HospitalInspections.org

Based on the review of records, policies and procedures review, the facility's governing body (an organized group or individual who assumes full legal authority and responsibility for operations of the facility) failed to ensure that the medical staff was held accountable for the quality of care that was provided to 1 out of 5 Sampled Patients (SP) to ensure the performance of a wrong site surgical procedure does not reoccur in the future. SP#2

Findings include:

Review of the facility's policies and procedures revealed a policy entitled Patient Safety, Risk Management Policy No. 701, Subject: Comprehensive System Analysis (Formerly Root Cause Analysis), Last Revised 03/09/2021 which included but wasn't limited to:

III. Procedure
A. CSA Incidents (Formerly Root Cause Analysis)
1. Incidents which require a CSA (case review/CSA) are identified collaboratively by the Departments of Risk
Management, Quality and Patient Safety, the involved Service Administrator(s), and the Chief Medical Officer.

2. These incidents may be classified as potential or actual reportable events to accreditation regulatory agencies. Examples include: (b) Sentinel Events (d) Clinically related occurrences or near misses, which may potentially impact organizational change and/or performance improvement.

E. Action Plan/Risk Reduction Strategies
1.The Risk Reduction Strategies are developed with the purpose to reduce the risk of recurrence and formulate
effective sustainable improvements. They include (a) Who is responsible for implementation (b) A timeline and how to measure effectiveness of actions taken.

2.The Action Plan is discussed at the end of the CSA meeting and is appointed to key people who will be
responsible to implement it & provide follow up. (a) The CSA risk reduction strategies will be tracked, trended, analyzed, and monitored for effectiveness and sustainability.

The facility's Quality and Patient Safety Plan 2022 - 2023 documented:
PERFORMANCE IMPROVEMENT PROCESSES
The facility sets priorities for its performance improvement activities that:
--Focus on high-risk, high-volume, high cost or problem-prone areas;
--Consider the incidence, prevalence, and severity of problems in those areas;
--Consider the effect on health outcomes, patient safety and quality of care.

Quality indicator data, including patient care data and other relevant data, are collected to monitor the effectiveness and safety of services and quality of care and to identify opportunities for improvement. The frequency and detail of data collection is specified by the facility's Quality and Patient Safety Councils.

The facility tracks medical errors and adverse patient events, analyzes their causes in a fair, safe, and just environment, and implements preventive actions and mechanisms that include feedback and education throughout the Health System. Actions focusing on performance improvement will be implemented, measured, and tracked to assure that improvements are sustained.

Quality Improvement reporting within the facility entities includes:
1. Pertinent quality improvement measurements, Patient Safety Indicators and Sentinel/Serious Events are reported to the Board of Trustees as determined by the facility's Leadership and Board.

Review of Operative Report #1 for SP#2 dated 05/19/2023 at 11:36 AM revealed:

Indication for Surgery: SP#2 incidentally found to have left sided renal mass. Imaging study done which showed 5.6 centimeters (cm) solid mass in the left kidney. SP#2 has history of hysterectomy, appendectomy, Caesarean (C-section), and peritoneal dialysis for which SP#2 was informed preoperatively of the difficulty of surgery due to adhesions.

Operation/ Procedure
Robotic assisted laparoscopic left radical nephrectomy with adhesiolysis and enterolysis.
Surgeon(s) MD1 - Urology Attending Surgeon and MD2 - Attending, Colon and Rectal Surgery
Findings: Significant adhesion of omentum and mesentery. The omentum and bowel were adhered to the anterior abdominal wall, specially in the lower abdomen and in the left upper compartment. As the omentum was adhered, the left lobe of liver or spleen was not visualized nor the descending colon.
Specimen(s) Left kidney.
Complications: None

Procedure Description
After the SP#2 was met in the preoperative area and informed consent was taken informing the pros and cons of surgery and the difficulty, we can encounter due to previous surgery and history of multiple peritoneal dialysis, SP#2 was properly identified, and marked for position, side, and laterality. SP#2 had antibodies noted. Blood cross match and hence blood was arranged without antibody. All questions and concerns were adequately addressed, and the patient was taken to the operating room, placed under general endotracheal anesthesia and prophylactic antibiotic was administered. A Foley catheter was placed in a sterile fashion, and an Orogastric tube placed, and the patient was then placed in a modified right lateral decubitus position. Care was taken to ensure that all pressure points were adequately padded, and the patient was secured to the operating table with tape. The patient was then prepped and draped in the routine sterile fashion. Time-out was performed, verifying to ensure the correct patient including the patient's name, Date of birth (DOB), type of surgery, the side of surgery, and the entire Operating Room staff was in agreement. With the help of Veress needle, pneumoperitoneum was achieved, and insufflation was done until 15 millimeters of mercury (mmHg). A 10-mm port was placed, the 30-degree camera was passed through the trocar, and laparoscopy was performed confirming no intraperitoneal injury but there were significant adhesion of omentum and mesentery adhering to the anterior abdominal wall and the adhesion has compartmentalized the abdomen into two compartments. Due to adhesion, I could not put the most cephalad port as the omentum was adhered to the left lobe of liver and spleen, but I could place the 12-mm assistant port and another 8 mm port caudally in a straight line parallel to the rectus abdominis muscle. But as I could not place the cephalad most port, I started adhesiolysis but still could not able to release the dense adhesion even after trying for 30 min to put the cephalad port safely away from the small bowel, omental and mesenteric adhesion. Then I decided to call Colorectal as they have more experience in adhesiolysis. Then MD2 (Attending, Colon and Rectal Surgeon) came immediately and helped in adhesiolysis. But MD2 could not succeed in that endeavor ... then we discussed our option of abandoning the case vs converting to open surgery but also felt that open will also not be easy looking at the amount of adhesion. Then MD2 suggested trying putting ports on the right side abdomen after giving supine position to the patient and try adhesiolysis and enterolysis. So, SP#2 was put into supine position from lateral position and put two ports on the right side and did adhesiolysis with enterolysis. Description of MD2's part of the surgery will be found in the operative procedure note. MD2, with a good effort and trying for almost one hour MD2 was able to do adhesiolysis to such an extent that I could see safe area to place my cephalad port. Also, MD2 helped in identifying the transverse colon to give some anatomical landmark which was obscured due to the amount of adhesion. Then again, I put the patient in right lateral decubitus position with left side up and placed the most cephalad port. Once the port placement was verified to be adequate, the robot was then docked.

