2016 NHSN - Ventilator Associated Events and Case Studies - Part 1

Author: Centers for Disease Control and Prevention (CDC)

I'm Cindy Gross. And I'm the subject matter expert for VAE and ventilator-associated pneumonia. We're currently in the process of bringing on a new employee who will also be the backup and her name is Krista Doline. So, you can look forward to seeing some responses from Krista in the near future as well when you submit VAE questions.

So before we get started, I just wanted to take a poll getting back to the Super Tuesday topic. How many of you have done or are doing in-plan VAE surveillance? Just out of curiosity. Ok. For the web streaming audience, that's-- I don't know, I saw about maybe a third of the audience. Maybe I'm being a little bit optimistic there.

And of those folks, how many of you are from LTACs because-- long-term acute care facilities, OK? And a handful of those. This year is the first year that we have CMS-required reporting for VAE and that is limited to LTAC facilities. Ok. So, our objectives today will be to obviously talk about VAE, the definitions and the surveillance algorithm. We can't talk about VAE without talking about pneumonia. So we will talk about the pneumonia event and touch on pedVAP which is the in-plan available event for pediatric locations.

We're going to touch a little bit about on how you enter VAE events into the NHSN application, going to do a little quick review of the VAE Calculator, and then we're going to accurately apply the VAE algorithms to the example cases. So, we all know that ventilator-associated pneumonia or VAP is an important complication of patients that are mechanically ventilated. Of course, it's also true there's other types of complications and adverse events that can occur in critically old patients who are required to be mechanically ventilated. There really is no valid reliable definition for the condition ventilator-associated pneumonia whether you're talking about a surveillance definition, if you're talking about clinical research or if you're talking about the actual clinical diagnosis of a patient with ventilator-associated pneumonia.

2016 NHSN - Ventilator Associated Events and Case Studies - Part 1

But we still need to conduct surveillance for these complications that occur in mechanically ventilated patients and track the prevention progress. So, you know that traditionally, we had the pneumonia-VAP definition and that includes some somewhat subjective elements, not to mention the chest X-rays. And it's neither sensitive or specific for actually detecting the condition of a ventilator-associated pneumonia. And that's not really ideal in this area of public reporting when your rates are being compared to other facilities and we've got pay-for-performance based on the-- those type of results. So, that being said, we knew that we need to come up with a different way to monitor for these types of events.

And the first step was to gather together a surveillance working group and that took place in 2011. And that was comprised of not just folks here from CDC, but also a lot of academic partners and professional society partners, nursing, respiratory therapy, SHEA, APIC, some of our federal partners at HHS and the NIH, the American Thoracic Society of Surgeons, Infectious Disease, lots of folks with lots of expertise participating in the development of this VAE event, and the event that was launched in 2013 in the NHSN application when we finalized the development. And ventilator-associated event at that time then replaced the traditional pneumonia-VAP event surveillance in-- originally in patients that were greater than 18 years of age. And then later subsequently, we adjusted that to location-based so it was patients in adult locations. The goal was to focus on objectivity, reliability and the ability to automate this particular event. And I know you all are anxiously are waiting for VAE to become CDA. And I promise we will be working on that very soon.

We wanted to enhance the ability to use the surveillance data to drive improvements in patient care and safety. So, a little focus on the website where you will find all things, VAE, this is what the webpage looks like. You, of course, can find the protocol there and access to the ventilator-- ventilator, VAE Calculator.

There's also some other really important features that I want to point out. And that is that there in addition to the FAQs that are found in-- within the protocol itself, there is an additional FAQ document that lives on the VAE website. And in fact, we have these FAQs for all our events. So if you're unaware of this, you want to check out this particular section for all events, CAUTI, CLABSI, SSI, MDRO. We even have an M-- miscellaneous FAQ. So, take a look at those FAQs.

And sometimes, before you submit your question to NHSN, you might just find the answer in the FAQ. In addition on the VAE website under the supporting materials, you'll find a document that's called VAE Surveillance Mechanical Ventilation Table. What this is, is it lists a bunch of commonly used ventilator modes. So, I don't know, do we have any IPs in here that are respiratory therapists? I don't see any hands.

Maybe we have some in our web streaming audience. But, we are using some ventilator data obviously to do VAE surveillance. And this document may be helpful for you when you're trying to figure out what kind of mode the patient is on. Is it in included mode or in excluded mode? And then finally, under the calculator and worksheet's section, you'll find the access-- another place to access the VAE Calculator as well as some of the manual data collection forms that you may find useful.

As far as ventilator-associated pneumonia in children, in pediatric locations, we're still using that traditional pneumonia-VAP definition. And this is where you will find that protocol. It's now labeled surveillance for pedVAP and new events because we have folks that were rightfully so kind of confused about where do I find pneumonia? Can I not use pneumonia again? And we're going to get into this a little bit more. But this is the website where you'll find the pneumonia protocol. And again, just to point out along with the protocol for pneumonia, you'll also find Chapter 2 of the NHSN, patient safety manual under the protocol section. Again, we have a frequently asked section-- frequently asked question section for pneumonia, specific questions for pneumonia. And under the supporting materials on this page, you'll find the worksheet and the example worksheet that Kathy talked about this morning that you can use for determining your infection window period, RIT.

You'll also find the Chapter 17 definitions for all the other specific events and types of infections. And the organism list is found under the supporting materials. So, when we're talking about pneumonia and VAE, there are some pathogen exclusions. And coincidentally and nice for you and all of us, they are the same for these two lower respiratory events. So, the same pathogen exclusions will apply for pneumonia-VAP and also for VAE. So we are excluding Candida species or yeast not otherwise specified, coagulase negative staphylococcus species and enterococcus species. These are all excluded for use in meeting the pneumonia definitions or the VAE, PVAP definition, unless isolated from a lung tissue or pleural fluid. There are indications of isolation of commensal flora of the oral cavity or upper respiratory tract, hence the reason why they're excluded.

