Agency for Heath Gare Administration PRINTED: tavtor2024 FORM APPROVED. SINFUENT OF DEFENCES (0) PRowoeveurmucmcum INDPLAN OF CORRECTION \Dinrrtcaion NUMBER HLza960001 whe. ‘COuPLETED osr2012024 SACRED HEARTHOSPITALON THEEMERALD cont 7900 US HWY 96 W BEACH, FL 32850 Pate {cack Boney Most Se Pee Be Fu Te FSI Ton On LS SETI POMPTON) ene (PACH COREE ACTON SHOULD BE coe a ‘CROSS REFERENCED 70 THEAPPROPRITE one 000 INITIAL COMMENTS, On September 10, 2028 through September 20, 2024, an unannounced compiaint survey for allegations contained within complaint number 2024012179, was conducted at Ascension ‘Sacred Heart Emerald Coast, Miramar Beach, Florda. AL the time of the survey, deficient practice was icentifie. 1181) 59A.3.270(4) FAC HEALTH INFORMATION MGMT -Operative Procedures (4) For pationts undergoing operative or other invasive procedures the medical record policies, must aiso requite: (a) The recording of prooperative diagnoses prior ro surgery (0) That operative reports be recorded in the health record immediately fliowing surgery or that an operative progress note is entered in the patient recor to provide pertinent information; and, (6) Postoperative information must inlude vital signs, level of consciousness, medications, blood components, complications and management of ‘those events, identification of direct providers of care, discharge information from the postanesthesia care area ‘This Statute oF Rule is not met as evidenced by: ‘Based on operating room (OR) sta interviews, Intorviow with tho county Medical Examiner, interview with the Pathologist and clinical record review, the hospital ated to ensure operative report were compiote anc accurataly vrtten for 1 of 6 patients sampled, Patient #1. During review of Patient #7°s operative report from August 2028, there were several discrepancies noted when compared with the pathology report, interviews Hoo Haat ATER Faas RUST {ABORATORY ORECTORS OR PROVDERIGUPPLIER REPRESENTATIVES SIGARTORE me ome SNE FORTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 191, Continued From page 191 conducted withthe Mesica! Examiner, the Pathologist, the Chief Medical Officer and 7 of 7 ‘operating room staf interviewed (Registered Nurse (RN) D, RN , RN Y, Scrub Technicians F and G, Carliied Registered Nurse Anesthetist © ‘and General Surgeon K). In August 2024, during @ scheduled splenectomy (a surgical procedure to remove the spleen}, Surgeon A mistakenly removed Pationt #1's lor instead of the spleen. The operative report ‘documents that tre spleen was removed. The ‘perativa report failed to mantion the pationt’s {ebdominal distention, failed to mention the presence of a megacclon (a condition where the colon, orlarge intestine, abnormally dates - become wider and larger). and aid to mention the removal ofthe Iver. Adcltonally, the operative report contradicts portions of stat imerviows regarding clamp usage, the sequence of events, the iting ofthe hemorthage (severe blaeding), and the cause of death. The operative report eosumens “ne cemplcations” “The findings include: ‘Areview ofthe operative report dated 8/21/24 for Patient #1 found the report was electronically signed and veriied by Surgeon A on 8/23/24 at S:14 PM Centrat Daylight Time. Surgeon Awas listed as the only surgeon. The “indication for Surgery’ and "Preoperative Diagnosis" were documented as "Splonic laceration with Hemoperitoneum; Severe splenomegaly; Splenic 10 mifimetersrteriat aneurysm and tet upper {quadrant abdominal pair.” The postoperative agnosis was "inre-abdominal hemarshege ‘associated with splenic srlery aneurysm rupture and cardiac arrest.” The section for “Complications” indicated "none apparent." The ATER Fae EATPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1191, Continued From page 2 191 operative report lacked identification of the members ofthe surgical team (the assistant and scfub technicians}. The pathology tissue request documented the specimen as “spleen issue." Surgeon A indicated the "spleen measured roughly 30 x 22 em (centimeters). Surgeon A described the introduction ofthe laparoscopic camera into the abdomen, then indicated “Significant homoperitonaurn (biood in tio abdomen} was noted, Ewtensive adhesions wore roted around majority ofthe spieen, the spleen oted to be gute enlarged.” Surgeon A indicated using wound rotrsctors placed into the fascial efect, appropriate positioning was achieved. "At ‘hia point using hand assist technique adhesions ‘nthe anterior surface of the spleen were carefully taken down utiizing laparoscopic hand ‘aselet technique. The entire splean was exposed noted to be severely deformed. Memopertonaum ‘was noted but no active hemorrhage (no active bleeding) was aopreciated. Splenic laceration ‘v2s appreciated al the inferir pole. No active blaeding was noted at this tme. Large size ofthe spleen we elected fo convert to open provedure.” ‘The surgeon then made an "epigasvic midine Incision,“ entering the addomen and documented, “spleen noted to he quite friable and certainly the lacge size made the dissection challenging, Spleen was mobilized medially 10 expose the Fetrogertoneal attachments. The spienorenal and splencphrenic ligaments were carefully taken ‘down and ligated wit energy daviee.” "Spleen was circuraforentialy dissected fr trom surrounding structures and was very mabile. At ‘his lime attention was turned to the splenic hhium. Splonic artery and voin wore carefully casected out rom the surrounding tssve. Splenic artery aneuryam was appreciated at the Ihlum. “The plan was to perform ligation of the splenic artery fest and subsequenlly splenic vein ATER Fae GTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1191, Continued From page 3 191 second, Plan fo perform ligation of the splenic artery close tothe spleen athe hilum proximal to the aneurysm. Just prior to achieving control of the splenic axtery with Endo GIA {orand nme) stapling device vascular load (insirument which simultaneously lays down a staple ine and transects the tissue, veins, andlor arteries } Unfortunately the aneurysm was noted to supe, Econsive intra-abdorina’ blood loss was sustained severely precluding visualization of key tenatomical structures atthe hilum.” .. “Sponges gradually removed from loft upper quadrant and vith great dificutty during ongoing bleeding | was ble fo control the ruptured sneurysm with surgical clamp and then gain defintive contrat vith Endo GIA stapling device vascular load 60 rim, Next. splenic vein was tigated also with Endo GIA stapling device vascular load 60 mm fire.” "Spleen was removed and passed off te field for pathology." “The word "iver" appeared nowhere on the operative report. The report aleo did not mention ‘the abdominal cistension or severe megacoton described by operating room staf. Pathologist: Aoviw of the surgical pathology report, dated 6/23/2024 at 217 PM found the comment, "no splenic issue identified, case discussed with (Surgeon AY The report indicated tha the tissue Gosignated as spleen was “Liver with mld chronic porta inflammation’ (0 00/1012024 at approximately 4:46 PA an interview was conducted withthe Pathologist. He stated the whole organ was received in a spacimen buckot fabelad as “splaen, however, he cid not see the specimen enly ohotos. He ATER SOTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 191, Continued From page 4 191 received about 8-10 slides to review, He states he was able to "elagnose it within @ millisecond, pretty obvious It was the liver” From the pictures ‘nid histotogy, there was litle quesiion about Porta inflammation but otherwise the ver, was & litle heavy -2 upper limits are 1800 grams, and this one was about 2100 grams, Mecical Examiner: (On 09/11/2024 at approximately 1:00 PM a telephone interview was conducted withthe tocat Medical Examiner (ME), The ME stated they ‘were intially notified of Patient #'s death on August 21st, niatly 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 renotifed ‘on August 25th or 25th by the Risk Managar who said we need fo tell you this death is not how it ‘vas reported, the liver was removed. The autopsy confirmed there was no iver. The liver ‘was portecily dissected of the dlaahragm. As a ‘orensic pathologist, that is one of the hardest ‘things to team to do. “Essentially the iver was autopsied out of that man’. There was.n0 evidence of cross clamping, no sutures, no texidence of eautery. The inferior Vena Cava (the ‘major vein that brings oxygen-poor blood fram the lower body back to the heart} was clearly lssected by the surgeon, Everything surrounding ths vor was completely untouched. “The spleen showed no evidence of aneurysm, no rupture, and no evidence this epleen was: {ouchad. The sploen stayed where tt was bom 10 be. The spleen was 420 grams ictal. There was ‘no evidence it was touched, not even looked al ‘The Medical Examinar said that a man's ver ie between 1800 and 2800 grams. The size ofa ATER OTSTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1191, Continued From page $ 191 ‘man's spleen fs typically between 200 and 350 prams, but a diseased spleen can be bigger. The IME stated the biggest helshe has seen was 800, grams, Interviews with Operating Room Stat: Staff Member ¥, an Operating Room RN (Rogistored Nursoy (0 0974012024 at approximately 2:45 PM an Interview was conductod with RN Y who indicated sho was working anather case across the hall lend ddr enter the OR (opereting room) of Patient #1 untl after the time of death. When she entered the room, the Scrub Tech (Technician) tend RN Circulator were present and asked her to ‘et the CMO (Chief Medical Officer). RNY Slated thatthe CMO eame into the OR and that is ‘uhen the specimen was discussed. The specimen was pulled out ofthe bucket, and we alt ‘ere tke "in shock” Immediately the CMO contacted the pathologist ang had the specimen ‘walked tothe fab. People m the room sai “this looks ke fiver