Laboratory Biorisk Management: What It Is and How to Improve It – Session Materials

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Date of session: 01/30/2024

Facilitator

Aufra C. Araujo, PhD

Centers for Disease Control and Prevention

DLSbiosafety@cdc.gov

Didactic Speakers

Kalpana Rengarajan, PhD, MPH, JM, RBP (ABSA)

Director of Research Safety and Biosafety Officer

Emory University

krengar@emory.edu

Aufra Araujo: All right. 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’m a PhD Health Scientist in CDC’s Division of Laboratory Systems. Thank you all for joining our first Extension for Community Health Care Outcomes, or ECHO, Biosafety session for 2024.

The topic for this interactive discussion is Laboratory Biorisk Management: What It Is and How to Improve It. Today’s subject matter expert is Dr. Kalpana Rengarajan from Emory University here in Atlanta, Georgia. Let me stop sharing these slides for a moment.

Our aim with the ECHO Biosafety project is to build a community of practice. And connecting names with faces helps us to do that. As a matter of fact, today we celebrate the one-year anniversary of this biosafety community of practice.

To help us celebrate, I would love to have all of you turn on your cameras so we can take a screenshot and say hello, see your faces and names, and maybe take a screenshot with all of you. That would be lovely. Oh, it’s so good to see you all.

I would like to ask everyone a quick icebreaker. We love icebreakers, which is already in the chat. What are your New Year’s resolutions for 2024? If you like to unmute and share with us your New Year’s resolution or enter in the chat, either way is fine.

I can start since I’m the one who posed the question. My New Year’s resolution is to practice yoga at least twice a week. So that’s it. I’ve been sedentary and sluggish lately. And I need to get on track. So, would anyone like to share?

Thanks, yes. Oh, lots of– that’s so cool. Go on more adventures. I love that. Do more kickboxing. Wow. I admire you.

That’s Jill. Wow, Jill. That’s so cool. A long time since I did kickbox. Read more. Spend more time in nature. Oh, I love all these New Year’s resolutions. No resolution. What was that one?

No resolution. I want to bake more and eventually do an immersion or handstand by the end of– inversion, not immersion. I’m seeing from a distance. Yeah, I spend less time on my phone. I guess that’s one resolution for me as well, should be. Knit my first pullover. Oh, I love this.

Wow, read the Christian Bible through. Enjoy life and become healthier. So many good– thank you, everybody, for participating. Let’s go back and share again the screen. I just love seeing everyone. Let me just say that– let me share again. All right. So next slide.

Technical issues with moving the slides here. Bear with me. OK. How do these ECHO sessions differ from other presentations? Since this is the first session of the year, I wanted to talk a little bit about the ECHO Model.

These sessions are different from webinars in that the main feature is the discussion of case or clinical laboratory challenges. The subject matter expert aims to share some applicable solutions that can be implemented in your individual laboratories. Our goal with ECHO is to bridge gaps, build community, and enhance biosafety. Since this is the first session of 2024, and we may have new participants joining, I think it is important to talk about the ECHO Model in more detail.

So what are the components of the ECHO Model? The ECHO Model includes these four basic principles. So we have listed here ABCD. A is for amplification of knowledge. Sessions are conducted in Zoom, which assists with democratizing knowledge. Because all participants can teach, and all can learn. The idea of the ECHO Model is to move knowledge not to move people.

B is for evidence-based approach, to share best practices, to improve quality of laboratory services, and safety.

C is for case-based learning with evidence-based best practices guiding the discussion.

D is the use of data on session evaluation. So we use data to create a feedback loop for program improvements. This approach forms a learning loop where participants learn not only from expert presentations but also from the shared community experience. It also creates a ripple effect. Because participants will share acquired knowledge with their laboratory colleagues.

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 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 sharing 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’ll introduce our subject matter expert, Dr. Kalpana Rengarajan, who will provide a didactic presentation and real case discussion. Then my colleague, Sabrina DeBose, will summarize today’s discussion. Closing comments and reminders will follow this. And we will adjourn this session.

Today’s session is being recorded. If you prefer not to be recorded, please disconnect now. After today’s meeting, the transcript, the audio recording, presentation slides, and other resources will be posted on the DLS ECHO Biosafety website. George will provide the ECHO Biosafety link in the chat as well. All right, so moving on.

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. All right.

Now for the best part. It is my pleasure to introduce today’s presenter, Dr. Kalpana Rengarajan. Kalpana is the Director of Research Safety at the Environmental Health and Safety Office at Emory University in Atlanta, Georgia. She has university-wide responsibility for oversight of developing, implementing, and maintaining environmental health and safety programs to control occupational exposures.

Kalpana possesses several degrees, including PhD in Immunology, Master of Public Health, Juris Master, and is a Registered Biosafety Professional. Kalpana has developed and taught countless professional development course. Kalpana provided biosafety support at the Serious Communicable Disease Unit at Emory University during management of patients infected with Ebola, Lassa Virus, and Mpox. She is a technical writer for ISO Laboratory Biorisk Management Standard and several others.

Kalpana serves as ABSA’s Pre-conference Course Committee Chair and has received the ABSA Hashimoto Award for Service and Honor, the Emory University Award of Distinction, which is the highest award for university staff for outstanding contributions, and the Daisy Award for Ebola work, among many others. Please join me in welcoming Kalpana today.

Kalpana, the floor is yours. And let me stop sharing so you can share your screen. I think you are still muted, Kalpana.

Kalpana Rengarajan: Can you hear me?

Aufra Araujo: Yes, we can hear you now.

Kalpana Rengarajan: Good morning, everybody. I would like to personally thank the CDC’s ECHO group, for all on the call right now for inviting me to present. And I would like to say I’m just going to share my experience and hopefully, we all on this call will learn a lot from one another, including me.

So basically, we wanted to talk a little bit on laboratory biorisk management. Several of you might have heard about something called CEN Workshop Agreement, which is also in short called a CWA 15793. This was published in 2006.

And what happened was a whole lot of international professionals under the European Consortium got together and developed this workshop agreement on best practices of laboratory biorisk management. And basically, this is a document that tells you a system of process how to control safety and security risks associated with handling and disposal of any biological agents, toxins, et cetera.