The only exception to this exclusion is when you're doing the pneumonia surveillance. For pneumonia 3, you can still use Candida species when you're meeting the pneumonia, PNU3 definition where you're using a matching blood culture and sputum culture or respiratory culture and blood culture. And we'll cover that a little bit more in detail later. And additionally as was talked about this morning, these same community-associated fungal pathogens are excluded for use as well for VAE and pneumonia. They're excluded for all NHSN events. So, let's talk and review just a little bit about what we have available for in-plan use and off-plan use when you're talking about lower respiratory surveillance. So, of course, an in-plan event refers to an event that you've selected in your monthly reporting plan. Those events that are available for selection in your monthly reporting plan are VAE in adult locations.

And if you're doing pediatric location surveillance for lower respiratory events, you would be using pedVAP. Remembering that NICU locations no longer have an in-plan event available as far as VAE or pedVAP. You can still do it, but you'll be doing it off-plan. An off-plan event is an event that is conducted by you, by choice. You're not held accountable for doing any of what the protocol says. You don't have to report it into NHSN. And you're doing it just for your own. You haven't selected it in your monthly plan.

Because you are not accountable for following all the rules, though that information whether you report it if-- even if you do report it to NHSN, if it's not included in your monthly plan, it's also not included in the aggregate data when we're doing data analysis to provide the national aggregate data. So, keep that in mind. So, to help you out on this, when you're entering your stuff into your monthly reporting plan in NHSN, there are some business rules behind the scenes that will not let you select events that are not eligible for the location.

So, you'll notice that seven-- 71 ICU and ICU are adult locations. And you can select VAE, but you'll notice that pedVAP is grayed out. So even if you want to do pedVAP in-plan in those adult locations, you will not be able to select that in your monthly reporting plan. Similarly for the pediatric location, you cannot select VAE, but you can select pedVAP. And you'll note for the NICU location, you cannot select either.

So, can I use the pneumonia definitions to assign a secondary BSI when doing CLABSI surveillance? And the answer is yes. Even though VAE is the only adult in-plan ventilator event, when you're doing in-plan CLABSI surveillance and you're trying to make a determination if a bloodstream infection is secondary to a lower respiratory tract event, you can still use the pneumonia definitions in adults, in children, in neonates. Pneumonia definition is available just like all of the events in Chapter 17 are available. You're not doing those events in-plan either, but you can use those definitions to assign a secondary BSI. So, repeat after me. Come on, altogether now. The pneumonia definition can be used as a site-specific infection for secondary BSI attribution when conducting CLABSI surveillance.

Even for adult patients. Ok. Good. Do we have it? That's a really, really, really common question. We understand the confusion. You'll find an FAQ in both the CLABSI FAQ document that I pointed out to you. The pneumonia document and the VAE document, you'll find an FAQ and that it will tell you the same exact stuff. Remember that for secondary bloodstream infections though when you're using the pneumonia definition, you can only report a secondary BSI if you have met or you can only assign-- you may report it if you want to, but you don't have to.

You can only assign a secondary BSI if you can meet the PNU2 or the PNU3 definition. Remember that. And also remember that pneumonia has excluded pathogen. So, if you have a bloodstream infection with Candida and you're not meeting a PNU3 using the respiratory culture and the blood culture that are matching for Candida, you can't assign a secondary BSI with Candida to PNU2. Ok. So, a little bit more on this. If you believe that there's a non-blood source of infection to which an LCBI may be secondary, the following must occur. And this applies to all secondary You have to first fully meet the site specific definition.

The blood culture must have a collection date in the secondary BSI attribution period of the site-specific infection. And then you must apply the guidelines in Appendix 1, the Secondary BSI-- in the Secondary-- in the BSI protocol. So, the blood must either be used as an element. And you're going to hear this again and again. I know Kathy talked about it this morning. I'm going to talk about it here as it relates to pneumonia and VAE. And tomorrow, you'll hear it again from Georganne when she covers the BSI protocol and secondary BSI assignment.

So the way that you can assign a blood as secondary is if the blood is used as an element to meet the definition or the-- a site-specific culture is used as an element. And the blood culture pathogen matches that specific-- that site-specific culture. So, let's look at how this applies to pneumonia. So BSI that's secondary to pneumonia can be secondary either by using a blood culture as the element of the definition because PNU2 uses an organism identified in blood as one of the elements to meet the PNU2 definition. The pathogen exclusions as I mentioned earlier do apply. So, you know, again back to the Candida or Enterococcus or Staph coag-negative. You will never have those organisms secondary to a pneumonia unless you have recovered them in a lung or a pleural fluid.

Ok. So let's see how this might look if you were going to put it into a worksheet. So, meeting the PNU2 definition, you could have an onset of cough. You can have an imaging-- the imaging test would be satisfied with an infiltrate fever and a blood culture.

When you're using the blood culture as an element to assign as a secondary, it has to occur in the secondary in the-- excuse me, has to occur in the infection window period. So your blood culture with acinetobacter baumannii is attributed as a secondary BSI to pneumonia. You would not have to call that a CLABSI or a primary BSI. Your date of event would be Day 7. That's the first date or the first element used to meet the definition.

The second way would be if you have a blood and a site-specific specimen culture, and here's the clue or the trick, the site-specific culture has to be used to meet the infection criterion. And then your blood culture matches that organism. The eligible site-specific cultures for meeting pneumonia are minimally contaminated specimen, so BAL, a protected specimen brushing, a pleural fluid or a lung tissue. Sputum is not an eligible specimen for meeting pneumonia That's another one that I should have you repeat after me. Sputum is not an eligible specimen for meeting pneumonia And there's actually a footnote that refers to this, it's footnote number 9. So here's our protocol for pneumonia 2.

You can see that you can meet it with organisms identified from a pleural fluid, a positive quantitative culture. And you also can use semi-quantitative equivalent for meeting that. So if your lab doesn't provide quantitative reporting, you can use the semi-quantitative reporting. And there's a footnote that addresses that.

Or, you can use a lung tissue. So when you have that, you can meet PNU2 and assign a BSI, a secondary if the blood culture matches. The only time you can use Candida again is for pneumonia When you have blood and a sputum or an endotrache or a BAL or protected specimen brushing that have a matching pathogen. And the patient must be immunocompromised. And that means they are immunocompromised by the definition provided in footnote number 10.

Ok. So again, a little review of how you would assign a blood as secondary using the site-specific specimen. You have onset of cough, you have infiltrate, you have fever and your laboratory component that is helping you to meet the PNU2 definition is a BAL with acinetobacter baumannii. And then later in your secondary BSI attribution period, you have a blood culture. And because that blood culture matches the site-specific specimen, you are able to attribute that blood culture as secondary to PNU. And your date of event is Day 7. Ok.

