8
CALI "1RNIA HEALTH A.'-(0 HUMAN SERVtCES AGENCY DEPARTMENT OF Pueuc HEALTH STATEMENT Of' DEFICIENCIES NfO Pl.AA OF COIWU:CTION (X1) PROI/IOER/S!Pl'UERICIJA IOEHTI FlCATION NIJMSER: (X2) MUI.Tll'lE COIISTRUCTION A.iUil.D(NQ ( )(.) ) ~Ti lru!M:Y COMl'lETEO Ht770 a.WIIG OM>al2014 NAMEOFPROV\Deft OR SUl'l't.ER ITREET NlORESS , CITY, STATE, ZIP COOE Loma Llmta Unlvenlty Medkal C.nt.r Murrieta llH2 Baxtor Road, MLM"r1et1 1 CA 12513 RNERSIOE COUNTY (X4)D SUMMAIIV llATU1':.'IT OF 0UlClEHCIF.S IU l"ftCMDER'S PlNI OF CORRECTION (XS) l'R£FIX I (EACH DEFICIENCY MUST IE PR£CUOEO IIY RJU. PREFIX (EAQI CORRECTM:J\CTION&HOUU> BECHOSS- COMfit.Em ! fllfOULAlOR'r ORUSC IOBlflFYlo!G N'ORMATION) 1AO l'IEfERENCS>TO THE ,N>PROPRIATE DEFICtelCV) TAG DATE I Tho fo!IOWDaiJ reflects lhe ftndioga Qf lho Department ol Publ'lc Heath during an Inspection mlt : l l Pr ep aration an d execution of I Compfaint Intake Hwnber. ' this plan of co rrec ti on does n ot CA00397790 - Stalantiated constitute an adm ission or Representing 1he Department of PubHc Health: agreement of the facts a ll eged or I SUJVe)'OI" ID# 2487, HFENS ' co nclusion s set forth on the I Statement of Deficiencies. Th is The inspection was imited lo lie apeciflc faciliy event investigated and does not represent the plan of cor rection is prepar ed i finding$ of a ful1 inspection of the facility. I and executed solely be cause it is i requir ed by th e Fede ral/State · Health and Safety Code Soctiol'l 1290, 3(9): F0< Law. i purposes of this section ·imme(iate J eopardy" I ! moana lituaticn In~ hi lloct1lee'a I !noncompliance with ooe « fllOC"e requirements of I - ilicensin has caused, er Is lkeJy to cause, aefiws The following represents Lo ma :injury or death to the patient. Linda University Med ical Cen ter i M urrieta's plan of correct ion. . ·' JHealth and Safety Code sedlon 1280.1 (-d) : ' This section 1h11 apply only lo loc:idents ffl:Unmg i oo or after Januar)' 1, 2007. Wlh respect lo I lncfdent& ocx:un1nt on or after Jaruary 1, 2000, \he .. .. amount of the ednmtraUve penalties assesaed . .) under 1uWvls5on {a- ) shall be up lo ooe hoodred - thousand dollars ($f00,000) per WD!atlon. Wth reapoct to incidents occurq oo or after January 1, 2009, lhe amount d lhe lldmlnlslrative penalties enessed Ul'lder aubdMslon (a) theft t>o up to fifty thoUSllnd dollars ($50,000) f<lf the Int edmlnistra1ive penalty, up to seventy-five thousand dollars ($75,000) for the second atA>sequ&nt administrative penalty, and up to one hundred I I I "'.7l l~ \ ("( ! lhousand dolars ($Hl0,000) for the fl i rd and ev~ I &5gt' j I Event ID:Blfl.11 2/2.7/2017 2:51:52PM lly elgni Mu documen~ I am aclu1wledglng lwoelpl of lhe eolil9 clla4iofl ,adr.ot. flgeCtl. 1(hry § TITLE MY delicleu,cy ltllement eid,ia wllh an •alorllk (') deno!at a .i,liclltncy Yfflk:tl Iha lnatllullon !Hay~ UCUWd tom ccnwclire I ls~ ht CChef .. reguasds provide lllffldent pro!ecllon 1o hi ,atienb. E.-pt Jor Nll1li,; hQmn, ._ loding1 abcMJ ent 80 dayl h *le of&UM!Y whether or not pi.it of cormaion II ~ - rnn~ homee, flO above tlndlnga end t)lena ol carectlon ..., alldouble 1-4 *ta fcllkMulg tho dale these documenl& are mado aWl!lable lo Iha flclllty. tr defi<:iencles are cited, en •JlllfO'IWd ,-n Ofcottllciion Is ,wqutalte t, oonlinuad llf\llll'MI parUclpatlon. f'llie 1ora Sllto-2567

Statement of Deficiency Loma Linda University Medical Center Document Librar… · Loma Linda University Medical Center Murrieta's Surgical Service and Medical Staff has developed,

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Page 1: Statement of Deficiency Loma Linda University Medical Center Document Librar… · Loma Linda University Medical Center Murrieta's Surgical Service and Medical Staff has developed,

CALI 1RNIA HEALTH A-(0 HUMAN SERVtCES AGENCY DEPARTMENT OF Pueuc HEALTH

STATEMENT Of DEFICIENCIES NfO PlAA OF COIWUCTION

(X1) PROIIOERSPlUERICIJA IOEHTIFlCATION NIJMSER

(X2) MUITlllE COIISTRUCTION

AiUilD(NQ

()()) ~Ti lruMY COMllETEO

Ht770 aWIIG OMgtal2014 NAMEOFPROVDeft OR SUlltER ITREET NlORESS CITY STATE ZIP COOE

Loma Llmta Unlvenlty Medkal Cntr bull Murrieta llH2 Baxtor Road MLMr1et11 CA 12513 RNERSIOE COUNTY

(X4)D SUMMAIIV llATU1IT OF 0UlClEHCIFS IU lftCMDERS PlNI OF CORRECTION (XS) lRpoundFIX I(EACH DEFICIENCY MUST IE PRpoundCUOEO IIY RJU PREFIX (EAQI CORRECTMJCTIONampHOUUgt BECHOSS- COMfitEmfllfOULAlORr ORUSC IOBlflFYloG NORMATION) 1AO lIEfERENCSgtTO THE NgtPROPRIATE DEFICtelCV)TAG DATE

I

Tho foIOWDaiJ reflects lhe ftndioga Qf lho Department ol Publlc Heath during an Inspection mlt l

l Preparation and execution of ICompfaint Intake Hwnber this plan of correction does notCA00397790 - Stalantiated

constitu te an admission or Representing 1he Department of PubHc Health agreem ent of the facts alleged or

ISUJVe)OI ID 2487 HFENS conclusions set for th on the I

Statemen t of Deficiencies Th isThe inspection was imited lo lie apeciflc faciliy event investigated and does not represent the plan of correction is preparedi finding$ of a ful1 inspection of the facility I and executed solely because it is

i required by the FederalState middotHealth and Safety Code Soctioll 12903(9) F0lt

Lawipurposes of this section middotimme(iate Jeopardy I moana bull lituaticn In~hi lloct1leea I noncompliance with ooe laquo fllOCe requirements of I

-ilicensin has caused er Is lkeJy to cause aefiws The followi ng represents Loma injury or death to the patient

Linda University Medical Centeri M urrietas plan of correction middot JHealth and Safety Code sedlon 12801 (-d) This section 1h11 apply only lo locidents fflUnmg

~

i oo or after Januar) 1 2007 Wlh respect lo I

lncfdentamp ocxun1nt on or after Jaruary 1 2000 he amount ofthe ednmtraUve penalties assesaed )under 1uWvls5on a-) shall be up lo ooe hoodred -thousand dollars ($f00000) per WDatlon Wth reapoct to incidents occurq oo or after January 1 2009 lhe amount d lhe lldmlnlslrative penalties enessed Ullder aubdMslon (a) theft tgto up to fifty thoUSllnd dollars ($50000) fltlf the Int edmlnistra1ive penalty up to seventy-five thousand dollars ($75000) for the second atAgtsequampnt administrative penalty and up to one hundred

I I I 7ll~ ((

lhousand dolars ($Hl0000) for the flird and ev~ I ~~ amp5gt jI

Event IDBlfl11 2272017 25152PM

lly elgni Mu documen~ I am aclu1wledglng lwoelpl of lhe eolil9 clla4iofl adrot flgeCtl 1(hry sect

TITLE

MY delicleucy ltllement eidia wllh an bullalorllk () denoat a iliclltncy Yfflktl Iha lnatllullon Hay~ UCUWd tom ccnwclire ~ I ls~ htCChef reguasds provide lllffldent proecllon 1o hi atienb E-pt Jor Nll1li hQmn _ loding1 abcMJ ent ~ 80 dayl ~ h le ofampUMY whether or not bull piit ofcormaion II ~ - flaquo rnn~ homee flO above tlndlnga end t)lena ol carectlon alldouble 1-4 ta fcllkMulg tho dale these documenlamp are mado aWllable lo Iha flclllty tr defiltiencles are cited en bullJlllfOIWd -n Ofcottllciion Is wqutalte t oonlinuad llfllllMI parUclpatlon

fllie 1oraSllto-2567

CAL1-ltJRNIA HEALTH-AND HUMAN SERVICES AGENCYDEPARTM~NTOF puauc H~fH - - ()(1) PRCll~UlPLIERIClIA (X2J MULTIPLE CONSTRUCTIONSlATEMENT Of OEFICIENCIES (X3) 0-Tpound SURVEV

ANO plJltNOF CORRECTION IDENTlfleAllON NUMllR COMPLETE)

ABUILDING

ljWijG 08fOIJ2014

STREET ADDRESS CITY STATE ZIP COOENAME OF PROIIDER OR SUPPUER

~etnlI Upda University M9~Jcal C11ter - Mt1rlltta 211062 ~11)tbullr Ro~d Murrieta C~ 92513 RIVER$11l_E COUtITY

t----r----------------~----- ------------------------1 SIIMlWf( STATEMOO OF l)fFICIENC~(M)IO 10 PROVIDERS PlNI Qf CQAAECTION (X5)

(EACH DEFICIENCY MUST BE PRECEEDEOav AJU PREFIX (EACH-CORRECTIVE ACTION SHOIJlD IE CROSSPREflX COMfgtiETE REGUIATGRY OR LSC IDENTifYltlG ltFGRMATION) TAG R~qep TO THI ~PROPRIATE DEFICIENCY)T~G OATe

subsequent vlolatloo AA administrative penalty lsaued aftilr middottluee years from tlle da1e ofthe last Issued lmmediale JeOf)ardy vQtlloomiddott1han be considered a first admlnistta~peoatty so long as the facilily has not received additionalmiddotImmediate jeopamy vielatlons aml is found by lhe depar-tment to be InmiddotsubslanUat compliance with all state and reder~middotficenslng laws and regulatlombull loe depallment ahall flave full discretion to consrder all factors when determining-the amovnl of an administrative penalty purswmt to thJs section

TJle ~ Cillifomla Clilde f ~egJlations 0ivislon 5 Chapter 1 Article 3 Section 70223 (b)(2 Surgical Service Gen~~ Requirements

(b) A oommlttee Egtf lt1t mediqf staff shJII be assigned reapoosltlftty for (2) Oevelepment maintenance ar-4 implemefllation of written 1icillciea and precltlures In CigtOSwltalibA with other appropriate llealth professionals and administration Policies shall be approved by the gQVemlng body Procedures atiaK ~ ipproved by I)~ ~dmlnlstretion IJlld medlcat (aff gt~ere such is a~prlate

B-a~ed on interview and record review the facility tailed 19

1 Implement their policy and procedure regarding safety In the operating room

2 DevEIIPp and lmprement a po)fP)( and pr~c~ure regarding the use of a surgical device (Aquamanlys Bipoiar Mand prece)

Loma Linda University Medical Center Murrietas Surgical Service and Medical Staff has developed maintained and implemented written policies and procedures in consultation with other appropriate health professionals and administration Policies were approved by the governing body Specifically a policies and procedure regarding safety in the operating room and policy and procedure regarding the use of surgical device [Aquamantys Bi-Polar hand piece] Corrective action taken include

151li2PMEven IP8LFl11

Slete-2567

CALIF001111 HeALJH ANPHUMAN S5RVJC5S AGENCY OIEPA_RTMENT OF PlJBLIC HIEALTH

5TATIMENr OF DEACIENCJES (XI) PRQVIOERSUPP~IERFCUA (X2) MULlllLE CONSTRUCTION Xii) ilAiE SlJRVEY AND P-AN Of CORR~ON IQENTIF]CATION NUMBER COMPLETED

A BIJllDINO

050770 BYmG 08012014

NAME OF PROIIDER ltlR SiUPPUEQ STREETADORES CITY STATE ZIP cooe Loma Unda Unlvtrillty Medical cemiddotnter bull Murrieta 21062 Baxter Road Murrieta CA 92563 RIVERSIDE COUNTY

CXf)ID PREFIX

TAG

SUMMARY STATEMENT OF OElICialCIES (EACH O~flelliNCY MUST JjE PRECEEDED BY FUU REGULATORY OR lSC IBENTIFYING INFORMATI~

ID PRlAX

TAG

PROVIDERS PLAN OF CORRECTION (EACH CORRECTIVI ACTION SHOUIO BE CROSSshy

REFEIVNCSgt TO THE APPROPRIATE DEFICIENCY)

(X5)

COMPLETE DATE

A root cause analysis was conducted

These failures resulted In

and opportunities for improvement were identified bull The aquamantys System

5102014

1 A f~ thlckn=S~ llierla~ ~ufT injury to fgt~tienl As left calf and

2 The sucgical staff to be unaware of what precautions and safeguards were needed fQr use of a surglcal device middot

[AM] was immediately removed from service and evaluated by the Clinical Engineering Department and found to be in good working order bull The AM representative

562014

These failures caused Patient Ata susialn a full lhickrtess thermal burn Injury ihat required extensive wound treatments to InellId~ ll $11191cal procedure) pl~ itie patient llt risk for ~111ed

provided re-training to the Operating Room staff on the proper use of the machine Training

5920 14

l)ealth deterioration hafTil includina death aAd had the patentlal lo place ait patrentsmiddotundergoirig the same surgicatmiddotprocedure lit risk for health ~terieratlOlI harm middotand ltteat-h

