September 21, 2024

Laboratory Professional Vaccine Compliance and Effect on Safety

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Format: MP3

Language: English (US)

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Last updated: November 28, 2023

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Laboratory Professional Vaccine Compliance & Effect on Safety (Presentation Slides)

Presentation slides for the session on Laboratory Professional Vaccine Compliance & Effect on Safety.

Oct. 15, 2024

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Transcript

Date of session: 11/28/2023

Facilitator

Aufra C. Araujo, PhD

Centers for Disease Control and Prevention

DLSbiosafety@cdc.gov

Didactic Speaker

Michael Pentella, PhD, D(ABMM)

Director, State Hygienic Laboratory, University of Iowa

Clinical Professor, College of Public Health, University of Iowa

michael-pentella@uiowa.edu

Aufra Araujo: Good afternoon, good morning, and good evening, everyone. My name is Aufra Araujo. And I want to extend a warm welcome from the Centers for Disease Control and Prevention in Atlanta, Georgia. I am a PhD Health Scientist in CDC's Division of Laboratory Systems. Thank you all for joining our 11th Extension for Community Healthcare Outcomes, or ECHO, Biosafety session. The topic for this interactive discussion is Laboratory Professional Vaccine Compliance and Effect on Safety. Today's subject matter expert is Dr. Michael Pentella from the State Hygienic Laboratory at the University of Iowa.

To foster a strong sense of community and facilitate networking among biosafety professionals, we encourage everyone to turn on their cameras during today's session. But we understand if you are unable to do so at this time. Our aim with the ECHO Biosafety project is to build a community of practice. And connecting names with face help us to do that.

All right, we can stop sharing these slides now. So hopefully, we can see everybody. Yeah, it's nice to see you all. I would like to ask everyone a quick icebreaker question. If you celebrated the Thanksgiving holiday last week, what was your favorite Thanksgiving dish? Feel free to unmute and share a little bit with us or enter in the chat box if you prefer. Let's see. I'm curious what people say.

Only two responses here – what happened, people? You didn't eat any food at Thanksgiving? Sweet potato casserole. Wow, that's my favorite dish as well. Fried turkey, all right. Cranberry, I like cranberry sauce. Mac and cheese. Pumpkin bread, ooh, that's nice. I've never had pumpkin bread actually.

Sweet potato casserole, it looks like sweet potato casserole is winning. Cherry pie. Any dessert is good. Apple cranberry pie. Yeah, all of the desert, agree, Sabrina. What's your favorite one, Dr. Pentella?

Michael Pentella: Well, I saw the list here. And I like so many of them. But the pumpkin cheesecake someone brought was really great.

Aufra Araujo: Oh, wow. Yeah, I think most of us have not had lunch yet. So we are all going to feel hungry now. All right, thanks, everybody, for participating. Before we continue, I'd like to address some technical aspects of our ECHO Biosafety sessions.

Please use the video capabilities of our device for this session. Currently all audience microphones are muted. When engaging the discussion, please unmute yourself to speak. 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 connected to Zoom by phone only at the time of discussion, please introduce yourself by stating your name and institution before speaking. How do these ECHO sessions differ from other presentations? These sessions are different from webinars in that the main feature is the discussion of cases or clinical laboratory challenges.

Our subject matter experts aim to share some applicable solutions that can be implemented in your individual laboratories. Our goal with ECHO is to bridge gaps, build community, and enhance biosafety. We encourage your active participation by sharing your knowledge and experience.

Each laboratory is unique, and your skill sets are unique so your contributions to the discussion are valuable. Here is a brief overview of today's session. I introduce our subject matter expert, Dr. Michael Pentella, who will provide a didactic presentation and real case discussion.

Then my colleague, Sabrina DeBose, will summarize today's discussion. Closing comments and reminders will follow this. And we will adjourn the session. Today's session is being recorded. If you prefer not to be recorded, please disconnect now.

Closed captioning is provided for this session. And you can find the link in the chat box. After today's session, the transcript, the audio recording, presentation slides, and other resources will be posted on the DLS ECHO Biosafety web page.

All right, now, it is my pleasure to introduce today's presenter, Dr. Pentella is the Director of the Iowa State Hygienic Laboratory. He has a Bachelor of Science degree in microbiology, a Master of Science in Clinical Microbiology, and a Doctorate in Infectious Diseases. He has over 40 years of experience in clinical and public health laboratories and over 20 years of experience in hospital infection control and epidemiology.

He is certified as an American Board of Medical Microbiology Diplomat. He is a member of several national committees, including the APHL Biosafety Biosecurity Committee. And he has authored several book chapters and articles on biosafety. Dr. Pentella, I'm so happy to say the floor is yours.

Michael Pentella: Thank you very much, Aufra. And thank you for that kind introduction. Good morning, everyone who's not on the East Coast. And good afternoon to everyone on the East Coast. It's a pleasure to be with you. And thank you for the invitation to present. I'll start sharing my screen. Everything good on your end?

Aufra Araujo: Yes.

Michael Pentella: OK, thank you. So today we're going to talk about vaccines and our biosafety program. And looking at our objectives here, we want to identify effective biosafety practices that strengthen our laboratory systems, and advance laboratory safety, and examine the biosafety concepts that apply to conducting risk management when performing laboratory activities.

And we're looking at the risk assessment process I know you're familiar with because this diagram represents that process in which we look at the hazards that we face in the laboratory. And while it's a circle, it's very fitting because it doesn't have a beginning and an end. It's a continuous process.

