- 53F VD SURGERY iNgg??TiQN LEVEL ii 8: Eli 4052 BALD CYPRESS WAY, BIN #6303 SS BE, FLORIDA. 3'23 .9 9-3 2.5 3 ~24. Inn? I . 5:24 CHAPTER 458.309, FLORIDA RULE 6488?9.0091. AUMINISTRATIVE CODE I NAME OF OFFICE SURGERY FACILITY CG 1541?4?47? FC-JISLU 7 04? L3 a 5-52. DAWOFINTEW i? STREET ADDRESS $152330 3 El 3244; PngaIciqum MAME Mgsawti?ia?sb 0 ngri Davie.? 32mm Giwm. (H) i ?6'95 . ch i?iLi II Swim?" 1344 . ?222944-. 6410.5 624 Requirement fur Piwsicimt Of?ce M0 NA chIIiI-I'mIE-Ilis LOVEJ i1 {)l?iire Surgury YEQ NO N45, l. The physiciI-Int?s) rem?sgurcd m?ce? based 51!!?le with tlIL oi medicine?64383 90091?) 3'12. A greet-nan Required {ll? ?435lein Siafi?i?rivilcges {(21138- I. 2. 1.11:: physiciams} of?ce is not accredited with II national amrnditing urganixaiiI?In 63. {he smgery is being perfumed outside a imspitnl, umbuintmy surgical altostinn clinic at (IiiIm medical Facility licensed by the. Department 21? Health or Ihe Agency I'm iilnrc ind), or Board 1: ut?guni?itnn 3'3 wi?IlI "i'I'tIi ?ing, \1/45 3. The phy$icianfsi I)erFtIrm$ as: de?ned in the Board i?a'l Compiianca \Vilh Basic Life I . . I 1/ 33b") I 33?: 3 PAC 1 Ii. The Slirgebl1l:$i) is an active licensed physiciani?si In The Slate of Floritinmcil?w .135 (?ItmplI'arIcu ?-th AdI-IInL-cci SupporI ortifimIionl??l?IR? 9. 1 9 nib)?? S. The equipment meets the curreni performance- antlardsfiirmi'?- -9. (iDFJ?liin). 25. Compliance with [?quipn? em and Suppli?? Requn-e II 00% (".ompliuncc with Crash Cm 9/ CLEIUQHKIJBII, dehmmn 01 of ?urge? ?5 51.5. b21122 28. eriI Anes?icsm General Requirements for O?lue Sumerv 29 Compliance wilh Additional with via 30, Compliance with Rec-every [6488?9009(4i bill. FACE v? i I g, . 3 ("om 31mm, with Rutwiremeufs for Level (Include. iiIIc I'Hliili?ell'lc??i for level il Of?ce surgery as well BR 1h II - 1% requirements 01: (limit! (I. Itmuiiar Le with the Anwrict In i SI. Compliance For app: opI cantiit?hter} .r inIIi ?10mm.- 4? II. I42, I I 32. with Additional -3 with [Emergency l?rcIImIiuI-IIsf i0. CtImplianac?I with Surgical 1" A ,li. Compliance with 34 Pump] with Additional and Supplieai??g- I2. Compliance with liposuction procedumsi?d?S-ii?JDiltl?ej, 4., 009K) (.1 13. Compl liill?? with Elective and Plastic' Surgery .. HI r? .4 in.? 9-00912X0I li'AC] 35. .2I~Ipiiu~with \Incaliwnl?murciufc BS It} 14. wiih ovemigiir stays meant cosmetic and plastic "36. with Additionnl Assismnce Ull?mr Pawn-ml surgervl 64138 i-?A Cl] by, FA l3. Compliance with 5135-5 rclu?on any stitgimi procatiIIrei?-?Iifi?v 9.009(380, 16. Cumpiietncc with anal-operative I7. Compiimcc with ancsihmic moniioriI1g?641386t009?23igL FACE 18, Compliance wiLlI policy and proceclut'cs 19. Compliance with risk I?I?Tiscciistnmus {E?imse Specify} T3255. m) i'IvE ?132; . \12. viiJami la?; 9043.4 N3.) Wm Lag-3L Sui; efI4 ?liwu "4.3 but?? 6343' D63 lb'H?i'WiLMois fh me.) rl) Inwdt?dh (Form Can-pl ieib44buf Mr bq?uf?guwg? 3 Chris was Mn? do LLIn?miwL QLL/tj?mn my? pf?lhd?f Q) [?be {f {William XL. HIM-J Q4991 was on ,Scribbxj. 1324 5% 4' r133 pMsIm 3m mamwi?tm?m Xm? if Wt [ultra {m 027/5 c?hmmk (lJW?tI??fol?I?A-Tl Coma/?e Cw DNMJ-wvib hw?ff?wa GIN-5M .. "Hug ?ic- mjl' TILL.) (?rmjk 4" . Gm have Iread at it report and the laws and reguiztt ions crammed herein explained and tie aiilrm that Inictmtatk an given Win rue and corra to the best of mygtawiadga fa ?l HERB Signature Msponsibie Party Date Investigator Date Revised 2013 0w um.? Farm ?2134,. Prue-Irma) +2 I?m; parsLMI ll,\l bel?l'tz if ??4413 (?k-Qafmaek LJC?LmC?-ihna) {nggoL/Itrf?i .- 6e38~9.0091 Requirement for Physician Gf?ce Registration; inspection on: Accreditation If the of?ce is determined to be in noncompliance, the physician shall be noti?ed and shall be given a mitten statement at the time of inspection. Such written notice shall specify the de?ciencies. Unless the de?ciencies constitute an immediate and imminent danger to the public, the physician shall be given days from the date of inspection to correct any documented de?ciencies and hotify the Department of corrective action. Upon written notification from the physician that all de?ciencies have been corrected, the Department is authorized to re? inspect for compliance. 1 have read and understand the above Section chule RAE. WM Signature ofF'aciIity Representative H) MHLO LIKES) L: do I (Q?Lad-qucaAE-i . I ITDSE N?sagent}? 0 (l 8 ME: (?aft-Dire ($41 A) MD 513?} [AM?M-sxitnf?nifw Low gigs dwrh" ..I QII we no); row.) page. me 33:5 cup-3&3- b3 ?'1er ts he Into, Ma. ?a?Aikf?/Ij 5 IL. mmwaxmimi A8 ?43 Mount, {mot/Ii ??th tee? cit-+41 New we mt win?z mac?fe-mo. writ?{M dc?? ?3113 bbwh?ui? EAL) If) 5&1!ka IA 3 (ieaaw-ihcdi I ON) I I) Lgvofcf-BJ?JRW; oil NB 4L5 ?Ht'j?jd mg i) {1 Ce 3; math 'f?o?a'r A2, 3?3) 6 M) (UL 7243: (It-em ms 1" Liege?m) An 5; 4:7 R?hmn 3-13 . . ?w-cn ISL ?7 . ?t IiibIIce-t cepi pm Is to De n. new LII) LA lit-0 A A *vItzc?Ji?e m. a . It} Qz?mvx Wo?iwm Zea/{w 56:- M?min 7&3 Ma??ga .. [\?f?lis H929 Lg; W438 .A mm br?l-MLL#1st @5731. mg MNMLEF ?Hug; (?aw "rum-4 .u GE) mag 1.32:: *5 is") ?jig?"96??gm 5-: 9.339% - I #5ch Fm?h M-?wwk? Uwf?px MW?amj) r2: Siamot 5L4 pM?io?aa/w K.) -. may?. ?if L2 m; Lima if ?if. ?v5 ?