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Support: Resources, Competence, and Awareness – Session Materials
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Transcript
Date of session: 05/30/2024
Facilitator
Aufra C. Araujo, PhD
Centers for Disease Control and Prevention
Didactic Speakers
William Pinard, MS, BRM/BSEC (IFBA)
Principal Member of Technical Staff, Global Chemical and Biological Security
Sandia National Laboratories
Allison Treloar, MS, CMDA(ASQ), MB(ASCP), BRM(IFBA)
Principal Member of Technical Staff, Global Chemical and Biological Security
Sandia National Laboratories
Aufra Araujo: Hi. Good afternoon, good morning and good evening, everyone. My name is Aufra Araujo, and I want to extend a warm welcome from the Centers for Disease Control and Prevention in Atlanta, Georgia. I am the CDC ECHO Biosafety Program lead and the Acting Safety Team Lead in CDC’s Division of Laboratory Systems. Thank you for joining our fifth Extension for Community Healthcare Outcomes, or ECHO, Biosafety Session for 2024.
The topic for this interactive discussion is Support: Resources, Competence, and Awareness. Today’s subject matter experts are William Pinard and Allison Treloar from Sandia National Laboratories in Albuquerque, New Mexico. I would like to ask everyone a quick icebreaker question, which is already in the chat so I will also read it. With the unofficial arrival of summer, many of you will be going on vacation soon. If you could take a summer vacation anywhere in the world, where would you go and why?
Let’s see. Curacao, Norway. Why? I want to know why. Stockholm. Some warm places, some cold places. National park in the U.S. Ireland. Family relatives in Ireland. That’s good.
Melbourne. Great city. Thailand. Just got back from Iceland. Beautiful landscape. Galapagos Islands. I’m with you. Who said that? Jonathan. Greece for the architecture and history. Alaska glaciers. Japan. Explore the country. Saint Croix. My gosh. I would go there too. Paris for the Olympic Games. You guys are giving me tons of ideas. Rafting the Grand Canyon in August. I love it. This is nice. Well, Thank you for participating in the icebreaker questions. Keep adding. I like to review those later as well.
Now I’d like to provide a brief overview of last month’s presentation, last month’s session in April, featuring Dr. Michael Stevenson from New Hampshire Public Health Laboratories, who presented on Planning: Developing and Achieving Biorisk Management Objectives.
Mike spoke about the ISO 35001 standard, discussed the pilot program to implement ISO 35001 at New Hampshire Public Health Laboratories, described their process to develop SMART biorisk management objectives, and highlighted the outcomes of the program. One particular quote from a participant in that session is shown on the slide. We had a total of 113 participants attending the session who were affiliated with 70 organizations.
The map on the right shows where these participants are located. The states shaded in green had participants from at least one organization. Also, in attendance were participants from eight national organizations located in El Salvador and Italy. We encourage you to share information about our biosafety sessions with your colleagues and to connect amongst yourselves via chat if you’d like.
So let me move to the next slide. Before we continue, I’d like to address some technical aspects of our ECHO Biosafety sessions. Please use the video capabilities of your device for this session. Currently, all audience microphones are muted. When engaging in the discussion, please unmute yourself to speak. Closed captioning is provided through Zoom for this session.
If you are experiencing technical difficulties during the session, please send a private chat message to George Xiang, who is labeled as CDC ECHO Tech. George will do his best to respond to your issue.
If you are connecting to Zoom by phone only at the time of discussion, please introduce yourself by stating your name and institution before speaking. We encourage your active participation by sharing our knowledge and experience.
Each laboratory is unique, and your skill sets are unique, so your contributions to the discussion are valuable. Here is a brief overview of today’s session. I introduce our subject matter experts, William Pinard and Allison Treloar, who will provide a didactic presentation and discussion. Then my colleague, Dr. Mary Casey Moore will summarize today’s discussion. Closing remarks then reminders will follow, and we will adjourn this session.
Today’s session is being recorded. If you prefer not to be recorded, please disconnect now. The transcript, audio recording, presentation slides, and other resources will be posted on the DLS ECHO Biosafety website a few weeks after today’s session.
I’d like to remind everyone that these slides contain presentation material from speakers who are not affiliated with CDC. Presentation content from external speakers may not necessarily reflect CDC’s official position.
Now, it is my pleasure to introduce today’s presenters. William Pinard is a Principal Engineer Program Project Lead with Sandia National Laboratories’ Global Chemical and Biological Security Group. In his 13 years at Sandia, he has focused his efforts on human capacity development and biorisk management systems development, including leading the development of training programs for the International Federation of Biosafety Associations’ professional credentials in Biorisk Management and Biosecurity and mentorship efforts.
He has also worked with institutions and professionals to design and execute biorisk-management system improvement projects through the CWA 15793 and ISO 35001 frameworks.
He serves as the country lead and strategic direction of Malaysia, the Gulf Cooperation Council, Türkiye, and has previously led work in Morocco, Egypt, Jordan, and Pakistan. William holds a Master of Science degree in Biodefense from George Mason University and is professionally certified in Biorisk Management and Biosecurity by the International Federation of Biosafety Association.
Allison Treloar joined Sandia National Laboratories’ Global Chemical and Biological Security Group in December 2022. She has spent over 35 years in pharmaceutical, academic, and clinical laboratories, most recently as director of the Office of Quality, Safety, Security and Emergency Preparedness and is the Responsible Official in New Mexico’s Scientific Laboratory Division. Allison’s experience spans high containment operations and management, regulatory compliance, quality management, personnel management, hazardous-material shipping, staff-training programs, emergency preparedness and response, laboratory security and inspections and audits.
