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UNIV. OF VERMONT - FLETCHER ALLEN HEALTH CARE 111 COLCHESTER AVE BURLINGTON, VT 05401 March 9, 2011
VIOLATION: CONTENT OF RECORD - INFORMED CONSENT Tag No: A0466
Based on staff interview and record review, the hospital failed to assure that a properly executed informed consent was obtained prior to a procedure requiring conscious sedation for 1 applicable patient in the targeted sample. (Patient # 54 ) Findings include:

Per review of the medical record for Patient #54 on 3/3/11, a consent for treatment for an invasive medical procedure performed under moderate sedation was not properly executed. The consent was not signed by the patient; the document stated "verbal consent" on the patient signature line. A procedure note dated 8/6/10 at 1235 hours stated that informed written consent for the procedure was obtained. During interview on 3/9/11 at 11:30 AM, the physician who performed the procedure confirmed that the report was in error and that he did document 'verbal consent' on the form. Per review on 3/9/11 at 11 AM, the hospital's policy on Informed Consent stated "If the patient or surrogate decision- maker is unable to provide a signature, the responsible provider should record an attestation confirming that the patient or their surrogate has consented to the treatment/procedure after being informed of the risks, benefits, and alternatives. The documentation should be sufficiently extensive to explain why a signature was not obtained." There was no attestation note in the medical record on why written consent was not obtained. During interview at 11:40 AM, the Clinical Director of Radiology confirmed that an explanatory note should have documented why written consent was not obtained.