Regulators and public health officials are sharpening their focus on waterborne pathogens in building water systems. For owners and operators of Medicare-certified facilities, that means new policies and procedures must be put in place to keep out of the federal regulatory spotlight. Owners and operators of independent and assisted living communities who want to stay ahead of the curve and out of the headlines should be aware of the rapidly changing legal and regulatory landscape and evaluate their current water management practices.
The rate of Legionnaires’ disease and other infections associated with waterborne pathogens is on the rise. The Centers for Disease Control and Prevention reports that Legionnaires’ disease is diagnosed in approximately 5,000 people annually in the United States, with an average hospitalization of 10.2 days at an average cost of approximately $30,000. The incidence rate nearly quadrupled between 2000 and 2014 and yet the disease is considered to be underdiagnosed and underreported.
Against this backdrop, on June 2, the Centers for Medicare & Medicaid Services issued a survey and certification memorandum — “Requirement to Reduce Legionella Risk in Health Care Facility Water Systems to Prevent Cases and Outbreaks of Legionnaires’ Disease ” (Ref: S&C 17-30-ALL) — requiring Medicare-certified facilities to implement policies and procedures to reduce the risk of waterborne health care-associated infections such as Legionnaires’ disease. A week later, CMS confirmed that the new policy applies to Medicare-certified long-term care facilities, hospitals and critical access hospitals and also serves to raise the general awareness about waterborne pathogen risks for all healthcare organizations. (Ref: S&C 17-30-Hospitals/CAHs/NHs REVISED 06.09.2017.)
CMS S&C 17-30 is the first regulatory policy to mandate proactive risk management measures relating to waterborne pathogens in healthcare facilities and the first such policy by CMS. Under the new policy, which took effect immediately, 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.” CMS specifically identifies Pseudomonas, Acinetobacter, Burkholderia, Stenotrophomonas, nontuberculous mycobacteria, and fungi as opportunistic pathogens of concern.
At initial surveys and periodic re-surveys (including complaint-driven surveys), CMS surveyors and accrediting organizations will review water management plans and documentation to verify that facilities have conducted a risk assessment, developed a water management plan and implemented the plan. Noncompliance may result in a citation with the CMS conditions of participation.
CMS S&C 17-30 is one piece of a continuum of updated guidance on waterborne pathogen risks in building water systems that began with the issuance of the Allegheny County Health Department’s Updated Guidelines for the Control of Legionella in Western Pennsylvania (October 2014) and includes ASHRAE/ANSI Standard 188 — “Legionellosis: Risk Management for Building Water Systems” the American Industrial Hygiene Association’s Recognition, Evaluation and Control of Legionella in Building Water Systems and several studies and reports from the CDC.1
The regulatory landscape also is shifting. After several high-profile outbreaks in 2014 and 2015, officials in New York issued regulations requiring building owners to register cooling towers and periodically test them for Legionella.
It is expected that the Joint Commission on Accreditation of Health Care Organizations will adopt a similar policy and update the Environment of Care standards to specifically address waterborne pathogen risks.
The public health and regulatory focus on waterborne pathogen risks is expanding and accelerating and will continue. Facilities specifically covered by CMS S&C 17-30 must take action to ensure compliance. Facilities not specifically covered should be aware of the trends and recognize that public health officials increasingly expect that the owners and operators of all at-risk facilities will take proactive steps to reduce waterborne pathogen risks.
Independent living and assisted living communities fit this profile because of building and population characteristics. Many independent living and assisted living communities have complex building water systems — components and devices identified in CMS S&C 17-30 as associated with the growth and spread of Legionella. Aging senior citizens, many of whom are in declining health, are considered to be particularly susceptible to infections caused by Legionella and other “opportunistic pathogens.”
Facilities not directly covered by CMS S&C 17-30 will not be subjected to periodic compliance inspections. Public health officials investigating suspected clusters or outbreaks of these diseases, however, will look to all facilities frequented by the affected individuals as the potential site of exposure, even those not regulated by CMS. Sporadic cases of infection not linked to an outbreak or cluster do not trigger public health investigations, but scrutiny may come from the affected individuals, their family members and their lawyers.
Compliance with CMS S&C 17-30 or other guidance, such as ASHRAE 188, may reduce the incidence of such infections, and documented compliance may be useful to defend the facility from regulatory enforcement actions, claims or lawsuits.2 Compliance with CMS S&C 17-30 is achieved through a three-step process: conduct a risk assessment, develop a water management program appropriate to the level of risk at the facility and implement the program. Documentation of all aspects of compliance is essential and will be necessary to establish that the program, in fact, was implemented.
Guidelines issued in 2015 and 2016 from ASHRAE and the CDC respectively describe a process for developing water management plans. There is no specific remedy or “one size fits all” solution that can be implemented for every building or situation. ASHRAE Standard 188 — cited by CMS and the CDC — is a process standard that provides a template for the development of a water management plan. The AIHA guidance addresses the technical qualifications of those involved in the design, implementation and oversight of a water management plan.
The road ahead
For regulated facilities, whether and how CMS will evaluate a water management plan and gauge its effectiveness remains an open question. The agency’s tolerance for positive environmental sampling results — with and without cases of disease linked to the facility by an epidemiologic investigation — remains unknown. Similarly, the agency’s ability to mandate specific remedial measures or to take action beyond issuance of a citation is not clear.
For all at-risk facilities, regardless of regulatory status, it is clear that the incidence of infections caused by waterborne opportunistic pathogens is drawing the attention of regulators and public health officials and soon may become a significant driver of cost, risk and legal exposure. Those involved in the design, construction, ownership, operation and maintenance of all at-risk facilities should be aware of the shifting landscape, evolving standards of practice and industry guidance and new regulations.
Outbreaks, clusters and even sporadic cases of disease, when linked to a facility, can be devastating for an industry that places a high value on resident safety. The legal and reputational costs, as well as operational and remedial costs, can be substantial.
Stakeholders should evaluate the risks associated with their facilities and consider how to best adapt to the changing regulatory and legal landscape. Although proactive, preventive measures are not a failsafe, a demonstrable commitment to resident safety can mitigate risk and exposure.
Susan E. Smith is leader of the Toxic Tort Practice Group at the law firm Goldberg Segalla. She has extensive experience counseling clients on public health outbreak investigations and environmental regulatory matters and in guiding clients through incident response and remediation. In recent years, Smith and her team have represented clients facing Legionnaires’ disease incidents, claims and lawsuits in more than 15 states.
The information presented in this article is for informational purposes only and not for the purpose of providing legal advice. Contact your attorney to obtain advice with respect to any particular issue or problem.
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1 See, e.g., “Health Care–Associated Legionnaires’ Disease Surveillance Data from 20 States and a Large Metropolitan Area — United States, 2015,” published by the CDC on June 6, 2017 (available at https://www.cdc.gov/mmwr/volumes/66/wr/mm6622e1.htm?s_cid=mm6622e1_w), “Outbreaks Associated With Environmental and Undetermined Water Exposures — United States, 2011–2012,” published by the CDC on August 15, 2015 (available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6431a3.htm), and “Hospitalizations due to selected infections caused by opportunistic premise plumbing pathogens (OPPP) and reported drug resistance in the United States older adult population in 1991–2006,” published in the Journal of Public Health Policy in September 2016 and authored by Elena Naumova, Ph.D., MS, and other researchers at Tufts University.
2 ASHRAE Standard 188 is available at https://www.ashrae.org/resources–publications/bookstore/ansi-ashrae-standard-188-2015-legionellosis-risk-management-for-building-water-systems.