Decontamination of Laboratory Equipment

Transcript

Date of session: 04/25/2023

Facilitator

Aufra C. Araujo, PhD

Centers for Disease Control and Prevention

DLSbiosafety@cdc.gov

Didactic Speaker

Shawn G. Gibbs, PhD, MBA, CIH

Dean

School of Public Health, Texas A&M University

sgibbs@tamu.edu

Aurora Le, PhD, MPH, CPH, CSP

John G. Searle Assistant Professor

School of Public Health, University of Michigan

aurorale@umich.edu

Aufra Araujo: Alright, let's get started. Good afternoon, good morning, and good evening, everyone. My name's Aufra Araujo. And I want to extend a warm welcome from the Centers for Disease Control and Prevention in Atlanta, Georgia. I'm a PhD Health Scientist in CDC's Division of Laboratory Systems, and I am the facilitator for this Extension for Community Healthcare Outcomes, or ECHO, Biosafety session.

Thank you for joining our third session. The topic for this interactive discussion is Decontamination of Laboratory Equipment. Our subject matter experts are Dr. Shawn Gibbs, the Dean of the School of Public Health at Texas A&M University, and Dr. Aurora Le, who is the John G. Searle Assistant Professor at the School of Public Health at the University of Michigan. For now, I'll stop sharing briefly so we can see each other. I would like to welcome all participants to maybe turn on their screens, have the courage to show their face to us, and say hi.

Let's see. Do we have anybody just calling on the phone? If so, if you could unmute and just introduce yourself, say your name and where you are calling from. I'm not sure if anybody is calling from the phone. I don't think so.

So then, you know by now, if you have attended other ECHO sessions, that I always like to start with sometimes– some type of icebreaker. The icebreaker today is a question. You just put in chat– yes or no. Does your laboratory have policies on decontamination, such as a chemical hygiene plan, for instance? So if you can just enter in chat– yay or nay.

Alright, thanks for participating. I love seeing the response. I don't see faces. I don't see people turning on their cameras other than our speakers. I see– oh, I see Dr. Iwen. I see Tara. OK,

Erin Bowles: Hello.

Aufra Araujo: Alright, I love seeing who is on the other side. OK. I don't have a camera, sorry. It's OK. Erin. Eating lunch– thanks for letting me know, OK, so– let's see. Erin, you don't have a camera, but would you like to say just a few words where you were calling from and if you do have or don't have some type of decontamination policy or a chemical hygiene plan or something like that. Would you like to unmute and just share with us? Just putting you on the spot.

Erin Bowles: Hello, everyone. I'm calling from the Wisconsin State Lab of Hygiene, and we do have policies for decontamination in our laboratory. We're also part of the University of Wisconsin, Madison. And so a lot of our policies are policies that are university-wide. We have a large biosafety group that sets those policies and would help out with something like that if it was a major– something major get contaminated. Otherwise, little spills and things– we would obviously clean up ourselves.

Aufra Araujo: Awesome. Thank you so much for sharing, Erin. Let's see. Just randomly calling somebody else. Nick Crosby, would you like to share with us about your decontamination policies or anything in your lab?

Nick Crosby: Yeah, so we have a spill response plan, which has a detailed section on what decontamination products we should use for individual spills. We have the chemical hygiene plan. We have about three more that I'm in the process of updating and getting in place. So yes, we do.

Aufra Araujo: Awesome. And sorry, I missed where you were calling from?

Nick Crosby: So I'm from the Utah Public Health Lab.

Aufra Araujo: Utah– awesome, thank you. Alright, so I appreciate everybody's participation and sharing and turning on camera and mic. This way, we get to know each other and know a little bit more of what you all do. Before we proceed, I want to briefly mention some technical details related to our ECHO biosafety session. Please use the video capabilities of whatever device you are using for this session as much as you can. We love to see you. All our microphones are now muted. During the discussion, please unmute yourself to speak.

If you are experiencing technical difficulties during the session, please send a private chat message to George Xiang, who is labeled as DLS ECHO Tech. He will do his best to respond to your issue, and he's waving to you now. If you are connecting to Zoom by phone only, at the time of discussion, please announce yourself by name and institution when beginning to speak.

Briefly, how do these ECHO sessions differ from other presentations? These sessions are different from webinars in that the discussion of case– to share some solutions– discussion of case or clinical– sorry– discussion of cases or clinical laboratory challenges are the main feature of the session. Our subject matter experts hope to share some solutions that will be translatable to all of you in your individual laboratories.

We encourage your participation in the discussion by sharing your knowledge and experience. Each laboratory is unique your skill set is also unique. So please do contribute to the discussion. Once again, we value the discussion amongst all of you and encourage you to share your own experience and challenges on the topic. Let me go back to the slides. Share screen again.

My slide's getting stuck. Now I think– yes. Alright, here is a brief overview of today's session. I'll introduce our subject matter experts– Dr. Shawn Gibbs and Dr. Aurora Le, who will provide a didactic presentation and real case discussion. Then, Commander Sabrina Debose from the CDC Division of Laboratory Systems will summarize today's discussion. Closing comments and reminders will follow, and we will adjourn the session.

Today's session is being recorded. If you do not wish to be recorded, please disconnect now. Closing captioning will be provided for this session. Please find the link in the chat box. The transcript audio recording and slide deck from today's session and other resource will be posted on the DLS ECHO Biosafety website.

Alright, now it is my pleasure to introduce Dr. Shawn Gibbs and Dr. Aurora Le.

Dr. Shawn Gibbs is Dean of the Texas A&M University School of Public Health. He has over 100 articles in industrial hygiene and environmental exposure assessment, focusing on disrupting transmission of highly infectious diseases. He was a member of the US Environmental Protection Agency Board of Scientific Counselors for Homeland Security and the Southeastern Conference Medical Task Force on COVID-19.

He was a US Faculty Fulbright Scholar to Egypt and has been PI of three Fulbright Junior Faculty Development Programs in Egypt and Libya. His research has helped to determine national policies, procedure, and best practices for response to Ebola virus disease, COVID-19, and other highly infectious diseases.

Shawn has held roles in organizations such as National Ebola Training and Education Center, Hispanic Health Disparities Research Center, NIOSH-funded Center for Agricultural Safety and Health, Center for Population and Aging, and Director of Research for the CDC, the DHHS-funded Nebraska Biocontainment Unit.

