COVID-19 Legal Update
Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines
On April 13, 2020, the Pennsylvania Department of Health released the Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines, which were developed with the Hospital and Healthsystem Association of Pennsylvania as a guide for resource allocation and prioritization of care in times of crisis. Pennsylvania has 154 general acute care hospitals with 34,416 licensed beds, of which less than 1/10th are ICU beds on a given day. In a crisis situation, preparation is crucial; however, a pandemic that effects the world as a whole requires collaboration of resources and a change in implementation of medical care. “Medical care shifts from focusing on individuals to promoting the thoughtful use of limited resources for the best possible health outcomes for the population as a whole.”
The Institute of Medicine has defined crisis standards of care as a “substantial change in usual healthcare operations and the level of care it is possible to deliver which is made necessary by a pervasive or catastrophic disaster.” The care provided moves from conventional where hospitals have normal bed capacity and staffing to contingency where the normal bed capacity is exceeded to crisis care – where the normal standard of care cannot be met. The shift in care which would trigger activation of the Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines would include:
- An event (or disease) that affects a large portion of the state’s population and/or health care resources.
- Lack of or critical shortage of essential equipment or medications such as mechanical ventilators, oxygen, antibiotics, antiviral medication or specific antidotes; vasopressors or other critical care medications; intravenous fluids or blood products; operating room equipment, space and staff, and hospital and/or ICU beds.
- Lack of or critical shortage of critical infrastructure, such as power, water and communications; security to maintain the safety of health care providers and patients; lack of personal protective equipment; lack of trained staff, and lack of or shortage of staff support (food, housing, water, etc.).
To address a change in the continuum of care, the Guidelines contemplate the identification of a physician as a Crisis Triage Officer (CTO) who is not involved in direct patient care but rather resource allocation. “These physicians should be familiar with the concepts of disaster operations specific to the incident, and should include trauma surgeons, intensive care physicians, emergency physicians, infectious disease and/or internists with extensive hospital experience.” Ideally, the CTO should be identified prior to crisis care implementation in order that he/she may be trained or cross-trained in disaster management, bias, ethics, etc.
In order to allocate resources, each hospital evaluates its own resource availability and consults with local and state health departments, to consider implementing criteria to restrict hospital admission. All patients are triaged, even those who are not suffering from the pandemic, using specific patient evaluation tools to constrain admission and limit transfer to critical care units. Resources are allocated based upon the goal of “saving lives” and “saving life-years.”
“Consistent with accepted standards during public health emergencies, a goal of the allocation framework is to achieve the most benefit for the entire populations of patients.” It is expected that hospitals will coordinate with outside governmental agencies and the community to add to their staff, allocate resources and communicate with the public.
The Guidelines include an easy flowchart called the “Patient Evaluation Model” which begins with an assessment by the CTO as to whether the patient, after triage, meets the criteria for inclusion in critical care and, if so, divides the patients into priority levels for receiving that care. The patient population is reassessed daily and care is changed accordingly.
As soon as resources are available and the severity of the event for which crisis care was implemented subsides, the hospital should return to contingency or conventional standards of care and the Department of Health should be notified.
The Guidelines include a list of circumstances under which a waiver of sanctions under EMTALA may be provided and a HIPAA waiver which allows covered entities to disclose needed patients’ protected health information (PHI) without individual authorization if necessary to treat the patient or a different patient or if the information would help treat a different patient, to persons at risk of contracting or spreading a disease or condition, and, with people involved with patients’ care where there is an imminent threat to public health/safety.
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