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MEDICAL STAFF

Tag No.: A0338

Based on staff interviews, clinical record review, review of medical staff bylaws and facility documentation review, the hospital failed to ensure that each member of the medical staff demonstrated competencies to perform each task within the scope of practice for which privileges had been granted for 1 of 5 surgeons sampled, Surgeon A. From May 2023 to August 2024, the hospital identified a total of 3 surgical errors. All 3 errors involved Surgeon A. In May 2023, Surgeon A removed part of Patient 5's pancreas instead of the intended adrenal gland. Surgeon A had not performed any other adrenalectomy at the facility. Corrective actions included to immediately stop scheduling adrenalectomies, counseling surgeons on the use of surgical markers and proctoring at least 5 cases. Proctoring was not completed as the hospital no longer performs adrenalectomies. In August 2023, Patient #6 was identified to have a bowel perforation following a partial colectomy (surgical procedure to removes part of the colon) performed by Surgeon A. Patient #6 died from infection complications. Corrective actions included referral to the Credentialing committee for potential actions. However, per Credentialing Manager interview, this is not one of the Credentialing committee functions. In August 2024, Surgeon A performed a splenectomy (removal of the spleen) on Patient #1. Surgeon A removed the patient's liver instead resulting in hemorrhage (severe and perfuse bleeding) and death. Surgeon A had not performed a splenectomy at this hospital in over 3 years, July 2021. The hospital suspended Surgeon A's privileges and initiated an investigation.

Interviews with 8 sampled operating room staff found 6 staff with concerns regarding surgical practices by Surgeon A (Registered Nurse (RN) D, RN E, Scrub Technicians F and G, RN H and RN Y ). These concerns were reported to the Operating Room Manager and/or Operating Room Director, but no further action was initiated. Staff interviews identified 2 additional patients with possible surgical errors that had not been investigated. Surgeon A was observed to sever the common bile duct on Patient #2 during a Cholecystectomy (removal of a gallbladder) in April 2024 and sever a ureter on Patient #4 during a partial colectomy in July 2024.

Cross Reference A0340: Medical Staff Periodic Appraisals

MEDICAL STAFF PERIODIC APPRAISALS

Tag No.: A0340

Based on staff interviews, clinical record review, review of medical staff bylaws and facility documentation review, the hospital failed to ensure that each member of the medical staff demonstrated competencies to perform each task within the scope of practice for which privileges have been granted for 1 of 5 surgeons sampled, Surgeon A. From May 2023 to August 2024, the hospital identified a total of 3 surgical errors. All 3 errors involved Surgeon A. In May 2023, Surgeon A removed part of Patient #5's pancreas instead of the intended adrenal gland. Surgeon A had not performed any other adrenalectomies (removal of adrenal gland) at the facility. Corrective actions included to immediately stop scheduling adrenalectomies, counseling surgeons on the use of surgical markers and proctoring at least 5 cases. Proctoring was not completed as the hospital no longer performs adrenalectomies. In August 2023, Patient #6 was identified to have a bowel perforation following a partial colectomy (surgical procedure to removes part of the colon) performed by Surgeon A. Patient #6 died from infection complications. Corrective actions included referral to the Credentialing committee for potential actions. However, per Credentialing Manager interview, this is not one of the Credentialing committee functions. In August 2024, Surgeon A performed a splenectomy (removal of the spleen) on Patient #1. Surgeon A removed the patient's liver instead resulting in hemorrhage (severe and perfuse bleeding) and death. Surgeon A had not performed a splenectomy at this hospital in over 3 years, since July 2021. The hospital suspended Surgeon A's privileges and initiated an investigation.

Interviews with 8 sampled operating room staff found 6 staff with concerns regarding surgical practices by Surgeon A (Registered Nurse (RN) D, RN E, Scrub Technician F and G, RN H and RN Y ). These concerns were reported to the Operating Room Manager and/or Operating Room Director, but no further action was initiated. Staff interviews identified 2 additional patients with possible surgical errors by Surgeon A that had not been investigated. Surgeon A was observed to sever the common bile duct on Patient #2 during a Cholecystectomy (removal of a gallbladder) in April 2024, and sever a ureter on Patient #4 during a partial colectomy in July 2024 resulting in a Urologist being called to the operating room for repairs during the surgery for Patient #4.

The finding include:

On 05/12/2023, Surgeon A was the Primary Surgeon involved in a wrong surgical procedure involving Patient #5. Identified was the removal of a portion of the patient's pancreas instead of an adrenalectomy. Prior to this adrenalectomy attempt, no other adrenalectomies had been performed at the hospital. The hospital investigated and implemented corrective actions following this event.

The hospital recommended to immediately cease the scheduling of adrenalectomies by either provider until proctoring is completed. The physicians involved were counseled on opportunities to utilize markers when performing procedures, and surgical proctoring for procedure by a provider who has experience with adrenalectomies, minimum of 5 cases would take place. The hospital indicated they were no longer performing adrenalectomies, therefore no proctoring was completed. This was confirmed by review of the operative log.

On 08/04/2023, Surgeon A was one of several physicians involved in an error culminating in the death of patient #6. Surgeon A performed a colon resection; identified post-surgically was a air and fluid collection in the abdomen and pelvis; concerns were identified for bowel perforation or a small leak at the anastomosis (a surgical connection between two body channels). Identified was the hospital's staff failure to follow sepsis protocol following a leak of a colon anastomosis. Corrective actions included the case being peer reviewed to determine education required for physicians involved, case to be reviewed by the Credentialing committee for potential action plan and to re-educate personal on inpatient sepsis alert process.

Per review of an email to the Medical Executive Committee (MEC), dated 10/09/2023, from the Chief Medical Officer, indicated that the Medical Staff Performance Improvement Committee (MSPIC) met; identifying the following concerns with Surgeon A's: "pattern of questionable decision-making; less so related to surgical technique and more related to post-operative management and complications; most of issues seem to revolve around bowel surgery ... ; recognition of difficult cases and has a higher volume than his regional colleagues; few cases have been done with another local surgeon as the "assistant."; questions regarding the number of facilities that Surgeon A covers left questions whether ample time is being allocated to each patient in the post-op setting; documentation seems hurried and often delayed and does not accurately reflect what the surgeon is able to eloquently state regarding his thought processes and actions upon review; and the surgeon is genuine, well intentioned, respected by the medical staff and has not had prior major issues, apart from the cases discussed over the past few months.

In the same email (10/09/2023), MSPIC recommends: a letter of guidance, counsel, warning or reprimand be issued by the MEC; conditions for continued appointment to include monitoring, proctoring and consultation with/by a peer (TBD - to be determined) - must have bowel-surgery cases reviewed on a monthly basis for next quarter and reviews should include the decision-making processes both before and after the surgical procedure; and Surgeon A must undertake specific CME (continued medical education) on Selected Readings in General Surgery (SRGS) focused on Large Bowel Disorder and SESAP (Surgical Education and Self-Assessment Program) 18 - Alimentary Tract and SESAP 18 - Advanced Alimentary Tract.