And what happened was this CEN Workshop Agreement, which was originally published in 2006, had a life cycle. And it had to be renewed. And at that point, the consortium decided it was not– they were not willing to renew that guidance document.

And therefore, at that point again, a whole lot of individuals who were involved in the CEN Workshop Agreement development decided why not approach the ISO group or the ISO Standards and ask them whether we can convert this workshop agreement into an ISO standard, which is more globally acceptable by everybody.

So the CEN Workshop Agreement 15793 after a period of time and working very hard with all of the experts on that, it got converted into the ISO Standards. So let’s quickly think about this, management system.

I would like to see if each one of you can quickly write your thoughts on your notes, sticky note, whatever you have. And what is your definition or thought process for a management system? If you can write it down, let me give you about 30 seconds. And then a couple of you can share. Unmute yourself. And share with the group what is your thought on management system, it would be good. OK. Any volunteers? A couple of you who can unmute and tell me what is your understanding of a management system.

Any volunteers? Please unmute yourself. I see Dylan Yacab has unmuted. Can you hear me?

Aufra Araujo: Kalpana, folks are entering their thoughts in chat as well. So I can read some of the thoughts.

Kalpana Rengarajan: That would be good. Because I’m not able to see the chat.

Aufra Araujo: Sure. So leading and training a team, a program that use leads or directs a team, checks and balances to help you achieve some sort of goal, having a hierarchy of people to have people to report to, system for methodically managing a goal. Those are some thoughts thus far.

Kalpana Rengarajan: Perfect. I see that multiple individuals have put in their thoughts. And it’s a combination of everything what I’ve read right now. So a management system is defined as a set of policies, procedures, and processes set by any organization to ensure that they can fill their tasks required to achieve an objective.

So an institution may have certain objectives. And then to achieve that objective, they have to perform certain tasks. And to perform those tasks, you need to have a set of policies, procedures, and processes in place. Does that make sense?

So you need to have the tasks to achieve your goals or your objectives. But to perform those tasks, you need to have certain set of policies or guidelines, procedures, and programs that will guide you to perform your task, ultimately, resulting in achieving your objective or goals.

Excellent. So as I told you already that the CEN Workshop Agreement got converted into the ISO 35001. And I’m not going to go through the history of why and how the whole thing got converted. But all that I want all of you to understand here is the first ever ISO Biorisk Management System for Laboratories and Other Related Organizations was first published in 2019, ISO 35001:2019.

Many of you may be familiar with multiple different types of ISO standards for laboratory quality management, et cetera, et cetera. But this is the first ever time we have the ISO 35001, which was very specific, which is the first international standard that defines the requirements for biorisk management, for labs. And again, as earlier mentioned to you on what is the management system, the purpose of publishing this document is to define the processes, to identify, assess, control, monitor, and mitigate any type of risks associated with hazardous biological materials in your institution.

So having said that, I am one of the technical writers who was involved in this publishing this. And then there came lots of questions as to where do we start? How do we follow this? Who monitors this? Who tells us we are following everything?

So having had so many questions from multiple individuals globally, the association decided or we decided that we will start developing guidelines as to how you can use and implement these ISO Standards 35001. So right now, we have a working group which has been working on developing these guidelines.

Again, these are only guidelines to see how any organization can review and how these guidelines can facilitate to implement the ISO 35001 Standard. Right now, it’s in the draft status. And it’s in review status right now. And we are hoping, hoping the final document would be published, the guidelines document by the ISO entity sometime the Spring of 2025. So that’s the latest update on that.

So what is, in a nutshell, the ISO 35001? In a nutshell, it’s going to tell you a very comprehensive process. It has specific principles that are being established and what are all the different components of this ISO standard and the guidance to implement them as appropriate.

So the way the management approach is defined in the ISO 35001, as you can see, I have listed about five bullets here. If and when you apply this management system approach, that leads to a definitive system by identifying, developing processes in your institution. There will be a structured system to achieve your objectives in a cost-effective manner.

Again, you can understand the interrelated other processes of the system. And the most important part is it helps you to continuously improve the system by measuring and evaluating. What is the big advantage if you can measure what you’re doing?

So you measure. You evaluate. And you can continuously improve. And of course, this also is based on the resources that are available to any institution. So having said all that, we are going to quick talk about this ISO 35001. Again, you have to remember this is not a checkbox kind of instructions that you’re going to get how to implement ISO Standards.

The ISO Standards are extremely performance-oriented. So when you read those ISO Standards and when you get an opportunity to finally read the guidelines. How to implement it, you will remember that it is performance-oriented. So what is possible in a smaller institution may not be the same equivalent in pharma or an industry or a bigger institution. So it’s purely based on performance and what you like to put in place in your institution.

ISO Standards are not mandatory for any institution to implement. ISO Standards is– I don’t know how many of you have animal facilities in your institutions and how many of your institutions are AAALAC accredited. So AAALAC accreditation is not a requirement. But having an AAALAC accreditation brings the institution to a certain benchmark level and gets you that feeling of, yes, you are doing something defined by an entity.

It’s the same thing. An institution does not have to implement ISO Standards. But implementing and following the ISO Standards sets the bar high. And that you’re following what you have to. So even if an institution tries to implement ISO 35001, you still have to follow your local, your county, your city, your state, your federal government requirements. Just because you do everything based on the ISO 35001 doesn’t mean that you’re exempt from the regulatory requirements.

So you have to remember that. And again, this is not a technical document. Again and again, I want to repeat this is more a performance-oriented guidelines document for you. And the principle here is what we call PDCA.

All of you would have heard this terminology of PDCA, which is basically a Plan and then Do, Check, and Act. In other words, if you want to roll out something, you plan how do you want to roll it out. And then once the plan is in place, you actually do or you implement it. And then check, maybe you want to check whether the system worked. You’re not just going to keep on checking boxes there.

But, see, I tried doing this. I planned it. I did it. And I’m going to check it. Did it work? And then the acts will be after you do the check part and the act part to see how can I further improve everything?