Subsequently the robotic instruments were introduced under direct visualization. I used one fenestrated bipolar on my left and a monopolar scissor on my right and a prograsp on the most caudal port. Due to the adhesion, there was no normal anatomical landmark, so I traced the transverse colon and tried to find the left colon which was then retracted medially by dissecting lateral to it there was no normal white line of told visible clearly. After that I tried to find the ureter, dense adhesion prevented me from finding it. To get some perspective of the anatomical landmark, I tried to visualize the left lobe of liver and spleen, as the omentum was covering it, I tried to make a window on the omentum to visualize the liver and spleen, that lead to bleeding, but I could see liver and most probably the spleen through the window. The descending colon was mobilized medially. I could identify the left gonadal vein and tried to march cephalad to get the renal vein. Then I tried to march cephalad towards the renal hilum. The adhesion was preventing proper anatomical landmarks to be visualized properly. But using all available normal landmarks, I identified and carefully dissected the renal artery and vein going to the structure on the left renal fossa and started dissecting the organ in the left renal fossa. After looking at the position of the structure in the left renal fossa and the reniform shape of it, I used stapler to staple the renal artery and vein separately. Then I made dissection around the left kidney to ensure that the kidney was completely mobilized circumferentially freeing from medial, lateral, and posteriorly and inferiorly. The resection bed was examined to ensure that there was no significant bleeding. Pneumoperitoneum was brought down to a pressure of SmmHg, and still no significant bleeding was noted. SurgiSnow was placed over the renal defect and by the renal hilum and Evicel was applied. The specimen was placed in a large endocatch bag All remaining ports were removed. under direct vision, and the robot was undocked. Then an Incision was made in the left iliac fossa and the specimen was retrieved along with the endocatch bag. The fascia at the incision site was closed ...The camera was reintroduced to confirm hemostasis as well as adequate closure of the incision. All skin port sites were closed with 4-0 Monocryl sutures and Dermabond was applied. I examined the specimen which was covered with omental fat and was reniform in shape. I sent it for histopathological examination. After SP#2 was reversed from anesthesia, SP#2 was shifted to the post op recovery area.

Plan: Admit for observation.

Operative Report Addendum by MD1 (Attending, Urology) on May 23, 2023, 12:21 PM.
The pathology informed that the specimen sent as left kidney on pathological examination is found out to be the spleen and not kidney. I came to inform of this to SP#2 immediately. The surgery was done on 05/16/2023.

Review of MD1's Urology Progress Note dated 05/18/2023 at 6:41 PM documented:
I talked to SP#2 for about one hour in detail about the results of the pathology that it is not the left kidney with the tumor and in fact it is a spleen. I explained to SP#2 about the difficulty I faced during the surgery and how it was difficult to identify any structure in that area and how this must have happened as there was adhesion all over the abdomen as SP#2 has peritoneal dialysis and had prior hysterectomy, appendectomy and C-section and I could not identify the kidney from the spleen. I discussed with SP#2 the future treatment plan. SP#2 understands how this complication happened and how the surgery was difficult. I will talk to internal medicine and infectious disease (ID) regarding when to start vaccination as SP#2 has splenectomy done. The final pathology report is not ready yet, but the pathologist informed me over phone that the specimen is spleen and not the kidney hence I personally informed SP#2 about this.

Review of Operative Report #2 for SP#2 revealed:

Review of the Operative Report dated 05/25/2023 at 7:57 PM documented: SP#2 with a history of Type 2 Diabetes since the age of 15 and high blood pressure. SP#2 started hemodialysis and then switched to peritoneal dialysis and has been on dialysis since January 14, 2020. SP#2 was seen by the Transplant Nephrology team on October 15, 2020. A Computed Axial Tomography (CAT) scan was done and was found to have a lymphoma, which was cured. After 3 minutes, A repeat CAT scan showed a large left renal mass and was seen by the Urology Service. SP#2 underwent on May 16, 2023, a robotic-assisted laparoscopy and left radical nephrectomy.

DATE OF OPERATION: 05/25/2023
ATTENDING SURGEON: MD6, Attending, Urology/Transplant Surgery *Final Report *
PREOPERATIVE DIAGNOSES: End-stage renal disease. Large left renal mass. Status post splenectomy
PROCEDURES: Exploratory laparotomy. Multiple lysis of adhesions. Left radical nephrectomy.
POSTOPERATIVE DIAGNOSES: Frozen abdomen. End-stage renal disease. Left renal mass. Status post splenectomy.
ANESTHESIA: General.
ASSISTANT: MD1 (Urology Attending).
JUSTIFICATION: SP#2 underwent on May 16, 2023, robotic-assisted laparoscopy and left radical nephrectomy. The surgery was very difficult. Few services involved because there was multiple adhesions, and there was no good plane. SP#2 basically had a frozen abdomen. Specimen was removed at that time, the left kidney, but the pathology came back to be the spleen. Now, the patient is readmitted for surgery open. We will try to do a left nephrectomy. The patient is well aware about the risks associated with surgery, and I was called because the surgery is going to be very difficult. The patient is aware of the risk would be bleeding, the mass cannot be removed because she has frozen abdomen, blood transfusions, infections, reoperation. The patient is going to proceed with surgery.

