CHELSEA: Hello, and welcome everyone. Thank you so much for joining our OneLab Network event today. We're going to give folks just minute or two to join in and get online. So thank you so much for your patience. We'll get started soon, and we look forward to this event Risk Assessment in Clinical Laboratories. 

Hello, everyone. Thank you so much for joining us today. We're very excited to have this session and get started. 

Before we begin, we would love to do a little bit of housekeeping to get us started in for today's session. So thanks again for joining. My name is Chelsea, and I am a consultant with Guidehouse, supporting CDC's OneLab initiative. I have a couple notes about the webinar before we dive in. 

If you are having any technical issues today, please feel free to email us at OneLab@CDC.gov. That's OneLab@CDC.gov. We'll be monitoring that inbox during the session. 

If you have questions throughout the session for our presenter and on this topic, you can submit those in the Q&A function. So you'll see in the bottom ribbon of your screen, there's a Q&A function. That's where you can post any questions you have. We'll have a Q&A session at the very end of the presentation where we'll try to get through as many of those questions as we can. But if we get any that we aren't able to get through, we'll do our best to send you an email back with an answer to your question. So try to leave it as not anonymous if you'd like us to respond back.

And if you have any questions that come up following this session, you can also email those to OneLab@cdc.gov. We'd love to hear feedback on the sessions or any ideas you have for future events or topics that you're looking forward to hearing some more information and educational material on. Note that we have posted the link to live captions in the chat. So please be sure, if you're going to use those live captions, that you keep this Zoom window open, as well as that Live Captions window. 

So let's take a look at our agenda for today. So we'll start by introducing some new and relevant OneLab resources, and we'll introduce today's presenter, Crystal Fortune. And then we'll have Crystal-- turn it over to her and present on Risk Assessments in Clinical Laboratories. We'll save that time for the Q&A, like I mentioned, and then we'll let you know what we have upcoming for our upcoming events. 

All right, so you'll notice that we have the chat box open for today's webinar. So we want to leave that open for your engagement. While utilizing the chat box, we please ask you to keep in mind the appropriate rules of engagement. So please feel free to use this function to connect with others, react to what you're hearing, share experiences that you've had, and asking questions to fellow participants. However, if you have questions for the presenter, that's where you use that Q&A function that I just mentioned before-- so not in the chat, in the Q&A function. 

Additionally, please engage with respect and professionalism. Any inappropriate language or conduct or any form of discrimination may result in removal from the webinar, so please ensure your comments are relevant to the topic. And if a moderator gives any direction regarding the chat behavior, please comply accordingly. Lastly, please notify moderators if you experience technical difficulties or observe any disruptive behavior throughout the session in the chat. 

And so let's practice the chat right now. So if you have any thoughts on what you're hoping to get out of today's session, this Risk Assessment in Clinical Laboratories, please drop that in the chat right now. What are you joining today? What are you hoping to gain from this session? What are your pressing issues in this topic area? Let us know. So let's see what each other is thinking. 

Right, let me check it out. So looks like risk assessment related to blood banking, I'm seeing. Overview of concepts, making sure that you're performing risk assessments correctly-- so this is a great one. "Learn how to do an effective and non-biased risk assessment for all clinical labs." That's great. 

See what else we're getting. When is the risk assessment appropriate? Is there a checklist to follow? Just a refresher on your skills. [INAUDIBLE] risk of infectiousness for respiratory swabs-- excellent. 

Awesome. Well, great information, and a great way to kick off the chat. So again, please feel free to use this chat to engage with others regarding the content of today's presentation. Ask each other questions. See what folks have done that are in your position that have helped them. We really like to encourage this opportunity for engagement here. Any questions for the presenter you can go ahead and put in the Q&A itself. 

All righty, so let's go ahead. I'm going to turn it over to our OneLab Network host, Alicia Branch. And Alicia will introduce us to some resources that we want to feature today and then introduce us to our speaker for today's session. So Alicia, I'll turn it over to you. 

ALICIA BRANCH: Thank you, Chelsea. Before we proceed to the main presentation, I'd like to share, as Chelsea said, a helpful OneLab resource related to today's presentation. It's Introduction to Laboratory Risk Management. It's the first in a series of courses focused on developing risk assessment strategies for laboratory settings. It covers risk management goals, terminologies, processes, associated activities. To access the course, scan the QR code on the screen. 

Next slide, please? I'll now read through two disclaimers and then introduce today's speaker. Slide decks may contain presentation material from panelists who are not affiliated with CDC. Presentation content from external panelists may not necessarily reflect the CDC's official position on the topics covered. Next slide, please. 

