St Francis Hospital

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 51739 Based on review of hospital policy, facility documents, medical record review, and interview, the facility failed to provide evidence of an effective Quality Assurance and Performance Improvement (QAPI) program to track adverse patient events, analyze their causes, and implement preventive actions and mechanisms, including those services furnished under contract or arrangement for 4 of 6 (Patient #4, #12, #15 and #16) sampled patients reviewed for surgical procedures. The findings included: 1. The “Peer Review” policy dated 6/13/2024, revealed, “... PURPOSE: The primary purpose of peer review is to ensure that patients receive quality services that meet professionally recognized standards of health care via ongoing objective, nonjudgmental, consistent, and fair evaluation by the Medical Staff. The goal of peer review process is to... Monitor and evaluate on an ongoing basis, the professional competence of individual practitioners ...” 2. Patient #4 presented to Hospital #4 on 1/26/2025 at 4:36 AM with the chief complaint of Abdominal Pain and Vomiting. The patient had been treated for the Abdominal pain over the past 3 weeks, but the pain was accompanied by vomiting on this day. The patient had been under the care of the Primary Care Physician or Provider (PCP) and had undergone testing that revealed he had Cholelithiasis (stones in the gallbladder). Patient #4 was scheduled to see his PCP the following week but felt the pain was too severe on this day, that he could not wait until appointment time. At Hospital #4, Patient #4 had blood work and an abdominal ultrasound which was suspicious for infection in the gallbladder. The on-call general surgeon for Hospital #4 was consulted and the decision was made to send Patient #4 to Hospital #1 to undergo a procedure not available at Hospital #4, an Endoscopic Retrograde Choleangiopancreatiography (ERCP - which is a medical procedure that allows doctors to visualize and treat problems with the bile duct and the pancreatic ducts). Patient #4 was transferred to Hospital #1 via Emergency Medical Services (EMS). Patient #4 was admitted to Hospital #1 on 1/26/2025 where he underwent gallbladder removal by Physician #1 on 1/28/2025. Following the surgery, Patient #4 had increased pain and worsening of liver function tests (LFTs) which required another surgical procedure, an ERCP. Two stones were visualized during the ERCP and a stent was placed in the common bile duct. Patient #4’s condition continued to worsen and Patient #4 had a Computed Tomography (CT) scan of the abdomen and pelvis on 1/31/2025 which revealed perforation (a hole or tear in an organ) of the common bile duct. Interventional Radiology (IR) procedure on 1/31/2025 revealed an obstruction of the common hepatic duct. A 2/1/2025 Progress Note revealed Patient #4 appears to have an occluded common bile duct from surgical clips. The physician recommended immediate transfer to another facility for Patient #4. Patient #4 was transferred to Hospital #2 by EMS on 2/2/2025. At Hospital #2, Patient #4 underwent a surgical procedure to reconstruct the bile duct on 2/3/2025. After the procedure, Patient #4’s condition improved. Five days post surgical procedure, Patient #4 was discharged home from Hospital #2 on 2/8/2025 in stable condition. During a telephone interview on 7/7/2025 at 9:55 AM, Patient #4 stated, “ ...my personal thought is I didn’t really, I don’t think I received a very good standard of care ...which led to complications that I think could have been prevented ...at [named Hospital #2] they had to completely rebuild my bile duct system ...” 3. Patient #12 was admitted to Hospital #1 on 3/11/2025 with a diagnosis of Abdominal Pain and Cholecystitis (inflammation of the gallbladder). Patient #12 had a laparoscopic gallbladder removal on 3/17/2025, performed by Physician #1. Nine days later, on 3/26/2025, an ERCP was performed that revealed an occlusion of the common hepatic duct at the level of multiple surgical clips. The diagnoses was complete transection of the common hepatic duct (the duct is completely cut). The patient’s condition worsened and developed a mental status change. The patient passed away on 4/8/2025. 4. Patient #15 was admitted to Hospital #1 on 6/8/2025, with a diagnosis of Abdominal Pain. Patient #15 underwent a Robotic Assisted laparoscopic gallbladder removal on 6/9/2025, performed by Physician #1. The patient underwent a second surgical procedure on 6/10/2025 to repair a posterior cystic duct leak at the surgical double clip area. Patient #15 had developed Peritonitis (inflammation of the abdominal wall). Patient #15 was discharged home from Hospital #1 on 6/15/2025. 5. Patient #16 was admitted to Hospital #1 on 6/10/2025, with a diagnosis of Ventral Hernia. Patient #16 underwent a surgical procedure on 6/10/2025 for hernia repair, performed by Physician #1. The patient was taken back to surgery on 6/12/2025 for exploratory laparotomy after continuing abdominal pain and developing tachycardia. During the exploratory laparotomy, the abdomen was revealed to be full of fluid in the abdomen, and two areas where the bowel wall appeared bruised and the surgeon removed and reconnect the small intestines. Patient #16 was placed in the Intensive Care Unit (ICU) on 6/12/2025. On 6/13/2025, Patient #16 developed multiorgan failure and the patient passed away on 6/13/2025. Refer to A-0286”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 51739 Based on review of hospital policy, documents review, medical record review, and interview, the facility failed to provide evidence of an effective Quality Assurance and Performance Improvement (QAPI) program which tracked adverse patient events, analyzed their causes, and implemented preventive actions and