So as you see on this slide, we're looking at risk and then the mitigation of risk. And vaccines come into play in that mitigation of risk. There are several mitigation control measures that we consider in risk mitigation in the biosafety program, engineering controls, of course. Using any biosafety cabinet or using biosafety level 3 as opposed to biosafety level 2 is very common.

And of course, administrative policies and controls on the policies we have in place for vaccines, for example, and the practices and procedures we have in place to offer vaccines to those in our laboratory to effectively reduce risk. And of course, the lowest level of control measures is PPE, the personal protective equipment.

So in our mitigation toolbox, some of the tools that we have for every laboratory is the vaccination program that our facility offers. Of course, that goes along with biosafety training, competency assessment, and other tools that we use every day. So these all support our mitigation efforts in the laboratory.

The role of the vaccine is really important to consider because based on your risk of exposure, your risk assessment process that you've identified that risk of exposure to various microbial agents that you're going to encounter in the laboratory, there may be an available effective vaccine to use. And the laboratory biosafety plan should include recommendations for vaccination of individuals with the potential of occupational exposure.

And we'll talk about how you have to work with occupational health in determining what vaccines are appropriate to offer. So in determining that vaccines that you're going to offer, you look at your risk assessment and what you encounter, which hazards you've identified, and the work that you perform in the facility. So every facility is different to some extent.

So what vaccines should you even consider? The Advisory Committee on Immunization Practices recommends that all adults receive influenza, the measles-mumps-rubella, MMR, varicella, tetanus-diphtheria-and-pertussis vaccines. Those are recommended for everyone. Now, some individuals because of their risk of occupational exposure are recommended to receive meningococcal vaccination.

And we'll talk about that more in a case study. Other vaccines that you might want to consider for laboratory risk of exposure to Salmonella typhi, typhoid fever. And we'll talk about that today. Of course, the anthrax vaccine for someone who may be working with that pathogen.

So it's all based on the employee's risk of exposure to it during their routine functions of their job. So in other situations, you have to consider special case situations, like working with rabies virus or doing necropsies, et cetera, to identify rabies infections. Smallpox is another one vaccine may be considered.

Now of course, for those individuals whose work activities place them at risk to exposure to blood and body fluids, OSHA says that we all need to receive the hepatitis B vaccine. It's required. It's an OSHA standard.

So let's start with the hepatitis B vaccine. So it's recommended for anyone at risk of exposure to blood and body fluids. And the vaccine series must be made available before that employee begins work at their assignment that places them at risk of exposure to the blood and body fluids, unless that employee previously received the complete series of the vaccine, they have antibodies to hepatitis B surface antigen, so they're either immune or they were immunized, or for some reason, the vaccine is contraindicated.

So it's a series of three intramuscular injections. And you've probably been through those. And there's also a two-does version as well. The first dose is followed at a minimum of four weeks by a second dose, which is then followed eight weeks later minimum by a third dose. So 16 weeks at least between the first and the third dose.

So then after they've completed the series about one to two months later, you test them for anti-HBs, the surface antigen, to make sure that they have responded to the vaccination. Now, some individuals will not be able to make antibodies that are detectable even after multiple attempts at the vaccine series.

We really don't know if those individuals are at risk of hepatitis B infection if they are exposed. But no one's really going to do that experiment to really see if they acquire the infection. But if they do get exposed, then they would go through the process of post-exposure prophylaxis.

The next one that we want to look at is the tetanus-diphtheria-and-pertussis vaccine, Tdap. It's given to all adults who have not been previously vaccinated or who didn't get the disease naturally. It can be administered regardless of the interval since the most recent tetanus or diphtheria toxoid-containing vaccine.

So adults with an unknown or incomplete history– and we'll probably be running into this with vaccine hesitancy being more widespread than it was in the past. So some individuals joining our laboratories may not have been vaccinated in the past for these. But it's a three-dose primary vaccination series.

And it should begin or complete on primary vaccination series, including the Tdap dose. So unvaccinated adults, you can administer the first two doses at least four weeks apart and the third dose 6 to 12 months after the second. So the next one we want to look at is the MMR, measles-mumps-rubella, vaccine.

So this has been recommended for all adults born 1957 or later with no evidence of vaccination or evidence of previous infection unless they have some medical contraindication for the vaccine. So you can test them for evidence of immunity. Or you can just repeat the dosage.

It contains a live virus. It should not be given during pregnancy, or if the employee is immunocompromised, or has some life-threatening allergic reaction to any of the components of the vaccine, or if the employee has recently received blood products, or is moderately or severely ill.

So let's do our first knowledge check, just to see if you're there and following. Which vaccine of the list does OSHA require to be offered? We are starting with an easy one. So I see we have 27 participants here. So we'll stop it here and share the results.

17 people chose hepatitis B vaccine, which was the intended response. One individual chose the MMR. So as you can see, the correct answer that was intended was hepatitis B vaccine. So going on to the next slide, let's look at where we get data for in selecting a vaccine.

Now, in the– oops that popped up again. In the U.S., we do not require reporting of exposures and incidents in the laboratory or lab-acquired infections, as you all know. But in Canada they do have a program and it dates back to 2016. They do surveillance on an annual basis of laboratory exposures to human pathogens and toxins.

And you can find it posted on their web page. So for calendar year 2022, they had 145 reports of laboratory incidents in Canada. And they had 40 that were confirmed laboratory exposures and two suspected lab-acquired infections. So the incident rate was 3.8 per 100 active licenses that they have in Canada.

