SOW Attachment 10 - VHA Directive 1061.pdf

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Department of Veterans Affairs VHA Directive 1061 Veterans Health Administration Transmittal Sheet Washington, DC 20420 August 13, 2014

PREVENTION OF HEALTHCARE-ASSOCIATED LEGIONELLA DISEASE AND

SCALD INJURY FROM POTABLE WATER DISTRIBUTION SYSTEMS

1. REASON FOR ISSUE: This Veterans Health Administration (VHA) Directive addresses the prevention of healthcare-associated Legionella Disease and Scald Injury from Potable Water Distribution Systems in VHA buildings.

2. SUMMARY OF CONTENTS: This Directive establishes policy for the prevention and control of healthcare-associated Legionella disease in VHA-owned buildings in which patients, residents, or visitors stay overnight.

3. RELATED ISSUES: None.

4. RESPONSIBLE OFFICE: The Deputy Under Secretary for Health for Operations and Management (10N) is responsible for the contents of this Directive. Questions related to the engineering aspects of this Directive are to be directed to the Office of Capital Asset Management, Engineering, and Support (10NA5) at 202-632-7900. Questions related to clinical aspects and validation processes in this Directive are to be directed to the National Infectious Diseases Service (10P4E) in the Office of Patient Care Services (10P4) at 513-246-0270.

5. RESCISSIONS: VHA Directive 2008-010, dated February 11, 2008, VHA Directive 2009- 009, dated February 25, 2009, and Information Letter 10-2013-006, dated May 3, 2013 are rescinded.

6. RECERTIFICATION: This VHA Directive is scheduled for recertification on or before the last working day of August 2019.

Carolyn M. Clancy, MD Interim Under Secretary for Health

DISTRIBUTION: E-mailed to the VHA Publications Distribution List on 08/15/2014.

August 13, 2014 VHA DIRECTIVE 1061

PREVENTION OF HEALTHCARE-ASSOCIATED LEGIONELLA DISEASE

AND SCALD INJURY FROM POTABLE WATER DISTRIBUTION SYSTEMS

1. PURPOSE: This Veterans Health Administration (VHA) Directive establishes policy for the prevention and control of healthcare-associated Legionella disease in VHA-owned buildings in which patients, residents, or visitors stay overnight. These types of buildings include, but are not limited to, acute care facilities, Community Living Centers (CLCs), domiciliaries, and Fisher Houses and other temporary lodging facilities (e.g. “hoptels”). AUTHORITY: 38 U.S.C.

7301(b).

NOTE: This Directive was developed to address areas in healthcare with a recognized higher risk for Legionella disease. It is anticipated that this Directive, and information gathered from its implementation, will serve as a template for further prevention policy in other VHA healthcare settings. Policy and guidance for full case investigations of confirmed or suspected healthcare-associated Legionella disease is not encompassed within the scope of this Directive.

2. BACKGROUND:

a. Legionella is a Gram-negative bacterium, which causes respiratory diseases collectively referred to as legionellosis. Legionellosis includes Legionella pneumonia, traditionally known as Legionnaires’ disease and hereafter abbreviated as “LD” for “Legionella disease”, and Pontiac Fever, a self-limiting respiratory illness. Disease is primarily caused by Legionella pneumophila; however, other species of Legionella can be pathogenic, particularly in transplant and other immunocompromised or high risk patients. The bacteria, found naturally in water, have been associated with disease from building water distribution systems. LD occurs after inhalation or aspiration of contaminated water, followed by a general incubation period of 2 to 14 days. Legionella bacteria are not transmitted from person-to-person.

b. Health care facilities are included in the types of buildings that have been associated with the transmission of Legionella to people. Cases of healthcare-associated LD (HCA LD) often arise from exposure to Legionella bacteria in hospital potable water distribution systems. The Centers for Disease Control and Prevention (CDC) guidance document on the prevention of healthcare-associated pneumonia defines laboratory-confirmed cases to be “definite” HCA LD if a patient has spent equal to or greater than 10 days continuously in a healthcare facility prior to the onset of LD, or “possible” HCA LD if a patient has spent 2 to 9 days in a healthcare facility prior to the onset of LD. NOTE: In January 2014, the CDC National Center for Immunization and Respiratory Diseases released an updated Legionellosis Case Report form, including guidance on determining if the case was definitely or possibly associated with a healthcare exposure. VHA Directive 1061 focuses on primary prevention activities for buildings where patients, residents or visitors stay overnight; in the event of a LD case suspected to be associated with any VHA building, case investigation and consideration of secondary prevention activities would be appropriate.

c. Persons at increased risk for LD include the immunocompromised (due to, for example, transplant, malignancy, renal disease, or diabetes), those over 50 years of age, those with chronic lung disease, and smokers. However, LD cases reported in the medical literature indicate that the disease can also occur in seemingly healthy individuals.