mechanisms, including those services furnished under contract or arrangement for 4 of 6 (Patient #4, #12, #15 and #16) sampled patients reviewed for surgical procedures. The findings included: 1. The “Peer Review” policy dated 6/13/2024, revealed, “... PURPOSE: The primary purpose of peer review is to ensure that patients receive quality services that meet professionally recognized standards of health care via ongoing objective, nonjudgmental, consistent, and fair evaluation by the Medical Staff. The goal of peer review process is to... Monitor and evaluate on an ongoing basis, the professional competence of individual practitioners ... POLICY... Duties and Responsibilities ...A quality concern is a concern with a significant or potential for a significant adverse effect on the patient’s well-being ...When a process is dependent primarily on the activities of physicians, the Medical Staff will provide leadership for the process measurement, assessment, and improvement ...All proceedings, records and activities related to peer review are protected by the Tennessee Statutes, including but not limited to Tennessee Code Annotated [TCA] 63-6219 and 42-USC 11101 SEQ and therefore all discussions will remain privileged and confidential ...” 2. Review of the “Tenant Determination of Eligibility” dated 9/6/2024, for Physician #1 revealed, “ ...Have you ever had denial, revocation, termination, suspension, reduction, loss, condition, restriction, or limitation of your medical staff appointment membership and or privileges or is any such action pending in process? Yes... To your knowledge, has information pertaining to you ever been reported to the National Practitioner Databank or Healthcare Integrity and Protection Databank? Yes ...Have you had any malpractice actions within the past five years (pending, settled, arbitrated, mediated, or litigated)? Yes ...” 3. Review of the “National Practitioner Data Bank” dated 9/18/2024 for Physician #1, revealed “...Date of judgement or settlement: 10/15/2008 ... Description of the procedure performed: Laparoscopic Cholecystectomy [removal of gallbladder] ...Specification Allegation: Failure to recognize a complication ...Descriptions of the allegations and injuries or illness upon which the action or claim was based: negligence and performing a laparoscopic cholecystectomy [a surgical procedure to remove the gallbladder, often performed using a minimally invasive technique called ‘keyhole surgery’. It involves making small incisions in the abdomen and using specialized instruments, including a camera to guide the removal of the gallbladder], failing to identify the biliary anatomy [the network of organs and vessels that make, store and transfer bile through the body. [Bile is a fluid the liver makes that helps digest food in the body] and clipping the common bile duct [a tube-like structure that carries bile from the liver and gallbladder to the small intestine] and a portion of the hepatic artery [a blood vessel that supplies oxygenated blood to the liver]. The insured performed a laparoscopic cholecystectomy with intraoperative cholangiogram [x-ray using contrast dye to visualize structure and flow of biliary ducts] ...There was extensive inflammation and scar tissue which made the procedure somewhat difficult. The insured [Physician #1] felt that he was able to identify the cystic duct [a short tube that carries bile from the gallbladder to the common hepatic duct, forming the common bile duct] and the surgery proceeded. Approximately 5 days postoperatively, the claimant developed jaundice [yellow discoloration of the skin]. ERCP [Endoscopic retrograde cholangiopancreatography -x-ray to examine and treat the bile ducts] revealed blockage of the common bile duct from clipping. The claimant was transferred to [named hospital] in [named city] where the bile duct injury was repaired. However, the claimant developed an abscess [a collection of infection that forms within the body] of the liver, a urinary tract infection and pneumonia as complications of the surgery... Date of judgement or settlement: 6/22/2009 ... Description of the procedure performed: Patient presented with hernia [a protrusion of tissue or an organ through the muscle wall usually in the abdomen or groin area]... Specification Allegation: Improper Performance ...Descriptions of the allegations and injuries or illness upon which the action or claim was based: Hernia sac sent was found on microscopic exam to have colon tissue adherent [stuck] to it ...a small hole was found in the sigmoid colon [the part of the large intestine that is closest to the rectum or anus] ...” 4. Review of the Performance Guidance Council Minutes (Hospital #1’s QAPI program minutes) dated June 2024-May 2025 revealed no documentation the QAPI programs had reviewed surgical adverse events, tracking, trending, causes or preventive actions. 5. Medical Record Review for Patient #4 revealed presentation to Hospital #4 on 1/26/2025 at 4:36 AM with the chief complaint of Abdominal Pain and Vomiting. The patient’s abdominal pain was in the right upper quadrant (RUQ) region of the abdomen, radiated towards the epigastric area (discomfort or pain in the upper abdomen, specifically below the ribs and above the navel), associated with nausea. The pain worsened with food intake, and the pain has occurred intermittently over the past 3 weeks. The patient has been evaluated by his Primary Care Physician (PCP) and has had an ultrasound as well as a hepatobiliary scintigraphy (HIDA scan - a nuclear medicine imaging test that assesses the function of the liver, gallbladder, and bile ducts) which showed cholelithiasis (a hardened deposit within the fluid in the gallbladder; may also be known as a stone) without acute colic (a sudden, severe, and often spasmodic pain in the abdomen or flank area, typically caused by the obstruction of a hollow internal organ.) The patient was also evaluated by gastroenterology (GI) and was told his blood work was normal. The patient was seen in the Emergency Department multiple times with ‘gallbladder flareups.’ The patient began vomiting on 1/25/2025 at 6:00 PM with severe abdominal pain in the RUQ; the pain began radiating to the back around midnight. The patient stated he had an upcoming appointment with the PCP the following week, but the pain was unbearable and could not wait until the scheduled appointment. The patient was seen a few days prior to this Emergency Department (ED) visit, and had an ultrasound confirmed Cholelithiasis. The patient stated at that time there were no stones in the bile duct and there was no infection present. Patient #4 also has a history of Type 1 Diabetes and Hypertension. The ED Provider at Hospital #4 documented on 1/26/2025 at 4:50 AM the patient had abdominal tenderness in the right upper quadrant and epigastric area. Laboratory testing was performed as well as an abdominal ultrasound. Patient #4 had the following elevated lab values: bilirubin (a yellowish substance found in bile, a digestive fluid produced by the liver) - 4.6 (normal adult level is 0.2 - 1.3); Aspartate Aminotransferase (AST - an enzyme found in various tissues, including liver, heart muscles, and kidneys; high levels can indicate damage or disease in these organs, particularly the liver) - 322 (normal level for adult man is 8-48; normal level for adult female is 8-43); Alamine Transaminase (ALT- an enzyme found primarily in the liver; elevated levels in the blood can indicate liver damage or disease) - 442 (normal level is 0-45); Alkaline phosphatase (ALP - an enzyme in the blood found in tissues, primarily the liver and bones; helps diagnose and monitor liver and bond conditions) -233 (normal level is 40-140). The ultrasound of the abdomen performed at Hospital #4 on 1/26/2025 at 7:04 AM revealed Cholelithiasis with gallbladder wall thickening and trace pericholecystic fluid (the presence of fluid around the gallbladder, often indicative of infection or inflammation) suspicious for acute cholecystitis (inflammation of the gallbladder). The common bile duct measures at the upper limits of normal. On 1/26/2025 at 8:18 AM, the ED provider at Hospital #4 discussed Patient #4’s case with the on-call general surgeon for Hospital #4. Their opinion was that Patient #4 needed to be transferred to another hospital that had capability to perform an Endoscopic Retrograde Cholangiopancreatography (ERCP - combines endoscopy and x-ray imaging to examine and treat problems in the bile and pancreatic ducts). Patient #4 was transferred from Hospital #4 via Emergency Medical Services (EMS) on 1/26/2025 at 10:34 AM to Hospital #1 in stable condition. Patient #4 was admitted with a diagnosis of Choledocholithiasis (gallstone blocked common bile duct). Patient #4 was scheduled to undergo a Laparoscopic Cholecystectomy (minimally invasive surgical procedure to remove the gallbladder) with Interoperative Cholangiogram (an x-ray of the bile ducts typically performed during gallbladder removal surgery) to be performed by Physician #1. Review of the “Laparoscopic Cholecystectomy with Interoperative Cholangiogram” dated 1/28/2025 performed by Physician #1, revealed “...gallbladder very large and inflamed... enlarged cystic duct 5 times normal size ...instead of placing clips over it with a high chance of falling off I decided to use an endostapler [a surgical stapling device used in minimally invasive procedures to join or fix tissues within the body] to completely transect [cut] the cystic duct and infundibulum [a funnel-shaped area connecting the body of the gallbladder to its neck where it joins the cystic duct]...due to inflammation which was severe in all areas, multiple clips were used along with cautery [a medical procedure that involves heat to destroy or remove tissue, often to stop bleeding]... the anatomy test was not correct to finish a cholangiogram safely ...” Review of the “Physician Progress Note” dated 1/29/2025, revealed “ ...worsening of Liver Function Tests (LFTs- a group of blood tests used to assess the health and function of the liver) ...patient also with increasing right upper quadrant and epigastric pain...we’ll plan for an ERCP for biliary decompression [the process of relieving pressure and obstruction within the biliary system, which includes the liver, gallbladder, and bile ducts] and stone removal today ...” Review of the “ERCP Procedure” dated 1/29/2025, revealed “ ... injected contrast [known as contrast dye or medium, is a substance used in medical imaging to enhance the visibility of internal body structures, making it easier to diagnose conditions] extended through the entire biliary tree ... 2 stones were observed ... in the common bile duct ... multiple attempts at balloon sweeps were only partly successful with removal of small stone fragments and sludge [a buildup of thick, pasty material in the gallbladder]... large stone kept moving above the level of the balloon and I could not get the balloon above the stone ... tried a basket but the stone would not still grip ... tried placing a plastic stent [a small, mesh tube device that is inserted into a body passage, like a blood vessel or other hollow structure, to help keep it open] but still could not get over the stone ... eventually decided to place a metal stent which I was able to get over the stone into the common hepatic duct above the level of obstruction ...” Review of the “Computed Tomography (CT) of Abdomen and Pelvis” dated 1/31/2025, revealed “ ...air within the abdomen status post ERCP suggesting perforation [a hole or opening in a body organ or tissue during a surgical procedure] of the common bile duct during ERCP ...common bile duct stent is present