CDC, our planners and our presenters wish to disclose they have no financial interest or other relationship with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. Next slide, please. 

And I'm excited to introduce our presenter today, Ms. Crystal Fortune. Crystal is the Safety and Outreach Specialist at the Montana Public Health Laboratory in Helena, Montana. She is a Registered Biosafety Professional and an Association of Biosafety and Biosecurity, which is better known as ABSA, International Public Health Special Interest Group member, and the 2023 APHL Thomas E. Maxson Award recipient. 

Crystal has over 15 years of experience in clinical laboratory and has worked in public health. Since 2004, she's primarily worked in training and outreach capacity. Since moving to the Montana Public Health Laboratory in 2009, Crystal has served as the state training coordinator, biosafety specialist, and ultimate responsible official for Montana's Select Agent Program. Her passion is laboratory safety, biosafety, and especially packing and shipping in infectious substances. She is excited to share information on performing risk assessments today. Our speaker for today is Ms. Crystal Fortune. 

CRYSTAL FORTUNE: Hi. Can you guys hear me? 

CHELSEA: Thank you. 

ALICIA BRANCH: Yes, we can hear you. 

CRYSTAL FORTUNE: I apologize for my technical difficulties getting online with you today. So again, as Alicia said, I'm Crystal. A lot of you guys know me through this network. Some of you may not. I'm aware that some of my coworkers are watching today, and I appreciate you being with me. 

If you have any questions, you can reach out to me directly. I can provide my contact information, and you can ask questions in the chat. And we'll have time for comments and questions throughout the conference today. So just to next slide, please. 

A disclaimer for today. I have nothing to disclose-- no financial interest. So next slide? So today, our agenda is to discuss risk assessment. We're going to talk about different lab-acquired infections, how they may have been prevented. We will talk about factors to consider when conducting a risk assessment. We'll talk a little bit about laboratory design and engineering controls, and then resources where you can find out some more. I heard people talk about blood banking and such, so we'll hopefully be able to answer some of those questions, or help you to know where to find answers. Next slide? 

So by the end of the session today, you should be able to apply a general overview of the risk assessment process, recognize hazards inherent in the lab environment, describe biosafety controls that can help to mitigate risk, and list resources that staff can use to guide the risk assessment process in their environment. Next slide? 

So a quick icebreaker, if you'd like to put in the chat. I know you guys played with the chat a little bit already to put in there a city that you'd like to visit and why. I have London up here, and someone mentioned history. And that's kind of the reason why I love London. 

I used to live in England right during the mad cow era-- or not quite a mad cow yet-- but lots of history in London. So great answers. Lots of overseas food. I appreciate food. Great answers, thank you. Next slide, please? 

OK, in summary today, we're going to talk about when science-- when we send out mixed messaging, how science can conceivably be threatened by that. And I want to ask you, can you think of an incident recently where mixed messaging might have threatened science? Feel free to put that in the chat. 

Anything tropical? Yeah, lots of COVID. I was expecting lots of COVID. 

Another episode that I think of prior to COVID, and one of my favorite things to talk about in my own training, was an incident involving a military facility in Utah that inadvertently shipped live Bacillus anthracis. And then, subsequently, FedEx will no longer take select agents. It wasn't so shocking, necessarily, to me that this happened. I mean, unfortunately, things like that happen. But what was shocking was reading the comments-- that's the first place I go when I see articles like that-- and looking at the comments. 

Like, people were completely unaware that these kind of things happen. And you know, and as a result, like I said, now FedEx will no longer take select agents. So we have to be really careful what we do in our job to make sure that these kind of things don't escape-- and, worse yet, that the public ends up finding out about it, because that indeed threatens our livelihood and science as we know it. Next slide? 

So this is just a quick overview of the order that I'm going to discuss today's topics. We'll talk again about pathogens and lab-acquired infections, biosafety program principles, a hierarchy of controls, risk assessment, and then additional resources. Next slide? 

So first, going over pathogens. Next slide, please? So we're kind of familiar, and may be familiar, with this chart from the Byers and Harding study, but I would like to familiarize you with a couple others. 

In 1941, [INAUDIBLE] Carlton Phillips conducted the first investigation of 50 lab-acquired typhoid fever cases resulting in six deaths. This was dating back to 1885. Of the 23 known cases of transmission, 16 were due to mouth pipetting. And then, as you see here, in 1951, the Sulkin and Pike study was expanded to 1,342 lab-acquired infections involving 69 pathogens, resulting in 39 deaths. 

In this chart, there was 31 cases of infection of Neisseria meningitidis, 11 of which were fatal. 16 of these were lab-acquired between 1985 and 2001. Eight of those were fatal. And the conclusion from those was that people were working outside of the biological safety cabinet. Next slide? 

