
same requirements for the positive urine culture of greater than or equal to 10 to the
5th and no more than two microorganisms. Now, you’ll notice that there is an asterisk
here for with no other recognized cause and for those astute clinicians, you’ll
notice that it’s not there for fever. And this is one of the questions that
we get the most and one that, you know, we are discussing how best to approach this. The reason it’s not there is because, to allow
— and this happens more with CAUTI than it does with CLABSI because, you know, with CLABSI
one you don’t have to have any symptoms. But you know, if the patient has a pneumonia
and they have a positive urine culture because they’ve pan cultured the patient,
if the fever is there the fever has to be utilized to meet the UTI criteria. If you’re doing pneumonia surveillance, you’ll
also have to use it for the pneumonia criteria, and that’s because at this point
we haven’t figured out a good way to operationalize clinical
judgment about where that UTI go — or where that fever is responsible for. And it may be responsible — it
may be due to both infections. If the patient has both infections they
may be running a fever because of both. I mean the body doesn’t —
does the body differentiate? I don’t know. So, the only way I think that we could
get around this would be if we were to identify a hierarchy of infections. Okay, if they have this and they have
this infection and this infection, you apply the fever to this infection. But you see that quickly becomes very complex. And so, that’s what we’re wrestling with. So for now the fever is a non-specific
symptom and you have to apply it to all potential infection types. Criteria in two, again this is in A so these
are catheter-associated infections you’ll see. Two, again, is for those patients that have
less than 100,000 but greater than 1,000. If the catheter is in place the symptoms
are exactly the same as they were for A. You’re going to have those symptoms
minus dysuria, frequency, and urgency. Additionally, however, you’re
going to have to have a positive UA and by positive we mean a dipstick that’s
positive for leukocyte esterase or nitrite. Or pyuria, that means greater than
or equal to 10 WBC’s of unspun urine. How many of you know whether or
not your lab spins your urine? Okay, how many of you don’t know? Yeah, so you need to see if it’s being reported
out to you or if not you need to clarify that with your laboratory because if it’s
spun urine, it’s greater than or equal to 10, if it’s unspun urine they’re going to be
looking at it under a high-powered field and it’s greater than five WBC’s to be positive. Okay? And, you could also
meet this using a gram stain if there’s microorganisms seen on unspun urine. Not many laboratories do this anymore. Questions that we do get
sometimes is what is trace? Is trace positive? Yeah, trace is positive. So if you have a trace leukocyte
esterase, it’s positive. Just like with one A; you know, we have
this top portion that was in place. We have the bottom portion that the catheter
was taken out the day of or the day before, that means that we’ve added back
in urgency, frequency, or dysuria. Just as above, this is the ones that have equal
to or greater than 1,000 but less than 100,000. And they have to have one
of the same positive UA’s. So the only difference between the top and the
bottom is the additional criteria of urgency, frequency, and dysuria, if the
catheter had just been removed. Clear? Yeah? Looks like everybody’s with me. Yay. So I’m not going to go over this diagram, I just want to point out
that it is in the protocol. Some people are very, you
know, they do much better with a flow chart than they do all of the text. So we do have it there. One is for — this one it happens
to be if the Foley is in place. We have one if the Foley is removed. There are similar flow charts
for three and four and for ABUTI. Now the criteria for the infants, one
year of age or less, is very similar. You’ll notice that three is very similar to one in that the colony-forming units is
greater than or equal to 100,000. The only difference between the adults — or
the all-age criteria and one and the three is that we’ve added, again, hypothermia,
apnea, bradycardia, lethargy, and vomiting. Other than that it’s exactly the same. The one difference that I’m going
to say is that you’ll notice that we have two asterisks down here. Rather than splitting this up, we have
simply said between those patients that have the catheter or those that had
it removed, we’ve just asterisked down here that if they had the catheter in place for
greater than two calendar days with the day of device placement being done and the
catheter was placed on the date of event, that they can utilize these symptoms here. Four is very similar to two, it’s the analogy of
two in that the colony-forming count is lower, it’s greater than 1,000 less than 100,000. Because of that you need a positive UA. The positive UA results are no different
for children than they are for adults. And, again, those additional
symptoms that I mentioned above. So, this, just to point out that this
double asterisks is how you’re going to determine whether or not this is a
catheter-associated device — or UTI or not. Asymptomatic bacteremic UTI — I’ll give you
a little bit of background for those of you that don’t know how this definition came about. Back in 2009 when we removed ASB, asymptomatic
bacteriuria, we didn’t anticipate a problem that would occur from that, and that was that
if a patient had a positive urine culture, but they didn’t have any symptoms,
it could no longer be called an ASB. It used to be that that could
be reported as an ASB. If it was recorded as an ASB, then it could be
said that an LCBI that occurred at the same time with a matching organism was secondary to that. Well, when we took away ASB, we now
had these positive blood cultures that matched a urine culture but
they couldn’t be called secondary and so if the central-line was
in place they became CLABSI’s. And that didn’t sit well with
people, it didn’t sit well with us. So, we developed asymptomatic bacteremic UTI. So this is for a patient that has a urinary
catheter in place or doesn’t have one, it could be catheter-associated
or not, and any age patient. So, we don’t have an infant one. They can have none of the symptoms that we’ve
mentioned for any of the other criteria. Okay? So, I’m not going to go through all those. They simply can’t have any
of the earlier UTI symptoms. Additionally, they have to have a positive
urine culture or greater than 10 to the fifth. Again, no more than two species, and a list of
specific uropathogens that have to be involved. And we’ll go over those in just a second. There has to be an accompanying,
matching blood culture with at least one organism to the urine culture. If all that occurs within a time-frame that
doesn’t exceed a gap of one calendar day between two adjacent elements, then this is an
ABUTI, and you would not call it primary BSI. Okay? That list of uropathogens are listed
here, as I told you it’s pretty broad — gram negative bacilli, staph
species, yeast, beta hemolytic strep, enterococcus, gardnerella vaginalis. We took these lists from —
I can’t remember the source, but we didn’t make this list up [laughter]. I can get you the list at
the source if you want it. Aerococcus urinae and choroni bacterium. You know, it’s very seldom that I hear
of an organism that doesn’t fit in here. So, and that complete list is,
you know, listing up the species as well as the genus, is on our website. Okay. So, just to say again, only the events for
ABUTI that had catheters in place for greater than two calendar days prior to the date of onset are catheter-associated
otherwise they are none. And then UTI’s is one of them that we get
a lot of questions about the recurrence. Is it new or is it a recurrence? Do we have to report a whole separate UTI? And the guidance here is no
different than it was for LCBI. We say look to see what evidence
of infection is still occurring, does it appear that the infection
has resolved clinically or are they still being treated
for the first UTI? If either of those is yes, then we would not
assign a UTI, we would say it’s a continuation. And that is irrespective of whether
or not it’s the same organism. So, I always use yeast as an
example because it happens so often. Somebody’s being treated for E. coli UTI and four days later they have a
positive urine culture for yeast. They’re probably still being treated at
four days and in that case, if they are, then you’re just going to add that yeast onto —
if you’ve reported the UTI, you’re going to add that yeast on as a pathogen to that, rather
than calling it a separate infection. Okay, you ready for another email? They get funnier as we go along. So, this is one we got. “Good afternoon. I have a patient who met all the criteria for
CAUTI on 1/21 when she spiked a fever, however, she was declared brain-dead on
1/18 and was only being kept around so her organs could be harvested. Would she be considered a CAUTI.” I thought, that’s a really
strange way to phrase that. She was only being kept around
so her organs could be harvested. The answer is yes, we do include
patients that are in hospital, you know, they’re organ-donation patients, because we
shouldn’t be giving them UTI’s even though, you know, they’re here for organ-donation. So, and we actually have reviewed
that decision with our patient — our organ transplant team and they
were in agreement with it, so yes. That got people talking. Okay, now we’re going to go on to key terms. So, obviously all CAUTI’s have to HAI. So we’re going to talk about POA versus HAI. Here’s where you might want to tune out if
you’ve heard this all more than you want to. A POA infection is one that
all criteria, all criteria, are present during the two calendar
days before the day of admission, the first day of admission,
and/or the day after admission, and are documented in the medical record. If it’s POA, you shouldn’t be reporting
it to NHSN, we are only interested in health care associated infections,
and acceptable documentation, again, does not include that reported by the patient. If the patient says I was
febrile, you can’t utilize that. You can if a report comes from the other
hospital that the patient’s febrile. And something I didn’t mention
is that we really, you know, we’re trying to balance what we
require for you to know and whatnot. We didn’t want you to have to go back
and ask the facility what the fever was. So, as long as it’s documented
that the patient was febrile, you can use that to meet
that part of the criteria. Physician diagnoses is not a
part of the CAUTI definition. So, a patient coming in and a physician says
he has a UTI, that is not sufficient to say that the patient had a UTI on admission. Okay? Patient is going to have to meet
the criteria during that time period. So here’s the unlucky family again. Grandpa Unlucky has been in an inpatient rehab
facility following multiple fractures sustained in a multi-car pileup when Atlanta sustained
the Snowmageddon of 2014 [laughter], otherwise known as a half
an inch of snow [laughter]. Yep. He’s now transferred by the way, to your
hospital with a Foley catheter which has been in place for two weeks and
reported by health care worker of fever the day before transfer
and a change in mental status. He’s afebrile on admission and his urine
cultures collected on admission are positive for greater than 100,000 CFU’s of E. coli. So, we’re going to vote again this morning. Which of the following is most accurate? He does not have a UTI. Has a UTI attributed to the new hospital. Or he has a UTI attributable to the rehab
facility and is POA to the hospital. Okay. Let’s see how you’ve done. Couple more seconds. So, 96% of you think that the patient has
a UTI attributable to the rehab facility and POA to the hospital, and
that is the correct answer. And let’s see why. So, he — on the date that he’s admitted
to your hospital there was a report of fever the day before transfer, which
was reported by a health care professional. And he had a urine culture collected,
which was greater than 100,000 of E. coli. So he meets SUTI one A, present on admission. Actually, attributable to the other hospital
and we do encourage you to communicate with other facilities to let them know when
you identify an infection that is attributable to them and if I was you I certainly would,
because I don’t want to be compared to somebody that was not collecting all of their data. Definition of a health care associated
infection, again, it’s considered HAI if all of the infection’s specific criteria were not
present during the POA definition time period. So, not POA, but they were all present on or
after the third calendar day of admission. Again, they have to occur within a
time period that does not exceed a gap of a single calendar day between
any two adjacent elements. And, did we define a gap day
as a calendar day in which none of the infection criteria are present. The transfer rule, as you all know, is if
the patient meets the criteria on the day of transfer or the next day,
we’re going to attribute that back to the transferring location. If it occurs after that time period,
after the day of transfer, the next day, it’s going to be attributable
to the receiving facility. And, you know, this applies also
to patients that are discharged. If they go home and then you find out
the next day, they come back and you find out that they have — even if they
don’t come back, if you find out, maybe you have communications
with your medical offices. But if you’re aware of it you’re going
to attribute that back to your facility if it occurs on the day of
transfer, the next day. I’m sorry, I said transfer, I meant discharge. Okay, warning. The next slide is very important. Does this work? [Ambulance sound] All right, here’s an example. And I say it’s really important because we
actually get this question all the time. I know that people don’t understand
this as well as they should. So this is an example that is not
present on admission, it is an HAI. Day one, the patient’s admitted. They’re asymptomatic. They have, however, a urine culture that’s
collected for 10,000 CFU’s of E. coli in the urine, but they’re asymptomatic,
as I said, and there’s no documentation in the two days prior that
they were symptomatic either. Second day they’re asymptomatic. The third day they run a fever. And the fourth day they have a culture, again, and they’re now 100,000 colony-forming
units of E. coli in the urine. This meets the symptomatic UTI criteria. They didn’t meet it in the POA. They had a positive culture but
they didn’t have any symptoms. You left that catheter in,
you know, for four days. It doesn’t say they had one
here, but you’re only going to report it if they did, probably, so. So, this is a UTI that’s got to
be reported for your facility. Okay? This is one of those examples
where it’s neither POA nor HAI and you’re not going to report anything. Patient came in and they were asymptomatic. They had a fever on the second day. The third day they’re asymptomatic again. The next day, I don’t know why, but
they do a culture on the patient. It happens. And it’s positive for 100,000 of E. coli. Asymptomatic five and six. So, we didn’t meet the criteria in the first
two days, and we didn’t meet them after that and we only had a positive
culture on day three or later. Day seven would be too long because there
would be a gap day here — two gap days here. So, this is one of those cases where
they don’t meet either criteria and it’s not going to be reported. Although, you and I believe they
have — may believe they have a UTI. Okay. Good news is we probably also would
think that they probably came in with it. Okay, I’ve covered this, the gap
day rule or the gap day definition. So, I’ll give you an example
of the gap day again. Patient is admitted on April 1st to the ICU. They put in the Foley Six
days later they had a temp. On 4/8 they’re asymptomatic, they’re afebrile. This is a gap day. They don’t have any suprapubic tenderness,
they have no CVA pain, they have no fever. It’s a gap day. The next day they have a positive urine culture. So, because there’s a single gap day here
and the Foley’s been in longer than two days, this is going to be a catheter-associated UTI. Again, if 4/9 had been asymptomatic, and 4/10 the urine culture had been
collected it would not be considered a UTI. Because there would have been two gap days. Okay. Our definition of an
indwelling catheter has not changed. That’s good to hear, hey? So it’s simply a tube that’s inserted into
the urinary bladder through the urethra, that’s left in place and is
connected to a collection system. It includes those patients
that are getting irrigations. Those patients are probably at higher risk of
UTI’s, so we include those patients as well. It doesn’t include straight, in and out
catheters, nor suprapubic catheters, no nephrostomy tubes, but if a patient has
suprapubic catheter or nephrostomy tubes, which happens sometimes, and a Foley, they are included in your
catheter-associated UTI surveillance. If the Foley’s there, they’re included. I got a question this week from
somebody that they had a patient, I think it was a spinal cord injury
patient, that they were doing — he was doing intermittent self-caths and
then at night the nursing staff was putting in a Foley catheter, and they
were taking it out every day. Is this something that you guys see? No? Okay, so she wanted to know if they were
eligible for CAUTI and my answer is yes, because the catheter was
in place each day for — an indwelling catheter was in
place some point of each day. So on the third night, they now
become eligible for a CAUTI. We get all sorts of crazy questions. Okay. And I think we’ve pretty much covered what
is the definition of a catheter-associated UTI. So, the only thing I want to highlight is it
is the date of the event that you’re looking at to determine whether or not
the catheter had been in two days. The date of the event, the date of the
last element used to meet the criteria. Discontinuation and reinsertion. We get this all the time, and as I said, we’re coming out within the
newsletter with guidance for this. But if the Foley catheter is discontinued and a full catheter day passes before a
Foley is reinserted then the day count for determining catheter-associated
UTI begins anew. Otherwise, it continues from
the previous catheter. So, I have two examples. Patient has a Foley, day three, day four. They took it out on day five. They put it back in on day six. And — I’m sorry, they took it out
on April 2nd, and they put it back in on April 3rd, this becomes day six. Continues from day five for Foley because there
was not a full calendar day without a Foley As opposed to this example down here where
they took the Foley out on April 2nd. There was no Foley for the whole day on
April 3rd and they replaced it on April 4th, this becomes new Foley day one, Foley day
two, and Foley day three on April 6th. On this date they’re eligible for another CAUTI. Okay? Again, somewhat arbitrary
but just trying to make a rule so that we all do it all the same. We just pretty much covered this; the date
of the event is the date of the last symptom. So if you have a temp on one day and a
urine culture the next day, this is — you’ve now met criteria,
this is your date of event. So, quick examples of a device-associated. Patient has a Foley inserted on
day one, they’re asymptomatic. The Foley remains in place and
they spike a fever on day two. They still have a fever on day three and they
have a positive urine culture on day four. That meets criteria, E. coli. Because they didn’t meet the
criteria in the first two days, even though they had a fever here, this
is a device-associated, this is a CAUTI. Okay? They would have had to have their culture
in the first two days for this to be a UTI but not a catheter-associated UTI. You’re just going to ignore this fever
then and utilize day three or day four. I’m sorry, I want to correct that. You can count the fever in here because what we
tell you to do is to look at the date of event. So scratch what I just said
because I don’t want to confuse you. It’s easy to do. It’s easy for me to get confused,
so just look at your date of event. Your date of event is day four here. It’s the date of the last element, because
that day is not in the first two days of the catheter, this is considered
a catheter-associated UTI. That’s really the easiest way to do it, and
it’ll get you into the least amount of trouble. And I can get in trouble sometimes,
in case you hadn’t guessed that. All right. This is not a CAUTI. Foley is inserted on day four. They have a temp of 100.6 the next day. They send the urine culture and it’s positive
for 100,000, they meet the SUTI criteria on this date, day five, but the Foley
hadn’t been in place for greater than two calendar days on
the date of event here. It had only been in, it was on its second day. So this is not catheter-associated UTI. This is also not a catheter-associated UTI. Foley inserted on day four, removed. They’re asymptomatic four days later, day eight. On day nine there’s still
no Foley, they have a fever. And on day 10 they have a
fever and they have candida. The date of event in this case
is day 10 and it was not the day of removal nor the next day, it was after that. So, it’s not considered CAUTI. Last example, I think. Patient comes into the ICU,
has a Foley put in on day four, removed on day eight, reinserted on day nine. And on day 10 they meet criteria. This is one of those reinsertion ones. This is going to be considered
a catheter-associated — oh wait, this patient has a Foley in place
for some part of each calendar day for greater than two days, and there was not a full
calendar day without a Foley in place. So this is a CAUTI. Is that clear? Location of attribution for CAUTI
is the same as it was for LCBI, it’s the location where the patient was
assigned on the day of the UTI event. And, again, the date of the
last element for the criteria, with the only exception being the transfer
rule which, I think, we’ve pretty much covered. If it occurs on the day of transfer
or discharge and the next day, it goes back to the attributing location. I’m just going to go over one example
here that we get a lot of questions about and that’s the small tie transfer rule. So in this case, patient is
in the ICU on day one of admit and on day two they’re also in the ICU. On day three they start in the ICU, then
they go to five west, then they go to CCU. And the next day they have
an HAI, in this case a UTI. This HAI is going to be attributable to the ICU since that was the first
location the day before the event. So this is, you know, your transfer rule time
period here, the day of transfer, the next day. And so this is the ICU here. Trying to expand that incubation
period, you know, to the longest time we can in those two days. Okay. Oh, this came through [inaudible]. I wanted — this was supposed to
come through in two different pieces. So we send out an email to people that said,
“It appears a user from your organization with user name XXX is in the process of
updating their SDN digital certificate. CDC is in the process of reviewing their status and will notify the user via email
when the process is complete. At that time the user will be able to log in.” So we get an email back from this person
that says, “I’ve already installed it on two computers a couple of weeks ago. You better make sure it works right
because it is a hassle to get this done and I did it all myself and it worked fine. Please do not screw it up.” [ Laughter ] Apparently, she’s worked
with us before [laughter]. Aren’t you glad those digital
certificates are going away? Has anyone here been Sammified
[assumed spelling]? Okay. Do you like it?>>Yes.>>All right, cool. All right. Sammified is a new system that you
guys will all be moving over to. Instead of digital certificates they
give you these cool little Bingo cards that they’ll have you put in codes
for and they’re good forever. So, I like this. Okay, now we’re just going to
very, very quickly, like I said, I’m not going to spend a
lot of time on data entry. I do just want to highlight three
fields here on this section. Urinary catheter — we’re going
to ask you to identify whether or not there is a urinary catheter in place
greater than two calendar days on date of event or if it had been removed but was in
place for greater than two calendar days. Or neither. There was not urinary catheter in place on
the day of event or not in place greater than two days on the date of event. Okay? This is going to drive
the system to identify this as either catheter-associated
or non-catheter associated. The location for device insertion
is optional, if you want it. Sometimes we get questions from facilities that
say, “Well, they put one in and they took it out then they put another one in. And there are different units
what do we put in?” We say, “You can make your own determination,
your own policy about what you want to do with that because we don’t
utilize that field right now. So, you know, you get to make your decision. And the date of device-insertion
is also optional at this point. I did get a question this week from somebody. It looks like on the form — I don’t see
it on here, maybe it’s on the screen. It actually says urinary catheter at time
of specimen collection and that’s an error. We missed pulling that off when we
changed the definition, so this is correct and it’s been there for a year
and a half and nobody noticed it until a user emailed me yesterday. So, just know that it’s at the date of event, is what we’re concerned about
with a catheter presence. Not the date of specimen collection. Okay, your summary data is collected pretty much
the same way it’s on the same forms as for LCBI. Again, you’re going to collect the number
of patients that are present at the time of the count, each day on the unit,
and enter that in this field here. And then the number of patients that have a
urinary catheter that are there at that time on that unit and enter it here for each
day, and then you’ll sum the numbers at the bottom at the end of the month. For NICU, I do want to point out that there
is no in-plan CAUTI surveillance for NICU’s. We no longer allow that because
they’re just used so infrequently in that patient population the
data’s not really that meaningful. But some facilities are opting
to continue to do this off-plan. So if you’re doing that,
those will be entered here. URC days and you’ll be stratifying
it by the different birth weights. And again, birth weight, not weight at that
time, but the weight of the baby at birth. Special care areas, there’s no difference
in how the data is collected here between a special care area
and an ICU or a ward. Unlike, you know, CLABSI’s you have permanent
or temporary central lines for LCBI’s, here it’s just a urinary catheter and it’s
enter — I do again, for all of these events or all of these location types you are going
to have to tell us if you’ve had no events for this month and that’s where you’re
going to check it here — CAUTI. If you don’t check that and you don’t enter any
CAUTI events you’ll get an alert and it’ll say, you know, we don’t know, do
you really not have any UTI’s or have you just forgotten to enter them? You’ll also get an alert if you
don’t enter your patient days or your urinary catheter days for that month. And so, this is the example of the alert. In-plan denominators are reported for
these locations with no associated events. So in this case the ICU, you entered summary
data, you told us how many patient days you had and how many urinary tract days you
had but you didn’t enter any CAUTI’s and you didn’t tell us that
there were no events. So you can — handy-dandy little thing here. You can just go down here
and check these if that’s so. A smart person might wait and do that. Probably not a good idea,
but you could do that, so. Again, if you want to collect your data
electronically, we’re happy to have you do that. We just ask that you concurrently
collect your data manually. You go on the unit or have whoever does
it on the unit collect it manually, do the patient count and the catheter day count at the same time each day and
collect it electronically. Also, compare those two for three months. As long as there’s no difference more than 5%
in either direction, you can then do that for that location, just use your electronic methods. If there is a deviation of greater than
5% than you got to start all over again and try to figure out where the problem
is, get it right, until you, you know — make changes until you are able to
get an accurate count electronically and then you can move ahead with that. So, you need to do it in location
for three months, minimum. Just another sign. I do want to say that oncology hospitals have to
report separately for all locations and units. Anybody from an oncology hospital here? Nobody. Okay. And to remind you that you’re
CMS reportable data has to be included in your monthly reporting plans. If you don’t put it in your monthly
reporting plan it will not be sent to CMS and you won’t be happy, they won’t be happy. Here’s your resources. This is the training site for
urinary tract infection information. We have Lectora, which is a self-paced
software program and does have self-testing, and there’s questions in there and
you have to score greater than 80%. We do expect that people will do the training
at least once before they utilize the system. And then we have — these webinars will be
on there as people have told you in April. I believe, I hope this one is down,
I think it is because it’s outdated. These are just the forms that you’ll use to
report your data, and more resources for you. This is a summary online listing of
all the training that’s available that would be pertinent to
you doing CAUTI training. Okay, so another funny email. So we sent this out, you know, we sent
— this is what we call blast email, to everybody that’s a participant, you know. We said, “We will be restarting NHS application
in a few minutes, please plan accordingly.” You know, because if people have
got data on there we want them to save it so it doesn’t get lost. And somebody reported back, “I haven’t started
baking yet, I don’t know if I’ll get to it.” [ Laughter ] I’m not sure what that meant, but [laughter]. I don’t know what she was referring
to, like baking the data, you know, like she didn’t get it in or if she was thought
she was talking to somebody else or what, but we weren’t really sure how to respond, so. Okay, so we have finished about 15 minutes
early and I’m going to look to Courtney to see before we get into the case studies. Do you want to take a break now or do
you want me to start for 15 minutes. [ Inaudible Speaker ] What’s that? [ Inaudible Speaker ] I’m sorry? Keep going? [ Inaudible Speaker ] For 15 minutes? Okay. We’ll keep going for 15 minutes.>>[Inaudible] questions.>>I can, but I would rather wait because
we might cover the question in the — you’re going to be extra special, you’re the only person that’s
going to get to ask a question. How do you like that? Go ahead. Go ahead [laughter]. [ Inaudible Speaker ] Page 23. Okay. Gap day. Page 23, oh my page is different
— my page is different than your page.>>I’m trying to resolve your three-day Foley
rule plus the gap day example of symptomatology. So you said that you have to
have the Foley in for three days by the last day of symptomatology. So in your gap day example you have a
temperature on 4/7, like Monday, whatever, and then you have a gap day, day two. And then you have a culture
on day three, Wednesday. You’re saying that if the
Foley was inserted on Monday?>>This one?>>This would count?>>No I didn’t [laughter].>>On the same day that they
had the first element or some –>>Thank you, is it this one?>>Yes.>>Okay, so –>>So, if instead of the
Foley being placed on 4/1 –>>Yes.>>The Foley was placed on 4/7.>>Okay.>>Because I’m trying to determine if the
Foley has to be in place for three days on the first day of symptoms, or on the
last day, and you just said the last day. Okay. So that means in this example,
this Foley can be placed on 4/7, the day of the temperature,
and then there’s a gap day, and then the day of the urine is the
third day, that’s three or more days.>>That is correct.>>So this would be counted as a CAUTI. Foley placed on the day of the
first symptom, that makes no sense.>>Well, hopefully, if the patient has
the fever they’re going to be looking to find out why the patient has a fever. Okay?>>Correct, but they placed the Foley on the
same day so it shouldn’t be related to that.>>And, clinically, I’m going to agree with you. And the hope is that most of the time if they
have a fever they’re probably going to try to figure out why they have
the fever and they’re going to collect that culture sometime sooner. There will be rare instances — we can sit
here and try to come up with situations that don’t work and those
situations do happen rarely. Okay?>>This is not an uncommon
situation, where they place a Foley because a patient is having problems. Not having problems due to
having the presence of a device.>>It’s a surveillance definition
and we made these rules because people asked for
them, users asked for them. Because before we had no minimum time period. Right? So, in that case it
still would’ve been a CAUTI.>>Without the ability to have some clinical
correlation, we can’t use these numbers to be able to drive performance improvement. I’ll just –>>I understand.>>Okay.>>I understand. Okay, so let’s — we’ll keep going. No, I don’t think so. Well — [ Applause ] [ Silence ] Okay, let’s start with our case study. Oh. So actually we’ll — so before we start
the case studies I wanted to share something that on the web that highlights the
importance of making good methodology when performing HAI surveillance. So, here we go. Escape — oops, that’s right. That’s not right, here. Here. Okay.>>Hi, I’m [inaudible] and my
CEO says I should talk to you because you’re hospital has zero health
care associated infections for three years.>>Yes, as the infection
preventionist I can say that’s true.>>Wow, that’s amazing. I mean, I have my organization [inaudible]
zero infections and we have had some ruts but we had a month here or there where we
have had none, but zero for three years. That’s incredible.>>Yes. We did it. I have zero infections, for three years.>>How? I mean, don’t you ever
have bacterial trans-location where the patient has no infection but the pathogen escapes the GI
tract and appears in a blood culture?>>We have those cases but my ID
doctor throws those out [laughter].>>Your ID doctor? What is he doing surveillance for?>>He always does surveillance after I
find the cases that meet the definition.>>Has he done any online training
on how to use the definitions or done any [inaudible] trainings on the NHSN
definition or gone to a [inaudible] training?>>No he is an ID doctor.>>So, despite the fact that you have
cases that meet the NHSN CLABSI definition, you don’t count them because your ID physician,
who has no training on epidemiologic definitions or NHSN training doesn’t
think they are NHSN cases?>>Yes. He is an ID doctor [laughter].>>Does he say they don’t meet
the NHSN CLABSI definition?>>He is an ID doctor [laughter].>>You already said they met the
definition why even have them look at them?>>He is an ID doctor [laughter].>>We established that. Have you been to training
on the NHSN definition?>>Yes, I have done many classes and do the
[inaudible] training on the definitions.>>So, you are having someone who is incompetent at using the definition override your
judgment as a trained epidemiologist.>>He is an ID doctor [laughter].>>Yes, and if I had a central
line infection I would want him to give advice on how to manage that infection. Why does he even want to
look at the CLABSI cases?>>He is very interested in CLABSI. As Chair of the Infection
Control Committee he gets a bonus for lowering the hospital’s
infections [laughter].>>Don’t you see that is a conflict of interest. Why would you allow that surveillance
to potentially be compromised like that?>>He is an ID doctor.>>Let’s talk about CAUTI. No CAUTI?>>We have zero HAIs. My ID doctor reviews them.>>Is your ID doctor’s name Dr. No? Let’s talk about SSIs. No small bowel infections? No colon surgery infections?>>I have had no HAIs for three years.>>How do you do surveillance for SSIs?>>I look at the microbiology results
and if there are none they are cleared.>>What about radiology results?>>I look at the microbiology results
and if there are none they are cleared.>>Why would a surgeon culture a gut leak, they
use the x-rays to find abscesses and then treat. How about MD notes, do you
read them on the cases?>>Doctors at my hospital write a lot.>>Yes, how do you assure yourself they
aren’t diagnosing a surgical site infection in their notes or describing a wound
infection if you don’t read the notes?>>Doctors at my hospital write a lot.>>Do you do a search for antibiotic therapy
post- surgery or returns to the O.R.?>>I have no HAIs for three years.>>I will take that as a no. So you never had a failed anastomosis
that resulted in an infection?>>We have those cases but my ID
doctor throws those out [laughter].>>Doesn’t he know that the definition
does not exclude them from being cases?>>Yes, but he disagrees with the definition.>>I can disagree with gravity but it
doesn’t mean that it no longer applies to me.>>He is an ID doctor. I have had no HAIs for three years.>>Liar. Oh, I feel an HAI coming on.>>I also have 100% hand hygiene compliance,
do you want to know how [laughter]? [ Applause ] [ Inaudible Speaker ] All right [laughter]. So, I don’t think I want to take
comments after that [laughter]. [ Inaudible Speaker ] Oh, the author’s here? Oh! [ Applause ] Oh, Bravo! Bravo. Who is the author? [ Inaudible Speaker ] Greg Meyers [assumed spelling]. Okay. Nice job. So that was just a little light-hearted. I thought you guys would enjoy that. I enjoyed it. Somebody sent it to me and, you know, I think
it’s really — it does drive home, you know, that we all need to do what we’re supposed
to do and I understand that there are — that the definitions are not perfect. Believe me, we get emails all the time
and we understand it and we are — I hope that you heard in the last two days
that we do listen to you and that we are trying to improve them, you know, where we can. So, we can go ahead and start one case
study and we’re going to just look at these, we’re not going to get into
surveillance versus clinical. We’re just going to learn, make sure that
we’re accurately reporting the definitions or applying the definitions and
we’ll try to optimize the consistency and that application and improve data quality. So, as I said yesterday, when you’re looking
through these case studies you might want to consider looking at them in this order. Is it a POA? If it’s a POA and they haven’t been
discharged in the last two days you can stop, we don’t need to have it reported at
NHSN, we’re only interested in HAI’s. Is it an HAI if it’s not POA? If it’s not an HAI — remember
we talked about there’s some that are not POA, that are not HAI — then stop. Finally — next you’re going to ask
yourself is it catheter-associated UTI. And then you’re going to need to look at where
to attribute it if it is a CAUTI So case one. Mama Unlucky is admitted unconscious
after she fell when three deer ran out in front of her while skiing. She has a broken femur. A Foley and a peripheral IV are inserted. On day three her Foley is removed, she’s
awake and making good recovery progress. On the fourth day she’s up with assistance
but she complains of pain on voiding, has a UA collected and it has
slight leukocyte esterase, negative nitrites, and 15 WBC’s on spun urine. The next day they collect a urine
culture which has 10 the fourth, or 10,000 CFU’s per ml of E. coli. So, questions for you is does this
patient have a CAUTI and if so what type? Choose yes, a SUTI one A. Yes,
a SUTI two A. Yes, an ABUTI. Or, no CAUTI at all. You can vote. A couple more seconds. Okay, so let’s see what you all say. Oh, we have some difference of opinions here. We have 50% say it’s a CAUTI two A,
and some people, 38% say no CAUTI. This is no CAUTI. Okay, so criteria were not met in the POA time
period and the patient does not meet criteria for UTI with dysuria and positive urine culture
and a UA — I’m sorry that do meet that, but the date of event was later
than the day after removal. Right? So, the Foley was removed on day three. The patient didn’t meet criteria
the date of event, until day five. Okay? So, it’s a UTI but it’s
not a catheter-associated UTI. Okay?

