What to know
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Slides
Transcript
Date of session: 08/27/2024
Facilitator
Aufra C. Araujo, PhD
Centers for Disease Control and Prevention
Didactic Speaker
Esmeralda Meyer, MD, JM, RBP (ABSA), CBSP (ABSA), BRM (IFBA), CPIA (PRIMR)
Emory University
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 am the CDC ECHO Biosafety Program Lead and the Acting Safety Team Lead in CDC's Division of Laboratory Systems.
Thank you for joining our seventh Extension for Community Health Care Outcomes, or ECHO, Biosafety session for 2024. The topic for this interactive discussion is Operations: Planning and Maintaining. Today's subject matter expert is Dr. Esmeralda Meyer from Emory University in Atlanta, Georgia.
I want to stop sharing for a moment, so I can have a view of everybody. If you can turn on your camera, that would be great, so we get to see each other and get to know each other. I would like everyone– I'd like to ask everyone a quick icebreaker question, which is already in the chat.
What's your favorite way to relax and recharge after a busy summer? I will start by calling on someone to unmute and respond. Well, maybe I'll start by sharing my own way. I just came from vacation. I was in Brazil visiting with my family. So there we go. That's my way of recharging after a busy summer. So I start by now calling on someone to unmute and respond and then ask them to choose the next person. Feel free to also put your answers in the chat. It's nice to have that friendly conversation so we get to see and know each other. Let's see. Cathy Moore, would you like to share how you recharge after a busy summer?
Cathy Moore: Well, I usually take off some of my faster running in the summer. So I'm ready to get started in the fall when it gets cool. And then, of course, that always has to be followed by massages, which I have one scheduled for Thursday.
Aufra Araujo: Oh, I like that approach. Would you randomly select somebody else to share?
Cathy Moore: All right, let's go with Betsy Parsons, please.
Betsy Parsons: Thank you. So my time to recharge and reconnect is spending as much time as I can in the woods in nature.
Aufra Araujo: Ah, I love that. Betsy, you want to pick someone else? Let's throw the ball.
Betsy Parsons: I'll go with Dale, because I see you next to me on the screen. Dale Jennings.
Dale Jennings: Hello. Ways that I like to unwind and relax is visiting family in Texas. So I go down and visit in Houston.
Aufra Araujo: So cool. Dale, are you going to pick someone else?
Dale Jennings: Yes, I'll pick Victoria Scranton.
Victoria Scranton: Well, being from Connecticut, one of my favorite things to do in the fall is to get out hiking in all of our beautiful foliage.
Aufra Araujo: I like that.
Victoria Scranton: And—
Aufra Araujo: We can just—
Victoria Scranton: –I'll toss the ball to Shoola.
Aufra Araujo: Shoola?
Shoola Escott: Yep. Hi, I also do massages in order to relax. And I love working in my vegetable garden, especially this time of year, since we're getting able to pick tomatoes. And cucumbers just finished, but the tomatoes are really coming in now.
Aufra Araujo: That's cool. Let's see what we see in the chat. So we have, yeah, watching football, hiking in the beautiful hillsides, took a cruise to Alaska about a month ago. Ooh, I envy you, Jonathan. That's on my bucket list– to go to Alaska and see the nature there. What else? I see beer, barbecue, and fire pit, knitting a sweater. Ooh, very meditative. Yoga? Some vacation time after the kids are back in school. Hanging out with family. Hanging out by the pool. That's so nice. Thank you, everyone, for participating. That's nice to get to hear what you've been doing. Let me share the screen again.
So now I'd like to provide a brief recap from last– if I can move my slide, from the last session in June. It featured Marian Downing and Dee Zimmerman, who presented on Support: Communication and Documented Information. Marian and Dee discussed the importance of top management commitment, clear communication, and proper documentation for implementing the ISO 35001 standard. They also highlighted the need for documentation to be integrated, standardized, and aligned with legal requirements, reflecting actual laboratory practices and ensuring proper control and retention. They stressed that these elements are essential for effective biosafety management and compliance. The slide shows a poll question from the session. And the responses for how root causes of biosafety incidents are communicated to laboratory staff at their institutions.
We had 94 participants attending the session who were affiliated with 60 organizations. The map on the right shows where these participants are located. The states shaded in green had participants from at least one organization. Also in attendance were participants from eight national organizations and organizations located in Canada and El Salvador.
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. Before we continue, I'd like to address some technical aspects of our ECHO Biosafety sessions. Please use the video capabilities of your device for this session.
Currently, all audience microphones are muted. When engaging in the discussion, please unmute yourself to speak. Closed captioning is provided through Zoom for this session. If you are experiencing technical difficulties during the session, please send a private chat message to George Xiang, who is labeled as CDC ECHO Tech. George will do his best to respond to your issue. If you are connecting to Zoom by phone only at the time of discussion, please introduce yourself by stating your name and institution before speaking.
We encourage your active participation by sharing your knowledge and experience. Each laboratory is unique, and your skill sets are unique, so your contributions to the discussion are valuable. Let me go to the next slide.
