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Based on record review, staff interview, and review of hospital policies, it was determined that that the hospital failed to ensure compliance with the hospital polices entitled, "Universal Protocol For Operative Procedures/Interventions To Prevent Wrong Patient, Wrong Site and Wrong Side Event" and "Time Out Protocol (Universal Protocol) Bedside Procedure", for relevant sample patient ID #6.

Findings are as follows:

A review of the hospital procedure entitled, Universal Protocol For Operative Procedures/Interventions To Prevent Wrong Patient, Wrong Site and Wrong Side Event, under Safety Factors, Anesthetic Blocks, states:

"Anesthetic blocks may be performed in the PACU or in the Operating Room. When performed in the PACU, the Time Out for the block is completed per the Universal Protocol for Bedside Procedures and documented on the Bedside Time Out documentation form.... Anesthetic blocks do not require site marking by the anesthesiologist. The anesthesiologist must remain in continuous attendance from initiation of the Time Out to completion of the block. The RN must remain with the anesthesiologist and patient from the initiation of the Time Out through the beginning of block administration".

A review of the hospital policy entitled "Time Out Protocol (Universal Protocol) Bedside Procedure", under item b), Time Out Process, states:

"After the patient is prepped and draped, just prior to beginning the procedure, the procedure team engages in a "Time Out". Active participation is required by all members of the procedure team. The team will pause to make a final check of the correct patient, correct procedure, and correct site and side".

In addition, under item d), it states: "The verifier signs the Bedside Procedure Form to document the completion of the briefing and Time Out". The hospital policy defines the "verifier" as, "The nurse, technologist, or assistant working with the patient who is responsible for verifying with the proceduralist the correct patient, procedure, and marking of the site/side of the intended procedure".

A review of the clinical record for patient ID #6 revealed a 14-year-old male who presented to the hospital for elective "right knee arthroscopic ACL (anterior cruciate ligament) reconstruction with cadaveric allograft" ambulatory surgery on 3/9/11. The patient arrived to the holding area at 0815 accompanied by his parents. The surgical site was initialed by the surgeon after appropriate patient identification per hospital protocol. The patient was seen by the Anesthesiologist. At 0850, a "Preoperative Verification Handoff" was completed by the Preoperative Nurse and the Intra-operative Nurse per hospital policy, confirming patient identification, history and physical in chart, consent completion, surgical procedure, allergies, NPO (nothing by mouth) status, and laterality surgical site marking.

At 0845, a bedside "Time Out for Invasive Procedures Form" signed by the Anesthesiologist revealed confirmation of patient ID (identification) by name and date of birth, procedure, consent completion, and site/side/marked/identified, for a "R (right) popliteal and femoral pnb (popliteal nerve block)". At 0920, this form was modified to reveal a "Left popliteal pnb procedure". At 0921 an additional "Time Out for Invasive Procedures Form" was signed by the Anesthesiologist for a "Right popliteal and femoral pnb", with notation that "wrong leg blocked inadvertently, patient leg marked on anterior surface, when pt turned prone marking not noted".

During an interview on 3/11/11 at 8:30 AM with the Risk Manager, she reported that after the Anesthesiologist had obtained patient consent, the "Time Out" for the popliteal nerve block had been done in the PACU (Post Anesthesia Care Unit) holding area by the Anesthesiologist and Circulating Nurse while the patient was in the supine position, and the site marking was clearly visible.

The patient's sister had been in the holding area with the parents prior to the patient's surgery, and had been coloring in a coloring book on the bedside table, which had been moved just outside the patient's room. The Anesthesiologist had placed his supplies, equipment, and documentation tool on the patient stretcher. The Circulating Nurse had left the room after the bedside Time Out had been completed to obtain another bedside table for the procedure. When the Nurse returned to the room, she found that the Anesthesiologist had turned the patient over to the prone position from the supine position while she was out of the room. The incorrect left popliteal area was then blocked. This error was immediately identified, and the parents were made aware.

During an interview on 3/11/11 at 11:00 AM with the Anesthesiologist, it was reported that he had entered the preoperative area at approximately 8:30 AM. This was his first case for the morning. At that time he met with the patient and parents. He has been performing blocks in the holding area outside the Operating Room. At approximately 8:40 AM he found the Circulating Nurse to assist him. At that time the consent was checked, and the parents were asked to leave the area. He indicated that "The Circulating Nurse and I went through the Time Out protocol and the patient was in the supine position". The nurse left the room, and "I had the patient turn over. I then started the procedure". He was on the patient's correct "right" side, the same side of the bed that he was on when the bedside Time Out had been done in the supine position. "The nurse returned with a bedside table to assist me, and questioned if I had the correct leg for the block. At that time I went to find the surgeon to explain that the patient was administered the block in the wrong leg. We then went to the parents to explain what had happened and offered several options. The parents and patient were agreeable to proceeding with the surgical procedure."

During an interview on 3/28/11 at 9:45 AM with the Circulating Nurse, it was reported that the nurse was the second circulator on the case. The Nurse had proceeded to meet the patient in the Holding Area prior to the procedure, and had performed the required patient verification handoff with the preoperative nurse. The Anesthesiologist had requested assistance with the block, and had produced the bedside form for the Time Out. This form was completed by the Anesthesiologist, with verification of correct patient, correct site, and correct side while the patient was in the supine position. The nurse "assumed that the block would be femoral". Because the supplies for the block procedure were "strewn all over the bed", the nurse proceeded to find the Anesthesiologist another bedside table for the supplies. Upon return, the nurse noted that the patient was in the prone position and the Anesthesiologist was performing an ultrasound of the popliteal space and advancing the electrical stimulator block needle. The solution was administered. The nurse did not remain with the Anesthesiologist through the beginning of the block administration per the hospital policy.

The Nurse then noted, "We just blocked the wrong leg". She indicated that although assisting with blocks is not an unfamiliar procedure, this was the first time she had assisted with a block with the patient in the prone position in the preoperative area. It was realized that "the correct side is now the opposite side of the bed from when the patient was supine".

It was determined that patient verification had taken place with the handoff, as well as the verification of the site marking. A Time Out had been conducted at the bedside, however this was done while the patient was in the supine position, and not just prior to the start of the procedure when the patient was in the prone position per hospital policy. This resulted in the Anesthesiologist preforming a popliteal region block on the wrong extremity.

In addition, the Circulating Nurse as the "verifier" had not signed the bedside Time Out form with the Anesthesiologist when the Time Out had been performed, per the hospital policy.

Based on record review and staff interview, it was determined that the hospital failed to ensure that Operative Reports include the times of surgery for 13 of 13 relevant sample patients (ID # ' s 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18).

Findings are as follows:

A review of the Operative Reports for patient ID # ' s 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 revealed no evidence that the times of surgery were included in these reports.

During an interview on 3/29/11 at approximately 11:30 AM with the Risk Manager, she provided the "Medical Staff Rules and Regulations" regarding what a detailed Operative Report "shall contain", which did not include the times of surgery.