Shawn is heavily involved in National Worker Training Programs in hazardous materials, disaster preparedness training, and hazardous waste worker training. He is a national leader in the research, training, and policy related to national and international response to highly infectious disease outbreaks. Shawn is very busy, and we do appreciate Shawn making the time to be here with us today.

Dr. Aurora Le is the John G. Searle Assistant Professor of Environmental Health Sciences at the University of Michigan School of Public Health. Her interdisciplinary research is centered around occupational safety and health, with specific focus in occupational health disparities, occupational justice, and psychosocial factors of work. She also does translational work in highly infectious disease mitigation and management, with a focus on training, education, prevention, and preparedness.

Her experience in this area includes previously assisting the Nebraska Biocontainment Unit with their research and programmatic activities during the 2014-2016 West Africa Ebola outbreak, serving as a subject matter expert and consultant for the National Disaster Medical System, and continuing as a subaward Principal Investigator and trainer for the National Institute of Environmental Health Sciences Worker Training Program. I am very thankful for Dr. Gibbs to introducing us to Dr. Le. I'm eager to hear both of your presentations today. I will stop sharing now, and the floor is yours as soon as I can stop sharing.

Shawn Gibbs: While Dr. Le is in the process of pulling up our slides, I would just like to say thank you to the CDC for hosting this event and thanks to all of you for joining us. I'd also like to point out– I'm really happy that, on our third slide, we thank Pete Iwen since he showed up for this. So Pete, we do give you a credit. Thanks for showing up.

Essentially, what we're going to be doing today is we plan to discuss the need to plan for decontamination of laboratory equipment following usage on samples with highly hazardous communicable diseases, also known as highly infectious diseases. We're also going to talk about communication strategies. And at the end, we're going to have some time for questions and answers at the end of the didactic presentation before we move on to the case-based breakouts. Back to you, Dr. Le.

Aurora Le: Yes, so as Doctor Gibbs mentioned, we'll be fielding questions at two points during this presentation versus at the end of the didactic portion before the case study and then after the case study. So if you have any questions that arise as we're speaking, do please feel free to put them in the chat, and then we will get to them once we get to that portion.

Our time here today is brought to you by the Prevention, Preparedness, and Response Consortium that Dr. Gibbs and I are both a part of, funded through the NIEHS Worker Training Program. But we'd also like to acknowledge the National Emerging Special Pathogens Training and Education Center, which Dr. Gibbs is affiliated with and I was formerly affiliated with, and then the Distinguished Lecturer Program at the American Industrial Hygiene Association and the Texas A&M School of Public Health, which I will actually be leaving Michigan for in several months and joining Dr. Gibbs there as well.

We'd like to give a special thanks to Pete Iwen, who is on this call– Professor of Pathology and Microbiology, Nebraska Public Health Laboratory, Biosafety Program Director extraordinaire. All of you on this call probably already know who he is. So hey– shout out, Pete. And then we'd also like to thank Dr. Scott Patlovich, who is the Assistant Vice President of Environmental Health and Safety at the University of Texas Health Science Center in Houston.

So these objectives are the basis of what we want to cover. So first is to be able to identify biosafety practices that strengthen laboratory systems and advanced laboratory safety, examine biosafety concepts that apply to conducting risk management when performing laboratory activities, and then apply these practices and concepts specifically to highly hazardous communicable disease scenarios or HHCDs.

And at the end of this webinar today, what we hope you will take away is the importance of developing a culture of safety within your organization but also empowering all employees to provide constructive feedback and to point out potential safety issues.

So these cool photos here are from various real-world events that we had with the evacuation and treatment of patients during the 2014/2016 West Africa outbreak and then subsequent exercises that we have done after. But this isn't how most HHCDs will arrive in most facilities. So unless the patient is coming into the hospital in a transport like this, you may not know what you're dealing with.

So the need to inherently design processes for the unknown is very necessary. And oftentimes, HHCDs aren't as clearly labeled as these images. Almost everything always starts out as influenza-like. So it's really important to establish risk assessment and standard operating procedures that protect workers, regardless of the information that you have on hand.

So just a refresher– with laboratory-associated infections, or LAIs, this results from work with infectious biological agents either during the course of laboratory or lab-related activities and the person may be symptomatic or asymptomatic. So synonyms for this include lab-acquired illness, lab-associated illness, or in Canada, they call it lab-acquired infection or intoxication.

So basically, as we all know, an LAI is an infection or illness that can be traced back to our labs and is the result of our responsibilities. And it's of the utmost importance that we do what we can to protect those who work with us in the laboratory and then, by extension, our communities. So whether it's a research lab or a clinical lab, the last thing that we want is for an infection to impact our team members and then our communities.

Most of them you will see potentially in clinical laboratories, but the most likely scenario is that you're already running a variety of tests, even before the HHCD is suspected or confirmed. So we really cannot stress enough the importance of preparing your procedures for the unknown.

OK, so Dr. Gibbs and I had the opportunity to write these two articles for the Synergist, which is the trade magazine for the American Industrial Hygiene Association. The first, that was published in 2018, was more so a reflection on the outbreak. In particular, we weren't trying to predict the COVID pandemic. But if you read it, it looks like that's what we're alluding to. We absolutely had no idea that COVID-19 was going to happen back in 2018.

But essentially, what we emphasize in these articles are the importance of risk assessment and knowing the quality of the risk assessment and the person conducting it. So we still, very much, think this to this day, although it is expanding– that the industrial hygiene field needs to actively increase its capabilities and quality of its members to essentially do these items both in operation but also in the development phase, working with engineers prior to marketing and manufacturing equipment.

Traditionally, industrial hygienists have been very strong on chemical safety, physical safety, radiation safety. But biohazard was something that fell through the cracks until we started getting to COVID-19. So really, what we're trying to emphasize is to not just identify potential solutions, potential exposures but also work on the solutions to reduce such exposures. So those are the links there, but you can grab them, or we can link them in the chat later.

So I think all of us have seen this. If you're undergrads in my class and I ask you, hey, what is this– oh– they'll always say food pyramid. But that's not it, clearly. So for us, this is a hierarchy of controls, which we live and die by in order to protect the workers themselves. But it's important to emphasize that these are not magical. They will not fix everything. Yes, you can use multiple higher controls in conjunction with each other. But this is only if you're able to identify the causal HHCD.

