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Amended CoP regulations concern informed consent
Required elements highlighted
Except as specified for emergency situations, all inpatient and outpatient medical records must contain a properly executed informed consent form prior to a patient receiving any type of treatment that requires informed consent.
The Centers for Medicare & Medicaid Services (CMS) recently amended the Conditions of Participation (CoP) regulations for hospitals to clarify the requirements for informed consent processes and forms, notes Stephen Frew, JD, a risk management specialist and web site publisher (www.medlaw.com).
An informed consent form, in order to be properly executed, must be consistent with hospital policies as well as applicable state and federal law or regulation, Frew points out.
A properly executed informed consent form, he says, contains the following minimum elements:
Material risks, Frew explains, could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but a high degree of severity. Hospitals are free to delegate to the responsible practitioner the determination of which material risks, benefits, and alternatives will be discussed with the patient, he adds.
If there is applicable state law governing the content of the informed consent form, the hospital's form must comply with those requirements, Frew notes.
A well-designed informed consent form, he adds, might include the following additional information:
The full text of the regulation is available on Frew's web site.