Here is a brief overview of today's session. I will introduce our subject matter expert, Dr. Esmeralda Meyer, who will provide a didactic presentation and real case discussions. Then my colleague, Commander Folasade Kembi 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. The transcript, audio recording, presentation slides, and other resources will be posted on the DLS ECHO Biosafety website a few weeks after today's session. I'd like to remind everyone that these slides, presentation slides from today contain presentation material from speakers who are not affiliated with CDC. Presentation content from external speakers may not necessarily reflect CDC's official position.
Now, it is my pleasure to introduce today's presenter. Dr. Esmeralda Meyer is the current director of the Institutional Animal Care and Use Committee, IACUC, Office at Emory University. She also served as the Associate Biosafety Officer with the Environmental Health and Safety Office. Esmeralda's professional background includes a medical degree from Universidad del Rosario, Colombia, and a Juris Master's from Emory University.
Her areas of interest include biorisk management, ISO standards, process improvement, issues associated with handling experimental animals, handling of hazardous compounds, occupational health, new molecular technologies, and the legal aspects associated with animal welfare, biological safety, and environmental compliance. Esmeralda is a member of ABSA International and serves on multiple sub-committees. Esmeralda, the floor is yours.
Esmeralda Meyer: Thank you, Aufra. Let me share this screen. Let's do a quick tech check. Can you see my screen?
Aufra Araujo: Yes.
Esmeralda Meyer: Perfect. Well, thank you very much for inviting me today. Good afternoon, everybody. Similar to the disclosure that Aufra just stated, the views and opinions expressed today are mine and don't represent my employer or anyone else. Very well. So today, I'll be talking about the planning and maintaining operations in the framework of the standard title, Biorisk management for laboratories and other related organizations, which provides the guardrails for managing risks associated with biological agents and toxins.
And we have a few polls for you, and so I encourage you to participate in those as well as posting your comments in the chat. Aufra will be helping me with those comments posted. So beware that we will pay attention and try to bring them up for discussion. OK, so biorisk management is vital for preventing lab-acquired infections, particularly as lab work with biological agents has expanded over the years and become more complex.
And this slide presented in 2007 is calling, or was calling, for increased attention to safe working practices. This need has only been supported by the adherence to standards such as the ISO 35001 and the development of a robust safety culture. So why do we do biorisk assessment and management? We do it to reduce or minimize the number and severity of accidents in laboratories. Ultimately, that is the goal.
The ABSA lab-acquired infection database that you see here is a specialized repository that stores documented reports, where lab personnel have acquired infections as a result of their work with biological agents or toxins. This resource is available to the biosafety professional on the ABSA website. I encourage you to visit if you haven't used it before. So here, we're going to have our first poll. And you should select all that apply. So, George, I'll let you launch that first one.
All right. So how did you do biorisk assessments? On the fly? I have a set of questions that I always ask? I use a software to calculate the risk? I use a spreadsheet such as the BioRAM? Or prepare a risk assessment matrix tailored to the risk at hand? So let's see. Everybody should be seeing those questions or those options. As you know, biorisk assessment has to be done in order to manage the risks associated with handling biologicals. So I'm curious to see how you do it.
All right. So we have– thank you, George. We have 62%. Even, I have a set of questions that I always ask, right? I prepare a risk assessment matrix tailored to the risk at hand. That is great. And if you have used BioRAM or a spreadsheet, others use a software. Do you mind sharing what kind of software you use? Maybe bow tie? Or on the fly, 16%. So hopefully, at the end of this presentation, you will be left with some tools to systematically have a way of continuing doing your risk assessments, perhaps enhance the system you're currently using, or start a new one. Test a new one. All right, thank you for your participation.
All right. Biorisk assessment is the first step in managing a risk. And it should be a systematic process. The CDC BMBL 6th edition is the cornerstone document in the field of biosafety. And it provides comprehensive guidelines for the safe handling of infectious microorganisms and hazardous biological materials in labs. Chapter 2, in particular of the BMBL, if you haven't seen, includes those principles and steps that can be used to create your own set of questions or minimally ensure that you have considered all potential questions to be asked.
Biorisk assessment can also be done using fillable forms, such as the one included in the WHO Lab Safety Manual in the monograph for risk assessment. The WHO monograph provides a thorough and integrated approach to biorisk management, and it combines elements for both biosafety and biosecurity to protect the lab personnel, the public, and the environment. And so it has short forms. It has long forms. Here is just an example of Annex 6, which has the front, the first page of that long template. And it gives you examples of what type of information needs to be included.
Here's just another tool to complete their biorisk assessment and prepare your biorisk management plan. BioRAM, which is short for Biological Risk Assessment Methodology, and I saw in the poll that some have used or are familiar with the BioRAM spreadsheet. That's great. It's a structured tool in the form of a worksheet, and it helps you identify, evaluate, and control the risks associated with their work. You will see a few keywords repeated throughout my presentation today. Identify, evaluate, control, manage. Those are keywords that, in essence, describe the process for biorisk management.
In this worksheet, you see options to evaluate the agent itself, the location, the spaces. It helps you prioritize the risks and the allocation of resources. And at the end on the right, you see a full-blown schematic of the outcome of that assessment.