She has served on numerous committees for the Association of Public Health Laboratories, or APHL, and holds credentials as a Certified Medical Device Auditor from the American Society for Quality and as a Molecular Biology Technologist and Specialist In Laboratory Safety from the American Society for Clinical Pathology. She is a certified Biorisk Management Professional through the International Federation of Biosafety Associations. Allison received her master’s degree in biology from Southern Connecticut State University. William and Allison, the floor is yours.
William Pinard: Excellent. Thank you so much, Aufra. And good morning. And good afternoon and evening to everyone here. I’m very excited and honored to be able to present to you on this. As Aufra mentioned, we have a task of covering a part of the ISO that I think often gets overlooked at times and can be a challenge. And so I did have to put in my front slide, of course, as with the CDC, while I am a Sandia National Labs employee, my thoughts and representative of my own and not the organization I work for.
Anything that we have in here are for illustrative purposes and we find these to be useful materials, but we’re not endorsing any company’s products or anything along those lines. And a lot of these resources do change over time. So we can’t speak towards the accuracy of them as they go forward, but they’ve been very useful in to us over in the past and hope they will continue to do so. So if you want to go into the next slide, please.
So as mentioned, this part of the ISO, the operational controls are really where everyone I think likes to focus in on. But the support functions are really critical. And so we’ll be talking about resources, competency, and awareness sections. And then we’ll leave to our next presenter, Marian Downey, next time, to cover things like communication and other critical pieces. When we talk about resources, we’re going to do it in two parts using both definitions of the word.
One being the actual resources that you’ll need at an institution to be made available. But secondly, the resources is in documentation that’s available out there to help support your laboratory and figuring out what you need in your own institution. As you’ve heard, I think over the last several sessions, including from Eric Cook on the system survey, kind of looking at a systems approach, understanding your own needs is the first step to making sure you get everything organized in your system, and ensuring that you have the right assessment that tells you this is what’s important.
These documents will allow you to help sort those out and put them into place for your own execution. So starting off on the resources side, we have some considerations for resource planning and allocations. And these all will go into your risk assessment to make sure you’re on the right path. And this comes to what kind of workers do you have, your skill sets, what kind of succession planning do you have as people turn over and move forward in the organization, and understanding where your turnover is going to occur.
Additionally, what kind of expertise you have, what kind of subject matter experts you have in specific topic areas, where you cross-train, understand their competency, mentoring, supervision, professional development. All of these pieces will be critical in understanding your own staff. Additional understanding, what kind of financial resources you will need. People often look at fancy new buildings, but the things that usually end up costing more over time is all of that maintenance, all of that work that goes on the everyday basis, the budgeting, figuring out where you’re going to be going in the future, and predicting all those things that are really easy to predict, like pandemics and everything else that resources will be pushed and strained upon.
From a building perspective, understanding your infrastructure, your equipment, the utilities and services, installation, and all these pieces are ones that I know– in the work that I do, mostly overseas, can be a challenge to figure out how do we find the right resources to make sure that these things are maintained over time. And it comes back often to this last one of maintenance here. One thing that I’m sure everyone is always looking for is more time. And so making sure you have an adequate amount of time to perform the work to ensure that all the staff are not overworked and able to complete their jobs both accurately and at a safe and measured pace.
In addition, all these other things that come in are– can we go back? We had one last line there. Looking at the performance aspects and understanding how both internal and external audits can come into play, how do you do your own performance measurements? how do you report that to leadership? And looking at all of the other functions of administrative and support. So we can jump right into the next one.
So our first question we want to fly out there is what resources are used in your own organization for guidance and meeting standards and regulatory requirements? And we have a few big ones, including the BMBL, the WHO Lab Biosafety Manual, national associations and society guidelines, like APHL or ASM. Or you don’t typically use any of the international resources or you only reference regulations and inspection guidance and documents. So if you want to check off ones that are relevant and then click submit.
So we see a lot from the BMBL and national associations with some– actually, more than expected on the WHO Lab Biosafety Manual. It’s great to see. And then, some WHO– Just what the requirements are. So that’s great to see. Excellent. Thank you. And going on to the next slide. So I’m going to talk briefly through a series of slides with lots of different resources on here.
I’m not going to go into a great detail on them just because we only have so much time. And we want to make sure this is all of value here. But you’ll see that George just put into the chat an example, a PDF with all the links to all the resources that will have throughout this entire presentation, so you can dig in and, and dig deep going through these. But we’ll look at international resources, like the ISO and CWA documents, things from WHO, including also some from the World Organization for Animal Health (WOAH), ABSA, IFBA, and Public Health Canada.
And then looking into the national ones, like the BMBL and others there, going into state resources and then jumping into some of those key programs at the end that kind of every institution will need for moving forward and their own institutions. Next.
So starting with the ISO and CEN Workshop agreements. So ISO 35001 is the big one. And that’s what we’ve been talking about in all of these sessions. There’s also the European Standards Organization.
It has a series of workshop agreements that are now expired or on their way out but are still very relevant and have a lot of useful information, especially what’s listed here, the CWA 16393. It’s the implementation guidance, which until the ISO implementation guide comes out, this serves as a very useful document to look at how to turn the ISO or other biorisk management systems into something in practice.
Over time, we’ll be able to add to the ISO realm, a similar document that will help even more. So we’re looking forward to seeing that hopefully soon. Next?
From the World Health Organization, they’ve recently, in the last five years or so, in 2019, they released the Laboratory Biosafety Manual, Fourth Edition, which has really been a shift in the way that people look at biosafety and it relies less on things like biosafety levels and more on risk assessments and understanding your direct needs.
