Biorisk Management: Continuous Improvement

Transcript

Date of session: 12/17/2024

Facilitator

Aufra C. Araujo, PhD

Centers for Disease Control and Prevention

DLSbiosafety@cdc.gov

Didactic Speaker

Patricia Olinger, JM

Varro Life Sciences

BEAMS, LLC

patty@varrobio.com

Aufra Araujo: 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 the CDC's Division of Laboratory Systems.

Thank you for joining our 11th Extension for Community Health Outcomes, or ECHO, Biosafety session for 2024 and the last ECHO session for this year. The topic for this interactive discussion is Biorisk Management: Continuous Improvement. Today's subject matter expert is Patricia Olinger from Varro Life Sciences and BEAMS, LLC Consulting.

For a moment I'll stop sharing these slides because I like to see everyone. And let's start with an icebreaker question. you know we always have an icebreaker. And that question is: What's the winter tradition that you are looking forward to? Let us know. Either feel free to enter in the chat. I will also randomly pick somebody just to hear from you, get to see your faces.

If you can, feel free to turn on your camera. It would be lovely to see you and hear your voices. Let's do first person. I see the name-- let's see. Oh, I see Jill. Jill Power. Would you like to share, Jill?

Jill Power: Hold on a minute. There we go. Good morning.

Aufra Araujo: Morning

Jill Power: What would you like me to share, my tradition?

Aufra Araujo: Yes. What's the winter tradition that you were looking forward to?

Jill Power: Well, I like to walk out in the snow, so I get some snowshoeing. Right now, it's 50 degrees in New Hampshire. So the snow is melting, so that'll take a while.

Aufra Araujo: Wow. That's lovely. I like to see a few days of snow when I have nothing else to do, and so this way, it doesn't bother me. But yeah, it's beautiful, and it would be lovely to have a winter snow time. Jill, would you like to randomly pick somebody from the list and ask them.

Jill Power Oh, I like that. Let me see. I know he's rather shy. I saw his name on here was Ivan, Ivan from Iowa. Are you there?

Ivan Vore: Hi there. Can you hear me?

Jill Power: There you are.

Aufra Araujo: Yes.

Ivan Vore: Nice. So I would say my favorite winter tradition, besides Christmas, is actually wrapping up the presents. That was this past Thanksgiving was the whole family came together, and nobody got to see-- nobody really saw each other's presents. But we all wrapped each other's presents and then put them by the tree. And so then I come back to Iowa, and then by the time I come back for Christmas, they'll all be there. So it's something to look forward to.

Aufra Araujo: That's lovely. Ivan, would you like to pick somebody randomly from the audience?

Ivan Vore: Sure thing. How about Sakura Stevenson?

Sakura Stevenson: Hi. Good morning.

Aufra Araujo: Good morning.

Sakura Stevenson: Hi. We cook gumbo for Christmas, so that's our tradition.

Aufra Araujo: Oh, that's awesome. And where are you calling from?

Sakura Stevenson: I'm originally from Japan, but I've been in Louisiana for 28 years.

Aufra Araujo: Oh, nice. It's nice to have you at the ECHO session. I read some-- thanks for sharing with us. I read some of the comments in the chat, so let's see. Feeding the deer. Oh, That's Patty Olinger, feeding the deer, oh, I love that. Eating too many Christmas cookies and doing some cross-country skiing. That's Jay. I can't read the last name because I'm too far from the screen.

Relax, and enjoy winter break. Yes, Nothing like enjoying cozy PJs with a cup of hot chocolate, you are-- you have the nicest traditions. I like that. Drinking hot chocolate, again, another one while watching Hallmark movies in holiday pajamas. Very similar.

Awesome. Thanks, everyone, for participating in the icebreaker. And now let me share again the screen. I stop sharing, so. OK, let's see, where did it go? Just one moment. I'm having some technical issues with re-sharing the screen. So much holiday excitement. I'm like, where did they spring went when I wanted to reshare?

All right, we are here. Everybody can see, right? Yes. So next I will do a little recap from last session.

And thanks, everybody, for participating in the icebreaker. Now let's provide this brief recap from last session in November. It featured Dr. Mike Pentella, who presented on Biorisk Management: Performance Evaluation. Dr. Pentella shared the State Hygienic Laboratory's journey in enhancing biosafety through a biorisk management evaluation under the ISO 35001 standard. Using gap analysis and external audits, the lab identified areas for improvement, including implementing a comprehensive biosafety policy and enhancing training, onboarding, and audit procedures. Despite challenges like staff turnover, the lab adapted through collaboration and perseverance. The evaluation fostered a stronger culture of biosafety and highlighted the value of external reviews in driving continuous improvement and leadership engagement.