So pathogen reporting and secondary bloodstream infection attribution for pneumonia 1 is not permitted as I indicated earlier. And in fact in the application, if you would happen to be entering your events, probably if you're Pennsylvanian, you are, I don't know if anybody else enters off-plan events. You could because you could be tracking them for your own purposes in your facility. But if you were entering these events into the NHSN application, in fact, again more business roles are behind the scene where as soon as you select PNU1 as your specific event, the pathogen and the secondary BSI fields will default to no and you cannot edit those to yes. Ok. Now, what happens if you report a PNU1 or you identify a PNU1, maybe you're not even reporting it but you're tracking it, and you've identified a pneumonia 1. And now later on, you have this blood culture and you're certain that that one is secondary to pneumonia? This gets back to what Kathy talked about this morning where we have major type of events and you can only report one event for pneumonia per 14-day RIT. So, what the guidance for that is you can meet a PNU1.

It will set an RIT for pneumonia. And then later on, if you find yourself in that situation where you are certain that that blood is secondary to a pneumonia event, you will be able to assign that as a secondary BSI to the PNU infection event if you can re-meet the definition using the blood as an element. So, in this example, the PNU1 is met on hospital at Day 8, the date of event is hospital Day 8. And then later on, you have a blood culture that was positive for Staph aureus. You do have a temp.

You have respiratory increase in respiratory secretions. You still have a chest X-ray infiltrate. It's an indication that that pneumonia is ongoing and continuing which is what the RIT is all about, allowing you to capture events there ongoing. So, what you will do if you're reporting it into NHSN, you will change the event, you'll modify and you'll change the event to a PNU2. And you'll be able to now because it's a PNU2 check secondary BSI and you'll be able to report the staph aureus as a secondary BSI and add that pathogen to the pneumonia event. If you're not reporting them in the NHSN, that's OK but you have the ability to assign the blood as secondary. You won't change your date of event. You will not set a new RIT based on that second pneumonia definition, but you will be allowed to assign the blood as secondary.

How many of you were aware of this? Couple hands. Ok. Good. Well then, I'm glad we covered it. Ok.

So now that we've gone over the ways and when you can use the pneumonia definition, let's do a little polling here, get your clickers ready. When can I use the pneumonia definitions? Never, always use VAE. When conducting in-plan surveillance on mechanically-ventilated children who are in pediatric locations. When opting to conduct off-plan surveillance in ventilated or nonventilated patients in any patient location. When determining if a BSI is secondary to a lower respiratory site. Or E, B, C and D.

Enter your responses. They're coming in fast and furious. Ok. Very good. Great.

That's exactly right. The answer is B, C and D. Great. Ok. Now, just a little bit of coverage of some changes to the pneumonia protocol in 2016. They were minimal. Really, the only change to the protocol itself was when meeting PNU3, we added the option to use a BAL and a protected specimen brushing. So, prior to 2016, it was limited to sputum or endotrache and now, you can use a protected brush-- a protected specimen brushing and a BAL.

The other changes that apply are those that are applicable to all the events. They deal with using a nonculture-based diagnostic test and the exclusion of events identified in patients who are determine to be brain dead and that are being sustained for organ donation. If the date of event is on the day they have been declared brain dead or after then you do not have to count that as a reportable NHSN event. Ok. On to VAE surveillance. So just a little recap of the evolution of VAE, we introduced it in January 2013. That was the initial release. And by July of 2013, we release another protocol which had a little update because we quickly determined that we were detecting VAEs when the patient really wasn't experiencing worsening of oxygenation.

It was just minor adjustments that the clinician was making in that lower PEEP range between zero and 5. And that adjustment between-- of the PEEP between zero and 5 really wasn't an indication of the patient having an issue with their oxygenation status but just in most cases, it was provided preference. So, physician A likes to keep their patient at PEEP of 3 and then on the weekend, physician B comes in and they up it to 5 because they like to maintain their patient on PEEP of 5 or, you know, zero to 3 or 3 to 6. So, we level that out so that any PEEP value between zero and 5 is to be interpreted as a value of 5 centimeters of water. In January 2014, that's when we did away with the age. Originally, it was all patients greater than or equal to 18. And then we just went similar to all the other events and made it location based.

So if the patient is in an adult location, they are eligible for VAE surveillance. If they're in a pediatric location, they are to be monitored using the pneumonia ventilator-associated pneumonia surveillance. Additionally in 2014, we remade a requirement that when you're determining your daily minimum PEEP and FiO2, that value needs to be maintained So we didn't want, you know, a crank down for five minutes and back up ending up allowing you to do-- not that we like to talk about gaming but it can occur. And so, if someone was seeing that the PEEP, the daily minimum PEEP was going to trigger a VAE like it cranked it down for five seconds and turn it back up and now, you can call that PEEP your daily minimum so, just another way of trying to keep things all level and fair. Purulent respiratory secretion definition was adapted. We provided some different ways to meet that definition. And the list of antimicrobial agents that were eligible for meeting the IVAC definition were refined a bit.

In 2015, we talked that third tier. Anyone who did VAE surveillance in '13 and '14, we had two separate events, possible and probable VAP and we just combined it and made it all one level of PVAP. And we just keep the name possible VAP because we run out of P names. If no value maintain-- If there was no value that was maintained for at least an hour, because we made that requirement in 2014 then we run across situations where a patient may go on to ventilator early in the day or late in the day or come off the ventilator early in the day, and then you don't have a value that was maintained for an hour because they weren't on the ventilator for an hour. So, we had to supply a caveat that if there was no value that was maintained for at least one hour that you just choose the lowest value available. We also introduced the removal of the community-associated fungal pathogens. This is actually where that exclusion started with VAE. And then this year, we expanded it to all HAI events.

And then finally in 2015 as Rashad mentioned this morning, we introduce the new denominator, Episode of Mechanical Ventilation. In 2016, really, no significant changes. We're trying. We are really trying not to make changes for you all. The only additions in 2016 actually should be helpful for you and that we added six new antimicrobial agents that are eligible for meeting the IVAC definition.

