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In-Premise Water System Educational Symposia 2017Summary MIAMI / ATLANTA / LOS ANGELES / IRVINE

In-Premise Water System Educational SymposiaSummary

November 7, 2017 University of Miami, Miller School of Medicine Lois Pope LIFE Center

Chaired by: Barbara Russell & Miriam Levy

November 9, 2017 Fernbank Museum of Natural History, Atlanta, GA

Chaired by: Pamela Falk

November 14, 2017 The Los Angeles Athletic Club, Los Angeles, CA

Chaired by: Santiago Chambers & Mary Virgallito

November 15, 2017 University of California - Irvine Student Center, Irvine, CA

Chaired by: Linda Dickey & Devin Hugie

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Professor Hans-Curt FlemmingProfessor Emeritus Biofilm Centre University Duisburg-Essen Water Academy Germany

Professor Hans-Curt Flemming has been working on biofilms for more than 30 years and is one of the pioneering initiators of biofilm research in Germany. His field covers aspects of biofouling, e.g. of separation membranes or other industrial systems, as well as fundamentals of the physico-chemical properties of biofilms and the central role of their extracellular polymeric substances (EPS). When he founded the Biofilm Centre at the University of Duisburg-Essen, he focused on questions regarding pathogens in biofilms and their survival, proliferation, contamination potential and possible countermeasures. Alongside that work, he also studied the phenomenon of Viable-But-Non-Culturable (VBNC) pathogens and their potential for resuscitation, particularly in biofilms. Prof. Flemming is fascinated with the biofilm mode of life and their emergent properties, which are responsible for their multicellular behavior and reason for their successful existence.

Professor Flemming (Professor Emeritus, Biofilm Centre, University Duisburg-Essen, Germany) set the scene by considering that bacterial biofilms are the oldest form of life on Earth, with 3.5 billion years of evolution behind them. They live with us, making up our own microbiomes, and we need them to ensure health. Bacteria are well adapted to take advantage of niche environmental conditions including extremes of temperatures, pH and minerals; they can be found in nuclear power plant waters and in the dead sea. What is the secret of this success?

Biofilms are collections of microorganisms that embed and stick together in a jelly of self-produced extracellular polymeric substances (EPS). This slime is a complex hydrogel of enzymes, polysaccharides, proteins, lipids, nucleic acids, chemical signals and plasmids which are loosely held together by weak physico-chemical forces such as electrostatic, ionic and hydrophobic interactions and hydrogen bridging. The EPS immobilise microorganisms and retains water, which prevents the cells from dehydrating and eventually provides food. The matrix is like a “stiff” water skeleton which gives architecture and mechanical stability, and helps the tissue-like structures to keep together and to adhere to surfaces. There are gradients of oxygen and of waste products within the matrix which generate lots of local heterogeneities and, thus, set the stage for a high bacterial species diversity. The sticky biofilm catches nutrients, and the enzymes within the matrix can digest the nutrient material for the bacteria to readily access. The bacteria co-operate and compete, there is continuous regeneration which (under the competitive environment) supports

successful organisms who tolerate and thrive in the conditions, and communication is completed via chemical signalling. As an individual, a bacterium may not survive, yet within “Fortress Biofilm” they are protected. Life within biofilms is physiologically distinct to that as a planktonic bacterium (even when of the same bacterial species), and biofilms develop emergent properties – where the combination of the whole is much stronger than the single – is the secret of their success. Biofilms are an example of collective biology which we can best visualise by considering the single tree versus a forest, or the single bee versus the complexity of the bee hive. Very different forces are in effect, and interactions are complex.

“Fortress Biofilm” protects bacteria from the actions of antibiotics and disinfectants. Reaction of these chemicals with the EPS matrix, including chelation and enzymatic degradation, rapidly leads to sub-toxic/sub-lethal concentrations which can then select for bacterial tolerance. This is also true for toxic metals, which can be chelated and undergo redox reactions in the biofilm, again leading to tolerance. Once the biofilm matrix is removed, then cellular tolerance to disinfectants, temperatures, metal ions etc. can be lost, thereby indicating that this is not a development of “Resistance”, which is understood as a lasting property, based on genetic changes.

Biofilms are present in our drinking water systems. “Professional” water bacteria have found their niche in this relatively new man-made habitat, with its wide range of materials and available nutrients, and seized this opportunity for new species variance. Indeed, Professor

Biofilms – the way Microorganisms Organize their Social Life in Drinking Water

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PROFESSOR HANS-CURT FLEMMING - SUMMARY

Flemming’s fascination started with the analysis of biofilms forming on nutrients released from the resin of an ion exchanger. The weakest link in the drinking water system distribution and supply chain is the in-premise / domestic installation. There are many different non-regulated material types and fittings used in these plumbing systems, they have large surface areas and poor thermal insulation leading to “warm” cold water, have multiple dead legs and dead ends, user habits lead to stagnancy of days to weeks, there is none or sub-lethal levels of systemic biocide, and there is little or no control as surveillance of water samples and in users is weak (and would not be popular). Biofilms occasionally can harbour facultative pathogens, such as Legionella spp., Pseudomonas aeruginosa, non-tuberculous mycobacteria and others. Materials in the water system, such as plastics and synthetic rubbers like ethylene propylene diene monomer (EPDM) or silicone, contain plasticizers and other low-molecular weight components which are biodegradable and offer a rich buffet of nutrients for water based bacteria, leading to dense biofilm formation. The use of elevated temperature and biocide can make elastomers more readily available as nutrients for bacteria. In addition, the surfaces of faucets are often affected by lime scale build up which is a wonderful protective structure for biofilm formation and duration.

Biofilms will form on any water-wet surface, and research has been completed on different plumbing and pipe materials including EPDM, silicon, polyethylene, cross-linked polyethylene (PEX), plasticized and chlorinated polyvinyl chloride, stainless steel, galvanised steel, cast iron, brass, copper and glass. All materials formed biofilms and supported both Legionella and their host amoebae. Highest Legionella counts were found on EPDM materials, where biofilms enjoy the plasticisers and will proliferate well on these surfaces – all flexible hoses contain such materials and therefore must be considered a risk. Lowest cell counts were found on stainless steel and PEX which are admitted for use in drinking water. Regarding water temperatures, biofilms form more prolific when hot water temperatures are less than 60 °C (< 140 °F). Up to 57 °C, Legionellae can grow until a sharp drop occurs at 60 °C. In most cases, Legionella survives best ingested in amoeba.

With regard to water testing and surveillance, culture techniques remain the gold standard for bacteria. However, many cells do not grow under culture plate conditions. Testing for Total Cell Number will always give a much higher count than culture. Cells that do not grow under culture conditions are not necessarily dead, they have just not cultured and are likely not in the growth metabolism stage. Instead they are Viable-But-Non-Culturable cells (VBNC), and under maintenance metabolism only. This is a stress response: bacterial cells can “play dead”, slow down their metabolism drastically, don´t grow and do not form colonies on a culture plate. Unfortunately, they cannot be found by standard methods for their detection. They cope with changes in environmental conditions (increased biocide levels or temperature) by evoking this transient loss of metabolism, similar to hibernation. Under these conditions bacteria can evade the effects of disinfection of the in-premise water system, antibiotics and also the human immune response. This transient loss of metabolism is then reversed, and cells resuscitate after the stress factor has alleviated or been removed. With culture-independent methods of microbiological analysis, it is apparent that silver ions or nanoparticles and silver impregnated materials have almost no effect on biofilms, and when copper ions are removed by use of a chelator (such as diethyldithiocarbamate (DDTC)) from water

samples, Legionella spp and Pseudomonas aeruginosa levels are readily detectable. Resuscitated bacteria can regain their cytotoxicity, sometimes with higher virulence. In the event of patient infection and environmental investigation, it is important to recognise that the detection level of clinically relevant bacteria with culture techniques could be low/zero, yet with culture independent methods they may be clearly detected and in significant numbers.

Professor Flemming identified five expensive misjudgements when relying on conventional anti-biofilm strategies for in-premise water systems:

1. No effective warning system as cell culture does not give a real picture. Clogging of pre-filters is a good indicator for some systems, and may be a useful surrogate warning system.

2. No information on the size, extent or location of biofilm if only sampling from the water outlets. In a water sample you may detect one or two culturable cells, but will not know how many remain in the system and in the biofilm. Intelligent water sampling at different points throughout the water system can help map out a contamination source – tracking from low bacterial numbers until you reach the highest. This could lead to a contaminated component such as a water softener or carbon filter, which can then be replaced.

3. Killing is not cleaning. Use of disinfection leaves dead biomass throughout the water system providing nutrients for good regrowth conditions. Adopting medical thinking, biofouling is mistakenly considered a “Technical Disease”, and it is perceived that if disinfected, the system will be healthy again, but this is only true for organisms with an immune system, which technical systems don´t have. Cleaning needs to disrupt both physical and chemical forces which keep biofilms in place by virtue of their matrix: the above-mentioned physico-chemical interactions, and covalent bonds of backbone EPS polymers. Crucial are exposure time, concentration applied, temperature and mechanical energy input for any disinfectant and cleaner. Physical methods such as air and ice scrubbing may be booster efficacy – in any case, cleaning is at least equally important as disinfection.

4. No nutrient limitation of influent water or nutrient leaching materials. Nutrients must be considered as potential biomass which is not reduced by use of biocides.

5. No optimization of countermeasures and efficiency control.

Biofouling is the formation of unwanted biofilms; a biological reactor in the wrong place, so to say. Biofilms will form in any in-premise water system, but they are only a problem when rising above our given threshold of interference. There is no silver bullet, we need to learn how to live with and manage biofilms through

• Limiting nutrient supply

• Optimising mechanical (shear) forces

• Developing efficacious cleaning strategies

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Professor Martin ExnerDean of Medical Education Managing Director of the Institute of Infectology and Infection Prevention University of Bonn Germany

Professor Dr. Martin Exner is one of the leading European experts in the field of environmental hygiene and public health. In addition, he is strongly involved in the development of German hygiene policy. Professor Exner completed his medical studies at the University of Bonn in 1977 and began work as a research assistant at their Hygiene Institute. In 1986, he became Head of Division for Disease and Environmental Hygiene at the City of Cologne’s Health Office and from 1988 to 1994 he was Managing Director at the Hygiene Institute of the Ruhr Area in Gelsenkirchen. In 1994, Professor Exner took over as Chair of Hygiene at the University of Bonn and has been the Director of the Institute for Hygiene and Public Health in Bonn, a WHO collaborative center for drinking water hygiene. In addition to his university work in research and teaching, Professor Exner dedicates a large part of his time to environmental, water and hospital hygiene. His other areas of expertise include food hygiene, general hygiene in epidemics as well as household and population hygiene. Professor Exner is also involved in health care issues such as hygiene in schools and kindergartens that are closely linked to the family’s health, as well as questions about the spread of infections caused by new pathogens.

Professor Martin Exner (Director of the Institute of Hygiene and Public Health, University of Bonn, Germany) began his presentation by quoting Daniel Boorstin with “the greatest obstacle to discovery is not ignorance – it is the illusion of knowledge”. We should recognise and apply this to risk assessing the water system within buildings. We know and understand risk regulation with the traffic light system – red, orange and green. A process of risk regulation should look where the risk could be, and then assess the risk in a scientific way, evaluate it to reflect if there are control strategies that can be applied, to discuss in a transparent way and to introduce rules to prevent or mitigate the risk. Ensuring the risk can be recognised and be translated to the healthcare environment in order to protect the health of a patient is the critical aspect for the Water Safety Team.

