Article

CLINICAL: Legal

Acquire Informed Consent

Protect your practice and your patients with education and documentation

With availability of several dry eye disease in-office treatments, such as intense pulsed light, punctal plugs and thermal pulsation, optometrists should acquire related informed patient consent to ensure patients can make a knowledgeable decision, while O.D.s can protect themselves from litigation.

INFORMED CONSENT

Informed consent, or the consent of the patient to the doctor to perform a specific medical procedure, can be given verbally, via written consent or both.

It should be comprised of the patient’s diagnosis and proposed medical procedure and possible benefits, alternative treatments and risks.

For example, the American Academy of Ophthalmology’s sample informed consent document for punctal plugs, from the Ophthalmic Mutual Insurance Company, lists the diagnosis as dry eye syndrome, how punctal plugs could help, alternative treatments, such as cyclosporine, and the risks, such as excessive tearing. (View the document at https://bit.ly/2WLrjUk .)

O.D. PROTECTION

To increase the likelihood of informed consent fully protecting the optometrist, in the event of litigation, keep these items in mind:

  • General consent won’t cover it. The general consent form, given to the patient upon check-in, covers the comprehensive eye health exam, such as dilation. It does not cover a specific medical procedure, such as punctal plug insertion, because it is not comprised of all the elements listed above.
  • All bases should be covered. The problem with verbal consent is even if the O.D. makes a note of it in the patient’s record, it comes down to her word vs. the patient’s. Written consent is stronger, but with either verbal or written consent alone, patients can claim they did not understand what was explained, so they signed the form, trusting the O.D.’s recommendation. As a result of all this, it makes sense for the O.D. to provide verbal and documented consent with a witness present. Specifically, the O.D. should go over the documented informed consent verbally with the patient, frequently stopping to ask the patient whether he fully understands and has any related questions, while a witness, such as a technician, is present to hear the conversation and see the patient sign the document.
  • Verbal/document language should be patient friendly. When the O.D. verbally explains the medical procedure and its associated possible benefits, alternative treatments and risks, neither scientific, medical nor legal language should be used, as this language is often difficult for patients not in these fields to understand. In the case of punctal plugs, for example, instead of saying, “This plug will be inserted into your puncta to continuously bathe the ocular surface,” the optometrist should say something along the lines of, “This plug will be inserted into your tear duct to prevent tear drainage, so your eyes don’t feel so dry. Does this make sense?”

PROTECTION FOR ALL

Informed consent protects patients in that it educates them on the proposed medical procedure and alternatives, so they can make an informed decision regarding whether to undergo the procedure. It protects optometrists in that it shows they provided patients with the said information prior to the patient electing to undergo the procedure. For O.D.s to fully ensure they are protecting their patients and themselves, it makes sense to consult with their state optometric associations in addition to federal law. OM