The~bull )microms ~re timicrorns lo he ~kin GatJsed by an ~ernal heat source Afult1lckness ti11m fs the

included the proper placement of the want when not in use and maintaining the alarm volume at an audible selling bull Staff were required to complete a quiz to assure

moat el(ere bum Involving aH tayers Qf 1kln Narve endings middotisma11 blood ves~s tiair tom~ s~t glands are in d~llQyeiI Subctt~n30Us fa tissue musde and ~ne may ~rio tgte lnVol~d (Referenced from Derm Net NZ (December 29 2013)-a resource for general practionerJ and dermalogists)

competency on the use of the AM Retaining was completed for staff not meeting 95 bull It was identified that the AM does not have an attachment holder for the wand and the company has

592014

Findingamp

The cllnleat tecord for Patient A was reviewed Patient Aw~s admitte(I middotQn Ap11 2~ 2014with the diiignosis ofoslep~(thn~ ofbQtb kne~s

no alternate The facility has designed a mechanism for placement of the want when not in use

59201 4

21272017 25152PMEvent 10BLFL11

Pag~3ots State-2567

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMlNT OF PUBLIC HEALTH

STATEMENT OF DEFICIENClES Q(1) PROVIDEflSUPPUERCUA (X2) MULTIPLE CONSTRUCTION (X3tDATE SURVEY AND PVN OF CORRECTION loemFlCATION NUMBER COMPIEfED

A~ILDtNq

05077~ BWING 080612014

NAME OF PROVIDER OR ~JPPUER

Loma Ll~dl University Med~I cn~r- - Mu_rri~

STREET ADDRESS Orr( STATE ZlP CODE

~8062 Baxlei Road Munlatll CA 92583 RIVERSIDE COUNTY

(X4)10

PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES

(EAQtDfflCIENCYMOSTBEPRECEEDEDSYFUU ]i~TORY OR LSC IDENTIFYING INFORMATION)

middot10 PROVIDERS PlAN OF CORRECTION PREFIX (EACH COAAECTllE AC110N SHOlApound1 BE CROSS

TIIG REFERENCED TO THE APPROPRIATE DEflCIENCY)

(Xii) COMPLET_E DATE

8202014(inflammation of th~joiJJ~ cartilage of he knees) The document-entitled-~Periopa~tive ReJX)rt1 dated

bull The policy Fire Prevention in the OR was

April 29 2014 l~edPatientAhad knee feplacement su~r-yfor 6oth knees

reviewed revised bull Physician practice was

The reportftrrther indkated the su(geon wsed an reviewed by the Surgical Aqualfl~ntys ~y~ten ~iring-Pa~ie)ll Ns surgery Quality Review Committee and 011 April 29 2014 appropriate actions have been

6262014

According deg the ~acturcJ insert the taken Aquama_Atys Syatefll Isbull surgical (cautery) deg4el~ l~ lf)qucl~- h~R~ pi~ ~ld the Audits will be completed for each Aqmicroamantya 61-pQlar piece whidl hlis an electric etrrreAl that generates heat to seal tissues in order use of the AM to assure that the

to help prevemt fgt4ood tos machine has been safely used before during and after the surgical

8 1520 14

Tt-Kt phyelclan Pragr~ii~Ncit_es~ dated M~ l procedure To date 100 has been 201-4 at 948 pm Indicated BIiaterai knee hemo11acs (drams)- iemoved withowt any difficulty achieved for the past 3 months

middotThe dressings_er~ dry andlhJitct Plfluse Results of the audit were t~ernets with pattAAtli911 Mi4 QifflJ~ welling incorporated in the OR Quality Calves are soft Len calf~th blisteringbull Dashboard and reported in

There was no qocumentation oi physician orders accordance with the established

that eddress~d the left calf bl~lering repor ting calendar Reports are forward to appropriate

The nursing Progress N~es dated May 6 201-t EI Z~6 pni inltfi~r~ Df(pli~lclans nane) rounded thl~ am andmiddotkgtOked middotat what she ~rred to

committees in accordance with the Quality oversight Structure

as an open bllsfer QA p~tler1t1J leg iround calf-area She said she saw il yesterday when she rounmiddotded Ordermiddot~~ g~n to piiTlillY (physician) to apply santyl ung (Wound treatmeitt) and wound nurse Person Responsible Director

consult Photo taken Perioperative Services

Event IO~LFL 1f IZf2017 25152PM

Page 4of 6 siate-2567

CAlIF0~NIA HEALTH AND MUMAN ~ERY10~ ~~EilCY 0~~~~ENT()F PUBLIC H_Wnt

STATEMENT OF DEFCIEtfQI~ ANO PLAN OF CORRECTION

(X1j PROVIDERSUPPLIERCUA IDENlIACATION NUMBER

(X2) MULTIPLE CONSTRUCTION

AIUIIJ)ING

(X3) DATE $URVEY WMPIBEO

050770 B WNG 080~01~

NM1fiQF_PR(IV1lllR OR ~UPPU8

L~ma Llndbull University Medlcal (ef119r- bull ~hmJeta 8T-REET AOORESS CllY STATE ZIP cooe

~11062 S11xter Road Murrieta CA 92563 RIViRSDE COUNTY

()(~)ID ~lM~_SJATEMEHT EgtF DEFICIENCIES ID PROlllJERS PlAN_OF PQRRIECTION PREFlX (EACHmiddotDEFICIEHCYMUSTSE 11RECEEDED BY FULL PREAX (EACH e0RREITIVEiCll9N IHOUUl lE CROSS

TIG AEGUlT)RY PISC IDENTIFYING lflgtRM~lIQN) TO REFERENCED Tl) THE NPROPRIATE DEfICIENCY)

The order to treat PalieAt As left ealf blister was written five days 1t~r he physician documented discovery of ttie bll~~riSJ-

The ckgteument entitled~Initial Inpatient Wound Cate Coosul~ ~fated M11y ~ 201-4 was reviewed Tue Q09~ment indicated On POIgt 11 (PUen Observation Day) nurse notedmiddota arge L (left) posl~~r calf wound 1)061 op (after SUtgeey)bullbullbull Large Left posterior calf Mt thickness W9umLpresumqbly cauaed by therm bum Injury from OR (O~ratlngR~) AQu1Bfllys hemoslasls sealerft

Dunng an interview wiih the Oper-ating Room Director (~D) on June 9 20-t-4 at 1middot45 pm the ORD s1aled same sugeons use the Aquamantys Bl-polar ha~ piece dlling procedures requiring cauleiy (in order -t~ ~ reventblood loss) The ORD also stated the device was use4 by t1rgeons when an Incision (erit) was smide Into the sijn She stat~ when a surgeqn was not using lhe device ltle d~vlc~ w~J r~rno~ectfrpm ~he ope~tlng cent)le

The ORO stated she w~s Informedby the Wound Care Nurse on MllY 6 201-4 thal PalienfA s11$taln~d a bum inlury io ll)e left -alf d11ring middota SU[lJ~ POced11reitat fflCly(~ffle 1118 tftlie Aquainantys System Toe ORD stat~ tier invesiigallen includedmiddoten 111tervlew with OperatingRoom technician (ORf) 1 wno was present during Patient As sw-glcat procedure s~ stated ORT 1 sfated when he ent~red the OR room he Saw moro steam than usual saw the device (Aguamantys) Jr1dermiddotthe ~tients leg yeUad

2172017 25152PME~nt IDBLFL11

Page Ii ofamp

CALI_FQRNI~ H~li AND HU~SE~r_ce~ AGENCY DEPARTMENT OF PUBLIC HEALTH

STAJ~lHT OF DEFICIENCIIES ()(1) PROIIOERSUPPUERCUA (X2) MULllPLE CONSTRLICTlON 9(3 DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER c~

-191~~ 05077-0 8WING

NA-A Of PROVID_Eft OR ~LfPU~ middotSlREEf ADDRESS CITY STATE_ZIP CODE

Lorna llndbull Ulllyeraity Medical Ceritlr bull Murrri ~IOJ2 Baxter RQad Murrieta CA ~2583 RIVERSIDE COUNTY

0(4)10 SIA4MA11Y STATliMENT OF DEflCIENCIES 10 PROIIOERS PIJN OF CORRlCTlON ()(5) PREFIX (EACH lIEACIENCY MUST BE liRECEEDED II( FULL PREFIX (EACH CORRCTIVEACTIOM lJ-iOULD 8E CROS~ COMPLETE

TAG REGULATORY OR ISC 11gtEfmFYING INFORMATION) TG REfERENCED TO THE APPROPRIATE DEFICIENCY) DATli

Stop and removed the d~lce

She ~~~ed MAii 5laffmiddotkrievno rAAQrt ncentdentsmiddotHke seeing-morel steam than usual from a device and to eheck the patlent No one (ofthe OR team) rep011ed the lncldent rhe JX)ffcy is to-te tie Charge Nurse es soon i~ p~sib_~ WMiJ ~m incident happens andgeAamptate an in(klenfrepoit

The ORD slated the faclllly policy and-p(ocedure r-egerdlngthe safe use of a ~autery ~evi_ce cfuring a surg~I prQC(ldure ~as J)Ol followed

The surgeon who performed the procedure was not avaHable 10 interview ~r ~D as she was on vacation

Ollring a follow up vislt oonducted-oriJuly 30 2014 the clinkal recQtds tor PatlemAwere reviewed Jtie ciilllcaf recoots lndlcateltf Paf~t A received extensive wound treatmenti ~ th_~ loft ~If following di~arge from the facility on May 9 2014 lhI reCQrds further lndkatod filatient A was readmitted on-JJtie 6 2014 for a ~urgical procedure to Femove large areas of necrosis (dead tissue) rom the bum injury site

On Jlly ~O iQ14 ~t e4011fJJ 80 Ale[Y~ w_as conducted with the Process Integrity Manaper (PIM) The PIM stated fhe racility1amp lnvestlgatloo of lhe incident was completed on-J~ne 11 2014 The PIM stated the surge~n who per-Winfl_d th~ silrgery di~ not attend the faeilltys review of-Ifie Incident but the assistant aurge~n was pre~ent Th~ PIM stated the facUltys review concluded II was twman

JiYlAt lQBLfl11 22712017 251 52P~

Pege II Qf n_

~ALIFORNIA HEALTH AND Hl)MAN ERVICES AGENCY DIEPARTMENT OF PUBIIC HEALTH

(XI) PROVloeRSUPfIERCLIA Q(2) MULTIPLE CONSlRUCTIONSTA~ OF OEFICIENCllS (X3) DATE SURVEY

ANO PlAN OF CORRECTION COMPLdED IDeNJIRCATtON NUMBER

AliJilhlNG B V00 050710 0~0amp1io14

NAME_OF P~VlaER OR IJLPPLIEM microST-RET AOORESS_CITY STATE ZIP CODE

tQma Linda U11fvffSlly Medl1-al ~eriter - Murrie(~ B~62 Bax~r Road Murrieta CA 92563 RlVEflSJDE COUNTY

(X4)10 SUMMARY SlATEMENT OF DEACtENCIES PROVIDERS PLAN OF CORRECTION (XSJ fREF1X

ID (EACH DEFICIENCY MUST BE PRaEEOEO BY FUil PREFIX (EACH CORRECmE ACTION SHOULO BE CROSSshy COMPLETI

REFERENCEO TO THE APPROPRIATE DEFICIENCY) DATER~991-ATOJilV QR Lsc IDENTIFYING INF~ITIOH) TAGTIG

error Ula caused Patj~middotntmiddot A to SU$~1n middota ull thiclm~ss uiermal b)rn to the left calf from the Aquamantys ~ivfcemiddotdtKing Pa~entAa surgery on Apr-ii 29 2014

The PIM stated-the surpeon who perfonnedthe prQcedur~ w~~ ~V~l~bl~ f9r lfl~rvlew because she was $UD-ltgtn vacationbull She sjated when 11 new _devlce is adept_e_d fofmiddotuse by the facility the manufacturer et the d~-~asbull technician oome fo ihe facility 19 prQYid~ argt lnasfrvice ~ining lb staff reg~ing ~fety ~ ~ Qse 9f ~4~- SJie slated the faality did not require doamenletloo lhat lndicateltil what staff had reeeivecHhe lrainiog fer (he AqJamantrs device the PlMi tatedmiddottlle t-aciliy did nof ~~W-~ pfly$1tj~nis tigt sJ-nd Che inbulltervlce training nCnamplliqti9(ls for Iha ~e of the device were localed on the top of the device

The PiM further 4tateqthfl cipe_raling room (OR staff did riotfonow fl~(~_citY1 POliq and ~res regiudiflO safety during Patient As surgical Focedure b)1 not-ensufing the cautery device (Aquamantys) WliS pr~ecfed when not loshyuse

lAe facility pelky Jtnd procedure entitled f ire Prevention ir-i tne Op~riitig R_~o~ ~te~i November 12 2013 Indicated _All staff enl~ring the Perioperallve Prooedurallrjv~lve areas will demonstrate kn9Yiledge of safIY and prevention a Nvrse ManagerChatga Nu~~C~ntca) 11_diKatQr ResponslbiUties 1tdlie2tiori arid dlt-ecllon-pf the eperatlng_s~ff _2 ~nforcemen~ ~f th_e dflpartments fire aafety procedur-ebull

2272017 25152PMEv~t IOBLR1-1

JlagG 7 Df 11State-2567

~FORNIA HEALTH AND HUMAN SEfVl(~~ ~~ENCY PEPAATMENT Of fgtUlIUC HEALTH

()(1) PRQVl~lJPPUERICUA (X2) MULTIPLE CONSTRUCTIONSTJ1flENT OF DEFICIENCIES (X3) ElfTl SURVEY AND PUif OF CORRECTION IDENTIACATION ~flER COMPIElffl

ABtH~itg IIWING050770 OB0612014

STREET AOORESS Clrt STATE21P oooe l~nt~ Lloda Unlverelty Medical Ceriter- Murr-le~

~E01 PROVlllllROff SlJPlU=R

~062 Baxter Rolld llunl~ CA 92amp6_l RIVERSIDE COUNTY

(l(S)

PREFIX lEACH aEFICIENCY MUST BE PREcmicroEDED ev FULL (X4)1D SUMMARY STATEMENT OF llEflCIENCIES P~VIDERS PlAN OF CORRECTION

