Legionella are bacteria. There are many disease-causing (pathogenic) species of Legionella bacteria. The pathogenic species most associated with outbreaks of disease is L.
The safe management of water in the built environment is a dynamic process that includes stakeholders with varying water management objectives. This is important, as according to the CDC, 6,100 people in in the U.S. were diagnosed with Legionnaires’ disease. CDC investigations show that 9 in 10 of these outbreaks were caused by problems that were preventable with more effective water management https://www.cdc.gov/vitalsigns/pdf/2016-06-vitalsigns.pdf.
The table below represents the major guidance and industry directives for the development and implementation of water safety and Legionella risk management programs. In many cases, they were developed by a committee of experts, and represent the best knowledge and guidance available.
ANSI/ASHRAE Standard 188:2015, “Legionellosis: Risk Management for Building Water Systems” was originally approved and published in June 2015. More than 5 million buildings in the U.S. are within scope of the standard’s requirements.
The Standard requires at a minimum that building owners establish and practice a Water Management Program for facilities with any of the following:
For potable (domestic) plumbing systems with any of the following, the Standard also applies:
Water Management Programs require continuous, ongoing implementation and maintenance. Like all other facility management programs, it takes time, expertise, resources, and independent confirmation to establish defensibility.
Below is a list ASHRAE 188 Frequently Asked Questions answered by Phigenics CTO and ASHRAE 188 Committee Member,
The Centers For Medicare & Medicaid Services (CMS) Requirement to Reduce Legionella Risk in Healthcare Facility Water Systems to Prevent Cases and Outbreaks of Legionnaires’ Disease (LD) was published on 2 June 2017. All Medicare and Medicaid certified healthcare facilities are within
The CMS Requirement states that healthcare facilities must have water management policies and procedures to reduce the risk of growth and spread of Legionella and other opportunistic pathogens such as Pseudomonas, Acinetobacter, Burkholderia, Stenotrophomonas, nontuberculous mycobacteria (NTM) and fungi in facility water systems.
CMS Surveyors for Medicare and Medicaid eligibility certification will expect facility managers to implement water management programs based on ANSI/ASHRAE Standard 188:2018 and the CDC Toolkit for Development and Implementation of Water Management Programs.
Water management programs must consider control measures such as:
Water management programs must specify testing protocols and acceptable ranges for control measures and corrective actions taken when control limits are not maintained. Results from monitoring and testing must be documented.
Below is a video that provides independent guidance on how to achieve compliance with the CMS Requirement S&C 17-30.
Having a water management program is the most defensible action to prevent Legionella in building water systems. A good water management program must be sustainable and comprehensive.
The purpose of a program is to make sure it is documented and that when implemented properly, optimizes the total cost of building water systems by improving safety and efficiency.
7 steps for developing a program are depicted in the infographic below. For the purposes of preventing Legionella, the following will focus on water safety.
Step 1: Form a Team
Establishing the Water Management Team is the critical first step in developing a Legionella Prevention and Risk Management Program. The Water Management Program Team (called the Program Team in the ASHRAE Standard 188) is responsible for all aspects of developing and implementing the program.
The Water Management Program Team is required to have one or more individuals selected from the following: the building owner or designee, employees, suppliers, consultants,
While specific
Step 2: Develop Program Goals
The team then should develop high-level program goals and can document them in an Executive Summary. While an Executive Summary is not part of a standard or regulation, it is a useful tool to support the program, especially with higher level management. It should also be viewed as a dynamic, living document. It helps to develop consensus and get the team members on the same page at the beginning of the process.
Examples of goals and objectives for a Comprehensive Water Management Program:
Step 3: Describe Water Systems
The third step in developing a Legionella Prevention and Risk Management program is to describe the water system.
There are two parts to describing the system: a system description in words, and a schematic of the system in a process flow diagram.
Process flow diagrams and system descriptions must describe how the water is received and processed, i.e. conditioned, stored, heated, cooled, re-circulated, treated, and delivered to end-point uses.
There should be separate process flow diagrams and system descriptions for potable water and utility water. All potable water systems and utility water systems must be identified.
The Water Management Team must confirm that the process flow diagrams and system descriptions accurately represent the water systems as built. This confirmation must be done with a site visit.