So here is conceptually what we talk as the plan, do, check, act. So you have the plan. Establish objectives, programs, processes according to your institution, whatever you want. And then implement the plan processes. Monitor, measure those activities and processes which you established here– you established here. You did it. Now you’re going to monitor and measure it and report the results.

And then act will be take actions to continuously improve. If you set ABC, let’s say A and B process worked. C did not work. This is where you’re going to evaluate why the C did not work and act on that C. And try and see whether you have to give up that point C or objective C or can you improve that particular bullet objective of C that you’re talking about.

Again, one more thing I want to mention to you, this is a continuous life cycle. So what you did and you kept improving after two years, if you look at it, you can further improve. You can further improve. There is no limitation on when this will be achieved. It is a continuous improvement. And it is a living process that you have to do.

So again, another question to the audience here. How could you improve a biorisk management at your own lab or your institution if some of your biosafety professionals, whatever it is, what if you can reflect and say, how could you improve that in your lab or in your institution short-term and long-term?

And then why do you, in your mind, think by having this time of short-term, long-term goal and implementing a management system process will be of any benefit? You can write your answers in the chat box.

And Aufra can read those to me. Write a couple of bullets as to why at this point you think you can improve your biorisk management process in your own lab institution, whatever. And what would be the benefits of it if you do it?

Aufra, do you have anything that’s popping up?

Aufra Araujo: Not yet. Oh, I see one.

Kalpana Rengarajan: OK.

Aufra Araujo: Cathy Moore mentioned manpower is always a challenge in our profession. Launching and empowering more junior personnel in the labs would be helpful. Jill Power wrote improve using safety monitors similar to quality monitors. Joanne Touchberry– sorry if I mispronounce anybody’s name– she wrote maybe implement periodic training. No, I lost it. More training and involvement of staff in the process.

Oh, now I have several. Maybe implement periodic trainings in safety. Another one wrote, a biorisk plan helps keep people safe, especially when there is employee turnover. It also helps keep people from getting complacent with the organisms they work with daily. Having our lab scientists more involved in the safety process would be good.

Yeah, Amen to that. Macey Henning wrote benefit with all the changes in staffing over the last few years, standardized systems make it easier to maintain as staff are trained.

Oh, we have lots of comments now. It’s difficult to read all of them, because all keep coming at the same time. Increasing communication with staff so that folks feel engaged and empowered, providing additional training and drills for staff to practice their skills. Wow, great comments here.

Kalpana Rengarajan: OK. Thank you so much, Aufra. And thank you to the audience for your very, very active input on all those things. So I agree with everything that you have listed there. Two things that caught me as she was mentioning was safety and convalescence.

I’m not saying those are the only two things that are important. But to me, when as I was listening, those are two things that caught me. And I’ll give you a very simple example. We all drive on the road. Let’s say we’re supposed to be at a 65 speed. I’m very positive 95% of us, including me, speed.

And then we always think, oh, we have never had a ticket. And we keep speeding. And one fine day, because of our complacence, that we don’t follow what we are supposed to and then we end up with a ticket. So once you get that ticket of whatever, $100 something, something depending on your state, the next immediate day you start literally going five miles below speed right there.

You start catching up your act. And you want to slow down yourself. So the complacence of thinking I won’t be caught, it’s OK to speed leading to something. And that cause, the effect is right now at this point, I don’t want to go into things like accident or anything. I’ll just make it more of a fine or a ticket you get. And then you catch up your act again.

So again, it’s the same thing. If you think about working in a laboratory space where all of you are talking about or managing that laboratory space, we all keep doing something. And at certain point, we become very complacent. And we don’t pay attention.

It’s a human behavior. And then suddenly, something happens and instead of being proactive, we become reactive. Because an incident occurred, or something happened. And then we start following the systematic way of doing things.

So again, the benefit of having a standardized biorisk management system, it would be more like a check and balance for whoever has oversight and for individuals to see that you are doing the right thing, keeping not only the safety of your own self, but safety of others who are in that laboratory space or wherever you all are working and also the institution from being fined and stopped.

And the most important part, since most of you are biosafety professionals here, I am sure you all will agree with me that technology is developing faster than what we can sit, understand, and do a risk assessment. Correct?

So every technique is different now. What is the most important thing? Before that, we talked about CRISPR. Now we are talking about artificial intelligence.

So there is never a dull moment in technology. And it’s speeding up so much, it is very hard for us as safety professionals to keep up with that. Have a risk assessment done to say yes, it’s safe for you to do or not safe for you to do. So if we already have an established, comprehensive management system in place, it’s literally like plug and play and say, OK, these are the type of questions I’m supposed to ask when there is a new technology popping up or somebody is going to use it. So definitely, having a management system will facilitate to implement anything you want as new as artificial intelligence and technology stage.

So now let’s think about your own institution or your office or whatever your job duties are right now. If each one of you can think about one or two challenges that you face today if you want to have a management system in place– if you could think about challenges you have right now and what are the top two things you would like to do in your facility, what would be your top priority?

This is your nightmare if you sleep, if you go to bed in the night. You can’t sleep because this is a nightmare. What are the top two things you would like to make a change to make it safe in your institution? You don’t need to mention your institutions. And Aufra, when you’re reading, you don’t need to read me the names.

Anything popping up, Aufra?

Aufra Araujo: Not yet. I see extending contract with occupational health. Resume safety audits to identify issues within the lab. Support from the policymakers. More emphasis on ergonomics due to the aging of lab staff. Let’s see, that’s it for now. One, employee buy-in support. Two, overarching effectiveness. Three, verification efforts.

Another one– the safety office would have more than two positions. There is far too much to manage for just two people. Another one– let’s see– to improve the communication between departments when a biosafety event occurs.

Instituting an occupational health program and more support from building maintenance and repair staff, top management buying and accountability, too much middle management and bureaucracy.

Kalpana Rengarajan: OK. So we have tons and tons of stuff. There again, I will mention what caught me more is the occupational health program pretty much to that extent. Few of you mentioned the same thing.

And I want to let whoever mention that, and whoever did not mention about occupational health, it’s perfectly all right. But this is one of the biggest challenges in all the institutions, all the institutions.

So we are all together on that, to have– there is no single place I have talked to have a perfect occupational health program. Because that is one of the programs that requires the largest amount of funding to establish properly, evaluate, and do things like that. So thank you very much.

