Editor’s note: This is part 1 of 2 on ethics in the operating room. The second installment will be published in the December issue of ENTtoday.
Explore this issue:October 2016
You are the chair of your medical center’s ethics committee and director of the hospital’s ethics consultation service. As an otolaryngologist with a busy surgical practice, you spend a good deal of time in the operating room and understand the special ethical challenges that this patient care center can pose for surgeons and staff. Additionally, you worked recently as the chief of the specialty surgical services.
Your presence is requested for a conference meeting with the hospital’s medical director, chief of surgical services, chief hospital nurse, and head nurse of the operating room. During this meeting, these individuals indicate that they are undertaking an effort to review all of the procedural rules and guidelines for the operating room (OR), including the recent statement by the American College of Surgeons on the responsibility of the primary attending surgeon during surgery. These leaders seek your input and advice regarding ethical considerations that could have a bearing on the revision and/or clarification of the procedural rules and guidelines. They realize that it is important to understand “ethics in the OR” for many of the everyday challenges and dilemmas that arise during the course of performing surgery.
You agree to provide your knowledge and perspectives, and those of other surgeons who participate in the ethics committee’s deliberations, for their consideration. The first set of procedures and rules for the primary attending surgeon that they would like for you to address includes the following:
- Informing patients, during the consent process, about staff members who will be a functional part of the surgical team, and alerting them to team members’ roles and experience level; and
- Informing patients clearly and concisely about the process of overlapping, sequenced, and multidisciplinary surgeries under the direction of the primary attending surgeon, and about how this practice might affect their care.
Patients are, in general, woefully lacking in information and understanding about who, specifically, is participating in their surgical procedures, and what role each participant will play. It is clearly the responsibility of the primary attending surgeon to clarify these roles to the patient during the surgical informed consent discussion and process. In the Statement of Principles, the American College of Surgeons explains that this responsibility should include “a discussion of the different types of qualified medical providers who will participate in their (patient’s) operation and their respective roles” (available at facs.org/about-acs/statements).
As surgeons, we must recognize that this responsibility has not been as thoroughly discharged as required, and many patients who are cared for in an academic medical center will not understand fully the levels of educational trainees who participate as part of their clinical and surgical care. This author readily admits to having failed on occasion to fully inform the patient of the roles that the medical students, residents, and fellows might discharge on their behalf and their specific roles in the patient’s surgical procedure(s). However, it is possible, if not likely, that the recent discourse on overlapping and sequenced operations may require that both academic and nonacademic otolaryngologists better inform their patients about surgical assistants (including physician assistants) and the extent to which they will participate in surgical procedure(s).
Many academic medical centers and community practices that utilize physician assistants in surgery are revisiting their procedures for informing patients of the types of providers who will participate in their clinical care in various settings. In non-surgical practices, patients are becoming increasingly aware of the use of midlevel providers (advanced nurse practitioners and physician assistants), as well as medical technicians and medical assistants. The situation is a bit more complicated in a surgical practice, due to the participation of a range of individuals in a patient’s surgical care.
Patients have the ethical right to understand just who is/will be participating in their surgical care and what role each participant will play. The implication is that a patient who presents for care in a teaching hospital is at least “aware” that medical students, nursing students, and physicians-in-training will be involved in their care. What role these trainees may be taking, and their level of experience, may be less clear to the patient. Some training programs are now posting signage that introduces the patient to the concept of trainee participation in their healthcare, and others provide an explanatory document explicitly indicating the types of trainees and a general description of their role in patient care. Disclosure and explanation need to become mandated processes in all educational settings.
Educating the Educators
The ethical implications in the surgical consent process are many. The patient has a fundamental, ethical right to self determination in her/his healthcare decisions. Such autonomy about what happens to a patient’s body requires both disclosure about all important aspects of the surgical procedure(s) and the knowledge of who will be performing any aspect of a procedure. Medicines have been prescribed, blood tests ordered, and non-invasive imaging studies conducted for decades with the “assent” of the patient, rather than an informed consent (with the exception of procedures that were part of a study approved by an internal review board). Surgical procedures, however, due to the nature of their invasiveness, require a high level of explanation, including risks/benefits; alternatives to care, including no surgery; and careful, thorough, and clear answers to the patient’s questions.
Surgical informed consent is a big responsibility, yet its conduct is often delegated to individuals who do not have the experience and knowledge of the primary attending surgeon. This is not a condemnation of the process, particularly in academic medical centers where junior resident physicians are often tasked with this responsibility. Rather, we must provide adequate oversight and education so that the individual who informs the patient will be prepared to present and discuss the goals, potential risks, and potential benefits in a way that allows the patient to make a determination based on accurate information. Moreover, this discussion does not obviate the primary attending surgeon’s responsibility to perform a comprehensive explanation of the surgical procedure in all aspects as part of her/his evaluation and recommendations to the patient for consideration.
Another common occurrence that bears some ethical consideration is the practice of having the patient sign the surgical informed consent document on the morning of surgery in the preoperative area. The document’s validity is based on the premise that the primary attending surgeon has adequately discussed the procedure with the patient, explained the risks and benefits as well as the alternatives to surgery, and answered the patient’s questions. We believe that this practice is consistently performed well across the country, but there are no solid data to confirm this premise.