to me." RNY "we all were like this Is definitely not the normal anatomy ofa spleen. You can ell between a liver and spleen. Basic knowledge of anatomy." She went on tc say that before the code had eccurred, she was being psy and fooked through the OR window and “ai! sould see was a huge megacolon” fa conchiion| ‘where the colon, oF large intestine, abnormally lates - become widor and larger). RNY recounted, after the patient's death, how Surgeon ‘Acame back ino the OR, not once but three times to state te them that the patlent suffered a ‘splenic aneurysm’ and there wes nothing that could be done fo save him. He also came into ak for the measurements of the spleen, ATER Fae STSTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1191, Continued From page 6 191 ‘Sta Member F, @n OR Scrub Technician and First Assistant (Serub Tech F) (On 08/10/2024 at approximately 3:14 PM an Interview was conducted with Slaf Member F, an (OR Scub Technician and First Assistant, Serub “Tech F stated she was informed by the RN Circulator ofthe patient's abdomen being elstonded, and because of what case wo wore ong we ware guessing it was blood pooting. Scrub Tech F thought that procedurally, we would have problorns with visuaization. Scrub Tech F ‘wont on to describe the surgical procedure. She slated they put the trocars (which creates an ‘8c0988 point nto the abdomen) in and saw there ‘was blood on both sides of the abdomen, but not fn insane amount, Right away we noticed Mow lated the colon was. We could see this cn the screen. Visualization was tight because of the colon. ‘She said the surgeen put in 3 tocars (5 big and 2 sina, Again, not able to 3ee 8 ft, “The hand post went tn, which allowed the surgeon access witn his hand. He did not have wiggle room, very limited due to the stze ofthe colon. It ‘was at thal point we bailed on the hand assist and ‘wont to open. As soon as the surgeon made the ‘abcorinat incision, tie "bowels spiling aut She said tothe surgeon that looked Tike @ megacolon,” in which Surgeon A replied it was @ "volvulus ofthe colon.” (vols is when the colon fwisis around the tissue that holds it in place). She indicated the surgeon is aissectng: sh is reacting with one hand and suctioning vith the other and sill holding back bowel io allow \isualzation. Anothor staff (RN E) came fn to assist wih retracting and hen a third sora technician, Serub Tech G assisted, Scrub Tech F stated the surgeon is dissecting, gat bleesing, ‘and recalls the gurgean stating there was a tear In the spleen. Bleeding increased a bit and we ATER Fane RESTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1191, Continued From page 7 191 asked for a second coll saver (a device that collects and returns a patients blood during surgery. which is then transfused back into the: patient) as one was not keeping up. Surgoon A asked for a stapler, vascular oad (staping device used in cntical vassal transection) ater the first slaple that's when we gol into the horrible bieed. Once into the bleed, there was ro going back and ‘we nevor had visualization again, There was no specimen at that time, just dissection. Cardiopulmonary Resuscitation (CPR) was. sated, ane the surgeon continued to work during compressions. She racated, stopping aside and seeing, with both hands, Surgeon A take the spacimen out and lay iton the drape. All the tochs, wo immediately noticed; 1. That doesn't look ike a spleen and 2. Itwas massive ‘compares to what you thought in your brain was, going to look like." ‘Scrub Tech F stated al one paint Surgeon K came in, be asked what happened, ghe thinks she told him, but couldn't answer his questions, ‘Sho wae tying fo Keep ik together and not ery. Scrub Tech F stated Surgeon K went around to ‘the back table and stated fo Surgeon A" aos Fike the liver to me," in whick Surgoon A replied “no that's the spleen.” Scab Tech F stated she and RN E wore talking ‘amongst themselves thatthe specimen looked tke tho iver, She stated on tne underside ofthe liver Ricokes tke a space where the galblader iad been. She eoked the CRNA (Certed Registored Nurse Anesthetist) i the patint had tad a previous cholecystectomy (gal badder femovel), she was tld "yes". When the CMO (Chief Mecical Otoer) was asked to come into the OR, we asked his was a safe place 1 tal He replied "yes" We tld him, "cone of us think ATER CATTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1191, Continued From page & 191 ‘what he took out isthe spleen, it looks tke the Iver". That is when the CMO looked at the specimen and called pathology. Sorub Tech F died thal Surgeon A, came back into the OR multiple times and kept teing us the spiaen had ‘an aneurysm, and it suptuted and was rexterating that to us, and after a rd time, asked Scrub Tech G. to measure the specimen Scrub Tach F, sald she looked at Surgeon A's operative note, and it never mentioned the colon.” Scrub Tech F stated the colon was @ ‘major factor in this case and sho vas taken back thatthe report never mentioned the colon. Scxub Tech F stated the Operative Note indicated "he ‘was able to conto! bloeding witha clamp, but not ine time cid he ever ask for a lamp. Which is ‘the one instrument you need to stop bleeding Bleeding ofthat magnitude youre not going to cauterize. He never asked for lamp" Because there was no clamping or trying fo cut off bleeding toad the source, we wore ltraly drowning. ‘She said she never had eyes on the spleen, andl ‘ever had eyes on the liver uni twas removed. Staff Member G, OR Scab Technician (07 09/11/2024 at approximately 8:24 AM, an intorviow sas conducted with Staff Member G an OR Scrub Technician. She statos she came into Patient #1's operating room around 6:10 PME because she received a text messaga from RN.H Inleating they needed an extra set of hands, She said when she scruboed in, Sugeon A was ligaturing a bunch. She had no visualization bbocauee she was near the patent's foot. Thoy ‘were using "ture drapes, which have pouches al sround and avery part was megacoton. When eama in t was pretty bloody but assumed from the megacolon, these pouches were all colon ATER Fane HOTTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1191, Continued From page 8 191 ‘She remembers Surgeon A asking for 3 GIA stapler with vascular load of 60 and then asked ‘or another call saver suction, and asked! for 3 ‘more stapler loa, sthich is fl. Al this point he stared bleeding a fot, She recal's while doing 2 staple load, she ceachod out wth a Kelly iamp multiple times. She Indicated, when tying to sschieve hemostasis, you clamp and then do cutting, “He (Surgoon A) nover took it tho clamp. Scrub Tech G stated at that point wo start coding the patient. Compressions sierte. ‘She recalls when she began compressions: (curing her 2 minutes) the specimen came cut = ‘that was when she saw the Iver on the table end ‘thought why is he doing that? | saw 3 lobes and the concave space ftom where [Pationt #1's] cgallbiadder had been, She stated that everyone knew it was the iver. They asked the CMO to look atthe specimen, That was wher the CMO looked at te specimen, tumed back around, his ‘eyes wide’ said to “gett tothe pathotogist now.” Staff Member D, RN Circulator (RN D) (0m 08/11/2024 at approximately 9:00 AM a telephone interview was conctucted with Stat ‘member D, RN Circuletor, RN D stated Surgeon A started the case laparoscopieally, noticed some blood in the abdomen and he had megacolon ‘which made it dificult to view. At tat time, Surgeon A was going to open (mine incision} ‘The patient's abdomen was distended, We ‘opened and at that me, we're moving the colon faround to get out of the wound and suctioning some blood which was minimal. Surgeon A asks {or the GIA stapler. She stated normaly when ‘working on the spleen, you dently end clemp the splenio artery ana vein. She said she didn't have ‘2 good view. The surgean was the one looking down int the abdomen. She says he fred the ATER OSTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1191, Continued From page 10 191 {st staple endl ask for 3 mare loads, Then the palient hemorthaged. We weat fom minimal suction to suctioning alot of blood, asked for a 2nd cel-saver (a device that collects and returns 2 patient's blood during surgery, whichis then transfused back lato the patient) My fst thought ‘was he didn't have control ofthe splenic artery fad vein or the hertormhage. The aode was called and we wore busy dealing with the herrorrhage, helsing anesthesia and hanging blood. Buring tis time, | saw the specimen on the fable. "Llooked tke the Iver and fot sick to ry stomach, [I know fhe took part of iver wo ‘werest oana be able to stop the bleeding’. She ‘shed the surgeon to identify the specimen, She slated that she is instructed to write down what the surgeon says, and he said "spleen, the spleen," | thought “excuse me?" Surgeon A insisted that was what itwas, and that's what | labeled tas. “tknew in my hear itwas the liver.” Surgeon A stated to them, "You guys realize the paliont died because he had a splenic aneurysm.” ‘We just looked athim and ain't respond. So ‘when he walked out of the room, we looked at leach other and agreed that looks tke the liver Sho deserbod the sploen was smaller with pimple ike rough area. The liver is puriish and smooth, Surgeon Acame in agaln and again, reiterating the cause of death - splenic aneurysm. RN D added f was tke he fot fhe reguraliated lenough we woutd repeat it. Noone responded, Staff Member E, RN Scrub (RN E) (0 00/11/2024 at approximatoly 01:45 PM, a telephone interview was conducted with Stat ember E, an RN Scrub was part ofthe surgical ‘eam for Patent #3, RN E algo provided a writen statement with her account of the events. RN E ATER ESTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1191, Continued From page 11 191 ‘52, the patient hed & large stdomen and Surgeon A could’ reach or see the spleen ‘adequately; that was