/7524? :3 1+ ..L;iom a: (Wrigu? Umaiw 6197?? . . (0 0 0 ?1c ?iffgw?ff Liam 55%? [gr dM-ui-?Hyn?nnvnu-u? i D??i??hagb f? .-.. .. . 4- . . - .: h?gwmw?>411tbmm?gm NWMN . "m 3r t! I 5pm - bppugmm?951? arr-w r?I-valrnL FM. . m: fih?l-T. . v,rn__r_m_m_ {Mgk {Elihg?r?zgmcue?g 3 . ?ij'm 5?33 MFEQG i Mam; 5339650437 Muir Mm .14 cw. W3 RS +9 dim .nqA-l ?many C6193 cag?? 2.4L. m1 ff; ti?? . Mkr?ss?crgxok Nam Nw 0 ?er mm . . WW8 ?mum-mW, 256 ta .9 It?E192 1m d4 gif {weakening $Lu??gu? ?Mtg ?13519 WM MM ME 533.: one) (Wad! LVN) ?f0 53 3 mum. ud?k??n?u?rl- Cliff? Etc} 5: Hub Cag?f/Qf?f?? O?M-gak 054?? 37573 9 a?wm aw Ci? 7 m4, Ha??m gm:- tintm?o-q-I: -n a . 4, w. ?mmp.91MA?o?qn?u-I -4. mun?4WEST DADE SURGERY. D.B.A.VAN1TY COSMETIC SURGERY 8506 SW 8TH ST MIAMI. FL 33144 December 16, 2013 Dept of Health Board of Medicine 4052 Bald Cypress Way, BIN Tallahassee- Fl 32399 Of?ce Surgery Department RE: PLAN OF CORRECTION: West Dadc Surgery, DBA Vanity Cosmetic Surgery 350 Location Address: 8506 S113 St. Miami. Fl? 33144 Date 11--22 2013 Registered Physicians: Dr Rami Ghurani ME 89365: Dr. Salas ME 103242; Dr Jonathan Fischer ME96746 (it Dr. Anthony Hasan \dE 7323015iddharth Bass. MD ME 79410 Conducted by: Deanna Pfoff. RN. LHC RM As of November 25. 2013. the of?ce surgery center has begun implementing the following deficiencies: Dr- Ismael Labrador. Administraton?Medical Director of West Dade Surgery. DBA Vanity Cosmetic Surgery is responsible forthecorrectixe action and ongoing compliance. The administrative staff. RN- surgeons and anesthesia personnel have been in serviced on December 4. 2013 for the following deficiencies and shall maintain compliance with Chapter 458.309 Rule 6488:9009]. F.A.C. 1. Attached to this plan ofcorrection is the updated Application with the c0rrect name of the Business 2. 7 Compliance with P1e-operati1e e1aluatiot1: Dr. lsmael Labrador met with his etedentialed physicians and discussed the Quality Assurance issues disco1 cred 1n the immediate preoperative during the Inspection have been correcred: these include the pin- sician signatme and the documentation of the ASA classi?cation It will be the responsibilities of Dr. Ismael Labrador administrator 1n maintaining the ongoing compliance 3. Tag 3 Compliance 11-1111 Patient ?Procedures records: -- a. Dr. Ismael Labradoi met with his credentialed plwsicians and discussed the Qualitv Assurance' tssues discovered in follon up appointment form during the inspection have been corrected: the Medical assistants will scribe for the physician as long as the physician signs off on each visit. It 11111 be the reSponsibilities of Dr. ismael Labrador. administrator in maintaining the ongoing compliance. b. Dr. Ismael Labrador met with his credentialed physicians and discussed the Quality Assurance issues discovered by having absent Operative notes in the medical record during the inspection have been corrected; those medical records contain a signed operative note by the surgeon. It will be the responsibilities of Dr. Ismael Labrador. administramr in maintaining the ongoing compliance. ltDE SURGERY. A. VANIT COSMETIC SURGERY 8506 81?. 8TH ST MIAMI. FL 33l-?i-4 Tag 9 Compliance with lnfonned consent; Dr. Ismael Labrador met with his administrative stall and discussed the Quality Assurance issues discovered in the documentation of the informed consents during the inspection have been corrected: Staff has been made aware that only the staff of the organization are instructed properly document the procedures in the informed consent; It will be the responsibilities of Dr. lsmael Labrador. administrator in maintaining the ongoing compliance. Tag 1 Compliance with Liposuction Procedures: Dr. Ismael Labrador met with his credentialed physicians and discussed the Quality Assurance issues discovered of not properly documenting the correct amount of ml's of Lidocaine during the inSpection have been corrected. Dr. Ismael Labrador demonstrated to each credentialed physician where those amounts of Lidocaine (11115) are to be documented in the "operating room record and then that information is transferred correctly in the physician operative report. The purpose is to ensure that no physician exceeds the state mandated amount of SOmg/kg of lidocaine per patient it will be the responsibilities of Dr. Ismael Labrador administrator in maintaining the ongoing compliance. Tag 12 Compliance with Li posuctigil cdmbination procedures; Dr. Ismael Labrador met with his credentialed physicians and discussed the Quality Assurance issues discovered of the discrepancy of the amount of Supernatant Fat (SNF) during the inspection have been corrected. Dr. Ismael Labrador demonstrated to each credentialed physician where the amounts of SNF are to be documented in the ?operating room record and then that information is transferred correctl1 in the ph11sician operative report The purpose is to ensme that no ph1 sician e1 ceeds the state mandated amount of 4000cc of SNF per patient. lt11ill be the responsibilities of Dr. Ismael Labrador. administrator 111 maintaining the ongoing compliance. Tag it 16 Compliance with Post -operati1e care Dr Ismael Labrador met 11- hit his Registered Nurses and discussed the Qualit1 Assurance issues discm ered of not proper!)? documenting to whom the patient is being discharge too during the inspection has been cerrected. The RV was documenting Discharge tO' '"l'tome instead or writing down "Spouse "family member caregiver ?thev have been instructed to how to properlv document. During the inspection one chart did have the 1aord' i'1'otel' however no patient leaves the premises without an adult present lt11ill be the reSponSihilities oi Dr. Ismael Labrador. administrator 1n maintaining the ongoing compliance Tag 19 Compliance with Risk Management: At the present time the organization chooses to perform 1heir risk management minutes on a quarterl1 basis. it will be the respOnsibiliu oi Dr Ismael Labi ad01 to ensure compliance bv conducting and documenting the quarterh Risk Management minutes. 7. 10. 11. ,11: WEST DADE SURGERY. D. B. A VANITY COSMETIC 8506 SW 8TH ST FLS 3l4~l Tag it 20 Compliance with ad\ erse incident compliance: The center had three ad1 eise incidents since the last inspection. All of the adverse incidents were reported to the Dept oi Health within the requested time lrame of ii tteen da\ 5. Taa#23 Hospital Privileges Dr. Hasan ME 78230 Board of Cosmetic Surger}r has expired. Dr. Bass ME 79410 the general surgeon does not have a board in Plastics. however attached are his training credentials for plaStics and/or cosmetic procedures. It will be the responsibilities of Ismael Labrador. Administrator. See attached document Tag it 25 Compliance nith ACLS certi?cation PACU Nurse has updated her file and she has a current ACLS card. It 11 ill be the responsibilities ol Dr. lsmael Labrador. administrator in maintaining the ongoing compliance. See attached copy of AC LS card. Tag it 31 Compliance with American Societv of Classi?cation for appropriate candidate for Level ill ofiicc snraert?: Dr. lsmael Labrador met with his credentialed CRNAS MD anesthesiologist and the Quality Assurance issues discovered of the lack of documentation of the ASA classi?cation during the inspection have been correCted. It was made aware to each credentialed staff member the importance to document ASA classification on their anesthesia 1? orm. There must be communication between both the surgeon and anesthesia personnel on what ASA Classi?cation is best For the patient. it will be the responsibilities of Dr. [smael Labrador.administrator in maintaining the ongoing compliance. All registered CRNAS have a signed protocol with the surgeons. The CRNAS have submitted to the Dept of Health their signed Protocol detailing their supervising physician. It 11 ill be the responsibilities at Ismael Labrador. MD. administrator 1n maintaining the ongoing compliance - -- 0n the day of the inspection we clari?ed with the inspector our current staff. We are notifying the State? that based on our database the following registered phvsicians are _N_o Longer working at our facility. Enrique Gomez Daniel Careaga. John Nees, Orlando Lloreme Camit harez .lercmv Ecksterin. Carlos Wiergering. Raul Rodriguez. Arnaldo Valls. and Jean Paul Font. Please be adx iscd 11c hat notified the State DOH ofthese - physicians 1n the past . We are notifying the State that based On our database the following registered physicians and clinical staff that are currently working. at our facilitv: Phlsicians: Jonathan Fishe1.Anthon1 Hasan. Rafael Salas. Rathhurant Siddarth Bass Enrique Pelayo. Paul Reil1. Jason Vera. Sergio Hernandez. Gabriel Dietsch- Demarko Bazan. . Cristopher Jorge. Alexandra ones. Mario de la Portilla. Lourdes Dieguez. Richard Lauriello. Set-1g Fook Lam. .lesus del Risco. .lustin Jimenez. Miguel Vasallo. Carolina Wilson. Frankie Lima. . Monica Gross Ramos. Susana Airala. Roberto Fernandez. Alex 4.53 4.55 i1: wesr DADE SURGERY A VANITY COSMETIC SURGERY 8506 sw 8TH 5r MIAMI Fe; 3144 Lazalie Stephane Otmezguine Osma: Creaich, RE: Massiei Ruiz. Yuneidys Aguilar. Jessica D. Coiiazo.CEmulators/Medical Assi?lams: Betsy Reyes, Yunia Calero. Graciela Rodriguez. Adiena Morell, Lama Muriedas. Su rgical Assista Lesrer Trastoy. .iorge Jova. Marieivys Romero. Mitdael Moreno. Mario Leciesma. Orlando Cardelies. Aibeno Toledo. have read this Plan of Correction Report and af?rm that the information given herein is true co rect to the best of my knowledge. DWI abrador. Administrator Date Plan of Correction was prepared b} Dr Laura A. Ley'na MBA. HSA. Physician Consultants, Inc. email: Piwsicianconsuh?aoi. com DEPARTMENT OF HEALTH OFFICE SURGERY INSPECTION FORM LEVEL II 82 Ill 4052 BALD CYPRESS WAY, BIN TALLAHASSEE, FLORIDA 32399- 3253 INSPECTION AUTHORITY CHAPTER 458. 309 FLORIDA RULE 6488 -.9 0091 FLORIDA ADMINISITRATIVE CODE DATE OF INSPECTION NAME on OFFICE SURGERY FACILITY 141% (02:5 V11 9776,, 516/3 439 631/814 03$, 3 5 a. #75" .7 9r STREET ADDRESS F4 PHYSICIAN NAME (5) LICENSEWNUMBERS 52-5702,. 32.493 "war? {92945252 TELEPHONE COUNTY A) gob .. WI 2342ch 0292292: xilr (9/23/5292 - 2; 7.53/2. 3 0 CITY, STATEIZIP 33 qt 3/ . IMC aims/r9 3 Requirement for Physician Of?ce Registration Requirements for Level 1] Of?ce Surgery - YES NO NA - - . I-l. The physician(s) is registered to perform of?ce-based surgery with the Board of 22 Transfer Agreement Required or Hospital Privileges [6433- 1/2! Medicine-6438 9. 