Surgeon A took a voluntary leave of absence from 09/20/2023 through 10/20/2023.

An email from Surgeon A to the Director of Quality, dated 01/12/2024, includes proof of completion of the required SRGS readings and CME modules, and a receipt for the courses, purchased on 01/08/2024. Self-assessment scores were included which revealed 4 parts to the Alimentary Tract module and 2 parts to the Advanced Alimentary Tract module. Surgeon A scored the following:

Advanced Alimentary Tract
- Advanced Alimentary Tract - Part I shows a Complete Initial score of 36%. Latest score 92%
- Advanced Alimentary Tract - Part II shows a Complete Initial score of 40%. Latest score 88%

A review of the "American College of Surgeons," website, which offers the SESAP 18 an SESAP 18 Advanced course indicates "To obtain CME credit, 80 percent of the questions must be answered correctly within three attempts. Additional review is offered until a score of 80 percent is achieved." Advanced CME | ACS (facs.org)

Presented for review, was a letter to Surgeon A, dated 01/23/2024, from the Chairman, Medical Staff Performance Improvement Committee indicating that six cases related to Surgeon A's Focused Professional Practice Evaluation (FPPE) were conducted. The cases were reviewed and discussed; there were no concerns identified. The letter also indicated that Surgeon A had successfully completed the CME on bowel surgery and that his FPPE was being closed. There were six (6) cases that were peer reviewed, specific to colon-rectal or abdominal surgeries that were performed between 11/04/2023 to 01/03/2024. However, there was no mention of Surgeon A's, "Complete Initial" failing score on Advanced Alimentary Tract, and there had been no mention in which order Surgeon A needed to complete the MSPIC recommendations (as Surgeon A completed the educational component after the performance of surgical case peer reviews). No proctoring was completed.

Surgeon A was re-appointed to the Medical Staff on 05/25/2024.

On 09/11/2024 at approximately 10:10 AM, an interview was conducted with the Director of Medical Staff Services and the Credentialing Manager (CM). The CM indicated that credentialing has nothing to do with peer review. These are completely separate. The CM stated they verify the applicants for initial appointment, education, licensure, employment peer references, boar certification, training, hospital affiliation and malpractice. Surgeons are required to turn in case logs for 24 months. We do background check on the initial appointment. All documentation is then reviewed by the credentialing committed and reverified every 2 years.

On 09/13/2024 at approximately 1:50 PM, an interview was conducted with the Director of Quality regarding ongoing physician performance evaluations (OPP). She stated that peer review and OPP were 2 separate things. When a physician comes up for evaluation - if he's had peer cases, this is noted 'verbally' that the physician has been through the peer review committee. Peer review is done based off of a question or concern about a practitioner.

On 09/13/2024 at approximately 4:00 PM, a telephone interview was conducted with the former Chief Medical Officer, leaving the position in January 2024. He stated that the cases from Surgeon A were sent to the MSPIC committee and reviewed, and it was determined based on a certain level of concerns expressed, Surgeon A was given a set of guidelines in order to stay credentialed. We investigated the cases and charts were handed off to individuals (other physicians) who blindly completed a review and could provide an unbiased evaluation of the charts in questions. Surgeon A met those recommendations, and he submitted documentation that he had completed the courses requested for him to take. When asked about the failing scores on the initial test, he stated it's not unusual to have a pretest to test gap knowledge. He stated I would put most 'weight' on the post test and that without information from the test-writers he could not comment further. As far as concerns with Surgeon A's competencies, he stated there were a few cases brought up via the Event Reporting System (ERS) and a few general nonspecific comments made, but that's conjecture and he requested real events and encouraged ERS reports and would investigate those and hand off to MSPIC.

On 09/16/2024 at approximately 6:00 PM, an interview was conducted with the current Chief Medical Officer (CMO) beginning this role on May 8, 2024. The CMO stated he had no concerns with Surgeon A's competencies, and no formal concerns, regarding Surgeon A, had been brought to him.

There have been no additional peer reviews completed for Surgeon A.

Identified to occur on 08/21/2024, Surgeon A was the Primary Surgeon involved in a wrong surgical procedure involving Patient #1. Surgeon A intended to perform a splenectomy; however, the patient's liver was removed resulting in the death of Patient #1 (cross reference A0959).

A review of Surgeon A's case log revealed he had performed only two splenectomies at the hospital since April 2021. His last splenectomy was over 3 years prior in July 2021.

The hospital detail report, showed a total of four splenectomies performed within the hospital, querying back to October 2019 to July 2024. The last splenectomy performed was by Surgeon K in September 2023.

Per clinical record review, Patient #1 presented to the hospital with worsening abdominal pain left-side and left chest on 08/18/2024. The patient was seen by Surgeon A, a General Surgeon, and admitted with pain consistent with an enlarged spleen and splenic mass, identified per imaging studies. Monitoring of the patient's hemoglobin and hematocrit (H&H) were ordered, along with additional imaging studies, monitoring of vital signs and a recommendation for a splenectomy (removal of spleen). The patient initially refused surgery, requesting to be discharged, but agreed to surgery after blood reports on his hemoglobin continued to decrease and the patient's abdominal pain failed to improve. The patient was initially offered transfer to a higher level of care, but due to the patient's continued decline of his hemoglobin, Surgeon A felt the opportunity to transfer the patient was no longer on option. The patient agreed to the surgical procedure on 08/21/2024, which was scheduled for at 4:00 PM.

On 09/10/2024 at 2:15 PM, an interview was conducted Staff Member Y, a Registered Nurse (RN) Circulator, regarding Surgeon A and the surgical case of Patient #1. RN Y stated that Surgeon A was "pleasant to work with," and stated that "cases that were routine he was very competent in, such as laparoscopic cholecystectomies, appendectomies, but we all had this eerie feeling", "how are we doing a spleen (splenectomy) at 4 (o'clock) in the afternoon?" RN Y, stated that Surgeon A is very typical for being late, stating he was late [date of event] and they didn't get back to room until 5-6 o'clock. RN Y stated that "splenectomies are not routine procedures and she can only think of 2 that were done in the past 2 ½ years." RN Y stated there were complaints about Surgeon A and that in the beginning of her career, when she worked at a hospital in another state, she kept hearing his name (Surgeon A), and it was never a good thing. RN Y stated that many technicians and nurses talked about him and bad outcomes, it was never good surgically. This was not a normal case and this was not a routine normal case[splenectomy] for Surgeon A. RN Y stated she had never participated in a splenectomy at this hospital, and it was not a routine procedure. RN Y stated that Surgeon A did not ask for help/assistance from another surgeon in this case, and that he could have. Help was available. We want the family to know the truth and never thought I would see something like this, this is a huge learning moment for everybody and prevent this from happening again from incompetency." RN Y had never completed an event report regarding Surgeon A.

