The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
|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.