CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
(X1 PROVIOERSlJPPLJEPJCU-6 X2) MULrJPLE CONSTRUCTION (X~)DATESURVEYCOMPLIITSD
STAEMffNT OF IJEflCIENCIES JfN rtFCAllON NUMSEgtlt ANO PLAN Oil CORRFCTlON
A8UILDllG
OWNG050100 12707fa01B
~JNE DF PROVIDER OR FllflfilleuroR ampTRElT fDORiSS CITYstATE 21P CODE
Suttin Modica Center Sacrr1monto
(M)10 SLMMARY $fATEMlITT OFOEF1ClENClES PR VIDERS LAN OF com~lCCI ()lt5)
PIUFIX (liJCH DEJtCIEMCY MUST aE FIRECEriOED BY rutL PRIFIX (EACH CORRG11Vi A0TlDN lH9ULD l CROSSmiddot CQMilElE
TAO 1HiGULAT0PY ClR tSC IIXWTIFlNU tNflORMATIOM) 10 JUF~bNClD lO TMiiAPPROPRIATEO FICJENCY DATE
The following refieols the findings oi lheOepartmant -of Public Health dur1ng an lnspeclion visit
Complaint lnlakc Number Preparation andor executlon of this Pian lcA00574266 CA00570948 Subslantlaled
iRepresenting the Oepartmont of Public Health I of Correction does not cohstiMbulle admlslon or agreement by the provider of the truth of tlle facts alleged or
Survey-or ID II- 2585 Pharmacy Gonsult~nt II i I conclusion set forth In the Statement of
The inspection was lmlted to me speciM facility event Investigated and does not repr$Senl the
I
i Deficiencies This gtIan of Correctio_n has been prepared andor executed solely
1indings of a full lhepectlon o1 tha aciiity llecause it Is requimd by feferal and state laws Healllrnnd Safely Code ampction 12803(9) For purposes of lhls section immediate jeopardt meana a situation In which lhe licen-see1s
noricomplance with one or more requllemenl9 t)f lkensurfJ has caused or is llkety to cause- serious Injury or death to the pallcntmiddot - The corrective action detalls commonce
on page 4 of this 2567
Healll1 and Safety Code 12803 (a) Commencing on ihe effective clilo of the reguaions adopted pursuanl to his section the director rmiy assess an administrative penally i_
against a licensee of a health facility licensed under middot subdivision (a) (b) or (Q of Section 125D for a 1 middotdeficiency con$lltutlng an immediate jeopardy I
volalon as determined by the department up to a maximum of sevanlybulllivc thousand dollars ($75000) for tha first admintslmlive petOlty up to one hundred thousand dollars ($1 ooOOO) for Uie second i subsequenl ad-mioistrative penalty and up to one middot hundred twenty-five lhousand dollars ($125000) for1the third and evey subsequenl violation An
admlnstrilive penally ISSLed after three years from i the dale of the last Issued immedtae feopanJy
lavenilDVR3111 121412018 90420AM
l3-ys1(11lfQ hiamp dOOLIJrlenl I ilm aclmowteclging remiddotcc1ptomiddot1ic eltl[re cilation paekot Paqca 1 hrv 18 J17 IIr Ari dnfiiHmcy statsment ending with anmiddotisensi tbulll danotos ii d~ncia11cy which hf irislllullan may bo 0xcu~ed lrom correGUng provid1no i is dot1onired hat other snfcgJaHfa ptoidu 1lff1chrnt proloittoo lo he pa~nB Elaquo-ap ort1Lrsing horle~ 1he findi01$ aooveare d1sdonable 90 dflys folowi110 IM darn of lUNey whelher or nol i plan of correclknl Is pro-1d-Od Flt1r c1urslnJ homes lfe nhove llrttlings end iiaru of corrocVoii are dlselowble 14 cloys following tho da1e these documents me mmlll evai11bl13 ta the facility Ir deliciQrdG~-o~ crted an approved plan ofcctttClion is req11ialte to conl1r1ued program
p~rllcipalton Pooe middot1 of18
CALIFORNIA HEALTH AND HU MAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STATEM~NT OF DFRClEHCICS (-I PflOVICIERJSUPPUtRICllA pn jULTIPL CONSTRUCTION )(3) ()TE SU~
AND PlAlil OF CORRECTON ID~NTIFIClirtOH ~IUrffi~R CQMPpoundeuroTEm
05010amp A8Ul~DlNG
El ANO -
121072018
$TfUET iODRESS CffY Si Aila 21P CODENAMe or PRoVtOER OR 8UPPER
2025 Cnpitol AVerue S~crar11~nto1 GA tl51gt1G-5616 SACRAMENtO COUNTYSutter M~dlol1I CantJ-t $_atrnmanto
V4110 PRlfrac14FIX
TAG
6UMtARY STATSIENT Of DffClfNCIES (EACH OfFlCIJJ-r1Ct 1ms Bl PRECEEOEO BY PUlL REGUIATORY PR LSC IOENTIFilNtl1t1JFORMATl()N)I
ID
PEfli~ TAG
PROV10RQiAM OF CORRECllO~i (EACH CORRECllV~ ACTION SHOUlP OE C~OlSbull RFFFREr~CED TO fHE APPROPRIATE UE=fJCIENCY)
(Xgt) COMlLfTI
DITE
vlolallon shall be considereo a nrst administrative penalty so long as the facility ha$ not received additional immediate feopardy violations and is found by lhe department to be In suhstrmtiaI
= compliance wilh all ulale and federal licensing laws and regulations The department shall have full discretion to consider au foctors when determining bull lhe amount of an administrative penalty pursuant lo his oecllon
middotHealth and Safety Code 12803 I(g) For the purposes of this section lmmcdiotc middot jeopardy means a situation in whfch lhe ficeneee 1s noncompilan~e with one or more requirements Of bull licensure has calised or is likely to came serlous Injury or dealh to the pallenI
I
I
I
i Heallh and Safety Code 12801 (b For purposes of this seclion adiJersF event includes any of ths following (4 Cara managemenl evenls li1dudi11g lhe following (A) A patient dealh or serious disability ijssociated wlthmiddota medication error lncludlng1 bul not llmiled to
an error involving the wrong drug the wrong dose the wrong patient lhe wrong time the wrong rate the wrong preparnlion or the wrong route of administration excluding reasonabe differences in cllrical judgment on drug selectlon and dose
Faclllty dotected the AE on 8ZBt 7 Facility notified tho AE to the Deportment on 125I18 1 Fadllly notified the patlentresponslbfe part on 829117
Event IDVRSlt 1 121142018 90420M
Page 2of 18 $111e-25S7
CILIFORNI HEALTH ANO HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HSAlTH
Xl) tROVJDERISUPPLlaRfCUAllTTlMENT OF DEFlClJlCtCS IOE~lIFlCATlON HUUElCR
050108
ANOtgtLANar CORf~-ECrtON
(X2) MU~ lrPll COHSTRUCflON (X3) IJAlE SURVFV CQMPllITED
A BUILOiNQ
BIMNG 1210712018
Si~leT ADORlfO CllYSiATE 2IP COD6NAMe or fROVD~R OR SUPllER 2825 Citpltol Alt-1uouo1 Siicramontomiddot CA 95818-5616 SAQllAMEN10 COUNTYSutter Medical Cantor Sacmmenta
PROVIOERG PLAtf OF CMRECTION [XS)tX4) O SUMMARY amTIMNr OF DEFICIINCleuro5 ID IrmaFtx (MCH CORRlCTIVI ncnolI SHOULD Bf c-imrn GOMPT1C
fAG RtGUlA10RY on ESC IDENnFYINO INFORMATION) rw HEHRENC~O TOTUC IPPROPRrAtE DEFICENCY OAre PREJIX (EACH IJFFICIENCY MWil BE PRlCl I0 lY Fllll
I I I
Adverse Event NotlficaUon Informed I
Health and Safety Code Section 12791 (c The facility shall inform the pallenl or tho party responsible for the patient of the adverse event by I the time th~ report Is rnade 11
I The GOPH verified that lhe facllty informed the
1patlent or 1he party responsible for lhe patient of the I I
[ adverse event oy the time the report was mde
I T22 OIVo CH1 ART3 70263 Pharmaceutlcol
I ServicesGeneral Requirements
[c) A pharmacy and 1herapeutlcs cornmilae or a committee QI equivalent composition shall be
I est~bHshed The committee shall co~ss1 of at least one physician one pharmacist the director of nursing service or her representative and lhe admlnls1rat Imiddot er hls reprnsentative
I1) The committee shall develop writen policies and I procedures for eslablishmrnt of sale and effeciive I systems for pmc11rement slorage dislriQUtion
dispensing and llsa of drugs and chernlcals The I pharmaclit in consultation with other appropriale Iihealth professionals and administrallon shall be responsible foe the develaprnenl and implementations of praccdurt)s Policies shaH be approved by lhe governing bltXiy Procedurns hall be approved by lhe administration and medical staff i where ~uch is appropriate I T22 DIV5 CH1 ART3 70263 Pharmaceutical I Services General RequiremerttG
i (g) No dnigs shall be administerAd exc9pl by
licensed personnel authorized lo admlnlsler dnigs
12142018 9D420AMEvent 10VRSll 1
Page 3 of ts Stals-2007
CALIFORNIA HEALTH ANO HUMAN SeRICES AGENCY DEPARTMENT OF PUSLIC HEALTH
(X2) MUlllPL~ COI-JSmUcT10N XJ) rJJlE SURVEYXI) fROVIDWJSUPP~GRICLIAIOENTlFJCAlIOt-1 MUMOER
-middotoso1os -
SiAT~MNT Of CEFICIENCllSmiddot COMfLElEOAND PLAN Or CORRECTION
A 6UILDlNG
o~middotw1Nu 12072018
StREET (J)00c3S crrv STAll Zif CODE
Sutter Medical Cfilnter sacrame11to NAME OfPiWV10ROR SIJPPUR
2625 Capitol Avenui Sacramtlnto1 CA 9581SM5616 SACRAMENiO COUNTY
X4)10 1middot-middot---======~------1------------------l1 SUMMARY StAlEMGNT OF OEfCteNCIGS 1 PROVlDERl flPN OF CORREdTlOH ilti) PfIEPIX (EACH OfFlCRNCY t1UST BE PAl(ipound0Hl EIY FlJll I P~lli 1middot ~- bullri0i-~~)bull1d lCfJ SHOULD aECit0$S COWHtiC
TAG fl[GULATORVORLSCIOtrnn~YJNGlllFORMATION) rrG middotbullmiddot 1APPACPRIAiDCFlmiddotIEHOr) DMe
i-------------------------________ middotmiddot-I l
I and _upon the ordet DI a person lawlully authorized to I Medication safety related to the use of the IV prescribe or furnish This shall not preclude the middot pumps Is continuous and ongoing and is
bulladministration of aerosol drugs by respiriitory accompllshed through an lnterdiscipBnary therap1sts The order shall Include the name or lhe approach Each discipline adding a layer of drug the dosage and the frequency of protection and or mitigation through defined ldmi111slratfau the route of administration if other workfloW processes Each layer ls designed to than oral and the dale lime and signature of the prescriber or furnisher Orders lot drugs should be written or transmitted by the presctiber or fumlsher I
Verbal otders for drugs shall be given only by a person lawfulJy authorized to pceocrlbo or furnish and shall be recorded promptly In tho patients medical record nottng the name of lhe person givng tho verbal order and tha signature of lhe lndMdualIreceiving the order The prescriber or furnisher shall
middotcountersign ha order within 48 hours (2) Medications and treatments shall ba
administered as ordered
During a Fedecal Complaint Validallon Survey conducied by (lie Deparlrnenl i24HJ thf-oiigh 128118 on adverse event was reported by lhe facility on 112518 and invesligated el thal lime
(lnlake number CA00570S4B) On 216118 a middot consumer complaint regarding the some lnclden1 middot wae received by the Department and was middot invcsligeled concL1rrentty (CA00574265)
The Demicroartmenlbulldetermined the facllily failed to ad1Y1tnislar madicatiot1s as prascribed by the physician and In accordance wilh facility policy_
reduce the likelihood of patient harm from an unintended IV medication administration event
Ealth discipline is an ad- hoc member of the Medication Safety Committee The Medication Safety Committee coordinates revews and responds to IV putnp issues The committee
review of indMdual events and or trends provide for the development of action plans as I needed Review of audits and the subsequent strategies are designed to reduce the potentla for future pump malfunctions which may result In an unintended medication administration The i committee meets quarterly Actions detailed ln this sccticn are ongoing