So again, I think pretty much most of you in the previous question asked, what are the top three things you would like to do, some of you have incorporated the challenges or factors, that kind of intervene in your program to establish a proper one.

So in this case, if I can ask you if you can list one or two factors you think is very important to have or to consider to implement a biorisk management system in your facility, what would be one or two challenges or factors to consider before you start working on your biorisk management system in your facility?

I know earlier somebody mentioned about mid-management interference, lack of support, all those things. So other than that, is there anything else?

Aufra Araujo: So some things start popping up in chat. Funding, leadership, consistency, expertise, staff adaptability to change and leadership support, learning all the rules and regulations, funding, buy-in from upper management. Factor to consider– somebody said relationship-building with staff to improve buy-in. Another one said accountability. OK, employee buy-in. Support from leadership and funding. So I think funding, support, accountability, and buy-in are top here.

Kalpana Rengarajan: OK. A lot of stuff here where I think if am I am at the same level as all of you here as a biosafety professional. Few of those things that you really cannot control. Because you could be in the mid-level management or you could be in the low-level level management. But we are not in the upper level as assistant VP, VPs, or provost and that kind of stuff.

So it’s kind of hard for our voices to be heard in some of these things. It’s very hard to make that change. I totally get it. And funding, as Aufra mentioned, is one of the biggest things. And it’s not somebody has the money and do not want to disburse that money.

It’s very, very hard these days to get funds, particularly researchers getting their grants. And researchers are the most important people who bring the grant on which the institution also runs right there.

When you want to implement a process, program, or a virus management system, you can see that you have a start point right there. And you have an endpoint, which we mean a success. But then you have tons and tons and tons of obstacles that you’re going to be facing or everybody faces in between. And a lot of those obstacles and things that you feel that you may face is what you mentioned in your previous answers.

So let’s look at this picture of an elephant right here. I’m sure most of you have seeing something similar. And you can see I have about six individuals here who are blindfolded and then asked to touch and feel the elephant right there. It’s just in a way to show you the individuals touching the different parts of the elephant and what they will engage.

But just so that to convert that into a language of management system here. Here, let’s start here. The person is touching the ears of the elephant. And the palatability here in this case, I feel is taking that message to your management system and saying to your management– upper management saying, why it is important to have a systemic process and program to make your institution or your program safe?

Now, that’s not too palatable for your management. Because they’re going to ask you, what are you asking me to do? Are you going to ask me to give you more money? So that’s not something that they like. That’s not a palatable information for them.

Then you have the second one, it’s a portion sizes. Now, if you’re going to give them a 350,000-page overview of what you would like to have to establish this, they are going to look at you again and say what? 350,000-page overview? Is this at all possible? This is a Himalayan task. Can we even do that?

So it is very critical, we think about portion sizes right there. And then somebody touching their tail here thinking it’s a sugar basically, when they hear it, do they want to consider this a sugar and good news? Or do they think it’s sour or a salty, whatever it is?

And this part, just to show you the emotions when somebody hears and somebody you’re going to deliver this message, and then the activity levels, the stress level. So all of us go through these different stress levels. What if a regulator steps into our campus and they start inspecting us?

Am I audit-ready? Are we going to fail? Do we have a process in place that we can comfortably say, I’m OK with these regulators to come and inspect me? So you go through that constant stress. So when you think about implementing something and taking it to the management, you have all these different types of thought processes that go on right there.

Having said that, now that I have said it’s a Herculean task or a Himalayan task of a 350,000-page overview of what you want to do, the first question that– even if you have the ISO Standard 35001 in your hand, even assuming tomorrow, the guidelines to include implement the 35001 is published, and you have that guidelines document, you still, by reading the whole thing, you’re going to be overwhelmed. And then you’re going to say, where do I start?

Because the ISO Standard 35001 is available. You can purchase it. You can read it. And it talks in different sections– it talks about from the objectives of an institution to the management commitment and then the operational part and lots of different sections go. You can read all the 50, 60, 70 pages line by line. But that is not going to help you. Because at the end of it, you’re going to be overwhelmed and think, where do I stop?

So I’m going to give you a quick, small example of what I did. But I wanted to really look at it and say, I want to start something. I want to look at something in a very systematic way and see how I can improve that process.

So the first part I would like to stress here is what we call as gap analysis. And again, before we even move with this gap analysis and what I’m going to explain, I want each one of you to remember that each one of you, you are doing the right thing given the resources and time you have, in some form shape or size, you’re still trying to achieve your goals and objectives to keep your institution safe. And you’re following the rules and regulations as much as possible right there depending on what you have.

So it is not that any one of you here on this call is twiddling your fingers and saying, I have never done this. What am I talking about? No. All of you are doing something. But all that we’re going to talk here is only a systematic approach to see how can we make it more streamlined, and we know that we are doing all these things?

So gap analysis is basically an assessment of your current performance– this is the definition– for the purpose of identifying differences between your current state of business and where you would like to go. You are at a point A and you want to go to point B. But to go to point B here, you want to understand where are we right now.

And you need to put yourself as to where am I right now against some kind of criteria. Let’s say we have a set of criteria. And then we say criteria one through 10, you may be fulfilling criteria one five and 10.

So you see that the criteria two, three, four, five, whatever, you have a gap. And you’re not there. So now you have to fulfill the criteria– two three, four, five, or all the missing ones, all the gap ones– to close this gap and then reach this point B where you want to be successful.

So the main thing that you’re going to answer is, where are we now? You’re all somewhere. It’s not that you’re not there. You are there. Where would we like to be? And how do we get there?

So three simple questions– Where are we right now? Where do I want to be? And how do we get there?

So I’m going to give you an example of a project I undertook. So we have an animal biosafety level 3 facility. We have always had one particular building in the animal biosafety level 3 facility which was built to handle ABSL-3 level work.

However, historically, we have never had any risk group 3 agents. I’m talking a few years ago. We never had risk group 3 agents. So we have never needed to use those rooms that were constructed as an ABSL-3 to use as an ABSL-3. So what we were doing is even though the facility was constructed as an ABSL-3 we were still using it as an ABSL-2 because we did not have a risk group 3 agent.