So let's look at another tool. This is– initially, it's provided on the ABSA website as a PDF, but it has multiple pages as part of that document. This was created by the Emerging Infectious Diseases Committee of ABSA International. We did it last year as an antimicrobial resistant fungus was making its rounds. So we figured there weren't a lot of resources available for the assessment, the risk assessment of fungi. This document brings together principles and contexts from different sources, such as the CDC BMBL, the WHO Lab Safety Manual, the BioRAM tool, and the BowTie model. So that's why I was curious to see what software was being used for biorisk assessment and management.
BowTie is one of those software available but is under license, and so you have to have the budget to sustain it. But these different sources and contexts allowed us to put together a very comprehensive tool, in this case, for the assessment of fungi. The history of risk management and biorisk management reflects really the evolving understanding of how to manage and mitigate risks associated with various activities.
It's been long used for biotechnology, for industries such as aerospace, medical or health care, and public health. The publication of the CEN Workshop Agreement, or CWA 15793 in 2008 represented really a significant milestone in biorisk management. And so this was largely overdue in terms of biorisk management. Like I said, the risk management for other industries and other professional entities had long been in place.
So it was an important document back in 2008. This document provided a framework for integrating biosafety and biosecurity into a comprehensive biorisk management framework. And it presented the basis of the ISO 35001. On the right, you see the CWA 16393, which is the guidance document for implementation of the 15793. So you have the biorisk management version, the 15793, and its accompanying document of how to operationalize or implement those guidelines or a structure indicated in the lab biorisk management.
All right. So as I said, it is your guidance for implementation. In addition, the CDC is currently supporting the implementation of the ISO 35001 in public labs. I encourage you to reach out to the CDC [Division of] Laboratory Systems to get started. The ISO standard, ISO 35001, can be acquired if you pay for a license. But if you reach out to the CDC [Division of] Lab Systems, chances are you can be or participate in that program.
You could ask, What is the difference? Why is there an ISO 35001? And the bottom line is that 15793 are the same workshop agreement is more regionally focused, particularly within Europe, while the ISO 35001 provides a globally recognized framework that is compatible with other ISO standards. So as a reminder, what is an ISO? An ISO standard for the International Organization for Standardization. That's what ISO means. Which is an independent, non-governmental organization with a membership of representatives from 165 national standards bodies. They develop voluntary consensus-based standards based on global expert opinions. Today, ISO has developed more than 23,000 international standards. The standard is intended to help organizations establish, implement, and continually improve a biorisk management. This is the case for the 35001.
In this particular standard, it is compatible, as I mentioned earlier, with other management ISO standards such as the ISO 9001, which is quality management, and the ISO 45001, which is occupational health and safety management. And it allows for integration with those other standards for risk management. Similar to the CWA 15793, the ISO 35001 requires organizations to develop a comprehensive biorisk management system.
It is represented here on the left with the black frame around the system. And the success of these biorisk management lies on that institutional leadership and commitment that you heard Marian and Dee talk about in the previous ECHO presentation or session. And that is critical to lay the ground and lay the foundation for the successful biorisk management plan. The hands-on work is laid out in the center. You see the four pillars represented here and the continuous improvement and monitoring with the arrows going from one square to the next one.
On the right, I like to present it as a spiral rather than a flat surface because the continuing improvement and the monitoring is not done at the initiation of your biorisk management. It happens every time that there is a change. And that's why it's called continuous improvement, because it doesn't go in a circle that goes from beginning to end, but it actually spirals and is done over and over again when the risks change, and the environment changes.
All right. So here, we have poll number two. Tell us where you are in the implementation of a biorisk management at your institution. Throughout the different ECHO sessions this year, you have been given snippets of the ISO 35001. So I'm curious, we're curious to know where you are in that process in your facilities. A, getting buy-in from the leadership, assessing the risks, drafting SOPs, operationalizing SOPs, evaluating operational controls, or if you are in one of those third or fourth rounds of review, continuing review, let us also know that, because that would be awesome.
We'll let George manage the poll. And then share it. Thank you, George. Let's see. 32% are assessing the risks. That's a good place to be. 21% evaluating operational controls. About 15% and 15%, getting buy-in from the leadership. Again, that is the foundation and ensuring that your biorisk management is going to be successful. And the other 15 is drafting SOPs. OK, great. And other. What is other? I'll let Aufra tell us. Maybe they're telling us what other stages you are in the biorisk management process.
Aufra Araujo: Well, I don't see any– maybe it's just now. It's starting to conduct program evaluation for improvements at ISMMS. Randy, you like to unmute and just expand on your response?
Randy Albrecht: Hey, good morning. Hey, Esmeralda.
Esmeralda Meyer: Hi, Randy.
Randy Albrecht: Yeah, so we've started to flush out our program. We have our roles and positions identified or possibilities and developed our plans and SOPs. And now we're starting to evaluate the effectiveness, looking for areas of improvement. So we're beginning that iteration process that I think is starting to become more formalized at our institution.