l(ey oles and responsibitlties
pharmacy accmJlltable-Pharmacy Director)
Pharmacy reviews and reports a11 medication relateq safety events which lncludes IV pump Issues Thmiddote review determines If an incident associated with an IV medication administration has potentially occurred or tf any Incident may have reached the patent SMCS continues to
middotThe facility failed to ei10ure that revlew and compare the alarm alertreport to
i1) The factl[ty policy and procedure for Ma11agernenl any reported pump Issues und or medication
i of High Alert Medications was developed and events I
12JW2U1B 9o0420AMEvent IDVRSl1 l
State-2567
CALIFORNIA HEAL7H AND HUMAN SEHVICES AGEHCY DEPARTMENT OF PUBLIC HEALTH
STAIEMENT OF DruCliJJCOS x1) PAOVIDEWSUPPLl~RCLIA X) MULTIPIE CONSTRUCTION ((~) FJATE SURVEY
ANO flLJJq DF CORRECl10N lDENllFICATION NUMEtf(middot COMPtllO
AllUtLDrNC3
aso1oa SWING 121072018
ilAME OF PROVfDR OR StlfPUER SWIHrflOOHms CITY STATE lP COOi
SultGr Mndi~I CGnh1t1 Sacramonto 2025 Capitol Avem1~ Sairamoneo CA 9Sa1(~SM6 SACRAMBlliO COUNTY
)(4)11) BUMMRi SlArEMCITT OF DFICiENCIES 10 PROVIDERS Pl11-l Ofl CORREOlON (lt5)
P~EFX (12ACH OlFCIENCY MUST flE PRECEEDEO av iuLL PRfHX (~ACH cORBECTIVE ACTION ~HDVLO ee CROSS- COMJLlTE tAG REPEREMCEP Ttl THE AilPR PRIArE 0euroFICJENCY1 OAflTAG RGULATORY OR LSC 108Nrl~YtIIG 1NFORMATl0N)
1----+------------------+---~~-------middotmiddot-Sio med staff~ accountable -Bto Med Director)
implemented to ensure safe adminisVation practlca 61 medlctlons tdentlfiM wilh high potential for Bio Med reports on pump maintenance devaslatlng consequences If an error occurs and evaluations andvolume of Issues resolved and
2) Medlcelions were administered per physician or number of pumps removed from servtce middotorder when Patfanl 3 wa)i adrnntstered 50 mllllgram (mg) of IV (inlravenoosly ln)ecled Uirough Sterile Processing Departrnent (SPO
i lhe vein) morphine a potent nareolic for part) over (Accountable -SPD Manager)Ione and a half hours Instead of the preoribed 1 mg per hour SPD reports on dlslnfectlon processes and
pump lflegrity escalations to Bio Med AH IV The medloalion ortor exposed Patient a to effects of pumps are sent to SPD for deaning and middot morphine overdose (166 times he precrtbed dose) disinfection including low blood pressure and subsequent death
RN staff (Accountable Chief N~rsingIFioding Director)
Review of PaUent Ds ci11ica[ record indicated he Nursing representation revlews and reports
middot was admitted to the facility on 8111117 for acule on documentation audits and concurrent
cespirnloiy failure (Inability of the lungs to maintain ntervlew audits for v1sual inspection rate n_orrnal respiratory functfon) P~Oant 3 n~ed0d high verification and volume llrnitlng chambers flow oxygen lnto lhe nose tn ensure oxygen delivery Actionsto blood and organs
I Actions taken to ensure that corrective actions i Review of Patient 3s physician orders dated
were effectivemiddot 827117 at345 pm Indicated morphine 250 mg in NaCl 09 [saline solullon] 250 ml [rnillillter) IV Drip The hospital developed corrective- actions [pronixed in tile pharmacy] CONTINUOUS
trorn the an~lyss of events1 informationconfinuousty lt1dminlstored ot the specified ral~l
obtained from the manufacturer exter-nal middot Initial dose 1 mghour [1mllhr (hour) is equal to 1 sources and subsequent internal Investigationmg of morphinehr] findings Interventions deslgned to prevent IV pump medication errors Including free flow Revlew of Patient 3s MAR (medicetion
admlnislratlon record) ndicaled the n~orphlne drip events have been added ta medication management pollltles procedures was started on 827117 at 854 pnt and slopped at
[902 prn (S minutes later)
12142018 90420MEve-nl IDVRSlI 1
Paso 5of rn Stote~2567
CALIFORNIA HEALH AND HUMAN SERVICES AGEHGY DEPARTMENT OF PUBLIC HlAJTH
STAffeM~NT 01 dfflCJENCJES ANO PlAM or CORReCTION
NMtE OF PROVIOlR OR 51JPfgtllER
(XU PROV[iRISUPlgtUERICLII (X2) MIJTJPle CONsrnucnm1 IOENltPICATION ilJMBlH
A tlUILOING
D5ofoa - e w~Q
STREET ffiDRESS (IT( $TiT ZIP CODG
X3f DAT~ SURJEV COMfl~tlO
12072018
Suitor Medical Glfrac14ntor Sacramento 2825 C~pitol Avenue Sacrnmonto CA Sml1GSG10 SACRPiMENiO COLINrr
-(X4) D SUMMIRY STATE MtNT OF OlFCIEIICES JOPREFIX EACH OEFJCll1fJCV MUST BE PRlC161)i llY FULL PREF(
TAO REGUcATOt(V OR ISC 10GHill1ilNG NFOFIMA110t~)
[ Review of Patient 3s nursing notes dated 6127117 bullindicated -At 902 pm pt [pa~enl) wih deocease In RR [respiratory rateJ oxygen saturalion down to 70s
Morphine gtt [drip Infusion tumed oft
bull At 906 pm EICU (Eleclronic Intensive Care Uni] called no rall back from PMA [Pulmonary iMedicine Altendin~] pt with sz [seizure- sudden I uncontrolled electrical diolurbance In themiddot brain] middot activity lasting about 25- secondsmiddot bull At 907 pm Dr returned page Updated on siwaian New order received lo start on BIPAP middot [bl-level posillve airway pressure is a type of device that helps with breathing] bull At 927 pm Dra bedside Discussing situation 1w1thwie l middot At 950 pm Decision made by wifewith Dr middot present lo transition to comfort care care directed al preventing or relieving suffering at end or llfeJ
During an interview on 126118 al 258 pm RN 6 middot verified Iha shorlly aner the morphine drip was lnitialed on 82717 Patient 31s respirat13ry rale and bulloxygen saturation dropped RN 6 slated he had stepped the morphine and called Resplralory
Therapy and the MD Mediltlel OoclorJ
Review of Potlent 3s physician orders dated 8127117 at 1052 prn lndlcalcd morphine 250 mg in NaCl 09 250 ml IV Drip CONTINUOUSdose 1mghour
Patient 3s MAR for 812717 Indicated the morphine drip was restarted at 11 59 pm with a comment In
PROVIDERS PLAN Of cortReCTION
IEIICH CORMCTIV~NntON StWUID BE CROSS-PlFERENCEO TOlHE APPROPRIATE DEFICJENCi)
i Bio med staff~ laccountab1e -Bic Med Director)
Education - BloMed (eQuip)
All staff demonstrate competency for diagnostic Inspection and repair per manufacturer guidelines Completed 318 100 of IV pumps were Inspected and tested per manufacturers recomrnendatlon Pump manufacturer blo techs remained n site and assisted wlth the revlew1 until completed All preventative maintenance and repairs are documented in our computerized maintenance middotmanagement system (CMMS) Bia-med comp1ete_sa scheduled at least annuaHy preventatlve maintenance inspection on all pump lnfwon pumps utilizing the Pump System Maintenance software At the completion of the inspection a sticker is placed on the device 1ndlcating date of current lnspectlon date of ~ext Inspection and name of Inspector Any IV pump that does not pass its scheduled
ix
I CO1IPlalE
OAlE
inspection per manufacturer-guidelinessoftware or is ldentlfled by frontline staff or pharmacy through medication safety reporting ls tagged sequestered from dincal areas and steps will be takeh by Bto-med If there ls a repeated failure of the same type during the preventative maintenance inspection window not to exceed one year) the pump Is referred to Risk Management for further action
Actions detaled in this section are ongoing
Evenl IDVRSlmiddot1 middotI 12~42018
Page 6 of 18 Stsle-2567
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PU6LIC HEALTH
STA1EMEITT OF OEFIClCNcms (X1 I PROVIDERISVPPLIERfClA (Y2J MULTPL6 COMTRUCTON (X3) DATE SURVE IDENTFICiATON NUitU3RANO PLAH OF CORRECTION CoMrLIHEO
A-BUllOiOO
8 MNG05010_ 121071203
~fN1E OF lROVOlR OR SJPftJiR STltEET gtDOR~SS ClT(STATI iIP cooEc 61tlier Med(car Center s~cr-dffiento ~025 Capitol Avenue- Saoramonto1 CA 95116$616 SAC~A~ENTO COUNTY
(x-1)0 SUMMARY 81ATEMENT OF DEMCIENCl~S 10 flRQVIOliRS PlAlf OF COR~ECTIOH lltS) PRPFIX (EA~H DFICfENCY Ul5T BE PRtClEtJED BY FlILL PREHlt iACl1 C MlCTlVEACTION SHOULD 01 CftOSSmiddot COMPLeTE
TA~ fte0ULA10Rl OR LSC 1J5fITJFYIMG INFORMATION TAO
nurse1s noteamp 11Pt now on comfort middotcare wJfe ready for morphJnato stait Patient 3s morphine drip
was stopped on 82817 al 125 am (1 hour 26 mlnule8 taler and a subsoquent nurses notes
Indicated middotbullgtt stopped pump wllhoul any alarms bag empty
middot Review of nurses notes daled 8128117 at 125 a111 indicated Upon checking lV pump noticed morphlna gll was completely empty withIV tubing full of air IV pump still running with green light pteSent no alarms present lV states volume
-infused bull15 ml Morphine gll turned oft charge RN (Registered Nuroe] on unit and nofi1ied [charge RN] checllted pump correclly set wllh lubing fully Inserted into channol correctlyBP [blood pressure) 8552 [normal blood pressure for a healthy adJlt Is 12080]
bullReview of e document titied Default Flowsheet Data middot in Palienl ls clinical recorti nvt~d b(ooU prassum from 3 am to (l am on 81017 ranged from 8148
to 69IS7 A nurses nole dated 828117 at 357 am indicated a Ould bolus wabull ordered to support blood
pressure
Morphine carries a black box warning which Is the Strongestwai-ning the United stated Food and 0mg Administration (US FDA) can require a manufacturer to pul on the drug label Part of the bloclt bogt
warning indlmlted LlfoffThreotening- Respiratory Deproaslon-Serious life-threatening or falal
middot respiratory clep(G$Slon may occur with middotuse of Morphine sulfate lnjacton Monitor for respiratory _depres$iOn1 e~pecially during lnitalion of Morphine
I 1middot I I i
I
I I i I I
I
bull I
I I I
I I
AEFEREiNC~D TO THEAPPROPRIATI= JEFCeNCV) AIE_____- Pharmacy accountable Pharmacy Director)
middotPharmacy reviews all medication related safety lssues and determines whether a posslble errorln IV medication admlnlstratlon has occurred1 or lf any error reached the patient
1818-32918 pump evaluation process Pharmacy dally report CUI) of flow events greater than 300 seconds oo 100 of infusion pumps
Those devices with flow events greater than 300 seconds were remiddotparted to the Nursing Department and BioMed removed from
patient use tagged and referred to BloMed (eQulp for diagnostic inspection
bull Dally reports run from 1282018 to 3282018 yielded 43 flow alarm events Upun Uiag11ostic insmicroectiqri and event investigation no free-flow of fluids occurred
Current process -Manufacturer Alarms Analytic Reports CQI) are compared to Medication Administration reports and the summary is reported to the Medlcation Safety Committee
Sterile Processing Department (SP
(Accountable-SP Manager)
All IV pumps are to be sent to SPD for ltleaning and dlsnfection SPD staff were educated in March 2018 reflectlng manufacturer
Evan IDVRSl11 121412018 9 recommendations StJff were also provided--------middot-----middotmiddotmiddot--------------- a checklist to assist in visual screening of tV
Paoo 7or 18 Sllaquota-2567
