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GI BioFire FilmArray Assay – We’ve Got a Test and a Result, Now What? · The SHEA Podcast

• 0:08
  SPEAKER_00: Welcome to the Diagnostic Stewardship Podcast brought to you by the Society for Healthcare Epidemiology of America, SHAY, promoting the prevention of healthcare associated infections and antibiotic resistance and seeking to advance the field of healthcare epidemiology and antibiotic stewardship.
• 0:24
  SPEAKER_00: SHAY is excited to launch the final episode of this podcast series, GIPCR Pathogen Panel.
• 0:30
  SPEAKER_00: We've got a test and a result, now what?
• 0:32
  SPEAKER_00: With the recent availability of a GIPCR Film Array assay, there's now the ability to detect 22 gastrointestinal pathogens from a single patient sample and obtain results within an hour.
• 0:44
  SPEAKER_00: However, there are concerns about its utility and questions regarding what to do with some results.
• 0:49
  SPEAKER_00: This has led to some institutions limiting the availability of the assay and others providing extensive education to clinicians in the hope that it will curb ordering of the assay.
• 0:58
  SPEAKER_00: This podcast will focus on the utility of the assay, its strengths and weaknesses, and stewardship considerations.
• 1:04
  SPEAKER_00: I'd like to welcome our two panelists today, Dr.
• 1:06
  SPEAKER_00: Trevor Van Skunavelt, Associate Professor of the Division of Infectious Diseases at the University of Nebraska Medical Center, and the Medical Director of Antimicrobial Stewardship Program at the University of Nebraska Medical Center.
• 1:19
  SPEAKER_00: And Dr.
• 1:19
  SPEAKER_00: Nick Moore, Assistant Professor of Medical Laboratory Science and Pathology, and Assistant Director in the Division of Clinical Microbiology and Department of Pathology at Rush University Medical Center.
• 1:32
  SPEAKER_00: I'm Chrissy Woods and I will serve as your moderator.
• 1:34
  SPEAKER_00: This is such a big topic, so I'd like to jump right into our conversation with this question.
• 1:39
  SPEAKER_00: Do you offer a PCR-based GI pathogen assay in your institution?
• 1:43
  SPEAKER_00: And if so, why did you decide to offer it?
• 1:46
  SPEAKER_00: And if you do not, why do you not offer it?
• 1:49
  SPEAKER_01: Thanks for having me on.
• 1:50
  SPEAKER_01: I'll just talk about our introduction of it.
• 1:53
  SPEAKER_01: We did it a number of years ago.
• 1:54
  SPEAKER_01: Our lab brought it on board and actually stopped offering routine stool cultures.
• 1:59
  SPEAKER_01: The reason they did this is one, it turned out to be a bit more uh time efficient for our lab.
• 2:05
  SPEAKER_01: Also, it's more sensitive.
• 2:07
  SPEAKER_01: It did create some questions with what to do with the results, but our lab felt like the um elimination of a lot of the uh sort of parasite testing that they felt was unnecessary was useful, and so they brought it on.
• 2:22
  SPEAKER_02: I'll also say thank you for the invitation to participate in this.
• 2:26
  SPEAKER_02: And at my institution, we validated the BioFire GI pathogen panel, but we decided not to implement it.
• 2:35
  SPEAKER_02: So we continue to perform traditional bacterial culture for enteric pathogens, and we do still perform some antigen testing for bacteria or parasite targets.
• 2:46
  SPEAKER_02: We had a couple of concerns around the performance characteristics of the assay itself, namely related to its specificity, and as was mentioned, that it is a little kind of unclear on what you do with results, especially if you have a specimen with multiple targets detected.
• 3:04
  SPEAKER_02: We also felt that there was a strong need to be able to continue to isolate bacteria of clinical importance that require susceptibility testing.
• 3:12
  SPEAKER_02: So in patients who have an enteric infection due to a typhoidal strain of salmonella or Shigella species.
• 3:18
  SPEAKER_00: So, Dr.
• 3:18
  SPEAKER_00: Van Skunneveld, in your institution, since you have the assay, are there controls in place or limitations around ordering the panel?
• 3:25
  SPEAKER_01: So when we introduced it, there actually weren't.
• 3:27
  SPEAKER_01: We developed a guidance document and did some education, but the lab wanted to see what the use was before they decided to introduce.
• 3:35
  SPEAKER_01: And our uh our institution is relatively reluctant to institute something like a hard stop or an inability to order.
• 3:42
  SPEAKER_01: But uh we did see over about 18 months a steadily increasing use in a GIF on the inpatient settings, where it often isn't appropriate, particularly after a few days in the hospital.
• 3:54
  SPEAKER_01: And so we actually introduced some restrictions after reviewing all that data.
