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But this may be too simplistic a view. Outside of the general understating about the risks inherent to the population and congregate nature of long-term care facilities, what more can be discerned about how we arrived at the current state of affairs in long-term care?
A Brief History
On December 31, 2019, Chinese health officials reported a cluster of acute respiratory illness in persons associated with the Hunan seafood and animal market in the city of Wuhan, Hubei Province in central China. [1], [2]
On January 21, 2020, the first identified cases of 2019-nCoV were reported in the United States. Also on January 21, 2020, the Centers for Disease Control and Prevention (CDC) activated its Emergency Operations Center to optimize coordination for domestic and international 2019-nCoV response efforts. [2]
On January 31, 2020, the CDC published its third Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus Health (updated from January 17, 2020). Initial guidance recommended testing of those individuals who were symptomatic (fever, symptoms consistent with lower respiratory infection such as cough or shortness of breath) AND had recent travel to mainland China OR had close contact with a person confirmed with the 2019-nCoV infection. [3]
On February 28, 2020, a case of coronavirus disease was identified in a woman resident in a long-term care skilled nursing facility in King County, Washington. [4]. The patient was identified because she met the “revised testing criteria for COVID-19 which included testing of persons with severe respiratory illness of unknown etiology.” [5] Epidemiologic investigation of the King County facility later(spacing) identified 129 cases of COVID-19 associated with the facility, including 81 of the residents, 34 staff members, and 14 visitors; 23 persons died. [4]
Shortly thereafter, on March 4, 2020, the CDC revised its guideline, Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19) to include “residents in long-term care facilities or other congregate living settings with symptoms” as high priority for COVID-19 nucleic acid or antigen testing. [5]
Since March of 2020, it has become clear that asymptomatic or presymptomatic infected individuals can, and do, spread COVID-19, and that older individuals and those with underlying health conditions are at highest risk. Despite this however, currently, the CDC guideline Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19)(last updated May 3, 2020), does not specifically identify asymptomatic long-term care residents as being at high priority for testing. Instead, the Guideline assigns priority (as opposed to high priority) to “persons without symptoms who are prioritized by health departments or clinicians for any reason…” [5]. Thus, it is possible that different states, and different facilities within a state, may prioritize testing for asymptomatic residents differently, thereby resulting in higher than expected transmission rates. This is especially true because geriatric patients may initially have milder or atypical presentation, as has historically been seen with influenza and other communicable diseases, thereby allowing for patients with atypical symptoms, and with substantial potential for viral shedding, to be mistakenly assessed. [6]
Other Factors in High Transmission Rates at Long-Term Care Facilities
Adding to this potential viral shedding by asymptomatic residents was the viral shedding of asymptomatic visitors and non-essential personnel. On March 4, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum regarding guidance for infection control and prevention of coronavirus disease in nursing homes. There, CMS called for screening of entrants into nursing homes and allowing entry only to those who were asymptomatic. [11] On March 13, 2020, revised guidance called for a general restriction of entry into the nursing homes of all non-essential persons. [12]. This contributed to the spreading of the virus. While a two week difference in guidance may not seem like much, recent reports suggest that a two week difference in implementation in social distancing guidelines may have resulted in tens of thousands of deaths in the US. [13].
The effect of delayed assessment, testing and isolation in long-term care facilities has also been compounded by evolving guidelines for testing of potentially exposed asymptomatic healthcare providers and the lack of access to reliable and rapid testing for those staff that squarely meet the testing criteria.[7] In addition, the use of interim, per diem and shared staff among multiple facilities has introduced additional sources of infection. [4]
Understaffing due to actual infection or mandatory quarantine for suspected infection, has further contributed to the scenario in the long-term care setting, and has resulted in sub-optimal staff to resident ratios in a time when more one on one supervision and care is mandated by isolation and infection control protocols. Isolation or segregation requirements for infected or suspected individuals may be untenable both in light of the patients’ rights and/or the patient’s underlying physical or mental capacity. For instance, in a recent article in the Miami Herald, spokeswoman for the Florida Healthcare Association, Kristen Knapp, was quoted as saying that nursing homes have been receiving “conflicting guidance from federal, state and local government entities” and that COVID-19 has required facilities to take actions they ordinarily would not take. Ms. Knapp said that homes in Broward County are being told by local health department officials to keep residents in their rooms with doors closed, which would “be a violation of health care standards on a normal day.” [8]
Inversely, isolation requirements have been further taxing on facilities suffering from understaffing and there may be a limited ability, or outright inability, to follow guidance regarding, e.g., restricted use of communal spaces such as dining spaces, when multiple residents require direct oversight, prompting or assistance with feeding (and for whom decreased oversight during meals results in less consumption, weight loss, choking hazards, decline in overall health and increased susceptibility to infection).