9. 009mm 2. The physician(sJ office is not accredited with a national accrediting organization . . . . . or Board approved organization 23. Compliance Trammg RequirementsiotlBli 9 009(4)(b)2 V, i 3 The physician?J performs surgery as de?ned in the Board Uta), 24 Compliance with Basic Life Support Ccttilication[6488- 9 FA 4. The surgeon(s)' IS an active licensed physician[s} In the State of HondanBS- 25. Compliance with Advanced Cardiac Life Support Certi?ca?on[64B8- b/ 9 009mm), 9 009mm): 5. The equipment meets the current performance 9 26. Compliance with Equipment and Supplies Requiredi??lBS- V. FA on The surgery is being performed outside a hospital, ambulatory surgical center abortion clinic or other medical facility licensed by the Department of Health or 376$?3gg?cir3 085k Cart Resuscitative Medications[6488 the Agency for Health Care Administration[64BB- 9. St}. The surgery is being performed pursuant to de?nition of o??tce surgery as . . . described" 64b3- 9 VI 28. Compliance With Anesthesra ProvIder[6438 General Requirements for Of?ce SII 29. Compliance with Additional 7. Compliance with pro-operative 30. Compliance with Recovery MortitorinEpSIIBS- -9 l/ 8. Compliance wid1 1/133, (Include the requirement for level 11 (?Tire surgery as well as the i 31. Compliance with the American Societyr ofAnesthesiologict' I 9. Compliance with Informed Classi?cations for appropriate candidates for level of?ce 1/ I surgerymas 9 009(c)(2n2, 5 i I I 0, Compliance with Surgical V66 gi?ompiies with Additional Training Requirements[64?ll3 9 . II. Compliance with liposuction 2/ 33 Complies with Emergency Prooedures[64 38 9 l/At 12. Compliance with liposuction combination procedures[6-lBll-9 009(2)(eJ, 3:033:21? p?a?kdd'?ma] Equlprnent and Elective Cosmetic and Plastic Surgery Procedures[64B8- 35? Complies with Anesthesia Provi de [3 64334900905) [13% FA i 14. Compliance with overnight stays except for elective cosmetic and plastic 36. Complies with Additional Assistance of Other Personnel surgeryf?4l3li- -9009(2)(t). . I 15 Compliance with overnight stays in relation to any surgical procedure[64384 If . 5 9. 009(2)( II), Miscellaneous Please Specify) I 16. Compliance with post-operative t/ I ll Compliance with anesthetic pg? l1 {m (5-2 33,61,333? CI Compliance with policy and procedures If) 1.3 W, (a 3; 22,2 . I9. Compliance with risk management 2/ 3 ., ,9 re} g. @619 2,2 20. Compliance with adverse incident 12/. 2:1" &3 n. my ?19 5/29 21. Compliance with Commena?A??j?W/e?i? 2:32;. 24922442229222? L412 ?2:5 2/2032: 9270/1) 2259/21;? <7902e2? xmwe?werfg ?zitvub 2 3324432122?? v; 22:. Aaron/cow?? 7722962922927? DrV/?Sacee/CM (were, -?szff>_ 102.021? f; none/20 3316? 2me 2.2222235 322. New 2272992222? (Wt? V0 4/19222 2332615; ?5:272:22 2.9? .- 2 35.2.. ?2053 M?/I??Mr/?ftrm ?53 0/0 (of: 540(er 2297/ 95/21/22 END I own?M?s meanercsoc Eden-221 24.2299/24th (?bum-257066229212 pro/e. have read and have 3;:an 2? Signature of q/ It; and laws and regulations concerned herein explained. and do af?rm that the intennation given herein7 is true a onecl to @of my knowledge. 2/732, @277, Dire Investigatorf/ Date Revised 07?201 3 (Civil/55' brill/mars (Hunger/232225294: Luce/ext? 2.222252022222222 (/ra (12.240782) 35/0 I Page Number OSR 79:12 meawrmr? mite/1:417:11, ., 1.191141? magma? 6191/2919 #4211! mam j?b My; @1101 Pbms??f?j?? 161216.026 ?10,4900 1-11 02. 911111944193? 11.1499po Exazwwa?zs K1912. 19,6. TD Elnora/r5 Law 1411M H19 1A.) 1774?? @159:er (2951951919111 sijaf?/l??xi) g} Ma?a/L91?, (46.11. 9 Faye. ms map 0919M 94/24/95sz And/1M; ?wbmmua wfoamwo #90 1/9919me5 519$ :0 Q1: . - Of?ce Surgery Inspection Form Date l1? 1 pi Facility Name 1/14/7193 6m 1,1144% 9 Signa?lr? of onsib_le HIParty I Inspecta?f 9/3/ I_/Date Date DEPARTMENT OF HEALTH OFFICE SURGERY INSPECTION FORM LEVEL ll 8% [it 4052 BALD CYPRESS WAY, BIN TALLAHASSEE, FLORIDA 323993253 AUTHORITY CHAPTER 458.309, FLORIDA RULE 6488-90091. FLORIDA ADMINISTRATIVE CODE 05? 350 NAME OF OFFICE SURGERY FACILITY lid.) [/1470/ {Zagmg/W DATE OF INSPECTIO I I STREET ADDRESS PHYSICIAN NAME (5) LICENSE NUMBERS 90?: ?rookies: MOW mo TELEPHONE UNTY $5 52- lb; (/30 7 worms Aki??/A) 792.3 0 CITY 8 Bi. (4Requirement for Physician Ori?ce Registration YES N0 NA Requirements for Level O?'ice Surgery YES "0 NA I. The physician(s) is registered to perform of?ce-based surgery with the Board of 22. Transfer Agreement Required or Hospital Staff Privileges [64138? Medicine-6438-99609lfl) 2. The physician?) of?ce is not accredited with a national accrediting organization or Board approved organization 23. Compliance with Training 1/ 3. The physician{s} performs surgery as de?ned in the Board {6438~9.009( Ufa}, 24. Compliance with Basic Life Support 4. The surgeon(s) is an active licensed physician(s) in the State of F]orida[64BS- genome), 25. Compliance with Advanced Cardiac Life Support Certi?cationf?dBB- 5. The equipment meets the current performance 26. Compliance with Equipment and Supplies Required[64B8- acronyms, 6a. The surgery is being perfonned outside a hospital, ambulatory surgical centerabortion clinic or other medical