Emerging Evidence Calls For New Responsibilities
Throughout all levels of healthcare, and certainly for nursing care facilities, the personnel hired, contracted, or credentialed to provide care and services are tasked with following the standard of care for that setting and the clinician’s licensure. The measure of compliance is determined by treatment guidelines that provide direction for what a clinician of the same education, training, and experience should or should not do when caring for a patient in the same or similar circumstances. Standards of care can be found in clinical textbooks, peer reviewed journal articles, and treatises from authoritative sources.
Compliance with regulatory guidance is not sufficient to assure the nursing care facility’s clinicians are in compliance with the standard of care. First, the standard of care is dynamic and constantly evolving, whereas regulatory guidance becomes effective on a specific date and continues until new regulations are promulgated by statute and/or issued through the regulatory review process. Additionally, regulations are not issued to be standards of care. Indeed, the Pennsylvania Department of Health Nursing Care Facility Locator Page includes a disclaimer of sorts, labeled by the Department as “Explanation,” that reads in part, “These healthcare facility search pages contain information regarding healthcare facility compliance with regulatory requirements for licensure and for certification.” There is no suggestion that the Department’s web pages address compliance with the standard of care. Regulations are not standards of care.
It is incumbent upon healthcare entities to be in compliance with the standard of care and its clinicians have a duty to provide care and services consistent with the standard of care. One such duty of healthcare clinicians is to educate clients so that they may make an informed decision regarding aspects of care being recommended. Legal nurse consultants understand that because the standard of care is dynamic it should be researched consistent with the date of when the care under review was provided. The same should be the practice of nursing care facilities establishing educational content for its clients. Relevant to the current public health emergency, this would include vaccine recommendations. Per the change of definition issued by the Centers for Disease Control and Prevention (CDC) in September 2021, a vaccine is no longer a product that produces immunity, but rather a product that provides protection.
Time has allowed for increasing evidence regarding the efficacy and long-term adverse effects of available COVID-19 vaccines and boosters. Of note, the available vaccine remains that formula approved by the Food and Drug Administration (FDA) under an emergency use authorization (EUA). As one would expect, some of the evidence suggests the benefits outweigh the risks and other evidence suggests just the opposite. Eventually, it will all get sorted out and we can hope to see increasing consensus based on objective data. In the meantime, it is not enough to follow only the regulatory guidance. If lawsuits ensue later, medico-legal consultants will look to the dates of peer reviewed articles and treatises to determine if nursing care facilities/clinicians knew, or should have known, the risks and benefits of the vaccine offered. In the meantime, it is my strong recommendation that nursing care facilities be careful to present both sides of the coin as more and more evidence emerges. This may require working with the pharmacy provider of the COVID-19 vaccine. If resistance is met, I strongly recommend that legal counsel be sought for guidance, remembering that liability has not been waived for Pennsylvania nursing homes or clinicians. Educational content delivered to clients should be reviewed and revised often to keep pace with emerging evidence.