when the case went from laparoscopic o open. The colon was huge, megacolon everywhere, and Surgeon Ahad 10 push bowel out of the way. RN E says she was holding retractors and did see ether the spleen or the liver unif the fiver was on the lable. RN E says thore was bowel all around the sides ond the bottom. The surgeon had a good working space, | could see vessels but | couldn’ identify or tok ‘the diference between the spleen and hepatic artery, he could saa the vessel, RI E added, in my opinion you see 2 large vessel you clamp it and cut t. Surgeon A did not use a clamp st any time and started to cul, Patient #1 had olher Issues and a large abdomen, megacolon, and reaching in there, Surgeon A should have known that ifthe spleen was moved over, he should have known al of tat RN E revealed, Surgeon A points cuta vessel he Intends to locate, and cuts with Ligasure (stument used to dissect and ses! blood vessels) and i starts bleeding profusely, He continued to Ligasure ané the heavy bleeding stops, Surgeon A wraps finger around the area he Intends fo cut next and ssid "ch that's scary" then said he could fee! the heartizorts beating under his fnger. Sutgean A then asks fora (brand name} powered stapler wih a vascular toad and kept saying he was having trouble getting the stapler around the structure, gots lt around and fired the stapler. The heavy bleeding starts again, other suction (cell saver) is obtained. There is ‘more blood coming out than te two suetions can handle. Surgeon A asks for another sieper load ‘and fies the stapler bind straight down into the bloody area. RN E repors thal Anesthasia (Staff Member C, CRNA. Certified Registared Nurse oyPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one H 191 Continued From page 12 191 ‘Anethetist) sfates, Patient #7 ie hypotensive and about to code. Staff C then stales the palit is coding begin CPR. RNE reporied, "immediately started chest compressions while the nurse cals code biue” Wrile the cade is going on, RN E reported that Surgeon A took out tho lver and placed on patents! legs and "I put ton the table” ‘The CMO was inthe room. We lookse a the spacimon and told ism it was the For and No 1peeded to look at, She said the CMO looked at the specimen ard said he was calling pathologist RN E repert the CMO's expressicn looked shookod looking, but she did not hear him say enything at that ime. RN E stated, "I then looked: in the abdomen for the liver and could not find it acked (Stall F, Scrub Technician) to also kook in the bomen forthe liver and neither of us could se6/L” Afar the time of death, Surgeon Alef the oom. He came back in twice fing us that the patient had a splenic artery rupture and that is, ‘wtiy he died, Staff Member K, 2 Genera Surgeon (0 99/12/2024 at approximately 07:00 PM an Intoriow was conducted with Staf K, a generat surgeon. Surgeon K said, received @ STAT request fo come in to assist. Las in the medical office bulding across the streot and came over. Compressions were in place, the CMO was running the code, then he called the code about 10 seconds lator. Surgeon K stated that he observed the organ on the back table. "did not say anything, (Surgeon ) made a comment and Idantited tas the spleen, ! gave him the eye and ‘walked away". Surgeon K stated that with his knowledge and expertise he would identty the spacimen 26 the fver. ATER STPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one H 191. Continued From page 13, 191 Physician M, The former CMO: (On 08/16/2024 at approximately 04:00 PA an Interview about OR documentation was Conducted wth Physician M, the former GMO of hospital. Regarding medical documentation, Physician M said that in goneral, what is charted Is considered accurate, wo rly on the physicians to document. We have too many physicians to review [documentation for accuracy], Physician M ‘was asked about the Operate Report omiting the megacolon. Physiclan M indicated that he ‘would expect clinically significant findings to be documented. I she nurseisorub technician indicatod this was signficant, "I would say tho OR staff are a better judge than me, then t tend to believe them at east” Curent GMO: (0 09/16/2024 at approximately 08:00 PM a telephone/zoom interview was conducted with the current CMO who stated that he was contacted by RNY that @ code blue was called, and then recelved a text from the anesthesoiogist that they ‘wore coding Pationt #1. | went into the operating room and staf were in active resuscitation. The procedure was a splenectomy, and saw the frgan was on the tabi, The CMO stated that it ‘was apparent that itwas not the organ {Surgeon ‘A)had intended to remove. The CMO stated ‘that he was notified afterwards by ths pathologist ‘that itwas the liver, Staff Member C, Cerified Registered Nurse ‘Anesthetist (CRNA C} (On 0972012024 at approximately 4:43 PM, an Interviow was conducted with Staff Member C. ATER Fane OTTAgency for Heath Gare Administration PRINTED: tavtor2024 FORM APPROVED. SINFUENT OF DEFENCES (0) PRowoeveurmucmcum INDPLAN OF CORRECTION \Dinrrtcaion NUMBER HLza960001 whe. ‘COuPLETED osr2012024 7900 US HWY 96 W ‘SACRED HEART HOSPITAL ON THE EMERALD COAE MIRAMAR BEACH, FL. 32550 ao Tae {ech GeneINDY MUST SE PREGEDED SY FUL REGULATORY O# GEM MVING NFOAMATION] a (PACH COREE ACTON SHOULD BE coe 1191. Continued From page 14 Corttiod Registered nurse Anesthetist (CRNA), ‘ho slated he has worked with Surgeon A quite fften, but had not bean through a splenectomy wilh him. CRNAC stated that the surgical pian was for laparoscopic hand assisied procedure, nd that he was able to see the screen but dic "ot see the spleen, there was mostly bowet on the screen notable to 69e much else. After about 16 minutos Surgaon A converted to an apen case, CRNA stated that Patient #1 remained stable, the vital signs were normal, Surgeon A ‘was expioring the abdomen, and Surgeon A made a remark about wondering what was going ton here, and kept exploring going from eft to fight side, Surgeon A commented on the bowel cistension, and it appeared ho was struggling. CRNA C did not recall Surgean A asking for @ clamp. At 6:23 PMs, Surgeon Awas briefed on paliont’s status and EBL (ectinated blood loss) ‘which was less than alter and transfusion of blood products 3s continuing at that tine. At 6:30 PM, Surgeon A was made aware of changes in hemogynamics and the code cart and ail available blood products were brought into the room, CRNA slated that a code was called 5 ‘minutos later (6:85 PM) and we all startod ‘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 of ‘and Surgeon A remained in the abdomen, CRNA C recalled socing Surgeon K walk to the foot of the bed looked at the specimen, CRNA stated ‘that he recalied a woman's voice stating, "Thats the fucking tver” Surgeon A: On 09/20/2024 at approximately $0.00 AM an 191 ATES ASTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one H 191. Continued From page 15 191 interview was conducted with Surgeon A who escribed the surgical procedure for Patient #1 Surgeon A stated he was positioned on Patient 41's right to be opposite from target organ se that he could look att straight. During the Laparoscopic hand assist procedure, Surgeon A slated he saw a massively distended colon as Patient #1 had a belly full of blood and bod is lnitant te bowel. Surgeon A commentod, that the bowel was so massive, twas obiterating any visualization. The blood was bright red and fresh ‘th alot of blood clois ane a large hematoma on lef side, Surgaon Astated he was able to vsuslze the spleen after moving the colon, Surgeon A describe the spleen as iregulac shaped wth a large amount of blood around it, Ceformed and large. Surgeon A identified the spleen visually on the monitor with the scope and used his left hand to bring it into the il. Surgeon A stated he also visualized other organs {0 include the smal and tage intestines, fver arc claphregm. Surgeon A slated he made the Cision to convert to an open case when realized hematoma, amount of bioed, colon and Patient #1's deteriorating clinical stuation. ‘Surgeon A indicated that once opened, the colon ‘gs 30 lage they had to ight ad battle with it to cently visualize Key structres, spleen and surrounding siuclures. Surgeon A stated that he ‘was aware ofthe large colon prior to surgery from CT scan (computed tomography imaging tes!) fend abdominal dstonton, Surgeon A stated he Idantfed the liver out of It comer of his eye. ‘Surgeon A stated thatthe fiver iooks dierent than ‘the spleen, He described a liver as having 2 lobes, sightly differant in color, ane mora reddish in appearence. Surgeon A desorbed Patient #1°s spleen as large, deformed, had a cyst and was significantly eniarged witha tear an bluish la calor. ooPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 191, Continued From page 18 191 Surgeon A confiemed visualization of liver ard spleen and used a surgical knife (Ligasure) to clssect around the spleen, as Patient #1 had extensive adhsions, and it helped to prepare to loasen the spieen and help to remove i. Spleen had old blood tke @ hematoma and ftesh biood. Due to colon distension, large abdomen and dotenorating condition, di trauma styfe incision {0 cloaly dantfy anatomy, assisted by stat to have clear view offs Surgeon A staied multiple times spleen was visualized and tnat twas deformed and enlarued. Surgeon A stated he was not able to completely Gissect the spleen free, and he visualized what he ‘hough! was an aneurysm and prepared to take contol off, Surgeon A stated that k was diffeutt 10 see due toe 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 sploen forward and flt the artery, but before he sould contol she ancuryem there ‘was a large pool of blood to ihe point was ‘exsanguinating. Surgeon A stated that It was 80 ‘much blood we could not say up witht. We had to get another suction device and activated Mass “Transfusion protocol du to Ke