The most common agent involved in exposure incidents was Neisseria meningitidis. They had five incidents representing 11.6% of their reports. So very interesting and very helpful to us here in the United States that they collect and publish this information. I always look forward to reading their findings.

And that led me to think about Neisseria meningitidis some more. We know that requires a BSL-2 laboratory to work in. But using BSL-3 practices, a biosafety cabinet to protect against aerosol and droplet exposure is what's recommended. Now, we know from past experience that 12 out of 32 lab-acquired infections with Neisseria meningitidis were fatal in laboratory techs preparing a suspension or doing a catalase test on the open bench.

And the U.S. CDC estimates there's about 3,000 isolates of Neisseria meningitidis per year. That's just an estimate. And the attack rate then is probably about 13 over 100,000, making laboratory techs way more susceptible than other adults in the same age group. And the age group they refer to is 30 to 59. So working at a biosafety cabinet it's extremely important.

Looking at this article by Sejvar from 2005 in The Journal of Clinical Microbiology, where they looked at cases of Neisseria meningitidis and laboratory-acquired infections from 1985 to 2002. And they didn't have all the ages of the patients. But they had the various serogroups. And as you can see, they've listed whether the person had a fatal outcome or survived the infection.

And there were a large number of fatal outcomes in this particular publication. So it tells you that Neisseria meningitidis is a huge risk for microbiologists. And having a vaccine is great. But until 2014, we didn't have a vaccine for Neisseria meningitidis group B. But now we do.

During a risk assessment for working with Neisseria meningitidis in the laboratory– and that would be the place to start– we know it's highly pathogenic. It causes very severe disease. It can be lethal. The infectious dose is low. And the transmission is through inhalation of aerosols. So those droplets that we create during our work are so important to protect against.

Looking then at when we're working in the laboratory, we're usually working with a high concentration the organism from a culture, where we've amplified the number of organisms. Working just with a sample say of spinal fluid that you're working with is a lot less risk than working with a culture plate, where you've amplified the organism. And of course, the volume you're working with makes a difference.

And what you're doing makes a difference on the benchtop. You could be preparing a Gram stain, for example, where you take a loopful of the organism and suspend it in saline. As you make that suspension, you're creating droplets, which you can be exposed to. And continuing with that risk assessment, you have to think about others in the laboratory as well.

They're at lower risk than those who are actually manipulating the agent in the laboratory. So you have to consider the individual susceptibility of the staff member. Have they been immunized? Are they immunocompetent? Are they immunocompromised, which would place them in much higher risk? And there is a vaccine available, as I previously described. And yes, there is treatment available.

But the disease can cause very serious sequelae, including the loss of limbs, for example. So even though there's effects of treatment, it's still a moderate to high risk from your risk perspective. So let's look at this case.

This situation was from April 27, 2012. A microbiologist in California, 25 years old, onset of fever, headache, neck pain, stiff neck. And next morning, they were transported by ambulance to the emergency room. And he lost consciousness.

On arrival, they noted a petechial rash and treated with ceftriaxone. And he went into respiratory arrest. And he died within three hours. So very quickly succumbed to the infection. In less than 24 hours from the onset of his signs and symptoms, he had passed away.

So the most likely cause, of course, you're thinking Neisseria meningitidis. And that's what I'm describing in this section of the talk. You can find this whole article from an MMWR from 2012. What is known about this case was there's probable aerosol transmission from what he was working with in the laboratory.

They did state that the safety training was inadequate. And they used multiple pieces of equipment that would cause droplet formation, like a plate spreader, a plate scraper. He flamed the loop instead of using disposable loops. And there was a pipette involved. The occupational practices in the lab, they used PPE. There was a lab coat. And they wore gloves. And they worked on the open bench when doing this work.

Now of course, you would recommend based on your risk assessment that they work inside a biosafety cabinet, so BSL-2 plus practices, replace that flame sterilization of a loop with a disposable plastic loop, use disposable closed front lab coats and eye protection because splash or splatter into the eye can cause you to acquire the infection as well.

Double gloves are a good practice, where you dispose of that outer glove when you you're leaving the biosafety cabinet. And of course, have an improved biosafety training program.

So the meningococcal vaccine should be part of the recommendations as well. So microbiology staff working with Neisseria meningitidis cultures should receive a single dose of meningococcal vaccine and repeat that dose every five years. And where at high risk, you could use a single dose of MCV4 and receive a booster dose every five years, if they remain at increased risk, according to MMWR November 2011.

And MCV4 is quadrivalent. It's a conjugate meningococcal vaccine. There's also MPSV4, which is a polysaccharide meningococcal vaccine. And that can be used in persons greater than 55 years old. Whereas the conjugate is through age 55.

Now there is the new MenABCWY vaccine, which may be used when both MenACWY and MenB are indicated on the same visit. And that's per an October 2023 ACIP recommendation. So they became available in 2014 the MenB vaccine. So this now covers the common serogroups that we face in the clinical laboratory.

And those who haven't been vaccinated before, can now get vaccinated with this new strain, or if they were just getting the MenB to complement what they've already received. So that's a good thing to consider. Another vaccine to consider is typhoid fever.

And this is a case of typhoid fever that was due to a laboratory-acquired infection. And they confirmed this infection by being the same as what the patient was working with in the laboratory by sequencing. This is a case from the Netherlands that was reported in Diagnostic Microbiology and Infectious Disease.

What we know from this case is the technician was seen in the emergency room with fever of unknown origin. The blood cultures were collected. And they grew a Gram-negative rod within 36 hours. So they identified it as Salmonella species. Then they did a stool culture on the same individual. And that was positive for Salmonella species as well.