Additionally, it's important to recognize that the perception of risk is very different for your organization when they voluntarily or intentionally take on the responsibility to treat a patient with an HHCD. By doing so, sometimes the responsibility and the expectations are greater. So I'll pass it on to Dr. Gibbs for the next portion.

Shawn Gibbs: Thank you very much, Aurora. So one of the things that I really want to highlight in this is preparing in advance. And as you're looking at this slide, one of the things that I'd like to read you– or talk about is– a number of years ago, we did a study asking device manufacturers their decontamination policies, their warranty information, and other information, essentially surrounding the use of the equipment on highly hazardous communicable diseases.

And we've been pushing on this issue since about 2014 And have been really encouraging them to get information out there in advance before you need it. Now, recently, we decided that, with Marburg and the other things that we've been dealing with lately– to reach back out and try to get additional information. What I'm about to read you is essentially excerpts from email correspondence that I've had with one manufacturer.

And just so you're aware, we started reaching out to about 14 manufacturers, and we started this on February 21. And we would email them every two weeks, asking for updated information around their warranties and their policies around what they do if there is an exposure to the equipment of one of these highly infectious diseases. And of those 14, so far, we've only had three respond.

And one of those, after getting four emails from us, responded on April 10, so this is after my fourth email. And the company simply responded, "We cannot comment on specific microorganisms outside of those that we have tested, which can be found in our 'Instructions of Use' document. There is no other information that we can provide," to which I then asked them, "Thanks for getting back to me and passing along the information. Does this mean that the usage of your equipment on samples from patients with pathogens, such as Ebola and Marburg, would not void your warranties, your service agreement, or require additional decontamination?"

The company then responded, "I did not state that. What I stated is the information we tested is in the link provided." I then responded to the company—"I'm not trying to be difficult, but I don't understand your response. Our question is about decontamination, and would usage of your equipment on samples from patients with such pathogens as Ebola and Marburg void your warranty or service agreements?"

The company then responded, "I appreciate your question, and I am certainly not trying to be disrespectful. But the only published information is in our 'Instructions of Use' document in the operations manual. I cannot speak about warranties or agreements or anything else."

I then followed up with, "I appreciate your position. However, the document provides provided only covers 11 microorganisms and does not discuss decontamination. There is estimated to be over a billion different species in existence. That leaves a lot of gray area that we are trying to understand the implications and uses of your equipment with those types of samples. Can you direct me to someone in your organization who can answer questions about decontamination, warranties, and service agreements?" The response I got from the company– and this was the final response– was on April 12, and said, "I will reach out to internal people. If they're interested in speaking with you, they will reach out to you." Thus far, no one has reached out to speak to me.

So as you can see, this is over the course of two months, just trying multiple platforms just to get basic information about what their recommendations and what the implications of using their equipment on this is. So this is definitely one of the reasons why we recommend that your SOPs have to be generated and written so that they can handle anything so that, once you have– a known or a suspected HHCD is detected, the potential need for additional contamination options may become apparent.

So essentially, your staff are now going to perceive risks that– they may perceive have changed, whereas before, they may not have perceived the risks as significant. Some staff may even not want to handle these types of specimens.

So, as a matter of fact, a number of years ago, I was doing a site visit for a clinical laboratory. And one of the people working in the clinical laboratory, when we were talking about highly hazardous chemical diseases, indicated to me that this is a biohazard and we have to treat this different. And it was a little surprising to me because the way they commented on it almost made it seem like they didn't perceive everything else they had been doing in the healthcare environment as biohazards.

I'm hoping they misspoke in that, but it makes you wonder– as you become more familiar in situations, oftentimes your guard drops, and your perception changes. So particularly when you're talking about highly hazardous communicable diseases, you definitely need to prepare in advance. Dr. Le, next slide.

So when it comes to the safety and how you're processing these equipments, you need to reduce the risk, in general, of your every day as best you can. So what you need to do is to conduct testing– if you find yourself in a situation where you have to conduct testing across multiple locations. This could be point-of-care or maybe even in a laboratory within the contaminated patient care area if you're dealing with a highly hazardous communicable disease.

You could even need to do testing in a clinical lab under a higher chain of custody and a more robust SOPs. You could even find yourself needing to move some of those testing equipment so that you can test for these diseases after you have a confirmed or suspected into some of your BSL-3 or other facilities. Next slide?

So when you're handling these specimens, whether you're going down two floors within your own facility, to your own clinical laboratory, or being shipped across the country to the CDC for confirmational testing, handling of these species requires following strict procedures to comply with both your internal policies but also various state and federal regulations. All of these components have to be considered in advance, and they have to come together so that you can handle these samples safely. Next slide.

Each potential test– if you're planning to bring in a highly hazardous communicable disease specimen, each potential test needs to be evaluated for risk. This involves looking at your SOP, how you're handling the samples before they get to the various pieces of equipment, how you're processing them- whether in your biosafety cabinet or, in some cases, in some facilities, on an open bench. You need to look into the various what-if scenarios and evaluating the actual process on non-highly hazardous communicable disease samples.

This should not be the responsibility of any single individual but part of your overall lab safety team. Remember, going back to what we were discussing earlier, not everyone is qualified to do these type of assessments. So the quality of these assessments are going to vary from individual to individual. That's why it's better to have multiple individuals involved, as well as providing feedback loops.

So what I want to focus on, with some time here, is the ambiguity around the manufacturer policies for usage of clinical laboratory equipment in the treatment of highly hazardous chemical disease patients. Decontamination and other processes have to be worked out in advance. And once they are worked out, they need to be clearly and easily accessible.

As I just mentioned with the study that we're– the information gathering that we're looking at now, waiting until you have a suspected or a confirmed patient will likely leave you in a situation where you're scrambling to find resources. And whether you're sending emails, filling out online support forms, or making phone calls, it may be more difficult to get those answers.

Usage of equipment is a must for the treatment of these patients and can be done safely. As Dr. Le pointed out in the first portion of this presentation, many of you are not going to opt in to treating a patient with a highly infectious disease but instead could find yourself dealing with the aftermath when you find that a patient that you processed normally later on turned out to be positive for one of these diseases.

Not all pieces of equipment are designed with user safety in mind, either for running the test or for repairing the equipment. I'd like to see manufacturers put more focus on this in the future. But for right now, we're just not seeing it. I know this is something that CDC and FDA have been pushing for as well.