CIUFORNIA HEILTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
X-3j DA1~ SURV~Y(llt1) PROVID[JSUPPlHJRCLIA ()12) MULllfLE CONSinUCTIONSTATlMENT OP 01FtCICrlCIES COMPLElEO10euroNT1ElCAflON NUMelRANO PVN OF CORRECTION
ABlJlDING
ll MNGQS0108 12m1r201s
s-rtuer AODfi~Sa CITY STATEZlf CODINAMi o PR011DEROR SUPP-IER
2625 Capitol Av1mu1r Sliclamonto middotCA ~a1e-se1s SAC~AMfNTO COUNTYSutter Medical Centrr1 Sacramonto
volutrol) will be use_d on cert-a1n high
(X~)IPmiddot SUMMARr $1ATEMCNT OF DtFICllNCIES I 10 PROVIOE~$middotPWI o= COMliCTIQr1 1lt5
PREFIX TAO
1 (MCH DEFICIENCY MUST BF PRftEiOED OY FULL RtGULATbRY Oflt LSCIOENtlFYINO mFORMAflON)
ifUFIX
rw (EACH tDAREcnVEACTION SHOUW ae (ROSSshy
REF-ER-1-mo ro iHf PPPROP~IATE oertCIENCY) COMPLEtl
OAH
pumps for potential flaw which may lead to an IV pump failure All staff demonstrated
Sulfale Injection or foHowhg a dose increase competency on the cleaning and vlsual Becaubulls of delay in maximum CNS eflect wilh I
in1ravenou~ly administered morphine (30 min) rapid inspection of lnfusion pumps
IV administration may result In overdosing The March 2018 Trainllig will continue on new
information for morphine under warnings indical~d hire and annually thereafter Hypotensiva [low blood pressure Effeclmay lnltlal training completed March 2018
cause severe hypotenslor In Eln ndividu11l wlmse ability to maintain their blood pressure has beenI Actions detaled In this section are ongoing
I compromised by depleted blood volumeMorphine must be Injected slowly rapid Intravenous RN staff f Accountable -Chief Nursing
administration rnay result in chest wall Director
rigidity lncreased Risk of Seizures in Patients wtth Staff have been educated to perform vlsual
Seiiure Disordera EltcitaHon of the central nervous inspection of pumps screening for cracks and
system resulling in convulsions [seizure activity] pump Integrity prior to use Any pumps
i may accompany high doses of morphine given identified with Issues whlch may increase the irlrnvenou$ly 1
bull risk for medication administration errors are
(Retrieved rom removed from service and sent to blo med for httpslldaitymedntrnnihgovdally111eltldruglnfoclrn diagnostic testing EdUCi3tlon was provided In aetidbull5b96eB3a-d878-4dd5-8460-83a985db4609 bull 2017 and again in 2018 and was reinforced
1official provider of FDA lnforrnatrcn [package
IInserts])
during observation audlts detaBed in following action (112)
1Review of Patient 3s vit signs (11tood pressure heart rate elc) indicated that 111s MAP (mean or 2 The High Risk Medication Policy was
middot avera-ge arterial blood pressure during a single revised Revision Include
ca1middotdlac cycle MAP of at least 60 is necessal) lo perfuse the coronary arteries that supply blood to middot the middotheart brain ancl kidneys norroal range le ~pproximatcily 70 ~ 110) was ~bove 60 before the
Smtirt pumps are to be used on all cqntinuous infusions of high lt1lert med1catlon A volume ilmitlngchamber
middot morphine infusion was sarted on 8127117 at 11 59 alert medications administered by
middot prn Review of Patient 3s MAP after the morptlne continuous 1V Infusion through the
drip was stoppcI on 82B17 al 1 25 am indiooleltI large volume pump (LVP) module per lhat it lad dmpped lo 57 al aam Review of Patient
policy3S physician orders dated 8128117 at 4 15 am When a volume limiting ch[lmber is indicated IV Dopamine (used 10 treat low blood lndlc_ated a two~hourvolume wlll be pressure 0~10 microgramkllogrsrnmlnute lo be added to the chamber Use of the
volume limittngchamber will be 12142018
Verifyon the MAR and volutrol In the comment box
EvcnlDVRSl11 documented every shft with ~Rate
Slnte-2557
CAUFOlNIA HFALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STtT~MEMT 01 d-1Cl~NCIES (Y PROVtOtRISUPPLl8RCtb (X2) MIJLrlPLE CONSTRUCTION (lt3) DATE SURVEiV AND flA~I Oi CORRECTION IDlUtfFC110N NUMBER COMfgtl[lYEO
A OlJflD1NG
050100 H WING 12107201$
NPME OF PROVJOSR Oil SUPPLIER SmEar ADDRESS CITY 9TATEZIP CODE
6utwr Medlc1atl Oentor1 Saotamonto 282S CiJpitO VQnun1Sutamcmtltgt CA 95816bullS616 SACRAMENTO COUNTY
X~ rLl PfitPlr
1AO
SUMMRY STATEMENT OF OlF1CllNC1es (ECl-1 OEf1CIENCf MUST nE PRECEeom Blt FUL 1u0ulATORYOR lSC DlNTIFYJNG l~fCJRMTlON)
titrated every 10 rnltmles far a 0081 of MAP between 60 and 65
IReview of physi9ian notes dated B28117 al 350 am indicated RN called to report 250 mg bag of morphine poeslbly given to tho patient over one haurMay use BIPAP to support breathing
Review of-the Palent 1bull Completed Medication Record Indicate( that Dopamine was started al 444 am on 8128117 for MAP less than 60
IReview of nurses ncles dale~ 828ffal 555 am lndica1ad 1New orders received ta $lop pressors middot [dopamine] anti remove BIPAP Nurses nbte dated 8128117 at 612 am indicated BIPAP removed
On 828117 al 633-am Patiertl 3 was pronounced dead The ciniral record indicated there were no orders lab res11Jls ot btood draws lo meijsure rno1microhine loXlcHy levels fonowing lhe ldenliUcaion of
the empty morphine bag Patient 3s discharge 1summe~ summary of U1e major treatments andIevents while hospilolited) doled 62B117 al 668 l am did not-address morphinG odministration
The above findingbull were aclltnowledgad by the iADHO (Mministrative Director of Hospital bullOperations) during lnle111lews on middotf24118 at 920 am and on i26118 at 15middot1 pm and with RN 8 on 112618 ot 10 am
middot During t1n inlervlew cm 12Rf18 at 258 p m bull RN 6 staled tlial on 812717 he started Patient 3bull
morphine infusion (11 69 pm per MAR) wilh tle
ID PR~F1X rG
PfJOYDEtS NAN Of COARlCTION x~
llACtt CDRRECTIW ACTlON SHOUlD ae CROSSshy COMPL~TC REFERENCEO TO fl-I AfPROfRIAT OlfCIENCf) OAre
In the event that a volume limftlng chamber Is n6t uvailabte for in indicated hgh alert medication st-aff wlll documentRate Verify (as defined in the Medication Administration policy) on the MAR every2 hours Independent double-checks The SMCS list of medications requiring an independent double-check may not match the EHR list for dual signature rnedications Alternative documentation may be employed so that SMCS staff can align their documentation with the SMCS standard (eg add a co-sign with a note lri MAR use 11given not co-signed option when a co-signature ts not required
3 The Medication Administration Policy was revised Revision Include Use of the LV Pump
i Choose the appropriate age- weght- andor unlt--1nsud prmiddotorne when starting the Infusion pump
b Enter the patients M edcal Record Number (MRN) when asked for Patient ID
t The Guardrails drug lbrary rs to be used for all medications unless the particular- drug does not exist in the library
d Only those medkations with the bolus feijture built Into the pump for that drug may be bolused from the pump
1211412016Even IDVRSlI I
Page Oo 18 Sate2587
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HEALTH AND HU MAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STATEM~NT OF DFRClEHCICS (-I PflOVICIERJSUPPUtRICllA pn jULTIPL CONSTRUCTION )(3) ()TE SU~
AND PlAlil OF CORRECTON ID~NTIFIClirtOH ~IUrffi~R CQMPpoundeuroTEm
05010amp A8Ul~DlNG
El ANO -
121072018
$TfUET iODRESS CffY Si Aila 21P CODENAMe or PRoVtOER OR 8UPPER
2025 Cnpitol AVerue S~crar11~nto1 GA tl51gt1G-5616 SACRAMENtO COUNTYSutter M~dlol1I CantJ-t $_atrnmanto
V4110 PRlfrac14FIX
TAG
6UMtARY STATSIENT Of DffClfNCIES (EACH OfFlCIJJ-r1Ct 1ms Bl PRECEEOEO BY PUlL REGUIATORY PR LSC IOENTIFilNtl1t1JFORMATl()N)I
ID
PEfli~ TAG
PROV10RQiAM OF CORRECllO~i (EACH CORRECllV~ ACTION SHOUlP OE C~OlSbull RFFFREr~CED TO fHE APPROPRIATE UE=fJCIENCY)
(Xgt) COMlLfTI
DITE
vlolallon shall be considereo a nrst administrative penalty so long as the facility ha$ not received additional immediate feopardy violations and is found by lhe department to be In suhstrmtiaI
= compliance wilh all ulale and federal licensing laws and regulations The department shall have full discretion to consider au foctors when determining bull lhe amount of an administrative penalty pursuant lo his oecllon
middotHealth and Safety Code 12803 I(g) For the purposes of this section lmmcdiotc middot jeopardy means a situation in whfch lhe ficeneee 1s noncompilan~e with one or more requirements Of bull licensure has calised or is likely to came serlous Injury or dealh to the pallenI
I
I
I
i Heallh and Safety Code 12801 (b For purposes of this seclion adiJersF event includes any of ths following (4 Cara managemenl evenls li1dudi11g lhe following (A) A patient dealh or serious disability ijssociated wlthmiddota medication error lncludlng1 bul not llmiled to
an error involving the wrong drug the wrong dose the wrong patient lhe wrong time the wrong rate the wrong preparnlion or the wrong route of administration excluding reasonabe differences in cllrical judgment on drug selectlon and dose
Faclllty dotected the AE on 8ZBt 7 Facility notified tho AE to the Deportment on 125I18 1 Fadllly notified the patlentresponslbfe part on 829117
Event IDVRSlt 1 121142018 90420M
Page 2of 18 $111e-25S7
CILIFORNI HEALTH ANO HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HSAlTH
Xl) tROVJDERISUPPLlaRfCUAllTTlMENT OF DEFlClJlCtCS IOE~lIFlCATlON HUUElCR
050108
ANOtgtLANar CORf~-ECrtON
(X2) MU~ lrPll COHSTRUCflON (X3) IJAlE SURVFV CQMPllITED
A BUILOiNQ
BIMNG 1210712018
Si~leT ADORlfO CllYSiATE 2IP COD6NAMe or fROVD~R OR SUPllER 2825 Citpltol Alt-1uouo1 Siicramontomiddot CA 95818-5616 SAQllAMEN10 COUNTYSutter Medical Cantor Sacmmenta
PROVIOERG PLAtf OF CMRECTION [XS)tX4) O SUMMARY amTIMNr OF DEFICIINCleuro5 ID IrmaFtx (MCH CORRlCTIVI ncnolI SHOULD Bf c-imrn GOMPT1C
fAG RtGUlA10RY on ESC IDENnFYINO INFORMATION) rw HEHRENC~O TOTUC IPPROPRrAtE DEFICENCY OAre PREJIX (EACH IJFFICIENCY MWil BE PRlCl I0 lY Fllll
I I I
Adverse Event NotlficaUon Informed I
Health and Safety Code Section 12791 (c The facility shall inform the pallenl or tho party responsible for the patient of the adverse event by I the time th~ report Is rnade 11
I The GOPH verified that lhe facllty informed the
1patlent or 1he party responsible for lhe patient of the I I
[ adverse event oy the time the report was mde
I T22 OIVo CH1 ART3 70263 Pharmaceutlcol
I ServicesGeneral Requirements
[c) A pharmacy and 1herapeutlcs cornmilae or a committee QI equivalent composition shall be
I est~bHshed The committee shall co~ss1 of at least one physician one pharmacist the director of nursing service or her representative and lhe admlnls1rat Imiddot er hls reprnsentative
I1) The committee shall develop writen policies and I procedures for eslablishmrnt of sale and effeciive I systems for pmc11rement slorage dislriQUtion