There came a time, there was a new investigator who came on campus and wanted to do some influenza work. And the strains of influenza work, the individual, was approved and USDA permit said that those strains have to be worked only at animal biosafety level 3. These are not any avian influenza viruses or anything. But there are certain strains which USDA permit says that it has to be handled at ABSL-3

If it is an in-vitro work it has to be BSL-2 enhanced. So now that we knew that we already have an ABSL-3, we thought it’s a very easy thing. These people can just get in and start working, which is not true. Because as I told you, the building was constructed several years ago. But we have never done any type of verification to see if this now qualifies to be an ABSL-3 after so many years.

So what I did was I used the CEN Workshop Agreement 15793, which is what is now converted to the ISO Standards, and read each section and started creating a document myself. There were about– when I say each line item– let’s say if it’s waste management. Under waste management, there were different items that were listed. I took each one of them as a line item.

So similarly from top to bottom, I created about 350 questions based on the CEN Workshop Agreement. So that was step one. And step two, what I did was started answering each of those questions and say, do we have this in place? Do we have this in place? If I did not have that in place, I would say no.

So in order to find out that, as I was going through, I also started giving a score saying if we have something in place comfortably– let’s say I’ll just give you an example. Do you have a Institutional Biosafety Manual in place? So we do have a biosafety manual. So I said, yes. Then I gave a score of one. And the scoring is purely internal, which developed. No regulation says you have to do that.

I would have given a, let’s say, to have an autoclave in place to autoclave your waste. The answer is yes. But there is a line item that says, do you verify and validate the functioning of your autoclave let’s say? The answer to that at that point was a no.

So you have an autoclave there. You do autoclave your waste before disposal. But periodic verification, validation by using spores to test the function of the autoclave, we didn’t have a program in place. So my point here is you may have something perfectly in place. That will be one. Something is in place, autoclave in place. But the validation program is not there. That means you’re not 100% covered on that. That would be a two.

And three will be a complete no. Do you have this? If the answer is 100% no, then you get a score of three. So otherwise, if you got one for a line item, you’re good to go. You’re audit-ready or inspection-ready. Two means you’re kind of halfway through. Three means absolutely nothing in place. So that was the way I had scored myself on each of these line items.

And again, the gap analysis which I did, allowed me to make sure what are the requirements in place? And to what degree are they implemented? Do we have it? And do we implement it?

For instance, if you have a biosafety manual, and if the biosafety manual was published in 1970 and we are talking something in 2000, now that is not acceptable. Because you have to review your manual to make sure it’s not just a document, but it explains all the processes.

Are we up to date on that? Are all current processes published in that biosafety manual correct? So you have a biosafety manual. That will be yes. But is it up to date? My answer will be two. So I’m just giving you an example of this. And this gap analysis, doing that helped me develop a implementation strategy for my future use.

So I said, OK. These are the things. What are my priorities? I cannot– if I got three on 100 items, I know for sure I cannot rectify those 100 items within a short period of time. I hope all of you agree. So that is where you have to prioritize and see what is your priority. Is your priority to make that three to a two or a one?

If your priority to improve the two? So that is where the strategy comes where you have to decide, what are the low-hanging fruits that is well within your control that you can take care of?

Certain things could be if you’re going to be asking for $100,000 to fix something, that’s not going to happen immediately. So this gap analysis helps you to see your current status and tells you where you want to be. And you can also prioritize your tasks and what you want to start doing.

Doing that gap analysis definitely helps you. The predicted outcomes is to make sure what is the gap in your program right now, develop an action plan to improve and follow the continuous improvement process. And then it also addresses other things like, how effective was your process? What are the follow-up activities? Do you have documented procedures and instruction?

That is the most important part. A lot of us do a lot of work. But we don’t document a lot of these things– so documentation of your procedures and instructions. Do you have good training programs? Somebody mentioned about training in one of your chat boxes.

Risk assessment– can we have some preventive actions we can do? And then are we compliant so we can avoid any type of fines in future?

So when I started doing this process with that animal biosafety level 3, whatever I wanted to do, it’s not a one-man show. It’s not a single individual involved. As you can see, I’m the biosafety officer. So I involve myself.

I involved a principal investigator who wanted to do that particular research. Involved a division of animal resources staff because it was a vivarium space, involved the occupational health. Wanted to make sure your HVAC systems and everything’s good to go so had to involve the campus services and the engineer. And more also important, is my IBC members.

So you can see that it’s the gap analysis when you start doing, you start working with multiple different team players to close some of those holes right there. So as already described this to you, I took the section and I said, OK, line. This is the summary of what is required. Is it applicable to you or not?

Do we have a return program? And then gave a scoring of one to three, meaning audit ready, in process kind of halfway through, nothing in place. And then eventually saying what is your implementation action required? And then who will be the responsible person?

Out of the 350 questions, I’m just giving you the overall sections here, the general requirements of policy. This is out of the CEN Workshop segments, which are the same in ISO segments right now– implementation, operation, checking, review, et cetera.

So I’m just giving you some examples here. I’m not giving you the whole thing. And what I found out when I did the gap analysis, the average score for general requirements came to 1.4 so on, and so forth. Now, you seen the review process there is a 1.8.

So you can see that we are still not picture perfect that time. You are above one, we are not a picture perfect one right there. So the overarching findings of that particular project, what I did was we figured out that we have a good biosafety program. But there were some written policies and procedures that needed to be further developed to be in line with the standards or requirements.

And then I also realized very quickly, honestly, when I started this, I wanted to do like a campus-wide implementation of CEN Workshop Agreement or ISO Standard, whatever you want to call it. But I realized when I went through the whole thing. I said no. This is not going to happen. I cannot do a campus-wide implementation.

Therefore I said, I’m going to start on a very, very small scale. And that small scale was I chose this one project, which had to address right there. Because we had to get the facility up and running for the PI. And then did the gap analysis just with that one small project and tried to get a snapshot also of our overarching biosafety program and then followed some implementation strategies right there.

So again, I mentioned to you this earlier. Gap analysis is intended as a living and evolving document. So if I did a gap analysis this year, that doesn’t mean I’m done. And you have to continuously do it to see your program that particular project or that particular program to see where are we next year? Where are we in 2026, so on and so forth?