On 09/10/2024 at 3:15 PM, an interview was conducted with Staff Member F, a Scrub Technician (Scrub Tech) and First Assistant. Scrub Tech F was asked if she had any concerns with the competency of Surgeon A. Scrub Tech F stated that there was once case where he was doing a robotic inguinal hernia, and she noticed he was dissecting on the wrong side. She said when she pointed this out to Surgeon A, he stated he was doing a "bilateral," despite the operative consent indicating a right inguinal hernia repair. Scrub Tech F stated she did not report this because the patient did have bilateral hernias and the the consent included "and all necessary other procedures", so she "didn't think he was doing something wrong." Scrub Tech F is familiar with the facility's incident reporting system, known as ERS (Event Reporting System). Scrub Tech F had never completed an event report regarding Surgeon A, or the wrong side surgery.

On 09/10/2024 at 3:57 PM, an interview was conducted with Staff Member H, an RN Operating Room (OR) Nurse. RN H stated she has never participated in a splenectomy. RN H was asked if she had any concerns with the competency or skills of Surgeon A, and replied for the most part, "no", but this was her first year working on the surgery side. RN H indicated that his patients "have been a little questionable to me" when it comes to their co-morbidities, and she stated his cases are often added at the end of the day when he is on call. RN H stated she has never had any issues with Surgeon A, and has no problems voicing concerns and feels leaders would act on those actions. She described Surgeon A, "in general, he can be very cavalier. So much so, I think it makes him dangerous." Staff Member H was familiar with the facility's incident reporting system, indicating she has completed an incident report and understands what needs to be reported. Staff Member H had never completed an event report regarding Surgeon A.

On 09/11/2024 at 8:24 AM, an interview was conducted with Staff Member G, a Scrub Technician (Scrub Tech), who stated that she has worked with Surgeon A multiple times. Scrub Tech G stated that Surgeon A is a likeable guy, fun, loud during "time-out". She stated she had her concerns when she worked with him, as she had previously worked at a trauma hospital in Colorado. The first few times working with him, she would raise an eyebrow. She explained this statement by stating, "He cut the common bile duct during a laparoscopic cholecystectomy (gallbladder removal) and broke scrub and went into hallway to take a phone call". She stated she assumed the call was to a GI (gastrointestinal) surgeon or another general surgeon. Scrub Tech G stated that Surgeon A did not put a stent in, he just closed it. In her experience, you do put a stent in. She stated that this incident was reported to the Operating Room Manager and Operating Room Director, but she was unaware of the outcome. The incident involved Patient #2. She also added that most of Surgeon A's laparoscopic cholecystectomies, she said it seems like 90% of them, would end up "open" (mid abdominal incision). She stated converting to an open procedure was so common "every time I would bring in a major tray and most of the time we would end up using them." Scrub Tech G referred back to Patient #2 stating that she "didn't feel he took it serious at all and he doesn't do the right thing". She stated "I don't trust him as a doctor [referring to Surgeon A], I hated working with him". When asked if any concerns were voiced preoperatively regarding the splenectomy scheduled for 08/21/24, she stated that all of us were wondering why we were doing a splenectomy here and why we were doing it so late in the day. Scrub Tech G added that even the Anesthesiologist questioned it. The concerns were brought to the charge nurse and to the Chief Medical Officer. Scrub Tech G stated, "anyone that has done a splenectomy knows you are going to bleed." Scrub Tech G added that staff call the hospital to see who is on call for surgery if their family need to come here, and if it is Surgeon A, they will wait. When asked if she felt comfortable in speaking up if she sees something that isn't right, she replied that she feels comfortable, but also at the same time, "I'm a Scrub Tech and the surgeon won't listen to a Scrub Tech unfortunately." Scrub Tech G didn't think incident reporting was part of her orientation process, but she had good resources available to her in the operating room. Staff Member G stated she was aware how to complete an event report in ERS, and knows why to report and says, "basically everything should be reported. Scrub Tech G has never completed an event report regarding her concerns with Surgeon A or when a laparoscopic procedure turns to an open procedure.

On 09/11/2024 at approximately 8:59 AM, a telephone interview was conducted with Staff Member D, an RN Operating Room Nurse. RN D stated she voiced concerns about the splenectomy scheduled, on 08/21/2024 at 4:00PM, to the Charge Nurse (CN). She stated she told the CN "she was not comfortable with the case and was concerned about the outcome." RN D wanted to make sure they had enough blood; stating that "spleens get a lot of blood." She stated she was told by the CN that the doctor was approved and credentialed. RN D said, she "didn't have a good feeling. I lacked confidence in the surgeon to do the case and she raised those same concerns". RN D stated that Surgeon A was about an hour late. The surgery was scheduled for 4:00 PM and the patient went into the OR at 5:20 PM. She recalled standing at patient #1's bedside while Surgeon A was speaking with the patient. She stated Surgeon A "made it sound like [the surgery] run of the mill, but I knew different." RN D, stated she had, "never been involved in something like this." During the interview, RN D stated "Everyone knows he's not a good surgeon," and added that staff would not bring their family if he was on call. RN D said there was a similar incident last year that has been under review. RN D stated, "I don't know how he was allowed to come back" and she had heard there were 8 cases against him. RN D reiterated that she did tell the charge nurse and talked to anesthesia and voiced the same concerns. Staff Member D had never completed an event report regarding Surgeon A.

On 09/12/2024 at approximately 12:08 PM, a telephone interview was conducted with the Director of Risk Management. He stated that it was brought to our attention by some of the OR staff that Surgeon A had severed a common bile duct and had never been reported. He stated they are working on that now and will be educating the staff. He stated he expected nursing staff and/or provider should have reported those issues immediately.

On 09/12/2024 beginning at approximately 9:25 AM, a simultaneous interview was conducted with the Operating Room (OR) Director and Operating Room Manager. The staff stated that if a procedure changed from what was originally planned, then staff do an ERS. The staff used the example - if a scheduled laparotomy converted to open, that would constitute and ERS. The OR Director stated that some of the concerns they are hearing about Surgeon A are just now being brought to their attention, such as Surgeon A's reputation in (city in Alabama). She did acknowledge that she 'has heard' staff indicate that they check to see what surgeon is on call first before they bring family to hospital and if it is Surgeon A they don't come in. But stated, staff each have their favorites, and this was not something that caused her concern. She said Surgeon A does a big volume, does a lot of cases, and has more inpatients. The OR Director stated that when surgeons are being recredentialed we give the committee the OR case logs, but we don't know how this is done at other hospitals. The OR Manager stated she had heard concerns voiced by staff, to include concerns from anesthesia, regarding the late start of the splenectomy scheduled at 4:00PM (08/21/2024). The anesthesiologist was informed that they had sufficient staff and all the necessary supplies/products needed to perform the surgery. The OR Manager indicated she had "fluffed" the staff, for this case. They had enough staff, all necessary products and equipment. The staff work 12-hour shifts and scheduling this procedure was within our scheduling window.