Review of Physician's Discharge Summary dated 05/30/2023 documented procedure: Left sided open nephrectomy. Pain controlled, postoperative course was uncomplicated; Nephrology was consulted for the end stage renal disease (ESRD) and SP#2 was dialyzed while in the hospital. SP#2 was discharged home on 5/30/2023 in stable condition and follow-up instructions for MD visits were provided.

Interview with the Director of Risk Management on 10/11/2023 at 11:39 AM revealed that a corrective action plan was not submitted with the report since what happened was a "known complication of the surgery". The Director of Risk Management stated that the medical record was not attached to the report because probably there was no prompt to do so. The Director of Risk Management stated if something is missing, they request the information and then it is submitted. The Director of Risk Management stated that a formal root cause analysis (RCA) was not conducted. The Director of Risk Management stated that peer review was consulted outside of the facility specific for urology as the physicians did not want the same group where MD1 worked. The Director of Risk Management stated that the peer review was conducted by conversation per MD3 (System Chief Medical Officer) and no documentation was provided to the surveyor.

Interview with the Pre-Operative Nurse Manager conducted in the pre-operative holding area on 10/11/2023 at 1:45 PM. The Pre-Operative Nurse Manager stated that the recovery and discharge area is also located adjacent to the 25 bays in the pre-operative holding area. The Pre-Operative Nurse Manager stated that the patients are greeted and informed of what to expect, vital signs are obtained, history and assessment will be documented also. The Pre-Operative Nurse Manager stated that anesthesia services will see the patient if necessary. The Pre-Operative Nurse Manager stated that the patients are all prepped in the pre-operative holding area.

Interview on 10/11/2023 at 2:30 PM - The Director of Risk Management stated a RCA was done and provided an email with the Subject title: RCA - Wrong Surgical Procedure. The email requested the presence of several participants at a Zoom conference call (video) meeting which was scheduled on 05/30/2023 from 2:00 PM to 3:00 PM.

Interview with MD1 (Urology Attending) was conducted on 10/11/2023 at 2:44 PM. MD1 stated that SP#2 requested robotic surgery for robotic nephrectomy. MD1 stated that they have done so many patients with adhesions. MD1 stated that during the surgery, the colorectal surgeon in the adjacent operating room was called to assist. MD1 stated that the colorectal surgeon removed the omentum, mobilized the intestine and adhesiolysis was performed. MD1 stated that the amount of adhesions was a little more than expected. MD1 stated that initially, the outcome was not known. MD1 stated that when the spleen was removed, it looked like a kidney. When MD1 was asked if there were any opportunities for improvement identified, MD1 stated the outcome (The removal of SP#2's spleen instead of the left kidney) was a known complication. MD1 supplemented the interview with an article: "Iatrogenic Splenectomy during Left Nephrectomy: A single-Institution Experience of Eight Years", dated June 22, 2011.

Interview with MD4 (Facility Chief Medical Officer) conducted on 10/11/2023 at 4:10 PM. MD4 stated when he was first told about the result of the surgery, he figured it would be best to send it out for peer review. MD4 stated that the facility does not have a peer review group for surgical urology. MD4 stated that the Chair of Urology reviewed the case and stated that it was a complication. Additionally, MD4 stated that the outside peer review agreed that what happened (The removal of SP#2's spleen instead of the left kidney) was a known complication.

Interview with the Assistant Chief Nursing Officer (ACNO) conducted on 10/12/2023 at 10:15 AM revealed when the organ is removed, it is placed on the back table and the surgeon is usually the one to visualize the organ.

Interview with the Quality Director on 10/12/2023 at 10:36 AM confirmed that there were no RCA documents and no corrective action plan. The surveyor reviewed the health system Medical Executive Committee Meeting notes dated May 8, 2023, June 12, 2023, July 10, 2023, August 14, 2023, September 11, 2023, and Public Health Trust Board of Trustee One-Day Committee Meetings dated May 24, 2023, June 28, 2023, July 31, 2023, August 30, 2023. The Quality Director also confirmed there was no Medical Executive Committee or Board of Trustee discussion documented related to SP#2's wrong site surgical procedure (The removal SP#2's spleen instead of the left kidney).

Interview with MD3 (System Chief Medical Officer) conducted on 10/12/2023 at 12:45 PM. MD3 stated that the case was interesting and reviewed at the Morbidity & Mortality Committee meeting. MD3 stated that the case was externally peer reviewed by a colleague at a hospital in another state who also performs urology surgeries. MD3 stated that the case was unusual in that when system/technical concerns were reviewed, there were no substantial recommendations. MD3 stated that the conversation was not documented and that this has been an unusual case with different levels of investigation.

Interview with MD4 (Facility Chief Medical Officer) conducted on 10/12/2023 at 1:07 PM for clarification. MD4 stated that the organ was not visible when taken from the patient during surgery, and that it was encapsulated and there was no way to tell what it was.

Interview on 10/12/2023 around 3:00 PM, MD4 provided pending communication to the medical staff regarding an opportunity for improvement that was identified to ensure quality and safety for patients that have had peritoneal dialysis and planning to have robotic or laparoscopic procedures.

