Legionella: An Introduction for Attorneys

Program Description:

On March 5, 2019, at 2:00 p.m. (ET), The TASA Group, in conjunction with industrial hygiene and environmental expert Megan Canright, presented a free, one-hour interactive webinar presentation, Legionella: An Introduction for Attorneys, for all legal professionals. During this presentation, Megan discussed:

• History and statistics
• Fundamental biology of the bacteria
• Regulations, standards and guidelines
• Core competencies for investigator
• Legal aspects
• Case studies

About the Expert:

Megan Canright has 15 years of experience in the fields of industrial hygiene and environmental health and safety. Her primary areas of expertise include occupational and environmental exposure assessment, indoor environmental quality, and the evaluation and control of waterborne pathogens in support of infection control. Megan is also involved in litigation support and oversight for numerous complex litigation claims for both plaintiff and defense attorneys. As a certified industrial hygienist, Megan is also very active in the local and national chapter of the American Industrial Hygiene Association, serving as the 2015-2016 chair of the AIHA Risk Assessment Committee. She is a graduate of the 2011 AIHA Future Leaders Institute and is the chair of the AIHA Future Leaders Institute Advisory Board.

Transcription: 

Rochelle: Good afternoon and welcome to today's presentation, Legionella: An Introduction for Attorneys. The information presented by the expert is not to be used as legal advice and does not indicate a working relationship with the expert. All material obtained from this presentation are merely for educational purposes and should not be used in a court of law sans the expert's consent, i.e., a business relationship where she or he is hired for your particular case. In today's webinar, Megan will discuss history and statistics, fundamental biology of the bacteria, regulations, standards and guidelines, core competencies for investigator, legal aspects, case studies. 

To give you a little background about our presenter, Megan Canright has 15 years of experience in the field of ended industrial hygiene and environmental health and safety. Her primary areas of expertise include occupational and environmental exposure assessment, indoor environmental quality and the evaluation and control of waterborne pathogens in support of infection control. Megan is also involved in litigation support and oversight for numerous complex litigation claims for both plaintiff and defense attorneys. As a certified industrial hygienist, Megan is also very active in the local and national chapter of the American Industrial Hygiene Association, serving as the 2015/2016 chair of the AIHA Risk Assessment Committee. She's a graduate of the 2011 AIHA Future Leaders Institute and is the chair of the AIHA Future Leaders Institute Advisory Board.

Attendees will require passcode. The word for today is Legionella. During the Q&A session, we ask that you enter this passcode into the Q&A widget for CLE reporting purposes. The Q&A is located to the left of your screen. Please remember that if you are applying for CLE credit, you must log onto to your computer as yourself and stay for the full 60 minutes. You're also required to complete the survey at the end of the program.

Please note that CLE credit cannot be given to those watching together on a single computer. Tomorrow morning, we'll send out a link with the archive recording of the webinar. The slides can be downloaded from the resource list at the widget at the bottom of your screen. Thank you all for attending today. And, Megan, the presentation is now turned over to you.

Megan: Great. Thank you, Rochelle, and thank you all for being here. What I'd like to do today is just give a short kind of introductory presentation on Legionella biology. We'll get into some of the standards and guidelines that are available and then talk about some legal implications and case studies for you. I do believe that we're gonna have a question-and-answer session both halfway through the session and then at the end as well. So, we'll try to get to your questions if you have them.

So just some training objectives for you here. We want you to understand just the basic biology of Legionella microbiology and then just general risks that are associated with Legionella growth in building systems. We also want to familiarize you with some of the regulation standards and guidelines that are available related to Legionella. We'll go through those. And then we also want you to be able to identify some of the key elements of a water management program so that risk can be controlled in a given building setting. And then finally, we're going to review the legal aspects of legionellosis and some case studies, just to give you some good examples of how we're dealing with Legionella in the field.

Okay. We're gonna cover some history and statistics first, the fundamental biology of the bacteria, as I said, regulation standards and guidelines. And we also want to get into core competencies for investigators. There's not a lot of guidance out there for what qualifies a Legionella investigator, and so we wanted to give you some thoughts on how to choose an expert and what to look for in an expert. We'll go over some legal aspects and then finish up with those case studies.

All right. So the history of Legionella. The Legionella bacteria has been around probably since before man but it wasn't discovered until 1976. Some of you may be familiar with the outbreak that occurred at the Bellevue-Stratford Hotel in Philadelphia. This is a really beautiful...a beautiful hotel. It was called the "Grand Dame of Broad Street." And it was built in 1904 for about $8 million, which today's equivalent...in today's equivalent dollars is about $227 million. So, a lot of effort and dollars went into making this hotel beautiful.

And in the summer of 1976, in Philadelphia, at this hotel, there was the convention of the American Legionnaires. There were about 4,000 attendees at this conference. As a result of the outbreak, there were 221 cases of illness and 34 deaths associated with this outbreak. And again, this happened during this Legionnaires' convention, which is ultimately why the bacteria was called Legionella.

And so in response to this outbreak, CDC really didn't know what the cause was. There were a lot of initial theories as to what was causing these illnesses. CDC deployed 20 investigators to Philadelphia to try and investigate the cause of these illnesses. There were theories ranging from chemical warfare to nickel carbonyl poisoning to fumes from copy machines and a terrorist attack. So, lots of theories as to what was happening.

And after five months of investigation, there really were no results. I mean, some of the initial conclusions was that it was definitely not bacterial. And so that takes us to January of 1977. So this investigation was going on for some time, not a lot of results. And it was actually Dr. Joseph McDade from CDC who eventually identified and was able to culture and isolate the bacteria. 

