Leadership: Roles, Responsibilities, and Authorities – Session Materials

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Date of session: 03/26/2024

Facilitator

Aufra C. Araujo, PhD

Centers for Disease Control and Prevention

DLSbiosafety@cdc.gov

Didactic Speaker

Joseph P. Kozlovac, MS, RBP, CBSP, SM(NRCM)

Agency Biosafety Officer, Agricultural Research Service

United States Department of Agriculture

joseph.kozlovac@usda.gov

Aufra Araujo: It’s time to get started. 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 for joining our third Extension for Community Health Outcomes, or ECHO, Biosafety session for 2024. The topic for this interactive discussion is Leadership: Roles, Responsibilities, and Authorities. Today’s subject matter expert is Joseph Kozlovac from the United States Department of Agriculture in Beltsville, Maryland.

Let me stop sharing these slides for a moment so we can all see each other, hopefully, if you turn on your camera. Yay, it’s so nice to see everyone. I would like to ask everyone a quick icebreaker question. George already put it in the chat. And I see people are already responding.

Spring brings a sense of renewal and new beginnings. Is there anything new you are looking forward to this April? Let us know in chat. Or even better, unmute yourself and turn on your camera if you’d like and share with us. We’d love to hear from you and get to know you a little bit more. Anyone interested in saying hi and unmuting?

Or just entering chat, I see flowers, me too. I’m looking forward to working my yard this spring. It’s been feeling cold for a long time here in Georgia. Can’t wait for warmer weather and being outside. Going on a cruise, oh, that’s lovely. I like that. Ooh, spring, I saw baseball season, opening day a few days away. That’s cool.

Can people hear me? Somebody said they cannot hear me? OK, maybe the problem was resolved. Increase your volume. My volume is in the max here. OK, warm weather, yes me too. Anybody you’d like to unmute and say hi? Say where you were calling from.

Shanna Henk: I’m in Fort Collins, Colorado. I work closely with Joe. I’m with USDA ARS as well. Hi, Joe.

Aufra Araujo: Nice to have you here, Shanna. Anybody else? All right, you are saving for talking later, I get that. That’s OK. Thank you all for participating in the icebreaker question. Now, I’d like to provide a brief recap from last year– last month’s presentation. Let me go back to my screen. You should be able to see the screen again, yes? Can you give me a thumbs up if you see? Yes, good.

All right, so this is a brief recap from our last session in February, featuring Eric Cook from Sandia National Laboratories, who presented a stepwise process to improve biorisk management systems. We had a total of 96 participants attending the session. These participants are affiliated with 62 organizations in the U.S.

In our scenario exercise, led by Eric, the participants were asked to identify individuals to assist in mapping an existing biorisk management system structure to ISO 35001. Suggested suggestions included facility and engineering staff, principal investigators, responsible officials, technical supervisors, security managers, and protocol committee chairs. So just a quick recap about that.

We encourage you to share information about our ECHO Biosafety sessions with your colleagues and to connect amongst yourselves via chat if you would like. We would like to close the gap. We have more people from all states participating.

All right, 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. Currently, all audience microphones are muted when engaging in the discussion. Please unmute yourself to speak. Closed captioning– 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’re 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. Let’s go to the next slide.

Next, I will introduce our subject matter expert, Joseph Kozlovac, 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. 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 session, the transcript, the audio recording, presentation slides, and other resources will be posted on the DLS ECHO Biosafety website, which the link will also be in the chat.

I would like to remind you, next slide, that these slides, the presentation slides today contain materials from speakers who are not affiliated with CDC. Presentation content from external speakers may not necessarily reflect the CDC’s official position.

Now, it is my pleasure to introduce today’s presenter, Joe Kozlovac is a seasoned biosafety professional with over 35 years of experience. He is a Registered Biosafety Professional (RBP) and a Certified Biological Safety Professional (CBSP). He earned his Bachelor’s in Biology from the University of Pittsburgh and a Master’s in Environmental Science and Policy from Johns Hopkins University. His most prominent contributions to the field, because there are many, to the field of biosafety include co-authoring CDC/NIH Biosafety and Microbiological and Biomedical Laboratories (BMBL) Appendix D, which focuses on in vitro and in vivo research on diagnostic activities involving pathogens that primarily affect agriculture animals. Joe also participates in the development of the ISO 35001 guidance document.

Currently, Joe is at the United States Department of Agriculture (USDA) Agricultural Research Service (ARS). We love our acronyms. Joe develops and implements biosafety policy. He chaired the USDA ARS International Biosafety and Biocontainment symposium series and co-chaired a National Science and Technology Council (NSTC) Health Security Threats Subcommittee working group, contributing to the Evidence-Based Laboratory Biorisk Management Science and Technology Roadmap. Joe actively engages in interagency efforts on biorisk management and biodefense, aligning with national strategies and executive orders. He has been recognized with several awards, such as the Arnold G. Wedum Distinguished Achievement Award and the Everett Hanel Jr. Presidential Award from ABSA International.

Joe, the floor is yours. I’ll stop sharing. So you can share your slides. Welcome.

Joseph Kozlovac: Well, thank you. I really greatly appreciate that kind introduction. One of the things I’d like to bring up is one of my mentors, Dr. Bob Hawley; whenever somebody calls me an expert in anything, this always comes to mind.

His definition of an expert is ex, which means former, and spurt, which means a drip under pressure. So I don’t think I’m ex yet because I’m still a practicing biosafety professional. So I guess I’d be more of a spurt.

