Health Law Update

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While we turn to science and laws to guide our response to matters in the healthcare industry, the entrance of the Ebola virus into our lives here in the U.S. has challenged our abilities, both from a medical and legal perspective. We know what to do, but our abilities to respond adequately, timely and responsibly have been delayed. In some cases, the coordination of care, resources and response requires a new way of thinking and breaking down silos existing in our public health and government agencies. The U.S. houses the most skilled experts in infectious disease and prevention, as well as the capacity to respond appropriately to this new infectious threat.  

The Ebola Virus

It is our responsibility, first and foremost, to ensure that accurate information is transmitted relating to the Ebola virus itself. It is most essential that we understand the epidemiology of the disease to help our clients appropriately prepare and respond.

All infectious disease experts indicate that while the Ebola virus is a serious infectious disease, it is not that hearty. According to the Centers for Disease Control and Prevention (CDC), it can be killed with bleach and hospital grade disinfectants. The virus is not airborne and can only be spread by an individual who has an active illness. Individuals are only contagious when they start showing symptoms, which include fever, muscle weakness, severe headache and (6-8 days after fever) diarrhea, vomiting, bleeding and bruising. It is only contact with bodily fluids, like blood, vomit, urine, sweat, saliva, tears, etc., that will spread the disease.

Therefore, healthcare workers are at heightened risk of transmission and the average public is not. It is our obligation to ensure this is widely understood to help contain unnecessary panic, but more importantly, focus our resources to help our healthcare workers and institutions appropriately prepare and manage the anticipated response to this virus.

Resources

Since the first patient was diagnosed and treated in Texas, several important steps have been taken to heighten the response in Texas and around the nation. The CDC has been actively updating its <a href="http://e.bakerlaw.com/collect/click.aspx?u=/G1GTPto3VXlT8F4Xb0dUbgI9+AlILLc/ibWb+kus5341IxnEp/FCAU8P/pCfDtW&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">recommended protocols</a> on its website since the first patient presented here in the U.S. Early identification and transfer of a patient to a higher level of care also is critical to prevent transmission of the disease. The CDC has produced an algorithm for the evaluation of a returned traveler and a checklist for patients evaluated for Ebola in the U.S., as well as information relating to caring for a suspected Ebola patient. In addition, The Joint Commission has produced several Ebola and emergency management <a href="http://e.bakerlaw.com/collect/click.aspx?u=/G1GTPto3VVXuWgvPQuajdzfWTnI2u9EUfSf20BGwvsi2wQa/sJfykP3IOtziBiA02LUKYtqAlg0GosENpsVlB4tEpMFQ4DB&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">protocols</a>.

There are four hospitals in the U.S. that have established biocontainment units:
<ul>
	<li>Emory Healthcare, Atlanta, Georgia</li>
	<li>National Institutes of Health, Bethesda, Maryland</li>
	<li>St. Patrick Hospital, Missoula, Montana</li>
	<li>University of Nebraska Medical Center, Omaha, Nebraska</li>
</ul>
In addition, both <a href="http://e.bakerlaw.com/collect/click.aspx?u=/G1GTPto3VXHctjM3ANOkS+ea5Bq/qCNxpxtuqzmOutOE21U3Kb3jwj1jw1BDKlT1ffjsMqcSda9jNEWCCVg/Q==&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">Emory Healthcare</a> and the <a href="http://e.bakerlaw.com/collect/click.aspx?u=/G1GTPto3VWAcWRMN1dxbkapotfa79d1y2SD5fIQ6d7xt1W26Pwd9CXFQRw3m2Ii93NHFjZkzSA=&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">University of Nebraska Medical Center</a> have shared their Ebola preparedness protocols with the public and the CDC.

While all four facilities have been accessed to care for individuals diagnosed with the Ebola virus and have successfully treated these patients, it is clear that every hospital is expected to have the capacity to recognize, detect and isolate a patient. Special isolation procedures and units need to be identified and significant training of personnel must ensue. To that end, the CDC has sent what it refers to as “FAST” teams to Texas, New York, Illinois and Virginia to work with hospitals that have indicated a willingness to care for Ebola patients.