One of the biggest headaches that we all ran into in the US Ebola response and some of the early COVID response was the ambiguity around the decontamination of equipment used for care on these patients. And in some cases, a manufacturer told individuals that they would have to destroy very valuable pieces of equipment and that there was no way to decontaminate them.

Or there's also a lot of questions as to whether or not decontamination is actually necessary. I would say if your processes are designed properly, and you're handling them properly, that– and oftentimes, decontamination may not be called for outside of your standard processes. All parties want to do the right thing in these situations.

And the health of those are responsible– and make sure that the safety and health of those who are in the lab is maintained. However, there remains a lot of unknowns that I believe should be addressed in advance, and that can be started by essentially making sure that your standard SOPs are well-known and cover the potential expansion to a highly infectious disease. Oh, sorry, next slide?

Communication is a big issue that can be corrected with minimal cost and effort. In this study, we conducted and our own expertise– there was not a clear route to ask questions or obtain documentation. We recommend that you start looking at this in advance, that as you sign up and reevaluate all of your standard cleaning and decontamination processes, that you also look at what you would do extra, if necessary, for various pieces of equipment or various SOPs that may also, later on, include either a known, a suspected, or an after-the-fact highly infectious disease.

The information is not available for manufacturers. This is still the case today. Again, you'll see that when you're trying to get the information from manufacturers, it'll be routed through multiple individuals, and you may not be able to get it in a timely manner. Additionally, one of the things that surprised us in this study is that there is a reliance on oral communication from on-site sales teams, which did not always match up with written documentation that was later then provided.

So as you're going through and establishing your various SOPs, it's good to make sure that you've got the documentation on this and that you're working with your appropriate state and local regulators as well because, particularly when you're dealing with oral communication, we all know how the telephone game works. Next slide? And over to you, Dr. Le.

Aurora Le: OK, so it's not all bad. So we want to talk about some HHCD opportunities to address potential issues. So again, improving the clarity of contact information for inquiries, including who and how to contact– as Dr. Gibbs just discussed, the time in which you are running those tests and wondering about the warranty is probably not the time to start figuring out who to contact for that warranty.

And then improving the timeliness of response– so a lot of these manufacturing companies have, again, generic form responses in particular. So if you're able to establish communication or, through some professional conference, get someone's card who is working a booth specifically for that specific manufacturing company– to be able to get a direct line of contact going to improve response timeliness.

And then we're also looking for improving clarity of digital guidelines. So a lot of these manufacturers have PDFs available online with very, very generic language, and that is done intentionally, for a reason, but, again, in this world of HHCDs, leaves a lot of ambiguity. And then also developing protocols beyond those that are present– so a couple of years ago, Ebola was the disease du jour. And then we moved on to COVID, which did not necessarily have the same categorization in terms of pathogen.

But also, when you're going through those processes, improving clarity on decontamination procedures that are compatible with one another– so a viral hemorrhagic fever that is mostly spread through bodily fluids– probably very different than something like SARS-CoV-2. So again, we're just trying to underscore advanced planning and recognizing that the equipment must be used for the benefit of all patients, and, if it's usage on specimens from HHCDs, making sure that it doesn't void warranties or result in the unavailability of that equipment for other patients.

So as Dr. Gibbs mentioned, we are working now on a follow-up study, which is the email correspondence that he read you earlier. So we're still encountering the same issues that we encountered back in 2017, unfortunately– some very preliminary data, multiple weeks, multiple requests.

Now 3 of 14 have responded. And despite everything that's happened with the multiple outbreaks– Marburg, COVID, et cetera– as our world is increasingly becoming smaller in terms of HHCD transmission, but also the frequency of events is increasing; it's maybe alarming but also not surprising to see that they still haven't necessarily updated their guidance in this particular area.

So, unfortunately, the onus is on us to determine the appropriate decontamination processes. And I guess the biggest takeaway is that, in this event, while we are encouraging you to get in advanced contact with your manufacturers, you cannot count on them to give you timely information. OK, back to you, Dr. Gibbs.

Shawn Gibbs: Thank you. So some considerations for decontamination– so as you take a look at this slide, remember– before you get into decontamination, at the most basic level, you need to start with cleaning. And the basic level there is you're removing the organic load– in some cases, maybe using soap and water, in some cases, just doing your best to blot off the damaged sample or the built-up biomass. Oftentimes, when you get into disinfection, it's going to involve the use of chemicals and/or heat application. And all of these are essentially trying to reduce the microbes on the surface of the object.

Now, what you need to take into consideration is what the impact of that will have on the piece of equipment because if you've got a half-million-dollar piece of equipment or a quarter-million-dollar piece of equipment, and your decontamination- your disinfection process essentially yields it useless, then is that worth the decontamination?

So one of the other things that I would say is, oftentimes, when you're thinking about post-

HHCD event and you're looking at decontamination, there's a legitimate question as to whether or not decontamination is necessary dependent upon the type of organism that you're dealing with or whether or not you're simply doing it as part of your risk-perception mitigation strategy, or if it's even necessary, and instead of decontamination, you can just better educate people and help them understand that– your existing SOPs and how they protect the personnel.

And this is one of those things that each laboratory, I believe, needs to look at independently. All of you operate high-level laboratories. You know there is not one singular cookie-cutter laboratory blueprint out there. Every clinical BSL-2, BSL-3 laboratory that I've been in all has grown organically. You'll start out with a blueprint.

Then you'll move in new equipment as time goes by. Things will get moved around. Additional space will be needed, and so on. So this is something that's going to require additional changes as your laboratory grows and as you get newer pieces of equipment, and as you start understanding more about the risks that you're encountering based upon the functions of your laboratory. Next slide?

I can't stress this enough. Oftentimes, if you're putting together your standard decontamination processes, they are likely to be very effective against most of your HHCDs. The exceptions, I would say, would be for your spore formers and your prions. But oftentimes, if you're simply just dealing with a biological or a viral or normal bacterial HHCDs, it's very likely that your existing SOPs for decontamination and/or cleaning will be affected.

Now, as part of that, you're going to really want to make sure that you're utilizing, on a regular basis, proper administrative controls, proper engineering controls, as well as the uses of proper personal protective equipment. And you'll need to utilize and really communicate this to your staff.

I would say one of the biggest disruptions or the biggest issues, that we see is essentially confusion, a lack of understanding amongst the personnel in place. And this is going to differ quite a bit between laboratories that are essentially volunteering to take highly hazardous communicable disease patients versus laboratories that are likely just providing clinical support to standard health care organizations that then, at some later point, find out that a patient sample that they processed a day or two ago later was from a patient who turned out to be positive for a highly hazardous communicable disease.