and extends the level of the cystic duct remnant and positioning is indeterminate [not exactly known]... multiple cervical clips within the gallbladder fossa [a shallow depression or indentation on the surface of the liver, specifically located between the right and quadrate [undersurface] lobes. It serves as the anatomical location where the gallbladder resides, storing bile produced in the liver] ...interval development of free fluid surrounding the liver and within the pelvis surgical drain and stable position interval development of small right pleural effusion [a buildup of fluid between the tissues that line the lungs and the chest] and basilar atelectasis [the collapse of the lower lobes of the lungs]...” Review of the “IR [Interventional Radiology] Placement Biliary Drain Cath [Catheter]” dated 1/31/2025, revealed “ ... Cholangiogram demonstrates diffuse intrahepatic biliary dilation [abnormal widening of the bile ducts within the liver] with obstruction of the common hepatic duct high within the porta hepatis [a deep groove on the inferior of the liver] ...unsuccessful attempt to access across the common hepatic duct obstruction. Level of obstruction appears to be above the level of the original cystic duct. Existing common bile duct stent does not align with the true lumen of the common hepatic duct above the level of obstruction ...multiple surgical clips just below the level of the common hepatic duct obstruction which could be the underlying cause for obstruction at this level ...” Review of the “Physician Progress Note” dated 1/31/2025, at 2:42 PM revealed, “ ...due to elevated bilirubin [a yellow substance formed during the breakdown of red blood cells] patient went to IR transhepatic drainage [a procedure to remove bile from the liver when a blockage prevents normal flow into the small intestine] today ...radiologist noted 3 possible scenarios of a common bile duct blockage ...spoke to the family about options ...additional option was hepatobiliary surgeon [a general surgeon who specializes in the diagnosis and surgical treatment of diseases affecting the liver, gallbladder, bile ducts and pancreas] and immediate transfer [to another hospital who has a hepatobiliary surgeon]...family is considering their options at this point no general surgical intervention recommended at this time ...” Review of the “Physician Progress Note” dated 2/1/2025, revealed, “...appears to have an occluded common bile duct from surgical clips ... concern regarding wire tip perforation of the common bile duct ...likely he will need repair of the common bile duct ...ideally to be in a tertiary center with a hepatobiliary surgical availability ...recommend immediate transfer in that regard ...” Review of the “Discharge Summary” from Hospital #1 dated 2/2/2025, revealed “...patient transferred to Hospital #2 per hepatobiliary [refers to the liver, gallbladder. and bile ducts, collectively forming the hepatobiliary system] surgery consult [consultation] for repair of common bile duct ...” Patient #4 was transferred to Hospital #2 via Emergency Medical Services (EMS) on 2/2/2025, at 11:42 PM. Patient #4 was admitted to Hospital #2 on 2/2/2025. Review of Hospital #2’s “Assessment and Plan” dated 2/2/2025, revealed, “ ...presents as a transfer from Outside Hospital [OSH - Hospital #1] after cholecystectomy on 1/28/2025, and post-operative course complicated by bile duct injury ...” Review of Hospital #2’s “Operative Report” dated 2/3/2025, revealed, “ ...Mild gentle dissection of the abdominal peritoneal spaces revealed bilious fluid in the right upper quadrant ...numerous metal staple fragments and clips present ... identified a large clip in the hilar plate...examined the porta hepatis... numerous metal staple fragments and clips present ...a stone was noted free in the right upper quadrant ...” After receiving surgical intervention on 2/3/2025, Patient #4 improved planned to be discharged from Hospital #2. Patient #4 was discharged from Hospital #2 on 2/8/2025 to his home. During a telephone interview on 7/7/2025 at 9:55 AM, Patient #4, complainant stated, “ ...my personal thought is I didn’t really I don’t think I received a very good standard of care ...which led to complications that I think could have been prevented ...at [named Hospital #2] they had to completely rebuild my bile duct system ...my bilirubin was still continuing to climb and by that point I was starting to turn jaundice ...they thought that there was a stone in it and they had another surgeon go in and to try to see if they could remove the blockage ...that was unsuccessful ...by Friday I was throwing up all and fully starting to turn yellow and that’s when the head radiologist decided to come in and put a drain tube ...that is when he discovered there were staples ... I received a bill for all three procedures ...after that third procedure [named Physician #1, Physician #2, and Physician #3] said there was another procedure that they could do, to try to help but it only would have about a 20% success rate ...they called it a hail Mary ...the other option they gave me was if I waited until Monday that they would bring in another surgeon from another hospital that had “special privileges” to be there ...[named Physician #1] said, “well I got his gallbladder out so I’m done” ...at that point it was between me and my wife we decided the best thing for us to do is to get out of there ...[named Physician #2] told us for what needed to be done, couldn’t be done at [named Hospital #1] and to transfer and that’s when we requested the transfer ...” There was no documentation provided by Hospital #1 that the hospital had reviewed surgical cases with post-op complications, analyzed cases of the post-op complications and developed and implemented interventions to prevent post-op complications. 