Most patients are aware of, and fear, nosocomial infections, and many not want to go into hospital because of this. How can we protect our patients and healthcare workers from infection risks in the most efficient way? What are the reservoirs and how can they be best managed? Typically, politicians and the economy do not like regulations as they cost money and realistically it takes 20-30 years between observation of a risk and risk regulation.

Pathogenicity is the property of an agent (e.g. bacteria) that determines the extent to cause illness. Primary pathogens could directly affect

a healthy person (e.g. Vibrio cholerae). Facultative pathogens are opportunistic, for example they require a skin lesion, a catheter, an underlying deficiency of the immune system, in order to successfully cause disease. Indeed, there is a calculation for characterising the risk, which depends on the pathogenicity and virulence:

concentration (number) of pathogens x virulence x antibiotic resistance x tenacity

specific vulnerability of the patient host

The transmission pathways, as described by the World Health Organisation, are Ingestion, Inhalation, Aspiration and Contact. Much work has been completed by Nick Ashbolt regarding the routes of inhalation and aspiration in order to model how many Legionella bacteria are needed to enter the lungs before triggering disease, however it is not a straight forward or clear calculation due to the myriad of variables.

Water and waste water are the most overseen reservoirs of infection, and we are yet to bring these areas under control. The responsibility of the public water system is with the municipal supplier up until the water meter, however the responsibility for the water once it enters the building or indeed the curtilage of the property, and past the water meter, is with the building owner. The quality of water at the faucet

Drinking Water and Waste Water Systems as Infection Reservoirs for Opportunistic Pathogens and Consequences for the Management

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PROFESSOR MARTIN EXNER - SUMMARY

and shower outlet is with the responsibility of building owner, and the fittings, sinks and basins are important reservoirs of disease. In Europe it is mandatory that the responsible person (the building owner) must take measures such that the water at the point-of-use “intended for human consumption is wholesome and clean”. In Germany the precautionary principle is adopted – to prophylactically protect against infection – and therefore water should be free in concentrations from any microorganisms which are a potential danger to human health. Germany does not use chlorine or similar disinfectants as a standard processing step in the drinking water system, and chloramine is not allowed in Germany as it is considered too toxic for human ingestion.

Main waterborne pathogens – those associated with primary pathogenicity – include Escherichia coli, Campylobacter, Cryptosporidium, Enterovirus and Norovirus. Facultative water based pathogens include Legionella spp., Pseudomonas aeruginosa, Coliforms (Enterobacteriacae), Klebsiella, non-tuberculous mycobacteria, Acinetobacter, Stenotrophomonas maltophilia and many others. These aquatic microbes are professional water bacteria and can build biofilms, develop disinfectant tolerance, regrow from the Viable But Non-Culturable (VBNC) state, and some can transform into Ultra-Microcells (which are so small they can pass through 0.2 micron filters).

The water distribution system from catchment to consumption, and in particular the last meter to the water outlet, plus cooling towers and the waste water system, is a complex reservoir of disease. In a recent paper by Gargano et al (Journal of Water Health, 2017), it was reported that most mortality from waterborne pathogens in the US is not from primary but from facultative pathogens. Quoting Winston Churchill as an example, Professor Exner confirmed “You must look at the facts because they look at you”. For Legionellosis in Germany in 2016, 992 cases were notified to the Federal Public Health Department, 96 % were hospitalised, the fatality rate was 4.7 %, there were 13 outbreaks and 1 outbreak recorded 24 cases. This is still a highly underestimated picture of those individuals affected by Legionella spp. Legionella is exclusively from the environment, and therefore is an entirely preventable disease and according to the German Competence Network of Community Acquired Pneumonia (CAPNETZ) it is officially estimated that between 15,000 to 30,000 cases of Legionellosis are occurring each year in Germany. Therefore, there is a strong public health reason to regulate this risk. The US Centres for Disease Control (CDC) has a fatality rate of 25 % in hospital acquired Legionellosis despite use of modern antibiotics. The most important source of infection is potable water, and the most important source for large population outbreaks is cooling towers. There are many papers published around these environmental sources, and these can be very helpful to support the Water Safety Team in establishing risks and budget priority, and for developing new guidance and regulation – never waste a good crisis!

The waste water environment begins at the siphon on toilets, sinks, basins, showers etc. and provides perfect bacterial growth conditions with a warm room temperature, high nutrient availability, inaccessibility of surfaces with low flow characteristics for prime biofilm formation, exchange of genetic material between cells, development of tolerance to heat, disinfectants and medication. It is the interface where clean and unclean meet, and in close proximity to the patient. All hospitals have problems nowadays with blockage due to disposable wipes being used and then flushed away down the toilet. They do not disintegrate as per toilet tissue, and rapidly block pipes leading to waste water back-up into neighbouring sinks, toilets, shower trays etc. Aerosols and

splash from sink traps have been well recognised as a contamination source when hand-washing and causing outbreaks in neonatal units, however risks also exist from flushing the toilet. With the toilet seat up, water droplets and aerosols will travel for 2 meters. Even with the toilet lid down, there is a minimum 25 cm spread of aerosols as they are jettisoned out of the gap at knee level. Toilets have been recognised as a reservoir for Pseudomonas aeruginosa with 10/12 toilets contaminated under the rim in one study. Newer design toilets for hospitals no longer have a rim, and may only have one flushing outlet in order to try and reduce aerosolisation. Another avenue of risk is the plumber and their tools. In Germany there is now a requirement for plumbers to separate tools used for waste systems from those used for potable water, and to have a tool cleaning regimen. This requirement follows an Enterobacteriacea outbreak involving 132 patients, where the outbreak strain was found in the kitchen drain. This kitchen drain had been unblocked using the same plumbers tools that had been used to unblock the toilet drains (following a blockage caused by flushed wipes) in patient areas. The transferred organism subsequently was splashed/aerosolised over the patient food trays..

Professor Exner stressed that we need to adopt simple hygiene strategies and do them well. If a water outlet is underused, for example the patient in the room is very ill and not using the bathroom or shower, then any chlorine within the water system will not reach the point-of-use. If it is only the peripheral areas that are contaminated, then a flushing program may be effective. The principle is to avoid systemic contamination of the water system and to have < 100 CFU of Legionella pneumophila per 100 mL water sample, however within high risk areas of healthcare facilities there should also be < 1 CFU per 100 mL pathogens. The German DVGW W551 Technical Measure, which is also available to download in English, is a code of practice for cleaning and disinfection which can support Water Safety Teams. Focus should be on “no waterborne pathogens”, and where there is risk of higher levels being found at the outlets then implement a flushing regimen, educating users to flush showers, sensor taps, other outlets. Sink drain outlet design is now preferred at the back of the basin, rather than the base, in order to avoid tap water running directly into the trap and causing splash and plumes of aerosols – it is important to offset the water flow. Detachable water faucets, that can be maintained “off-line”, are now available, and in high risk patient areas point-of-use Water Filters can be installed to manage risks.

Overall the knowledge accumulated in recent years recognises the tremendous opportunity to contract water based infection and consequences for patient safety when these risks are not addressed. We must take the opportunity to learn from the available materials and share experiences to provide the best protection for patient health.

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Joseph O. Falkinham, III Ph.DProfessor of MicrobiologyVirginia Polytechnic Institute and State University USA

The Falkinham lab focuses on understanding the epidemiology, ecology, physiology, and genetics of the non-tuberculous mycobacteria (NTM); primarily the Mycobacterium avium complex (MAC). NTM are environmental opportunistic pathogens whose source of infection includes soil and drinking water. Lab studies have identified physiologic features of NTM that are determinants of their ecology and transmission to humans: including, surface hydrophobicity, attachment to surfaces, concentration in aerosols, resistance to disinfectants (e.g., chlorine), growth in protozoa and amoebae, and ability to grow on low concentrations of organic matter at low oxygen levels. Thus, NTM are ideally suited for growth and persistence in household plumbing. Significantly, NTM isolated from patients and their household plumbing share the same DNA fingerprints. Further, households with well water sources and high hot water heater temperatures seldom have NTM and that carbon-containing, in-line filters, including those in water taps and refrigerators, harbor high numbers of NTM. Current laboratory studies involve studying the behavior of NTM in household hot water heaters and describing the mechanism of exclusion of NTM from household plumbing by members of the genus Methylobacterium. Many of these aforementioned aspects and characteristics are transferable to hospital water systems. In 2003, Dr. Falkinham received the Gardner Middlebrook Award for his contributions to Mycobacteriology.

Professor Falkinham (Professor of Microbiology, Virginia Polytechnic Institute and State University, USA) focused on one particular group of Opportunistic Premise Plumbing Pathogens (OPPPs) – the family of non-tuberculous mycobacteria (NTM). These are the most extreme OPPPs, the most difficult to treat, the most difficult to eliminate, and the most difficult to culture. Risk factors for developing clinical NTM disease include:

• Occupational lung damage (typically seen in smokers, farmers, weavers, etc.)

• Individuals with previous lung infections treated with antibiotics (antibiotic treatment removes competitor organisms leaving the lung open to colonisation and infection by NTM)

• Individuals who are HIV positive

• Chronic Obstructive Pulmonary Disease/bronchiectasis

• Gastric reflux (individuals may aspirate stomach content after drinking contaminated water – NTM are tolerant of stomach acids and low pH)

• Households where the water system temperature is between 50 – 125 ˚F (10 – 50 ˚C). NTM are infrequent in homes with hot water temperatures above 130 ˚F (55 ˚C)

• Individuals who are female, taller than average (> 5’ 8), slender (BMI 20-25), older (average 58 years)

• Genetic predisposition – some are carriers of Cystic Fibrosis gene

• Environmental/domestic predisposition – such as living in large, but low occupancy houses with multiple bathrooms and underused water outlets

• Individuals undergoing open chest cardiac surgery, where the risk for mycobacterial infections have been traced to the heater-cooler machine

Professor Falkinham shared that involvement with heater cooler equipment had changed his working life – indeed until recently he did not know what a heater-cooler or who a perfusionist was, until cardiac patients were diagnosed with NTM infections. The heater cooler machine is wheeled in and out of the Operating Room and serves to

Surrounded by Waterborne Mycobacteria

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PROFESSOR JOSEPH FALKINHAM - SUMMARY

keep the blood at 37˚ C and to cool the patient during open heart procedures. It has a water tank on-board, which has been historically filled with standard tap water. Unfortunately, one heater-cooler machine manufacturer has a design where an electronics cooling fan draws aerosolised bacteria across the water tank surface and out into the surgical field within the operating room. The cardiac surgery infection reports are unexpectedly all of the same species (Mycobacterium chimaera) and genetic fingerprint, and this finding points to the manufacturing plant in Germany as being the source point of NTM colonisation, where leak testing of the machine was completed with local tap water. When any piece of kit or equipment is checked for leakage using a water source, despite draining, there is always a residual of water left within. This may then dwell in warm conditions, often with nutrient sources present, so that thick biofilms form ready for installation into your facility or process. Disinfection prior to installation, as part of the instructions for use or for the on-site commissioning process, will not ensure the equipment is clean or safe from pathogen colonisation, and be a risk for infection ongoing.