I’m happy to be here to talk about biorisk leadership. And you can see in the title slide that I have here a lot of the leadership responsibilities, both for top management within an organization, as well as some of these responsibilities may trickle down to those of us who have responsibilities for establishing and supporting biorisk management programs overall. So let’s get started.

OK, why are we not– there we go. Similar to the CDC disclaimer, I just want to let you know that these ideas in the presentation are solely my own. And they do not necessarily reflect the views of the Agricultural Research Service, the Department of Agriculture, or the United States government.

So I liked this article. Well, this one paragraph in this article because I don’t necessarily agree with all the findings that were put forth by this paper that came out of– from three Stanford researchers. But I do think that life science does need to call leadership.

We do need to develop leaders that represents and integrates technical and social expertise, leaders must instill safety and security as core missions because when this paper was written, I think it was back in– it was in 2015, we just came off of a series of fairly high-profile biosafety mishaps, one might say.

And that had an impact on many organizations. And they can still be felt to this day. And I also think that it’s applicable to the biorisk profession because we really do need to develop leaders. We need to develop biosafety professionals at a basic level even, because there’s more roles for biosafety professionals at this point in time than there has ever been before.

When I came into the profession, you might see a job opening once, twice, maybe three times a year. And now, you can see 30 or 40 of them in a month, easily. So why is the call to leadership so important? And when we look at organizational safety, or biosafety, biorisk management, however you want to put it, really, only the top and senior leaders within an organization can ensure biosafety and safety as part of the organizational value and part of the institutional culture.

As a biosafety officer, as my colleague Jim Whelchel has frequently pointed out, is that we lead from the second chair. We’re never those in direct control of the organization. We’re typically always in a support function. And if you don’t have top management and leadership support for your biosafety or biorisk management program, it’s really not going to be successful.

So therefore, their engagement is crucial for long-term success. And in many cases, biosafety professionals can be shy about telling the leaders what to do with how to lead biosafety. And in many cases, leaders have– take the view of, well, this is safety, or biosafety. This is in the realm of biosafety or safety professionals, which isn’t true.

Because safety, biosafety, it’s a management function, just like any other management function just like finance, communications, HR, all those types of activities within an organization that leadership actively manages, safety needs to be one of those. And it needs to be put at the forefront as well.

And in many cases, I think standards, like ISO 35001, the biorisk management standard, or even other safety management systems can be useful in this regard. Because– oh, sorry. Because they can define roles and responsibilities from the very top level to the most junior level of their staff.

And ISO 35001 does define the couple levels of management. They have top management, these are the folks that have the power and authority to delegate. They can delegate authority. They can provide resources within the organization. They set and define, typically, the organizational vision.

They, through accountability, will model the values of the organization, set objectives, and policy, as well, like I said, delegate authority to lower levels of management. These are the individuals that I like to say that are in the C-suite. So if you’re familiar with corporate lingo, these would be the folks with the C’s in front of their names, the CEO, the Chief Executive Officer, the COO, Chief Operational Officer.

Those types of really top leadership, I guess, if you want to look at a government standpoint, for my agency, it would be the ARS Administrator would be the top management position within my agency. Or at CDC, it would be the CDC Director. So I’m sure you have similar types of roles in your organizations that you represent.

In any case, top management is going to delegate the actual day-to-day activities of a biorisk management program to senior management. So these are the individuals that are more operational, though they’ll be able to assign budget as well as human resources. Typically, they’ll have authority at a department level with decision-making authority. They are more of manager types of roles, typically a level down from top management.

And then you also have scientific management. So these are your folks that are at your front lines. These are your principal investigators. They’re responsible for the scientific program on a day-to-day basis. And they’ll really be the boots on the ground on adhering to the biorisk management program. And they’ll do this through participating in inspections, ensuring that their staff are trained and competent, development of standard operating procedures, as well as those ensuring that their staff are competent in conducting those operations, looking at those critical safety behaviors.

ISO 35001, although not in so many words, does cover most of these, kind of what I say biosafety management program elements. And you’re going to find that I switch back between biosafety and biorisk. It’s sometimes– I just have problems in switching terminologies because I’ve been around for a while.

But most biosafety and biorisk management programs, or even safety and health programs in general, are going to have the following core elements. They’re going to have, of course, commitment and leadership from management of the organization. Employee participation is really critical as well. You’re going to have elements where you have hazard identification and assessment.

This will be like your risk assessment processes, hazard prevention and control. How are the labs designed? What are the procedures that you put into place to address the risks of the biological hazards that you happen to be working with or actually, not the biological hazards, or whatever other hazards.

What kind of information and training program? And then of course, evaluation of program, because one of the goals, of course, is continual improvement. So if you look from the three bubbles, the 12 to 3 o’clock are really focused on leadership, commitment, and engagement because they’re the ones that are really going to be defining the policies, the goals, and the vision, and ensuring that the– that the biorisk management program aligns with the organization’s vision.

Because if you have a misalignment between the biorisk management program and the organization’s vision, then you’re going to come at loggerheads. And it will be difficult for the biorisk management program to be really successful.

And then, of course, from about 4 o’clock on, it collectively represents employee engagement because employees are going to participate in the risk assessment process, the development of SOPs, training review of SOPs. And they’re going to participate in program assessments. And program assessment is critical to continual improvement, which brings us to the next slide.

All those elements are going to be broken down into a PDCA, Plan, Do, Check, Act, system. So because we’re looking for continual improvement through a cycle of planning, implementing, reviewing, and improving the processes and actions that an organization undertakes to meet the goals. So I’m going to do an inspection, for example. I’m going to plan how I’m going to do that. I’m going to figure out what’s the scope of the inspection.

