The famed Mayo Clinic has implemented informed-consent procedures after Minnesota officials cited the clinic for failing to obtain federally mandated written permission from patients undergoing major surgical procedures, including organ transplants.
According to the 13-page complaint issued by the Minnesota Department of Health, a review of 12 cases at a Mayo facility in Rochester, Minn., showed that none of the patients who underwent major procedures gave written consent.
Under long-standing policy, Mayo physicians told regulators they obtained oral consent from patients and noted that in patient records.
Mayo spokesman Brian Anderson said the clinic now is complying with federal requirements.
George Annas, a professor of medical ethics at Boston University, said written permission and discussions with the surgeon are important to ensure that the patient has given informed consent to a major procedure.
"The key is that the patient knows what is going to happen and what the risks are," said Annas, noting the wording of the consent form needs to be understandable.
The state inspection found Mayo Clinic records "revealed that the physician documentation of the content of the informed consent varied widely."
Under federal Department of Health and Human Services regulations, written consent must be obtained prior to major procedures, and a copy must be in the patient's medical file. The requirement has been in place for more than two decades.
Federal officials said they were not aware of any other recent cases in which a major medical facility was out of compliance with the written-consent requirements.
The Mayo Clinic citation was the result of an on-site inspection May 22. The inspection followed a complaint filed by Minnesota attorney David B. Ketroser, who represents a Mayo patient. A federal lawsuit filed by that patient is pending.
In the report, state inspectors said Mayo officials told them they "didn't agree with the federal definition of written consent."
"There is no …