Another factor at play in the spread of COVID-19 in long-term care facilities, has been the unavailability of personal protective equipment (PPE), lack of access to PPE for individual facilities and health care providers, and on the other end of spectrum, loosening of requirements for PPE to lesser effective measures (i.e., not requiring N95 masks).
Historically in the long-term care setting, PPE has been the least effective control for the spread of infection, in the established hierarchy of controls (i.e., engineering, administrative and source controls) because of its reliance upon worker involvement and dependence on proper fit and correct, consistent use.[9] Despite its low historic efficacy, PPEs have been identified as the most common use item for the prevention of spreading COVID-19, and are certainly the most prevalent in the subacute long-term care setting. However, it must be noted that even PPE have levels of efficacy. According to the CDC, the most effective use of N95 masks or higher level respirators are recommended for health care providers who have been “medically cleared, trained and fit tested.” [9] In the same guide, the CDC acknowledged that, “the majority of nursing homes and outpatient clinics, including hemodialysis facilities, do not have respiratory protection programs nor have they fit tested CCP, making use of respirators unachievable.” [9]
Therefore, according to the CDC, the next best option to an already sub-optimal infection control mechanisms in the long-term care setting, would include “the use of cloth face covering or facemask over the mouth and nose of an infected person to contain their respiratory secretions” which “might reduce the risk of transmission from both symptomatic and asymptomatic people.” (emphasis added). [9] Moreover, the CDC recommended that where there were shortages of PPE, that facemasks should be prioritized for health care providers, then symptomatic patients, then asymptomatic patients. But as is known, persons may be infected with the disease while they are asymptomatic or pre-symptomatic, and historically, elderly patients may manifest with atypical symptoms that may be misinterpreted, especially in a crisis setting.
While it is true that some of the guidance offered by the CDC, including triage procedures and source control, should already be part of an overall policy of infection control for long-term care facilities, the paper conceded that universal source control had been relatively ineffective in identifying infected individuals, as had symptoms screening, thereby making it more difficult to identify and isolate the human sources of infection upon which to implement the infection control policies. [9] To date, guidance has not extended to tips on maintaining cloth or other facemask coverings on the faces of elderly, potentially confused, patients or those who are unable for physical or psychological reasons to tolerate extended face covering, not to mention the need for thorough and immediate hand washing each time the face covering is touched, the practical application of which renders the face covering, as a means of source control, useless.
Moreover, in separate guidance regarding the decontamination and reuse of filtering facepiece respirators (FFP), such as an N95, the CDC acknowledged that typically these single use disposable masks are not approved by the manufacturer for routine decontamination and reuse. [10]. Notwithstanding, in the face of PPE shortages, governmental guidance included decontamination and reuse of PPE, including, not touching the inside of a decontaminated FFR, visually inspecting for compromised integrity of the PPE and visually checking for proper seal. [10] Another recommendation included issuing five respirators to each healthcare worker who may care for patients with suspected or confirmed COVID-19, having each provider wear one FFP for the entire day, then store it in a breathable paper bag for at least five days while wearing the other masks on rotation, allowing at least five days before re-wearing a mask. [10] These untested recommendations, even if followed to the letter, allow for even less efficacy of an already low-efficacy infection protocol.
Recognizing that the uncertainty and inherent fallibility to the measures undertaken to combat this global pandemic cannot be charged to healthcare providers alone, many states and the federal government have provided immunity from liability to healthcare providers engaged in the unprecedented care of COVID-19 patients, with limited resources.
Immunity - Current State
With a better understanding that so many of the factors leading up to the high rate of infection in long-term care facilities were outside of their control, is it right or fair to hold those facilities liable? Should facilities get immunity? Conversely, does accountability under these circumstances yield better or worse care for residents of long-term care facilities?
The plaintiff’s bar, family members and pro-resident advocacy groups are vehemently opposed to immunity for long-term care facilities. The primary concern is that immunity in this instance may be a slippery slope of lack of accountability in a more general sense, in addition to lax procedures in the immediate emergency.
For example, Richard Mollot, Executive Director of the Long-term Care Community Coalition, a nursing home resident advocacy group, was recently quoted by npr.org as saying, "Providing blanket immunity to nursing homes for any kind of substandard care, abuse, or neglect is an extremely poor and dangerous idea anytime, and particularly so in regard to COVID-19… Nursing homes are themselves more strained, more understaffed than they are on a usual basis, leaving residents even more vulnerable to infection and neglect." [14]
Are concerns like these valid in the face of the current immunity legislation? First, there is no widespread immunity for all actions or inactions in a long-term care setting. In fact, immunity if it is granted at all, is directly tied to the conduct or omissions in providing services to COVID-19 patients, and is generally closely tied to omission or actions caused by lack of proper equipment and staffing. The legislative or gubernatorial actions undertaken thus far exclude conduct that is willful, grossly negligent or in bad faith. State-granted immunity does not protect long-term care facilities from federal governmental regulation, inspection or, where appropriate, sanctions, nor from negligent or deficient practices that predated the effective date of the immunity-granting legislation. For instance, if the facility had insufficient staffing or improper infection controls prior to the effective date of the legislation, an argument can be made that immunity will not attach. Moreover, even if immunity attaches, it is limited to the term of the legislation.
Federal Government Action - Immunity
The Federal Government has increased efforts to contemporaneously inspect nursing homes with a stricter emphasis on infection control policies. For example, the Centers for Medicare and Medicaid Services (CMS), charged with surveying nursing homes, has made efforts to prioritize surveys around infection control. [16]
The Federal Government has also granted immunity under the Public Readiness and Emergency Preparedness (PREP) Act which “provides immunity from liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.”
State Action – Immunity
Some states have already provided immunity to health care providers, with explicit inclusion of long-term care facilities, assisted living or skilled nursing homes either through legislation or executive order.
In New York, for example, an epicenter of COVID-19 in the US, The Emergency or Disaster Treatment Protection Act provides “immunity from liability, civil or criminal, for any harm or damages alleged to have been sustained as a result of an act or omission in the course of arranging for or providing health care services, if the health care provider of a facility was arranging for or providing health care services pursuant to COVID-19 emergency rule or in accordance with applicable law, the act or omission occurs in the course of arranging for or providing health care services and the treatment of the individual is impacted by the health care facility or health care professional's decisions or activities in response to or as a result of the COVID-19 outbreak and in support of the state's directives; and the health care facility or health care professional is arranging for or providing health care services in good faith. Immunity does not apply if the harm or damages were caused by an act or omission constituting willful or intentional criminal misconduct, gross negligence, reckless misconduct, or intentional infliction of harm by the health care facility or health care professional provided, that acts, omissions or decisions resulting from a resource or staffing shortage shall not be considered to be willful or intentional criminal misconduct, gross negligence, reckless misconduct, or intentional infliction of harm.
Similarly, on April 1, 2020, the Governor of Illinois, JB Pritzker, issued, Executive Order 2020-19, wherein he directed that during the pendency of the Gubernatorial Disaster Proclamations, Health Care Professionals, Health Care Facilities and Good Samaritans as defined in the Order, “shall be immune from civil liability for any injury or death alleged to have been caused by any act or omission …which injury or death occurred at a time when a Health Care [provider] was engaged in the course of rendering assistance to the State, by providing health care services in response to the COVID-19 outbreak, unless it is established that such injury or death was caused by gross negligence or by willful misconduct of said Health Care [provider]."
The governor of Connecticut, Ned Lamont, issued a similar order, Executive Order No. 7U, directing that any health care professional or health care facility shall be immune from suit for civil liability for any injury or death alleged to have been sustained because of the individual's or health care facility's acts or omissions undertaken in good faith, while providing health care services in support of the State's COVID-19 response, including but not limited to acts or omissions undertaken because of a lack of resources, attributable to the COVID-19 pandemic, that renders the health care professional or health care facility unable to provide the level or manner of care that otherwise would have been required in the absence of the COVID-19 pandemic and which resulted in the damages at issue, provided that nothing in this order shall remove or limit any immunity conferred by any provision of the Connecticut General Statutes or other law. Such immunity shall not extend to acts or omissions that constitute a crime, fraud, malice, gross negligence, willful misconduct, or would otherwise constitute a false claim or prohibited act.