We did supply also some clarifications just putting a little bit more information in the protocol defining matching organism because to meet a secondary BSI to VAE, you have to have a matching organism so we want to provide that definition for you. And then, a little bit more guidance on how to collect the Episode of Mechanical Ventilation denominator. Aside from that, those were the only real changes to the protocol other than again, the same things that apply to all of the HAI definitions, the use of nonculture-based diagnostics and then also the exclusion of the events in the patients that are brain dead and being maintained for organ donation. Just a quick reminder that when you're doing VAE surveillance, as Kathy mentioned this morning, the Chapter 2 guidance with infection window period, RIT, secondary BSI attribution period does not apply to VAE. So, when you're doing VAE, you're looking at the VAE protocol and you're not even thinking about Chapter 2. Ok. So, who is eligible for VAE surveillance? Patients that are in acute care hospitals, long term acute care hospitals and inpatient rehab facilities. Patients that are in adult locations in those facilities and if you happen to have a pediatric patient in adult location, as long as they are physiologically similar to an adult, you would also include them in your VAE surveillance.

It's not a function anymore of we can't put that child in. If they're being cared for in an adult location, it's likely that they are thought to be similar to an adult, otherwise they'd be shipped off to a pediatric ICU or-- and if you don't have one in your facility, they'll be turfed out to a facility that does. It's not recommended however and we have only heard about this from one facility that if you have children from neonates to the geriatric patient in a similar unit, you wouldn't want to be putting those neonates into VAE surveillance. So who's not eligible for VAE surveillance? Patients who have been ventilated patients on high frequency ventilation, and those that are on extracorporeal life support.

They are not eligible for VAE surveillance and this is key, during the time that they are receiving those therapies. So, if you're browsing through a chart and if you found out the guy was on high frequency ventilation, you can't just toss him aside and say, oh I don't need to follow him, he is, you know. It's just during that period of time when they are on those receiving support with those specific modes of ventilation.

We'll touch a little bit more on that later. I do want to emphasize that when a patient is on a conventional mode of ventilation and they are also receiving these types of additional support, prone positioning, nitric oxide therapy, helium-oxygen mixture sometimes referred to as heliox, and epoprostenol therapy. They are still included. They are on a conventional mode-- As long as they are on a conventional mode of ventilation, they are included in VAE surveillance. And patients who are receiving Airway Pressure Release Ventilation support or APRV or related mode, they also are included in VAE surveillance. It is just that while they're on that APRV mode, you'll only be monitoring for the detection of a VAC using the FiO2 parameter. So, while we're there, what is APRV? Well, this is a mode of mechanical ventilation that's characterized by continuous application of positive airway pressure with an intermittent pressure release phase. Thank you respiratory therapy people and others who provided that definition.

Used-- This is used in patients with acute lung injury and acute respiratory distress syndrome and also sometimes after major surgery to prevent or treat atelectasis. So, this is just a mode, a different type of a mode of ventilation that's provided. Other names that you might run across are BiLevel, Bi Vent, BiPhasic, PCV+, DouPAP. And that document that I referred you to under supporting materials, that is one of the things that that will be useful for because it outlines some of those modes that you may run across in your facility that would qualify as an APRV mode.

The best thing I can tell you to do is talk to your respiratory therapist or your critical care colleagues. They're going to know if they're using that type of mode of ventilation in your facility. And they're also going to be able to help you out in how you're going to identify that that mode is being used.

So, reach out to those colleagues. You need to know this because when a patient is on this type of mode, as I said, you can only evaluate for VAC, identification of a VAC using the FiO2 parameter. So when the patient is on APRV for the entire calendar day, since changes in PEEP that are indicated in this surveillance may not be applicable to the APRV mode. You're not going to be monitoring for changes in PEEP when the patient is on APRV. So, when you're entering PEEP into the calculator when you're making your daily minimum PEEP determination, if the patient was on APRV for that calendar day, you won't be using anything documented under the PEEP parameter in your medical record of the respiratory therapist's documentation for determining your daily minimum PEEP for that day. If the patient is on APRV for a portion of the calendar day and this also, this thought process also applies to these patients that are on the excluded mode of ventilation. If they're on mode of ventilation APRV for a portion of the calendar day, that portion of the calendar day when they're on a conventional mode of ventilation, you can use those documented PEEP values that you find in the chart for selecting your daily minimum PEEP value. So, we've talked about exclusions So, let's-- pick your clickers up again and let's answer this question.

If a patient's admitted with a community-acquired pneumonia, they are excluded from VAE surveillance for 14 days. True or false. Ok. I'm going to close the poll and you are absolutely correct. Fourteen percent of you are incorrect but that's OK. We'll talk it up to a drop in the blood sugar, rise in the blood sugar after lunch.

All patients who are eligible for VAE surveillance are to be included in VAE surveillance. So, if they have been on the ventilator greater than two days and they are not on a mode, an excluded mode, they're to be included in VAE surveillance. There are no exclusions when you're doing VAE surveillance based on admitting diagnoses, underlying illnesses. And remember that Chapter Two Present on Admission thing does not apply to VAE surveillance. So the algorithm requires that a patient has a period of stability on the ventilator that's followed by worsening in oxygenation. So typically, you shouldn't be capturing events that represent ongoing worsening because if you have established a period of stability, it means the patient came in, put on the ventilator, they stabilized and then, after that stabilization if they worsen again, this could be an indication that it's a new ventilator-associated event. And a patient with a community-acquired pneumonia may truly experience a complication from being on the ventilator.

So we don't-- we certainly don't want to exclude them from the surveillance. Ok. So we're going to dive into the VAE algorithm. We're going to spend a lot of time on the first tier, the VAC tier. That is the foundation. And if you don't get that right, you're going to progress on and identify IVACs and PVAPs and maybe, you're going to be misidentifying IVACs and PVAPs. So here's our algorithm. It's three-tiered.

The first is the ventilator-associated condition and that is based solely on worse-- evidence of worsening oxygenation after a period of stability. The second tier is the IVAC level and that's the infection-related ventilator-associated complication, not condition but complication. And this uses some of the infection and inflammation identifiers that you may find in a patient's medical record. And then the third tier is where we're pulling in some laboratory data, identifying a possible VAP. All right. The key to VAE is that there's no chest X-ray needed.