(lACH CORRECTIVE ACTION SHOULD SE CROSS COMPLETE REFERENCED TO THE APPROPRIAl DEACIENCr) TAG REGUIATORY EgtFHSC JflENTIFYlIQ ~Oru41)T19N) QATE

Tlile pelicy further indicated Can1rollingHeal Sources 1 Ga4fefY A Never place lfle cautery peAcilon the patient Place the centautetymiddotpencR in the protective holster to prevent a~dintar activation ofcauterybull

A review of the manual instrOGtiorts entitled- hj11amantys Syamptem and Bil)Olar Seefers dated January 9 2013- lodkated Precautions Surgery should 1gt41 performed li)y-98f$Onl wllh adequate training andmiddotpreparstioo Plaquo$~el stlolld (Uily 1mderiland the nature ar-id use of RF (radio frequefley-electclcalmiddotcurrent) tJefore pertooningshyelectrosurgical piecedures to avoid itie risks ofmiddot 1hregk and bum hazards to both patJent and ~ratorbull

The middotfacility falled- to irilplemont their ptllfcy and procedure-regarding safety In the operating room and1aHedmiddotto develop and implement a policy and procadure regarding tbe use of a surgical device which was ltie ~l~cl ~W of Patient A iMilainlng a full thickness thermalmiddot bum Iltgt his left calf

This facility failed to preveAt the deliciencyQes) BJ described above ~I cau~eif or Is likery to cause serious 1Juiy c)r dllath Jo the pa~l~ll lirid 11Wef9te constitutes an Immediate jeopardy w)thill the meaning of Health and sarety Cede SecU911 12803(-g)

21272017 25t52PMEvent IOBLFL11

PaQB80f8

Page 2: Statement of Deficiency Loma Linda University Medical Center Document Librar… · Loma Linda University Medical Center Murrieta's Surgical Service and Medical Staff has developed,

CAL1-ltJRNIA HEALTH-AND HUMAN SERVICES AGENCYDEPARTM~NTOF puauc H~fH - - ()(1) PRCll~UlPLIERIClIA (X2J MULTIPLE CONSTRUCTIONSlATEMENT Of OEFICIENCIES (X3) 0-Tpound SURVEV

ANO plJltNOF CORRECTION IDENTlfleAllON NUMllR COMPLETE)

ABUILDING

ljWijG 08fOIJ2014

STREET ADDRESS CITY STATE ZIP COOENAME OF PROIIDER OR SUPPUER

~etnlI Upda University M9~Jcal C11ter - Mt1rlltta 211062 ~11)tbullr Ro~d Murrieta C~ 92513 RIVER$11l_E COUtITY

t----r----------------~----- ------------------------1 SIIMlWf( STATEMOO OF l)fFICIENC~(M)IO 10 PROVIDERS PlNI Qf CQAAECTION (X5)

(EACH DEFICIENCY MUST BE PRECEEDEOav AJU PREFIX (EACH-CORRECTIVE ACTION SHOIJlD IE CROSSPREflX COMfgtiETE REGUIATGRY OR LSC IDENTifYltlG ltFGRMATION) TAG R~qep TO THI ~PROPRIATE DEFICIENCY)T~G OATe

subsequent vlolatloo AA administrative penalty lsaued aftilr middottluee years from tlle da1e ofthe last Issued lmmediale JeOf)ardy vQtlloomiddott1han be considered a first admlnistta~peoatty so long as the facilily has not received additionalmiddotImmediate jeopamy vielatlons aml is found by lhe depar-tment to be InmiddotsubslanUat compliance with all state and reder~middotficenslng laws and regulatlombull loe depallment ahall flave full discretion to consrder all factors when determining-the amovnl of an administrative penalty purswmt to thJs section

TJle ~ Cillifomla Clilde f ~egJlations 0ivislon 5 Chapter 1 Article 3 Section 70223 (b)(2 Surgical Service Gen~~ Requirements

(b) A oommlttee Egtf lt1t mediqf staff shJII be assigned reapoosltlftty for (2) Oevelepment maintenance ar-4 implemefllation of written 1icillciea and precltlures In CigtOSwltalibA with other appropriate llealth professionals and administration Policies shall be approved by the gQVemlng body Procedures atiaK ~ ipproved by I)~ ~dmlnlstretion IJlld medlcat (aff gt~ere such is a~prlate

B-a~ed on interview and record review the facility tailed 19

1 Implement their policy and procedure regarding safety In the operating room

2 DevEIIPp and lmprement a po)fP)( and pr~c~ure regarding the use of a surgical device (Aquamanlys Bipoiar Mand prece)

Loma Linda University Medical Center Murrietas Surgical Service and Medical Staff has developed maintained and implemented written policies and procedures in consultation with other appropriate health professionals and administration Policies were approved by the governing body Specifically a policies and procedure regarding safety in the operating room and policy and procedure regarding the use of surgical device [Aquamantys Bi-Polar hand piece] Corrective action taken include

151li2PMEven IP8LFl11

Slete-2567

CALIF001111 HeALJH ANPHUMAN S5RVJC5S AGENCY OIEPA_RTMENT OF PlJBLIC HIEALTH

5TATIMENr OF DEACIENCJES (XI) PRQVIOERSUPP~IERFCUA (X2) MULlllLE CONSTRUCTION Xii) ilAiE SlJRVEY AND P-AN Of CORR~ON IQENTIF]CATION NUMBER COMPLETED

A BIJllDINO

050770 BYmG 08012014

NAME OF PROIIDER ltlR SiUPPUEQ STREETADORES CITY STATE ZIP cooe Loma Unda Unlvtrillty Medical cemiddotnter bull Murrieta 21062 Baxter Road Murrieta CA 92563 RIVERSIDE COUNTY

CXf)ID PREFIX

TAG

SUMMARY STATEMENT OF OElICialCIES (EACH O~flelliNCY MUST JjE PRECEEDED BY FUU REGULATORY OR lSC IBENTIFYING INFORMATI~

ID PRlAX

TAG

PROVIDERS PLAN OF CORRECTION (EACH CORRECTIVI ACTION SHOUIO BE CROSSshy

REFEIVNCSgt TO THE APPROPRIATE DEFICIENCY)

(X5)

COMPLETE DATE

A root cause analysis was conducted

These failures resulted In

and opportunities for improvement were identified bull The aquamantys System

5102014

1 A f~ thlckn=S~ llierla~ ~ufT injury to fgt~tienl As left calf and

2 The sucgical staff to be unaware of what precautions and safeguards were needed fQr use of a surglcal device middot

[AM] was immediately removed from service and evaluated by the Clinical Engineering Department and found to be in good working order bull The AM representative

562014

These failures caused Patient Ata susialn a full lhickrtess thermal burn Injury ihat required extensive wound treatments to InellId~ ll $11191cal procedure) pl~ itie patient llt risk for ~111ed

provided re-training to the Operating Room staff on the proper use of the machine Training

5920 14

l)ealth deterioration hafTil includina death aAd had the patentlal lo place ait patrentsmiddotundergoirig the same surgicatmiddotprocedure lit risk for health ~terieratlOlI harm middotand ltteat-h

The~bull )microms ~re timicrorns lo he ~kin GatJsed by an ~ernal heat source Afult1lckness ti11m fs the

included the proper placement of the want when not in use and maintaining the alarm volume at an audible selling bull Staff were required to complete a quiz to assure

moat el(ere bum Involving aH tayers Qf 1kln Narve endings middotisma11 blood ves~s tiair tom~ s~t glands are in d~llQyeiI Subctt~n30Us fa tissue musde and ~ne may ~rio tgte lnVol~d (Referenced from Derm Net NZ (December 29 2013)-a resource for general practionerJ and dermalogists)

competency on the use of the AM Retaining was completed for staff not meeting 95 bull It was identified that the AM does not have an attachment holder for the wand and the company has

592014

Findingamp

The cllnleat tecord for Patient A was reviewed Patient Aw~s admitte(I middotQn Ap11 2~ 2014with the diiignosis ofoslep~(thn~ ofbQtb kne~s

no alternate The facility has designed a mechanism for placement of the want when not in use

59201 4

21272017 25152PMEvent 10BLFL11

Pag~3ots State-2567

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMlNT OF PUBLIC HEALTH

STATEMENT OF DEFICIENClES Q(1) PROVIDEflSUPPUERCUA (X2) MULTIPLE CONSTRUCTION (X3tDATE SURVEY AND PVN OF CORRECTION loemFlCATION NUMBER COMPIEfED

A~ILDtNq

05077~ BWING 080612014

NAME OF PROVIDER OR ~JPPUER

Loma Ll~dl University Med~I cn~r- - Mu_rri~

STREET ADDRESS Orr( STATE ZlP CODE

~8062 Baxlei Road Munlatll CA 92583 RIVERSIDE COUNTY

(X4)10

PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES

(EAQtDfflCIENCYMOSTBEPRECEEDEDSYFUU ]i~TORY OR LSC IDENTIFYING INFORMATION)

middot10 PROVIDERS PlAN OF CORRECTION PREFIX (EACH COAAECTllE AC110N SHOlApound1 BE CROSS

TIIG REFERENCED TO THE APPROPRIATE DEflCIENCY)

(Xii) COMPLET_E DATE

8202014(inflammation of th~joiJJ~ cartilage of he knees) The document-entitled-~Periopa~tive ReJX)rt1 dated

bull The policy Fire Prevention in the OR was

April 29 2014 l~edPatientAhad knee feplacement su~r-yfor 6oth knees

reviewed revised bull Physician practice was

The reportftrrther indkated the su(geon wsed an reviewed by the Surgical Aqualfl~ntys ~y~ten ~iring-Pa~ie)ll Ns surgery Quality Review Committee and 011 April 29 2014 appropriate actions have been

6262014

According deg the ~acturcJ insert the taken Aquama_Atys Syatefll Isbull surgical (cautery) deg4el~ l~ lf)qucl~- h~R~ pi~ ~ld the Audits will be completed for each Aqmicroamantya 61-pQlar piece whidl hlis an electric etrrreAl that generates heat to seal tissues in order use of the AM to assure that the

to help prevemt fgt4ood tos machine has been safely used before during and after the surgical

8 1520 14

Tt-Kt phyelclan Pragr~ii~Ncit_es~ dated M~ l procedure To date 100 has been 201-4 at 948 pm Indicated BIiaterai knee hemo11acs (drams)- iemoved withowt any difficulty achieved for the past 3 months

middotThe dressings_er~ dry andlhJitct Plfluse Results of the audit were t~ernets with pattAAtli911 Mi4 QifflJ~ welling incorporated in the OR Quality Calves are soft Len calf~th blisteringbull Dashboard and reported in

There was no qocumentation oi physician orders accordance with the established

that eddress~d the left calf bl~lering repor ting calendar Reports are forward to appropriate

The nursing Progress N~es dated May 6 201-t EI Z~6 pni inltfi~r~ Df(pli~lclans nane) rounded thl~ am andmiddotkgtOked middotat what she ~rred to

committees in accordance with the Quality oversight Structure

as an open bllsfer QA p~tler1t1J leg iround calf-area She said she saw il yesterday when she rounmiddotded Ordermiddot~~ g~n to piiTlillY (physician) to apply santyl ung (Wound treatmeitt) and wound nurse Person Responsible Director

consult Photo taken Perioperative Services

Event IO~LFL 1f IZf2017 25152PM

Page 4of 6 siate-2567

CAlIF0~NIA HEALTH AND MUMAN ~ERY10~ ~~EilCY 0~~~~ENT()F PUBLIC H_Wnt

STATEMENT OF DEFCIEtfQI~ ANO PLAN OF CORRECTION

(X1j PROVIDERSUPPLIERCUA IDENlIACATION NUMBER

(X2) MULTIPLE CONSTRUCTION

AIUIIJ)ING

(X3) DATE $URVEY WMPIBEO

050770 B WNG 080~01~

NM1fiQF_PR(IV1lllR OR ~UPPU8

L~ma Llndbull University Medlcal (ef119r- bull ~hmJeta 8T-REET AOORESS CllY STATE ZIP cooe

~11062 S11xter Road Murrieta CA 92563 RIViRSDE COUNTY

()(~)ID ~lM~_SJATEMEHT EgtF DEFICIENCIES ID PROlllJERS PlAN_OF PQRRIECTION PREFlX (EACHmiddotDEFICIEHCYMUSTSE 11RECEEDED BY FULL PREAX (EACH e0RREITIVEiCll9N IHOUUl lE CROSS

TIG AEGUlT)RY PISC IDENTIFYING lflgtRM~lIQN) TO REFERENCED Tl) THE NPROPRIATE DEfICIENCY)

The order to treat PalieAt As left ealf blister was written five days 1t~r he physician documented discovery of ttie bll~~riSJ-

The ckgteument entitled~Initial Inpatient Wound Cate Coosul~ ~fated M11y ~ 201-4 was reviewed Tue Q09~ment indicated On POIgt 11 (PUen Observation Day) nurse notedmiddota arge L (left) posl~~r calf wound 1)061 op (after SUtgeey)bullbullbull Large Left posterior calf Mt thickness W9umLpresumqbly cauaed by therm bum Injury from OR (O~ratlngR~) AQu1Bfllys hemoslasls sealerft

Dunng an interview wiih the Oper-ating Room Director (~D) on June 9 20-t-4 at 1middot45 pm the ORD s1aled same sugeons use the Aquamantys Bl-polar ha~ piece dlling procedures requiring cauleiy (in order -t~ ~ reventblood loss) The ORD also stated the device was use4 by t1rgeons when an Incision (erit) was smide Into the sijn She stat~ when a surgeqn was not using lhe device ltle d~vlc~ w~J r~rno~ectfrpm ~he ope~tlng cent)le

The ORO stated she w~s Informedby the Wound Care Nurse on MllY 6 201-4 thal PalienfA s11$taln~d a bum inlury io ll)e left -alf d11ring middota SU[lJ~ POced11reitat fflCly(~ffle 1118 tftlie Aquainantys System Toe ORD stat~ tier invesiigallen includedmiddoten 111tervlew with OperatingRoom technician (ORf) 1 wno was present during Patient As sw-glcat procedure s~ stated ORT 1 sfated when he ent~red the OR room he Saw moro steam than usual saw the device (Aguamantys) Jr1dermiddotthe ~tients leg yeUad