So they initially concluded that the cause was a viral agent. The bacteria would not grow on standard mediums. And they attempted to grow this viral particle as they thought in eggs. And this is a common isolation technique for viral particles. But what they found was that it was actually a bacteria. And this bacteria that they identified matched a lot of these samples, the bacteria that was identified in patient samples that were submitted from those who became ill. That was how the bacteria was identified, and as a result, it was named Legionella pneumophila, which essentially means lung loving bacteria. 

And the disease was reproduced in guinea pigs. And guinea pigs are a really good model for lung infections. And then the bacteria was also required unconventional staining methods and specific nutrients in order to culture it. So that was kind of how we discovered the bacteria. There were likely many epidemics prior to 1976, and we just didn't associate these epidemics or these illnesses with this bacteria since it hadn't been discovered yet. 

When the CDC went back and looked at samples that were collected from other clusters of pneumonia, they found that there were several other epidemics that had occurred prior to 1976. So in 1957, in Spam City, there were 78 cases of pneumonia between June and August. In 1965, in D.C., there was a cluster that was identified at St. Elizabeth Hospital that was eventually linked to Legionella bacteria. And then also at the Bellevue-Stratford Hotel just two years prior to this initial discovery outbreak, there were 20 cases and 2 deaths at a Independent Order of Odd Fellows convention at the same hotel. There were likely outbreaks and likely cases of Legionellosis long before we had discovered the bacteria.

So in terms of statistics...and I'm sorry, I have a typo here that I didn't catch previously. But there were 7,500 U.S. cases reported in 2017. So not 75,000, 7,500. And this has increased, you know, when compared to previous years. In 2016, we saw about 6,200 cases. And in 2015, we saw about 6,100 cases. And so we do see an increase in the number of cases that are reported each year. And there are a lot of hypotheses or theories about why this could be happening.

We certainly may have an increased awareness and ability to test for the bacteria. So some new diagnostic capabilities have been seen in the last decade. We may have a higher disease burden. So we may actually be seeing more disease in the population. This could be because our buildings are becoming more complicated, our potable water systems are becoming more complicated. So it could be truly an increase in the number of diseases that we're seeing in the population. 

What we do know is that there's likely underestimation just due to lack of diagnosis and reporting. So, legionellosis is really...at least Legionnaires' disease is really indistinguishable from other pneumonia. It just looks like pneumonia, like any other chest infection pneumonia. And so you can't tell if the pneumonia is associated with Legionella bacteria unless testing is performed. 

So we do think that the true number, the true disease burden in the population is between 18,000 and 25,000 cases per year. So, compared to 7,500 reported cases in 2017, that's a lot of cases that are going underreported and undiagnosed in the population. And that's based on a CDC estimate. This is a graph courtesy of Centers for Disease Control that shows how you can see...you can see really visually here how the number of reported cases have been increasing since the year 2000. 

And so when we compare the reported cases between 2017 and 2000, we see that there's been a five and a half times increase in the number of reported cases. So this is a really important disease for Public Health and something that if we don't control now will continue to increase and we'll continue to see public health impact.

This is another graph that's provided by the CDC. There is some seasonal variability in the reported cases that we see in the U.S. So as you can see here, there tend to be more cases reported in the summer months...spring and summer months and maybe into the fall. There's a lot of theories as to why this might be. Certainly, we think that there could be some association with the cycling of cooling towers or winterization of cooling towers. 

So of course, in the winter months, these cooling towers might be off, hopefully drained, but they may just be sort of stagnant during those winter months when your HVAC needs are not as high. And then as those cooling towers come back online in those summer months as the temperatures get hotter, we may see some increase associated with just cooling towers. That certainly doesn't explain the number of cases associated with other sources, but there could be just again temperature variability that's impacting various water systems that could be associated with this sort of seasonal variability. But we do see that in the U.S.

So in terms of what is legionellosis, there's two diseases associated with Legionella bacteria. And I wanted to just kind of review basically, very basically the science and the general risks associated with Legionella bacteria. Okay. So it's a gram negative bacteria. It's a pathogenic bacteria or at least some of the types of Legionella are pathogenic. And it really survives or it lives in two different forms, a planktonic stage, which means that the bacteria is sort of somewhat dormant but it's in a biofilm and it's sort of associated with other bacteria. So it's stuck in this biofilm within water systems. And then it can also exist in the sessile or free-floating form so that it actually is able to leave the biofilm and travel downstream in water systems in a free-floating form.

And as I mentioned, Legionella has probably been around since before man and it's a naturally occurring bacteria. And it occurs just naturally in water systems. And these systems can be lakes, rivers, surface water, groundwater, and they can also proliferate and amplify within soils. So I say usually in parentheses, but there are some thoughts that Legionella are ubiquitous in nature so they're around. 

We expect to see them, to some level, in water systems. We don't always see them in water systems, but it's not uncommon to find them in water systems. And typically, when these systems are controlled, we see Legionella concentrations in low numbers. So the real risk that's associated with Legionella is the amplification or the growth of the bacteria when these growth conditions are not controlled in various water systems. So we're really looking at amplification and growth as a primary risk and something that we want to control.

In terms of the illnesses associated with Legionella, exposure to the bacteria occurs typically from contaminated mist or aerosols that originate from a contaminated source. So you have a source of water, the bacteria begins to grow in that source of water and then that water that's contaminated with the bacteria is either aerosolized or nebulized into a mist or an aerosol. And those aerosols are inhaled into the lungs by patients or persons that come down with the illness.