Step 4: Analyze Water Systems for Safety & Efficiency
Once the process flow documents have been confirmed with a site visit and approved by the Water Management Team, the next step is to analyze the system. Most community water utilities produce and distribute safe, high-quality water that complies with EPA regulations and is safe for intended use. However, the water provided by public water utilities is not sterile. Once the water is delivered to buildings it goes through building water systems that have may have one or all of the following characteristics:
The water may also go through one or more of the processing steps:
Water quality can be changed by each processing step!
Building water systems consist of potable and utility water systems. Potable water consists of fixtures such as sinks, showers and fountains. Utility water is primarily boilers and cooling towers.
The system analysis should encompass both a safety analysis and an efficiency analysis for potable and utility water. These steps are done simultaneously but are noted separately because the terminology used to describe the process is different. When doing a safety/hazard analysis, the team is looking for hazard or compromised safety. When doing an efficiency analysis, the team is identifying opportunities for optimizing water, energy, and asset use. For the purposes of this topic “Legionella Prevention and Risk Management”, the focus will be on safety.
The safety analysis is also commonly known as a “hazard analysis” as the system is being evaluated for hazards that would compromise safety. The first step in conducting a hazard analysis is to answer the question “What are the hazards or potential hazards at each processing steps?
Building water system hazards are physical, chemical, or microbial agents with the potential to cause harm under certain conditions.
An example of a physical hazard is water. Scalding is a very serious problem. Injuries to the elderly, the very young and to people with disabilities such as diabetes can be horribly severe. Water temperatures above 130 F can scald in less than a minute. The very old and very young are highly susceptible to scalding. It is important to control the temperature of hot water exiting the heater with a tempering valve. Do not control hot water temperature by the water heater temperature setting. If you use anti-scald valves, they must be maintained.
Lead is an example of a chemical hazard. Where testing shows elevated levels of lead, you should:
Disinfectants and disinfection by-products are also chemical hazards:
One of the most important reasons for this regulation is that disinfection by-products (listed) can be toxic and/or carcinogenic. For example, nitrosamines and
The following are examples of microbial hazards in the built environment.
Below is an example of the system analysis and the format it could be structured in. You’ll identify the hazard or potential hazard, determine if the risk is significant, and what the basis is for the team to determine if the risk is significant. Under the risk basis, you will need to provide defensible documentation as to why the decision was made that the risk was or wasn’t significant. This can include industry best practices, data, or other information used to determine risk basis.
Then, the controls for that hazard are documented. If the controls must be applied in order to reduce the hazard, then this becomes a control location, or in HACCP terminology a critical control point (CCP). We will discuss control locations in much more detail in the next section, as this will carry over to the next step of the process. The last column of this table indicates a cost impact. It is useful for water management teams to identify the financial impact of the changes they’re making.
Processing Step Description |
Potential Safety Hazard B = Biological |
2. Cold water filtering (potable) |
B - Growth of microorganisms on filter surfaces |
4. Hot water distribution (potable) |
B - The temperature of the water delivered throughout the facility and to the points of use is between 105 and 120 F, which is conducive to microorganism growth. P - The presence of copper, lead and other heavy metals as a result of pipe corrosion |
The next step in analyzing the water system is to answer the question, “Is the risk of harm from the identified hazards significant?” The team must make a defensible decision about the risk of harm from identified hazards.
It is important to note that
From: Mayo Clinic published in Infection Control and Hospital Epidemiology 2014, 35, 556-563.
For other buildings, it is not feasible to take population risk into consideration because there are no designated spaces for specific individuals.
The following is what the table should look like after answering question 2.
Processing Step Description | Potential Safety Hazard B = Biological C = Chemical P = Physical |
Risk Significant? Yes/No |
|
2. Cold water filtering (potable) | B - Growth of microorganisms on filter surfaces | No | Improperly maintained filters can increase microbiological growth, however cold water temperatures could reduce the risk of growth. Water is also chlorinated by the city. |
4. Hot water distribution (potable) | B - The temperature of the water delivered throughout the facility and to the points of use is between 105 and 120 F, which is conducive to microorganism growth. P - The presence of copper, lead and other heavy metals as a result of pipe corrosion | Yes | Hot water distribution systems have has been associated with severe cases of |
The third and final step is to answer the question, “What controls are being applied or could be applied at the processing step to reduce or eliminate the hazards?” Control options:
Combinations of these controllable parameters are the basis for all hazard control approaches in water management of the built environment.
Water management teams should always insist on the hazard control option that is the:
Microbial hazard control options for utility water include:
Microbial hazard control options for potable water include:
By the time all 3 questions are answered, the table should look like the following.