The box on this slide shows a participant's comment about the positives of participating in an ISO 35001 audit. 135 participants-- and you see the numbers there on this slide-- attended the session, and those participants were affiliated with 82 organizations. The states on the map, shaded in green, had participants from at least one organization. Also in attendance were participants from 12 national organizations and at least one organization located in Canada, and another organization in Mexico.

We encourage you to share information about our ECHO Biosafety sessions with your colleagues and to connect with each other via chat if you'd like. Before we continue, I would like to address some technical aspects of our ECHO Biosafety sessions. Please use the video capabilities of your device for this session as much as you can. 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 your 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 will introduce our speaker, subject matter expert Patricia Olinger, who will provide a didactic presentation and real-case discussion. Then, my colleague, Commander Folasade Kembi, will summarize today's discussion. Closing comments and reminders will follow, and we'll adjourn this session.

Today's session is being recorded. If you prefer not to be recorded, please disconnect now. The transcript, audio recordings, presentation slides, and other resources will be posted on the DLS ECHO Biosafety website a few weeks after today's session. All right. So I'd like to remind everyone that these slides contain presentation material from speakers who are not affiliated with CDC, and presentation content from external speakers may not necessarily reflect CDC's official position.

Now, it is my pleasure to introduce today's presenter. Patricia Olinger is a recognized leader in public health, specializing in bio-detection, global health preparedness, biorisk management, with a strong passion for wellness. She is the chief relationship officer for Varro Life Sciences, a pioneer in innovative pathogen detection. She is also the founder and CEO of BEAMS, LLC Consulting. Patty serves on multiple advisory boards for businesses and nonprofits focusing on biorisk management, disinfection, indoor air quality, health, and wellness.

As executive director of the Global Biorisk Advisory Council, or GBAC, Patty developed and led the GBAC STAR Facility Accreditation Program during the COVID-19 pandemic to promote safer environments. At Emory University, she served as Assistant Vice President in Research Administration, playing a pivotal role on Team Ebola in 2014. Additionally, Patty convened ISO Technical Committee 212 Working Group 5, leading the development of ISO 35001:2019, the biorisk management standard for laboratories and related organizations, which you are very familiar with now because all biosafety sessions this year discussed biorisk management.

So Patty, we are grateful to have you with us to lead the last biosafety session for this year. The floor is yours.

Patricia Olinger: Thank you so much. First, I'm honored to be here today. Having been so involved with the development of biorisk management in 35001, seeing how far we've come in a program like this, I really hand it off to the ECHO lab team for promoting this and actually having me here today. So next slide, please.

So one of the questions that we get asked all the time is, where are we with the standard? In the biorisk management standard for laboratories and other related organizations, 35001, they're currently-- and I say currently-- is not a formal certification body. And what does that mean?

With ISO, there are certification bodies, and they have to follow a certain process-- believe it or not, there's a standard for the standard-- in how you would actually certify. And right now there is not a certification body that has taken up 35001. But there are a couple of different groups that are currently looking at that.

The first class, one of the things that you have to have is actually certified lead auditors. And the first class for lead auditor training will be held in Malta in February, which, if you've never been to Malta, it's a wonderful place. It's very beautiful. It's just off the tip of Italy. It is being taught by Dr. Stefan Wagener, and if you know who Stefan is, he actually is, really, the father, I call, of the whole biorisk management initiative, where we started out with the CEN Workshop Agreement, which then led to the ISO standard.

This last summer, we also published the competency standard, which was the ISO Technical Specification 5441. And we're about ready to publish the implementation standard, which will help a lot of people because it provides extra guidance for some of the elements, for all the elements actually, within the standard. Next slide, please.

So let's start out with a question. Are you currently implementing a biorisk management quality system in your laboratory? It's OK to say no. It's OK. There is no wrong answer here. But it does give us an idea of where we currently are in the implementation phase.

While you're answering this and thinking about it, I will tell you that there is a move worldwide on implementation. A lot of the nonprofits that actually fund laboratories are now starting to require a management system. A biorisk management system approach in their laboratories, if they're-- for the laboratories that obtain funding from them. And we're also seeing some governments starting to look at biorisk management and, again, 35001 for their laboratories that contain specifically more in the BSL-3 and the BSL-4 areas.

It's not uncommon, I will tell you, that we see that a lot of people don't know where to start. And hopefully maybe after today we can help with that. Next slide, please.

So for me one of the things-- and if there's anybody on-- and I think I saw Esmeralda join. When we first started looking at biorisk management and implementing it here at Emory University, one of the first questions that I would receive was, do you-- actually, it was really kind of funny was, do we need to have a software? And I used to say yeah, maybe.

But we ended up actually creating a roadmap. And this roadmap has been used in multiple different countries, in multiple different areas, and in our discussions with implementation guide on biorisk management because, really, it helps you with a framework. It's almost like a Gantt chart but a little bit more visual.