• 3:59
  SPEAKER_01: We found basically no meaningful results from people after about 72 hours.
• 4:04
  SPEAKER_01: They found a few things, but they were mostly things people already knew were there or didn't actually do anything about, or things where we had a one-off assay like neurovirus, where you could easily test for it.
• 4:15
  SPEAKER_01: I should mention we never have reported C diff on this assay because we didn't think molecular diagnostic of C diff was the ideal way to go.
• 4:23
  SPEAKER_01: And so C diff skill testing remained as it had been sort of through a tiered stage testing.
• 4:28
  SPEAKER_01: And so what we did was introduce a restriction where if you've done the test once as an inpatient, you couldn't do it again because it's very sensitive.
• 4:37
  SPEAKER_01: And if it was more than 72 hours after the patient had been hospitalized, we actually put a hard stop there where you couldn't do it unless you called and our micro lab director had approved it.
• 4:47
  SPEAKER_01: By doing that, we actually decreased use about 30% and what we considered inappropriate use by about 85% over the course of about 15 months.
• 4:57
  SPEAKER_00: Dr.
• 4:58
  SPEAKER_00: Moore, in your institution, you don't have the GI pathogen assay available.
• 5:02
  SPEAKER_00: You do have the PCR-based respiratory assay available.
• 5:05
  SPEAKER_00: So can you talk about any controls or limitations around ordering that panel, which listeners can potentially use if they're thinking about implementing diagnostic stewardship of PCR-based assays?
• 5:15
  SPEAKER_02: Sure.
• 5:16
  SPEAKER_02: And I think you know, our experience with our respiratory pathogen panel was part of the reason why we elected not to bring in a gastrointestinal panel.
• 5:25
  SPEAKER_02: So we found that utilization of our respiratory pathogen panel was wildly being overutilized, and it was implemented really without any type of restrictions or best practice or guidance.
• 5:36
  SPEAKER_02: It was it simply just kind of replaced our existing assay, which was batch performed.
• 5:41
  SPEAKER_02: It was an old Luminex platform, and we just kind of swapped it out, but we didn't really explain or tell the providers how it should be utilized.
• 5:49
  SPEAKER_02: So a few years ago, um we got together with providers from infectious diseases, infection control, and our ED and as well as our internal medicine and hospitalists to really kind of come together to develop what are appropriate ordering criteria and clinical indications for inpatients to have the large multiplex assay performed.
• 6:12
  SPEAKER_02: We also completely eliminated the large panel from ED providers.
• 6:17
  SPEAKER_02: They only order a more narrow panel that just tests exclusively for influenza and RSV, and only during the typical kind of respiratory viral season, which is about November to April.
• 6:32
  SPEAKER_02: One of the other things we did to kind of audit and ensure compliance was that we partnered with our quality improvement office, and they would actually in real time audit and look at providers who were ordering respiratory pathogen panels.
• 6:47
  SPEAKER_02: And if anyone seemed to be an outlier, those individual providers were contacted through a champion in their department to kind of explain how the panel should be utilized with the hopes that it would impact future decision making.
• 7:02
  SPEAKER_00: So some challenges of these panels is in their inappropriate interpretation and in reimbursement.
• 7:07
  SPEAKER_00: Do either of you offer guidance on what to do with test results?
• 7:10
  SPEAKER_00: Is there other education that you think needs to be provided in tandem?
• 7:14
  SPEAKER_00: And given the reimbursement landscape, should an institution think about offering the panels if they don't already?
• 7:20
  SPEAKER_01: That's a complicated question, but uh, you know, there are challenges with interpretation with any molecular panel and that you're just detecting molecular markers.
• 7:28
  SPEAKER_01: And so we do perform some confirmatory culturing on our data pattern panel, which I agree 100% that that is important to continue to do.
• 7:36
  SPEAKER_01: Some of those paths you really do need to know what they're sensitive to.
• 7:40
  SPEAKER_01: We did develop an extensive six-page guidance document.
• 7:43
  SPEAKER_01: It sort of said if you have really bad diarrhea, you should treat some of these, and if you don't, you shouldn't.
• 7:48
  SPEAKER_01: Because in some of these, there really isn't a lot of public information about what it means if you find EPAC, particularly in combination with other organisms.
• 7:57
  SPEAKER_01: So we tried to model that after what the IDC guidelines have said.
• 8:01
  SPEAKER_01: We did roll that out.
• 8:02
  SPEAKER_01: There's an active link in the results that people can go to.
• 8:06
  SPEAKER_01: I do get questions about it, people do ask us about it.
• 8:09
  SPEAKER_01: And the reimbursement really is an issue.
• 8:11
  SPEAKER_01: In the inpatient setting, because it's all bundled, it's a little different than in the outpatient setting where the patient may get the bill for the assay that's relatively large.