Now, the clinical microbiologist had 16 days prior to the onset of symptoms performed a serotyping of Salmonella strain in the laboratory. And they found that the strains that the clinical microbiologist was infected with were identical to the index case by whole genome sequencing.

That index patient had recently traveled to India, where it's assumed they acquired the Salmonella typhi. The occupational practices in this lab didn't reveal any major breach of practices. So the case really demonstrates the need to be aware of the risk of laboratory-acquired infections. And the laboratory did not offer typhoid vaccine to staff.

And this patient was not immunized for typhoid fever. They used BSL-2 practices, which would be consistent with CDC recommendations since there was not a significant risk of aerosols. But if you look a little more deeply at this, Salmonella typhi does have some risk for those of us in the United States.

The CDC estimates that there's about 5,700 infections with Salmonella typhi annually in the U.S. and about 620 hospitalizations. This map here is from 2020. And the darker blue is from 26 to 50 cases in the year. And the lighter is 11 to 25, and as you can see as it goes down there.

Now, some areas of the country have had no cases at all. And I think that that's something to consider in your risk assessment process. If you're not expecting to see the case, there's always that potential. But if you've seen a number of cases every year in the 26 to 50 range, I think you'd want to seriously consider offering it even in the 6 to 10 range.

But that's something that you have to make decision what's your reasonable risk that you can tolerate. It's an interesting vaccine. It needs a booster every two years for the injectable form and every five years for the oral vaccine. So it is recommended for those who work with Salmonella typhi.

Let's take a poll here. We didn't identify the likely risk in this case through the investigation. But what would you think would be likely risk for someone? Could it be handwashing, insufficient training, surface contamination, ineffective disinfectant, possibly cell phone use in the lab? What would you rate as the highest risk?

So I'll give you a little bit of time here. So sharing the results. And you can see that it's spread out because all of these are possible. Ineffective disinfectant could be if they had the mixed disinfectant up daily. They may not making the right concentration. But I agree. That's probably low. Handwashing and cell phone use and surface contamination are the big three.

So thank you very much for those responses. Let's go on then. So you've had a case of an incident in your laboratory that resulted in an infection. You definitely want to repeat that risk assessment and go back and see what you need to consider to protect others in the future.

And you also want to consider repeating it under different circumstances as well, like after a lab move, or a change in personnel, or change in consumables, et cetera. So on a national basis, if Salmonella typhi became more widespread, you want to consider that as well. So there's a lot of times when you need to repeat that risk assessment.

Now, I want to talk a little bit about special circumstances and vaccination that we need to consider. And the four I want to cover today are anthrax, smallpox, rabies, and Ebola. Anthrax vaccine, I remember receiving this one myself around 2003. And that was being provided and recommended for public health laboratorians at that time because of our risk of exposure after the 2002 anthrax attack incidents.

So they were giving pre-exposure vaccination to public health laboratorians. And vaccination was being offered for anyone working with clinical Bacillus species, isolates, or unknown powders, or who may be involved in processing environmental specimens as part of a biothreat response. So that is a good vaccine to consider. And I know many people have participated in that vaccination program.

Another one to consider is a smallpox vaccination. They use live vaccinia virus for this. You have to take precautions with this because being a live virus, it could be spread to other individuals, of course. And smallpox vaccination was required for all laboratory personnel who work with variola-specific PCR testing and also for personnel who could be involved in processing specimens referred for possible smallpox testing.

And personnel who decline vaccination are not permitted to perform variola testing or specimen processing. So it has to be given to laboratory workers who directly handle cultures or non-highly attenuated vaccinia virus. When we faced monkeypox the summer before last, we were happy that we had staff who were vaccinated for smallpox, so they can safely handle mpox.

So I wanted to call your attention to the change in pre-exposure prophylaxis schedule that ACIP put out in 2022. And this article can be found in Morbidity and Mortality Weekly Report. Rabies vaccination is required for all employees working in areas where rabies virus testing occurs, so public health laboratories, veterinary diagnostic laboratories, where they do animal microscopy or they're working doing direct fluorescent antibody staining, they're working with any of those two areas and have a risk of exposure to rabies virus.

They need to be vaccinated. Two doses are given intramuscularly on day 0 and 7. And then the change in the recommendation– we used to check titers every three years. They changed it to every six months and then get a booster if the titer is less than 0.5 international units per mL. We moved it to six months because cases have been identified, where people three years were found not to have any detectable vaccine.

And you don't when they went to a level of undetectable for the vaccination titer. So you want to go there and check them more frequently. It's very distressing. And I know we had one person in our laboratory who did not have a detectable titer. And that was very worrisome for them, as they thought of what they had performed in the laboratory and didn't have a detectable titer.

So it's very worthwhile to add this to your biosafety plan to check titers every six months.

Ebola vaccine, ACIP recommends the use of this vaccine, Ervebo, FDA-approved, this live attenuated recombinant vesicular stomatitis virus vaccine in which the gene encoding for the glycoprotein of VSV has been replaced with a gene encoding for the glycoprotein of Ebola.

It's the Zaire strain. And so healthcare workers have designated Ebola treatment centers or laboratorians working in BSL-4 labs, it's recommended that they receive this vaccine. So let's do a polling question. With regard to your organization, do you have an in-house occupational health service program? Or is it a contract service? Or do you have other occupational health resources available to you? Or you do not have occupational health resources for your third choice.