facility licensed by the Department of Health or 03511 Cart Resuscrtahve Medicanon516488- the Agency for Health Care xx 6b. The surgery is being performed pursuant to de?nition of o?ice surgery as described in 64113.9?009? JG) 1/ 23. Compliance with Anesthesia M. General Requirements for Of?ce Surgery 1 29. Compliance with Additional 7. Compliance with preoperative t/ 30. Compliance with Recovery 3. Compliance with Patient/Procedures requirements outlined Requirements for Level {Include the requirement for level 11 Of?ce surgery as Well as the 9. Compliance with lnf'onned Compliance with the American Society ofAnesthesiologist?s Classi?cations for appropriate candidates for level in of?ce 10. Compliance with Surgical \x 32. Complies with Additional Training 11. Compliance with liposuction 33. Complies with Emergency 12. Compliance with liposuction combination 34. Complies with Additional Equipment and Supplies[6433- 13. Compliance with Elective Cosmetic and Plastic Surgery ProCedures??ttBS- ammo), 35. Complies with Anesthesia Compliance with overnight stays except for elective cosmetic and plastic 36. Complies with Additional Assistance of Other Personnel IS. Compliance with overnight stays in relation to any surgical p1oeeduref64BB- Miscellaneous (Please Specify) I 16. Compliance with post-operative a. (- f) 0 15/9 if) 17. Cornpliance with anesthetic 3/ WA :1 0' w' 63/2 .707? -. 18. Corrlpiianee with policy and procedures V, 19. Complianccwith l/ Vie/$961) 1 20. Compliance with adverse {443-? NEW uo our? JIM er Heart) - Comments: W610 r0 MOW SW on: mmw?cte memgas 26/123 nil/N 0 514,01? tMMersm/Nt; /c1; wow/WM. fleck-H toe/res LUNG LL: matter/um Ww?r/nro tit/Des W}em Ham-7% memon mm 15W (05:2, Won/m ?rmer/I 9 Mt?lw/?tomevtm fmy?ye?? FW ?lvmr'me/E WW ewe/Ween: Mm ?re MAI com). have reeot?a um RRW and the laws and regulations ccncernec Signature 0 espons?lbl? Party Revised ereI'n xplained and do af?rm lhj/llh/J alien given herein is two an 5770:2154, 6W WngA?/ come/WV)? ?ee/?ew I55 9 WQW We 0 75" Mew/?? investigator rrect [o the best of my knowledge. Date Of?ce Surgery InsPeetion Form Date [e 5 Hg 5 Page Number of Facility Name OSR r210 (?le Mlb?r/Ub/ 5%me 0; ?eas/wax {Mm/re . 1402/45/43 Maj/A13]; MM A?sww 15:50:64.5 9&6? Jr 100 (459/159 i $me Mgr/55" /w?/9/W??wmr 55/204 I rim/5;; 5/4222 be:- @549? (ad/paw, $2.7 m/pgzv/r/ mow/u: MAEMWL a? .7 47km W424 01 2mg? ?imk. Mag/M Hm, 30mg. wa? M/s 9/02; Mgzi/ mag/Mp I 2/12)ka ngV? cg"? f/ i\ WW - Signatur of Responsible Da hfg/? ng?/v M. *7 3 pector Date 02/17/2016 1:500 .00 Vanity Cosmetic Surgery 8506'swsm ST .. 98% 1- MIAMI, Ra: Dept of Health Board of medicine 4052 Bald Cypress Way, BIM Tallahassee FL 32399 Of?ce Surgery Dbpartment -. RE: PLAN OF CORRECTION: - West Dade Surgery, DBA Vanity Cosmetic Surge 350 Location Address: 8506 SW 8 St, Miami, Fl 33144 Date of Inspection: 1/13/2016 Register physicians: Dr. Jonathan Fisher ME99849, Dr. Rafe] Salas ME108242, Dr. Sidd Bass ME79410, Dr. Eric Valladares ME91049, Dr. Arnaldo Valls ME82727 Conducted by: Rachelle Springer, RN As of January 13, 2016 the office surgery center has begun implementing the following db?ciengies: Dr. Ismael Labrador, Administrator/ Medical Director of West Dade Surgery, DBA Vanity Cosmetic Surgery is responsible for the corrective action and ongoing compliance. The administrative staff, RN, surgeons and anesthesia personnel have been in serviced for the following de?ciencies and shall maintain compliance with Chapter 458.309 Rule 64B8-9.0091, F.A.C. . 1. Tag #5 Equipment meets the current performance standard: All equipment was re inspected by -Mart Medical Equipment a sticker was place an all the missing equipment. It would be the responsibility of Dr. Ismael Labrador, administrator in maintaining the ongoing compliance. See attached document. 2. Tag #8 Compliance with Patient/Procedure Records: Dr. Ismael Labrador and our staff had a meeting to discuss the value of a complete chart, and the importance of the operative reports. Both Dr. Mcadoo, Dr. Salas, and all the other physicians registered in our of?ce have understood. It would be the responsibility of Dr. Ismael Labrador, administration in maintaining the ongoing compliance. 3. Tag #9 Type of anesthesia: Dr. Ismael Labrador has changed the anesthesia consent form, now all anesthesia providers can either circle MD or CRNA to be more speci?c on anesthesia provider. It would be the responsibility of Dr. Ismael Labrador, administration in maintaining the ongoing compliance. 4. Tag 10 Missing. CPT Codes: All Anesthesia logs were reviewed and re?written by the administration, all CPT codes are on site, and surgery logs are current. It will be the responsibility of Dr. Ismael Labrador, administration in maintaining the ongoing compliance. 5. Tag #18 Compliance with policy and procedures manual: At the present time Vanity chooses to perform qirarterly assurance policies with all the doctors and employees on staff. . It will be the responsibility of Dr. Ismael Labrador, administration to ensure compliance by conducting and documenting them quarterly. 