water safety management

Legionella and Other Waterborne Pathogens: Developing and Sustaining an Effective Water Safety Program: Part I. A system-wide perspective across Trinity Health

2021 Michigan Safety Conference

Russ Olmsted, MPH, CIC – Director, Infection Prevention Management, Trinity Health, Livonia, MI

Joseph Ham, B.S.E. - Regional Sales Manager, Michigan, DuBois Chemicals

Agenda

• Review facility potable water testing methods / draft procedure

• Understand Risk factors for waterborne infection and mitigation

strategies

• Review options to collect previous test results and evaluate at

System level

• Review testing frequencies based on Reliability Centered

Maintenance

• Define minimum guidance

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• Burden of waterborne disease in the U.S. caused by 17 different waterborne pathogens, 2014 experience:

- 7.15 million illnesses

- 601,000 emergency department visits

- 118,000 hospitalizations

- 6,630 deaths

- $3.33 billion in direct healthcare costs for hospitalizations and emergency department visits

- Source: Findings | Water-related Topics | Healthy Water | CDC

©2020 Trinity Health, All Rights Reserved 3

Estimates of Impact on Human Health from Waterborne Diseases

https://www.cdc.gov/healthywater/surveillance/burden/findings.html

• Nontuberculous Mycobacteria (NTM) accounted for 30% investigations, Pseudomonas sppaccounted for the next greatest number of investigations (18.7%) and then Burkholderia spp(10.4%)


Beyond Legionella; CDC Investigations of Waterborne Pathogens; Perkins KM, et al. Infect Control Hosp Epidemiol 2019

• Waterwater drains are increasingly a source of outbreaks of infection caused by multidrug-resistant organisms

• Almost all occur in ICUs or hem/oncinpatient units

• Drain disinfection procedures had limited efficacy

• Recommendation: follow handwashing sink design specifications in FGI 2018 Guidelines

• If med prep is adjacent to sink – install a barrier in between to prevent risk of contaminated water droplets


Biofilm-associated Reservoir of Waterborne Pathogens

Carling P. Wastewater drains: epidemiology and interventions in 23 carbapenem-

resistant organism outbreaks. ICHE 2019; Hota S, et al. ICHE 2009

• Invasive Mycobacterium chimaera infection associated with heater–cooler devices (HCDs) in cardiac surgery was identified as a new disease entity in 2014

• As of 09/2017, ≈120 cases have been recognized globally;

• Source: mycobacterial device contamination at the manufacturing site of the LivaNova(formerly Sorin) 3T

• Incubation period = median of 17 months (3–72 mo.)

• Estimated annual incidence: 156–282 cases for the 10 major valve replacement & 51–80 cases in the U.S.


Water Reservoirs In Medical Devices; M. chimaera and heater-cooler unit – global outbreak

Sommerstein R, et al. Emerg Infect Dis 2018

• The temporary shutdown or reduced operation of a building and reductions in normal water use can create hazards for returning occupants.

• Check for hazards before reopening after a prolonged period of building inactivity. Hazards include mold, Legionella (the cause of Legionnaires’ disease), and lead and copper contamination from corroded plumbing

• Flush hot and cold water through all points of use (e.g., showers, sink faucets)

• Flushing may need to occur in segments (e.g., floors, individual rooms) due to facility size and water pressure. The purpose of building flushing is to replace all water inside building piping with fresh water.

• Other water-using devices, such as ice machines, may require additional cleaning steps in addition to flushing, such as discarding old ice. Follow water-using device manufeacturers’ instructions

• See also: Guidance for Reopening Buildings After Prolonged Shutdown or Reduced Operation | CDC

The connection between Pandemic Response & Waterborne Disease: CDC Guidance for Reopening Buildings After Prolonged Shutdown or Reduced Operation


https://www.cdc.gov/coronavirus/2019-ncov/php/building-water-system.html

Regulatory & Accreditation Requirements on Water Safety


CMS expects Medicare certified healthcare

facilities to have water management policies

and procedures to reduce the risk of growth

and spread of Legionella and other

opportunistic pathogens in building water

systems.

• Conduct a facility risk assessment

• Implement a water management

program that considers ASHRAE 188 &

CDC Toolkit

• Specify testing protocols and acceptable

ranges for control measures,document

results & corrective actions


Regulatory & Accreditation Requirements

for Water Safety Program

Upcoming Joint Commission Requirements



Applicable National Standard & CDC Recommendations

Focus on Legionnaires’ Disease: Summary of Elements in CDC Toolkit


• Cause: Legionella bacteria; 60 different species, majority caused by L. pneumophila serogroup 1

• Transmission:

- After Legionella grows and multiplies in a building water system, water containing Legionella can spread in droplets small enough for people to breathe in. People can get Legionnaires’ disease or Pontiac fever when they breathe in small droplets of water in the air that contain the bacteria.