threatening catastrophic hemorrhage, trying to gett under contol. Surgeon A stated he did not use stapler Lntiatar the hemorrhage started. Surgeon A slated tho sploon was sill atlachod and had ‘adhesions, and he used an energy device to teke ‘fown adhesions. Patient #1 was bieding faster ‘than we could continue to supoost and replace im with blood products. His main conceen wes to ‘ot control of biescing. Surgeon A stated that despite best etfs, they coud not see the sources ofthe bleeding and the patient was getting ATER Fae ROASTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 191, Continued From page 17, 191 progressively worse and went into cardiag ares, Surgeon A raveaied he used clamp over the splenic artery before using the siaoier device, and before any bleeding or culling occurred. Surgeon {stated he has to remove the clamp in erder to ullize the stapler device because the clamp was in the way. The patient was not bleeding profusely when the clamp was removed, i happened when he prepared to introduce the ‘evice, Surgeon A siated he but put stapler device down because helore you can staple you have 10 bo able to see what you are staping. ifs 8 sucgica! instrument. Surgaon A stated the stapler device was Introduced after about 15 minutes of cardiac arrest 3s 9 last resort hoping that fhe could get crantel 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 bind, belly fall ef blood and colon in the way. he Identified what he fet were the spleen anc the aneurysm and tried io siapie below that, This was happening during ches! compressions. He stated ho used 2 fires withthe stapling device ooross the: btu of te spleen, and removed the organ, after 5:7 minules laler we called the code and had no progeess, Surgeon A stated he gave the organ to his aselstants who asked him what twas, and he told them twas the spleen, Surgeon A stated that ro ane informed hie that it was the iver. Surgeon A confirmed that he did go down to the laboratory after the procadtre to inspect the specimen but it dit nat click with me, Iwas, Cistraught, Surgeon A added that he found out it ‘vias the Fver 2 days fer when the pathologist (Stal), called him and told him the specimen ATER Fane OTTPRINTED: tavtor2024 "FORM APPROVED ‘Agency for Heatth Care Adminstration, SIRTEMENTOFEROENEES | et) FROWETEURPLERTUR TWAT PAE CONSTROETION [paionre aime IMDRUNOF CORREETIN (Binrecarion wowace aoone ‘SoMPLETED Pe ym osv20/2024 7000 US HWY 96 W SACRED HEARTHOSPITAL ON THEENERALD con [OPONS IMATE Pate {cack Boney Most Se Pee Be Fu onan. EACH CORRECTNE ATEN SHOULD BE cole 1S FSI Ton On LS SETI POMPTON) He ‘ORO HEPEMENEZO 70 THE SPORODTE ore 1181) Continued From page 18 Hae ‘was the Ber Surgeon A stated that he calied the CMO and told io itwas the liver. Later that day the CMO then Informed bim there would be an investigation Surgeon A verified that the operative report was ‘rue and accarale to best of his knowledge at tho ‘ime and ho has not made any addondums to the ‘operative report leaming it was the ver lass it #1280) 59A.3.275(2), FAG ORGANIZED MEDICAL 230 S556 STAFF - Commitions (2) Each hospitars organized medical staff shall termine its appropriate committee structure ‘and shall provide thatthe following required committee functions are caried out with sufficient periodicity to assure their objectives being Bohioved by separate committee, combined committees, or commitiee ofthe whole: (2) Coordination ofthe actuties and general policies of me various departments, (0) Interim deciston making for the organized medical staf between staff meetings, under such limitations as shail be set by the organized medical staf {}Foliowrup and appropriate disposition of at Teports deating withthe various stat functions. (4) Review of ail applications for appointment and reappointment to all categories of staff, and recommendations on each to the governing board, including delineation of pivieges to be granted in each case, and right of hearing and ppesrance, Except in emergency cases, ATER EST ‘STATE FORA “ wor Vesna 0047PRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230 Continued From page 19, 290 recommendations to the goveming board for vwithcraoral of any privieges of a member ofthe organized mecical stator cismissl from the organized mecical staff willbe made only after a thorough investigation by the organized medical staff ora committe thereof, wih the subject member being alven the ght of hearing belore the organized medical sta ora cormittee ‘thereof if requested within a reasonable immo as specified inthe hospta's bylaws. (6) Mecical records curently maintained esenbing the condition, treatment, and progress of patient in sufiiont completeness to assure transferable comprehension of he case at any time, (1) Clinical evaluation ofthe quality of mesical care provided to ei categories of patents on the basis of documented evidence, {} Review of hospital admissions with respect fo ‘eed for admission, length of stay, discharge practices and evaluation ofthe services ortered and provided {) Surveitance of hospital infection potentials {and cases and the promotion ofa preventive and corrective program designed fo minimize these hazards. () Surveiiance of pharmacy and therapeutic policies and practices within the insitston () Hospital tests may be ordered oniy bythe attending physician, or by another censed health professional that licensed health professional is ‘acting within his scope of practice as defined by ‘applicable faws and rules ofthe agency, Nothing herein shal be construed to expand ar restrict Suh laws and rules pertaining to the practice of the vatlous health professions. “This Statute or Rule is not met as evidenced by: Based on staff interviews, ciizal record review, review of medical staf bylaws and facity ATER CATTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230 Continued From page 20, 290 ocumentation review, te hospital falled to ensure that each member ofthe medical sta ‘emonsizated competencies to perform each task vithin the scope of practice for which privileges have been granted for 1 of 5 surgeons sampled, Surgeon A. From May 2028 fo August 2024, the hospital denttied a total of 3 surgical errors. A'S errors involved Surgeon A. In May 2023, ‘Surgeon & removed part of Patient #5's pancreas Instead of the intended adrenal gland. Surgeon A pad not performed any other adrenalectomies (omovat of adrenal gland) at the fact. Corroctve actions included to immadiately stop scheduling adrenalectomies, counseling Surgeons on the use of surgical markers and proctoring al least § cases. Proctoring was not ‘completed as the hospital no longer performs adrenalectomies. In August 2023, Patient #6 was identified to have a bowel perforation folowing a partal colectomy (suryical procedure to removes part of the colon) performed by Surgeon A, Patient #8 died ftom infection compicalions. Corrective actions included rferral to the rodentiaing committee for potential actions. However, per Credentialing Manager interview, ‘this is not one ofthe Credentialing commitie ‘unctions. 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 hemorrage (severe and pertuse bleeding) and death, Surgeon A had not performed a spienectomy at this hospital in over 3 years, sinco July 2021, The hosoital susponciod Surgeon A's privileges end initiated an Investigation. Interviews with 8 sampled operating room stait ‘ound 6 stat with concems regarding surgical practices by Surgeon A (Registered Nurse (RN) D,RNE, Scrub Technician F and G, RN H and ATER Fae TOTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230, Continued From page 24 290 RNY), These concems wore reported tothe Operating Room Manager andlor Operating Room Director, but no further action was intiated, Staf inierviows identified 2 additonal patients vnth possible surgical erors by Surgeon A thal had not been investigated. Surgeon Awas ‘observed to sever the common bile duct on Patient #2 during a Cholecystectomy (removal of ‘2 gallladdan in Age 2024, and sever a urator on Ptient #4 during a partial colactomy in July 2024 resulting in @ Urologist being called to the ‘9perating room for ropairs dunng the surgery for Pationt #4 ‘The finding inckide (07 05/12/2025, Surgeon & was the Primary ‘Surgeon involved in a wrong surgical procedure Involving Paliant #5. Identified was the removal of a portion of the patient's pancreas instead of fn adrenalectomy. Prior to this adrenalectomy allempt, no other adrenalectomies had been performed at the hospital. The hospital investigated and implemented corrective actions {olowing this event ‘The hospitat recommended fo immediately coase the scheduling of adrenalectomies by either provider until practoring is completed. The Physicians involved wore counsoled on ‘opportunites to uiize markers when performing procedures, and surgical proclonng for procedure bya provider who has experiance with ‘adrenalectories, minimum of 5 cases would take place. The hospital indicated they were no ionger performing adzenalactomies, vierefere ao proctoring was completed. This was confirmed by review ofthe operative toa, (n 08/04/2023. Surgeon A wes one of several ATER OATPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230 Continued From page 22, 290 physicisns involved in an error eueiating in the ‘eath of patiant #6. Surgeon A performed a colon resection; identified past-surgically was a air and ‘uid coletion in the abdomen and pelvis; concerns were identified for bowel perforation or 12 small oak atthe anastomosis (a surgical connection between two body channels} Identiied was the hospital's staff feture to follow sopsis protocol folowing a feak of a colon ‘anastomosis. Corrective actions included the case being peer reviewed to determine education requited for physicians involved, case fo be reviewed by the Credentialing cormmities for potential action plan and fe re-educte personal ‘n inpatient sepsis