Esmeralda Meyer: That's great. Thank you. Thank you, Randy, for sharing. Anything else, Aufra? Otherwise, I'll move forward.
Aufra Araujo: Yes, so there are two others with similar response. So I'm compiling the response. They are more in a consultant position. So they don't have an institution, where they work to implement it. So they are just interested in learning more about it.
Esmeralda Meyer: Perfect. All right. So let's move on. This cartoon represents the stages of the ISO 35001 as a continuum. And today, I will focus on operational planning and maintenance. The next session with Ben Fontes will focus on emergency planning and response. After planning their R&D planning at the top of the first or the top pillar, if you will, within the PDCA cycle. And so after planning, there are lots of questions to be asked to operationalize what was identified in that planning phase.
These questions will help you truly understand the requirements, assess your current capabilities, and identify the necessary steps to establish an effective biorisk management system. Here are some key questions to consider. And so I'm not going to go through all the questions for each one of the pillars, but for practical purposes, differentiating planning and operation step of the plant and the due stages of PDCA, mostly planning is going to be what will be done, what can go wrong, what is the likelihood of occurring, what are the consequences, what controls are in place, right? The "whats." And the operations is "how." Are the controls working? Are the SOPs being followed? Who is doing the work?
So planning and operational planning, as you see here, are two critical stages. I have them circled as "planning" in bracket six and then operations in bracket eight. So these are two critical stages within the biorisk management system, each within a distinct focus. While both contribute to the overall goal of effectively managing biological risks, they differ in scope a bit. The nature of the activities involved in each one are slightly different. And you'll see why.
While the planning phase shown above as number six focuses on establishing the context for the biorisk management system, determining what needs to be achieved, and how to align biorisk management with the organization's overall goals and regulatory requirements. In contrast, number eight on operations or the planning or operational planning includes that operational planning focuses on the practical aspects of executing that biorisk management, including resource allocation, assigning responsibilities, ensuring that all operational activities are carried out safely and in compliance with the biorisk management system established.
So again, having or looking and understanding what the planning means at the plan stage versus operational planning at the due stage is important. And I will ask you to participate in this matching activity so that we can discuss further what that entails. And so we have six examples of activities listed on the right. And then we have two columns, one for planning phase, and one for operational planning. So the matching activity that George has just launched has multiple options on the dropdown menu so that you can select, for example, risk assessment. If you have risk assessment, here is number six. Is this part of your planning phase under the plan option of PDCA? Or is it part of operational planning under the due phase of the PDCA cycle?
Number two, we have understand context of the organization. Is it planning phase under planning or operational planning under the due phase? And then strategies to mitigate risk. And then we'll do the next poll to have the other three activities. And just know there is no right or wrong. Just because you think it's planning phase or operational planning and is in the other column, still needs to get done. It's just when you do it, and how you do it.
All right, let's see. Very good. So for risk assessment, we have 100%. Sorry, 100% voted, and the majority has activities includes culture. See, activities include cultures or genetic modifications of organisms. And that was indicated as– that's interesting. So your risk assessment is going to be in the planning phase. And your understand the context of the organization is going to be in your planning phase. The strategies to mitigate the risk is going to be in your planning phase. So let's hold the next or pull the next poll, George, if you will.
And that's it. All right. So let's look at the answers here. On the operational planning side, you'll have activities include culture, genetic modifications of microorganisms. This would have been based on your risk assessment. The engineering controls included to use the biosafety cabinet, that's going to be associated with your established SOPs or understand the context of the organization and then standard operating procedures for the activities identified in the risk assessment. So all of these three activities are under operational planning. You would have identified the need for those and how you go about are going to be part of your operational planning.
Thank you for participating. Because planning and operational planning are linked, let me show you a few of the details about planning. It is about setting the strategic direction and the framework for managing the biorisks identified, ensuring that the organization has a clear understanding of those risks, objectives, and resources needed. Again, that's all the planning needs to focus. What will be done? What can go wrong? What is the likelihood of occurring? What are the consequences? What controls are in place?
While operational planning, which you'll see later, is about translating that strategic framework into specific actions and controls that manage the biorisk on a day-to-day basis, ensuring that all operations are conducted safely and in line with the established biorisk management system. Both are essential, but they operate at different levels within the organization with planning, focusing on the "what" and the "why," while operational planning focuses on the "how" and when it's done and who does it.
Awareness is a foundational element in the operational planning of a biorisk management plan. The assumption is that all personnel are informed, vigilant, and competent in managing biorisks. Within the operational planning, there needs to be considerations of how emerging threats are going to be handled. This is also addressed as part of the emergency response that you will see in the next session. However, as part of the operational planning, labs, and ancillary personnel need to understand when public health conditions change.
And again, it's that continuing refinement and evaluation and assessment that needs to happen as part of the PDCA. Here are a few sources of information that allow you to be aware of emerging outbreaks. The top row includes two sources from CDC– the Outbreaks list and the Health Alert Network. You can subscribe to those resources and you get notifications. And at the bottom left, it's hosted by the World Animal Health Information System. And the lower right is the WHO Emergency Outbreak site.