So that is a living and evolving document. And the more you do it, you start closing your gaps more and more and more. So it is a good way to determine your current situation where critical action is needed. And slowly as you start closing your gaps, you will start getting that support from your upper management.

So, again, remember there are only certain things as a biosafety professional you can do. There are certain things, it’s not in your control. You don’t have any oversight. You don’t have control.

But when you close the gaps of certain things that is well within your control, that is your way of telling your management, we had these gaps with limited resources. I was able to close these gaps. And we are well and safe at this point. But there are bigger gaps. That is not in my control. And therefore, I’m bringing it to your attention. What is the liability to the institution? What is going to be the issue if we don’t attend some of those gaps right there?

And again, it is only your job to let your management know what is the risk, what’s the liability. You don’t have any control on some of those line items for you to close yourself. And at that point, it becomes the institution’s responsibility to say this is very risky. I cannot take this risk. I have to address this gap.

Same time, I know several of us, including me, we always say we need more resources. We need more manpower. We need more PhDs. All that when we take it to your management and say, OK, we are not up to the speed with the program and therefore I need two more PhDs, they are going to ask us why. Tell me why.

So this is where I always say try to address the low-hanging fruits, which you can address without asking for extra resources. Then that is your buy-in to your management saying these are things which I could do. But then to do the next part of it, we need additional resources.

So again, to implement a successful management program, this is my experience, I’m telling you, step one is to perform a good gap analysis by analyzing the existing program process system. Compare the gap analysis results of previous years and current years. And then continuously go through that review process, if not every year at least every two years.

There is not a definition as to how frequently you have to do it. You can do it on a periodic basis and see whether you’re getting closer and closer to your goals and objectives for that year.

Again, the first year when I did it, I’m telling you the scores, just giving you some examples of line items or general sections of policy, hazard identification, et cetera, et cetera. So I’m just trying to show you two years continuously here. The first year this was the score.

The second year, the score was this. So as we started refining and refining, so you can see that 1.27 became one. That shows something that was in the level 2, I was able to improve it and make it better.

Now 1.05 to 1.02 was not a huge improvement. But that’s all I could do. As you can see, if you go through the third year, even though your objective could be to make everything as a one, sometimes in second year, you could have got a one. But the third year, you may have a 1.05.

Doesn’t mean something went wrong. But your mind, your thought process is so much into this management system and you want to continuously improve. You’re not satisfied with what you have done. And you feel like you can do it a little better. So that little better in the third year makes it a 1.05.

So that shows that you’re continuously, continuously improving. And maybe in the third year, there could be a little change in one of the rules and regulations, subtle change, which you still don’t have time to implement. And therefore, from one in the second year, you could have jumped to 1.05. Again, these scores are not any regulatory scores. These are internal scores. You can keep it any way you want.

Now is an exercise for each one of you. If you would like to improve just one thing immediately that comes into your head with the resources you have, a low-hanging fruit which you can improve, what is that one program you would like to address?

It could be a waste management. It could be autoclave. It could be anything. And then when you want to improve that, at this point, what do you think are your key challenges and factors? And then so what is the program you would like to address right away, your biggest challenge right now? What are the challenges for that to improve that program?

And the third part of it is, what would you consider at this point? List one or two things to start addressing those gaps. You know the challenge, the two challenges you listed. So what is it that you would like to take home right now and see what would you like to address and address it as a gap? And how can you improve it?

Aufra, you can start reading if you’re getting anything.

Aufra Araujo: Yeah, one person entered occupational health program, but no comments on challenges or how do you address that, not yet, no.

Kalpana Rengarajan: OK. So we need to have the program you want to improve, what’s your challenge, and what at this point can you address to improve that within your limitations without asking for anything from anybody?

It could be as simple as you have not even done a gap analysis there. So you may want to do a gap analysis of that particular program you want to address right now. It could be that.

Aufra Araujo: No comments in chat yet. I also would like to add if someone prefers to unmute and speak up, feel free. Oh, some comments now in the chat. Let me read some. Autoclave verification, finding times when they are free, simulated waste loads for all the labs, new data loggers, make a schedule for autoclave so can find the time to start verifying efforts. And another one also wrote on waste management gap analysis.

Kalpana Rengarajan: So somebody who said something like creating a log for people to enter the times of use and stuff like that for the autoclave. To that individual, my question is, are you talking about a campus-wide rollout? Or are you talking about you want to start thinking about one small group and start doing it? Whoever wrote that.

So you may have 200 autoclaves on your campus. Are you talking about rolling this out to 200? Or are you talking about you’re going to take one department, let’s say the biochemistry department, and start testing this with the biochemistry department first? If that individual can say something, that would be nice.

Aufra Araujo: They entered in chat they were thinking about campus-wide.

Kalpana Rengarajan: Campus-wide. OK. Just wanted to know that. Thank you. OK. So I think majority of them talks about waste management and autoclave and one or two on occupational health. So now I’m going to go down to the next one.

Aufra Araujo: There is one more, Kalpana, Let me read. Risk assessments, keeping pace with rapid advancing technologies and tests, educate management awareness for buy-in on the importance, and improve communication proactively. I like that.

How would you do that when you want to say something to your management on the new techniques, risks, da, da, da, da? What would be your start point right there? The individual who said something about that, can you come up with one or two ideas, how you would like to educate your management on that? And feel free to either enter in chat or unmute yourself and speak up if you’d like.

Robin Riddervold-Cotten: Can you hear me?

Aufra Araujo: Yes.

Robin Riddervold-Cotten: So this is a little hard. I think I would start out as re-emphasizing that safety is a priority. It’s number one.

We have built a robust safety culture. But no matter what we do here, It all falls back on safety. Because getting them into that frame mark that if there was an accident or exposure, we’re looking at this more than just work. It’s a person’s life. There’s legal ramifications.

If something were to come back on us, it gets out in the media, there’s several ramifications. And we’re here to help support you. And we need your buy-in because there is so much advancing technology. And it is hard for us. Because every time we turn around we’re getting pressure to add this test, that test. And sometimes, they don’t think about reaching out to safety individuals to say, hey, we need a risk assessment.