6. Medical record revealed Patient #12 was admitted to Hospital #1 on 3/11/2025 with a diagnosis of Abdominal Pain and Cholecystitis (inflammation of the gallbladder). Review of the “Operative/Procedure Reports” dated 3/17/2025, revealed Patient #12 underwent a Laparoscopic Cholecystectomy (performed by a tiny video camera and special tools through several small incisions to see inside your abdomen and remove the gallbladder), performed by Physician #1. Patient #12 underwent this surgery 76 days after Patient #4 underwent a surgical procedure performed by the same physician. Review of Patient #12’s ERCP dated 3/26/2025, revealed, “ ...Common hepatic duct occlusion at the level of multiple surgical clips ...” Review of the Patient #12’a “ERCP Procedure” dated 3/26/2025, revealed, “ ...multiple clips seen in the area of the expected cystic duct and common hepatic duct with complete transection of bile duct at the level of common hepatic duct ... Diagnosis: Complete transection of common hepatic duct...Course: Worsening ...Patient will ultimately need to transfer to a facility where hepatobiliary surgery available ...” Review of the “Consultation Notes” dated 4/4/2025, revealed, “ ...I cannot explain her mental status changes or decreased mentation ...I think strong consideration for transfer to [named Hospital #3] or similar hospital with adequate coverage ...hesitant to proceed with any operative intervention here at the moment ...” Review of the “Discharge Summary” dated 4/8/2025, revealed, “ ...Status post cholecystectomy 3/17/2025, status post intrahepatic biliary drainage 3/26/2025, status post bile duct stent 3/31/2025 ...surgical oncologist recommend transfer patient to Hospital #3 for higher level of care ...However, patient appeared to be decompensating ...family at this time would like to focus on comfort ...Hospice consulted for General Inpatient Care (GIP) hospice evaluation ...admitted patient under GIP here at our facility ...patient passed away on 4/8/2025, at 7:43 AM ...” The hospital failed to provided evidence QAPI had analyzed and reviewed Physician’s #1’s post cholecystectomy complications for Patient #12’s surgical complications and no documentation of interventions to prevent post-operative complications. 7. Medical record review revealed Patient #15 was admitted to Hospital #1 on 6/8/2025, with a diagnosis of Abdominal Pain. The “Operative/Procedure Reports” dated 6/9/2025, revealed Patient #15 underwent a Robotic Assisted Laparoscopic Cholecystectomy with Infrared Fluorescence Imaging cholangiography (combines the benefits of robotic surgery with the enhanced visualization provided by fluorescence imaging to improve the safety and precision of gallbladder removal). This procedure was performed by Physician #1. Review of Patient #15’s “Exploratory Laparoscopy, Repair of Cystic Duct” dated 6/9/2025, revealed, “ ...posterior cystic duct leak at the double clip area ...Mild bile peritonitis [inflammation of the abdominal wall] ...Placement of 15 French drain [a medical device used for post-surgical wound drainage] ...” Review of the “Discharge Summary” for Patient #15 dated 6/15/2025, revealed, “ ...On presentation patient was septic secondary to acute cholecystitis. Patient underwent robotic laparoscopic cholecystectomy on 6/9/2025. Status post cholecystectomy patient continues to complain of severe abdominal pain and was taken back to the Operating Room (OR) and was found to have posterior cystic duct injury [damage to the cystic duct, which carries bile from the gallbladder to the common bile duct, during surgical procedures, particularly laparoscopic cholecystectomy]. Converted to open for cystic duct repair on 6/10/2025 ... Patient was also advised to follow-up with general surgery within 2 weeks of discharge ...” Patient #15 was discharged home from Hospital #1 on 6/15/2025. The hospital failed to provided evidence QAPI had analyzed and reviewed Physician’s #1’s post cholecystectomy complications for Patient #15’s surgical complications and no documentation of interventions to prevent post-operative complications. 8. Medical record review for Patient #16 revealed an admission to Hospital #1 on 6/10/2025, with a diagnosis of Ventral Hernia (a bulge or protrusion of tissue through a weakness or opening in the abdominal wall). Review of the “Operative/Procedure Reports” dated 6/10/2025, revealed Patient #16 underwent a Robot Assisted Incarcerated Incisional Hernia Repair (a minimally invasive surgical technique that uses a robotic platform to repair hernias that occur after previous abdominal surgery). Patient #16’s “Exploratory Laparotomy” dated 6/12/2025, revealed, “ ...abdomen was full of turbid [thick] appearing ascites [buildup of fluid in abdomen] and immediately below the midline incision a portion of small intestine was noted to be very thin ... Adjacent to this injured area of bowel were 2 areas where the bowel wall appeared ecchymotic [bruised] bordering on Ischemic [lack of blood supply] ... therefore, chose to resect this with the injured portion of the intestine ... transferred to the Intensive Care Unit [IC]) in critical condition ...” Review of the “Discharge Summary” for Patient #16 dated 6/13/2025, revealed, “ ...initially presented to the hospital on 6/10/2025, for robotic assisted incarcerated incisional ventral hernia repair ...6/11/25, patient [pt] continued to have abdominal [ABD] pain and tachycardia [heart rate greater than 100 beats per minute] ...CT [Computed tomography - medical imaging technique that uses x-rays to create detailed cross-sectional images of the body] ABD was done which showed large amount of free intraperitoneal air with free fluid suggest perforation of bowel ... Pt then taken to emergent OR [operation room/surgery] for repair on 06/12/25 [2025] ...developed Septic Shock [a widespread infection causing