Testing for Clostridium difficile Infection


Hello, my name is Dr. Carolyn Gould. I’m a medical officer in the Division of Healthcare Quality Promotion at CDC, and I’m happy to speak with you today as part of the CDC Expert Video Commentary Series on Medscape. In this video commentary, I’d like to address laboratory testing for Clostridium difficile infection, or CDI. I’ll be discussing which patients should be tested for CDI, the pros and cons of different testing methods, and why repeat testing during a single episode of diarrhea is discouraged. C. difficile is a spore-forming, gram-positive anaerobic bacillus that produces two exotoxins, toxin A and toxin B, which cause damage to the large intestine, resulting in diarrhea among infected patients. While C. difficile is the most commonly recognized cause of antibiotic-associated diarrhea, it accounts for only 15-25% of all such diarrheal episodes. The likelihood of a patient having CDI is increased if the patient has received antibiotics in the previous 8-12 weeks, is over 65 years of age, and has 3 or more diarrheal stools in a 24-hour period. Because patients who have received antibiotics or have recently recovered from CDI may be colonized without any symptoms, it is important that only diarrheal stools — in other words, those stools that take the shape of the container they are in — be tested for CDI. In any case, reliable testing for CDI remains challenging. At this time the most common testing method for CDI in U.S. hospitals is the enzyme immunoassay (or EIA) to detect toxins A and B in the stool. Although these tests provide results rapidly and are easily performed, the sensitivity of the commercially available EIAs is relatively low. Despite the high specificity of these assays, clinicians are often aware of their poor sensitivity, resulting in routine ordering of multiple stools in patients without reassessment for the presence of diarrhea. Such repeat testing should be discouraged as it may lead to a greater risk of a false-positive result. Therefore, repeat testing should be based on whether the patient is still having diarrhea and, if possible, a more sensitive testing method should be used. Remember that if there is a high suspicion of CDI, empiric treatment may be warranted to avoid delays in therapy. The tissue cytotoxin assay, which also tests for free toxin in the stool, is generally more sensitive than the EIAs and was historically viewed as the gold standard test for the diagnosis of CDI. However, the tissue cytotoxin assay is more difficult to perform than the EIA and has a relatively slow turnaround time, which limits its usefulness in the clinical setting. When using either an EIA or the tissue cytotoxin assay, it is important that stools be either transported to the laboratory within 2 hours or refrigerated because the toxin degrades rapidly at room temperature. Recently, the toxigenic culture, in which stool is cultured for C. difficile and a toxin assay is performed on any isolate to determine whether it is toxin producing, has become the new gold standard against which to compare the sensitivity and specificity of other tests. The main limitation of the toxigenic culture is that it is labor intensive and can have a very slow turnaround time. However, there are now other approved, rapid methods that approach the sensitivity and specificity of toxigenic culture in diagnosing CDI. These include the use of polymerase chain reaction (or PCR) tests to detect toxin-producing C. difficile or 2-step testing paradigms that use the highly sensitive but nonspecific antigen EIA with confirmatory testing of positive results. Healthcare facilities should consider moving toward the use of more sensitive testing methods as a means of quickly and reliably identifying patients with CDI. This will allow for more rapid implementation of isolation precautions to prevent transmission as well as prompt initiation of therapy to improve patient outcomes. However, with more sensitive testing, it is even more important to ensure that only patients with active diarrhea are being tested; otherwise, the tests are more likely to detect asymptomatic colonization. Currently, there are no recommendations for active surveillance testing or isolating asymptomatic patients on the basis of their being colonized with C. difficile. Moreover, patients who have recovered from CDI will often remain colonized for a prolonged period, and therefore repeat testing of patients to prove cure should be discouraged. Given that both the incidence and severity of CDI have increased over the past several years, it is important that clinicians become more aware of how to recognize, diagnose, treat, and prevent CDI. The bottom line? Suspect CDI in patients who have received antibiotics in the previous 8-12 weeks and have had 3 or more diarrheal stools in a 24-hour period. For testing, the current gold standard is a toxigenic culture, but turnaround time is slow. For clinical laboratories, rapid tests that approach the sensitivity and specificity of toxigenic culture include PCR tests or 2-step testing paradigms that use rapid antigen assays with confirmatory testing We at CDC hope that this brief overview of the laboratory diagnosis of CDI and how it can be optimized to aid in both prevention and treatment has been helpful. For further information on the prevention of CDI and other healthcare-associated infections, visit the Web resources listed on this page. Thank you for watching.