VHA DIRECTIVE 1061 August 13, 2014

d. Given the various factors and complexities associated with LD (e.g., host susceptibility, pathogen virulence, water distribution system configurations and conditions), 100% prevention of LD is likely not possible. However, prevention and control practices can be implemented to reduce the risk of exposing people to Legionella in building water distribution systems. The Legionella prevention activities in this Directive involve assessing risks, monitoring water quality and implementation of commensurate engineering controls to limit the growth of Legionella. Use of engineering controls to limit Legionella growth includes ongoing monitoring of implemented controls, validating that the control measures are effective at inhibiting Legionella growth, and modifying implementation or type(s), as necessary. By focusing on engineering controls, this Directive can be viewed as a horizontal intervention that can improve the overall microbiological quality of facility water, not just the inhibition of Legionella growth.

e. Legionella growth in building potable water distribution systems is primarily suppressed by the implementation of engineering controls such as maintenance of appropriate water temperatures or biocide (e.g. residual oxidant) levels. Application of more than one control may be necessary for the successful inhibition of Legionella growth.

(1) Maintenance of Appropriate Water Temperatures in Building Water Distribution Systems.

(a) Water temperatures at 124 degrees Fahrenheit (°F) (51.1 degrees Celsius (°C)) or higher are necessary to inhibit Legionella growth in hot water systems.

1. For most adult individuals, 110°F at the water outlet (e.g., sink tap, showerhead) will minimize the risk of scalding and is consistent with the plumbing code adopted by the Department of Veterans Affairs (VA) for VHA buildings. At 117°F the risk of scalding increases significantly. At 140°F, second degree burns may occur after only 3 seconds of exposure. Some people, either due to illness, disabilities, extremes of age or side effects of medication, may be less sensitive to hot water temperatures or have impaired or reduced reactions and thus are at an increased risk for tissue damage caused by extended exposure to hot water.

2. It is not possible to maintain water temperatures at the outlet that kill Legionella bacteria and simultaneously eliminate the possibility of scald injury in persons partially or fully insensitive to hot water temperature or having delayed or impaired response capabilities. The water temperature and accompanying safety requirements in this Directive address the risk of inhalation or aspiration of live Legionella bacteria while minimizing the risk of scald injury from exposure to domestic hot water.

(b) Cold water systems (temperature at 67°F (19.4°C) or lower) tend to be too cold to foster growth of Legionella. Cold water in piping and fixtures can reach ambient environmental temperatures exceeding 68°F (20°C) during prolonged periods of low flow or non-use. Use of piping system insulation, automatic drain devices, and recirculation to limit the rate and duration of an increase in cold water temperature in combination with appropriate biocide levels can be effective at preventing Legionella growth.

(2) Maintenance of Biocide at a Recommended Level for Legionella Control.

(a) Minimum concentrations of various biocides (e.g. oxidizing agents such as chlorine) can inhibit the growth of Legionella in building potable water distribution systems. The use of one or more installed systemic water treatment system(s) may be necessary to supplement any residual disinfectant present in incoming water (from municipal or central plant sources).

NOTE: The United States (U.S.) Environmental Protection Agency (EPA) regulates contaminant levels and disinfectant treatment for use under the Safe Drinking Water Act (42 U.S.C. §§300f, et seq.). U.S. EPA delegates primacy to States for the regulation and enforcement of the Act within individual State boundaries if the standards set by the State are at least as stringent as EPA’s.

(b) The efficacy of biocides on suppressing or killing waterborne pathogens is dependent on multiple factors such as water quality, organic and inorganic contaminants, pH levels, water hardness, disinfectant concentrations, and contact time. Therefore, the minimum concentration of biocide necessary to suppress bacterial growth may vary from building to building and even within buildings.

f. Installation of non-systemic systems or processes has been used in some buildings as mechanisms to provide further control of Legionella growth or delivery.

g. This Directive was developed by the VA Legionella Expert Work Group, a multidisciplinary team consisting of subject matter experts from transplant centers, healthcare engineering, infectious diseases, pathology and laboratory medicine, infection prevention and control, construction and facilities management, public health, occupational safety and health, and healthcare operations.

3. POLICY: It is VHA policy that an ongoing program for HCA LD prevention, including provisions necessary for the prevention of scald injury, is implemented in all VHA buildings in which patients, residents or visitors stay overnight. This program must be established with written policy in accordance with, at a minimum, the requirements defined in this Directive.

4. RESPONSIBILITIES:

a. Under Secretary for Health. The Under Secretary for Health is responsible for:

(1) Establishing and providing resources for the national VHA Water Safety Program, with key subject matter expertise provided by the Office of Capital Asset Management, Engineering, and Support (OCAMES), and the National Infectious Diseases Service (NIDS).

(2) Authorizing the VHA Water Safety Program to conduct assessments and surveys related to implementation and ongoing monitoring of this Directive and prevention and control of waterborne pathogens, including Legionella, at VHA facilities.

(3) Authorizing the VHA Water Safety Program to develop and issue competency requirements, initial and continuing education, and additional requirements and guidelines for water safety.

b. Deputy Under Secretary for Health for Operations and Management. The Deputy Under Secretary for Health is responsible for:

(1) Appointing the VHA Water Safety Program Director; and

(2) Ensuring effective engagement of clinical and healthcare engineering resources.

c. VHA Water Safety Program Director. The VHA Water Safety Program Director is responsible for:

(1) Developing and issuing competency requirements, initial and continuing education, and any additional requirements and guidelines for the prevention of waterborne pathogens, including Legionella.

(2) Conducting assessments and surveys related to the implementation and ongoing monitoring of this Directive.