OK, let's share the results. OK, most people have it as a contracts service. Four of you have it as occupational health service in the facility. And four of you don't have access to occupational health resources. I've had it both. Here at the university, we have the occupational health resource available to us. But I've also worked in a laboratory, where we had it available as a contract service.

So I think it's very important to consider. And especially those of you who do not have this resource, to see if you can't convince administration to make that available to you.

The other vaccines to consider. Working in shared workspaces, as we do in the laboratory, it's very important to consider transmission among us. And I know I've seen this multiple times through the years. It became very predictable, especially when winter sets in.

We all get exposed to viruses whether in the workplace and outside the workplace. Or we can bring it to work. And especially laboratorians and other healthcare workers, we're not always very good about staying home when we could be infectious because we feel that commitment to getting the work done. But it's very important that we consider protecting ourselves and our coworkers.

So all employees should be offered the influenza vaccine through their annual facility-wide immunization clinic or through a employee's private healthcare provider. I think it's really excellent that that's available to us. And we should now also consider SARS-CoV-2 and RSV. Personally I've gotten my influenza and SARS-CoV-2 already this year. I need to get my RSV very soon.

So one of the things you have to consider when looking at vaccination is the ethical considerations for mandatory vaccination. It's very rare for laboratories other than for hepatitis B vaccine to have an absolute mandate that you have to be vaccinated. This particular article looked at the ethical and organizational considerations of mandatory COVID-19 vaccination of healthcare workers from the laboratory's perspective.

So you have several listed here as seven compelling reasons. The patient safety concerns because many of us who work in a laboratory work with patients, whether it be drawing blood or other activities that put us in contact with patients. So as the least restrictive approach to achieving patient safety. And you need to have an opt out criteria, whether that's based on religious beliefs or medical contraindications if you're going to have a mandatory system.

And there have to be alternative methods for preventions made available too. Maybe it's PPE, like wearing a respirator, N95, or reassignment so that they don't expose others. New employees should be informed of policy and consequences of noncompliance. And mandatory vaccination policies need to be transparent. And there should not be any expense to the employee. It should be no cost to the employee and easily accessible.

And a lot of studies have been published, especially in the infection control literature. When the vaccine is brought to the individuals on the floors, they have much better compliance than if they have to find time to get away from their patient care activities or other lab testing activities and go to an occupational health clinic and get vaccinated.

So my polling question for you is, what vaccine does your organization offer routinely? And you can have multiple answers here, of course. OK, getting some responses now. Oh, this is really interesting.

So let's share the results. And as you can see, by far influenza followed by COVID, and then meningococcal, and Tdap, and MMR. No one offers the typhoid on today's presenters. We haven't offered it here in Iowa either. We've looked into it and asked people about it. But there wasn't any interest.

But that was probably a decade ago. And so I think we need to look at it again. So let's stop sharing. And thank you for those responses. Well, I wanted to conclude then with this portion, the didactic portion, with saying that I hope you recognize that vaccines are an important part of your organization's biosafety plan and contribute to the culture of safety for the laboratory.

And on your roadmap for your biosafety program, you see that stop two for mitigation. You would select it. And stop six, occupational health program. And of course, your training and education should include information about vaccines as well. And vaccines can then contribute to creating a really good culture of safety in your laboratory.

OK, is there any questions in the chat before I move on to the next portion of the program that I should handle?

Aufra Araujo: Yes, so thank you so much, Dr. Pentella, for the presentation this far. I'm excited about the case discussion. But I've been monitoring the chat. And there is a question and a comment. So the first question is from Erin Bowles. And she's saying, is there any data on Neisseria meningitidis LAIs related to use of MALDI for identification if the organism is spotted and prepared for MALDI BSC? What method of ID is recommended if MALDI shouldn't be used? This is a question she has been asked recently by a clinical laboratory. Would you like to discuss that?

Michael Pentella: Sure. Thank you very much for that question. MALDI is a really good example because you want to do all you can to prevent exposure. So you have to be working with the plates and preparing the method inside of a biosafety cabinet. And I would also do the tube method instead of the spot method. That would reduce your risk of exposure as well.

And then putting it on the MALDI itself, that's a closed system on it. So I would feel safe putting it on the MALDI. But then you also– and I'll add to this. We also have the challenge because in the public health lab, we want to sequence our isolates as well. So we've gone through the process of killing the organism before it goes to sequencing.

So we go through the kill step, and then the extraction, and then the sequence to protect the next individuals who will be handling that sample. So that's what I would do.

Aufra Araujo: Perfect. Other comment from Cathy Moore. She said, the tricky question here is the cost. What our organization offers and recommends are two separate questions. So there is the offering of vaccine, and then the cost of vaccine.

Michael Pentella: Yes, there's a significant cost to have a vaccine program, particularly if you're doing a contract service for this. And I would weigh the cost as a value added in my presentation to administration because you're enhancing the biosafety program and doing more to create that culture of safety.

So you know that if you have an exposure and in the worst case scenario you have a fatality, the cost of that would be huge. And we know that occurs with Neisseria meningitidis, for example. So you're balancing that against the cost of the vaccine. And I think even the cost of follow up to an exposure was a lot greater as somebody who has not been vaccinated versus somebody who has been vaccinated because you're going to then have follow-up appointments, lost time at work, the time it takes to record all the information for the follow up.

All that is going to cost you a lot more. So it's a matter of a balancing act. Yes, it is costly. But it's more of an investment in adding value to your safety program.

Aufra Araujo: Those are very important points to justify for when needed why that would be relevant.

Michael Pentella: Yes. Good question.

