Hospital Compliance During COVID-19
While hospitals are on the front lines of the novel coronavirus (COVID-19) pandemic, they must continue to manage their legal risk as they treat their patients and work to flatten the curve.
The novel coronavirus (COVID-19) pandemic is unprecedented, and hospitals around the country are taking unprecedented measures to contain the virus while treating those who have been infected. While these hospitals deserve commendation, they also face the very real possibility that they are putting themselves at risk for substantial liability in civil litigation and administrative enforcement proceedings.
As new developments continue unfold, hospital administrators, physicians, and staff must remain cognizant of the legal implications, and they need to make sound decisions based on the advice of legal counsel. As we discuss below, despite everything they are doing for the good of the nation and the world at large, hospitals still need to be careful to protect themselves as well. Ultimately, mistakes are not going to be forgiven, and employees, patients, families, and federal regulators are going to be pursuing claims against hospitals for alleged negligence and compliance failures for years to come.
During the COVID-19 crisis, there are a number of legal mistakes that hospitals need to avoid. In addition to the ordinary risks that attend to running a hospital and treating patients, there are several risks specific to operating during the pandemic as well. These risks not only relate to the unique aspects of COVID-19, but also have to do with treating extraordinarily large volumes of patients, operating from temporary locations, the high risk of employees becoming infected with the virus, and the difficult decisions that many hospitals will need to make when they run short on medical equipment and supplies.
In order to mitigate these risks, hospitals need to be prepared. This means having the necessary policies and procedures in place, and it means having a plan for possible contingencies. So, in addition to adhering to the usual healthcare compliance best practices, hospitals must also implement measures to avoid mistakes such as:
1. Assuming that Normal Legal and Regulatory Requirements Can Be Ignored
This is a big one. In times of crisis, people have a tendency to focus only on the present, forsaking concerns about future implications. Whether this is driven by the practicalities of the present circumstances or an assumption that any reasonably necessary transgressions will be overlooked, it is unfortunately a misguided approach that needs to be avoided.
As the novel coronavirus (COVID-19) pandemic continues to worsen, the strain on America’s hospitals is going to continue to increase as well. However, this is not an excuse for oversights or mistakes. If anything, hospitals need to enhance their diligence in order to maintain compliance, make the right decisions about patient care, and ensure that they are doing everything necessary to maintain a defensible position in audits, investigations, and litigation.
2. Failing to Adopt Policies and Procedures that are Specific to the COVID-19 Crisis
In just about every respect, the COVID-19 crisis is unique from anything that any hospital administrator or physician has faced in his or her lifetime. The novelty and magnitude of the situation demand a unique response, and this is equally true with regard to hospitals’ compliance and risk mitigation efforts as it is with regard to their efforts to stop the spread of the virus.
With this in mind, hospitals need to adopt policies and procedures that are specific to the crisis. These policies and procedures should touch on virtually all aspects of hospital administration and operation, including:
- Compliance with Executive Orders issued in response to the COVID-19 crisis
- Compliance with the Emergency Medical Treatment and Labor Act (EMTALA)
- Disaster preparedness and emergency response
- Employee health and safety
- Employment law matters (i.e. compliance with the Families First Coronavirus Response Act)
- Health data privacy and security
- Maintaining appropriate internal and external transparency
- Operating from temporary facilities (i.e. tents, convention centers, parking garages, and hotels)
- Ongoing assessment of new health and legal risks
- Patient screening and testing
- Patient treatment and quarantine
This list is not exhaustive, but it should give you an idea of the breadth of the issues of which hospital administrators, doctors, and other personnel need to concern themselves during the novel coronavirus (COVID-19) pandemic. This truly is a dire situation; and, while hospitals will play an integral role in helping America recover, those that fail to protect themselves will face substantial risks as a result of their efforts.
3. Failing to Effectively Implement Adopted Policies and Procedures
Another all-too-common mistake, particularly when time is scarce, is developing the necessary policies and procedures but then not taking the steps required in order to implement them effectively. If your hospital adopts policies and procedures in response to the pandemic but does not implement them, not only will they be entirely ineffective, but they could also increase your hospital’s risk of liability in civil litigation or administrative enforcement proceedings.
Simply put, knowing what you need to do and then failing to do it is not looked upon favorably in the legal realm. However, willful ignorance can have the same effects. So, during the novel coronavirus (COVID-19) pandemic, it is imperative that hospitals assess their risks, address their risks, and then take the steps necessary to mitigate them.
What does it mean to effectively implement compliance policies and procedures? In the healthcare context, and with regard to the COVID-19 crisis in particular, effective implementation requires:
- Dissemination and Publication – Hospitals will need to promptly disseminate their COVID-19 policies and procedures to all relevant personnel, and they will need to publish appropriate compliance notices in appropriate locations throughout their temporary and permanent facilities.
- Education and Training – While it might seem like there is no time available, hospitals must adequately educate and train their personnel regarding appropriate COVID-19 compliance. Education and training programs should be tailored to individual employees’ roles, and education and training should be documented once completed.
- Contemporaneous Notes – Maintaining contemporaneous documentation is a crucial component of effective hospital risk mitigation. This is true universally, but it is particularly true in circumstances such as the COVID-19 crisis where decisions need to be made quickly based on the best information available. By taking contemporaneous notes during patient care (as opposed to retrospective notes), doctors and other providers can not only improve the quality of their notes, but also help protect the hospital (and themselves) from liability.
- Monitoring and Enforcement – In order to ensure that education and training are effective and that providers are maintaining adequate contemporaneous notes, hospitals must continuously monitor compliance and enforce their personnel’s compliance obligations when necessary. This does necessarily not have to be a retributive or disciplinary effort. Although discipline may be necessary in egregious cases, oftentimes, it will be sufficient to provide additional training or simple reminders that compliance is necessary for everyone’s benefit.
Once again, this list is not exhaustive, and different hospitals will need to take different steps toward fully implementing their policies and procedures and integrating them into their operations. In order determine what is necessary given their own unique circumstances, hospitals will need to work closely with their compliance counsel throughout the development and implementation processes.
4. Not Having a Plan in Place Should the Facility Reach Capacity
Some of the recent headlines related to the novel coronavirus (COVID-19) pandemic have focused on the fact that many of the nation’s hospitals are beginning to reach capacity (and already far exceeding capacity in some cases). If your facility is at risk of reaching capacity during the pandemic, it is absolutely essential that you have the necessary preparations and protocols in place to address this situation when it happens.
Here, too, different hospitals will need to take different measures. However, in all cases, there is a significant amount of work to be done. Triaging, testing, and treating patients offsite all involve a multitude of practical and legal complications, and hospitals that have not planned ahead will not be in a position to manage the risks involved.
5. Treating Patients on a Discriminatory Basis
What happens when a hospital’s demand outpaces its supply? While this has never been a large-scale concern in the United States, it has suddenly become a day-to-day reality for many hospitals. In particular, hospitals are increasingly facing the risk of having have more patients than they have ventilators.
Recently, there has been news of hospitals in Italy adopting policies that favor younger patients over older ones. While this may seem to be the most ethical alternative (although decisions should still generally be made on a case-by-case basis), this type of policy is a breeding ground for discrimination-based litigation. When difficult decisions need to be made, hospitals and doctors will need to make their decisions with due consideration for all of the various implications involved.
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Oberheiden P.C. is a federal healthcare compliance and defense law firm that is representing hospitals nationwide during the COVID-19 crisis. If you have questions or concerns and would like to speak with an attorney, you can call 888-680-1745 or contact us online for a complimentary consultation.