2172017 25152PME~nt IDBLFL11

Page Ii ofamp

CALI_FQRNI~ H~li AND HU~SE~r_ce~ AGENCY DEPARTMENT OF PUBLIC HEALTH

STAJ~lHT OF DEFICIENCIIES ()(1) PROIIOERSUPPUERCUA (X2) MULllPLE CONSTRLICTlON 9(3 DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER c~

-191~~ 05077-0 8WING

NA-A Of PROVID_Eft OR ~LfPU~ middotSlREEf ADDRESS CITY STATE_ZIP CODE

Lorna llndbull Ulllyeraity Medical Ceritlr bull Murrri ~IOJ2 Baxter RQad Murrieta CA ~2583 RIVERSIDE COUNTY

0(4)10 SIA4MA11Y STATliMENT OF DEflCIENCIES 10 PROIIOERS PIJN OF CORRlCTlON ()(5) PREFIX (EACH lIEACIENCY MUST BE liRECEEDED II( FULL PREFIX (EACH CORRCTIVEACTIOM lJ-iOULD 8E CROS~ COMPLETE

TAG REGULATORY OR ISC 11gtEfmFYING INFORMATION) TG REfERENCED TO THE APPROPRIATE DEFICIENCY) DATli

Stop and removed the d~lce

She ~~~ed MAii 5laffmiddotkrievno rAAQrt ncentdentsmiddotHke seeing-morel steam than usual from a device and to eheck the patlent No one (ofthe OR team) rep011ed the lncldent rhe JX)ffcy is to-te tie Charge Nurse es soon i~ p~sib_~ WMiJ ~m incident happens andgeAamptate an in(klenfrepoit

The ORD slated the faclllly policy and-p(ocedure r-egerdlngthe safe use of a ~autery ~evi_ce cfuring a surg~I prQC(ldure ~as J)Ol followed

The surgeon who performed the procedure was not avaHable 10 interview ~r ~D as she was on vacation

Ollring a follow up vislt oonducted-oriJuly 30 2014 the clinkal recQtds tor PatlemAwere reviewed Jtie ciilllcaf recoots lndlcateltf Paf~t A received extensive wound treatmenti ~ th_~ loft ~If following di~arge from the facility on May 9 2014 lhI reCQrds further lndkatod filatient A was readmitted on-JJtie 6 2014 for a ~urgical procedure to Femove large areas of necrosis (dead tissue) rom the bum injury site

On Jlly ~O iQ14 ~t e4011fJJ 80 Ale[Y~ w_as conducted with the Process Integrity Manaper (PIM) The PIM stated fhe racility1amp lnvestlgatloo of lhe incident was completed on-J~ne 11 2014 The PIM stated the surge~n who per-Winfl_d th~ silrgery di~ not attend the faeilltys review of-Ifie Incident but the assistant aurge~n was pre~ent Th~ PIM stated the facUltys review concluded II was twman

JiYlAt lQBLfl11 22712017 251 52P~

Pege II Qf n_

~ALIFORNIA HEALTH AND Hl)MAN ERVICES AGENCY DIEPARTMENT OF PUBIIC HEALTH

(XI) PROVloeRSUPfIERCLIA Q(2) MULTIPLE CONSlRUCTIONSTA~ OF OEFICIENCllS (X3) DATE SURVEY

ANO PlAN OF CORRECTION COMPLdED IDeNJIRCATtON NUMBER

AliJilhlNG B V00 050710 0~0amp1io14

NAME_OF P~VlaER OR IJLPPLIEM microST-RET AOORESS_CITY STATE ZIP CODE

tQma Linda U11fvffSlly Medl1-al ~eriter - Murrie(~ B~62 Bax~r Road Murrieta CA 92563 RlVEflSJDE COUNTY

(X4)10 SUMMARY SlATEMENT OF DEACtENCIES PROVIDERS PLAN OF CORRECTION (XSJ fREF1X

ID (EACH DEFICIENCY MUST BE PRaEEOEO BY FUil PREFIX (EACH CORRECmE ACTION SHOULO BE CROSSshy COMPLETI

REFERENCEO TO THE APPROPRIATE DEFICIENCY) DATER~991-ATOJilV QR Lsc IDENTIFYING INF~ITIOH) TAGTIG

error Ula caused Patj~middotntmiddot A to SU$~1n middota ull thiclm~ss uiermal b)rn to the left calf from the Aquamantys ~ivfcemiddotdtKing Pa~entAa surgery on Apr-ii 29 2014

The PIM stated-the surpeon who perfonnedthe prQcedur~ w~~ ~V~l~bl~ f9r lfl~rvlew because she was $UD-ltgtn vacationbull She sjated when 11 new _devlce is adept_e_d fofmiddotuse by the facility the manufacturer et the d~-~asbull technician oome fo ihe facility 19 prQYid~ argt lnasfrvice ~ining lb staff reg~ing ~fety ~ ~ Qse 9f ~4~- SJie slated the faality did not require doamenletloo lhat lndicateltil what staff had reeeivecHhe lrainiog fer (he AqJamantrs device the PlMi tatedmiddottlle t-aciliy did nof ~~W-~ pfly$1tj~nis tigt sJ-nd Che inbulltervlce training nCnamplliqti9(ls for Iha ~e of the device were localed on the top of the device

The PiM further 4tateqthfl cipe_raling room (OR staff did riotfonow fl~(~_citY1 POliq and ~res regiudiflO safety during Patient As surgical Focedure b)1 not-ensufing the cautery device (Aquamantys) WliS pr~ecfed when not loshyuse

lAe facility pelky Jtnd procedure entitled f ire Prevention ir-i tne Op~riitig R_~o~ ~te~i November 12 2013 Indicated _All staff enl~ring the Perioperallve Prooedurallrjv~lve areas will demonstrate kn9Yiledge of safIY and prevention a Nvrse ManagerChatga Nu~~C~ntca) 11_diKatQr ResponslbiUties 1tdlie2tiori arid dlt-ecllon-pf the eperatlng_s~ff _2 ~nforcemen~ ~f th_e dflpartments fire aafety procedur-ebull

2272017 25152PMEv~t IOBLR1-1

JlagG 7 Df 11State-2567

~FORNIA HEALTH AND HUMAN SEfVl(~~ ~~ENCY PEPAATMENT Of fgtUlIUC HEALTH

()(1) PRQVl~lJPPUERICUA (X2) MULTIPLE CONSTRUCTIONSTJ1flENT OF DEFICIENCIES (X3) ElfTl SURVEY AND PUif OF CORRECTION IDENTIACATION ~flER COMPIElffl

ABtH~itg IIWING050770 OB0612014

STREET AOORESS Clrt STATE21P oooe l~nt~ Lloda Unlverelty Medical Ceriter- Murr-le~

~E01 PROVlllllROff SlJPlU=R

~062 Baxter Rolld llunl~ CA 92amp6_l RIVERSIDE COUNTY

(l(S)

PREFIX lEACH aEFICIENCY MUST BE PREcmicroEDED ev FULL (X4)1D SUMMARY STATEMENT OF llEflCIENCIES P~VIDERS PlAN OF CORRECTION

(lACH CORRECTIVE ACTION SHOULD SE CROSS COMPLETE REFERENCED TO THE APPROPRIAl DEACIENCr) TAG REGUIATORY EgtFHSC JflENTIFYlIQ ~Oru41)T19N) QATE

Tlile pelicy further indicated Can1rollingHeal Sources 1 Ga4fefY A Never place lfle cautery peAcilon the patient Place the centautetymiddotpencR in the protective holster to prevent a~dintar activation ofcauterybull

A review of the manual instrOGtiorts entitled- hj11amantys Syamptem and Bil)Olar Seefers dated January 9 2013- lodkated Precautions Surgery should 1gt41 performed li)y-98f$Onl wllh adequate training andmiddotpreparstioo Plaquo$~el stlolld (Uily 1mderiland the nature ar-id use of RF (radio frequefley-electclcalmiddotcurrent) tJefore pertooningshyelectrosurgical piecedures to avoid itie risks ofmiddot 1hregk and bum hazards to both patJent and ~ratorbull

The middotfacility falled- to irilplemont their ptllfcy and procedure-regarding safety In the operating room and1aHedmiddotto develop and implement a policy and procadure regarding tbe use of a surgical device which was ltie ~l~cl ~W of Patient A iMilainlng a full thickness thermalmiddot bum Iltgt his left calf

This facility failed to preveAt the deliciencyQes) BJ described above ~I cau~eif or Is likery to cause serious 1Juiy c)r dllath Jo the pa~l~ll lirid 11Wef9te constitutes an Immediate jeopardy w)thill the meaning of Health and sarety Cede SecU911 12803(-g)

21272017 25t52PMEvent IOBLFL11

PaQB80f8

Page 3: Statement of Deficiency Loma Linda University Medical Center Document Librar… · Loma Linda University Medical Center Murrieta's Surgical Service and Medical Staff has developed,

CALIF001111 HeALJH ANPHUMAN S5RVJC5S AGENCY OIEPA_RTMENT OF PlJBLIC HIEALTH

5TATIMENr OF DEACIENCJES (XI) PRQVIOERSUPP~IERFCUA (X2) MULlllLE CONSTRUCTION Xii) ilAiE SlJRVEY AND P-AN Of CORR~ON IQENTIF]CATION NUMBER COMPLETED

A BIJllDINO

050770 BYmG 08012014

NAME OF PROIIDER ltlR SiUPPUEQ STREETADORES CITY STATE ZIP cooe Loma Unda Unlvtrillty Medical cemiddotnter bull Murrieta 21062 Baxter Road Murrieta CA 92563 RIVERSIDE COUNTY

CXf)ID PREFIX

TAG

SUMMARY STATEMENT OF OElICialCIES (EACH O~flelliNCY MUST JjE PRECEEDED BY FUU REGULATORY OR lSC IBENTIFYING INFORMATI~

ID PRlAX

TAG

PROVIDERS PLAN OF CORRECTION (EACH CORRECTIVI ACTION SHOUIO BE CROSSshy

REFEIVNCSgt TO THE APPROPRIATE DEFICIENCY)

(X5)

COMPLETE DATE

A root cause analysis was conducted

These failures resulted In

and opportunities for improvement were identified bull The aquamantys System

5102014

1 A f~ thlckn=S~ llierla~ ~ufT injury to fgt~tienl As left calf and

2 The sucgical staff to be unaware of what precautions and safeguards were needed fQr use of a surglcal device middot

[AM] was immediately removed from service and evaluated by the Clinical Engineering Department and found to be in good working order bull The AM representative

562014

These failures caused Patient Ata susialn a full lhickrtess thermal burn Injury ihat required extensive wound treatments to InellId~ ll $11191cal procedure) pl~ itie patient llt risk for ~111ed

provided re-training to the Operating Room staff on the proper use of the machine Training

5920 14

l)ealth deterioration hafTil includina death aAd had the patentlal lo place ait patrentsmiddotundergoirig the same surgicatmiddotprocedure lit risk for health ~terieratlOlI harm middotand ltteat-h

The~bull )microms ~re timicrorns lo he ~kin GatJsed by an ~ernal heat source Afult1lckness ti11m fs the

included the proper placement of the want when not in use and maintaining the alarm volume at an audible selling bull Staff were required to complete a quiz to assure

moat el(ere bum Involving aH tayers Qf 1kln Narve endings middotisma11 blood ves~s tiair tom~ s~t glands are in d~llQyeiI Subctt~n30Us fa tissue musde and ~ne may ~rio tgte lnVol~d (Referenced from Derm Net NZ (December 29 2013)-a resource for general practionerJ and dermalogists)

competency on the use of the AM Retaining was completed for staff not meeting 95 bull It was identified that the AM does not have an attachment holder for the wand and the company has

592014

Findingamp

The cllnleat tecord for Patient A was reviewed Patient Aw~s admitte(I middotQn Ap11 2~ 2014with the diiignosis ofoslep~(thn~ ofbQtb kne~s

no alternate The facility has designed a mechanism for placement of the want when not in use

59201 4

21272017 25152PMEvent 10BLFL11

Pag~3ots State-2567

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMlNT OF PUBLIC HEALTH

STATEMENT OF DEFICIENClES Q(1) PROVIDEflSUPPUERCUA (X2) MULTIPLE CONSTRUCTION (X3tDATE SURVEY AND PVN OF CORRECTION loemFlCATION NUMBER COMPIEfED

A~ILDtNq

05077~ BWING 080612014

NAME OF PROVIDER OR ~JPPUER

Loma Ll~dl University Med~I cn~r- - Mu_rri~

STREET ADDRESS Orr( STATE ZlP CODE

~8062 Baxlei Road Munlatll CA 92583 RIVERSIDE COUNTY

(X4)10

PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES

(EAQtDfflCIENCYMOSTBEPRECEEDEDSYFUU ]i~TORY OR LSC IDENTIFYING INFORMATION)

middot10 PROVIDERS PlAN OF CORRECTION PREFIX (EACH COAAECTllE AC110N SHOlApound1 BE CROSS

TIIG REFERENCED TO THE APPROPRIATE DEflCIENCY)

(Xii) COMPLET_E DATE

8202014(inflammation of th~joiJJ~ cartilage of he knees) The document-entitled-~Periopa~tive ReJX)rt1 dated

bull The policy Fire Prevention in the OR was

April 29 2014 l~edPatientAhad knee feplacement su~r-yfor 6oth knees

reviewed revised bull Physician practice was

The reportftrrther indkated the su(geon wsed an reviewed by the Surgical Aqualfl~ntys ~y~ten ~iring-Pa~ie)ll Ns surgery Quality Review Committee and 011 April 29 2014 appropriate actions have been

6262014

According deg the ~acturcJ insert the taken Aquama_Atys Syatefll Isbull surgical (cautery) deg4el~ l~ lf)qucl~- h~R~ pi~ ~ld the Audits will be completed for each Aqmicroamantya 61-pQlar piece whidl hlis an electric etrrreAl that generates heat to seal tissues in order use of the AM to assure that the

to help prevemt fgt4ood tos machine has been safely used before during and after the surgical