Actually, I don’t even like to use the word inspection. I’d rather utilize the term assessment. I think it’s a better term. You plan it, you actually execute, you do it. You check if you met your goals. And then if you need to make improvements. Then you act. And it’s a continual cycle. And I’m sure some of the earlier speakers probably really hit this quite a bit.

This is an illustration that I took from a book that I really like. And I guess it’s starting to get a little bit dated now. But it’s a book by a guy by the name of Terry Mathis and Sean Galloway. They’re safety professionals, safety management consultants, I suppose would be a better word.

But they wrote this book, STEPS to Safety Culture Excellence. There’s another book that’s written by a guy by the name of James Roughton called Developing an Effective Safety Culture. One of the things that I found is that the safety disciplines actually have gone down this road and actually provided more thought. And the biorisk management profession is sort of at the nascent stage of looking at management systems.

But one of the things I like about this slide, in particular, is when you’re looking to improve safety, there’s a need to address both the traditional safety management compliance aspects, which would be represented by the pillar on the left-hand side, where it says compliance. And then that’s very much a management-led process. And as you can see one of the support strings towards management is leadership.

But the other half of that is culture. How do your employees reinforce those values and hold each other accountable for the safety, both for following procedures, keeping them and the institution safe, with the goal of reaching excellence? And of course, it’s a goal that you’re never going to reach.

And there’s a play between these two. And the relationship between, say, a biorisk management system and safety culture is one of interdependency. A strong safety culture is going to reinforce a biorisk management system. And an organization with a poor biorisk management system is going to inhibit the development of a strong safety culture.

Let’s move on. I’m sure I communicated everything. Yes, so what is culture? If you look at the third bullet by Dan Peterson, he’s now passed but was once a really known safety and management guru. And he once recounted talking to an employee. He described culture, well, that’s just how we do things around here.

And that’s true because culture is the unwritten rules that are taken for granted, the values, underlying assumptions that impact an organization on a day-to-day level. It’s important to note that organizational cultures are not generally good or bad, right or wrong. They’re either aligned or misaligned with the organization’s environment.

But I can tell you, having observed a number of different organizations, you can actually tell what the safety culture is. Sometimes you work– you walk into a place, and it’s like, wow, they really care about safety here. It’s more noticeable by an outsider than it is by somebody that’s been in as part of that culture because it sort of just becomes blocked out, just how they act.

Organizational cultures can be affected by the subcultures, especially in large organizations. This can cause problems, especially if you want to improve or change the culture. And culture change, from at least what I’ve seen in a fairly mature organization, where we have an established culture, if you want to actually change it, that can be extremely hard.

And that’s why I have that last bullet, where culture eats strategy for breakfast. Because even if the organization’s assumptions, as needed– that we need to change our culture, some of the members of that organization are going to hold on to the old paradigm because it was a source of pride, or self-esteem, or it’s just– they don’t want to make the change. And that can become a problem.

And one of the reasons why I say strategy eats culture for breakfast is oftentimes, organizations won’t bring their rank-and-file employee into the development of a strategy early on. They come in fairly late after a lot of the decisions have been made. And I think that’s probably a mistake. And I think that if you’re looking to develop a strategic plan, you need to really engage and involve everyone within the organization.

This decision making into their governance, planning, management, reporting, all their policies, what their goals are. And again, the overarching goal is to develop a biorisk management culture where you’re continually improving at all aspects.

So with that, I want to take a little bit of time, and if you get a piece of paper out, and what I want you to think about is take a minute, think about your organization and the culture that your organization has. And then talk about– write down one or two things that you like about your workplace culture and one or two things that you’d like to change. And thinking about that, if you wanted to improve your safety culture at your organization, what would be the number one thing that you would focus on? And how would you change– make that change?

And some of the questions to ask yourself relative to a safety culture is safety, and biosafety, and biosecurity integral part of all of our operations? Are employees encouraged to identify report issues, hazards, and accidents to take appropriate action without being punished? That fourth question has a lot to do with psychological safety and can actually– if you have a very good culture, where folks are expected to bring their ideas, even contrarian ideas are respected and addressed.

And is there a clear accountability at all levels following your safety. So I’ll give you a minute. And then I’ll let my CDC colleagues, Aufra, tell me what’s in the chat, going on in the chat.

Aufra Araujo: Nothing yet. I think folks are thinking. Yes, feel free to either enter a few words in the chat box, or unmute yourself and share some thoughts, some of your thoughts on your experience about organization culture.

Joseph Kozlovac: That gives me an opportunity to wet my whistle. Nothing yet, huh?

Aufra Araujo: Nothing yet.

Joseph Kozlovac: Well, hopefully, I didn’t put you all to sleep thus far. So well, I mean, continue to think about it. And as we go, feel free to throw things into the chat.

Aufra Araujo: OK, Joe there’s some comments now. Let me read a couple. I’d like to incorporate biosecurity more into our daily operations and risk assessments. That’s one. Another one. We do not stand on titles. So all levels of the organization can be heard and listened to. We also have employees who want to learn and get better. Where we struggle with is accountability.

Joseph Kozlovac: Accountability can be a challenge. It definitely needs to be well-defined. And it should be well-defined in policy.

Aufra Araujo: Another thought is in our agency, I think having a full-time safety, biosafety officer at every location would be a great way to initiate change in safety culture. It would demonstrate a commitment to safety from leadership at all levels.

Joseph Kozlovac: I don’t disagree with that, depending upon the size and resources of your organization.