• 8:20
  SPEAKER_01: And so I think institutions in general tend to be looking at these because one, they're expensive, and two, because the reimbursement landscape is seems to be somewhat changing on these as well.
• 8:31
  SPEAKER_02: I agree.
• 8:32
  SPEAKER_02: And kind of what we did at our institution was really to try to educate all of our incoming house staff about the testing methodology itself and especially kind of highlighting some of the limitations.
• 8:43
  SPEAKER_02: So again, we're detecting nucleic acid sequences that that are common in these targets, but it does not necessarily mean that that organism is alive or viable.
• 8:53
  SPEAKER_02: It could be continued shedding due to a previous infection that has since resolved.
• 8:59
  SPEAKER_02: So I think it's really important, and we stress that a physician has to interpret the context of the test results within the clinical context of the patient.
• 9:09
  SPEAKER_02: I think it is important that we think about the reimbursement aspect and how this will affect laboratories, especially in light of changes that have come from Medicare payers and potentially some private insurers as well, who feel that they might not pay for these assays because they view them more as a surveillance test rather than a true diagnostic assay.
• 9:31
  SPEAKER_00: So I think we've heard that there is really sort of a multidisciplinary approach to this, that this type of testing doesn't just affect one type of department.
• 9:39
  SPEAKER_00: What do you think the role is of leveraging other departments in the stewardship process?
• 9:44
  SPEAKER_02: So I think again in our institution we did that quite well around respiratory pathogen panel testing.
• 9:50
  SPEAKER_02: So again, we kind of partnered together.
• 9:52
  SPEAKER_02: It started off being a laboratory project, but we realized for it to be effective, we had to go and reach out to the physicians who are ordering the test, and they really had to be on board if we were going to ask them to kind of change their practice.
• 10:06
  SPEAKER_02: So we started with the emergency department, which was where about 60% of our orders were coming from for the respiratory pathogen panel, and again, because that was the only test that was available.
• 10:19
  SPEAKER_02: So we had two of our ED physicians become champions and really rolled out all of our plans to all of the other providers who work in or rotate through our emergency department.
• 10:31
  SPEAKER_02: We had to have the buy-in from our quality improvement office because I think they're tasked across institutions with doing a lot of things.
• 10:40
  SPEAKER_02: So we had support and directive from our chief medical office to our quality partners to get this done.
• 10:47
  SPEAKER_02: And then we had to have the resources in our IT team in terms of kind of making changes to the order panels and the pathways in our electronic medical record.
• 10:59
  SPEAKER_02: And then obviously the lab directors, myself and our other director, were deeply involved in this process as well.
• 11:07
  SPEAKER_01: Yeah, I think that's a great example of sort of the multidisciplinary way of doing this.
• 11:11
  SPEAKER_01: And we did something similar with our GI Pathgen panel, where it was really our what we call our clinical effectiveness group, which is our IT EHR people along with some quality improvement people who worked with us to develop this along with the microbiology lab personnel.
• 11:29
  SPEAKER_01: I think it's really important when you're doing these to think about not only the clinical resources, but the IT resources and leveraging those and then leveraging sort of the people you want to implement it.
• 11:41
  SPEAKER_01: Ours was sort of across the institution.
• 11:43
  SPEAKER_01: And so other than working with our hospitalists, who are probably the most common orders of this, we didn't have a specific clinical group that we worked with other than the experts to develop the sort of plan for what we were gonna do.
• 11:56
  SPEAKER_00: What metrics do you think would be worthwhile to follow when implementing or stewarding PCR essays?
• 12:01
  SPEAKER_00: For example, have you noticed any changes in antibiotic use, whether empiric or therapeutic, as a result of your stewardship efforts?
• 12:08
  SPEAKER_00: And if not, do you think stewardship efforts are worthwhile for these essays?
• 12:12
  SPEAKER_01: A great question also.
• 12:14
  SPEAKER_01: I think if you're gonna establish metrics with these essays, you first have to establish what you think is best practice and then sort of measure use against what you think is best practice.
• 12:24
  SPEAKER_01: There are sort of two approaches to that.
• 12:26
  SPEAKER_01: I think and you you've seen them both described.
• 12:28
  SPEAKER_01: One is to sort of put hard stops in, to stop doing it altogether, and then occasionally let people do it, or to sort of give feedback and monitor.
• 12:37
  SPEAKER_01: Depends a little on which resources you have.
• 12:40
  SPEAKER_01: And so I think for the metrics, you have to decide what you think are appropriate first.
• 12:45
  SPEAKER_01: I think for stewardship, these assays, particularly the rapid assays, the multiplex ones, are sort of opportune areas for stewardship because we do a number of these and we actually include review of them as part of our stewardship program, particularly the meningitis assay, the blood culture assay.