Additionally, the CDC is considering a plan aimed at creating a regional and tiered hospital approach to Ebola patient care, and several state governors and local officials have begun this undertaking. For example, the Texas governor recently identified <a href="http://e.bakerlaw.com/collect/click.aspx?u=GrQc80HBlMjuP2uflNIJZpvYO23hH0A559IS/gDGWoYEAymkdglRThqmefv6dHIYIRXN8NmBPKY=&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">two facilities</a> that will serve as referral centers for the treatment of Ebola patients and has appointed a Task Force on Infectious Disease Preparedness and Response that produced <a href="http://e.bakerlaw.com/collect/click.aspx?u=GrQc80HBlMjuP2uflNIJZpvYO23hH0A5q39i+QKcBpk2+Ok8sXVuWyZTDyoQOJ7J80Qcu97K374/qhHx7ThHcUIJvtLS2BPv9F7sB5iZJ6u0ZWE+Hc1NvQ==&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">specific recommendations</a> on October 17, 2014.

Critically, the special capacity for pediatrics has been identified as a specific need. In Illinois, the mayor of Chicago, Rahm Emanuel, and the Chicago Department of Public Health <a href="http://e.bakerlaw.com/collect/click.aspx?u=/G1GTPto3VXgIsF0ZZI0UdmrbFRPvzyVmI2+GX3Tg44uXajYwmQ7/4bbSpMXQqpY/kIacwP3homBciDAS244Zpv663ofUyoJqOdiF0g1rAHyBSsM6wOvnzdWwKA0gF7OkvcWD05arb+v32teog/vpgFGWPclZt2hp9ouddaIjplSiiG54hthN5lSNUwvCj4R+M9XTGFdBMtPthHIBBbN/g==&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">announced</a> the formation of a network of resource centers that is preparing to provide care for Ebola patients in Chicago, which includes one pediatric facility and three other adult acute care providers working together to coordinate their response and establish best practices, protocols and appropriately trained personnel.

On October 20, 2014, the CDC updated its guidelines for healthcare workers, involving recommendations for <a href="http://e.bakerlaw.com/collect/click.aspx?u=/G1GTPto3VXlT8F4Xb0dUbgI9+AlILLc/ibWb+kus50SQFT1hJqt0971XGuGSF67sQdQI6ME4svU8lalhNvpQQ==&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">Personal Protective Equipment</a> (PPE). The “donning and doffing” (putting the gear on and taking it off) of PPE is a critical safety component in the management of Ebola patients. One of the most confounding issues to date has been the practical concern that PPE is not widely or readily available due to a significant backlog of requests and orders. This raises the question of how can the production and purchase of PPE be expedited—especially for facilities identified as designated referral centers for suspected Ebola cases? At the time of publication, we are unaware of any official recognition of the need to expedite the purchase and processing of requests for PPE and other special supplies for facilities in cities identified as likely entry points and resource centers for Ebola patients. This situation also has worked to impede the ability of many facilities to train and drill clinical staff in the safe and effective donning and doffing of PPE.

Hospitals also have seemingly been left on their own in addressing many of the practical issues associated with managing the treatment team. For example, how to address the limitations inherent in the PPE’s ability to accommodate every body type, as well as physical limitations and medical conditions that may necessitate a clinical worker’s withdrawal from the treatment team. Our advice has been to ensure the health and safety of the healthcare workers, and if such safety may be compromised due to their physical or other limitations, such individuals should not be included in the first line care of Ebola patients.

Issues involving the use of medical trainees, such as residents and interns, have arisen, since they are usually present in the emergency room and around the hospital on various rotations and, in fact, may be among the first individuals to have contact with a patient. While the Accreditation Council for Graduate Medical Education (ACGME) has put out <a href="http://e.bakerlaw.com/collect/click.aspx?u=jRYOrR8N39QUG7xoOV3z6sdXm122ueSr0M4xUzhTLrf0Ho9o9Q6rcv0rBQdWgwAGl/Mh8eGjVjZEYZbg8wps6Zmh/z5JG3DLNwp1n7Adycf456higV22p6NSiOR+GiGL&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">guidance</a> expecting that such students will be properly trained and supervised, many medical schools have determined that its students and residents should not be allowed to treat Ebola patients. Thus, training for residents and interns will be important to ensure identification of the disease, even if further care in other areas of the hospital may be restricted.