Processing Step Description | Potential Safety Hazard B = Biological C = Chemical P = Physical |
Risk Significant? Yes/No |
Controls Applied or Could be Applied | CCP (Control Location) Yes/No |
Cost Impacts A = Avoidance O = OPEX C = CAPEX |
|
2. Cold water filtering (potable) | B - Growth of microorganisms on filter surfaces | No | Improperly maintained filters can increase microbiological growth, however cold water temperatures could reduce the risk of growth. Water is also chlorinated by the city. | 1.Maintain filters according to manufacturer's recommendations 2. Change filters when |
No | O - Could result in higher costs if filter changes are increases C - Maintaining filters properly would reduce/eliminate replacement |
4. Hot water distribution (potable) | B - The temperature of the water delivered throughout the facility and to the points of use is between 105 and 120 F, which is conducive to microorganism growth. P - The presence of copper, lead and other heavy metals as a result of pipe corrosion | Yes | Hot water distribution systems have has been associated with severe cases of |
1 - Flushing of the system is performed per the guidelines developed by the WMT 2 - Emphasis will be placed on the identification, removal, or mitigation of potential dead-legs that may exist within the distribution system 3 - Filtration at critical locations can be applied if necessary. 4 – Monitor oxidant levels at distal locations | Yes | O - Increased flushing will increase water usage and costs O - Manpower to identify and remove C - Cost of potential filtration equipment A - Decreased likelihood of negligence lawsuit |
Step 5: Specify Control Locations, Control Limits, Monitoring, and Corrective Actions
When the potential hazard is indicated as a “significant risk”, a control must be applied to the location in the process step. This location is designated as a control location.
For each control location that was established in the System Analysis, the team must decide:
Control location (also called a critical control point in HACCP terminology) is the location at which control must be applied to control the hazard. Examples could include:
A control limit (also called a critical limit in HACCP terminology) is the range of the applied control measure. It must be:
For example:
Monitoring and Frequency
The purpose of monitoring is to determine if control applied at the control location is within the control limits. The means, method, and frequency of monitoring must be established by the team.
Corrective Actions
For practical guidance click: Ask A Legionella Consultant: Common Mistakes With Control Locations, Control Limits, Monitoring, and Corrective Actions
Once the team has specified control locations, control limits, monitoring, and corrective actions, they are documented in a Systems Control Summary.
Processing Step | Safety Hazard or Efficiency Opportunity | Control Point | Control Limits | Monitoring | Frequency | Corrective Action | Verification Procedure |
4. Cold water distribution (potable) | Safety | Supplemental disinfection | 0.5 - 4.0 ppm as Cl2 free residual oxidant (FRO) | Perform free chlorine test on |
Daily during startup, monthly after start-up | Check product feed; call vendor if not operating properly; consider increased product feed after consultation with WMT | Quarterly review of data log sheets |
6. Cooling towers (utility) | Efficiency - water and energy use reduction | Chemical addition | 4 ppm phosphate 2 ppm polymer 3.0 cycles of concentration |
Phosphate test kit Polymer test kit Conductivity meter |
Once per week Once per week Continuous |
Consider increase / decrease feed Consider increase / decrease feed Increase / decrease blowdown Contact Check incoming water quality |
Completion of utility verification Quarterly review |
Step 6: Develop Verification Strategy
As defined in ANSI/ASHRAE 188-2015, verification is initial and ongoing confirmation that the WMP is being implemented as designed. Verification is:
Verification is done to:
If verification is not done, or if it is done but not documented, then it’s just as if no control was applied to the system.
Documents used as verification records:
Step 7: Develop Validation Strategy
As defined in ANSI/ASHRAE 188-2015, validation is initial and ongoing confirmation that the WMP, when implemented as designed, effectively controls the hazardous conditions through the building water systems. Validation is a Quality Control (QC) function. Validation evidence must include confirmation that conditions at sentinel points fall within sentinel points targets (parametric validation).
Validation evidence may include:
Chlorine disinfection is the most sensible, simplest, safest, least hazardous and least expensive means to control microbial hazards in building water systems. Application issues are often overstated as objections by vendors selling more complex and expensive alternatives.