They also have a series of monographs that are detailed looks into specific topics, including risk assessment, lab design, biosafety cabinets, personal protective equipment, decontamination and waste, and then outbreak preparedness, and resilience. So there’s a lot more detail, a lot more things to look at along the way as you look at the biosafety manual. And then, the Laboratory Biosecurity Guidance has been around for a very long time now. It’s from 2006. But we know we’re almost imminent due for the release of the new version of that.
So that’s something to keep your eyes out on, looking at a risk-based approach to biosecurity, which should be released I think in the next few months at the latest is kind of what I’m hearing. But some great guidance to look at the best practices perspective and risk-based perspective of these topic areas. Next.
I did want to pull in– and even though we’re here from a human health perspective, the World Organization for Animal Health has a section in their Terrestrial Manual, which covers biosafety and biosecurity. And the reason I wanted to plug this here, and, again, later on, is that there’s greater and greater emphasis on one health and the approach of bringing the two together. So oftentimes, the veterinary sector and the human health sector come together and these programs. And so, the more you cross understand where each other is coming from, I think the better. And I know even– and Allison can probably speak all day about the coordination between the human and animal health labs within the Scientific Lab Division in New Mexico.
So understanding what their resources are, I think is a great benefit as well. Next? So looking at the next poll question, we wanted to see, do you feel that your organization has adequate resources to assess biosecurity specifically? It’s yes, we have excellent resources. Yes, but resources are limited for some aspects. No, it’s difficult for us to find ways to assess biosecurity. Or no, we have no resources for assessment.
And while people work on this poll, I think, typically speaking, when you look at the biosecurity side of things, it’s not as well developed as the biosafety side. People have been thinking about and doing biosafety a lot longer than biosecurity. So oftentimes it kind of gets added onto. And it fits in a weird spot between biosafety officers and security officers, at least in the U.S., and probably even weirder places on the international scale.
I think this is a topic area that that’s always one that can use a little extra attention and a little extra thought from those who are involved in safety to ensure that there’s benefits on both sides. And so I’m glad to see that we have a lot of resources out there, maybe still limited, but 64% having at least resources, but are limited, or 25% for excellent.
Hopefully those who are finding it difficult will be able to benefit from some of these resources, the Lab Biosecurity Guidance and things like that, to help think about their own practices without the need for lots of extra resources, because, luckily, looking at free documents is free and can help push things along a little bit. Next slide?
There’s lots of things to flag from professional associations. And I wanted to put under the international resources, ABSA International, while it’s primarily a U.S.-based organization. And seeing a lot of the names on here, we have lots of representatives from there.
They are attracting greater and greater international attention and partnerships and individuals. So they are becoming a kind of a greater resource on the international side. But they have training courses that allow for access to lots of different resources, including things like their Principles & Practices of Biosafety, their annual– both their Biosafety Conference and biennial Biosecurity Symposium. Lots of webinar series.
And I did want to plug the Training Tools & Resources group that’s there. This committee gathers resources from all over to try to consolidate a lot of information that can be shared freely throughout organizations who are looking for additional templates or training materials, or documentation, or whatever it may be. And I put the link in here. As you have your own, you can also submit those things to be shared within the community as well. So this is a crowdsourced group to allow for lots of information to be passed back and forth amongst the biosafety community. Next.
Finally, on the international side, Public Health Canada does a lot in the biosafety world, both within Canada and internationally. So I did want to flag that they have their Canadian Biosafety Handbook, and then also, they have a series of Pathogen Safety Data Sheets, similar to any other data sheet that you’d be looking out for, but on the pathogen side.
And I think was trying to do a count earlier, and they’re well over 100 different pathogens that you can access and it gives you all sorts of details on them, which I think is a thing that’s very valuable and seen, and used throughout the world. The one thing to note, the Canadian Biosafety Handbook is set up very similarly, I think, to some of the U.S. side, as it’s very regulatory based for Canadian resources.
So that’s the only thing to be careful about is understanding what parts are their requirements and what parts are best practices along the way. So we can go on to the next slide. And as we jump into the– and then this last slide on international, there’s lots of other databases and banks to look at. You’ll see that the International Federation of Biosafety Associations, IFBA has just banks and banks and banks of resources and documents.
You’ll see similarly APHL, the Government of Canada, Netherlands, Denmark, and others have lots of different resources out there or libraries of resources. And then there’s also here Biosecurity Central that’s based out of Georgetown University in a consortium with others that are just massive resource dumps that you can look at and find very useful information, including anything from risk assessments to documentation, and beyond, depending on which one you look at. So now I will turn it over to Allison to keep going on the state and national sides.
Allison Treloar: All right. Thank you, Will. So happy to be here with everybody today. So our national resources come out between the CDC and the NIH. We have, of course, the BMBL, which was updated in 2020, and takes a risk-based approach to biosafety, laboratory biosafety. Of course, the CDC’s Division of Laboratory Systems, Biosafety Resources and Tools is a fantastic resource to consider and peruse through that site. There’s lots of great information in there.
The NIH Office of Science and Policy has resources as well. Dual Use Research of Concern is something that can be accessed when we’re looking at biosecurity. In our facilities, there’s lots of different frequently asked questions and fact sheets. And there’s the National Science Advisory Board for Biosecurity, which is a great resource for current biosecurity concerns and is for your facility. Can I have the next slide, please? Thank you.