So in this chart, then, we see how the risk looks for microbiologists who are dealing with the bacteria in its concentrated form compared to the general population. So it's a good demonstration of why risk assessment is important. So when you look at E. coli O157, for example, it doesn't take very much for someone to become infected. The infectious dose is relatively low. 

So when you think about a child in the daycare, I had recently-- or relatively recently-- seen an article about the first person-to-person transmission of E. coli O157 in a daycare from a child that had eaten contaminated food. But then when you consider if a child has a dirty diaper, whatever, is on the floor, getting on toys, what have you-- so in reading the comments, I felt like it was a good example of how science was misconstrued. 

When you think about the general public compared to microbiologists, so the microbiologist is like 6 and 4-- excuse me, 641 compared to 0.08 in 100,000 people. E. coli is 8.3 to 0.96. Neisseria meningitidis, 25.3 to 0.62 per 100,000 people. So you can see, since we deal with the concentrated form, our risk of contracting a lab-acquired-- or an infection with these in general-- is much higher. Next slide? 

This is data that was recently published in The Lancet in February, 2024. The study covered 309 cases by the time all was said and done-- that's how many they included-- caused by 51 pathogens, mostly bacterial. Almost 50% of them were caused by Salmonella enterica, followed by Salmonella typhimurium, were 21 cases of Salmonella enteritis. And these were caused by spill accidents. Four of seven Neisseria meningitidis were due to procedural error, and three of these four actually resulted in a fatality. 

When you're looking at these data, we want to interpret with caution because several factors may have influenced the results, especially reporting. So we want to make sure that we ensure a safe, non-punitive reporting mechanism, because without good data, we don't all the considerations that we need to take into account when we're doing our risk assessment. Some of you may have heard of the Heinrich Pyramid that says one serious accident is preceded by 29 minor accidents, preceded by 300 near-misses, preceded by an unknown number of unsafe practices and conditions. And if these aren't reported, we can't fix what we don't know is broken. Next slide? 

So these are some interesting cases that I've heard about throughout my career as a Biosafety Officer. The first one I wanted to highlight was in 2009, a Chicago researcher that had insulin-dependent diabetes myelitis died after being exposed to an attenuated strain of Yersinia pestis, which is the causative agent of plague. The strain that he was working with was not known to have ever caused an infection, so it's possible that he didn't take proper precautions. But on autopsy, it was discovered that he had an undiagnosed hereditary hemochromatosis, so this attenuated strain had the Iron acquisition taken out of it, and it might have been that he had so much iron in his blood that it enabled that Yersinia pestis to become virulent. So we don't know how he was exposed or if he actually told the doctors the nature of his work, and he died within just a few days of becoming sick. 

In the ABSA database in January 1996, they're a clinical micro lab that had three medical students working in it. Between 23 and 28th of January, six of 19 medical technologists developed diarrhea, and they found out that the transmission was from the faucet handles of the hand-washing sink. 

In 2012, a California scientist was researching Neisseria meningitidis. He left the lab around 5:00 PM on Friday with no symptoms. Two hours later, he had developed headache, fever, and chills. Before the weekend was over, he had died. That facility was charged with failure to provide a safety enclosure and failure to provide vaccinations-- which probably wouldn't have helped in this case, I believe, if I remember correctly. He was doing research towards the type B meningitis vaccine. His family brought a wrongful death suit in excess of $20 million. When I was doing research for biosafety once, I saw, actually, an attorney's ad that was a wrongful death suit that mentioned this case. 

Also, in the ABSA LEI database was the incident in New York that described 10 Brucella exposures from when laboratorians were working with Brucella on an open bench. They didn't have a reason to believe that the cultures would contain Brucella. A total of 219 workers were exposed. 71 received prophylactic treatment. 

And in 1988, there was a case of a wife of a hospital microbiologist who had become infected. And she had not visited the lab and didn't have any risk factors. So probably a good example of the microbiologist then bringing something home to her. So next slide, please? 

So the goal of the risk assessment, then, is to break the chain of infection. If we can do anything in this chain-- like whether it be the agent getting into the body, or if the agent gets into the body, keep the person from getting sick. If the person gets sick, any treatment-- anything that we can do to prevent an infection from occurring is our goal with the chain of infection. Next slide, please. 

So we'll talk now a little bit about the biosafety and principles. Next slide, please. So I'd like, if you could put in the chat, what do you think is wrong with this picture? And disclaimer, these are pretty old pictures, so probably before lab safety as we know it today. 