So communication– both internal and external, particularly in advance, really helping your personnel understand why you do various cleaning, why you do various decontamination– just for all the standard biosafety hazards that you encounter on a daily basis in your laboratories, but also how that protects them and protects the laboratory from the unknowns. Next slide?

Aurora Le: Yes, so in summary– we're going to stop talking soon and then get to the interactive portion. But I also wanted to say– thank you to George for- as we've been talking, he's been dropping in the links in the chat to all the papers and articles that we've referenced. So, in summary, we would just like to emphasize that we can reduce the likelihood of LAIs. But as you know, we cannot ever truly eliminate that risk. We, as industrial hygienists, say there's no such thing as zero risk, but we can significantly reduce it, including for HHCDs.

Just again– it's highly likely that an HHCD sample will be in the lab before you're even aware and confirm that there's an HHCD event. And then identification of potential risk from your equipment, procedures, and personnel within your lab for LAIs should not be done at the last minute. And then consideration of decontamination processes need to be planned in advance to handle all scenarios to go for a more all-hazards approach.

So before we get to our breakout sessions, I briefly scanned the chat, and I just saw one comment that, rather than a question, it says the links were shared with their management team– from Tara. She says we are in the process of relocating our lab in September, going from a BSL-2 to four BSL suites– four BSL-3 suites within our new location. I don't see any other questions in the chat. But at this time, if you have questions, please feel free to unmute yourself and ask us.

Aufra Araujo: So thank you so much for the presentation, Dr. Le and Dr. Gibbs. While we wait for folks to add their questions in chat, I have one question– and we were talking about– actually, I had a question about the agreements with the companies and all that. But based on Shawn's mention of the email, I don't need to ask that question.

My other question is, should risk assessments include the potential likelihood and consequence of the manufacturer not responding to the service needs of the laboratory? How would you address that? For either of you.

Shawn Gibbs: Dr. Le, would you like me to answer, or would you like to go?

Aurora Le: You can start off.

Shawn Gibbs: So I think that there's two ways to look at this. Number one, I think whether you're a BSL-2, a BSL-3, or a clinical laboratory out there, I think that you are likely establishing and/or have relationships with, likely, the technical personnel or the cells personnel that were involved in helping you obtain the equipment. I would go back in and tap those relationships now, as you're putting together your standard SOPs, and take into consideration what would you do if either you intentionally or accidentally find yourself dealing with an HHCD situation.

And one of the reasons why I think we have to do that in advance is because, with particularly some of the things that we're doing right now, we've literally submitted questions via email, just soliciting information. We've filled out the online submission forms. We've called in, asking these questions, both as people who are trying to provide information to others in the field but also as potential purchasers. And the information that we're getting back is gray at best.

I think the manufacturers got a lot of pushback from some of the hard stances they took in 2014, 2015. And I think, instead of addressing and saying something along the line of, we've tested against these organisms, and this is the decontamination strategy that we recommend for these organisms that will not damage the equipment and are likely to be applicable to these types of other organisms, they're simply just really narrowing their scope. So I think that they need to prepare in advance because if they find themselves with too specific a question, I think the manufacturers are likely to keep pulling back.

Aurora Le: Yes, and we got a comment from Erin echoing those sentiments– refusal of manufacturers to take responsibility for biosafety and how to decontaminate equipment, rather than discarding it, makes clinical laboratories very reluctant to provide care to patients with a suspected HHCD. They just want to send them somewhere else.

Shawn Gibbs: Erin, I think you're very– I think that's very accurate. I think the US has set up a network of facilities that can handle those transfers. And I think that the US can handle a small number of those transfers. But depending upon what would happen, there's only a small number of facilities– you're talking about 13 facilities in the United States who have, essentially, agreed, at the national level, to take these patients. And those 13 facilities do not have huge bed capacity.

Matter of fact, we were talking about Pete earlier, and he's at one of the larger facilities, which has approximately a 10-bed capacity. But that also depends upon the acuity of the patients. That also depends upon the staffing level, which has taken a huge hit. And I think that right now, the national plan is to transfer these patients. But as we saw in the early days of COVID, there could come a point– or there could become an event where that may or may not be an option.

And I think a lot of these facilities– you're correct– are saying, hey, we'll just transfer it. But there's a whole lot of question when someone shows up at your facility that you were never planning to take– even if you are fortunate enough to be able to transfer it, then what do you do in the aftermath of having had one of those patients in your facility? We didn't even get into a whole host of conversations around Category A waste and other things like that coming out of the patient care facilities and the laboratory processes. But good observation, Erin.

Peter Iwen: Hey, Shawn, Aufra, Aurora, this is Pete again. Thanks for your presentation. To me, why are we still having this discussion? We started this back in 2014, and nothing has been solved at all, in my opinion. And we're dealing with manufacturers that are for-profit, and I just think that they're going to find the easiest way to do what they do that won't cut into their profits.

Now, to me, one of the ways to address this issue is– I know that the CDC has been talking with the FDA about this. I don't know where this has gone. Shawn, I know we've had that discussion as well. When is the FDA going to get involved in this discussion? And it's going to take a big hammer to get these manufacturers to move.

Shawn Gibbs: 100% agree with everything you said, Pete. And you and I were part of that workshop– what was that? Six, nine months ago– with device manufacturers to talk about this. And we're now even having difficulty getting information around, oh, you got this piece of equipment. Which disinfectant wipe would you recommend that's not going to damage the surface? And they're just pulling back harder on the information, in my opinion.

Peter Iwen: So how many manufacturers participated in our workshop that they were invited to?

Shawn Gibbs: To my understanding, I believe there were less than a half dozen, and they more listened. I don't think they actively participated.

Peter Iwen: I agree. I'm not even sure we had that much. But it's just amazing we are still discussing this issue today because I don't think anything has been done. And it's more than just these patient care biocontainment unit laboratories. Every frontline laboratory out there could potentially handle something bad, and the potential is there to have a laboratory-acquired infection occur. But again, we haven't solved anything in my discussion on this. And I hope that we don't drop the ball on it, Shawn and Aurora, and I hope we keep squeaking.

Aurora Le: Oh, we'll keep squeaking. I have no sense of time. But I was like, oh, my gosh, 2014 was nine years ago? What?