The Early AIDS Epidemic in the United States: Views from Atlanta and Hollywood

The Early AIDS Epidemic in the United States: Views from Atlanta and Hollywood


Booker Daniels: Good afternoon, everyone. How are you today? Outstanding. I’m Booker Daniels. I’m a member of the staff at the Division of HIV/AIDS Prevention at CDC. It’s my esteemed privilege to be somewhat moderating or just introducing these incredible individuals for this panel session today. The title of our session today is The Early AIDS Epidemic in United States Views from Atlanta and Hollywood. And throughout the course of the conference there will be many sessions where people say there are two individuals that don’t require any introduction. These two individuals certainly do not. But I will introduce them, nonetheless. Seated to my right immediately is Dr. Harold Jaffe, Associate Director for Science at CDC. And prior to this role he served 27 years as most notably as a medical epidemiologist and part of the initial AIDS investigation team and a former director of NCHHSTP. We’re also joined by Dr. Jim Curran, who is currently the dean of the Rollins School of Public Health at Emory, Rollins University, Rollins School of Public Health at Emory University. Prior to this role, he had a career at CDC for 24 years and he was the initial director of the Regional AIDS Task Force on the initial outbreak of the epidemic. With that, I’ll turn it over to the panelists and we’ll get underway. [Applause] Harold Jaffe: I wanted to thank Booker for the kind introduction. I thought he was going to say: If there are two people who shouldn’t be introduced, it would be Jim and me. But it’s a pleasure to be here, and it’s a pleasure to be on this session with Jim who played such a key role in the investigations of the early history of the AIDS epidemic. I guess the first question is why should you care? What difference does it make what went on 30 years ago? And I guess I can think of a few reasons. First of all, judging by the looks of at least some of you, you were too young to have remembered this epidemic and may not have been born. So this is a bit of a history lesson. Secondly, for those of you who are physicians but only have cared for AIDS patients after the mid-1990s, this is a reminder of what a terrible disease this was in the pre-treatment era. And, thirdly, I think this is an important illustration of the power of epidemiology and the epidemiological method to understand a new disease, to understand how it’s transmitted and even prevent it without even knowing what the cause is. So we’re going to try to do this both through a lecture, which I hope is going to be more or less factual, and also clips from this film “And The Band Played On.” It’s less factual but I think it’s helpful in understanding the main events of the time. The film was released by HBO in 1993. And it was based on the book of the same name published in 1987 by Randy Schultz, who was an openly gay reporter for the San Francisco Chronicle, and very sadly died of the disease himself. The film uses actors, I think some of whom you’ll recognize, playing the parts of real people. And Jim Curran is one of the real people, and I’m going to be periodically asking him to make comments as we go along. So here I’ve listed some of the main characters you’re going to see in the film. Obviously many, many more people were really involved, and the movie, I guess, picked people for dramatic effect. The roles of some of the people, particularly Jim Curran and Don Francis, are quite distorted. Again, I think for dramatic purposes. The film starts with a scene from the intensive care unit at UCLA Hospital in the fall of 1980. This scene was of special interest to me because I trained in medicine at UCLA and had left just six years before and had spent many nights in that intensive care unit. So let me show you that first clip. [Video] >> Thank you. Thank you very much. Thank you. Thanks very much. Thank you. >> Doctor? >> Here we are. [Crowd cheering] >> No T. cell count. I’ve got to tell you, Dr. Gotlieb, this is weird, man, he doesn’t have any. >> How can he not have any T cells? >> His immune system’s gone. [Typing. Phone ringing] >> Good morning. Good morning, Dr. Gotlieb. [Knocking on door] >> Can I talk to you for a minute? I just got this in the mail from our man in LA, Dr. Shandera, got it from a Dr. Gotlieb, I think you ought to look at it right away. >> Jim, looks like there’s a very weird epidemic breaking out among gay men in Los Angeles. There have been five cases of pneumocystis with no contributing disease within the past few months and already two fatalities. Plus I made calls to New York San Francisco and it seems they’ve had similar cases. I think this ought to go into the weekly newsletter as soon as possible. What did you do that for? >> I don’t decide what goes into the newsletter. I can only recommend. But, Mary, we’ve got a new administration; you want to see this published so people can read it, or do you want to see it killed? Harold Jaffe: Well, the article was in fact published, but it didn’t even make the cover of the MMWR on June 5th, 1981. As mentioned in the film, the article described five young previously healthy homosexual men who were treated for biopsy-proven pneumocystis pneumonia at three hospitals in Los Angeles. Two of them had already died. These cases seemed very unusual in several respects. First, virtually all previous reported cases of pneumocystis in the United States, at least in adults, were in persons with an obvious cause of immune deficiency such as an organ transplant recipient or someone receiving cancer chemotherapy. But these men did not have those risk factors. Secondly, it was a mystery as to why they were all homosexual men and, third, why were they coming from Los Angeles and possibly San Francisco and New York. So let me first ask Jim for his thoughts when this article was published. Did you cross out the title? Jim Curran: Well, as cute as the guy is, I’m not him. The context, Ronald Reagan was elected President over Jimmy Carter, and it was very high inflation and unemployment. And there was an immediate domestic hiring freeze and a travel freeze on CDC staff. We were fortunate to have a mentality at CDC where everybody wanted to work on the new problem. And this was a new problem. So there was a lot of enthusiasm among the staff. But very little money and inability to hire new people. So the context was a very dire economic environment in which to study a new problem. But the CDC was a fertile place to do it. It’s always painful to watch movies. The real history behind the MMWR was that there was a clerk named Sandra Ford who was handling requests for pentamidine-isethionate, which is a second line drug to treat pneumocystis. She noted some requests which had almost always been in people with cancer, underline immune deficiency, coming from requests for people with no underlying disease in New York and California. Called attention to her supervisors in the Parasitic Disease Division, and they couldn’t get any information out of New York. They were trying to hold the information back, and Dr. Gotlieb, Dr. Wayne Shandera, the EIS officer and others, accumulated the information and sent it into CDC to the Parasitic Disease Division. The title and stuff had already been decided actually by the head of the MMWR at the time, Mike Gregg, before Harold and I saw it. It was kind of delivered to us and we were asked because we had been studying hepatitis B and hepatitis B vaccine in gay men in the STD division, to talk to our contacts in the gay community. So, in fact, we actually at the time would be maybe the only part of CDC other than parts of the hepatitis division that had any programmatic context and contact with the gay community. And it should have been left in homosexual men. Harold Jaffe: Just a month later, the mystery became even more mysterious. Let me show you the next clip which depicts a CDC staff meeting. >> Okay. What we’ve got in Los Angeles, San Francisco and New York is a number of gay men who have been hit with a variety of opportunistic infections and really that’s all we know. I’ve asked Don to join us because for the last three years he’s been tracking hepatitis B virus in gay men and before that worked on the ebola fever epidemic in Africa. >> Thanks for joining us. >> What we’ve got to do is hit the phones, spread out and contact all the departments in all major metropolitan areas as usual so they can do a hospital-to-hospital search for cases. >> Make sure of the epidemiology. >> Talk to the patients, talk to doctors who may have treated those patients, friends, relatives. No question too stupid or too personal. >> Sexual relationships, too. >> Household chemical cleaning, diet. >> Could be a bad batch of street drugs. >> Pets. >> Maybe they all got the same kitty litter. >> John, I’m going to go to New York this afternoon, take a look at this disease. Can you come with me? >> Sure. >> If I knew these blotches would turn purple, I would have brought some bags to match. Here. Look at my book. When I was still human. I was the best in the business. Ask anybody. Leave it to me to get some disease nobody ever heard of. Kaposi’s sarcoma. Even my doctor had to look it up. Nothing to worry about, he said. Usually happens to Italian men in their 60s who continue to live a normal life until they die of something else. Do I look like an Italian man in my 60s? Now I do. 160. Why do they make things like this that nobody can ever solve? Harold Jaffe: So just a month later, July 1981, we started to hear about young men with malignancy Kaposi’s sarcoma. Some had also developed pneumocystis pneumonia and others had other forms of opportunistic infections, things like cerebral toxoplasmosis or cryptococcal meningitis. Now up until this time Kaposi’s sarcoma was a very rare disease in the United States. It had been described about 100 years earlier by the dermatologists Morris Kaposi, and the disease he described was one that had a male predominance. And typically occurred in men age 70 or older. Based on cancer registry data, it was estimated that in the mid-70s there were only three or 400 cases occurring each year in the United States. When it did occur, it was most often in men from southern Europe, Italy, Greece and those of Ashkenazi Jewish ancestry. The disease that Kaposi described, which is called classical Kaposi sarcoma, looks just like this. It’s a typically kind of raised plaque lesion, most often on the lower extremity and progresses very slowly. So if you read the textbooks at the time, they would say that an elderly man is more likely to die with this disease than from this disease. What was being seen, though, in these young gay men, even though pathologically or histologically — thank you very much — nice to have a moment of levity during this. Pathologically, you couldn’t tell the difference, the two forms of the disease looked the same, but clinically they’re quite different. The form that was being seen in these young gay men was much more aggressive. So here’s a man with these multiple skin lesions. If you saw them in clinic one week he might have two or three. A few weeks later he might have ten or 12. And a few weeks later he might look like this. And the disease was not limited to the skin. So here’s an example of a patient who has an oral lesion. These same lesions could be seen farther down in the gastrointestinal tract. They were seen in the lung and they were vascular. They could bleed. So some patients were actually bleeding out into their lungs or into their intestine and dying of the disease, which was extremely rare before the AIDS epidemic. Now there was a clue in the literature. If you look at the cancers that occur in people following organ transplant, particularly renal transplants, Kaposi’s sarcoma occurs at increased frequency. In contrast to what we were seeing with these young gay men, there’s no male predominance. And the most interesting feature is that there are case reports where it was possible to either taper the level of immune suppression or actually stop the drug or the disease would go into remission or sometimes even disappear. So there was clearly some very tight link between the immune system and this malignancy, although at the time we really didn’t know that was. Early in the summer of 1981 we were getting case reports simply by physicians calling us and saying: I think I saw one of those cases that you’re interested in. And we would very dutifully write down all the information we could by hand and stick it in a file. That was our system. And at that point we said, well, that’s not really very good, is it? We really need a national surveillance system. And to do that you need a case definition. So we made one up. Notice that the disease was not called AIDS at the time. It actually had no name. We were using KSOI for Kaposi’s Sarcoma Opportunistic Infection. The case definition that we made up said that we wanted to know about individuals who had proven Kaposi’s sarcoma or one of about a dozen severe opportunistic infections. We weren’t interested in this form of Kaposi’s sarcoma in the elderly. So we said patients less than 60. And, of course, we excluded anyone who had a known form of immunosuppression. So we made this definition available to major teaching hospitals, oncologists, infectious disease specialists and health departments. We said if you see a case like this please report it to your health department who will in turn report it to CDC. So let me ask Jim at this point what your thoughts were kind of in the middle of the summer of ’81. Jim Curran: I think in retrospect, one of the most important things that was done was the development of this case definition, which was highly, highly, highly specific. We knew it was insensitive. And we made a bunch of iceberg slides and sent them around saying that this was only the tip of the iceberg. But these conditions were so uncommon and they required, in the case of pneumocystis, open lung biopsy at the time to make a diagnosis. It required a pathologic diagnosis for both Kaposi’s sarcoma and the infections. And they were so rare in the developed countries that you could be sure that this was going to be part of this new epidemic. And that allowed us to determine whether a new case was part of it or not part of it, whether it was occurring only in gay men, was it occurring only in New York and California, and ultimately led to the definition — I mean, the determination of the epidemiologic patterns which led to prevention recommendations and convinced virologists and others that this was caused by a blood-borne and sexually transmitted virus. Harold Jaffe: Let’s move ahead to a little bit later in the summer of 1981. [Video] >> Do you have many gay friends? >> Not too many, no. Two doctors I know in medical school, I still stay in touch with them. >> Are they a couple? >> Yes, actually. 15 years. >> Kiko — Kiko is my lover — we have a wide circle of friends and most of them are in relationships, or want to be in relationships. >> So what are you saying? >> Lots of men go to these bathhouses, but there are tens of thousands of gay men in this city, maybe a couple hundred thousand, cops, and waiters, and teachers and lawyers and ditch diggers and athletes. >> Don’t talk loud, so they can’t hear you down the block. >> I’m sorry. I don’t mean to lecture. I just don’t want you to come away from your tour of the bathhouses thinking that’s how all gay men live. >> Last night we lost another one. In three weeks this handsome young, guy turns into the elephant man. We found out it was caused by some rare parasite that only sheep get. So I called a vet to ask what they do when sheep get it. They shoot them. >> Good luck. Thank you. >> Hi, Bill. Madrid Department of Public Health. >> Let me see if I can find the boss. [Music] >> Those two guys there, are they strangers? >> Maybe. Probably. >> They just met and now they’re going to go in — >> Right. >> It’s interesting. >> Listen to me. Imagine yourself in a place like this. It’s only filled with women, I mean, really beautiful women. Imagine one of those Penthouse women, she wants to go into that little room with you, nothing between you but a little towel, are you going to tell me you wouldn’t go into that little, consider dropping that towel? Yeah, I know men would give up food for it. >> How are you? >> Good. >> [Inaudible] from the Centers for Disease Control. >> So what’s the problem? >> There may be some kind of an epidemic spreading in the gay community, and I’d like to just come in and have a look around. >> I’m sorry, that’s impossible. We have to protect the confidentiality of our clients. >> I know, but, Eddie, you know I speak on behalf of the Gay Liberation Committee, the city council, the state assembly, I can tell you without fear of contradiction you are regarded second only to Abe Lincoln as a citizen that would fight to the death to protect civil liberties. So let’s cut the crap, it’s 10:00 in the morning for God’s sake. Let us in. >> Thelma, only for you. >> Thank you. Thanks, Eddie. >> How many men come here a night? >> Hundreds, every night of the week. Some bathhouses more than a thousand. >> What’s this? >> Poppers. They’re a quick, cheap high. Harold Jaffe: You probably recognize some of the actors there, Serena McKellen and Lily Tomlin and Phil Collins. The actor who played me is a person named Charles Martin Smith, whose previous big role was Terry the Toad in American Graffiti. So that probably tells you everything you need to know. This is based on a visit that Bill Darrow, our research sociologist, who you will see later in the film, and I made to a bathhouse in Atlanta, the club baths. The reason we went was we had learned from talking to some of the early cases that many had visited bathhouses and many of them had used nitrate inhalants and we wanted to learn more about it. We got permission from the owner. We turned up one night. We were fairly obvious because we were the only ones wearing clothes. We were sitting there in our government blue blazers at a table and saying, excuse me, I wonder if I could talk to you. Quite amazingly, almost all these men were perfectly happy to sit down and talk to us. And, as I said, we were particularly interested in learning about the use of these inhalants. You can see some of these in some of these labeled bottles. Locker room is a good name, because they smell like sweat socks. You could buy these in the bathhouse. In fact, it was popper night when we went. You could get them for a discount. We also discovered, though, that you could buy them in bars and bookstores in these much more mysterious looking unlabeled brown bottles. And we wondered: What’s in this stuff? In theory, it should be amyl butyl or isobutyl nitrite used to enhance gay sex, but we really didn’t know. So we bought some of these and brought them back to Atlanta, had them tested chemically to look for a contaminant. We didn’t find any. We even had them used in animal experiments where they were aerosolized to see whether they would suppress the immune system of, I think, rats. I’m not sure. And they didn’t. So it didn’t entirely exclude the possibility that these played a role. But I think it made it a little less likely. I think maybe we were thinking gosh, this is it, we’ll get rid of this stuff. End of epidemic, we’ll all be heroes. But it unfortunately didn’t turn out to be quite that easy. Let me ask Jim, at this point in time, did you think it was likely there was an environmental cause of the disease, or did you think it was more likely it was infectious? Jim Curran: I had been coming from the STD world and we had been working on hepatitis B vaccine trials. And from the beginning this suspiciously looked a little like hepatitis B, a lot like hepatitis B. So that always, I think, was for most of us was most likely that it was due to a sexually transmitted agent. Whether it was some sort of mutant cytomegaly virus or some kind of concatenate of agents. I think most of us believed that was the most likely cause. It would have been a thrill and a wonderful thing for the world if something as simple as poppers could have been it and we could have turned into Carrie Nation and gone through and broken all the bottles in the country and saved 30 million lives. But it wasn’t to be. Harold Jaffe: Let’s move on now to a CDC in the early autumn of 1981. [Typing] >> What do we think, what do we know, what can we prove. >> Zip. >> Only gays. >> Think but can’t prove. >> Only males. >> Think but can’t prove. >> Semen depositors. It’s in the semen, unless there’s something specifically unusual about this disease, it shouldn’t make a difference where the semen is deposited, whether in the anus or in the vagina, which could mean that women will be getting it also. >> Good point. Focus on that. >> All we know so far is that the immune system stops functioning completely, all cases. >> No but can’t prove. >> What we have here looks more like a sexually transmitted disease than syphilis does. >> Think or prove? >> I can’t prove that the sun isn’t going to turn into a bran muffin next Tuesday. After 20 years of doing this I know what I know. >> That’s not what I’m talking about. >> It’s pure supposition, but it’s more than strong enough to justify a definitive study. >> I agree with Phil. >> Single infectious agent with high probability of sexual transmission. >> Viral or bacterial? >> Just think and prove it’s viral, but it’s only a guess. >> Guess. >> Let’s assume it is a virus. Now, the question is, is it one that we already know that has become lethal, or is this some kind of brand new virus we haven’t seen before? >> Here’s a stat to chew on. In seven months the number of cases jump from five to 152 in 15 states. >> Seven months. >> But the spooky part is that so far the mortality rate has been 40 percent. >> 40 percent? >> According to the doctors taking care of these patients the mortality rate could ultimately turn out to be 100 percent. >> 100 percent. >> My God. >> Let’s set up a case control study based on the premise it’s sexually transmitted. Harold Jaffe: Having worked for Jim Curran for many years I can say with great confidence he never said think or prove even once, did you? I don’t think so. But anyway we did the case control study. Selecting the cases was pretty straightforward. We decided that we would try to interview every living reported case in one of four cities in person that had to be homosexual men with either pneumocystis or Kaposi’s sarcoma or both. But it wasn’t so obvious how to select the controls. Did we want men and women? Just men? Heterosexual men? Homosexual men? Both? We finally decided that we would recruit apparently healthy homosexual men who were within five years of the age of the case that they were matched with. They had to be of the same race and live in the same city. But then how do you do that? So we spent a long time thinking about the best way to do it. And I’m not sure we ever came up with a good solution. First we thought okay we’ll ask the cases, the names of their friends who are not their sex partners. And less than half of them could do that, which was probably a hint right there. So then we decided we would go a different route and we would go, first of all, to the private practices of physicians who saw mainly gay male patients in their cities and ask them to recruit for us. And secondly we would go to public STD clinics that primarily served gay men. Now, we knew there was an obvious bias in this, because by definition a man going to an STD clinic must be pretty sexually active. We figured we know that. We’ll have to take it into account. But it was a relatively easy way to get controls relatively quickly. As Jim indicated in the film that was set up with the idea that we were probably looking for sexually transmitted disease, and obviously the fact that it was occurring in a number of highly sexually active gay men was consistent. But because these men frequently were using drugs, not just the nitrite inhalants but a variety of street drugs we couldn’t rule that out. As I mentioned, we interviewed cases and controls in person as is shown in the next clip. [Video] >> Stick around here. Coming right back. [Bell] >> Dr. Mary Guinan, please. >> I’m a friend of Dr. Konig’s. >> Your name? >> You can tell him. He has no idea who you are and we’ll pretend we never heard of you. >> You guys ahead of me? >> You can go ahead. We got nothing to do except go to a Halloween party, during rehearsal. >> I know. >> [Inaudible], but I happen to think you’re a genius. >> Double genius as a director and choreographer. >>You? >> Robbie Campbell. Self-appointed KS poster boy. You look surprised. >> No. Curious, maybe. >> If the gay community doesn’t start raising hell, do you think Reagan’s going to do a damn thing? >> I wish I had your courage. >> Courage. No. I’m scared to death. I just have this absurd determination to live, don’t you? [Knocking on door] >> It’s open. >> Dr. Guinan? >> Yes. >> I expected the neighborhood, the hotel, this room even, but I think it would take Filini to cast such a beautiful, young woman in a sweat suit as the doctor I’m supposed to reveal my most intimate sexual eccentricities to. >> I’m Mary Guinan. The reason for the sweat suit is somebody stole every piece of clothing I brought with me from the laundromat this morning. Would you mind signing these two consent forms? One is for the questionnaire and one is for the specimens I need to collect. >> What specimens? >> Blood, urine, a swab from the inside of your mouth and another from your rectum. In this study, some had the disease and some like you have no symptoms. >> I really don’t mind if you know all this about me. I’m just not too sure I want to know. Is there a name yet for this disease? >> The gay press calls it gay pneumonia or gay cancer and the straight press doesn’t mention it at all. >> I was hung up in traffic coming over here. Gay Halloween parade was on. Have you seen it? >> I didn’t know they had one. >> Yeah, they do. It’s really pretty amazing. [Music] >> Party’s over. Harold Jaffe: Well, I want to know why Richard Gere didn’t play me. [Laughter] [Applause] That sounds like a vote of support, or at least I’ll take it that way. Well, we didn’t interview Richard Gere and Mary Guinan only had her underwear stolen, not all of her clothes. But the rest of this is pretty realistic. We did interview these men in our government rate hotel rooms, which were not very luxurious. We did get 25 bucks in San Francisco. We did get funny looks from the desk clerks about why these young men were coming up to see the CDC doctors. But it was remarkable that these men, once we started talking, really were quite open and willing to talk about what had been going on in their lives. Think about it. What if I came to you now and said you know I don’t mean to bother you but I’m from the federal government and I’m going to ask you everything I can think of about your sex life, drug use and anything else, I’m not sure you’d be that happy to talk to me. But here, these men were really scared, appropriately so. Many of them had friends who had died or were sick, and they wanted to know what was going on. They wanted to know if they were at risk, maybe what they could do to help themselves. So they were remarkably open in talking to us about what they had been doing. So these next few slides come from the original case control study. First of all, to show you where the patients came from, the four cities I mentioned. The majority of cases, three-quarters, were white, which fit the demographic profile at the time. And let me go back here. Here’s some of the variables comparing the patients seen on the left with the two control groups. Remember the clinic control group comes from an STD clinic and the others come from a private medical practice. So in terms of history of sexually transmitted diseases, the cases were more likely to have gonorrhea or syphilis than either of the control groups. They also used more different street drugs and the use of poppers the nitrite inhalants, was essentially universal in both groups. Looking in more detail at some of the sexual activity differences, here we see the median number of sex partners for the cases was more than twice as many for either control group. Again, one of those control groups comes from a public STD clinic. The cases had a higher proportion of partners from bathhouses and they were more likely to start having sex at a younger age. In a mltivariate analysis, which I’m not showing you here, these same sexual variables seem to be the most important. But when we published the study we were fairly cautious. We said we thought the occurrence of Kaposi’s sarcoma and pneumocystis pneumonia in these homosexual men is associated with certain aspects of their lifestyle. We went on to say that sexual activity seemed to be the biggest difference. But because drug use was so highly correlated, so related to sexual activity, we really could not rule out a possible role for those drugs. Now, the next clip doesn’t come from the film, it actually comes from a national broadcast, NBC news. I wanted to show it to you because it shows you how the case control study was presented in the press and it also shows you the real Bobbie Campbell and the young or younger Jim Curran, who looks almost the same as Jim Curran today. [Video] >> Scientists at the National Centers for Disease Control in Atlanta today released the results of a study which shows that the lifestyle of some male homosexuals has triggered an epidemic of a rare form of cancer. Robert Bazell now in Atlanta. >> Bobbie Campbell of San Francisco and Billy Walker of New York both suffer from a mysterious newly discovered disease which affects mostly homosexual men but has also been found in heterosexual men and women. The condition severely weakens the body’s ability to fight disease. Many victims get a rare form of cancer called Kaposi’s sarcoma, others get an infection known as pneumocystis pneumonia. Researchers know of 413 people who have contracted the condition in the past year. One-third have died and none have been cured. >> Death didn’t scare me. It was living with this for a long time. That’s more frightening than death. >> Investigators have examined the habits of homosexuals for clues. >> I was in the fast lane at one time in terms of the way I live my life. And now I’m not. >> The best guess is that some infectious agent is causing it. Today, researchers here at the National Centers for Disease Control say they have found several cases where people who had been sex partners both had the condition. Scientists say this probably means they are dealing with some new deadly sexually transmitted disease. The investigators see this as a serious public health problem. >> From an epidemic point of view there have been more deaths from Kaposi’s sarcoma and pneumocystis pneumonia than have occurred with all the cases of toxic shock syndrome and the Philadelphia outbreak of Legionnaire’s disease combined. >> Researchers are now studying blood and other samples from the victims trying to learn what is causing the disease. So far they have had no luck. Robert Bazell, NBC News, Atlanta. Harold Jaffe: Jim, other than any comments about your youthful appearance, is there anything else you’d like to say about what you thought was going on at the end of the case controlled study? Jim Curran: Well, first of all, Harold Jaffee and Martha Rogers, Kelon Troy, many people were the leaders in the case control study and put together a rather complex study design and implemented it to include 75 or 80 percent of living gay men in the United States and published it rapidly. So that was quite a feat. I want to just give you a couple other contexts. One is we knew that the controls were matched. And by matched, we meant that they were matched for certain characteristics. They were matched by sexual orientation. They were matched by age, within three years. They were matched by the city where they lived at the onset of the case’s symptoms, and they were matched by race. All of the cases — all of the controls were interviewed by the same person that the case was interviewed by to try to minimize to some extent interview bias. And we thought that we would be overmatching by picking people who were symptomatic with STD symptoms and that would minimize the chance of finding a sexually transmitted variable. In retrospect, of course, many of the controls were almost certainly infected with HIV themselves leading to a lot more overmatching. So that made it even more remarkable that sexual variables were the most important ones. But in retrospect, that’s not remarkable at all, because when any new, rare epidemic occurs, and this was rare at one time in gay men, then the ones most likely to catch it are going to be the ones with the extraordinary number of exposures. And that’s how it was in the gay community in the mid-’70s, if you caught HIV. You were most likely from San Francisco and New York, most likely going to bathhouses. By the time the virus was discovered, however, half a million gay men were already infected, and the disease became endemic in the gay community and exposure became much, much more frequent and likely. The last thing I’d like to say is that people didn’t believe in this epidemic then. I mean, gay men who didn’t live in New York and California didn’t believe in the epidemic. Even gay men who did live in New York and California thought it occurred to other people, because it was relatively infrequent. At the time of the case controlled study, maybe the cases were occurring in 15 states. That left something like 35 states where they weren’t occurring. The Reagan Administration knew about this, of course. I interviewed only one case — Harold sent me to New York. So I was coordinating the New York work with EIS officers there. But there was one case that wanted to be interviewed by the head of the task force. That was the managing director of the Joffrey Ballet. A very busy man. He was so busy because the next week — he had pneumocystis pneumonia once. He was going to be hosting Nancy Reagan for the opening of the Joffrey Ballet in which her son, Michael, was a ballet dancer. Harold Jaffe: Ron. Jim Curran: Ron — Michael. Sorry. Wrong son, the right wing one. Ron was the ballet dancer. He did that and then the next, couple days later he was back in Bellevue Hospital with his final fatal case of pneumocystis. We know at least Nancy Reagan had some exposure to this five or six years before the president spoke about it openly. Harold Jaffe: The last bit of the newscast, it was mentioned that some of the cases were thought to perhaps be sexual partners. This information came to us from Dr. David Auerbach, who was a CDC medical officer assigned to Los Angeles County. Through his contacts in the gay community in Los Angeles he had learned that this was the case. And he wanted to interview these men to verify this. But he had never actually done this kind of work before and wanted some help. So we were able to send out Bill Darrow, our research sociologist, who had been previously a syphilis public health investigator, had done a lot of this, to help David out with the interviews. So the answer to the question about sexual relationships came just a few days later, as shown here. [Video] >> Jim, I got a call from LA. >> Wait, I am on the phone. >> I got a call from LA. This could be the first real lead to prove this thing is sexually transmitted. My plane leaves in 40 minutes. >> We don’t have the budget. >> Don’t sweat it, I’ll front the money. You’ll pay me back. >> If you think you have definitive proof it was brought in by a UFO, please send it in to us. Thank you. >> You don’t know a man from New York with a French Canadian accent, very handsome, sheik? >> I don’t think so. I very seldom — wait a minute. This might help somebody else, right? >> Right. >> Of course I know him, from the bathhouses. I never had sex with him. But almost everybody I know has or wants to. >> Fine. Then he gave me hepatitis, so it’s quite possible he gave me this, too. >> The moment I first spied him at the tubs, I was so crazy about him. He was so gorgeous. >> Can you just give me his phone number, address or any way I can get ahold of him? >> All I know, he’s French Canadian. He’s an airline steward based in New York. I don’t even know which airline. >> That’s okay. If you can just give me his name. >> I called him Dougie, nickname. >> And his full name? [Phone ringing] >> Hi, Mary. >> Hi. You back in town. >> Just for the night. I’m probably nuts, but I’m on my way to New York to try to find a very sexually active French Canadian airline steward. >> Gatan Dugas. Bill Darrow. >> Hello. >> Nice to meet you. >> Nice to meet you. >> Sit down. Take all the time you need. >> Thank you. >> Thank you. >> Thanks very much for coming in. >> Well, I’m very flattered to be asked. Although I have no idea what I’m here to discuss. Would it disturb you if I smoke? >> If you need to, go ahead. Mr. Dugas, did you have sex with any of these people? >> Is that what I’m here for, to talk about my beautiful lovers? Now I am flattered. If you don’t mind my saying, I can’t possibly imagine why you would be interested. >> We’ve been finding substantial evidence to suggest that one of the ways this disease may be transmitted is sexually. >> Wait a minute. All I have is skin cancer which is not contagious. And you know it. >> No one is accusing you of anything. We just need to know as much as we can. >> You know, I adore doctors, but I must say if this is an epidemic, this gay plague thing, it’s your fault for not stopping it. It’s not mine. >> That’s exactly what we’re trying to do. And we need everybody’s help. So if you could give me the names and addresses of all your lovers and start with the people on this list, please. >> My friend, we’re talking about thousands of men all over the world, whose faces I cannot even remember and you want names. >> As many as you can remember would help. >> My book’s in my apartment. Call me. >> What’s the number? >> I’ll call you. >> Listen: Help me, don’t help me, that’s up to you. But don’t fuck with me. I’m not playing games here. >> Not before six, and not after 6:30. >> Thank you. >> And remember something: Whatever it is, if I got it, someone gave it to me. >> All right. This is how it breaks down. This is Patient 0, an airline steward from New York and the starting point of this particular group. Now, these are the eight with whom he had direct sexual contact, these four in New York. These four in LA. This is LA 3. He had sex with LA 2. This man from Florida who in turn had sex with this Florida man. Two from Georgia, one from Texas and so on. In all, 40 cases in 10 cities are verifiably linked to Patient 0 which strongly suggests this is a sexually transmitted disease. >> That’s great. Absolutely terrific work. >> Bill, that is the first sign of real proof. >> Good job. Harold Jaffe: I recently came across an interview that Bill Darrow gave about this investigation. And he said, well, these three men, they never met, they never had sex, yet they named the same guy in New York. I actually dropped my pen. Auerbach’s mouth was just hanging open. He practically fell off of his chair. So these are the slides that Bill Darrow showed us in Atlanta. You can see that Gatan Dugas the out-of-California KS case, is linking together these two clusters of cases in Southern California. And here he’s linking together cases from Los Angeles to New York City and then the slide that you saw in the film where he’s in the center of this cluster of 40 cases, sexually linked between 10 North American cities. Now when we published this in a journal, we had a legend on it. And Gatan Dugas was indicated as 0 and there was one, two, three, four, five, and so on. When the American press saw this, they said Patient 0, he’s the guy who started it, he’s the guy who brought this disease, whatever it was, to North America, which, of course, was never our intent, and we have no proof that that was true. On the other hand, knowing what we know now that this is a sexually transmitted disease, it wouldn’t take that many people like Gatan Dugas, people who were very sexually active, very mobile, going to bathhouses all over North America, somebody like that actually could have spread a lot of infection relatively quickly. And I believe that two other members of the cluster were also flight attendants. So, Jim, I wonder at the conclusion of the presentation by Bill Darrow what you were thinking. Jim Curran: Well, you know, this was very convincing to us who didn’t much need convincing when it was published in the American Journal of Medicine and the MMWR, they did an analysis of what if five to 10 percent of men in the United States were gay and they had — how many had — what is the likelihood that these — this was like 40 percent of the cases that had been diagnosed in the United States that were alive in gay men. So what is the chance they would be linked in a cluster? And I think one of our statisticians said the chance was one times 10 to the minus 12th. But there’s still an awful lot of people that didn’t want to believe that this was related to sexual transmission. Because the implications of it or the fact that it could be caused by a virus was probably too great for people to deal with. But it was a very important investigation for that reason. Now, I’ve looked back on these things, and I’d like to think what we know about the pathogenesis of HIV and the transmission of HIV, and I think of this cluster and I also think of the cluster that we saw in the dentist, Kimberly Bergalis case, and the fact that we didn’t see things in other healthcare professionals. And it makes me think we had to have with this cluster and what we had to have in particular with the dentist case is a lot of highly pathogenic, high viral load early cases with short periods of time between infection and disease in order to do this. If the average case here went from 10 years after transmission, it would be extremely unlikely that you could link something like this up. So you had to have probably, in retrospect, high viral loads and high pathogenic titers. Harold Jaffe: I think as all of you who have ever worked at CDC, people at CDC walk around with these little green lab notebooks. I actually have no idea why. For those of you who will see the film “Contagion” that comes out in a few weeks, I think one of the key lead characters Kate Winslet, who plays the epidemiologist, has one. So I had one, even before Kate Winslet. So I took this photo of a page from my notebook. I think the date is November 1982. And it’s a phone call that I received from Dr. Art Ammann, who is a well-known pediatric immunologist at UC San Francisco, who wrote the book, literally, on congenital immunodeficiency. And what he told me over the phone was that there was a child born there in March of 1981 who had RH disease, incompatibility of blood type between the mother and the child, causing a severe anemia in the newborn requiring six exchange transfusions. The child left the hospital but then began developing a whole series of complications, recurrent infections, fat malabsorption and immunologic abnormalities, opportunistic infection with microbacterium and avium. So Dr. Ammann did a very extensive immunologic workup on this child and said: This does not fit with any known form of congenital immunodeficiency. It looks like AIDS, except no one’s ever described AIDS in children, how could that be. He also learned that all the blood from this child had been received from Irwin Memorial Blood Bank. This next clip will show you that investigation. This clip I think is the least accurate of the ones I’ve shown you. Art Ammann is morphed into a woman played by Angelica Houston. You’re going to hear a number of speeches that were never made. You’ll hear the term “GRID”, which stood for Gay Related Immune Deficiency which was the term we never used at CDC. [Video] [Baby crying] >> Harold Jaffe, CDC. [Baby crying] >> Hi. >> How do you do? >> Harold Jaffe. >> So it’s true? >> He was born here 20 months ago. >> An RH baby. >> Within a week his entire blood volume had been replaced six times. Now he has Zostera, practically zero T cell count, more opportunistic disease than we know what to do with. >> And he had 13 donors? >> All from Irwin Memorial. That’s all I could find out. They keep a lid on the place so tight it’s like the Pentagon. So forget about getting a list of donors from them. >> The first irrefutable case caused by transfusions and these people are stonewalling us. I know what we need. Somebody just to scare the hell out of them. >> Only Attila the Hun could. >> Selma Dritz. [Laughing] >> I got it. But there’s one problem, two problems. I’m freezing, that’s one problem. Let’s get some coffee. One of the donors died from the disease two months ago. >> We can’t prove that. >> What do you mean we can’t prove it? How can we not prove it? >> He was one of the richest, most socially prominent families in town. He swore to his dying breath he wasn’t gay. >> What’s the difference what he said? If somebody dies from it you can’t mistake it for whooping cough. >> According to his doctor he died from encephalitis. It’s on his death certificate. >> Talk to the doctor. >> Get him to say what, he lied? >> Somewhere in this town there’s got to be somebody that — a gay man he had sex with or what about his family, do they know? >> My brother wasn’t gay. And I can assure you no matter how hard you search you’re not going to find one shred of evidence to suggest the contrary. He was on the board of several corporations. He was the chairman of the fundraising community for Saint Patrick’s. He was meticulous. He was meticulous in concealing his other life, even from me. >> Excuse me. I would like to remind everyone — I’d like to remind everyone that these are not regulations. These are not regulations from the CDC. This is a workshop where every agency connected to the blood industry can evaluate the information that the CDC has found and together we are hoping to be able to arrive at some course of action. >> One option is to establish guidelines to keep people who are at high risk from donating blood to begin with. >> Banning homosexuals from giving blood won’t protect the blood supply. What it will do is stigmatize them. Reminds me of blood banks rejecting donations from blacks for fear of syphilis. >> Have you any idea of the civil rights implications — >> Civil rights, my ass. My son is a hemophiliac. And if homosexuals are infecting the blood supply, why not keep them from becoming donors? >> What do mean the entire gay community? Then what, separate drinking fountains, one for gays and one for humans. >> Don’t start that gay rights crap with me. There’s 20,000 hemophiliacs in this country and GRID has become the second leading cause of death amongst them. We have rights, too, and one of them is the right to stay alive. >> I know that we’re dealing with a very complex and highly emotional issue, but it would help for all — >> How can you expect us to be unemotional, when at least one person is dying every day from a disease that doesn’t even have a name. Now, if the CDC can’t bother to come up with a name, at least it should stop the media from calling it GRID. We have enough people hating gays without having the entire stigma of this disease placed on us. Especially since it has been shown that this disease is no longer merely gay-related. Now, I make a motion to officially call this disease Acquired Immune Deficiency Syndrome, or AIDS. >> Questions or discussions on this issue, please? >> I second it. >> All right. All in favor of Dr. Valor’s motion? Motion’s carried. >> The FDA Advisory Panel to the Blood Banks feels that the evidence for nearly all of this is inferential. The CD’s evidence of blood transmission cannot be warranted until the CDC shows definitively that an infectious agent causes this disease. Nothing about it even exists in the peer reviewed medical literature. Not one case. Evidence of such blood transmission is lacking. >> May I point out that the blood industry is under the jurisdiction of the FDA and the FDA, according to Dr. Bovey, does not acknowledge that there’s an epidemic because there’s no evidence that it’s a blood-borne disease. >> Suppose, for example, the small amount of blood by some unlikely chance is contaminated, with no tests to find out which blood is safe and which isn’t, what do you suggest we do? Destroy the entire blood supply in America, because some of it may or may not be contaminated? >> No, no. Well, in fact, testing — testing is the second option that we should discuss. Now, we at the CDC have found, we’ve found that the hepatitis B test is 88 percent effective in identifying patients with this disease. >> Is the CDC seriously suggesting that the blood industry spend $100 million a year to use a test for the wrong disease because we’ve had a handful of a transfusion fatalities and eight dead hemophiliacs. >> How many dead hemophiliacs do you need? How many people have to die to make it cost efficient for you people to do something about it? 100? A thousand? Give us a number so we won’t annoy you again until the amount of money you begin spending on lawsuits makes it more profitable for you to save people than to kill them! >> The disease called AIDS, Acquired Immune Deficiency Syndrome, sounds less deadly, more like a diet pill. >> Medical researchers are warning… the risk of contracting the disease AIDS. >> Henry Penia, who has AIDS, got into a minor traffic accident. So police called the hazardous materials team. >> The impact on blood banks could be disastrous. Harold Jaffe: As I mentioned, this scene isn’t very factually correct. For those who might have known her, Selma Dritz was a very nice lady nothing like portrayed in the movie. AIDS was not named at this meeting. And Don Francis, for those who knew him, recall that he made many passionate speeches during his career, but he didn’t make that particular one. Jim, you looked very nervous at the end of that meeting. Maybe you can tell us why. Jim Curran: The events, as I remember them, is the very careful investigation, we had a few cases of what looked like transfusion-associated AIDS. And indeed the blood banks were hiding behind confidentiality issues in New York and California in investigating them. The only one really that was investigated very thoroughly initially was the one that Harold was involved with in San Francisco with the baby. When the three cases occurred in patients with hemophilia, young men who had received essentially untreated factor concentrates pulled from tens of thousands of blood donors each year, it was a canary in the coal mine type of experience in the sense that if anybody was going to get a new virus, these men were likely to get it. And that really convinced most people that this was new. Now, there were two meetings. There was a meeting, a broad meeting of the blood banking community, and there were smaller — it was a smaller meeting in HHS. And the blood banking community, it is really true that the blood banking industry and the blood banking leaders were quite resistant to any change or any screening or any questioning, and Dr. Bovee, it was not his most proud moment. And he had, unfortunately, worse moments on behalf of the American Association of Blood Banks going forward. But there was really very little reaction from the gay community. We had pretty good contacts with many people in the gay community. And I think they were more or less convinced that this was really true and were not standing up in public and screaming civil rights and things like this at this blood banking meeting. The other thing about the name AIDS itself, is a lot of people had been looking for a name. And a lot of us had talked to several people. There was a guy named — several doctors in New York and a lot of us at CDC thought Acquired Immune Deficiency Syndrome was accurate and also had an acronym which might live a while and would be something that could be used. So there was a meeting in Washington of blood banking officials. It was kind of a semi public meeting that Jeff Copeland chaired. And we arranged for Don Armstrong, who was the head of ID at Memorial Sloan Kettering, to make a suggestion to the PHS that the term AIDS be used. So there was a guy, it wasn’t this guy, it wasn’t at that meeting, and it was kind of prearranged by CDC to use the term AIDS. What else can I say about this meeting? That’s about it. I think what we were nervous about mostly is there wasn’t any consensus at this meeting. And it was a highly public meeting quoted in the press and everywhere else. And it was quite clear that the blood banks and the CDC were at odds. The National Heart and Lung Blood Institute was also at odds and basically what do a bunch of infectious disease epidemiologists know about blood banking anyway. Harold Jaffe: Well, fortunately, discussions that were held more in private over the next few months were more productive. And just three months later, in March of 1983, the U.S. Public Health Service issued the first guidelines for prevention of the disease that was known as AIDS at that time. But, first of all, the guidelines said that persons at increased risk of the disease those were signs and symptoms, their sex partners, sexually active gay and bisexual men with multiple partners, Haitian entrance into the U.S. which was contentious at the time, all we knew was that Haitians living in Miami and New York City were getting the disease. We knew that the disease was occurring in Haiti itself. We actually did a case controlled study trying to figure out what the risk factors were and we didn’t come up with anything. So we said for public health purpose we’re going to say that Haitians should not donate blood. Now, this clearly led to a lot of discrimination in the Haitian American community, which was undoubtedly not what we wanted. But at the time we didn’t really have a choice, or at least I didn’t think we did. Intravenous drug users were getting the disease, patients with hemophilia. And then the recommendations went on to say to avoid getting the disease, avoid sexual contact with persons known or suspected to have it. But having multiple partners increases the risk. In here it says it’s a temporary measure, but many of you know it’s still a requirement in the United States that blood bankers not accept donations from homosexual men. So despite the denial that went on at that meeting, these guidelines came out, which I think even in retrospect were essentially correct. Jim, can you tell us anything what went on between that meeting and the formulation of the guidelines? Jim Curran: There was increasing consensus that this was likely to be caused by infectious agent. And increasing concern that it was present in the blood supply. So that drove the consensus recommendations, and we were able to have these recommendations come from all public health service agencies, but also be endorsed simultaneously by the American Association of Blood Banks, American Red Cross, National Gay Task Force and many — American Association of Physicians for Human Rights. So we had AMA, lots of groups like this. So I think there was in general quite a proud moment for CDC that these recommendations could be promulgated well before the cause of the syndrome was discovered. Harold Jaffe: In fact, the first publication describing what we now know as HIV was made in May of 1983 by Luc Montagnier and his colleagues in Paris, that was recognized by the 2008 Nobel Prize in medicine. And it was another year before Robert Gallo and his colleagues at the NCI really established that the virus was the cause of AIDS. And as I mentioned, I think this is rally an important illustration of the power of the epidemiologic method to understand a new disease. Now, I’d like to say that the story of AIDS ended in 1983, but if it had, you wouldn’t be here. So let me just give you a snapshot of the next few years. So here’s May of 1985, the first 10,000 cases mainly in New York, San Francisco, Los Angeles, Miami. 1989, here’s the first 100,000 cases, large numbers in places like Puerto Rico, Houston, Dallas, Seattle, Chicago, Atlanta. And then by the end of 1995, the first half million cases. So at this point really every major metropolitan area in the United States was reporting cases. And finally, our most recent data, from June of 2010, with more than a million reported cases and more than half a million deaths. These numbers are important. But I don’t think they give you maybe the most important part which is the human face of the epidemic. To do this I’m going to show you the very last clip of the film, which includes a number of people who had the disease or were advocates for the cause. I know who a lot of them are but not all of them. But I’ll say the ones I know anyway. [Video] Yesterday you came to lift me up as light as straw and brittle as a bird. Today I weigh less than a shadow on the wall, just one more whisper of a voice unheard. Tomorrow leave the windows open as fear grows please hold me in your arms. Won’t you help me if you can to shake this anger. I need your gentle hands to keep me calm, ’cause I never thought I’d lose. I only thought I’d win. And never dreamed I’d feel this fire beneath my skin. I can’t believe you love me. I never thought you’d come. I guess I misjudged love between a father and his son. Things we never said come together. The hidden truth no longer haunting me. Tonight we touched on the things that were never spoken. That kind of understanding sets me free. Because I never thought I’d lose. Only thought I’d win. I never dreamed I’d feel this fire beneath my skin. I can’t believe you love me. I never thought you’d come. I guess I misjudged love between a father and his son. Things we never said come together. The hidden truth no longer haunting me. Tonight we touched on things that were never spoken. That kind of understanding sets me free. ‘Cause I never thought I’d lose. Only thought I’d win. I never dreamed I’d feel this fire beneath my skin. I can’t believe you love me. Never thought it would come. I guess I misjudged love between a father and his son. Harold Jaffe: Thank you. [Applause] Booker Daniels: I’ll try to keep my composure. We have ten minutes for questions for the panelists. If you would, form a line in the center of the aisle and we’ll direct some questions. Member from the Audience: Since the theme of this involves a little bit of Hollywood, if you could write the end of the script, what would it look like? Jim Curran: As a result of a safe and effective vaccine and curative therapy, in the year 2000 and blank, HIV was eliminated from 90 percent of the countries on earth with the promise of eradication not too far behind. [Applause] Member from the Audience: Thank you for the presentation. I actually was one of those people who — I’m not that young. But I do — I was young enough not to pay that much attention in the early ’80s. You mentioned a little bit about once or twice about the movie “Contagion” that is coming out. We know that Hollywood dramatizes things for effect as we saw in this presentation. How can we as public health workers, not just in respect to HIV, but in respect to any type of infectious disease, how can we then communicate with communities who are going to be going to see this motion picture to help them understand what it is that we do and what they can do? Harold Jaffe: I haven’t seen the film myself. Although, several people from our office have. And I think it’s some horrible disease that kills just about everybody. I think the message from public health is that’s why we’re here. I mean, there is no such disease. Thank goodness. But if there ever were, that’s why we’re here. So I think that’s the message that CDC would want to get across. Jim Curran: It’s hard — the problem with this movie for Harold and I and other people who are at CDC we’re actually real people. And we have real names and then we see ourselves and we see all the changes and all this sort of thing. And so it’s hard for us and our friends and family to look at this and get beyond the personal part of it. But if you step back from this, if you look at And The Band Played On as a movie, in general I think you see in CDC and parts of the country reacting quite positively and doing the best we could under the circumstances to combat the epidemic. And this was occurring in somewhat of a sea of denial and there was some neglect. Probably wasn’t quite as blatant as Randy Schultz in the movie portrayed it. But it certainly was there. There was a lot of denial and neglect on the part of many, many people. I think in general, names aside and who did what aside, the CDC, staff and faculty and people we worked with and the people we worked with in the gay community, and the people we worked with who are HIV positive, were extremely courageous and worked very well together to get to the bottom of the problem. So if the public sees this and all they see is CDC working hard with the gay community about a disease which was a really, really horrible disease, with an unknown cause, people getting needle sticks when they were investigating cases, not knowing what it meant, not knowing what their future was, but still having the courage to go do it, I think in a sense it’s public health at its best. They could have used somebody more handsome, though. Member from the Audience: Just one question. You remarked about perhaps being more a pathogenic virus early on. Couldn’t it also be the phenomenon of a lot of acute infection going around where the guys were very recently infected and still very sexually active in those houses as opposed to it being more pathogenic? Jim Curran: I think the fact that you could link up a number of cases to somebody who had sexual contact, all of whom had sexual contact with somebody reasonably recently. In a lot of these cases that had contact with Gatan Dugas, just like the dentist case, people were getting sick and getting AIDS within a couple of years, within three years. So you had to have a cluster of people with a rapid infection. That’s one of the things that I think stopped a lot of the demonstration of healthcare workers associated cases because most of them would be in isolation and also would be long, long incubation periods. So I think it’s probably potentially a combination of both. But I think there had to be — in order to have the detection with people with end stage disease linked to individuals who were still alive, you had to have some kind of epidemic situation. If I were the movie character I would say: Think, can’t prove. [Laughter] Although I never said that until now. Member from the Audience: Took us, what, about four years before we actually had a test for HLB 3 LAV and 1985 we introduced that test. Yet it wasn’t universally accepted. Can you kind of talk a little bit about that? Some of the issues that we dealt with back then. Jim Curran: I have a cartoon I showed. One of the things that our laboratories did when the virus was isolated, we got a lot of reagent from the National Cancer Institute. Our jobs, John Ward, Charlie Schaible, Paul Feorino, Tom Peterman, a lot of people worked with the American Red Cross to demonstrate the sensitivity and specificity of the blood test and blood banking situation because it was about to be rolled out in blood banks nationwide. Unfortunately, the study that Harold did, he had several thousand gay men who were tested from a San Francisco hepatitis cohort, and demonstrated that the longer people were infected, not only were they infected a long time earlier, but the longer they infected, if they had positive antibody, the longer they were infected, the more sick they were to be. And Dr. Feorino tested specimens we had from blood donors and found out that essentially having a positive antibody was equivalent to being infected unlike a lot of other viruses. So it was a dangerous virus and having the antibody meant you had the virus and there was no treatment. So what came from a real need and urgency to get the infection led to a lot of distrust, particularly in the gay community about what would happen to the test results, who would know, who would tell whom, what would happen to my insurance status, what would happen to my identity? Because, after all, if you were a man with a positive antibody test, you were probably gay, at least that’s what people thought. And to this day, when we see somebody with HIV, our own brains always say to us I wonder how she got it or I wonder how he got it. So that was the thing that led to the concern. There was essentially nothing that could be done for these people. But we were promoting the test and people were not always happy about that. Harold. Harold Jaffe: I think the other thing to say is the test really was first rolled out for the blood banks, because there were at that point hundreds of transfusion cases, and we had no way to prevent them other than voluntary disclosure of a man being homosexual or injection drug user. So really the point of the test initially was to screen donated blood because of a concern that people would go to blood banks to get the test because there was no other place to go led to CDC setting up a series of alternative test sites where people could go if they wanted to be tested but not be blood donors. Member from the Audience: First, thank you for the session. Thank you both for your service. Two simple questions: First, how do you think the AIDS epidemic has changed the thinking and practice of public health today? And the second is what do you think, the second simple question, what do you think is the perception in the general population in the U.S., I’ll keep it to the U.S., the current thinking about AIDS and in that regard what is our biggest challenge going forward in that regard? Harold Jaffe: I’ll do the first one because I think it’s easier. It was interesting. Gary Nobel is sitting in the audience. I think he would confirm this. The thinking at the CDC in the early ’90s was that the year of infectious diseases was over. We had vaccines. Small pox had been eliminated eradicated. We had antibiotics. And CDC’s mission was changing. So we started growing in areas of chronic disease and environmental health. And there was really no expectation that suddenly we would have to sort of say, wait a minute, there’s more out there than we knew about. But there was. And HIV became the prototype of the emerging infection, and now we’re aware of dozens, if not more than that, of infections that we had no idea would infect humans that we thought were only in animals or didn’t know about it at all that suddenly popped up. So I think it told us that we weren’t as smart as we thought we were, and infectious disease era was far from over. Jim Curran: I’d rather answer that one again, so I’ll try. Couple things in CDC that were going on. Harold and I worked in STD research before AIDS came along, and people used to say to us, when they thought there ought to be more contact tracing, how come you don’t treat AIDS like any other STD? And my comment usually was: What do you mean, just ignore it? Because that’s really what people did with STDs. They essentially ignored them as public health problems, for the most part. What made AIDS different was of course that it was fatal. And the fatality and the activists who were dying people themselves called attention to something that was so important that it deserved more attention. But there was no magic bullet. And so Bill Darrow was either the only doctorally trained behavioral scientist or one of two or three at the CDC in 1981. Now there are hundreds and hundreds and hundreds. And so I think that changed. I think the recognition and respect of behavioral and social scientists and social determinants of health occurred in parallel with the beginning of the AIDS epidemic. I’m not saying it wouldn’t have occurred anyway. But it was certainly stimulated by AIDS and a lot of behavioral scientists at CDC kind of cut their teeth on AIDS. And it was okay to talk about sexual behavior. The other thing that happened was a new relationship with nongovernmental organizations occurred with direct funding and partnership with state and local health departments, because of the general horrible distrust of government at all levels by many people in the communities. And that’s something which I think is renewed public health. I forgot your last question, Paul, but it was something about — Member from the Audience: Perception. Jim Curran: I think people think it’s pretty much over and not paying too much attention to it, largely because it hasn’t been in the press very much. It’s not publicized very much, because not as many people are dying. And you know every year four million plus people have sex for the first time in the United States. So since HARK, there’s been 60 million new Americans having sex for the first time in an era where there hasn’t been as much publicity. That’s sort of the way I would summarize it. It’s not over. And more people are infected than ever and they’re going to be really crunched by the economic crush in the United States and the impossibility of healthcare reform. I think we’re going to see more and more people lined up to get treatment in the future. Booker Daniels: With that, we’ll have to conclude our panel session. Our time is up. Let’s give a round of applause to our panelists one more time. [Applause]