On 09/11/2024 at approximately 1:46 PM a telephone interview was conducted with Staff Member E, an Operating Room Registered Nurse. RN E stated she brought forth concerns preoperatively, stating that the majority of staff and anesthesia and the CRNA (Certified Registered Nurse Anesthetist) all voiced their opinion and didn't think we should be doing this procedure [splenectomy]. RN E stated that she didn't think "Surgeon A was a great surgeon and didn't think it would end well," and indicated this hospital is "not a trauma facility." RN E stated this was an elective surgery and that 'splenectomies can go bad very fast', and starting the surgery at 5:30 PM (surgeon was late) wasn't smart with limited staff; and not smart for the patient. She stated, the patient should have been somewhere where they do splenectomies on a regular basis and staff that are qualified. RN E added that Surgeon A has had a prior wrong site surgery and people in the OR voiced concerns about his skills to the Charge Nurse and to the OR Director. RN E stated she was familiar with the facility's incident reporting system in ERS. RN E stated she has not completed an ERS this time; "never done it before, wish I had."

During an interview conducted with Surgeon A, on 09/20/2024 beginning at approximately 10:00 AM, Surgeon A stated that he has performed probably '20 - 30 splenectomies" in his career, three at this hospital including the one on 08/21/2024. Surgeon A describes the events that occurred for patient #1. Stating he was 'on call' and received a call from the Emergency Department for patient #1 who had acute onset of abdominal pain and discomfort. Based on his imaging studies, physical examination findings and laboratory findings a splenectomy was recommended. The patient was not wanting surgery. He advised the patient that this hospital does not have "interventional radiology" (a medical specialty that uses minimally-invasive procedures to diagnose and treat disease in the body - often used to treat splenic injuries in stable patients through a procedure called splenic artery embolization). Patient #1 wanted to be discharged. Surgeon A indicated that would be against medical advice, as the patient wanted to drive home 6 hours. Surgeon A offered to transfer the patient to a higher level of care, but the patient refused. He had placed the patient on the OR (operating room) schedule, to ensure space availability for 08/20. Surgeon A continued to monitor Patient #1's clinical condition, and the blood counts kept diminishing and the scans were showing there is a problem. Again, he had a conversation with the patient recommending transfer to a higher level of care. The patient didn't want to do that and didn't want to consider having the procedure done. By Day #3, the patient was really sick and now indicates he wants something done. At this point, Surgeon A stated, that Patient #1's condition has deteriorated and we've lost window to transfer to higher level of care and patient #1 became very distended. Surgeon A felt that patient #1 was no longer stable enough to transfer, indicating that transfers can take up to 24-48 hours to occur. Surgeon A stated that no staff members approached him with concerns about this procedure. He did speak with the anesthesiologist to ensure all blood products were available. The surgeon stated that "splenectomy" is not a simple procedure and normally he would have another physician assist him, but based on the availability of help in the OR, a Surgical Scrub Technician First Assistant (Scrub Tech F), he felt confident he could take care of patient #1. Surgeon A added that if she had not been available, he would have called another Surgeon. Surgeon A stated that he coordinated with the anesthesia team and with the CMO and they had worked on making sure blood products were available.

Brought to the attention of the Director of Quality and Risk Management on 09/05/2024 by the CMO, was Patient #4. Patient #4 had presented to hospital to have a stent remove following a laparoscopic hand-assisted left colectomy completed by Surgeon A on 07/02/2024. During the patient's surgery, Surgeon A cut the right ureter requiring additional surgical intervention by a urologist. This failed to be reported at the time of the incident.

On 09/13/2024 at approximately 1:50 PM, an interview was conducted with the Director of Quality regarding the Medical Staff Performance Excellence Committee (MSPEC) and peer review. The Director of Quality stated physicians have ongoing physician performance evaluations completed, and when a physician comes up for evaluation, if he has had any peer review cases that information is provided here and signed off by the department chair. The peer review process and the ongoing physician performance evaluations are two separate things. Peer review occurs when there is a case of concern, either by a peer, another physician or the SERT Team (Safety Event Response Team). They will make a request for peer review. Peer review is reviewed by the MSPEC committee which includes 3 separate corporate affiliated hospitals that are pooled together, which creates the Midwest MSPEC.

On 09/20/2024 at approximately 9:00 AM, an interview was conducted with the Chairman, Medical Staff Performance Improvement Committee, Midwest Market. He stated the process works when the Director of Quality and her team identify a case to come to peer review or to the SERT process. This gets presented at the MSPEC committee. It is an overall process where we have a doctor in that field review and talk about the case. We discuss if we think the care is acceptable or unacceptable. Sometimes we need to send the case out for more review. We can't make a determination until we receive advice from other doctors. There is a standard MSPEC form and quality post guide for the form which addresses different elements of the case. We perform this review fairly and objectively and equally apply it.

A review of the facility's policy and procedure entitled "Incident/Event Reporting," PolicyStat ID 12512812, last approved 10/2022 indicates "All health care providers and all agents and employees of ... shall report all suspected and/or identified incidents/events and medical errors. The information should be documented factually and reported in a timely manner without the fear of retaliation or reprimand. The policy defines "Incident/Occurrence: An incident is any event or circumstance not consistent with the normal routine operations of the hospital and its staff or the routine care of a patient. It may be an error, an accident, or a situation which could have or has resulted in injury to a person or damage to hospital equipment or property. This applies to incidents occurring in hospital operated facilities or occurring in another health care facility prior to current admission." The procedure indicates "I. Incident/event reporting is the responsibility of every hospital staff member, contract worker, physician and student." ... ...."X. Risk Management will investigate and report the event, if appropriate, to regulatory agencies."

A review of the facility's Medical Staff Bylaws, 02/2021, identifies in Article 5, beginning on page 24 the duties of "The Executive Committee is delegated the primary oversight authority over professional activities and functions of the Medical Staff and performance improvement activities regarding the professional services provided by Medical Staff member with clinical privileges. This authority may be removed or modified by amending these Bylaws and related policies. The Executive Committee is responsible for the following:
(a) Acting on behalf of the Medical Staff in the intervals between Medical Staff meetings (the officers and the CMO are empowered to act as a group in urgent situations between Executive Committee meetings;
(c) Recommending directly to the Board on at least the following:
1. ... ....
2. the mechanism used to review credentials and to delineate individual clinical privileges;
3. applicants for Medical Staff appointment and reappointment;
4. delineation of clinical privileges;
5. participation of the Medical Staff in performance improvement activities and the quality of professional services being provided by the Medical Staff;
6. the mechanism by which Medical Staff appointment may be terminated;
7. hearing procedures; and
8. other appropriate reports and recommendations that the Executive Committee has received from Medical Staff committees, departments, clinical services, and other groups.
Article 5. E. - "Performance Improvement Functions" indicate that "The Medical Staff is actively involved in the measurement, assessment and improvement of at least the following:
1. Patient safety, including processes to respond to patient safety alerts, meet patient safety goals, and reduce patient safety risks;
3. Medical assessments and treatment of patients
6. Operative and other procedures, including tissue review and review of discrepancies between pre-operative and post-operative diagnoses
7. Appropriateness of clinical practice patterns
11. Sentinel events including root cause analyses and responses to unanticipated adverse events
17. Accurate, timely, and legible completion of medical records
19. Review of findings from the ongoing and focused professional practice evaluation activities that are relevant to an individual's performance; and
20. Communication of findings, conclusions, recommendations, and action to improve performance to appropriate Medical Staff members and the board.