- Less commonly, people can get sick by aspiration of drinking water containing Legionella.

• Populations at increased risk:

- People > 50 years

- Current or former smokers

- People with a chronic lung disease (like chronic obstructive pulmonary disease or emphysema)

- People with weak immune systems or who take drugs that weaken the immune system

- People with cancer

- People with underlying illnesses such as diabetes, kidney failure, or liver failure

• Outcome:

- Case-fatality rate: 10% (25% for healthcare-associated)

Quick Facts on Legionnaires’ Disease


CDC. https://www.cdc.gov/legionella/clinicians.html

https://www.cdc.gov/legionella/clinicians.html

• Legionnaires’ disease:

- Incubation period = 2-14 days. Most cases have illness onset within 10 days of exposure, but up to 16% of cases have onset more than 10 days after exposure.

- Presumptive healthcare-associated Legionnaires’ disease:• A case with ≥10 days of continuous stay at a healthcare facility during

the 14 days before onset of symptoms.

- Possible healthcare-associated Legionnaires’ disease: • A case that spent a portion of the 14 days before date of symptom

onset in one or more a healthcare facilities, but does not meet the criteria for presumptive HA-LD.

Classification of Healthcare Associated Legionnaires’ Disease (HA-LD)


Focus On Mitigation and Control of Legionella



Highlights of System-wide guidance and

support of member hospital water safety

management programs

Acknowledgement and thanks: Don Nasko – Director, Facilities & Infrastructure & Trinity Health

Water Safety Management Taskforce


Complex Water Distribution Network + Biofilm + Gaps in Water Safety Program = Safety Risks

About 1 in 2 (48%) of Legionella outbreaks are due to

more than one of these problems:

• 65% are due to process failures, like not having a

Legionella water management program.

• 52% are due to human error

• 1 in 3 (35%) are due to equipment, such as a

disinfection system, not working.

• About 1 in 3 (35%) are due to changes in water quality

from reasons external to the building itself, like nearby

construction.

Biofouled water pipes = extreme challenges for disinfection


It’s the Condominium Life for Microorganisms!

• Kessler WD, et al. Hospital-acquired Legionella Pneumonia Outbreak at an

Academic Medical Center: Lessons Learned. Am J Infect Control 2021, in

press.

- Detected an outbreak of 13 cases of HA-LD at an academic healthcare

facility that had copper-silver ionization system in place

• Transplant & Hem/Onc units. Some patients initial presentation were gastrointestinal

symptoms

- Just prior to outbreak, there was a switch from high flow ionization system

to a low flow system, resulted in need to open bypass valves incorporating

water, and potentially sediment, from rarely used plumbing into the system

- Response: flushing, hyper-chlorination, return to high flow and POU filters

Just a Word or Two on Supplemental Disinfection


Problem statement

Unknown variation in the Water Management Program (WMP)* including hazard analysis, documentation, and monitoring across the National and Regional Health Ministries. Current code requirements may not be sufficient to ensure high quality water safety.

Goal statement

Provide a standard WMP Framework that ensures regulatory compliance as well as meets or exceeds industry standards as minimally articulated in ASHRE 188-2018. Establish Trinity Health WMP standard protocols to be used in construction activation, facilities operations, and unoccupied space that will help mitigate the risk of waterborne pathogens.

Business case

A standard WMP will improve rigor at the Ministry level with the goal of mitigating risk, increasing safety, reducing liability and protecting the Ministry reputation.

Resources required

System Office representatives FAM, IP, REGULATORY, OTHERS AS NEEDED.

Ministry representatives from Facilities / Construction, IPC and Safety.

Will reference external subject matter experts to advise task team as required.

Potential PM from the EPMO.

Primary metrics

The Trinity Health primary metric is to identify compliance with ASHRAE 188-2015 standard, CDC toolkit guidelines and Trinity Health specific protocols.

Charter For System Water Safety Guidelines Development


Water safety management system guidance

• The Water Management Team must:

- Include a person designated by the ministry’s executive management leadership with authority to make command decisions about water restrictions or other response measures

- Include a Facilities Management colleague with knowledge of the ministry’s building water systems

- Include an Infection Preventionist with board certification in infection prevention and control from the Certification Board of Infection Control and Epidemiology, Inc., i.e. "CIC.", an epidemiologist, or an IP actively working towards obtaining CIC.