Reducing infection in the outpatient dialysis facility

Reducing infection in the outpatient dialysis facility


[ Music ]>>Hello and welcome to today’s webinar, Tune
in to Safe Healthcare: Reducing Infection in the outpatient dialysis facility – Results
of the Standardizing Care to Improve Outcomes in Pediatric End Stage Renal
Disease or SCOPE Collaborative. Hosted by the Centers for
Disease Control and Prevention and the Making Dialysis Safer
for Patients Coalition. CDC’s mission is to save lives and protect
the health and safety of Americans. My name is Priti Patel and I
am a medical officer who serves as the Dialysis Activity Leader within the
Division of Healthcare Quality Promotion at the Centers for Disease
Control and Prevention. I am also the Medical Director of the Making
Dialysis Safer for Patients Coalition. This webinar is part of a series of infection
control related webinars the CDC hosts along with a variety of external partners and experts. The Making Dialysis Safer for Patients Coalition
is a collaboration of diverse organizations who have joined forces with the
common goal of promoting the use of CDC’s recommended interventions and resources to prevent bloodstream infections
in dialysis patients. I am pleased to introduce the featured
speakers for our webinar today. Dr. Bradley Warady is a Professor
of Pediatrics at the University of Missouri, Kansas City School of Medicine. He is the Director of the Division of
Nephrology and the Director of Dialysis and Transplantation at Children’s
Mercy Hospital. Dr. Alicia Neu is a Professor of Pediatrics and
the Division Director for Pediatric Nephrology at the Johns Hopkins University
School of Medicine. She is also the Director of Pediatric
Dialysis and Kidney Transplantation at the Bloomberg Children’s
Center at Johns Hopkins Hospital. Both Doctors Warady and Neu are members of
the project committee for the American Society of Nephrology or ASN, Nephrologist
Transforming Dialysis Safety Initiative. I’ve had the pleasure of interacting
with them on that committee and experiencing first hand their
passion for preventing infections. Doctors Neu and Warady helped to spearhead
the development of the SCOPE collaborative, the topic of today’s presentation. And it remains the faculty leads of the
collaborative since its launch in 2011. Before we get started there are a
few housekeeping items to cover, we welcome your questions,
please submit any questions or comments you have via your chat window
located on the lower left hand side of the webinar screen any
time during the presentation. Questions will be addressed after
the presentation as time allows. To ask for help please press the raise hand
button located on the top left hand side of the screen if you need to chat with someone
for technical assistance during the webinar. To hear the audio please ensure your
speakers are turned on with the volume up, the audio for today’s conference should
be coming through your computer speakers. In addition, the speaker’s slides from
today’s presentation will be provided to participants in a follow up email. Without further ado I’d like to turn it
over to our first presenter, Dr. Warady.>>Well, thank you Priti very much for that
introduction and I just want to begin by saying that Dr. Neu and I are very honored
to be able to provide this webinar to give folks some insight into the
activities of the SCOPE collaborative. Knowing how many people that have signed up for
this webinar, it’s great to hear that there’s so many of us around the nation that have
the goal of decreasing the rate of infection in patients on dialysis, both
pediatric and adult patients. I suspect that many of you
are not pediatric providers and so I thought I’d give you two
background slides to give you a little bit of insight into pediatric dialysis. This slide is from the 2011
annual report of the NAPRTCS, or the North American Pediatric Renal
Trials and Collaborative Studies. An organization that has had a registry of
pediatric kidney disease for more than 25 years. And here we’re looking at the primary
diagnoses associated with the development of end stage kidney disease in
children based on some 7,000 children. You note that the most common diagnosis
is focal segmental glomerulus sclerosis or steroid resistant nephrotic syndrome. Followed by aplastic, hypoplastic,
dysplastic kidneys and obstructive uropathy. The latter generally being posterior urethral
valves and then a host of other disorders. Again, for the adult practitioners you’ll
note the absence of systemic hypertension or diabetes mellitus as a cause of end stage
kidney disease in the pediatric population. This next slide also from the
2011 report of NAPRTCS looks at the dialysis modality by age group. You’ll note that PD is in yellow and
hemodialysis is in blue and we divided it into four different age groups
at dialysis initiation. So you’ll see that in those children who
initiate dialysis at less than 2 years of age the vast majority are
prescribed peritoneal dialysis. Some 95% largely because hemodialysis
is very complex in these young infants and there’s a lack of adequate vascular access. Both increasing age of the children when they’re
cared for in a pediatric dialysis program. You’ll note a progressive increase
in the percent of the children who received hemodialysis such
as in the adolescent population. There’s near equal distribution of children
on peritoneal dialysis and hemodialysis. Now if we were just going to look at
adolescent individuals who are cared for in adult programs the vast majority of
those children do in fact receive hemodialysis. But you might ask why did we
focus on reducing peritonitis in the SCOPE collaborative
as our initial project. And really three major reasons for that,
number one peritonitis is the leading cause for hospitalization in the pediatric PD
patient, not only in the U.S. but globally. Recurrent peritonitis is a leading
cause for PD failure and the need to transfer the children to hemodialysis. And then finally maybe most importantly,
infection is a leading cause of mortality in children who receive chronic
peritoneal dialysis. [ Pause ] This slide reviews the variability
in peritonitis rates that we see in the pediatric population, we’re looking at
peritonitis rate in months between infection. So we look at the mean data from the
NAPRTCS you can see that the mean rate is about 1 infection every 28 patient months. This data here is from the international
pediatric peritoneal dialysis network where the mean infection rate is approximately
one infection every 20 patient months. But each of these dots represent the peritonitis
rates at different centers across the U.S., different pediatric dialysis centers. So you can see the great variability with
these centers having very frequent episodes of peritonitis and this center here
having very infrequent peritonitis. And this variability in the peritonitis
rate suggested there is variability in the care provided these children. And our hypothesis has been that if we can
develop more uniform approaches to care that we would indeed seek
improvement in the rates, a decrease of infections in
these children on chronic PD. [ Pause ] So the SCOPE collaborative is part of the Children’s Hospital Association’s
quality transformation network which utilizes a quality improvement process
to increase implementation of standardized care of practices, or as we call them care bundles. This system is such that we’re utilizing again
the SCOPE collaborative which has experience with CHA, the Children’s Hospital Association, in the experience facilitating
national collaboratives. CHA has established collaboratives not only
with end stage kidney disease but a number of other disorders affecting children. Their model also includes multidisciplinary, multi-institutional faculty
which we’ll get to in a moment. As I mentioned to you already the NAPRTCS
that’s our data coordinating center, so all the data is located centrally of
the NAPRTCS and the NAPRTCS has 25 years of experience with data collection in
pediatric CKD, dialysis and transplantation. With data from over 140 pediatric
nephrology centers across North America. Now most important to this collaborative
structure are the site teams, as I said before there are
multidisciplinary teams that are testing and implementing the care of bundles. Now in each team there must be
pediatric nephrology representation and pediatric dialysis nurse representation. But there also may be individuals from the QI
department, infectious disease, even surgeons. And so the makeup of the team
in individual sites does vary but there’s always pediatric nephrology
and pediatric dialysis nurses. These teams report process and outcome data on a
monthly basis and they participate in workshops and webinars and ListServ’s and we’ll
come back to that in a few moments. [ Pause ] This is a map that just gives you visualization
of where these sites are that are participating in the SCOPE collaborative
some 40 sites as you can see. Each represented by a star and the names of the individual sites are
located here around the map. And virtually all of the largest pediatric
dialysis programs in the country are part of this truly national collaborative
to decrease peritonitis and exit site infection in
these children on chronic PD. [ Pause ] Now once again, the SCOPE collaborative is
part of this quality transformation network that utilizes quality improvement to increase
implementation of standardized care practices. This system also requires a
process to ensure ongoing, reliable performance of standardized care. And the education elements of corporate
teams so if need be they can change behavior to increase the implementation
of these standard practices. I want to emphasize from the start that
while I’m sharing with you our experiences with the processes in the
pediatric dialysis program, these same processes can most
definitely be incorporated into adult dialysis programs as well. So, we’re going to go over each of
these processes in the next few slides. We need to standardize care as
part of the SCOPE collaborative if we hope to decrease peritonitis rates. And so to do that we’ve established three sets
of care bundles, a PD catheter insertion bundle which addresses both the intraoperative and the
immediate post-operative care of that catheter. The training bundle which focuses on the
training of the patient and family prior to going home on peritoneal dialysis. And the follow up care bundle which addresses
the content of the monthly clinic visits and the evaluation, the education that
takes place during those periods of time. This slide reviews the content of
the PD catheter insertion bundle. So the catheter exit-site orientation
is in the lateral or downward position since those positions seem to be associated
with the lowest rate of peritonitis in children. A first generation cephalosporin is provided
intravenously within 60 minutes prior to the incision for the PD catheter placement. No sutures are utilized at the
exit-sites to decrease the likelihood of catheter exit-site infections. And postoperatively the catheter
is immobilized once again to decrease the likelihood
of exit-site infection. There are no dressing changes within the
first 7 days and then only in a sterile manner until that exit-site is well-healed and then
no catheter utilization for the first 14 days. [ Pause ] This slide reviews the patient and caregiver
training bundle, the training is performed by a qualified nurse on a 1 to 1
ratio with that patient and family. Ideally there’s a primary provider
and an alternate for each patient. There’s appropriate teaching age
and there’s unit training protocols that are based upon the content
of the pediatric guidelines from the International Society
for Peritoneal Dialysis. There are specific protocols that are utilized
in teaching that address aseptic techniques, exit-site care and we utilize
the recommendations of the World Health Organization
for hand hygiene. Post training there’s a concept test and
a demonstration test and a home visit to occur again with each training. Finally, our third bundle is the PD
catheter and exit-site follow up care bundle. And this is the content of those monthly
visits, so at each visit the exit-site is scored by the nurse utilizing a
scoring system that was developed by the International Pediatric
Peritoneal Dialysis Network. And during each visit there are key
aspects reviewed of hand hygiene, exit-site care and aseptic techniques. Now one component of this bundle that very few
sites utilized before the SCOPE collaborative is the utilization of a six month
demo test and concept test and that is every six months while
that patient is receiving PD. And this is a means to review the retention
of the information that has been shared with the patient and the family
as part of the training process. There is focused retraining
after each peritonitis episode and then prophylactic antibiotics are
used following touch contamination or any of the breaks in technique
according to the guidelines of the International Society
for Peritoneal Dialysis. And this is particularly important because
we see that coag negative staph is one of the most common organisms that gives rise
to peritonitis in our patient population. Now, the next important issue to
address is auditing and it’s important that we audit our performance so that
we can insure reliable performance of the standardized care and if indeed
we see that we are not achieving that reliable performance, it
allows us to modify behavior to again hopefully improve the implementation
of these standardized care practices. Now, in most quality processes, one looks
at a subset of data and then analyzes that as part of quality improvements. We do something different in SCOPE, we gather
compliance data on every catheter insertion, on every initial training session
and on every single follow up visit. So we have a robust data set of compliance that helps us again achieve the best
possible outcome in these children. When we look at compliance in the SCOPE
collaborative, we look at it as an all of none phenomena, so for instance this
are the components of the training bundle. If we’re looking at compliance
and training we have to be compliant in all aspects of the bundles. So for a nurse to say that
she has been compliant in conducting the training bundle
she has to be compliant in all of these different elements
of that training bundle. It’s truly an all or none phenomena and
thus we have a very high bar to achieve in the SCOPE collaborative but we
think that is the best approach to achieving the optimal
standardized care practices. [ Pause ] Now the next important process in this overall
initiative is to teach the clinical teams to change their behaviors and to
teach them how to engage patients and families to implement the best practices. I think this is one of the most important
components of this entire initiative. This engagement of patients and families,
clearly when you’re conducting a procedure like peritoneal dialysis that occurs in the
home, we have to have a seamless partnership between the clinical team and the patients and
families if we hope to achieve the best success. And so I think this has been
an integral component of SCOPE that is now being shared
across our collaborative. We teach the clinical teams to use
quality improvement methodology to increase implementation of
these standardized care practices. And the model employed by SCOPE
is the model for improvement. This includes the use of plan, do,
study, act cycles or PDSA cycles, small tests of change that drive improvement. Also crucial in this entire process
is developing a culture of safety. Patient safety, especially infection prevention,
must be a priority in the dialysis unit of every member of the health care team
including the patient and their families. And all of these stakeholders must
be empowered to implement that change if we hope to achieve the best outcomes. This is an example of the
PDSA cycle and the improvement that was experienced at one of our centers. This is data from Nationwide
Children’s Hospital. Here we’re looking at monthly
compliance rates as well as rolling 12 month cumulative compliance
rates for insertion compliance reflected by the redline, training compliance
reflected by the blue line and a follow up compliance by the green line. But the focus here on the 12 month rolling data
on the insertion compliance you can see early on there was zero compliance in
terms of the insertion processes. But over time there were marked
improvements again following the introduction of these three different products
following their previous day cycles, most recently the catheter insertion check list. [ Pause ] This is the checklist that has been used by
Nationwide Children’s Hospital and I’m not going into great depth about the checklist. Other than to say that the checklist
includes information on the proper antibiotic to use prior to catheter insertion. The dose of the antibiotic, what to do
postoperatively, how to address the exit-site and a host of factors all that
addressed optimal catheter care. Now what’s important is not only
did this product assist the folks at Nationwide Children’s Hospital
in improving their outcome. But this product was shared amongst all
the collaborative sites and incorporated into other sites as well
to improve their outcome. So the sharing of resources among collaborative
sites within SCOPE have been another key product and something that has lent
itself to improved outcomes across all 40 centers participating
in the collaborative. [ Pause ] Next we need to support the teams with monthly
transparent data and networking sessions. Another key aspect of the SCOPE collaborative
and this slide is from the homepage of the NAPRTC, just to highlight the fact
that there’s real time data that is available to be shared among all the sites in a transparent manner that
are participating in SCOPE. These data like I said are real time
and anyone can see anybody else’s data. This is very, very important for
the quality improvement process. Centers need to be able to track their own
data so they can see how they are doing and they can identify areas
where they’re struggling and where some change in
behavior may be helpful. They can also view other center’s data to allow
them to identify centers who are doing well, so that they can reach out to those
centers and learn from their experience. Something else that again is
incorporated into our DNA in pediatrics, it could also be utilized by adult providers. I’m going to quote Jane Steward, Jane works
with us at CHA and she stated that the model for this philosophy of transparency is to
steal shamelessly and share seamlessly. And that’s something that all of us
practice in the SCOPE collaborative. Now we also share information
on the volume of data that we’re receiving with
all of our participants. So this is an example of data
that we share with our team, data collected between October
2011 and October 2016. So you can see we had over 1,200
enrollments and information on more than 1,000 catheter insertions. We have information on almost 1,100
training sessions and 15,000 follow up forms. And information on 833 infections, nearly
600 episodes of peritonitis and 237 episodes of exit-site peritoneal infections. So this robust data base
allows us to analyze these data and hopefully generate important information
that may ultimately be incorporated into bundles and help us decrease the rate of peritonitis. We also shared information with our teams on the
rate of infection, here we’re looking at data on the aggregate monthly
exit-site infection rate. So here we’re looking at months between
infections, this is all exit-site infections and this is the same data but
characterized by infections per patient year. Now here we’re looking at the months over time. And I think what should be evident to you is
the great variability that occurs on a month to month basis in the number of infections
that are seen across the collaborative. But if you look at it as a 12
month rolling average you can see that there has indeed been a gradual
improvement in the exit site infection rate. Once again here’s a month between infection,
the rolling 12 month cumulative data and here’s the infections per patient year. And so you note that early on October
2011, the annualized rate was somewhere around 0.38 infections per patient year and we
progressively improve to somewhere around 0.15, 0.14 infections per patient year. Other data that we share with our team
related to exit-site is data like this. A control chart, so here we’re looking at
once again the annualized infection rate. And we’re looking here at data
just on 22 centers who provided us with historical data before the initiation
of the collaborative and then looking at the experience of those same centers
following the initiation of the collaborative. So here’s the historical data
and the mean pre-study right here and here’s the post collaborative
data over 57 months. These are the monthly collaborative
rates of exit-site infection. And you can see that we’ve seen a progressive
improvement, still more work to be done, but a progressive improvement about a 25%
decrease in the rate of exit-site infections. But I show you this as just another
example of the kind of data that we share with all the sites within our collaborative
on a regular basis to point out our success and to point out the challenges
that are still in front of us. Now, while looking at infection
rate is critically important we look at another outcome metric and that is the
fiscal impact of infection prevention. And we do that by combining the data
from SCOPE with data from the PHIS, a data base that is the Pediatric
Health Information System. That’s a data base that includes information
from more than 45 children’s hospitals across the nation, including fiscal data. And by combining these data we find to
date that the median cost of a treatment of peritonitis was about $14 thousand
per episode with higher costs associated with patients who experience an ICU stay,
who experience septic shock in association with their hospitalization or who
have developed fungal peritonitis. Well, you might ask well where
does all this networking occur? And I think this is again critically
important to the success of SCOPE. So we have monthly webinars and in those
webinars we have the participation of one or more representatives from virtually all
40 centers that are participating in SCOPE. The webinars may be educational sessions,
we may be sharing challenging cases. We may be discussing potential
new initiatives but it’s a way to truly hear from one another’s experience. Maybe the most important networking
opportunity is the twice yearly, face to face learning sessions that we have. This gives us an opportunity to sit
at the same table with individuals, learn from their expertise and their insights
that we can incorporate into our own sites. We hear failures, we hear success stories
and I think all that has allowed us to then generate more PDSA
cycles, more improvement, that has been shared across the collaboratives. So this is a kind of interaction, again
it’s occurring here in pediatrics. It certainly can occur in adult
programs as well and is key to the improvement practices
that we’re experiencing. There’s an eGroup list serve,
there’s a practice inventory where the nurses are collecting information on
pediatric practices, not only those that are within the bundle but even
outside the bundle and the again, review of that information lends
itself to more information in terms of how we might decrease
infection risk in our patients. And then there’s regular online sharing of resources amongst all the
participants from the collaborative. Finally we need to scientifically
assess the impact of our effort, we need to take all the data
that we’ve collected. We need to analyze the data and
we need to publish that data so that it can be shared amongst the
dialysis community both peritoneal dialysis and hemodialysis, both pediatric and adults,
and so now I’m going to hand over the microphone if you will to Alicia Neu, she’s going to review
the analysis of the data that we’ve collected on PD and she’ll also introduce the new
initiative in SCOPE that of the assessment of hemodialysis patients,
so Alicia it’s all yours.>>Great, thanks Brad, so again
as Dr. Warady said the final step in the QI process is the scientific
assessments of the impact of the effort. And he’s already shown you how we continuously
assess that impact using control charts. And as he mentioned we intermittently perform
rigorous statistical analyses on all of the data that we collect on all these patients. And we recently published the results of an
analysis of the first three years of SCOPE. These were published in KI and the title page
from that manuscript is shown on this slide. Excuse me. I’ll briefly review the results
of that analysis which focused on the improvement in follow
up bundle compliance. And the change in peritonitis rates over
those first three years of the collaborative. As Dr. Warady mentioned there are currently 40
pediatric dialysis units participating in SCOPE but in order to be included in the analysis
that I’m presenting, a center had to be in the collaborative at the
time of launch in October 2011 and there were 29 centers at that time. The analysis was further limited to
those centers which had provided patient and infection counts for the
13 months prior to launch. Or historic data to which the post-launch
infection rates could be compared, 24 centers met these criteria. From which there were 644 patients enrollments,
751 catheter insertions, 319 training sessions and 7,977 follow up forms submitted in
the first 36 months of the collaborative. As mentioned by Dr. Warady, compliance for
all three bundles is assessed as all or none. Meaning that every patient’s catheter insertion
training session or follow up event had to comply with all of the elements of the
respective bundle to be considered compliant. Infection rates for each center were calculated as an annualized rate using
the formula shown on this line. And then the collaborative rates were
calculated as the mean of the center rates. So, I should emphasize that although more than
640 patients were enrolled in the collaborative, because the central hypothesis of SCOPE is that
more uniform practices across centers will lead to a reduction in infection
rates at those centers. For statistical purposes the unit of interest
is the dialysis facility and not the patients. So the effective sample size for
these — this analysis is 24. This slide shows the monthly compliance
with each of the care bundles over time with PD catheter insertion bundle in
blue, the training bundle in orange and follow up care bundle in green. Note the significant month to month
variability in both the training and catheter insertion compliance. This is in large part due to the low number of
these events, we would typically get between 2 and 25 catheter insertion or
training events reported every month. In addition, it’s related against an all or
none compliance scoring, so if you completed 90% of the insertion bundle you don’t get
a score of 90 you get a score of 0. Conversely, the average number of follow up
events is about 250 per month and as you can see across the collaborative the follow up care
compliance slowly but steadily increased over the first three years of the collaborative. It increased so that by just over two years
after the collaborative launch we hit a level of 80% compliance with follow up care. Changes in bundle compliance over time
were assessed using generalized linear mix model techniques. Which confirmed that the probability
of compliance with the follow up care bundle increased significantly over
the first 36 months of the collaborative. That’s highlighted here in the red box. Not surprisingly given the variability
in compliance and the small number of events every month, these models could not
detect a significant increase in compliance with either the insertion
or the training bundle. Although it’s impressive that we were
able to ultimately achieve 80% compliance with the follow up bundle there may be some in
the audience who are wondering why it took us over two years to reach this
level of compliance. As a reminder the PD catheter follow up bundle
requires that hand hygiene, exit-site care and aseptic technique be
reviewed with the patient and the care giver at every
single follow up visit. The bundle also requires that the
patient and family demonstrate competence with these procedures using both the concept
of demonstration tests every six months. Again, compliance is scored as all or none, so
if you review exit-site care and hand hygiene but not aseptic technique, you get scored
as a zero for that follow up event. The PD providers in the audience will
immediately recognize the difficulty in getting all of these bundle elements
into an already busy PD clinic visit. That requires review not only of infection
prevention but also the many other aspects of the care of these complex patients. Thus, it’s not surprising that centers
may be able to implement some but not all of the bundle elements consistently
at every single visit. In fact, this figure shows both the
monthly overall compliance with a follow up bundle here in this solid line. Along with the compliance with each of the
subcomponents in the various dotted lines. Note that compliance with nearly all of
the elements individually achieved a 70 to 80% compliance level within
a few months of the launch. But overall compliance which again requires
that we do every single one of these things in every single visit did not
reach 80% until the fall of 2013. Again, if you were previously surprised
that it took us over two years to get 80%, you may now be surprised
that we got there at all. And achieving this level of compliance was
only possible because the entire care team at each center participated in
the quality improvement process. Each center as Dr. Warady mentioned is charged
with developing ideas to increase compliance. They are to test them in a few patients, they
get feedback from the entire healthcare team and from the patients and then they either
spread it to other patients if it was successful or if it wasn’t successful they
go back to the drawing board. They modify it and try again. These small test of change, the development
in testing of ideas does not stop at the individual dialysis unit
and as Dr. Warady said the strength of the SCOPE collaborative
is the sharing of resources. Ideas, processes, tools,
experiences and resources are shared and stolen freely across
the SCOPE collaborative. This slide shows examples of the some of the
resources that have been developed and shared across the collaborative to
increase follow up compliance. Some centers, some fortunate centers have a
dedicated nurse educator whose sole job during the PD visit is to make sure the
topics of exit-site care, hand hygiene and aseptic technique are reviewed. Many centers have developed visual aids such as
posters or flip charts to help in the review. And then one of the most popular
methods is to have the patient or the family actually perform
the exit-site care in the clinic. This not only allows you to review hand
hygiene and exit-site care but also allows you to have a demonstration of the
competence during that visit. Not only is it difficult to include all
of the reviews in each and every visit but review fatigue is a significant problem. It doesn’t matter how fancy your flip chart
is, if it’s the only resource you have to review exit-site care it doesn’t take long
before it’s no longer an effective review. Again, the sharing of resources is incredibly
important and this slide shows examples of some of the techniques to minimize review fatigue
that have been shared across the collaborative. This includes having the patient or their
family monitor the hand hygiene practices of the providers in clinics. That includes everyone, the doctor, the
nurse, the dietician, the social worker. Another very popular technique
is to use Glo Germ. For those of you who are not familiar with Glo Germ it’s a substance
that’s visible under black light. And so the patient or their family
puts the Glo Germ on their hands, they then perform hand hygiene and then they
put their hand under a black light and any areas where the hand hygiene wasn’t
effective will glow. It’s very popular particularly
among adolescent boys. Many centers have developed video games and
the picture here in the bottom left hand corner of the slide is a video game that
we developed here at Hopkins. And our dialysis nurse, Barbara
Case, intentionally makes mistakes at several steps of the aseptic technique. And the patient is instructed to click
the mouse whenever they see a mistake and the video game immediately tells them
whether they’ve correctly identified a mistake. And then finally some centers
will have the patient or family record themselves performing
the dialysis procedure in the home. Every patient and caregiver has to
demonstrate competence with this procedure. But there’s a difference between performing
the procedure in a clinic and performing it in the home on a day in and day out basis. So they record themselves performing
the procedure using a phone or a tablet, they then bring the recording into the
clinic where it’s reviewed with a nurse or a nurse educator and then opened
in a non-accusatory environment. The patient and the family are reminded that
the goal of the review is not to place blame but to identify ways to improve their technique. These are just a few of the examples of
the many resources that have been developed across the collaborative,
as Dr. Warady mentioned. They’re shared by centers on the eGroup or
may be presented on the monthly webinars or at our face to face learning sessions. And then they’re made available
on the online at the CHA or the Children’s Hospital Association website. Moving from compliance to infection
rates because again the goal of the collaborative is not just to get people
to do all these things during clinic but rather to see whether or not all these things
actually can reduce infection rate. Among the 24 centers included in this analysis
there were 206 peritonitis episodes reported over 3,778 patient months in the 13
months prior to the collaborative launch. These same centers reported 320
infections over 8,853 patient months in the 36 month post launch period. While it is tempting to compare these
two crude rates, we need to remember that the post launch rate here includes the
entire 36 months following collaborative launch including that two year period
when the implementation of the follow up care bundle was low. Thus a comparison of these rates would not
test the hypothesis that more uniform delivery of care will reduce infection rates. Because it includes in the postop period a time,
or a post launch, not postop, post launch period when a time when care was not uniform. In order to test that hypothesis you have
to look at average monthly peritonitis rates which allows you to detect
trends and rates over time. To do this a model was fit using
average monthly peritonitis rates and this analysis revealed a
statistically significant reduction in monthly peritonitis rates. From a rate of 0.63 episodes
per patient year to a rate of 0.42 episodes per patient
year at 36 months post launch. This slide shows the average monthly
peritonitis rate in the prelaunch period to the left of this red vertical line. And the 36 month postlaunch
period to the right of this line. Also displayed is the monthly follow up
compliance here in the green dotted line, these data graphically suggest that as follow up bundle compliance increased the
variability in peritonitis rates decreased. In order to determine the level
of follow up compliance required to achieve a significant decrease in infection
rates, we performed a sensitivity analysis in which we compared the peritonitis
rate in the prelaunch period, I’m sorry, I’m going to go back one slide. In the prelaunch period here
with rates following achievements of various levels of follow up compliance. So the rates in this time period were
compared to this, this time period to this. The results of that analysis
are shown on this slide. The mean compliance threshold is here in the
first column and the ratio of peritonitis rates in the prelaunch period over the rate in
the time period after achievement of each of the compliant thresholds are
shown in this fourth column. Since it is a ratio of prelaunch rates
over postlaunch rates the lower the rate after the compliance threshold
isn’t reached the larger the ratio. This analysis confirmed that as mean compliance
increased the peritonitis rates decreased so the ratio increased. Reaching statistical significance
at a mean compliance of 80%. At which the prelaunch peritonitis
rate was 42% higher than the rate in the month following achievement
of this level of compliance. Although, I hope you’ll agree with me that
this is impressive, our work is not done and the SCOPE center continues to work to
maintain compliance with the follow up bundle and to increase compliance with
the insertion and training bundle. We’ve also developed research groups which
have within the collaborative which have tried to identify whether there are clinical or
demographic factors or even other care practices that may influence infection rates. We’ve also developed innovation groups that
have thought to optimize care practices, not specifically included in the bundles. Including improving identification
and treatment of touch contamination, developing health literacy sensitive
education and review materials. And increasing patient and family engagement
in the quality improvement process. We now move to the hemodialysis project and as Dr. Warady mentioned it is our more
recent project and it launched in 2013. Like the PD project the HD project seeks
to reduce HD access related infections by increasing implementation
of standardized care practices. While it is well recognized that
the single most effective way to minimize HD access related infections
is to reduce the use of catheters. It’s also well known that catheter use
remains common in pediatric patients. This slide is taken from the U.S.R.D.S. And it shows hemodialysis access type
among prevalent pediatric patients, hemodialysis patients in the United States. As you can see a majority of children
and particularly young children, continue to have a catheter
as their hemodialysis access. There are many reasons for this including
the fact that the majority of children on dialysis actually receive a kidney
transplant within two years of reaching ESRD. Until a more permanent access
is not always warranted, in addition it may not be technically feasible, as Dr. Warady mentioned to
create a vascular access. Specifically, an AV fistula
in a very small child. Thus any effort to minimize HD access
related blood stream infections in children must include efforts aimed at
reducing catheter associated infections. Therefore the HD project includes standardized
practices for accessing tunneled catheters as well as AV fistulas and AV grafts. The specific practices including the HD catheter
connection procedure is shown on this slide. And includes the requirement for
hand hygiene using the WHO protocol and appropriate personal protective equipment
for the provider and a mask for the patient. The protocol does require
scrubbing of the catheter hub with an appropriate antiseptic solution. While the SCOPE bundle was largely based on
the recommendations from the CDC it does differ from the CDC recommendations in that it allows
sodium hypochlorite to be used to scrub the hub. In addition, the procedure for povodine
iodine does not specifically include a scrub but rather applying and allowing the agent to
dry according to manufacture recommendations. SCOPE is planning to work with the CDC to
evaluate these practices and the bundle elements to more closely align with CDC recommendations. After the hub is prepped the catheter is
connected to the lines using aseptic technique, the provider then removes gloves
and performs hand hygiene. The hemodialysis disconnection cap
change procedure is shown on this slide. Again it largely follows the CDC guidelines, except some additional agents
are allowed for the hub scrub. The agents that are included in the SCOPE
bundle are shown here and the agents that are consistent or included in the
CDC recommendations are shown bolded. This slide shows the protocol for dialysis
catheter exit-site care and dressing change. And as with all the protocols
require proper hand hygiene and PPE. The agents for prepping the catheter
exit-site and the allowable antibiotic ointment or creams applied to exit-sites differ
slightly from the CDC recommendations. And again with the agents including the CDC
recommendations being bolded on this slide. Again after the dressing change — well, the frequency of dressing
change is shown here on the slide. And it depends on the type
of the dressing change used. After the dressing is changed the
provider should remove their gloves and perform hand hygiene. The procedure or the protocol for accessing an
AV fistula or graft is shown here and includes that the patient should wash
the site with soap and water. Proper hand hygiene and appropriate PPE are used by the provider unless self-cannulation
is performed. The site is prepped with an
acceptable antiseptic solution and again the acceptable solutions
in the SCOPE bundle are shown. With the CDC recommended solutions bolded. After inserting the needles with
aseptic technic, the gloves are removed and appropriate hand hygiene is performed. Finally the decannulation
procedure is shown here and includes the appropriate
hand hygiene both prior to and after the procedure and appropriate PPE. As with the PD project the HD project
requires that all patients cared for in the unit be enrolled in the project. Obtaining data at the patient
level is included in order to identify clinical and
demographic characteristics. That may increase risk for infection,
especially in high risk populations. This slide details the data collection process for individual patients enrolled
in the collaborative. Unlike the PD project it is not
required that every single procedure in the hemodialysis unit be audited. It would obviously be too labor intensive to audit every single time a patient’s access
was connected and disconnected from the tubing. Therefore centers are advised to audit a
random sample of those procedures every month, they’re encouraged to rotate
the audit so that every shift and as many providers are audited as possible. As noted in the top half of the slide the
targeted number of audits is twice the number of patients cared for in a unit with
a maximum of 30 audits per month. Obviously this means that not every
patient enrolled will have a connection or disconnection audited. In order to ensure that patient level practices
are captured on every enrolled patient. Centers are also asked to provide a follow
up form which includes care practices for every patient at least annually. Just as for PD the data are
submitted online and are available for centers to review in real time. And we obviously also review the data
on our webinars and at our workshop. And the data shown on this slide
represented at the workshop last fall at which time there were
25 centers entering data. From these sites nearly 500 patients have
been enrolled and nearly 5,000 audits or observations have been submitted. This includes more than 3,000 audits
procedures involving catheters and more than 1,300 involving AV fistulas or grafts. The breakdown of those audits
are shown on the slide. 77 infections reported during the over
4,300 catheter months of follow up and 2 infections reported in nearly
1,800 fistula graft months of follow up. Note that centers are asked to
report any positive blood cultures or other infection events and then each
of these events is centrally adjudicated by an infectious disease specialist
to determine if the event qualifies as an access associated infection. So these numbers represent
the adjudicated infections. This slide shows the monthly compliance with
the care bundles across the collaborative with catheter care compliance in red and AV
fistula, AV graft care compliance in blue. Each point shows the compliance
for that care bundle in that month. In general compliance with AV
fistula and graft care is quite high. Compliance with a catheter bundle is more
variable and hovers between 60 and 80%. Although it has increased
slightly over the last few months. A compliance deep dive at our last learning
session in the fall revealed that failure to apply an antibiotic ointment or
cream at the exit-site at the time of a dressing change was the
single most important contributor. To non-compliance with the catheter bundle. This slide shows the monthly rate of catheter
associated infections across the collaborative, following collaborative launch in June 2013. The rates are presented as the number
of infections for 100 patient month. Unlike the PD project which had a uniform
launch date for the initial 29 sites, meaning all centers began
implementing the bundles and collecting and submitting data in October 2011. The HD project has allowed a rolling launch,
that is centers can begin implementation and enrollment any time after June 2013. The number of patient months
and events is along the X axis. And as you can see for the first year and a half
or so there were very few centers entering data which was related to delays in obtaining
IRB approval, consent and ensuring that all of the providers were trained
according to the bundles. Prior to the center’s launch, as
such the number of patient months and the number events was relatively low. As the number of centers and therefore
patients increased the rates actually increased to more accurately reflect the rates across
multiple centers rather than just a few. As you can see as time has gone
on, although there continues to be some variability, the
rates have begun to drop. And since November 2015, the monthly bloodstream
infection rate catheter associated bloodstream infection rate, has been less than
two infections per 100 patient months. Again, these data suggest that the rates are
decreasing but this chart doesn’t allow us to compare the rates prior to and after
implementation of the care bundles at any center or across the collaborative. Conversely, this chart which is a
U chart allows us to do just that. And these are data taken from 15 centers that
provided historic data that is infection counts and patient counts for the 12 months prior to
the implementation of the bundles in their unit. As well as the rates following
implementation of those bundles. And this chart represents
or provides the results that show a 32.5% decrease in infection rate. From a rate of four episodes or bloodstream
infections per 100 patient months, prior to launch to 2.7 catheter related
bloodstream infections per 100 patient months after launch. As the number of centers and patients
enrolled increases and in particular as we obtain historic data from
additional centers we will be able to perform statistical analyses. As we have for the PD project. I’d like to close very quickly by
acknowledging all of the SCOPE team members and especially our patients and
their families whose hard work Brad and I have had the great
privilege to present today. And who continue to work tirelessly
to improve the care and the lives of children with end stage renal disease. We recognize that we’ve covered
a tremendous amount of information in a very short period of time. But our hope is that we’ve conveyed to you that quality improvement can successfully reduce
access related infections in dialysis patients. Although SCOPE is focused on children
with ESRD, as Dr. Warady said. The basic tenants of the project can be applied
to even the largest adult dialysis facility. The key to the success include
creating a culture of safety in which every healthcare provider
and every patient is engaged in the power to minimize infection. And again using small steps of change to bring
about improvement and spreading those changes to other patients, other shifts
and potentially even other units. We have just a few minutes here, 7 minutes
or so to be able to take a few questions but we have provided our contact information on
this slide, please feel free to reach out to me or Dr. Warady or Jane Stewart at the Children’s
Hospital Association if you have any questions or want to learn more about SCOPE. [ Background noise ]>>Thank you Dr. Neu and Dr. Warady
for your time and expertise today and for sharing with us your experiences. We have a few questions that have come in. Just a reminder to please submit
your questions via the chat window if you have additional questions. Located on the lower half,
left-hand side of the webinar screen. So the first question for our presenters
that has come in via the chat window is, what tools do you have to help
get family members engaged? [ Background noise ]>>Well, you know I’ll respond
to that first, I don’t — I think the first thing is to incorporate the
family members into discussion of patient care. And one of the things that we’ve done in our
own centers to begin to get them engaged is to actually have them participate
in the root cause analyses that take place following the
development of the infection. And one of our own patients who developed
peritonitis having the families sitting at the table and providing their
perspective on infection risk. Was extraordinarily valuable to our healthcare
providers and was truly a great example of engagement of the patient and the family
into improving outcomes of the patient. So, I think that is one way we get them engaged. One other way that we get them engaged is
that we have a regular meetings if you will, with the dialysis families with no agenda
other than things that they want to address to improve the care of their children. And I think that’s very different than
a clinic atmosphere where everyone is on a tight timeline to get the work done. But having a session where there’s
just an agenda really generated by the family’s themselves. I think allows us to really build on that
partnership between the health care providers and the family and I think it really
lends itself to engagement, Alicia.>>I agree Brad and I think again
engaging them in the process, the QI process is very important. You know, we’re implementing some of these
things, the educational and the review materials and so we seek their feedback and
we ask them for ideas, you know. We’re reviewing this with you every month, do
you have ideas of how we can make this better. And they like getting involved in that way. I think most centers also have their data
posted in the clinic and you know it’s pointed out to the patients and the families. So they can share in the improvements and share in the results every time
they come in into the clinic.>>I do want to point out
one other thing that we do on a regular basis is that
we look at our results. And we have, thankfully experienced
great success as part of our involvement in the collaborative in terms
of decreasing infection rates. And we regularly thank the
families, thank the patients for their contribution to those great results. Because again if we are focused
on a home therapy, we recognize that while we provide the
education and the oversight, it’s the families and the patients that are conducting
the therapy on a nightly basis. And so it is that partnership and I think we
have to recognize their significant contribution to the great outcomes we’re experiencing.>>Right and I think that can
translate to the hemo-unit as well, I mean we’re part of the auditing of the
connection and disconnection that many, many centers have someone
auditing the procedure. And so the patients or the family
knows that that’s what’s going on and they can take part in that process. They know that preventing infection is
important and that the unit takes it seriously. And they can share in that.>>We have a couple of other attendees who
are asking similar questions about what kinds of materials are available on the SCOPE website. I believe that most of what
you showed when it comes to facility specific information
would be presumably available just to those facilities that
are participating in SCOPE. But are there other materials
that are available more broadly?>>There are some materials that are
available more broadly, you’re exactly right, the center specific data
are on a separate website. There’s also some material that
is on a SCOPE specific site, the Children’s Hospital Association and so
you actually have to register to get on it. But most of it is publicly available, I think
we have some people from the association, they could correct me if I’m wrong on the call. Alicia just to clarify — so go ahead.>>I just want to emphasize if there are any
pediatric dialysis programs that are listening to the webinar that are not
participants in SCOPE to date. They certainly have the opportunity to
join the SCOPE collaborative by again, contacting either Children’s Hospital
Association or Alicia or myself.>>Thanks [cross-talk] Just to clarify,
Alicia were you saying that most of the tools are available publicly?>>Many of the tools are available on the
website and again I’m trying to search out some folks and confirm that as well. And we’re certainly happy to
share, I mean one of the goals of the Children’s Hospital Association is
to spread what we have learned in SCOPE. Beyond the SCOPE collaborative. And so you know this kind of
forum and sharing the information with other dialysis units is
certainly part of the mission of the Children’s Hospital Association. So, we’ll try to make sure we
get those things available.>>That’s all the time we have today
for answering questions for those of you who submitted questions that weren’t answered
we’ll try to send out some information to address some of those by
email after the presentation. I did want to just mention one other
comment that was submitted, not a question, that just says kudos to all of those who
were involved in the SCOPE collaborative. This is a true collaborative effort so
wanted to pass that along to the presenters and anybody else from SCOPE
who might be joining today. So before we end today’s
webinar I wanted to mention that to receive continuing education you must
complete and pass the posttest activity at, at least 75% or greater and
complete the webinar evaluation. So when you close out of this webinar
a post-meeting web page will appear that will have detailed instructions about completing the continuing
education posttest and evaluation. For those on the phone who currently
aren’t logged in to ready talk online to obtain CE please go to www.cdc.gov/tceonline. The access code for this webinar is WC0131. A follow up email will also be sent out
this afternoon with detailed instructions about completing the continuing
education post test and evaluation. With that I’d like to once again thank
our speakers as well as all of you for taking the time to join us today and for
your commitment to keeping patients safer.