I want to spend a few minutes talking about the chain of infection concept because it tells us how infectious diseases spread. And it is highly relevant in the context of biorisk management. By implementing measures that target each link in the chain, organizations can significantly reduce the risks of lab-acquired infections and other incidents involving biological agents. There are six components for an infection to occur, and these components are linked. If at any time the link is broken, the infection is minimized or does not happen at all. Let's see how each component relates to the biorisk management principles.
At the top, you have the infectious agent. And that is the microorganism that causes the infection. In the context of the biorisk, management organizations need to understand the nature of the biological agents they work with, including their modes of transmission, potential impact on health, what type of susceptibilities there are, et cetera. If you move clockwise– and the arrows point to potential ways to disrupt the progression of that link or maintaining that link, how can we disrupt the link, is the goal on infection control or decreasing the risk for infection.
If we move clockwise, the reservoir is the environment in which the infectious agent normally lives, grows and multiplies. Humans, animals, environmental surfaces, for example. In the context of biorisk management, identifying and controlling reservoirs include managing waste, the contaminating surfaces, proper storage of samples. Then if we move– and so a way to disrupt that link is through disinfection, washing hands, for example.
Then we move on the third link. That is the portal of exit. Is the path used by the biological agent to leave the reservoir, whether it's respiratory, blood-based, body fluids? And during the operational planning, there is a review of containment equipment, waste disposal, and activation methods. So a way to disrupt that is through your surgical mask, for example. Number four, at the bottom, you have the method by which the infectious agent is transmitted from one host to another.
So, for example, direct contact, is it airborne? Is it via fomites? And that is the mode of transmission. During the operational planning, ventilation systems, for example, and other engineering controls are reviewed. You see what PPE is available, what sizes you have. Is it the appropriate PPE that is needed for the pathogen that you're dealing with? And is it adequate for the risk at hand? So a way to disrupt this could be physical distancing as it was in the case during the COVID pandemic or coughing etiquette distance.
Then we have the route through which the infectious agent enters a new host. So you have potentially mucosal membranes, open wounds, respiratory tract. So donning and doffing of PPE. How it's not about the PPE– it's how you use the PPE, how you put it on, how you remove it, the body system, for example. And is somebody's watching you on how you are removing, how you're doffing that PPE and potential cross-contamination?
Last but not least, you have the susceptible host, which is the individual who is vulnerable to infection due to underlying health conditions. The lack of previous exposure, weakened immunity are factors that increase the susceptibility of an individual to become infected. And so you can see this principle is included in the ISO 35001 as having a robust occupational health program.
I recall at our institution during the Zika outbreak a few years ago, occupational health was a big deal as part of the biorisk management plan put in place for investigators who were going to work with samples potentially infected with Zika virus. And so it will depend on the pathogen at hand, whether you need a more robust or less emphasis on your occupational health. But there is no doubt that there needs to be an occupational health program associated with as part of your biorisk management plan.
In addition to operational planning, there are other activities that require procedures for safely decommissioning equipment and facilities, protecting personnel doing the work, ensuring that spaces are decontaminated. Equipment maintenance– so it's not only having the right equipment, but also ensure that it is maintained appropriately. That is not going to break down when you most need. It includes a schedule for regular maintenance, proper training for the use of that equipment, and the contamination of that equipment.
You may also be aware, for example, in research spaces, centrifuges are deemed to be the most contaminated piece of equipment. And so, if you need to have samples or run through the centrifuge, do you have the correct SOP and individuals trained to use the centrifuge and then clean up afterward? Physical security involves defining access control systems, surveillance, secure storage of biologicals. And I'll talk about inventories and some more detail on these different aspects of the operations section.
But all in all, transport of biological materials is also part of this operations because samples need to be moved. And transport not only means moving in a car or in a transport vehicle. It means also moving samples between spaces, from different facilities in the same campus or different buildings, et cetera. In our 2021 publication, we provided considerations for increasing lab safety and biosecurity in the context of managing emerging infectious diseases such as COVID-19.
And so what we did at the time, the ISO 35001 had been released, and the COVID pandemic was at full blast. So we put together some great heads, as you see in the authorship here, members of ABSA International. And what we did was in the context of handling samples related to COVID, how could the ISO 35001 increase that safety for the laboratorians handling those samples? I would like to highlight here one of the comparison tables that we included in the paper, because it exemplifies operations in the context of responding to an outbreak.
You heard me say it earlier. The operations elements of the plan-do-check-act cycle includes putting the SOPs to work. And that means ensuring the engineering controls, for example, are working, aerosol containment devices match the centrifuge where those will be used, validation of inactivation methods are in place for the different samples to be handled. It's not a cookie cutter. It's not like you can use the same method of validation for all your samples.
It depends on the sample. It depends on what they're in. And it depends what you're going to be doing. What is going to be the downstream analysis of those samples? So there are various, and that's why we call them considerations. Because there were a lot of questions to be asked regarding– to assess the needs and what needed to be done to handle those samples safely.