Aufra Araujo: We’re having some great thoughts here. What I like about my organization is that we get a lot of ideas and interest on how to improve biosafety in our organization. The not so great part is that they think it’s the responsibility of the biosafety officer, rather than something we are all empowered to change.

Joseph Kozlovac: Yeah, that’s something that my colleague Sean Kaufman speaks out quite a bit on. And probably one of his criticisms of those that are in my profession that are biosafety professionals is we got to stop doing biosafety for them and doing biosafety with them. And I think that is an important point and something that should be reinforced. Because it’s easy to do it for them because like are we really meeting our role, if that’s actually what we’re doing?

Aufra Araujo: I’m trying to incorporate all the thought– now there are lots of comments. I’ll read one more. And then we will move on. I like that we have a culture where communication is open from quality and safety to lab testing personnel. I would like to change the overall attitude in the lab regarding safety. Safety is the most important aspect of lab work, but it’s treated like an annoyance a lot of times.

Joseph Kozlovac: That’s true. And I can– one of the things that I’ve noticed, and sometimes it actually makes me laugh, you go to some workplaces, where you see safety is job one. That’s not true. Safety is not one– we’re a support function. Yes, we should have safety incorporated as a value. But if you’re a diagnostic laboratory, is safety the– it’s actually developing results.

Or if you see that on a trucking– on a license plate, safety is my job one, it’s like, yeah, or safety is my business, no, your business is moving stuff from point A to point B. It’s good that you’re being safe. Although having seen some of these trucks on the road, I kind of doubt that. But anyway, so we can move on.

I think, especially as biorisk professionals, development is a strategic plan for improving laboratory biorisk management programs is something that we should do. I can tell you my own journey. Back in 2013-2014, when my agency was really thinking about we need to actually improve our safety within the agency, we did what most safety programs do.

We assessed our safety program, tried to identify gaps. We did benchmarking with other organizations that were similar size in nature to ours. We did some surveys of employees to assess what they thought– where they thought.

And then we actually started acting. And what the propensity is to address the gaps, right? So what I would have wished we would have started with was developing the strategic plan prior to doing any sort of assessment of the program. Where do we want to be in five years, regardless of where we are now?

And so that’s why I have begin with the desired end in mind. And you want to actually align all your biosafety, biocontainment, biosecurity, and safety activities around that overarching strategy. And I like to use appreciative words. There’s a change management system called appreciative inquiry which I really like.

It’s not a– it’s not a gap analysis of where you’re doing things not so great. It’s actually it’s like– it’s an analysis of what are we doing really well? And how can we apply that to other areas? One of the other reasons why I really like it, it involves employees from all levels. It’s very inclusive for the organization.

And the other way– the reason why I like it is because each of these processes are homegrown. And the plan needs to be designed to serve the institutional compass, providing clear and consistent directions toward success. There was a guy– he was a noted writer on leadership, business leadership. And one of the things that he said, his name was Warren Bennis, he said to choose a direction, an executive has to develop a mental image of the possible and desirable future state of the organization. This image would be your vision.

So the vision is your leadership’s mental image of where they want the organization to go. And for the vision to actually have any impact on the employees, it has to be conveyed in a dramatic and enduring way. Everybody in the organization has to have a common understanding of the goals and directions, key elements, and effective communication of the vision.

We want it to be simple. All jargon and technobabble has to be eliminated. If you can use metaphors or analogies, that’s great. A verbal picture is worth a thousand words. It should be repeated. And it has to be clear where it’s going to provide guidance to those that are making decisions on a day-to-day basis. This is how– this is what our goal is. This is where we want to go. So this is going to be incorporated into all my decision-making.

Communicating your vision, especially if you can tie it to current events, is really useful. And the mission statement is essentially the organization’s vision translated into written form. For many corporate leaders, it’s a vital element in any attempt to motivate employees, to give them a sense of priorities.

But again, it should be short, concise, a statement of goals and priorities. And of course, goals or specific objectives that relate to specific time periods. I just have an example of some goals. Actually, when I was looking back at these, they’re not specifically really good goals because we’re not bound in time. I think a really good goal should actually be bound in time.

Again, this is where we’re bringing back in top management, responsibility for defining an authorized biorisk policy is the responsibility of top management. Their ongoing and proactive involvement in developing and communicating the biorisk management policy is critical. And the policy, as you’re developing, should go through a PDCA process, Plan, Do, Check, Act. And it should be reviewed on a routine basis.

But one of the things it really needs to do is define the roles and responsibilities at all levels within the organization. And the policy and its supplemental documentation needs to identify a chain of responsibility for information on biorisk-related issues. And I have a couple down here. But I think some of the real key ones are risk assessment and risk management processes, compliance.

What are the legal requirements that our organization has to meet? And that’s really a key role of a biosafety professional is making sure that leadership understands the legal requirements that are applicable to your organization’s mission.

Having a way to define and assess the program and any corrective actions taken, defining when you have upset conditions, like incidents, accidents, or even non-conformance. So you’ve got to remember that safety and operational excellence are really tied closely together. And I’ll give you an example in a little bit about that.

So here’s my advice. The biorisk management policy should support the organization’s culture, set organizational objectives for biorisk management, describe the rules which demonstrate that organization’s top management is committed to implementing and monitoring an effective biorisk management.

So you want to start with the end in mind. And you got to remember that the written policy is just another means of communicating the policy. Now, ours and top management’s attitude towards employee safety are going to speak a heck of a lot louder than what’s written on paper. What we do or fail to do is going to impact whether our folks follow the policy.