(3) Evaluating the reports submitted by each Veterans Integrated Service Network (VISN) regarding implementation of this Directive at VISN medical facilities.

(4) Providing consultative assistance to the VISNs and facilities, as needed.

(5) Defining VISN-level liaison responsibilities and competency requirements.

d. VISN Director. The VISN Director is responsible for:

(1) Ensuring that all facilities within the VISN comply with this Directive and any policies and guidance from the VHA Water Safety Program for prevention of HCA LD, prevention of scald injuries, and water safety.

(2) Prioritizing resources and support for implementation of this Directive for all facilities within the VISN.

(3) Ensuring completion of initial implementation and annual reporting requirements, completion of clinical and environmental testing, and subsequent submission of the reports to the VHA Water Safety Program.

(a) Providing the VHA Water Safety Program with progress reports on actions taken by facilities to meet the implementation requirements for every facility within the VISN.

(b) Providing the VHA Water Safety Program with progress reports on expected completion dates and supplemental actions taken to implement the engineering control strategies.

(c) Assigning a VISN-level staff member as the water safety liaison for communication between VHA Central Office and VISN or facility staff regarding water safety and Legionella prevention actions, policies, and guidance. The VISN-level liaison is expected to be knowledgeable in VHA policies and guidance for prevention of HCA LD, prevention of scald injuries, and water safety. NOTE: Additional guidance regarding the VISN-level liaison responsibilities and competency requirements will be provided by the VHA Water Safety Program Director.

e. Medical Facility Director. The medical facility Director is responsible for:

(1) Ensuring that the medical facility establishes a multi-disciplinary Facility Water Safety Committee no later than October 1, 2014. The Facility Water Safety Committee is required to be chaired by the medical facility Associate Director, or equivalent, and report to the medical facility Director. This committee must include, at a minimum, representation from the following areas: Engineering/Facilities Management, Infectious Diseases, Infection Prevention and Control, Pathology and Laboratory Medicine, Hemodialysis (if performed on site), Safety/Industrial Hygiene, and Occupational Health. NOTE: If the medical facility Director does not have a required member (e.g. Infectious Disease) then the medical facility Director should work with the VISN Director to identify a representative within the VISN to participate on the Facility Water Safety Committee. Other stakeholders in facility water use (e.g., labor partners, dental, sterile processing, and supply) may be included on the Facility Water Safety Committee, as appropriate.

(2) Establishing a medical facility HCA LD prevention policy which specifies responsibilities and incorporates written HCA LD prevention plans no later than February 2, 2015.

(3) Ensuring that each building subject to this Directive has a written HCA LD prevention plan, including provisions necessary for the prevention of scald injury. The written plan(s) must be in compliance with the requirements of this Directive and any guidance issued by the VHA Water Safety Program Director.

(a) Each HCA LD prevention plan must be approved by the medical facility Director no later than December 31, 2014.

(b) The medical facility Director must certify that each building subject to this Directive has a written HCA LD prevention plan and approve the initial plan(s), and recertify annually thereafter.

(c) The medical facility Director must submit the initial and annual facility HCA LD prevention plan(s), certifications, and approvals to the VISN Director.

(4) Ensuring that the actions in the written HCA LD prevention plan(s) are implemented.

(5) Ensuring that the medical facility has decommissioned all indoor, open decorative water features from all of its buildings, and future design plans do not include the installation of such indoor, open water features. NOTE: The use of indoor, open decorative water features has been epidemiologically-linked to LD in the healthcare setting.

(6) Ensuring that each building subject to this Directive conducts at least quarterly environmental water testing for Legionella in accordance with this Directive, and submits the results to the VISN Director.

(7) Providing annually to the VISN Director a summary of the medical facility’s clinical Legionella testing results and number of cases of LD (definite HCA LD, possible HCA LD, and community-associated LD).

(8) Ensuring that all cases of LD are reported to the appropriate public health authority in accordance with applicable statutes, regulations, and with current VHA policy for infectious disease reporting, protecting health information, and release of information.

(9) Requesting consultative assistance from the VHA Water Safety Program, through the VISN-level water safety liaison, on issues related to Legionella implementation of prevention efforts, if needed.

f. VHA Facility Chief of Staff and Associate Director of Patient Care Services. The VHA facility Chief of Staff and Associate Director of Patient Care Services are responsible for:

(1) Ensuring that the medical facility has access to clinical care staff with expertise in infectious diseases to assist in diagnosis and treatment of LD. NOTE: Diagnostic testing of pneumonia patients for LD, especially when healthcare-association is suspected, can provide important information for surveillance and remediation purposes. Full details on requirements and recommendations for clinical testing and diagnostic awareness can be found in Appendix C.

(2) Ensuring that clinical staff involved in direct patient care are notified when cases of definite or possible HCA LD are identified to increase diagnostic awareness.

(3) Ensuring that clinical staff involved in direct patient care are notified when routine environmental water testing is positive for Legionella to increase diagnostic awareness (see Appendix C, paragraph 3 for more information).

g. VHA Facility Chief Engineer or Facility Manager. The VHA Facility Chief Engineer, Facility Manager, or equivalent is responsible for:

(1) Ensuring that the maintenance of appropriate water temperatures in the hot and cold potable water distribution system(s) is in accordance with Appendices A and B and the facility’s approved HCA LD prevention plan(s).

