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Based on review of documentation and interviews, the Facility failed to ensure that performance improvement activities tracked medical errors and adverse patient events, analyze their causes and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.

Findings included:

Background information:

The Facility reported that a wrong site surgery occurred on 12/16/10 in which the scheduled surgery, to release a contracture (tight band of tissue preventing the finger to extend to the straight position), was to be performed on the right ring finger. During the surgery, the Surgeon flipped the hand from prone [palm down] to supine [palm up] to complete the surgical release of the contracture. The supine area of the right ring finger/hand was not marked pre-surgically. There was no visual aide to indicate the wrong finger was incised. The Surgeon made an incision on the right middle finger in error.

The error was recognized immediately and the incision closed.

1) Review of the Policy titled: Operative Site Identification and Verification Process (Universal Protocol), section titled Purpose, indicated that the policy is to ensure verification of the correct patient, procedure, operative site, side and/or level, position..Point V. indicated that "in all cases with laterality, multiple structures (such as fingers or toes), or multiple levels (such as spine), the Attending surgeon or fellow must externally mark the patient's site to be operated on with a permanent marker. The mark should be the initials of the surgeon or fellow marking the site. The intended site must be marked such that the mark will be visible after the patient has been prepped and draped.

The policy regarding marking of the surgical site for body parts including the fingers and toes does not consider the possibility for procedures that may circle the digit and marking at least the correct finger to be operated on - both front and back. "Flipping" the digit from front to back in order to track a contracture or ligament was not considered for surgical site marking and/or conducting another intra-operative time out procedure to re-verify correct site.

2) The Nurse Manager for Surgical Services was interviewed in person on 1/10/11 at 9:40 am. The Nurse Manager for Surgical Services [NMSS] said the policy does not address situations in which the surgeon decides intraoperatively, to change the surgical incision site. The NMSS said that if it is known that an incision will be made on both sides of the hand, then both sides are marked pre-surgically. In this case, the decision to make more than the one incision was made in the course of the surgical procedure. The NMSS said the policy is written in a general sense for marking the hand sites pre-surgically. As a result, the opportunity for this error to occur again is generalizable.

3) The Scrub Technician was interviewed in person on 1/10/11 at 10:03 am. The Scrub Technician [ST] said that two time outs for site verification occurred: 1) before the injection and 2) before the incision. The ST said s/he knew the flip of the hand occurred, but s/he did not actually visualize the hand and note the wrong finger [middle finger] being cut. The ST said that no one picked it up - the Surgical Assistant, Circulating Nurse or s/he because the operative site is small [the hand] and is further obscured by drapes and the surgeon's hands holding the Patient's hand in position for the operative procedure. The ST said it is not usual clinical protocol to stop an operative procedure and re-mark the site with another time out if the plan/operative site changes intraoperatively.

4) The Circulating Nurse was interviewed in person on 1/10/11 at 10:30 am. The Circulating Nurse said she was present pre-operatively when the right ring finger/hand was marked. The Circulating Nurse said there were two time outs: 1) Prior to injection of the local anesthetic and 2) Before the surgical incision. The Circulating Nurse said she was not aware of the hand being flipped and first knew of the error when two dressings were applied [on the middle and ring fingers] at the end of the operative procedure. The Circulating Nurse said she made a comment to the Surgeon and was told it would be discussed later because the Patient was alert [general anesthesia was not used for the procedure]. The Circulating Nurse said the policy is general and needs to be changed to ensure both sides of digit [fingers or toes] are marked pre-operatively, even if the plan is to make only one incision on one side, and take another time out.

5) The Surgical Assistant was interviewed on 1/10/11 at 11 am by telephone. The Surgical Assistant [SA] said the procedure started on the ulnar side [little finger side] and s/he was positioned at the Patient's armpit, holding the hand in position. The Attending Surgeon was closest to the Patient's hand. The SA said the Attending Surgeon flipped the Patient's hand and the presenting finger was the right middle finger. The SA said the Surgeon did not mark the site because the surgical marking pen can bleed on to the other finger when pressed together. The SA said he would have spoken up if s/he had note the wrong finger was incised.

6) The Chairman of Surgery was interviewed by telephone on 1/11/11 at 1:30 pm by telephone. The Chairman of Surgery said s/he agrees the policy needs to be changed to include such instances of having to flip a hand and make additional incisions.