Click here to see full whitepaper of chlorination of
Monochloramine is increasingly promoted for direct on-site addition to premise plumbing for supplemental disinfection. Notwithstanding the claimed advantages,
1) Microbial control is inadequate
2) It results in higher proportions of Mycobacterium, Pseudomonas, Acinetobacter and nitrifying bacteria in biofilms
3) It induces the viable-but-nonculturable (VBNC) state in Legionella
4) Higher concentrations of nitrite and nitrate (regulated drinking water contaminants) can occur
5) It degrades to ammonium ion in premise plumbing treatments which can lead to nitrification
6) Corrosivity of elastomers and other construction materials is significant
7) Volatility is very high
8) The application is more complex due to
9) The application is more expensive because the cost of chlorine is very low
10) N-Nitrosodimethylamine (NDMA), a potent carcinogen, in
Megan Cochran, Phigenics Regional Manager answering "Why is it Important to Comply with the SDWA?"
Legionella testing is the process of obtaining a water sample and analyzing it to detect the presence of the bacteria.
Legionella testing done to confirm effectiveness is defined as validation. Testing for Legionella is done to confirm that a Water Management Program is effective at controlling Legionella, which is defined as a hazard. It is also done to discover the source of exposure after a disease case is reported.
There are two general types of Legionella tests: Microbial culture tests (spread plates and field sampler “dipslides”) and molecular tests (Polymerase Chain Reaction, PCR). For microbial culture, L. pneumophila serogroup 1, serogroups 2-14 and Legionella spp. should always be determined for every isolate.
An independent, third-party testing service provides improved defensibility by removing real or perceived commercial conflict of interest or bias toward proprietary water treatment solutions.
Sampling locations are decided by the Water Management Team. Locations may include incoming water, showers, misters, ice machines, faucets, cooling towers and decorative water features. Phigenics recommends collecting post-flush samples from plumbing fixtures, when Legionella testing is done as part of routine validation to confirm WMP effectiveness. Call us to learn why.
Testing should be undertaken after a Water Management Team has confirmed that a program has been implemented as designed (verification). The frequency of testing is determined by the Water Management Team and is often monthly, quarterly or semi-annually.
Any response should be predetermined and documented as a “contingency response” in the Water Management Program. Contingency responses should include a review of the verification data and may include activities such as flushing or hyperchlorinating the water system. Call us to learn more.
The CDC has five considerations for laboratory expertise: ELITE accreditation, the performance of culture method, level of identification, willingness to save samples and experience with environmental risk assessment and sampling. Click here to see how Phigenics meets the CDC’s criteria.
To learn more about Phigenics Legionella Testing Services please visit: www.phigenics.com/testing
Walmart's adoption of a portfolio approach to cooling water management program is
Click here for additional details
Note that after clicking on a video, you will be prompted to
Chlorine disinfection is the most sensible, simplest, safest, least hazardous and least expensive means to control microbial hazards in building water systems. Application issues are often overstated as objections by vendors selling more complex and expensive alternatives.
Click here to see full whitepaper
Monochloramine is increasingly promoted for direct on-site addition to premise plumbing for supplemental disinfection. Notwithstanding the claimed advantages,
Click here to see full whitepaper
Thousands of preventable injuries and deaths are annually caused by microbial, chemical and physical hazards from building water systems. Water is processed in buildings before use; this can degrade the quality of the water. Processing steps
We conducted this study to determine what sample volume, concentration, and limit of detection (LOD) are adequate for environmental validation of Legionella control.
The Water Manager provides facility managers and building owners with non-conflicted and defensible guidance to create safer, more efficient water systems. Subscribe to learn best practices from independent experts on reducing cost and increasing safety. We never sell water treatment products-our only bias is providing meaningful and accurate information.
Click here to go to the Water Manager Blog
The purpose of the Phigenics course is to enable learners to improve facility water system safety and efficiency.
Marty Detmer, Phigenics Regional Manager answers "Why should I invest in a Water Management Program?"