NTM represent microorganisms that surrounds us, and there are many species identified, currently totalling 170. There are those which are “slow growing” (> 3 weeks to show colonies under culture conditions) such as

• Mycobacterium avium complex (which despite the name we are more likely to contract from pigs)

• M. intracellulare (soil associated)

• M. chimaera• M. kanasasii (associated with old cattle yards in central US such as

Kansus and Chicago)

and those which are relatively “rapid growing” (3-7 days to show colonies), such as the clinically relevant species

• M. fortituitum (infections linked to ice and ice machines)

• M. chelonae

• M. abscessus (associated with water, primarily in the south and south east US, and is a very antibiotic-resistant species which is very difficult to treat)

It is critical to determine the species to understand the patient’s source of infection (water or soil) and to identify the best antibiotic treatment regimen. Spare a thought for the clinicians who have a maximum of 5 minutes spent on NTM at medical school, therefore all of the learning happens on the hoof and in the field.

NTM have a self-made, thick, lipid, outer membrane which make them impermeable. They have a very slow entry of nutrients (a mechanism which helps them resist disinfectant exposure), yet a rapid metabolism in order to main this lipid layer. This slow growth coupled with active metabolism, ensures they adapt relatively quickly to environmental changes. They prefer to adhere to surfaces and form biofilms rather than stay in the planktonic phase – so combining the biofilm matrix protection alongside their thick lipid outer-membrane means they are highly resistant to all disinfectants (especially chlorine – disinfectants kill off the competitors to allow NTM to thrive in the chlorinated environment), can use catalase to destroy hydrogen peroxide, are desiccation-resistant not only from the thick waxy cell membrane but also from residing within the water rich biofilm matrix, grow under reduced oxygen levels (happily grow in stagnant water and grow at oxygen concentrations down to 6 %), grow on low organic carbon levels (50 micrograms per litre) and are

amoebae resistant. Providing there is long enough exposure, UV light can kill NTM cells, but otherwise they are almost indestructible. In an experiment where 100 billion M. chimaera cells were injected as an inoculum in a heater-cooler machine, within 5 minutes of water circulation most had disappeared from the water flow, only ~ 1 million cells remained in the water flow (0.001 %). They stick to the tubing walls and storage tank surfaces, form a biofilm and then sporadically shed bacterium into the water flow. This action is also true of other OPPPs. Cells growing in biofilms do not behave the same as planktonic cells – neither do professional water-adapted cell populations behave the same as laboratory grown cell cultures – the former are much tougher. However, remove cells from the biofilm or nutrient poor water systems, and grow them up overnight, and they can lose/reduce in tolerance. Tolerance is transient to match the environmental stresses and conditions.

Regrettably, lack of physician knowledge and understanding of this bacterium and the associated patient symptoms, means a diagnosis can often take 2-3 years. A typical treatment pathway would be 3 or 4 different antibiotics, with the patient already very sick with cough, night sweats, debilitating fatigue and lifelong susceptibility to reinfection. The presenting patient will likely be female, an active and alert woman who had suddenly been hit with incapacitating fatigue with an associated persistent cough, and likely treated for asthma, pneumonia, flu and allergy before hopefully uncovering the true problem. There are an estimated 85,000 people in the US suffering from NTM infection, but this is the tip of the iceberg and many may never be diagnosed. Mycobacteria are the ideal pathogen – causing fatigue, weight loss, chills, fevers – yet the host survives albeit with a much reduced “life”. Culture is not easy, with long incubation times on nutrient poor growth media with a little magnesium sulphate, ammonium sulphate, glycerol and tap water before colonies are visible. The NTM grow slowly, not because they have a peculiar nutrient requirement, but as a result of expending most of their metabolic energy to make the outer membrane.

Interestingly, Professor Falkinham explained how NTM are easily concentrated in aerosols due to their charged membranes; they rise as air bubbles to the surface in a body of water, and are expelled as the bubble bursts at the water surface. This is one reason why the air just above a body of water can hold much higher concentrations of NTM than in the water itself. In addition to the heater coolers, NTM infections have been traced to aerosols generated by humidifiers and hot tubs/spas.

NTM, like many OPPPs, are amoebae-resistant. Their catalase activity protects them from the amoebae digestive enzymes. They have cellular mechanisms supporting adaption to conditions before onset of death – for example, temperature tolerance of NTM is broad. They arrive in cold water, often < 50 °F (< 10 °C), but can survive at 140 °F (60 °C). Those growing in US hot water systems, adapt to temperatures around 107-113 °F (42-45 °C), and then can survive short periods of 140 ˚F (60 °C). However, if normally resident at 77 °F (25 °C), sudden exposure to 140 °F (60 °C) could lead to cell death. NTM can adapt thermally due to the presence of trehalose, a disaccharide molecule, which is present in significantly higher quantities in those cells that survive the high hot water temperatures – the higher levels of trehalose are driven by the hot environment, and the higher the level of trehalose the higher the tolerance to hot water. More thought should be given before just turning the hot water temperature up. â

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SUMMARY - PROFESSOR JOSEPH FALKINHAM

â NTM are present in natural soils and waters, potting composts, drinking water distribution systems, premise plumbing, water heaters, medical kit and equipment, refrigerator water and ice, hot tubs, spas, therapy pools, humidifiers. Professor Falkinham highlighted a patient case whose home water outlets had been sampled in the search for the source of her NTM infection. One culture plate had confluent growth, estimating 100,000 M. abscesses per mL from a sample collected from the refrigerator water dispenser. The patient, following her doctor’s advice, was drinking 6 x 8 oz. glasses of water / day and ingesting an estimated 1 billion NTM bacteria / day. Regrettably, the patient also suffered gastric reflux, so every night when she lay down, she risked infection via aspiration. Other equipment recommended for decommission and removal included misters, hot tubs, spa and therapy pools in order to mitigate risk of NTM transmission. Certain geographies are more affected by NTM than others – for example in Finland, where there are peat rich soils with high numbers of NTM (1 million NTM per gram of potting compost), there is also the favoured culture for sauna – putting water onto hot rocks which creates aerosolised NTM. Most HIV positive patients in this region have M. avium complex. Therapy and hot tub pools, with jets creating bubbling and aerosols also carry risk of exposure to NTM. Misting devices too are also very effective at transferring NTM into our lungs.

NTM are 1000 x more resistant to chlorine than Escherichia coli, yet E. coli is still considered the benchmark organism for systemic disinfectant performance. In the water treatment plant, the concentrations of chlorine used would typically kill E. coli within 3 seconds, but would need at least 6 hours’ exposure to kill NTM - hence NTM survive the water treatment plant processes. Additionally, such disinfectant performance is completed on laboratory grown organisms in suspension which are much feebler that those water-adapted organisms found within water system biofilms. Remediation for the latter needs robust protocols for cleaning, including initially disrupting the biofilm by use of an enzyme-detergent mixture to break hydrophobic bonds, salts to break ionic bonds and enzymes to break down DNA, lipids, polysaccharides and proteins. However, it is important to understand the tolerance of plumbing materials and installed fittings and equipment, and if such treatments are compliant with local drinking water rules before applying. Remediation should also include proactive removal of dead ends, mitigation of stagnancy by reducing size of the water system rather than just flushing which can rapidly and effectively fill a room with high levels of contaminated aerosols, drain water heaters, implement high temperature shock (> 55 ˚C / 140 ˚F), and point-of-use 0.2 micron filtration. Point-of-use 0.2 micron filters are effective as a barrier in preventing transmission from the premise plumbing either to the user/patient or medical equipment (e.g. bronchoscopes) if used for final rinsing.

Professor Falkinham concluded that these critters are not the old ball game, we need to adapt and change the rules in order to best manage them.

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SUMMARY - PROFESSOR JOSEPH FALKINHAM

Dr. Mike WeinbrenConsultant Microbiologist Infection PreventionUnited Kingdom

Dr. Mike Weinbren has been a consultant microbiologist since 1990. His interest in water microbiology was first stimulated when working at Queen Mary’s University Hospital Roehampton, which housed the regional Burn unit where water / bathing equipment was a formidable source of cross infection. In 1999 he moved to work at the University Hospital of Coventry and Warwickshire and was the Director of Infection Prevention and Control overseeing the new hospital construction which, at the time, was the largest Private Finance Initiative build in Europe. Pseudomonas aeruginosa outbreaks on Neonatal and Adult Intensive Care Units, as well as a Legionella contamination of the drinking water system of the newly built hospital rekindled his interest in water microbiology.

Mike is currently Chair of the Healthcare Infection Society working party regarding Water Management for Healthcare Microbiologists, which is in the process of producing new guidance for infection control teams.

Pseudomonas aeruginosa in the hospital setting: The original and historical waterborne adversary

Dr Mike Weinbren (Consultant Microbiologist & Director of Infection Prevention, UK) reflected back to Florence Nightingale, the first person to link hospital design to patient outcome. Ever since this time hospital design has been repeatedly shown to cause patient illness and do harm. In medieval years people believed that “smell” transmitted illness rather than water supplies or waste water itself. It was not until the late 1970s that the transmission of Legionella through aerosolisation and contamination of potable water supplies was uncovered, and now another 50 years on we are looking at the periphery of the water system with concern regarding the exchange of plasmids and ever increasing developments in antibiotic resistance.

Dr Weinbren referred to UK guidance, particularly Health Technical Memorandum (HTM) 04-01 and Health & Safety Executive Guidance (HSG) 274 which focus on Pseudomonas aeruginosa and Legionella spp. risk management, yet despite this documentation we still see outbreaks and worse, we still see outbreaks in healthcare facilities. Legionnaires’ Disease remains under diagnosed, and where only the urinary antigen test diagnostic is being used we continue to underdiagnose as only Legionella pneumophila serogroup 1 is picked up.

Healthcare water systems are not just a facilities and engineering issue, it needs cross-functional vision and input. With the new build for University Hospital Coventry and Warwickshire, it was believed by construction installers that the water systems were so modern and sophisticated, that water hygiene would never be a problem at the site.

Legionella was detected in the cold water within 3 months of opening the hospital, following siting of the main cold water storage tank in the plant room which was incubating nicely at 35 °C (95 °F). Not only was Legionella isolated from the cold water, but there was also a Pseudomonas aeruginosa outbreak on the Neonatal Intensive Care Unit from contaminated water outlets. The outbreak was terminated with the use of sterile water for the neonates and use of alcohol gels after hand washing. The Legionella contamination in the cold water system was found to be both temperature control and stagnancy related. Chlorine dioxide continuous dosing at 2 ppm was increased to 4-5 ppm and then flushed through to the outlets in order to mitigate the problems.

In another outbreak, 2 weeks after opening the facility, Pseudomonas aeruginosa was isolated from 6 patients on the same day. The question asked at the time was “is this an outbreak”? In this facility, 3 x Intensive Care Units and 2 x High Dependency Unit had been combined – as separate entities most of the units would not investigate n=1 Pseudomonas aeruginosa infection. The primary investigation did not reveal anything, so an environmental investigation was launched to assess the water sources. Dr Weinbren stressed that in an investigation scenario, it is important not to heat/disinfect the water outlet, and to collect immediate water samples into neutralised sample bottles (sodium thiosulphate neutraliser). Typically, a 50:50 mix of cold and warm water is collected from the water outlet into the sample bottle. Storage and shipping conditions are important – ensure the â

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â correct temperatures are adhered to and that the sample is tested within 24 hours of collection. In Dr Weinbren’s clinical microbiology laboratory, a vacuum source is used to pull the collected water volume through a membrane, which is then placed on an appropriate agar plate for incubation. A Pseudomonas aeruginosa colonisation is usually easily identifiable by its characteristic blue-green coloured colonies. All 12 outlets from the ICU had been sampled, 5 had high levels of Pseudomonas aeruginosa detected with confluent growth on the agar plates. Infection control measures were revised immediately, with staff using alcohol gels post hand washing, only negative outlets were used for patients and further testing was undertaken on the kitchen water supply. Repeat sampling of the ICU outlets found that 2 of the previously negative samples were then strongly positive (following swabbing of the end of the faucet outlets). This raised further questions, including where was the source of the contamination? What other areas of the hospitals were affected? What were the routes of infection?

