By Gregory Freeman, Author

Consent forms missing one or more elements are a common problem found by surveyors with the Healthcare Facilities Accreditation Program (HFAP), based in Chicago.

The 2017 quality report from HFAP summarizes the consent form deficiencies regarding HFAP standard “Medical Records 10.01.16 — Informed Consent,” saying the trending deficiency is one or more required elements missing from the consent form.

“While consent forms are used in legal proceedings to protect institutions (the documentation of consent), they are, first and foremost, evidence of an interactive process that should emphasize ‘informed’ — an act of intentional affirmation on the part of the patient,” the report says. “To this point, informed consent is included in additional locations in the Conditions of Participation relating to patient rights and surgical services. To achieve the intent of the standard, consents must be written in simple language such that the meaning of the document is repeatable by the patient.”

Because of the large percentage of the population with literacy deficits, and the larger percentage with medical literacy challenges, consent documents should be written so as to be understood by all, HFAP says.

The report cites the following examples of surveyor citations:

• missing consent for anesthesia;

• consent not written in simple sentences or at a fourth-grade level;

• consent missing alternative therapies;

• consent missing anticipated benefits and risks;

• procedure name abbreviated and not further documented for easy comprehension;

• date and time missing.

The HFAP report is available online at: