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SURGICAL SERVICES

Tag No.: A0940

The Hospital was out of compliance with the Condition of Surgical Services.

Findings included:

The Hospital failed to assure that policies regarding surgical counts were effective and ensured all surgical items were accounted for and not retained in patients after surgery.


Refer to TAG: A-0951.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on record review and interview the Hospital failed to ensure that policies regarding surgical counts were effective and that all surgical items were accounted for and not retained in patients after surgery.

Findings include:

1. Patient #1 was scheduled to have an open splenectomy on 2/17/19. Patient #1's splenectomy was completed and the surgical counts were performed two times and were reported as correct. After the surgery Patient #1 was transferred to the Post Anesthesia Care Unit (PACU) where he/she became hypotensive (low blood pressure)requiring vasopressors (medications used to treat hypotension). A bedside ultrasound (imaging which uses sound waves to produce pictures of inside the body) was performed showing signs of bleeding. Patient #1 was brought back to the Operating Room (OR) where a retained malleable retractor (from the previous surgery) was discovered inside the patient.

2. Patient #2 underwent a bilateral lung transplant on 3/12/19. From 3/12/19 to 3/21/19, Patient #2 returned to the OR multiple times to have the vacuum dressing (a negative pressure dressing for wounds) changed along with multiple surgical sponges being removed and replaced. Patient #2's Operative Note, dated 3/21/19, indicated that all surgical sponges were removed and the chest was closed. On 3/22/19, Patient #2 received an x-ray revealing a retained surgical sponge. On 3/26/19, Patient #2 returned to the OR for removal of the retained sponge.

The Surveyor interviewed the Risk Manager on 5/2/19 at 8:30 A.M. The Risk Manager said that Patient #1's case was reviewed by a multidisciplinary group on 2/18/19. The Risk Manager said that, in Patient #1's case, the Surgical Scrub counted a retractor that was still in use during the surgery and the Circulating Nurse acknowledged the count. The Risk Manager said that, at some point after the count was completed, the retractor was retained in Patient #1's abdomen. The Risk Manager said that the count process was reviewed and it was determined that the Count Policy needed to be changed. The Risk Manager said Patient #2 required multiple wound packing procedures in the OR where multiple sponges were being removed and replaced over several days. The Risk Manager said that, on 3/21/19, the Operative Note indicated that all sponges were removed before the wound was closed. The Risk Manager said that the Count Policy did not address this type of scenario (where a patient received multiple surgical dressing changes) and that corrective measures were being reviewed.

Review of the document titled "Collaborative Case Review", dated 4/24/19, indicated that the Hospital determined the surgical instrument count policy was ambiguous and the review group discussed recommendations for changing the current policy.

The Surveyor interviewed the Nurse Manager of the OR on 5/2/19 at 10:00 A.M. The Nurse Manager said that the Count Policy was vague and was not clear about counting instruments that were in use and could be visualized by staff. The Nurse Manager said that a new policy was developed that corrected this with an added second step/count that would prevent this event from re-occurring. The Nurse Manager said that the new policy was yet to be approved and it needed to be reviewed by two or three more committees. The Nurse manager acknowledged that the Count Policy had not been updated with changes as of 5/2/19. The Nurse Manager said that the Count Policy changes were discussed in the April 2019 staff meeting so that all staff would be aware of the policy change. The Nurse Manager said that staff meetings are available to be reviewed by staff who were unable to attend. The Nurse Manager said there was no process in place to ensure all OR staff were aware of the changes prior to the policy being approved. The Nurse Manager acknowledged that it was possible that some OR staff were unaware of the practice/policy changes.

The Hospital provided the Surveyors with an updated draft policy titled "Surgical Counts and Prevention of Retained Surgical Items (RSI)" on 5/9/19. The draft policy addresses a new process for counting instruments including "a count verified upon final closure" and a new process for counting sponges that includes "an X-ray being taken upon permanent closure to assure all packing has been removed". The Risk Manager acknowledged that the draft policy had not yet been approved.