8 1520 14

Tt-Kt phyelclan Pragr~ii~Ncit_es~ dated M~ l procedure To date 100 has been 201-4 at 948 pm Indicated BIiaterai knee hemo11acs (drams)- iemoved withowt any difficulty achieved for the past 3 months

middotThe dressings_er~ dry andlhJitct Plfluse Results of the audit were t~ernets with pattAAtli911 Mi4 QifflJ~ welling incorporated in the OR Quality Calves are soft Len calf~th blisteringbull Dashboard and reported in

There was no qocumentation oi physician orders accordance with the established

that eddress~d the left calf bl~lering repor ting calendar Reports are forward to appropriate

The nursing Progress N~es dated May 6 201-t EI Z~6 pni inltfi~r~ Df(pli~lclans nane) rounded thl~ am andmiddotkgtOked middotat what she ~rred to

committees in accordance with the Quality oversight Structure

as an open bllsfer QA p~tler1t1J leg iround calf-area She said she saw il yesterday when she rounmiddotded Ordermiddot~~ g~n to piiTlillY (physician) to apply santyl ung (Wound treatmeitt) and wound nurse Person Responsible Director

consult Photo taken Perioperative Services

Event IO~LFL 1f IZf2017 25152PM

Page 4of 6 siate-2567

CAlIF0~NIA HEALTH AND MUMAN ~ERY10~ ~~EilCY 0~~~~ENT()F PUBLIC H_Wnt

STATEMENT OF DEFCIEtfQI~ ANO PLAN OF CORRECTION

(X1j PROVIDERSUPPLIERCUA IDENlIACATION NUMBER

(X2) MULTIPLE CONSTRUCTION

AIUIIJ)ING

(X3) DATE $URVEY WMPIBEO

050770 B WNG 080~01~

NM1fiQF_PR(IV1lllR OR ~UPPU8

L~ma Llndbull University Medlcal (ef119r- bull ~hmJeta 8T-REET AOORESS CllY STATE ZIP cooe

~11062 S11xter Road Murrieta CA 92563 RIViRSDE COUNTY

()(~)ID ~lM~_SJATEMEHT EgtF DEFICIENCIES ID PROlllJERS PlAN_OF PQRRIECTION PREFlX (EACHmiddotDEFICIEHCYMUSTSE 11RECEEDED BY FULL PREAX (EACH e0RREITIVEiCll9N IHOUUl lE CROSS

TIG AEGUlT)RY PISC IDENTIFYING lflgtRM~lIQN) TO REFERENCED Tl) THE NPROPRIATE DEfICIENCY)

The order to treat PalieAt As left ealf blister was written five days 1t~r he physician documented discovery of ttie bll~~riSJ-

The ckgteument entitled~Initial Inpatient Wound Cate Coosul~ ~fated M11y ~ 201-4 was reviewed Tue Q09~ment indicated On POIgt 11 (PUen Observation Day) nurse notedmiddota arge L (left) posl~~r calf wound 1)061 op (after SUtgeey)bullbullbull Large Left posterior calf Mt thickness W9umLpresumqbly cauaed by therm bum Injury from OR (O~ratlngR~) AQu1Bfllys hemoslasls sealerft

Dunng an interview wiih the Oper-ating Room Director (~D) on June 9 20-t-4 at 1middot45 pm the ORD s1aled same sugeons use the Aquamantys Bl-polar ha~ piece dlling procedures requiring cauleiy (in order -t~ ~ reventblood loss) The ORD also stated the device was use4 by t1rgeons when an Incision (erit) was smide Into the sijn She stat~ when a surgeqn was not using lhe device ltle d~vlc~ w~J r~rno~ectfrpm ~he ope~tlng cent)le

The ORO stated she w~s Informedby the Wound Care Nurse on MllY 6 201-4 thal PalienfA s11$taln~d a bum inlury io ll)e left -alf d11ring middota SU[lJ~ POced11reitat fflCly(~ffle 1118 tftlie Aquainantys System Toe ORD stat~ tier invesiigallen includedmiddoten 111tervlew with OperatingRoom technician (ORf) 1 wno was present during Patient As sw-glcat procedure s~ stated ORT 1 sfated when he ent~red the OR room he Saw moro steam than usual saw the device (Aguamantys) Jr1dermiddotthe ~tients leg yeUad

2172017 25152PME~nt IDBLFL11

Page Ii ofamp

CALI_FQRNI~ H~li AND HU~SE~r_ce~ AGENCY DEPARTMENT OF PUBLIC HEALTH

STAJ~lHT OF DEFICIENCIIES ()(1) PROIIOERSUPPUERCUA (X2) MULllPLE CONSTRLICTlON 9(3 DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER c~

-191~~ 05077-0 8WING

NA-A Of PROVID_Eft OR ~LfPU~ middotSlREEf ADDRESS CITY STATE_ZIP CODE

Lorna llndbull Ulllyeraity Medical Ceritlr bull Murrri ~IOJ2 Baxter RQad Murrieta CA ~2583 RIVERSIDE COUNTY

0(4)10 SIA4MA11Y STATliMENT OF DEflCIENCIES 10 PROIIOERS PIJN OF CORRlCTlON ()(5) PREFIX (EACH lIEACIENCY MUST BE liRECEEDED II( FULL PREFIX (EACH CORRCTIVEACTIOM lJ-iOULD 8E CROS~ COMPLETE

TAG REGULATORY OR ISC 11gtEfmFYING INFORMATION) TG REfERENCED TO THE APPROPRIATE DEFICIENCY) DATli

Stop and removed the d~lce

She ~~~ed MAii 5laffmiddotkrievno rAAQrt ncentdentsmiddotHke seeing-morel steam than usual from a device and to eheck the patlent No one (ofthe OR team) rep011ed the lncldent rhe JX)ffcy is to-te tie Charge Nurse es soon i~ p~sib_~ WMiJ ~m incident happens andgeAamptate an in(klenfrepoit

The ORD slated the faclllly policy and-p(ocedure r-egerdlngthe safe use of a ~autery ~evi_ce cfuring a surg~I prQC(ldure ~as J)Ol followed

The surgeon who performed the procedure was not avaHable 10 interview ~r ~D as she was on vacation

Ollring a follow up vislt oonducted-oriJuly 30 2014 the clinkal recQtds tor PatlemAwere reviewed Jtie ciilllcaf recoots lndlcateltf Paf~t A received extensive wound treatmenti ~ th_~ loft ~If following di~arge from the facility on May 9 2014 lhI reCQrds further lndkatod filatient A was readmitted on-JJtie 6 2014 for a ~urgical procedure to Femove large areas of necrosis (dead tissue) rom the bum injury site

On Jlly ~O iQ14 ~t e4011fJJ 80 Ale[Y~ w_as conducted with the Process Integrity Manaper (PIM) The PIM stated fhe racility1amp lnvestlgatloo of lhe incident was completed on-J~ne 11 2014 The PIM stated the surge~n who per-Winfl_d th~ silrgery di~ not attend the faeilltys review of-Ifie Incident but the assistant aurge~n was pre~ent Th~ PIM stated the facUltys review concluded II was twman

JiYlAt lQBLfl11 22712017 251 52P~

Pege II Qf n_

~ALIFORNIA HEALTH AND Hl)MAN ERVICES AGENCY DIEPARTMENT OF PUBIIC HEALTH

(XI) PROVloeRSUPfIERCLIA Q(2) MULTIPLE CONSlRUCTIONSTA~ OF OEFICIENCllS (X3) DATE SURVEY

ANO PlAN OF CORRECTION COMPLdED IDeNJIRCATtON NUMBER

AliJilhlNG B V00 050710 0~0amp1io14

NAME_OF P~VlaER OR IJLPPLIEM microST-RET AOORESS_CITY STATE ZIP CODE

tQma Linda U11fvffSlly Medl1-al ~eriter - Murrie(~ B~62 Bax~r Road Murrieta CA 92563 RlVEflSJDE COUNTY

(X4)10 SUMMARY SlATEMENT OF DEACtENCIES PROVIDERS PLAN OF CORRECTION (XSJ fREF1X

ID (EACH DEFICIENCY MUST BE PRaEEOEO BY FUil PREFIX (EACH CORRECmE ACTION SHOULO BE CROSSshy COMPLETI

REFERENCEO TO THE APPROPRIATE DEFICIENCY) DATER~991-ATOJilV QR Lsc IDENTIFYING INF~ITIOH) TAGTIG

error Ula caused Patj~middotntmiddot A to SU$~1n middota ull thiclm~ss uiermal b)rn to the left calf from the Aquamantys ~ivfcemiddotdtKing Pa~entAa surgery on Apr-ii 29 2014

The PIM stated-the surpeon who perfonnedthe prQcedur~ w~~ ~V~l~bl~ f9r lfl~rvlew because she was $UD-ltgtn vacationbull She sjated when 11 new _devlce is adept_e_d fofmiddotuse by the facility the manufacturer et the d~-~asbull technician oome fo ihe facility 19 prQYid~ argt lnasfrvice ~ining lb staff reg~ing ~fety ~ ~ Qse 9f ~4~- SJie slated the faality did not require doamenletloo lhat lndicateltil what staff had reeeivecHhe lrainiog fer (he AqJamantrs device the PlMi tatedmiddottlle t-aciliy did nof ~~W-~ pfly$1tj~nis tigt sJ-nd Che inbulltervlce training nCnamplliqti9(ls for Iha ~e of the device were localed on the top of the device

The PiM further 4tateqthfl cipe_raling room (OR staff did riotfonow fl~(~_citY1 POliq and ~res regiudiflO safety during Patient As surgical Focedure b)1 not-ensufing the cautery device (Aquamantys) WliS pr~ecfed when not loshyuse

lAe facility pelky Jtnd procedure entitled f ire Prevention ir-i tne Op~riitig R_~o~ ~te~i November 12 2013 Indicated _All staff enl~ring the Perioperallve Prooedurallrjv~lve areas will demonstrate kn9Yiledge of safIY and prevention a Nvrse ManagerChatga Nu~~C~ntca) 11_diKatQr ResponslbiUties 1tdlie2tiori arid dlt-ecllon-pf the eperatlng_s~ff _2 ~nforcemen~ ~f th_e dflpartments fire aafety procedur-ebull

2272017 25152PMEv~t IOBLR1-1

JlagG 7 Df 11State-2567

~FORNIA HEALTH AND HUMAN SEfVl(~~ ~~ENCY PEPAATMENT Of fgtUlIUC HEALTH

()(1) PRQVl~lJPPUERICUA (X2) MULTIPLE CONSTRUCTIONSTJ1flENT OF DEFICIENCIES (X3) ElfTl SURVEY AND PUif OF CORRECTION IDENTIACATION ~flER COMPIElffl

ABtH~itg IIWING050770 OB0612014

STREET AOORESS Clrt STATE21P oooe l~nt~ Lloda Unlverelty Medical Ceriter- Murr-le~

~E01 PROVlllllROff SlJPlU=R

~062 Baxter Rolld llunl~ CA 92amp6_l RIVERSIDE COUNTY

(l(S)

PREFIX lEACH aEFICIENCY MUST BE PREcmicroEDED ev FULL (X4)1D SUMMARY STATEMENT OF llEflCIENCIES P~VIDERS PlAN OF CORRECTION

(lACH CORRECTIVE ACTION SHOULD SE CROSS COMPLETE REFERENCED TO THE APPROPRIAl DEACIENCr) TAG REGUIATORY EgtFHSC JflENTIFYlIQ ~Oru41)T19N) QATE

Tlile pelicy further indicated Can1rollingHeal Sources 1 Ga4fefY A Never place lfle cautery peAcilon the patient Place the centautetymiddotpencR in the protective holster to prevent a~dintar activation ofcauterybull

A review of the manual instrOGtiorts entitled- hj11amantys Syamptem and Bil)Olar Seefers dated January 9 2013- lodkated Precautions Surgery should 1gt41 performed li)y-98f$Onl wllh adequate training andmiddotpreparstioo Plaquo$~el stlolld (Uily 1mderiland the nature ar-id use of RF (radio frequefley-electclcalmiddotcurrent) tJefore pertooningshyelectrosurgical piecedures to avoid itie risks ofmiddot 1hregk and bum hazards to both patJent and ~ratorbull

The middotfacility falled- to irilplemont their ptllfcy and procedure-regarding safety In the operating room and1aHedmiddotto develop and implement a policy and procadure regarding tbe use of a surgical device which was ltie ~l~cl ~W of Patient A iMilainlng a full thickness thermalmiddot bum Iltgt his left calf

This facility failed to preveAt the deliciencyQes) BJ described above ~I cau~eif or Is likery to cause serious 1Juiy c)r dllath Jo the pa~l~ll lirid 11Wef9te constitutes an Immediate jeopardy w)thill the meaning of Health and sarety Cede SecU911 12803(-g)

21272017 25t52PMEvent IOBLFL11

PaQB80f8

Page 4: Statement of Deficiency Loma Linda University Medical Center Document Librar… · Loma Linda University Medical Center Murrieta's Surgical Service and Medical Staff has developed,

CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMlNT OF PUBLIC HEALTH

STATEMENT OF DEFICIENClES Q(1) PROVIDEflSUPPUERCUA (X2) MULTIPLE CONSTRUCTION (X3tDATE SURVEY AND PVN OF CORRECTION loemFlCATION NUMBER COMPIEfED

A~ILDtNq

05077~ BWING 080612014

NAME OF PROVIDER OR ~JPPUER

Loma Ll~dl University Med~I cn~r- - Mu_rri~

STREET ADDRESS Orr( STATE ZlP CODE

~8062 Baxlei Road Munlatll CA 92583 RIVERSIDE COUNTY

(X4)10

PREFIX TAG

SUMMARY STATEMENT OF DEFICIENCIES

(EAQtDfflCIENCYMOSTBEPRECEEDEDSYFUU ]i~TORY OR LSC IDENTIFYING INFORMATION)

middot10 PROVIDERS PlAN OF CORRECTION PREFIX (EACH COAAECTllE AC110N SHOlApound1 BE CROSS

TIIG REFERENCED TO THE APPROPRIATE DEflCIENCY)

(Xii) COMPLET_E DATE

8202014(inflammation of th~joiJJ~ cartilage of he knees) The document-entitled-~Periopa~tive ReJX)rt1 dated

bull The policy Fire Prevention in the OR was

April 29 2014 l~edPatientAhad knee feplacement su~r-yfor 6oth knees

reviewed revised bull Physician practice was

The reportftrrther indkated the su(geon wsed an reviewed by the Surgical Aqualfl~ntys ~y~ten ~iring-Pa~ie)ll Ns surgery Quality Review Committee and 011 April 29 2014 appropriate actions have been

