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ALLEGHENY GENERAL HOSPITAL 320 EAST NORTH AVENUE PITTSBURGH, PA 15212 Nov. 21, 2017
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on a review of facility documents and medical records (MR) aand staff interview (EMP), it was determined that the facility failed to properly execute an informed consent for one of two medical records reviewed (MR1).

Findings included:

Review of "Allegheny General Hospital Medical Staff Rules and Regulations" on November 20, 2017, at 10:00 AM revealed, "Approved by the AGH Medical Executive Committee - 9/19/2016" revealed, "... The policies and procedures contained in the AGH Operating Room Policy Manual shall be enforced by the Perioperative Executive Committee through its designee(s) and the Operating Room Policy Manual shall be enforced by the Perioperative executive Committee through its designee(s) and the Operating Room Director or his/her designee. ... 1. Documents and Consents A medical history, physical exam, preoperative diagnoses and appropriate laboratory data must be in medical record prior to any elective surgical procedure. ... All surgical operations and procedures shall be performed only with the informed consent of the patient or his legal representative, except in emergencies. Consents must be completed in accordance with Administrative and Nursing Policies on informed consents. ..."

1. Review of MR1 on November 20, 2017, at approximately 11:00 AM revealed a consent form dated October 4, 2017, which did not specify the type of the procedure the patient was scheduled. The form included a list of endoscopic procedures, but the specific procedure was not indicated.

2. During an interview on November 20, 2017, at approximately 11:25 AM, EMP3 indicated, "Usually the numbers are circled." EMP3 confirmed that the specific procedure should have been documented on the consent for MR1.