Aufra Araujo: All right, the other one – Kayle Cirrincione wrote, I know it's not vaccination. But the question is, what are your thoughts of requirement of TB testing for exposure in a TB lab?

Michael Pentella: Yes, that's a really good question. And I would adhere to the practice of testing regularly for TB exposure. Whether you do a PPD or doing an interferon gamma release assay, that's up to your facility. But I would suggest that you have people tested at least annually, and if you can, every six months would be a good idea, depending on how much TB you see in your facility.

That risk assessment process again, how much of the hazard do you run into in your facility? I know when I worked in a clinical laboratory, we tested everyone on an annual basis. And we found even a positive in at least two people that I can recall. And they were both very experienced individuals who had excellent technique.

So it was very beneficial because otherwise, you risk the individual later in their lifetime coming down with the TB infection and not detecting it versus detecting a latent infection in somebody who got exposed in your laboratory. So thank you for that question because it's really important to consider TB screening for your laboratory staff.

Now, as far as vaccine, we don't offer that to laboratorians in the US. It's not recommended. But it was discussed at one time when in the early 1990s, we saw a resurgence of TB that was associated with the HIV epidemic. And many of us were seeing more TB cases than we had in the past. So good question. Thank you.

Aufra Araujo: One more question from Marcia Pindling. I find that accidental exposure from Neisseria meningitis occurs late at night. And lack of experience with the organism or limited time workload increases the risk of misidentified Gram staining results. It's just a comment.

Michael Pentella: Yeah, that's a good comment too. If they're only working with a sample, say a CSF, I think I mentioned I don't get too concerned about that because of the small number of organisms in that sample. It's working with the amplification from culture. And all the cases were actually working with cultures. So that's good to remember.

Aufra Araujo: OK and Marcia says, misidentification of Gram staining results often precedes MALDI ID. I don't know. I'm not an expert in this area. But any thoughts, Dr. Pentella?

Michael Pentella: I'm not quite sure I caught that. Could you repeat it for me please, Aufra?

Aufra Araujo: Yeah, I'm not sure if I'm understanding the way it was written. Misidentification of Gram staining results often precedes MALDI ID.

Michael Pentella: Oh, I see. Some people are just taking the organism and putting it on the MALDI without even thinking if it could be a Neisseria meningitidis. And that's a really good point. And I've heard this said at meetings too, that the laboratorians like the MALDI because you don't have to think so much about what the morphology of the organism is and what it could be.

You just put it on the slide. And the MALDI will identify it for you. And while that makes life easy for you, it doesn't make you safe because you need to be thinking what the organisms can be. And I hope we don't lose that as we're training individuals to work in the laboratory because we should be training people to think about what the organism could be and what safety precautions I need to take to work with that organism.

Aufra Araujo: That's right.

Michael Pentella: So thanks for that comment.

Aufra Araujo: OK, I think we got all the questions in the chat. And maybe we can go ahead and start with the case discussion.

Michael Pentella: Thank you, Aufra. I'll move to the facilitated discussion. And I hope you're seeing this part. So what I've created is a situation. And then I have seven inserts to give you as well.

And with each situation comes two questions for us to discuss the situation. So this is a laboratory in a large metropolitan area. And they see a lot of international patients because they have a lot of large teaching hospitals. So some of you who know me know I used to work in Boston for the state of Massachusetts at the Massachusetts State Public Health lab.

And I was thinking of that when I wrote this. So we got a lot of patients there. And they came to the United States for treatment. And they would come from many global destinations. So you're the new biosafety officer to this laboratory. And there's been a long gap between when the last biosafety officer left their position and your starting.

So one of the first questions you receive from a staff member is about the need for influenza vaccine, which gets you to thinking, what vaccines do you want these folks to receive? And for our discussion, I thought we'd start with, where do you start for your considerations? Four vaccines are needed. And what information do you need to make your recommendation for vaccines?

So any of you like to get on camera and get off mute and tell us your thoughts? Or type them into the chat. And I will open the chat so that I'm reading it as well.

Madison Moore: Hi. I'm Madison Moore from the Utah Public Health Lab. I think it would be good to start and see where your patients are predominantly coming from and what diseases are prominent in their countries. And/or what diseases are you routinely identifying within your own laboratories?

Michael Pentella: Yeah, that's an excellent starting point, Madison. I think you would get that data from likely the reportable disease reports because they still need to be reported to the health department. Even though the resident wasn't necessarily a resident of that community, it'd still be reported.

So starting with that would really help you to see where you're going to need– what vaccines you're going to need to think of based on the past experience. How many years back would you go in looking at the data? And this is purely arbitrary. 10 years? Yeah, 10 years would be a good choice, going back 10 years.

So get the past experience information and then determine what vaccines you need to offer. And doing a site-specific risk assessment, that's a really good place to start. And identify the hazards of the lab space. Good places to start. And positivity rate of clinical samples coming in, excellent information.

So you're acquiring this information. And who are you going to talk to? Who would you consult with? Well, I would talk to the staff because they'll tell you what they've been seeing, especially the folks that have been there for a number of years. They'll share the unusual cases with you and help you know what's been happening.

So let's go to the next insert. So I want you to know that the lab tests human samples. But I think you already figured that out. Now, what is the first vaccine that everyone is required to have? And how will you select other vaccines that are going to be offered? So I think we've answered that. Hepatitis B, yes. Those who typed that in, thank you.

And now you're going to select the other vaccine. So beyond the laboratory staff themselves, who should you be in consultation with here on selecting other vaccines? And you guys talked about this. We're not going to do rabies testing at this lab. This is just a clinical lab.

