How Nursing Home Operators Can Stay Atop Shifting Coronavirus Regulations

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By Myla Reizen

Nursing homes and other senior care facilities have tragically become an epicenter of the coronavirus epidemic. In Florida alone, there have been more than 4,900 deaths as of mid-July, with at least 2,300 coming from nursing homes and long-term care facilities representing more than 45% of the deaths in the state. In the United States, nursing homes and other long-term care facilities account for more than 57,000 deaths as of mid-July, according to an analysis by the New York Times. 

Other nations have done better. Australia has had just 43 deaths in the Australian government subsidized residential aged care facilities as of July 22, 2020 – and fewer than 12 cases overall for the entire nation. Australian experts, Paris Petranis, a partner at K&L Gates and Judi Coombe, a Senior Operations Consultant at Ansell Strategic, point to a few areas to explain their success in containing the virus: the nation had imposed new aged care standards the previous year, which allowed for a faster response; federal regulators spoke with one voice regarding standards and guidance about what steps to take; and aggressive work by the national quality and safety commission to get providers up to speed.

The United States is continuing to address the challenges facing nursing homes and other long-term care facilities. But are current efforts enough? And what do nursing facility operators need to know now to stay on top of rapidly shifting regulations from a number of state and national agencies?

Nursing home and other long-term facility guidance in the United States has been rather fragmented during this time– there is guidance from the CDC and the Centers for Medicare and Medicaid Services and other agencies as well as state agencies, but no one clearinghouse for all this information. That creates challenges to stay on top of the current best thinking – and then make sure all employees know what the standards are and abide by them. And facilities have reported ongoing shortages of PPE and hand sanitizer, as well as often having less staff than desired to take care of their patient population. 

American long-term care facilities must also prepare for possible investigations and lawsuits – and even criminal charges – related to the care of patients in their facilities. While U.S. Health and Human Services Secretary Alex Azar has urged governors to consider extending protection to health care workers so that they felt “shielded from medical tort liability” when providing COVID-19-related care, at least a quarter of the states have some form of immunity protections. Some states are just beginning to ramp up investigations – Pennsylvania and New Jersey are two states that have begun probes into nursing home possible negligence or misconduct. 

One facility has already been assessed over $600,000 in fines due its response to the COVID-19 outbreak at its facility. Several civil lawsuits have also been filed and it’s safe to say that there will be a significant number of lawsuits filed regarding quality of care.

Getting accurate information on what’s happening in nursing homes has been challenging in some states. Recent federal regulations require nursing homes to report certain data to the CDC on a weekly basis, including suspected and confirmed COVID-19 infections among residents and staff, deaths related to COVID-19 infection, including resident and staff, PPE and hand hygiene supplies, staff shortages, and resident access to testing. In the long run, this transparency will benefit both families and employees who will be able to access information on conditions in each facility.

The federal government has set aside $80 million to regularly survey facilities. Operators need to be prepared to quickly and accurately respond to state and federal surveys.

Regardless of whether they have COVID-19-positive cases, there are several steps facilities should take to enhance their overall compliance with guidance, and more specifically guidance being followed – and documented – in case questions arise about decisions made at various points in time and what the state and federal guidance was at that time. When nursing home operators get questions from regulators or are involved in litigation, it will be critical to detail what information they had at the time of the incidents and what regulations advised at that particular time.

Five key steps to be taken are:

–Dedicating one person who is tasked with reviewing all the available guidance on a regular basis – everything from CDC, CMS, state departments of health and other sources – and sharing those with appropriate executives. Policies and protocols should be evaluated against the current guidance to see if any necessary changes should be made and what training is necessary to carry that out. 

–Creating systems to ensure that policies are being followed. Is someone tracking how often hand sanitizers are being used, for example? Do staff know they are being monitored for compliance? And is there a system to determine when the sanitizer bottles are running low so they can be replaced before they’re empty? Are employees being tested on a regular basis and is their temperature being taken before entering the facility?

–Training, training, training. Provide ongoing training to staff and make sure the training is appropriate to the staffers involved – handing everyone a document is not enough. Many workers will need to be briefed and trained verbally as well to ensure everyone gets the message.

— Nursing homes should consider self-assessments or mock surveys to assess their preparedness level and compliance with regulatory guidance. Records of any self-assessments or other actions taken to demonstrate compliance of changing regulatory guidance should be created. Meanwhile, standard documentation of compliance with policies and training should continue to be maintained. 

–Make sure the decision-making process is well documented and approved at the highest levels – C-suite executives should sign off on policy changes. And document and keep files on guidance received, memos of implementation and what they did as guidance changed.

It’s clear that organizations that house our seniors will never go back to pre-COVID-19 practices. Not all facilities will survive the wrenching changes that will be necessary for success. But those that do will be the ones that can quickly respond to constantly updated guidance, do an excellent job of training and equipping their staff, and embrace a culture of protection that goes the extra mile to care for our most vulnerable.

Myla Reizen is a partner in the Miami office of K&L Gates, where she is a member of the global health care and FDA practice group. She concentrates her practice in health care law, representing health care systems, hospitals, nursing home providers and other health care entities. 

For recent developments in health care law and regulation, K&L Gates has articles and podcasts that focus on the most recent developments: https://www.klgates.com/kl-gates-triage

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