There is also some thought that aspiration can occur. So this is essentially accidental choking on either water that's contaminated that patients are drinking or it also could be contaminated ice cubes that patients are chewing on and accidentally choking or aspirating these contaminated sources into their lungs. So once that exposure occurs, you can have two associated illnesses.

There's Legionnaires' disease, which you may have heard of. This is a pneumonia or a lung infection that is caused by the bacteria. And then we also have Pontiac fever. And, Pontiac fever is not an infection. It's thought to be more of a response to an endotoxin produced by the bacteria, and it essentially causes mild sort of flu-like symptoms but again without evidence of infection into the lungs.

And various people are susceptible to these illnesses. Typically, persons who are immunocompromised or have some underlying illness are more susceptible to Legionnaires' disease. And then we do know that even healthy individuals who have no known immunocompromisation are susceptible to Pontiac fever. 

There are different incubation periods associated with these different organisms. And the incubation period is defined as the period between the point of exposure and the onset of symptoms. So that incubation period for Legionnaires' disease is about 2 to 14 days. And for Pontiac fever is much shorter, between one and two days. 

And these incubation periods can certainly change. If a person is exposed and they are on a course of antibiotics that has some coverage for Legionella, then that incubation period can certainly be extended because those antibiotics can have some, you know, efficacy against Legionella, which can extend the incubation period. The incubation period can also be much shorter, especially in persons who have underlying disease like COPD, if they're smokers, etc., the infection can take on symptoms a lot more quickly.

The primary agent that is typically associated with Legionnaires' disease is Legionella pneumophila. Again, this is lung loving Legionella. And it's thought that Legionella pneumophila serogroup 1...we call it Lp1 in our industry. It's thought that that is one of the primary agents or the most virulent serogroups of Legionella...or species of Legionella. 

When we look at the diagnostic tests, the most common screening diagnostic is the urinary antigen test. And this urinary antigen test only looks for Legionella pneumophila serogroup 1. So it's possible that we could have some overestimation of the number of times that that agent causes the illness because we're looking for that agent more frequently. 

There's really no good dose response established for exposure to Legionella in the onset of illness. So the thought is or the theory is, is that even one bacteria could cause an infection and it really depends upon the susceptibility of the host. Certain factors certainly make people more susceptible or less susceptible to getting Legionnaires' disease, certainly the elderly. If someone is a smoker or has some other underlying immunocompromisation, especially something that has to do with the lungs or if someone's undergone a recent surgery or transplant and is immunocompromised or taking medications that suppress the immune system. Those individuals are typically more susceptible to acquiring Legionnaires' disease than otherwise healthy individuals.

In terms of the building systems or the buildings that can be most susceptible to having a Legionnaires' disease outbreak or have risk factors that could lead to the amplification of Legionella, we see this in hotels, hospitals, long-term care facilities, cruise ships. You can probably see a pattern there. Anywhere where there's a collection of persons who might be immunocompromised or have underlying health symptoms or anywhere where you might have a collection of a large group of people in an enclosed environment. And then certainly we think that evaporative cooling systems, things like cooling towers, which produce aerosols as part of their very operation, obviously, those systems might be more susceptible to amplification than other systems. Although we are seeing cases associated with potable water systems than other systems as well.

In terms of the growth conditions, what we're looking at is the source of the water. So if the water comes from a natural source such as a lake or a source that has a high organic load or sediment load, that can certainly lead to growth conditions for Legionella because there's more food available for the Legionella to grow. Low water flow or stagnant water is associated with Legionella growth. Legionella grows really well typically between 95 degrees and about 120 degrees or so. We see a growth range, a wide growth range between 80 and 120. We even see growth outside of that range, but that's typically the area that's...the range that's most susceptible. 

Anywhere where there's low disinfectant residual. So if there's low chlorine residual or whatever the municipality is treating as a disinfectant, if we have low to no disinfectant, that certainly can be associated with Legionella growth. And the presence of commensal organisms such as amoeba. You may remember amoeba from your high school biology class. And Legionella actually can utilize the amoeba to proliferate and grow as a host. So, the presence of those organisms can increase the susceptibility of a water system to grow. And then, of course, the presence of sediment, scale, algae or other biofilms. And these really can lead to, again, a food source for Legionella and a place for a Legionella to anchor and grow within a water system.

Here's just a growth temperature chart that we've put together. And again, you can kind of see that favorable growth range is typically between 77 and 113. It's kind of a primary growth range. And then we have an ideal growth range between 90 and 108 degrees Fahrenheit. There are some guidance documents that disagree with this, but this is kind of what we found has been most consistent among the publications.

And then I just briefly wanna cover some of the regulation standards and guidelines that are available for you. Not all of these...there are some regulations in the U.S., but we don't have...they're certainly not widespread. Most of what we do have is either a voluntary standard or guidelines here. So I'm gonna go through just some...briefly some of these guidelines that are available for you. 

Back in 2015, ASHRAE, which is the Association of Heating, Refrigeration, and Air Conditioning Engineers, published a voluntary standard that was just recently updated last year in 2018. And essentially, what this voluntary standard does is it establishes a minimum risk management process for building water systems. Although it's not an enforceable standard necessarily, there are some, you know, exceptions to that especially with healthcare. I mean, I'll talk about that later.

It's not an enforceable standard, but it becomes the reference industry standard of care, especially in litigation projects where we are. It's a voluntary standard, but we expect people to understand what the best practices are. So that's kind of what this ASHRAE standard has become. And it really covers these risk management requirements for commercial buildings, institutional, industrial buildings, and multi-unit residential buildings. It does not cover single-family homes, although some of the practices and procedures can certainly be implemented in those settings.