If your building needs a Legionella water management program or remediation services, you may consider working with one or more Legionella consultants. Deciding whether to work with consultants at
We didn’t write the previous paragraph—it’s straight from the Centers for Disease Control and Prevention (CDC). Our credentials as Phigenics Legionella consultants match the CDC standards so closely, they might as well have been written with us in mind. In this blog post, we’ve placed the CDC’s guidelines on the left and our credentials on the right:
Level of experience:
|
Phigenics has developed comprehensive water management programs to combat Legionella in 50 states and multiple foreign countries. We have Legionella-specific experience from the We have extensive expertise |
Laboratory expertise:
|
We are certified as proficient in the Environmental Legionella Isolation Techniques Evaluation (ELITE) program administered by the CDC. In fact, we have passed every proficiency test since the beginning of the CDC ELITE program with 100% correct scores. We are also EPA-NELAP certified for the analysis of drinking water. Phigenics analytical services laboratories are certified as proficient in the Environmental Legionella Isolation Techniques Evaluation (ELITE) program administered by the Centers for Disease Control and Prevention (CDC) for using the Phigenics patented PVT Test and the ISO 11731 spread plate method. Phigenics delivers the fastest and most accurate Legionella testing service for water systems found in commercial, institutional, and industrial facilities. We provide independent confirmation that water treatment products and services have been applied correctly (verification) and that the water treatment applied is effective (validation). We perform comprehensive testing, including Legionella |
Environmental risk assessment expertise: For example, how much experience does the company have with environmental risk assessments and/or sampling for Legionella? Can they describe situations where they performed an environmental risk assessment and/or Legionella sampling in a facility of your size/type? |
Phigenics is an EPA-NELAP certified laboratory for the analysis of drinking water and provides a wide range of testing services for biohazards. Phigenics also provides complete testing services required by the Safe Drinking Water Act. As a Legionella testing company, we have performed environmental risk assessments and samplings for facilities of all sizes and types. |
Remediation expertise For example, how frequently does the company provide remediation services and can they describe situations where they remediated Legionella from a building water system in a facility of your size/type? Can the company discuss the benefits and challenges associated with multiple approaches to remediation? |
Phigenics assists hundreds of building owners, from a myriad of industries, to effectively manage their water systems. Phigenics' clients include over 70 Veterans Health Administration facilities, Mayo Clinic, Walmart, the National Security Agency, Pernod Ricard, and multiple state and private universities. We are familiar with the benefits and challenges associated with different approaches to remediation and have written numerous white papers on the subject. |
Water management expertise: For example, how much experience does the company have creating water management programs compliant with industry standards for a facility of your size/type?What level of support does the company provide with creation and implementation of water management programs? What is the spectrum of services they offer once the water management program is established? |
We have created hundreds of sustainable, comprehensive water management programs for facilities of every size and type. Phigenics ensures that every water management program is implemented as designed (verification) and that the program effectively controls the hazardous conditions throughout the building water systems (validation). All team members have access to phiMetrics, a web-based platform developed by Phigenics, to bring data front and center with charting and alerting capabilities. Water management team members can analyze real-time data and respond appropriately in any situation. |
Knowledge of codes, standards, and regulations: For example, does the company have previous experience working in your state and/or jurisdiction? How familiar is the company with state and local building codes in your jurisdiction, water treatment regulations, healthcare accreditation and survey requirements, and public health reporting requirements? Local building code officials or your health department may be good resources for knowledge about existing codes, standards, and regulations. |
After working in all 50 states, Phigenics’ independent, expert representatives are knowledgeable in the SDWA compliance process and individual state requirements for additional testing. Our Legionella consultants are well-versed in state and local building codes, water treatment regulations, healthcare accreditation and survey requirements, and public health reporting requirements. |
Potential conflicts of interest: For example, does the company have interest in promoting specific services or products? |
As an independent Legionella company, Phigenics does not sell water treatment products. Instead, we provide independent guidance on improving safety and efficiency. |
Whether you’re looking for an independent Legionella testing company, a Legionella consultant, or a comprehensive water management program to improve both safety and efficiency, Phigenics can help.
Phigenics is an innovative and INDEPENDENT water management company that meets the increasingly complex needs of facility owners and managers to improve overall water safety while reducing operational (water, chemical, energy) and capital costs. Our innovative solutions and business model represent a clear shift in thinking.
We do not sell chemicals or water treatment equipment and we are not driven to provide a solution that is restricted to an internal product line.
Corporate Office / Lab:
Phigenics, LLC
Arkansas Office / Lab:
Phigenics, LLC
Phone: 1.844.850.4087
Client Service Desk: 1.630.733.8029
Fax: 630-717-8528
Email: info@phigenics.com
© 2023 Phigenics, LLC. All rights reserved.
Phigenics is an innovative water management company that meets the increasingly complex needs of facility owners and managers to improve overall water safety while reducing operational (water, chemical, energy) and capital costs. Our innovative solutions and business model represent a clear shift in thinking. We do not sell chemicals or water treatment equipment and we are not driven to provide a solution that is restricted to an internal product line.
Phigenics LLC
3S701 West Ave, Suite 100
Warrenville, IL 60555
Phone: 844.850.4087
Fax: 630-717-8528
Email: info@phigenics.com
© 2022 Phigenics. All rights reserved.