Based on the review of records and interviews, the facility failed to ensure that 1 out of 5 Sampled Patients (SP) received care in a safe setting when the wrong site surgery that occurred was not investigated to ensure the safety of future patients experiencing similar circumstances. SP#2

Findings include:

Review of the facility's policies and procedures revealed a policy entitled Care of the Patient Policy No. 400.005, Subject: Patient Rights and Responsibilities, Last Reviewed 09/20/2023, which included but wasn't limited to:

II. Procedure
B. The Patient's Bill of Rights and Responsibilities
xiv. Receive Care in a Safe Setting

Further review of the facility's policies and procedures revealed an additional policy entitled Patient Safety, Risk Management Policy No. 701, Subject: Comprehensive System Analysis (Formerly Root Cause Analysis), Last Revised 03/09/2021 which included but wasn't limited to:

III. Procedure
A. CSA Incidents (Formerly Root Cause Analysis)
1. Incidents which require a CSA (case review/CSA) are identified collaboratively by the Departments of Risk Management, Quality and Patient Safety, the involved Service Administrator(s), and the Chief Medical Officer.

2. These incidents may be classified as potential or actual reportable events to accreditation regulatory agencies. Examples include: (b) Sentinel Events (d) Clinically related occurrences or near misses, which may potentially impact organizational change and/or performance improvement.

E. Action Plan/Risk Reduction Strategies
1. The Risk Reduction Strategies are developed with the purpose to reduce the risk of recurrence and formulate effective sustainable improvements. They include (a) Who is responsible for implementation (b) A timeline and how to measure effectiveness of actions taken.

2. The Action Plan is discussed at the end of the CSA meeting and is appointed to key people who will be responsible for implementing it & provide follow up. (a) The CSA risk reduction strategies will be tracked, trended, analyzed, and monitored for effectiveness and sustainability.

Review of Operative Report #1 for SP#2 dated 05/19/2023 at 11:36 AM revealed:

Indication for Surgery: SP#2 incidentally found to have left sided renal mass. Imaging study done which showed 5.6 centimeters (cm) solid mass in the left kidney. SP#2 has history of hysterectomy, appendectomy, Caesarean (C-section), and peritoneal dialysis for which SP#2 was informed preoperatively of the difficulty of surgery due to adhesions.

Operation/ Procedure
Robotic assisted laparoscopic left radical nephrectomy with adhesiolysis and enterolysis.
Surgeon(s) MD1 - Urology Attending Surgeon and MD2 - Attending, Colon and Rectal Surgery
Findings: Significant adhesion of omentum and mesentery. The omentum and bowel were adhered to the anterior abdominal wall, specially in the lower abdomen and in the left upper compartment. As the omentum was adhered, the left lobe of liver or spleen was not visualized nor the descending colon.
Specimen(s) Left kidney.
Complications: None

Procedure Description
After the SP#2 was met in the preoperative area and informed consent was taken informing the pros and cons of surgery and the difficulty, we can encounter due to previous surgery and history of multiple peritoneal dialysis, SP#2 was properly identified, and marked for position, side, and laterality. SP#2 had antibodies noted. Blood cross match and hence blood was arranged without antibody. All questions and concerns were adequately addressed, and the patient was taken to the operating room, placed under general endotracheal anesthesia and prophylactic antibiotic was administered. A Foley catheter was placed in a sterile fashion, and an Orogastric tube placed, and the patient was then placed in a modified right lateral decubitus position. Care was taken to ensure that all pressure points were adequately padded, and the patient was secured to the operating table with tape. The patient was then prepped and draped in the routine sterile fashion. Time-out was performed, verifying to ensure the correct patient including the patient's name, Date of birth (DOB), type of surgery, the side of surgery, and the entire Operating Room staff was in agreement. With the help of Veress needle, pneumoperitoneum was achieved, and insufflation was done until 15 millimeters of mercury (mmHg). A 10-mm port was placed, the 30-degree camera was passed through the trocar, and laparoscopy was performed confirming no intraperitoneal injury but there were significant adhesion of omentum and mesentery adhering to the anterior abdominal wall and the adhesion has compartmentalized the abdomen into two compartments. Due to adhesion, I could not put the most cephalad port as the omentum was adhered to the left lobe of liver and spleen, but I could place the 12-mm assistant port and another 8 mm port caudally in a straight line parallel to the rectus abdominis muscle. But as I could not place the cephalad most port, I started adhesiolysis but still could not able to release the dense adhesion even after trying for 30 min to put the cephalad port safely away from the small bowel, omental and mesenteric adhesion. Then I decided to call Colorectal as they have more experience in adhesiolysis. Then MD2 (Attending, Colon and Rectal Surgeon) came immediately and helped in adhesiolysis. But MD2 could not succeed in that endeavor ... then we discussed our option of abandoning the case vs converting to open surgery but also felt that open will also not be easy looking at the amount of adhesion. Then MD2 suggested trying putting ports on the right side abdomen after giving supine position to the patient and try adhesiolysis and enterolysis. So, SP#2 was put into supine position from lateral position and put two ports on the right side and did adhesiolysis with enterolysis. Description of MD2's part of the surgery will be found in the operative procedure note. MD2, with a good effort and trying for almost one hour MD2 was able to do adhesiolysis to such an extent that I could see safe area to place my cephalad port. Also, MD2 helped in identifying the transverse colon to give some anatomical landmark which was obscured due to the amount of adhesion. Then again, I put the patient in right lateral decubitus position with left side up and placed the most cephalad port. Once the port placement was verified to be adequate, the robot was then docked.

