Lutheran cited for missing Informed Consent documentation

During its triennial onsite survey last month, The Joint Commission cited Lutheran for failing to comply with its Informed Consent policy. Among the charts reviewed, the required documentation was either incomplete or missing. Because of this finding, surveyors will evaluate this area of documentation more closely during future visits.

Lutheran policy: Informed Consent – The Rights and Responsibilities of the Individual

Obtaining Informed Consent presents an opportunity to establish a mutual understanding between the patient and the licensed practitioner about the care, treatment and services that the patient will receive. More than a signed document, Informed Consent is a process that considers patient values and preferences, complies with law and regulation, and includes patient education about the risks, benefits and alternatives of a proposed treatment. Utilizing the informed consent process helps the patient to participate fully in decisions about their care, treatment and services.

"Anyone who knows me well knows that I don’t like paperwork or bureaucracy. I’ve always ruffled at the notion of written consents for standard, low-risk procedures,” said Julia Whitaker, MD, Critical Care Medicine.

“I have, however, always felt it’s very important to communicate well with our patients and their families about what we are doing and why we’re doing it, in a way that they feel supported and involved in their care.”

“The reason I’ve come around to doing the paperwork is, like it or not, we get evaluated by organizations like The Joint Commission for completing these. If I fail to comply with these documentation requirements, people whom I appreciate and who support us end up having to try to explain my behavior,” Whitaker said. “For the system to run well, we have to work as a team and support each other."

In order to comply with the policy and demonstrate that we are engaging in this process, we must ensure the following steps by the:

Clinician: An Informed Consent form shall be signed, dated and timed, and the process documented in the progress notes.

Patient or patient’s decision maker: The signature of the patient or the patient’s legal representative, along with the date and time the Informed Consent form is signed.

Witness: The date, time and signature of the person witnessing the patient or the patient’s legal representative signing the Consent form.

Exceptions to Informed Consent may be needed in the case of a medical emergency, when time is of the essence. Clinicians may proceed with presumed consent in emergency circumstances during which the patient is unable to give consent and there is no available authorized surrogate decision maker or treatment-guiding Advance Care Planning document.

Immediately following the emergency procedure, an Informed Consent form must be filled out with the procedure description, its risks and benefits, and the reason for the emergency procedure. A note to the emergency nature of the procedure must also be documented in the medical chart.

Physicians with questions about the policy are encouraged to reach out to the medical directors in their specialty or care area.