The Kentucky Legislature passed, Senate Bill 150, An Act relating to the state of emergency in response to COVID-19 and declaring an emergency. The legislation provides that a health care provider, who in good faith renders care or treatment of a COVID-19 patient during the state of emergency, shall have a defense to civil liability for ordinary negligence for any personal injury resulting from said care or treatment, or from any act or failure to act in providing or arranging further medical treatment, if the health care provider acts as an ordinary, reasonable, and prudent health care provider would have acted under the same or similar circumstances. The defense under this Act includes a health care provider who: prescribes or dispenses medicines for off-label use to attempt to combat the COVID-19 virus; provides health care services, upon the request of health care facilities or public health entities, that are outside of the provider's professional scope of practice; or utilizes equipment or supplies outside of the product's normal use for medical practice and the provision of health care services.
As of the writing of this article, several other states have issued executive orders limiting lawsuits against nursing homes, including: Arkansas, Arizona, Georgia, Hawaii, Michigan, New Jersey, Rhode Island and Wisconsin. However, many more states have yet to pass legislation or implement executive orders despite intense lobbying from pro-healthcare groups.
In Florida for example, despite intense lobbying from the Florida Healthcare Association and other pro-long-term care groups, Governor DeSantis has yet to issue an executive order extending the sovereign immunity currently enjoyed by certain health care facilities providing services under color of state action, though he says it is “under review.” [8] Intense political pressure, lobbying, and in some cases state constitutional framework, have prevented the passing of immunity legislation across many states. [8]
Lack Of or Limits to Immunity – Best Practices
To be clear, even with immunity provisions, the limits will be challenged. Does immunity extend to corporate owners? What constitutes gross negligence or bad faith? What level of staffing is adequate in a global pandemic and what about residents who succumb to preventable non-COVID causes exacerbated by lack of staffing or drained resources? How far in time and scope will immunity will be extended? Will executive orders granting immunity pass constitutional muster in the first place? The Plaintiff’s bar and patient advocacy groups will push the envelope to find weaknesses in the provisions. Therefore, long-term care facilities cannot rely on after-the-fact immunity alone for protection from suits, and must proactively defend themselves against claims in their day to day operations:
- Seek out and implement best practices and guidelines afforded by agencies responsible for assessing the safety of the long-term facility.
For example, on May 13, 2020, CMS introduced a Toolkit on State Actions to Mitigate COVID-19 in Nursing Homes, which offers guidance to those who provide oversight and assistance to nursing homes, providing them with additional resources to aid in the fight against coronavirus disease within nursing homes, outlining best practices for a variety of subjects ranging from infection control to workforce and staffing.”
- Assign one or more persons with experience and training in infection prevention and control (IPC) to obtain, manage and disseminate information about prevention control and oversee facility policies and implementation. [15]
Clinical and non-clinical staff should be educated regarding the implementation, stocking and restocking of sanitation stations as guided by the CDC. Routine housekeeping inspections and rounds should include inspection of, and notation, regarding the availability of PPE, sanitation (hand sanitizer) and other recommended modalities, either at the bedside or in strategic locations, as required by state or federal guidelines.
If there is a change in facility policy to comply with new CDC or governmental guidance, maximum effort should be made to disseminate the information to the health care providers, and ensure uniformity of action within the facility. Documentation by way of emergency or temporary policy should be considered. Implementation through brief but frequent in-service or team meetings should also be considered.
Facility administration should be mindful of the requirements needed for immunity to attach. In some legislation, immunity is contingent on compliance with, or treatment of, the state health emergency. If there are actions undertaken by which the facility can be deemed to have failed to comply with the provision of care on behalf of the state, immunity may not attach. For example, in at least one legislative article, COVID-19 patients could not be turned away by the facility, in order for sovereign immunity to attach.
- Document, document, document.
If documentation was important in the day to day defense of long-term care cases before, it is even more important in the quickly evolving landscape of COVID-19. Documentation of means and measures to obtain PPE or respiratory aids, for example, especially if taken by administrators or non-clinical personnel, is paramount.
The CDC guidelines or guidance from other governing bodies should be documented in a static format. The facility should not simply rely on websites to document the guidance it is following. Websites will be updated over time to reflect evolving guidance, and previous guidance may not be accessible. It may be difficult to determine in 2021 exactly what guidance was being offered in March of 2020 as opposed to May or June, and many websites reflect updated information, making archived information difficult or impossible to access. This static documentation should include documentation regarding compliance with guidelines available at the time, availability of tests, guidelines for sequestration of residents and evolving measures for infection control. Administration should assist in documentation of non-clinical conditions such as measures to obtain PPE, testing kits and/or the changing guidance from governmental agencies.