Erin Bowles: You would have thought the COVID thing would have resurrected some of the discussion, or the Sudan Ebola virus, or the Marburg, or the monkeypox. It's still not there. It amazes me.

Shawn Gibbs: Well, and every time one of these pop up, we have the same conversation around medical devices and waste every time.

Aufra Araujo: Yeah, short-term memory here in the States, unfortunately.

Peter Iwen: And as a clinical microbiologist, I've learned, especially from the Ebola event that happened, this is not a microbiology-only issue. Every clinical lab out there has to deal with this. Even though I'm not a blood banker or chemistry or any of that, they all deal with the same issue. And again, we need to keep talking about it. We need to get a bigger hammer. And we need to work this out because this is going to keep coming up.

Shawn Gibbs: So Pete, facilities like where you're at, and the other 12 in the country who are planning to take this– I'm going to tell a little story about something one of the EMTs told me when we were preparing to do one of the Ebola transports. And this was one of the US Ebola transports in Nebraska. And I'm talking through the EMT. We're getting ready to do it.

And he just looks at me, and he goes, "Shawn, we've trained for this. You've planned for this."

We're ready for this. I know exactly what I'm walking into. This person's coming in with a giant E sketched on their head that they have Ebola. On a Friday night, I never know what I'm walking into when I get out of my ambulance. And what I would say is that holds for all the clinical laboratories in the country as well. On a Friday night, they never know what's going to come into their laboratory.

When you're planning for it, when you're expecting something like this, and when you're at one of the facilities that can and will take one of this, that's very different from the hundreds and thousands of other facilities whose plan is to move them over to those 13. They just never know what they're going to run into on a Friday night.

Aurora Le: Great discussion. We'll have more time for discussion, actually, but we want to get into our breakout groups. Don't worry. You don't have to remember all of this because we will put the scenario and the questions in the chat once you get to your breakout rooms. George is going to help us put you in breakout rooms– about five people. Please just have– informally designate one person in your group to be the recorder and then someone to report out. It can be the same person recording or not.

So in this scenario, we have– a supervisor in the local health department informs you that a sample you tested 24 hours ago was from a patient now determined to have Marburg virus disease. The patient had the following test done in your clinical lab– blood cultures, molecular assays, CBC count with automated differential, and then basic and complex metabolic panels.

So we'd like you to discuss these five questions, and then we'll report back out once we regroup. You'll have about 10 minutes in your breakout group, just to keep this in mind. So we want you to discuss– what are the risks to the lab personnel– those who ran the test, but also those who just generally work in the lab? What should the lab personnel be told, and what should they do? Should you shut down the entire lab? How would you decontaminate the equipment or the entire lab? And how do you start your decontamination plan?

So again, once we get you in your breakout rooms, we'll put the scenario and the questions in the chat for everybody. But I will stop screen sharing now and then, George, if you could help place everybody who's not a presenter into groups. Thank you.

[No audio available for the breakout room sessions]

Aufra Araujo: I will just say that it was a very productive discussion. And I encourage the participants in that room to speak up. Don't be shy. You were speaking during the breakout session.

Aurora Le: Someone was supposed to be reporter.

Aufra Araujo: So who were there– Kerri, Joyce? I'm going to start calling on you if there are no volunteers. There we go. Joyce, go for it.

Joyce Oetjen: OK, so we all basically agree. We first start off with our risk assessment, assessing what was done where, if there was any type of contamination outside of the biosafety cabinet, going over the PPE that was used, what type of testing was done, anything that might have generated aerosols outside of biosafety cabinets. Also, looking for signs and symptoms so that people could be aware of.

So definitely, a big thing was notification so that– we should be honest, be upfront with the people, even if the people are– this was 24 hours ago. So try to track everyone who had participated in any of the type of work. Contact them. Notify them of the situation. Have them be aware of the signs and symptoms.

And we would also try to bring an occupational health and any type of consultants– work through any of their questions and concerns. We did this with, also– in consultation with the CDC. So even if people who have gone on vacation– try to track them so they can monitor their situation.

Beyond that– so definitely, what type of PPE was used. So should you shut down the clinical lab? Now, one of the things that came up was certain things are often done in segmented areas. If it's an area that you can closed down, that you can maybe clean that particular section, that area. If it's a wide-open laboratory, that becomes much more difficult. You try to shut down the entire laboratory– that's difficult. Again, it's been 24 hours since then.

So looking to see if there's a way to mitigate the situation is– what's the HVAC for that area? Who is in that location trying to clean any of the benchtops or pieces of equipment that were used? But try not to– in general, if it's a whole open lab– to not necessarily shut down everything, if possible. You can segment it.

Aurora Le: We're just going to have you– group one cover number one.

Joyce Oetjen: Oh, sorry about that.

Aurora Le: No, that's OK. I was like, you were on a roll. Thank you, Joyce. So room two– I'm sorry if I mispronounce your name– Kalpana, Katelyn, Sabrina, and Sakura. So what did you all discuss in terms of what lab personnel– what should lab personnel be told and what should they try to do? Did you discuss anything different than perhaps what Joyce's group mentioned? I can hear someone talking but very, very faintly.

Katelynn Koskie: OK, can you hear me now?

Aurora Le: Yes.

Katelynn Koskie: OK, perfect. Thank you very much. So we pretty much covered what Joyce had talked about– contacting occupational health, figuring out who was in the area, who was in the room, things like that. I think she covered it very well.

Aurora Le: Thank you.

Shawn Gibbs: So before we go off of this, I'd also add you can utilize your local health department to help you in this situation. And they're likely going to be involved in setting up monitoring plans, not only for the health care workers involved but also the laboratory personnel involved. And often, those monitoring plans are twice-a-day check-ins for anywhere between 14 to 28 days.

Aurora Le: Thank you, Dr. Gibbs. Room three– sorry, I don't see who is in room three, but I'll just let you unmute yourself. Should you shut down the entire lab?

George Xiang: Hey, Dr. Le, there was no room three by the way I set it up.

Aurora Le: Oh, there was no room three.

George Xiang: So the next room is four.

Aurora Le: OK, four then.

George Xiang: Apologies.

Aurora Le: It's OK. Four, did you think you should shut down the entire lab? You had Leila, Michael, Robin, Shoolah, and Kayzad in that room.

