HospitalInspections.org

Based on record review and staff interview it has been determined that the hospital failed to assure that polices governing surgical care are designed to assure the achievement and maintenance of high standards of medical practice and patient care relative to implementation of appropriate count procedures for 1 of 3 sampled patients who underwent hernia repair using framed mesh, Patient ID # 1.

Findings are as follows:

Hospital Policy titled "Surgical and Procedural Counts-Retained Surgical Items" states in part:

" Policy
C. The circulating nurse is responsible for initiating the implementation of the appropriate count procedures and for documenting correctness or applicability in the intraprocedure record.

II. Soft Goods
2. All soft goods inserted into the wound and not intended to be left after closure are counted.

IV. Small Miscellaneous Items
A. All Miscellaneous items are accounted separately
C. Small miscellaneous items will be accounted for on all procedures.
E. These items are not instruments, and counts will be performed at the same time as needles and sharps. Small miscellaneous items will be documented."

Clinical record review for Patient ID #1 revealed that on 3/11/2019 the patient underwent a laparoscopic repair of two ventral hernias using framed mesh. The surgeon's operative note indicates that a 6x8 inch framed mesh was inserted into the abdominal cavity, the graft was tacked in place and the frame was decompressed and removed from the mesh. Additional tacks were placed to secure the mesh.

A Hospital Incident Report dated 3/14/2019, states in part, " A ...male underwent a laparoscopic repair of 2 ventral hernias with mesh implant on 3/11/2019. While the patient was in the recovery room, the surgeon identified the patient had a retained foreign body from the ventral mesh repair. The patient returned to the operating room for a laparoscopic retrieval of the frame for the mesh. "

During an interview with the surgeon on 03/19/2019 at 12:30PM he explained that the mesh is specifically for ventral hernias and that it has an attached frame. He explained that the mesh is rolled prior to being inserted into the abdominal cavity, it is tacked into place and the frame is pulled free and removed from the abdomen. He stated that after he pulled the frame down from the mesh he said, "I'll grab that in a minute," as he wanted to place more tacks to be sure the mesh was properly affixed.

The surgeon further stated that after applying the additional tacks he viewed the area, noted no bleeding and the procedure was completed. He stated that immediately after the completion of the procedure as he was dictating his operative note, he realized he had not removed the frame. He checked with the scrub tech who confirmed that it was not removed. The patient was informed, a new consent was obtained and the patient returned to the operating room for laparoscopic removal of the retained surgical item. The mesh frame was removed, and the patient was discharged home later in the day, as scheduled. The surgeon further stated that he had been instructed in the use of the product several years ago and has completed "approximately 50" hernia repairs using the framed mesh since that instruction.

During an interview with the circulating nurse on 3/19/2019 at approximately 9:30 AM, she explained that she is responsible for confirming appropriate signed consents and performing surgical counts with the scrub technician. The nurse acknowledged that the frame was not added to the count sheet. She also stated that this is the only product used at the hospital that has a frame attached to the mesh which is inserted and then removed by the surgeon.

During an interview with the Physician's Assistant on 3/19/2019 at approximately 1:00 PM, he stated that while he was only in the room for part of the procedure, he thought that the mesh frame would have been on the count sheet. He also stated that this framed mesh is the only product used at the hospital with an attached frame that needs to be separated from the mesh and removed prior to closure.

During an interview with the Operating Room Nurse Manager on 3/18/2019 at 2:00 PM, she stated that the product, when first introduced at the hospital, was presented by the company representative assigned to their hospital and the doctors were given instructions on use of the product. She could not explain why the mesh frame was not added to the count sheet as the facility policy states that all items that are not intended to be left in the wound need to be added to the count sheet.