Is that a good thing? OK. I thought so. The algorithm is progressive in terms of the criteria to be met. So, you have to meet VAC to proceed to IVAC. You have to meet IVAC to proceed to PVAP. And it's not to imply that VAC is OK but IVAC isn't and PVAP isn't.

It's each tier as you progress up, it's not necessarily worse. The fundamental definition of the VAE algorithm is the VAC. And IVAC is just additional evidence that maybe that this ventilator-associated condition is related to an infection. And the PVAP is just an indication that maybe this ventilator-associated condition that is maybe related to an infection is related to an infection of the respiratory tract. So, you meet VAC no matter which level that you're reporting at. So, throw away the thought process that it really doesn't matter as long as I don't get to the PVAP level.

Throw away the thought process that PVAP is the same as pneu-VAP. They're two different events. They're detecting two different things. We want to be focusing on preventing VAE whether you've met a VAC an IVAC or a PVAP. And additionally, let me add also that all three levels are reportable so it's not just that you only have to report if you get to the PVAP level. If you identify a VAC, it's reportable, if you're doing VAE in-plan surveillance. If you only get to the IVAC level, it's reportable if you're doing in-plan VAE surveillance.

If you get the PVAP level, it's reported. So, all three events, no matter what level you end up identifying are to be reported when you are conducting in-plan VAE surveillance. Ok. Just a couple of definitions to run through and I'm not going to read them to you. But the ventilator definition is the same one that we use-- have used for years. With the pneumonia definition, it's defined as a device to assist or control respiration inclusive of the weaning period. So, even when the patient is being weaned, whether they are on and off the ventilator in a given day, they are still included and they are still defined as the ventilated. This would be a person that's receiving support from the ventilator through a tracheostomy or an endotracheal intubation tube.

And that sub-bullet, any time a patient is receiving support by those modes, it's not considered ventilator. They're not considered on a ventilator or they wouldn't be counted as being ventilated when you're collecting your denominator data unless that those particular modes are delivered through a tracheostomy. And then in that case, a tracheostomy or an endotracheal tube, they would be considered ventilated. An episode of mechanical ventilation is a period of days which the patient was mechanically ventilated for some portion of each consecutive day.

So if there is a break in ventilation for a full calendar day, you're starting a new episode of mechanical ventilation. If a patient goes-- is on the ventilator today, tomorrow morning they're on the ventilator, they take them off for eight hours and they say, "Oh, no, this isn't working," they put the person back on, there was no break in mechanical ventilation for a full calendar day, it's still one continuous episode of mechanical ventilation. So, let's really tear apart this VAC definition.

The patient is on a mechanical ventilator for greater than two days. That's the first requirement. They have a baseline period of stability or improvement that is immediately followed by sustained period of worsening oxygenation. So, what are we talking about? And this is all based on FiO2 and PEEP parameters which these are the key ventilator parameters that can be adjusted depending on the patient's oxygenation needs. And-- Here, you will find the definitions for PEEP and the definition for the fraction of inspired oxygen or FiO2.

And if you are looking at meeting a VAC definition using the PEEP parameter, you need to establish a baseline period and then have evidence of worsening oxygenation which gives you a greater than or equal to 3 centimeters of water over that baseline period. If you're looking, excuse me, to meet the VAC definition in the FiO2 parameter, you would be looking for an increase with evidence of worsening of oxygenation where you have a 20-point increase over your baseline. Here's the snapshot from the protocol.

So, when we're talking about FiO2 and PEEP ventilator settings and when we're talking about meeting the VAC definition, we are talking about using the daily minimum FiO2 and PEEP. So there'll be lots of ventilator settings maybe, maybe there won't, maybe there'll just be a few recorded in the paper or the electronic medical record. And you'll find this either in the respiratory therapy section of your medical record or the critical care nursing flow sheets. But somewhere in the patient's record when they're on a ventilator, you're going to see the recordings of the ventilator settings and that's important too. You're looking at the ventilator settings. You're going to be looking at the-- looking at these ventilator settings for the-- across the full calendar day. So, from 00:00 to 23:59, you'll be looking at all of the settings that were recorded for that patient each calendar day. And you're going to determine the daily minimum PEEP and FiO2 from those settings.

When you're choosing the daily minimum PEEP and FiO2, you'll use all eligible settings. So, when the patient is-- let's get back to those people who are on excluded modes, if they're on an excluded mode for a portion of the calendar day, of course during that timeframe, you won't use any documentation of PEEP and FiO2 because they're excluded. But for portions of the calendar day that they may be on a conventional mode, you will use those documented settings. You will include settings while the patient is being weaned. Of course when they're off of the ventilator, you're not going to find settings. But as long as they are ventilated for some portion of each calendar day, you will find settings documented in the medical record and you will use those to select your daily minimum values. Ok.

So, the only settings that aren't eligible will be when the patient is on high-frequency ventilation or extracorporeal life support or when the patient is-- during periods of time when the patient is not receiving mechanical ventilation support. So maybe there's a trial going on and they've been disconnected from the ventilator, they're just getting low [inaudible] maybe, but they're not connected to the ventilator. So they're not-- during that period of time, you're not going to be finding PEEP and FiO2 settings to use when you're selecting your daily minimum PEEPs and FiO2. From all of that gathering of information, you will be choosing the lowest FiO2 and PEEP during that calendar day that was maintained for at least one hour. So-- And if there is no value that was maintained for at least one hour which we talked a little bit about that as being a change, you'll just choose-- you'll simply choose the very lowest value for that day. And that will occur when ventilation is initiated late in the day or ventilation is discontinued early in the calendar day. You may only end up having one or two values and neither one of them are the same. So, you'll just choose the very lowest one.

How many of you have some kind of electronic means of determining this daily minimum PEEP and FiO2? OK. And that's good. I'm glad. I'm happy. But make sure it's being determined according to the protocol.

And it's not just looking at "Oh, what's the lowest value for the day," or it's not looking at the calendar day, it's looking at some other capture period. So, make sure that when you're collecting this daily minimum PEEP and FiO2 values and it's being fed to you electronically, that it is set up accurately and according to the protocol. So let's go through a couple of examples and see if you're going to do it manually, how you would fare with this. In this example, we have mechanical ventilation mode that is acceptable. It's a conventional mode all day long.