SURGICAL SERVICES

Tag No.: A0940

Based on staff interviews, interview with the county Medical Examiner and patient medical record review, the hospital failed to ensure surgical services were provided in accordance with acceptable standards of practice and that operative reports were complete and accurately written for 1 of 6 patients sampled, Patient #1. During a planned splenectomy (removal of the spleen), Surgeon A, a general surgeon, removed Patient #1's liver instead of the spleen and documented the spleen was removed. The operative report documented an inaccurate sequence of events compared to staff interviews including the use or lack of use of surgical clamps and when the surgical stapler device was deployed. The report failed to include the presence of a megacolon (a condition where the colon, or large intestine, abnormally dilates - become wider and larger), listed an inaccurate cause of death and failed to include the removal of Patient #1's liver.

The findings include:

Cross Reference A0959, Operative Report: Based on operating room (OR) staff interviews, interview with the county Medical Examiner, interview with the Pathologist and clinical record review, the hospital failed to ensure operative report were complete and accurately written for 1 of 6 patients sampled, Patient #1. During review of Patient #1's operative report from August 2024, there were several discrepancies noted when compared with the pathology report, interviews conducted with the Medical Examiner, the Pathologist, the Chief Medical Officer and 7 of 7 operating room staff interviewed (Registered Nurse (RN) D, RN E, RN Y, Scrub Technicians F and G, Certified Registered Nurse Anesthetist C and General Surgeon K).

In August 2024, during a scheduled splenectomy (a surgical procedure to remove the spleen), Surgeon A mistakenly removed Patient #1's liver instead of the spleen. The operative report documents that the spleen was removed. The operative report failed to mention the patient's abdominal distention, failed to mention the presence of a megacolon, and failed to mention the removal of the liver. Additionally, the operative report contradicts portions of staff interviews regarding clamp usage, the sequence of events, the timing of the hemorrhage (severe bleeding), and the cause of death. The operative report documents "no complications".

OPERATIVE REPORT

Tag No.: A0959

Based on operating room (OR) staff interviews, interview with the county Medical Examiner, interview with the Pathologist and clinical record review, the hospital failed to ensure operative report were complete and accurately written for 1 of 6 patients sampled, Patient #1. During review of Patient #1's operative report from August 2024, there were several discrepancies noted when compared with the pathology report, interviews conducted with the Medical Examiner, the Pathologist, the Chief Medical Officer and 7 of 7 operating room staff interviewed (Registered Nurse (RN) D, RN E, RN Y, Scrub Technicians F and G, Certified Registered Nurse Anesthetist C and General Surgeon K).

In August 2024, during a scheduled splenectomy (a surgical procedure to remove the spleen), Surgeon A mistakenly removed Patient #1's liver instead of the spleen. The operative report documents that the spleen was removed. The operative report failed to mention the patient's abdominal distention, failed to mention the presence of a megacolon (a condition where the colon, or large intestine, abnormally dilates - become wider and larger), and failed to mention the removal of the liver. Additionally, the operative report contradicts portions of staff interviews regarding clamp usage, the sequence of events, the timing of the hemorrhage (severe bleeding), and the cause of death. The operative report documents "no complications".

The findings include:

A review of the operative report dated 8/21/24 for Patient #1 found the report was electronically signed and verified by Surgeon A on 8/21/24 at 9:14 PM Central Daylight Time. Surgeon A was listed as the only surgeon. The "Indication for Surgery" and "Preoperative Diagnosis" were documented as "Splenic laceration with Hemoperitoneum; Severe splenomegaly; Splenic 10 millimeter arterial aneurysm and left upper quadrant abdominal pain." The post-operative diagnosis was "Intra-abdominal hemorrhage associated with splenic artery aneurysm rupture and cardiac arrest." The section for "Complications" indicated "none apparent." The operative report lacked identification of the members of the surgical team (the assistant and scrub technicians). The pathology tissue request documented the specimen as "spleen tissue." Surgeon A indicated the "spleen measured roughly 30 x 22 cm (centimeters). Surgeon A described the introduction of the laparoscopic camera into the abdomen, then indicated "Significant hemoperitoneum (blood in the abdomen) was noted. Extensive adhesions were noted around majority of the spleen, the spleen noted to be quite enlarged." Surgeon A indicated using wound retractors placed into the fascial defect, appropriate positioning was achieved. "At this point using hand assist technique adhesions on the anterior surface of the spleen were carefully taken down utilizing laparoscopic hand assist technique. The entire spleen was exposed noted to be severely deformed. Hemoperitoneum was noted but no active hemorrhage (no active bleeding) was appreciated. Splenic laceration was appreciated at the inferior pole. No active bleeding was noted at this time. Large size of the spleen we elected to convert to open procedure." The surgeon then made an "epigastric midline incision," entering the abdomen and documented, "spleen noted to be quite friable and certainly the large size made the dissection challenging. Spleen was mobilized medially to expose the retroperitoneal attachments. The splenorenal and splenophrenic ligaments were carefully taken down and ligated with energy device." ..... "Spleen was circumferentially dissected free from surrounding structures and was very mobile. At this time attention was turned to the splenic hilum. Splenic artery and vein were carefully dissected out from the surrounding tissue. Splenic artery aneurysm was appreciated at the hilum. The plan was to perform ligation of the splenic artery first and subsequently splenic vein second. Plan to perform ligation of the splenic artery close to the spleen at the hilum proximal to the aneurysm. Just prior to achieving control of the splenic artery with Endo GIA (brand name) stapling device vascular load (instrument which simultaneously lays down a staple line and transects the tissue, veins, and/or arteries ) unfortunately the aneurysm was noted to rupture. Extensive intra-abdominal blood loss was sustained severely precluding visualization of key anatomical structures at the hilum." ... "Sponges gradually removed from left upper quadrant and with great difficulty during ongoing bleeding I was able to control the ruptured aneurysm with surgical clamp and then gain definitive control with Endo GIA stapling device vascular load 60 mm. Next, splenic vein was ligated also with Endo GIA stapling device vascular load 60 mm fire." ... "Spleen was removed and passed off the field for pathology."

The word "liver" appeared nowhere on the operative report. The report also did not mention the abdominal distension or severe megacolon described by operating room staff.

