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The information reviewed during the unannounced complaint investigation survey on November 22, 2024, provided evidence that the facility failed to substantially comply with this Condition of Participation by failing to provide well organized surgical services in accordance with acceptable standards of practice. During a surgical procedure five surgical sponges were retained inside the patient. The patient returned to the emergency room, at which time, they took them back to the operating room and found the sponges. The patient died and the cause of death was determined to be sepsis from the retained foreign objects.
A discussion took place with the survey team and the facility's administrative staff regarding the survey team's concerns related to Surgical Services on November 22, 2024, at 11:00 AM.
The Immediate Jeopardy was called at 11:30 AM on November 22, 2024.
The facility submitted an acceptable Immediate Jeopardy Removal Plan at 3:23 PM on November 22, 2024
The Immediate Jeopardy was removed on-site on November 22, 2024, Condition of Participation non-compliance remains.
The surveyor validated the Immediate Jeopardy Removal Plan was substantially implemented by education documentation, policy and procedure review, interviews and reviewing audit template.
Cross reference
§482.51 (b) Operating Room Policies

Based on a review of facility documents, medical records (MR), and staff interviews (EMP), it was determined that the facility failed to ensure high standards of medical practice in surgical services by failing to follow policy to prevent retained surgical sponges after surgery for one of one medical record reviewed (MR1).

Findings include:

On November 22, 2024, review of facility Policy Title: Surgical/Procedural Count with a last revision date of May 2024, revealed " PURPOSE: To provide guidance to perioperative/procedural personnel for preventing retained surgical items (RSIs) during operative or other invasive procedures. ... POLICY: I. When to count: A. All counts are performed between the registered nurse (RN) circulator and the scrub person B. Initial Counts i. Should be performed prior to incision to establish a baseline by the RN circulator and the scrub person. ii. Baseline instrument counts will be performed for all planned or potential intrathoracic or intra-abdominal operations ... C. When new items are added to the surgical field in the number in which the item is packaged i. Example - 4x4s are counted by 10s, Lap sponges are counted by 5s D. Before the closure of a cavity within a cavity - sponges and sharps are to be counted. ... PROCEDURE: I. Who counts - RN circulator and the scrub person II. How to count - A. Item counts should be performed in the same sequence each time. i. Counting sequence begins at the surgical site, proceeding to the mayo stand, back table and finally items discarded from the surgical field. B. Items should be counted audibly and concurrently viewed during the counting process by the RN circulator and scrub person III. Linen and trash should be not removed from the operating room until the completion of the procedure and patients leaves the operating/procedural room. IV. Sponges A. Prep sponges ... ii. The RN circulator is responsible to confirm that all prep sponges are secured following the patient prep and are not removed from the operating/procedural room until case competition B. Remove band around sponges, separate and count sponges at initial count and as they are added to the surgical field ... F. Sponges that are placed in the operative site during the procedure should be denoted on the paper count sheet and announced when they are removed from the operative site. i. Sponges that were " in " during a count should be confirmed as removed from the operative site on subsequent counts. ... VIII. General Information A. Integrity of the surgical counts are documented in the patient ' s intraoperative record. B. Documentation of counts are to include: i. Type of counts performed - sponges, sharps, instruments, small items, etc. ii. The number of counts performed. iii. Names and titles of the RN circulator and the scrub person performing the counts. a. Two individuals who are simultaneously on orientation should not count together. ...

On November 22, 2024, review of MR1 revealed a patient with an admitting diagnosis of Malignant neoplasm of head of pancreas (cancerous tumor) had a Whipple Procedure (operation to treat tumors in the pancreas) completed on September 19, 2024. The review of the surgical sponge count from the Whipple procedure showed the count was correct at the end of the procedure. The patient was readmitted to the facility on October 15, 2024, due to abdominal pain. A CT scan revealed 5 foreign bodies within the abdomen consistent with lap pads (sponges). Patient was taken to the operating room for removal of the foreign bodies. While in the operating room patient suffered cardiac arrest and CPR was performed. Return of spontaneous circulation was achieved and temporary abdominal closure was placed. Before leaving the operating room patient suffered additional cardiac arrest and spontaneous circulation was not able to be achieved. Death was pronounced and the coroner was contacted. Further review of MR1 revealed the death certificate listed cause of death to be sepsis, Gossypiboma (retained foreign object from surgical procedure), Complication of Whipple Procedure.

On November 22, 2024, at approximately 2:35 P.M. an interview with EMP1 confirmed sponges were retained in the patient during the Whipple procedure.