Dr Weinbren explained that to undertake an investigation into the source of a contamination it is necessary to look for the location of the biofilm within the water system. Planktonic forms captured in a water sample represent only 1 % of the bioburden of a water system and give relatively little information regarding the location. There were more than 8000 water outlets at this hospital, so an investigation into the contamination source is no small task. It is important to undertake both pre- and post-flush sampling (flushing for 2 minutes) in order to determine if contamination/colonisation is systemic (in the main water supply) or peripheral (close to the outlet). In order to get a “true” pre-flush sample and to find peripheral contamination, it will be necessary to prevent staff from using an outlet overnight and take the water samples very early in the morning (before 6 am). Risk of infection from a water outlet varies, and generally reduces, during the day as the water outlet is used and the volumes of water are passed. The greater the water turnover per outlet the lower the risk, conversely the more outlets installed then the higher the risk. This may be one reason why neonates are at heightened risk of waterborne pathogens; not only are they immune-naïve, but may be exposed to the first slug of water from an outlet which is potentially presented with higher bacterial concentrations in the small volume gallipots used for washing neonates and their incubators. In the neonatal unit it was agreed that no water outlets could be deemed safe, so a policy for point-of-use water filters was implemented.

Washing hands with contaminated water is a real concern – particularly with the continuing drive for hand hygiene compliance. Dr Weinbren explained that behind the inspection panel above or below the fitting outlet, you will find the hot water and cold water feed pipes, flexible hoses were commonly used for ease of plumbing to the fitting itself and may still be found in older fittings, and a thermostatic mixing valve (TMV). At a hand washing basin, the cold water supply is rarely used, and therefore the cold water pipe becomes a dead leg which can develop very high microorganism levels. The TMV and the flexible hoses are well known peripheral contamination hot spots with confluent growth frequently found from swabs taken from the TMV and on the inside of the flexible hoses. Flexible hoses are typically lined with nutrient rich EPDM rubber which supports strong biofilm growth, and is one of the reasons they have been banned from use in healthcare facilities in some countries. Despite such widespread contamination at the periphery, hand washing may not be a strong route for patient infection. Dr Weinbren has undertaken some simple experiments where nurses were asked to wash their hands in

contaminated water (6-700 CFU / 100 mL Pseudomonas aeruginosa contaminated water), and with “no attempt to dry” hands were pressed into an appropriate low nutrient agar plate. Only 1/15 plates grew Pseudomonas aeruginosa, so he believes hands are a relatively low risk for transmission. For an organism to reach the patient it has to remain viable on the hands and reach a site on the patient where it can cause disease/infection. A similar scenario could be splash onto clothing or an apron, which is then transmitted via contact whilst leaning over a patient.

Rinsing medical equipment in hand wash basins led to a Pseudomonas outbreak in Nottingham. The water was tested, and the drain sampled. Whilst the water was found to be negative, the splash back and aerosol created from the contaminated siphon onto clean equipment was found to be the route of infection. Hota et al published similar environmental findings, where a Canadian intensive care unit used a UV light source and fluorescent dye to show splash from a sink travelling 1 meter. The use of screens to partition the sink may help prevent splash onto nearby surfaces. In another example, cleaning staff were using spray bottles with a disinfectant sanitiser which was diluted in the bottle by tap water, and which provided a carbon source for Pseudomonas aeruginosa. The cleaner was actually inadvertently spraying the outbreak strain around the intensive care unit.

It is possible to discover an outbreak strain by accident, and Dr Weinbren described how he had left some agar plates with Meropenem discs to understand the antibiotic resistance pattern of a Pseudomonas aeruginosa strain on the bench over a weekend, and discovered Stenotrophomonas maltophilia on the plate (Stenotrophomonas is resistant to Meropenem). Stenotrophomonas is slower growing and prefers a temperature of around 30 °C (86 °F), therefore an accidental extended period left out on the bench was ideal conditions for it. Both Pseudomonas aeruginosa and Stenotrophomonas maltophilia were present despite a 4-5 ppm chlorine dioxide level in the water supply. It is naïve to believe that systemic chemical disinfection would make any difference to these tolerant professional water based pathogens. When typing bacteria from a polymicrobial plate, the laboratory may only pick one or two colonies, so it is possible to miss the outbreak strain when completing the typing. A realistic number of colonies should be picked for typing, however with a confluent plate it is not easy to pick a representative number!

In the Coventry and Warwickshire outbreak, there was concern that the plastic pipework was supporting the Pseudomonas growth. Anonymous sampling of multiple intensive care units across the East and West Midlands in the UK was undertaken and revealed that they all had Pseudomonas aeruginosa in their water supply and up to 50 % of their water outlets were colonised. Samples were taken at the end of the day when considered “low risk” following a day’s worth of use and flushing, so this was an optimistic picture. Stenotrophomonas was also found in those areas where duel testing of water samples was undertaken. None of the intensive care units believed they had a problem with Pseudomonas aeruginosa transmission before this study, and that the events seen were “normal” rates of infection.

How do water outlets become contaminated? Firstly, Dr Weinbren suggested to watch cleaning staff to ensure they follow the correct hygienic protocol (wiping from clean to dirty areas, and with new or folded cloth techniques etc.). He completed this observation within his unit, and was disappointed to see the cleaner completed the

SUMMARY - DR. MIKE WEINBREN

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DR. MIKE WEINBREN - SUMMARY

process perfectly, and yet then watched the cleaner use the same cloth on each faucet and basin fitting in the intensive care unit. The cloth was a metro system for transfer of bacteria. Certainly small numbers of bacteria are present in the influent water which can lead to contamination, however we install heavily contaminated fittings and components in the water system, and then assault it with retrograde contamination at the periphery. Hand wash basins should only be used for hand washing. Adequate activity space (the space between the faucet outlet and the basin) is key to reducing risk of retrograde contamination, particularly if there is a point-of-use water filter fitted. Point-of-use water filters are very effective at protecting high risk patient populations from waterborne pathogens, however, attention must be paid to the activity space, splashback, adaptors and fittings to ensure they are not leaking, otherwise unfiltered water can still reach the patients. All water outlets should be considered “dirty”, and steps taken to protect users and the nearby environment from it. An innocent hand wash station in a pharmacy preparation area could lead to splash onto critical drugs and drug delivery sets. A dirty sluice, where the sluice hopper is next to the store for clean bedpans, could lead to contamination. Nurses potentially track dirty patient fluids through wards and along corridors to dispose down a sluice sink – perhaps it would be better to position more “dirty” sinks where it is practical and have clean hand wash basins separately identified.

Dr Weinbren noted the work of Joachim Kohn, an extraordinary man, who used his medical and engineering skills to design many devices and methods that we still use today, including an ambulance for burns patients, the first protein reference unit, electrophoresis and a sump/siphon which heats up every day to kill the bacteria present. His suggestion back in the 1960s that pathogens could be transmitted from the water outlet to the patient was laughed at by the medical profession in the UK, and he was derided for this position until finally in 2012 following the deaths of neonates at a Belfast hospital led to guidance which recognised this critical risk. The waste water is the next area of concern. Wipes are disposed of down the toilet which leads to area of slow flow and blockage. Into this same waste system, we are pouring antibiotics, and contaminated waste from infected patients. Emerging pathogens are being brewed in our hospital waste water reactors, where the result is rich biofilms, where exchange of plasmids and resistances is common, and where new bacteria are growing up in the system. The drainage systems are a highway for bacteria to move across the hospital. This is supported in a paper published by Breathnach et al, where it took their team 4-5 years to track down the source of a recurrent highly resistant pathogen. Eventually it was traced to the waste water system, and back up from the showers; the hospital experienced 300 drain blockages per year. Blockages must feature as part of the water safety plan and be recognised as a risk for infection.

It is only possible to identify hazards if you have the knowledge to recognise them. This takes a trained eye. Susceptible pathogens, such as a sensitive Pseudomonas aeruginosa, do not have much attention paid to them. It is more likely that the resistant or unusual organisms get in the spotlight and are investigated. However, it is the sensitive bacteria that go under the radar until an investigation unearths them. Most of the damage to humans by infection is done by these sensitive strains, these stealth bacteria. Hopman et al have published data (2017) from a recent move by a Dutch hospital to remove all the sinks and drains from an intensive care area following a chronic problem with a resistant waterborne pathogen. Since removing all of the outlets, they have had a significant drop across all Gram negative infections in this patient group. Certainly food for thought for what our future and better hospital design should be.

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Dr. Paul McDermottDirectorPJM-HS Consulting Ltd United Kingdom

Paul McDermott, PhD, has significant practical experience in occupational health and safety, specializing in the fields of biosafety and biosecurity, and incidental exposure to biological agents in workplaces. He is a Fellow of the Royal Society of Public Health, a Member of the Water Management Society, a Fellow of the Institute of Healthcare Engineering and Estate Management, a member of the Healthcare Infection Society’s Working Party on water management, IOSH, and Institute for Safety in Technology & Research. Before setting up PJM-HS Consulting in 2014, Paul gained 13 years’ experience working as a Specialist Inspector in Great Britain’s Health and Safety Executive (HSE). His specialist regulatory role in HSE’s Biological Agents Unit involved undertaking inspections and audits, and enforcement of health and safety legislation in biocontainment facilities. He has also been instrumental in the production of key national guidance documents in this field and represented HSE at numerous governmental and industry-led forums and conferences, both nationally and internationally. As well as his contained-use expertise, Paul has a strong reputation in the effective management of waterborne infections, in particular Legionella and Pseudomonas aeruginosa. Paul has acted as expert witness in a number of legal cases, and was a key contributor in the review of the current Approved Code of Practice (L8) and its associated technical guidance (HSG274). Paul is currently Authorizing Engineer (Water Safety) at a number of NHS Trusts.

Pseudomonas aeruginosa and other Waterborne Pathogens in your hospital water? The “Not Us” Myth

Dr Paul McDermott (Director, PJM-HS Consulting Ltd, UK), previously of the Health & Safety Executive and now an independent water hygiene consultant, confirmed that in the UK and some other European countries there is a reasonable level of awareness for waterborne Healthcare Acquired Infections, including those caused by Pseudomonas aeruginosa and Legionella pneumophila, and that his presentation would share some of the UK experiences and corrective actions to avoid similar consequences elsewhere in the future.

Asking the audience for a show of hands, it was evident no one present was sampling and testing their hospital water for Pseudomonas aeruginosa, and only a handful were sampling for Legionella pneumophila. Dr McDermott continued that it is almost certain both these organisms are present in hospital water systems, and that with vulnerable patients, exposure can cause disease. The scientific literature is rife with new and emerging waterborne pathogens including environmental mycobacteria, Aeromonas hydrophila, Stenotrophomonas maltophilia, Serratia marcescens. Risks from infection by carbapenemase-producing-organisms (CPO) /carbapenemase-resistant Enterobacteriacae (CRE), that are being

found increasingly in hospital waste water systems, are a growing concern. Patients within hospitals are at the greatest risk due to their often low immune status and their being in an environment serviced by highly complex water systems which can be difficult to manage, are often modified or extended, and contain a mix of material types types used in their construction. There is also a wide range of patient uses for water, including drinking, food preparation, bathing and cleaning, as well as specialist uses, such as endoscope washing.