So for example, if you have a laboratory director who is walking through the laboratory, and they see one of their employees that is doing something that’s not their procedure or something that potentially is inherently dangerous, let’s say they’re doing something on the open bench they shouldn’t be doing because you have another employee that’s working in the biosafety cabinet and doing something that’s critical.

If that lab director doesn’t stop and make the correction right then and there and leaves to go to a meeting or whatever priority that they had, if they don’t make that stop and make the correction, they just communicated to their employees that, look, getting the job done is more important. And my meetings– going to my meeting is more of a priority than your safety. So I think those are the kind of things that you have to think about.

Oh, one thing is the picture on the is, in this case, little brother is watching, which means employees are always watching what leadership is doing. And that’s actually a picture of my grandson when he was two, when he was attending his first ABSA conference.

This is just an example of a policy statement. One of the other things that leadership, executive leadership, is responsible is for compliance and with the regulations. Whether an inspection is announced or unannounced, the rule of management is to ensure that the organization is prepared to deal with regulatory visits and minimize the impact on operational status of the organization.

That means your staff, your facilities need to be prepared every day for that regulator to walk in. So one of the things that I recommend is that organizations actually develop a procedure to have in place regarding regulatory inspections and ensure that staff are well aware of their roles and responsibilities.

And it’s not even a bad idea to, maybe on an annual basis, rehearse and do a dry run. And again, PDCA, Plan, Do, Check, Act, and update it as necessary. So now, I’m going to be speaking to my biosafety colleagues. One of the– we have the opportunity to provide service to different stakeholders.

Of course, we have a duty to the institutions and our employers. We also have a duty to our clients, especially if we happen to be consultants or other stakeholders. But we have a duty to our professional societies as well as the communities in which the institutions that we serve are located.

And we should always keep that in mind because what one of us does can have impact on many of the other biosafety professionals out there. So what do we do? We manage the biosafety program. We do provide technical leadership, and risk assessment, and knowledge on biosafety principles and practices.

And we share this with folks, such as the laboratorians. We develop policy and procedures based on guidance that we receive from top management. We establish training programs. And this last bullet, where we have a liaison with the department.

So one of the unique roles that we have is we’re going to communicate with the C-suite, in many cases, down to the rank and file employee. And because of that, when we’re doing our jobs really well, we can serve as institutional glue, uniting the organization, especially relative to the biorisk management program.

So if you want to become a leader in the biosafety profession, one of the things that I’ve observed over 35 plus years, technical or professional credibility is a big deal in the biosafety profession. All the leaders in the biosafety profession that I’ve observed were technically proficient in the core competencies. And you can find out what our core competencies are if you look at the CBSP exam on the ABSA, they will have a list of what’s in those exams. And that pretty much defines kind of what the core competencies are.

But beyond that, they’ve also distinguished themselves and developed expertise in specific areas of biosafety risk assessment, high containment laboratory operations, agriculture, field applications. And in many cases, they taught or published in these areas as well.

So early in my career, the big focus was on technical competency. But having said that, we’ve all met managers that were technically competent, but they– but they had no inherent knack for details of managing, such as setting expectations, motivating and developing others. And this kind of underscores the need for our profession to focus on this soft management skills that can be developed in your strengths through training. And a lot of that can be done through mentoring and training opportunities.

Actually, I think any profession, not just the biorisk profession, needs to make communication a strength. In reality, I think leadership comes down to three things, influence, impact, and inspiration, what I like to call the three I’s. And you can’t have impact, influence, or inspire anyone without effective, clear, communication in all the methodology.

So clarity is especially important to people because it’s uncertainty that’s demotivating. And you cannot become that institutional glue I mentioned in the last slide without effective communication skills. And it’s something that can be learned and overcome.

Believe it or not, when I first joined the profession, I had lots of problems even introducing a video to people. I just had a– put the video in and say, here’s the title. And I struggled with that. And now, I pretty much– after forcing myself into every public speaking engagement I could ever get, I’ve become somewhat comfortable with it.

This is something that biosafety professionals struggle with. And we can very much assist leaders in three leadership activities, ensuring that their messaging is correct, coming up with appropriate metrics, and measuring accountability for all levels of employee.

And one of the things that when you have leaders, when they’re first engaged in safety in a real way, they’re often surprised by what they learn. Now safety is very much more complex than what they thought. It’s really tied to operational excellence, as I mentioned earlier, and more indicative of the health of an organization.

Now, I think probably one of the perfect examples of this is what Paul O’Neill did with Alcoa in 1987. His first presentation as CEO started, I want to talk to you about worker safety. And basically, he lost a lot of stockholders, who were more interested in hearing recapitalization, those kind of investment strategies.

But he said every year, numerous Alcoa workers are injured. They miss a day of work. I intend to make Alcoa the safest company in America. And O’Neill was arguing that investors should treat safety as a key indicator of the effectiveness of the management team.

And he had a clear– he had a very clear vision and wanted to focus on safety to develop continuous improvement across the entire company, which did happen because within a year of him taking over as CEO, Alcoa’s profits hit a record high. So focusing on safety, because safety touches on every operational level, can be a way to improve the entire organization. I think Paul O’Neill proved that.

Some of the issues that leadership ends up being concerned with is you have to remember as a biosafety professional, they have multiple competing priorities. What’s the impact of what you want to do on the bottom line? What’s a regulatory, required, versus good practice? How are we implementing accountability? How are we managing perceptions?

And a lot of times is what does safety mean to them? I think at the rank and file, employee safety means– or safety means to the employee, I’m going to go home the same way that I came into work, and I’m not going to track anything home to my family.

