January 8, 2018

Faced with tight time constraints and pressure to maximize operating room efficiency, anesthesiologists may end up spending less time obtaining patient informed consent.  Resist that temptation, Washington, D.C.-based attorney Judith Jurin Semo, JD., urged attendees at ANESTHESIOLOGY^® 2017.  “Informed consent is a process, not a form to be signed,” and a two-way dialogue between the anesthesiologist and patient is best to ensure that the patient understands all of the risks, no matter how small some of those risks might be.  “The buck ultimately stops with you, the physician,” she said, which means that it should be you, the anesthesiologist, who obtains the informed consent based on a direct exchange with the patient.

“It’s great if the patient comes in beforehand and if you are able to obtain informed consent in advance of the day of surgery,” Ms. Semo said.  “But often, you have to obtain informed consent on the same day as the procedure.  You, the anesthesiologist, have such an incredibly important role.  To me, your role in the care of the patient is critically important.  But because you do not have a prior relationship with the patient, the patient does not know you.  Often, by the time they see you, they are so anxious that they may not be able to fully appreciate the information. That’s something to understand.”

The information above and the material below is a summary of selected takeaways from Ms. Semo’s presentation based on her copyrighted materials.  (The summary is copyrighted material, owned exclusively by Ms. Semo. ABC does not own the copyright to this summary material, nor does ABC attest to its accuracy or completeness.  Notwithstanding, Ms. Semo has consented to ABC’s publication of the summary material below.  All other requests to use, copy, reprint, or republish this summary must be first directed to and approved by Ms. Semo.)

• What kind of form are you using?  In many facilities, anesthesia consent is merged with the general consent for surgery.  Those general consent forms often lack sufficient detail on the full range of anesthesia-specific risks.  Use a separate consent form that describes all of the anesthesia-related issues.  Ms. Semo also suggests talking with your professional liability carrier regarding informed consent.  
• Discuss all risks with the patient.  Some severe risks may be highly infrequent, but the patient always needs to appreciate that, while these risks are not necessarily anticipated, they do exist.
• Know the pertinent laws in the state(s) in which you practice.  Requirements regarding the specific types of risks that must be disclosed to patients can vary widely from state to state.  Texas, for example, specifically requires disclosure of specific risks associated with general anesthesia, MAC, epidurals, and spinals, and requires use of a specific informed consent form.  Understand your state laws and know that they can be very specific regarding the risks of anesthesia that must be shared with patients.  Be sure your informed consent form complies with these laws. 
• In addition, know whether your state has apology laws, and if it does, make sure you understand the scope of those laws, including what they do not cover, as well as your facility’s policy in this matter, and review with your professional liability carrier their approach to apologies.  Apology laws also vary widely from state to state.  Most of these laws protect sympathy statements but not statements of fault.  Also, be aware that if your state has an apology law, that doesn’t necessarily mean that you are going to have protection.  Separately, some states mandate that you disclose unanticipated outcomes.
• Obtain informed consent for all parts of the anesthesia care plan.  If you’re planning to do a block for postoperative pain, obtain consent for the block.  The risks associated with nerve blocks are different from those associated with anesthesia; patients must understand what they are.  Use a separate consent form for the nerve block.  Again, your professional liability carrier can be an excellent resource. 
• Consider, and communicate about, the anesthetic technique you’re planning to use.  You may plan a regional anesthetic, but what happens if the regional converts to a general anesthetic?  Have you reviewed this with the patient?  Anticipate the changes that could happen during the procedure. Is there a chance that a nerve block will be needed after the patient has been anesthetized?  It may not be common, but it can happen.  The patient needs to understand the risks and give consent.
• Does the patient understand who is going to be providing the services?  Include this information in the informed consent.  If you practice in an anesthesia care team, the patient should understand who will be participating in the patient’s care.  Are you in an academic practice, or even in a nonacademic practice, in which students rotate through the OR?  The patient should know this, and that information should be included in the consent.
• Consider the type of setting in which the anesthesia is being performed.  For example, anesthesia performed in an ambulatory surgery center or in an office has different risks than anesthesia performed in a hospital.  There may be fewer personnel and less equipment in an ambulatory surgery center (ASC) or office, which can increase the risk of anesthesia, which may include the risk that the patient may need to be transported to the hospital.  Does the patient understand this? Some states have very specific requirements regarding informed consent for different types of surgical settings.  Know these laws.
• Be aware of the regulatory underpinnings of informed consent.  What are the informed consent requirements of the Centers for Medicare and Medicaid Services and those of the various accreditation agencies?  For example, if you are in an ASC, an informed consent that is part of the general surgery form may not meet the CMS Conditions for Coverage.
• Document all cases carefully.  “Remember, every case seems to be routine until it’s not routine,” Ms. Semo said.  “That’s why you need to have a good practice of documenting all cases.”  Understand the policies and advisories related to your clinical practice. It is your clinical judgment whether or not to follow a clinical practice guideline.  However, if you think it is not appropriate to follow a clinical practice guideline or order a test in a given case, document why.
• Understand your professional liability carrier’s guidelines regarding documentation.  And document the process of informed consent.  A case may not be decided based on informed consent, but the informed consent can affect the professional liability carrier’s decision whether or not to recommend settlement.

Ms. Semo urged anesthesiologists to find the time for that important patient-doctor exchange.  “Try and get to know the patient to the extent that you can,” she said.  “If you can have some contact with them before the day of surgery, try to maximize your involvement preoperatively.  I know I’m talking about a lot of extra work, but part of what you’re trying to do is ensure the patient understands the risks, and thereby to assist in protecting yourself.”  This contact offers an opportunity to ask patients what questions they have.

With best wishes,

Tony Mira
President and CEO