What is your process? And how are you going to systematically implement that standard, especially when you're going through it for the very first time? So think about that throughout this whole presentation because we'll get back to that at the end. Next slide, please.

So I'm going to recap on a couple of things. You've had some amazing speakers. And when I went through the talks that you've gone through this year, it was really nice to see a lot of the folks that were your subject matter experts are actually working on the 35001 standard. And others I've been on committees with, and it was just really nice to see where friends and colleagues from my past.

But when we're looking at-- just to recap a little bit, the quality management system really is based on that whole plan-do-check-act philosophy. It's a model. It's a standard process where you're identifying your current activities.

And what you'll find as you're going through this process is that you are already doing many of the elements in a biorisk management system or a quality management system. You just may not have documented it or may not have recognized it. You're looking at your implementing plans. You're putting things together. You're putting goals and objectives in place. Next slide, please.

So you want to have a comprehensive evaluation of your organizations, both the activities, your operations. You need to know and what you might have heard in one of your talks in the past was you need to know where you are. You need to have that gap analysis, your legal register, the process that then establishes your goals and programs that you may need to develop, that you may recognize, or that you may identify that you don't have something in place. So you're improving your efficiencies in the whole footprint of your organization. Next slide, please.

So when you go through the process of the whole cycle, that first going through that roadmap, the resulting plans are deployed throughout your organization. They usually are through existing management mechanisms and operations. It's always interesting to me where people think that they have to start from scratch, only to recognize that they already have a lot of the systems in place.

As the system evolves, it's continually evaluated. And that's the beauty of a management system, is that you learn, the more you evaluate. You want the objective is to better your program and to better your organization. And that's the whole concept of continual improvement. Next slide, please.

So wow, it's easy, right? I always get that. Well, it sounds really easy. And then you get what we call deer in the headlight look, that people are like, I am not sure where to start. Or they become overwhelmed. And so what I'm here to say is nothing is perfect, and you need to continue to move forward to continually improve. Next slide, please.

So as we talked about or as I mentioned, that whole fundamental aspect of a quality management system is based on the philosophy of plan-do-check-act. It's a Deming philosophy. And it's really the fundamental principle. It's a scientific method of iteration.

Once a hypothesis is confirmed or negated, executing the cycle again will extend the knowledge further. People look at it as a circle, and I'm going to dismiss that a little bit in the next couple slides. But the important thing is you're repeating the cycle so that you are continually improving. Next slide, please.

So I want you to envision an open coil or spring. In my past, I'd have people say, oh, I did the cycle. And it always-- the one that reminds me of this was an auditing program, where one of my teams came forward and said, we do it all the time. We plan it. We implement it. We do our audits. And then we put it in the file. And it's like, well, that's great. How are you using it to continually improve?

And they really were just drawing a circle in the sand. They were just going through the cycle. They really were not evaluating it at the end to determine how they could better their program. So I want you to start to think of envisioning this as an open coil, a loop, so that one of the loops is only one of the cycles. Each cycle, or looping, brings you closer to a goal or bettering your program, continually improving. Next slide, please.

So with quality systems and management systems approach, it's based on the belief that when you begin each cycle, your knowledge and skills are limited compared to that when you complete the cycle. You're continually learning, which is really what we want to do. We want to learn more about our programs. We want to learn more about the science that's being done in our laboratories, what our limitations are because this also helps us with talking with leadership and management, especially when it comes to wanting more resources. When we better can articulate our program, instead of just going to management and saying, I'm really, really busy, I need more headcount, you'll be able to articulate it better. Next slide, please.

This is actually one of my favorite slides. When I think about a PDCA cycle and where you're starting out, and every time you go through the cycle, you're bettering and improving the quality of your program. Next slide, please.

So again, I can't talk about this enough. Really, the whole cycle is the power of the Deming concept. It lies in its apparent simplicity. As scientists, we have a tendency to complicate things. We want detail. We want perfection. And while I get that, getting to simplicity is really important because, even though as a scientist, we want that for our own work, as you know, going into a lab, as a biosafety officer, as an EHS professional, scientists don't like complexity. They want things simple. And so this is an easy concept to understand, but it is not necessarily an easy concept to accomplish. Next slide, please.

Also I would say that it's becoming more difficult at times. With, as technology advances, on one hand, things become much easier; on the other hand, it becomes much more complicated from a standpoint. We get preoccupied with more and more information. It is so easy in today's world-- and there's a lot of discussion about AI and biosafety and biosecurity and just life in general that we're finding that we're just inundated, and we get overwhelmed sometimes with the amount of information that's coming at us.

It's really important to think about this whole aspect of simplicity as you're designing your programs. We have some very important programs that we are managing with some of the hazards that we're working with. And so the less, I would say, complicated things are, the easier it is sometimes to manage and the less things that can break.