Well, that’s very, very similar with senior leadership because nobody wants to have somebody get hurt on their watch. But they also have to think about impacts upon the organization, esprit de corps, credibility, those sorts of things also are in the back of their mind.

And the reason why I had the chairs there was I was going to throw in leading from the second chair. But since I introduced that earlier, I’m not going to– some of you might have been wondering, why do I have a picture of two chairs there?

So how do you get buy-in from a skeptical leader? When a leader is considering your idea, there’s three things that are going to come to their mind. This is the rock wall that you need to climb. And if you get a no to any of the three, you don’t get further. And of course, if you get a yes to all three, you get a yes to your idea.

So when you’re making a presentation to leadership, you really want to think about these three considerations. Why is your idea going to be successful? Why does it work? Because if you can’t demonstrate that, if they have doubts, it doesn’t make sense to them, or they just don’t get it, then you’re not going to get a yes. And this is actually a place where many biosafety professionals may have difficulty is at this initial proposal stage.

The second question is this worth my resources, time, energy, money? If the answer is no, you’re not going further. And a lot of times, historical and regulatory precedents, using units that they can understand and relate to, as well as prioritizing objectives will assist you in getting to yes.

And then the last question is, are you the right champion? Are you able to lead this, execute this idea? And should this be the person I give a yes to? Or is there someone else I want to execute this effort? That’s going to actually be totally dependent upon their experience with you as a biorisk professional.

Have you been competent and consistent? Do you have a successful track record? I had a colleague, basically, he was a competent safety professional. But one of the things that he did frequently is he would point out problems. But he would never give solutions. And because of that, he really lost a lot of credibility with his senior leadership to the point where they no longer took his advice.

And that’s something that you don’t want to have happen as a biosafety professional or biorisk manager. Or actually, I guess, any kind of professional that’s going to be talking to senior leadership. So here are some tips.

My approach to speaking and the truth to leadership, you want to be able to state your case. You want to be clear, succinct in your communication. This definitely helps your ability to speak to leadership. Brevity versus incompleteness. You definitely want to know your facts.

You want to be able to provide references. You want to speak in units that they– language they understand. Things like dollars, units of production, square footage. And you want to offer options to a particular problem, never just identify a problem, come with a couple solutions.

Prioritize whether it’s urgent, essentially, or economically desirable, and keep your cool. Don’t ever come off condescending, even if you are the subject matter expert. Be respectful in the face of questions or suggestions that are not on point. Do not be impatient.

Remember, going soft on the people and hard on the issues is usually the best way to go, especially when speaking to those in authority. And you want to respect their time. I had a boss, I’d go into his office, and we’d be talking, and I could tell when– he had a tell, just like when playing poker, he had a tell that I picked up on that whenever he was pretty much done, and was done with the conversation, and was at that point, just being polite, but wasn’t absorbing anything, as soon as I saw that first evidence of the tell, I graciously excused myself and let him get back to doing whatever he had to do next.

That’s one thing is safety professionals, biosafety professionals, biorisk management professionals that we need to do is we need to create leadership champions. Because only top and senior leadership can ensure safety as an organizational value and ensure that it becomes part of the institutional culture. Therefore, engaging is crucial for long-term success of the programs that we manage.

Again, this is something that many biosafety officers have had problems doing. And I think standards like ISO 35001, especially since it spells out roles and responsibilities, can be useful in this regard. But also, you need to really develop relationships.

One of the things that I do is I look at who’s in my organization, who’s looking to become leaders, and basically sell them on biosafety and biorisk management as appropriate. We want to coach and assist them in their messaging, which is really, really useful.

Coaching them to say the right things about biorisk management, have them model the behaviors they want to see and develop, help them develop metrics and accountability, and their ability to connect with folks. Actually, in some cases, stories or anecdotes are very useful in reinforcing perceptions relative to the biorisk management program.

This is one of the things that apparently I’m noted for, at least according to one of my colleagues. You got to be persistent. More importantly, you have to be prepared when the answer is no. And don’t get upset. You’re going to have obstacles and other setbacks.

One time, it took me 10 years to get a policy that I thought was necessary through the gatekeepers, through leadership, to buy into it. It took a long time. So take whatever plan you have, if it fails, you review, reevaluate, revise. Again, plan, do, check, act, right? This is personally as a biosafety professional, you should be doing it.

Be patient. Follow up if you’ve dropped off an idea with leadership and they haven’t got back to you yet. You want to follow up respectfully, but not so to the point where you become annoying. You want to keep focused. And eventually, you’re going to succeed. And of course, I had to put my favorite quote from Calvin Coolidge in there, “Persistence and determination alone are omnipotent.” I believe that.

So how do we improve biosafety programs and culture? We change perceptions. And we do that by what we think of among ourselves, or how we communicate, how we demonstrate actions and will actually impact how we are perceived as professionals. So some of my final thoughts.

Biorisk management professionals need to engage with leadership and become comfortable in communicating with leadership. You want to continually improve and develop technical and leadership competencies. Clear, consistent communication is essential. Remember the three I’s.

Active participation by leadership and champions is essential. Otherwise, you’re not going to be successful in improving your safety program. Use pleasant persistence. And remember that the pursuit of excellence is a path, rather than a destination. Continual improvement is the goal.

So what I would suggest is figure out where you are with your biosafety or biorisk management system at this point. And see how you can incrementally improve, rather than actually– so I want to go from A to Z, which most times, you’re not going to be successful. So take it in small bites, making small improvements, continually over time. And you can have an outstanding biorisk management program. And with that, I think we can go to the group exercise.