Subsequently the robotic instruments were introduced under direct visualization. I used one fenestrated bipolar on my left and a monopolar scissor on my right and a prograsp on the most caudal port. Due to the adhesion, there was no normal anatomical landmark, so I traced the transverse colon and tried to find the left colon which was then retracted medially by dissecting lateral to it there was no normal white line of told visible clearly. After that I tried to find the ureter, dense adhesion prevented me from finding it. To get some perspective of the anatomical landmark, I tried to visualize the left lobe of liver and spleen, as the omentum was covering it, I tried to make a window on the omentum to visualize the liver and spleen, that lead to bleeding, but I could see liver and most probably the spleen through the window. The descending colon was mobilized medially. I could identify the left gonadal vein and tried to march cephalad to get the renal vein. Then I tried to march cephalad towards the renal hilum. The adhesion was preventing proper anatomical landmarks to be visualized properly. But using all available normal landmarks, I identified and carefully dissected the renal artery and vein going to the structure on the left renal fossa and started dissecting the organ in the left renal fossa. After looking at the position of the structure in the left renal fossa and the reniform shape of it, I used stapler to staple the renal artery and vein separately. Then I made dissection around the left kidney to ensure that the kidney was completely mobilized circumferentially freeing from medial, lateral, and posteriorly and inferiorly. The resection bed was examined to ensure that there was no significant bleeding. Pneumoperitoneum was brought down to a pressure of SmmHg, and still no significant bleeding was noted. SurgiSnow was placed over the renal defect and by the renal hilum and Evicel was applied. The specimen was placed in a large endocatch bag All remaining ports were removed. under direct vision, and the robot was undocked. Then an Incision was made in the left iliac fossa and the specimen was retrieved along with the endocatch bag. The fascia at the incision site was closed ...The camera was reintroduced to confirm hemostasis as well as adequate closure of the incision. All skin port sites were closed with 4-0 Monocryl sutures and Dermabond was applied. I examined the specimen which was covered with omental fat and was reniform in shape. I sent it for histopathological examination. After SP#2 was reversed from anesthesia, SP#2 was shifted to the post op recovery area.

Plan: Admit for observation.

Operative Report Addendum by MD1 (Attending, Urology) on May 23, 2023, 12:21 PM.
The pathology informed that the specimen sent as left kidney on pathological examination is found out to be the spleen and not kidney. I came to inform of this to SP#2 immediately. The surgery was done on 05/16/2023.

Review of MD1's Urology Progress Note dated 05/18/2023 at 6:41 PM documented:
I talked to SP#2 for about one hour in detail about the results of the pathology that it is not the left kidney with the tumor and in fact it is a spleen. I explained to SP#2 about the difficulty I faced during the surgery and how it was difficult to identify any structure in that area and how this must have happened as there was adhesion all over the abdomen as SP#2 has peritoneal dialysis and had prior hysterectomy, appendectomy and C-section and I could not identify the kidney from the spleen. I discussed with SP#2 the future treatment plan. SP#2 understands how this complication happened and how the surgery was difficult. I will talk to internal medicine and infectious disease (ID) regarding when to start vaccination as SP#2 has splenectomy done. The final pathology report is not ready yet, but the pathologist informed me over phone that the specimen is spleen and not the kidney hence I personally informed SP#2 about this.

Review of Operative Report #2 for SP#2 revealed:

Review of the Operative Report dated 05/25/2023 at 7:57 PM documented: SP#2 with a history of Type 2 Diabetes since the age of 15 and high blood pressure. SP#2 started hemodialysis and then switched to peritoneal dialysis and has been on dialysis since January 14, 2020. SP#2 was seen by the Transplant Nephrology team on October 15, 2020. A Computed Axial Tomography (CAT) scan was done and was found to have a lymphoma, which was cured. After 3 minutes, A repeat CAT scan showed a large left renal mass and was seen by the Urology Service. SP#2 underwent on May 16, 2023, a robotic-assisted laparoscopy and left radical nephrectomy.

DATE OF OPERATION: 05/25/2023
ATTENDING SURGEON: MD6, Attending, Urology/Transplant Surgery *Final Report *
PREOPERATIVE DIAGNOSES: End-stage renal disease. Large left renal mass. Status post splenectomy
PROCEDURES: Exploratory laparotomy. Multiple lysis of adhesions. Left radical nephrectomy.
POSTOPERATIVE DIAGNOSES: Frozen abdomen. End-stage renal disease. Left renal mass. Status post splenectomy.
ANESTHESIA: General.
ASSISTANT: MD1 (Urology Attending).
JUSTIFICATION: SP#2 underwent on May 16, 2023, robotic-assisted laparoscopy and left radical nephrectomy. The surgery was very difficult. Few services involved because there was multiple adhesions, and there was no good plane. SP#2 basically had a frozen abdomen. Specimen was removed at that time, the left kidney, but the pathology came back to be the spleen. Now, the patient is readmitted for surgery open. We will try to do a left nephrectomy. The patient is well aware about the risks associated with surgery, and I was called because the surgery is going to be very difficult. The patient is aware of the risk would be bleeding, the mass cannot be removed because she has frozen abdomen, blood transfusions, infections, reoperation. The patient is going to proceed with surgery.

Review of Physician's Discharge Summary dated 05/30/2023 documented procedure: Left sided open nephrectomy. Pain controlled, postoperative course was uncomplicated; Nephrology was consulted for the end stage renal disease (ESRD) and SP#2 was dialyzed while in the hospital. SP#2 was discharged home on 5/30/2023 in stable condition and follow-up instructions for MD visits were provided.

Interview with the Director of Risk Management on 10/11/2023 at 11:39 AM revealed that a corrective action plan was not submitted with the report since what happened (The removal of SP#2's spleen instead of the left kidney) was a "known complication of the surgery". The Director of Risk Management stated that the medical record was not attached to the report because probably there was no prompt to do so. The Director of Risk Management stated if something is missing, they request the information and then it is submitted. The Director of Risk Management stated that a formal root cause analysis (RCA) was not conducted.