Pathologist:

A review of the surgical pathology report, dated 8/23/2024 at 2:17 PM found the comment, "no splenic tissue identified, case discussed with (Surgeon A)" The report indicated that the tissue designated as spleen was "Liver with mild chronic portal inflammation".

On 09/10/2024 at approximately 1:45 PM an interview was conducted with the Pathologist. He stated the whole organ was received in a specimen bucket labeled as "spleen", however, he did not see the specimen only photos. He received about 8-10 slides to review. He states he was able to "diagnose it within a millisecond, pretty obvious it was the liver." From the pictures and histology, there was little question about portal inflammation but otherwise the liver, was a little heavy -as upper limits are 1800 grams, and this one was about 2100 grams.

Medical Examiner:

On 09/11/2024 at approximately 1:00 PM a telephone interview was conducted with the local Medical Examiner (ME). The ME stated they were initially notified of Patient #1's death on August 21st. Initially the ME's office was informed that this was an inpatient death from complications of splenectomy. We were informed the death was not due to trauma but a cyst, and we declined jurisdiction. We were then renotified on August 25th or 26th by the Risk Manager who said we need to tell you this death is not how it was reported, the liver was removed. The autopsy confirmed there was no liver. The liver was perfectly dissected off the diaphragm. As a forensic pathologist, that is one of the hardest things to learn to do. "Essentially the liver was autopsied out of that man". There was no evidence of cross clamping, no sutures, no evidence of cautery. The Inferior Vena Cava (the major vein that brings oxygen-poor blood from the lower body back to the heart) was clearly dissected by the surgeon. Everything surrounding this liver was completely untouched. The spleen showed no evidence of aneurysm, no rupture, and no evidence this spleen was touched. The spleen stayed where it was born to be. The spleen was 420 grams total. There was no evidence it was touched, not even looked at. The Medical Examiner said that a man's liver is between 1800 and 2800 grams. The size of a man's spleen is typically between 200 and 350 grams, but a diseased spleen can be bigger. The ME stated the biggest he/she has seen was 800 grams.

Interviews with Operating Room Staff:

Staff Member Y, an Operating Room RN (Registered Nurse):

On 09/10/2024 at approximately 2:15 PM an interview was conducted with RN Y who indicated she was working another case across the hall and didn't enter the OR (operating room) of Patient #1 until after the time of death. When she entered the room, the Scrub Tech (Technician) and RN Circulator were present and asked her to get the CMO (Chief Medical Officer). RN Y stated that the CMO came into the OR and that is when the specimen was discussed. The specimen was pulled out of the bucket, and we all were like "in shock." Immediately the CMO contacted the pathologist and had the specimen walked to the lab. People in the room said "this looks like liver to me." RN Y "we all were like this is definitely not the normal anatomy of a spleen. You can tell between a liver and spleen. Basic knowledge of anatomy." She went on to say that before the code had occurred, she was being nosy and looked through the OR window and "all I could see was a huge megacolon" (a condition where the colon, or large intestine, abnormally dilates - become wider and larger). RN Y recounted, after the patient's death, how Surgeon A came back into the OR, not once but three times to state to them that the patient suffered a 'splenic aneurysm' and there was nothing that could be done to save him. He also came in to ask for the measurements of the spleen.

Staff Member F, an OR Scrub Technician and First Assistant (Scrub Tech F)

On 09/10/2024 at approximately 3:14 PM an interview was conducted with Staff Member F, an OR Scrub Technician and First Assistant. Scrub Tech F stated she was informed by the RN Circulator of the patient's abdomen being distended, and because of what case we were doing we were guessing it was blood pooling. Scrub Tech F thought that procedurally, we would have problems with visualization. Scrub Tech F went on to describe the surgical procedure. She stated they put the trocars (which creates an access point into the abdomen) in and saw there was blood on both sides of the abdomen, but not an insane amount. Right away we noticed how dilated the colon was. We could see this on the screen. Visualization was tight because of the colon. She said the surgeon put in 3 trocars (1 big and 2 small). Again, not able to see a lot. The hand port went in, which allowed the surgeon access with his hand. He did not have wiggle room, very limited due to the size of the colon. It was at that point we bailed on the hand assist and went to open. As soon as the surgeon made the abdominal incision, the "bowel is spilling out". She said to the surgeon that it looked like a "megacolon," in which Surgeon A replied it was a "volvulus of the colon." (volvulus is when the colon twists around the tissue that holds it in place). She indicated the surgeon is dissecting; she is retracting with one hand and suctioning with the other and still holding back bowel to allow visualization. Another staff (RN E) came in to assist with retracting and then a third scrub technician, Scrub Tech G assisted. Scrub Tech F stated the surgeon is dissecting, got bleeding, and recalls the surgeon stating there was a tear in the spleen. Bleeding increased a bit and we asked for a second cell saver (a device that collects and returns a patient's blood during surgery, which is then transfused back into the patient), as one was not keeping up. Surgeon A asked for a stapler, vascular load (stapling device used in critical vessel transection), after the first staple that's when we got into the horrible bleed. Once into the bleed, there was no going back and we never had visualization again. There was no specimen at that time, just dissection. Cardiopulmonary Resuscitation (CPR) was started, and the surgeon continued to work during compressions. She recalled, stepping aside and seeing, with both hands, Surgeon A take the specimen out and lay it on the drape. All the techs, we immediately noticed; 1. That doesn't look like a spleen and 2. It was massive compared to what you thought in your brain it was going to look like."

Scrub Tech F stated at one point Surgeon K came in, he asked what happened, she thinks she told him, but couldn't answer his questions. She was trying to keep it together and not cry. Scrub Tech F stated Surgeon K went around to the back table and stated to Surgeon A - "It looks like the liver to me," in which Surgeon A replied "no that's the spleen."

Scrub Tech F stated she and RN E were talking amongst themselves that the specimen looked like the liver. She stated on the underside of the liver it looked like a space where the gallbladder had been. She asked the CRNA (Certified Registered Nurse Anesthetist) if the patient had had a previous cholecystectomy (gall bladder removal), she was told "yes". When the CMO (Chief Medical Officer) was asked to come into the OR, we asked if this was a safe place to talk. He replied "yes". We told him, "none of us think what he took out is the spleen, it looks like the liver". That is when the CMO looked at the specimen and called pathology. Scrub Tech F added that Surgeon A, came back into the OR multiple times and kept telling us the spleen had an aneurysm, and it ruptured and was re-iterating that to us, and after a 3rd time, asked Scrub Tech G, to measure the specimen.

Scrub Tech F, said she looked at Surgeon A's operative note, and it "never mentioned the colon." Scrub Tech F stated the colon was a major factor in this case and she was taken back that the report never mentioned the colon. Scrub Tech F stated the Operative Note indicated "he was able to control bleeding with a clamp, but not one time did he ever ask for a clamp. Which is the one instrument you need to stop bleeding. Bleeding of that magnitude you're not going to cauterize. He never asked for clamp." Because there was no clamping or trying to cut off bleeding to find the source, we were literally drowning. She said she never had eyes on the spleen, and never had eyes on the liver until it was removed.

