On April 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released a memorandum revising its guidelines on obtaining informed consent for invasive procedures and sensitive examinations when individuals other than the primary physician are involved. To remain compliant, anesthesiology departments and their representatives, such as attending anesthesiologists, must now inform patients and their family members when residents, or medical, nurse anesthetist, or anesthesiologist assistant students, will be performing invasive procedures or other important tasks related to surgery. Such procedures and tasks include endotracheal intubation or other aspects of airway management, invasive line placement, and administration of anesthesia, both general and regional (asamonitor.pub/3xDjm88).
“The performance of invasive procedures by anesthesia trainees is critical for developing competent anesthesiologists and other anesthesia professionals who can manage complex and emergent situations. However, this educational obligation must be carefully balanced with the ethical imperatives of patient autonomy, self-determination, justice, beneficence, and nonmaleficence.”
This revision comes after several mainstream media reports highlighted the practice of subjecting patients to sensitive examinations by various learners without their consent, with emphasis on examinations performed while the patient was under anesthesia (asamonitor.pub/45Lpt6H). Even prior to such reports, medical literature supported abandoning this practice in exchange for a more transparent one (Obstet Gynecol 2019;134:1298-02).
Mastery of the technical skills of airway management and invasive line and regional block placement is essential for all anesthesia trainees. At the end of training, our learners must confidently manage routine airways in daily practice as well as in emergent situations where swift, decisive action is required. To achieve this goal, trainees need hands-on experience with a wide variety of patients, under appropriately supervised conditions. While the level of supervision may change as a trainee’s technical skills, confidence, and decision-making abilities develop, it is never wholly eliminated. This balance maintains a standard of patient safety and promotes an effective learning environment.
While such practical experience is a crucial component of anesthesia training, it is equally important to uphold patient autonomy and self-determination, as this new CMS requirement emphasizes. Patients must be informed about the medical care they receive, in compliance with informed consent standards; they subsequently are entitled to make decisions about the proposed procedures and treatments. The shared information must include risks and benefits of trainee participation in their care. Patients then elect whether to allow such participation, including performance of invasive procedures like line and block placement. Respecting patient autonomy is a fundamental principle of medical ethics that has evolved over recent decades, from the patient serving as a collaborator in decision-making with the medical team to acting as the leader. Anesthesiologists are obligated to assist patients in this process by providing evidence-based answers to questions and acknowledging uncertainty where it exists (Anaesthesia 2021;76:1442-5).
To comply with the new CMS guidelines, uphold patient autonomy, and retain a learning environment that supports the needs of our trainees, anesthesiologists should clearly communicate several key details in the informed consent process regarding trainee participation in invasive procedures and anesthesia administration. They should indicate the learner’s degree of experience and the level of supervision provided throughout the procedure. Such disclosure allows the anesthesiologist to assess the patient’s comfort with the trainee’s involvement. Additional patient questions or concerns may arise; providing adequate answers is not only part of the informed consent process but also empowers the patient as a proponent of their own care while the anesthesiologist serves as an advocate for the trainee’s education. It may also be appropriate to discuss emergency protocols, assuring the patient that the anesthesiologist is prepared to immediately take over the procedure should any concerns arise. Such reassurance helps patients feel that their safety is of the highest priority. This reassurance reinforces patient autonomy as well as justice by ensuring that patients in comparable situations are treated similarly. In addition, the concepts of beneficence and nonmaleficence are also supported by enabling patient empowerment, preventing harm from occurring, and allowing for the best training opportunities for the next generation of anesthesia practitioners.
The performance of invasive procedures by anesthesia trainees is critical for developing competent anesthesiologists and other anesthesia professionals who can manage complex and emergent situations. However, this educational obligation must be carefully balanced with the ethical imperatives of patient autonomy, self-determination, justice, beneficence, and nonmaleficence. Incorporation of additional details regarding trainee involvement into the informed consent process strikes this balance, ensuring trainees continue to receive the necessary, practical experience, while respecting both the established medical-ethical and new CMS standards for informed consent.
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