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CMS Regulations and Legionella

legionella

CMS Regulations and Legionella

MCN Healthcare has received many questions about Centers for Medicare and Medicaid Services (CMS) regulations and legionella.

Facilities must develop and adhere to policies and procedures that inhibit microbial growth in building water systems that reduce the risk of growth and spread of legionella and other opportunistic pathogens in water.

CMS issued a policy memorandum on June 2, 2017 (revised on June 9, 2017) to raise awareness about facility requirements to prevent Legionella infections. This policy memorandum applies to Hospitals, Critical Access Hospitals (CAHs) and Long-Term Care (LTC). However, according to CMS, it is also intended to provide general awareness for all healthcare organizations.

The bacterium Legionella can cause a serious type of pneumonia, called LD, in persons at risk such as individuals who are at least 50 years old, smokers, or those with underlying medical conditions such as chronic lung disease or immunosuppression. Outbreaks have been linked to poorly maintained water systems in buildings with large or complex water systems including hospitals and long-term care facilities. CMS is aware of multiple recent LD outbreaks in hospitals and long-term care facilities as reported by the Centers for Disease Control and Prevention (CDC), state and local health departments, or investigated by State Survey Agencies.

Outbreaks generally are linked to environmental reservoirs in large or complex water systems, including those found in healthcare facilities such as hospitals and long-term care facilities. Transmission from these water systems to humans requires aerosol generation, as can occur from showerheads, cooling towers, hot tubs, and decorative fountains. Legionella is less commonly spread by aspiration of drinking water or ice.

Legionella can grow in parts of building water systems that are continually wet, and certain devices can spread contaminated water droplets via aerosolization. Examples of these system components and devices include:

  • Hot and cold water storage tanks
  • Water heaters
  • Water-hammer arrestors
  • Pipes, valves, and fittings
  • Expansion tanks
  • Water filters
  • Electronic and manual faucets
  • Aerators
  • Faucet flow restrictors
  • Showerheads and hoses
  • Centrally-installed misters, atomizers, air washers, and humidifiers
  • Nonsteam aerosol-generating humidifiers
  • Eyewash stations
  • Ice machines
  • Hot tubs/saunas
  • Decorative fountains
  • Cooling towers
  • Medical devices (such as CPAP machines, hydrotherapy equipment, bronchoscopes, heater-cooler units)

Pertinent Regulations:

  • 42 CFR §482.42 for hospitals: “The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.”
  • 42 CFR §483.80 for skilled nursing facilities and nursing facilities: “The facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.”
  • 42 CFR §485.635(a)(3)(vi) for critical access hospitals (CAHs): CAH policies must include: “A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel.”

Per the memorandum, 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.

An industry standard calling for the development and implementation of water management programs in large or complex building water systems to reduce the risk of legionellosis was published in 2015 by American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE). In 2016, the CDC and its partners developed a toolkit to facilitate implementation of this ASHRAE Standard. Environmental, clinical, and epidemiologic considerations for healthcare facilities are described in this toolkit.

CMS surveyors will review policies, procedures, and reports documenting water management implementation results to verify that facilities:

  • Conduct a facility risk assessment to identify where Legionella and other opportunistic waterborne pathogens (e.g. Pseudomonas, Acinetobacter, Burkholderia, Stenotrophomonas, nontuberculous mycobacteria, and fungi) could grow and spread in the facility water system.
  • Implement a water management program that considers the ASHRAE industry standard and the CDC toolkit, and includes control measures such as physical controls, temperature management, disinfectant level control, visual inspections, and environmental testing for pathogens.
  • Specify testing protocols and acceptable ranges for control measures, and document the results of testing and corrective actions taken when control limits are not maintained.

Healthcare facilities are expected to comply with CMS requirements to protect the health and safety of its patients. Those facilities unable to demonstrate measures to minimize the risk of LD are at risk of citation for non-compliance with the CMS Conditions of Participation. Accrediting organizations will be surveying healthcare facilities deemed to participate in Medicare for compliance with the requirements listed in this memorandum, as well, and will cite noncompliance accordingly.

StayAlert! issued a notice, in June, addressing  CMS regulations and Legionella.  Example policies and procedures were provided with the notice.  Sign up for a FREE TRIAL of StayAlert! Now.

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