Yes, talking to occ health. That would be really important if you have access to occ health. And I'd also at this point let your administration know whether you're reporting to the director, which is likely or biosafety officer. Let your director know that you're looking at the vaccines so that they're not going to be surprised or hearing about it from other staff.

Yes, as Kayle commented, some vaccines need to have a vaccinated person to give it. Yes, live attenuated vaccines particularly. So let's look at insert number two. So you start with the risk assessment, which you guys had identified, and review the hazards in the lab, which you mentioned, and then think about what's reasonable to encounter because you can't vaccinate against everything in that you might risk entering into your facility.

For example, if you're not an Ebola treatment center, should you really be offering Ebola vaccine? So what data will you need to do your risk assessment from? And what governmental agencies could be of help? CDC, that's a good resource.

And I'm thinking more local. Your health department, yes. The local health department should have really good data for you. So connecting with the infectious disease specialists, the epidemiologists at your local health department will be really great for this situation.

Let's look at the next insert then. So the lab has multiple sections, chemistry, hematology, micro-immunology, urinalysis, toxicology. And let's not forget the people in sample receiving because too often they get neglected. So you're going to need to have risk assessments. Maybe they've been previously done. But you at least need to update them because it's been that gap since the last biosafety officer and you joining this laboratory.

So based on your risk assessment, you're going to look at likely mitigation tools. And what data and information do you need to determine the vaccines? We've covered that pretty good in this. But repeating that risk assessment would be very helpful to you in this situation.

I'll go on to the next insert. So this laboratory has a contract with an occupational health clinic. And it's located off site. When would you contact them in this procedure? After you've made your decision or do you want to partner with them? What do you guys think?

Those who have contract services, what do you typically do? Medical questionnaire from staff. That's a good thing to have. But I'm thinking the occupational health clinic, how are you going to contact them? When would you contact them rather?

Preemptively, yeah. I think that would be the best approach. You want to engage them now so they can be thinking about what you're thinking of. Maybe they have other clinical labs in the community that they offer contract services to as well. And they can know what's common to be offered so that they can get with you and make sure that you're offering what's most appropriate.

So what services will you look for from that occupational health clinic? Well, they may need to acquire the vaccine, right? How would you handle that? In the past, we looked for them too. Fit for duty, yes. They actually sent someone to the laboratory to give the vaccines.

So they sent a nurse practitioner to us who could deliver the vaccine and give the injections. And that was very helpful as well. And when we do the– even though we have occ health as part of the university, when we do our influenza clinic on an annual basis, they come to the laboratory because we have about 200 people working here. And it's way more convenient rather than us going to another site.

When there was COVID available, we had to go to another site to get our COVID vaccines. Discuss with occupational health what you want them to provide and what they can do. So now, this laboratory has a biosafety committee. And it has a charter. And it meets monthly.

And I really recommend that you have a biosafety committee. It's extremely helpful. The biosafety officer can co-chair the committee, which we have our biosafety officer co-chairing with our chemical safety officer. And the committee will review the policies and procedure and make recommendations.

They also review all the lab exposures and other incidents. So what do you see the role of the committee in the selection of vaccines? Would you bring this to them? And what actions would you want them to take?

So what do you think? How are you going to engage your biosafety committee? Because hopefully, they're not just meeting and never talking to others about safety in the institution. Risk assessment review, that's a good comment, Madison. They could be doing a risk assessment review. Providing a service on the pathogen and services. Yes, that would be excellent as well.

So I also would like to see them really engaged in the selection of vaccines so that they can be proponents to others saying that the safety committee looked at this. And we think it's a very good idea that our colleagues receive this vaccine. Of course, it's ultimately the individual's decision.

But if they are part of that selection process and then be proponents with the staff of getting vaccines, it will help overcome any vaccine hesitancy that there might be out there. And there is vaccine hesitancy. I know that our rate of influenza vaccine is nowhere near 100%.

Looking at this insert, you observe the conversation with some staff that the knowledge level regarding biosafety is minimal. So before employing the vaccine program, you need to make it a success. So as Marcia commented, providing in-service on the pathogens and the risk is a really good answer to that question to make it successful.

And so what other tools would you provide besides an in-service to help staff accept the vaccine program that you're establishing? How are you going to communicate with them besides an in-service?

I'll give you one idea that we use. We have a weekly message of the week that goes out every Monday morning. So if we want people to be aware about influenza and COVID vaccines, for example, we put that in the message of the week and the value of the vaccine. We sometimes put biosafety messages in that.

Another tool that we use is we have an all-staff meeting. And the biosafety officer presents about pathogens at the all staff meeting and can talk about the vaccine program at that time. So however you can communicate, whether it be signage, whether it be messages and emails, whether it be an in-service, use those tools available to you.

And then the last insert is there was vaccine hesitancy. So it's a well-known problem among healthcare workers, including laboratorians. So it has the potential to be very detrimental to your vaccination program. So how are you going to deal with vaccine hesitancy?

So we've talked about the messaging. And how can you deal with vaccine hesitancy? So any other thoughts here? Discussing the risks of being unvaccinated, yes. Pointing those risks out. And also pointing out the safety of the vaccines. Finding out why they are hesitant, engaging them in conversation, allowing them to express their concerns are all very good ideas.

Well, open door policy, yes. Excellent idea. I wanted to call your attention to a website. The APSA International website has a database of laboratory-acquired infection articles and a really huge database. There's 590 lab-acquired infections listed. 120 of those are clinical labs. And 22 involve fatal cases.