A lot of people saying, no gloves, no caps-- ick. So much is wrong. So yes, definitely, no gloves. 

Another thing that I'd like to point out in this is there's not any safety cups. A lot of the centrifuges that we use nowadays have safety cups that we enclose the samples in with the lids on them. So good calls on those, thank you. Next, or next slide, please? 

Biosafety is the application of combinations of practice, procedure, facilities, and equipment to protect against pathogens. Exposure in the lab is a very real possibility, as we've seen, and we must be prepared to minimize exposure to our staff, the external environment, and the public. This responsibility lays on every staff member, whether bench scientists, support staff, or management. Next slide? 

So the first principle was containment. To ensure successful containment, all staff need to be aware of the hazards that are present and what we have in place to mitigate them. This includes understanding and respecting facility design and adhering to safety policies and procedures. 

So there's two levels of containment that we'll talk about. First is primary containment, which is the protection of personnel in the immediate laboratory environment from exposure to infectious agents. Two primary barriers we think about is personal protective equipment and the biological safety cabinet. We also want to consider other engineering controls such as we just talked about-- safety centrifuge cups to contain aerosols and broken tubes. 

Secondary containment is protection of the laboratory environment external to the lab from exposure to infectious materials. So if there's a breach at all within the primary containment, this is a step that keeps it from entering the environment external to the laboratory. So we want to look at decontaminating our waste. We want to look at making sure that we don't hand wash-- or, excuse me, wash our hands in the same sink where hazardous materials are disposed of. Directional air that keeps contaminated air from entering clean spaces. We also want to keep doors closed and badge access to those who don't need to be there. 

Next slide, please. This chart shows the different safety controls in their order of effectiveness. A lot of people consider PPE the first line of defense, but there are lots of measures put in front to protect you, and PPE actually serves as a final barrier. Next slide, please? 

So moving on, then, when we talk about physically replacing the hazard, elimination, we can look at safety equipment, replacing, physically removing. We can look at safety equipment such as the instruments that can recap-- I'm sorry, I think you're on a different slide, sorry. Moving on to the Biosafety Levels. I apologize. 

Four Biosafety Levels that differ based on combinations of lab practice and technique, safety equipment, and laboratory facilities. Each combination is specifically appropriate for the type of work being done. The descriptions are found either in the CDC NIH manual, the Biosafety in Microbiological and Biomedical Laboratories, or the WHO Laboratory Biosafety Manual. And it's helpful if laboratories have both of these on hand. 

I think you're a slide ahead of me. If you could go back one? Thanks. 

The general rule is that the worse the bug is, the higher the containment level. Most clinical labs would generally fall into the Biosafety Level 2. Some lab facilities, such as your public health labs, may have a Biosafety Level 3, where, for example, they may work with TB samples, rule-outs for select agents, that kind of stuff. And then, if you have the Biosafety Level 4, that's going to be like your CDC, NIH labs. Those are the ones that deal with the most dangerous agents. 

Next slide, please? Inherent in all laboratories, we should have a biosafety or-- excuse me, a biohazard sign posted whenever infectious agents are present. We want to recognize that people are an inherent risk-- "inherent" meaning that left over after all the other practices we put in place-- so they need to be trained and competent in biosafety practices and principles. We want to decontaminate our work surfaces as needed, and make sure that you allow the correct contact time, treat all infectious-- or make sure that all the infectious and potentially infectious wastes are decontaminated. 

Next slide? And then, as the biosafety levels increase, we want to make sure that they're located separate from public areas, that they have the directional airflow, that the doors are self-closing, that they lock, that they're designed for easy contact or decontamination, that the air does not recirculate into non-lab areas, biosafety cabinets away from the high-traffic areas, and then we want to make sure that our staff are protected-- not only for their own selves, but so that they can keep from protecting others outside of the lab. 

So we will give them vaccines, and then, also, we do surveillance, different monitoring, such as for TB, incident reporting. If they have symptoms of the agents that they actually deal with, we want to make sure that they report those. We want to make sure that we have eyewash stations. And then, also, as far as the centrifuge, we want to make sure that we check the tubes for cracks and chips, make sure the centrifuge is balanced, disinfected weekly and after any spills or breakages. 

Make sure that the O-rings on the cups are not cracked. Make sure that the buckets are seated. Close the lid and allow it to come to a complete stop before opening. I'm pretty sure that the reason that that feature is designed now is many of us old-school people may or may not have used pencil erasers to stop a centrifuge from spinning. Next slide, please? 