On the right, you see examples of mitigation measures as operations in the lab were initiated. It may be that centrifuge cups were not enough for the number of samples that were being processed. As you recall, during the pandemic, it was a massive amount of samples being processed at one time. Facilities that were not initially allocated to be laboratory or deemed to be spaces fit for processing samples had to be used because there was no choice.
And so that's where the biosafety officer will go in, do the risk assessment and determine what was needed in order to have a safe space for the laboratory and to process samples. So there were various opportunities to put to work the ISO 35001 and the principles in this standard to ensure that all the questions were asked in a systematic way when handling particular types of samples.
One example I like to give because Kalpana Rengarajan and myself were doing those risk assessments, was from high containment in BSL-3, where some of the samples were handled. But we needed to transfer those samples outside to lower containment. And so we worked with the investigators to determine and establish validation methods and inactivation methods to make sure that those samples had no viable virus after coming outside from high containment outside to lower containment for additional downstream analysis.
And so that is a tip that I like to give, right? Recruit your investigators to help in the process of inactivating or establishing inactivation studies, how to test them, how to ensure that those samples are safe to be handled, to be transferred to lower containment. And it's a collaboration between the biosafety office and the scientist. The take-home message here is that the planning and operations work hand-in-hand, and they feed off each other. Like I said earlier, they're not independent, even though you could– or we try to bucket them in planning or operations because it's the plan-do-check-act. But they feed off each other.
The planning phase accounts for all the skills, knowledge and abilities, what should be done and the operations phase is what can be done and is really the reality check. During the COVID pandemic, additional engineering controls were needed to protect not only laboratorians but also ancillary personnel. So it was not only the laboratorians, those handling the samples directly, but also who was in the front desk receiving samples or interacting with patients coming in?
Relocation of equipment was a big deal due to the limitations in space and the equipment available. Also during the COVID pandemic, we saw personnel who were not familiar with handling human samples, handling human samples. And so the competencies and the training needed that needed to be provided to this individuals were critical. So it brings up the importance of having a set of core competencies in your personnel. Who is doing– right? The "who is doing?" question.
So it's a good segue to talk about competencies. And I have four elements in determining that competency– knowledge, skill, attributes, and experience. They're not exclusive. They're all complementary. The training and competency are the front end of designing and operationalizing a virus management system. An institution can have all good wishes. You can have the buy-in of your leadership. You can have the resources. But if you don't have the buy-in of your laboratorians and ancillary personnel who are going to be doing the actual work, then your biorisk management system is not going to work. It's not going to be successful. As Randy indicated earlier, going into the effectiveness of your system is going to be low.
Risk at the level of personnel include, for example, personnel not informed of new operations, personnel not listed, or they're not listened to when they have concerns. Remember, they are at the front and center of handling certain types of samples. And if they're seeing something and they're not listening to your potentially having gaps in your process or downplaying the potential risk, overestimating the experience of personnel. Here, you have examples of sets of competencies for laboratorians.
APHL at the top includes a competency assessment for public health labs. In its first edition, the ISO 5441, which was recently released, defines the role of a biorisk management advisor, or BMA, and sets forth the competencies needed. It defines the management advisor as a competent individual who provides advice, guidance, and assurance to the senior management of an organization on issues related to biorisk management and includes competencies for different work areas and continuing education.
The Guidelines for Biosafety Laboratory Competency that were published in the MMWR by the CDC and APHL in 2011 are as good then today as they were in 2011. It provides five competency domains, including potential hazards, hazard control, administrative control, emergency preparedness for working safely with biologicals and hazardous materials. And I like this– you'll see later on– because the work with biological materials or biohazards is not limited to the biologicals. There are various other risks associated with handling these materials in the lab, and I'll allude to that in a few slides.
Last but not least, you have the ABSA International document published as part of the OSHA Alliance, and it defines a biosafety professional with the skills and the knowledge and the requirements for performing that activity. All this is to say that you need to have competent personnel in the lab to safely handle biological, chemical, radioactive materials, infectious materials, toxins, and should also include here, genetically-modified materials which increase the risk of handling this.
So let's launch here poll number four. What other information do you include in your biorisk assessments? It's "A," general safety. Do you include fire safety? Do you include electrical safety? Compressed gases? Chemical safety? Any other aspect that you include in your biorisk assessment? All right. What do we have, George? Great. General safety. General lab safety, 88%. Chemical safety comes second, 78%. That's great to hear. Fire safety, electrical safety, and other. I'm interested in knowing what "other" could be. Do we have anything, Aufra, in the chat?
Aufra Araujo: Let's see. These additional areas are siloed and reviewed by relevant departments. Randy mentioned that. Another comment is waste disposal. That's—
Esmeralda Meyer: Waste management?
Aufra Araujo: –all we have for now. Security.
Esmeralda Meyer: OK, good. Good, good, good. So it's a good segue for other elements of operations. As you see here, the ISO 35001 includes other elements to be included under the operations and operational planning. Here are examples for general safety. During COVID, some of you may have encountered personnel relocating to spaces that were not meant to be labs for processing samples. Material inventory, it always presents a challenge. It's mostly seen as an administrative burden, and it could be until something goes missing, and the only way of knowing is back-checking who had the last access, who removed it, who processes it, et cetera. So, yes, it could be an administrative burden, but is truly an asset to have if you have it.