Interview with MD1 (Urology Attending) was conducted on 10/11/2023 at 2:44 PM. MD1 stated that SP#2 requested robotic surgery for robotic nephrectomy. MD1 stated that they have done so many patients with adhesions. MD1 stated that during the surgery, the colorectal surgeon in the adjacent operating room was called to assist. MD1 stated that the colorectal surgeon removed the omentum, mobilized the intestine and adhesiolysis was performed. MD1 stated that the amount of adhesions was a little more than expected. MD1 stated that initially, the outcome was not known. MD1 stated that when the spleen was removed, it looked like a kidney. When MD1 was asked if there were any opportunities for improvement identified, MD1 stated the outcome (The removal of SP#2's spleen instead of the left kidney) was a known complication. MD1 supplemented the interview with an article: "Iatrogenic Splenectomy during Left Nephrectomy: A single-Institution Experience of Eight Years", dated June 22, 2011.

Interview on 10/12/2023 around 3:00 PM, MD4 (Facility Chief Medical Officer) provided pending communication to the medical staff regarding an opportunity for improvement that was identified to ensure quality and safety for patients that have had peritoneal dialysis and planning to have robotic or laparoscopic procedures.

The facility failed to ensure that SP#2 received in a safe setting when MD1 removed SP#2's spleen instead of the left kidney.

Based on the review of records, interviews, and review of the facility's Safety Plan, the facility failed to have an effective Quality Assessment Improvement (QAPI) program in place to track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning related to the wrong site surgery in 1 out of 5 Sampled Patients (SP). SP#2

Findings include:

Review of the facility's policies and procedures revealed a policy entitled Patient Safety, Risk Management revealed a policy entitled Policy No. 701, Subject: Comprehensive System Analysis (Formerly Root Cause Analysis), Last Revised 03/09/2021 which included but wasn't limited to:

III. Procedure
A. CSA Incidents (Formerly Root Cause Analysis)
1. Incidents which require a CSA (case review/CSA) are identified collaboratively by the Departments of Risk
Management, Quality and Patient Safety, the involved Service Administrator(s), and the Chief Medical Officer.

2. These incidents may be classified as potential or actual reportable events to accreditation regulatory agencies. Examples include: (b) Sentinel Events (d) Clinically related occurrences or near misses, which may potentially impact organizational change and/or performance improvement.

E. Action Plan/Risk Reduction Strategies
1.The Risk Reduction Strategies are developed with the purpose to reduce the risk of recurrence and formulate effective sustainable improvements. They include (a) Who is responsible for implementation (b) A timeline and how to measure effectiveness of actions taken.

2.The Action Plan is discussed at the end of the CSA meeting and is appointed to key people who will be responsible to implement it & provide follow up. (a) The CSA risk reduction strategies will be tracked, trended, analyzed, and monitored for effectiveness and sustainability.

The facility's Quality and Patient Safety Plan 2022 - 2023 documented:
PERFORMANCE IMPROVEMENT PROCESSES
The facility sets priorities for its performance improvement activities that:
--Focus on high-risk, high-volume, high cost or problem-prone areas;
--Consider the incidence, prevalence, and severity of problems in those areas;
--Consider the effect on health outcomes, patient safety and quality of care.

Quality indicator data, including patient care data and other relevant data, are collected to monitor the effectiveness and safety of services and quality of care and to identify opportunities for improvement. The frequency and detail of data collection is specified by the facility's Quality and Patient Safety Councils.

The facility tracks medical errors and adverse patient events, analyzes their causes in a fair, safe, and just environment, and implements preventive actions and mechanisms that include feedback and education throughout the Health System. Actions focusing on performance improvement will be implemented, measured, and tracked to assure that improvements are sustained.

Quality Improvement reporting within the facility entities includes:
1. Pertinent quality improvement measurements, Patient Safety Indicators and Sentinel/Serious Events are reported to the Board of Trustees as determined by the facility's Leadership and Board.

Review of Operative Report #1 for SP#2 dated 05/19/2023 at 11:36 AM revealed:

Indication for Surgery: SP#2 incidentally found to have left sided renal mass. Imaging study done which showed 5.6 centimeters (cm) solid mass in the left kidney. SP#2 has history of hysterectomy, appendectomy, Caesarean (C-section), and peritoneal dialysis for which SP#2 was informed preoperatively of the difficulty of surgery due to adhesions.

Operation/ Procedure
Robotic assisted laparoscopic left radical nephrectomy with adhesiolysis and enterolysis.
Surgeon(s) MD1 - Urology Attending Surgeon and MD2 - Attending, Colon and Rectal Surgery
Findings: Significant adhesion of omentum and mesentery. The omentum and bowel were adhered to the anterior abdominal wall, specially in the lower abdomen and in the left upper compartment. As the omentum was adhered, the left lobe of liver or spleen was not visualized nor the descending colon.
Specimen(s) Left kidney.
Complications: None

