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ADVENTHEALTH DAYTONA BEACH 301 MEMORIAL MEDICAL PARKWAY DAYTONA BEACH, FL 32117 June 10, 2021
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on interview and medical record review, the facility failed to ensure that a properly executed informed consent was obtained and placed on the patient's chart before surgery for 1 (Patient #8) out of 6 sampled patient medical records reviewed for properly executed surgical consents. The failure to obtain a properly executed surgical consent placed the patient at risk for inadvertent; and/or, a wrong procedure performed.
The findings include:

An interview was conducted with Employee A, MD on 06/10/2021 at 10:41 AM, and confirmed that he drew a line through the original procedure and the consent was not appropriately documented for Patient #8 as required. The consent should not be documented with the initials AVR. He stated nursing should have completed the consent correctly. [Consent submitted]

An interview was conducted with Employee E, RN (Operating Room Circulator) on 06/10/2021 at 2:41 PM. She confirmed that surgical consents should be reviewed with the patient and doctor, should be completed with no initials, and if changes were made, the consent should be initialed and signed with a date and time of the change.

A review of the surgical consent form signed by Employee A, Surgeon, indicated that Employee A, Surgeon documented the initials AVR and ascending aneurysm hand written behind a crossed out procedure written as "Coronary Artery Bypass X 3-4." There was a line drawn through the initial handwritten procedure, and on the consent was an initial; however, no indication of when the consent was amended could be determined at review.

A review of the facility hospital-wide policy & procedure HPP 800.25 "Informed Consent" was conducted and copy obtained. Under specifics, section I. Definition. A properly executed informed consent form contains at least the following. At line H. date and time consent is obtained. It was documented at Section XIII. How to Complete the Hospital Consent Form, section B. "The name of the operation/procedure will be filled in with limbs and body parts being accurately and completely identified, i.e. right leg. Abbreviations should be avoided on the consent form.