And think about this last statement here. It says, if you're introducing something a new form, a procedure, a policy, make sure you know what it is. And I say that because, in a lot of times, people will say, well, of course, we do. Make sure you beta test it. Make sure that you talk to your scientists, you have people that are out there that are going to have to do it, test it, because what's easier, What, in your mind, that you think is straightforward, sometimes when it's actually implemented is not. Next slide, please.

So biorisk management systems, again, I'm going to just harp on this whole plan-do-check-act. And I want you to think about this cycle because we're going to get back to it, and there will be an activity that we'll do as well. So I think you have to hit the button again. And you can go ahead and hit it, right there, one more time.

So just an overall structure, you have a plan. What's your policy? Are you planning? Could be your biosafety cabinet certifications. You then implement or do.

You then monitor and measure, audits, inspections. I like study because, I mean, people, when they hear the terms audits and inspections and that somebody's checking up on them, sometimes it has a negative connotation to it. And so if we're studying our systems, our programs to better them, that fits a little bit better into our world and then act.

What are the corrective actions that we need? What are the preventatives? Maybe it's a validation of, yes, what we thought we had is actually in place. Is there any program in management, things that need to be communicated? And how are you communicating this back to leadership? Next slide, please.

So one thing that I think that's important is the concept of knowing where you are in the middle of the forest. I have run into situations over the years where we start going down this pathway of defining our program, of doing our legal register, only to have leadership go, oh my gosh, you're going to give me a score. You're going to let me know that I maybe have a problem in a certain area. It's like, yeah.

And the argument is, if you want to better your program, if you are working with high-risk pathogens, high-risk hazards, you really need to know where you are in the middle of the forest. If someone blindfolded you and put you in the middle of the forest but did not give you the direction on how to get out, you could be wandering around that forest for days. If you knew the direction as how to get out, then you can-- you better know how to manage your program. Next slide, please.

One thing that I didn't see a lot of discussion in the talks this year is that of gap analysis and risk assessment. There are multiple different risk assessment programs out there for you to consider, things as simple as the agent risk assessments that you'll see that came out of Health Canada. I know Emory had implemented the biological agent reference sheets.

These are really wonderful risk assessments. But let's take it a step further. If you've never done TapRooT, or HAZOP, my favorite was the Zurich Hazard Assessment, where it actually formally teaches you how to identify risks and hazards and then be able to put them in a-- whether this is a 6 by 6-- I've seen them as 4 by 4s and 5 by 5-- where you actually plot them out, the hazards out, looking at likelihood versus consequence. It's sometimes amazing because you'll find that what you might think is a hazard, when you start looking at it this way, maybe it doesn't hit the yellow or the red. But when you see something in that yellow and red area, it gives you the opportunity to then put mitigation strategies in place and move that hazard down into, hopefully, the green areas.

It's a really powerful process. And it's also something that I get a kick out of a lot of times because people will ask me, so what's your risk-- and I have in the past in regulatory agencies, where they've asked me, what's your risk assessment process? And it's like, first, you have to let me know what it is you want me to do the risk assessment on.

Is it a regulation? Is it a program? Is it a process? Is it an actual element or an agent? Let me know what you want me to do the risk assessment on because risk assessment we do every single day, even though we don't think about it formally.

Every time we get in a car and drive down the road-- and those of you in Atlanta-- and yes, I've lived in that area for 15 years-- when we drive down 85, we're taking-- it's a risk assessment.

Every time you walk outside, anything that we do, there's a risk associated with it. We may not think about it, but there's a whole process. And so when you're looking at different parts of your program, you are thinking about this in areas of likelihood versus consequence and where you're going to spend your resources. Next slide, please.

So do you feel comfortable with the concept of risk assessment? Awesome. And there are some really good programs out there on risk assessment training. And I know that there's a couple that are going to be coming out even further. One thing that I would challenge you is think about all the different areas that you can build into your programs that feed into a formal risk assessment program. Next slide, please.

Process mapping-- I was a-- actually, to me, process mapping is a very important part of program development as well as continuous improvement and a great communication tool. I was actually taught process mapping or part of process mapping team when I was with pharmaceutical industry. And it is something that it never ceased to amaze me where you would take-- it didn't matter what it was, waste management, the process of-- the whole process of biosafety cabinet, annual certification, and biosafety cabinet certification, and maintenance, it didn't matter what it was, the whole process on your NIH protocol review program.

When you map it out and then you sit in a room and you go through it with teams, it never ceases to amaze me to say-- have people say, that's not how it really works because what you find is that what you might think how it is maybe supposed to work, only to find out that there people have workarounds because maybe a step is too complicated. Process mapping is an extremely valuable tool for continually improving your programs. Next slide, please.

So have you ever used process mapping to evaluate a program or process? So for those-- more people have not than have. And I will tell you that it's one of the things that, if you get the opportunity to take a class on process mapping, you can get very-- I know people who are very professional at doing this that I was very fortunate to have worked with.