And the ASHRAE standard talks about design requirements, construction requirements, installation of water systems, commissioning of water systems, operation, and maintenance of these systems, you know, moving forward in time and then, of course, service of these systems. And there is a special annex for healthcare. We'll talk about CMS shortly. But CMS released a memo recently, which has required healthcare facilities to implement water management practices that consider the ASHRAE guideline. So, again, that's where we're kind of establishing this minimum standard of care. And really the basic statement of the ASHRAE 188 standard is that you need to have a multidisciplinary team and that that team needs to have a plan that is implemented in order to control and manage water systems in their particular building.

We also have this ASHRAE Standard 12-2000. Again, it's another voluntary standard. We do expect that there is a revision that is going to be coming into play this year, in 2019. And the difference between the 12-2000 standard and the 188 standard is that the 12-2000 standard really gives sort of a practical implementation guideline. So it gives specific recommendations on how to minimize Legionella growth in building systems, giving very specific recommendations for varied water systems, whether those are potable water systems, industrial water systems, pools, and spas, etc. And it does say that sampling should only be carried out for very specific purposes if you're trying to assess outbreak situations or validate controls in response to known illness.

We then have some guidance from the Centers for Disease Control. This guideline was originally released in 2016 and then was again revised in 2017. Again, not a regulatory requirement, it's a guideline only. But it does give some guidance on how to develop a written plan, how to implement water management practices. It gives a really good layman's review of the biology and the growth conditions that Legionella requires. I mean, it does give some limited guidance on performing risk assessments as well as gives some template forms that can be used for assessment. It also provides some health surveillance guidance for healthcare facilities, which is really useful for helping to identify cases.

We also have the AIHA guidance from 2015. This is also under revision and is expected to come out 2019-2020 timeframe. This is a industrial hygienist who put this guideline together, so people who do what I do. It's a non-regulatory best practice guideline. It is really geared towards prevention versus, you know, response and outbreak investigation. And it gives a really practical guidance for how to implement preventive measures, how to do a risk assessment. It gives a really good definition of risk assessment, which is not really clearly defined in a lot of the other guidelines. And then it also gives some really good guidance on collecting and interpreting samples. You'll see that in the AIHA guideline.

So now into some of the regulatory requirements that are out there in the United States. As of right now, New York and New Orleans are really the only areas that have implemented enforceable regulation. Some other states and municipalities have guideline documents, but these are... New York and New Orleans are the only areas that have regulations. So for the New York State, New York state enacted these regulations in 2015 following the New York outbreaks that were experienced during the summer of 2015. Yes, they are regulatory requirements and they are enforceable by public health. And then they really only cover cooling towers, which are thought to be sort of one of the higher risk systems.

The requirements are that registration of cooling towers be performed so that the state can keep a database of all cooling towers. A written maintenance program and plan is required for managing cooling towers. Certified inspectors and inspections are required to be performed on cooling towers with an annual certification requirement. They do list some general qualifications for professionals who are gonna be involved in this certification and assessment and maintenance of cooling towers. And then they also require sampling of cooling towers for bacteria, for Legionella, and for general water quality parameters.

One of the things to point out about the New York codes are there is a special section for hospitals and health care facilities. And that is defined in Article 28 of the public health law. So they do mandate that certain requirements are implemented that are different from the general buildings for health care facilities. So you can go on to the website and read all about that regulation for New York State. 

New York City also implemented their own regulations. So they're very similar to New York State. There are some general differences between the state and city regulations. New York City requirements require more frequent sampling on a more frequent interval and they do require reporting of positive Legionella results to the Department of Public Health Agency. Weekly inspections are required and six monthly disinfection with a written report detailing the disinfection procedures that are performed for cooling towers. So those are just some of the differences between the state and the city regulations.

And we really have a lot of other regulations...sorry, other guidelines and voluntary standards that are out there. The United Kingdom has a really great guideline document called the L8 Guidelines. Those are available for download publicly on the internet. The World Health Organization has a guideline for Legionnaires' disease and legionellosis. The Cooling Technology Institute has some great guidelines for practical management of cooling towers. The European Center for Disease Prevention and Control, this is the European equivalent of the CDC. They have a great guideline document that's available. OSHA, the Occupational Safety and Health Administration has some guidelines for occupational control of Legionnaires' disease.

And then really the common thread between a lot of these guidance documents is a really comprehensive water management program and plan. All of the guidance documents say that it's...the key to preventing legionellosis and Legionnaires' disease and Legionella related illness is to have a really good management system in place to help control this amplification within building water systems. And those key elements is, again, very common among all of the guidelines, but pretty much break down into having water system flow diagrams available, having a documented risk assessment done for your building, and that has to be specific to the building in question and these systems that are present. The development of hazard control measures to control amplification for each of those areas of risk. The establishment of monitoring parameters and values, so ways that you can check the validity and efficacy of your program using parameters that can be tested. Establishing a contingency plan in case those risk controls break down and you do see amplification in the system. And then verification and validation.

And verification and validation are essentially auditing of your program to make sure that the building is doing what they're saying or committed to doing. And then validation is some kind of sampling or quantitative data to assess the efficacy of the program. And that kind of takes us to the first break following just a brief overview of the biology and regulations and guidelines that are available. If there are any questions, I'd be happy to take them.

Rochelle: Thank you, Megan. If all the attendees can enter in the passcode for today, which is Legionella and any questions that you have for Megan. Our first question is, which has a higher fatality rate, Legionnaires' or Pontiac fever?

Megan: That's a great question. So Pontiac fever typically is again such...it can impact even healthy individuals. So there's typically a much quicker recovery. We do see a higher mortality rate associated with Legionnaires' disease. That typically approaches 20% to 40%. And again, these are some estimates from CDC. 