- Conduct a risk assessment of engineered water systems and hazard analysis to include at risk populations

- Notify system office of any possible or presumptive cases of healthcare -associated Legionnaires' Disease by the end of the next business day after the existence of a case, suspected case or a positive laboratory result is identified.

- Use updated 2020 CSTE criteria for surveillance and classification of Legionnaires' Disease

Summary of System Guidance ver. 1.0 Requirements

• Facilities management:- Operates and maintains

mechanically engineered utility systems that provide air, water, electricity and medical gases, etc.

- Subject matter expertise on design and operation of potable water system in the facility

- High level of awareness of disruptions in the built environment, plans for renovation/construction and responds to work orders

• Infection Preventionist:- Oversees ongoing surveillance

of healthcare associated infections that include HA-LD

- Continual watch for clusters of infections - especially if there is cluster of similar pathogens in time and space

- Responsible for reporting of diseases to public health and key liaison to public health for investigations and response to HA-LD and any other unusual HAIs


Highlighting Complimentary Roles & Importance of Facilities Management & Infection Preventionist


Member Hospital & Long Term Care Facilities Water Management Program & Plan

must:

• Be developed and maintained for each licensed healthcare facility

• List WMT member's name, title, and contact information

• Identify the Chair, Executive sponsor and include executive management designee

authorized to act on recommendations of WMT

• Adhere to ASHRAE 188-2018 and utilize the CDC toolkit

• Describe the engineered water systems and create simple flow diagrams

• Predetermine and include corrective actions when control limits are out of

specification

• Implement routine sampling of potable hot water loop(s) for Legionella

• Predetermine and include emergency communication plans when control limits are

out of specification

• Describe the control points and set control limits

• Record and document all activities and findings


Monitor chemical and physical conditions of potable water to include:

• Control limit defined as range between 0.2 - 4.0 ppm of residual chlorine, measured

quarterly

• Maintain potable (domestic) hot water storage tank(s) at ≥ 120°F, measured quarterly

• Include evaluation of external factors in building hazard analysis

• Avoid or minimize installation of faucet aerators as much as possible for new construction

design

• Exceed ASHRAE 188 standard for new construction/ renovations and start up flushing and

testing prior to occupancy – refer to Guidance 1.0 for specifics

• Define flushing and testing for occupancy of fixtures in inactive patient care areas / zones

prior to being brought back on-line

• Identify a water safety leader at each RHM with training and certification in Legionella

water management risk mitigation, e.g. Legionella Water Safety and Management

Specialist (ASSE/IAPMO/ANSI 12080 Standard: Professional Qualifications Standard for

Legionella Water Safety and Management Personnel)


Current Testing Minimum Standard for Bulk and Hot Water Storage Locations

Applies to Licensed Acute Care and Long Term Care Facilities

• Domestic Hot Water (potable) Loops

• 10 locations per loop identified by the WMT risk assessment

• Water sample: 1 first draw only [see also Hirsh MB, et al. Evaluation of Recommended Water

Sample Collection Methods and the Impact of Holding Time on Legionella Recovery and Variability from

Healthcare Building Water Systems. Microorganisms 2020, 8, 1770]

• 250mL minimum – verify with vendor that sample collection bottles pre-filled

with sodium thiosulfate

• Collect samples every six months

• 20 per year per identified hot potable water loop

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• Corrective actions:

• If < 30% of sampling locations detect Legionella – continue

monitoring described in Water Management Plan (WMP)

• If ≥30% of sampling locations detect Legionella;

• Follow procedure described in the ministry’s WMP to include;

• person responsible for taking the corrective action,

• required response time,

• who needs notification,

• documentation of actions and

• retesting the sampling location(s) that were positive


• Guidance Water Safety Requirements that Exceed Standards and Recommendations:

- Sample potable water system biannually for Legionella:

• Collect at least 250 mL of water from each location identified in ministry WMP

• For plumbing fixtures; collect first sample immediately after turning on hot water flow

• Submit samples to a laboratory that is proficient in detection of Legionella spp. as

determined by membership in CDC ELITE Program, uses current applicable ISO

Standard method for detection of Legionella and has capability to detect Legionella at <

1CFU/mL

• Collect samples of hot water from a minimum of 10 sampling locations in the potable

water system within each hot water distribution loop

• Detection of Legionella is defined as ≥ 1 CFU (non-outbreak condition) from any

sampling location


• Upcoming ASHRAE 514 – Request for comments coming out in April

• Potable water sampling techniques, frequencies and standards

• Planktonic (free floating) vs Sessile (fixed in biofilm) bacteria risk in domestic water and mitigation strategies

• Current data (as known) showing new risks and hazards

- Develop Reliability Centered Maintenance (RCM) testing location and frequency

• Supplemental Disinfection:

- Copper Silver ionization

- Monochloramine vs chlorine domestic water disinfectant

• Future state: Collect data showing where HAI patient "positive tested" legionella is transmitting?