Staff Member G, OR Scrub Technician

On 09/11/2024 at approximately 8:24 AM, an interview was conducted with Staff Member G an OR Scrub Technician. She states she came into Patient #1's operating room around 6:10 PM because she received a text message from RN H indicating they needed an extra set of hands. She said when she scrubbed in, Surgeon A was ligaturing a bunch. She had no visualization because she was near the patient's feet. They were using "turtle drapes", which have pouches all around and every part was megacolon. When I came in it was pretty bloody but assumed from the megacolon, these pouches were all colon. She remembers Surgeon A asking for a GIA stapler with vascular load of 60 and then asked for another cell saver suction, and asked for 3 more stapler loads, which is a lot. At this point he started bleeding a lot. She recalls while doing a staple load, she reached out with a Kelly clamp multiple times. She indicated, when trying to achieve hemostasis, you clamp and then do cutting. "He (Surgeon A) never took it [the clamp]". Scrub Tech G stated at that point we start coding the patient. Compressions started. She recalls when she began compressions (during her 2 minutes) the specimen came out - that was when she saw the liver on the table and thought why is he doing that? I saw 3 lobes and the concave space from where [Patient #1's] gallbladder had been. She stated that everyone knew it was the liver. They asked the CMO to look at the specimen. That was when the CMO looked at the specimen, turned back around, his 'eyes wide' said to "get it to the pathologist now."

Staff Member D, RN Circulator (RN D)

On 09/11/2024 at approximately 9:00 AM a telephone interview was conducted with Staff member D, RN Circulator. RN D stated Surgeon A started the case laparoscopically, noticed some blood in the abdomen and he had megacolon which made it difficult to view. At that time, Surgeon A was going to open (midline incision). The patient's abdomen was distended. We opened and at that time, we're moving the colon around to get out of the wound and suctioning some blood which was minimal. Surgeon A asks for the GIA stapler. She stated normally when working on the spleen, you identify and clamp the splenic artery and vein. She said she didn't have a good view. The surgeon was the one looking down into the abdomen. She says he fired the first staple and ask for 3 more loads. Then the patient hemorrhaged. We went from minimal suction to suctioning a lot of blood, asked for a 2nd cell-saver (a device that collects and returns a patient's blood during surgery, which is then transfused back into the patient). My first thought was he didn't have control of the splenic artery and vein or the hemorrhage. The code was called and we were busy dealing with the hemorrhage, helping anesthesia and hanging blood. During this time, I saw the specimen on the table. "It looked like the liver and I felt sick to my stomach, [I] knew if he took part of liver we weren't gonna be able to stop the bleeding". She asked the surgeon to identify the specimen. She stated that she is instructed to write down what the surgeon says, and he said "spleen, the spleen," I thought "excuse me?" Surgeon A insisted that was what it was, and that's what I labeled it as. "I knew in my heart it was the liver." Surgeon A stated to them, "You guys realize the patient died because he had a splenic aneurysm." We just looked at him and didn't respond. So when he walked out of the room, we looked at each other and agreed that looks like the liver. She described the spleen was smaller with pimple like rough area. The liver is purplish and smooth. Surgeon A came in again and again, reiterating the cause of death - splenic aneurysm. RN D added it was like he felt if he regurgitated enough we would repeat it. No one responded.


Staff Member E, RN Scrub (RN E)

On 09/11/2024 at approximately 01:45 PM, a telephone interview was conducted with Staff Member E, an RN Scrub was part of the surgical team for Patient #1. RN E also provided a written statement with her account of the events. RN E said, the patient had a large abdomen and Surgeon A couldn't reach or see the spleen adequately; that was when the case went from laparoscopic to open. The colon was huge, megacolon everywhere, and Surgeon A had to push bowel out of the way. RN E says she was holding retractors and didn't see either the spleen or the liver until the liver was on the table. RN E says there was bowel all around the sides and the bottom. The surgeon had a good working space, I could see vessels but I couldn't identify or tell the difference between the spleen and hepatic artery, he could see the vessel. RN E added, in my opinion you see a large vessel you clamp it and cut it. Surgeon A did not use a clamp at any time and started to cut. Patient #1 had other issues and a large abdomen, megacolon, and reaching in there, Surgeon A should have known that if the spleen was moved over, he should have known all of that.

RN E revealed, Surgeon A points out a vessel he intends to locate, and cuts with Ligasure (instrument used to dissect and seal blood vessels) and it starts bleeding profusely. He continued to Ligasure and the heavy bleeding stops. Surgeon A wraps finger around the area he intends to cut next and said "oh that's scary" then said he could feel the heart/aorta beating under his finger. Surgeon A then asks for a (brand name) powered stapler with a vascular load and kept saying he was having trouble getting the stapler around the structure, gets it around and fired the stapler. The heavy bleeding starts again, another suction (cell saver) is obtained. There is more blood coming out than the two suctions can handle. Surgeon A asks for another stapler load and fires the stapler blindly straight down into the bloody area. RN E reports that Anesthesia (Staff Member C, CRNA - Certified Registered Nurse Anesthetist) states, Patient #1 is hypotensive and about to code. Staff C then states the patient is coding begin CPR. RN E reported, "I immediately started chest compressions while the nurse calls code blue" While the code is going on, RN E reported that Surgeon A took out the liver and placed on patients' legs and "I put it on the table". The CMO was in the room. We looked at the specimen and told him it was the liver and he needed to look at it. She said the CMO looked at the specimen and said he was calling pathologist. RN E report the CMO's expression looked shocked looking, but she did not hear him say anything at that time. RN E stated, "I then looked in the abdomen for the liver and could not find it. I asked (Staff F, Scrub Technician) to also look in the abdomen for the liver and neither of us could see it." After the time of death, Surgeon A left the room. He came back in twice telling us that the patient had a splenic artery rupture and that is why he died.


Staff Member K, a General Surgeon:

On 09/12/2024 at approximately 01:00 PM an interview was conducted with Staff K, a general surgeon. Surgeon K said, I received a STAT request to come in to assist. I was in the medical office building across the street and came over. Compressions were in place, the CMO was running the code, then he called the code about 10 seconds later. Surgeon K stated that he observed the organ on the back table. "I did not say anything. (Surgeon A) made a comment and identified it as the spleen, I gave him the eye and walked away". Surgeon K stated that with his knowledge and expertise he would identify the specimen as the liver.


Physician M, The former CMO:

On 09/16/2024 at approximately 04:00 PM an interview about OR documentation was conducted with Physician M, the former CMO of hospital. Regarding medical documentation, Physician M said that in general, what is charted is considered accurate, we rely on the physicians to document. We have too many physicians to review [documentation for accuracy]. Physician M was asked about the Operative Report omitting the megacolon. Physician M indicated that he would expect clinically significant findings to be documented. If the nurse/scrub technician indicated this was significant, "I would say the OR staff are a better judge than me, then I tend to believe them at least."

