The ASA guidelines make it clear: Physician anesthesiologist, certified registered nurse anesthetist, and certified anesthesiologist assistant participation in all deep sedation procedures provides the safest patient care overall. Yet, throughout the country, deep sedation is being provided by qualified nonanesthesia professionals, backed by Medicare regulations that permit for the administration and supervision of deep sedation by nonanesthesiologist physicians, oral surgeons, dentists, and podiatrists. So, what is at risk and how should directors of anesthesia services or nonanesthesia professionals wishing to administer deep sedation proceed? Kurosh Takhtehchian, DO, Associate Clinical Professor of Anesthesiology at University of Illinois Health at Chicago, shared his decade of medical legal expertise on the issue with ASA Monitor.
Central to the ASA guidelines is the concern that clinicians who are not anesthesia professionals may not recognize that sedation and general anesthesia are a continuum and unintentionally deliver general anesthesia to patients without having the training or experience to respond appropriately. “This puts patients at risk for losing consciousness and having airway complications, and if the clinician has difficulty ventilating, the dynamics of the situation will quickly change unnecessarily, increasing patient morbidity and mortality,” Dr. Takhtehchian explained.
Therefore, ASA recommends that those requesting privileges to provide deep sedation must be able to recognize in a timely manner that a patient has entered a state of general anesthesia and be able to maintain a patient’s vital functions until appropriate recovery to a desired level of sedation or alertness. Further, it is recommended that the granting, appraisal, and revision of these clinical privileges be awarded on a procedure-specific and time-limited basis that accounts for the type and complexity of the procedures the qualified person may administer in accordance with the rules and regulations of the health care facility, its accrediting organization, and local, state, and federal governmental agencies.
Grey legal zone
Though the ASA guidelines on deep sedation are clear, Dr. Takhtehchian noted that actual administration of the procedure can be a bit of a legal grey zone, as regulations and privileges can vary between hospitals and states, with some states holding much more stringent rules than others. However, one element of the guidelines and law is straightforward: Any qualified clinician who administers and monitors deep sedation must be dedicated to that task and different from the individual performing the diagnostic or therapeutic procedure. To do otherwise is to risk fraudulent billing. One example would be if a clinician billed a government entity to reimburse for both the procedure and anesthesia, Dr. Takhtehchian said. “You must be dedicated to the task of solely monitoring the patient’s hemodynamics, respiratory status, and vital signs, and be able to provide anaesthetic or pain relief, if necessary,” he said. “To not perform this dedicated task is not only recognized as improper care, but illegal in terms of billing for Medicare, Medicaid, or any other insurance.”
Of course, unique situations may demand unique solutions to care, such as if a patient is crashing and requires an emergent procedure. “Ultimately though, one should not be doing deep procedural sedation without an anesthesia professional involved unless it’s a time-restricted emergency where life and limb are at risk,” Dr. Takhtehchian said.
What happens if a patient is at risk and a nonanesthesia professional who is not privileged to provide deep sedation does so? There is a higher likelihood that the patient will go into the next stage of deep sedation. Dr. Takhtehchian said, if that happens, to immediately call an anesthesia professional who will be able to monitor the patient, provide adequate airway and vital sign support, and stay until the patient is stabilized. “If the clinician is not an anesthesia professional, there is an inherent tendency and risk that they will focus on the therapeutic or diagnostic procedure and not be aware of aspects that an anesthesiologist manages. This will put the patient at risk for complications,” Dr. Takhtehchian said. Such a scenario would be considered negligence, potentially resulting in legal action with long-lasting implications both financially and professionally.
If a patient has damages or complications due to administration of deep sedation by a nonqualified provider, the patient or patient’s family can file a wrongful injury or death lawsuit in which the patient’s attorney would be required to prove all four essential elements of the case: 1) duty, 2) breach, 3) injury, and 4) causation. Dr. Takhtehchian explained that duty would be the established relationship between the patient and anesthesia professional, something easily proven by hospital records and documentation. Because the ASA guidelines on deep sedation are clear, the breach of duty would also be difficult to dispute – the anesthesia professional has a clear duty to the patient to provide a standard of care established by the guidelines of medical societies (such as ASA) and the bylaws of the hospital. In the case of deep sedation, medical legal experts would testify that the governing body of ASA has a long-standing statement from a qualified committee that outlines the best standard of patient safety, and acting against these guidelines places the patient at risk.
Injury or harm to the patient would also be clearly documented, proving that the damages resulted from negligence and the breach of standard of care defined by ASA guidelines. “Lawyers acting on behalf of the patient can attain experts in the field to highlight the four essential elements of a malpractice suit and prove beyond a reasonable doubt that injury or death was caused by a breach of duty – and this would be very detrimental,” Dr. Takhtehchian said.
Lasting legal implications
A guilty finding for negligence in this case would follow the clinician’s entire career. For example, some hospitals or companies that provide malpractice insurance could penalize physicians by listing them in the National Practitioner Data Bank (NPDB). The NPDB is a web-based repository established by the U.S. Congress in 1986 that contains information on medical malpractice payments and certain adverse actions related to health care professionals, practitioners, and suppliers and prevents them from moving between states without disclosure or discovery of previous damaging performance. This can, of course, impact future employment opportunities as well as cause monetary, emotional, and psychological damages for the physician.
Ultimately, Dr. Takhtehchian noted that the guidelines exist for a reason and should be followed as much as possible, with the rare exception when not acting would cause harm, injury, or death to the patient. “In most cases, it is always better for the physician to be aware of guidelines and legal regulations and ramifications, so that if a situation were to occur where the anesthesia professional is being coerced, they can point to the legal perils that are at play. Being pressured to act outside of the standard of care, for example by administering deep sedation when one is not qualified or privileged to do so by the governing bodies, the institution, or the state and federal authorities, is a risk not worth taking. The nonanesthesia provider can effectively point out the implications of not following guidelines and standards of care and not act carelessly against what is recommended.”
The full ASA Statement on Granting Privileges for Deep Sedation to Non-Anesthesia Professionals can be found here: asamonitor.pub/3pHCMEX.