And then in immunocompromised individuals in healthcare settings, that mortality rate can reach upwards of 50% or higher. So we really do...because Legionnaires' disease affects those immunocompromised individuals, we tend to see that there's a higher risk of death or very severe illness with Legionnaires' disease versus Pontiac fever.

Rochelle: Next question. How far can the legionella bacteria travel from the site of an outbreak?

Megan: That's a great question. So there's a lot of studies on cooling tower mist and the ability of mist to travel for various distances. So there's a lot that goes into that, definitely certain conditions, atmospheric and environmental conditions, that will impact how far those mists can travel. But with cooling towers, we can see that there's been evidence to suggest that those mists can travel up to a few miles, so certainly, you know, about a few miles away from where the cooling tower is located.

With other sources, you don't tend to see that same dynamic where you have a cooling tower outdoors that is releasing mist as part of its very function. So in potable water systems, you tend to see that it's more localized to a given building. But there definitely needs to be a source. The other thing to mention is that Legionnaires' disease, there's not a lot of evidence that it can be transferred from person to person. So it's not a communicable disease as far as we know at this point. So you don't get spread from person to person.

Rochelle: Next question. If only have regulations, how best to establish standard of care?

Megan: Also a great question. So these guideline documents, what we tend to see, especially with the ASHRAE and the sort of voluntary guidelines is that those become the standard of care and they become regulation and they become adopted into regulation and law. Typically that happens...we see anywhere from 5 to 10 years after publication of a guideline document. 

In this case, we're seeing that that ASHRAE guideline as well as the CDC guidelines and some other documents that are out there, those are already being referenced as the standard of care in litigation projects that we work on. So it really is already established even since 2015 as, you know, the standard of care. And it's already being referenced as something that building owners and operators should be aware of. If they're not aware of it, that's not a good enough reason for there to be no liability. So, just because they don't know about it doesn't mean there's not liability.

Rochelle: Next question. Is the medical treatment different in pneumonia caused by Legionnaires' disease and other causes?

Megan: So just as a caveat here, I'm not a medical professional, so this is just based on...this answer is just based on my experience and peripheral work with medical professionals. But you certainly want to...whenever there are medical issues related to a case that you might be working on, you certainly want to confer with a medical doctor. As far as I know, there are different antibiotics that are more effective against Legionella and Legionnaires' disease and infection than others. Some general course antibiotics can have some partial coverage, which is again one of the reasons why you can see an extension of that incubation period in persons who might be taking those antibiotics. And then, as with any other bacteria, some antibiotics work and others don't depend on the species and the genera that's present, the causative agent there. But yeah...so yes, some antibiotics work better against the Legionella infection than others.

Rochelle: Next question. How common is it for multiple persons to be exposed to Legionella but only one individual contracts it?

Megan: That's a great question. And we really don't know. We do know that some percentage of the population is just generally exposed to Legionella and has no resulting disease. So you come out healthy... Again, we know that it typically impacts immunocompromised individuals in terms of acquiring the illness. But there are general members of the population who do have zero conversion to the Legionella antibodies. So they've been exposed and they don't have the illness. So again, we do know that there are some factors that make certain individuals more susceptible than others. But for some reason, some people acquire the illness and others don't.

Rochelle: Next question. How is voluntary compliance followed?

Megan: How is voluntary compliance followed? I'm hoping I'm following the question here correctly. But essentially, I think what the question is asking is if these voluntary guidelines are out there... They are pretty comprehensive in what they're requiring and so I think the question is, you know, what do we pick and choose first? How do we start implementing these guidelines? Obviously, we're not gonna be fully compliant with all the requirements of 188, you know, from zero to 60 and in a single day. So what do we prioritize?

And we really need to rely on that risk assessment. So that risk assessment process is the key process for implementing any of these recommendations. And really that risk assessment will help to prioritize risks, identify the highest risks that might be available or present on a site. And using those prioritizations, the building can focus on those highest priority risks first and then continuously improve their Legionella management program over time. So it really is sort of a continuous improvement program and a moving or a living program where you're moving towards compliance over time. I hope that answers the question.

Rochelle: Next question. Does any states require the installation of equipment for system monitoring and prevention of Legionella?

Megan: I'm sorry. Can you repeat that one more time, Rochelle?

Rochelle: Do any states require the installation of equipment for system monitoring and prevention of Legionella?

Megan: So aside from the New York requirements and the New Orleans requirements, I'm not aware of any other regulations that are in the U.S. So, as part of those regulations, I'm not aware of any mandatory equipment installation. There are other than, you know, what's required in terms of managing...you know, registering cooling towers and managing cooling towers with sampling and that sort of thing. There are requirements for maintaining and maintenance of those systems, but I'm not aware of any sort of secondary treatment systems or any specific equipment that's required to be installed as part of those regulations.

Rochelle: And now last question for this section. What test is required for a medical provider to determine whether pneumonia is due to Legionella, i.e., a blood test?

Megan: Great question. And again, I'm not a medical professional, but as far as I peripherally I'm exposed to this type of information, there are several diagnostic tests for Legionella infection. The first is that screening tool that I mentioned, which is the urinary antigen test. And that is just a urine sample is collected and then subjected to this test. And it looks only for that Legionella pneumophila serogroup 1 agent. So if you have another infectious form or pathogenic form of Legionella that's causing the infection, the urinary antigen test will not pick that up. So, therefore, that's kind of why it's a screening tool.

We also can identify Legionella infection through various cultures. So that would be culture of blood samples, lung tissue samples, lung biopsy. And then, of course, in order to diagnose the pneumonia, you're looking for a chest X-ray of some kind there. Again, I'm not a medical professional, but as far as my knowledge goes, that's my understanding.