Michael Adjei: So this is Michael. Our discussion was that we should suspend lab operations. We checked the agent pathogen data sheet. We realized that it's susceptible to bleach and ethanol, so we will probably perform surface decontamination and do a thorough risk assessment to see if we really need to decon the whole lab.

Aurora Le: Awesome.

Robin Riddervold-Cotten: And so one of the things also is that when we did the risk assessment that should help drive what areas and where to go to– this is Robin– and that we were concerned because we pulled up the safety data sheet because it can survive, it says, up to four to five days on a contaminated surface and survive in liquid or dried material for a number of days. So we definitely wanted to make sure that we did a thorough decontamination of all the area.

Aurora Le: Thank you. And then I'll actually lump the last two together, then. So group five, which is Keith, Nick, Pete, Tara, and Tyler– should you decontaminate the entire lab or the equipment used? Robin had some feedback on that– and then how would you start a decontamination plan?

Nick Crosby: So this is Nick from Utah. So we're all going to the same place on this one. It all starts with your initial risk assessment and what you've got in place. So some of the things we talked about is the path of travel and making sure that we know exactly where it went through. And the best way we found about getting to that is being open and honest and saying, this is what we suspect happened. Please let us know if you had any contact that may have occurred.

So once you know that, and you have an existing plan in place for how to start working through those different areas, that gets you your decon plan, so you know where to start. And then what else you weren't expecting can now pop up, and you go, OK, now we have to activate this particular portion of it.

And then, when we're done, do a small risk assessment to see what did we miss? What do we need to revise, and how do we need to go about the procedure? So as far as deconning the entire lab and the equipment, I hate to say it, but it depends, and it all depends on the path of travel and what was done, and who was possibly exposed.

Peter Iwen: Yeah, and it would be difficult, in many of our facilities, to shut down a lab because we still have other people to take care of. But number five stuck out to me– how do you start a decontamination plan? Well, as we talked in our group, you don't start now. You have a decon plan in place prior to the situation happening.

And it's the scenario– and we've dealt with this with COVID– people sitting in the intensive care unit with COVID– a bad disease and COVID– are asking to get vaccinated. It's a little late, folks, to get vaccinated when you're already severely infected with the virus. So planning ahead, I think, goes a long way. And I'm hearing all– from the other folks as well, that a process of communication is how you inform people.

We all work in a high-risk environment, and these things can happen. And I'll tell you, they have happened, not with Marburg, not with. But we've all had probably a Brucella exposure or a Neisseria meningitidis exposure or a Francisella tularensis exposure. The difference, again, is that those type of exposures, you can prophylaxis. Marburg– I don't think there's any prophylaxis you're going to do. But the point is that these things do happen, and that's the environment that we deal with. So being prepared is really where it comes in my mind for all of these types of scenarios.

Aurora Le: Thank you. It sounds like y'all had really productive discussions. Usually, when I do breakout rooms, sometimes it's like, oh, I'm not in it, but there's a lot of silence, so very productive. We're going to have a wrap-up discussion, but I just want to finish with a few slides– again, just referring to some biosafety guidelines.

The CDC and NIH have their 6^th edition 2020 Biosafety in Microbiological and Biomedical Laboratories; the WHO manual, 4^th edition from 2020; and the Nebraska Isolation and Quarantine Manual, which myself and Dr. Iwen and Gibbs contributed chapters in that goes beyond a laboratory, if you're interested as well, from Nebraska Press.

And then just reiterating some CLIA items related to biosafety. So again, procedures must be established, accessible, observed to ensure protection from the various occupational hazards, but the lab director must also ensure that the physical plant and environmental conditions of the lab are appropriate for the testing performed. And the lab director must ensure that it is a safe environment.

I think especially because a lot of you work in high-risk scenarios, though, as you have turnover, folks who retire, folks that come in, it's important to get everybody on the same page in terms of, again, what we emphasized in the beginning safety culture. Safety culture and emphasizing the importance of not just protecting yourselves but the entire community as well.

And then thinking about, again, CLIA requirements applicable to safety. Construction and arrangement of the lab equipment must ensure enough space, ventilation, and utilities, requirements, and compliance with all your state, local, federal guidelines, policies, and procedures to assess employee and consultant competency, performing and documenting maintenance and function checks and having sufficient staff. And then, of course, making sure that your chain of custody and all of that is very rigid and squared away ahead of time.

So with that, we finished the talking portion of this webinar. So I'm going to stop sharing this screen. Those are our emails in case you would like to contact us. But we want to give you all an opportunity just for some more open-ended discussion or additional questions before we wrap up. So feel free to unmute yourself.

Robin Riddervold-Cotten: This is Robin. I just have one comment. I think it was Shawn that had mentioned about the communication. And I'm sure all the other public health labs on here know this, and a good working relationship that a lot– or at least our hospitals, we have a good relationship with our Sentinel Clinical labs so that something like this, if it comes into the lab, they're going to immediately report it to their infection control.

Immediately, that is going to be reported on to the state public health laboratory and their commissioners. So right away, a good working relationship of communication with the epidemiologists. They're going to be right there serving and helping with those risk assessments, hopefully, and helping with monitoring of the signs and symptoms.

And I think, mostly, everyone has a good plan in place and a good relationship with their epidemiologists and public health labs and that structures with the hospital. So that communication is key, like Shawn had brought up. So immediately, that's going– that's a reportable disease– point blank, period. And so immediately, that's going to start investigation and start action immediately. So I just want to make that comment.

Shawn Gibbs: Yeah, and I'd also like to say– you want to make sure that you maintain those relationships. When I'm talking to various emergency preparedness people, the thing they always say is, you don't want to be exchanging business cards for the first time at the emergency. So as those positions turn over, Robin– you're dead on. You want to make sure you're maintaining those and that there's an understanding and a level of trust between you.

Peter Iwen: And I might add to that discussion also that– I don't know how many people on this call are public– represent public health laboratories, whether it's a state or jurisdictional public health lab. But having the public health lab relationship with the private labs in their state, to me, is very important because I think a lot of the private laboratories frequently don't even know who their public health or how to contact their public health lab.

And certainly, if you're going to be sending samples to a CDC or doing anything along those lines, you need to have that relationship in place as well. So as a public health lab director, I really want the labs out there to be able to contact me for my help in what they're dealing with as well. So that's why we have a state training coordinator, as well, to open up those communication lines.