So I’d like to talk a little bit about a regional associations and some other government entities at the national level. They’re affiliate organizations, such as the New England Biosafety Association, which is one of the older biosafety associations in the United States. Chesapeake Area Biological Safety Association is another one. Arizona Biosafety Alliance. There’s Front Range Biological Safety Association, and plenty more around the country.
And a lot of these associations have either in-person regional meetings, or since the pandemic, of course, online virtual meetings. Certainly, sign up to be part of their groups and monthly webinars, informational webinars, and resources that you can tap into. The Department of Transportation, of course, has the manual for Transporting Infectious Substances Safely. That becomes important as a lot of our public health laboratories are part of the LRN and we’re constantly shipping and receiving hazardous materials and potential select agents.
And then on the animal and plant side, the USDA Agricultural Research Service has an annual Biosafety and Biocontainment Symposium. And they post the products of that symposium for review. And they also provide professional development courses. So you can log on and take online course and get information that way, or disseminate information to staff in your facility that way. There’s also the USDA’s Biorisk Management Manual, which is published along with APHIS, the Animal Plant Health Inspection Service. And it provides a great way to manage biorisk with animal and plant health and laboratories. Next slide, please.
So with the state level, there’s a lot of hidden gems. We have national, international resources and regional, but there’s a lot of expertise that’s really right next door geographically speaking. And it’s really worth it to look around in your own state and in the other departments, not only in your health departments, but all these other hidden departments that you may not interact with and cultivate resources and relationships right in your own state.
So what types of documents and resources do you see at the state level that would allow you to better implement safe and secure practices in your laboratories And you can put some ideas in the chat. And we’ll take a look at those. We’ll give you a minute to think about it. Yeah. You just– go ahead.
Aufra Araujo: Allison, I was just going to mention, I see that people enter some comments in the chat, and I saw that Will was responding and commenting. But people can feel– if you feel comfortable, you can unmute and talk as well, or enter in the chat. If you want to turn on the camera, that would be even better. But, yes. Back to you, Allison.
Allison Treloar: Thank you. So I see in the chat– you can reference biological waste regulations. Absolutely. Environment departments handle the waste. The North Carolina Department of Environmental Quality. So we know where to go to for waste. And these are great, because that’s extremely important in laboratories. We generate quantities of waste and different types of waste.
And we need some expertise to call on about disposing of these. And Tennessee Department of Environment and Conservation. And private labs share best practices. That’s a great resource. The difference between public labs and private labs is usually funding and resources, in my experience. So they may have some resources and practices that we can learn from and share.
All right. Well, thank you. So my next question is, do you rely more on local resources or national resources to improve your biorisk management? And I know we had the poll question for international resources, but do you use national resources? And then, which ones do you find most helpful? And again, you can enter in the chat or unmute.
All right. We have California OSHA. The comments are coming fast and furious. So I’m trying to keep up.
William Pinard: It looks like we have lots of national. We have– my favorite answer is it depends.
Allison Treloar: Yep.
William Pinard: Yep.
Allison Treloar: That is the wide perspective. Because as laboratories, we’re subject to regulation and we tend to focus on national and even accreditor standards. And so looking out, looking outward nationally can be hard, because we’re focusing in on our specific requirements. We need to– OK. We need to pass our inspections and be credentialed and certified. And that’s important to our organizations.
But there’s a lot of resources out there to use. We have both, CDC, national. Excellent, excellent. So it’s good to see that there’s a lot of broad use of local and national resources. All right. The next slide, please. So in the state of New Mexico, which is my experience and my career, we have lots of little hidden departments that you may not think about that we can go to for resources. And to realize not all states and regions are organized in the same manner, but I can tell you what we have here in the state of New Mexico.
There’s the Bureau of Health and Emergency Management. And their brief is to provide state-wide incident management, hazmat response, radiation detection and response. The Department of Homeland Security and Emergency Management, of course, more of a federal agency, but located in the state, so we can go to them for emergency management and preparation training. They provide lots of state-wide training to first responders.
And as laboratories concerned with biosafety and biosecurity, they are happy to tell you, more than happy to have you involved in their emergency management resource for information that you may not know on the federal level. So we have FBI with our weapons of mass destruction coordinators. These are located in every state at your FBI, friendly, local FBI office.
And they can really provide resources for facility security and personnel reliability. That’s their expertise. And they’re also very happy to help out. The Environment Department, I think that was the number one answer in state resources that are used. There’s a hazardous waste bureau. New Mexico also contains the OSHA office. So for worker safety concerns in New Mexico, they’re located there. There’s– pardon me.
There’s the, of course, Department of Health, which is a broad ranging octopus of a department in all of our states. And that’s where you’re going to find most of the information on vaccinations of your occupational health specialist, if you don’t have one on site. And of course, your friendly neighborhood epidemiologists who have all the great information on public health that you’ll need for the risks that you identify in your own laboratories.
So it’s really worth investigating and establishing connections with your colleagues in different departments and agencies. And you can use state-wide networking opportunities to introduce yourself and make connections, because as emergency responders say, the worst time to meet people is during an emergency. So get to know these people and make connections. So since we ended on Department of Health, let’s go to worker health programs on the next slide. And getting a little bit more into the ISO 35001 requirements.
I serve on the working group for the implementation guidance for 35001, so I take it personally when everybody mentions that it’s not out yet, but we’re working very hard and we’re hoping to have it out by at least the end of this year or the beginning of 2025. It’s a pretty deep document. So what I’m going to give you really is a little preview into what our group is considering for inclusion into the implementation guidance. And it’s not written in stone and it’s not approved, but it’s just what we’re thinking about as considerations for each of these 35001 standard points.
