The onset of active Ebola infections in the U.S. places hospitals and health care facilities in somewhat “uncharted waters” regarding their respective legal risks related to clinical care and the clinicians providing that care under the hospital’s auspices. The following core principles should be considered by any hospital or health care facility when considering its internal risk management strategy in relation to Ebola and infectious disease in general.
Establish Policies, Demonstrate Compliance
Establish an organized, multidisciplinary framework that demonstrates compliance with best practices and available guidance by putting in place policies and procedures (or enhancing those presently in place) specific to infection control and particularly for those who contemplate caring for patients with potentially highly infectious conditions. Policies and procedures should include:
Care protocols for those suspected of having infectious diseases, such as Ebola, or who otherwise require isolation;
Environment of care concerns, storage and treatment of infectious waste and hygiene/housekeeping concerns, transportation of patients and remains of expired patients;
Use of personal protective equipment (PPE), perhaps at different levels, depending on level of interaction with patients;
Use of isolation rooms and systems;
Staff follow-up and monitoring post-exposure; and
Mechanisms to track staff who care for such patients, ensuring support and follow up
Consider Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS), state law and any accrediting body guidance or requirements in development of new policies and procedures.
Train Staff, Demonstrate Due Diligence
Demonstrate due diligence in fully educating front-line and all other staff through the initiation of comprehensive, rigorous training so that they know and can consistently follow the above policies and procedures. Staff should be educated to:
Identify the signs and symptoms and correlating factors in diagnosing Ebola (the emergency department is a special area of concern);
Reduce risk of transmission to themselves, coworkers, other patients and visitors through the use of stringent isolation measures and PPE; and
Provide necessary clinical care using care protocols specially developed for potentially highly infectious patients
Maintain vigilance with the policies and procedures above to ensure staff compliance. Audit behavior to ensure that best practices that take into account CDC guidance, as well as real-time experience from those in the field, are diligently followed, where applicable. Intervene immediately where any lapse in policy, procedure or process is identified, and share lessons learned.
Reduce Error Risk
Keep attention high and staff focused to reduce risk of errors. Ensure that the framework developed and educational efforts are collaborative among medical staff, nursing staff, and other clinical and non-clinical team members. Communicate with front-line staff frequently and provide updates to policies, procedures and processes as soon as available, explaining the reason and rationale for changes. Provide a forum for sharing ideas and concerns. Consider an internal special task force (comprised of clinicians and representatives from non-clinical areas) or utilizing existing infectious disease committees to help identify risks and ways to address them.
Know Your Capacity
Avoid getting in over your head—identify what your facility can and cannot handle. Consider a SWOT analysis by evaluating Strengths, Weaknesses, Opportunities and Threats of both physical and human resources. Consider also undertaking a process of confirmation and documentation of facility capabilities to help guide patient care and potential transport if a suspected case is identified in your facility or another facility nearby. The following are examples of questions a facility should be able to answer:
What processes are available to test for Ebola infection?
Are isolation rooms really equipped to provide isolation for Ebola patients? The CDC has identified only four hospitals in the country with intensive isolation units (Emory University Hospital in Atlanta, Georgia; National Institutes of Health in Bethesda, Maryland; Rocky Mountain Laboratory in Hamilton, Montana; and Nebraska Medical Center in Omaha, Nebraska, as noted in press reports), and is in the process of identifying other designated hospitals with advanced treatment capabilities for infectious disease.
How would potentially highly infectious lab specimens or waste be handled?
Are hospital laundry facilities equipped and willing to process laundry for Ebola patients?
What other features does your facility have—or lack—that might make it a better or less effective place to treat suspected Ebola patients?
Do you have the capabilities to staff-up and segregate staff treating suspected or known Ebola patients from other patient care activities?
Is there a CDC-designated treating hospital nearby, and what is the protocol for transferring suspected or known Ebola patients to it?
Consider Existing Laws
Remember that existing health care and related laws still apply. Perhaps most relevant, the Emergency Medical Treatment and Labor Act (EMTALA) requires that participating hospitals provide a medical screening examination to all individuals who present for care to determine the presence or absence of an emergency medical condition. If an emergency medical condition is identified, the hospital must stabilize the individual, within the facility’s capability and capacity, and effectuate an appropriate transfer to a higher level of care, when necessary. This obligation is not abrogated by the suspicion of or known diagnosis of Ebola or any other medical condition, and the risk of misdiagnosis of a disease that in many ways mimics others prevails.
Informed consent is implicated when patients are recommended to receive experimental medications not yet approved for use by the U.S. Food and Drug Administration or plasma or blood transfusions from individuals who have recovered from Ebola.
In addition, state and federal laws regarding confidentiality and privacy, including Health Insurance Portability and Accountability Act of 1996, remain in full force and effect. Consider refresher education on the need to maintain patient confidentiality, even where the matter is of worldwide interest.
Address Staff Concerns
Consider employee matters. Be prepared to deal with concerns of staff. Support of and care for staff does not stop at the end of a shift or with the recovery or demise of a patient with an infectious disease like Ebola. Consider the following questions:
How will the hospital address situations where staff refuses to care for a patient with Ebola? Is there value in identifying a response team to provide care and receive advanced training?
Will a post-duty quarantine be implemented to isolate staff before they return to other patient care duties, and how will the 21-day period be accounted for (i.e., paid leave or paid time off)?
What obligations do staff have to comply with these types of requirements? What outside assistance might be needed to ensure staff compliance (i.e., travel restrictions)?
Communicate, Communicate, Communicate
As with any emergency preparedness matter, a hospital caring for a patient with Ebola must be prepared to implement an emergency communications protocol that contemplates communications with regulatory agencies, including the CDC, state and federal health care agencies and departments of health. Work with internal and/or external communications consultants to assist in controlling press inquiries and responses, and ensure legal review and sign-off on any public statements.