Aufra Araujo: Excellent discussion. Thank you both so much, everyone, for participating. I would like to invite my colleague, Commander Sabrina DeBose, Safety Team Lead in CDC's Division of Laboratory Systems, to provide a summary of the discussion to bring us all together. Sabrina, the floor is yours.

Sabrina DeBose: Yes, thank you, Aufra. I appreciate that. And we want to thank you all for the discussion about decontamination of laboratory equipment. So I would provide a summary of the group's discussion. Some of the take-home messages that we heard– it's important to express concern that the manufacturers refusing to take responsibility for biosafety and how to decontaminate equipment safely makes clinical and public health laboratory reluctant to provide care.

Another point is discussion had been ongoing since 2014, and we should have been a little bit further along with solutions or suggestions. It's important that the FDA is involved in the discussion to make more progress. Another point– it's important to not drop the ball and that we continue to work with and move forward to get the manufacturers to accept their responsibilities.

We did have a lot of discussion during the case discussion, and some of the take-home points from there was– make sure– or it's important to conduct risk assessments. Renew your plans– not only renew but make sure you have plans in place. It was also acknowledged that, if there is a situation, it is difficult to shut down an entire lab. That's why it's very important to plan ahead. We always want to be prepared.

One of the last take-home messages or discussions that we just had in this call is it is important to create a relationship with epidemiologists. Communication is the key. One moment. It's important to maintain those relationships and to create a level of trust. In public health labs and private labs, it's important to establish those relationships.

One of the last– very last suggestions was to use your state coordinator in that role to establish those relationships. And those are the take-home summary points from the group's discussion. Thank you.

Aufra Araujo: Thank you, Sabrina. I'd like to give you an opportunity to Shawn and Aurora. If there is any other discussion point that they would like to add to the summary, now is the time.

Shawn Gibbs: Oh, go ahead, Aurora.

Aurora Le: Oh, no, go ahead, Dr. Gibbs.

Shawn Gibbs: You first.

Aurora Le: Oh, I was just going to thank Sabrina for that summary. That's all I have to say.

Shawn Gibbs: I would thank Sabrina for the summary, and I would just like to double-underline the communication, particularly in advance. I think that's the key here. Just the communication from the labs to their personnel, from the personnel back to the lab directors, and that communication relationship building with your local health department– all of those are key in preparations to respond to something like this, including the ability to calm people down.

If you're a laboratory that's not opting into a highly infectious disease response and you find yourself involved in a highly infectious disease response, it's very possible some of your people in the lab may be thrown quite a bit by this, even if it's something that happened afterwards. So you need to communicate with them need to reassure them and their families in the community.

Aurora Le: Yeah, and then we just wanted to thank everybody for their time. And then, Aufra, I'm sure you have some closing comments about evaluations and things.

Aufra Araujo: I do. Thank you all. Especially a big thank you to Dr. Le and Dr. Gibbs. Thank you, all participants, for taking part in our discussion today. We hope you find this discussion valuable in the important work that you engage with in your individual laboratories. We look forward to your participation in future sessions as we dive into specific laboratory biosafety topics. Our next session, we'll have– I will announce. But just– I would just say now since I see Dr. Iwen in the screen here– will be our presenter for the next session.

Soon, you'll receive an email containing a post-session survey link from the DLS Evaluation mailbox. It will take about two minutes to complete. Please continue to complete these surveys. Your feedback is very valuable to us. We read every comment and use your feedback in planning upcoming sessions.

Some examples of using your feedback from previous surveys was we shortened intro at the beginning of each session. We incorporated breakout rooms, such as we did today. We shared the documents and resources discussed during the presentation in the chat and also on our ECHO web page. We also share your response with the presenters for their consideration. We appreciate your time and attention in completing the post-session surveys so we all can improve as we move through these sessions all the way through November.

If you have any additional comments, please send an email to DLSbiosafety@CDC.gov. I'd like to share our last slide. OK, we are excited to have our next session in May. It will be on Tuesday, May 30– always the last Tuesday of each month, at noon Eastern time.

The topic will be "PPE Use (Who, When, What, Why, and How)," which will be presented by Dr. Peter Iwen from the University of Nebraska Medical Center. We are really excited to have Pete discuss and present next month. Please visit the DLS ECHO Biosafety website to view all upcoming sessions.

If you have any questions, as I mentioned before, remember you can reach out to us at DLSbiosafety@CDC.gov. Now we will adjourn. And once again, thank you so much for your participation, and thank you, Dr. Gibbs and Dr. Le. Have a nice rest of the day, everyone. Bye.

Additional resources and related publications

• Le A, Gibbs S. (2018, April). IH's Role in Preventing the Transmission of Highly Hazardous Communicable Diseases.
• Le A, Gibbs S. (2022, June/July). Preparing for the Next Pandemic: IHs Are Needed Now More Than Ever.
• Centers for Disease Control and Prevention. (2023, January 17). Hierarchy of Controls.
• Iwen PC, Garrett JL, Gibbs SG, Lowe JJ, Herrera VL, Sambol AR, Stiles K, Wisecarver JL, Salerno KJ, Pirruccello SJ, Hinrichs SH. An Integrated Approach to Laboratory Testing for Patients with Ebola Virus Disease. Laboratory Medicine, 2014 Nov;45(4): 146–51.
• Iwen PC, Smith PW, MD, Hewlett AL, Kratochvil CJ, MD, Lisco SJ, MD, Sullivan JN, Gibbs SG, Lowe JJ, Fey PD, Herrera VL, Sambol AR, Wisecarver JL, Hinrichs SH. Safety Considerations in the Laboratory Testing of Specimens Suspected or Known to Contain Ebola Virus. American Journal of Clinical Pathology, 2015 Jan;143(1):4-5.
• Herstein JJ, Buehler SA, Le AB, Lowe JJ, Iwen PC, Gibbs SG. Clinical Laboratory Equipment Manufacturer Policies on Highly Hazardous Communicable Diseases. Public Health Reports, 2019 Jul/Aug; 134(4);332-37.
• Centers for Disease Control and Prevention. (2020). Biosafety in Microbiological and Biomedical Laboratories, 6th ed.
• World Health Organization (2020). Laboratory Biosafety Manual, 4th ed.
• Cieslak TJ, Kortepeter MG, Kratochvil CJ, Lawler JV. (Ed.). (2020). Nebraska Isolation and Quarantine Manual. University of Nebraska Press.