Medical waste disposal is another primary concern due to the sheer volume and virulence of the waste caused by the Ebola virus. In Texas, the U.S. Department of Transportation (DOT) worked with state and local officials in granting special waivers for the packaging, transport and disposal of medical waste (including sheets, towels, curtains, PPE and other things that do not typically fall within a Category A type waste stream). The U.S. Department of Health and Human Services (HHS) has acknowledged this issue and on a recent hospital preparedness <a href="http://e.bakerlaw.com/collect/click.aspx?u=/G1GTPto3VWkskhjc1z2gVh8bbJX/44fNn+EvaNf72/FToBhZ6qjPu91m+WuJodQe0t8DD0mCn6xmrj0i1Xizj0jO958nbgBNEuYIw9SYJX9ZUPE1BD6R19lcrNL98dus2cyPr5dn4Nhqm/+FccqBg==&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">call</a> held by the Assistant Secretary for Preparedness and Response at HHS, the DOT indicated that it has since worked with several waste carriers across the country, Stericycle, Veolia as well as the CDC, to develop a waste packaging system and non-site-specific waiver to transport accumulated waste from anywhere in the country. The DOT’s Pipeline and Hazardous Materials Safety Administration has posted a safety advisory <a href="http://e.bakerlaw.com/collect/click.aspx?u=6IbMHz1PohYCSDYRgcbc7YqCUY/IaYBtSw0R8GJEWRHCTuGm4Sx6xmQMlnPcOQmfc1FDjDUKBdV4NfChfF3flxvijY+zCuE8h4dIW+urIITsbVh35YeszVjjw/OE7Y0RLkT36Fac92NyYwuJmKqePg==&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">notice</a> and <a href="http://e.bakerlaw.com/collect/click.aspx?u=6IbMHz1PohYCSDYRgcbc7VZTHGPmHl+ccKSiDtlAqGMpNhrWiHF4HUARNQtyqfwIMJeuElrOWQCp2GaFCiiyNGv3+8xs0UYrXz/mlS/76hMAgmQc/R4bHxsCBsj9VkCp&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">guidance</a> to its website that prescribes best practices on packaging suspected Ebola contaminated waste.

Quarantine Laws

Most prominently, the legal issues of quarantine have arisen for the first time in many years. The ability of the state and federal government to protect the general health and welfare of its citizens comes into conflict with our notion of personal liberties. This will be an issue we will hear and see more of as various state legislatures convene and the medical community works to contain the virus.

Each state has its own set of quarantine laws, the rights and powers of which also differ by state. While a majority of states authorize quarantine by the department of health, others empower the public health officer to order quarantine or require a judicial order from the courts. Although many states have worked to update their public health laws, they have lagged behind with quarantine laws, some of which may date back more than 100 years. Inconsistencies between state public health and quarantine laws will become more obvious as a greater number of states confront the issue of healthcare workers returning from West Africa. One approach, and a vehicle that already exists, is the <a href="http://www.publichealthlaw.net/MSEHPA/MSEHPA.pdf">Model State Emergency Health Powers Act</a>, which was proposed as a state standard for comprehensive public health quarantine and emergency powers laws.

The federal government has the authority to issue quarantine under certain circumstances identified in the Public Health Services Act. Such authority exists under the Commerce Clause of the U.S. Constitution and focuses on the prevention of the introduction of communicable diseases from foreign countries and transmission between states, if the state response is found to be insufficient. The role of the CDC is a direct relation to this power and the interplay between federal and state quarantine authority has been the subject of daily reports in the press.

In Texas, the state health department had the authority to issue quarantine, known as a “control order,” applicable to individuals and property since the first patient presented to the emergency room in Dallas. The state’s Health and Human Services commissioner chose not to issue the control order initially, electing first to allow individuals to self-monitor. Many have criticized this action. In fact, to date, governors in New York, New Jersey and Illinois have more readily used their state’s quarantine authority after the experience in Dallas. The quarantine of healthcare workers and individuals suspected of carrying the disease will be governed by the quarantine laws of each state.

The Texas Task Force on Infectious Disease Preparedness and Response in its <a href="http://e.bakerlaw.com/collect/click.aspx?u=GrQc80HBlMjuP2uflNIJZpvYO23hH0A5q39i+QKcBpk2+Ok8sXVuWyZTDyoQOJ7J80Qcu97K374/qhHx7ThHcUIJvtLS2BPv9F7sB5iZJ6u0ZWE+Hc1NvQ==&amp;rh=ff001b262651b576da5bae5fa54f98bca7515727" target="_blank" rel="noopener">recommendations</a>, indicated that these quarantine laws be improved and strengthened to allow authorized enforcement of the control orders. Currently, Texas control order authority does not allow the commissioner the authority to enforce the order via law enforcement if the individual leaves the designated premises and moves into the public domain. Thus, the issues of personal freedom vs. public health once again are thrust into the limelight and likely will be debated in legislatures across the U.S.

For now, we are limited by our laws and the judgment of public health authorities in state and local government to ensure that we practically produce and disseminate capital, intellectual, medical and hard asset resources to allow our hospitals, physicians, nurses and facilities experts to help quell this disease in the U.S. and export our knowledge in a more robust way to those countries more seriously impacted.

Ebola Matters of First Impression; Law Lags Behind Policy