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Based on review of patient medical records, hospital approved procedures and staff interviews, the hospital failed to ensure that operating room staff implemented effective "time-out" procedures to ensure accurate identification of the intended surgical site by all members of the operative team for 1 of 4 patients reviewed undergoing surgical procedures (Patient #2).

Failure to ensure that all members of the surgical team (surgeon and assistant surgeon, anesthesia, circulating nurse, and surgical technician) consistently implemented a uniform process for identifying and ensuring accurate identification of the intended surgical site risked patient health and safety.

Findings:

The hospital's approved policy and procedure, "Universal Protocol: Operative/Procedural and Site/Side Verification", (No. 695.00.00 dated 3/10) was reviewed. Under Site Marking: Procedure on page 2, item 4 directed, "The mark must be visible after the patient is prepped and draped." Under Time Out on page 3, item 3 directed, "The time out which involves active communication will include the following elements:..correct site..." Item 5 directed, "The surgery/procedure will not start until the time out process in completed."

Patient #2- Per record review, underwent a same day surgical procedure for elective foot surgery on 4/30/2010. The Informed Consent signed by the patient and the physician on 4/22/2010 gave permission for LEFT plantar foot repair for a possible tendon tear. However, on the day of surgery, the surgeon, anesthesiologist, 2 circulating RNs and the surgical technician identified the RIGHT foot as the operative site, and completed the incision, procedure and closure on the wrong foot. The error was identified in the recovery room and the patient was returned to the Operating Room for the same procedure on the correct (left) foot.

Review of the record showed a pre-anesthetic assessment for a LEFT foot tendon repair dated 4/30/2010. Review of the History and Physical dated 4/22/10 correctly identified the site as LEFT. Pre-operative orders identified the site as LEFT. The operative anesthesia report documented, "repair R (Note: Incorrect) ...tear", although notes on the same form correctly documented "L(eft)."

Review of the Nursing OR (Operating Room) record documented that the patient arrived in the OR at 1303 (1:03 p.m.), that a "Time Out" was called at 1320, and that the operative site was marked and verified. The OR record verified that the History and Physical (with correct information) was on the chart during the procedure, as was the Pre-Op Diagnosis: Painful LEFT flexor Tendonitis.

Staff interview on 5/25/2010 revealed that the correct site had been marked for Patient #2 with an indelible (permanent) marking pen by the surgeon prior to the procedure.

Interviews with Operating Room staff on 5/26/2010 regarding operating room activities in general revealed that Time Out procedures varied based on the surgeon and the circulating RN in the case.

Although, for Patient #2, the site had been specifically marked and was documented as verified in the Operating Room, the entire surgical team (surgeon, anesthesiologist, RNs and technician) failed to individually and collectively as a team participate in an effective Time Out procedure to visualize the marking and verify the correct site, thereby jeopardizing the health and safety of the patient. No one stopped the process or questioned that they had not actually seen the marking prior to draping, prepping and cutting patient tissue. No one identified discrepancies in the informed consent, History and Physical, or pre-anesthetic assessment.

Failure to uniformly implement hospital approved policy and procedure through physician and staff training, and verified by supervisors through on-going internal monitoring and audits, risked the health and safety of surgical patients.