Rochelle: Thank you, Megan. You can continue with the presentation.

Megan: Great. Great questions, thank you for those. Okay. I'd like to briefly go over some core competencies for investigators and qualifications that you want to look for when you're consulting with someone about Legionella or Legionella growth and amplification. I mean, these core competencies, they are really collected from the guidance documents that are available, mostly the AAHA guideline, which is one of the first guidelines to sort of identify core competencies. There is also... CDC recently, I believe last year, put out a guideline or some sort of points of consideration for selecting a Legionella consultant. And that is available online on the CDC website. These recommendations are very consistent with those CDC guidelines as well.

So in terms of a competent professional, this is gonna be someone who is providing consulting, collecting samples, doing a risk assessment, making recommendations for control. So somebody that's not just a field technician but somebody that is providing recommendations and interpretation of risk assessment information and sampling information. So this person should have professional certifications and/or a Bachelor of Science in industrial hygiene, environmental health, or some kind of related science or engineering degree. So engineering, life sciences, chemistry, physics, any kind of discipline that's similar to those there. We want them to have some basic background education in a related science.

You're also gonna wanna look for at least two years of experience under the direction of a certified industrial hygienist, a registered sanitarian, a registered environmental health specialist, or some other licensed professional. This can certainly be a licensed professional engineer, someone with building and mechanical experience. And you want that experience to be in the areas of building water systems, so they should be very familiar with building water systems and how water is delivered in various systems.

They should be familiar with building water equipment. They should understand the basic microbiology of the organism and the basic science and risks for growth and amplification. This person should understand sampling methodologies, analytical methodologies, and of course, the personal protective equipment that should be worn during the risk assessment procedure and during an analysis of building water systems.

And they should be familiar with the general pathways of exposure and the general concept of exposure assessment for Legionella. You also preferably would see some kind of postgraduate or some kind of professional education in the subjects of waterborne pathogens, their habitats, their ecology, physiology, pathology, and then control methods. So you want this person to be familiar, not only with the risk assessment, so the ability to look for areas of risk and find areas of risk within a system but also to make qualified recommendations for controlling those risks, mitigating those risks in a variety of different water systems. So not just cooling towers but you want them to have a wide array of experience in potable water, industrial water, pools, and spas, a variety of different water systems there.

In terms of their minimum competencies, you want them to have a basic knowledge of Legionella common sources, how Legionella is transmitted from a source to a person, and what the general disease symptoms and outcomes of exposure might be. These person should be able to recognize potential amplification within various points of service within a building water system. They should be able to assess those sources using commonly available methods, so not just quantitatively but qualitatively. They need to be able to collect valid measurements for parameters that can help to assess risk and they should be able to collect samples. They should also be able to recommend suitable mitigation strategies for the control of Legionella. So where they do identify areas of risk, they should be able to recommend a variety of different mitigation strategies for addressing those risks. 

And then they should be able to develop a site-specific monitoring program. I mean, this is...the key there is site-specific. Every building is different and you really want your professional to be able to provide recommendations in a variety of different settings. And that monitoring program should be specific to the risks of the building that's being assessed. And that should include a verification plan, so an auditing plan and also a validation plan or a sampling plan to continue to evaluate the efficacy of their recommendations over time.

And there's a lot of kind of potential for conflicts here. What we're seeing as the trend today in the United States is there's tendency toward a turnkey service. So we're seeing a lot of water treatment contractors, a lot of engineering firms providing a turnkey service where they're assessing Legionella risk, making recommendations that might include the implementation of their proprietary treatment equipment or treatment program. And that really does result in sort of a conflict of interest there. So treatment contractors are offering consulting. It doesn't mean that they're not qualified. You do wanna make sure that they have some level of independence when they're making recommendations.

There are no regulatory requirements for qualification or certification at this point. So that can also kind of create some conflicts there where you don't...there's really no validated way to evaluate the qualifications of persons performing this type of work. So really anybody can come in and say that they're a Legionnaires' expert without having to provide a certification or any proof of their experience. 

As I mentioned, most of the standards that we have, with the exception of New York and New Orleans, are voluntary and they're not "enforceable." We do see again that these documents are becoming the standard of care and they're being referenced in litigation cases. But they are not technically enforceable at this point. Some other issues that you might encounter, template water management plans. 

So as I mentioned, many of these guidance documents recommend a water management plan to implement in your building. And you can download water management plans from the internet, but those plans are templates. They're sort of fill in the blank. There's no risk assessment or site-specific considerations that are taken to account with those template water management plans. So they really are not that useful. And it can really even get building owners into trouble if they have a template water management plan but they're not really implementing it well. Maybe it looks really nice on paper and it's sort of up on a shelf in the engineering office, but they're not really implementing the program. That can put a building owner into an even more precarious position where there's a negligence claim that can come into play if there are cases identified with that building.

And then finally just some other conflicts to think about in terms of team members. Again, most of these documents require or recommend a multidisciplinary team. So you can really see conflicting team member objectives within a building water management team. Certainly, facilities is often overwhelmed. They have a lot of work that they have to do on site. The Legionella management is not their only job. They're wanting to get it controlled and dealt with very quickly.

Legal representatives might be concerned about legal ramifications, publicity considerations. An administrator might want to be involved from a very high level scenario but not really understand sort of the intricacies of Legionella control and so may make sweeping recommendations that aren't necessarily looking at the finer details.

And then EH&S and infection control. Certainly your infection control preventionals in a healthcare setting are most concerned about the health of their patients, and they're gonna wanna take the most conservative approach, which can conflict with other members of the team as well. So just some things to think about when you're dealing with these issues in any building setting.