So improving that communication– hey, if you’re thinking about this, consider about this. Give us a heads up so we can also look at risk assessments, what you’re going to need for PPE and things like that. We’re here to support you and help you keep your staff healthy, keep you happy, keep people feeling like they’re safe. Just ideas right there.

Kalpana Rengarajan: Excellent, Robin. I’m with you there on that. So here you want the management buy-in top down. That goes to labs and stuff that they understand they have to communicate to, let’s say, the safety professionals, Robin, and whatever that is.

So if Robin was given only five minutes to talk to the upper management– you remember all of you should know that they don’t have any more time or patience to listen to a 30-minute slide deck right there. So if you want to put that in a nutshell, it is very, very critical in one slide or two slides saying, and you can give examples of other– without mentioning names of institutions– when things have happened, what they have been fined, what has been a fatality.

You could do any number of ways so that catches their eye and that makes them understand how that communication is extremely important and your group or safety group is critical in playing a team work along with that group to make sure that it’s done safely. And it’s safe for everybody.

So yes, you can do it in a one or two slides if you’re given an opportunity show them what is happening. This is what it is, why do you need this. And giving examples of what has happened with other institutions, one or two. How much fine, how much media effect it had and that kind of stuff. Excellent. Thanks, Robin.

So that was just an example there. So the answer here is, remember, I mentioned to you that a 350,000-page overview is not going to be possible. But a 10-page overview is extremely possible.

And as I mentioned to you earlier, that was an example where I showed you with that particular avian influenza work where I took this as a challenge and tried to do. And today, we do a lot of work in that same facility with SARS-CoV-2 and everything. And every year we run it. And we make sure everything is good to go right there.

So I am personally a strong proponent of baby steps. So I’m sure will concur with me that baby steps do count as long as you’re moving forward. Instead of staying in the same place complaining, complaining and feeling frustrated with things that is not in your control, you taking charge of something that is in your control and a small difference, you can make one step forward, that will take you moving forward.

And as you start taking the steps, the management will turn around to see what you’re doing. And definitely sooner or later, that support will be there. Maybe the effect will not happen, you will never have an instantaneous gratification, definitely.

So for instance, a person who said something about the autoclave. My thought process would be instead of doing a campus-wide implementation of how can you log all your whenever you do the autoclaving, I would recommend choose one autoclave and see who are the users of that autoclave. There may be three labs that use that particular autoclave.

Then all that I would like to do is see if I can sit and talk to the three labs and say, hey, I’m going to roll this out. I want to put in this sign-in sheet. I want to see whether you can log in when you’re using. And more important, include them, your customer, as part of developing that process. And ask them, hey, this is what my thought process is. Will you review this and tell me is this possible or give me your suggestions how we can do it.

When you involve your customer and give them that importance, they start listening. So once you do that one autoclave, you can expand it to the department, which is five autoclaves in the biology department. Then you talk to your supervisor or upper management and say, I tried this with one autoclave. Then I tried it with two or three then with the department one. Now I’m ready to roll it out.

And if I roll this out, these are the advantages that you’re going to have. And as Robin mentioned, keeping up with regulatory requirements, no fines, safe for everybody, all those kinds of pointers you can bring that too.

So again, to reiterate, baby steps count as long as we keep moving forward, but not standing in the same place and chasing our own tail. Having said that, I would like to see if we have any more questions.

Aufra Araujo: Thank you, Kalpana, for your excellent and informative presentation. We will open briefly for questions if anyone has any final questions before I introduce Dr. Sabrina DeBose, who will summarize the discussion for us. Feel free to unmute yourself if you have anything you’d like to ask or comment.

Olivera Marjanovic: Hi. Thank you for a wonderful presentation this is Olivera from the California Department of Public Health. I have a question regarding the future of potentially having accrediting bodies doing accreditations for institutions as is done for quality, ISO Standards and quality. Is that something that is talked about?

Kalpana Rengarajan: So right now we don’t have an accreditation body or a process for that. But once these guidelines and stuff happen for implementation of the ISO Standards, people may start thinking about it. And ABSA is one of them who’s thinking about it.

Olivera Marjanovic: Great. Thank you so much. That’s wonderful.

Aufra Araujo: Thank you for that question. There is one other in the chat, Kalpana. And I will read it for you. Why is it so difficult to have buy-in into a system which we, the technical people, can see the importance as plain as daylight? They increased testing, but yet the safety aspects for us is not priority. So I guess they mean there is increased testing. But yet the safety aspect is not a priority. Do you have any comments, Kalpana?

Kalpana Rengarajan: Unfortunately, the world of safety is its own in a little permit shell or something. Like it or not, anybody pays attention to it, you should be more proactive to make sure all this doesn’t happen. The tendency is always well if something is running, everything is going well, why do we even worry about it? Why do you talk about all that? Everything is going good right now with what you have.

Unless and when there is something bad that happens and incident that happens, there is a huge liability to the institution, that’s where they start catching up their act. Unfortunately, people think having a proactive approach does not always mean that it’s a financial responsibility.

Yes, there is a financial responsibility to a lot of things. But there are so many things that individuals can say, yes, let’s address it proactively with very minimal financial obligation. And then that leads us to spend more and to make it much better.

It’s just that culture of reactive is more dominant than proactive. That’s the truth of it in my opinion.

Aufra Araujo: Along those lines, Kalpana, another question. Do you think safety will become as well-known known as QA in the future?

Kalpana Rengarajan: I hope so. I’m not somebody to promise that. I can only– I try my best to do that in my institutions. I do have investigators. Sometimes they do work with benign stuff. But when I go tell them something, they’re like I’ve been here for 35 years. Nothing has happened to me. Thank you for your consideration. But I’m not going to follow what you tell me. I’m like, OK.

I’ve done my due diligence. I’ve told them. But deep in me, I know it’s a benign level 1 stuff. So I’m not too worried. But not following what you want to do, it just frustrates you.

But then I have learned over a period of time, am I going to change that small 5% who does not want to listen to anything? Or do I want to work with the 90% of the people in the bell-shaped curve? Whether they like it or not, they follow with you.