So your worker health program says the organization shall ensure that risks to worker health are managed effectively. Well, as usual, it’s a very broad statement. So how are we going to address that? And some of the points that we’re looking at are that organizations should really determine what the scope and components of your health program are based on the risk in your facility. Are you going to include a pre-employment health check?
Are you going to ask about prior exposures or existing conditions? What kind of worker medical history do you want to take? Are you going to identify specific people who could have potential exposures based on job duties? What are the mitigation measures you’re going to use? What are the emergency measures? If you’re working with something pretty bad, everything from isolation to transportation, are they going to go to a local ER?
Are they going to isolate at home and not come into work? What kind of prophylaxis or post-exposure treatment is going to be available? And then, what kind of, of course, records are you going to keep? And then, what are the outputs of your program? Are you relying on prevention? Do you have contingency plans? Do you have plans that cover contractors and visitors?
Is there going to be increased awareness or provision of information to workers on the potential risks, signs and symptoms and consequences of exposure? OSHA did that, so it’s probably a pretty good thing to include. And then, how are you going to measure program effectiveness? So that’s a little preview of worker health programs. And let’s move on to the next slide.
William Pinard: And, Allison, I did want to just point out, we just heard from the– also keeping in mind, the state regulations that may include what can and can’t be included.
Allison Treloar: Yes, yes. Also very important. Thank you for pointing that out. All right. So 35001 does drill down a bit on vaccination programs. There’s requirement to establish and implement vaccination policy as part of the worker health program. So how can we go about this? It should, of course, be based on the risk assessment and cover any workers who may be potentially exposed. It should identify any workers, visitors, or contractors, or anyone else who may be exposed and are eligible for vaccination based on that risk.
We should control access to areas where work requires vaccination. So you’re not going to just let anybody want into the rabies lab, perhaps, that isn’t vaccinated. There must be a schedule for titer checks. Efficacy and safety information provided any conditions for pre- and post-employment vaccinations. A procedure for declination. And then, also what happens if there are non-responders to the vaccines, because those people are out there. And you have to have a plan for that.
And then, of course, records retention. So this is just a little bit about what the working group is suggesting for that. And I’m going to turn it over to Will for the next set of slides.
William Pinard: Excellent. Thanks, Allison. And I apologize. I had to turn off my camera. My internet is pretty stable where– unstable where I am right now. So trying to make sure I don’t lose everyone. But after looking at the resources, jumping into the competence section, and wanted to talk through just a series of things that look at competency and certification before jumping into a few key aspects that is covered within the ISO, such as behavioral factors and worker management, and personnel reliability. So we can go to the next slide?
I think we got lucky in our timing here. So we have– the CWA 16335 was the biosafety professional competence. And just as we were putting together this slide deck and sending it in that day, the ISO dropped 81240, which is the ISO version of the same updated document. So ISO now has a standard on professional competency as well for biosafety. We listed out some of the key things that you see here, including what kind of things that the CWA talks about, such as the role of the professional within the organization, qualifications and background, and going into the detail of what it does.
And it had 25 core competencies listed from the idea of– oh, boy. We just went all over the place. So everything from the general coursework requirements and education to the specific areas, from occupational health and biosafety and human factors, and many, many, many more. But then it also covers lots of things like models of how these different things can fit within your organization. So it gives you some training specifications and tasks that professionals should be doing, and things of that nature.
So these outline what the options are. And yet we can go on to the next one. So our next poll question, we wanted to see, do you feel that external worker certifications or credentialing would help to promote a culture of biosecurity and biosafety in your organization? And while this comes up, I did want to note we had a few other comments that came in.
So earlier on, there was a few others that suggested some additional resources out there that are excellent. And we had a question about food safety and animal health as well. And all of these resources, I think, are valuable for all of them. The one thing to note is that oftentimes food safety has additional kind of considerations and requirements from a national and international perspective. So I just want to keep in mind that this would be a baseline for some of those discussions, as opposed to the big picture for it.
So it looks like a lot of people think it could be useful, a few not, and some kind of on the fence. So we will talk about a few of them here and look at what they are, a little bit. Given the time, we don’t want to spend too much time on it. But if you go to the next slide, we can start looking at what some of those that are out there. Because we have a fair number. And I won’t go into the details here, but this is from ABSA International.
They have two primary credentials, one of which is being a Certified Biosafety Professional and the Registered Biosafety Professional as the second. And these are both two credentials that you get as a well-established biosafety professional. These aren’t ones that you go out and get on day one. It takes into account a lot of experience and knowledge before you’re able to get this. You can see here, it’s a relatively limited number. And I hope these numbers are correct.
I got these off of the ABSA website in the last two weeks, so it should be pretty close. But it was me counting them manually in an Excel spreadsheet, so I may be a little bit off. But these are the gold standard that you see, people who are CBSPs and RBPs are well represented within ABSA and have shown that their work has been well recognized by the community. And if you want to go on to the next slide, you’ll see that there’s a newer credential that’s out there on the international scale.
And this is from the International Federation of Biosafety Associations. And they have a series of credentials. One is kind of their level one, which focuses on biorisk management. So biosafety and biosecurity. And then, level two, which focuses in on specific areas within that. So biosecurity or waste, biosafety cabinets, and others. And one thing to note here is– I think this one serves a really good purpose in helping to kick start someone in their career. It’s not for day one, but it’s something that early on in your career, you can work towards something like this to become certified—
Excuse me. To show that you have a pretty solid baseline for biosafety, biosecurity, and the specific areas, as opposed to the absent ones, which take I think a lot longer and greater expertise to get to. And so this is I think a good one to look at for early career professionals who are building out their expertise before they get to that point. So this is a way that you can get at least early recognition of your competency, prior to spending the many years it may take for your RBP or CBSP. Next.