But again, into a little bit of the Legionella legal exposure here. Again, we reported mortality rate as 20% to 40% in the general population and approaches 50% or higher in health care. So you're getting large numbers of cases or the potential for large number of cases and large numbers of deaths and certainly illnesses. So a single outbreak can result in dozens to hundreds of cases as we've seen. We talked about the previous outbreaks earlier in the training. 

If cases survive...patients survive after acquiring Legionnaires' disease, they can spend weeks to months recovering in the hospital. There can be very severe permanent impairment depending on the severity of the illness. And then, of course, there's the cost of the investigation or remediation. So, taking the healthcare piece or the recovery piece aside, the investigation and remediation of Legionella issues can cost tens of hundreds of thousands of dollars. So these are very, very costly situations.

Claims and Litigation Management Alliance reports that there are multi-million dollar legal exposure issues related to Legionella in building water systems. From public settlements, we know that the settlements have ranged from $250,000 to $5.2 million per claim. Obviously, these settlements are greater if deaths are involved. And we really don't know because a lot of these settlements have confidentiality stipulations. So we don't know what the settlement amount is. 

And what we've seen, in our experience, is that this ASHRAE voluntary standard, as I mentioned earlier, has established a standard of care. So there is no longer a really good excuse that you didn't know about this issue. Building owners and operators are expected to know because of the number of guideline documents that are available. A water management plan, to some extent, should be in place. And if you do have a good water management plan that covers your major risks, this can prevent a negligence or an out will exposure claim in a given claim. So something to consider in terms of being proactive about implementing these water management plans.

And just some quick liability considerations before we get into some of our case studies. Two or more cases that are linked to facility is the definition of an outbreak for CDC. That's within a short time period, I believe it's a month. So if you see two cases, that's when you can expect to see an inspection or an involvement of the local public health department. This is a reportable illness. So anytime Legionnaires' disease is identified and diagnosed, there are requirements for that healthcare facility who diagnosed it to report that to CDC. So this is how CDC and local departments of Public Health know about these illnesses.

You don't need to have a patient sample that matches an environmental sample in order to establish exposure. That is not something that we've seen as a requirement in the litigation claims that we've worked on. You can have just the presence of Legionella in a source and a patient who acquired the illness. And that can be enough to try to establish that there was exposure or the potential for exposure.

And then something else to consider is if there are poor management plans or poor management procedures in place in a given building, you often will see multiple sources. So you have many people involved. You've got a building owner, a building manager. You might have a cooling tower contractor. You might have a pool contractor. All of these people can and do impact the risk of amplification within a building water system. And all of these people can be brought into a litigation claim. So, not only are there multiple sources, but there are multiple parties who have liability in any given system.

And just to note. I'm not sure how many of you are familiar with the issues that were going on in Flint, Michigan related to Legionella and water quality. But the department of human health services director, Nick Lyon, was criminally indicted for his role in the issues that occurred in Flint, Michigan. Now, he's still in office and still serving in his role. Last year, there was a hearing in August of 2018, which basically stated that the case needs to go to trial. But that is something that is pretty unprecedented in this field is that a public health director was criminally indicted for his role.

And just some quick case studies. I think I've got two here just to kind of run you through on what we wanted...to kind of give you a good example of some of the issues that might be seen in some of these cases. I also wanted to just briefly go over some known cases and outbreaks. I'm not gonna go into these in detail. These are all publicly available on the internet. You can just google Legionnaires' disease outbreaks and up they will pop. But you can see, back in 2018, we're having multiple outbreaks over time. And so this is something that we're starting to see more frequently, and it's certainly a public health concern. Some even think it's a public health emergency at this point, so multiple outbreaks and even multiple outbreaks in New York since the implementation of those guidelines or those regulations rather. So it continues to be an issue that we all need to be aware of.

The first case study I wanted to review with you is with a brand new hospital. It's a seven-story hospital tower, and they had two types of outbreaks, Pseudomonas, which is another waterborne pathogen and Legionnaires' disease within three months of this new tower opening. So the Pseudomonas outbreak occurred in the neonatal intensive care unit. There were 17 cases and 4 deaths. And they found additional colonizations with more surveillance. So they actually noted that some of the babies were actually colonized but didn't have the illness.

And then we also concurrently saw a Legionella outbreak in the intensive care unit and step down unit. And so we had two initial cases and we had two more cases following that initial outbreak. What the hospital did to respond is they did what's called a primary disinfection or a shock treatment of the potable water. And this had minimal impact on the levels of Legionella that we saw in the water. So there really wasn't a marked reduction in Legionella concentration in the water after these disinfections. Litigation is still currently ongoing, the highest settlement we've seen to date is $2 million. But that is still ongoing.

Some of the key risk factors that we identified when we went through and did the risk assessment, we saw low hot water temperatures. Remember, Legionella grows really well within a certain range. And hot water systems typically operate within those ranges or slightly above. So we saw low hot water temperatures right in the growth range of the bacteria. We saw failing mixing valves, which are things that mix hot and cold water together. So we saw that those were failing resulting in some transfer of cold and hot water across the pipes. There were expansion tanks that were poorly installed. And then we saw these sinks that were in the rooms in both the NICU and the ICU. And if you can imagine, a NICU or an ICU patient is not mobile. And so those room sinks, the sink that's in the room of the patient, they're not gonna be used very often. 