But even something simple as you start here, like with waste management. It goes into this box. The box gets picked up if it's full, and yes, no, maybe questions. You'll be surprised.

There's also something called concept mapping, which is not as formal as process mapping. But this is a very powerful tool that is simple to learn. And also you can become much more-- there's actually a formal process where you use certain types of boxes for certain types of questions. But even the simple process mapping can help with defining program elements. Next slide, please.

So this gets into actually one of my favorite areas. And it's one of the things-- on almost every single one of these elements, you could take a whole week and spend in a course just working on mastering the different elements of this area. Basically, with check and study-- and I tend to the term study, as I said before, more than check-- you're gathering data. You're analyzing the data. You're looking at different measures or metrics.

I don't think we use that part of the whole basically audit program enough. How many biosafety cabinets do you have? What's the percentage of them that when you go look at your annual audit that are in compliance with their certification? How many things do you have to verify and validate, as far as, are your fire extinguishers all in the right place? How many were not in place? And then so we are really studying the program when you're going through this area. Next slide, please.

Audit programs to me are kind of the cornerstone of a lot of programs. They are really one of those things that help you identify the normal chain of process or flow there. They help you identify programmatic gaps. It's not uncommon that you find maybe you've trained on something, and only to find out that 70% of the people still are not doing it correctly.

And so you might need to step back and look at your training program. Am I communicating the right information? How do I make sure that people have the right information? So they really do help you look at program gaps. Next slide, please.

Oh, and again, when the risk increases, those program gaps are very scary. And those are the gaps that you really need to-- if you did your risk assessment profile, those are the gaps that would go to that red area that you really need to mitigate and fill. Next slide.

So audit programs-- the slide that I did not include is that I am a big proponent of-- I'm very supportive of self-inspections because, to me, when a researcher actually does an audit themselves, then they learn, too. They are the owners. They are the ones responsible for the safety in the lab.

Now, that being said, if you're utilizing the same audit forms, it actually is something that you both can learn from one another. So when you have the lab personnel do their audit before you go in and you do your audit and you find that they-- let's say it doesn't matter. Maybe they think that they're in compliance with something or that they're doing OK. And you're looking at it, and it's like, no, I don't see it that way.

It gives you an opportunity to sit down with them and talk. You learn from them. They learn from you.

The other aspect, it could be the other way. Maybe they think that they're not doing very well. And you think, no, you're OK. It gives you that, again, that opportunity to communicate.

And when you're building that relationship with those researchers and your facilities, that's important because you want them, if they have questions, to come forward with those questions with you. So don't just check boxes. Develop a program that provides multiple purposes.

I really believe in integrated audit programs. And make it simple and flexible and provide a strong foundation to build on. I believe in giving scorecards. And there are a couple great examples out there on how you take your audit program and build a scorecard.

Things that we've learned over the years, you never give researchers A, B, C, D. [LAUGHS] They don't like that, or percentage. Smiley faces and red light-- red and yellow and green actually work better for a lot of researchers. And I don't mean to make light of that, but again, the perfectionist, detailed-oriented scientists like to argue.

I think if you give them a number, I think I'm a 3.7, as opposed to, again, you're audit ready. You're good to go. Smiley face. Yeah, you're OK. Could do better, or a sad face or red.

Giving them those colors gives them an opportunity. You can always turn that into a number behind the scenes for yourself. But making it almost gamification is important.

The other thing is that your audits really are the basics of risk assessment. It can be, if structured correctly, a training tool. As an example, I use the biosafety cabinets again.

If you are letting them know that-- in your audit, you ask a question, have you-- has your biosafety cabinet been certified in the last 12 months? If it's not-- and this is a very basic question-- then they realize that it's supposed to have been certified in the last 12 months. It gives you the opportunity to incorporate that into a training tool or a training event.

It gives you an idea of knowledge assessment. Again, have I trained the information appropriately? It can also-- everybody talks about safety culture and behavior. It's always one of those things that it's hard to define sometimes.

You know it when you see it. And you can tell if people are coming back to you for questions and engaging with you, again, that opportunity to develop a relationship. It is a culture and can be a behavioral assessment.

It provides you with opportunity for the measures and metrics, which is so valuable. And it helps you verify and validate. Next slide, please.

So do you feel that your biorisk audit program performs the way you want it to? Well, for those of you who answered either no or kind of, don't feel that you're alone. Obviously, there's a lot, but there's a lot that we can do together and improve on our audit programs.

Again, to me, it's a cornerstone of a biorisk management system approach. And it's something that really helps with that whole continuum of improvement of your program. Next slide, please.

So the management review specific to biorisk management system elements and requirement, it's part of, I would say, a critical piece as far as to communicate back to leadership. It's also a part of your own internal program review.