In England & Wales (2015), a total of 382 Legionnaires’ Disease cases were confirmed: 191 from the community, 177 from travel abroad, 14 hospital-acquired cases. In the UK, Legionnaires’ Disease is notifiable, so all confirmed cases must be reported to Public Health England. Hospital-acquired cases make up a very small number, only 3.7 %, but this must be considered in the context that hospital water systems demand the highest standards of control, despite which there was still an increase in the numbers reported in 2014. In England and Wales there are 7.4 Pseudomonas aeruginosa bacteraemia cases reported per 100000 population, which is equivalent to 4,500 cases per annum. There is no requirement to

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report if diagnosed, and the highest rates are notably found in men older than 75 years. However, the data do not specify precisely how many of the cases were associated with hospital in-premise water systems, but these may be significant.

Dr McDermott continued by reporting a UK hospital case, where 8 Legionnaires’ Disease cases were reported between 2007-10, including a hospital visitor, and 2 fatalities resulted. Following an historical lookback, another fatality was recognised from 2002. The hospital had significantly improved their water remediation, however it was not enough to prevent further problems. A systemic chlorine dioxide dosing had been installed, but it was not managed correctly - neither the hot water temperatures nor chlorine dioxide levels were being monitored effectively at the outlets. Following introduction of chlorine dioxide, the hospital reduced the dosing rate so considerably lower levels were found at the outlets, additionally showerheads and thermostatic mixing valves were not being serviced or cleaned. Normally showerheads would be maintained on a quarterly basis in hospitals in the UK to remove scale and biofilm build up, yet in this hospital the service was completed on a 6 monthly basis. Thermostatic mixing valves, which offer a huge surface area and often have high plastic content creating favourable nutrient access for bacteria, need to be dismantled, properly cleaned and maintained on a regular basis. This was also lacking. The case was high profile, yet when prosecuted the fines were relatively low (£100,000 fine plus £162,000 costs), as it was considered that heavily fining the National Health Service would adversely affect the quality of services to local hospital populations.

It is clear that someone on site needed to take responsibility for the water quality, and this would usually be what the UK recognise as the “Responsible Person” - often the Facilities Manager or Engineer. It is important to recognise that these individuals may not have the infection prevention or clinical knowledge required to understand the impact of changes to water system management. Hence the need for, and importance of, an effective Water Safety Team contributing to the Water Management plan. A cross-functional group of individuals who have the knowledge and skills to recognise hazards and risks associated, and to manage multifaceted factors in a holistic way.

A further two high profile cases were then presented, this time with fines of up to £1.8 million despite one of these cases having no evidence to support the route of infection. Here the culpability of those who should have been managing risks was taken into account, along with the severity of the outcome of infection, using newly introduced sentencing guidelines. It seems clear that, in future, financial penalties imposed on offenders will increase and be more reflective of the damage that failing to manage risks from exposure to Legionella can cause.

Moving on to discuss Pseudomonas aeruginosa outbreaks, Dr McDermott presented a case history from two Belfast hospitals where babies in the neonatal intensive care units had been infected – there were a total of 7 infections and 4 fatalities. Colonised faucet fittings were implicated. The Northern Ireland Regulation and Quality Improvement Authority published their report in May 2012, where it was recognised that many things had contributed to the tragedies including communication plans, independent validation of water management arrangements and that the development of Water Safety Plans needed to address problems with other waterborne pathogens, not just Legionella spp. An addendum was written to support the UK’s Department of Health’s Health Technical Memorandum (HTM) 04-01 to help manage risks from

Pseudomonas aeruginosa in augmented care units – it is important to protect the most vulnerable patients - with practical advice on how to achieve this, what the water system outlets should look like and how to avoid colonisation at the periphery of the water system (which is where most Pseudomonas contamination is found).

Water Safety Groups need to recruit the correct expertise in order to develop and manage a water plan under these circumstances, and they need up to date information to help with decision making. England and Wales must sample and test all water outlets in augmented care areas at least every 6 months, and undertake resampling and remedial actions if the results are above set alert levels (1 to 10 CFU / L). This is a challenging job for even the largest hospital trusts. In Dr McDermott’s view, the logic for the 6 monthly test period is perhaps questionable, as this represents only a tiny picture of what colonisation may be present, and there is no indication or evidence that a negative outlet would remain negative for the 6 month period. However, it is highlighting the level of risk from Pseudomonas aeruginosa, and enabling proactive approach to managing this waterborne pathogen. In another neonatal case, Dr McDermott presented on 4 neonates that had tested positive for Pseudomonas aeruginosa where 1 baby developed septicaemia and died. The clinical and environmental samples were examined and those from a hand wash basin in the hospital nursery and the baby that died were found to be indistinguishable, implicating the hand wash basin as the source of infection. A serious incident investigation was led by the head of clinical investigations, and a report published with findings and recommendations relating to the locations of soap and emollient dispensers, disposable glove and apron dispensers, clinical trolleys, plus lime-scale on some faucet outlets, hand hygiene of parents and visitors to the unit. Hand hygiene audits for clinical staff were frequent, but nothing covered parents and visitors or cross infection in these areas. The mode of transmission was unknown, but the role of splashing onto surrounding surfaces and articles was considered as a potential cause. The report highlighted

• Improving design of soap dispensers to avoid dribbling waste as soap can provide a nutrient source for Pseudomonas and to avoid wet hands touching the soap dispenser outlet

• Storing gloves, aprons, trolleys more than 2 meters from the sink to avoid the splash zone

• Using clear and better signage for all hand wash users – including parents and visitors

• Removing thermostatic mixing valves (TMVs) where possible

There is much discussion regarding TMVs, and where there is credible scalding risk it is obvious that they should remain. In a neonatal ICU, where able bodied nurses, parents and visitors can blend the water for their own comfort, there is likely to be no need for a TMV. Risk assessments can now enable the Water Safety Team to decide if they are appropriate for new installations. As has been said, if TMVs are present, they require a rigorous maintenance and cleaning regimen. A third case study covered a Haematology/Oncology unit, where there had been one Pseudomonas aeruginosa case in 2010 and another identical case in 2013 – both fatalities. Swab samples were taken from the shower tray and an identical strain was found in foul drainage. The investigation revealed that a previous blockage had led to a “back up” of waste water into the shower tray, and this had likely led to the second case of disease. In a final example case, there were no fatalities, however clinical surveillance kept popping up Pseudomonas aeruginosa â

DR. PAUL McDERMOTT - SUMMARY

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â infections from one area of the hospital. The outbreak strain and source was found in refillable sanitiser spray bottles. The cleaner had been toping them up with contaminated tap water and the level of disinfectant was below the recommended concentration.

In recognising hazards, Dr McDermott considered stagnancy / water turnover / water age – where more water is stored in hospitals than is needed. In the UK, the recommended storage capacity is around 12 hours’ supply, however there are always redundancies built in, and in some cases, more than a week of supply is stored, in Dr McDermott’s experience. Additionally, with increasing alcohol gel hand hygiene and patients being released earlier from hospital, turnover at the water outlets is is likely to decrease. In numerous cases, due to space limitations in many hospitals, little used shower rooms and hand washing areas are used to store kit and equipment. In the UK, we usually have too many outlets in healthcare facilities, so the level of redundancy can be very high. How can the Water Safety Team act to keep stagnancy down? Firstly, remove unnecessary water outlets, ensuring that supply pipework is retraced to the main circulatory pipework and removed, and bring into effect an audited flushing regimen. Flushing for water hygiene purposes should always take precedent over any conflicting water-saving green initiatives or goals.

There are basics in water management, which include

• Keep the system clean by reducing nutrients and particulates in the influent water to a minimum, assessing materials in the system for bacterial nutritional access, regularly cleaning tanks and fittings

• Keep the hot water hot (leaving the boiler at 60 °C / 140 °F, and returning in the loop to the boiler at 55 °C / 157 °F

• Keep the cold water cold (< 20 °C / 70 °F)

• Consider using a systemic biocide where appropriate and if allowable

• Consider the vulnerability of the patients exposed

• Develop the best possible water safety group and water safety plan by having cross-functional input in decision making

All sounds easy, but is actually difficult to do well. In the UK there is a plethora guidance for Legionella management – the Approved Code of Practice (L8) which reflects UK health and safety regulations, which are mandatory and must be applied, Technical Guidance (HSG 274 Part 2) which advises how to do it, and Health Technical Memorandum 04-01 from the Department of Health for addressing waterborne pathogen risks in healthcare. Yet cases are still found.

Pseudomonas aeruginosa will eat almost anything and can thrive on very little – they are metabolically agile and utilise multiple food sources. This is important when considering hazard and risk assessments. Pseudomonas aeruginosa has a similar temperature range as Legionella pneumophila, the bacteria multiplying where temperatures are between 20-45 °C (68-113 °F), are mainly dormant < 20 °C (68 °F) and do not survive > 60 °C (140 °F). Pseudomonas aeruginosa is common in biofilms, enjoys stagnation, usually contaminates the periphery of a water system, can live in very nutrient poor waters, and importantly the level of antibiotic resistance is increasing at a rapid rate which is of concern for us all and highlighted recently by the World Health Organisation. Shaving a patient using water is a high risk activity, the hazard is Pseudomonas aeruginosa in the water. Whilst it is possible such bacterial contamination is incoming with the mains water supply, it is far more likely that the biggest risk is retrograde contamination of the water outlets at the periphery. Anything within a 2 meter splash radius of a

wash hand basin could potentially contaminate or be contaminated by the outlet and should be considered a dirty zone; this is where the Water Safety Team need to focus their attention.

Pseudomonas aeruginosa can cause infections in almost any part of the body, including the respiratory system, bloodstream, heart, nervous system, ears, eyes, bones, joints, gut, urinary tract and skin infections. Pseudomonas aeruginosa infections are commonly found in Cystic Fibrosis, ICU and Burns patients, patients with impaired immune systems, patients with breaches in their skin defences (catheters), preterm babies and other augmented care patients. Dr McDermott confirmed that patients, or their contaminated body fluids, can contaminate water outlets (back splash to the faucet outlets). Contaminated water from the outlets could then be used to wash hands, fill containers, or create splash from the sink onto other surfaces or patients nearby. Outlets may be contaminated if they are touched by dirty hands, or by dirty cleaning cloths or cleaning solutions. The Water Safety Team needs to look at options to design out Pseudomonas risk such as

• ensuring there are off-set, or rear drain holes, low splash basin surfaces, impervious splash backs

• rearranging the position of soap dispensers and hand sanitisers so that users avoid dripping dirty water or soap over the fitting

• use faucet designs that lack high plastic content or aerators and can be demounted and dissembled for cleaning and disinfection

• ensure wash hand basins are only used for washing hands, not for washing other items or disposing fluids

• ensure there is effective cleaning of water outlets – from top to bottom, clean to dirty, using multiple cleaning clothes and training cleaning staff with clear and audited protocols. If the cleaning teams do not understand the consequences of their cleaning, they will continue to do things wrong – a positive training and feedback loop should be nurtured with the cleaning staff

In the UK we have an Act of Parliament and comprehensive guidance regarding the implementation of controls required for the effective management of in-premise waterborne pathogens, whilst in the US there is relatively little guidance. Dr McDermott was hopeful that stronger legislation would follow in the US, and that learning from other countries would better support future Water Management Plans for US hospitals and patients.

