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455 TOLL GATE RD

WARWICK, RI 02886

PATIENT RIGHTS

Tag No.: A0115

Based on record review and staff interview it has been determined that the hospital failed to provide care in a safe setting for patient ID #1.

Findings are as follows:

During a complaint investigation and record review at the facility on 3/16/2018, it was revealed that patient ID #1 went to the facility on 3/14/2018 for a right partial, possible full, nephrectomy. Review of the patient's medical record revealed the patient was brought to the pre-operative area at approximately 7 AM. In the pre-op area the physician and preprocedure nurse did a Procedure Verification of the patient's name, date of birth, allergies and medications. The record revealed the procedural site/side/level was marked as "right" side.

The patient was brought to the OR (operating room) and placed on the operating room table. Once in the OR a "time out" was performed, confirming the patient, procedure and site. The patient's abdominal area was prepped by the Circulator Nurse preceptee (staff B). The surgeon felt the patient was not in the optimal position, and the patient was repositioned by the surgeon and the scrub tech (staff A). The surgeon then left the room to scrub for the procedure. When the surgeon returned to the OR, he and the scrub tech draped the patient and a final "time out" was performed. However, the marking for the surgical site was not visible at this time, due to being covered by the drapes. The surgeon then asked for a Bookwalter Extension, which was not in the room, and the two Circuulator Nurses (staff B and staff C) left the room to retrieve the equipment. While the nurses were out of the room, the surgeon and scrub tech proceeded with the surgery, and an incision was made on the patient's left abdomen.

When the assisting surgeon entered the room, he questioned why the incision was made on the left side (abdomen), when it was a right sided nephrectomy that was to be performed. The surgery was immediately stopped, when the error was realized. The surgeon then sutured the left incision of the abdomen, and then proceeded to perform the surgery on the "right" side of the abdomen.

When interviewed on 3/16/18 at approximately 4 PM, the scrub technician revealed the mark was not visible during the time out, and was not visually confirmed during the time out procedure. This information was confirmed during subsequent interviews on 3/16/18 and 3/19/18 with the Circulator Nurse preceptee and the surgeon (staff E) performing the surgery, as well as with the Circulator Nurse preceptor (staff C), and SRNA (student registered nurse anesthetist, staff F).

The hospital failed to provide a safe setting for the patient, by failure to follow policy, during a surgical procedure resulting in an abdominal incision on the wrong side of the patient.

SURGICAL SERVICES

Tag No.: A0940

Based on record review, staff interview and review of hospital policies it has been determined that the facility failed to impmlement the policy "Universal Protocol for Correct Patient, Procedure, Site Side Surgery and Invasive Procedures" for patient ID #1.

Findings are as follows:

Review of the hospital policy entitled "Universal Protocol for Correct Patient, Procedure, Site Side Surgery and Invasive Procedure" under "Purpose" states in part: "...to assure the correct site, procedure and patient when undergoing any operative or invasive procedure."

Under "Site Marking" states: item #1 "Site marking is required for all procedures involving laterality...." Item # 3 states: "...is sufficiently permanent to be visible after the skin preparation and draping."

Under "Pre Operative Briefing (Operative Room Only)" item #2 states: "Surgeon verbally verifies procedure site/side/level and visually verifies site marking ..." Item #5 states: "Circulating RN verifies needed equipment/implants are available to complete procedure."

Under "Time Out" item #5 states: "The surgeon/practitoner performing the procedure: Verifies the procedural marking..." "Ensures that all questions or concerns vocied by any team member are resolved prior to the start of the procedure."

Record review for patient ID #1 revealed the patient went to the facility on 3/14/2018 for a right partial, possible full nephrectomy. Review of the patient's medical record revealed the patient was brought to the pre-operative area at approximately 7 AM. In the pre-op area the physician and preprocedure nurse did a Procedure Verification of the patient's name, date of birth, allergies and medications. The record reveals the procedural site/side/level was marked as "right" side.

The patient was brought to the OR (operating room) and placed on the operating room table. Once in the OR a "time out" was performed, confirming the patient, procedure and site. The patient's abdominal area was prepped by the Circulator Nurse preceptee (staff B). The surgeon felt the patient was not in the optimal position, and was repositioned by the surgeon and the scrub tech (staff A). The surgeon then left the room to scrub for the procedure. When the surgeon returned to the OR, he and the scrub tech draped the patient and a final "time out" was performed. However, the marking for the surgical site was not visible at this time, due to being covered by the drapes. The mark was not verbalized during the time out procedure, as per hospital protocol. The surgeon then asked for a Bookwalter Extension, which was not in the room, and the two Circuulator Nurses (staff B and staff C) left the room to retrieve the equipment. While the nurses were out of the room, the surgeon and scrub tech proceeded with the surgery, and an incision was made on the the patient's left abdomen.

When the assisting surgeon entered the room, he questioned why the incision was made on the left side, when it was a right sided nephrectomy that was to be performed. The surgery was immediately stopped when the error was realized. The surgeon then sutured the left incision of the abdomen, and then proceeded to perform the surgery on the "right" side of the abdomen.

When interviewed on 3/16/18 at approximately 4 PM, the Surgical Scrub Technician (staff A) revealed that after the patient's abdomen was prepped and draped the mark was not visible and was covered by the drape. When the time out was performed, nobody on the procedural team made mention of the mark not being visible, and the procedure proceeded without this step in the time out process being completed. Additionally, the tech revealed that prior to the incision being made, the two nurses stepped out of the room to retrieve the Bookwalter Extension, which was not in the room at the start of the procedure.

During an interview on 3/16/18 at 4:30 PM, the preceptee Circulating Nurse (staff B), revealed the mark was visible in the pre-op area, and was on the correct surgical site. However, when the patient was brought to the OR (operating room) and was prepped and was draped, the mark was not visible, due to being covered by the drapes. During the time out process nobody confirmed the visibility of the operative site mark. Staff B also revealed, that she and her preceptor stepped out of the OR prior to the incision, to retrieve the Bookwalter extension, which was not in the OR at the start of the procedure. She further stated that she and her preceptor should not have stepped out of the OR to retrieve the needed equipment. Staff C was interviewed on 3/19/18 at 9:45 AM, and also confirmed that the mark was not visible after the patient was draped, and the mark was not confirmed during the time out. The surgeon who performed the procedure (staff E), confirmed in an interview on 3/19/18 at 9 AM, that the mark was not visualized during the time out, and revealed it is everybody's responsibility to acknowledge visualization of the mark.

The facility failed to follow their policy regarding verification of the site mark for the surgical procedure, and failed to have all necessary equipment available for the procedure, resulting in staff leaving the OR at the start of the surgery. This resulted in the incision being made on the wrong side/site.