Aufra Araujo: Great, thanks, Joe. Do you want to describe the group exercise before we go in breakout rooms?

Joseph Kozlovac: I certainly can. So you all, whether or not are a biosafety professional, you now are the biosafety officer of the medical school with a staff of 500 professionals and support personnel. Basic research and diagnostic work is carried out at biosafety level 2, principles, practices, and facilities.

One of the things you’ve noticed, in comparison to previous years, over the past 12 months, there has been an increased number of incidents, significant near-misses, and laboratory-associated infections. You report your findings to your supervisor, who’s the dean of research. She reviews your data, and within a day, asks you to develop a plan consisting of your approach to improve safety culture in the medical school community in order to mitigate the events you reported. What’s your approach to the situation?

So some of the things, be cognizant of personnel and fiscal constraints. Having more people and funding may help but you’re probably going to not get them. And you’ll have to address the situation using your current level of personnel and funds. You’ll also remember, regardless of the cliche, do more with less, you cannot do more with less. But you must be practical and reasonable in your approach.

How should you develop a plan to ensure that you can sell the plan to upper management? And what can you do to convince them to buy into the plan, so that ownership and champion the plan? And how can we have leadership demonstrate their commitment to improving biosafety to the workforce?

Aufra Araujo: So with that, we’ll go into breakout rooms. I’m looking at the time, I’m thinking maybe five minutes in breakout rooms, so you can just talk with each other. I think we are planning groups of five people in rooms. Please don’t leave. Go to the breakout rooms and talk about it. Maybe in smaller groups, there is more opportunity for talking and sharing our thoughts.

And then after five– just five minutes, doesn’t need to be perfect, because we’ll come back, everybody here in the big room. And then we’ll share. We’ll have time for sharing. That’s the purpose of the ECHO session is to hear from you. It’s the idea that everybody teaches, everybody learns. So we want to learn from each other.

So let’s do this. George will move us into breakout rooms. And then we’ll come back in five minutes. And George put in the Word document with the text that is showing on the screen right now for the exercise, the case that will be discussed. And that will be also shared. But in case there are any glitches with sharing Zoom when we are in breakout rooms, you can access this document now in the chat. So good, let’s go in breakout rooms then.

[No audio available for breakout room session]

Joseph Kozlovac: Welcome back, everyone. So what did you all come up with?

Jonathan Koolpe: Nobody wants to start. I can start. we quickly discussed, getting somewhat specific, we had– at my institution, it’s a pretty large institution that I work at. And a few years back, we had noticed that there’s a fair amount of needlestick instances, sharps instances happening. And so we addressed that. It was– we get this report, monthly report, and annual, and it was increasing.

And it’s obviously not a good thing. And so it was brought to the attention of a various leaderships, and our biosafety committee, and programs were implemented across the board through inspections and whatnot to adjust this culture to highly discourage and pretty much stop the practice of recapping needles, for instance, because that’s– as we are well aware, that’s a great way to stick yourself by recapping a needle when it’s not needed, when that’s certainly not necessary.

And since that time, that program has been very successful. We’ve just made it through all the labs, and the PIs, and the lab managers, and that sort of thing. We’ve gotten the word out to not do this practice, to cease this practice. And it’s worked pretty well. And we’ve had a lot of support from upper management, certainly, it was all supported. So yeah. Cost/benefit, I mean, you could switch to safe sharps, most labs don’t do that because it’s more costly. So I guess you’d say the compromise was to stop the recapping practice.

Joseph Kozlovac: Yes, definitely, I think that was a good idea. And I like what Cass Buckley says, you have to dig into the root cause of the issue. And many places don’t– they’re willing to come up with a surface answer, things like situational awareness or situational awareness, that sort of thing, rather than going into what was the root cause. And usually, one of the things you can find is you can trace back almost any incident to inadequate risk assessment or a failure to modify the list to an acceptable level.

Aufra Araujo: Joe your voice is a little bit faint. Can you speak up a little louder?

Joseph Kozlovac: OK, sorry.

Aufra Araujo: A little better, yes.

Joseph Kozlovac: Leyma, you have your hand up.

Leyma De Haro: Hi, yes, actually, that’s a perfect segue to our group. That’s exactly what we talked about. So we thought we should start by looking at all the incidents in your hypothetical scenario and look at the root causes. And see if there’s a common theme in the root causes of all these hypothetical incidents.

And then, depending on that, then you could decide on a plan. So for example, if there was a change in process, maybe we would have to look at the process and see if that there was something in the process that was causing a higher incidence of incidence. Or maybe there was a lot of staff turnover. And maybe there was newer, less trained staff. So then maybe we would have to focus more on the training. Or maybe there was a change in PPE, and then we would have to look at that. And then we would take it from there. That’s what we discussed.

Joseph Kozlovac: Yeah, anyone else?

Leyma De Haro: We also discussed possibly involving the staff to discuss this with leadership and let them champion the cause because they’re at the source. They’re at the point of hazards. And they can hear from the staff how that impact their productivity, their workflow, their morale. So just hearing from the staff as well was something we discussed.

Joseph Kozlovac: That’s a great point. And that was actually one of the things that I had in my notes for this exercise was consider formation of a committee consisting of safety office, leadership, also having personnel in different areas of expertise relative to laboratory operations. If you need to bring in external consultants, behaviorists, but definitely want to have employees from the impacted areas to take a look at it because remember, we’re looking to change culture. Very good.

Aufra Araujo: Somebody added in chat, Joe, it jumped away from me. Something along the lines of explaining why it matters when talking with leadership. It just moved away with other comments. But if somebody who was writing in chat would like to talk more about that along the lines of why it’s important, explaining the reason behind it, what’s the relevance. I think was something like that.

