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Complaint NJ00164628

Based on staff interviews, review of one of two medical records (Patient #6 [P6]) for trauma patients having a surgical procedure and facility document review, it was determined that the facility failed to ensure the implementation of policies and procedures governing surgical care in accordance with acceptable standards of practice.

Findings include:

1. The facility failed to implement policies and procedures by ensuring that all sponges intentionally retained in a patient as packing during a surgical procedure are accounted for and documented on the patients intraoperative record. (Cross refer to Tag A 0951).

2. The facility failed to implement policies and procedures by ensuring that an x-ray is performed prior to closure of a wound for those cases that instruments and sponges cannot be counted such as emergency and trauma cases. (Cross refer to Tag A 0951).

Complaint NJ00164628

Based on staff interviews, review of one of two medical records (Patient #6 [P6]) for trauma patients having a surgical procedure and facility document review, it was determined that the facility failed to: 1) implement policies and procedures by ensuring that all sponges intentionally retained in a patient as packing during a surgical procedure are accounted for and documented on the patients intraoperative record; and 2) that an x-ray is performed prior to closure of a wound for those cases that instruments and sponges cannot be counted such as emergency and trauma cases.

Findings include:

On 6/6/23, a review of P6's medical record was conducted with S4. P6 arrived at the ED (Emergency Department) on 5/4/23 at 9:43 AM as a trauma for a possible crush injury. P6 was emergently taken to the Operating Room (OR) for an exploratory laparotomy (surgical procedure where the abdomen is opened and the abdominal organs are examined for injury or disease), splenectomy (surgery to remove a diseased or damaged spleen), abdominal packing, and abdominal wound vac placement (vacuum-assisted closure to aid in the closure of abdominal wounds).

A review of the intraoperative portion of P6's first OR procedure, dated 5/4/23 ,was conducted with S5 (Operating Room Patient Care Technician/Scrub Tech) and S8 (Operating Room Nurse) at 10:43 AM and revealed the following:

Review of the "Counts by Panel" section indicated that there was no documentation of an initial, closing, or final count performed for all sponges, needles, sharps and instruments used for the procedure. The initial count section stated, "EMERGENCY CASE-TRAUMA". S5 confirmed that the counts are completed by the circulating Registered Nurse (RN) and the scrub person and that the counts were deferred for this case due to the emergent nature of the procedure.

The closing and final count sections stated, "LAPS LEFT AT ABDOMEN AS PER MD. ALL TEAMS MADE AWARE".

The procedure ended at 11:40 AM and P6 left the OR at 11:58 AM. Upon interview, S5 and S8 explained that the intraoperative report's closing and final count sections should indicate the number of lap (laparotomy) sponges that were used in the packing of the abdomen.

P6's second OR procedure, an exploratory laparotomy, took place on 5/6/23. The patient arrived in the OR at 9:22 PM. The "Counts by Panel" section indicated that the initial, closing, and final counts were correct and stated, "2 LAPS THAT WERE INTENTIONALLY RETAINED FROM PREVIOUS CASE WAS [sic] REMOVED."

The Operative Report stated, "PROCEDURE PERFORMED: Removal of liver packs and abdominal closure. ... INDICATIONS FOR PROCEDURE: The patient previously had an open abdomen with a major liver laceration, which was packed at the initial procedure. [P6] did clinically stabilized [sic] and is being taken back for abdominal reexploration with removal of liver packs. DESCRIPTION OF PROCEDURE: ... [MD] began by removing the laparotomy pads from the left lobe of the liver wound. ... [MD] then closed the midline rectus fascia ... and closed the skin using surgical staples. ..."

P6 left the OR at 11:04 PM.

P6's third OR procedure, reopening of recent laparotomy and removal of foreign body, took place on 5/7/23. The patient arrived in the OR at 11:50 AM. The "Counts by Panel" section stated initial, closing and final counts were correct and stated, "2 retained laps from previous surgery were removed and portable xray was done on the abdomen to confirm all retained sponges were removed."

The Operative Report stated, "PROCEDURE PERFORMED: Reopening of recent laparotomy and removal of foreign body. ... INDICATIONS FOR PROCEDURE: The patient is a trauma patient status post laparotomy with open abdomen and secondary closure. Following [his/her] abdominal closure, [P6] was noted to have retained foreign bodies on x-ray. [P6] is being taken back for removal of foreign bodies. DESCRIPTION OF PROCEDURE: ... [MD] found two retained laparotomy sponges in the left upper quadrant. These were both removed. We did obtain portable x-rays of the entire abdomen ... [MD] did not see any evidence of retained foreign body on these films. ..."

P6 left the OR at 1:13 PM.

On 6/6/23 at 11:07 AM, an interview was conducted with S22, Trauma Medical Director. S22 explained that following a routine post operative chest x-ray on 5/7/23, retained lap sponges were identified. S22 then indicated that per policy, an x-ray should have been obtained prior to closure of the abdomen on 5/6/23.

On 6/7/23, an interview was conducted with S6, OR Director of Nursing. S6 explained that due to the emergent nature of the case, sponges, sharps, and instrument counts were not done. The intraoperative report dated 5/4/23 indicated that laps (sponges) were left at the abdomen. Review of the facility policy titled, "Sponge, Sharps and Instrument Count Policy," effective date 5/4/23 stated, " ... Policy Statement: Sponges should be counted on all procedures. Sponge counts should be taken: Before the procedure to establish a baseline. Before closure of a cavity or within a cavity. Before closure begins. At skin closure or the end of a procedure. ... Sponge, ... counts should be documented on the patient's intraoperative record. Documentation should include: ... e. ... sponges intentionally retained as packing. ..."

After review of the policy, S6 was questioned regarding whether the staff should have indicated the number of lap sponges left in the abdomen as per the policy. S6 stated "Yes, the staff should have documented the number of lap sponges left in the abdomen and that it is part of the re-education process that has been provided to the staff in the OR."

The policy also stated, "... Policy Statement: ... VI. Handling Cases without counts: b. For those cases that instruments cannot be counted such as emergency, trauma, ... an x-ray must be performed prior to closure of the wound ..." S1 (Vice President of Quality, Regulatory and Safety) and S6 indicated that this policy statement pertains to lap sponges as well.

There was no documentation that an x-ray was done during P6's second OR procedure on 5/6/23 prior to the closing of the wound. On 6/7/23, S1, S2 (Director of Quality) and S23 (Chief Nursing Officer) agreed that an x-ray should have been performed prior to closing of the wound on 5/6/23.

The above findings are not in accordance with the facility's policy and procedure.