New Tool to Prevent Infections During Chemotherapy

New Tool to Prevent Infections During Chemotherapy


Hello, my name is Lisa Richardson,
and I’m an oncologist and medical officer at the Centers for Disease
Control and Prevention. I’m pleased to speak with you today
as part of the CDC Expert Video Commentary Series on Medscape about an educational
Web site aimed at reducing infections in cancer patients—preventcancerinfections.org As clinicians, we know that neutropenia,
or low white blood cell counts, is the most serious hematologic toxicity cancer
patients face while receiving chemotherapy. Despite advances in oncology care,
infections from both community and healthcare settings remain a
major cause of hospitalization and death among this vulnerable population. Each year 60,000 cancer patients are
hospitalized for chemotherapy-induced neutropenia fever and infections, and one patient
dies every two hours from this complication. The impact an infection has on cancer patients
serves as a reminder of how important it is to counsel our patients about the things
they can do to protect themselves. Preventcancerinfections.org
is an excellent tool you can add to your existing
patient education materials. It encourages patients to take the right
steps toward preventing infections during chemotherapy by providing them
with information, action steps, and tools. A risk assessment for neutropenia
is the Web site’s main feature. After answering a few questions relating
to type of cancer, stage, and age and other factors a patient’s risk for developing neutropenia
is determined to be either high or low. The online tool then provides tailored information
that will help your patients recognize and respond to the signs and symptoms
of possible infections as well as how to be proactive to lower their
risk for developing infections. While this program is targeted
to patients and caregivers, it was also developed with clinicians in mind. Once a user enters this Web site, they
may continue as a patient, caregiver, or provider by entering the appropriate portal. The Web site’s language is then
tailored to the chosen audience. For example, the provider’s risk
assessment questionnaire asks about the patient’s Eastern Cooperative
Oncology Group performance status, whereas the patient and
caregiver’s risk assessment, asks about their activities during the day. If you provide care for cancer
patients receiving chemotherapy, I encourage you to visit this Web site. There are several ways to use this tool with your patients. You can complete the online questionnaire
with your patient and provide them with a printed copy of the questionnaire and
their results, as well as tailored messages. You also can email them this information. Another option is to print out a PDF
of the questionnaire, complete it on your patient’s behalf, give it to your patient and encourage them to visit
PreventCancerInfections.Org on their own. And finally, visit
CDC.Gov/Cancer/PreventInfections for additional resources to share with your
patients including posters and fact sheets. We at CDC hope that this tool will help us all
become better stewards for our patients by doing all we can to prevent
infections during chemotherapy. Thank you for your time.