• 13:03
  SPEAKER_01: Because those are very meaningful clinical results we think people should act on.
• 13:07
  SPEAKER_01: We sometimes do the GI patch control, but we don't do that regularly.
• 13:11
  SPEAKER_01: Uh, but I think it is worth monitoring what people are doing because it can result in because of the diagnostic questions or uncertainty that can come out of them, it can result in some antibiotic misuse.
• 13:23
  SPEAKER_01: It can also result in perhaps better antibiotic use because people aren't treating empirically or you know, knowing that they might miss something.
• 13:31
  SPEAKER_02: I think from one of the things in the lab that it's important to monitor is that one of the things that you are going to have to start tracking if you aren't tracking it already is your positivity rate for all of these potential pathogens that can be detected if you're going to be going to this more syndromic approach where you can have, you know, 20 plus different markers that are able to be detected.
• 13:54
  SPEAKER_02: And you're going to have to start thinking about tracking and monitoring dual infections as well.
• 13:59
  SPEAKER_02: And I think that's important because the data are there in the literature to show that yes, this is a much more sensitive assay.
• 14:06
  SPEAKER_02: And yes, you will detect things that you might not have a standalone test in your lab that you previously offered, and you are likely going to see evidence of multiple pathogens recovered from specimens when you start to use this test.
• 14:23
  SPEAKER_02: But I think it's important if you do that that you have to kind of establish a baseline of what that will be when you implement this test.
• 14:30
  SPEAKER_02: And then that's going to be what you use to look back on to compare if you start to see increases beyond what your new baseline might be.
• 14:39
  SPEAKER_02: And I think that's important because that could indicate a couple of different things.
• 14:43
  SPEAKER_02: A, you just have more people coming through who have GI problems and a pathogen that's been detected.
• 14:49
  SPEAKER_02: It could indicate a potential problem in the laboratory where there might be some contamination or failure to perform the procedure in as careful, safe as a way as possible to mitigate contamination between specimens when they're being handled.
• 15:04
  SPEAKER_02: It's also important to make sure you talk to your infection control group and let them know that they're going to start to see things that they might not have seen before.
• 15:12
  SPEAKER_02: So that potentially could drive up your days on contact precautions, depending on what pathogens or pathogens are being reported.
• 15:21
  SPEAKER_02: And then I think especially if you're working with pediatrics, you're going to have to worry about or think about calls from those types of providers who might see results with multiple coinfections and again worrying about potentially over-treating them or how to manage those.
• 15:38
  SPEAKER_02: I do think it's important again to monitor how providers are using the information for the pathogens that aren't routinely tested.
• 15:46
  SPEAKER_02: For example, in our hospital, we don't routinely report out or test for SAPO virus, but I know that as a target.
• 15:53
  SPEAKER_02: So what's the clinical significance of that?
• 15:56
  SPEAKER_02: And again, because you're not cultivating the virus in culture, but it could be present from a previous infection.
• 16:03
  SPEAKER_02: And I also think that just like with a culture or an antigen test, there should be clear guidelines on who qualifies for the panel testing, especially for these inpatients.
• 16:14
  SPEAKER_02: So they shouldn't be hospitalized for more than three days, which is, I think, very typical of facilities who still do culture-based testing, that you're not likely to have or acquire a gastrointestinal pathogen like this when you're in the hospital.
• 16:29
  SPEAKER_02: It's more likely that you're coming into the hospital with these from the community.
• 16:33
  SPEAKER_02: And really, I think it's also important to stress that with these multiplex assays, there should be no retesting that occurs, given again that these can you can be detecting nucleic acids from nonviable organisms.
• 16:46
  SPEAKER_02: And not only that, especially in children, we know that these pathogens can be shed for weeks to months after a clinical cure, meaning you could still detect the nucleic acid sequence, but the patient no longer has an active infection.
• 17:01
  SPEAKER_00: This is a very big topic, and I think this has been a very informative discussion.
• 17:04
  SPEAKER_00: We've covered a lot of ground, including the potential uses and limitations of these assays, as well as tips for engaging other departments in stewardship of them.
• 17:12
  SPEAKER_00: I'd like to thank our two panelists, Dr.
• 17:15
  SPEAKER_00: Van Skunaveld and Dr.
• 17:16
  SPEAKER_00: Moore, for sharing your perspectives and experiences on diagnostic stewardship of PCR-based assays.
• 17:22
  SPEAKER_00: Looking to expand your knowledge in diagnostic stewardship, you can join us at the Sixth International Conference on Healthcare Associated Infections, Dicennial 2020.
• 17:30
  SPEAKER_00: This conference will be held in Atlanta, Georgia from March 26th to March 30th and is co-hosted by Shea and the CDC.
• 17:38
  SPEAKER_00: Find out more at www.dicennial twenty twenty.org.