Current CMO:

On 09/16/2024 at approximately 06:00 PM a telephone/zoom interview was conducted with the current CMO who stated that he was contacted by RN Y that a code blue was called, and then received a text from the anesthesiologist that they were coding Patient #1. I went into the operating room and staff were in active resuscitation. The procedure was a splenectomy, and I saw the organ was on the table. The CMO stated that it was apparent that it was not the organ (Surgeon A) had intended to remove. The CMO stated that he was notified afterwards by the pathologist that it was the liver.

Staff Member C, Certified Registered Nurse Anesthetist (CRNA C):

On 09/20/2024 at approximately 1:43 PM, an interview was conducted with Staff Member C, Certified Registered Nurse Anesthetist (CRNA), who stated he has worked with Surgeon A quite often, but had not been through a splenectomy with him. CRNA C stated that the surgical plan was for laparoscopic hand assisted procedure, and that he was able to see the screen but did not see the spleen, there was mostly bowel on the screen not able to see much else. After about 15 minutes Surgeon A converted to an open case. CRNA C stated that Patient #1 remained stable, the vital signs were normal, Surgeon A was exploring the abdomen, and Surgeon A made a remark about wondering what was going on here, and kept exploring going from left to right side. Surgeon A commented on the bowel distension, and it appeared he was struggling. CRNA C did not recall Surgeon A asking for a clamp. At 6:23 PM, Surgeon A was briefed on patient's status and EBL (estimated blood loss) which was less than a liter and transfusion of blood products as continuing at that time. At 6:30 PM, Surgeon A was made aware of changes in hemodynamics and the code cart and all available blood products were brought into the room. CRNA C stated that a code was called 5 minutes later (6:35 PM) and we all started working on resuscitation, except for Surgeon A, who remained in the patient's abdomen, while staff were rotating and performing chest compressions. CRNA C stated that during chest compressions, he saw them passing an organ off, and Surgeon A remained in the abdomen. CRNA C recalled seeing Surgeon K walk to the foot of the bed looked at the specimen. CRNA C stated that he recalled a woman's voice stating, "That's the fucking liver".

Surgeon A:

On 09/20/2024 at approximately 10:00 AM an interview was conducted with Surgeon A who described the surgical procedure for Patient #1. Surgeon A stated he was positioned on Patient #1's right to be opposite from target organ so that he could look at it straight. During the Laparoscopic hand assist procedure, Surgeon A stated he saw a massively distended colon as Patient #1 had a belly full of blood and blood is irritant to bowel. Surgeon A commented, that the bowel was so massive, it was obliterating any visualization. The blood was bright red and fresh with a lot of blood clots and a large hematoma on left side. Surgeon A stated he was able to visualize the spleen after moving the colon. Surgeon A describe the spleen as irregular shaped with a large amount of blood around it, deformed and large. Surgeon A identified the spleen visually on the monitor with the scope and used his left hand to bring it into the field. Surgeon A stated he also visualized other organs to include the small and large intestines, liver and diaphragm. Surgeon A stated he made the decision to convert to an open case when realized hematoma, amount of blood, colon and Patient #1's deteriorating clinical situation. Surgeon A indicated that once opened, the colon was so large they had to fight and battle with it to gently visualize key structures, spleen and surrounding structures. Surgeon A stated that he was aware of the large colon prior to surgery from a CT scan (computed tomography imaging test) and abdominal distention. Surgeon A stated he identified the liver out of left corner of his eye. Surgeon A stated that the liver looks different than the spleen. He described a liver as having 2 lobes, slightly different in color, and more reddish in appearance. Surgeon A described Patient #1's spleen as large, deformed, had a cyst and was significantly enlarged with a tear and bluish in color.
Surgeon A confirmed visualization of liver and spleen and used a surgical knife (Ligasure) to dissect around the spleen, as Patient #1 had extensive adhesions, and it helped to prepare to loosen the spleen and help to remove it. Spleen had old blood like a hematoma and fresh blood. Due to colon distension, large abdomen and deteriorating condition, I did trauma style incision to clearly identify anatomy, assisted by staff to have clear view of field.
Surgeon A stated multiple times spleen was visualized and that it was deformed and enlarged. Surgeon A stated he was not able to completely dissect the spleen free, and he visualized what he
thought was an aneurysm and prepared to take control of it. Surgeon A stated that it was difficult to see due to a large hematoma around spleen and active blood coming from somewhere. Assistants were working hard to suction blood, pushing colon out of the way, retract and look.

Surgeon A stated he reached in with his left hand and brought spleen forward and felt the artery, but before he could control the aneurysm there was a large pool of blood to the point it was exsanguinating. Surgeon A stated that it was so much blood we could not stay up with it. We had to get another suction device and activated Mass Transfusion protocol due to life threatening catastrophic hemorrhage, trying to get it under control. Surgeon A stated he did not use stapler until after the hemorrhage started. Surgeon A stated the spleen was still attached and had adhesions, and he used an energy device to take down adhesions. Patient #1 was bleeding faster than we could continue to support and replace him with blood products. His main concern was to get control of bleeding. Surgeon A stated that despite best efforts, they could not see the source of the bleeding and the patient was getting progressively worse and went into cardiac arrest.

Surgeon A revealed he used clamp over the splenic artery before using the stapler device, and before any bleeding or cutting occurred. Surgeon A stated he had to remove the clamp in order to utilize the stapler device because the clamp was in the way. The patient was not bleeding profusely when the clamp was removed, it happened when he prepared to introduce the device. Surgeon A stated he but put stapler device down because before you can staple you have to be able to see what you are stapling. It's a surgical instrument.

Surgeon A stated the stapler device was introduced after about 15 minutes of cardiac arrest as a last resort hoping that if he could get control of the aneurysm that would give Patient #1 a fighting chance. Surgeon A stated that he reached in with left hand and again this is blind, belly full of blood and colon in the way, he identified what he felt were the spleen and the aneurysm and tried to staple below that. This was happening during chest compressions. He stated he used 2 fires with the stapling device across the hilum of the spleen, and removed the organ, after 5-7 minutes later we called the code and had no progress.

Surgeon A stated he gave the organ to his assistants who asked him what it was, and he told them it was the spleen. Surgeon A stated that no one informed him that it was the liver. Surgeon A confirmed that he did go down to the laboratory after the procedure to inspect the specimen but it did not click with me, I was distraught. Surgeon A added that he found out it was the liver 2 days later when the pathologist (Staff T), called him and told him the specimen was the liver.

Surgeon A stated that he called the CMO and told him it was the liver. Later that day the CMO then informed him there would be an investigation.

Surgeon A verified that the operative report was true and accurate to best of his knowledge at the time and he has not made any addendums to the operative report learning it was the liver.