In the Safety Standards, we want a qualified supervisor to create a safe environment, complete with SOPs, available First Aid, and SDSes. We want our staff to be trained and competent, aware of the potential hazards, and to follow the rules and procedures in our Safety Manual. They need to make sure, like I talked about, to report incidents and near-incidents. 

Again, considering the primary and secondary barriers. The primary barrier is most critical because if they don't use their PPE and their Biosafety Cabinets, for example, properly, then they're not protected. They may have a false sense of protection. And then, again, if they don't respect the design of the facility, if they're leaving the laboratory with their PPE on, if they're propping the doors open or what have you, all of those things are breaches in the safety of the design of the lab. 

You also want to audit your program. So investigate any safety reports and make improvements to the program. And then, assess it again to make sure that the changes are actually working. This should be a continuous process just like any other quality program. Next slide, please? 

One of the recurrent problems in micro labs is the switch-over to automation. So we want folks to consider the characteristics of colonies before placing them on an automated instrument where there's an exposure-- or possibility of an exposure to aerosol. So typically, growth from a sterile source, aside from an obvious contaminant, is not going to be a good thing. So especially if it, on a gram stain, is a gram-negative-- Diplococci, if it's a slow grower on blood, no growth on MacConkey, typically, you're going to know that before you even make a Gram stain. 

So be aware of those and work inside of a Biosafety Cabinet. If it's possible to inactivate those samples before you put them on an automated instrument, do that, too, because then you're going to end up exposing other people in the lab. And I believe that there was a study in one of the Southern states-- I can't remember which one-- where several people in a microbiological laboratory were exposed due to this very thing. 

Hand washing. Excuse me, next slide, please. Hand washing should not be underestimated. 

I have here some steps of how to properly wash your hands. Warm or cold water, it doesn't matter. If the hotter water is going to end up kind of chapping your hands, you want to make sure that you don't compromise that barrier. You do want to make sure to lather your hands. Get between your fingers, your cuticles, around your nails. 

Scrub your hands for at least 20 seconds. We've all heard dissing the "Happy Birthday" song. I recently heard you could also do "The Alphabet Song." Rinse your hands well under clean, running water. Dry your hands using a clean towel, or air dry them. I've heard things about air drying too. I'll leave you to decide. 

Use a paper towel to turn off that tap-- or, some laboratories actually have hands-free sinks. Again, I talked about the laboratories that had the development of diarrhea. That was due to the hand-washing sink. So using a paper towel or a hands-free sink is pretty important, especially in a microbiology lab. 

As far as the alcohol-based hand sanitizer, we want to use at least 60%. I will warn you, though, to be aware of some of the limitations with that. If your hands are visibly contaminated, you know, and then, even if they're not, use it in a pinch. I would probably always follow up with regular hand-washing because some pathogens, such as Norovirus, are not always killed by the alcohol. Next slide, please? 

Clinical labs do not necessarily know from one day to the next what they might encounter. The Sentinel Lab definition relatively recently changed to say that any lab that can encounter an infectious disease, regardless of their facility type-- so to try to help our clinical labs be a little bit more prepared, immunizations. If there's an immunization against anything, I'm kind of a proponent. 

So hepatitis B, Neisseria meningitidis. There is now the Neisseria meningitidis type B vaccination. When we have outbreaks, we can get vaccinations to smallpox, anthrax, different things that are out there. 

You can establish a relationship with your local Public Health. Make sure to get news on what might be circulating. Consider trigger points we talked about. And talk to your doctors, too, and have them tell you if they have an infectious-- or infectious patient, a highly infectious patient, or they think someone has been exposed to something, establish a relationship with them so that they can warn you before they send samples over to you. One of our policies is that labs actually give us a call before they send in rule-out samples, or samples of bioterrorism or highly infectious agents, or make comments on the forms or something so that our own staff can be prepared. 

And know your staff. Know how they handle stress, what their comfort level is. We try not to expose our staff to anything or make them do tasks that they're not comfortable doing. If they have children or elderly patients, maybe they don't want to do stuff that might put them at risk. And have them tell their supervisor if they think they might be immunocompromised. 

Next slide, please? So PPE acts as a barrier to protect skin, mucous membranes, or respiratory tract from exposure. We want to use this in the case of splash and splatter. 

If the person needs to wear a respirator, they need to be fit-tested and trained annually. Respirators do need to be maintained. And keeping in mind, again, that they do not completely eliminate risk. 

Gloves should not be worn outside the laboratory. They need to be removed when they're contaminated. Or if you notice that there's a hole, you don't want to wash them or anything because then, that can compromise their integrity. So we don't want to reuse those. And dispose of them in a biohazard container, or wherever you discard your waste, before you leave the lab environment. 