It looks like the values are documented about every three hours throughout the day. So we want to pick the lowest value that was maintained for at least an hour for FiO2 and PEEP, and that would be 0.70. It was documented at 6 p.m. And at 9 p.m., it was still at 0.70 so clearly, it was maintained for at least an hour. And the PEEP setting, the daily minimum value for that calendar day, would be 5.

Ok. What happens when we have values that are-- they are recorded every hour or more frequently? Well, in the protocol, you'll find guidance that tells you exactly how to do this. And note that you want to have a repetitive documentation. So if it's-- if it is recorded every 15 minutes, you're going to need five consecutive readings.

So, you're going to need a reading at 9 o'clock, 9:15, 9:30, 9:45 and 10 o'clock to assure that that was definitely maintained for at least one So let's look at an example of that. So, we have this patient who is documented sometimes throughout the day, every hour. And our lowest value on this calendar day is 0.70 for FiO2, however at 4 a.m., it's already bumped up to 0.80 so that's not eligible for your daily minimum FiO2. So we go to our next highest value which is 0.75 and that is maintained for at least an hour from 12 p.m.

To 3 p.m. So that would be your daily minimum FiO2. Looking at our PEEP, its' pretty easy-peasy, that's 8 all day long. Ok.

So here, we have an example of when you may not have a value that's documented for at least an hour and this is a patient who was ventilated late in the day, started at an FiO2 of 0.8 and then dropped down to 0.7. We clearly can't establish a period of time that was maintained for a full hour so this is the example of when you will simply select the lowest value for the calendar day. Ok. All right now, it's your turn. The patient is intubated at 2 p.m., PEEP and FiO2 are set at the following values through the remainder of the calendar day. What are the daily minimum PEEP and FiO2 values for this calendar day? Get your clickers ready. You'll have the handouts so that if I advanced up to the next slide, that gives you the options, you'll be able to-- OK. Let's see how we're doing here.

So, most of you have said it's A, and you are correct. We have a value of 5 which is the lowest value and it was definitely maintained for greater than one hour. And that was maintained from 2 p.m. We have a value of 0.40 and that was documented at 6 p.m.

It was not adjusted in to 8 p.m. So we have 0.5 and 4-- or 5 and 40. How about this one? Here's your options. Ok. Most of you have chosen 4 which is 0.5 and 0.60 and that's correct. Some of you selected 5 and 0.40. So let's look at why it is 5 and 0.60.

So, at 8 p.m., the-- in this case, the values were documented or the patient was documented, settings were documented every hour. And the lowest value for PEEP was 5 and that was maintained until 9 p.m. So we have two consecutive readings, an hour apart. So, that is correct. Our lowest value on FiO2 was 0.40, however, at 9 p.m. Which would be the consecutive reading that you're required to have, it was bumped up to 0.5. So, we need to have consecutive readings an hour or more apart and that only happens when we get to 0.60. OK? So, you can argue that well, it was 8 at 0.4-- it was 0.4 at 8 p.m.

And it wasn't changed until 9 p.m. And you may be right. However, if it was documented at 9 p.m., if we really want to split hairs, that means it was maintained at 0.40 until 8:59. So, it's not a full hour. This guidance was introduced for standardization.

So, we get that you could argue that, what I've just said, but we have to provide a means of standardization and the consecutive values is the way we went. Ok. So in general, when selecting the daily minimum PEEP and FiO2 for each calendar day, what to do, throw out the lowest value, choose the most consistent value, select the value using any 24-hour time period, or choose the lowest value that is maintained for at least an hour. This is in general. There may be some exceptions. And this one is easy. We'll look at that.

[ Laughter ] Would you-- Look at that. [ Laughter ] Just look at it. [ Laughter ] All right. Meeting the VAC definition, you're going to use the daily minimum FiO2 and PEEP values that we just spent a lot of time talking about how you gather those values. Both of those values are used to establish your period of stability and both-- and also for identifying your worsening oxygenation. You don't want to compare values that occur within a calendar day to say, "Well, the patient wasn't stable, you know, he was all over the place." We're not looking at stability within the day. We're looking at stability across the day.

Was the patient to be-- able to be maintained at a certain value, very lowest value from day to day to day? Did they have some period of each consecutive day when they were able to be sustained at that level? And that is how we're basing stability. Remember that daily minimum PEEP values of zero to 5 are considered equivalent. So, when you're using the Calculator or when you're making your determinations, you need to convert any value that is between zero and 5. And in this example, the daily minimum was determined to be zero but when you put it into the Calculator, you'll note that it switches it to 5. And that's what you should be also doing if you're doing manual determinations which I don't know why you would be doing that. Just always use the Calculator.

Ok. Your period stability is the baseline of stability or improvement that has to be sustained for greater than two calendar days, and it is immediately followed by an increase in the daily minimum PEEP or FiO2 which is indicating an evidence of worsening oxygenation. So, if you've established the baseline period of stability or improvement in the PEEP parameter, your evidence of worsening oxygenation has to occur where? In the PEEP parameter. If you have established a baseline period of stability in the FiO2 parameter, you're looking for the evidence of worsening oxygenation in the FiO2 parameter. So, now, we're going to go through these examples. I told you we're going to spend a lot of time on VAC. I promised we're going to speed through IVAC and PVAP. All right.

So, let's look at this. This is an example of baseline. This is the baseline period of stability you see in the FiO2 parameter. Mechanical ventilation day 1, 2, and 3, we have a baseline of 30 which is followed by an increase of 25 over that baseline period. So that would meet the VAC definition. Next example is the baseline period of improvement. The patient went from a FiO2 of 35 on day 2 and down to an FiO2 of 30.

So, they actually had a baseline period of improvement. They then had an increase over both days of the baseline, that's key and the VAC definition was met. Here, we have an example of not a baseline, you have an increase. You start out on day 1, mechanical ventilation day 1 and 2, and it looks like, oh boy, we've a got a baseline period but then you bumped up 5 to 35.