dispensing and llsa of drugs and chernlcals The I pharmaclit in consultation with other appropriale Iihealth professionals and administrallon shall be responsible foe the develaprnenl and implementations of praccdurt)s Policies shaH be approved by lhe governing bltXiy Procedurns hall be approved by lhe administration and medical staff i where ~uch is appropriate I T22 DIV5 CH1 ART3 70263 Pharmaceutical I Services General RequiremerttG
i (g) No dnigs shall be administerAd exc9pl by
licensed personnel authorized lo admlnlsler dnigs
12142018 9D420AMEvent 10VRSll 1
Page 3 of ts Stals-2007
CALIFORNIA HEALTH ANO HUMAN SeRICES AGENCY DEPARTMENT OF PUSLIC HEALTH
(X2) MUlllPL~ COI-JSmUcT10N XJ) rJJlE SURVEYXI) fROVIDWJSUPP~GRICLIAIOENTlFJCAlIOt-1 MUMOER
-middotoso1os -
SiAT~MNT Of CEFICIENCllSmiddot COMfLElEOAND PLAN Or CORRECTION
A 6UILDlNG
o~middotw1Nu 12072018
StREET (J)00c3S crrv STAll Zif CODE
Sutter Medical Cfilnter sacrame11to NAME OfPiWV10ROR SIJPPUR
2625 Capitol Avenui Sacramtlnto1 CA 9581SM5616 SACRAMENiO COUNTY
X4)10 1middot-middot---======~------1------------------l1 SUMMARY StAlEMGNT OF OEfCteNCIGS 1 PROVlDERl flPN OF CORREdTlOH ilti) PfIEPIX (EACH OfFlCRNCY t1UST BE PAl(ipound0Hl EIY FlJll I P~lli 1middot ~- bullri0i-~~)bull1d lCfJ SHOULD aECit0$S COWHtiC
TAG fl[GULATORVORLSCIOtrnn~YJNGlllFORMATION) rrG middotbullmiddot 1APPACPRIAiDCFlmiddotIEHOr) DMe
i-------------------------________ middotmiddot-I l
I and _upon the ordet DI a person lawlully authorized to I Medication safety related to the use of the IV prescribe or furnish This shall not preclude the middot pumps Is continuous and ongoing and is
bulladministration of aerosol drugs by respiriitory accompllshed through an lnterdiscipBnary therap1sts The order shall Include the name or lhe approach Each discipline adding a layer of drug the dosage and the frequency of protection and or mitigation through defined ldmi111slratfau the route of administration if other workfloW processes Each layer ls designed to than oral and the dale lime and signature of the prescriber or furnisher Orders lot drugs should be written or transmitted by the presctiber or fumlsher I
Verbal otders for drugs shall be given only by a person lawfulJy authorized to pceocrlbo or furnish and shall be recorded promptly In tho patients medical record nottng the name of lhe person givng tho verbal order and tha signature of lhe lndMdualIreceiving the order The prescriber or furnisher shall
middotcountersign ha order within 48 hours (2) Medications and treatments shall ba
administered as ordered
During a Fedecal Complaint Validallon Survey conducied by (lie Deparlrnenl i24HJ thf-oiigh 128118 on adverse event was reported by lhe facility on 112518 and invesligated el thal lime
(lnlake number CA00570S4B) On 216118 a middot consumer complaint regarding the some lnclden1 middot wae received by the Department and was middot invcsligeled concL1rrentty (CA00574265)
The Demicroartmenlbulldetermined the facllily failed to ad1Y1tnislar madicatiot1s as prascribed by the physician and In accordance wilh facility policy_
reduce the likelihood of patient harm from an unintended IV medication administration event
Ealth discipline is an ad- hoc member of the Medication Safety Committee The Medication Safety Committee coordinates revews and responds to IV putnp issues The committee
review of indMdual events and or trends provide for the development of action plans as I needed Review of audits and the subsequent strategies are designed to reduce the potentla for future pump malfunctions which may result In an unintended medication administration The i committee meets quarterly Actions detailed ln this sccticn are ongoing
l(ey oles and responsibitlties
pharmacy accmJlltable-Pharmacy Director)
Pharmacy reviews and reports a11 medication relateq safety events which lncludes IV pump Issues Thmiddote review determines If an incident associated with an IV medication administration has potentially occurred or tf any Incident may have reached the patent SMCS continues to
middotThe facility failed to ei10ure that revlew and compare the alarm alertreport to
i1) The factl[ty policy and procedure for Ma11agernenl any reported pump Issues und or medication
i of High Alert Medications was developed and events I
12JW2U1B 9o0420AMEvent IDVRSl1 l
State-2567
CALIFORNIA HEAL7H AND HUMAN SEHVICES AGEHCY DEPARTMENT OF PUBLIC HEALTH
STAIEMENT OF DruCliJJCOS x1) PAOVIDEWSUPPLl~RCLIA X) MULTIPIE CONSTRUCTION ((~) FJATE SURVEY
ANO flLJJq DF CORRECl10N lDENllFICATION NUMEtf(middot COMPtllO
AllUtLDrNC3
aso1oa SWING 121072018
ilAME OF PROVfDR OR StlfPUER SWIHrflOOHms CITY STATE lP COOi
SultGr Mndi~I CGnh1t1 Sacramonto 2025 Capitol Avem1~ Sairamoneo CA 9Sa1(~SM6 SACRAMBlliO COUNTY
)(4)11) BUMMRi SlArEMCITT OF DFICiENCIES 10 PROVIDERS Pl11-l Ofl CORREOlON (lt5)
P~EFX (12ACH OlFCIENCY MUST flE PRECEEDEO av iuLL PRfHX (~ACH cORBECTIVE ACTION ~HDVLO ee CROSS- COMJLlTE tAG REPEREMCEP Ttl THE AilPR PRIArE 0euroFICJENCY1 OAflTAG RGULATORY OR LSC 108Nrl~YtIIG 1NFORMATl0N)
1----+------------------+---~~-------middotmiddot-Sio med staff~ accountable -Bto Med Director)
implemented to ensure safe adminisVation practlca 61 medlctlons tdentlfiM wilh high potential for Bio Med reports on pump maintenance devaslatlng consequences If an error occurs and evaluations andvolume of Issues resolved and
2) Medlcelions were administered per physician or number of pumps removed from servtce middotorder when Patfanl 3 wa)i adrnntstered 50 mllllgram (mg) of IV (inlravenoosly ln)ecled Uirough Sterile Processing Departrnent (SPO
i lhe vein) morphine a potent nareolic for part) over (Accountable -SPD Manager)Ione and a half hours Instead of the preoribed 1 mg per hour SPD reports on dlslnfectlon processes and
pump lflegrity escalations to Bio Med AH IV The medloalion ortor exposed Patient a to effects of pumps are sent to SPD for deaning and middot morphine overdose (166 times he precrtbed dose) disinfection including low blood pressure and subsequent death
RN staff (Accountable Chief N~rsingIFioding Director)
Review of PaUent Ds ci11ica[ record indicated he Nursing representation revlews and reports
middot was admitted to the facility on 8111117 for acule on documentation audits and concurrent
cespirnloiy failure (Inability of the lungs to maintain ntervlew audits for v1sual inspection rate n_orrnal respiratory functfon) P~Oant 3 n~ed0d high verification and volume llrnitlng chambers flow oxygen lnto lhe nose tn ensure oxygen delivery Actionsto blood and organs
I Actions taken to ensure that corrective actions i Review of Patient 3s physician orders dated
were effectivemiddot 827117 at345 pm Indicated morphine 250 mg in NaCl 09 [saline solullon] 250 ml [rnillillter) IV Drip The hospital developed corrective- actions [pronixed in tile pharmacy] CONTINUOUS
trorn the an~lyss of events1 informationconfinuousty lt1dminlstored ot the specified ral~l
obtained from the manufacturer exter-nal middot Initial dose 1 mghour [1mllhr (hour) is equal to 1 sources and subsequent internal Investigationmg of morphinehr] findings Interventions deslgned to prevent IV pump medication errors Including free flow Revlew of Patient 3s MAR (medicetion
admlnislratlon record) ndicaled the n~orphlne drip events have been added ta medication management pollltles procedures was started on 827117 at 854 pnt and slopped at
[902 prn (S minutes later)
12142018 90420MEve-nl IDVRSlI 1
Paso 5of rn Stote~2567
CALIFORNIA HEALH AND HUMAN SERVICES AGEHGY DEPARTMENT OF PUBLIC HlAJTH
STAffeM~NT 01 dfflCJENCJES ANO PlAM or CORReCTION
NMtE OF PROVIOlR OR 51JPfgtllER
(XU PROV[iRISUPlgtUERICLII (X2) MIJTJPle CONsrnucnm1 IOENltPICATION ilJMBlH
A tlUILOING
D5ofoa - e w~Q
STREET ffiDRESS (IT( $TiT ZIP CODG
X3f DAT~ SURJEV COMfl~tlO
12072018
Suitor Medical Glfrac14ntor Sacramento 2825 C~pitol Avenue Sacrnmonto CA Sml1GSG10 SACRPiMENiO COLINrr
-(X4) D SUMMIRY STATE MtNT OF OlFCIEIICES JOPREFIX EACH OEFJCll1fJCV MUST BE PRlC161)i llY FULL PREF(
TAO REGUcATOt(V OR ISC 10GHill1ilNG NFOFIMA110t~)
[ Review of Patient 3s nursing notes dated 6127117 bullindicated -At 902 pm pt [pa~enl) wih deocease In RR [respiratory rateJ oxygen saturalion down to 70s
Morphine gtt [drip Infusion tumed oft
bull At 906 pm EICU (Eleclronic Intensive Care Uni] called no rall back from PMA [Pulmonary iMedicine Altendin~] pt with sz [seizure- sudden I uncontrolled electrical diolurbance In themiddot brain] middot activity lasting about 25- secondsmiddot bull At 907 pm Dr returned page Updated on siwaian New order received lo start on BIPAP middot [bl-level posillve airway pressure is a type of device that helps with breathing] bull At 927 pm Dra bedside Discussing situation 1w1thwie l middot At 950 pm Decision made by wifewith Dr middot present lo transition to comfort care care directed al preventing or relieving suffering at end or llfeJ
During an interview on 126118 al 258 pm RN 6 middot verified Iha shorlly aner the morphine drip was lnitialed on 82717 Patient 31s respirat13ry rale and bulloxygen saturation dropped RN 6 slated he had stepped the morphine and called Resplralory
Therapy and the MD Mediltlel OoclorJ
Review of Potlent 3s physician orders dated 8127117 at 1052 prn lndlcalcd morphine 250 mg in NaCl 09 250 ml IV Drip CONTINUOUSdose 1mghour
Patient 3s MAR for 812717 Indicated the morphine drip was restarted at 11 59 pm with a comment In
PROVIDERS PLAN Of cortReCTION
IEIICH CORMCTIV~NntON StWUID BE CROSS-PlFERENCEO TOlHE APPROPRIATE DEFICJENCi)
i Bio med staff~ laccountab1e -Bic Med Director)
Education - BloMed (eQuip)
All staff demonstrate competency for diagnostic Inspection and repair per manufacturer guidelines Completed 318 100 of IV pumps were Inspected and tested per manufacturers recomrnendatlon Pump manufacturer blo techs remained n site and assisted wlth the revlew1 until completed All preventative maintenance and repairs are documented in our computerized maintenance middotmanagement system (CMMS) Bia-med comp1ete_sa scheduled at least annuaHy preventatlve maintenance inspection on all pump lnfwon pumps utilizing the Pump System Maintenance software At the completion of the inspection a sticker is placed on the device 1ndlcating date of current lnspectlon date of ~ext Inspection and name of Inspector Any IV pump that does not pass its scheduled
ix
I CO1IPlalE
OAlE
inspection per manufacturer-guidelinessoftware or is ldentlfled by frontline staff or pharmacy through medication safety reporting ls tagged sequestered from dincal areas and steps will be takeh by Bto-med If there ls a repeated failure of the same type during the preventative maintenance inspection window not to exceed one year) the pump Is referred to Risk Management for further action
Actions detaled in this section are ongoing
