Nearly five months into the worst global pandemic since the Spanish Flu of 1918, it should come as no surprise to the long-term care industry that COVID-19 is creating unprecedented legal and reputational risk for owners, operators, and senior managers. As more and more regulatory agencies begin to vigorously investigate the dramatic spikes in fatalities in nursing homes and other long-term care facilities, owners and operators should be vigilant in their continued efforts to follow all local, state, and federal regulations governing their operations.  However, in the midst of this chaotic environment marked by constantly changing governmental guidance, it is critical that owners and operators of long-term care facilities continue to proactively conduct regular, daily COVID-centric facility and patient assessments.  Both the assessments and any operational or care-related changes resulting from these assessments need to be meticulously documented. This documentation may be essential to prove that all appropriate diligence was taken to protect residents long after the fact when regulators, private litigants, and the public are engaged in after-the-fact evaluations focused on the extent and nature of a facility’s efforts to protect its residents.    

Nursing homes and long-term care facilities that have experienced an unusual number of deaths resulting from COVID-19 should expect multiple administrative inspections and investigations.  Among other things, these investigations will focus on:

• The nature and quality of care provided to residents;
• Record-keeping practices within the facilities;
• Timely and accurate sentinel event reporting;
• The consistency (or any lack of consistency) between public statements and internal records; and
• Overall compliance with regulatory requirements governing nursing homes in your jurisdiction.

Owners and operators of nursing homes and long-term care facilities should also be alert to the possibility that information generated during what appears to be a “routine” administrative inspection can be shared with other investigating agencies, including personnel associated with law enforcement – local, state and federal. Receipt by law enforcement of “routine” administrative reports documenting significant facility record-keeping deficiencies, standard of care violations, or an unusually high death rate may result in follow-up law enforcement activity. 

A facility may first learn of law enforcement focus when an agent appears at a facility seeking to “informally” question owners, operators, and/or employees about several “routine” issues.  The facility’s receipt of a subpoena or Civil Investigative Demand for documents (“CID”) may also serve to alert the facility of a law enforcement focus. And in very unusual cases, law enforcement might decide to execute a search warrant seeking a facility’s documents – both hard-copy documents and those which are electronically maintained and stored. Owners and operators of facilities that have experienced an unusually high death rate should be alert to the fact that familiar regulators sometimes coordinate with law enforcement, such that what appears to be a routine inspection followed by a follow-up request for documents is part of a coordinated investigation with law enforcement under the guise of routine administrative process.  To prepare for these events, and any ensuing investigation, we recommend that nursing homes and long-term care facilities take the following steps. 

Step 1: Ensure Your Facility is Complying with Relevant Standards and Guidelines

Owners and operators of a nursing home or long-term care facility should immediately make sure its facility is in complete compliance with the most recent CDC, CMS, and local guidance related to COVID-19. This includes, but is not limited to:

• Taking all necessary precautions recommended by CDC and CMS;
• Adhering to any additional standards mandated by state and local licensing agencies;
• Identifying a COVID-19 point-person within the facility who is in charge of monitoring any changes in federal, state, and local requirements and briefing the relevant teams in order to implement those changes in a timely fashion;
• Meticulous, timely, and accurate compliance with federal and state record keeping and reporting obligations, including sentinel event reporting obligations; and
• Adherence to and timely compliance with all internal policies regarding timing of notification to families.

Step 2: Document Your Facility’s Compliance Efforts and Steps to Mitigate Risk

Going forward, if you are the owner or operator of a nursing home or long-term care facility, we recommend that you take the time now to mitigate the impact of a any protracted subsequent investigation.   To that end, consideration should be given to enhancing your legal and operational compliance procedures so as to allow you to quickly prove that, at all times, you were in compliance with local and national standards.  Here are some specific steps you can take:

• Document all steps taken to comply with CDC, CMS, state department of health, and other local guidance related to infection control procedures, personal protective equipment (“PPE”), symptom screening, and facility staffing;
• Because of constantly changing guidance, make sure to date all changes in procedures and to refer to the guidance that mandated each change;
• Memorialize any issues encountered in complying with government mandated practices, procedures, or other guidance that are outside the facility’s reasonable control, such as shortages of tests or PPE;
• Implement document holds to prevent any documents from going missing due to inadvertent keystrokes and to eliminate any possible suspicion of evidence destruction;
• Timely generate and maintain accurate sentinel event/incident reports;
• Make sure that public statements made by the facility are consistent with internal records;
• Make sure all medical and treatment records correspond to billing records; and
• Train employees what to do in the event that law enforcement visits the facility with a subpoena, a search warrant, or to “informally” interview employees.

Health officials have predicted that this virus will come in phases and is likely to return next year, or even later this year. If the virus returns, facilities could experience additional surges in related deaths and again be visited by regulatory inspectors. We are still in the early stages of this virus and there is a lot yet to be learned. We will continue to monitor developments and provide updates as we develop further insights about the government’s response to regulatory issues confronting nursing home and long-term care facility owners and operators. In the meantime, nursing homes and long-term care facilities should begin to implement these or similar practices now in order to avoid exposure later.