(a) Documenting the facility’s policy for the implementation and monitoring of temperature limits in the hot and cold potable water distribution systems (e.g., hot water tanks, if used, circulating water in the distribution systems, and at the outlets), including written explanation of any conditions or circumstances that may delay implementation of water temperatures, in accordance with Appendices A and B and the facility’s approved HCA LD prevention plan(s).

(b) Preparing written documentation of engineering procedures according to the requirements in Appendix B for the prevention of scald injury.

(c) Ongoing monitoring of the temperature levels in the building’s potable water distribution system(s) to ensure they are within the requirements defined in Appendices A and B and the facility’s approved HCA LD prevention plan(s).

(d) Verifying that implementation and monitoring of water temperature levels is in accordance with the facility’s written policy.

(2) Continuous monitoring of incoming water quality entering building(s) (from municipal or central plant sources) as required in Appendix A and the facility’s approved HCA LD prevention plan(s).

(3) When a water treatment system(s) is present in a building to deliver a biocide (e.g.

oxidant residual) into the system, ensuring the maintenance of appropriate biocide levels for Legionella control in the building’s potable water distribution system(s) in accordance with Appendix A and in compliance with applicable regulatory requirements for safe drinking water and effluent concentrations.

(a) Biocide-based water treatment systems are subject to Federal and State statutes and regulations which typically identify acceptable biocide(s) and specify construction and operating requirements. Installed systems must be specifically approved or recognized for the intended use by the State regulatory water authority. Documentation of system(s) approval, design, installation, and operation shall be maintained current.

(b) Documentation of the facility’s policy for biocide concentration levels in the hot and cold potable water distribution systems. This includes documentation of minimum and maximum biocide levels, allowable disinfection byproduct levels, biocide monitoring method and frequency, and any other requirements in accordance with Appendix A and in compliance with operating permits.

(c) Ongoing monitoring of biocide and disinfection byproduct levels in the building’s potable water distribution systems to ensure they are within the guidelines defined in Appendix A and in compliance with operating permit requirements.

(4) Ensuring that any treatment measures implemented in building water distribution systems are functioning according to the manufacturer’s specifications for the particular system that is being used and at recommended capacity for Legionella inhibition.

(5) Conducting Infection Control Risk Assessments in cooperation with other facility stakeholders to address the potential impact of construction and maintenance of water systems on growth or transmission of waterborne pathogens and to determine the extent of precautions, disinfection, and system or component commissioning requirements.

(6) Ensuring that newly installed piping and distribution system components are flushed of debris and disinfected prior to being placed into service. Piping and components must be cleaned and protected from accumulation of debris and contamination prior to and during installation. Documentation of flushing and disinfection must be maintained.

(7) Ensuring unused water branch lines and dead-legs are removed and capped at the main supply/recirculation supply lines to limit stagnation and reservoirs for Legionella growth in accordance with the approved HCA LD plan(s).

(8) Ensuring that only steam is used for building humidification purposes. Comply with prohibition of ultrasonic humidifiers, foggers, misters, spray humidifiers, and tank type humidifiers.

(9) Assessing and documenting competency of contractors and the contractor’s personnel as part of the acquisition process prior to the start of any work on facility water systems, including water treatment. Competencies must be re-assessed on an on-going basis, or whenever there is a change in contractors or the contractor’s personnel performing the work. At a minimum, the contractor’s competency should be assessed and documented on an annual basis. A copy of any assessment or documentation must be submitted to the supporting VISN Contract Manager.

(10) Ensuring competent personnel are available at all times to address water system operations.

(11) Forwarding notification to all medical facility employees when:

(a) Maintenance and repair procedures will be taking place that could affect the water system;

(b) Maintenance and repair procedures have been completed; and

(c) Affected systems have been tested and are returned to normal operation.

(12) Providing the Facility Water Safety Committee, Safety Committee, and Infection Control Committee with an annual report of the water system maintenance and monitoring and any Legionella mitigation actions taken.

h. VHA Facility Chief of Pathology and Laboratory Medicine. The VHA Facility Chief of Pathology and Laboratory Medicine Service is responsible for:

(1) Ensuring that the laboratory has access to L. pneumophila urinary antigen testing.

VHA-designated Transplant Centers need to consider on-site availability of L. pneumophila urinary antigen testing.

(2) Ensuring access to a clinical laboratory that can perform cultures on respiratory secretions for Legionella, with identification at the species level, and can determine the serogroup of L. pneumophila.

(3) Ensuring that clinical cultures for Legionella and urinary antigen tests are performed in accordance with current VHA policy on laboratory testing.

(4) Ensuring that results from laboratory tests and clinical cultures for Legionella are entered into the Computerized Patient Record System (CPRS) as soon as testing is completed.

(5) Providing annually to the Infection Control Committee and the Facility Water Safety Committee the:

(a) Total number of urinary antigen tests and clinical cultures for Legionella ordered; and

(b) Total number of persons with positive results for Legionella.

(6) Ensuring that the Laboratory Service is involved in the process of selecting a laboratory that can perform environmental water and swab cultures for Legionella (see Appendix C, paragraph 2 for requirements and guidance on selecting an environmental testing laboratory).

i. Facility Water Safety Committee Chair. The Facility Water Safety Committee Chair is responsible for:

(1) Conducting an annual assessment to determine which buildings fall subject to this Directive.