Did we meet our goals this year? Are we having challenges with the goals? It's not just something that you do at the end of the year, which it is something that you do at the end of the year. But you should be putting pieces in place to continually look at, are we getting close? Do we need to change direction to meet our goal? Next part.

The other thing is you want to ensure that you are ongoing and practical involvement with top leadership and management. Those are the individuals who will help with resources. They help get roadblocks out of the way. And I think that's important to remember.

You want them to know what you're doing. And sometimes we don't get a lot of opportunity to stand in front of them, explaining our programs. They're also the group of individuals that it's the be quick, be fast, be gone.

You get in there. You state your statement. And you're gone. And you want to leave an impression for that management review. And as you're building your quality system, you are gathering that data to make them that end-of-year or that annual report-- you want to impress on them the needs and where you are in the middle of the forest, basically. Next part.

So think about different questions. Is the current biorisk management system suitable or adequate for your intended purpose? And what decisions or actions relative to biorisk management system need to be made to ensure continual improvement? And again, as all the elements that we've talked about help feed into, what do you need to do to make sure that continually improving? Next slide, please.

So you saw this slide before. Go ahead and hit the button four times. I want to take you through a little bit of an exercise. So remember this, the policy, the plan, you're doing the implementation, the monitoring and checking, and corrective action, preventive action, and program management review. Let's look at a couple of examples or an example. Next slide, please.

Sometimes it's easy to just map out an idea. So if we look at emergency preparedness and response, if you hit the button, so planning-- we plan, plan, plan all the time. We're always planning.

You have emergency response plans. You have spill response plans. You might have medical emergency response plans. And we have security plans. Next.

Then we're doing things. We're communicating that plan. Then we're looking at training. We're training responders, our employees on what's expected from them. Next button.

We're then to-- we're going to check. We're going to conduct drills. That's part of kind of doing as well. But we're conducting drills. And during the drills, we're evaluating. Are we doing what we should be doing? Is everything working appropriately?

We also have actual emergencies. And do you follow up after those emergencies to make sure that everything is in place? Did we respond like we hoped to respond? If not, why not? Do we have all the tools that we need to have in place? Next slide.

And again, you're evaluating that performance in the drills. You do a write up at the end. You adjust plans when and where necessary. Next slide, please.

So question, what are some other examples that fit into this? List them in the chat.

Aufra Araujo: Oh, I see conducting inspections. Do you care to expand on that Charlotte?

Charlotte Waggoner: Just general safety inspections in lab. You can do this-- you have your plan, your safety plan, and then you educate everybody about it. And then you do your actual inspections, and then you evaluate using a bunch of metrics.

Patricia Olinger: Absolutely. Training is a great-- or labs inspections are a really great one, when you think about it. Waste management is one. I mean, just about anything that you're doing, training, training—

Charlotte Waggoner: Yeah, I was going to say training, yes.

Patricia Olinger: Yep. And when you-- this is sort of like that very beginning stages of process mapping it out because you start looking at, are we doing all these things? And to give you a structure to then write it up, and it can be very helpful. Next slide, please. Thank you, Charlotte.

So implementing a quality management system is really connecting dots. And sometimes we know have all these dots, and we have program elements out there. But we really don't know what those dots, when we connect them together, look like. And so what you're looking at doing is connecting all the dots of your program.

And it can be overwhelming at times, believe me. But it's also one step at a time. Take one bite of the elephant, as they say at a time. And continue to move forward. Next slide.

So I want you to think about that biorisk management roadmap for implementation in this-- we have roadblocks or bumps in the road, you might say, those little yellow bars there in the road. You are going to run into those. Sometimes they're bigger roadblocks than others, but you will run into it.

Find a buddy. Find people who are also going through it at the same time, having a community that you can talk to and work with. And the ECHO lab program is one of those communities that is great because you're trying to do this together. This is-- I've used this in resource-limited countries and laboratories and some very sophisticated laboratories. So think of that roadmap, and think of the main elements that you need to be going through for your cycle. Next slide, please.

So final question, do you have a roadmap? Whether it's a roadmap or a Gantt chart for your biorisk management system implementation? So again, sometimes the roadmap itself helps you define and helps you explain.

Like I started in the very beginning, when we first started looking at management system implementation at Emory, I was asked by senior leadership if I needed software. And it was like, no, maybe. But it really provides you with a very visible visual on some of the key milestones that you're trying to accomplish when you start implementing a management system. Next slide, please.

And from that wellness standpoint, I think this is probably one of the things that we need to remind ourselves is patience because quality programs aren't built on the philosophy. Or they're built on the philosophy of continual improvement. And teamwork-- nothing is perfect, and nothing-- you're always trying to achieve better in these programs, and all things that are good, take time.

So sometimes when you're feeling overwhelmed, either find that buddy, pick up the phone, or just step back and take a deep breath. I think that's one of the things that, for my career, has been something that's been very important to remember and remind myself. Next slide.