organ failure and dangerously low blood pressure] and required multiple vasopressors [medications that constrict blood vessels, increasing blood pressure and increasing blood flow to vital organs] and antibiotics...On 06/13/25 [2025], patient [Patient #16] continued to decline and develop multiorgan failure ...Family made the decision to make him a DNR [Do Not Resuscitate - a legal document that instructs healthcare providers not to perform cardiopulmonary resuscitation if a person’s heart stops or the person stops breathing] ...family made the decision to transition the patient to comfort care ...extubated [removal of tube from trachea after artificial ventilation], and pressors were turned off ...pronounced dead at 1606 [4:06 PM] on 06/13/25 [2025]...” The hospital failed to provided evidence QAPI had analyzed and reviewed Physician’s #1’s post cholecystectomy complications for Pt #16’s surgical complications and no documentation of interventions to prevent post-operative complications. 9. During an interview on 7/7/2025 at 12:00 PM, when the surveyor requested to interview Physician #1, the Administrative Director of Clinical Quality Improvement stated, “ ...he [Physician #1] just feels like he did something wrong ...so he doesn’t want to talk ...I won’t speak for him, but he’s been advised to not speak with anyone unless he has counsel present ...” When asked about peer review, the Administrative Director of Clinical Quality Improvement stated, “...unfortunately peer review is privileged and confidential ...” During a telephone interview on 7/8/2025 at 3:15 PM, when asked to explain why he decided to use an endostapler to completely transect the cystic duct for Patient #4 Physician #1 stated, “ ...in that particular case it was very inflamed and when it is so inflamed, the inflammation is wider than the width of the clip ...you can use a stapling gun, which staples on both sides and transects, cuts in half at that area so that’s what was used ...I never shot a cholangiogram because the anatomy was not correct to finish it safely without disrupting the little room needed for the important endostapling device ...” When Physician #1 was asked the reason he did not finish it safely, he stated, “ ...it was a very difficult case but when you’ve done as many as I have, I did as safe as I can with a very hard gallbladder ...” When asked if he knew he had stapled through the patients common bile duct he stated, “ ...I don’t remember that part but what I do remember is that the Gastrointestinal (GI) doctor was involved and then he shot a cholangiogram and then he ended up putting a stent ...then all I remember is I was at the bedside of the patient ...I told him well it’s either an injury that come from my clips or this stent that was put in went through the common bile duct ...I wasn’t notified that he requested transfer that evening ...we had planned that I was going to get around it they were going to fix it ...they never let us fix and they request to be moved that night ...there certainly wasn’t any urgency or anything at that time but that that was their request ...” When asked if he would have seen the stone or staples blocking the common bile duct he stated, “ ...no because I didn’t shoot him [the cholangiogram] because there was little room to do it safely ...there was too much inflammation to do it and not enough room to do it on the cystic duct ...” When asked if there was not enough room, why would he just not open the patient up, pivoting from a laparoscopic procedure he stated, “ ...I run across that weekly ...I’ve been doing this for decades ...you don’t know how many gallbladders I have taken out where there’s so much inflammation ...you do what you surgically are trained to do and that’s safe and that’s what I did ... and yes I do open some cases when I feel it needs to be ...so there’s no neglect or anything ... I didn’t think I needed to open him ...” When asked if he felt that he should have shot the cholangiogram he stated, “ ...you are not really doing it to find stones it’s just to make sure everything’s flowing correctly ... you’re just making sure you don’t injure the common bile duct ...stones are easily retrievable by ERCP ...so that’s the gold standard so you’re not shooting a cholangiogram to get rid of stones you’re just shooting the cholangiogram to make sure the anatomy’s good ...” When asked if he shoots a cholangiogram with every gallbladder procedure he stated, “ ...no, it is selective ... I shoot cholangiograms to find the anatomy if I feel there is inflammation and obviously everything doesn’t look normal that is when I shoot a cholangiogram ...” During a telephone interview on 7/8/2025 at 3:51 PM, when asked if he could disclose the peer review process, the Chief Medical Officer (CMO) stated, “ ...he [Physician #1] is under a Focused Professional Practice Evaluation [FPPE] and that’s all I am at liberty to talk to you about...we believe this will probably end up in a malpractice case...we advised them to have council when they spoke with you...they have been advised because of the nature of the case to make sure they stay within the bounds of discoverability ...” During a telephone interview on 7/8/2025 at 4:00 PM, when asked to tell me about his role in Patient #4 care, Physician #2 stated, “ ...so patient had gallbladder removed and the doctor called me next day and stated the patients bilirubin went up to six ...so typically right after the gallbladder surgery it’s one of two things ...most of the times it is a stone in the bile duct or two there is a bile leak ...either of which requires an ERCP ...I went in there and at a point I was hitting an obstruction ...there was a small stone and my thought was this was a stone that was what’s causing the obstruction, but I couldn’t get my stent in ... I was able to get a metal stent in ...the next day his symptoms got worse ...his bilirubin got higher so obviously this stent was not working ...called radiology to do a biliary drain ...when [named Physician #1] did the surgery he had completely clipped the common bile duct ...that explained in hindsight I could not get my stent up because that was completely clipped ...