alert process, Per review of an email to the Medical Executive Committee (MEC), dates 1010812023, from the Chief Medical Officer, indicated thatthe Medical Staff Performance Improvement Committee (MSPIC) met: identifying the following concems “nih Surgeon A’s:"pallern of questionable erision-making: less 20 related to surgical ‘ochnique and more related ‘0 post-operative management and complications; mast of issues ‘00m to revolve around bowel sugary recognition of dificut cases and has a higher ‘volume than his regional colleagues; few cases have bean done with another locat surgeon as the “assistan.", questions cogarding the number of ‘acilities that Surgeon A covers fet questions ‘nether ample time is being allocated to each pationtin tie post-op setting; documentation seems hurried and often delayed and does not ‘accurately reftect what the surgeon is abte to cloquently sta regarding his trought procosses {end actions upon review: and the surgeon is ‘penuine, wel intentioned, respected by the ‘medical stall and has not had prior major issues, apart from the cases discussed over the past few ATER Fane ROTOPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230 Continued From page 23, 290 months, In the same email (19/09/2023), MSPIC recommends: a lller of guidance, counset, “warning or reprimand be issued by the MEC; conditions for cninued appointment to inciude ‘moritoring, proctorng and consultation witivby & peer (TBD'- to be determined) - must have bowol-surgary casos reviewed on a monthiy basis ‘or next quarter and reviews should include the \ecision-making processes both before and after ‘the surgical provedure; and Surgeon A must tundortake spocie CME (continued medicat education) on Selected Readings in General Surgery (SRGS) focused on Large Bower Disorder and SESAP (Surgical Education andt Self-Assessment Program) 18 - Alimentary Tract ‘and SESAP 18 - Advanced Alimentary Tract Surgeon A took a voluntary leave of absence from (09/20:2028 through 1012012023. ‘An emai fromm Surgeon to the Director of Quality, dated 0171212024, includes proof of completion of the required SRGS readings and (OME modivies, ane a receipt forthe courses, purchased on 04/08/2024, Solf.assesement scores were included which revealed 4 parts to the Alimentary Tract module and 2 parts to the ‘Advanced Aimentary Tract module. Sutgeon A scored the folowing Advanood Alimentary Tract + Advanced Almentary Tract - Part | shows @ Complete Ini score of 36%, Latest score 92% = Advanced Alimentary Tract - Part shows a Complete inal score of 40%, Latest score 88% ‘A aview of the “American Collage of Surgeons,” ‘website, which offers the SESAP 18 an SESAP. ATER Fae OTSTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230, Continued From page 24 230) 18 Advanced course indicates "To obtain CME red, 80 percent ofthe questions must be answered correctly within three attempts. ‘Actioral review is offered untl a score of 80 percent is achieved.” Advanced CME | ACS (facs.or9) Presented for review, was a lller to Surgeon A, ated 01/23/2024, from the Chairman, Modical Staff Performance Improvernent Commitee indicating that six eases related fo Surgeon A's Focused Professional Practice Evaluation (FPPE} ‘wore conducted, The cases were reviewed and ciscusseds there were no concerns identified ‘The fetter aiso indicated that Surgeon A had successfully completed the CME on Bowe! surgery and that his FPPE was being closed. “There were six (6) cases that were peer reviewed, speciic lo colon-rectal or abdominal surgeries that were performed between 17110472028 to 01/08/2024, However, there was no ‘mention of Surgeon A's, "Complete initial failing score on Advanced Alimentary Tract, and there had been ro mention in which order Surgeon A needed to complete the MSPIC recommendations (as Surgeon A completed the ‘educational component afer the performance of surgical case peer reviews), No proctoring was completed. Surgeon A was re-appointed to the Medical Staff n 05125/2024, (02 09/11/2024 at approximately 10:10 AM, an Interview was conducted with tie Director of Medical Staff Services and the Credentialing Menager (CM). The CM indicated that credentialing has nothing to do with peer review. ‘These are completely separate. The CM stated they verify the appears for intial appointment, ATER Fane RESTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230 Continued From page 25 290 education, feensure, employment peer {0 tum in case logs for 24 months. We do ‘documentation is then reviewed by the yoars oer eases, this ie noted ‘verbally’ thatthe question oF concern about a practioner. recommendations, and he submited documentation that he had completed the ‘weight’ on the posttest and that without references, boar cetification, training, hospital affiation and malpractice. Surgeons are required background check on the intial appointment. All credentialing committed and severifed every 2 (0 08/1312024 at approximately 1:50 PM, an interview was conducted with the Director of (Quality regarding ongoing physician performanes evaluations (OPP), She stated that peor roview and OPP were 2 separate things. When a physician comes.up for evaluation - if ho's had physician has been through the peer review committee, Peer review is done based off ofa (0 09/13/2024 at approximatay 4:00 PM, a telephone interview was conducted withthe ‘former Chief Medical Officer leaving the position in January 2024. He stated that the cases from Surgeon A were sent fo the MSPIC committee ‘and reviewed, and twas determined based on a certain level of concerns expressed, Surgeon A. ‘nas given a set of guidefines in order to stay credentialed. We investigated the cases and charts were handed of to individuals (other physicians) who blindly completed a review and ‘ould provide an unbiased evaluation of the chats in questions, Surgeon A met those. coursgs requested for him to take. When asked bout the failing scores on the inital test, he sated its not unusual to have a pretest to test ‘gap knowledge. He stated | would put most ATER Fae ROTOPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 230 Continued From page 28 230) information ftom the testnriters he could rot ‘comment further. As far as concerns with Surgeon A's competencies, he stated there were 2 few cases brought up via the Event Reporting System (ERS) and a few general nonspecific ‘comments made, but that's conjecture and ne requested real events and encouraged ERS reparts and would investigate those and hand off 10 MSPIC, (On 0911612024 at approximately 6:00 PM, an Interview was conductod withthe cutront Chvet Mocical Officer (CMO) beginning this role on May 5, 2024, The CMO staled he had no concerns vith Surgeon A’s competencies, and no formal concems, regarding Surgeon A, had beer brought to him, ‘There have been no addlional pact reviews completed for Surgeon A, Identiied to eceyr on 08/2112024, Surgeon A was the Primary Surgeon involved in a wrong surgical procedure invoiving Patient #1. Surgeon A intended fo perform a splenectorny; however, the patient's iver was removed resulting ia tho death of Patient #1 (cross reference H0191), ‘Aoview of Surgeon A's case log reveaiod he had performed ony two splonectomies at the hospital Since Apit 2021. His last splenectomy was over 3 yeas prion July 2021 “The hospte! deta report, showed a total of four splensctomies performed within the hospital, querying back to October 2078 to July 2024. The last splenectomy performed was by Surgeon Kin September 2023, Per clinical racord review, Patient #t presented to ATER Fane EOEPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 230, Continued From page 27 230) ‘the hospital wath worsening abdominal pain lef-side and tefl chast on 08/18/2024. The Patient was seen by Surgeon A, a General Surgeon, and admited with pain consistent with fan enlarged spleen and splenic mass, identiied por maging studies. Monitoring of the patients hemoglobin and hematoorit (H&H} were ordered, slong with addtional maging studies, monitoring of vita signs and a recommendation for a splenectomy (removal of spioon). The patient into refused suegery. requesting to be lscharged, but agreed to surgery after blood reports on his hemoglobin continued to decrease end the patient's abdorrinal pain failed 10 Improve. The pationt was italy offered transfer to a higher level of care, but due to the patient's continued dectine of his hemagiabin, Surgeon A ‘elt he opportunity to transfer the patient was no longer en option. The patient agreed to the surgical procedure on 03/2/2024, which was scheduled for st 4:00 PM, (On 09/10/2024 at 216 PM, an interview was conducted Staff Member ¥, a Registered Nurse (RN) Circulator, regarding Surgeon & and the surgical case of Pationt #1. RNY stated that Surgeon A was “pleasant io work wi,” and slated that "cases that were routine he was very compeient in, such as laparoscopic chotecystectomias, appendectomies, but wo all hd this eere feeing’, “how are we doing a spleen (splenectomy) at 4 (o'clock) in te afternoon?” RNY, stated that Susgeon A is very ‘typical for being laie, stating he was tae [date of event] and they dict got back to room unt 5-6 O'dock. RN Y statad that ‘splenociomies are not routine procedures and she can only think of 2 ‘thet were done inthe past 2 % years.” RNY Slated there were complaints about Surgeon A znd tha in the beginning of her career. when she ATER Faas REETAgency for Heath Gare Administration PRINTED: tavtor2024 FORM APPROVED. ‘worked at & hospital in another state, she kept hearing his name (Surgeon A}, and il was never 2 ‘00d thing. RNY stated that many technicians ‘nd nurses faked about him and bad outcomes, twas never good surgical. This was nota ormal ease and this was nota rautine normal caselsplenectomy] for Surgeon. RNY stated she had never paricpated in a splenectomy al ‘his tospital, ang it was nota routine procedure. RN Y