And even though you've jumped to 70, because you did not have a baseline period immediately preceding that increase which was evidence of worsening oxygenation, the VAC definition is not met. OK, now, let's look at a couple of examples. What if the increase over the baseline period meets the requirement relative to one baseline day? And this is a tricky point that will trip up a novice VAE user. The point in this is that you're looking at your baseline period and in this case, in the PEEP parameter, we have a baseline period of improvement. We went from 10 to 7 to 5. We jumped up to 8 which is 3 centimeters over the second day of the baseline period. However, it's only one day over the first day of the baseline period so I'm giving you the answer here.

Very good. So, there is no VAC identified. Do you see the point there? The increase has to be relative to both days of the baseline period. Let's do another one. So, your VAC definition is not met. Let's take a look at this one.

What if the increase is for one day and then there's a decrease? So, you have a baseline period in the PEEP parameter of 5 on day 2 and day 3. You go over the baseline period on day 4 by 3 centimeters but then you bumped back down, what do you think? Yeah, that's right. Good job. So again, this is an example of you must have your worsening oxygenation sustained for greater than two-- greater than or equal to two days. So, it went up one day relative to the baseline period and it was relative to both days. But on your second day, it was not greater than 3 centimeters over the baseline period. It was not sustained at greater than 3 centimeters of water over the baseline period.

OK, so, is that a general rule that if you up and then go down, it doesn't work? And the point here is, yeah, I mean that's not just-- you can't just say, "Oh well, if it goes up and down then it must not meet the definition." You must look at the actual increase relative to the baseline. So in this example, we had a baseline on mechanical ventilation day 2 and 3 at 5. It increased by 5 centimeters of water on day 4. And then, it did go down to 8, but both days are still greater than 3 centimeters over the baseline period.

Very good. Nice job. And for you 16%, you'll get it. It's OK.

All right, when we have discrepant changes, the PEEP goes up and theFiO2 goes down. We understand that this is an issue and that this is common to do tradeoff where you'll increase the PEEP so that you can bring the FiO2 down. And we acknowledge that we don't have a way just yet to address this in the VAE protocol. So, even though tradeoff, there is a mode that is already-- process that is used in ventilated patients, if you detect a VAE because there is tradeoff occurring, it is reportable. Sorry, we're working on that. Another trip up that can happen is remember that your baseline period and your worsening of oxygenation, you're meeting the definition looking at a baseline period of stability and improvement and the worsening So, you can establish a baseline in PEEP and then find worsening in the FiO2 parameter.

Ok. So now, we're going to just take this example and walk through the complete protocol or the complete algorithm. We have the parameters met to establish a 2-day period stability. And we have a worsening oxygenation occur in the PEEP parameter.

So, in this case, we had stability in both parameters but we only met the definition for the VAC component in the PEEP parameter. So, we do meet the VAC definition and why didn't we meet it in the FiO2 parameter? And remember, you don't have to meet it in both. It only has to be identified in one or the other. You may identify it in both but for it to be reportable, it only has to be identified, a VAC definition only has to be met in one parameter. So, why didn't we meet it in this FiO2 parameter? It was not, what's the word? Sustained. Good, very good, right.

So, we did have a baseline. We did grow-- go up over-- equal to 20 over that baseline period on day 4 but that increase of greater than or equal to 20 was not sustained for at least two days. So, our date of event and this is an important concept, is the date of worsening oxygenation. So, that's day 1 of the required greater than or equal to two days of worsening oxygenation. It's not the date when all of the VAE criteria are met. And it's not the date of the first day of the baseline period.

It's the date of the onset of worsening oxygenation. So the earliest that could be in a patient's mechanical ventilation episode would be day 3. And the first possible day that the full VAC definition could be met would be day 4 because you need at least two days of baseline and at least two days of worsening oxygenation. So, in this example, our date of event is Vent Day 4. The date of event is important because this is used to define your VAE Window Period. So, throughout Chapter 2, 7-day window period, remember you're not using that, you're using the VAE protocol. The VAE protocol uses a VAE Window Period which is the date of event, the two days before and the two days after.

The date of event also sets your 14-day VAE event period, somewhat similar to the 14-day repeat infection timeframe that you use for all other events, but you need to be following the VAE protocol and the guidance related to the 14-day event in the VAE protocol when you're doing VAE. So, each VAE is 14 days in duration. Day 1, the event date is day 1. So, if June 1st is the date of onset of worsening oxygenation and a VAC is reported, you didn't meet IVAC or PVAP, the second VAE cannot be detected or reported until June 15. Then that would mean the date of event would be June 15. You don't upgrade within the 14-day VAE event period.

So if you reported a VAC and you have some additional evidence some time within that 14-day period that now you could maybe meet IVAC or PVAP, forget about it. You're only going to report the VAC, you're not going to upgrade. You may not report a new VAE until that 14-day period has elapsed. And the other reason that the 14-day event period is established is that that's the time period in which blood culture collection dates must occur when you're going to be establishing whether a blood is secondary to VAE. So, the VAE Window Period, we touched a little bit on that, is the period days around the event date. It is defined as a two days before and two days after.

And that's generally how it falls out unless the event is detected early in the ventilation episode. Because if a patient's not eligible for VAE surveillance on those first two days of ventilation so we're not going to use those first two days to establish whether or not they meet IVAC or PVAP. But in general, it is a 5-day window as illustrated here, the day of event, the two days before and the two days after. Here's the exception that I just discussed. And here's the illustration of that.

A patient was only ventilated for a total of three days when we had the onset of worsening oxygenation. You can establish a baseline in those first two days, but you can't meet and have a date of event during mechanical ventilation day 1 or 2. And you can't use information gathered during mechanical ventilation day 1 and 2 to go on to meet IVAC or PVAP. So, let's look at this example. If our date of event that we were-- with our little example was event day 4 and our two days before are ventilation day 2 and 3, and ventilation day 5 and 6 are our two days after. What's wrong with this picture? Do we have a 5-day VAE Window Period in this example? And I see some head shaking no and you're correct.

And that is because that baseline was established using the first two days. So, only-- or day 2 and 3, so, you really have a kind of a little shorter VAE Window Period so you have your date of event one day before and two days after. Ok. That's VAC. Do you have it down? Does everybody think they're doing it right? You're going to walk out here and be VAE gurus. All right, moving on to the infection, IVAC, infection-related ventilator-associated complication, IVAC, this uses temperature and white blood cell counts, and the administration of antimicrobial agents. Here's your screenshot from the protocol. The first portion is that you identify an abnormal temperature or white count.