Evenl IDVRSlmiddot1 middotI 12~42018
Page 6 of 18 Stsle-2567
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PU6LIC HEALTH
STA1EMEITT OF OEFIClCNcms (X1 I PROVIDERISVPPLIERfClA (Y2J MULTPL6 COMTRUCTON (X3) DATE SURVE IDENTFICiATON NUitU3RANO PLAH OF CORRECTION CoMrLIHEO
A-BUllOiOO
8 MNG05010_ 121071203
~fN1E OF lROVOlR OR SJPftJiR STltEET gtDOR~SS ClT(STATI iIP cooEc 61tlier Med(car Center s~cr-dffiento ~025 Capitol Avenue- Saoramonto1 CA 95116$616 SAC~A~ENTO COUNTY
(x-1)0 SUMMARY 81ATEMENT OF DEMCIENCl~S 10 flRQVIOliRS PlAlf OF COR~ECTIOH lltS) PRPFIX (EA~H DFICfENCY Ul5T BE PRtClEtJED BY FlILL PREHlt iACl1 C MlCTlVEACTION SHOULD 01 CftOSSmiddot COMPLeTE
TA~ fte0ULA10Rl OR LSC 1J5fITJFYIMG INFORMATION TAO
nurse1s noteamp 11Pt now on comfort middotcare wJfe ready for morphJnato stait Patient 3s morphine drip
was stopped on 82817 al 125 am (1 hour 26 mlnule8 taler and a subsoquent nurses notes
Indicated middotbullgtt stopped pump wllhoul any alarms bag empty
middot Review of nurses notes daled 8128117 at 125 a111 indicated Upon checking lV pump noticed morphlna gll was completely empty withIV tubing full of air IV pump still running with green light pteSent no alarms present lV states volume
-infused bull15 ml Morphine gll turned oft charge RN (Registered Nuroe] on unit and nofi1ied [charge RN] checllted pump correclly set wllh lubing fully Inserted into channol correctlyBP [blood pressure) 8552 [normal blood pressure for a healthy adJlt Is 12080]
bullReview of e document titied Default Flowsheet Data middot in Palienl ls clinical recorti nvt~d b(ooU prassum from 3 am to (l am on 81017 ranged from 8148
to 69IS7 A nurses nole dated 828117 at 357 am indicated a Ould bolus wabull ordered to support blood
pressure
Morphine carries a black box warning which Is the Strongestwai-ning the United stated Food and 0mg Administration (US FDA) can require a manufacturer to pul on the drug label Part of the bloclt bogt
warning indlmlted LlfoffThreotening- Respiratory Deproaslon-Serious life-threatening or falal
middot respiratory clep(G$Slon may occur with middotuse of Morphine sulfate lnjacton Monitor for respiratory _depres$iOn1 e~pecially during lnitalion of Morphine
I 1middot I I i
I
I I i I I
I
bull I
I I I
I I
AEFEREiNC~D TO THEAPPROPRIATI= JEFCeNCV) AIE_____- Pharmacy accountable Pharmacy Director)
middotPharmacy reviews all medication related safety lssues and determines whether a posslble errorln IV medication admlnlstratlon has occurred1 or lf any error reached the patient
1818-32918 pump evaluation process Pharmacy dally report CUI) of flow events greater than 300 seconds oo 100 of infusion pumps
Those devices with flow events greater than 300 seconds were remiddotparted to the Nursing Department and BioMed removed from
patient use tagged and referred to BloMed (eQulp for diagnostic inspection
bull Dally reports run from 1282018 to 3282018 yielded 43 flow alarm events Upun Uiag11ostic insmicroectiqri and event investigation no free-flow of fluids occurred
Current process -Manufacturer Alarms Analytic Reports CQI) are compared to Medication Administration reports and the summary is reported to the Medlcation Safety Committee
Sterile Processing Department (SP
(Accountable-SP Manager)
All IV pumps are to be sent to SPD for ltleaning and dlsnfection SPD staff were educated in March 2018 reflectlng manufacturer
Evan IDVRSl11 121412018 9 recommendations StJff were also provided--------middot-----middotmiddotmiddot--------------- a checklist to assist in visual screening of tV
Paoo 7or 18 Sllaquota-2567
CIUFORNIA HEILTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
X-3j DA1~ SURV~Y(llt1) PROVID[JSUPPlHJRCLIA ()12) MULllfLE CONSinUCTIONSTATlMENT OP 01FtCICrlCIES COMPLElEO10euroNT1ElCAflON NUMelRANO PVN OF CORRECTION
ABlJlDING
ll MNGQS0108 12m1r201s
s-rtuer AODfi~Sa CITY STATEZlf CODINAMi o PR011DEROR SUPP-IER
2625 Capitol Av1mu1r Sliclamonto middotCA ~a1e-se1s SAC~AMfNTO COUNTYSutter Medical Centrr1 Sacramonto
volutrol) will be use_d on cert-a1n high
(X~)IPmiddot SUMMARr $1ATEMCNT OF DtFICllNCIES I 10 PROVIOE~$middotPWI o= COMliCTIQr1 1lt5
PREFIX TAO
1 (MCH DEFICIENCY MUST BF PRftEiOED OY FULL RtGULATbRY Oflt LSCIOENtlFYINO mFORMAflON)
ifUFIX
rw (EACH tDAREcnVEACTION SHOUW ae (ROSSshy
REF-ER-1-mo ro iHf PPPROP~IATE oertCIENCY) COMPLEtl
OAH
pumps for potential flaw which may lead to an IV pump failure All staff demonstrated
Sulfale Injection or foHowhg a dose increase competency on the cleaning and vlsual Becaubulls of delay in maximum CNS eflect wilh I
in1ravenou~ly administered morphine (30 min) rapid inspection of lnfusion pumps
IV administration may result In overdosing The March 2018 Trainllig will continue on new
information for morphine under warnings indical~d hire and annually thereafter Hypotensiva [low blood pressure Effeclmay lnltlal training completed March 2018
cause severe hypotenslor In Eln ndividu11l wlmse ability to maintain their blood pressure has beenI Actions detaled In this section are ongoing
I compromised by depleted blood volumeMorphine must be Injected slowly rapid Intravenous RN staff f Accountable -Chief Nursing
administration rnay result in chest wall Director
rigidity lncreased Risk of Seizures in Patients wtth Staff have been educated to perform vlsual
Seiiure Disordera EltcitaHon of the central nervous inspection of pumps screening for cracks and
system resulling in convulsions [seizure activity] pump Integrity prior to use Any pumps
i may accompany high doses of morphine given identified with Issues whlch may increase the irlrnvenou$ly 1
bull risk for medication administration errors are
(Retrieved rom removed from service and sent to blo med for httpslldaitymedntrnnihgovdally111eltldruglnfoclrn diagnostic testing EdUCi3tlon was provided In aetidbull5b96eB3a-d878-4dd5-8460-83a985db4609 bull 2017 and again in 2018 and was reinforced
1official provider of FDA lnforrnatrcn [package
IInserts])
during observation audlts detaBed in following action (112)
1Review of Patient 3s vit signs (11tood pressure heart rate elc) indicated that 111s MAP (mean or 2 The High Risk Medication Policy was
middot avera-ge arterial blood pressure during a single revised Revision Include
ca1middotdlac cycle MAP of at least 60 is necessal) lo perfuse the coronary arteries that supply blood to middot the middotheart brain ancl kidneys norroal range le ~pproximatcily 70 ~ 110) was ~bove 60 before the
Smtirt pumps are to be used on all cqntinuous infusions of high lt1lert med1catlon A volume ilmitlngchamber
middot morphine infusion was sarted on 8127117 at 11 59 alert medications administered by
middot prn Review of Patient 3s MAP after the morptlne continuous 1V Infusion through the
drip was stoppcI on 82B17 al 1 25 am indiooleltI large volume pump (LVP) module per lhat it lad dmpped lo 57 al aam Review of Patient
policy3S physician orders dated 8128117 at 4 15 am When a volume limiting ch[lmber is indicated IV Dopamine (used 10 treat low blood lndlc_ated a two~hourvolume wlll be pressure 0~10 microgramkllogrsrnmlnute lo be added to the chamber Use of the
volume limittngchamber will be 12142018
Verifyon the MAR and volutrol In the comment box
EvcnlDVRSl11 documented every shft with ~Rate
Slnte-2557
CAUFOlNIA HFALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STtT~MEMT 01 d-1Cl~NCIES (Y PROVtOtRISUPPLl8RCtb (X2) MIJLrlPLE CONSTRUCTION (lt3) DATE SURVEiV AND flA~I Oi CORRECTION IDlUtfFC110N NUMBER COMfgtl[lYEO
A OlJflD1NG
050100 H WING 12107201$
NPME OF PROVJOSR Oil SUPPLIER SmEar ADDRESS CITY 9TATEZIP CODE
6utwr Medlc1atl Oentor1 Saotamonto 282S CiJpitO VQnun1Sutamcmtltgt CA 95816bullS616 SACRAMENTO COUNTY
X~ rLl PfitPlr
1AO
SUMMRY STATEMENT OF OlF1CllNC1es (ECl-1 OEf1CIENCf MUST nE PRECEeom Blt FUL 1u0ulATORYOR lSC DlNTIFYJNG l~fCJRMTlON)
titrated every 10 rnltmles far a 0081 of MAP between 60 and 65
IReview of physi9ian notes dated B28117 al 350 am indicated RN called to report 250 mg bag of morphine poeslbly given to tho patient over one haurMay use BIPAP to support breathing
Review of-the Palent 1bull Completed Medication Record Indicate( that Dopamine was started al 444 am on 8128117 for MAP less than 60
IReview of nurses ncles dale~ 828ffal 555 am lndica1ad 1New orders received ta $lop pressors middot [dopamine] anti remove BIPAP Nurses nbte dated 8128117 at 612 am indicated BIPAP removed
On 828117 al 633-am Patiertl 3 was pronounced dead The ciniral record indicated there were no orders lab res11Jls ot btood draws lo meijsure rno1microhine loXlcHy levels fonowing lhe ldenliUcaion of
the empty morphine bag Patient 3s discharge 1summe~ summary of U1e major treatments andIevents while hospilolited) doled 62B117 al 668 l am did not-address morphinG odministration
The above findingbull were aclltnowledgad by the iADHO (Mministrative Director of Hospital bullOperations) during lnle111lews on middotf24118 at 920 am and on i26118 at 15middot1 pm and with RN 8 on 112618 ot 10 am
middot During t1n inlervlew cm 12Rf18 at 258 p m bull RN 6 staled tlial on 812717 he started Patient 3bull
morphine infusion (11 69 pm per MAR) wilh tle
ID PR~F1X rG
PfJOYDEtS NAN Of COARlCTION x~
llACtt CDRRECTIW ACTlON SHOUlD ae CROSSshy COMPL~TC REFERENCEO TO fl-I AfPROfRIAT OlfCIENCf) OAre
In the event that a volume limftlng chamber Is n6t uvailabte for in indicated hgh alert medication st-aff wlll documentRate Verify (as defined in the Medication Administration policy) on the MAR every2 hours Independent double-checks The SMCS list of medications requiring an independent double-check may not match the EHR list for dual signature rnedications Alternative documentation may be employed so that SMCS staff can align their documentation with the SMCS standard (eg add a co-sign with a note lri MAR use 11given not co-signed option when a co-signature ts not required
3 The Medication Administration Policy was revised Revision Include Use of the LV Pump
i Choose the appropriate age- weght- andor unlt--1nsud prmiddotorne when starting the Infusion pump
b Enter the patients M edcal Record Number (MRN) when asked for Patient ID
t The Guardrails drug lbrary rs to be used for all medications unless the particular- drug does not exist in the library
d Only those medkations with the bolus feijture built Into the pump for that drug may be bolused from the pump
1211412016Even IDVRSlI I
Page Oo 18 Sate2587
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CILIFORNI HEALTH ANO HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HSAlTH
Xl) tROVJDERISUPPLlaRfCUAllTTlMENT OF DEFlClJlCtCS IOE~lIFlCATlON HUUElCR
050108
ANOtgtLANar CORf~-ECrtON
(X2) MU~ lrPll COHSTRUCflON (X3) IJAlE SURVFV CQMPllITED
A BUILOiNQ
