Mayo skipped written consent

| Saturday, Dec. 20, 2008

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 written surgical consent," one administrator told inspectors. "We don't use them here."

Inspectors reviewed a dozen cases at Mayo's Rochester Methodist Hospital, including those of patients who underwent liver, pancreas and kidney transplants. The kidney-transplant recipient was younger than 18, according to the report.

Other cases reviewed included a woman who underwent surgery for breast cancer and a hysterectomy patient. Another patient underwent three abdominal surgeries for which no written consent was obtained.

In a written response to the state complaint, Mayo officials said they would correct the problem in two phases by the end of the calendar year.

"The policy will be revised, communicated and implemented throughout Mayo Clinic Rochester, including both hospitals and the clinic," the response states.

"That did happen," said Anderson, the Mayo spokesman.

A few months before the complaint was filed, a group of Mayo physicians published articles in an internal publication, "Mayo Clinic Proceedings," detailing legal and ethical requirements for obtaining informed consent.

"Medical informed consent is ethically, morally and legally mandated by the fiduciary responsibilities flowing from the patient-physician relationship," the March 2008 article states.

Ketroser said he filed the complaint after reviewing records of his client, George R. Studnicka, who charged that he never consented to major throat surgery in 2001.

Studnicka, confined to a federal prison in South Carolina, was transferred to Mayo for treatment from a federal prison hospital in Minnesota.

Ketroser said he discovered the Mayo policy in reviewing Studnicka's case. He said he approached HHS officials and then Minnesota health officials.

"A signed consent form doesn't prove the patient has given an informed consent, but it at least proves the patient had consented to something," Ketroser said. "Without a signed consent form, there's no definitive proof the patient was involved in a consent for anything."

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