Next slide, please? So in general, Biosafety Cabinets are classified according to the method by which the air volumes are recirculated or exhausted. Typically, in most laboratories, they use the Class II Biosafety Cabinet, which provides product, personnel, and environmental protection. That has key features such as opening in the front, inward airflow. It has HEPA-filtered intake, HEPA-filtered exhaust. 

That protects the intake, obviously, your product, the exhaust, your environment, and the worker. It needs to be isolated from high-traffic areas. It needs to be maintained. 

People need to know how to use it, to watch that magnehelic gauge. They need to make sure to check the certificate, make sure that it's been certified on time and that that's not expired. Check the sash height. Make sure that you can somehow visibly check that airflow if it's using a Kimwipe. And, when you work inside a cabinet, to work far enough inside the grill that you're not pulling stuff out, and also to work slowly so that you're not pulling stuff out of that cabinet. Next slide? 

Challenges in the lab-- anywhere, but in the lab, especially, workforce shortages, staff burnout. Lots of retirements, financial constraints that might lead to some safety shortcuts. Safety is not always a priority. It's kind of a little bit more the bottom line sometimes, and some of this stuff isn't taught in school. 

Human error, though, it accounts for about 65% of lab accidents. So we do want to make sure that our staff adheres to containment policies, microbiological practices, and techniques. The lab should adopt a Biosafety or Operations Manual that identifies all the hazards that might be encountered and specifies the practices and procedures that are designed to minimize those risks. Persons working with infectious agents or potentially infected materials should be aware of the hazards and be trained and proficient in the practices and procedures that they need to use to handle those materials safely. 

Next slide? What's wrong with this picture? Yeah, I'm so proud to see so many people say "cell phone use." This is another thing that is a little bit controversial in the lab. So cell phone is the primary thing I want to point out here Thank you. 

Next slide, please? Yeah, ugh. [LAUGHS] All right, so in this next block, we'll go into the meat-and-potatoes risk assessment. We'll talk about risk evaluation, task evaluation, and some helpful resources. Next slide? 

So when we do a risk assessment, we want to look at all the operations to determine the risk and then determine what's acceptable, what can be abated. Everybody needs to be a part of the process. Everybody should adhere to the outcomes. 

We want to consider how exposures can occur, what can-- when we bring in new instruments, new tests-- such as I had a laboratory bring on PGD testing. We want to consider the education level of the worker, the experience level, the technical proficiency, their work habits, longevity, competency, health, even their mental capacity that day. 

Keep in mind, that risk is never zero. Adverse consequences can occur if risk is underestimated. But then, we also don't want to overestimate a risk, because excessive safeguards can actually cause more harm.

The information in the risk assessment will guide selection of the different Biosafety Levels, the practices, safety equipment, facilities safeguards. So in this chart here, you see where it's low risk up to high risk. So you're looking then at the likelihood that something can happen based on-- or, excuse me, as opposed to, then, the consequence of something happening. 

And you kind of just plot that inside that matrix. And then, anything that plots within that high to moderate level-- very high, moderate level-- we want to try to bring down as low as possible to a level that you will be able to handle working with that in your lab. If that's not possible, then you may want to consider not doing it in your lab. I kind of liken it a little bit to the IQCP process. 

Next slide, please? This is just some definitions of the different risk groups. They kind of mostly, but not always, coincide to biosafety levels. Depending on the concentrated forms, the culture or the pathogen might be in a higher risk group than the Biosafety Level we work in. 

Sometimes, we'll use what we call "enhanced practices." So if we have high-risk pathogens-- Brucella Coccidioides, Blasto, Francisella, that kind of stuff-- we might want to use, if we don't have a Biosafety Level 3, we might want to use a respirator, or a biosafety cabinet, or a double gloves. So those are some enhanced practices we might be using. 

Next slide, please? We want to consider our routes of exposure. So we have skin-- intact skin is a barrier. But if we have chapped skin, that can cause-- that creates a compromise. 

Parenteral inoculation, obviously, if you poke yourself. Mouth or GI tract-- so anything that's transmitted via the fecal-oral route. Mucous membranes, splashes into the eyes or mouth. Some of you may know this story of Beth Griffin who contracted Herpes B virus from monkeys. 

The lungs-- so considering aerosols in the laboratory. And we want to use our practices-- again, facility design, engineering controls, et cetera-- to try to keep pathogens from entering any of these routes of exposure. Next slide, please? 

OK, a little bit of background on this picture. This laboratorian-- again, it's an older picture-- is working with Yersinia pestis. So now-- yeah, wow. Yeah, I thought that Yersinia pestis would make it just a little bit more interesting, this photo. 