[named Patient #4} needed hepatobiliary surgery and we made the decision to transfer the patient ...” When asked if the common bile duct being clipped was something that could have been seen he stated, “ ...we want to see a good cholangiogram ...if it is going past the gallbladder most common interpretation is that there is an obstruction there, which is usually a big stone or a stricture ...clipping across the duct is extremely unusual, I have not seen one of these in practice ...to be honest the patient needed to be repaired and that was only going to be done by hepatobiliary surgery, which is why the patient was transferred ...we did not have hepatobiliary surgery available in [named Hospital #1] ...” When asked if he had any idea how that could have happened he stated, “ ...the surgeon over clipped it, that’s the only explanation ...what happened in this case is [named Physician #1] cut the cystic too close to the hepatic duct and clipped the hepatic duct closing the bile duct completely ...unfortunately it’s a narrowing inside the duct, there’s no way for me to get a stent through a clipped duct ...unfortunately the fix for that was something that could not be done at [named Hospital #1] ...I personally felt happy that he got transferred to [named Hospital #2] where he could get more appropriate care and in a timely manner ...” During a telephone interview on 7/9/2025 at 10:00 AM, when asked what is a peer review, the Administrative Director Clinical Quality Improvement stated, “ ...peer review exactly what it says, it typically is not someone that is part of the same team ...so for instance if we send an incident ...someone reviews the case based off of their history and determine if they felt like the quality of care was met ...” When asked to explain what a FPPE is she stated, “ ... that is when peer review finds that there are opportunities in a particular case to prevent it from happening again ...” When asked if there were any disciplinary actions against Physician #1, she stated, “ ...I do not know ...” Continued telephone interview on 7/9/2025 at 12:34 PM, when asked if she knew who reported the incident to risk management she stated, “ ...I don’t know because for instance there are times where the physician will call and say this was a complication that I had in a procedure ...we take that information and we send it to peer review ...they review for quality of care, utilization of resources, how was the behavior of the people involved, were there physician issues that need to be addressed, non-physician issues that need to be addressed ...they ask are there process changes which would prevent this from happening again ...” Continued telephone interview on 7/9/2025 at 4:00 PM, when asked if Risk Management reached out to the patient she stated, “no” ... When asked if the hospital billed the patient for the procedures related to the incident she stated, “ ...if it would have been something that the hospital may have caused then we would have put the account on hold until the complete review was done ...we did not hold his account ...the hospital is not responsible because the physician is not our employee ... he is considered a contractor ...” When asked what actions the hospital has taken in regard to Physician #1, she stated, “ ...I have to see what all I can release ...I will get my legal team involved ...” When asked about Quality Assurance and Performance Improvement (QUAPI) she stated, “ ...we call it Performance Guidance Council which is the meeting that I facilitate, but that does not go to peer review ...everything eventually goes up through the medical executive board as well as the governing board ... so the Performance Guidance Council would not discuss anything related to this incident ...unfortunately it’s protected and confidential information but it does go up through the medical executive board and the governing board ...I think it goes up through both ...” During a telephone interview on 7/9/2025 at 4:09 PM, when asked if he remembered Patient #4, Physician #3 stated, “ ...I’m very well aware ...I’m also part of the peer review committee at [named Hospital #1] and also the interventionist who was essentially brought in to, you know, to fix said problem ...they are very aware of exactly what transpired ...the patient underwent a cholecystectomy ...a few days later the patient had an ERCP where they also placed a stent ...patient’s bilirubin was still rising so they consulted interventional radiology to place the biliary drain and that’s when it was discovered that his common bile duct was interestingly enough clipped shut ...I think that the GI doctor did not recognize that the stent he placed did not go above the level of the “obstruction” and [named Physician #1], of course, didn’t really think that there was anything going on ...they were looking for stones or whatever and when I did the cholangiogram it was flat out clear that the common duct was stapled shut ...the existing stent that was there was doing nothing because it was below that level ...I was able to put a drain into to decompress the biliary ducts ...I was the one who brought up the entire thing ...I never really seen anything quite like this ... there is so many staples where the duct was occluded ...I was the one who raised it to the concern of the hospital and let everyone know that this was a very bad outcome ...