So excellent resource that you can go. And you can look up, type in the search. If you wanted to look up Salmonella typhi, just look that up and search. And all the articles involving Salmonella will come up. And so I think it's a really good resource for you as biosafety officers. And I'll take any more questions. I think you have a wrap-up discussion by Sabrina next. Correct, Sabrina?

Sabrina DeBose: Yes, that is correct. Let me come on camera.

Aufra Araujo: While Sabrina is coming up, thank you so much, Dr. Pentella. This was an excellent presentation and discussion. I think you can stop sharing these slides at this point.

Michael Pentalla: There we go.

Aufra Araujo: Perfect. And I'd like to invite Sabrina to share briefly a summary of the discussion today. Sabrina.

Sabrina DeBose: Yes. Can you all hear me OK?

Aufra Araujo: Yes.

Sabrina DeBose: All right, so first, everyone, we want to say thank you for the robust discussion today regarding the laboratory professional vaccine compliance and effects on safety. So let's see. I will provide a summary of just the discussion points of individuals coming off and speaking, and also comments that were in the chat.

We received excellent responses from the four poll questions regarding OSHA and vaccines, the likely risk at your facility, your organization and the use of occupation programs at your facility. Some of the responses were, you do have access. You have in-house resources. Some are contracted out to a contractor.

And in the poll we also heard where some did not have access to the occupational health program. During the poll, what vaccines were offered? The most common ones that you all responded to were influenza, COVID, rabies, and Tdap, as well as MMR. Additional discussions regarding the cost of vaccines. There were ways to cover the costs is to look at it as a value-added factor to the administration.

It's a matter of balance. It's a matter of having that balance act of adding that safety component to your program. The other comments were on TB testing. You want to consider TB testing. And make sure it's conducted at least annually, if not every six months. You want to also consider the hazards that you may encounter in your facility, if you are choosing to incorporate TB testing.

Another discussion was on MALDI. And the comment was misidentification of Gram staining results often proceed MALDI ID. Dr. Pentella suggested that some individuals are placing the strain directly on the MALDI without identifying the morphology, which could result in unsafe practices at your facility.

During the case discussion, some of the comments were– well, I'll give you an example of an overview of the case discussion. The new biosafety officer coming in suggested that you ask questions. Some of the comments were, in order to figure out what's going on, you should conduct a site-specific risk assessment. You want to identify the hazards that are in that particular laboratory space.

Have that conversation with the occ health program individuals at your facility. You want to also reach out to the administration to let them know that you're looking at the vaccines. Have that connection with infectious disease specialists at your local health department as soon as possible.

You want to engage your biosafety committee by getting them involved with risk assessment reviews and engaging them during the vaccine selection. When engaging with the staff about vaccines, you want to communicate the importance about the value of being vaccinated, such as holding meetings, email communication, and signage in order to get that message across.

Another way of addressing vaccine hesitancy is to find out why the individuals are hesitant, having that open door policy to answer any questions, and also allow staff to discuss their concerns. So Dr. Pentella, that was an overview of the discussion. I would like to turn it back over to you in case there's anything else you would like to add.

Michael Pentella: Well, thank you for covering that so thoroughly, Sabrina. I think those are excellent points. And I'm looking through the chat. Maybe one thing that we didn't cover as well was the question about the MALDI because when I looked at that, I had a second thought. And let me go back to that.

I'm trying to find it, sorry. No, can't find it in the list on there. But my thought was on that. As you said, allow people to do the Gram stain. But sometimes they misinterpret the Gram stain. And misidentification could occur. And that's what the poster, Marcia, was saying.

Incorrectly reading the Gram stain can result in exposure. And that's something that I would advise people it can occur. And you have to make sure that people are experienced at reading the Gram stain. But it's a good example to use why people should consider getting the vaccine so that they don't risk an accidental exposure from misidentifying something or misinterpreting something that they're doing in the laboratory. So it's another reason to get vaccinated.

Aufra Araujo: Thank you so much, Dr. Pentella, for an excellent presentation, and for the summary, Sabrina. I also would like to thank all participants for taking part in a discussion. This was clearly a topic that was needed. And you waited a whole year for this presentation.

So thanks. Now I would like to talk about the post-session survey. In the chat is the link to the survey for today's ECHO session. It will take you directly to the Qualtrics survey. So this survey should take no more than two minutes to complete. And your participation is voluntary.

Previous survey feedback has greatly contributed to session improvements throughout this year. We appreciate your time in completing the survey. If you have any questions about the survey or the ECHO Biosafety sessions, please reach out to us at dlsbiosafety@cdc.gov. This session marks the final ECHO Biosafety session of 2023.

We are excited to announce that the ECHO Biosafety sessions will resume in 2024. If you'd like, you can also enter in the chat any suggestions for safety-related topics that you'd like to see discussed in future ECHO Biosafety sessions. You will receive an email message with the details of the ECHO Biosafety sessions in 2024 once we have an official start date.

Please stay tuned for updates. Thank you all for your ongoing support and survey feedback, which have contributed greatly to the success of these sessions. As a reminder, you can access the transcripts, audio recording, presentation slides, and other resource from previous ECHO Biosafety sessions on the DLS ECHO Biosafety website and from today's session as well in a couple of weeks.

Now, we will adjourn. I thank you for attending, participating. And I hope you were intentional about having a fantastic day. I will see you next year if I don't talk with you before then. So thank you so much. We will adjourn now. Bye.