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Based on interview and documentation review the Hospital failed to ensure that: 1. methods such as observation were used to ensure that staff were in compliance with policy related to time-out and site marking, and 2. methods such as observation was included in the corrective action plan to ensure staff were in compliance with policy related to time-out and site markings.

Findings included:

1. Review of the Policy/Procedure titled Universal Protocol indicated that staff were required to perform a time-out for invasive/surgical procedures.

Review of Quality Data, dated 4/10 to 9/10, indicated that compliance with time-out documentation was included in data collected by the Department of Surgery. The compliance rate improved from 94% in 4/10 to 100% in 9/10.

The Director of Outpatient Services was interviewed on 12/15/10 intermittently throughput the survey. The Director was asked if time-out monitoring included a method such as observation to ensure compliance with the actual steps involved with time-out. The Director said observations were not part of Quality data collection.

2. It was reported that the Patient (Patient #1) was diagnosed with a displaced fracture of the small right finger and was scheduled for a closed reduction and pinning. The surgery was performed on 11/30/10. Prior to the procedure Patient #1 ' s right small index finger was marked with a purple marker on the outer aspect of the right small finger. Once in the surgical suite a nerve block was performed, Patient #1 was anesthetized, and was under monitored anesthesia care. A time-out was performed prior to the start of the procedure and all participants in the procedure actively participated. Patient #1 ' s hand was positioned palm side up. The Surgeon performed a closed reduction and the C-Arm image intensifier (radiologic device used in surgery to provide real time imaging during procedures) was used to confirm the position of the finger. The drill, used to insert the pins, malfunctioned. The Surgeon and Surgical Technician ' s attention was diverted from Patient #1 in order to trouble shoot. During the diversion Patient #1 ' s hand pronated (palm side down). Once the drill was repaired the Surgeon resumed the procedure, did not realize the change in position, and inadvertently inserted the pins into the right index finger. As the dressing was being applied and drapes were being removed the Surgeon realized the error. The surgical area was re-prepped, Patient #1 was redraped, the pins were removed, and new pins were inserted into the right small finger.

The Hospital conducted and immediate investigation and developed a corrective action plan.

Review of the corrective action indicated that education regarding time-out as well as site marking was included however; the plan did not include a method (such as observation) of determining compliance with time-outs or site marking re-education.