BIMNG 1210712018
Si~leT ADORlfO CllYSiATE 2IP COD6NAMe or fROVD~R OR SUPllER 2825 Citpltol Alt-1uouo1 Siicramontomiddot CA 95818-5616 SAQllAMEN10 COUNTYSutter Medical Cantor Sacmmenta
PROVIOERG PLAtf OF CMRECTION [XS)tX4) O SUMMARY amTIMNr OF DEFICIINCleuro5 ID IrmaFtx (MCH CORRlCTIVI ncnolI SHOULD Bf c-imrn GOMPT1C
fAG RtGUlA10RY on ESC IDENnFYINO INFORMATION) rw HEHRENC~O TOTUC IPPROPRrAtE DEFICENCY OAre PREJIX (EACH IJFFICIENCY MWil BE PRlCl I0 lY Fllll
I I I
Adverse Event NotlficaUon Informed I
Health and Safety Code Section 12791 (c The facility shall inform the pallenl or tho party responsible for the patient of the adverse event by I the time th~ report Is rnade 11
I The GOPH verified that lhe facllty informed the
1patlent or 1he party responsible for lhe patient of the I I
[ adverse event oy the time the report was mde
I T22 OIVo CH1 ART3 70263 Pharmaceutlcol
I ServicesGeneral Requirements
[c) A pharmacy and 1herapeutlcs cornmilae or a committee QI equivalent composition shall be
I est~bHshed The committee shall co~ss1 of at least one physician one pharmacist the director of nursing service or her representative and lhe admlnls1rat Imiddot er hls reprnsentative
I1) The committee shall develop writen policies and I procedures for eslablishmrnt of sale and effeciive I systems for pmc11rement slorage dislriQUtion
dispensing and llsa of drugs and chernlcals The I pharmaclit in consultation with other appropriale Iihealth professionals and administrallon shall be responsible foe the develaprnenl and implementations of praccdurt)s Policies shaH be approved by lhe governing bltXiy Procedurns hall be approved by lhe administration and medical staff i where ~uch is appropriate I T22 DIV5 CH1 ART3 70263 Pharmaceutical I Services General RequiremerttG
i (g) No dnigs shall be administerAd exc9pl by
licensed personnel authorized lo admlnlsler dnigs
12142018 9D420AMEvent 10VRSll 1
Page 3 of ts Stals-2007
CALIFORNIA HEALTH ANO HUMAN SeRICES AGENCY DEPARTMENT OF PUSLIC HEALTH
(X2) MUlllPL~ COI-JSmUcT10N XJ) rJJlE SURVEYXI) fROVIDWJSUPP~GRICLIAIOENTlFJCAlIOt-1 MUMOER
-middotoso1os -
SiAT~MNT Of CEFICIENCllSmiddot COMfLElEOAND PLAN Or CORRECTION
A 6UILDlNG
o~middotw1Nu 12072018
StREET (J)00c3S crrv STAll Zif CODE
Sutter Medical Cfilnter sacrame11to NAME OfPiWV10ROR SIJPPUR
2625 Capitol Avenui Sacramtlnto1 CA 9581SM5616 SACRAMENiO COUNTY
X4)10 1middot-middot---======~------1------------------l1 SUMMARY StAlEMGNT OF OEfCteNCIGS 1 PROVlDERl flPN OF CORREdTlOH ilti) PfIEPIX (EACH OfFlCRNCY t1UST BE PAl(ipound0Hl EIY FlJll I P~lli 1middot ~- bullri0i-~~)bull1d lCfJ SHOULD aECit0$S COWHtiC
TAG fl[GULATORVORLSCIOtrnn~YJNGlllFORMATION) rrG middotbullmiddot 1APPACPRIAiDCFlmiddotIEHOr) DMe
i-------------------------________ middotmiddot-I l
I and _upon the ordet DI a person lawlully authorized to I Medication safety related to the use of the IV prescribe or furnish This shall not preclude the middot pumps Is continuous and ongoing and is
bulladministration of aerosol drugs by respiriitory accompllshed through an lnterdiscipBnary therap1sts The order shall Include the name or lhe approach Each discipline adding a layer of drug the dosage and the frequency of protection and or mitigation through defined ldmi111slratfau the route of administration if other workfloW processes Each layer ls designed to than oral and the dale lime and signature of the prescriber or furnisher Orders lot drugs should be written or transmitted by the presctiber or fumlsher I
Verbal otders for drugs shall be given only by a person lawfulJy authorized to pceocrlbo or furnish and shall be recorded promptly In tho patients medical record nottng the name of lhe person givng tho verbal order and tha signature of lhe lndMdualIreceiving the order The prescriber or furnisher shall
middotcountersign ha order within 48 hours (2) Medications and treatments shall ba
administered as ordered
During a Fedecal Complaint Validallon Survey conducied by (lie Deparlrnenl i24HJ thf-oiigh 128118 on adverse event was reported by lhe facility on 112518 and invesligated el thal lime
(lnlake number CA00570S4B) On 216118 a middot consumer complaint regarding the some lnclden1 middot wae received by the Department and was middot invcsligeled concL1rrentty (CA00574265)
The Demicroartmenlbulldetermined the facllily failed to ad1Y1tnislar madicatiot1s as prascribed by the physician and In accordance wilh facility policy_
reduce the likelihood of patient harm from an unintended IV medication administration event
Ealth discipline is an ad- hoc member of the Medication Safety Committee The Medication Safety Committee coordinates revews and responds to IV putnp issues The committee
review of indMdual events and or trends provide for the development of action plans as I needed Review of audits and the subsequent strategies are designed to reduce the potentla for future pump malfunctions which may result In an unintended medication administration The i committee meets quarterly Actions detailed ln this sccticn are ongoing
l(ey oles and responsibitlties
pharmacy accmJlltable-Pharmacy Director)
Pharmacy reviews and reports a11 medication relateq safety events which lncludes IV pump Issues Thmiddote review determines If an incident associated with an IV medication administration has potentially occurred or tf any Incident may have reached the patent SMCS continues to
middotThe facility failed to ei10ure that revlew and compare the alarm alertreport to
i1) The factl[ty policy and procedure for Ma11agernenl any reported pump Issues und or medication
i of High Alert Medications was developed and events I
12JW2U1B 9o0420AMEvent IDVRSl1 l
State-2567
CALIFORNIA HEAL7H AND HUMAN SEHVICES AGEHCY DEPARTMENT OF PUBLIC HEALTH
STAIEMENT OF DruCliJJCOS x1) PAOVIDEWSUPPLl~RCLIA X) MULTIPIE CONSTRUCTION ((~) FJATE SURVEY
ANO flLJJq DF CORRECl10N lDENllFICATION NUMEtf(middot COMPtllO
AllUtLDrNC3
aso1oa SWING 121072018
ilAME OF PROVfDR OR StlfPUER SWIHrflOOHms CITY STATE lP COOi
SultGr Mndi~I CGnh1t1 Sacramonto 2025 Capitol Avem1~ Sairamoneo CA 9Sa1(~SM6 SACRAMBlliO COUNTY
)(4)11) BUMMRi SlArEMCITT OF DFICiENCIES 10 PROVIDERS Pl11-l Ofl CORREOlON (lt5)
P~EFX (12ACH OlFCIENCY MUST flE PRECEEDEO av iuLL PRfHX (~ACH cORBECTIVE ACTION ~HDVLO ee CROSS- COMJLlTE tAG REPEREMCEP Ttl THE AilPR PRIArE 0euroFICJENCY1 OAflTAG RGULATORY OR LSC 108Nrl~YtIIG 1NFORMATl0N)
1----+------------------+---~~-------middotmiddot-Sio med staff~ accountable -Bto Med Director)
implemented to ensure safe adminisVation practlca 61 medlctlons tdentlfiM wilh high potential for Bio Med reports on pump maintenance devaslatlng consequences If an error occurs and evaluations andvolume of Issues resolved and
2) Medlcelions were administered per physician or number of pumps removed from servtce middotorder when Patfanl 3 wa)i adrnntstered 50 mllllgram (mg) of IV (inlravenoosly ln)ecled Uirough Sterile Processing Departrnent (SPO
i lhe vein) morphine a potent nareolic for part) over (Accountable -SPD Manager)Ione and a half hours Instead of the preoribed 1 mg per hour SPD reports on dlslnfectlon processes and
pump lflegrity escalations to Bio Med AH IV The medloalion ortor exposed Patient a to effects of pumps are sent to SPD for deaning and middot morphine overdose (166 times he precrtbed dose) disinfection including low blood pressure and subsequent death
RN staff (Accountable Chief N~rsingIFioding Director)
Review of PaUent Ds ci11ica[ record indicated he Nursing representation revlews and reports
middot was admitted to the facility on 8111117 for acule on documentation audits and concurrent
cespirnloiy failure (Inability of the lungs to maintain ntervlew audits for v1sual inspection rate n_orrnal respiratory functfon) P~Oant 3 n~ed0d high verification and volume llrnitlng chambers flow oxygen lnto lhe nose tn ensure oxygen delivery Actionsto blood and organs
I Actions taken to ensure that corrective actions i Review of Patient 3s physician orders dated
were effectivemiddot 827117 at345 pm Indicated morphine 250 mg in NaCl 09 [saline solullon] 250 ml [rnillillter) IV Drip The hospital developed corrective- actions [pronixed in tile pharmacy] CONTINUOUS
trorn the an~lyss of events1 informationconfinuousty lt1dminlstored ot the specified ral~l
obtained from the manufacturer exter-nal middot Initial dose 1 mghour [1mllhr (hour) is equal to 1 sources and subsequent internal Investigationmg of morphinehr] findings Interventions deslgned to prevent IV pump medication errors Including free flow Revlew of Patient 3s MAR (medicetion
admlnislratlon record) ndicaled the n~orphlne drip events have been added ta medication management pollltles procedures was started on 827117 at 854 pnt and slopped at
[902 prn (S minutes later)
12142018 90420MEve-nl IDVRSlI 1
Paso 5of rn Stote~2567
CALIFORNIA HEALH AND HUMAN SERVICES AGEHGY DEPARTMENT OF PUBLIC HlAJTH
STAffeM~NT 01 dfflCJENCJES ANO PlAM or CORReCTION
NMtE OF PROVIOlR OR 51JPfgtllER
(XU PROV[iRISUPlgtUERICLII (X2) MIJTJPle CONsrnucnm1 IOENltPICATION ilJMBlH
A tlUILOING
D5ofoa - e w~Q
STREET ffiDRESS (IT( $TiT ZIP CODG
X3f DAT~ SURJEV COMfl~tlO
12072018
Suitor Medical Glfrac14ntor Sacramento 2825 C~pitol Avenue Sacrnmonto CA Sml1GSG10 SACRPiMENiO COLINrr
-(X4) D SUMMIRY STATE MtNT OF OlFCIEIICES JOPREFIX EACH OEFJCll1fJCV MUST BE PRlC161)i llY FULL PREF(
TAO REGUcATOt(V OR ISC 10GHill1ilNG NFOFIMA110t~)
[ Review of Patient 3s nursing notes dated 6127117 bullindicated -At 902 pm pt [pa~enl) wih deocease In RR [respiratory rateJ oxygen saturalion down to 70s
Morphine gtt [drip Infusion tumed oft
bull At 906 pm EICU (Eleclronic Intensive Care Uni] called no rall back from PMA [Pulmonary iMedicine Altendin~] pt with sz [seizure- sudden I uncontrolled electrical diolurbance In themiddot brain] middot activity lasting about 25- secondsmiddot bull At 907 pm Dr returned page Updated on siwaian New order received lo start on BIPAP middot [bl-level posillve airway pressure is a type of device that helps with breathing] bull At 927 pm Dra bedside Discussing situation 1w1thwie l middot At 950 pm Decision made by wifewith Dr middot present lo transition to comfort care care directed al preventing or relieving suffering at end or llfeJ
During an interview on 126118 al 258 pm RN 6 middot verified Iha shorlly aner the morphine drip was lnitialed on 82717 Patient 31s respirat13ry rale and bulloxygen saturation dropped RN 6 slated he had stepped the morphine and called Resplralory
Therapy and the MD Mediltlel OoclorJ
Review of Potlent 3s physician orders dated 8127117 at 1052 prn lndlcalcd morphine 250 mg in NaCl 09 250 ml IV Drip CONTINUOUSdose 1mghour