A lot of people say, no Biosafety Cabinet, which is awesome. I'm kind of really curious what's in that, I'm assuming, 1,000-liter graduated cylinder he has sitting there. But yeah, very cluttered cabinet as well, so cloth mask. In all fairness, it was the '60s, but-- [LAUGHS] Yeah. 

All right , next slide, please? No eye protection, for sure. OK, so when we're looking at task evaluations, granted, a lot of these are kind geared towards the micro lab. We're looking at anything that can create aerosols that are ubiquitous in the laboratory. 

So thinking about catalase tests-- when it's making that bubble and pop, that's actually putting energy into that, and it's spreading bacteria around. The meningitis cases that we talked about were due to folks not working under the Biosafety Cabinet. So they can be exposed even when they're not in the room. 

So when we're considering factors for the risk assessment, I have here, and there should be a link to the Pathogen Safety Data Sheets. Canada has most of the pathogens that we're going to encounter in the Pathogen Safety Data Sheets. So you can find lots of information about the host range, the route of infection, risk group, infectious dose, if known, treatment, vaccination information, survival outside host, PPE, what kind of sterilants, or decontamination, or whatever you need to know about that pathogen to be able to work safely. And there's an app for that. And it's free, no ads. Next page? 

This is just an example of a catalase risk assessment. And you can see here where they started in the kind of more moderate range. and then working under a Biosafety Cabinet or inside of a closed tube actually was able to bring that risk down to low. Next slide? 

And this is just mapping out that exact process. So they took the catalase test. What were the steps of the catalase test, the potential hazards related to it? What could they do to eliminate those hazards? What was the PPE they could do, and what kind of training did the staff need to be able to do that test safely? 

Next slide? So here's a rundown of the resources that are available to you. We'll go through those real quickly. Next slide? 

The "BMEL," the sixth edition, which came out a couple of years ago, has a really good appendix geared towards clinical labs. It includes biorisk management, risk assessment, risk mitigation, emphasizes the use of a multidisciplinary team, talks about policies, and PPE, and engineering controls, and stresses the importance of non-punitive reporting. Next slide, please? 

This is an awesome document. It's an oldie but goodie, and it's perfect for the person that was asking about the blood banking. It's a free download. You can get the PDF version. There should be a link in your chat. 

It goes into great detail concerning risk assessment in clinical labs. It goes through all the common testing areas, such as microchemistry, hemo, blood banking. Covers all the phases of testing-- so pre-analytical, sample collection, processing, transport to and within the lab, analytical. For the testing platforms, what might generate aerosols-- pipettes, glass slides, et cetera. 

Post-analytical-- so disposal, waste handling. Clean spaces versus dirty-- so sinks, computers, phones. And then, other hazards as well-- so chemical hazards, electrocution, slips, trips, and falls. So pretty much any hazards you can include in the laboratory, they tell you how to approach those risks. 

Next slide? And these are just screenshots of the different activities. This is breakdown of activity by portal of entry. Next slide? Hazards associated with some of the common activities, along with likelihood and consequence of exposure. 

Next slide? This is another resource that's available free of charge-- some APHL best practices. So it features some of the risk assessments designed by Alaska, Colorado, Florida, Iowa, and New York. So this talks about the goal of risk assessment and how they vary by facility-- a good demonstration of that. That they have certain things in common, by pathogen, mode of transmission, likelihood of exposure, and activities, but that this is a continuous process. We talked about that a little bit earlier. It's not one and done. 

Next process? Or, excuse me, next slide? The Biosafety Checklist, also available free of charge. So you can do a good inspection of your facility-- site checks, reporting, infection control training, and inventory. Next slide? 

This document is free of charge. There's a crossover to the public health professional competency safety domain. So it talks about hazards, hazard controls, and administrative controls. This recognizes that there's residual risk in the lab leftover after everything else is in place, so making sure that our staff are trained and competent in how to use mitigations. 

Next slide? The CLSI Guideline in 29A4. This one is not free of charge. It costs about $180. It's available by electronic format only, but you can download that from the CLSI website. Next slide? 

And these are some other available resources for you. Both of these are free of charge. You have the Hospital Respiratory Protection Program Toolkit. It tells you types of respirators and when to wear them. 

And the "Clinical Laboratory Preparedness Guide," a.k.a. "The Bluebook," is a comprehensive guide that covers pathogen-specific information. There's safety information, packaging and shipping information, and other job aids and references. This one's actually under renovation right at this second, but it is the original still available to you. 

Next slide? One more free picture, which-- we can skip over this and move on to questions since we've only got a couple of minutes. Yeah, too crowded, for sure. And there was stuff on the grill, too. 