I think that's it. So again, I really want to thank everybody and also the ECHO lab team for what you're doing, implementing the management system approach in your laboratories. This is-- being the convener for ISO and having been on the steering team for the development of the CEN Workshop Agreement, it's been a long time coming, and it's exciting to see laboratories working on this and moving this whole initiative forward. So thank you.

Aufra Araujo: Thank you, Patty, for your excellent and informative presentation. We will open the floor for ideas, questions, or additional discussion points from the audience. We appreciate and encourage the discussion amongst all participants and invite you to share your experiences and challenges on this topic.

Please remember to turn on your camera and microphone, if you can, and introduce yourself. I see one question here. You were talking about software per your question. You were asked about software. So somebody is asking what software would you recommend.

Patricia Olinger: That's-- I don't have any specific software. There is some software out there, but it's really, how do you need to organize your program? How do you look at, developing, let's say, a form that you can do your audits on?

And there are-- I would say, with your team here, ask what other people are using right now And. How you're managing the inventory of your biosafety cabinets. I think we-- we started out using a lot of Excel spreadsheets, and I think we're starting to move past that. But there's a lot of technology that's now available to us that really wasn't when I was managing the labs.

And that's exciting. And like I said before, it can also be very overwhelming. So teamwork and the community is, I think, important.

Aufra Araujo: Yeah. Thank you for that, Patty. I was wondering, this last question, when you were asking about roadmap, who you were asking who has a roadmap, I'm curious-- from the audience, I think I saw about five or six people from the audience said that they have a roadmap for biorisk management. I'm curious to hear, what is that roadmap for them?

So whoever responded that, sorry to put anybody on the spot. But I'm curious. And I think while people are thinking about other questions, perhaps folks could open their mic and share how they do that, amongst those people who said yes, they do have a process. So would you mind sharing what that process looks like for you or your institution?

Esmeralda Meyer: Hi there. Hi, Patty.

Patricia Olinger: Hey. I was going to say, if Esmeralda doesn't jump on here, she better.

Esmeralda Meyer: Hi, y'all. So it's interesting because, in particular, due to my current duties, I am applying the biorisk management framework that I learned with Patty and the PDCA cycle as part of animal care and use. And so it's a system and it's a framework that is really a multipurpose. And it just needs to be applied.

So I use it for animal care and use as a current director of the IACUC here at Emory. And how do I know I have a roadmap? We use key performance indicators that basically give us grades.

And it tells us-- you'll never achieve 100% training compliance. You'll never achieve 100% of resolution of pending items and inspections, corrective actions. But you have to have a number.

And so that's my roadmap. As Patty said, you need to have a goal, and on that spiral, it will-- you have at least 100% is your ideal. But if you get 80% or whatever your number is going to be that is acceptable to your institution in terms of risk, then that's where you want to go. So that's how we manage. That's how I manage our goals and our roadmap.

Aufra Araujo: Excellent. Thank you so much for sharing that, Esmeralda. Anybody else would like to share what's their process? It's a shy crowd today. Or you can write in the chat if you're unable to unmute.

Another question-- on the other hand, those who responded they don't have a roadmap, I'm curious, what are the pain points, like why they don't have? Is it-- why is that? Would you like to open the mic or enter in the chat what is it making it difficult to start?

Randy Albrecht: I can jump in real quick and piggyback a little bit off of Esmeralda's comments. And we've started the process. We've started outlining our program and identifying the key stakeholders and so on and so forth and starting to think about some of the key metrics.

But then there's these other things that come up that derail us, some of these new regulatory frameworks and policies. And now we're thinking about how we're going to incorporate them. So in some sense, it's not a static program. And we have to figure out how we're going to incorporate these other elements and then expand into oversight for those areas.

And then sometimes, especially at the end of the year, I kind of joked, this is when we start to look at making sure we've met all the compliance requirements for the year because we only have 14 days left. So it's a bit of a challenge. But hopefully, as things calm down, we can reassess and then see how to move forward with this.

Aufra Araujo: Thank you so much for sharing. Yeah, like it was said before, perfection is never going to exist, perfection. That's why it this continuous improvement.

Thanks, everyone. One last chance, if there is any question, anything people would like to ask Patty or share. I don't see anybody. No more comments in the chat. Nobody unmuting.

So OK, that was an excellent discussion. Thank you so much for those who share. Thank you everyone for participating today in this session. Now I invite my colleague, Commander Sade Kembi, who is a Health Scientist in CDC's Division of Laboratory Systems, to provide a summary of the discussion from today's session. Sade, over to you.

Folasade Kembi: Thank you, Aufra. So since we did not have so much [AUDIO OUT] the challenge here—

Aufra Araujo: Can anybody give a thumbs up if they can hear Sade?