Procedure Description
After the SP#2 was met in the preoperative area and informed consent was taken informing the pros and cons of surgery and the difficulty, we can encounter due to previous surgery and history of multiple peritoneal dialysis, SP#2 was properly identified, and marked for position, side, and laterality. SP#2 had antibodies noted. Blood cross match and hence blood was arranged without antibody. All questions and concerns were adequately addressed, and the patient was taken to the operating room, placed under general endotracheal anesthesia and prophylactic antibiotic was administered. A Foley catheter was placed in a sterile fashion, and an Orogastric tube placed, and the patient was then placed in a modified right lateral decubitus position. Care was taken to ensure that all pressure points were adequately padded, and the patient was secured to the operating table with tape. The patient was then prepped and draped in the routine sterile fashion. Time-out was performed, verifying to ensure the correct patient including the patient's name, Date of birth (DOB), type of surgery, the side of surgery, and the entire Operating Room staff was in agreement. With the help of Veress needle, pneumoperitoneum was achieved, and insufflation was done until 15 millimeters of mercury (mmHg). A 10-mm port was placed, the 30-degree camera was passed through the trocar, and laparoscopy was performed confirming no intraperitoneal injury but there were significant adhesion of omentum and mesentery adhering to the anterior abdominal wall and the adhesion has compartmentalized the abdomen into two compartments. Due to adhesion, I could not put the most cephalad port as the omentum was adhered to the left lobe of liver and spleen, but I could place the 12-mm assistant port and another 8 mm port caudally in a straight line parallel to the rectus abdominis muscle. But as I could not place the cephalad most port, I started adhesiolysis but still could not able to release the dense adhesion even after trying for 30 min to put the cephalad port safely away from the small bowel, omental and mesenteric adhesion. Then I decided to call Colorectal as they have more experience in adhesiolysis. Then MD2 of colorectal surgery came immediately and helped in adhesiolysis. But MD2, Attending, Colon and Rectal Surgeon could not succeed in that endeavor ... then we discussed our option of abandoning the case vs converting to open surgery but also felt that open will also not be easy looking at the amount of adhesion. Then MD2, Attending, Colon and Rectal Surgeon, suggested trying putting ports on the right side abdomen after giving supine position to the patient and try adhesiolysis and enterolysis. So, SP#2 was put into supine position from lateral position and put two ports on the right side and did adhesiolysis with enterolysis. Description of MD2's part of the surgery will be found in the operative procedure note. MD2, Attending, Colon and Rectal Surgeon, with a good effort and trying for almost one hour MD2, Attending, Colon and Rectal Surgeon, was able to do adhesiolysis to such an extent that I could see safe area to place my cephalad port. Also, MD2, Attending, Colon and Rectal Surgeon helped in identifying the transverse colon to give some anatomical landmark which was obscured due to the amount of adhesion. Then again, I put the patient in right lateral decubitus position with left side up and placed the most cephalad port. Once the port placement was verified to be adequate, the robot was then docked.

Subsequently the robotic instruments were introduced under direct visualization. I used one fenestrated bipolar on my left and a monopolar scissor on my right and a prograsp on the most caudal port. Due to the adhesion, there was no normal anatomical landmark, so I traced the transverse colon and tried to find the left colon which was then retracted medially by dissecting lateral to it there was no normal white line of told visible clearly. After that I tried to find the ureter, dense adhesion prevented me from finding it. To get some perspective of the anatomical landmark, I tried to visualize the left lobe of liver and spleen, as the omentum was covering it, I tried to make a window on the omentum to visualize the liver and spleen, that lead to bleeding, but I could see liver and most probably the spleen through the window. The descending colon was mobilized medially. I could identify the left gonadal vein and tried to march cephalad to get the renal vein. Then I tried to march cephalad towards the renal hilum. The adhesion was preventing proper anatomical landmarks to be visualized properly. But using all available normal landmarks, I identified and carefully dissected the renal artery and vein going to the structure on the left renal fossa and started dissecting the organ in the left renal fossa. After looking at the position of the structure in the left renal fossa and the reniform shape of it, I used stapler to staple the renal artery and vein separately. Then I made dissection around the left kidney to ensure that the kidney was completely mobilized circumferentially freeing from medial, lateral, and posteriorly and inferiorly. The resection bed was examined to ensure that there was no significant bleeding. Pneumoperitoneum was brought down to a pressure of SmmHg, and still no significant bleeding was noted. SurgiSnow was placed over the renal defect and by the renal hilum and Evicel was applied. The specimen was placed in a large endocatch bag All remaining ports were removed. under direct vision, and the robot was undocked. Then an Incision was made in the left iliac fossa and the specimen was retrieved along with the endocatch bag. The fascia at the incision site was closed ...The camera was reintroduced to confirm hemostasis as well as adequate closure of the incision. All skin port sites were closed with 4-0 Monocryl sutures and Dermabond was applied. I examined the specimen which was covered with omental fat and was reniform in shape. I sent it for histopathological examination. After SP#2 was reversed from anesthesia, SP#2 was shifted to the post op recovery area.

Plan: Admit for observation.

Operative Report Addendum by MD1, Attending, Urology on May 23, 2023, 12:21 PM.
The pathology informed that the specimen sent as left kidney on pathological examination is found out to be the spleen and not kidney. I came to inform of this to SP#2 immediately. The surgery was done on 05/16/2023.

Review of MD1's Urology Progress Note dated 05/18/2023 at 6:41 PM documented:
I talked to SP#2 for about one hour in detail about the results of the pathology that it is not the left kidney with the tumor and in fact it is a spleen. I explained to SP#2 about the difficulty I faced during the surgery and how it was difficult to identify any structure in that area and how this must have happened as there was adhesion all over the abdomen as SP#2 has peritoneal dialysis and had prior hysterectomy, appendectomy and C-section and I could not identify the kidney from the spleen. I discussed with SP#2 the future treatment plan. SP#2 understands how this complication happened and how the surgery was difficult. I will talk to internal medicine and infectious disease (ID) regarding when to start vaccination as SP#2 has splenectomy done. The final pathology report is not ready yet, but the pathologist informed me over phone that the specimen is spleen and not the kidney hence I personally informed SP#2 about this.