[named Patient #4] is going to essentially have a common bile duct reconstruction ...I could count 16 staples but some of them are kind of overlapping so I’m not sure if that’s all of them but at least 16 staples ...did not have any idea why that many would be there to begin with ...typically you will see 2 staples ...” When asked if he could tell me if he knew of any disciplinary action was taken against [named Physician #1] he stated, “ ...that would not be for me to say ...I would ask that that kind of request go through more official channels ...I hate this happened to this guy ...in my opinion this really shouldn’t have happened ... I don’t have any information on the surgical literature of this incidence but to me this is the kind of thing that really shouldn’t happen ...this is the first case of this I have ever seen and there were two patients that had this happen to by the same surgeon within three months ...I don’t think that [named Hospital #1] has done everything that they are allowed to do by law ...I can say these cases were reviewed ...when that committee feels something was egregious enough and that no corrective action could be taken those are things that would result in fair hearings ...when you’re dealing with a physician things are elevated to the next level but we follow a series of rules and those rules ...people are then observed, they go through remediation training we make or recommendations that we make and that’s how any peer review process works inside all hospitals ...my question would be to the with Administrative Director Clinical Quality Improvement and the CMO ...what is the hospital doing to make sure that this isn’t happening again and I think that’s exactly the right place to put the question would be the CMO ...he has the authority to speak on behalf of [named Hospital #1]...” During an interview on 7/15/2025 at 9:20 AM, when asked what actions have been implemented to prevent this incident from happening again, the Chief Medical Officer stated, “ ...I will tell you we followed our process, there were events that occurred which triggered a meeting ...there were certain things that were discussed under peer review and expectations were set ...then there was a follow up meeting at the general peer review meeting which is the last option ...then we continue his FPPE and noticed that there were events that occurred that triggered us to do a deep dive in comparison to his surgical peers ...He was brought into peer review for a discussion and again set expectations ...” When asked if he reviewed the National Practitioner Data Bank before hiring [named Physician #1] and discovered there were similar incidents, he stated, “ ...I did not hire him, he’s not my employee ...” When asked if he felt [named Hospital #1] was responsible for Physician #1, since he has privileges here, he stated, “ ...he is not our employee ...he is an independent practitioner who has privileges here at the hospital ...I pay him nothing ...I have no employment contract with him ...” When asked who has oversight over [named Physician #1], he stated, “ ...medical staff does ...there is a credentialing committee, a peer review committee and medical executive committee ...” When asked who tracks surgical adverse events he stated, “ ...the peer review committee ...anything of quality will come up through peer review ...it was on advice of counsel to keep it under the veil of peer review ...the more things you have outside of peer review, the easier it is to pierce the veil ...” When asked if hospital staff suspected he was under the influence he stated, “ ...no, because we would have stopped him and immediately drug tested him ...” When asked if he could provide any documentation that reflected how (named Hospital #1) had implemented policy changes, corrective actions or review of peer review data containing adverse events he stated, “ ...peer review is the ability for physicians to discuss things openly and honestly without the scrutiny of others and so that is what we are struggling with, because if I gave you all the minutes the physicians will no longer talk ...they don’t want the [named state] or if this ends up going somewhere else to hear what their thought process was ...” 10. Review of an email dated 7/15/2025 at 12:29 PM, from the Senior Vice President of General Counsel Operations at the hospital’s Corporate office stated Physician #1 has been placed on indefinite administrative leave effective 7/10/2025. With this leave, Physician #1 was barred from practicing in all settings-inpatient, outpatient, and ambulatory and the hospital and medical staff re in the process of the medical peer review process and will assure that the hospital is provided adequate notice in the event that he is allowed to return to practice. During a telephone interview on 7/16/2025 at 2:15 PM, when asked to clarify Hospital #1’s quality improvement program, the Administrative Director Clinical Quality Improvement stated, “ ...surgical adverse events, sentinel events, abuse allegations, etc., are discussed in peer review and escalated to our corporate office ...Our Performance Guidance Committee will cover if it was somethineg regarding to the quality of care ...we report it but it is handled internally ...they are the ones that measure, analyze, and track any adverse patient events related to surgery ... then they come up with preventive measures, actions they need to take or correct ...that is where all of that is tracked and trended..” When asked, so the hospital does not do any tracking and trending related to physicians she stated, “ ...that is correct ...” The hospital failed to provide evidence of an effective QAPI program to track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital; stating the hospital is not responsible for physicians actions, since they are a contract employee, however, Physician #1 was performing surgery inside and on the premises of the hospital.”