6262014

According deg the ~acturcJ insert the taken Aquama_Atys Syatefll Isbull surgical (cautery) deg4el~ l~ lf)qucl~- h~R~ pi~ ~ld the Audits will be completed for each Aqmicroamantya 61-pQlar piece whidl hlis an electric etrrreAl that generates heat to seal tissues in order use of the AM to assure that the

to help prevemt fgt4ood tos machine has been safely used before during and after the surgical

8 1520 14

Tt-Kt phyelclan Pragr~ii~Ncit_es~ dated M~ l procedure To date 100 has been 201-4 at 948 pm Indicated BIiaterai knee hemo11acs (drams)- iemoved withowt any difficulty achieved for the past 3 months

middotThe dressings_er~ dry andlhJitct Plfluse Results of the audit were t~ernets with pattAAtli911 Mi4 QifflJ~ welling incorporated in the OR Quality Calves are soft Len calf~th blisteringbull Dashboard and reported in

There was no qocumentation oi physician orders accordance with the established

that eddress~d the left calf bl~lering repor ting calendar Reports are forward to appropriate

The nursing Progress N~es dated May 6 201-t EI Z~6 pni inltfi~r~ Df(pli~lclans nane) rounded thl~ am andmiddotkgtOked middotat what she ~rred to

committees in accordance with the Quality oversight Structure

as an open bllsfer QA p~tler1t1J leg iround calf-area She said she saw il yesterday when she rounmiddotded Ordermiddot~~ g~n to piiTlillY (physician) to apply santyl ung (Wound treatmeitt) and wound nurse Person Responsible Director

consult Photo taken Perioperative Services

Event IO~LFL 1f IZf2017 25152PM

Page 4of 6 siate-2567

CAlIF0~NIA HEALTH AND MUMAN ~ERY10~ ~~EilCY 0~~~~ENT()F PUBLIC H_Wnt

STATEMENT OF DEFCIEtfQI~ ANO PLAN OF CORRECTION

(X1j PROVIDERSUPPLIERCUA IDENlIACATION NUMBER

(X2) MULTIPLE CONSTRUCTION

AIUIIJ)ING

(X3) DATE $URVEY WMPIBEO

050770 B WNG 080~01~

NM1fiQF_PR(IV1lllR OR ~UPPU8

L~ma Llndbull University Medlcal (ef119r- bull ~hmJeta 8T-REET AOORESS CllY STATE ZIP cooe

~11062 S11xter Road Murrieta CA 92563 RIViRSDE COUNTY

()(~)ID ~lM~_SJATEMEHT EgtF DEFICIENCIES ID PROlllJERS PlAN_OF PQRRIECTION PREFlX (EACHmiddotDEFICIEHCYMUSTSE 11RECEEDED BY FULL PREAX (EACH e0RREITIVEiCll9N IHOUUl lE CROSS

TIG AEGUlT)RY PISC IDENTIFYING lflgtRM~lIQN) TO REFERENCED Tl) THE NPROPRIATE DEfICIENCY)

The order to treat PalieAt As left ealf blister was written five days 1t~r he physician documented discovery of ttie bll~~riSJ-

The ckgteument entitled~Initial Inpatient Wound Cate Coosul~ ~fated M11y ~ 201-4 was reviewed Tue Q09~ment indicated On POIgt 11 (PUen Observation Day) nurse notedmiddota arge L (left) posl~~r calf wound 1)061 op (after SUtgeey)bullbullbull Large Left posterior calf Mt thickness W9umLpresumqbly cauaed by therm bum Injury from OR (O~ratlngR~) AQu1Bfllys hemoslasls sealerft

Dunng an interview wiih the Oper-ating Room Director (~D) on June 9 20-t-4 at 1middot45 pm the ORD s1aled same sugeons use the Aquamantys Bl-polar ha~ piece dlling procedures requiring cauleiy (in order -t~ ~ reventblood loss) The ORD also stated the device was use4 by t1rgeons when an Incision (erit) was smide Into the sijn She stat~ when a surgeqn was not using lhe device ltle d~vlc~ w~J r~rno~ectfrpm ~he ope~tlng cent)le

The ORO stated she w~s Informedby the Wound Care Nurse on MllY 6 201-4 thal PalienfA s11$taln~d a bum inlury io ll)e left -alf d11ring middota SU[lJ~ POced11reitat fflCly(~ffle 1118 tftlie Aquainantys System Toe ORD stat~ tier invesiigallen includedmiddoten 111tervlew with OperatingRoom technician (ORf) 1 wno was present during Patient As sw-glcat procedure s~ stated ORT 1 sfated when he ent~red the OR room he Saw moro steam than usual saw the device (Aguamantys) Jr1dermiddotthe ~tients leg yeUad

2172017 25152PME~nt IDBLFL11

Page Ii ofamp

CALI_FQRNI~ H~li AND HU~SE~r_ce~ AGENCY DEPARTMENT OF PUBLIC HEALTH

STAJ~lHT OF DEFICIENCIIES ()(1) PROIIOERSUPPUERCUA (X2) MULllPLE CONSTRLICTlON 9(3 DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER c~

-191~~ 05077-0 8WING

NA-A Of PROVID_Eft OR ~LfPU~ middotSlREEf ADDRESS CITY STATE_ZIP CODE

Lorna llndbull Ulllyeraity Medical Ceritlr bull Murrri ~IOJ2 Baxter RQad Murrieta CA ~2583 RIVERSIDE COUNTY

0(4)10 SIA4MA11Y STATliMENT OF DEflCIENCIES 10 PROIIOERS PIJN OF CORRlCTlON ()(5) PREFIX (EACH lIEACIENCY MUST BE liRECEEDED II( FULL PREFIX (EACH CORRCTIVEACTIOM lJ-iOULD 8E CROS~ COMPLETE

TAG REGULATORY OR ISC 11gtEfmFYING INFORMATION) TG REfERENCED TO THE APPROPRIATE DEFICIENCY) DATli

Stop and removed the d~lce

She ~~~ed MAii 5laffmiddotkrievno rAAQrt ncentdentsmiddotHke seeing-morel steam than usual from a device and to eheck the patlent No one (ofthe OR team) rep011ed the lncldent rhe JX)ffcy is to-te tie Charge Nurse es soon i~ p~sib_~ WMiJ ~m incident happens andgeAamptate an in(klenfrepoit

The ORD slated the faclllly policy and-p(ocedure r-egerdlngthe safe use of a ~autery ~evi_ce cfuring a surg~I prQC(ldure ~as J)Ol followed

The surgeon who performed the procedure was not avaHable 10 interview ~r ~D as she was on vacation

Ollring a follow up vislt oonducted-oriJuly 30 2014 the clinkal recQtds tor PatlemAwere reviewed Jtie ciilllcaf recoots lndlcateltf Paf~t A received extensive wound treatmenti ~ th_~ loft ~If following di~arge from the facility on May 9 2014 lhI reCQrds further lndkatod filatient A was readmitted on-JJtie 6 2014 for a ~urgical procedure to Femove large areas of necrosis (dead tissue) rom the bum injury site

On Jlly ~O iQ14 ~t e4011fJJ 80 Ale[Y~ w_as conducted with the Process Integrity Manaper (PIM) The PIM stated fhe racility1amp lnvestlgatloo of lhe incident was completed on-J~ne 11 2014 The PIM stated the surge~n who per-Winfl_d th~ silrgery di~ not attend the faeilltys review of-Ifie Incident but the assistant aurge~n was pre~ent Th~ PIM stated the facUltys review concluded II was twman

JiYlAt lQBLfl11 22712017 251 52P~

Pege II Qf n_

~ALIFORNIA HEALTH AND Hl)MAN ERVICES AGENCY DIEPARTMENT OF PUBIIC HEALTH

(XI) PROVloeRSUPfIERCLIA Q(2) MULTIPLE CONSlRUCTIONSTA~ OF OEFICIENCllS (X3) DATE SURVEY

ANO PlAN OF CORRECTION COMPLdED IDeNJIRCATtON NUMBER

AliJilhlNG B V00 050710 0~0amp1io14

NAME_OF P~VlaER OR IJLPPLIEM microST-RET AOORESS_CITY STATE ZIP CODE

tQma Linda U11fvffSlly Medl1-al ~eriter - Murrie(~ B~62 Bax~r Road Murrieta CA 92563 RlVEflSJDE COUNTY

(X4)10 SUMMARY SlATEMENT OF DEACtENCIES PROVIDERS PLAN OF CORRECTION (XSJ fREF1X

ID (EACH DEFICIENCY MUST BE PRaEEOEO BY FUil PREFIX (EACH CORRECmE ACTION SHOULO BE CROSSshy COMPLETI

REFERENCEO TO THE APPROPRIATE DEFICIENCY) DATER~991-ATOJilV QR Lsc IDENTIFYING INF~ITIOH) TAGTIG

error Ula caused Patj~middotntmiddot A to SU$~1n middota ull thiclm~ss uiermal b)rn to the left calf from the Aquamantys ~ivfcemiddotdtKing Pa~entAa surgery on Apr-ii 29 2014

The PIM stated-the surpeon who perfonnedthe prQcedur~ w~~ ~V~l~bl~ f9r lfl~rvlew because she was $UD-ltgtn vacationbull She sjated when 11 new _devlce is adept_e_d fofmiddotuse by the facility the manufacturer et the d~-~asbull technician oome fo ihe facility 19 prQYid~ argt lnasfrvice ~ining lb staff reg~ing ~fety ~ ~ Qse 9f ~4~- SJie slated the faality did not require doamenletloo lhat lndicateltil what staff had reeeivecHhe lrainiog fer (he AqJamantrs device the PlMi tatedmiddottlle t-aciliy did nof ~~W-~ pfly$1tj~nis tigt sJ-nd Che inbulltervlce training nCnamplliqti9(ls for Iha ~e of the device were localed on the top of the device

The PiM further 4tateqthfl cipe_raling room (OR staff did riotfonow fl~(~_citY1 POliq and ~res regiudiflO safety during Patient As surgical Focedure b)1 not-ensufing the cautery device (Aquamantys) WliS pr~ecfed when not loshyuse

lAe facility pelky Jtnd procedure entitled f ire Prevention ir-i tne Op~riitig R_~o~ ~te~i November 12 2013 Indicated _All staff enl~ring the Perioperallve Prooedurallrjv~lve areas will demonstrate kn9Yiledge of safIY and prevention a Nvrse ManagerChatga Nu~~C~ntca) 11_diKatQr ResponslbiUties 1tdlie2tiori arid dlt-ecllon-pf the eperatlng_s~ff _2 ~nforcemen~ ~f th_e dflpartments fire aafety procedur-ebull

2272017 25152PMEv~t IOBLR1-1

JlagG 7 Df 11State-2567

~FORNIA HEALTH AND HUMAN SEfVl(~~ ~~ENCY PEPAATMENT Of fgtUlIUC HEALTH

()(1) PRQVl~lJPPUERICUA (X2) MULTIPLE CONSTRUCTIONSTJ1flENT OF DEFICIENCIES (X3) ElfTl SURVEY AND PUif OF CORRECTION IDENTIACATION ~flER COMPIElffl

ABtH~itg IIWING050770 OB0612014

STREET AOORESS Clrt STATE21P oooe l~nt~ Lloda Unlverelty Medical Ceriter- Murr-le~

~E01 PROVlllllROff SlJPlU=R

~062 Baxter Rolld llunl~ CA 92amp6_l RIVERSIDE COUNTY

(l(S)

PREFIX lEACH aEFICIENCY MUST BE PREcmicroEDED ev FULL (X4)1D SUMMARY STATEMENT OF llEflCIENCIES P~VIDERS PlAN OF CORRECTION

(lACH CORRECTIVE ACTION SHOULD SE CROSS COMPLETE REFERENCED TO THE APPROPRIAl DEACIENCr) TAG REGUIATORY EgtFHSC JflENTIFYlIQ ~Oru41)T19N) QATE

Tlile pelicy further indicated Can1rollingHeal Sources 1 Ga4fefY A Never place lfle cautery peAcilon the patient Place the centautetymiddotpencR in the protective holster to prevent a~dintar activation ofcauterybull

A review of the manual instrOGtiorts entitled- hj11amantys Syamptem and Bil)Olar Seefers dated January 9 2013- lodkated Precautions Surgery should 1gt41 performed li)y-98f$Onl wllh adequate training andmiddotpreparstioo Plaquo$~el stlolld (Uily 1mderiland the nature ar-id use of RF (radio frequefley-electclcalmiddotcurrent) tJefore pertooningshyelectrosurgical piecedures to avoid itie risks ofmiddot 1hregk and bum hazards to both patJent and ~ratorbull

The middotfacility falled- to irilplemont their ptllfcy and procedure-regarding safety In the operating room and1aHedmiddotto develop and implement a policy and procadure regarding tbe use of a surgical device which was ltie ~l~cl ~W of Patient A iMilainlng a full thickness thermalmiddot bum Iltgt his left calf

This facility failed to preveAt the deliciencyQes) BJ described above ~I cau~eif or Is likery to cause serious 1Juiy c)r dllath Jo the pa~l~ll lirid 11Wef9te constitutes an Immediate jeopardy w)thill the meaning of Health and sarety Cede SecU911 12803(-g)

21272017 25t52PMEvent IOBLFL11

PaQB80f8

Page 5: Statement of Deficiency Loma Linda University Medical Center Document Librar… · Loma Linda University Medical Center Murrieta's Surgical Service and Medical Staff has developed,

CAlIF0~NIA HEALTH AND MUMAN ~ERY10~ ~~EilCY 0~~~~ENT()F PUBLIC H_Wnt

STATEMENT OF DEFCIEtfQI~ ANO PLAN OF CORRECTION

(X1j PROVIDERSUPPLIERCUA IDENlIACATION NUMBER

(X2) MULTIPLE CONSTRUCTION

AIUIIJ)ING

(X3) DATE $URVEY WMPIBEO

050770 B WNG 080~01~

NM1fiQF_PR(IV1lllR OR ~UPPU8

L~ma Llndbull University Medlcal (ef119r- bull ~hmJeta 8T-REET AOORESS CllY STATE ZIP cooe