And I’m going to jump back to Allison for this one, as she has, I think, far more experience in it than I do, and she can give a lot better experience for that.
Allison Treloar: OK. Thanks, Will. So nationally and internationally, the American Society of Clinical Pathologists offers a Qualification in Laboratory Safety, a QLS. And it’s really for professionals involved in any phase of laboratory safety– would be in compliance training, developing or managing programs, and also, if you just work in a laboratory, it can help you have an actual credential saying that you work safely and you know how to work safely in a laboratory.
And some of the competencies for this qualification is in management. So we need to know our regulatory requirements and agencies, and your regulations and guidelines. General safety, so ergonomics, fire safety, electrical, how to work with compressed gases, a little bit of radiation safety. Work practices, and, of course, the universal how to clean up that spill. Chemical safety is included, because you rarely work with biological agents without grabbing a chemical. So we’re going to go over the classifications.
Incompatible mixtures. Signs and labeling and, of course, how to manage your chemicals. Biohazard control mostly from an infection-control perspective and protocols that are used to prevent exposure. And lastly, physical environment. Equipment use, disinfection and decon, disposal and waste management. So these are all parts of the qualification in laboratory safety from the board of certification from ASCP. And it’s really just an exam-based certification. You can register for it and take it on and get your certification.
So on paper, we can show that we know the concepts of risk management, but how do we manage the behavioral factor? Somebody can show you a lot of paper that they’re qualified, but, really, how do we know who they are inside when it comes to safety? Can we have the next slide, please? Thank you.
So we have to look at competence and behavioral factors and worker management. So how are we going to address the risk associated with inappropriate behavior? Or what people do when they get into a laboratory and are under time pressure or some kind of pressure? We have to take a preventative approach to managing risks associated with individuals and using our risk assessment, what those risks are, and mitigating them. So we can take a varied approach to managing our behavioral risks.
We have our documents, procedures, checklists, and SOPs that are going to tell you exactly what to do and when to do it, and how to do it if they’re good. We have our occupational health and safety program to have our prevention and response to exposures. We want to have manager training in observation and recognition of behaviors. We always talk about changes in behaviors. What change? Does their behavior change?
Promoting personal reliability. That’s part of a culture of safety. If you see something, say something. Don’t walk by that spill. Don’t let that unidentified person into your building.
Establishing communication, consultation, and feedback processes. If workers are constantly berated for bothering people with their problems that aren’t really problems, they’re not going to come and report situations that are unsafe or security issues to you. Conflict management and resolution.
If there’s problems with coworkers and you let it go, and it’s unresolved, those are going to boil up in the laboratory and there’s going to be increased risk and safety risk, and security risks there. And while we’re doing that, we have to respect individual privacy and dignity. And that’s we can do that by just not posting people’s names and talking about what’s going on with individuals and keeping everything as private as we can within our risk management program with regard to individuals.
All right. Can we go to the next slide, please? So 35001 directs us to provide assurance that workers are reliable, trustworthy and competent, and to identify individuals who may pose a biosecurity or biosafety risk. And we need to be as transparent as possible when we’re performing this. And we can do that by identifying people through a risk assessment or how we’re going to identify those people in the risk assessment. Management is the one that’s ultimately responsible for establishing the policy and the program for personnel reliability.
And they can do that by defining personal reliability requirements for each position in the organization. As we know, there’s a wide variety of responsibilities in a laboratory and some of them have pretty complex responsibilities. And we need to point out who those are and what type of reliability requirements we’re going to look at before they get to a point where they’re handling things like select agents or radioactive materials. We need to control access to materials and location based on risk. So that’s going to be part of your risk assessment and policies.
Who are we letting into what locations and under what security requirements? We need to establish a screening program, at the very least, identity verification, education and employment, and then have periodic reviews when responsibilities change. And these measures should determine the willingness of personnel to support a strong safety and security culture. Because, I think, in every organization there’s always one or two people who are going to do things that maybe not so safe or not so security conscious, based on their own personal beliefs and experience. And we need to know that as soon as possible, so that we can make sure that we can control access to information and materials, so they remain secure and safe.
And then, these requirements have to be consistent with everyone to the point of each person in each role, transparent and documented. And any screening results that we do have, we’re going to treat them as sensitive and personally identifiable information. So that’s where you want to get human resources involved and make sure that there’s a method in a way to document these and keep it secure. Can I have the next slide, please?
All right. So we have another poll question. And our bunny is going to ask what resources– Oops, my question got you covered. There we go. What resources are available to you for training? And you can select all that apply. Are they going to be organization-provided training in house? External subject matter experts that come in? Anything from national societies or associations, online material, in-person meetings, other laboratories or universities material?
Do you go online and look for other programs? Subscriber-based programs that provide webinars. Regulator or certifier programs that offer some training or self-study. And we’ll give you a minute to select those.
All right. And the results are in. OK, a large number use organization-provided, of course. Wonderful. National societies and association material. 84%. A lot of other laboratories in universities, subscriber programs, and regulator certifier programs. Or lower. Anything that’s free is wonderful. And self-study programs are also used at a pretty high percentage. That’s surprising. Good. All right. Thank you so much for answering. And I’m going to hand it back over to Will.
William Pinard: Thanks, Allison. So going into this last section on awareness and training, we’re going to go through this relatively quickly. We want to make sure we stick within our time, but we’re going to think a little bit about how are staff made aware of program elements. We’re going to talk about a few different training opportunities before we send you back over to the CDC. And if you want to go to the next slide, I did want to point out that Joe Kozlovac had mentioned that there’s also, outside of what we’re talking about here, a risk management certificate, which I think would fall nicely within our conversation on training.