6. Tag #19 Compliance with risk management program: At the present time the Vanity chooses to perform their risk management minutes on a quarterly basis with physician's review. It will be the responsibility of Dr. Ismael Labrador, administration to ensure compliance by conducting and documenting them quarterly. 7. Tag #26: Compliance with equipment and Supplies Required: Dr. Ismael Labrador met with his staff and discussed the proper ways of washing the instrumentation. At this moment we are only using single use disposable Laryngoseope Blades, staff IS aware that they must wash 1n high level disiIifectant or autoclave the Laryngoscopes if they were to re?use. It will be the responsibility of Dr. Ismael Labrador, administration' 1n maintaining the ongoing compliance 8. Tagtt 27 Compliance with Crash Cart Resuscitative Medications: Dr. Ismael Labrador and staff was not aware of the past changes on April 2015;-Our administration has order all missing medication in its right dosage It would be the reSponsibility of Dr. Ismael Labrador, administrator 1n maintaining the ongoing compliance. See attached document 9. Tag#34 complies with Additional Equipment and Supplies: All missing 120000 of sterile water without preservative for Dantroline was order and was placed 111 the crash cart. It would be the responsibility of Dr. Ismael Labrador, administrator in maintaining the ongoing compliance. See attached picture. On the day of the inspection we clari?ed with the inspector our" current staff. We are notifying the State that based on our database the following registered physicians and clinical staff that are currently working at our facility: . . . Physicians: Jonathan Fisher, Rafael Salas, Siddarth Bass, Arnaldo Valls, and Eric Valladares. Jesus del Risco, Jason Vera, Sergio Hernandez, Gabriel Diets ch, ristopher Jorge, Alexandra Cortes, lourdes Dieguez, Richard Lauriello, Miguel Vasallo, Caro a Wilson, Christina vera; Carlydela sz, Frankie Lima, Susana Airala, Alex Quinones, Richard Eckert. MD Anesthesia: Jorge Melgen; Carlos Lazalle. . RN: Maritza Rodriguez, Nereida Rodriguez. Surgical Assistants/Technologist: Cesar Martinez, Mitdael Moreno, Lester Trastoy, Mario Ledesma, Yaite Fernandez, Jose Ramon Jaime, Alberto Toledo, Jorge uerte, Klovys Castellanos, Jorge Reyes,Gilberto Iviricu, Marleivys Ramirez, Carlos Diaz Circuiators: Carolina Mourelo, Yanedys Arencibia, Lianys Blain, Graciela Rodriguez, Adiena' Morell. I have read this Plan of Correction Report and af?rm that the information given herein IS true and correct to the best of my knowledge. . 6* . . STATE OF FLORIDA Office Surgery Center gov File it 420 Insp 281 NAME PERMIT NUMBER DATE OF INSPECTION Eres Plastic Surgery 350 . Oi'i?l1i2017 poms Busmass AS STREET ADDRESS TELEPHONE tit EXT 8506 SW 8TH STREET (305] 262-6070 CITY COUNTY - MIAMI FLI33144 License Relations Of?ce Surgery Registration DANIEL License 129254 CHAVEZ. CAMILLE DENISE License it 68329_ FISHER, JONATHAN GEORGE 5 License it 96746?- JARIAL, RAVINDER SINGH License it 9321 PASCUAL, AMARYLLIS License 94686 SALAS. RAFAEL EMERICK MD License it 198242 VALLADARES. ERIC RAUL License #91049 VALLS, ARNALDO License it 82727. - VERDEZA, CARLOS MD -- - License 97208 -- -- Of?ce Surgery Registration Regdirement for Physician Of?ce Registratiori 1. The physician(s} is registered to perform office?based surgery with the Board of Medicine Yes 2- The physician{s) of?ce is not accredited with a national accrediting organization or Board approved organization No 3. The physicianis) performs surgery as de?ned in the Board Rule . - Yes 4. The surgeon(s) is an active licensed physician(s) in the State of Fiorida?64Ba? -- Yes 5. The physician{s) noti?ed the Department, in writing of any changes to the registration information. . I Yes 6. The registration is posted in the of?ce {6438? -- Yes Osteopathic standard ofcare for surgery 54815-14007 added to cunentposiing of 6438-9.009 at time of inspection. 7. The equipment meets the current performance I Yes 3. The surgery is being performed outside a hospital. ambulatory surgical center, abortion clinic or other medical facility licensed by the Department of Yes Health or the Agency for Health Care 8a. The surgery is being performed pursuant to de?nition of of?ce surgery as described In FAG. I Yes General Requirements for Office Surgery 9. Compliance with pie-operative . Yes immediate pre-op evai not timed. 9a. The surgeon(s) examined the patient immediately before the surgery to evaluate the risk of anesthesia and of the surgical procedure to be perionned Yes immediate pre?op evai form not timed. 9h. The surgeonts] delegated the preoperative heart lung evaluation to a quali?ed anesthesia provider withi? the scope of-the provider?s practice and, if Yes applicable, protocol. 10. Compliance with PatienIJProcedures - Yes 1 1- Compliance with informed No Anesthesia consent fonrr does notprovidera choice of anesthesia provider. 