2016 NHSN – Infection Prevention and Surveillance in LTC

2016 NHSN – Infection Prevention and Surveillance in LTC


>>Welcome to Atlanta
and the start of the 2016 NHSN
Annual Training. We tried to order
some pretty weather for those of you who have come from the north, and I hope we did alright. My name for those of
who I haven’t had the privilege to meet yet
is Nimalie Stone. And I’m the medical
epidemiologist for long-term care here
in the Division of Healthcare Quality
Promotion at the CDC. And I am thrilled
that we are beginning our annual training this year with long-term care content. This is our first
year where long-term care has had an
opportunity to present, so I appreciate all of
you being a part of this and we hope that
with your feedback, we can continue
to make this part of the agenda in the future. Some of you will be
here with us for the entire week of the training, but others will
just be here today focused on the long-term
care content, and we really appreciate
and thank you for your travel and spending
some time with us and welcome you again —
just a few housekeeping items to cover before we start
with the presentations. If there is an emergency, please
note the nearest exit sign and the locations around the room. Safety first, right? CDC and our planners,
presenters, as well as spouses and partners
wish to disclose that we have no
financial interests or other relationships
with the manufacturers of commercial products,
suppliers of commercial services or
commercial supporters. Our planners have reviewed
content to ensure there’s no bias. And presentations
will not include any discussion of the unlabeled
use of a product or a product under investigational use. CDC did not accept
commercial support for this continuing
education activity. And no specific
case studies will be addressed during
the training. Continuing Education
credits are available and instruction on how to apply for CE credits are in your folders. Please be sure to
scan in and scan out daily with Avaris so we can note your
attendance for the training. Also, note in the
resource manual a few handouts for long-term
care are in the back. Please feel free to
bring coffee, water and snacks into the
conference room. If you have any travel, parking, registration or
logistics questions, check with our colleagues
from Avaris at the front desk. Also, team members
from the NHSN Help Desk will be out front to answer or address other questions you may have. No photography inside the CDC is allowed. Please put your phones on
silent or vibrate mode. Also, we ask that all
of you hold your questions until the end
of each presentation. And with all that said,
why don’t we get started with our
preconference session? And in the next — So,
here in the next 30 minutes or so, I wanted
to have the opportunity to share with you
a perspective on some of the Infection
Surveillance and Prevention activities
have happening in long-term care
and I think many of you have heard me
talk before, so I was trying to think
of what I could say that would be novel
or interesting, and I thought, well since
this is our first time up here talking with you
as part of this NHSN training, let’s just do
a little retrospective and go back to 2009,
when in August, CDC hosted the Healthcare-Associated
Infections, HAI Surveillance in
Long-term Care Conference. And this was a group of academic partners, health
department partners, colleagues that represented
most of the nursing home professional
organizations like AMDA, the Society for Post-acute
and Long-term Care Medicine, the American
Healthcare Association, and the goal of the
discussion was to help guide CDC’s planning
around implementation of surveillance,
HAI surveillance infrastructure for
long-term care. This was before NHSN
had a component for long-term care facility
providers to report. And here were some of the takeaway, highlight summary statements
that came from that conference. CDC in partnership with national
collaborators is committed to developing a national HAI
Surveillance program tailored for an accessible to
long-term care facilities. In addition, the top
priority of this HAI Surveillance Program will be to provide information
and support for quality improvement
efforts among participating facilities. So it’s just a major
rationale for creating this surveillance
infrastructure. And we walked out with a proposed plan that there would be a
long-term care component designed within the
framework of NHSN based on the existing modules
we had available for hospitals and other
healthcare settings, but with adaptation
for the long-term care population and
for providers. So this was August 2009. That’s five and a half years ago. And then a few years
after that, about three years in fact, in 2012,
we saw the release of the long-term care
facility infection reporting component within NHSN. And right on the heels
of that came the updated infection
surveillance definitions for long-term care
facilities that was a joint effort published by
CDC and the Society for Healthcare Epidemiologist
of America/SHEA, and what was convenient
and not by accident was that these efforts informed
one another so as the criteria for surveillance were
being developed by our academic partners
and researchers and nursing home partners in the field as the McGeer definitions for long-term care
were being revised, we were integrating
those criteria into the infection
reporting events within NHSN, so there would be
congruence if you will and alignment between those efforts. And a few months
later, we looked at how many facilities had come in to the long-term
care facility component and this is three years ago
in February of 2013. So that’s about five,
roughly months after the component
had been released, and there 61 nursing homes
represented among 14 states. And you can see most of
the states had just one or two nursing homes that
had gotten enrolled, a couple which had
tried to maybe actively engage nursing
home providers in the conversation had gotten a few more. And Vermont was planning
this for a couple of years — for several years in fact
before NHSN came live. So they had quite a bit of
traction already in their state. So this is what the
map looked like three years ago when component
was pretty new. And here it is today. Three years later, we can
see we’ve got quite a few more states and quite
a few more facilities, 280 nursing homes that
have enrolled and are now actively
eligible to report. They may not all
be reporting and I think that’s important
to recognize, but one of the big hurdles,
right, is enrollment. So these have — these
280 facilities have actually made it through
the enrollment process with help and successfully,
and they represent 38 states, plus the
District of Columbia. And here you can see
more than a handful of states that have
worked intentionally with providers to engage nursing homes in this, supported them, and much of this
effort has been led by our state health department. How many of you are
here representing your state health
department today? Fantastic. Well, I applaud you
and thank you for all the work that you have
done in this effort. And then many of you
probably are representing quality improvement
organization or QINs. How many of you are representing QINs? Welcome. So it’s about half and half. That’s fantastic. Well hopefully you all
know each other already. If not, this is a
fabulous opportunity to meet and talk about
how your activities and efforts align with one another’s, especially in long-term care especially in the
next few years. So what were some
of the drivers for NHSN use in these
first three years of our experience with a component? I think as I mentioned
already, the state HAI programs engaging nursing
homes and promoting it as a tool for
supporting prevention efforts around C.
difficile infection and multidrug-resistant organisms. In addition, we
found that hospital systems or hospital
partners were working with their affiliated
nursing homes and long-term care facilities to help them start to
get involved in NHSN. There have been some policy
statements, probably written by folks who
are here in the room about the importance and
the opportunity that NHSN reporting offers
for long-term care when it comes to HAI Surveillance. One of the biggest statements
that came out from the Department of Health
and Human Services in the spring of 2013
was the HAI Prevention Roadmap and the Action
Plan to eliminate HAIs. And there was a chapter
specifically focused on long-term care that
made NHSN enrollment and reporting one of the top
priorities for this setting. And then not that long
ago, just nine months ago, I guess last summer,
the counsel for State and Territorial
Epidemiologists put a position statement
that also endorsed and encouraged the use of
NHSN as the standard setting for Infection Surveillance
in long-term care. So we’ve also seen in
this timeline a lot of awareness of the
role of NHSN reporting from state and federal incentive programs. For example, all of
you are intimately connected to the CMS
reporting programs and other post-acute
care settings like long-term acute
care hospitals and inpatient rehabilitation
facilities not — in addition to dialysis clinics
and acute care hospitals. About a year ago,
Nevada became the first state to require
NHSN reporting from skilled nursing
facilities, and they’re still in the midst of
implementing that. And then interestingly, you
know, the survey process and the regulatory process
is a very powerful driver of change in
the nursing homes. And if you are not
connected to and working with your state survey
agency and the folks that do oversight
of nursing homes, I would encourage you
to get to know them and make them aware of
the work you’re doing, because I think again,
there’s a lot alignment between everybody’s
goals to raise the quality and safety
in these facilities, but in Wisconsin,
there were surveyors starting to ask when the
visit nursing homes, they just ask about
NHSN — Do you know it? Have you heard of it? Do you use it? Just part of your
surveillance program, and although it was
not a requirement and there was not
citation or deficiency if you said, no, I’ve
never heard of it, the fact that people
were talking about it and being asked about
it really started to get facilities interested
in paying attention. So we have kind of had a
facelift, not that long ago. And our website has got
a lot of new training resources and Angela
and others will kind of walk you through those
resources later in this session. But one the strengths
and one of the reasons why we wanted to see
NHSN become an — you know, become a
resource for long-term care was the power of
standardization — the power of standardizing our
approach to identifying events and tracking our data
and reporting our data. And as you hopefully are
aware, the component current affords reporting
options for facilities in urinary tract
infection surveillance, as well as
multidrug-resistant organism and C. difficile
surveillance through laboratory identified
events surveillance, as well as some prevention
process measures such as adherence to hand hygiene and gown and glove use. And there’s a lot of
interconnectedness between use of antibiotics. For example in urinary
tract infections and how that has
impact on our rates of resistant C. diff that are
activities at the bedside. So there was some
strategy to how these initial early events
were rolled out. I wanted to share
briefly a little bit of information from analysis
that we did to look at some of our very,
very early adapters of the long-term care
facility component, and these were the facilities
that enrolled and reported data with the first two full
calendar years that the system was up and available,
and that’s January of 2013 through December of 2014. There are about 200
facilities that had enrolled in that time frame, and you can see the median
bed size was about a hundred. The daily census was comparable, 99. The median staff hours
per week that were given to Infection
Control was 14 — 14 hours a week for Infection
Control in these facilities. You can see the inner
core trial range there from as low as eight hours
a week to the high, well, you know — This
75 percent was 24 hours, so that’s still not a lot
of time if you think about how much work there is
to do in infection prevention and incorporate not
just surveillance, but all the teaching
and prevention work to make a change
if you’re looking at event outcomes that you want to see go down, so not a lot of time. And in that cohort,
three-quarters of them have submitted at least one
monthly reporting plan so the question is, okay, you’re enrolled, how many of them are actually
trying to use the system? And in this two-year
window, we saw 155 put at least one month of
reporting intention. Now submitting a
plan doesn’t mean that you completed the month, right, so there is more to see there. Let’s see, when we looked
at the month intended versus the month of
completed, you see a range, but actually it’s not that bad, right? Our sort of most
successful event reporting is actually urinary
tract infection, which kind of surprised
me a little because that’s one of the more
complex events to report. There’s more signs and
symptoms surveillance, in addition to looking at
laboratory data, right? So you have to do a
little more on the chart, but 81 percent of the
facilities that intended to report a month with the data completed that, and C.
difficile, I don’t think it
anyone was surprised as our most popular
event to report, and about 74 percent
of the time, people got it done
for that month. So pretty good, actually. So 83 percent of
facilities overall who had a reporting plan
or more submitted — completed at least one month of
data in this two-year period. But then we tried to
look at little bit more at the stability
of reporting. So is this a one and
done, or did I get it and start reporting
and stay reporting? So we defined consistent
reporters, people who had — or facilities I should say
that had completed at least six or more months of data in a calendar year. And there, you can
see in the red box that from calendar
year 2013 to ’14, we saw pretty substantial
drop in consistent reporting. In 2013, we had 70
facilities representing 75 or 76 percent of the
facilities intending to report one month
or more data actually consistently report,
so six months or more of reporting, but then
in 2014, we saw that fall off to less than 50 percent — 47 in 2014. So we wondered maybe
what could have accounted for that,
and we looked at — We don’t have a huge amount
of information about these facilities, right,
but we looked at, you know, well, how
did the consistent reporting cohort
change geographically? And what’s interesting,
you can see there are a couple of places in
particular where in 2013, we had a lot more folks consistently
reporting that they kind of fell off in calendar year 2014. And if those of you who work in the health
departments, you know, we have projects that pretty
much go from year to year. So, we are going to focus
on this effort for this calendar year and
then budgets change or priorities change
or we have finished this, and so we move
to our next effort. And what you’re
seeing is that when that external support goes away, then the internal
motivation to sustain engagement in the
system seems to fall. And I don’t if many of you are probably familiar
with long-term care. How many of you
work primarily with long-term care in
your positions? So not a huge number,
but for those of you who have worked with
nursing home providers, you know that there are reasons
why this could happen — that in fact, there
are quite a few barriers to sustaining
voluntary reporting. Now, remember there are no
incentives except in Nevada, there’s no other place
where this is a must-do. There’s not a penalty
or a financial driver to engage in NHSN
for nursing homes. And things like staff
turnover, limitations in Infection Prevention
staff and resources, and we looked at the current
landscape of these, and I consider these
facilities perhaps the higher end of
the curve in terms of their willingness
to dedicate time to infection prevention
because they actually went through the steps and hurdles
of getting enrolled. So here we are at
sort of the higher functional or more
committed group and yet there’s not a lot
of time being given to nursing home Infection
Prevention work. And there are a lot of
competing priorities. So as this project ends
and people move onto the next thing, it’s
very hard for them to maintain and sustain their engagement. In addition, I think this is an important message for all of us. Facilities, currently
nursing homes using NHSN may not be getting
the maximum value and benefit from their own data. And there are some reasons
for that we can explore. And I think some of you
who have experience already working
with nursing homes and NHSN reporting,
could probably teach us why some of those
challenges are there. But we have to make
NHSN more useful and valuable to the providers so that they want to stay involved. So external partners
like you and programs that drive NHSN use by nursing homes are
incredibly important right now to help
them become aware of the system but also to use it. And participation
and collaboratives really does help
maintain engagement and provide some scaffolding
if you will for accountability. It also really
creates a powerful forum for sharing experiences in seeing how individual
facilities experience may compare to peers, and
that’s again something that you all can bring to those providers that
you’re working with. So what’s going to
happen in the next few years, I just wanted
to highlight things, most of which you already are aware of. But just in case you
hadn’t heard, there are some great opportunities
in the next year or two coming to nursing
homes to help support these kinds of
activities and the work that you’ve already been doing,
lays the foundation for that. So, we’ve seen incredible
attention to reducing antibiotic-resistant organisms and C.
difficile in our communities, and
we have messaged quite a lot in the last year and
a half the importance of health departments
to be at the hub of coordinating work
and communities to reduce resistance and improve antibiotic use and stewardship and across the healthcare spectrum. And there are a lot of
different activities that colleagues in health
departments can engage within including looking
at the way transitions of care occur and
where do people move and how do they move,
and we know that there are certain dyads or
triads that share a lot of patients within a
community or region and if there’s a problem in one
of those facilities, it’s going to somehow
influence and impact those others that are
sharing that population. So understanding that continuum of care and how people
move is a critical piece to addressing prevention. Promoting NHSN Surveillance
as vehicle for mapping and tracking
facility-level data, we see the benefit of
this when we work at the hospital partners
who have a lot of data for a few years now,
and you can really see the way we can target
our prevention work with those facilities that
seem to have a bigger problem. And wouldn’t it be nice
to know where those pockets of needs might
be in other parts of the healthcare continuum
in particular nursing homes where we don’t have a lot of data yet. There are opportunities
for health department partners and quality
improvement organizations to help with implementation
of prevention and stewardship activities
to bring again community of care partners
together, to facilitate conversations, improve
quality of care and information flow
when people are moving, and there’s
an opportunity really to measure the impact, the
change of all of these activities and find those gaps and close those gaps. This is where we want to see our regional prevention
work take us. In addition and not by accident, our colleagues at
CMS are working to drive C. difficile
prevention in the same — using the similar,
very similar strategies around collaboration and
information sharing and identifying the strategic
communities that need support. So, the CMS C. difficile
reporting and reduction project which
has been announced and is in the early
stages of getting kicked off is happening
within the framework of the National
Nursing Home Quality Care Collaborative and
those of you work with the QIO
programs are already very much involved
in that effort. In fact, in its first
few years, the Nursing Home Quality Care
Collaborative has already brought a large
number of nursing homes into the group
— over 7,000. The CDI Project goal is
to recruit 15 percent of nursing homes
across the country. That’s roughly 2,000
— a little over 2,000 facilities to
enroll into NHSN and sustain CDI reporting over
the course of the project. And you can see it is a multiyear effort. And the participant
facilities working in this collaborative and this
CDI Project piece of it, which you could see is a subset,
right, at the larger group. They will receive
training and support on CDI reporting and then
everyone involved in the collaborative will
get education and resources around C. difficile prevention
and antibiotic stewardship. And you can see some
of the types of information and pieces
of that program that will be rolling out
over the next few years. So, why do it now? Because doing — getting involved now and doing this work
now will hopefully get these facilities prepared for whatever might come in the future. When we were at that
conference all those years ago in 2009
talking about well where else could we go with
HAI Surveillance data? Here were some of the things
that we could eventually get to. We could look at the scope,
the burden if you will of HAI’s in long-term care at national level. This is how we leverage the
powerful data of NHSN and all of the information
reported by hospitals. We can look at the HAI
incident rates in this setting and
inform our prevention and control policies and efforts. We can be strategic in
the places that we work. We can provide quality of care measures for regulatory
and licensing, which is how we’ve
seen NHSN evolve in hospitals and other
post-acute care settings over the last decade,
and eventually perhaps, there would
be the opportunity to use those same
measures to guide transparency in making
this data that is so powerful accessible to
all including our consumers and the patient’s themselves
who rely on these facilities. And there are step-stones
around — along that path. We’re not quite there yet, but
I do hope that you’re aware of large regulatory
update being made to the nursing home requirements
for participation at CMS released in
the summer, that incorporates quite a lot
of new expectations for Infection Prevention and Control programs
in nursing homes. This is just a quick
highlight of some of those new regulations, things
like a risk assessment of the population that
guides the resources and staffing planned for
care in that building, integrating Infection Prevention into the larger
Quality Assurance and Performance Improvement
program that every facility needs to have,
having an annual review and update of the
Infection Prevention Program including
policies and procedures, again that would keep up
with the changing population that you’re caring for in the building. Something very new is
the expectation of antibiotic use protocols
and monitoring as part of stewardship in every nursing home and designating
an individual to be the Infection Prevention control officer,
and in particular, making sure that individual has specific infection
prevention training, which is a huge
need and gap right now, which has to
be closed in order for any of this other stuff to work. And then having not
only that designated individual with infection
prevention training, but also making sure
that for the bedside frontline caregiving
staff, there is education and training as well
around infection prevention practice, so
very positive changes, but I do think this is a big,
big heavy lift as well — so to be aware that
your partners that you’re to, to bring
into a conversation about NHSN are also seeing this looming out there in the future. They have to see how
working with you and working within your
programs are going to help them achieve
these goals and actually service resources
to their programs and not as perhaps distractions,
right, that I’m not going to get this work done
that I must get done. So we have to do a lot
to align our efforts. I wanted to quickly
mention that there’s some legislation that came out
in the Fall of 2014, so it’s been out there for a little while. The Improving
Medicare Post-Acute Care Transformation
Act or IMPACT Act which was intended
to align measures of quality in
reporting among all of the providers delivering
post-acute care in this country and hopefully
this language — this terminology is
familiar to all of you that we have acute
care hospitals, right, and we used to just
focus so much of our work there because
people stayed there for a long time and generally by the time they were
ready to leave, they were safe enough to go home. But now as we’ve seen lengths of stay change and
shorten and shorten and we’ve seen different
payment incentives, we’ve got a whole new
crop of providers that help patients who
are leaving acute care hospitals but are
not ready to go back into their homes, be
safely transitioned, and this post-acute care arena
is probably the place where we need to be starting
to shift all of our focus because people are
still receiving high level acute care, right. So, these are
long-term acute care hospitals that are
all for intensive purposes like step-down ICUs. People are on ventilators. They’re receiving IVs. They’re — they have
wounds and we know that those are the
trifecta of risk factors for resistant organisms
and antibiotic exposure and the
complications from that. We have inpatient
rehab facilities that are trying to
strengthen somebody and get them independent
again before they can go back into their
environment and home and be strong enough and safe enough to recover
their function, and then skilled nursing
facilities which are the biggest
post-acute care provider, also providing more
and more not a destination for
care, but a bridge. So I’m only coming for
a few weeks to rehab or get my skilled
care needs met before I go back to my home
in the community. So right now, there’s a
lot of differences in the way payment is going
into post-acute care and also the way we track and measure quality in
these settings. The goal of this
legislation was frankly to better align and to
make it more equitable, because you may
be receiving very similar care in two
different places and getting very
different resources, and that’s kind of a problem. So, this was intended
to look at the whole post-acute care arena
and address some of those disparities in payment
and measures of quality. And so currently, we
know that CMS has quality reporting
incentive programs for long-term care
acute hospital and inpatient rehabilitation
facilities that include NHSN reporting, right? Everybody’s aware of that. And now we have kind
of a door open that if we want to see alignment
and standardization across post-acute
care, that NHSN reporting could be a
natural next step for skilled nursing
facilities, and that’s the reason I
raise this today. It’s not here yet
and we don’t know when, but I think
there’s precedent and there is potential now for
that to come in the future. So, just to summarize — I think all of you have seen yourself, that nursing homes are
really being expected more and more to take
action in tracking and preventing the spread of HAIs. And we hope that providers
will see NHSN as a resource to support their
prevention efforts by providing that data
for action and allowing them to track their
current opportunities for improvement and measure
the change in their efforts. Nursing homes are
starting to look at NHSN and thanks again to you, we’re starting to see reporting
and use of the system grow. We have evidence that consistent
reporting can be done. It’s feasible but it takes a lot of external support
and resources. And we need to continue
leveraging these opportunities coming
in the next year to grow the industry’s involvement. And the message — one
of the key messages I hope that you all agree
with and can take to frontline nursing
homes in your states is that this is an
exciting opportunity to get involved now,
take advantage of the help, take advantage
of the resources and the knowledge that
all of you are going to bring to them so
they will be prepared for whatever the future might look like. The facilities that
are now starting to get involved in surveillance and prevention programs will
be seen in their community as progressive forward
thinking leaders, and that they will
have in place a lot of the expectations the programs
to meet whatever regulatory or quality incentives
may come down the road. So I’m going to stop there, and thank you so much for your time. I think we have a
minute maybe or two for questions if
anyone has a question. [ Applause ] Yes, here in the front. [ Inaudible Question ] So the question for those of you in the back is in
long-term care, often times residents
may have a primary care physician that is not a
part of the facility, responsible for their
prescriptions, and if we’re talking about
antibiotic stewardship, how do we engage those
primary care providers in the discussion
and engage them? It’s a very good question. Long-term care is
a large spectrum, right and in nursing homes, generally there are physician leaders that can help corral
the provider’s practicing in their building. These are the medical
directors, the physician leaders in
those nursing homes. But, when you start
to move into some of the more community-based
facilities, residential care or assisted
living, then the model changes and you do have each
individual person has their own caregiver, their
own doc, and there may or may not be somebody
at the building itself, coordinating
those care decisions. There — Our division
does recognize that stewardship has to
come and the message around antibiotic use has to
be across all care settings, so hospitals, long-term
care and outpatient. And we do have actually
quite a lot already around improving antibiotic
use in primary care for pediatrics and
we’ve started to move that discussion
to look at adults who are receiving
antibiotics for respiratory tract infections. We know there’s a
large spectrum and a lot of overuse of antibiotics for things like bronchitis for example. So there are members of our team that are focused on outpatient and there are conversations
with some of those primary care
providers and even things like Minute Clinics, and
there’s a whole new world, right, of primary care evolving in Urgent Care. So we are talking to those
providers and figuring out how does stewardship
look in outpatient care. But you’re right,
we do have to make sure we continue to expand that. Anybody else brave
enough at the start to stand up — Yes in the back? [ Inaudible Question ] So — Help me see how that —
What could we do — I’d like — The question is how
do we help improve communication at Care
Transition actively sort of now, instead of trying
to look back at old data and say, oh,
there’s a problem here. We should go. There — We have put
some pieces of, I guess, tools out like there’s
an inner-facility communication transfer form, which actually I have to credit
our colleagues from Utah. They were the ones that
got us started and really very graciously
allowed us to share with the rest of everyone out
there that example form, right, that you can use to catch
key infection prevention and antibiotic use was there
and history of MDRO. Carriage or infection
was part of the tool. So we have health departments
who are trying to operationalize that
within in collaboratives that bring hospitals and
nursing homes together. It’s a little tricky to
have real-time data when we don’t have much data
yet from long-term care, but how many of you are familiar with the TAP analysis
within NHSN? I see several hands. Yes, good, that’s wonderful to hear. I’m sure it’ll come up
again probably this week. But that kind of — The
goal of that strategy is to target those
communities or facilities where there are — where they’re
having SIRs that are higher. That could become — be
— The more and more of you that have access to
that data in real time and have group-sharing
information with you, that can
be used perhaps to feedback more quickly
information to the community to get that conversation going,
but I — we can talk. I’d love to hear some thoughts, and I know many of you do work with cross collaborative settings, right? You bring groups
together already, so maybe there are forum
that exists to have that conversation and
to make that more of an active intervention
within your groups. So I want to be mindful
of the time and also I’m probably the least
important person up here this afternoon,
because my colleagues who are coming up next
are really the folks who make NHSN go and
provide the educational resources and tools and
content and slides that you hope — can
take advantage of as you got out and
engage nursing homes.

Welcome: Clinical Evaluation & Management of Infants with Congenital Zika Infection

Welcome: Clinical Evaluation & Management of Infants with Congenital Zika Infection