SUMMARY - DR. PAUL McDERMOTT

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Stephen A. Streed, MS, CICSystem Director of Epidemiology & Infection PreventionLee Health USA

Stephen A. Streed, M.S., CIC, has been active in infection prevention since 1977, after receiving a B.S. in 1974 and a M.S. in Preventive Medicine/Environmental Health in 1975, both degrees from the University of Iowa. He is currently working on his doctoral dissertation in Public Health (DrPH), which focuses on immunization acceptance among healthcare workers. His first infection control position was at the University of Iowa Hospitals and Clinics and involved infection surveillance and statistical analysis of surveillance data, computer program development and the development and presentation of infection control education. He remained at the University of Iowa Hospitals and Clinics until 1990, when he assumed the Directorship of the Hospital Epidemiology-Infection Control Department at the Wake Forest University/Baptist Medical Center (WFUBMC), in Winston-Salem, North Carolina. Mr. Streed remained at WFUBMC until May of 1999, when he accepted a position in industry to work on epidemiology software development and marketing. Following that, he returned to hospital practice in 2006 and is currently the System Director of Epidemiology/ Infection Prevention at Lee Health in Fort Myers, Florida, a five hospital, 1,600-bed health system in Southwest Florida. He has served two terms on the APIC National Board of Directors and is now immediate past president Florida Professionals in Infection Control (FPIC), a statewide organization dedicated to improving patient outcomes through infection prevention. Mr. Streed has been Certified in Infection Control (CIC) since 1983 and he has authored numerous abstracts, journal articles, position papers and book chapters based on his research in hospital epidemiology, infection prevention, environmental disinfection technologies and the use of computer- assistance surveillance. And finally, Mr. Streed was the 2017 recipient of the Carole DeMille Award, APIC’s prestigious lifetime achievement award in Infection Prevention.

Waterborne Pathogen Risk Mitigation in Acute Care Settings: An Infection Preventionist’s Perspective

Mr Stephen Streed (System Director of Epidemiology & Infection Prevention, Lee Health, USA) shared his 41 years of experience and lessons learned regarding “all you need to know about infection prevention”, and particularly an equation where:

Dose x Time x Virulence = Probability of Infection

Host Resistance

This is a simple Infection Prevention equation, where recognising the source amplification (Dose), extended duration or frequency of exposure (Time), with full strength and range of pathogenicity (Virulence) being applied to the hospital environment with an immunosuppressed user population (Host Resistance), enables the mind to focus on managing the modifiable risk factors.

Regarding water safety, the sources or reservoirs of risk include bathing and tub immersion, faucets and water features and some of the most common pathogens associated are Pseudomonas spp., Legionella spp., non-tuberculous mycobacteria, Burkholderia spp., etc. Strategies for completely identifying and removing all risk are an aspirational goal, but need a holistic view which includes building construction and design, unlimited resources for repurposing and refurbishment in order to achieve this utopia. Risk mitigation identifies strategies to reduce risks and thereby reduce adverse events. There are categories of risk and risk mitigation including risk acceptance (recognition without mitigating actions), avoidance (preventing access or using sterile water only), limitation (lowering the dose or frequency of exposure) or transfer (making it someone else’s’ problem). â

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â Mr Streed drew similarities between the hospital water system and the human circulatory system with regards to infectious risk mitigation. There should be aseptic insertion of devices, routine care and assessment, plus protected biological integrity of lines (limited and controlled access, plus proactive removal when no longer needed and immediate removal if considered a possible source of infection). Differences recognised between the systems in that typically a bloodstream infection would be a monoculture as opposed to polymicrobial species as would be seen in a water sample. We should be as concerned about biofilm formation and build up in our water systems as we are on heart valves, joint prosthesis and IV lines.

Drawing from an historical case (Helms et al, Annals, 1983) which reported on Legionnaires’ Disease case epidemiology with a 46 % fatality rate in Haematology/Oncology patients. The environmental assessment covered air handlers, chiller units, a water feature at the main entrance, and the potable water supply. The potable water was frequently positive, and therefore was considered the source. Control measures were implemented including faucet aerator removal, an increase in free chlorine systemic disinfectant levels to 5 ppm on both the hot and cold water, temperature lowered in the water heaters from 126 °F to 105 °F (52 °C to 40.5 °C) - to avoid gassing off of chlorine - until free chlorine levels of 3-5 ppm were sustained at the outlets before water temperatures were then adjusted back to original levels. Five years later, a further publication, this time on efficacy of continuous hyper-chlorination. The paper described Legionella-negative water samples, but 4 cases of Legionnaires’ Disease diagnosed. Environmental assessment was unable to find a reservoir, however the investigation did reveal >1000 µg/mL trihalomethanes in the water system, with significant corrosion damage to the pipework and the number of reported leaks per month had risen from 0 to 5.2. The Chlorinator equipment acquisition cost was $75K, plus $12.5K in ongoing costs to operate annually which was a substantial investment, however not a large cost compared to the cost of an infection in a Bone Marrow Transplant patient.

Kanamori and co-workers (2016), having reviewed more than 2000 citations regarding healthcare outbreaks associated with a water reservoir and infection prevention strategies, have recently advised the following:

• Standards of potable water should adhere to US public health guidelines

• Hot water at the outlet should be at the highest temperature allowable - preferably > 124 °F (> 51 °C)

• Following any known water disruption post “Do Not Drink” signs at outlets as water quality will be compromised

• Maintain standards for potable water at < 1 coliform / 100 mL

• Only rinse semi-critical equipment with sterile/filtered or tap water followed by alcohol rinse

• Undertake periodic monitoring of water samples for growth of Legionella

• Recognise that Legionella eradication can be technically difficult, temporary and expensive. Potential methods of eradication include filtration, UV light, ozonation, heat inactivation (>140 °F / 60 °C), hyper-chlorination and copper-silver ionization

• Routine screening, disinfection or permanent removal of all water outlet aerators is not warranted at present – but may be proactive to remove them

• Increased stagnancy at water outlets with the increasing use of alcohol gel hand hygiene lead to increased risk at faucets

• Showers – consider prohibiting the use of showers in neutropenic and other high risk patient groups

• New construction and refurbishment – it is critical to consider faucet and sink design/placement, the curvature of the sink to minimise splash back, engineer flow rates to avoid stagnation and yet avoid splash, detailed pre-commissioning water management is needed (e.g. low use/stagnation intervals between plumbing sign-off and building/ward occupancy). When renovating it is critical to remove dead legs back to the main pipework, flush lines thoroughly before using, do not build in dead ends for future expansion as this will simply engineer in a problem for the future, and do not accept them in any plans

Final words of advice from Mr Streed embraced the development of a robust Waterborne Pathogen Plan for your facility. The CMS memorandum has grabbed everyone’s attention, but waterborne outbreaks remain a serious issue in healthcare buildings despite 40 years of trying to manage the problem. We need take these problems seriously.

SUMMARY - STEPHEN STREED

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Olga Guzman, RN, BSN, CICDirector of Infection Prevention and Control EducationKaiser Permanente Fontana Medical Center USA

12 years in Infection Prevention, currently working at Kaiser Permanente as the Director of Infection Control for Fontana/Ontario Medical Centers. Certified in Infection Prevention. Current President elect for the Inland Empire APIC chapter. Chapter co-author in the Neonatology “Management, Procedures, On-Call Problems, Diseases, and Drugs” 25th edition book, 2013.

Our Story, Lessons Learned – Pseudomonas aeruginosa

Olga Guzman (Director of Infection Prevention and Control Education, Kaiser Permanente Fontana Medical Centre, USA) gave a local perspective, sharing the Infection Preventionist’s experiences learnt following a reactive pathway to a Pseudomonas aeruginosa outbreak in a neonatal intensive care unit and understand strategies that can be adopted in the absence of US guidance. This case reflects a new hospital and Neonatal Intensive Care Unit facility that was opened in May 2013. The NICU facility changed from a 35 bed open bay layout to a 28 private single bedded room (with a sink in every room), and from a 450 bed shared room hospital facility to 314 private rooms (with a sink in every room), and from a 4 tower building design to a 7 tower high rise building with a more complex water system. The water systems were flushed and general water bacterial testing undertaken as per the routine protocols prior to opening up the new hospital. Infection Prevention were involved in all the pre-construction planning meetings, however, being present versus understanding the implications of the water system changes and building design undertaken is a different matter.

From as early as the end of May 2013, multiple organisms were appearing in the NICU population, with a spike early in August 2013 of 4 x neonatal Klebsiella pneumoniae infections, followed by Serratia and Pseudomonas infection between August and October. At this point the infection prevention team decided to take a deeper look into this new patient setting versus the old one. It wasn’t just a case of private rooms versus open bay layout, this was a very changed environment with new and additional equipment found, some needing specialist cleaning, new touch surfaces without well-defined processes on who was cleaning what and when, breast pumps were in every room as were warmers for breast milk, and there were computers in every room. We needed to understand what risks had been introduced to the environment, what new behaviours were needed, and how best to manage them. For example:

• Access to alcohol hand gels was not easy, nor was it understood when to apply the gels (e.g. on entry to the private room or before touching the baby)

• A checklist on who would be responsible for equipment i.e. delineating kit to nurses, respiratory care, changing the disinfectant and having protocols

• Updates to central line care protocols, CLABSI – including “do not enter” signage for line insertion procedures and bandage changes. With increasing micro-premies now being supported, this procedure is a critical step for them

• Ventilator kit and equipment – implemented a solution for cleaning the ventilators. Suction devices being used for the babies were being kept inside the incubator which is a horrible bacterial growth risk

A ventilator-associated pneumonia Pseudomonas case was detected in late August, which was brought to the attention of the multidisciplinary team. At the time, the team were more worried about the Klebsiella cases, however a significant Pseudomonas aeruginosa event then followed in November when one of a set of quads expired due to bacteraemia following a positive eye culture. The multidisciplinary team joined to discuss the case and a second sibling was affected, and sadly died the next day. Key team members in the hospital were activated and a data mining system set up to look at cultures across the hospital, find the start of these infections and the source, and identify transmission routes. The microorganisms involved were not multi-drug resistant. Human and environmental sources were investigated, and environmental sampling included water, faucet aerators, respiratory equipment, soap, breast milk, bed humidification and eye drops.

The engineering team inspected all of the faucets – all were found to have aerators (throughout the medical centre). The team partnered with the regional laboratory, who coached them over the phone on how samples should be taken. Correct sampling is critical for such an investigation. Cultures of the water and the aerators, respiratory kit, lotions, soaps, breast milk from the donor bank, humidifier beds and the cleaning solutions were undertaken. Of all the initial samples taken, it was the water and faucet aerators that returned positive results. At this point, a specialist consultant group were brought in to support as the in-house knowledge was not considered sufficient.