We also just looked at...along with infection control, we looked at some key equipment that was identified associated or possibly associated with the illnesses. And we saw that ventilators were high-risk. We saw some breast milk pumps that mothers were cleaning in just regular tap water. And then we also thought maybe some medications were involved. And really, in the end, we found that... These are just some of the water sample results. A result here that's shaded green was anything from 1 to 10 CFU per mL. Anything that's yellow is 10 to 100 CFU per mL. And anything that's red is over 100 CFU per mL. And so for potable water, those are kind of the buckets of...sort of low, medium and high risk buckets that we place, at least according to the AIHA guideline.

So you can see sort of some of the results that we saw in some of these rooms. We looked at pre and post-flush samples. So pre-flush samples are really representative of the water that's coming out of a localized fixture, so the water that people are first exposed to. And then the post-flush samples are more representative of what's in the circulating water because we flush that water out to the nearest branch so that it's representative of what's more in the system as a whole versus at a given fixture. So you can see here we're seeing a lot of load...sorry, medium to high-risk results in the pre-flush samples associated with those sinks within the ICU.

And so what we found is that, as you can see the bottom picture here, this is the fixture that was installed in those in-room sinks. And that fixture was not the original design. It was an engineered design saving. So the contractor selected a different fixture that was not originally recommended. What they should have installed were these sort of gooseneck, stainless steel gooseneck fixtures, which have a much lower risk of stagnant water sort of staying in the fixture after it's used. And then also what was on the inside of these fixtures was a coated cast iron. So it was a low-cost fixture as compared to a high-cost fixture, but there were reasons that that high-cost fixture was recommended.

And so what we did is we cracked open some of these original fixtures and we found high levels of the bacteria living and growing within these fixtures. Those fixtures that were in those rooms, in the NICU and the ICU, not only were they low used but they were really conducive to bacterial growth as well. And that was the cause of the outbreaks there. And here you can see, we cracked some open and did some sampling on the interior, lots of good surface area for bacteria to grow inside that fixture.

Second case study, and I'll run through this quickly here. This is at Jimjilbang Spa in California. It was a three-story spa. It's a very high-end spa with a high-profile clientele, many who were elderly, many had underlying illnesses. And a Jimjilbang Spa, for those of you who don't know, is a Korean day spa. We saw 12 Legionnaires' disease cases in both male and female patrons. There were no deaths. And these patrons were in separate facilities. So there's a separate male and female facility, which doesn't really have much opportunity for cross exposure. 

Public health was involved. And I say encouraged because it was a very strong encouragement, but they encouraged the spa to close for further investigation. And the spa was losing several thousand dollars a day just by being closed, and that was a voluntary recommendation, but of course, it's a pretty strong encouragement or strong recommendation when Public Health is involved. And Public Health came in and they focused on the potable hot water. This is a floor plan of the facility. It's really cut in half here on the left side are the womens' saunas and spa rooms and on the right or the mens' saunas and spa rooms. These blue circles up here, these are various temperature spas. So there's a cold, a medium and a hot temperature spa and then we've got various saunas and showers that are associated in these facilities as well. 

These are some pictures. You see some sitting showers here. There's some saunas or standing showers. And you can see some of the scale and build up that we saw in some of these shower outlets here on the bottom picture there. These were some of the water sample results. So we looked at samples that were compared between Department of Public Health and our samples. We saw that the men vanity sinks...these were sinks that the men didn't use very often. It was the last sink in the row, which people tend to use the first sinks in a row of sinks. And so we saw some higher concentrations there. We also saw some high concentrations in the treatment room showers. So these Korean day spas have treatments where they provide a showering in a sort of a handheld shower head and those are used during the treatment. So we saw a high-level there as well. 

We also saw some kind of medium samples...medium risk samples in the women's fountain. There was sort of a decorative fountain in the women's area. And we also saw some coming in from the municipal supply. So Legionella was getting into the building from the municipal supply. So we really found a couple of different sources here. The investigation was very expensive. The remediation was even more expensive. There was significant public health oversight and ongoing follow-up. So, up to two years later after the outbreak was ended, Public Health was still involved in requiring check-in.

This was the only time I've ever seen a public health agency mandate that a secondary treatment system be installed. So they installed a chlorine dioxide system. And there were multiple lawsuits that were related to the public closure and the cases that were seen. The litigation is still ongoing here, and we've seen settlements between $200 and $500,000 here in this case.

So just to kind of close up, you know, hopefully we gave you a really good brief introduction for Legionella, how it relates to building water systems, how it relates to risk amplification and exposure, and just some kind of guidelines regulations that are out there and some case studies, along with sort of the legal exposure related to Legionella. So really prevention with Legionnaires' disease is really the key. We wanna prevent these illnesses from occurring. And the best way to do that is to manage our building water systems with a continuous improvement model. Remediation of these issues, once they've already occurred, is difficult at best. So it's always best to prevent versus try to respond to outbreak where outbreaks are known cases. And with that, I think we'll finish up with our last question and answer session.

Rochelle: Thank you, Megan. If all the attendees can enter in the passcode, which is Legionella. Unfortunately, we do not have time for questions. Unanswered questions that were submitted during this presentation will go directly to Megan. Please note that if you are applying for CLE credit, you must have attended for the full 60 minutes of this presentation. You're also required to complete the survey at the end of the program. Please note that all certificates will be sent out via email in 24 to 48 hours.

I wanna take this opportunity to thank everyone for attending and most especially, Megan Canright, for her time and effort in creating this presentation. If you would like to speak with Megan or if you would like to speak with a TASA representative regarding an expert witness for a case you are working on, please contact us at 1-800-523-2319. One of my colleagues will be following up with you regarding your feedback on today's presentation. Again, thank you all for attending. This concludes our program for today.

Megan: Thank you all.