Facilities and equipment tends to be a facility's chore. However, there is value on having facilities and engineering associated with your biosafety committee, with your biosafety risk assessment. And last but not least, the contamination, as somebody mentioned, yes, inactivation of materials, waste management deserves a specific place in your management plan. The CDC BMBL included Appendix K for inactivation and verification procedures.
The WHO Lab Safety Manual also has a separate monograph for the contamination and waste management. So check them out if you haven't. If we keep the topic of the recent outbreak, transportation, occupational health program, a robust occupational health program, biosecurity, ancillary personnel, I like to always stress that because it's not just the laboratorians who may be exposed to cross-contamination or exposure. Also, your environmental services personnel, contractors coming to do the biosafety certification, biosafety cabinet certification, and the animal care personnel, of course.
We continue. So here is poll number five. Continue to ask this question almost in every webinar because it is important. So how are SOPs reviewed at their institution? As often is necessary, annually, periodically. So we're asking you again, tell us, How are your SOPs reviewed? How often? OK. 52% are they're reviewed annually. As often as necessary, 32%. And periodically, whatever periodically means 16%. Thank you. Yeah, so annually seems to be the most frequent case.
And the next poll, how are changes to the SOP communicated? Dee and Marian also asked a similar question during the webinar. And I'll like to reiterate that here. Very important to review them, but it's as important to communicate those changes. So how is it done? Newsletter, during the inspections, during lab meetings, or there is another method. Tell us what other methods you use to communicate those changes. OK. What does the polls say? 69% during lab meetings. Great. And 33% newsletters or other. So if you want to unmute and tell us what "other" means?
Aufra Araujo: So I see some comments in the chat, Esmerelda, that some change is communicated in weekly meetings as well as echoed in the bi-weekly safety committee meetings.
Esmeralda Meyer: Nice.
Aufra Araujo: SOP change required to be read by training plan. Document control system sends out notifications.
Esmeralda Meyer: Great.
Aufra Araujo: Other, depending on the SOP, all lab members must confirm that they have reviewed it in iPassport.
Esmeralda Meyer: Great.
Aufra Araujo: Others, email blasts. Document control software requires them to read and sign off on significant changes. So those are some of the comments in chat.
Esmeralda Meyer: Great. Yeah, using software. It definitely helps. Sorry.
Aufra Araujo: That's OK. We also have a listserv for our PIs and researchers that we send out information in as well.
Esmeralda Meyer: Listservs. Yes, we use those. Very good. Distribution list, right? Yep. Yeah. Excellent way. Important– one of the things that was successful during the Ebola days was the morning huddles. And so if there are changes in shift and you're working around the clock, those shift changes and the huddles to communicate anything that is happening, whether it's an SOP that has changed or needs to be changed, those are the things that need to be communicated at those times. So yeah, great. Thank you.
All right. So as important as reviewing and updating the SOP, is the communication. The MMR here– and I'm going to switch now to standard operating procedures. But the MMWR published this document for Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Labs. There are other examples on this slide that provide you with some frameworks for standard operating procedures.
Constantly when I needed it, I would go to the Sandia National Labs website. They have Core Biorisk Management Document Templates. They're really good. And you just tailor them. You don't have to use them as they are, but it's a good starting point versus starting from a blank document. So I encourage you to check out some of these resources for standard operating procedure templates.
All right. So by integrating the "who," the "how," the "when," the "where" into the overall biorisk management strategy, operational planning ensures that handling of biological materials is done safely, consistently, and in compliance with regulatory and organizational requirements. And so this is truly a holistic approach that helps maintain the integrity of your biorisk management and protects the health and the safety of your personnel, the environment surrounding the location, and then the community.
As all standard operating procedures and processes come to life in the laboratory, the next question is, Are those controls, SOPs, and processes working? And so this is where the next performance improvement part of the PDCA comes in place. And so consider having those meetings led by managers or short meetings, however it is that works, so those what is working, what is not working type of questions can be discussed and can be collected over time.
Sometimes changes to the standard operating procedures don't need to happen right away because you need to assess what is happening, what is the root cause of, Why is this SOP not working? and then determine whether changes need to be made. So there needs to be discussion. There needs to be thought put into them before changes are made to your standard documents. Ultimately, it's a continuous process and needs to be based on the risks that are identified. And again, I like to move to my last slide as a take-home message.
The lab safety is really everyone's responsibility. So you need the buy-in from your institution, from your leadership as much as you need from the laboratorians and the teams that are handling and are at the front and center of working with those samples. Communication is critical. As has been said in past webinars, I reiterate that here, whether it's at the level of the standard operating procedures and processes put in place as it is changes that need to be made or new risks that are coming to your location.
And last but not least is the ongoing process to review what you have in place as your risk management plan, and then how to improve it. What can be done to improve, to be more efficient and efficacious? As a reminder, this is what the ISO 35001 is. We talked about operationalizing, the planning phase. And importantly, make sure that you involve all your stakeholders in your organization to ensure your biorisk management plan is successful. I'll be happy to take any questions here.