12. Surgical Logs contain con?dential patient identi?er. time of arrival in the operating suite. documentation of completion of the medical clearance as No performed by the anesthesiologist or the operating physician. the surgeon's name, diagnosis, CPT Codes, patient ASA oiassi?cation, the type of parocedure. of surgery, the anesthesia provider. the type of anesthesia used, the duration cfthe procedure. and any adverse incidents Some log sheets identified that were incomplete. Adverse incident not speci?ed on con?dential patient identi?er ifs 136372, 90907, 49693 12a. The surgeon(s) completed Love! Love! lli or Liposuction over 1,009cc procedures Yes 12b. Surgical Logs are maintained for six years after last patient contact Yes Page 1 7i1112017 Office Surgery Center Insp 2B1 Eras Plastic Surgery File it 420 13. Compliance with liposuction Yes 13a. The surgeon(s) removed no more than 4.000 cc offat Yes 13b. The surgeon(s) injected no more than 50mgikg of Lidocaine for tumescent liposuction Yes 14. Compliance with Elective Cosmetic and Plastic Surgery Yes 14a. Surgery was completed in under 8 hrs. Yes 14b.Patients were discharged within 24 hrs. Yes 14c. If Patients time in of?ce exceed 23 hrs. 59 minutes patientwas transferred to a hospital. WA 15. Compliance with overnight stays except for elective cosmetic and plastic WA 1 5a. Only elective cosmetic and plastic surgery patients stayed past midnight NIA 15b. Overnight stays were limited to the physician? of?ce him No overnight stays have done at this facility. 18. Compliance with overnight stays in relation to any surgical WA 163. Two monitors were present (one monitor was ACLS certi?ed} 16b. Monitor to patient ratio was kept at 1 monitor to 2 patients Yes 16c.0nce physician signed a timed and dated discharge order. single monitoring began by a ACLS certi?ed monitor Yes 16d. The surgeonis) was reachable by telephone and available to return to the of?ce within 15 minutes Yes 17. Compliance with post-operative Yes 18. Compliance with risk management Yes 18a.Risk Management program includes the identi?cation. investigation. and analysis of the frequency and causes of adverse incidents to patients Yes 18b. Risk Management program includes the identi?cation of trends or patterns of Incidents Yes 38:. Elsi: Management program inciudes the development of appropriate measures to correct. reduce. minimize. or eliminate the risk of adverse incidents Yes 0 a on gsp?eigiisk Management program inciudes the documentation of these functions and periodic review no less than guarterly of such information by the Yes 19. Compliance with adverse incident reportingi?tiBBrQ?UQiZHk}. [458.351 (4). F31 Yes Requirements for Level I {Liposuction} Office Surgery 20. Compliance with Training Yes 21. Compliance with Equipment and Supplies Yes 21a. Of?ce has intravenous access supplies. oxygen, oral airways, and a positive pressure ventilation device Yes 21 b. Of?ce stores the following medications at manufacturer's recommendation: Atropine 3 mg; 50 mg; Epinephrine 1 mg in 10 ml: Yes Epinephrine 1 mg in 1 in! via], 3 vials total; and Hydrocortisone 100 mg Requirements for Level II Of?ce Surgery 22. The surgeonis) have Transfer Agreements or Hospital Staff Privileges for a iicensed hospitai within reasonable proximity (30 mtns.) Yes . 23. Compliance with Training Yes 24. At least one assistant is certi?ed with Basic Life Support Yes 25- The surgeon{s) are currently certi?ed with Advanced Cardiac Life Support Yes 26. The of?ce has the following equipmentisupplies: a Benzodiazepine must be present in the of?ce; Positive pressure ventilation device (eg. Ambu] plus oxygen supply: End tidal CO2 detection device; Monitors for blood pressureiEKGliygen saturation; Emergency intubation equipment, which shalt at a minimum include suction devices. endotracheal tubes. Iaryngoscopes. cropharyngeai always. nasopharyngeal airways and bag valve mask apparatus that are speci?c; De?brillator with de?britlator pads or de?brillator gel. or an Automated Extemal De?brillator unit (AED): Suf?cient back up ??ower is required to allow the physician to safely terminate the procedure and to allow the patient to emerge from the anesthetic. ail without compromising ofthe procedure or the environment of care; Sterilization equipment and soiutlon and 1V equipment. Yes Crash cart contains: Adenosine 18 mg; Albuterol 2.5 mg with small voiume nebulizer; Arniodarone 300 mg; Atropine 3 mg: Calcium chloride ?1 gram; Yes Dextrose 50%; 50 mt; 50 mg; Dopamine 200 mg minimum; Epinephrine 1 mg in 10 ml; Epine hn'ne 1 mg in 1 ml viat. 3 vials total; Flumazenil 1 mg: Furosemide 40 mg: Hydrocortisone 100 mg; Lidocaine appropriate for cardiac administration 00 mg: Magnesium suifate .2 grams; Naloxona 1.2 mg; A beta blocker class drug; Sodium bicarbonate 50 mgi50 ml: Paralytic agent that is appropriate for use in re id sequence intubation; A calcium channel blocker class drug; and, lntralipid 20% 500 ml solution (only if non-neuraxial regional blocks are performed}. 6458- 28. Compliance with Anesthesia Yes 29. Compliance with Additional Yes Requirements for Level ill {Include the requirement for level Of?ce surgeryvas well as the requirements outlined) 30. Compliance with the American Society of Anesthesiologists Classi?cations for appropriate candidates for level itt of?ce Yes . 