It’s a 15-credit program from Indiana University of Pennsylvania that focuses in specifically on biorisk management. So that’s another resource out there that we didn’t have on our list. But definitely fits the fits the idea. So just to, again, get you guys asking a few questions here. When we think about resources and competencies, they’re critical for the effective design and development of a strong biorisk management system. All of the preparation in the world will be useless, though, if you don’t distribute that out to the working staff within the institution.
So just to think about a couple of questions here. At your facility, how were you made aware of your biorisk management system, their policies, any sort of investigation outcomes, performance, nonconformities or anything like that? How do you actually get your information on the system itself? Who is responsible for ensuring that the staff actually hears these things. And what does biorisk management training look like in your facility?
So a few different things. If you want to either unmute or toss in the chat any thoughts there. We’d be curious to see what it looks like on your side. And also, I see that Martha as well has added a few things while we see for responses, that the CDC has documents on personnel suitability for select agents. And then also she had mentioned before on employee medical records and retention. So there’s, there’s lots of resources out there.
I’d love to see all the extra resources come in. And so maybe, George we can add some of those to the list that we have already, because the more resources, the better is always my opinion. And so, anyone have any thoughts on just how things are reached out to for your biorisk management system? How do you find out about this information?
Travis Burns: Hi, this is Travis Burns with UC Davis. We get notified we have a lab safety program lead, who gets notified of new PIs coming in, and they reach out to get set up for lab hazard assessment training and if they need any BUAs or any other chemical inventory things. So it’s mostly just– we’re at the mercy of the UC letting them know.
William Pinard: Excellent. Thank you for that. Yeah. And I think that’s the case in a lot of places. But it’s nice to have the new hire pieces as well to make sure that they’re being brought in and up to speed. I see a few other comments coming in about routine internal auditing and annual requirements. are required, especially with BSL level-determination for job descriptions, in-house training, safety updates sent out to the labs, inspections. All those things are ways to disseminate the information.
So it’s something that you see a lot of different ways to get this out there. And I don’t want to go into too much detail, because I don’t want to get in the way of Marion Downing for the next talk that will cover communication, because of how critical communication is to a lot of these pieces. Can we go to the next slide? And we just had another one coming in for who’s responsible and that’s the safety and security officers. And the directors are responsible for their awareness.
And the training is completed on a monthly basis, both online and in-person. So that looks like there’s lots of great things going on at Rolinda Bailey’s institution. That’s great to see. So we talked just about a few different options here for awareness, some of which are training, some of which are just making sure people are aware. And that’s things internal, including some of the office staff trained events can be on or off site, dedicated meeting times, lunch and learns, announcements. We see lots of flyers and posters and emails, and listservs, and all of those fun ways to communicate electronically and in paper form.
There’s also a lot of external trainings that happen from different types of subject matter experts, whether it’s roadshows by a wide variety of specialty individuals, nonprofits, associations, government bodies, private companies doing demos of their new trainings, their new equipment. You see these things that at ABSA. At all of their conferences, they have all the different vendors showing off their, their latest and greatest as well. So there’s lots of opportunities in awareness for training there.
If we go on to the next slide, we’re going to talk just about a few specific things that are out there before we wrap it up. Can we get the next slide, please? Thank you. So we’d be remiss if we didn’t bring up CDC and NIH, and the Division of Laboratory Systems biosafety trainings that have things that go into chemical fume hood safety, centrifuge safety, and biosafety cabinets, risk management, and other things. The big courses that you see for people who are really diving in as a professional is also the National Biosafety and Biocontainment Training Program, which is a two-year program that’s kind of a research training award that goes into all sorts of specialty pieces on biocontainment.
And you’ll see the images there of someone working in a suit practicing their dexterity within their PPE. So this is a routine program that goes through the NIH that I think has been really valuable, getting some high caliber and quality biorisk management professionals. And you’ll see in the top right-hand corner some of the different areas that it covers along the program. Next slide.
Next, there’s lots of different things that look at how to become credentialed for the HIPAA certifications. And these are just a few places that do this. Some groups like the Frontline Foundation, the Biosafety Training Institute. Other professional associations have specific trainings. These are typically on the international side, but we always want to throw out what options are there. And even our own group, Sandia National Labs. As I mentioned, I’m the lead for this type of program, but these are currently special access required.
But we’re trying to find a way to make it open to the public. And so, if we’re successful, we can try to make that known, where we have 12-week study programs for biorisk management and security. And we’re currently working on a waste management one. And I’m sure more moving forward from there. Next slide?
Then for training, as well– This is something that we’ve had available in the past. And Sandia has a global buyer risk management curriculum, which is, I think, currently 42 courses plus some draft and piloted courses that cover four to eight hours that look at all different aspects of buyer risk management, from a laboratory level, a management leadership level. And there’s some that are kind of on a restricted side, that are laboratory design, but these have the materials, plus all the instructor guides and everything else to go along with it.
And then any kind of additional SOP, templates, program plans, manuals, and things of that nature. So that’s something that we try to make available where we can. We have some restrictions, but our team is always willing to work and see how we can make this as broadly available as possible. Next slide, please. And so, really, just to wrap it up in this last minute or so. having the right resources for your facility is essential for the safe and secure operation of your laboratory.