- Patient population

- Fixture type

- Total number of HAI legionella patients last year

- Develop a hierarchy of where data points to most frequent legionella high CFU positives?

• For example, Shower heads, cooling towers, hot water tank storage, sinks, ice machines, etc.

External Subject Matter Experts – Helpful & Important


Simple Water Flow Diagram

Control measures and Hazard Analysis


Domestic Water Flow Diagram

Municipal Water

Fire Suppression

Municipal Water

Cooling

Towers

Decorative

Fountain

Ice

MachinesSinks/

Showers

1. Receiving

2. Cold Water

Distribution

3. Heating

4. Hot Water

Distribution

5. Waste

Hot

Water

Tank

Sinks/

Showers

Sanitary

Sewer

Toilets

Hazard Analysis - Control Measures

Municipal Water

Fire

Suppression

Municipal Water

Cooling

Towers

Decorative

Fountain

Ice

MachinesSinks/

Showers

1. Receiving

2. Cold Water

Distribution

3. Heating

4. Hot Water

Distribution

5. Waste

Hot Water

Tank

Sinks/

Showers

Sanitary

Sewer

External

Hazards

Stagnation

Conditions

for Bacteria

Spread

Temperature

Permissive

Toilets

Monitor Control Measures

Municipal Water

Fire Suppression

Municipal Water

Cooling

Towers

Decorative

Fountain

Ice

MachinesSinks/ *

Showers

1. Receiving

2. Cold Water

Distribution

3. Heating

4. Hot Water

Distribution

5. Waste

Hot

Water

Tank

Sinks/ *

Showers

Sanitary

Sewer

Visual

Inspection

Check

Disinfectant

Level

Check

Temp

* Monitoring at representative fixtures close to and far from the central distribution point is

recommended. It is not necessary to routinely monitor water conditions at every tap.

Flushing

Control Measures and Corrective ActionsIdentify

Control

Points

Control

MeasuresAdded

Disinfectant,

elevated

temps, etc.

Routine

Monitoring

Within

Limits

?

Corrective

Action

Document

Results

Enhanced

Monitoring

Within

Limits

Document

Results

Document

Results

Document

Results

Document

Results

YesNo

Yes

No

Training Opportunities

• https://specialpathogenslab.com/asse-12080-certification/?utm_campaign=IAPMO&utm_medium=email&_hsmi=99817057&_hsenc=p2ANqtz--

D3AgYXRumX9KYn0gXLym1lQG10ElYZA-

Aes5FnpMZuP6btPdSeKXUbWtiBovQEubUYvfxMhqMg6bzrbN7vUrlr3pIPw&utm_content=99817057&utm_source=hs_automation

• ASSE International is in the final stages of producing a professional qualifications standard

for a Legionella Water Safety and Management Specialist http://www.asse-plumbing.org/

• Alternative: Water Management Certification by the Water Quality Association

https://www.wqa.org/•

34

http://www.asse-plumbing.org/

https://www.wqa.org/

CDC Recent Publications

• Toolkit for Controlling Legionella in Common Sources of Exposure (Legionella Control Toolkit)

(cdc.gov)

• Legionella Environmental Assessment Form (LEAF) (cdc.gov)

• PreventLD Training - Preventing Legionnaires’ Disease Training | EHS | CDC

• Water Infection Control Risk Assessment (WICRA) for Healthcare Settings (cdc.gov)

35

https://www.cdc.gov/legionella/downloads/Control-Toolkit-All-Modules.pdf

https://www.cdc.gov/legionella/downloads/legionella-environmental-assessment-p.pdf?ACSTrackingID=USCDC_248-DM49781&ACSTrackingLabel=2%20New%20Legionella%20Tools&deliveryName=USCDC_248-DM49781

https://www.cdc.gov/nceh/ehs/elearn/prevent-LD-training.html?ACSTrackingID=USCDC_248-DM49781&ACSTrackingLabel=2%20New%20Legionella%20Tools&deliveryName=USCDC_248-DM49781

https://www.cdc.gov/hai/pdfs/prevent/water-assessment-tool-508.pdf

Example of Water Infection Control Risk Assessment (WICRA), CDC



Thank you and now to Part 2. Building

Water Health: Legionella Safety

Joseph Ham – DuBois Chemical

water safety management

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