Review of Operative Report #2 for SP#2 revealed:

Review of the Operative Report dated 05/25/2023 at 7:57 PM revealed: SP#2 with a history of Type 2 Diabetes since the age of 15 and high blood pressure. SP#2 started hemodialysis and then switched to peritoneal dialysis and has been on dialysis since January 14, 2020. SP#2 was seen by the Transplant Nephrology team on October 15, 2020. A Computed Axial Tomography (CAT) scan was done and was found to have a lymphoma, which was cured. After 3 minutes, A repeat CAT scan showed a large left renal mass and was seen by the Urology Service. SP#2 underwent on May 16, 2023, a robotic-assisted laparoscopy and left radical nephrectomy.

DATE OF OPERATION: 05/25/2023
ATTENDING SURGEON: MD6, Attending, Urology/Transplant Surgery *Final Report *
PREOPERATIVE DIAGNOSES: End-stage renal disease. Large left renal mass. Status post splenectomy
PROCEDURES: Exploratory laparotomy. Multiple lysis of adhesions. Left radical nephrectomy.
POSTOPERATIVE DIAGNOSES: Frozen abdomen. End-stage renal disease. Left renal mass. Status post splenectomy.
ANESTHESIA: General.
ASSISTANT: MD1, Urology Attending.
JUSTIFICATION: SP#2 underwent on May 16, 2023, robotic-assisted laparoscopy and left radical nephrectomy. The surgery was very difficult. Few services involved because there was multiple adhesions, and there was no good plane. SP#2 basically had a frozen abdomen. Specimen was removed at that time, the left kidney, but the pathology came back to be the spleen. Now, the patient is readmitted for surgery open. We will try to do a left nephrectomy. The patient is well aware about the risks associated with surgery, and I was called because the surgery is going to be very difficult. The patient is aware of the risk would be bleeding, the mass cannot be removed because she has frozen abdomen, blood transfusions, infections, reoperation. The patient is going to proceed with surgery.

Review of Physician's Discharge Summary dated 05/30/2023 documented procedure: Left sided open nephrectomy. Pain controlled, postoperative course was uncomplicated; Nephrology was consulted for the end stage renal disease (ESRD) and SP#2 was dialyzed while in the hospital. SP#2 was discharged home on 5/30/2023 in stable condition and follow-up instructions for MD visits were provided.

Interview with the Director of Risk Management on 10/11/2023 at 11:39 AM revealed that a corrective action plan was not submitted with the report since what happened was a "known complication of the surgery". The Director of Risk Management stated that the medical record was not attached to the report because probably there was no prompt to do so. The Director of Risk Management stated if something is missing, they request the information and then it is submitted. The Director of Risk Management stated that a formal root cause analysis (RCA) was not conducted. The Director of Risk Management stated that peer review was consulted outside of the facility specific for urology as the physicians did not want the same group where MD1 worked. The Director of Risk Management stated that the peer review was conducted by conversation per MD3 (System Chief Medical Officer) and no documentation was provided to the surveyor.

Interview with MD1 (Urology Attending) was conducted on 10/11/2023 at 2:44 PM. MD1 stated that SP#2 requested robotic surgery for robotic nephrectomy. MD1 stated that they have done so many patients with adhesions. MD1 stated that during the surgery, the colorectal surgeon in the adjacent operating room was called to assist. MD1 stated that the colorectal surgeon removed the omentum, mobilized the intestine and adhesiolysis was performed. MD1 stated that the amount of adhesions was a little more than expected. MD1 stated that initially, the outcome was not known. MD1 stated that when the spleen was removed, it looked like a kidney. When MD1 was asked if there were any opportunities for improvement identified, MD1 stated the outcome (The removal of SP#2's spleen instead of the left kidney) was a known complication. MD1 supplemented the interview with an article: "Iatrogenic Splenectomy during Left Nephrectomy: A single-Institution Experience of Eight Years", dated June 22, 2011.

Interview with MD4 (Facility Chief Medical Officer) conducted on 10/11/2023 at 4:10 PM. MD4 stated when he was first told about the result of the surgery, he figured it would be best to send it out for peer review. MD4 stated that the facility does not have a peer review group for surgical urology. MD4 stated that the Chair of Urology reviewed the case and stated that it was a complication. Additionally, MD4 stated that the outside peer review agreed that what happened (The removal of SP#2's spleen instead of the left kidney) was a known complication.

Interview with the Quality Director on 10/12/2023 at 10:36 AM confirmed that there were no RCA documents and no corrective action plan. The surveyor reviewed the health system Medical Executive Committee Meeting notes dated May 8, 2023, June 12, 2023, July 10, 2023, August 14, 2023, September 11, 2023, and Public Health Trust Board of Trustee One-Day Committee Meetings dated May 24, 2023, June 28, 2023, July 31, 2023, August 30, 2023. The Quality Director also confirmed there was no Medical Executive Committee or Board of Trustee discussion documented related to a to SP#2's wrong site surgical procedure (The removal of SP#2's spleen instead of the left kidney).

Interview with MD3 (System Chief Medical Officer) conducted on 10/12/2023 at 12:45 PM. MD3 stated that the case was interesting and reviewed at the Morbidity & Mortality Committee meeting. MD3 stated that the case was externally peer reviewed by a colleague at a hospital in another state who also performs urology surgeries. MD3 stated that the case was unusual in that when system/technical concerns were reviewed, there were no substantial recommendations. MD3 stated that the conversation was not documented and that this has been an unusual case with different levels of investigation.

The facility did not follow its own policies when it failed to ensure an effective Quality Assessment Improvement (QAPI) program was in place to track medical errors and Sentinel events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning related to SP#2's wrong site surgical procedure.