Making sure that all those pieces get hit from worker health and vaccination programs to the resources that you need for infrastructure maintenance and equipment, and everything else. Ultimately, it’s the responsibility of the organization to provide appropriate resources for the system, which is always a challenge and I think something that we all recognize it can be tough. And then organizations around the world have put together content to support the strong development of a system. So the more we can share, there’s no need to reinvent the wheel.
From a competency perspective, understanding and documenting a facility’s competency needs is really critical. And there’s a lot of credentialing programs in existence to really ensure that those minimum standards can be met. And then behavioral and other human factors are a growing field and getting more attention to ensure that personnel reliability needs are met to protect the workforce and the facility. And then, finally, from an awareness perspective, we just kind of touched on this a little bit, but creating a system will not improve safety or security if the staff doesn’t know what the system is.
And I think that’s probably the biggest thing that thought I can say for these systems is their execution is critical on the staff to understand it. And previewing for a next session, communication, communication, communication. So, Marion, hopefully, you’ll talk about communication. And then, finally, understanding the different training requirements of different staff members is going to be essential to establishing a well-organized and structured system, as different groups within your laboratories will require different levels of knowledge and different levels of capabilities.
So you may be able just know and be aware others need to be able to apply and execute actual actions. And Dee Zimmerman is also talking about documentation next month. Excellent. That is a one-two punch that I hope to be able to see. I don’t want to miss that one. So with that, thank you guys so much. I appreciate all your time and attention and added resources and everything else. It’s been a fantastic time. And over to you, Aufra.
Aufra Araujo: Thank you so much, Will and Allison. We have a few minutes. So if anyone has any questions, please feel free to unmute and ask your question. OK. All right. If there are no questions– I see thank you notes in the chat, which is excellent. That was excellent presentation and discussion. So I will invite my colleague, Dr. Mary Casey Moore, who is a Health Scientist in the CDC Division of Laboratory Systems, to provide a summary of the discussion during today’s session. Mary, over to you.
Mary Casey Moore: Thank you, Aufra. Can you hear me well? Good. OK. So between the poll questions, collaborative group discussions, and our Q&A session, the group covered a lot of ground today. So here are some of the key points that were brought up. During our poll questions, we learned that 89% of the group utilizes the BMBL for guidance in meeting standards and regulatory requirements, followed by the national association guidance documents with 62%. 64% of the group also felt that their organization had resources for biosecurity but were limited in some aspects.
Majority have felt that having an external worker certification would help promote a culture of biosecurity and biosafety within their organization. And lastly, when looking at the types of documents available for training, majority use national association materials. However, there are responses had high input as well, including organizations that provided training themselves, laboratories or university materials, and also external subject-matter experts. During our plenary discussion, we also explored the types of documents and resources available at the local and national levels.
During this time, the chat chimed in, saying that they rely more on national resources to improve their biorisk management, which mimic what we saw in the poll. These included resources from APHL, OSHA, Canada Pathogen and many others. It was also noted among the group that many use both local and national resources, and that national resources provided wider perspectives and good virtual training options. When addressing awareness, many people in the chat noted that there are multiple avenues to ensure staff are aware of biorisk management systems, including onboarding routine, auditing, in-house trainings, safety updates sent out from the labs, competency assessments and others.
Some also mentioned that the safety/security officers and directors are responsible for this awareness, with managers and supervisors being responsible at section levels. Overall, today’s discussion highlighted the importance of not overlooking this plethora of resources we have in our tool kit. And we appreciate everyone’s active participation in these discussions. William or Allison, would you like to add any additional details about the discussion points that I may not have covered?
William Pinard: No, I think you covered that very well. And I do just want to say thank you again. And if there’s anyone who wants to reach out with any questions, I’m happy to have them share my email and they can reach out to me directly.
Allison Treloar: Yeah, absolutely. I was very, very pleased with everybody’s additional resource information. It’s good to see where to go and where to get good quality.
Aufra Araujo: All right. Sorry about that. I’m having some technical difficulties here. And I’m just launching. OK. All right. You should be able to see the slides now. Is my presentation–
William Pinard: Yeah. I’m sure.
Aufra Araujo: OK, good. So thank you. Sorry about that. Thank you for your terrific presentation, William and Allison. And for the summary, Mary. Also a big thank you to the members of this biosafety community of practice for participating in the discussion today. Now, I would like to talk about the post session survey. The QR code on the slide in the link in the chat will take you to the Qualtrics survey. This survey should take no more than two minutes to complete.
Your responses will be anonymous. So no unique identifying information will be sought or kept. In the feedback we receive, we will be summarized in aggregate only. Your participation is voluntary, but we strongly encourage so we can continue improving the ECHO Biosafety Program and achieve better outcomes with this community of practice. We appreciate your time in completing the survey. If you have any questions about the survey, the ECHO Biosafety sessions, or if you have a laboratory biosafety challenge you’d like to present during the ECHO Biosafety session, please reach out to us at dlsbiosafety@cdc.gov.
So the next slide. We are excited, as we mentioned before. We are excited to have our next session on Tuesday, June 25 at noon, Eastern time.
William Pinard: It looks like you’re back, Aufra. Yes.
Aufra Araujo: OK. I’m sorry about that. Let me start from the slide. I don’t know what’s happening with my computer. We are excited to have our next session on Tuesday, June 25 at noon, Eastern time. The topic of discussion will be Support: Communication, and Documented Information presented by Marion Downing and Dee Zimmerman. As a reminder, you can access the transcripts, audio recordings, and presentation slides from previous ECHO Biosafety sessions on the DLS ECHO Biosafety website.
And with that, we will adjourn. Thank you for attending today’s session and I hope you were intentional about having a safe and fantastic day. We look forward to seeing you again next month. Bye.