31. Complies with Additional Training Yes 32. Emergency pciicles and procedures are periodicaily reviewed. updated, and posted in a conspicuous location. Yes Page 2 7(1112017 Office Surgery Center InspiiE 281 - Eres Plastic Surgery File 420 32a. Emergency policies and procedures cover the fotiowing: 3 Aims Biockage (foreign body obstruction}; . Allerg Reactions: c. Bradycardia: d. Bronchospasm; e. Cardiac Arrest; f. Chest Pain; g. Hypoglycemia; . h. Hypotension; i. Hypoventit ation; Laryngospasrn: Local Anesthetic Toxicity Reaction: and Matignent Hyperthermia. 33 Of?ce has the foil owing equipmentisupplies: at least 720 mg of dantroiene on site (itc halogenated anesthetics or are utilized); must be Yes comperebte to a free standing ambulatory surgical center. including. but not limited to; recovery capability, and must have provisions for proper recordkeeping: Blood pressure monitoring eqUIpment; end tidal (:02 monitor: pulse oximeter. emergency intubation equipment and a temperature monitoring device; and Table capable of trendelenhurg and other positions necessary to facilitate the surgical procedure 34. Complies with Anesthesia Yes 35. Complies with Additional! Assistance ofOther Personnel Yes Remarks: Per Chief Operating Officer Giannina Sepo. Dr Amaryliis Pascual has not performed surgen'es since 5i10i17.- Operative note missing from charts 134841, 138844 and 255 found at time of inspection and added to charts. 144582 also missing operative report i have read and have had this inspection report and the laws and regulations concerned herein explained, and do af?rm that the information given herein Is true and correct to the best of my knowledge. I have received a copy of the Licensee Bitl of Rights. Inspector Signature: TAYLOR. Date?!? 7 Page 3 7111mm? Representative: Giannina F. Sopo 12.3106 512232-151" . ["14 33144 I II ?g?ia z; II . . 022%" - i222: 1302-.2002122 21-2 . .- 101.21. 02.22212 5101201302 29952-313010 Wlay; BIN 132-31213? 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QA 250.2100 211500110202} 0222111213312 1122212011011 101321?: 32.000: 0012221021 12122 1222222022 0011211210100 '0 211001.302; 222121; 212.0 2112211201 2512292521112 13032: 101321032000 2220012221111. 032113 1102101221112 .020 20232222212220 0'17." 0022101021210 2:222:11. 3121 20032 101. 111-1125: 001322? 301913212391 10021212201111.1210 01.322513: Manager '11; 02222020101122: 2210' 021002210 2011201222122. 212.}. .I. I 11020 11-0221. 1101': 1112222 016011'0222210'1200021000 110221113 11. 00 0.2322 00122002 '10 11.20. 120.21 021.1231 12122122 1011110 1:2 . 9?1 118 Sil HIE .113 2310.112 150 11119-93 21211211211430 11-2130 021;: .13 DEPARTMENT OF HEALTH OFFICE SURGERY INSPECTION FORM LEVEL II 3: 4052 BALD CYPRESS WAY, BIN FLORIDA 32399-3353 INSPECTION AUTHORITY CHAPTER 458.309. FLORIDA STATUTES: RULE 6483-30091. FLORIDA ADMINISTRATIVE CODE .. teem cum its-?557 NAME OF SURGERY FACILITY STREET ADDRESS '33. 9 71+ 5+ PHYSICIAN NAME LICENSE NUMBERS .32. 532"?! (pact) 5 @1sz FYI-3 9 ?3 I2 ?hmfen I416 gay-5? NO A Requirement-t far vacl II 0 [?ne Surgery [.10 NA Requirement for Physician Of?ce Registration 23.. ?l'tansrer Agreement Required Iinsniutl Sluff Privileges [64mi- I The physicianis) Is mgist?rtti In eriIIrm tamer. hinted stirgury will: the Band Mudiuinc-?fm?- .I 900mm Ithysiciuni?s) nifica' Is nut accredited witha Itccmiiling [inard tIppIthd tit'gtlnizatiun 23. Campitanut With MIDWHMIIJZ 3. The. physician?t} perform surgery as In lht?. _k 24. (.?unmliancc with Iiasic Lilli Support MCI d. is an physician?s) in .?I?tatcoi [iitltiliuIMBHo 25. Luntpiiance with Advanced Cardiac. Lii'tt Sullpott 26.0.nnp1hmce with Equipment and Suppjies Reqtlircdl?ml?- 5. The. meets the perittrmance 63.1119 surgery is: being lillisiilt! II Imspilai. ambulatory surgical center, ciinic t?tf IIth'cI licensed by the Duputtmum at Health at the hgencv for Hmilh Cart: 27. Compiinncu with Crash Catt itusust?italivc Medicaiinn5 ii=lii8~ 9009(4m?3n. i?ACf (II). 'i?itd surgery is heir-g performed puntnant dufinilinn or Office surgery as described in General RquIim-nunm for Statget-g T. t'inmptiuItt-I: with pre?ultumtive 28. with Anesthesia 29. L?Omnlinnca with Addititmal FAQ 30. Cumpiia nw with Recover}: Monitnrin??dB?-Q?t?rgt?j?nd. RRKS ?g R. [ZIItIIpIinnce with PatiEniII?racudurt-Js Requirements rm- Level (Include the rEqutrement [or lanai II Ot?cu surgery as well In; 31. Campiinllce with tile Society cl?Aanltt-tiniogiul?s Ciansificlttittns int candidates for lcvui Itl?l?iut?. 3?2. L?bmpiics with Additional Training 33. Complies with Emergency 3st. (hmpiius with Addition!? Equipment 35. L'Umplieai with Anesthesia 3ft. with Assistuncu Other Personnel FACI requirements oIIlIiI-ch with - ti). with Surgical Ii. Compliance whit liposuction I2. Cumplinnca willt Iipusutniurt combination FACI ii i3. Domitian? with iliccliI-PI: and I?llmic Surge?): I4. (hmpiialtcc with law-might stays excapl I'tIrcIcClIt-I: cosmutlc and plastic sutgutyi?fiBB-Etimi 11m. PACI KK 15. with Overnight stays in Io anysurgiwi pItIchtureIMBti- MCI [Please 3139::in Oompiitmcu with l'iAtjil i1 E'iompiitnt'c with lt'i. Cinnplianu: with pniicy and manu{titanili?vtitltitiujtiy Withrisk mnmgumunt 12'? If}? I Sag [915' kg; 293. 10. Compliance with adverse incident rupnrring?ui?? 1) I (lumpliumtu ml Kin-8 ?57 I "Vaiann ?x W63 Lav-cl ?zgtii??rmi? RIMH FZIIZ I?lri' i?lQ +VIitt