slated that Surgeon A didnot ask for helprassistance from another surgeon inthis cease, and that he could have. Holp was avaliable. ‘Wo want the family to know the tuth and never thought | would see something tke this, this is 9 huge learning moment for everybody and prevent this from happening again from incompeteny.” RN Y had never completed an event report regatéing Surgeon A. (On 09/10/2024 at 3:15 PM, an interview was conducted with Sta Member F, a Serub “Technician (Scrub Tech) and Firs Assistant, Scrub Tech F was asked ifshe hag any concerns vith the competency of Surgeon A. Scrub Tech F slated that there was once case where he was oing a robotic inguinal hernia, and she noticed be was dissecting on the wrong side. She said ‘when she pointed this out to Surgeon A, he stated he was doing a"bilatora" despite the operative consent incicating a right Inguinal homia repat. Scrub Tech F stated she did not report this because the paint did have bilateral hernias and the the consent included “and all nocessary othor procedures", so she "oid think he was doing Something wrong.” Scrub Tech Fis fama wth ‘the factiy’sincidem reporting system, known as, ERS (Event Reporting System). Sorub Tech F had never completed an event report regarding ‘Surgeon A, or the wrong side surgery. SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 230, Continued From page 28 230) ATER TTAgency for Heath Gare Administration PRINTED: tavtor2024 FORM APPROVED. HLza960001 SINFUENT OF DEFENCES (0) PRowoeveurmucmcum INDPLAN OF CORRECTION \Dinrrtcaion NUMBER neuLoNe whe. ‘COuPLETED osr2012024 ‘SACRED HEART HOSPITAL ON THE EMERALD COAE 7900 US HWY 96 W MIRAMAR BEACH, FL. 32550 Pate {cack Boney Most Se Pee Be Fu ene Te FecOLATORT om Ss EENTIFYNG NFORWTION we (PACH COREE ACTON SHOULD BE coe 1230 Continued From page 29, ‘think it makes him dangerous, report and understands what needs to be 2 event report regarding Surgeon A. conducted with Staff Member 6, @ Scrub (0m 09/1002024 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 ina splenectomy. RN H wa asked if she had any concerns with the competency oF skls of Surgeon A, and replied for the most part, “no”, but his was her frst year working on the surgery side. RIN H incicatod thal his patients “have been a ile questionable fo mo" whan comes to thelr co-mortidites, and she stated his cases are often added ai the end of the day when ho ison call. RN H stated she has never hag any Issues with Surgaon A, and has ne probloms voicing concerns and feels leaders would act on ‘those actions. She described Surgeon A, "in ‘general, he can be very eavalier, So much 60,1 ‘Stat Member H ‘was famtiar withthe fecity’s incident reporting system, indicating she has compteted an incident reported. Staff Member H had newer completed 0m 09/11/2024 at 8:24 AM, an interview was “Technician (Scrub Tech), who stated that she has ‘worked with Surgeon A muitiple times. Scrub ‘Tech G staied that Surgeon Ais a ikeable guy, fun, loud during "ime-cut”, She stated she had hor concerns when she worked with bim, as she had previously worked at trauma hospital in Colorado. The frst few times working with him, she would raise an eysbraw, She explained this statement by stating, "He cut the common bile ‘luct during a laparoscope cholocystectomy (gallbiadder romoval and broke sorub and went into hattway to take a phone call". She stated she ‘asoumed the call was to Gl (gastrointestinal) ‘surgeon or another general surgeon, Scrub Tech G stated that Suigeon A ded not puta stent in, he 230) ATER Faas HOTTAgency for Heath Gare Administration PRINTED: tavtor2024 FORM APPROVED. SINFUENT OF DEFENCES (0) PRowoeveurmucmcum INDPLAN OF CORRECTION \Dinrrtcaion NUMBER HLza960001 ewe ‘COuPLETED osr2012024 ‘SACRED HEART HOSPITAL ON THE EMERALD COAE 7900 US HWY 96 W MIRAMAR BEACH, FL. 32550 ao Tae {ech GeneINDY MUST SE PREGEDED SY FUL REGULATORY O# GEM MVING NFOAMATION] ene (PACH COREE ACTON SHOULD BE coe a ‘CROSS REFERENCED 70 THEAPPROPRITE one 230 Continued From page 30 Just closed i, In her experience, you do puta slentin, She slated that this incident was reported to the Operating Room Manager and Operating Room Director, but she was unaware ofthe outcome. The incident involved Patient #2, ‘Sho also added that most of Surgeon A's laparoscopic cholecysteciomies, she sald it seoms like 90% of thor, would end up “open” (mid abdominal incision), She stated converting {0 an open procedure was so cormman "every ‘ime! would bring in a major ray and most ofthe time we would ond up using them.” Scrub Tech G referred back to Pationt #2 stating that she "Gide feet ne took it serious at al and he doesn't othe right thing”, She stated "I don't ust him ‘8a docl [refering to Surgeon A), hated ‘working with him". When asked if any conceme ‘were voiced preoperatively regarding the splenectomy scheduled for 08/21/24, she stated ‘that all of us were wondering why we were doing 8 splenectomy here anc why we were doing t 50 late in the day. Scrub Tech G added that even ‘the Anesthesto‘ogist questioned it. The coneams. ‘were brought to the charge nurse and to the Chief Mecical Officer. Serub Tech G stated, “anyone ‘that has done a splenectomy knows you are ong to bised.” Scrub Tech G added that stat cal the hospital to see who is on call for surgery i ‘their family need io come hore, and Hits Surgeon A, thoy will wait. When asked if se felt comfortable in speaking up f she sees something ‘that it ight, she reptiod that she feats comfortable, but also al the same time, "Im a Scrub Tech and the surgeon wan't ister fo 3 Scrub Tach unfortunately." Soruo Tech G didn't {think incident reporting was part of her orientation process, bul she had good resources available to her in the operating room. Staff Member G slated she was awace how to complete an event report in ERS, and knows why to report and says, 230) ATER REETPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230, Continued From page 31 290 “basically everyhing should be reported. Scrub ‘Tech G tas never completed an avent report regarding her cancers with Surgeon A ot when a laparoecopie procedure tums to an open procedure. (On 09/11/2024 at approximately 8:59 AM, a telephone interview was conducted with Stat Member 0, an RIN Operating Reom Nurse, RN slated she voiced concomns about the splenectomy scheduled, on 08/21/2024 at 4:00PM, tothe Charge Nurse (CN), She stated sho told the CN “she was not comfortable with the case and was concemed about the outcome.” RN D wanted to make sure they had enough blood; stating that "splaens get a ot of biood. She stated she was told by the CN thet the doctor ‘was approved and credentialed, IRN D sad, she “alin hava @ good feeling. [lacked confidence in the surgeon to do the case and she raised ‘those same concems". RN D slated that Surgeon A was about an hour late. The surgery ‘was scheduled for 4:00 PM and the pationt went into the OR 95:20 PM, She recalled standing at pationt#'s bedside white Surgeon Awas yeaking with the pation". She stated Surgeon A “made it sound ike [the surgery] run ofthe mi, but | knew diferent" RN D, stated she had, never bean involved in something Fke this.” During the ntorviw, RN D sisted "Evoryone knows he's ot a good surgeon,” and added that statf would not bring their fami I he was on cal, RN D sai there was a similar incident last year ‘that has been under review. RN stated, "I dont. know how he was alowed to come back” and she had heard thore were 6 cases against hin. RN D- reiterated that she did tell the charge nurse and talked to anesthesia and voiced the same coneeens. Staff Member D had naver completed ln event report regarding Surgeon A AERPs CSOTAgency for Heath Gare Administration PRINTED: tavtor2024 FORM APPROVED. (0 09/12/2024 at approximately 12:08 PM, a telephone interview was conducted with the Director of Risk Management. He stated that it ‘a8 broughl to our attention by sorne of the OR staf that Surgeon A had severed a common bite uct and had never been reported. He stated ‘they are warking on that now and weil be ‘educating the staf. He stated he oxpactod rursing staff andor provider should have reported those issues immediately (0 0971212024 beginning at approximately 8:25 AM, a simuitaneous interview wes conducted with ‘the Operating Room (OR) Director and Operating Room Manager. The staf stated that fa procedure changed from sthat was originally planned, then staff do an ERS. The staff used ‘the example - fa scheduled laparotomy converted fo open, that would constitute and ERS. The OR Director stated that some of the concerns they are hearing about Surgeon Aare Just now being brought to thelr attention, euch as Surgeon A’ reputation in (city in Alabama). She ld acknowledge that she 'has heard’ sta! Indicate that they check to see what surgeon is (on caf frst before they bring family to hossital sand fits Surgeon A they don’t come in, But slated, staff each have tele favorites, and this ‘was not something that caused hor concem. She said Surgeon A does a big volume, dss 2 lot of ca868, anc has more inpatients. The OR Director slated that whon surgeons are baing recredentisied we give the commitee the OR cca9e logs, but we don’ know how this is done at ther hospiials. The OR Manager etated she had heard concerns voiced by staff 0 include concems from anesthesia, regarding the late stat ofthe splenectomy scheduled at 4.0080 (08/21/2024). The anesthesiologist was informed SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230 Continued From page 32 290 ATER Fane OTSTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230 Continued From page 33 290 ‘thet they ad suffeiont staf and al the necessary ssupplies/products needed to perform the surgery. The OR Manager indicated she had "fufed the slat, for this ease. They hed enough staf, at necessary products and equipment. ‘The staft ‘work 12:Rour shifis ans scheduling tis procedure was within cur scheduling