Staffing changes, including redistribution or optimization of staff, especially where the changes are occasioned by COVID-19, should also be documented. Considerations including reduced staff capability due to outbreak, and or the need for staff optimization to provide segregation of residents, and especially where the redistribution or optimization results in staffing ratios that are contrary to state or federal mandates or guidelines, require documentation.
In the age of Electronic Medical Records (EMR), special consideration should be given to the ability to contemporaneously document non-traditional fields including PPE shortages, low grade fevers and other symptoms or causes of infection that may not have been previously identified as relevant considerations in the EMR pre-COVID-19.
Where PPE shortages mandate re-use or conservation of PPE contrary to typical practice guidelines or manufacturer instructions, the means of decontamination, as well as affirmative notation that the PPE was visually inspected for function and fit, should be undertaken and documented.
- Protect against “bad faith” “gross negligence and willful conduct.”
Uniformly, legislative immunity will not extend to gross negligence, bad faith or willful misconduct. Anyone who has litigated long-term care cases knows that gross negligence, bad faith or willful misconduct can be proven through repeated patterns of seemingly innocuous conduct. Therefore, administration and all healthcare providers in the long-term care setting should be mindful. Reduced inspections and ever changing mandates can provide a false sense of laxity that may defeat even the best intended immunity.
In all, the current landscape is continually changing for us all as a result of COVID-19. For long-term care facilities, dealing with the most vulnerable population in congregate settings, there is no room for relaxing policies and procedures, even in the face of immunity.
[1] World Health Organization. Novel coronavirus (2019-nCoV). Situation report 1. Geneva, Switzerland: World Health Organization; 2020.
[2] Patel A, Jernigan DB. Initial Public Health Response and Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak – United States, December 31, 2019 – February 4, 2020. MMWR Morb Mortal Wkly Rep 2020; 69:140-146. DOI http://dx.doi.org/10.15585/mmwr.mm6905e1external icon
[3] CDC. Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus – February 1, 2020. https://emergency.cdc.gov/han/han00427.asp
[4] McMichael TM, Clark S, Pogosjans S, et al. COVID-19 in a Long-Term Care Facility – King County, Washington, February 27 – March 9, 2020. MMWR Morb Mortal Wkly Rep 2020; 69:339-342. http://dx.doi.org/10.15585/mmwr.mm6912e1external icon
[5] CDC. Evaluating and testing persons for coronavirus disease 2019 (COVID-19). Atlanta, GA: US Department of Health and Human Services, CDC; 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html
[6] Kimball A, Hatfield KM, Arons M, et al. Asymptomatic and Presymtomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility – King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep 2020;69:377-381 http://dx.doi.org/10.15585/mmwr.mm6913e1
[7] CDC. Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. (Updated May 19, 2020) https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html
[8] Sexton, Christine. “Healthcare groups ask Florida governor for legal immunity during COVID-19 pandemic.” The Miami Herald. April 23, 2020. https://www.miamiherald.com/news/health-care/article242239046.html
[9] CDC. Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. Updated May 18, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.htmlCDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Finfection-control%2Fcontrol-recommendations.html
[10] CDC. Decontamination and Reuse of Filtering Facepiece Respirators. Updated April 29, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html
[11] CMS. Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in nursing homes. March 4, 2020. https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/qso-20-14-nh.pdf
[12] CMS. Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes (REVISED). March 13, 2020. https://www.cms.gov/files/document/qso-20-14-nh-revised.pdf
[13] Glanz, James and Robertson, Campbell. “Lockdown Delays Cost at Least 36,000 Lives, Data Shows.” New York Times. May 22, 2020. https://www.nytimes.com/2020/05/20/us/coronavirus-distancing-deaths.html
[14] Jaffe, Ina. “Nursing Homes Ask States for Immunity From Civil Suits Amid COVID-19.” npr.org. April 23, 2020. https://www.npr.org/sections/coronavirus-live-updates/2020/04/23/842153768/nursing-homes-ask-states-for-immunity-from-civil-suits-amid-covid-19
[15] CDC. Preparing for Covid-19 in Nursing Homes. Updated May 19, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html
[16] CMS. Suspension of Survey Activities. Updated March 4, 2020. https://www.cms.gov/files/document/qso-20-12-allpdf.pdf-1