The temp abnormality is greater than 38 or less than 36. And the white count is greater than or equal to 12,000 cells per cubic millimeter or less than or equal to 4000 cells per cubic millimeter. So in our example, if we have a little bit more data to the table, we see that this person definitely has some abnormal temps as well as white counts. You don't need to have both, you just need to have one. You don't need to have multiple within the VAE Window Period, you only need to have one, one temp, one white count. As long as there's an abnormal temperature or a white count in that VAE Window Period, that's documented. It is to be used to meet the IVAC definition. Regardless of whether the patients had a fever for a month or three months, you're still-- you're only looking at that 5-day window period, and if you find an abnormal temp or white count in that 5-day period, you are to use it.

So, that being said, if you're conducting in-plan VAE surveillance in your ICU, do you need to assess daily minimum and maximum temperatures for all ventilated patients? Every day, all day for the whole year for every patient, do you need to do that? Right. I heard some yeses. The answer is no. You only need to collect that information if you've meet the VAC definition. Don't waste your time gathering all of those parameters that are used to meet IVAC and PVAP on all of your patients that are ventilated in your units where you're doing VAE surveillance. You only need to collect information once you've meet the VAC definition. And then, if you meet the VAC definition and you can't find a temp or a white count, don't even look at the medical administration record. Don't waste your time.

Don't look at the labs. Only for those patients that meet the VAC where you'll be gathering additional information and start with temp and white count, that's the easy stuff to find. Here's another one. If the temperature or the white count or laboratory-- or lab criteria for meeting PVAP or present prior to the detection of VAE and also present within the VAE Window Period, they can be used to meet the IVAC definition.

So, this is the person that-- this is the person that has met the VAE, the VAC definition. Now, you're looking to see if they meet IVAC. And then subsequently, if they meet IVAC, you're looking at laboratory information.

Can you use it if it was also present within the VAE Window Period and was present prior to the detection of the VAE? Can you use it? And that answer is yes. It doesn't matter if that information was present outside of the VAE window as long you're detecting it within the VAE Window Period, it's eligible for use. Ok. The second step of the IVAC definition is the antimicrobial criterion.

It's probably the most complicated portion of an already complicated protocol. The rules for meeting the criterion aren't perfect but we needed to standardize and provide an assessment for antimicrobial therapy without you needing to know dosing or renal function or all those other things that may go into the administration and the prescribing pattern of an antimicrobial agent. It's mostly antibacterials, fungals and antivirals.

There are some drugs that are not included which are listed here. There's a broad range of agents that could be used to treat healthcare-associated And it's not just antimicrobial agents that are used to treat respiratory-related infections. We had some concerns expressed in 2014 about how you could meet the IVAC definition and then go on to meet the PVAP definition when the patient-- what triggered meeting the IVAC definition was an antimicrobial agent that wasn't even used for a satisfying-- for treatment of a respiratory infection. So, we tried to address this.

There is no perfect way to do it. Keeping in mind that we aren't necessarily just looking for infections related to the respiratory tract so, you may develop-- you may meet an IVAC definition and the patient has nothing going on respiratory. But what we did was removed any of the oral agents that would not be used in an ICU setting to treat a respiratory tract infection. So, we did pare it down a little, it's still not perfect. So to meet that antimicrobial parameter of the VAE IVAC section, you have to have a new antimicrobial agent and that's defined as an agent that's in the appendix, and an agent that was initiated on or after the third calendar day of mechanical ventilation, and in the VAE Window Period. The new agent must be continued for greater than or equal to four consecutive days. And if there-- And there's no requirement that that same antimicrobial agent be given on the four consecutive days. So, you could have a couple of agents paired together to give you the four consecutive days.

A new agent has to be administered either IV, IM, via the digestive or the respiratory tract. So, no topical agents. A QAD or Qualifying Antimicrobial Day is the day in which the patient was administered an antimicrobial agent that was determined to be new and it was administered within the VAE window period. Again, you need four consecutive QADs to meet the antimicrobial portion of the IVAC definition. And if the patient is started on antimicrobial agents and expires before you meet that fourth day, well, you didn't meet the IVAC definition. You'll just report the event as a VAC. We get that question quite frequently. Whenever you're looking at the same agent days between administration, we'll count as a Qualifying Antimicrobial Day.

This was our way of addressing renal dosing. So, if you have a patient that they're renal dosing the antimicrobial agents, we want it to be able to capture four consecutive days. So, days between the same agent will be counted as a Qualifying Antimicrobial Day. And you can see this nicely illustrated when you use the VAE Calculator. You see that the days 8 and 10 are counted as a Qualifying Antimicrobial Day. In contrast, days between administration of different antimicrobials do not count as Qualifying Antimicrobials Days. That would be an indication of the, you know, they changed the antimicrobial agent, maybe they were fine-tuning.

So, in this example, levofloxacin And that does give you two Qualifying Antimicrobial Days. Then you have a gap. And then ceftazidime was started on day-- mechanical ventilation day 7. And because you have that agent administered for four consecutive days, it is meeting the four Qualifying Antimicrobial Days so you don't have a total of seven or you don't have a total of six days-- seven days, you have a total of five. Ok. All right, so, the date of initiation of the antimicrobial agent is important when you're looking at using the VAE Calculator. Follow the directions.

It does tell you to check all of the corresponding days shown on the screen. And this is important because checking those days will determine if the agent was new. So, if you have these antimicrobial agent started in-- outside of the VAE Window Period, it's not going to count as a new agent. So you're not going to meet your Qualifying Antimicrobial Days. You're not going to meet the IVAC definition. If I only entered the days that it was administered within the VAE Window Period, the definition would have been met and I would have an error identified in IVAC. Ok.

Back to our example, we have an elevated temp. We also have some elevated weight counts there, they are available. We have an antimicrobial agent administered for four consecutive days. It started in the VAE Window Period.

It is new and continued for four days. Note that the four days can accumulate outside, can fall outside of the VAE Window Period. It's just important that it started within the VAE Window Period. So, here's a question for you. Do you count an antimicrobial agent as new if it is new as a result of de-escalation or simply a switch from one agent to another in the same drug class? And the answer is yes. And again, this is one of those pieces that is not

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