>>Good morning, everybody. Welcome. Welcome to Atlanta. It’s going to be 99 degrees
today, so it’s good that we’re in here where the
air-conditioning is and I think we’re going to
have a great day-and-a-half. Just by word of sort of
introduction as to who I am, I’m Georgina Peacock,
I’m the Division Director for Human Development
and Disability within the National
Center on Birth Defects and Developmental
Disabilities here at CDC. And I’d like to welcome you on
behalf of my Center Director, Dr. Coleen Boyle, as
well as the staff here that have been working on this
issue, to this meeting sponsored by CDC in collaboration with the
American Academy of Pediatrics. The National Center
on Birth Defects and Developmental Disabilities
has a long history of working with AAP on emergency and
non-emergency situations, all with the common goal
of bettering the lives of babies and children. We work every day at our Center
around birth defects prevention and research, understanding
developmental disabilities, protecting people with blood
disorders and improving health for people with disabilities. And the Zika response, as we’ll
learn over the next two days, really embodies all
of these areas. We’ve been all hands on deck at
the Emergency Operations Center since this was activated
early this year. We have, from our Center
have had almost half of our staff either detailed
fulltime or part-time in efforts working
on this response. And, in addition to the work of
our Center, the National Center on Birth Defects and
Developmental Disabilities, there are of course many
Centers and offices, in fact, probably every single
one of them here at CDC working on this response. Our purpose over the
next day-and-a-half is to discuss the clinical
evaluation and management of infants born in
the United States with congenital Zika
virus infection, from birth to one year, and
to inform the interim guidance on appropriate care and support for vulnerable infants
and their families. Today’s Zika outbreak
us unprecedented. Never before in history
has a bite of an infected mosquito resulted
in a devastating birth defect. Zika virus infection is a
recognized cause of microcephaly and other serious brain
anomalies, however, the full spectrum of the affects of Zika virus infection
during pregnancy has not been fully recognized. As of July 7th, 2016 there
are 346 pregnant women in the United States and
D.C. and 303 pregnant women in the US territories
with laboratory evidence of possible Zika
virus infection. Nine infants with birth
defects have been born to women who had Zika infection in
pregnancy in the United States. We are literally learning
more about Zika every day and the CDC continues to
evaluate all available evidence and to update recommendations
with new information that becomes available. As more infants are identified with congenital Zika virus
infection interim guidance is needed to help healthcare
providers to determine appropriate medical
and developmental evaluation and management of these
infants and, of course, that’s why you all
are here today because we need the expertise
here to help inform this. We value the input
and collaborations of our stakeholders and
partners and are happy that you can join us here
today and look forward to the important conversations
that are going to go on over the next couple days. And now I’d like to introduce
my friend and colleague, Dr. Fan Tait, she’s the
Associate Executive Director at the American Academy of
Pediatrics and the Director of the Department of
Child Health and Wellness. Thank you.>>Thank you, Georgina. Wow. She gave the
background on that. I’m here to say thank you from the American
Academy of Pediatrics. I will tell you I work with CDC
and with other Federal partners, with other organizations
around Zika. It has been a great privilege. It’s so important, and I think
you all being here speaks to the importance, right? Just so you know, to pull off
a meeting like this in what, three weeks, four weeks max,
we started talking about that, takes a remarkable amount
of work from the CDC, also from our staff
at the Academy. But what I’ve been most, not
surprised but most honored by is when we asked you all
to come you said, yes. You know, and in a three-week, essentially a three-week
period of time. We know you have day jobs, night
jobs, weekend jobs, families. And we actually talked about
whether we could ask people to come in this short
period of time. At the Academy we are
always trying to give – we don’t always, but we’re
trying to give two months, three months’ time when you’re
scheduling something like this, and I tell you when
Laura put out the call or we all did I would say
unless there was an emergency from the people that
we asked, you’re here. So I am so honored to be a
part of not just the Academy and the pediatricians
here, but all of you here. So this is so important. I was thinking about what I
might say for just a minute or two, and we need to get
to work so it’s not going to go much longer,
not much longer. But I also wanted to just
call out family voices, right, because when we have any meeting
like this we’re so grateful to have family – wave your
hand, Jennifer – family. This is why we’re here, right? It’s for the children
and for the families. And, Jennifer, we’re so grateful
that you’re here to help us to see that North Star of what
we can do that would be the best for the children
and families, right? I’d also like to thank you
all for being on calls prior to this meeting, right, to get
here, but there’s so much to do. We thank you. If I haven’t had a chance,
I’m pretty much a hugger, if I haven’t hugged you or
at least had the opportunity to shake your hand please
know how much it means to all of us that you’re here. And, Sonia, thank you and so
many others for the leadership. Thank you, all, we’ll
be talking.>>Thank you to Georgina
and to Fan and to all of you for being here today. I’m just going to give
a few brief remarks and then we’re going to get
started because, as Fan noted, we have a lot of
work to do today and we’ve already been working
hard before this meeting. So our top priority
at CDC as part of the Zika response efforts is to protect pregnant
women and their babies. And many of these
efforts have been focusing on preventing Zika
infection in pregnant women. We’ve issued travel
guidance, encouraging women or asking women not to travel
to affected areas, and for women who must travel to or
who live in an area with active Zika transmission
we have given guidance on ways to prevent mosquito bites and
to prevent sexual transmission. However, as of July 7th, and
there will be new numbers coming out today and they
are bigger than this, but already there are more
than 650 pregnant women who have evidence of
possible Zika infection in the United States
and its territories. So we have a lot of work to do. Because of this there
is an urgent need to develop interim guidance for
the evaluation and management of infants born with
congenital Zika virus infection to give these children
the best chance to reach their full potential. CDC in collaboration with our
partners and other investigators across the globe are working
as quickly as possible to collect data on the affects
of congenital Zika infection. However, at this time these
data are severely limited. Therefore, it’s essential
that we work with experts in children’s health
and development to gain individual input to
inform this interim guidance. We are grateful to colleagues
from the American Academy of Pediatrics, they’ve
been fantastic. I still remember the day we
called them and asked them about this and they
didn’t say are you kidding? So, who have worked with us
rapidly to plan this meeting. Together we have
invited you here today to convene a broad range of
nationally recognized experts who can provide us with
individual expertise to help us with the development
of this guidance. And before we begin I’d like
to join Georgina and Fan in thanking you for taking time out of your busy summer
schedules to be here. Briefly, I’d like to outline
the plan for the meeting. This morning we’ll have a
series of talks to make sure that we’re all familiar with
Zika virus, its epidemiology and what is already known
about the prenatal affects on the infants with Zika
virus, including the affects on the brain and the eyes. Then this afternoon
we’re going to assemble into breakout sessions
for discussion. So there’ll be three
breakout groups. Please stick with the one
that you’re assigned to. The rooms are really tight. We have just enough space, so
if you swap rooms you might have to sit on somebody’s lap. That’s not a good thing. And we will reconvene at the
end of the day for each group to briefly present the summaries
of their breakout discussions and also discuss any issues,
overlap issues or things that we’re concerned about. Then tomorrow morning we’ll
get back together again for a more formal
discussion with slides that summarize where we’re at. We’ll go back into
breakout groups, and then we’ll get together
at the end of the day. Because of the limitations on
breakout session space we had to place limits on
the number of people that could attend this meeting. There was a lot of people
that wanted to attend that weren’t able to attend. And, therefore, I wanted
to just make you aware that these full group
sessions are being webcast, live streaming on the web. So for those that are
participating by webcast if you have questions we’ll
be taking those by e-mail and we have someone here that
will be monitoring that box and we’ll be taking
those questions at the end of the morning. The e-mail box is
[email protected] When you send questions
please include your name and your professional
affiliation. We may not have time to
answer all the questions, but we’ll answer as many
as we can at the end of the morning session and
then we’ll answer the rest after the meeting. For media questions, there’s
a separate place for media. Please e-mail [email protected] After the meeting we’re
planning to compile and synthesize the individual
input that we received from experts here today and
this input will inform the development of interim
guidance that will be published in CDC’s Morbidity and
Mortality Weekly Report or MMWR. And we realize that these
will be interim guidance, that they’ll be updated as more
information becomes available. So just some housekeeping items. If you need to go
to the restroom it’s out that door there,
go to the right and then it’s the first
hallway to the right and then they’ll
be on your left. And with no further
discussion I want to introduce Doctor Marc
Fisher and he’s going to be giving the first talk
on Zika virus epidemiology. Marc is a Medical
Epidemiologist here at CDC’s Arboviral
Diseases Branch.>>Thank you, Sonia. Good morning, everyone. As Sonia said, I’m
an Epidemiologist in the Arboviral Diseases
Branch, and I’m just going to give a brief overview of
some information on epidemiology on Zika virus, which
probably everyone is already familiar with. So the objective is to update
the epidemiology of Zika virus in the Americas and
the United States. Just for quick review, Zika virus is an RNA flavivirus
that’s related to Dengue, Yellow Fever, Japanese
Encephalitis and West Nile viruses and it’s
transmitted to humans primarily by the Aedes Stegomyia
species, mosquitos. Typically causes
asymptomatic infection or a mild Dengue-like
illness, but recent outbreaks as we’ll discuss have identified
new modes of transmission and clinical manifestations. These are the principal vectors
of Zika virus in the Americas. Aedes Aegypti is the primary
vector, also the vector of Chikungunya and
Dengue and Yellow Fever. Aedes Albopictus is
also a component, although less efficient
vector likely for transmitting to humans for various reasons. These vectors also transmit
Dengue and Chikungunya. They lay their eggs in
peridomestic water containers and live in and around
households, and their peak feeding time is
during the day although they can also bite at night. Aedes Aegypti is more efficient
for transmitting the virus to humans because it tends
to live in and around humans, primarily it bites humans
more than Aedes Albopictus which bites other
animals, as well. And then Aedes Aegypti
is an interrupted feeder so it can bite multiple people
during a single blood meal and, therefore, transmit to
various people during a single blood meal. This slide shows the
approximate geographic range of Aedes Aegypti and Aedes
Albopictus in the United States. So this is not where the
vector necessarily is, but the possible range of that. And so the brown shows the
overlap of the two species of mosquitoes, the
yellow shows areas where Aedes Aegypti
might be alone, and then the blue shows areas where Aedes Albopictus
may be alone. In addition to vector
borne transmission, a number of other
non-mosquito borne modes of transmission have
been identified now, including intrauterine
transmission resulting in congenital infection, most
importantly for this meeting. Intrapartum from viremic
mother to newborn. Sexual transmission,
laboratory exposure, and likely blood transfusion. In addition, there’s possible
transmission through organ or tissue transplantation
and breast milk, and there’s also a
current investigation of possible transmission through
close personal contact during a fatal case currently in Utah. As far as clinical
course and outcomes, most infections are
asymptomatic and the clinical on this is usually mild. Most characteristic
findings are fever, rash, arthralgia or conjunctivitis. Symptoms typically last
for several days to a week. Severe disease requiring
hospitalization is uncommon and fatalities are rare,
although have been reported. The newly identified clinical
manifestations are microcephaly and other congenital anomalies, which we’ll hear a
lot more about today. Guillain-Barré syndrome and other neurologic
syndromes are being identified and reported, and then
thrombocytopenia has been reported in a small
number of cases. Distinguishing Zika from Dengue and Chikungunya viruses
is important. The viruses are transmitted, as
we said, by the same mosquitoes with a similar ecology. They can circulate
in the same area and likely rarely can
cause some co-infections. The diseases have
similar clinical features. Most importantly as far as
Dengue it’s important to rule it out because proper
clinical management with Dengue can improve the
outcome, and at the bottom of the slide there I
have the link to the WHO Dengue Clinical
Management Guidelines. So as far as Zika virus
diagnostic testing, RT-PCR should be performed
for viral RNA in serum that’s collected
less than seven days after illness onset and urine
collected less than 14 days after illness onset, and these
guidances are continually being revisited and updated as needed
as we have new information. In addition, evaluating RT-PCR
for viral RNA in amniotic fluid and semen appears to be useful,
but the full implications of finding the RNA in
those specimens is unclear. Serology for IgM and then
neutralizing antibodies can be performed in serum and
cerebral spinal fluid and immunohistic
chemical staining, or IHC, and RT-PCR can be performed
for viral antigens and RNA and tissues, including placenta. Serologic diagnosis
is difficult. The Zika virus serology can
be positive due to antibodies against some of the other
related flaviviruses, Dengue in particular,
and including somebody who has received Yellow Fever
vaccine or previously infected with the Yellow Fever virus. Neutralizing antibody testing
is more specific and may be able to discriminate between these
cross-reacting antibodies when it’s a primary
flavivirus infection, meaning the first time
somebody has been infected with any flavivirus,
however, it’s difficult to distinguish the infecting
virus, particularly in people who are previously
infected or vaccinated with a related flavivirus. So moving on to the
epidemiology, the virus itself was first
isolated from a monkey in the Zika Forest
in Uganda in 1947. Before 2007 there were only
sporadic human disease cases reported from areas of
Africa and Southeast Asia. And then in 2007 the first
outbreak was reported from Yap Island in the
Federated States of Micronesia. And after that there
were subsequent outbreaks in the Pacific, in particular
islands in the Pacific, and in 2013 to 2015
there were more than 30,000 suspected cases
reported from French Polynesia and other Pacific islands. As far as the Americas in May 2015 the first locally
acquired cases in Brazil in the Americas were
reported from Brazil with transmission
likely occurring for some time prior to that. And then as of July 14th, 2015 local transmission has now
been reported in 40 countries or territories in the
Americas and further spread to other countries in
the region is likely. This map shows as of
today areas with ongoing or active transmission with
primarily being in the Americas and then some other countries or territories outside
the Americas. Moving on to the
Americas specifically, locally transmitted cases from those 41 countries
and territories. As of July 14th, this
is from January 1st, 2015 through July 14th,
2016 there have been more than 500,000 cases
reported from the Americas. Only 20% of those cases have
been laboratory confirmed, the remainder are suspect cases. You could see that by
far the largest number of cases have been reported from
Brazil, followed by Colombia, and then a list of
several other countries. This shows a breakdown
of those suspected and confirmed locally
transmitted cases in the Americas by region, which you can see the
largest proportion are from South America, as you saw
with most of them accounted for by Brazil and Colombia. The next followed by
that the Caribbean Region and then Central America. As far as the United
States local mosquito borne transmission of Zika virus
has not been reported in the Continental
United States, although non-travel related
cases are currently being investigated in Florida. In 2011 through 2014 11
laboratory confirmed cases were identified in travelers
returning to the US from areas with local transmission and
then with current outbreaks in the Americas cases among
US travelers have increased substantially and these
imported cases may result in virus introduction and local
spread in some areas of the US that have the competent vectors
or through sexual transmission. This shows as of July 13th
the numbers of cases reported in US states and
territories from January 1st, 2015 through July 13th, so
there have been 1,316 travel associated cases, with 1,305 of
those reported from US states. Travel associated here includes
the travelers themselves, their sexual contacts or infants
who were infected in utero in a pregnant woman
who was traveling. As far as locally acquired
cases these are all so far from the territories, with
the bulk of them being from Puerto Rico, as
you see, 96% of those. These are presumed to be local
mosquito borne transmission, but obviously in a place where there’s active ongoing
mosquito borne transmission you cannot distinguish what
might be sexual transmission. In addition, there has been
one additional case reported from a US state that
was acquired through laboratory transmission
through a needle stick in a worker who was working
with a live viral culture. This shows the breakdown
of the state of residence of the US travel
associated cases. This is the 1,305 travel cases. You can see about 45% of
the cases are accounted for from two states, New
York State and Florida, followed by California,
Texas, New Jersey. And this shows the epidemiologic
curve of these cases over time. You can see that the cases were
still increasing through June and we imagine they will
still be up in July. This is just reporting
the artifact so far through the July 13th date, but
you can see cases where it began to be reported at
the end of last year, increased over the first
quarter of the year, and have now thus
far peaked in June. It shows a breakdown of
the sex of the cases, with about two-thirds
of them being female. Presumably this is somewhat a
testing bias, so people testing for women who are pregnant
or concerns about pregnancy, but requires further evaluation. This shows a breakdown of
the age groups of the cases, so you could see the majority
of cases have been in adults, in particular in
younger adults from 20 up through 60 essentially, which probably reflects
again mostly travel related and traveling age. A little over 100 cases
have been reported in people under the age of 20. It shows the clinical
signs and symptoms of those travel associated
cases, and you could see the two most
common symptoms reported being fever and rash, followed
by arthralgia, and about half the patients have
conjunctivitis and about a third of the patients, although
you can see about half of those patients have
unknown status regarding their arthralgia and conjunctivitis so the number may actually
be a little higher than that. So moving on to current
guidance, who should be tested for Zika virus infection? The current recommendations are
that patients with fever, rash, arthralgia or conjunctivitis
who may have been exposed to Zika virus through
travel to an area with ongoing transmission
or an epidemiologic link to another laboratory
confirmed case, either through vertical
transmission, sexual contact or association in time
and place should be tested for Zika virus infection. In addition, testing
should be offered to asymptomatic pregnant
women who have a history of either travel or
residence in an area with ongoing transmission or had
sexual contact with a partner who had symptoms of Zika
virus during or after return from travel to an affected area. CDC has worked with
State Health Departments to establish strategies to identify possible
local transmission in the United States. This includes doing surveys of
household members and neighbors of travel associated
confirmed cases. Blood donor screening
is being performed in some areas of
the United States. Investigations of
unusual clusters of rash illness may identify
some local transmission or expanded testing of people
who have had no known exposure but have a more specific
constellation of clinical findings is being
performed in some areas. So, for example, some
places will test a person who has not traveled
but have three or four of the typical symptoms
of fever, rash, arthralgia or conjunctivitis. In addition, when and
if there is a case of local transmission we’ve
worked with Health Departments to establish strategies to
identify additional cases and to define the geographic
scope of the outbreak. So this includes surveying of
household members and neighbors within a 150-yard radius
or so around the case, that’s basically
the flying radius of the primary vector
mosquitoes. Notifying local healthcare
providers and laboratories of the possibility
of local transmission to increase their awareness
and look for additional cases. Syndromic surveillance is
being performed in some areas for evidence of increased
febrile or rash illness and changes from the
status or baseline. Laboratory based
surveillance for Zika virus or other arboviruses
that may be mistaken for Zika virus is
being performed. Community outreach is being
performed in many areas to increase the communities’
awareness and to look for cases. As I mentioned, blood donor
screening is being formed in some areas. And mosquito surveillance
is performed secondarily, only essentially around the
cases to look for evidence of possible local transmission. So, finally, as far as reporting
cases, Zika virus disease and congenital Zika virus
infection are now nationally notifiable conditions. The Council of State and Territorial Epidemiologists
approved an interim case definition at the
end of February 2016 and a revised definition was
just approved a few weeks ago at their Annual Meeting
in June and will be posted on their website
hopefully very shortly. Healthcare providers
are encouraged to report suspected
cases to their State or Local Health Department
to provide assistance with investigation and
laboratory testing. And then State Health
Departments should report laboratory confirmed
cases to CDC according to those CST case definitions. And pregnant women and congenital infections
are being followed through the US Pregnancy
Registry, both here and US States and
in Puerto Rico. And timely reporting to these
Health Departments allows further assessment of
the risk of infection and possible transmission
to reduce further the risk of local transmission and to mitigate the
risk of further spread. I think that’s all.>>Questions, anyone?>>Yes?>>Micheal Sauer,
University of Chicago. I hope everyone can hear me. What about seasonality? Is the peak in Brazil, what’s
the peak of the season, how does that translate
into our tracking and surveillance efforts?>>Right. So obviously for the
experience we’ve had so far in the Americas we don’t
know the seasonality, we can only base it based on
when the vectors are most active and things like Dengue, for
which we have known seasonality. So basically in the
Continental United States and subtropical areas the
seasonality would be typical for other mosquito borne
viruses, so we’re in the peak of it now, would begin
at sort of late spring, transmission would peak around
this time into late summer and then presumably
wane towards the sort of late summer, beginning
of fall. In other more tropical areas
we really don’t know the seasonality right now. It usually varies by wet
and dry season rather than necessarily
temperatures, although in places like Brazil they
do have a winter and there is a seasonality
to Dengue and we’re in that low season currently.>>Do you think that’s
in part due to the low, the dropping incidents in
the States, the July data?>>Oh, no, I think the July
data is just where we haven’t yet had reporting
for July, you know, those data as of July 13th
there’s a several week delay in reporting into our National
Arboviral surveillance system. So I don’t think we can say
whether July will be higher or lower than June
at this point as far as travel associated cases.>>Thank you for
your presentation. Can you just comment
on breastfeeding and what we know about that? That was – okay.>>Sure. So Zika
virus RNA has been identified in breast milk and
there’s a report, I believe two case reports of
live virus being identified in breast milk out
of French Polynesia. There have been no documented
known cases of transmission through breast milk, but
that is a possibility. At this point we believe
that the risk is low enough and the benefits of
breastfeeding are high enough that we still are recommending
breastfeeding for women who are living in and
possibly exposed to or even infected
with Zika virus.>>Thanks, Marc. I don’t know if this is working,
but do you know anything yet about the characteristics
of the virus? I mean we’ve seen some
genograms about the split from the African lineage,
but is there anything that you know that’s
different about say the viruses that are involved so far
compared to baseline?>>So far, all of the viruses
that have been isolated in the Americas, including from
travelers in the United States, have been of the Asian lineage. They’ve been, all of
them very closely related with very few genetic
differences and they’ve all been
very closely related to previous isolates from the
Asian strain, mostly for example from that 2007 Yap
outbreak there have not been any differences. So at least right now there’s
no evidence of a change in the virus itself as far
from what we’re seeing. I think there’s a lot more to
be done on that, obviously. Yes?>>Does inspecting and testing
for the virus in Puerto Rico, we have found 80%
are asymptomatic. The social history
helps us a lot. And when you mentioned
the factors that sometimes the patient
comes with headaches and general malaise or
sometimes one of the things that can lead you to suspect,
and when you ask relatives if they have had the rash, the
fever or anything then if one of them is positive
we try to test them. Because due to the high
percentage of people who present no symptoms
you have to – the social history is
very important when trying to pinpoint who is positive.>>Thank you. Yes, and I think a point to highlight there is there
is likely, as with Dengue, clustering in households
because these mosquitos are so closely associated in
households, although the data for Zika specifically
are not there yet. But thank you. Question?>>I have two questions. One on what you said. I’m a Physician who practices in
Southern California and I care for pregnant women, and a lot
of patients either have traveled to Central or South America
right before they got pregnant or during pregnancy, but
they have no symptoms and their spouse as far as they’re aware
have had no symptoms. But you were talking
about that there’s so much asymptomatic infection, so I’m just wondering are we
going to move to some point where we actually just recommend
testing all pregnant women who have a travel history or a
partner with a travel history, even without symptoms, or
we’re not there yet or?>>So I think there’ll be
more discussion about testing of pregnant women and some
updates to the guidance of it, of testing pregnant women, but right now the
recommendations are to test pregnant women who
have a known exposure either through travel or through sexual
contact and to offer testing to asymptomatic women who
also have known exposure who have either pregnant
women who have traveled or again have sexual contact,
but not routine screening of all pregnant women
in the United States where there’s no known
ongoing transmission.>>Yes, I think there’s
not a whole lot more that I can say right now. The investigation is ongoing. Again, it was a very unusual
situation with a fatal case, which obviously is
very uncommon. So the primary case was
much sicker than most cases and had some other
extenuating circumstances, and that there is
an apparent case that had close personal contact
with that person and the mode of possible transmission is
still being investigated.>>Do you have evidence
that efforts that control Dengue
will also work for this?>>So there’s no data
to that effect, right, because the control
efforts are still ongoing, but there’s no reason to
believe that the same efforts for Dengue wouldn’t
control this as far as the mosquito borne
transmission, right? There are some unique aspects of this virus regarding
sexual transmission and congenital transmission,
which can occur with Dengue, but not to this extent. But for mosquito borne
transmission it’s the same mosquito, is the same ecology, so the same control
effort should be effective.>>So I asked this question to a
lot of people, is there any way to detect Zika virus exposure
in the newborn blood spots that would be collected as
a part of newborn screening?>>So that’s a difficult
question and I’m not a laboratory person. There are some difficulties
in performing the assays on the blood spot, itself,
which there are groups that are working on that. Beyond that there’s
the issues of, which will be discussed
here this afternoon, the interpreting, the
interpretation of those results. So that would not be any
different than performing it on a specimen collected from
venipuncture, but you need to interpret the
serologic and PCR results. But right now I think the
primary limitation is just the technical limitations of
performing the assays, in particular the serologic
assay on the blood spot. The assays are not validated
for that specimen at this time.>>If you could, obviously,
it’d be a great means for population based
surveillance or assessment of broad based exposure
in a pretty effective way.>>Correct.>>But you really
need to get tested.>>Yes, and the limitation
of the serologic assay, so for PCR testing I think
that would be very useful. That’s likely to be positive if the baby was infected
perinatally, possibly not if they were infected in utero.>>Currently we are
trying that in Puerto Rico because we have five years
back of that, that we could go to those tests and see if
Zika had come previously. And we’re trying to
see if it is possible because if it is
possible and that outcome and know we have microcephaly
and these things hadn’t shown up then it would change
the whole ballgame.>>Correct, and Puerto
Rico you’re going to have that particular problem of
cross-reactivity with Dengue if you’re doing a
serologic assay, yes.>>Yes.>>I just had a question
related to lab testing. What’s the general availability
of the PCR kind of in the US in terms of Health
Departments and commercial labs?>>Right, so PCR assays
were developed at CDC, one in Fort Collins
and one in Puerto Rico, and those assays have
been distributed to all of the State Health Departments and other public
health laboratories in the United States and there
are now commercial laboratories that are performing the testing. It changes very quickly so I don’t know exactly
how many currently, but the PCR assay is widely
available at this point in the United States both through public health
laboratories and through some
commercial labs. The serologic testing is
a little more limited, that’s being performed
currently only through public health
laboratories, but there are several commercial
laboratories that have assays that may be available soon. Yes?>>What is the cost associated
with testing pregnant women?>>I do not know that. Does anybody else know the – no,
there is no cost when performed at public health laboratories
I guess I can tell you. I don’t know the cost associated
at commercial laboratories. Sorry.>>I know you may not be able to
answer, but is there a strategy that one might do
urine testing for this, as well as other diseases
of STDs in populations that might be a strategy
for early detection in populations at risk?>>Right, so some of
the ongoing evaluation of laboratory diagnostics
is looking for better diagnostic specimens or alternative, which
includes urine. Urine appears to be a good
specimen for molecular testing, certainly in the first week to
two weeks after symptom onset or exposure and maybe
further beyond that there may be
other specimens that also could be
positive or useful for longer periods of time. So in that sense urine
is a recommended specimen for diagnostic testing
for the first couple of weeks after onset. Whether it could be used
for screening depends on how long somebody
would have RNA in urine, and we really just
don’t know that. So if you had a pregnant
woman who was several months out from her exposure or
onset we don’t know what the usefulness of doing
molecular testing in urine would be at this time.>>This may be covered later
on, but are there any efforts to look at the genetic
modification of the mosquito that carries the vector?>>So as far as for …>>Yes, so there are a number of
genetically modified mosquitos that have been developed
for Aedes mosquitoes to reduce transmission
of Dengue and Chikungunya and those are being employed
in certain areas and, again, because it is the
same mosquitos, same ecology it could
potentially be an effective use for Zika virus, but those
are really still in kind of evaluation and pilot phases
right now, are not being used in large scale prevention
efforts. Thank you very much. [ Applause ]>>So the next three
talks are going to be about clinical manifestations
in infants with Zika, congenital Zika infection. And this first one was put
together and was supposed to be delivered by
Dr. Cindy Moore and she got called to a meeting
at WHO, a WHO meeting in Brazil and so she’s unable to be
here today and so I’m going to be speaking on her behalf. I think what we’ll do is we’ll
give these three talks together – my talk, Dr. Trevathan’s and
Dr. Ventura’s and then we’ll all
answer questions, the three of us together,
if that’s okay. So I’m going to be talking
about congenital Zika syndrome, and as I think most of you know
the manifestations in infants that have been – for which a
causal relationship has been established are the microcephaly
and serious brain anomalies. So in April CDC, we published a
paper in the New England Journal of Medicine where we
stated that we felt that Zika virus is a
cause of microcephaly and serious brain anomalies. But what we know from other
teratogens, for example, Thalidomide, Accutane,
and Rubella, is that what you see
initially is usually the tip of the iceberg. And so we expect that
there will be other levels, other more mild features or
even some that are more severe, and we’ll be talking
about those today. This talk is going to
focus on the pattern, the recognizable
pattern of anomalies that has been seen
associated with Zika virus. So this is focusing on
that little narrow part that helped convince us
that Zika virus is a cause of these problems,
cause of birth defects, but today we’ll be
talking more broadly about other birth defects, developmental disabilities
alone, other adverse pregnancy
outcomes, et cetera. So, first of all, I want to
talk about the mechanism, the pathogenesis that
we believe is involved in prenatal Zika
virus infection. And so we believe that the
initiating factor is damage to those central nervous system
cells by the Zika virus, itself. So that leads to destruction of existing central
nervous system tissues, of brain tissues, and disruption of future developmental
processes. That leads to a loss
of brain volume, which ends up causing
severe microcephaly, and I’ll show you some
pictures, misshapen skull with overlapping suture and
redundant scalp skin and that’s because the brain was
meant to be bigger, it was growing bigger, and then
the skull appears to collapse on itself and, therefore, the
skin of the scalp is redundant. There’s also neurologic
dysfunction and severe neurologic
dysfunction in these kids has been
reported – hearing, vision, swallowing problems to
such an extent that they, some kids have needed a G-tube. Global developmental impairment,
limb contractures, hypertonia, epilepsy and extreme
irritability. And this is what we have been
calling the recognizable pattern or congenital Zika syndrome. So I’m just going to go through
some of the parts of that. I’m going to very briefly
discuss the brain and the eye since we have real experts
here to discuss that. This is the cranial morphology. The microcephaly, as I
said, has been severe. Most kids with microcephaly in Brazil have had head
circumferences greater than three standard
deviations below the mean. There’s been a partial
collapse of the skull with overlapping sutures. There’s been occipital
bone prominence. And you can see in this
drawing here how this appears in these children
with the prominence of the occipital bone here. They oftentimes have a small
or absent anterior fontanelle and sometimes so small
that it’s difficult to do a postnatal
cranial ultrasound. Scalp rugae and you can kind of see in the picture here and there are some
more pictures later on. This is consistent
with a condition known as fetal brain disruption
sequence, and this is something that was quite rare before Zika and I’ll show you some
pictures about that. Not all of the babies that have
had severe microcephaly have this fetal brain disruption
sequence phenotype, but a good proportion
of them do. So this is some information about fetal brain
disruption sequence. This is from a paper that
Dr. Moore published in 1990. She and I both published a
paper on this condition in 1990, which is very ironic
I think to both of us. It was first described in 1984
by Russell and colleagues, but had been noted
back as early as 1836. What appears to occur
in these kids is that there is destruction
of the brain which results in a collapse of the
fetal skull, microcephaly, that overlapping of the
scalp or scalp rugae or sometimes that’s called
Cutis verticis gyrata, and neurologic impairment. And the cases that
have been seen in the past have been associated
sometimes with infection. There’s at least one case of
cytomegalovirus or CMV infection with vascular disruption
where the baby had almost like a stroke prenatally
and with fever, but in most cases the
cause was unknown. And there was a review paper
that was published in 2001 that looked at all
the kids that up until that point
had been reported with fetal brain
disruption sequence and at that time there were 20 babies
in the medical literature. So this is really
rare before Zika. These are some pictures
that Cindy has gotten from her colleagues in Brazil. And here you can see the scalp
rugae, again scalp rugae, the prominent occipital
bone here and here and here, or you can see with the 3D CT
how impressive the overlapping sutures are, and then again
that occipital prominence here, overlapping sutures here. The brain anomalies I’m just
going to briefly discuss because Dr. Trevathan is going
to talk about this much more. These babies have
thin cerebral cortex. They have intracranial
calcifications. And, as you know, intracranial
calcifications are seen in other infections, as well, but these are in
different areas. They’re primarily
subcortical in location. There’s also been
hydrocephalus, hydranencephaly, gyral anomalies, polymicrogyria. Some people have
said lissencephaly, but experts that we’ve
talked to say it’s more like polymicrogyria by imaging. Absent or hypoplastic Corpus
callosum and then hypoplasia of the cerebellum
or cerebellar vermis. And here are some
pictures, these are images that are courtesy of
Dr. Bill Dobyns from the University of
Washington in Seattle and Dr. André Pessóa
from Brazil. Here you can see at the
top the calcifications, the subcortical calcifications, and you can see the large
ventricles and then extra fluid in the extra axial spaces and
very small cerebellum here. Ocular findings, there’s
been structural retina and anterior eye anomalies
and posterior eye anomalies, and I’m going to leave all
the rest of the discussion of the eye to Dr. Ventura. They’re also, these
children have also had congenital contractures. And some kids have had
isolated contractures. There’s been club foot. There’s also been kids that have
multiple congenital contractures or arthrogryposis. It can be large joints,
small joints, upper limbs, lower limbs or all of the above. And this hasn’t been
previously associated with the fetal brain
disruption sequence phenotypes, so this is something that
is different, it’s not seen in all kids with Zika infection
but it has been seen in a number of them even from the very
first reports from Brazil, the report that we
published in MMWR in January. They have been seen in
other congenital infections, like Rubella and Varicella. And here’s just some pictures, again from Dr. Pessóa
from Brazil. Here you can see lower
limb contractures here and the hips and the feet. Again, in the lower
limbs and hips, and then here you can see upper
and lower in this child here. There are other severe
neurologic sequelae that have been seen, and
there’s not really a lot known right now. These children are old
enough to know a lot about their long-term medical
and developmental outcomes and very little is
known about mortality. We know something about
mortality in children with fetal brain disruption
sequence, but not about – not for these children with
congenital Zika infection. There appear to be
of the children that have been reported motor