7) The Attending Surgeon was interviewed by telephone on 1/12/11 at 1:25 pm by telephone. The Attending Surgeon said s/he did not mark the finger after the flip/second incision because the marking pen tends to bleed onto the other finger next to it.

8) A root cause analysis of the wrong site surgical error was done. The team identified the policy needed to be changed to include such instances for marking each side of the hand for all hand/finger surgeries.

However, at the time of the survey, the policy had not been changed and therefore, there was opportunity for such an error to occur again.

Based on review of the Hospital Policy titled: Operative Site Identification and Verification Process (Universal Protocol) on 1/10/11, interviews and review of documentation, the Hospital failed to ensure that actions were immediately taken aimed at performance improvement to change the policy and prevent such an error from occurring again.

Findings included:

1) A root cause analysis of the wrong site surgical error was done. The team identified the policy needed to be changed to include such instances for marking each side of the hand for all hand/finger surgeries.

Despite all members of the team achieving consensus that the Policy needed to be changed to include marking of both sides of extremities that can be flipped [the hand and foot, both with digits, (fingers and toes), at the time of the survey, the policy had not been changed and therefore, there was opportunity for such an error to occur again.

See also Tag A0288

Based on review of the Hospital Policy titled: Operative Site Identification and Verification Process (Universal Protocol) on 1/10/11, interviews and review of documentation, the Hospital failed to ensure that policies governing surgical care were immediately taken to change the policy and prevent such an error from occurring again to assure the achievement and maintenance of high standards of medical practice and patient care.

Findings included:

1) The Surgical Assistant was interviewed on 1/10/11 at 11 am by telephone. The Surgical Assistant [SA] said the procedure started on the ulnar side [little finger side] and s/he was positioned at the Patient's armpit, holding the hand in position. The Attending Surgeon was closest to the Patient's hand. The SA said the Attending Surgeon flipped the Patient's hand and the presenting finger was the right middle finger. The SA said the Patient had moved at that time and they moved the tourniquet down the arm, which was presumed to be uncomfortable. The SA said it was realized the wrong finger was incised. The SA said the wrong incision was closed and the correct finger was incised and the procedure was finished. The SA was asked why the incorrect finger was not picked up at the time of the flip. The SA said the middle fingers are not as clearly identified as the thumb or little finger because they are "border fingers" and easier to identify. The SA said the ulnar side is harder to operate on. The SA said that an additional issue was the Patient moving at the time of the flip and added a distraction. The middle finger just presented to view easily. The SA said the Surgeon did not mark the site because the surgical marking pen can bleed on to the other finger when pressed together. The SA said he would have spoken up if s/he had note the wrong finger was incised.

This Surveyor viewed the photos the Attending Surgeon took pre-operatively which clearly demonstrated an arrow pointing to the right ring finger along with his/her initials. There was a mark on the top/palm down side of the right hand only. The mark was very clear and no blur of the marking pen was visualized. This Surveyor also made a mark on her own fingers and did observe the sterile marker used intraoperatively does blur on the next/adjacent finger when pressed together.

2) The Chairman of Surgery was interviewed by telephone on 1/11/11 at 1:30 pm by telephone. The Chairman of Surgery [CS] said this case was unusual in that it was the same surgeon, same procedure and two incisions. The CS said a second pause is done if the operative procedure is known to involve two separate surgical procedures or if the surgeon changes intraoperatively. The CS said s/he agrees the policy needs to be changed to include such instances of having to flip a hand and make additional incisions.

3) The Attending Surgeon was interviewed by telephone on 1/12/11 at 1:25 pm by telephone. The Attending Surgeon [AS] said that operative procedures performed on the hand required that blood needed to be removed or squeezed out before the incision is made to reduce blood loss. A tourniquet is also applied to stop blood flow to the hand/fingers. The AS said s/he did not mark the finger after the flip/second incision because the marking pen tends to bleed onto the other finger next to it.

4) A root cause analysis of the wrong site surgical error was done. The team identified the policy needed to be changed to include such instances for marking each side of the hand for all hand/finger surgeries. However, at the time of the survey, the policy had not been changed and therefore, there was opportunity for such an error to occur again.