Our attention turned to what was going on outside the NICU and in the adult populations. There were some adult cases, a little higher than the old facility, but nothing that was considered as significant. Urinary tract infections were up, so initially looked at how this was being â

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â addressed and how staff were bathing the adults who were catheterised. Patient surveillance for Pseudomonas infection was not something that had been completed, and the team were unsure of the baseline. A literature search revealed a paper from 2001 which found a baseline of 3 % in the neonatal population may be expected, however as Pseudomonas aeruginosa is not part of the normal neonatal flora, it has been suggested that any Pseudomonas infection be investigated. Potential sources for infection included the hands of healthcare workers, all water sources, donor milk and formulae options, breast pump kit, respiratory kit, hand soap and lotion, NICU incubators/humidifiers, bathing procedures, eye drop medications (diluted with water), visitors and outside sources. The breast pumps were very interesting pieces of equipment with regular rinsing and cleaning in the sinks within the private rooms. They were easily and frequently contaminated. One of the positive faucets were disconnected and dissected, and analysis revealed a rough cast surface highly suited to supporting biofilm, and a dead space which allowed for a perfect oxygen/water interface preferable for bacteria such as Pseudomonas. A series of actions followed including,

• Removal of aerators

• Exchange of laminar flow devices

• Follow up environmental samples collected by contracted environmental hygienists

• Deep cleaning of the unit with dedicated staff from the NICU

• NICU closed to new admissions

• Babies moved to “clean” rooms

• All positive babies placed under contact precautions

• All ventilators replaced with clean vents

• All beds/incubators replaced

• All breast pumps / kits replaced

• Hand washing procedures reinforced - 1 minute initial scrub followed by alcohol gel for staff and parents/visitors

• Visitor traffic control: gown on entry, personal belongings bagged and no food allowed in the unit, sign in sheet, education on hand hygiene for all visitors

• Sterile water for all neonate baths

• Water system hyper-chlorination to NICU and surrounding area

• Disinfected sinks – 600 fixtures cleaned to a specific protocol

• Point-of-use water filters installed

• Weekly surveillance cultures (rectal) started

• All environmental and patient specimens sent to an outside lab for DNA typing

All cultures came back negative, and for 3 months everything went well, so the point-of-use water filters were removed. The unit was clear of Pseudomonas for almost 7 months, and the NICU had been reopened for new admissions, and the new nursing controls were kept in place. However, in June 2014 there was another death and another outbreak. What had happened this time? We invited the CDC and CDPH to help us with the investigation, and also invited support from the Kaiser Permante National Facilities and Quality and Performance Improvement team. The CDC collected their own data, and access was given to all the electronic records. They reviewed all 31 cases, and no significant risk factors were identified: 16 cases were < 1000 g; 18 cases Hispanic; 27 % cases had tachycardia within 48 hours. Some gaps were found in hand hygiene. Environmental sampling was undertaken, and from 42 samples taken from point-of-care water, the faucets and drains were the key areas of contamination with 31/45 (69 %) culture positive for Pseudomonas

aeruginosa. The conclusion from the CDC was that there was not enough positive matching between the samples and the patients, however the presence of point-of-use water filters led to an absence of new cases which strongly suggested the relationship to waterborne infection source. CDC suggested changes to hand hygiene and water filters were installed at each point-of-use.

After the CDC investigation, the NICU remained closed to new admissions until cleared. Point-of-use water filters became a standard of care due to the high risk patient population, water system evaluation and remediation projects started, a 3 months’ faucet study in the NICU has been completed to compare the rate of colonisation over time with the replacement “goose neck” design variant (the data was inconclusive). The baseline after the outbreak for the facility is around 4 % colonisation with Pseudomonas. To summarise, the following changes have been implemented and are in progress in the NICU

• POU water filters have been installed

• Dead legs have been identified and removed

• Self-flushing protocols for all the automatic faucets

• Daily monitoring of secondary disinfection

• Daily monitoring of temperature

• Heat exchanger has been upgraded

• Program of work initiated to mitigate water pressure issues due to distribution

• Water sampling plan in place for waterborne organisms

• Preventative maintenance plan in place with ice machines, eye-wash stations, emergency showers and drinking fountains included

• Regular team meetings to review results

Activities are still on-going, however, we are now close to achieving “control” of the risks. The filters remain in place to provide a layer of safety where high risk populations are present, and certainly in the NICU where < 26 weeks’ gestation versus > 26 weeks seems to be critical for colonisation and infection risk. The electronic faucets have an automatic cleaning program; however, we have not as yet decided how often to implement the cleaning cycle. Monochloramine is the systemic disinfectant employed in the facility, and at 3 months post-installation the total bacterial counts have seen a reduction, although the Legionella counts remain higher than desired. Further water testing is on hold until the other issues with flow and temperature are resolved. The key points to remember and to implement in order to avoid a similar experience in another facility include

• A comprehensive water management plan and risk assessment should be included as part of the engineering plans for a new hospital

• Temperature and water flow – need active management

• Flow restrictors – can contribute to fixture contamination

• Secondary disinfection may become a standard in healthcare

• Point-of-Use water filters are an easy and immediate solution whenever water contamination is an issue

• Consultation with an infection control practitioner along all phases of construction including fixture and fittings selection is key

• Ongoing vigilance and communication amongst the cross-functional water management team must take place and on a regular basis

• A water risk assessment must be a continuous process – it is not done once. We will continue indefinitely and help develop new national Kaiser Permante standards to be incorporated in all new construction

SUMMARY - OLGA GUZMAN

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Steven Cutter, MBA, HFDP, CHFM, FASHE, is responsible for all aspects of campus facility management as well as oversight of the in-house project design and management team. He has been in the health care management field for more than 40 years and brings a wealth of practical problem solving and project management experience to his classes. He is a Certified Healthcare Facility Manager (CHFM), a Healthcare Facilities Design Professional (HFDP), and is a former member of the development teams for both of these Certifications. Steven is also a voting member of the ASHRAE 188 Committee and is a member of the Healthcare Guidelines Revision Committee.

Steve Cutter (Director of Engineering Services, Dartmouth-Hitchcock Medical Center, USA) shared his 40 year experiences of facility management and presented his perspective on the water related concerns that a Water Management/Safety Team should focus on. His talk covered suggested best practices and an overview of the guidance from ASHRAE 188 and the CDC toolkit including:

• Building the team

• Creating flow diagrams and risk assessments

• Designing, installing and managing in-premise water systems to mitigate infection risks

• Water system management challenges

• Regulatory requirements

According to a the Centers for Disease Control (CDC), in 2011, about 75,000 patients with hospital acquired infections (HAIs), died during their hospitalization, more than half of these occurred in intensive care units. There are many causes of these infections including pneumonias, central line bloodstream infections, urinary track infections and surgical site infections. While HAI’s from waterborne pathogens are not a leading cause, the numbers of reported cases is increasing and hospitals need to manage this risk.

Recently the Centers for Medicare & Medicaid Services (CMS) issued S&C (survey & certification) 17-30 to state survey agencies. This document requires healthcare facilities to “develop and adhere to policies and procedures that inhibit microbial growth in building water systems that reduce the risk of growth and spread of Legionella and other opportunistic pathogens in water.” In addition, the 2014 Facility Guideline Institute (FGI) Guidelines for design and construction of Hospitals and Outpatient Facilities includes language in the potable water system section focused on reducing the risk of waterborne pathogens.

Mr. Cutter stressed the importance of Healthcare facilities developing a water management plan that assesses and mitigates the risks of waterborne pathogens in their potable water systems. Two important documents referenced in CMS S&C 17-30, include ASHRAE 188-2015 Legionellosis: Risk Management for Building Water Systems and a CDC toolkit titled Developing a Water Management Program to Reduce Legionella Growth and Spread in Buildings.

Mr Cutter acknowledged that there are many risks in healthcare, CLABSI, CAUTI, VAP, SSI, Clostridium difficile, workplace violence, HIPPA, cybersecurity, misdiagnosis etc., with new ones appearing on the horizon rapidly. Healthcare facilities should develop a process to assess the risks of waterborne pathogens and develop mitigation strategies. This will involve a team of people who have to understand and balance the risks of waterborne pathogens as well as other risks and make decisions about where and how to apply resources, using advice and best practices from the available documents. Generally the process will include:

• Establish a team – the bare minimum should include Health & Safety, Infection Prevention, Facilities Engineering staff – plus others who are important such as Clinical Microbiologists, cleaning staff, laboratory staff etc. The team will refresh, expand and evolve over time

• Develop a diagram of water within the building – this should cover flow direction, number of outlets, identify patient types and locations, identify equipment and any relevant documentation. The diagram should not be the building drawings or the detail of the riser systems, but a simple enough diagram that is understandable by all of the Water Safety Team members. Color coded diagrams can help identify where high risk patient areas are or identify high risk equipment or processes. Also included should be â

Water Management Program Development from a Healthcare Facility Manager’s Perspective

Steven Cutter CHFM, HFDP, MBA, FASHEDirector of Engineering ServicesDartmouth-Hitchcock Medical Center USA

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SUMMARY - STEVEN CUTTER

information such as understanding where the source water originates, any seasonality effects, disinfectant residuals from the municipal provider etc.

• Determining what control strategies can be employed, what limits or ranges should be set and how often to review them. A program of monitoring should be established – this could be measuring temperatures at worst case points, or throughput. Specific high risk equipment, such as ornamental water features, will need an additional and effective maintenance program with accountable resource allocated

• Operating procedures for exceptional events (system start up / shut down) should be clear and well known, e.g. if the unit is unoccupied for a certain number of days, then a flushing regimen will be needed

Mr Cutter concluded his presentation by summarising the areas which need extra attention and detail in the Water Safety Plan regarding risk mitigation, including

• Back flow prevention

• Cooling towers

• Water filters

• Ice machines

• Hot water heaters

• Aerators (risk assessment discussion with the team – hospital A versus hospital B will be different)

• Showerheads (some areas may have a different plan to other areas)

• Water features

• Other – such as Medical equipment (e.g. heater coolers)

• Construction procedures, including commissioning and decommissioning

• Temperature – thermal ranges reflected in current plumbing codes and regulatory standards reflect a max. of 120 °F (49 °C) at the water outlet for scalding prevention but the hot water storage temperature can and should be higher if possible. Increasing the hot water storage temperature could be an effective control measure

• Dead legs – abandoned plumbing, often hidden, is very common in both old and new buildings. An ongoing program of eliminating dead legs should be in the management plan. Most water systems will have 2 supplies, one active and one inactive. This piping arrangement may create a dead leg condition in the active supply. A well designed arrangement will provide for flushing the inactive piping section and a the management plan should include procedures to flush before use

• Take care to avoid shower hoses sitting with water stagnating in the loop

• The use of high efficiency, point-of-use filtration, particularly in high risk areas, should be considered. This is similar to the HEPA filtration in ventilation systems serving protective environment rooms

• The use of secondary disinfection should be considered where other control measures may not be adequate. Facility managers should check with local and state authorities having jurisdiction before adding disinfectants to potable water systems

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Mr Robert Hinton Hinton (Director of Operations and Maintenance, University of Washington Medical Centre, USA) is responsible for 1.7 million square feet of healthcare facility and during his presentation shared his experiences of a Legionella outbreak and the implementation of a strong Water Safety Plan since this event. Mr Hinton confirmed that he had been in position for approximately 1 year when their facility had a Legionella outbreak in September 2016. Legionella pneumophila was detected in the domestic water and chlorination of the water system was undertaken. In August 2017, 2 more patients were infected with Legionella and this time the L. pneumophila was found in the water outlet fittings and not in the water system. The investigation tested water fixtures, ice machines etc., and a CDC elite certified laboratory was utilised to complete the testing. It is important to note that the laboratory could only process 35-40 samples at a time; this can be a rate limiting step in an investigation, so best to check the capacity of the laboratory before taking the water samples. At the time there was significant construction work in progress at the facility. One unit had moved and another one had been empty for 6 months, the hot water system was also under refurbishment leading to water restrictions with no showering, and bottled water for drinking and hygiene. Hand washing was allowed, point-of-use Water Filters were installed and ice machines were taken out of operation.

