Required elements for the standards expand the guidance, noting that authorization from a patient who does not understand what he/she is consenting to does not constitute informed consent. This is why the informed consent discussion is an integral part of the process.

The Importance of the Primary Language

Hospital policy must define how it will meet the requirement to use the patient’s primary language for the informed consent discussion. And the same applies to the written information on the Informed Consent Form to be signed. Policy may include a process that reviews an Informed Consent Form written in English through the use of interpreter services in lieu of requiring translations of the form. Using interpreter services will meet the needs of the patient’s primary language if the patient also consents to this process. Regardless of the process, write Informed Content Forms using simple sentences. Use plain language that is easily understood, preferably in the patient’s primary language. 

Federal and state law govern when the use of interpretive services must be offered to the patient.

Both the discussion and consent should be separately documented in the patient’s medical record. This is where ACHC Surveyors will look for evidence that the discussion took place, that a non-English-speaking patient agreed to the format in which this was conducted. The Surveyors also look for documentation that the patient subsequently consented to treatment having been given sufficient information to make an intelligent choice among alternative available options.

Hospitals should review their process with legal counsel, the compliance officer, health information/medical records leadership, and risk management leadership.