(2) Developing written HCA LD prevention plan(s) for each building subject to this Directive in accordance with this Directive and requirements promulgated by the VHA Water Safety Program. The written HCA LD prevention plan(s) must contain, at minimum, all of the components delineated in Appendix A, paragraph 1. These components address building associated risk assessments, implementation and monitoring of engineering controls (see Appendix A and B for details), validation that the engineering controls are effectively preventing Legionella growth (see Appendix C for details), and scald prevention.

(3) Reviewing the written HCA LD prevention plan(s) at least annually and updating as necessary.

(4) For each building subject to this Directive, establishing the policy for conducting environmental water testing for Legionella, to include:

(a) Determining the number and location of outlets tested and the frequency of such testing, which must be in accordance with at least the requirements in Appendix C, paragraph 2.a.

(b) Determining who at the building level is responsible for: collecting environmental water samples, ensuring that the water samples are transferred to the environmental testing laboratory, receiving the results, and reporting the results to the Facility Water Safety Committee, Safety Committee and the Infection Control Committee.

(c) Determining the laboratory that will conduct the environmental water testing using the requirements and guidance in Appendix C, paragraph 2.b.

(5) Conducting routine meetings to review the records from implementation of the HCA LD prevention plan(s).

(a) Routine committee meetings must be held at least quarterly. The reviews must assess, at a minimum, building associated risk(s), documented verification of policy implementation (e.g., implementation of engineering controls, water quality testing, water pressure, scald control), any results from water testing for Legionella, whether any engineering controls were not within specified limits and why that may have occurred, whether any corrective actions were taken on engineering controls, whether the HCA LD prevention plan(s) needs to be updated, and whether there have been any cases of LD diagnosed at or potentially associated with each building.

NOTE: If the Facility Water Safety Committee discusses any case of LD, patient information must be de-identified prior to sharing the information with the committee.

(b) The Facility Water Safety Committee is to meet as necessary to address any non-routine Legionella control issues and HCA LD.

(c) Documenting in the minutes any corrective actions that were initiated for maintaining water temperature and oxidant residual at appropriate levels to inhibit Legionella growth, and documenting the effectiveness of the corrective actions taken.

(d) Ensuring the results of the reviews are communicated to the medical facility Leadership Team, Safety Committee, Infection Control Committee, and any other local committees as appropriate for the medical facility.

5. REFERENCES:

a. American Society for Heating, Refrigerating and Air-conditioning Engineers (ASHRAE). Guideline 12-2000. Minimizing the Risk of Legionellosis Associated with Building Water Systems; 2000.

b. American Thoracic Society and Infectious Diseases Society of America. Guidelines for the Management of Adults with Hospital-acquired, Ventilator-associated, and Healthcare-associated Pneumonia. American Journal of Respiratory and Critical Care Medicine.

171(4):388-416; 2005.

c. Association of Water Technologies. Legionella 2003: An Update and Statement by the Association of Water Technologies (AWT); June, 2003.

http://awt.org/IndustryResources/Legionella03.pdf.

d. Centers for Disease Control and Prevention. Guidelines for Environmental Infection Control in Health-care Facilities. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Morbidity and Mortality Weekly Reports.

52 (RR10):1-42; 2003. www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm.

e. Centers for Disease Control and Prevention. Guidelines for Preventing Healthcare-associated Pneumonia. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. Morbidity and Mortality Weekly Reports. 53(RR03):1-36;

2003. www.cdc.gov/mmwr/preview/mmwrhtml/rr5303a1.htm.

f. Department of Veterans Affairs Office of Inspector General. Assessment of Legionnaire’s Disease Risk in Veterans Health Administration Inpatient Facilities. Report No.

07-00029-151; June 20, 2007. http://www.va.gov/oig/54/reports/VAOIG-07-00029-151.pdf.

g. Department of Veterans Affairs Office of Inspector General. Healthcare Inspection:

Prevention of Legionnaires’ Disease in VHA Facilities. Report No. 13-01189-267; August 1, 2013. http://www.va.gov/oig/pubs/VAOIG-13-01189-267.pdf.

http://awt.org/IndustryResources/Legionella03.pdf http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5303a1.htm http://www.va.gov/oig/54/reports/VAOIG-07-00029-151.pdf http://www.va.gov/oig/pubs/VAOIG-13-01189-267.pdf

h. Department of Veterans Affairs, Veterans Health Administration, Executive Decision Memorandum. Indoor Decorative Water Features in VHA Healthcare Facilities. Approved November 26, 2012. Located at http://vaww.nlc.portal.va.gov/EDMs/EDMDocuments/2012%20Approved%20Executive%20D ecision%20Memos/EDM%20Indoor%20Decorative%20Water%20Features.pdf. NOTE: This is an internal VA Web site and is not available to the public.

i. Facilities Guidelines Institute. Guidelines for Design and Construction of Health Care Facilities, 2010 edition. Chicago: American Society of Healthcare Engineering of the American Hospital Association; 2010.

j. International Code Council. International Plumbing Code (IPC), Chapters 1 through 6 2009 IPC. International Code Council, Inc.; 2009.

k. Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, et al. Infectious Diseases Society of America/American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults. Clinical Infectious Diseases 44:S27-72; 2007. l. Occupational Safety & Health Administration (OSHA). OSHA Technical Manual, Section III: Chapter 7. Legionnaire’s Disease. Effective date: January 20, 1999.

l. World Health Organization (WHO). Legionella and the Prevention of Legionellosis.

WHO Press; 2007. http://www.who.int/water_sanitation_health/emerging/Legionella.pdf.

m. 40 CFR part141. National Primary Drinking Water Regulations.

n. 40 CFR part142. National Primary Drinking Water Regulations Implementation.

6. DEFINITIONS:

a. Anti-scald device. Anti-scald device is a temperature actuated appurtenance used in plumbing systems to reduce/stop water flow exceeding a defined temperature. Individual anti-scald devices must meet American Society of Sanitary Engineers (ASSE) 1062 Standard. Anti-scald devices may be add-on or integrated into plumbing fixtures or integrated into water tempering valves.

b. Biocide. For the purpose of this Directive, a biocide is a chemical agent or substance which can deter, inactivate, or kill microorganisms.

c. Chlorine. Chlorine is an EPA listed biocide chemical (oxidant) approved for use in the treatment of potable water to control/inactivate waterborne bacteria, viruses, and protozoa. In high concentrations, it can be used for the disinfection of water systems and their components.

d. Chlorine dioxide. Chlorine dioxide is an EPA listed biocide chemical (oxidant) approved for use in the treatment of potable water to control/inactivate waterborne bacteria, viruses, and protozoa.

e. Clinical testing. Clinical testing encompasses the spectrum of diagnostic modalities that are used to elucidate the cause of a disease process. In particular, for this Directive, they are http://vaww.nlc.portal.va.gov/EDMs/EDMDocuments/2012%20Approved%20Executive%20Decision%20Memos/EDM%20Indoor%20Decorative%20Water%20Features.pdf http://vaww.nlc.portal.va.gov/EDMs/EDMDocuments/2012%20Approved%20Executive%20Decision%20Memos/EDM%20Indoor%20Decorative%20Water%20Features.pdf http://www.who.int/water_sanitation_health/emerging/legionella.pdf specific for the diagnostic modalities used to determine the presence of LD. These clinical testing modalities include culture for Legionella species, Legionella pneumophila urinary antigen testing, serological testing using IgG and IgM antibodies with acute and convalescent serology (convalescent serology is obtained “after the fact” and can help confirm a diagnosis in retrospect), and nucleic acid antibody/molecular diagnostic testing. There is an expectation that appropriate clinical testing is done as standard practice by providers when caring for patients with a certain disease process.

f. Clinical Validation. Clinical validation is the process of determining if the primary engineering controls and any supplemental water treatment systems are successfully inhibiting Legionella growth in the potable water distribution system(s) by monitoring the occurrence of HCA LD. For the purpose of this Directive, clinical validation encompasses diagnostic testing of HCA pneumonia cases for LD when indicated and heightened awareness for diagnostic testing when Legionella is detected in environmental samples.

g. Community-associated Legionella disease (CA-LD). In general, CA-LD is a laboratory-confirmed case of Legionella disease in which the patient has not had contact with the healthcare setting in the 10 days prior to onset of illness.

h. Control measure. A control measure is any action or activity that can be used to prevent or eliminate a hazard or reduce the hazard to an acceptable level. [WHO, 2007].

i. Continual or Continuous. For the purposes of this Directive, continual or continuous refers to the almost uninterrupted monitoring and control of: water quality, incoming water pressure, biocide levels, and water temperatures. This can be achieved through the use of automated measurement/control devices, typically connected to the Building Automation System (BAS), at various locations such as water source equipment and throughout the water distribution system. Central recording of measurements is needed at least every 30 minutes and instantaneously during out-of-control limit (alarm) conditions. More frequent measurement recording for some or all parameters/locations may be required by the Facility Water Safety Committee or the State (or its delegated local water authority).

j. Corrective action. Corrective action is any action to be taken when the results of monitoring indicate that a primary or supplemental control is not within the established control limits.

k. Disinfection. Disinfection is an irreversible inactivation of microorganisms on a surface or in a system and the reduction of those microorganisms to non-hazardous levels. Low level chemical disinfection of potable water systems can be accomplished through the use of EPA listed biocides. High level disinfection for new installations or maintenance of piping, equipment, and components is conducted in accordance with the requirements of the International Plumbing Code (IPC 2009), American Water Works Association (AWWA C651- 05), and VA Master Construction Specifications.

l. Distal. Distal means remote. In plumbing systems “distal” piping, equipment, or water outlets can be either physically or hydraulically remote, or in instances both, from a source point.