Patient 3s MAR for 812717 Indicated the morphine drip was restarted at 11 59 pm with a comment In
PROVIDERS PLAN Of cortReCTION
IEIICH CORMCTIV~NntON StWUID BE CROSS-PlFERENCEO TOlHE APPROPRIATE DEFICJENCi)
i Bio med staff~ laccountab1e -Bic Med Director)
Education - BloMed (eQuip)
All staff demonstrate competency for diagnostic Inspection and repair per manufacturer guidelines Completed 318 100 of IV pumps were Inspected and tested per manufacturers recomrnendatlon Pump manufacturer blo techs remained n site and assisted wlth the revlew1 until completed All preventative maintenance and repairs are documented in our computerized maintenance middotmanagement system (CMMS) Bia-med comp1ete_sa scheduled at least annuaHy preventatlve maintenance inspection on all pump lnfwon pumps utilizing the Pump System Maintenance software At the completion of the inspection a sticker is placed on the device 1ndlcating date of current lnspectlon date of ~ext Inspection and name of Inspector Any IV pump that does not pass its scheduled
ix
I CO1IPlalE
OAlE
inspection per manufacturer-guidelinessoftware or is ldentlfled by frontline staff or pharmacy through medication safety reporting ls tagged sequestered from dincal areas and steps will be takeh by Bto-med If there ls a repeated failure of the same type during the preventative maintenance inspection window not to exceed one year) the pump Is referred to Risk Management for further action
Actions detaled in this section are ongoing
Evenl IDVRSlmiddot1 middotI 12~42018
Page 6 of 18 Stsle-2567
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PU6LIC HEALTH
STA1EMEITT OF OEFIClCNcms (X1 I PROVIDERISVPPLIERfClA (Y2J MULTPL6 COMTRUCTON (X3) DATE SURVE IDENTFICiATON NUitU3RANO PLAH OF CORRECTION CoMrLIHEO
A-BUllOiOO
8 MNG05010_ 121071203
~fN1E OF lROVOlR OR SJPftJiR STltEET gtDOR~SS ClT(STATI iIP cooEc 61tlier Med(car Center s~cr-dffiento ~025 Capitol Avenue- Saoramonto1 CA 95116$616 SAC~A~ENTO COUNTY
(x-1)0 SUMMARY 81ATEMENT OF DEMCIENCl~S 10 flRQVIOliRS PlAlf OF COR~ECTIOH lltS) PRPFIX (EA~H DFICfENCY Ul5T BE PRtClEtJED BY FlILL PREHlt iACl1 C MlCTlVEACTION SHOULD 01 CftOSSmiddot COMPLeTE
TA~ fte0ULA10Rl OR LSC 1J5fITJFYIMG INFORMATION TAO
nurse1s noteamp 11Pt now on comfort middotcare wJfe ready for morphJnato stait Patient 3s morphine drip
was stopped on 82817 al 125 am (1 hour 26 mlnule8 taler and a subsoquent nurses notes
Indicated middotbullgtt stopped pump wllhoul any alarms bag empty
middot Review of nurses notes daled 8128117 at 125 a111 indicated Upon checking lV pump noticed morphlna gll was completely empty withIV tubing full of air IV pump still running with green light pteSent no alarms present lV states volume
-infused bull15 ml Morphine gll turned oft charge RN (Registered Nuroe] on unit and nofi1ied [charge RN] checllted pump correclly set wllh lubing fully Inserted into channol correctlyBP [blood pressure) 8552 [normal blood pressure for a healthy adJlt Is 12080]
bullReview of e document titied Default Flowsheet Data middot in Palienl ls clinical recorti nvt~d b(ooU prassum from 3 am to (l am on 81017 ranged from 8148
to 69IS7 A nurses nole dated 828117 at 357 am indicated a Ould bolus wabull ordered to support blood
pressure
Morphine carries a black box warning which Is the Strongestwai-ning the United stated Food and 0mg Administration (US FDA) can require a manufacturer to pul on the drug label Part of the bloclt bogt
warning indlmlted LlfoffThreotening- Respiratory Deproaslon-Serious life-threatening or falal
middot respiratory clep(G$Slon may occur with middotuse of Morphine sulfate lnjacton Monitor for respiratory _depres$iOn1 e~pecially during lnitalion of Morphine
I 1middot I I i
I
I I i I I
I
bull I
I I I
I I
AEFEREiNC~D TO THEAPPROPRIATI= JEFCeNCV) AIE_____- Pharmacy accountable Pharmacy Director)
middotPharmacy reviews all medication related safety lssues and determines whether a posslble errorln IV medication admlnlstratlon has occurred1 or lf any error reached the patient
1818-32918 pump evaluation process Pharmacy dally report CUI) of flow events greater than 300 seconds oo 100 of infusion pumps
Those devices with flow events greater than 300 seconds were remiddotparted to the Nursing Department and BioMed removed from
patient use tagged and referred to BloMed (eQulp for diagnostic inspection
bull Dally reports run from 1282018 to 3282018 yielded 43 flow alarm events Upun Uiag11ostic insmicroectiqri and event investigation no free-flow of fluids occurred
Current process -Manufacturer Alarms Analytic Reports CQI) are compared to Medication Administration reports and the summary is reported to the Medlcation Safety Committee
Sterile Processing Department (SP
(Accountable-SP Manager)
All IV pumps are to be sent to SPD for ltleaning and dlsnfection SPD staff were educated in March 2018 reflectlng manufacturer
Evan IDVRSl11 121412018 9 recommendations StJff were also provided--------middot-----middotmiddotmiddot--------------- a checklist to assist in visual screening of tV
Paoo 7or 18 Sllaquota-2567
CIUFORNIA HEILTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
X-3j DA1~ SURV~Y(llt1) PROVID[JSUPPlHJRCLIA ()12) MULllfLE CONSinUCTIONSTATlMENT OP 01FtCICrlCIES COMPLElEO10euroNT1ElCAflON NUMelRANO PVN OF CORRECTION
ABlJlDING
ll MNGQS0108 12m1r201s
s-rtuer AODfi~Sa CITY STATEZlf CODINAMi o PR011DEROR SUPP-IER
2625 Capitol Av1mu1r Sliclamonto middotCA ~a1e-se1s SAC~AMfNTO COUNTYSutter Medical Centrr1 Sacramonto
volutrol) will be use_d on cert-a1n high
(X~)IPmiddot SUMMARr $1ATEMCNT OF DtFICllNCIES I 10 PROVIOE~$middotPWI o= COMliCTIQr1 1lt5
PREFIX TAO
1 (MCH DEFICIENCY MUST BF PRftEiOED OY FULL RtGULATbRY Oflt LSCIOENtlFYINO mFORMAflON)
ifUFIX
rw (EACH tDAREcnVEACTION SHOUW ae (ROSSshy
REF-ER-1-mo ro iHf PPPROP~IATE oertCIENCY) COMPLEtl
OAH
pumps for potential flaw which may lead to an IV pump failure All staff demonstrated
Sulfale Injection or foHowhg a dose increase competency on the cleaning and vlsual Becaubulls of delay in maximum CNS eflect wilh I
in1ravenou~ly administered morphine (30 min) rapid inspection of lnfusion pumps
IV administration may result In overdosing The March 2018 Trainllig will continue on new
information for morphine under warnings indical~d hire and annually thereafter Hypotensiva [low blood pressure Effeclmay lnltlal training completed March 2018
cause severe hypotenslor In Eln ndividu11l wlmse ability to maintain their blood pressure has beenI Actions detaled In this section are ongoing
I compromised by depleted blood volumeMorphine must be Injected slowly rapid Intravenous RN staff f Accountable -Chief Nursing
administration rnay result in chest wall Director
rigidity lncreased Risk of Seizures in Patients wtth Staff have been educated to perform vlsual
Seiiure Disordera EltcitaHon of the central nervous inspection of pumps screening for cracks and
system resulling in convulsions [seizure activity] pump Integrity prior to use Any pumps
i may accompany high doses of morphine given identified with Issues whlch may increase the irlrnvenou$ly 1
bull risk for medication administration errors are
(Retrieved rom removed from service and sent to blo med for httpslldaitymedntrnnihgovdally111eltldruglnfoclrn diagnostic testing EdUCi3tlon was provided In aetidbull5b96eB3a-d878-4dd5-8460-83a985db4609 bull 2017 and again in 2018 and was reinforced
1official provider of FDA lnforrnatrcn [package
IInserts])
during observation audlts detaBed in following action (112)
1Review of Patient 3s vit signs (11tood pressure heart rate elc) indicated that 111s MAP (mean or 2 The High Risk Medication Policy was
middot avera-ge arterial blood pressure during a single revised Revision Include
ca1middotdlac cycle MAP of at least 60 is necessal) lo perfuse the coronary arteries that supply blood to middot the middotheart brain ancl kidneys norroal range le ~pproximatcily 70 ~ 110) was ~bove 60 before the
Smtirt pumps are to be used on all cqntinuous infusions of high lt1lert med1catlon A volume ilmitlngchamber
middot morphine infusion was sarted on 8127117 at 11 59 alert medications administered by
middot prn Review of Patient 3s MAP after the morptlne continuous 1V Infusion through the
drip was stoppcI on 82B17 al 1 25 am indiooleltI large volume pump (LVP) module per lhat it lad dmpped lo 57 al aam Review of Patient
policy3S physician orders dated 8128117 at 4 15 am When a volume limiting ch[lmber is indicated IV Dopamine (used 10 treat low blood lndlc_ated a two~hourvolume wlll be pressure 0~10 microgramkllogrsrnmlnute lo be added to the chamber Use of the
volume limittngchamber will be 12142018
Verifyon the MAR and volutrol In the comment box
EvcnlDVRSl11 documented every shft with ~Rate
Slnte-2557
CAUFOlNIA HFALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STtT~MEMT 01 d-1Cl~NCIES (Y PROVtOtRISUPPLl8RCtb (X2) MIJLrlPLE CONSTRUCTION (lt3) DATE SURVEiV AND flA~I Oi CORRECTION IDlUtfFC110N NUMBER COMfgtl[lYEO
A OlJflD1NG
050100 H WING 12107201$
NPME OF PROVJOSR Oil SUPPLIER SmEar ADDRESS CITY 9TATEZIP CODE
6utwr Medlc1atl Oentor1 Saotamonto 282S CiJpitO VQnun1Sutamcmtltgt CA 95816bullS616 SACRAMENTO COUNTY
X~ rLl PfitPlr
1AO
SUMMRY STATEMENT OF OlF1CllNC1es (ECl-1 OEf1CIENCf MUST nE PRECEeom Blt FUL 1u0ulATORYOR lSC DlNTIFYJNG l~fCJRMTlON)
titrated every 10 rnltmles far a 0081 of MAP between 60 and 65
IReview of physi9ian notes dated B28117 al 350 am indicated RN called to report 250 mg bag of morphine poeslbly given to tho patient over one haurMay use BIPAP to support breathing
Review of-the Palent 1bull Completed Medication Record Indicate( that Dopamine was started al 444 am on 8128117 for MAP less than 60
IReview of nurses ncles dale~ 828ffal 555 am lndica1ad 1New orders received ta $lop pressors middot [dopamine] anti remove BIPAP Nurses nbte dated 8128117 at 612 am indicated BIPAP removed
On 828117 al 633-am Patiertl 3 was pronounced dead The ciniral record indicated there were no orders lab res11Jls ot btood draws lo meijsure rno1microhine loXlcHy levels fonowing lhe ldenliUcaion of
the empty morphine bag Patient 3s discharge 1summe~ summary of U1e major treatments andIevents while hospilolited) doled 62B117 al 668 l am did not-address morphinG odministration
The above findingbull were aclltnowledgad by the iADHO (Mministrative Director of Hospital bullOperations) during lnle111lews on middotf24118 at 920 am and on i26118 at 15middot1 pm and with RN 8 on 112618 ot 10 am
middot During t1n inlervlew cm 12Rf18 at 258 p m bull RN 6 staled tlial on 812717 he started Patient 3bull
morphine infusion (11 69 pm per MAR) wilh tle
ID PR~F1X rG
PfJOYDEtS NAN Of COARlCTION x~
llACtt CDRRECTIW ACTlON SHOUlD ae CROSSshy COMPL~TC REFERENCEO TO fl-I AfPROfRIAT OlfCIENCf) OAre