Hyper-chlorination was undertaken, and with 1100 water fixtures at the facility this was no small task. Chlorine was introduced into the water supply and fixtures flushed until 50 ppm was measured at each outlet. This took 8 hours to accomplish, and then the water was held for 8 hours enable the chlorine to have an effect, each outlet was then checked to ensure > 2 ppm chlorine remained at each outlet. Once confirmed, all outlets were then flushed until the chlorine level had fallen back to < 2 ppm. This process took 24

Implementation of a Water Management Plan from a Facilities Management Perspective

Robert T. Hinton, PEDirector of Operations and Maintenance University of Washington Medical Center USA

Robert currently serves as the Director of Operations and Maintenance at the University of Washington Medical Center where he oversees a staff of 65 that are responsible for the daily operations and maintenance of a 1.7 million square foot academic research hospital. He has served as the Safety Officer specializing in regulatory compliance. After a Legionella outbreak in 2016, Robert spent the past year dedicated to implementing a strong water management plan. Robert is also a licensed Fire Protection Engineer practicing in Washington State.

hours to complete, and a lot of man power. Legionella testing was completed to check if the process had been successful, and there were 2 positives at 1 CFU / mL which were deemed acceptable. The water restrictions were removed, and the point-of-use water filters removed. Some elements of the plan were continued such as daily flushing of patient room fixtures, monitoring and flushing in construction areas, measurement of disinfection levels of incoming water, field measurement of disinfection and temperature levels, and Legionella surveillance of the water system. 500 water tests were completed, with approximately 3.5 % returning a positive result, usually approximately 1 CFU / mL and limited to a few areas, two of the rooms had 40 CFU / mL. Point-of-use water filters were installed in high risk patient areas for added security.

Mr Hinton’s advice in implementing a Water Management Plan included the following key pointers

• In establishing a Water Safety Team, it is important to have cross-functional input and include individuals with knowledge and experience in infection prevention, industrial hygiene, facility managers, plumbers etc.

• Describing the building water system needs to be completed. It is difficult to add control measures without having the plan in place to identify all of the components, kit and equipment (e.g. ice machines, drinking fountains, hydrotherapy pools, birthing tubs etc.)

• It is also important to know your water supply. When Mr Hinton initially installed water filters, they were clogging after approximately 6 days usage – the municipal plant does not manage the particulate loading in the water and is therefore delivered to the facility unfiltered. Within the water distribution system there are many different types of material, corrosion, biofilms etc., so the particulate levels may increase further â

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SUMMARY - ROBERT HIINTON

• Determine the hot water storage and circulation temperatures – the regulations state < 120 °F (< 49 °C) at the faucets, however newer water system designs allow for higher circulation temperatures. As hot water systems have a lower residual of chlorine, temperature as a control measure becomes more important

• Water storage tanks are high risk equipment – it is important to monitor temperatures and disinfection levels, have a maintenance program to regularly drain, clean and disinfect, and include the storage tanks in any Legionella surveillance sampling activity

• Cooling towers are frequently linked to outbreaks, and it is recommended to treat them with dual biocide to reduce the build-up of tolerance, to monitor treatment and disinfection levels, periodically clean them and have a treatment plan in place prior to testing

• Evaluate faucets and showers – handheld showers are ideal for growth, and some patients do not shower often due to their medical condition which lead to stagnancy. Laminar flow devices, especially low flow devices, should be assessed in high risk areas.

• Check pipework before chlorination – pin hole leaks and compatibility issues may be a problem

• Dead legs – Mr Hinton found 200 ft. of dead legs when doing renovation work, and their facility has an ongoing plan to work through each ward to update and renovate. It is impossible to know where all the dead legs are without going into the ceiling and looking down at the pipes

• The water system in ice machines itself is very difficult to clean, however for any kit or equipment it is critical to follow manufacturer’s recommendations – drain lines, ensure compatibility with different sanitizers, ensure plumbing codes for air gaps are followed for equipment such as ice machines, and if additional information is needed to complete a risk assessment ask the manufacturers to provide it. Spa, hot tubs and decorative water features are incredibly difficult to clean. Unfortunately, it may not be possible to persuade Executive management to remove water features such as fountains

• Construction activity has significant risk associated, in particular from stagnancy, therefore a flushing regimen with back up cleaning and disinfection prior to commissioning and return to patient use should be adopted. Flushing will draw in new chlorine levels and allow planktonic bacteria to be removed. Flushing during construction may be for 20 minutes every 5 days for example, but once occupied the outlets should be flushed daily for at least 2 minutes

• Filtration can be helpful in reducing the patient risk from Legionella bacteria. Consideration should be given to filtering the incoming water to the facility and also at the point-of-use in high risk patient areas. Filter changes need to be documented, indeed all activities need to be documented

• Follow the activities prescribed in your plan that have been agreed by the cross functional water management team. Review documentation and data frequently and be careful about pre-determining action based on disinfection and temperature data – corrective actions must be agreed for when set limits are exceeded. Environmental sampling could be an important part of the plan, particularly for target high risk locations. Temperature, chlorine and pressure are more easily measured, and when overlaid on the schematic plans can help pinpoint areas of concern and focus remedial works

Mr Hinton concluded that their own work continues as does their learning about safe management of in-premise water systems, and, as they learn more their risk assessment and the water management team become stronger.

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Dr. Vicky KatsemiEMEA Product Manager Medical Water Pall Medical Germany

Vicky Katsemi has a PhD in Biochemistry from the Wolfgang Goethe-University Frankfurt am Main, Germany. After completing post doctorate research on protein biochemistry and immunology at the Pasteur Institute, Athens, she moved to industry, starting with a sales & export position at a German Biotech company. Moreover, Vicky has an MBA from the European Business School and Durham Business School. Since 2008 Vicky has been working for Pall Corporation, within their Medical business unit and focused on Healthcare Water, including water-based pathogen microbiology, water hygiene, membrane technologies and European legal requirements for drinking water quality.

Filtration in Hospital Water Systems

Dr Vicky Katsemi (Product Manager – Pall Medical) described the journey that water travels from source to the municipal plant, through purification stages, release to the water pipe network, and then distribution into cities and individual buildings. It is important to keep in mind the change in conditions, from the distribution network where water pipes are large, the water relatively fast flowing and kept cold as pipes are usually positioned well underground, to inside the building, where there are small diameter pipes, low flow, temperature gain and a significant increase in available surface area and materials for bacteria to adhere to. The in-premise water system represents only 1 % of the distance that the water has travelled in this entire journey, and yet it represents 25 % of the surface area that the water is exposed to.

Particulates, micro-organisms, endotoxins, disinfectants and disinfectant by-products are all present in this water to a greater or lesser extent. Hospital facilities contain different wards, with patient occupants with different immune status and water quality needs and are generally large buildings with many miles of pipework, varied usage patterns and multiple material types with excellent conditions for biofilm formation. Therefore, water quality in different parts of a building may vary.

When analysing in-premise water filtration needs, some key parameters need to be considered. For bacterial removal, typically 0.1 – 0.2 micron filtration should be applied. However, not all contaminant affecting quality is bacterial; particulates offer a high nutrient / carbon / adherence source for bacteria. Particulate filtration at the point of entrance to a building or strategically positioned on cold or hot water loops within, can help reduce nutrient availability and requirements for fittings maintenance.

Filtration positioned at the Point-of-Entry (POE) is on influent cold water, before the water heater, so filtration choices can include flat sheet and/or hollow fibre products. Hollow fibre “straws” are typically held together at both ends by glues called resins, and these resins may provide a nutrient source for bacteria, as they consist of organic polymers. Moreover, they have limited compatibility with hot water temperatures, as they tend to soften and in some cases release the fibres. Sterilising grade filtration at the POE is not usually required, however the level of automation required by facilities staff may be an important variable. Hot water systems typically have higher particulate and microorganism loads than cold water systems, partly due to re-circulation and temperature. However stainless steel housings and thermally tolerant flat-sheet media filter cartridges can help improve water quality, where there are concerns.

Areas such as dialysis or endoscopy reprocessing usually have a separate water supply, treatment, distribution and storage system to the rest of the hospital. These are specialist loops which typically include softeners, carbon filtration steps and reverse osmosis. It is prudent to use 0.1 or 0.2 micron sterilising grade filtration upstream to protect softeners, carbon filters and reverse osmosis resin beds, and downstream a 0.1 or 0.2 micron sterilising grade final filtration step, which may also be positively charged for endotoxin retention. The needs in these specialist systems are complex, and an effective 1 filter / 1 system solution is unlikely, particularly where there are long downstream pipe runs.

Biofilms form on all water wet surfaces. How quickly the biofilm will establish and grow, depends on the temperature, flow, materials used and nutrients available. Bacteria co-habiting in a biofilm are in the perfect environment for sharing genes and plasmids, and â

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â in doing so share and develop their resistance and optimise their tolerance. Disinfection survivors become the dominant species, the microbiome diversity changes, and stronger control measures are needed to impact this population.

Point-of-Use (POU) sterilizing grade filters, according to FDA (Food & Drug Administration, Validation of Microbial Retention of Sterilizing Filters, July 12 – 13, 1995; Food & Drug Administration, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, September 2004), have an absolute retention when challenged with > 10E7 Brevundimonas diminuta per cm2 effective filtration area, when run under in-use processing conditions. A question often raised is, “What is the difference between log reduction and sterilizing grade?”  Simply put, if there are 10E10 bacteria per litre in the water and a filter with a 7 log (99.99999 %) reduction claim is used, then ~1000 bacteria per litre will remain in the litre of effluent.  If “0” is required in the filtrate, as is the requirement for most pathogens, then a proven sterilising grade filter should be employed, which can be validated according to the internationally recognized standard method ASTM F838-15a (American Society for Testing and Materials, Standard F838-15a — Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration, 2015) to provide “0” downstream of the filter.

POU sterilising grade filters have been in use since the mid-1990s, and are often the last protective barrier and control measure in place before at-risk individuals such as neonates, cancer, burn and transplant patients. Environmental hygiene and cleanliness in the vicinity of the filters, or indeed any water fittings, is critical, and particular care must be taken, if cleaning the filter outlet to avoid retrograde contamination – it is important to follow the manufacturer’s advice. Inclusion of cleaning staff as an extension of the Water Safety Team is important, and they must be regularly trained and updated. Filter exchange must be documented correctly.

There are several guidelines and independent publications worldwide supporting the efficacious use of POU filters as part of a Water Safety Plan approach for high risk populations including Vianelli et al. (haematology-oncology), Trautmann et al. (adult intensive care), Zhou et al. (liver organ transplant), Garvey et al. (burns), and Demirijan et al. (Legionella contamination and Legionnaires’ outbreak). POU filtration is also included in guidelines such as the World Health Organisation (WHO 2011), Health Technical Memorandum (HTM 04-01, UK), Health and Safety Guidance (HSG 274, UK), European Technical Guidelines for the Prevention, Control and Investigation of Infections Caused by Legionella species (eCDC 2017). Finally, the German Organisation for Gas and Water DVGW have recently published a helpful information sheet on criteria for selecting POU filters (DVGW TWIN No 12, 2017, also available in English language). Many of these are accessible on the internet for further review and to help support Water Safety Teams.

SUMMARY - DR. VICKY KATSEMI

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