ALICIA BRANCH: Thank you, Crystal. 

CRYSTAL FORTUNE: Yeah. 

ALICIA BRANCH: We'll go ahead and take a few questions. If we don't get to your question today, please, if you haven't submitted anonymously, we'll try to get to it later. If you have any questions after today, you can email the OneLab inbox. It's onelab@cdc.gov. 

OK, let's answer a few questions. We'll do this one that someone sent. It's anonymous. "What are your recommendations or thoughts for handling small amounts of human blood and manipulating cultures on lab benchtops? Our clinical labs have no have minimal to no BSCs, and we've tried to push for BSCs, but in the meantime, we recommended things like a splash shield, dividing spaces, reduced traffic to dirty areas, et cetera." 

CRYSTAL FORTUNE: Honestly, those are the recommendations that I make in lieu of no Biosafety Cabinets, is the face shields, respirators, splash shields-- whatever you can do to try to keep those splashes. Blood is mostly splashes into the eyes and mucous membranes. So we want to make sure that we avoid those. 

As far as cultures, you want to make sure that you're not inhaling any aerosols. So if you can add a respirator, an N95 to that, that'll protect you. And then, also, make sure that no one else is present in that area while you're working on that, so that there's not any inadvertent exposures. 

And then, also, keep track of any symptoms. If you notice any symptoms within, like, a couple of weeks of working with that, make sure that you report those. And report what you were working with to your physician so that they can make sure to treat you accordingly 

ALICIA BRANCH: Yeah, that is definitely-- and that's why it's important to do a risk assessment for all the procedures and things that you do in the laboratory. Let's take this one. This one, it's an interesting question. They want to know what your thoughts are on using reusing plastic biohazard bags when they're not visibly soiled and only used-- and only used to transport sealed primary containers? 

CRYSTAL FORTUNE: Well, they're not meant to be reused, so my thoughts are that I would not reuse them at all. I have seen biohazard bags reused, but no, that's not a best practice. So yeah, I would definitely say that those should-- because you don't know what is on that primary container. It may look clean, but it may not be clean. So I would definitely say to dispose of those. I know it may cost a little bit extra, but it's not worth it to inadvertently expose yourself-- or, worse yet, even someone outside of the laboratory. 

ALICIA BRANCH: Absolutely. This is-- someone wants to know, how often should you do a risk assessment? 

CRYSTAL FORTUNE: Any time that you are bringing on something new into the laboratory. So whether it be a new instrument, a new test, if you have a new person, if you're having a new design in your laboratory. We're moving our laboratory into a new space, so we're going to be doing a pretty extensive risk assessment. 

You're just wanting to look at each part of that environment, and kind of just looking for any breaches that you can mitigate, address any gaps between safety, to-- oh, there's a tripping hazard here, or whatever, or, this one is 20 feet, you know, or 100 feet from a Biosafety Cabinet. Anything like that, we want to make sure that we want to put stuff a little bit closer, close the gap between the danger and our staff. 

ALICIA BRANCH: OK, let's take one more, and then we'll try to answer the other questions offline. AABB, new standard emphasized risk assessments for blood bank. Do you have any examples of what need what needs to be risk-assessed, especially for blood bank? 

CRYSTAL FORTUNE: Honestly, it has been a long time since I've worked in a blood bank, so I don't want to lead you astray in that. But I would recommend looking at the document that I addressed in the training, the biosafety-- the "Risk Assessment for Clinical Laboratories." Look through that, because it's pretty extensive in pointing out all of the different hazards that are inherent in the clinical laboratory, and that can give you some pretty good tips. 

And if there's stuff in there that you're not sure of, I would definitely reach out to any listservs you have. You can reach out to your clinical labs or, excuse me, to your public health lab. You can certainly email me or the OneLab. And what I don't know, I certainly try to find out for people. But I'm sorry that I'm not a great resource on that right at this moment. [LAUGHS] 

ALICIA BRANCH: Yeah, a blood bank was my very first lab job.

CRYSTAL FORTUNE: So you may have [INAUDIBLE]. 

ALICIA BRANCH: No, that was eons ago. [LAUGHS] 

CRYSTAL FORTUNE: [LAUGHS] It's all electronic, now and that alone kind of boggles my mind. So-- 

ALICIA BRANCH: Thanks again, Crystal, for presenting today on such an interesting, yet sometimes challenging topic for laboratory professionals. We are offering one PACE credit for today's webinar and have implemented a new process for obtaining your credit. You can get your PACE certificate immediately on the OneLab REACH in your My Learning Hub for easy access. 

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