~11062 S11xter Road Murrieta CA 92563 RIViRSDE COUNTY

()(~)ID ~lM~_SJATEMEHT EgtF DEFICIENCIES ID PROlllJERS PlAN_OF PQRRIECTION PREFlX (EACHmiddotDEFICIEHCYMUSTSE 11RECEEDED BY FULL PREAX (EACH e0RREITIVEiCll9N IHOUUl lE CROSS

TIG AEGUlT)RY PISC IDENTIFYING lflgtRM~lIQN) TO REFERENCED Tl) THE NPROPRIATE DEfICIENCY)

The order to treat PalieAt As left ealf blister was written five days 1t~r he physician documented discovery of ttie bll~~riSJ-

The ckgteument entitled~Initial Inpatient Wound Cate Coosul~ ~fated M11y ~ 201-4 was reviewed Tue Q09~ment indicated On POIgt 11 (PUen Observation Day) nurse notedmiddota arge L (left) posl~~r calf wound 1)061 op (after SUtgeey)bullbullbull Large Left posterior calf Mt thickness W9umLpresumqbly cauaed by therm bum Injury from OR (O~ratlngR~) AQu1Bfllys hemoslasls sealerft

Dunng an interview wiih the Oper-ating Room Director (~D) on June 9 20-t-4 at 1middot45 pm the ORD s1aled same sugeons use the Aquamantys Bl-polar ha~ piece dlling procedures requiring cauleiy (in order -t~ ~ reventblood loss) The ORD also stated the device was use4 by t1rgeons when an Incision (erit) was smide Into the sijn She stat~ when a surgeqn was not using lhe device ltle d~vlc~ w~J r~rno~ectfrpm ~he ope~tlng cent)le

The ORO stated she w~s Informedby the Wound Care Nurse on MllY 6 201-4 thal PalienfA s11$taln~d a bum inlury io ll)e left -alf d11ring middota SU[lJ~ POced11reitat fflCly(~ffle 1118 tftlie Aquainantys System Toe ORD stat~ tier invesiigallen includedmiddoten 111tervlew with OperatingRoom technician (ORf) 1 wno was present during Patient As sw-glcat procedure s~ stated ORT 1 sfated when he ent~red the OR room he Saw moro steam than usual saw the device (Aguamantys) Jr1dermiddotthe ~tients leg yeUad

2172017 25152PME~nt IDBLFL11

Page Ii ofamp

CALI_FQRNI~ H~li AND HU~SE~r_ce~ AGENCY DEPARTMENT OF PUBLIC HEALTH

STAJ~lHT OF DEFICIENCIIES ()(1) PROIIOERSUPPUERCUA (X2) MULllPLE CONSTRLICTlON 9(3 DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER c~

-191~~ 05077-0 8WING

NA-A Of PROVID_Eft OR ~LfPU~ middotSlREEf ADDRESS CITY STATE_ZIP CODE

Lorna llndbull Ulllyeraity Medical Ceritlr bull Murrri ~IOJ2 Baxter RQad Murrieta CA ~2583 RIVERSIDE COUNTY

0(4)10 SIA4MA11Y STATliMENT OF DEflCIENCIES 10 PROIIOERS PIJN OF CORRlCTlON ()(5) PREFIX (EACH lIEACIENCY MUST BE liRECEEDED II( FULL PREFIX (EACH CORRCTIVEACTIOM lJ-iOULD 8E CROS~ COMPLETE

TAG REGULATORY OR ISC 11gtEfmFYING INFORMATION) TG REfERENCED TO THE APPROPRIATE DEFICIENCY) DATli

Stop and removed the d~lce

She ~~~ed MAii 5laffmiddotkrievno rAAQrt ncentdentsmiddotHke seeing-morel steam than usual from a device and to eheck the patlent No one (ofthe OR team) rep011ed the lncldent rhe JX)ffcy is to-te tie Charge Nurse es soon i~ p~sib_~ WMiJ ~m incident happens andgeAamptate an in(klenfrepoit

The ORD slated the faclllly policy and-p(ocedure r-egerdlngthe safe use of a ~autery ~evi_ce cfuring a surg~I prQC(ldure ~as J)Ol followed

The surgeon who performed the procedure was not avaHable 10 interview ~r ~D as she was on vacation

Ollring a follow up vislt oonducted-oriJuly 30 2014 the clinkal recQtds tor PatlemAwere reviewed Jtie ciilllcaf recoots lndlcateltf Paf~t A received extensive wound treatmenti ~ th_~ loft ~If following di~arge from the facility on May 9 2014 lhI reCQrds further lndkatod filatient A was readmitted on-JJtie 6 2014 for a ~urgical procedure to Femove large areas of necrosis (dead tissue) rom the bum injury site

On Jlly ~O iQ14 ~t e4011fJJ 80 Ale[Y~ w_as conducted with the Process Integrity Manaper (PIM) The PIM stated fhe racility1amp lnvestlgatloo of lhe incident was completed on-J~ne 11 2014 The PIM stated the surge~n who per-Winfl_d th~ silrgery di~ not attend the faeilltys review of-Ifie Incident but the assistant aurge~n was pre~ent Th~ PIM stated the facUltys review concluded II was twman

JiYlAt lQBLfl11 22712017 251 52P~

Pege II Qf n_

~ALIFORNIA HEALTH AND Hl)MAN ERVICES AGENCY DIEPARTMENT OF PUBIIC HEALTH

(XI) PROVloeRSUPfIERCLIA Q(2) MULTIPLE CONSlRUCTIONSTA~ OF OEFICIENCllS (X3) DATE SURVEY

ANO PlAN OF CORRECTION COMPLdED IDeNJIRCATtON NUMBER

AliJilhlNG B V00 050710 0~0amp1io14

NAME_OF P~VlaER OR IJLPPLIEM microST-RET AOORESS_CITY STATE ZIP CODE

tQma Linda U11fvffSlly Medl1-al ~eriter - Murrie(~ B~62 Bax~r Road Murrieta CA 92563 RlVEflSJDE COUNTY

(X4)10 SUMMARY SlATEMENT OF DEACtENCIES PROVIDERS PLAN OF CORRECTION (XSJ fREF1X

ID (EACH DEFICIENCY MUST BE PRaEEOEO BY FUil PREFIX (EACH CORRECmE ACTION SHOULO BE CROSSshy COMPLETI

REFERENCEO TO THE APPROPRIATE DEFICIENCY) DATER~991-ATOJilV QR Lsc IDENTIFYING INF~ITIOH) TAGTIG

error Ula caused Patj~middotntmiddot A to SU$~1n middota ull thiclm~ss uiermal b)rn to the left calf from the Aquamantys ~ivfcemiddotdtKing Pa~entAa surgery on Apr-ii 29 2014

The PIM stated-the surpeon who perfonnedthe prQcedur~ w~~ ~V~l~bl~ f9r lfl~rvlew because she was $UD-ltgtn vacationbull She sjated when 11 new _devlce is adept_e_d fofmiddotuse by the facility the manufacturer et the d~-~asbull technician oome fo ihe facility 19 prQYid~ argt lnasfrvice ~ining lb staff reg~ing ~fety ~ ~ Qse 9f ~4~- SJie slated the faality did not require doamenletloo lhat lndicateltil what staff had reeeivecHhe lrainiog fer (he AqJamantrs device the PlMi tatedmiddottlle t-aciliy did nof ~~W-~ pfly$1tj~nis tigt sJ-nd Che inbulltervlce training nCnamplliqti9(ls for Iha ~e of the device were localed on the top of the device

The PiM further 4tateqthfl cipe_raling room (OR staff did riotfonow fl~(~_citY1 POliq and ~res regiudiflO safety during Patient As surgical Focedure b)1 not-ensufing the cautery device (Aquamantys) WliS pr~ecfed when not loshyuse

lAe facility pelky Jtnd procedure entitled f ire Prevention ir-i tne Op~riitig R_~o~ ~te~i November 12 2013 Indicated _All staff enl~ring the Perioperallve Prooedurallrjv~lve areas will demonstrate kn9Yiledge of safIY and prevention a Nvrse ManagerChatga Nu~~C~ntca) 11_diKatQr ResponslbiUties 1tdlie2tiori arid dlt-ecllon-pf the eperatlng_s~ff _2 ~nforcemen~ ~f th_e dflpartments fire aafety procedur-ebull

2272017 25152PMEv~t IOBLR1-1

JlagG 7 Df 11State-2567

~FORNIA HEALTH AND HUMAN SEfVl(~~ ~~ENCY PEPAATMENT Of fgtUlIUC HEALTH

()(1) PRQVl~lJPPUERICUA (X2) MULTIPLE CONSTRUCTIONSTJ1flENT OF DEFICIENCIES (X3) ElfTl SURVEY AND PUif OF CORRECTION IDENTIACATION ~flER COMPIElffl

ABtH~itg IIWING050770 OB0612014

STREET AOORESS Clrt STATE21P oooe l~nt~ Lloda Unlverelty Medical Ceriter- Murr-le~

~E01 PROVlllllROff SlJPlU=R

~062 Baxter Rolld llunl~ CA 92amp6_l RIVERSIDE COUNTY

(l(S)

PREFIX lEACH aEFICIENCY MUST BE PREcmicroEDED ev FULL (X4)1D SUMMARY STATEMENT OF llEflCIENCIES P~VIDERS PlAN OF CORRECTION

(lACH CORRECTIVE ACTION SHOULD SE CROSS COMPLETE REFERENCED TO THE APPROPRIAl DEACIENCr) TAG REGUIATORY EgtFHSC JflENTIFYlIQ ~Oru41)T19N) QATE

Tlile pelicy further indicated Can1rollingHeal Sources 1 Ga4fefY A Never place lfle cautery peAcilon the patient Place the centautetymiddotpencR in the protective holster to prevent a~dintar activation ofcauterybull

A review of the manual instrOGtiorts entitled- hj11amantys Syamptem and Bil)Olar Seefers dated January 9 2013- lodkated Precautions Surgery should 1gt41 performed li)y-98f$Onl wllh adequate training andmiddotpreparstioo Plaquo$~el stlolld (Uily 1mderiland the nature ar-id use of RF (radio frequefley-electclcalmiddotcurrent) tJefore pertooningshyelectrosurgical piecedures to avoid itie risks ofmiddot 1hregk and bum hazards to both patJent and ~ratorbull

The middotfacility falled- to irilplemont their ptllfcy and procedure-regarding safety In the operating room and1aHedmiddotto develop and implement a policy and procadure regarding tbe use of a surgical device which was ltie ~l~cl ~W of Patient A iMilainlng a full thickness thermalmiddot bum Iltgt his left calf

This facility failed to preveAt the deliciencyQes) BJ described above ~I cau~eif or Is likery to cause serious 1Juiy c)r dllath Jo the pa~l~ll lirid 11Wef9te constitutes an Immediate jeopardy w)thill the meaning of Health and sarety Cede SecU911 12803(-g)

21272017 25t52PMEvent IOBLFL11

PaQB80f8

Page 6: Statement of Deficiency Loma Linda University Medical Center Document Librar… · Loma Linda University Medical Center Murrieta's Surgical Service and Medical Staff has developed,

CALI_FQRNI~ H~li AND HU~SE~r_ce~ AGENCY DEPARTMENT OF PUBLIC HEALTH

STAJ~lHT OF DEFICIENCIIES ()(1) PROIIOERSUPPUERCUA (X2) MULllPLE CONSTRLICTlON 9(3 DATE SURVEY AND PLAN OF CORRECTION IDENTIFICATION NUMBER c~

-191~~ 05077-0 8WING

NA-A Of PROVID_Eft OR ~LfPU~ middotSlREEf ADDRESS CITY STATE_ZIP CODE

Lorna llndbull Ulllyeraity Medical Ceritlr bull Murrri ~IOJ2 Baxter RQad Murrieta CA ~2583 RIVERSIDE COUNTY

0(4)10 SIA4MA11Y STATliMENT OF DEflCIENCIES 10 PROIIOERS PIJN OF CORRlCTlON ()(5) PREFIX (EACH lIEACIENCY MUST BE liRECEEDED II( FULL PREFIX (EACH CORRCTIVEACTIOM lJ-iOULD 8E CROS~ COMPLETE

TAG REGULATORY OR ISC 11gtEfmFYING INFORMATION) TG REfERENCED TO THE APPROPRIATE DEFICIENCY) DATli

Stop and removed the d~lce

She ~~~ed MAii 5laffmiddotkrievno rAAQrt ncentdentsmiddotHke seeing-morel steam than usual from a device and to eheck the patlent No one (ofthe OR team) rep011ed the lncldent rhe JX)ffcy is to-te tie Charge Nurse es soon i~ p~sib_~ WMiJ ~m incident happens andgeAamptate an in(klenfrepoit

The ORD slated the faclllly policy and-p(ocedure r-egerdlngthe safe use of a ~autery ~evi_ce cfuring a surg~I prQC(ldure ~as J)Ol followed

The surgeon who performed the procedure was not avaHable 10 interview ~r ~D as she was on vacation

Ollring a follow up vislt oonducted-oriJuly 30 2014 the clinkal recQtds tor PatlemAwere reviewed Jtie ciilllcaf recoots lndlcateltf Paf~t A received extensive wound treatmenti ~ th_~ loft ~If following di~arge from the facility on May 9 2014 lhI reCQrds further lndkatod filatient A was readmitted on-JJtie 6 2014 for a ~urgical procedure to Femove large areas of necrosis (dead tissue) rom the bum injury site

On Jlly ~O iQ14 ~t e4011fJJ 80 Ale[Y~ w_as conducted with the Process Integrity Manaper (PIM) The PIM stated fhe racility1amp lnvestlgatloo of lhe incident was completed on-J~ne 11 2014 The PIM stated the surge~n who per-Winfl_d th~ silrgery di~ not attend the faeilltys review of-Ifie Incident but the assistant aurge~n was pre~ent Th~ PIM stated the facUltys review concluded II was twman