NOTE: The term “distal water site” was used in previous VHA Legionella prevention policy to refer to points where the end user accesses the water; this term has been replaced by “outlet” in this Directive.

m. Emergency Remediation. Emergency Remediation is the process of implementing immediate, temporary actions to reduce the amount of Legionella in a water distribution system.

n. Engineering Control limit. An engineering control limit is a minimum and or maximum value at which a parameter must be maintained in order to prevent or eliminate a hazard or reduce the hazard to an acceptable level. For example, a minimum hot water temperature of 124 degrees Fahrenheit (°F) inhibits Legionella growth in building hot water systems.

o. Environmental Validation. For the purpose of this Directive, environmental validation is the process of testing the building’s potable water distribution system(s) to determine if engineering controls are successfully inhibiting growth of Legionella.

p. Flushing of Outlets. Flushing of outlets is the process of opening outlets such that hot and cold water flows out of the outlet for a specified period of time (specific duration varies with purpose and process). The purpose of routine flushing is to prevent stagnating conditions in pipes which could result in tempering of water temperature, dissipation of biocide, and establishment of favorable conditions for Legionella growth.

q. Healthcare-associated Legionella disease (HCA LD). HCA LD is a laboratory-confirmed case of Legionella disease that is epidemiologically-linked to the healthcare facility.

HCA LD cases may be “definite” or “possible”. The definitions below for these classifications are based on information in the CDC 2003 guidelines for prevention of healthcare-associated pneumonia and the updated CDC Legionellosis Case Report form released in January, 2014.

NOTE: Each case of LD should be assessed for linkage to the facility on a case-by-case basis taking into account any related factors (e.g., a change in definition during a LD outbreak, molecular matching of patient and environmental isolates).

(1) Definite HCA LD. “Definite HCA LD” is a laboratory-confirmed case of Legionella disease with an inpatient stay that is equal to or greater than 10 days of continuous inpatient stay prior to onset of illness. [CDC Guidelines, 2003; CDC Legionellosis Case Report form, 2014]

(2) Possible HCA LD.

(a) “Possible HCA LD (inpatient)” is a laboratory-confirmed case of Legionella disease in which a patient has spent 2 to 9 days in a healthcare facility prior to onset of illness. [CDC Guidelines, 2003]

(b) “Possible HCA LD (inpatient and outpatient)” is a laboratory-confirmed case of Legionella disease in which the patient had exposure to a healthcare facility for a portion of the 10 days prior to onset of illness. [CDC Legionellosis Case Report form, 2014]

r. Healthcare-associated Legionella Disease (HCA LD) Prevention Plan. The HCA LD Prevention Plan is the written plan required for every VHA building where patients, residents, or visitors stay overnight. The HCA LD Prevention Plan focuses on identification of risks and implementation of engineering measures for control of Legionella growth, monitoring of the control measures, validation that the measures are effective at suppressing Legionella growth, and implementation of corrective actions when indicated. The HCA LD Prevention Plan is to be reviewed at least annually for any updating.

s. Hyperchlorination. See “Shock chlorination”.

t. Immersion Bath. Immersion bath is a bath in which an individual’s entire body or a body part is submerged in water.

u. Legionella. Legionella is a Gram-negative bacterium that is naturally found in water and has been associated with building water distribution systems and cooling towers. Over 50 species and 70 serogroups have been identified.

v. Legionella Disease (LD). LD is the term used in this Directive for the disease traditionally known as “Legionnaires’ disease;” a type of pneumonia caused by pathogenic species of the bacterium, Legionella. Most, but not all, cases of disease are caused by the species Legionella pneumophila serogroup 1.

w. Legionellosis. Legionellosis refers to diseases (Legionnaires’ disease, Pontiac Fever) caused by pathogenic species of Legionella bacteria. Legionnaires’ disease is defined above (see “Legionella disease”). Pontiac fever is a milder respiratory infection and symptoms resolve without treatment.

x. Legionnaires’ Disease. See “Legionella disease.”

y. Mitigation. Mitigation is a process of implementing actions to reduce the amount of Legionella in a water distribution system (also called “remediation”).

z. Mixing Valve. Mixing valve is a generic reference to a class of water tempering devices.

Mixing valves used for tempering hot water in potable water systems must meet the requirements of the International Plumbing Code (IPC 2009), American Society of Sanitary Engineers (ASSE 1016/1069/1070), and VA Master Construction Specifications.

aa. Monitoring. Monitoring, for the purpose of this Directive, refers to the process of routinely checking water quality of incoming water (from municipal or central plant) and implementation of primary and any supplemental engineering controls to determine if the controls are within established minimum and maximum limits.

bb. Monochloramine. Monochloramine is a type of chloramine. Chloramines are most commonly formed when ammonia is added to chlorine. An EPA listed biocide chemical (oxidant) approved for use in treatment of potable water to control/inactivate waterborne bacteria, viruses, and protozoa.

cc. Outlet. Outlet is a point in the potable water distribution system where the individual (also known as the “end user”) accesses the water. Examples include faucets, showers, ice machines, and drinking fountains. NOTE: In previous VHA Legionella prevention Directives, the term “distal site” was used instead of “outlet.”

dd. Oxidant residual. Oxidant residual is the amount of available oxidant present in the water system and at the outlet after demand has been satisfied. Required oxidant residuals in a water system are, in-part, determined by: water quality, water system conditions (piping system corrosion, water flow/turnover, etc.), presence of disinfection by-products, and type and quantity of microorganisms requiring inactivation.

ee. Point-of-use filter. Point-of-use filter is a micropore filter specifically designed for use in preventing the passage of Legionella bacteria, other specific microorganisms, and particle contaminants present in water. Typically, these filters are fitted to water outlets or installed in water supply lines proximal to equipment (e.g., ice machines, drinking fountains).

ff. Potable Water Distribution System. Potable water distribution system is a water distribution system (hot water and cold [unheated] water) within a building or structure primarily used for drinking, sanitation, food service, and personal hygiene meeting EPA and state drinking water standards.

gg. Primary control measures. Primary control measure refers to the main or routine methods used to suppress Legionella growth in building potable water distribution systems.