I would rather spend time with people who are willing to listen and improve more and more than working with individuals– I’m not saying I refuse to work. I would like to work with that percentage of people too. But when they fight, fight, fight with you, you need to learn how to pick your battles.

And I have learned to pick my battles I’m like, OK you’re close to retirement. Good luck with that.

Aufra Araujo: Thanks again, Kalpana, for an excellent presentation. That was also an excellent discussion. Thank you everyone for participating. Now, I will invite my colleague, Commander Sabrina DeBose, who is the Safety Team Lead in the CDC’s Division of Laboratory Systems to provide a summary of the discussion from today’s session. Sabrina, over to you.

Sabrina DeBose: Thank you. Thank you, Aufra. So as mentioned, today I will be providing a discussion. And we want to say thank you for the robust discussion concerning laboratory biorisk management.

So this summary of discussion is from the participants. One of the first questions that were asked participants were provided with several examples of the definition of biorisk management. Two examples that we received were system of a methodically reviewing a goal and also checks and balances to ensure you achieve some sort of goal.

The other question that was placed in the chat– the other question that was asked– challenges implementing a risk management system were identified as, lack of manpower, and an example was given. They could launch and empower more junior personnel in the labs would be more helpful.

Another challenge that was provided, improving communication with staff. A solution to that was to make sure staff feel involved and valued. And also a lack of training– a suggestion was incorporated to implement periodic training and safety.

An additional question that we had that you all provided discussion to, suggestions for making three changes to the management system at your facility. One example was extend the contract with the occupation health services, place more emphasis on the ergonomics due to the aging of laboratory staff as well as when to improve the communication between the departments when a biosafety event occurs.

Another question that was asked and there was discussion on, what factors are important before implementing a biorisk management system in your facility? Some of the points that were provided– funding, buy-in from management, and having accountability.

Another question is, which is one program you would like to address? And what are key challenges and factors? I noted three of the examples that were provided.

One was autoclave validation. Two, an example was given of waste management gap analysis. And three, risk assessment– they were finding it challenging with keeping pace with the advancing technologies and improving communication with safety officers and the programs. So that concludes the overview of the discussion. Thank you.

Aufra Araujo: Thank you, Kalpana and Sabrina, for the summary. Kalpana, is there anything else you’d like to add to Sabrina’s summary of discussion?

Kalpana Rengarajan: Sure. Thank you, Sabrina, for summarizing. I just want to tell the audience we are all in this together. There’s no perfect institution, no perfect situation anywhere. But my take-home message on this, I would like each one of you to think when you get back to your work, don’t constantly worry about all those problems that you think you have to solve.

Just think about one small thing and say, can I look at this problem and what is it that out of this, if I have to do a gap analysis– let me do a big-picture gap analysis. You don’t have to do a picture-perfect one, but a very quick big-picture gap analysis. What do we have? What is it I need to have? And out of these items, is there something I can take care of?

For instance again, going back to the example of autoclave login to make sure who the users are, as I suggested, if the individual who said that feels like you don’t know who is using, what is happening, don’t start a big picture. Baby steps again.

Talk with one autoclave user, two or three groups if they are, work with them, run it by them. Run that for two or three months to see how that works. That buy-in with your customer is important. Then you expand it.

So here we are, safety professionals, not to solve the world’s problem. That is totally impossible. But we can solve small things. And as we do this incremental dosage of improving your program, you will start seeing a big-picture improvement in your program. So that is very, very critical. And I forgot to mention one example.

I use that same strategy for all regulatory requirements. For instance, everybody should have a bloodborne pathogen exposure control plan in your institution. OSHA requires that you review it. And you have to make sure that it is reviewed and revised on an annual basis. It’s a regulatory requirement.

So what I do is I have one or two of my team members look at it every year. We change the team member to review the regulations. And then line item by line item, we go through. And then we see is there any gap or did OSHA pushing something new that we were not aware of? That helps us to see that we have to implement it. And we continue to use the same strategy of gap analysis process improvement for multiple things in our program.

And it did not happen overnight. I want all of you to know that. This did not happen overnight. I’ve been in this job for 18 years now. So over a period of 18 years, I have slowly rolled this out to multiple different things. So everybody can do it.

You can all do it. You’re all doing it. It’s just a question of a systematic approach and more important, documenting what you’re doing. That is more important.

Aufra Araujo: Thank you. Thank you so much, Kalpana, for a terrific presentation and the audience for a great discussion. Now I would like to talk about the post-session survey. You know I have to talk about the surveys.

In the chat is the link to the survey for today’s ECHO Biosafety session. It will take you directly to the Qualtrics survey. This survey should take no more than two minutes to complete. So all we ask, two minutes. And your participation is voluntary, but strongly encouraged so we can continue improving the ECHO Biosafety Program and achieve better outcomes with this biosafety 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 real laboratory biosafety case or challenge– today in chat, you enter several challenges– so if you have any topic challenge that you’d like to present during one of these sessions throughout this year, please get in contact with us throughout our dlsbiosafety@cdc.gov inbox. That will be also in the chat.

We are excited to have our next session on Tuesday, February 27. And I just want to share the screen really quick. Let’s see. All right. So that session will be– the topic will be A Stepwise Process to Improve Biorisk Management Systems presented by Eric Cook, who is the Biosafety Officer at Sandia National Laboratories.

As a reminder, you can access the transcripts, audio recordings, and presentation slides from previous ECHO Biosafety sessions on the DLS ECHO Biosafety website, which will also be in the chat. And today’s session materials will also be on that website in a few days.

Now we adjourn. Thank you for attending. And I hope you were intentional about having a fantastic day. Thank you so much.

Kalpana Rengarajan: Can I say something?

Aufra Araujo: Yes, Kalpana.

Kalpana Rengarajan: If anybody wants to contact me offline, I’m more than happy to talk to you. You can email me anytime. Thank you.

Aufra Araujo: All right. Thank you everyone. Bye now.

Additional Resources and Related Publications 

1. European Committee for Standardization. (2011, September). CEN Workshop Agreement: Laboratory biorisk management.
2. International Organization for Standardization. (2019, September). ISO 350001:2019: Biorisk management for laboratories and other related organisations