While it can be reasonably construed that a patient who shows up for a surgical procedure has given “assent” to the surgery, signing the consent on the morning of surgery usually does not allow for further discussion of concerns and questions that the patient might have developed since the last visit with the otolaryngologist. And, we must realize that the patient has likely not slept well the night before, may have awakened much earlier than usual, is probably hungry and thirsty, and is very nervous about what is to occur. All of this can potentially affect the integrity of the informed consent process.
Additionally, we can likely agree that the document of “informed consent” signed by the patient is just a document and does not necessarily reflect the patient’s understanding of the nuances of the information. The informed consent process is just that—a process—in which the emphasis is placed on the discussion between patient and surgeon, and during which it is determined that the patient understands the information, has had ample opportunity to ask questions, and has had these questions answered fully by the informing surgeon. The document is not as important as the discussion and process of understanding.
The second issue of concern presented by the medical center leadership for your input is the development of guidelines and standards for the disclosure of potential overlapping or sequenced surgical procedures to the patient, and the oversight of proper conduct for such occurrences. The foundational concepts (professional and ethical) for any surgical procedures involving trainees as assistants are two-fold:
- The physical presence of the primary attending surgeon in the operating room during the critical or key portions of a surgical procedure; and
- The delegation of the non-critical portions of a procedure to a trainee (usually a resident physician) who is capable of performing these portions safely and appropriately when the primary attending surgeon is not physically present in the operating room.
At this time, in the absence of specialty-derived statements, the decision regarding what constitutes the critical or key portions of a given procedure is left up to the primary attending surgeon.
These responsibilities, with regard to a patient in surgery, cannot be discharged while simultaneous or concurrent procedures are underway, because the primary attending surgeon should not place herself/himself in a position where physical presence is required for key portions of the surgeries at the same time. For this reason, concurrent or simultaneous surgical procedures are discouraged on the basis of our ethical responsibilities to both patients.
Some surgeons may pose the argument that the immediate availability of a “backup” surgeon who can perform certain key or critical elements on one patient while the primary attending surgeon is performing or teaching key and critical elements in another room, makes this is an acceptable practice. Ethically speaking, this is an example of “co-management” of a patient, which would require preoperative disclosure to the patient, along with explanation, resulting in the patient’s consent. The patient may not agree to such an arrangement, and the primary attending surgeon will need to acquiesce to the patient’s wishes, rearranging the surgeries so they are not concurrent. Even if the patient agrees to the possibility of a backup surgeon—or co-management—the second surgeon must then become adequately familiar with the patient’s medical history and medical data, along with the scope of the procedure, and must meet the patient for an examination and discussion, just as if she/he were the primary attending surgeon. With so many risks, it just doesn’t make ethical sense, so the best course of action is not to schedule concurrent or simultaneous surgical procedures.
On the matter of overlapping or sequenced operations, the ethical implications are slightly less worrisome but still depend on the ability of the primary attending surgeon to do the following:
- Adequately plan the surgical procedures, taking into account that the procedures may not follow the “plan”;
- Completely disclose the potential risks (no substantial “benefits” to the patients are likely) to both patients when overlapping or sequenced operations are planned;
- Ensure that a backup attending surgeon will be immediately available for either patient’s procedures;
- Provide an honest disclosure of who will be taking part in each operation, as well as their roles, training, and capabilities; and
- Finally, explain why such scheduling is warranted.
Patients should also be introduced to the planned “backup” surgeon, as previously noted.
Level of Training
Although this will likely change in the near future, experience indicates that many patients agree to surgery—particularly in an academic setting—without being fully aware of the levels of training of otolaryngology residents (and perhaps medical students, as well), or the invasive procedures these trainees might be performing on them. Many primary attending surgeons do a fine job of explaining to patients how each member of the surgical team plays a role in the performance of the operation and teaching them about the importance of “learning by doing” in a medical education setting. And, most patients agree to be a part of this education process, after they understand how residents learn to be capable and safe surgeons under the guidance of a senior surgeon.
A few patients, for one reason or another, are not comfortable with trainees performing parts of their surgical procedure, and the primary attending surgeon must manage this situation with understanding, support, and discussion. It is possible that the patient may have misleading or inaccurate information, believing that a patient is “experimented” on at a teaching hospital. Every effort must be taken to explain the true circumstances surrounding the multiple levels of experience of the surgical team in a teaching hospital, with the oversight and involvement of the primary attending surgeon serving the pivotal role.
However, if a patient continues to refuse to have trainees take part in her/his surgery, and cannot be dissuaded from that decision through education and explanation, then a teaching hospital may not be the best place for the patient to have surgery, and the physician may offer a referral to a community surgeon. No surgeon wants to put a patient in an untenable position; nor should the surgeon be placed in one. Mature professional judgment, based on experience and understanding of the patient’s perspective, can lead to an amicable resolution to this dilemma.
The operating room, like the emergency department and intensive care unit, is a unique clinical setting where patients’ lives are held in the balance, and the balance may depend upon careful planning and preparation and meticulous execution of these plans. Within an operating room, the course of surgery is much like an orchestra performance—each section, each performer has a specific job to do, yet they must all be done in the harmony of safety, placing the patient’s well-being as the most important priority. The operating room is not a “haven” from ethical dilemmas, but rather a focused application that balances of the ethical principles of autonomy, beneficence, nonmaleficence, and social justice.
Part 2 of “Ethics in the Operating Room,” which will be published in the December 2016 issue of ENTtoday, will focus on bedside evaluation skills.
Dr. Holt is professor emeritus in the department of otolaryngology-head and neck surgery at the University of Texas Health Science Center in San Antonio.