Also in the discussion in the breakout room, I’m going to put Stacy on the spot. Where is Stacy? She had some very relevant comments, as well, I felt. Would you like to share with the group, Stacy?

Stacy Agar: Oh, sure. So I said a little bit about what the other individuals have already said is, first of all, to assess what the incidents were, what the laboratory-associated infections were. And I actually used with Aufra, I used the example of the sharps, which the first speaker brought up. We also here had an increased number of sharps incidents.

And so what I suggested on our breakout session was that you look at what training the staff already have and what do you have at your disposal, and then re-issue training or modify training to help incorporate some of the safety issues that you’ve seen. Thereby, you’re not really increasing the cost as much.

And then reissuing this training pointed towards the groups who need that specific training. That’s essentially, that’s as far as we got on our breakout session. Thanks, Aufra.

Aufra Araujo: Thank you.

Joseph Kozlovac: Awesome. I’m really happy with the robust discussions that took place.

Aufra Araujo: Now some other things in chat is – implement timelines or milestones with action officers to inspire ownership.

Joseph Kozlovac: And I also like the Peter’s ideas to even step back, engage– what was the initial risk assessment process and what did it miss? I think that was an excellent idea.

Aufra Araujo: Excellent discussion, everyone. Once again, let’s thank Joe for a great presentation. And thank you all for participating in the discussion, the breakout rooms discussion, and in the big room discussion. Let’s see, I need to move on. Next, I’d like to invite Sabrina to summarize the discussion.

Sabrina, would you like please to summarize the discussion? Commander Sabrina DeBose, who is the Safety Team Lead in the CDC Division of Laboratory Systems will provide a summary of the discussion from today’s session. Sabrina, over to you.

Sabrina DeBose: Yes, thank you, Aufra and we want to thank you all for a great discussion regarding leadership, roles, responsibilities, and authorities. So for right now, as Aufra mentioned, I will summarize the discussion among the participants.

There were several comments when participants were asked what’s your organization culture. Examples of those comments range from having supportive leadership to working in an environment where communication is open from the quality, safety, and lab testing personnel. And someone also gave an example where leadership is not on board and lots of changes are needed.

From our breakout session, some of the suggestions were to look at the common theme, root cause of the incidents. An example is given that if there was a change in the process, this may be a reason for the increase in incidents. Another example provided involving staff to bring concerns to leadership. Whereas if leadership is hearing the concerns from the staff, it may help to see it from their viewpoint.

Another suggestion was if you’re noticing an increased number of sharp incidents at your facility, you may want to look at your training and incorporate some of the safety features that you’re seeing at your facility. I’m sorry– incorporate some of the additional safety concerns that you’re seeing into your training.

Another suggestion was to implement milestones and goals and also review your risk assessment process to see what it may be missing. So once again, thank you. That was an overview of the discussion that was shared today amongst the participants. Joe, I would like to turn it over to you to see if there’s any additional comments you would like to provide.

Joseph Kozlovac: I’d just like to thank everyone for your time. I’m really grateful that you allowed me the generosity of an hour and a half. So thank you. And if you have any questions, I’m sure you can find me. My address and email address is fairly public. So joseph.kozlovac@usda.gov.

Aufra Araujo: All right, Thank you so much, Joe for your presentation and discussion. And Sabrina, thank you for providing this summary. Now, I would like to talk about the post-session survey. In the chat, George will put the link to the survey for today’s ECHO Biosafety session. It will take you directly to the Qualtrics survey.

The survey should take no more than two minutes to complete. And your participation is voluntary. But it’s 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 you would like to present during the ECHO Biosafety session, please reach out to us at dlsbiosafety@cdc.gov.

Now, I’d like to share just one slide for the next session. Let’s see, yes, please give me a thumbs up if you can see the slide. Can you see the slide?

Alicia Violette: I can’t see it right now, Aufra.

Aufra Araujo: Oh, thank you, Alicia. Yes, too many windows open here. All right, we are excited to have our next session on Tuesday, April 30 at noon Eastern time. The topic of discussion will be Planning: Developing and Achieving Biorisk Management Objectives, presented by Dr. Michael Stephenson, who is the Deputy Laboratory Director at New Hampshire Public Health 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. I think that will be in the chat as well. So I’d like to take a moment, before we close today’s session, to make a couple of announcements.

CDC’s OneLab Network next webinar will be on Risk Assessment in Clinical Laboratories. And it will be tomorrow on March 27, and can help laboratory professionals identify and assess for hazards, mitigate risk, and assess resources to conduct risk assessments in clinical laboratories. Registration information can be found through the QR code on this slide. And also there will be a link in chat box.

Now, we would like to invite you to register to CDC’s second annual OneLab Summit. This is a free three-day virtual event that connects laboratory professionals in real time to support a unified response to laboratory education and training needs. Attendance is open to all interested or involved in the laboratory profession.

This year’s theme is Thrive: People. Planning. Preparedness. I think this will increase their knowledge of laboratory training development tools and practices, gain insights from the clinical and public health laboratory community’s success and resilience, and network and collaborate with peers, laboratory professional partners, and CDC experts in laboratory education and training.

Also, we will learn more about OneLab and its community of practice. We love the community of practice here. And also P.A.C.E. credit will be offered. Registration is occurring now with the QR code on the slide or through the link in the chat.

And now, we will adjourn. Thank you all for attending today’s session. I hope you are intentional about having a safe and fantastic day. Thank you so much. It was really nice seeing you all here.