JiYlAt lQBLfl11 22712017 251 52P~

Pege II Qf n_

~ALIFORNIA HEALTH AND Hl)MAN ERVICES AGENCY DIEPARTMENT OF PUBIIC HEALTH

(XI) PROVloeRSUPfIERCLIA Q(2) MULTIPLE CONSlRUCTIONSTA~ OF OEFICIENCllS (X3) DATE SURVEY

ANO PlAN OF CORRECTION COMPLdED IDeNJIRCATtON NUMBER

AliJilhlNG B V00 050710 0~0amp1io14

NAME_OF P~VlaER OR IJLPPLIEM microST-RET AOORESS_CITY STATE ZIP CODE

tQma Linda U11fvffSlly Medl1-al ~eriter - Murrie(~ B~62 Bax~r Road Murrieta CA 92563 RlVEflSJDE COUNTY

(X4)10 SUMMARY SlATEMENT OF DEACtENCIES PROVIDERS PLAN OF CORRECTION (XSJ fREF1X

ID (EACH DEFICIENCY MUST BE PRaEEOEO BY FUil PREFIX (EACH CORRECmE ACTION SHOULO BE CROSSshy COMPLETI

REFERENCEO TO THE APPROPRIATE DEFICIENCY) DATER~991-ATOJilV QR Lsc IDENTIFYING INF~ITIOH) TAGTIG

error Ula caused Patj~middotntmiddot A to SU$~1n middota ull thiclm~ss uiermal b)rn to the left calf from the Aquamantys ~ivfcemiddotdtKing Pa~entAa surgery on Apr-ii 29 2014

The PIM stated-the surpeon who perfonnedthe prQcedur~ w~~ ~V~l~bl~ f9r lfl~rvlew because she was $UD-ltgtn vacationbull She sjated when 11 new _devlce is adept_e_d fofmiddotuse by the facility the manufacturer et the d~-~asbull technician oome fo ihe facility 19 prQYid~ argt lnasfrvice ~ining lb staff reg~ing ~fety ~ ~ Qse 9f ~4~- SJie slated the faality did not require doamenletloo lhat lndicateltil what staff had reeeivecHhe lrainiog fer (he AqJamantrs device the PlMi tatedmiddottlle t-aciliy did nof ~~W-~ pfly$1tj~nis tigt sJ-nd Che inbulltervlce training nCnamplliqti9(ls for Iha ~e of the device were localed on the top of the device

The PiM further 4tateqthfl cipe_raling room (OR staff did riotfonow fl~(~_citY1 POliq and ~res regiudiflO safety during Patient As surgical Focedure b)1 not-ensufing the cautery device (Aquamantys) WliS pr~ecfed when not loshyuse

lAe facility pelky Jtnd procedure entitled f ire Prevention ir-i tne Op~riitig R_~o~ ~te~i November 12 2013 Indicated _All staff enl~ring the Perioperallve Prooedurallrjv~lve areas will demonstrate kn9Yiledge of safIY and prevention a Nvrse ManagerChatga Nu~~C~ntca) 11_diKatQr ResponslbiUties 1tdlie2tiori arid dlt-ecllon-pf the eperatlng_s~ff _2 ~nforcemen~ ~f th_e dflpartments fire aafety procedur-ebull

2272017 25152PMEv~t IOBLR1-1

JlagG 7 Df 11State-2567

~FORNIA HEALTH AND HUMAN SEfVl(~~ ~~ENCY PEPAATMENT Of fgtUlIUC HEALTH

()(1) PRQVl~lJPPUERICUA (X2) MULTIPLE CONSTRUCTIONSTJ1flENT OF DEFICIENCIES (X3) ElfTl SURVEY AND PUif OF CORRECTION IDENTIACATION ~flER COMPIElffl

ABtH~itg IIWING050770 OB0612014

STREET AOORESS Clrt STATE21P oooe l~nt~ Lloda Unlverelty Medical Ceriter- Murr-le~

~E01 PROVlllllROff SlJPlU=R

~062 Baxter Rolld llunl~ CA 92amp6_l RIVERSIDE COUNTY

(l(S)

PREFIX lEACH aEFICIENCY MUST BE PREcmicroEDED ev FULL (X4)1D SUMMARY STATEMENT OF llEflCIENCIES P~VIDERS PlAN OF CORRECTION

(lACH CORRECTIVE ACTION SHOULD SE CROSS COMPLETE REFERENCED TO THE APPROPRIAl DEACIENCr) TAG REGUIATORY EgtFHSC JflENTIFYlIQ ~Oru41)T19N) QATE

Tlile pelicy further indicated Can1rollingHeal Sources 1 Ga4fefY A Never place lfle cautery peAcilon the patient Place the centautetymiddotpencR in the protective holster to prevent a~dintar activation ofcauterybull

A review of the manual instrOGtiorts entitled- hj11amantys Syamptem and Bil)Olar Seefers dated January 9 2013- lodkated Precautions Surgery should 1gt41 performed li)y-98f$Onl wllh adequate training andmiddotpreparstioo Plaquo$~el stlolld (Uily 1mderiland the nature ar-id use of RF (radio frequefley-electclcalmiddotcurrent) tJefore pertooningshyelectrosurgical piecedures to avoid itie risks ofmiddot 1hregk and bum hazards to both patJent and ~ratorbull

The middotfacility falled- to irilplemont their ptllfcy and procedure-regarding safety In the operating room and1aHedmiddotto develop and implement a policy and procadure regarding tbe use of a surgical device which was ltie ~l~cl ~W of Patient A iMilainlng a full thickness thermalmiddot bum Iltgt his left calf

This facility failed to preveAt the deliciencyQes) BJ described above ~I cau~eif or Is likery to cause serious 1Juiy c)r dllath Jo the pa~l~ll lirid 11Wef9te constitutes an Immediate jeopardy w)thill the meaning of Health and sarety Cede SecU911 12803(-g)

21272017 25t52PMEvent IOBLFL11

PaQB80f8

Page 7: Statement of Deficiency Loma Linda University Medical Center Document Librar… · Loma Linda University Medical Center Murrieta's Surgical Service and Medical Staff has developed,

~ALIFORNIA HEALTH AND Hl)MAN ERVICES AGENCY DIEPARTMENT OF PUBIIC HEALTH

(XI) PROVloeRSUPfIERCLIA Q(2) MULTIPLE CONSlRUCTIONSTA~ OF OEFICIENCllS (X3) DATE SURVEY

ANO PlAN OF CORRECTION COMPLdED IDeNJIRCATtON NUMBER

AliJilhlNG B V00 050710 0~0amp1io14

NAME_OF P~VlaER OR IJLPPLIEM microST-RET AOORESS_CITY STATE ZIP CODE

tQma Linda U11fvffSlly Medl1-al ~eriter - Murrie(~ B~62 Bax~r Road Murrieta CA 92563 RlVEflSJDE COUNTY

(X4)10 SUMMARY SlATEMENT OF DEACtENCIES PROVIDERS PLAN OF CORRECTION (XSJ fREF1X

ID (EACH DEFICIENCY MUST BE PRaEEOEO BY FUil PREFIX (EACH CORRECmE ACTION SHOULO BE CROSSshy COMPLETI

REFERENCEO TO THE APPROPRIATE DEFICIENCY) DATER~991-ATOJilV QR Lsc IDENTIFYING INF~ITIOH) TAGTIG

error Ula caused Patj~middotntmiddot A to SU$~1n middota ull thiclm~ss uiermal b)rn to the left calf from the Aquamantys ~ivfcemiddotdtKing Pa~entAa surgery on Apr-ii 29 2014

The PIM stated-the surpeon who perfonnedthe prQcedur~ w~~ ~V~l~bl~ f9r lfl~rvlew because she was $UD-ltgtn vacationbull She sjated when 11 new _devlce is adept_e_d fofmiddotuse by the facility the manufacturer et the d~-~asbull technician oome fo ihe facility 19 prQYid~ argt lnasfrvice ~ining lb staff reg~ing ~fety ~ ~ Qse 9f ~4~- SJie slated the faality did not require doamenletloo lhat lndicateltil what staff had reeeivecHhe lrainiog fer (he AqJamantrs device the PlMi tatedmiddottlle t-aciliy did nof ~~W-~ pfly$1tj~nis tigt sJ-nd Che inbulltervlce training nCnamplliqti9(ls for Iha ~e of the device were localed on the top of the device

The PiM further 4tateqthfl cipe_raling room (OR staff did riotfonow fl~(~_citY1 POliq and ~res regiudiflO safety during Patient As surgical Focedure b)1 not-ensufing the cautery device (Aquamantys) WliS pr~ecfed when not loshyuse

lAe facility pelky Jtnd procedure entitled f ire Prevention ir-i tne Op~riitig R_~o~ ~te~i November 12 2013 Indicated _All staff enl~ring the Perioperallve Prooedurallrjv~lve areas will demonstrate kn9Yiledge of safIY and prevention a Nvrse ManagerChatga Nu~~C~ntca) 11_diKatQr ResponslbiUties 1tdlie2tiori arid dlt-ecllon-pf the eperatlng_s~ff _2 ~nforcemen~ ~f th_e dflpartments fire aafety procedur-ebull

2272017 25152PMEv~t IOBLR1-1

JlagG 7 Df 11State-2567

~FORNIA HEALTH AND HUMAN SEfVl(~~ ~~ENCY PEPAATMENT Of fgtUlIUC HEALTH

()(1) PRQVl~lJPPUERICUA (X2) MULTIPLE CONSTRUCTIONSTJ1flENT OF DEFICIENCIES (X3) ElfTl SURVEY AND PUif OF CORRECTION IDENTIACATION ~flER COMPIElffl

ABtH~itg IIWING050770 OB0612014

STREET AOORESS Clrt STATE21P oooe l~nt~ Lloda Unlverelty Medical Ceriter- Murr-le~

~E01 PROVlllllROff SlJPlU=R

~062 Baxter Rolld llunl~ CA 92amp6_l RIVERSIDE COUNTY

(l(S)

PREFIX lEACH aEFICIENCY MUST BE PREcmicroEDED ev FULL (X4)1D SUMMARY STATEMENT OF llEflCIENCIES P~VIDERS PlAN OF CORRECTION

(lACH CORRECTIVE ACTION SHOULD SE CROSS COMPLETE REFERENCED TO THE APPROPRIAl DEACIENCr) TAG REGUIATORY EgtFHSC JflENTIFYlIQ ~Oru41)T19N) QATE

Tlile pelicy further indicated Can1rollingHeal Sources 1 Ga4fefY A Never place lfle cautery peAcilon the patient Place the centautetymiddotpencR in the protective holster to prevent a~dintar activation ofcauterybull

A review of the manual instrOGtiorts entitled- hj11amantys Syamptem and Bil)Olar Seefers dated January 9 2013- lodkated Precautions Surgery should 1gt41 performed li)y-98f$Onl wllh adequate training andmiddotpreparstioo Plaquo$~el stlolld (Uily 1mderiland the nature ar-id use of RF (radio frequefley-electclcalmiddotcurrent) tJefore pertooningshyelectrosurgical piecedures to avoid itie risks ofmiddot 1hregk and bum hazards to both patJent and ~ratorbull

The middotfacility falled- to irilplemont their ptllfcy and procedure-regarding safety In the operating room and1aHedmiddotto develop and implement a policy and procadure regarding tbe use of a surgical device which was ltie ~l~cl ~W of Patient A iMilainlng a full thickness thermalmiddot bum Iltgt his left calf

This facility failed to preveAt the deliciencyQes) BJ described above ~I cau~eif or Is likery to cause serious 1Juiy c)r dllath Jo the pa~l~ll lirid 11Wef9te constitutes an Immediate jeopardy w)thill the meaning of Health and sarety Cede SecU911 12803(-g)

21272017 25t52PMEvent IOBLFL11

PaQB80f8

Page 8: Statement of Deficiency Loma Linda University Medical Center Document Librar… · Loma Linda University Medical Center Murrieta's Surgical Service and Medical Staff has developed,

~FORNIA HEALTH AND HUMAN SEfVl(~~ ~~ENCY PEPAATMENT Of fgtUlIUC HEALTH

()(1) PRQVl~lJPPUERICUA (X2) MULTIPLE CONSTRUCTIONSTJ1flENT OF DEFICIENCIES (X3) ElfTl SURVEY AND PUif OF CORRECTION IDENTIACATION ~flER COMPIElffl

ABtH~itg IIWING050770 OB0612014

STREET AOORESS Clrt STATE21P oooe l~nt~ Lloda Unlverelty Medical Ceriter- Murr-le~

~E01 PROVlllllROff SlJPlU=R

~062 Baxter Rolld llunl~ CA 92amp6_l RIVERSIDE COUNTY

(l(S)

PREFIX lEACH aEFICIENCY MUST BE PREcmicroEDED ev FULL (X4)1D SUMMARY STATEMENT OF llEflCIENCIES P~VIDERS PlAN OF CORRECTION

(lACH CORRECTIVE ACTION SHOULD SE CROSS COMPLETE REFERENCED TO THE APPROPRIAl DEACIENCr) TAG REGUIATORY EgtFHSC JflENTIFYlIQ ~Oru41)T19N) QATE

Tlile pelicy further indicated Can1rollingHeal Sources 1 Ga4fefY A Never place lfle cautery peAcilon the patient Place the centautetymiddotpencR in the protective holster to prevent a~dintar activation ofcauterybull

A review of the manual instrOGtiorts entitled- hj11amantys Syamptem and Bil)Olar Seefers dated January 9 2013- lodkated Precautions Surgery should 1gt41 performed li)y-98f$Onl wllh adequate training andmiddotpreparstioo Plaquo$~el stlolld (Uily 1mderiland the nature ar-id use of RF (radio frequefley-electclcalmiddotcurrent) tJefore pertooningshyelectrosurgical piecedures to avoid itie risks ofmiddot 1hregk and bum hazards to both patJent and ~ratorbull

The middotfacility falled- to irilplemont their ptllfcy and procedure-regarding safety In the operating room and1aHedmiddotto develop and implement a policy and procadure regarding tbe use of a surgical device which was ltie ~l~cl ~W of Patient A iMilainlng a full thickness thermalmiddot bum Iltgt his left calf

This facility failed to preveAt the deliciencyQes) BJ described above ~I cau~eif or Is likery to cause serious 1Juiy c)r dllath Jo the pa~l~ll lirid 11Wef9te constitutes an Immediate jeopardy w)thill the meaning of Health and sarety Cede SecU911 12803(-g)

21272017 25t52PMEvent IOBLFL11

PaQB80f8