Ensuring Your Patients Know the Risks Before a Procedure

We’ve already discussed the importance of obtaining legal permission from patients before performing any medical procedure. Now we’re going to tackle a tougher topic along the same lines: ensuring that your patient is aware of the risks inherent to the procedure he or she is considering.

Know “List A”

The Texas Medical Disclosure Panel (Part 7, Chapter 601 of the Texas Administrative Code) dictates what specific risks must be discussed to provide adequate informed consent under the law for certain procedures. Most physicians and health care providers have heard of “List A procedures.” For example, one common List A procedure—epidural anesthesia—requires that physicians disclose the following risks:

  • Nerve damage
  • Persistent back pain
  • Headache
  • Bleeding/epidural hematoma
  • Infection
  • Medical necessity to convert to general anesthesia
  • Brain damage
  • Chronic pain

The List A procedures are divided into systems or specialty categories such as “anesthesia” or “cardiovascular system.” The State of Texas provides an expansive list of risks associated with List A procedures here.

“B List” Just As Important

“List B procedures,” on the other hand, are medical procedures for which no specific risks must be disclosed to a patient to legally constitute “informed consent.” Examples of List B procedures include local anesthesia, removal of extraocular foreign bodies, and biopsy of prostate, bladder or urethra, to name just a few.

Like List A procedures, List B procedures also require a risk-benefit discussion to ensure your patient is fully informed. The difference with List B procedures is that the law does not specify which particular risks must be disclosed in order to be considered “informed consent.” That means, as a physician and health care provider, you must discuss whatever risks and hazards you deem relevant and necessary to ensure that your patient is fully informed before moving ahead with a given procedure. This often entails discussing the most common risks, as well as risks that are less common, but more serious. Likewise, just because a specific risk for a List A procedure is not listed in the statute, health care providers still should discuss that risk with their patients where appropriate, even if they are not legally required to do so.

There also are some procedures not included on List A or List B. Prior to those procedures, the law requires that you disclose the risks that a reasonably prudent physician performing such a procedure would disclose under the same circumstances.

As with all things in medicine, you must use your education, training, and experience, along with your clinical judgment and the patient’s particular situation, when determining what to include in your informed-consent discussion. But you must know what procedures are on List A, and absolutely include the listed risks for that procedure in your informed-consent conversation with your patients.

Get It in Writing

While the statute does not require that the risks be disclosed in writing, there is a legal presumption that the risks were properly disclosed to a patient if they are in writing and signed by the patient. The only way patients can rebut the written disclosure—and actually have a claim under the law for lack of informed consent—is to prove (1) that the signature on the consent form is not theirs, or (2) they did not have the legal capacity to sign the consent form when they signed it, both of which are very rare circumstances.

On the other hand, if the informed consent discussion is not in writing and signed by the patient, then a patient (and her attorney) can attempt to claim that the risks were not disclosed. The burden then shifts to the defendant/physician to prove that the risks inherent to the procedure were indeed “adequately disclosed” to the patient in some other manner—typically through a verbal conversation. This puts the defendant/physician in a he-said/she-said situation, which is never desirable from a physician’s perspective. Instead of the patient having the burden of proof—which is the case for proving medical negligence—the burden has shifted to the physician to prove that the conversation took place and that the disclosure of risks was adequate. Always document informed-consent discussions.

A Few More Tips

While a consent form is a must, it is always advisable and good practice to also document your informed consent conversation in your medical record for the patient—either in your office chart or the operative note, or (preferably) BOTH! Even a note as simple as “discussed the risks and benefits in detail with the patient and her husband” will further substantiate that the informed consent discussion took place. This is particularly true at most facilities when signing of consent forms is handled by the nursing staff. This practice is certainly OK, but it is ultimately the physician’s responsibility to ensure that the patient has been adequately “consented” before the procedure takes place. That involves a personal conversation with the patient at some point prior to the surgery.

The bottom line: know the List A procedures and make sure you and your facility’s consent forms include every required disclosure; have a detailed conversation with your patient about the risks and benefits of every procedure and document it; and always have your patient sign a consent form for any invasive procedure with reasonable and statutorily-required risks disclosed on the form.

— Kimberly K. Bocell is a former registered nurse and a shareholder at Dallas’ Chamblee, Ryan, Kershaw & Anderson, where she represents healthcare providers in all facets of health law.

Posted in Expert Opinions, Government/Law.