Aufra Araujo: Thank you so much, Esmeralda, for your excellent and informative presentation. We will open the floor for ideas, questions, or additional discussion points from the audience. Let's see. We appreciate and encourage the discussion amongst all participants and invite you to share your experience and challenges on this topic. Please remember to turn on your camera if you can and the microphone and introduce yourself. And also looking the chat to see if there is any question.
So if there are no questions or comments, we will move on to the next– one more chance. OK. We'll move on to the discussion part. And let me just– that's when I'd like to introduce my colleague, Commander Folasade Kembi, who is the health scientist in CDC's Division of Laboratory Systems, to provide a summary of the discussion from today's session. Sade, over to you.
Folasade Kembi: Thank you, Aufra. And thank you, Esmeralda and all the participants. So today, some things were posted in the chat, and some polls were also provided. So the first poll was, how do you do biorisk assessment? And 62% of participants stated that have a set of questions that they always ask. 62% prepared a risk assessment matrix tailored to the risk. 9% use BioRAM and 16% on the fly. So a question was asked on the chat that, What is BioRAM? Which the speaker addressed.
Also, Biosafety Risk Assessment Methodology and ABSA International Biorisk Evaluation Tools for Fungi were dropped into the chat. So also, the CWA 16393: Laboratory biorisk management guidelines for the implementation of the CWA. So also, the CWA 15793: Laboratory biorisk management standard were posted on the chat. So to the question that participants should tell us where they are in the implementation of their biorisk management at their institutions, while 32% of participants are currently assessing risk, 21% are evaluating operational controls, and 15% getting a buy-in from leadership.
Some of our participants don't have an organization. Some are not currently at a laboratory institution, but a consulting firm. However, they are interested in learning about this subject. An individual who– one of the participants is starting to conduct program evaluation for improvement. And links to sources of information of emerging outbreaks were also provided on the chat. They include the CDC Outbreaks, the CDC Health Alert Network, the World Animal Information System, and the WHO Disease Outbreak News.
To put the ISO 35001 standard to work are a resource that was used for concentration for laboratory biosafety and biosecurity during the coronavirus disease in 2019 pandemic was also provided and added in the chat. To determine laboratory competency, some competency resources were provided in the chat. They include the APHL Laboratory Biosafety Competency Assessment Form, the ISO/TS 5441 2024 Competency Requirements for Biorisk Management Advisor, the CDC MMWR, and the ABSA Biological Safety Officer Competency were provided on the chat.
Information that participants include in their biorisk assessment include general laboratory safety. 88% of participants include that in their biorisk assessment, 44% include fire safety, while 78% include chemical safety. Others that are also included in biorisk assessment include ergonomics, RAM/XRD usage, lasers, waste disposal practices, emergency response, and security.
One of the participants stated additional areas apart from the ones that was pulled, they are siloed and reviewed by different departments. Then SOP reviewed annually, most people, most participants here review their SOP annually and as needed and when there is a big change. So changes in SOP are communicated at 69% of participants communicate changes during lab meetings, 33% via newsletter, at 27% during inspection, and 33% through other means.
And the other means provided on the chat include the eDoc system, the listserv, personnel during their retraining, during virtual meetings, during competency assessments. It's also done through email blast and document control software, which also require that staff sign after reviewing the changes in the SOP. Then one of the participants also used iPassport, which also requires lab members to confirm that they have reviewed the AI iPassport. Thank you. Over. Over to you.
Aufra Araujo: Thank you for your interesting presentation, Esmeralda, and for the summary, Sade. Also, a big thank you to all members of this Biosafety Community of Practice for participating in the discussion today.
Now I'd like to talk about the post-session survey. The QR code on the slide and the link in the chat will take you to the Qualtrics survey. The survey should take no more than two minutes to complete. Your response will be anonymous, so no unique identifying information will be sought or kept. And the feedback we receive will be summarized in aggregate only. Your participation is voluntary, but we strongly encourage that you complete the survey so we continue improving the ECHO Biosafety Program and achieve better outcomes with this Community of Practice. We appreciate your time in completing the survey.
If you have any questions about the survey, the ECHO Biosafety sessions, or if you have a laboratory biosafety challenge you'd like to present during the ECHO Biosafety session, please reach out to us at the DLSbiosafety@cdc.gov. Let me move to the next slide.
Now, this is my last slide. We are excited to have our next session on Tuesday, September 24, at 12:00 PM Eastern Time. The topic of discussion will be Operations: Emergency Response and Contingency Plans presented by Benjamin Fontes, who is the Senior Associate Director and Biosafety Officer at Yale Environmental Health and Safety. As a reminder, the transcripts, audio recordings, and presentation slides from previous ECHO Biosafety sessions are available on the DLS ECHO Biosafety website.
And today's session and resource will also be available on that website in about three to four weeks. With that, we will adjourn. Thank you for attending today's session. I hope you were intentional about having a safe and fantastic day. We look forward to seeing you again in September. Bye.