window. (0 09/11/2024 at approximatoly 1:46 Ma ‘elephone interview was conducted with Stat Member E, an Operating Room Registered Nurse. RN E stated she brought forth concerns prooparativaly, stating hat the majordy of staf fend anesthesia and the CRNA (Certified Registered Nurse Anesthetist) al voiced thelr ‘opinion and dign' think we should be doing this procedure jsplenectorm}. RN € stated thet she ide think "Surgeon Awas a great eurgeon and cet think it woud and wel," and incicated this hospital is "not a trauma facility.” RN E stated ‘this was an elective eurgery and thst 'splonectomies can go bad vary fast, and starting the surgery at §:30 PM (surgeon was late) wasnt ‘omar with limited sta; and not ema forthe patient. She stated, the patient should have been Somewhere whore they do splenecfomies on a regular basis and staff that are qualified. RN E ‘added that Surgeon A has had a prior wrong she surgery and people in the OR voiced concerns: about his skis (0 the Charge Nurse and tothe OR Director, RNE stated she was familiar vith ‘the faciy’s incident reporting system in ERS. RN E statod sho has not completed an ERS this time; "never done it hefore, wish had." During an interview conducted with Surgeon A, on (09/20/2024 beginning at appcoximately 10.00 AN, Surgeon A stated thet he has performed probably "20-30 splenectomies” in Ws career, tee at this hospital including the one on 0821/2024. AUER Faae RESTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230, Continued From page 34 230) Surgeon A describes the events that aocurred for patient #4, Staling he was ‘on calf and received 2 vall from the Emergency Department for patient Uv had acute onset of abdarinat pain and tiscomfor. Based on his imaging studies, physical examination findings anc laboratory {ndings @ splenectomy was recommended. The pationt was not wanting surgery. He advised tho patlont that this hosptat dows not nave “intarventionat radiology’ (a modical specalty that ses minimaly-invasive procedures to diagnose ‘and treat disease in the body - often used fo treat splenic injuries in stable patants through a procedure called splenic artery embolization). Patient #1 wanted to be discharged. Surgeon A Indicated that would bo against medical advico, fs the patient wanted to drive home 6 hours. Surgeon A offered to transfer the patient to 8 Nigher lavel of care, but the patient refused. He had placed the patient on the OR (operating oom) sohedule, to ensure space avaisbiity for 08/20. Surgeon A continued to monitor Patient 1's clinical canction, and the bloods counts kept iminishing and the scan were showing there is a problem. Again, he had a conversation with the pationt recommending transfor toa higher level of care. The patient didnt want to do that and didnt ‘ant to consider having the procedure done. By Day #3, the patent was really sick and now Indieates he wants somathing done. At this point, ‘Surgeon A stated, that Patient ft's condition has \eteriorated and we've fost window to transfer {0 Higher lovel of care apd pationt #$ became very stended. Surgeon A felt thet patient #1 was no longer stable enough to transfer, indicating that transfers can take up to 24-48 hours to occur Surgeon A stated thet no sta members ‘approaches nim with concerns about this, procedure. He aid speak with the anesthesiologist to ensure af blood products ooPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230 Continued From page 35 290 ‘were aveiiabie, The surgeon stated that "splenectomy" is nola simple procedure and normally he would have ancther physician assist in, but based on the availabilty of help the (OR, a Surgea) Scrub Technician Fist Assistant (Sorub Tech F),he fet confidant he could take care of patient #. Surgeon A added that if she had not been avatable, he would have called ‘another Surgeon. Surgeon A stated that ho cooedinated with the anesthesia team and with the CMO and they had worked on making sure blood products ware avaliable. Brought tothe attention ofthe Director of Quelily and Rsk Management on 08/05/2024 by the CMO, was Patient #4, Patient #4 had presented ‘0 hospital io have a stent remove following 4 laparoscopic hand-assisted left colectomy ccompiated by Surgeon A on 0770212024. Duving the pationts surgery, Surgeon A.cut the Fight ureter requiring additional surgioa intervention by a urologist. This flied lo be reported al the time ofthe incident (01 09/432024 at approximately 4:50 PM, an Interview was conducted with the Director of (Quality regarding the Medical Staff Performance Excellence Committee (MSPEC) and peor reviow. The Director of Quality staied physicians have ongoing physician performance evaluations completed, and when a physician comes up for jevaivation. fhe has had any peer review cases ‘that information is provided here and signed off by the depariment chair. The peer review process and the ongoing physician performance fevalvations ato two separate things. Pear roview ‘occurs when there isa ease af concern, either by 1 peer, another physician or the SERT Teor (Safety Event Response Team}. They wil make 2 request for peer review. Peer review is AERPs RESTAgency for Heath Gare Administration PRINTED: tavtor2024 FORM APPROVED. SINFUENT OF DEFENCES (0) PRowoeveurmucmcum INDPLAN OF CORRECTION \Dinrrtcaion NUMBER HLza960001 whe. ‘COuPLETED osr2012024 ‘SACRED HEART HOSPITAL ON THE EMERALD COAE 7900 US HWY 96 W MIRAMAR BEACH, FL. 32550 ao Tae {ech GeneINDY MUST SE PREGEDED SY FUL REGULATORY O# GEM MVING NFOAMATION] a (PACH COREE ACTON SHOULD BE coe 1230 Continued From page 36 reviewed by the MSPEC committee which Includes 3 separate corporate affliated hospitals that are poojed together, which creates the Midwest MSPEC, (on 09/20/2024 a approsimatay 00 AM, an interview was conducted withthe Chaiman, Metical Stat Performance improvement Commitoo, Midwost Markt, Ho stated tho process works when the Diector of Quaity and her team identify 2 case to come to peer review oF 19 8 SERT process, This gos presented at the MSPEC committee, isan overall process were we have doctor in that field review and talk about the cage. We discuss wo thek the cate is accoplabio or unaccoplabla, Somatimos ‘we need to send the ease out for more review ‘We cant make a determination unt we receive axvica from otter doctors. Theres a slandard MSPEC form and quay post guide forthe form ‘nbich addresses ciferent elements of te case ‘We perform this review fairly and objectively and equally apy Areview ofthe factity's Medical Staff Bylaws, 10212021, identifies in Aticle 8, beginning on page 26 the duties of "The Exocutive Committe is Slegated the primary oversight authority over professional activities and functions of the Medical Staf and performance improvement activites regarding the professional services provided by Medical Staff member with cinical privieges. This authority may be removed or mmodifed by amending these Bylaws and related policies. The Executive Commies is responsible Tor the flowing (2) Acting on behalf ofthe Medica Sta in the Intorvais between Medical Staff meetings (the officers and the CMO ara empowered to act as a group in urgent situations between Executive 230) ATER Faae OTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPTALON THEEMERALDCOAE [HUME MAT ORM rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230, Continued From page 37 230) Commitee meetings: (c). Recommending dieetty to the Board on at least the folowing en 2. the mechanism used to review exedemtiats and {0 delinsata inalvicual clinica privleges: 3. applicants for Medical Staff appointment and reappointment; 4. Gelineaton of cnical privtegos; 5. participation ofthe Modicat Statin performance improvement activities and the {ually of professional services boing provided by the Medical Stat, 6, the mechanism by which Medicat Steft ppointment may be terminated: 7. bearing procedures; and 8. other appropriate reports end recommendations that the Executive Commitioe has received from Madical Staff committoes: epartments, clinica services, and other groups. Aatige 8, €, - "Performance improverrent Functions" indicate that "The Medical Staff's ‘2ctivaly involved in the measurement, ‘assessment and improvement of a ieest the ‘olowing: 4. Patient safety, including processes to respond {0 patient safety alerts, meet pallent safety goals, and reduce patient safety risks 3. Medical assessments and treatment of patients 6. Operative and other procedures, inctuding tissue review and review of discrepancies between pre-operative and post-operative lagnoses 7. Appropriateness of clinical practice patterns 11, Sentinel events incuding root cause analyses ‘and responses Io unamticipated adverse events 17. Accurate, timely, and legible completion of rmesical records 19, Review of findings fram the ongoing and focused professional practice evaluation activities ATER Fae CESTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED zsseooet wg osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1230 Continued From page 38 230) ‘thet ore relevant to an individuals performance; and 20. Communication of findings, conclusions, recommendations, and action to improve performance to appropriate Medical Sta ‘members and the board, Class tt #407 396,0187(1 044, F.S. Approp Measure - Ongoing aor Eval of ProolSysiems (6) The development of appropriate measures to minimize the tsk of adverse incidents to pation, Including, but not inited to: 4, Development, implementation, and ongoing evaluation of procedures, protocols, and ystems {0 accurately identity patienis, planned procedures, and the correct site ofthe planned procedure £0 as to minimize the performance of 2 surgical procedure on the wrang patient. a ‘wrong surgical procedure, a wrongesite surgical procedura, ora surgical procedure otherwise ‘nreiated to the palients diagnosis or medical condition. This Statute oF Rule is pot met as evidenced by: ‘Based on staff interviews, patient madical record review, hospital docurnonts roviaw and reviow of the hospita’s policy and procedure, the fecity failed to ensure that staf reported any quality pationt safely concer to the Risk Maniagor for Investigation, This staffs faire in reporting ‘oneemns with competency led to the hospitats ‘altar in identifying opportunites te improve patient heaith outcomes. ATER TET ‘STATE FORA “ wor Hesston sont 300147PRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 407 Continued From page 39 aor The findings inctude: Patient medical record review was conducted for Patient #1, Patient #1 was the subject of a wrong sile Fwrong surgery resulting inthe patients oath, Pationt #1 was scheduled for a laparoscopic splenectomy by Physician A. Physician A removed the urong organ, the liver, instead of tne patents spleen, resutng in the patient's hemorrhage, cardiac arrest and death (0 09/1012024 at 2°18 PM, an interviow was conducted Staff Member Y, a Registered Nurse (RN) Circulator, regarding Surgeon A and the surgical case of Patient #1. RNY stated that Surgeon A was "pleasant io wotk with," and slated that "cases that were routine he was very ‘competent in, such as laparoscopic, cholecyslectemias, appendectomias, bul we all had this ees feeling’, "now are we doing a spleen (splenectomy) at 4 (o'clock) in the figragon?” RN Y, stated that Surgeon Ais very typical fr being aie, stating he was late (date of event] and! they dit get back to room unti 5-6 oldock. RNY stated that ‘splenectomies are not routine procedures an she can only think of 2 ‘that were done in the past2 % years.” RNY slated there were complaints abou! Surgeon A and that in the beginning of her career, when she ‘worked ata hospital in another stato, sha kept rearing his name (Surgeon A}, and itwas never a good thing. RIN Y stated that many technicians ‘and nurses talked about him and bad outcomes, ites never good surgicely. Staff Member ¥ had ever completed an event report regarding Physician A, (01 09/10/2024 at 3:75 PM, an interview was, conducted with Staff Member F,a Serub “Technician (Scrub Tech) and First Assistant ATER Fae CTTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 407 Continued From page 40 aor Scrub Tech F was asked ifshe had any concems th the competency of Surgeon A. Scrub Tech F slated that there was ones ease where he was ing a robotic inguinal emia, and she noticed he was dissecting on the wrong site, She said ‘when she pointed this out to Surgeon A, he stated he was doing a “bilateral” despite the operative consent incicating a ight inguinal hema repac. ‘Scrub Toch F stated she did not report this because the patient cid have bilateral hernias and ‘the the consent included “and all nevessary other procoures", 50 she “didnt think he was doing somthing wrong” Scrub Tech Fis falar wit the faciy’s incident reporting system, known os, ERS (Event Reporting System), Sorub Tech F had never completed an event ropoxt regarding Surgeon A, or the wrong side surgery. (0 09/10,2024 at 3:57 PM, an interview was conducted with Staff Membar #, an RN Operating Room (OR) Nutse. RN H siated she has never participated ina splenectomy, RN H was asked if she had any concerns with the competency or skis of Surgeon A, and replied forthe most pert, no", bu this was her first year working on the surgery side, RN H incicatod thal his patients “have been a ble questionable to me" when t comes to their co-morbidities, and she stated his cases are often added at the and af the day whon ho ison call, RN H stated sho has never had any issues with Surgeon A, and has ne problems ‘voicing concerns and feels leaders would act on those actions. She described Surgoon A, "in ‘eneral, he can be very cavalier. So much 30, think makes him dangerous.” Stat Member H ‘as familiar with the faclty's incident reporting system, indicating she has completed an incident report and understands what needs to be reported. Staff Member H fad never completed an event report regarding Surgeon A ATER RESOPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 1407, Continued From page 44 aor (01 00/11/2024 at 8:24 AM, an interview was conducted with Sta Member G, 2 Scrub “Technician (Sorub Tech}, who stated that she has worked with Surgeon A multiple tines. Scrub “Toch G statad that Surgeon As a tkeabie guy, fun, loud during "Ume-ou”, She stated she had her concerns when she worked with him, as she bad previously worked at a traurna hosplial in Colorado. The frst few times working with him, she would reise an eyebrow. She explained this statement by stating, "He oul the common bile {uct during a laparoscopic cholecystoctomy (galiadder removal) and broke scrub and went into hatway to take a phone call, She stated she assumed the call was loa Gl (gastroiniestinal) ‘surgeon or anather general surgeon, Serub Tech G stated that Surgeon A did not put a stent in, he just closed it In her experience, you do puta stant in, She stated that this incgent was, reported to the Operating Room Manager and Operating Room Director, but she was unaware fof the outsame. The inciientinvaived Patient #2 Sho also added that most of Surgeon A's lagaroscopic cholecysteciomies, she sab feems tke 90% of them, would end up "open" (mid abdominal incision}. She stated converting {o.an open procedure was so.common “every ime i would bring ina major ray and most of the time we would ond up using them.” Scrub Tach G referred back to Patient #2 stating thal she “lr fet te took it serious al all and te doesn't othe right thing", She stated "I don't ust him fs a doctor [referring to Surgeon Al, hated ‘working with him’. ‘When asked if any concarne ‘wore voiced preoperativaly regarding the splenectomy scheduled for 06/21/24, she slated ‘that all of us were wondering why we were doing = splenectomy hare and why we ware doing i 5 late in the day. Sora Tech G added that even ATER RESTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 407 Continued From page 42 aor ‘the Anesinestologist questioned il, The cancems. ‘were brought lo the charge nurse and to the Chief Meslcal Officer. Sesub Teah G stated, "anyone thet has done a splenectomy knows you are jpoing to bleed" Scrub Tech G added that stat ‘al the hospital to see wha is on call for surgery i theic family need to come here, and if itis Surgeon A, they will weit, When asked if sho felt comfortable in speaking up if sto soes something ‘that fst ight, she reptiod tat she feats comfortable, but also al the same time, "Tm a Scrub Tach and the surgeon won't isten to a Scrub Tach unfortunately " Scrub Tach G didn't think incident reporting was part of her axentation process, but she had good respuroes available to hor in the operating room. Staff Member G sated she was aware how to camplete an event report in ERS, and knows why to report and says, “basically everything should be eeporied. Scrub ‘Tech G has never completed an event ceport regarding ter concems with Surgeon A ar when laparoscopic procedure turns to an open procedure, (0 09/11/2024 at approximately 8:59 AM, 2 telephone inteniow was conducted with Stott Member D, an RN Operating Room Nurse. She slated she use fo be a Scrub Tech and became nurse in #998. RN D stated she voiced concerns about the splenectomy scheduled, on 0821/2024 {at 400M, to the Charge Nurse (CN). She slated she lold the GN “she was not comfortable ‘with tho case and was concerned about the outcome." RN D wered to meke 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 8d, she "didn't have a good feeing. | lacked cantenee in the surgeon te do the case and she raised those same concerns". RN D stated that ATER ESTPRINTED: tavtor2024 FORM APPROVED. Agency for Heath Gare Administration SINFUENT OF DEFENCES (0) PRowoeveurmucmcum pay mre ConSTaUeTON [parame ame INDPLAN OF CORRECTION \Dinrrtcaion NUMBER naman ‘COuPLETED HLza960001 wns. osr2012024 7900 US HWY 96 W SACRED HEART HOSPITAL ON THEENERALDCOAE [AUREUS rer: {ech GeneINDY MUST SE PREGEDED SY FUL ene (PACH COREE ACTON SHOULD BE coe me REGULATORY O# GEM MVING NFOAMATION] He ‘CROSS REFERENCED 70 THEAPPROPRITE one 407 Continued From page 43 aor Surgeon A was about an hour late, The surgery ‘wes scheduled for 4:00 PM and the patient went into the OR at 5:20 PM. She recalled standing at pationt 1's bedside white Surgeon Awas speaking wit the patient, She stated Surgeon A made it sound ike the surgery run ofthe mil but | knew diferent." RN D, stated she had, never been involved in something Eko thi.” During the interviow, RN O stated "Evaryone knox ho's rot a good surgeon,” and added that staif would not being their ferity he was on cal, RN D said there was a similar incident last year ‘that has been undar review. RN D stated, "I don't ow how he was allowed to come back” and she had heard there were 8 cases against him. RN D reiterated that she dis tl the charge nurse ard talked to anesthesia and voiced the seme concerns. Staff Momnner D had never completed ‘an event report regarding Surgeon A (0 09/11/2026 at aporoxinately 1:46 PM telephone interview was conducted with Stat Member E, an Operating Ream Registered Nurse. RN E stated she brougit foth concerns preoperatively, stating thal the majority of staff ‘and anesthosia and tho CRNA (Certified Registered Nurse Anesthetist) al voicad thelr opinion and didn't thing we should be doing this procedure fsplenectoeny}, RN E stated that she ide think "Surgeon Awas a great surgeon and cc think it would end wel," and incicated this hospital ls “nol trauma facity.” RN E stated this was an elective surgery and that 'splenectomies can go bad very fast, and starting ‘the surgery at 5:20 PM (surgeon wes late) wasnt smart with Hnited staf and not smart fr the patient. She stated, the patient should have been Somewhere where they do sptenectomies on a regular basis and staff hat are qualifad. RN E ‘added that Surgeon A has had a prior wrong site ATER ae OTT