Esmeralda Meyer: We can.

Aufra Araujo: Oh, they can.

Esmeralda Meyer: We were-- we weren't able to hear her. We heard her for a minute, and then it went away.

Aufra Araujo: OK, is it better now?

Esmeralda Meyer: It is now.

Aufra Araujo: OK, Thank you. So we didn't have [AUDIO OUT]

Alicia Violette: Aufra, I think we're actually hearing Sade through your mic.

Aufra Araujo: OK. Go ahead, Sade.

Folasade Kembi: OK. So the first question that I think is currently implementing biorisk management in your lab. 7% responded, yes, that that is fully in place and, only 43, we only have 43 responders. That 5% said yes, they are in the process. 26% said no, but they are planning to. 21% have no plans. And 12%, they don't know where to start.

So hopefully the discussion today helped a bit. And you can also contact our DLS to help if you don't know where to start. Then the next question is, do you feel comfortable with the concept of risk assessment?

We have 48 responders, and 88% said, yes. 10% said, kind of. And 2% responded, no. Then the next question is, have you ever used process mapping to evaluate a program or process? 33% of 51 responders stated, yes, and 67% stated, no.

Then do you feel your biorisk audit program performs the way you want it to? 19% of 42 responders said, yes. 67% responded kind of, but they can do better. And 14% said no, but they would like to learn more.

So today, a few questions and examples asked, what do they do in their laboratories that fit into the PCDA outline? And the response was conducting inspections and training.

What we discussed last-- which I don't think I necessarily have to repeat, is the roadmap for implementation of biorisk management system, as 60% of the 38 respondents said, yes, they do have a roadmap for implementation. 34% said, no, and 50% said, they are working on it.

So we had examples from people that said, yes, and we also have one example from somebody that said, no. So that's it. Thank you.

Aufra Araujo: Thank you, Sade. Patty, would you like to add anything else?

Patricia Olinger: No, just to remember that nothing's perfect. Take one step at a time. Think about-- there are some things that I know and I'll make sure that the ECHO team is aware of, if and when they get launched, as far as communities of practice and that with biorisk management, as we get closer and closer to actually having certification programs more formalized.

And then also just remember, I mean, those of you who have implemented a biorisk management program, you don't have to go through final-- OK, here's the convener for ISO saying this. You don't have to go through formal certification to implement a quality management system in your facility. It is something that is a goal, and it's achievable.

And you may be certifiable at the end. And that's a joke. But it is something that, as you go through it, you learn more and more about your program and become more and more comfortable with it. So yeah, happy holidays, Merry Christmas, Happy Hanukkah, and enjoy the next two weeks with family.

Aufra Araujo: Awesome. Thank you for your terrific presentation, Patty, and for the summary, Sade. Also, a big thank you for all members of this biosafety community of practice for participating in the discussion today. I have a few announcements that I'd like to share with you all before we conclude today's session.

First, I'd like to discuss the post-session survey. The QR code on the slide and the link in the chat will take you to the Qualtrics survey. This survey should take no more than two minutes to complete. Your response will be anonymous, and so no unique identifying information will be sought or kept.

And the feedback we receive will be summarized in aggregate only. Your participation is voluntary, but we strongly encourage you to participate 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 one of the ECHO Biosafety sessions in 2025, please reach out to us at DLSbiosafety@cdc.gov.

As part of DLS' continuous improvement and commitment to biosafety and biosecurity, DLS is offering free access to the ISO 35001:2019 standard. This slide provides information about the standard, and the next slide provides instructions on how to contact us to gain access to it.

So let's see. I think I can move to the next slide. And here you have the information on how to contact us to gain access to the ISO 35001 standard. And the slides will be posted as well at our CDC ECHO Biosafety web page.

Now, while this session marks the final ECHO Biosafety session for 2024, we are excited to announce that these sessions will resume in 2025. 2025 will be our third year conducting these facilitated discussions about biosafety. You will receive an email message. If you are in our distribution list, you will receive an email message with the details once we have an official start date.

Please stay tuned for updates via email. And on the-- if you are not on our distribution list, on our more than 500 people on our distribution list, you can check our DLS ECHO Biosafety website, and you see the QR code on the screen and the link also in chat. So you can check and find out what the topics will be and the exact dates. But usually, the sessions are conducted on the last Tuesday of each month.

Thank you all so much for your ongoing support and survey feedback, which have contributed greatly to the success of these sessions. Your engagement in the ECHO Biosafety community of practice is invaluable. As a reminder, the transcripts, audio recordings, the presentation slides from previous ECHO Biosafety sessions are available on the DLS ECHO Biosafety website, and the link is in the chat.

Thank you for attending today's session. As we adjourn, I hope you were intentional about having a safe and fantastic day. And we look forward to seeing you next year and wish you all a happy holidays. Bye.

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