and cognitive disabilities, seizures, swallowing
difficulties, vision loss and hearing impairment,
hypertonia and spasticity with tremors, and irritability
with excessive crying. We’re really at this point at
an early stage and, as I said, this is something that’s been
seen with other teratogens when we identify something
that causes problems, when women are exposed to it
during pregnancy we recognize that early on we’re really
seeing the tip of the iceberg. And so we’re really at a time
where we’re learning a lot about Zika, congenital
Zika infection. We know that in some
cases there have been, and Dr. Ventura has
reported some of this, about brain eye anomalies
without microcephaly, but we don’t know how
often that occurs. There has been central
cranial nerve dysfunction only at birth versus later. Are there other neurologic
anomalies with origin in the embryonic period or are their non-neurologic
congenital anomalies. Those are all questions
that need to be answered. I do want to note that
there are other things that cause what looks like
congenital Zika syndrome, and so we really do need to do the laboratory
testing whenever possible. There are other infections that
can cause similar features, congenital CNV seems to be
the most similar phenotype and there are some very
rare genetic conditions that can cause features
that are similar to that of congenital Zika syndrome. So one of the ways that CDC
is working to get answers to what the spectrum
that is seen with congenital Zika
infection is the US Zika Pregnancy Registry. And this is a Pregnancy
Registry, this is to monitor pregnancy and infant outcomes following
Zika virus infection during pregnancy, and that information
is being used already to inform clinical guidance
and public health response. This is a registry
that is dependent on the voluntary
collaboration of state, tribal, local and territorial
health departments. And pregnant women with
laboratory evidence of Zika virus infection
and exposed infants born to these women, as well as sometimes the women might
not have been identified but if their infants
have laboratory evidence of congenital Zika virus
infection then their mothers would be put into the
registry, as well. Dr. Peacock mentioned
these numbers earlier, these are last week’s numbers, these numbers will
be updated today and are quite a bit
higher today, but this is last week’s numbers. So 346 pregnant women who
have any laboratory evidence of possible Zika virus
infection in the US 50 States and District of Columbia. Those are women that
have been reported to that Zika Pregnancy Registry. And then you can see 303 women
in the three territories, the three US territories
– Puerto Rico, US Virgin Islands
and American Samoa. I just want to mention that the
US Zika Pregnancy Registry is used for collecting
information on all those babies, except for the babies
in Puerto Rico and for that there’s another system
and you can see it’s written down here, the Zika Active
Pregnancy Surveillance System, or ZAPSS, that’s being
used in Puerto Rico. And I think Georgina also
mentioned these numbers, these are the numbers of
babies that have been noted as having poor outcomes. Most of the women have
not yet delivered and so for most women there’s
not information, but there have been
nine live born infants who have birth defects
who we believe are related to Zika virus infection in the
US and District of Columbia. As Marc mentioned,
those are all cases that were travel associated. There hasn’t been documentation of mosquito borne
transmission in the US. And pregnancy losses
with birth defects, six. And then you can see the numbers
for the pregnancy outcomes in the United States
territories. So I just want to
acknowledge, first of all, Dr. Moore for putting together
this talk and then the kind use of information, photographs
and imaging from Drs. Pessóa, Fonseca, Ventura and Dobyns. And I think we’ll
just go straight into Dr. Trevathan’s talk. So Dr. Trevathan is Professor
of Pediatrics and Neurology at Vanderbilt and he’s also
representing the American Academy of Pediatrics Section
on Neurology, and he’s going to be talking about
neurologic manifestations of congenital Zika infection. I’m going to get
your slides up, so.>>Thank you, Sonia. I’m going to dive
into some areas that I think have been
alluded to both by Dr. Peacock and Dr. Rasmussen and talk about how we may be seeing
just the tip of the iceberg. I know we all hope that the
iceberg we’re not seeing yet is not too problematic, but
I am going to take the liberty to do what we sometimes do
in neurology and take a look at some pathology and some
animal models and some of what we know already
from human data, that Dr. Rasmussen has
eloquently reported. And describe what I think is at
least likely, possible to likely that we will be seeing
as clinicians, as neurological manifestations
in children, not just the children that we
know about now but perhaps those that we’ll be seeing
in the future. I’ll be making some real
broad generalizations based on at least my review of the
literature and discussion with experts, but then also
drilling down selectively in some areas that I
think might be helpful for us to think a bit more. And I think consistent with what
Dr. Rasmussen has just presented the data that we have to
date are really consistent with the idea that there are at least two broadly defined
mechanisms that we’re seeing and it’s more complicated
than that. I mean I understand we have
geneticists in the room and there’s some evidence that
Zika actually is impairing some of the manifest gene
expression and that could be one of the important mechanisms. But in general there’s a
disruption of brain development that is taking place, in
addition to disruption of already developed
brain tissue. And these, there’s
evidence in the pathology that these two independent
mechanisms broadly speaking are occurring simultaneously
or at least in the same infant
at different times. I think there’s an impression that there’s some very important
immunologic mechanisms. Perhaps cytokines could be
playing an important role, and that’s important for
us thinking about some of the neurological
manifestations because having an
inflammatory response, in addition to disruption
of development, in addition to damage of previously developed brain
does have certain implications in terms of what we may
expect to see later. Now one of the reports that’s
come out, it’s a tragic report, that’s also there
have been other cases that have been shared with
several of us in Neurology from Brazil in which
there’s been hydranencephaly or just really a replacement of previously developed
brain by fluid. Tragically, many of us who trained clinically
years ago remember that before imaging this
was easy to diagnose, all you did was take the
baby into a dark room, put a flashlight up against
the skull and the head lights up like a lightbulb
because there’s really no or very little brain
tissue in there and the light is just
distributed through the fluid. And that is actually
what has been reported by Sarno and colleagues. Now I added the blue arrow
there, up there under the image in A to make a couple of points. That’s really the fluid that’s
replacing the brain tissue, but if you look you can see that there’s a dramatic
asymmetry, all right? So there’s one hemisphere that’s
been almost completely replaced by fluid, another hemisphere
that’s severely damaged, but yet there’s still
some cortex that’s intact and in spite of all of
the damage that’s there. And I think that there’s
a symmetry in some of the other developmental
findings we’re seeing or are going to be helpful in understanding what we’re
going to see in the future. Now a real breakthrough in understanding the
developmental abnormalities with Zika occurred with the
publication of the group from Hopkins, Tang and others, reported in cell, stem cell that the Zika virus actually
directly invaded human neuro progenitor cells and actually
reproduced within the cells. In some cases there was
actual inducing of cell death, in others there was disruption
of cell function, cell cycles, and then transcription within these human
neuro progenitor cells. Now, as an aside, this
type of abnormality in these human neuro progenitor
cells has been associated in other types of models
with disruption both globally and also more focally
of neuronal migration and cortical development, as well as subcortical
abnormalities. It’s also been the case that these findings have
already been reproduced. I think one of the happy sides of the Zika story scientifically
is the absolutely impressive rapid response of science
to address this problem. The eloquent research that’s
been published already in a short amount of
time is impressive. So Tang’s and colleagues’
findings have already been reproduced and actually
taken forward so that they’re seeing
now more specific findings in in vitro models of
brain development looking at how Zika impairs development
of human neurospheres and human brain organoids. One of those articles in
Garcez, just recently, and colleagues
published this, and even those of us who are not
basic neuroscientists, laboratory neuroscientists,
you can see the difference in the sphere there in the
A image, perfectly round, normal looking human
neurosphere, and then in B it’s
shrunken, malshaped and is just not forming
or developing adequately, and that is very clearly
an abnormality that is seen in models in which there’s
abnormal development of the neurons and migration
of neurons, both globally and in some cases more focally. Here’s another image
from Garcez looking at a human brain organoid
models, and it’s very clear in this model that
Zika virus disrupts and impairs the normal
development of this in vitro model of human
brain development. Now an article that also
is fairly recent in nature, Cugola and colleagues show that there’s an animal
model, a mouse model for causing microcephaly that’s
very clearly directly causally related to the infection
of Zika virus with invasion and disruption of
progenitor cells. And you can see in the
picture of the mouse fetuses that there’s not only
really microcephaly, but also just major
growth restriction and this has received
quite a bit of attention. But what I’d like to draw your
attention to is not just that, not just that there’s
overall small brain, small size of the body, but there is a very
specific disruption of cortical development
in the temporal lobe and in the motor cortex. I don’t know that they
did a survey of all areas of the cortex, but clearly
shown in the temporal and the motor areas
of the frontal lobes in these animals there’s
abnormal cortical development and also there appears
to be disruption of the normal cortical
morphology. Also, there’s been an article
from Lee and colleagues that, likewise, has demonstrated
this small brain, microcephaly, as
a model in mice. And in this case it was
not the Brazilian strain, it was an Asian strain of Zika
virus causing this abnormality, and they reproduced the
work of Tang and others, invasion of progenitor cells. But what they have done, too,
is to describe and report some of the neuropathology. And, again, what they’ve
demonstrated is not just a dropout in the total
number of neurons, but also disorganized
cortex, a thin cortex, an increased neuronal
cell death. Again, all these findings
that are seen in animal models that are predictive
of certain types of abnormalities in humans. Now moving to some
of the human data, this is from Driggers and colleagues’ report in the New England Journal
earlier this year of a fetus that was tragically
infected with Zika and they have fetal MRI, as
well as a fetal neuropath. And the MRI, one of the things
that’s really very clear is thinning, dramatic thinning
of the corpus callosum. Corpus callosum is very
clearly too small and is thin. This is a large structure
relatively speaking and something that’s more
obviously seen as a marker when there’s severe impairment of cortical development,
neuronal migration. And then in the neuropath
they show disorganization of the cortex and this, again,
is consistent I would say with the previous animal
data that’s been seen. For some of us in Neurology some of what we’re seeing here is
reminiscent of what we’ve seen in CMV, as has been
mentioned before. And this is from some
work published by White and in Pediatric
Neurology recently, really more of a review of the
type of imaging abnormalities that have been seen with CMV. And in this situation they’ve
pointed out in the images to your left really CMV
being causally associated with this congenital perisylvian
syndrome in which frontal and temporal lobes are
abnormally formed, the cortex and subcortical white matter, and that there is very typically
polymicrogyria in the cortex around the perisylvian region. This, again, is consistent
with some of the neuropathology from the animal studies on Zika and then I think also what we’ve
seen in some of the neuropath from some of the
early human data. There’s also to your
right there’s images that really emphasize a
cleft within the cortex and this is the type
of abnormality that also is associated with
polymicrogyria within the cleft and areas of abnormally
formed cortex and other ways around the cleft. These types of lesions are
extremely highly epileptogenic, and when occurring
in a focal area of cortex very often
people can appear and children can appear
normal initially at birth and then develop seizures
in the first several months or even later in life. Here’s another picture
of one of these clefts that has polymicrogyria
within the walls of the cleft, and as you can see it’s
dramatically asymmetric although neither hemisphere
is completely normal. But the reason I point this
out is that there are cases that neurologists
see quite frequently in which one hemisphere can
be almost completely normal and the other has a demonstrated
cleft with polymicrogyria within it and so forth, and sometimes these children
can be dramatically unremarkable developmentally for the
first several years of life and then present with
seizures later on or they develop infantile
spasms or hemispasms very early. And so they often are not
microcephalic at birth. Lastly, let me just show an
example of some of the fine work of Ruben Kuzniecky, who
is an Adult Neurologist and epilepsy Specialist at NYU. Ruben has been interested
in this for over 20 years and the reason is because
if in taking care of adults, young adults with
intractable epilepsy with onset of the seizures in adolescence. Well, Ruben has pointed
out time and time again over the last 20 years and
it’s consistent with what most of us have seen is that one
of the more common causes of intractable focal epilepsy
in young adults and adolescents who don’t even have onset of
any clear neurological symptoms until that age are these types of neuronal migration
abnormalities associated with clefts, polymicrogyria
and thickened cortex. And in the image that’s to the far right there’s
actually an asymmetry in which one hemisphere
is relatively normal and then another hemisphere has
dramatically abnormal cortex with large areas of
polymicrogyria and a cleft and multiple different
types actually of cortical migration
abnormality. So what Dr. Rasmussen
was pointing out that what we’re seeing
in some of the cases of Zika so far is actually
technically not as consistent with lissencephaly
as polymicrogyria. I agree it does turn out to be
a very important distinction and is more consistent
with mechanisms that can produce these initially
less severe malformations that don’t manifest
until later in life. And so I think one of the things
we’re going to have to think about in looking at Zika is
realize that manifestations of a congenital anomaly may not
be readily apparent for months or even years or longer,
and how do we deal with that as clinicians and
as epidemiologists, I think is going to
be quite a challenge. So here I’ve summarized at
least the way I would think about these issues
that lay ahead for us. I think the column on the left, the infants that are
clearly abnormal at birth, and I believe this is work
group two for us, correct? This is a tragic situation, but I think relatively
easy to predict. These are children and this
would include the abnormalities that Dr. Rasmussen described
in more detail than I did, children that really
have profound motor and cognitive impairment, most
of them will meet diagnosis for cerebral palsy, they’re
all going to have profound, with an emphasis on profound,
intellectual disability. One thing that we
don’t often talk about because these children
are so severely impaired is that they do tend to have
cortical visual impairment and cortical auditory
impairment. How that impacts recommendations
for auditory screening and visual screening I think
is something worth discussing. For the pediatricians, one of
the things that’s a real problem that also Dr. Rasmussen
brought up is that initially these babies
are often able to suck, but as they become several
months old they lose their ability to suck, lose their
ability to feed, they can appear to regress during that time,
and I would suspect that most if not all of these
children are going to have severe problems
with feeding. Hypotonia is usually truncal
hypotonia, goes along with a lot of these types of
abnormalities that we’re seeing, and you put that truncal
hypotonia problems with gag reflex, problems with
feeding together and seizures, that really presents problems with aspiration pneumonias,
respiratory problems. Very soon there’s pulmonologists
and hospitalists involved in the cure of those children. The classic situation
here is onset of seizures in the first few months of
life, infantile spasms tend to be rare, epilepsy syndrome, tends to be relatively
common among children with these types
of abnormalities. And so as we educate
clinicians about what to expect I think a focus
on infantile spasm and how to recognize those
abnormalities will be important. Now of those who are initially
normal appearing at birth and, again, I don’t want to
play epidemiologist here, but I know this has
got to be a discussion and a concern among
the epidemiologists because we don’t really
know the number of people who have been exposed
at this point. But nevertheless among children
who appear normal at birth but who have one of
these milder forms of developmental brain
problems that I’ve mentioned, they tend to develop
what we would classify as acquired microcephaly
even though the etiology is developmental. And actually some of these
children may actually not meet diagnostic criteria
for microcephaly, their head circumference may
be above the second percentile, but they can have a
deceleration in head growth and then also have
developmental delays that are in one or more domains. And then, of course, the domain in which they have their
developmental delay would be related to the neuroanatomical
location of the associated
brain malformation. It will take us quite some time to know whether there’s
a pattern there that we can predict. As with the children that
are symptomatic at birth, these children will be
expected to have a higher rate of myoclonic epilepsy
and infantile spasms, but as with the cases that have
been reported for many years from adult epilepsy centers I
think we can also expect people to be relatively
asymptomatic if there’s a focal or even abnormality
isolated to one hemisphere, may not really present
until later in childhood or adolescence with
seizures and what appears to be developmental regression, and then that developmental
regression is often associated with an increased frequency
of subclinical seizures. So I think epilepsy and
developmental delays are going to be important to
look for in those kids that look normal at birth. Those who are abnormal at
birth I think will be familiar to pediatricians who care
for children with severe to profound microcephaly
from multiple other causes. I don’t want to end without
mentioning what’s already been mentioned, which is we know
that Zika is causally related to Guillain-Barré, both in
Brazil and in French Polynesia, and very often we
think of Guillain-Barré as being an adult problem but Guillain-Barré can also
affect children, two year olds, three year olds can
have Guillain-Barré. And so we’ll need to make sure
our colleagues are well versed in Guillain-Barré. There’s been a report or two on
myelitis, how often this occurs. I do not know. I think that one of the more
common questions I’ve had has been what is the risk to the
developing brain among children after they’re born during
the first two years of life if they are infected by Zika? I do not have any data on this. I don’t know the
answer to the question. It’s one that I feel
certain will be a question that will be ongoing for some
time and I’d be interested to personally know if
people have data on that. I’ve relied very much
on the work of others, and although my conclusions
are not necessarily those that have been in
these publications that I’ve listed here I’d
be happy to share these with you if you would like. Thank you. [ Applause ]>>And our next speaker
is Dr. Camila Ventura. She is an Ophthalmologist at
the Altino Ventura Foundation in Brazil, and she’s
going to be talking about ophthalmologic
manifestations.>>Good morning. It’s a pleasure to be here. I’d like to thank CDC and Dr.
Rasmussen for the invitation. To start with I would like to
acknowledge my team in Brazil at the Altino Ventura
Foundation, for sure this is
all about teamwork. As well as all of our partners
from Brazil and abroad, they have been helping
us along our way. And for you to understand where
we are standing right now. It’s important for you
to understand where, how did we start, and how did we
get involved with Zika syndrome, congenital Zika syndrome. So by October 2015 we
already knew that we had cases of microcephaly in
Brazil since May, and that people were talking
about that it was related to Zika, but we did not
have anything to prove it. By November 2015 this
association was proven to exist, and as we can see here the
impact in our population in Brazil how the peak of
microcephaly just went up mainly between November and December,
October to December, I’m sorry, and it was really fast and very,
very important for our country. So this was where
we were standing. Also, it’s very important for
you to know that Pernambuco, which is the red state as you
see on the map, it’s located in northeastern Brazil, it was
the first state to report cases of microcephaly in Brazil and it’s still considered
the epicenter because it’s also the state that
has the most amount of cases of congenital Zika
syndrome, more than 25%. So Altino Ventura
Foundation, we are located in northeastern Brazil and we
are a nonprofit Eye Hospital and Rehabilitation Center, so we
are in the Capitol of Pernambuco and this is a nonprofit
organization. We see about 35,000 patients
every month for eye care and we perform about 2,000
eye procedures a month. So it’s quite a lot, that’s
why we’re a reference center in northeast. Also, as for the
Rehabilitation Center we cover, we rehabilitate patients
according to their impairment, visual, auditory,
motor and intellectual. Right now in our Rehabilitation
Center we have more than 3,500 patients and
from those 156 babies with congenital Zika syndrome. They are being treated
at our institution. And so how did we get involved
with congenital Zika syndrome? It started that in December 2015
we organized three taskforces. In total we saw 128 babies
and their mothers because at that point we did not know if
mothers had ocular findings, as well, or only the babies. We found out that only
babies had ocular findings. The ocular exam included
the otoscopy, motility, bio microscopy, which is the
anterior segment examination, the fundoscopy, the
posterior segment examination, and we performed fundus
photography of all 128 babies. So as for the ocular
findings, now we are seeing, because at birth you cannot
actually diagnose strabismus and these strabismus they vary until six months of age, but
now these babies are growing and we are actually
assessing the strabismus, but also the segments that
these babies did not have and now they’re presenting
with time. But mainly the fundus
alteration, so this is what we mostly
see in these babies, and we were the first
ones to report the retinal and optic nerve alterations,
but now we see that these babies also
have vasculature findings. So as for the retinal
alterations, basically, we see scars, chorioretinal
scars as you see in this image, but also we can have
pigmentary changes as you can see in
this other image. And as for the chorioretinal
scar or atrophy it’s very important
to know that it varies according to the location, so you can
have let’s say a macular lesion, you can have a nasal
lesion, the size also varies so you can have a very small
and maybe you can miss that out if you’re not being,
observing it really well, but it can also be a very
extensive lesion in the eye. The shape also varies, it can
be circular or oval lesion or it can have more of
a disky form aspect. And the number of
lesions also vary. You can have an isolated
scar or multiple scars. As for the pigmentary changes, we see that these
babies they can have more of a focal pigmentation
in the macular region, but they also can have
diffused, so it really varies, as well as the pigmentary
aspect, it can be something like very fine but also
gross mottling pigmentation. And it can be isolated so
you can see only the pigment or it can be associated
to the scar. So it really varies a lot, and we’re learning
from this very much. Also, the optic nerve findings, in this picture we see all the
three findings we can find. The optic nerve, hypoplasia,
the pallor that we see in the optic nerve, as well as the increased
cupping. So this is a very good
image to show that. The vascular findings
we are seeing with time, so this is one image which shows
the attenuation of the vessels, but we were not the first
ones to report the hemorrhages that these babies have. Miranda and collaborators, they have described
these hemorrhages, as you see inferiorly. And also the abnormal
peripheral vasculature that you can see superiorly, and
it was also reported by Miranda. As for the anterior
segment alterations, from our 256 babies we have
not seen any anterior segment alteration, but it has been
reported in literature, the iris coloboma, the lens
subluxation, and cataracts. And also in previous papers
we have seen people describing microftalmia like pelvit. So talking about since
we are here to discuss, this is what we are actually
doing nowadays in Brazil and trying to advertise
and make sure these babies, they have an exam at least
within one month of birth, but also we find
it very important to document these fundus
because many of these babies that they are born
without ocular findings. Because they have a central
nervous system impairment, many times the optic nerves
are changing along the way, so it’s good to have the
documentation of the baseline to have this comparison. And we are talking
about all babies born, especially in the epidemic
areas, like Brazil right now. It’s very hard to have this
done, but this is something, the ideal world, right? Also, it doesn’t really matter
if the mother had symptoms or not, we defend that all
babies should be screened really and, also, as Dr. Rasmussen
said, we published a paper with a baby that did
not have microcephaly but had other neurological
and ocular findings, so it’s very important to
include all of these patients. And we also say that if the
patient has an ocular finding it’s very important
to refer this patient to at least a pediatric
ophthalmologist. Right now we are
following these babies, the pediatric ophthalmologist
and the retinal specialist in our institutions, we
are following these babies. Because the treatment is
actually multidisciplinary and, also, you have the magnifying
glasses that you can use to stimulate these babies,
patching and therapy visual, therapy simulation, but
it’s also very important that the retina specialist will
see these fundus and will detect if there is any change. So we’re working
as really a team. But, also, we think it’s not
only about having a lesion or not, actually both, all
babies should be followed at least during the
first year of age. And we would say we are
trying to this in our region where the retina specialist will
follow these babies every six months during the first year
of life because it’s a scar and it’s a past infection and
all of that we expect it not to change much, so
that’s why the six months. And the pediatric
ophthalmologist because of the visual
development they are following every three months these babies. But it’s very challenging,
of course, like I said it’s a
multidisciplinary team. We have a lot of
therapists, neurologists, ENT working with us, and
it’s a very costly treatment. We are going through a very
difficult moment in Brazil with all the political
and economic crisis. That’s why we’re
gathering help from all over because the cause is really
big, these babies need our help. And it’s very touching,
like I said to many of you, it’s touching to deal
with these patients and see how they can do
better with treatment. So thank you so much
for your attention. [ Applause ]>>Justin Obatim, Augusta, Georgia. In the animal data you showed
it was striking the intrauterine growth restriction, but
that’s not been the phenotype in humans. Was there any data
on the placenta of those animal models?>>Are you asking from those articles I…>>Yes.>>I don’t recall seeing the percentile data there, now… There are some of these human
cases in which Zika was isolated from the amniotic fluid and
that was one of the ways that they documented
exposure, for example. But I don’t recall an actual
histopathology of the placenta, itself, in the articles. But I’m not the best
person to speak to that. Yes, sir?>>Yes, there was an article
recently in [inaudible] looking at placenta and then there
was an article that came out, I saw it yesterday. First author was T-A-B-A-T-A from “Human Placenta”, it was showing different cell types at different stages of development.>>I’m Sharon Lehman,
she had a section on AAP, on opthalmogy and I am really very pleased that both of you talked about cortical visual impairment. Just as a co-incident three weeks ago we had a pediatric cortical visual impaired review… and then this week [inaudible]spoke to a group of teachers of visually impaired early intervention people. And this was a
very big topic. And many times in children who have all these neuro
developmental problems the cortical visual impairment
gets overlooked, and I think that
it’s going to be – and the early intervention
people at this meeting were
also very concerned that the recommendations that we
make speak to early intervention and not just the
initial treatment. So thank you for
bringing that up. I think that we’ll have to
discuss the follow-up in Brazil and the follow-up at
least in the United States because as we spoke, you know, the retina specialists
are probably not going to be interested in seeing these
children in the United States. So I think we’ll
have to modify things to fit clinical care here,
but really thank you both for bringing that up because
it is so often overlooked.>>Yes, I totally agree
with what you’re saying, and that’s why we want to emphasize we are following
these babies and we see that many do not reach the
milestones for the age according to their age, you know, the
vision according to the age. And this for sure
has to do with CNS.>>Georgina Peacock
from CDC. Ed, you talked about the
loss of suck and the increase in feeding problems over time,
is that only in the children that would develop seizures? I know this is somewhat
speculation, or do you think there’s
a possibility of some developmental regression
in all of the babies regardless of the development of seizures?>>Yes, again, with
the disclaimer that I’m projecting
based on other types of situations that we’ve seen. I think that’s a separate
issue from the seizures. I mean the seizures can
exacerbate the overall situation because you’re having
a lot of seizures and you can’t control your
secretions you’re going to be more likely to aspirate. But in these children that
are severely microcephalic and I would say especially those that have severe frontal
lobe dysfunction, you know, as we’re all designed
over simplistically that as our brain
develops we shift from that reflex
sucking mechanism to more or intentional chewing,
swallowing activities that are more related
to higher structures. And so those higher brain
structures are not intact, then they tend to develop
those more severe swallowing and feeding problems after
a few months of life. So I think it’s more related
to the brain injury, itself, the loss of feeding ability than
it is actually the seizures.>>This is Susan Wiley from Cincinnati, and I want to mirror
thanking you about the functional vision
assessment and thanking about cortical vision. But my question is
actually for the babies who are not microcephalic at
birth, do we have any knowledge that there’s an asymmetry of
head circumference to the rest of the growth parameters or is
that not necessarily apparent to the degree that we know that? I mean so, you know, recognizing
that some kids are going to have a normal
head circumference, but is it disparate from their
somatic growth in those kids? So you would kind of put two
categories of children up?>>Yes.>>One with clear microcephaly,
those without microcephaly, and what we should do to
be thinking about them? But whether there’s data to suggest a relative
microcephaly compared to somatic growth?>>Yes, I don’t know that. Again, I’m projecting based on what we’ve seen
in other conditions. And I would say especially,
I mean it would be nice to know what you’ve seen in
Brazil, but since the pathology and the imaging that we’ve
seen can be quite asymmetric, both in terms of
brain destruction and then abnormalities of
actually brain development, you know, abnormalities in
migration, in other conditions that have that sometimes the
head size may not be technically abnormal or below
the second percentile because one hemisphere is normal
and then those children are not as easy to pick up early on.>>Now the case that we reported
actually there was a cranial facial disproportion and also
– but the head circumference, like I mentioned, was normal
but the brain findings, the baby had ventriculomegaly
classification. So he had the neurological
findings that has been reported, but you look at the baby and you
see that there is cranial facial for sure, it’s not something
that will pass by you and you do not realize it.>>So one side of the
face was a different size?>>One side is like
you see that it’s not – you would think actually that
the baby has microcephaly, but once you measure
it’s within the growth.>>Oh, I see.>>We are following this baby and the brain keeps
following the normal curve, not within like the 90%. It’s a little bit under, but
not considered microcephaly. Do you understand?>>Yes, yes.>>And it keeps in the curve,
but you look at the baby and you see, oh, it’s not, the proportions are
not normal for a baby.>>Hi I’m Yvonne Maldonado,
[inaudible]. And what’s striking to me and to all of us obviously are the dramatic Microcephaly and
[inaudible]. But when you look at other congenital infections as you pointed out, CMV and Rubella, which again are also [inaudible] we haven seen those dramatic findings. And yet my understanding is that there are Zika
disruptors throughout the brain, and not just in the neuro
genitor cells, and do you have any idea
why this is so profound? And would this virus
relative to, say, CMV and especially Rubella,
which can be quite devastating in terms of the same
cellular drop-off?>>Others may have a
different impression, but, no, I don’t know. And I would agree this is,
to me, the neuropathology and imaging that we’ve seen so far is actually much more
concerning, both in terms of the brain injuries to the
babies that are microcephalic but also I think the potential of what these mechanisms
could do to children that initially pass screens. So I would agree with you,
this is a new territory.>>So one other comment is that as you know there’s
also literature that suggests that antibody dependent
enhancements, for example when
he’s in vitro looking at adding Dengue virus
antibodies to cell in vitro models results in
higher cellular destruction. And whether or not there’s some
cross-reactivity with that, additional inflammatory
response. I think somebody else brought
up this issue of inflammation, but I think that may be another
cofactor that I don’t know if that’s been looked at yet. So, for example, women who
are – I know it’s hard to do but to distinguish between
Dengue co-infected women versus not and whether that
Aedes may actually lead to additional cellular drop-off?>>A question for
our epidemiologists.>>Yes, I knew Marc
would probably — [ Inaudible ]>>I’m interested as to why
this is being seen here now and whether previous
Dengue infections in an area could be contributing
at a population level. There is the one study that you
mentioned that looked in vitro and suggested that there could
be an increased severity, but I’m not aware of any data, and it is very difficult
serologically to find a population that is
not previously Dengue infected in these parts of South
America and suggest that there’s greater severity
of disease compared to or not. I think it’s an unknown.>>Yes, Fernando Cerna,
American Academy of Pediatrics, Puerto Rico. These soft signs that you have
mentioned on the neurological and ophthalmological they’re
not necessarily are just with microcephalic babies. Do you have any data on
when was the mother infected or when was the Zika
was diagnosed, if it was in the
first trimester, second or third trimester
of pregnancy?>>Yes, so one of our
publications we wanted to see what were the
risk factors associated with the ocular finding
and we actually saw that the first trimester
is related, so probably the ocular
findings, the infection occurred in the first trimester so that
the baby had the ocular findings and consequently I
believe the microcephaly. And also another risk factor
was the cephalic perimeter, so the smaller the
head circumference was at birth – oh, I’m so sorry.>>We had some signaling
from the back of the room and I think that’s what
he was trying to tell us.>>So also the head
circumference was also another risk factor. So what makes me believe that
the eye infection occurred in the first trimester, the head
stopped growing severely, right, and then the ocular
findings also appeared in the same moment. What we are seeing now as
ocular findings are scars. We are not seeing
active disease. And that’s why we are
not treating these babies with steroids or trying to find
some treatment for these babies because actually now
it’s a past infection and we believe it was
the first trimester. [ Inaudible ]>>I know that my
constituents are dying to know the answer to this. How did Brazil respond
to the parents? How did you support the numerous
parents that were having to deal with all, you know, the children
that they had to support? What – how did your state, your country support the
parents dealing with this?>>That’s a great question. We thought it was very important
to give parents support and since the beginning. We saw many mothers depressed, many of the families did not
want to show their babies, they would cover
their babies up. They would come with the babies
covered, would leave treatment with the babies covered. They could not handle the
pressure from media also and from people around,
the curious people. So because of that we have
formed a support group for the mothers,
basically mothers. We were actually
mentioning how fathers they in these moments it’s very
hard to maintain a family when you have a baby
that cannot stop crying. These babies have
a neurological cry. I actually have on my phone, I have recorded their
cry, it’s insane. And all the therapies
involved because the babies, these are 256 babies, we are
trying to see them weekly. It’s not easy. We have, like I said,
a political issue when we are not being
paid for these babies. But we are having
donations and grants. We’re trying to get as
many help as we can. And mothers have responded so
well to support, psychological, psychiatrists, as well as some
of them they need psychiatrists. But mothers are helping
themselves. So, okay, my baby
cannot swallow. Every time, like you said, they have swallowing
issues, they really do. So one mother discovered
a way of feeding the baby and they are teaching – oh, so we make every week while
the baby is being treated, stimulated, ocular, motor, the mothers are also being
treated with support group. So I find this very important. It’s not only about
seeing only the babies, but everything around them. It’s a whole family that
changes once you have a baby with congenital Zika syndrome.>>I am not aware of do you know
whether anyone has ever looked at congenital CMV and arthrogryposis?>>In what?>>Arthrogryposis? Because we’ve got so many. [ Inaudible ]>>It was really interesting
looking at onsite – oh, I’m sorry, Lisa Hunter, I’m at
Cincinnati Children’s Hospital in Pediatric Audiology
– and really interested in the congenital ophthalmology
anomalies and thinking about parallels with
the auditory system, but haven’t been able
to find data yet. And I’m wondering from
Brazil with the testing that is done there, there
are some really good ENT and audiology research
facilities, is there any data about to come out
or any knowledge about what the parallels may be? I’m worried about dual sensory
impairment, both hearing and vision in these children and the profound
developmental effects that may occur as a result.>>They certainly have auditory
findings, and we’re trying – this is something that the
next paper we’re working on is assessing. We have assessed
38 babies and all, these babies have been assessed
by ENT, neurology, orthopedics, ophthalmologists, all of them. And we want to – nobody
has, no publication has come out about the auditory findings,
and it’s very important. The tests, in the beginning
every – when we had 138 babies in the beginning we tested them
with – it’s a screening test. I don’t know in English,
but it also has errors so it’s not so precise. You have the same, when the
baby is born you screen first and then you have the
real auditory test. So we did not want
to rely on that test, that was why we during, like a long time we did
not publish those findings. It took a lot to have the real
tests, the more specific test.>>Diagnostic.>>Yes, the diagnostic,
exactly, but now we have for the 38 babies I
was telling you about, so this is something we
are working on for sure. And it’s mainly unilateral
what we are seeing.>>I’m curious.>>Unilateral.>>So I’m going to have the
questions stop so we can stay on time, otherwise, we will
get severely behind today. So we have a break right
now for 15 minutes. If you want to ask Dr. Trevathan or Dr. Ventura questions during
the break that would be great, and we’ll come back
at ten-thirty for the next series of talks. Thanks so much.