Primary control measures often used in building potable water distribution systems include at least one of the following: appropriate water temperature(s) and treatment with biocide(s) (e.g.

oxidizing agent).

hh. Process flow diagram. Process flow diagram is a systematic representation of the sequence of steps or operations used in the production or manufacture of particular item [WHO, 2007].

ii. Remediation. Remediation is the process of implementing actions to reduce the amount of Legionella in a water distribution system (also called “mitigation”).

jj. Resident. Resident is defined here for the purpose of clarifying which buildings fall subject to this Directive. In the phrase “VHA buildings in which patients, residents or visitors stay overnight”, the term “resident” refers to Veterans who are under residential-type care such as provided at a Community Living Center or domiciliary.

kk. Shock chlorination. Shock chlorination is the application of hypochlorite, usually in the form of a solution, to the water distribution system at higher than normal levels for remediation purposes.

ll. Supplemental or Supplementary Water Treatment. A measure used in addition to routine (primary) control measures to inhibit the growth of Legionella in building water distribution systems.

mm. Thermal eradication. Thermal eradication is the temporary resetting of the temperature in the hot water distribution system to 160°F - 170°F (71°C - 77°C) while continuously flushing each outlet in the system for at least 30 minutes (also known as “super heat and flush").

nn. Validation. Validation is the process of obtaining evidence that a plan is effective. For purposes of this Directive, validation specifically refers to verifying that the primary and any supplemental engineering controls are effective at inhibiting the growth of Legionella in building potable water distribution systems. The two validation methods used are environmental water testing for Legionella and clinical testing of pneumonia patients for Legionella.

oo. Water distribution system. Water distribution system is a system used for the distribution of potable water (site and building) which includes all piping, water treatment, equipment, controls, fixtures, and components.

pp. Water System Management Point. A specific position, device, fixture, or water distribution system component used for the monitoring of conditions or performance or the control of the system or its individual components.

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APPENDIX A

PREVENTION PLANS FOR HEALTHCARE-ASSOCIATED

(HCA) LEGIONELLA DISEASE (LD)

1. COMPONENTS OF A HCA LD PREVENTION PLAN: A HCA LD prevention plan must include:

a. Schematic (single line) diagrams of the site distribution and domestic water systems (hot and cold). Each diagram must be kept current and include diagrams of how water is distributed, circulated, stored, heated and cooled, treated, and monitored. The diagrams must be accurate representations of existing conditions and focus on main areas of water distribution and processing system(s) and identify any areas in which water is processed differently (e.g., hemodialysis and sterile processing). Further information on what comprises a schematic diagram will be provided by the VHA Water Safety Program.

b. A risk assessment of the building for HCA LD. At least annually, assess the building for factors that may indicate increased risk for HCA LD. Factors can include, but are not limited to:

patient population risk factors, presence of building units associated with increased risk (e.g.

transplant units), past cases of HCA LD, ability to implement engineering controls to prevent Legionella growth, past positive environmental testing results, and location of the building in an area of the country with recognized higher incidence of LD. Implementation of previous years’ HCA LD plans and their findings should also be included in the risk assessment. NOTE: This risk assessment can be useful when implementing the validation activities in Appendix C and determining follow-up actions.

c. Identification of water system management points for the building’s potable water distribution system(s), and, based on the schematic diagrams, where monitoring and controls can be implemented to prevent the growth of Legionella and prevent scald injury.

d. Establishment of engineering control strategies. Specifically, the HCA LD Prevention Plan needs to:

(1) Establish the engineering control limits for each strategy to inhibit Legionella in the environment (see paragraph 2 below).

(2) Identify control mechanisms for preventing scald injury from water that is too hot (see Appendix B).

(3) Establish a schedule to routinely monitor implementation of the control strategies.

NOTE: Since this Directive focuses on the implementation of engineering controls to prevent Legionella growth, “monitoring” refers to assessment of the levels of the control measures (e.g., water temperature, biocide level) in the water distribution system and water quality, not the amount of Legionella. Rather, assessment of Legionella in the water distribution must be included as a mechanism to validate that the engineering controls are effective.

APPENDIX A

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(4) Establish a dead-leg elimination and prevention plan. Plan components include:

identification of existing dead-legs, dead-leg risk assessment, removal prioritization, removal schedule, and prevention.

e. Documenting when each water quality and control measure was monitored for condition compliance and corrective action taken (what and when).

f. Validation that the control measures are effectively inhibiting Legionella growth (see Appendix C).

g. Process flow diagrams of the different control strategies and monitoring for each building’s hot and cold water distribution systems. NOTE: Each diagram is to focus on main areas of water distribution and processing and identify any areas in which water is processed differently (e.g., hemodialysis and sterile processing).

2. ENGINEERING CONTROL STRATEGIES AND LIMITS FOR ONGOING

PREVENTION OF LEGIONELLA GROWTH: Maintenance of appropriate water temperatures and…