In the event that a volume limftlng chamber Is n6t uvailabte for in indicated hgh alert medication st-aff wlll documentRate Verify (as defined in the Medication Administration policy) on the MAR every2 hours Independent double-checks The SMCS list of medications requiring an independent double-check may not match the EHR list for dual signature rnedications Alternative documentation may be employed so that SMCS staff can align their documentation with the SMCS standard (eg add a co-sign with a note lri MAR use 11given not co-signed option when a co-signature ts not required
3 The Medication Administration Policy was revised Revision Include Use of the LV Pump
i Choose the appropriate age- weght- andor unlt--1nsud prmiddotorne when starting the Infusion pump
b Enter the patients M edcal Record Number (MRN) when asked for Patient ID
t The Guardrails drug lbrary rs to be used for all medications unless the particular- drug does not exist in the library
d Only those medkations with the bolus feijture built Into the pump for that drug may be bolused from the pump
1211412016Even IDVRSlI I
Page Oo 18 Sate2587
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HEALTH ANO HUMAN SeRICES AGENCY DEPARTMENT OF PUSLIC HEALTH
(X2) MUlllPL~ COI-JSmUcT10N XJ) rJJlE SURVEYXI) fROVIDWJSUPP~GRICLIAIOENTlFJCAlIOt-1 MUMOER
-middotoso1os -
SiAT~MNT Of CEFICIENCllSmiddot COMfLElEOAND PLAN Or CORRECTION
A 6UILDlNG
o~middotw1Nu 12072018
StREET (J)00c3S crrv STAll Zif CODE
Sutter Medical Cfilnter sacrame11to NAME OfPiWV10ROR SIJPPUR
2625 Capitol Avenui Sacramtlnto1 CA 9581SM5616 SACRAMENiO COUNTY
X4)10 1middot-middot---======~------1------------------l1 SUMMARY StAlEMGNT OF OEfCteNCIGS 1 PROVlDERl flPN OF CORREdTlOH ilti) PfIEPIX (EACH OfFlCRNCY t1UST BE PAl(ipound0Hl EIY FlJll I P~lli 1middot ~- bullri0i-~~)bull1d lCfJ SHOULD aECit0$S COWHtiC
TAG fl[GULATORVORLSCIOtrnn~YJNGlllFORMATION) rrG middotbullmiddot 1APPACPRIAiDCFlmiddotIEHOr) DMe
i-------------------------________ middotmiddot-I l
I and _upon the ordet DI a person lawlully authorized to I Medication safety related to the use of the IV prescribe or furnish This shall not preclude the middot pumps Is continuous and ongoing and is
bulladministration of aerosol drugs by respiriitory accompllshed through an lnterdiscipBnary therap1sts The order shall Include the name or lhe approach Each discipline adding a layer of drug the dosage and the frequency of protection and or mitigation through defined ldmi111slratfau the route of administration if other workfloW processes Each layer ls designed to than oral and the dale lime and signature of the prescriber or furnisher Orders lot drugs should be written or transmitted by the presctiber or fumlsher I
Verbal otders for drugs shall be given only by a person lawfulJy authorized to pceocrlbo or furnish and shall be recorded promptly In tho patients medical record nottng the name of lhe person givng tho verbal order and tha signature of lhe lndMdualIreceiving the order The prescriber or furnisher shall
middotcountersign ha order within 48 hours (2) Medications and treatments shall ba
administered as ordered
During a Fedecal Complaint Validallon Survey conducied by (lie Deparlrnenl i24HJ thf-oiigh 128118 on adverse event was reported by lhe facility on 112518 and invesligated el thal lime
(lnlake number CA00570S4B) On 216118 a middot consumer complaint regarding the some lnclden1 middot wae received by the Department and was middot invcsligeled concL1rrentty (CA00574265)
The Demicroartmenlbulldetermined the facllily failed to ad1Y1tnislar madicatiot1s as prascribed by the physician and In accordance wilh facility policy_
reduce the likelihood of patient harm from an unintended IV medication administration event
Ealth discipline is an ad- hoc member of the Medication Safety Committee The Medication Safety Committee coordinates revews and responds to IV putnp issues The committee
review of indMdual events and or trends provide for the development of action plans as I needed Review of audits and the subsequent strategies are designed to reduce the potentla for future pump malfunctions which may result In an unintended medication administration The i committee meets quarterly Actions detailed ln this sccticn are ongoing
l(ey oles and responsibitlties
pharmacy accmJlltable-Pharmacy Director)
Pharmacy reviews and reports a11 medication relateq safety events which lncludes IV pump Issues Thmiddote review determines If an incident associated with an IV medication administration has potentially occurred or tf any Incident may have reached the patent SMCS continues to
middotThe facility failed to ei10ure that revlew and compare the alarm alertreport to
i1) The factl[ty policy and procedure for Ma11agernenl any reported pump Issues und or medication
i of High Alert Medications was developed and events I
12JW2U1B 9o0420AMEvent IDVRSl1 l
State-2567
CALIFORNIA HEAL7H AND HUMAN SEHVICES AGEHCY DEPARTMENT OF PUBLIC HEALTH
STAIEMENT OF DruCliJJCOS x1) PAOVIDEWSUPPLl~RCLIA X) MULTIPIE CONSTRUCTION ((~) FJATE SURVEY
ANO flLJJq DF CORRECl10N lDENllFICATION NUMEtf(middot COMPtllO
AllUtLDrNC3
aso1oa SWING 121072018
ilAME OF PROVfDR OR StlfPUER SWIHrflOOHms CITY STATE lP COOi
SultGr Mndi~I CGnh1t1 Sacramonto 2025 Capitol Avem1~ Sairamoneo CA 9Sa1(~SM6 SACRAMBlliO COUNTY
)(4)11) BUMMRi SlArEMCITT OF DFICiENCIES 10 PROVIDERS Pl11-l Ofl CORREOlON (lt5)
P~EFX (12ACH OlFCIENCY MUST flE PRECEEDEO av iuLL PRfHX (~ACH cORBECTIVE ACTION ~HDVLO ee CROSS- COMJLlTE tAG REPEREMCEP Ttl THE AilPR PRIArE 0euroFICJENCY1 OAflTAG RGULATORY OR LSC 108Nrl~YtIIG 1NFORMATl0N)
1----+------------------+---~~-------middotmiddot-Sio med staff~ accountable -Bto Med Director)
implemented to ensure safe adminisVation practlca 61 medlctlons tdentlfiM wilh high potential for Bio Med reports on pump maintenance devaslatlng consequences If an error occurs and evaluations andvolume of Issues resolved and
2) Medlcelions were administered per physician or number of pumps removed from servtce middotorder when Patfanl 3 wa)i adrnntstered 50 mllllgram (mg) of IV (inlravenoosly ln)ecled Uirough Sterile Processing Departrnent (SPO
i lhe vein) morphine a potent nareolic for part) over (Accountable -SPD Manager)Ione and a half hours Instead of the preoribed 1 mg per hour SPD reports on dlslnfectlon processes and
pump lflegrity escalations to Bio Med AH IV The medloalion ortor exposed Patient a to effects of pumps are sent to SPD for deaning and middot morphine overdose (166 times he precrtbed dose) disinfection including low blood pressure and subsequent death
RN staff (Accountable Chief N~rsingIFioding Director)
Review of PaUent Ds ci11ica[ record indicated he Nursing representation revlews and reports
middot was admitted to the facility on 8111117 for acule on documentation audits and concurrent
cespirnloiy failure (Inability of the lungs to maintain ntervlew audits for v1sual inspection rate n_orrnal respiratory functfon) P~Oant 3 n~ed0d high verification and volume llrnitlng chambers flow oxygen lnto lhe nose tn ensure oxygen delivery Actionsto blood and organs
I Actions taken to ensure that corrective actions i Review of Patient 3s physician orders dated
were effectivemiddot 827117 at345 pm Indicated morphine 250 mg in NaCl 09 [saline solullon] 250 ml [rnillillter) IV Drip The hospital developed corrective- actions [pronixed in tile pharmacy] CONTINUOUS
trorn the an~lyss of events1 informationconfinuousty lt1dminlstored ot the specified ral~l
obtained from the manufacturer exter-nal middot Initial dose 1 mghour [1mllhr (hour) is equal to 1 sources and subsequent internal Investigationmg of morphinehr] findings Interventions deslgned to prevent IV pump medication errors Including free flow Revlew of Patient 3s MAR (medicetion
admlnislratlon record) ndicaled the n~orphlne drip events have been added ta medication management pollltles procedures was started on 827117 at 854 pnt and slopped at
[902 prn (S minutes later)
12142018 90420MEve-nl IDVRSlI 1
Paso 5of rn Stote~2567
CALIFORNIA HEALH AND HUMAN SERVICES AGEHGY DEPARTMENT OF PUBLIC HlAJTH
STAffeM~NT 01 dfflCJENCJES ANO PlAM or CORReCTION
NMtE OF PROVIOlR OR 51JPfgtllER
(XU PROV[iRISUPlgtUERICLII (X2) MIJTJPle CONsrnucnm1 IOENltPICATION ilJMBlH
A tlUILOING
D5ofoa - e w~Q
STREET ffiDRESS (IT( $TiT ZIP CODG
X3f DAT~ SURJEV COMfl~tlO
12072018
Suitor Medical Glfrac14ntor Sacramento 2825 C~pitol Avenue Sacrnmonto CA Sml1GSG10 SACRPiMENiO COLINrr
-(X4) D SUMMIRY STATE MtNT OF OlFCIEIICES JOPREFIX EACH OEFJCll1fJCV MUST BE PRlC161)i llY FULL PREF(
TAO REGUcATOt(V OR ISC 10GHill1ilNG NFOFIMA110t~)
[ Review of Patient 3s nursing notes dated 6127117 bullindicated -At 902 pm pt [pa~enl) wih deocease In RR [respiratory rateJ oxygen saturalion down to 70s
Morphine gtt [drip Infusion tumed oft
bull At 906 pm EICU (Eleclronic Intensive Care Uni] called no rall back from PMA [Pulmonary iMedicine Altendin~] pt with sz [seizure- sudden I uncontrolled electrical diolurbance In themiddot brain] middot activity lasting about 25- secondsmiddot bull At 907 pm Dr returned page Updated on siwaian New order received lo start on BIPAP middot [bl-level posillve airway pressure is a type of device that helps with breathing] bull At 927 pm Dra bedside Discussing situation 1w1thwie l middot At 950 pm Decision made by wifewith Dr middot present lo transition to comfort care care directed al preventing or relieving suffering at end or llfeJ
During an interview on 126118 al 258 pm RN 6 middot verified Iha shorlly aner the morphine drip was lnitialed on 82717 Patient 31s respirat13ry rale and bulloxygen saturation dropped RN 6 slated he had stepped the morphine and called Resplralory
Therapy and the MD Mediltlel OoclorJ
Review of Potlent 3s physician orders dated 8127117 at 1052 prn lndlcalcd morphine 250 mg in NaCl 09 250 ml IV Drip CONTINUOUSdose 1mghour
Patient 3s MAR for 812717 Indicated the morphine drip was restarted at 11 59 pm with a comment In
PROVIDERS PLAN Of cortReCTION
IEIICH CORMCTIV~NntON StWUID BE CROSS-PlFERENCEO TOlHE APPROPRIATE DEFICJENCi)
i Bio med staff~ laccountab1e -Bic Med Director)
Education - BloMed (eQuip)
All staff demonstrate competency for diagnostic Inspection and repair per manufacturer guidelines Completed 318 100 of IV pumps were Inspected and tested per manufacturers recomrnendatlon Pump manufacturer blo techs remained n site and assisted wlth the revlew1 until completed All preventative maintenance and repairs are documented in our computerized maintenance middotmanagement system (CMMS) Bia-med comp1ete_sa scheduled at least annuaHy preventatlve maintenance inspection on all pump lnfwon pumps utilizing the Pump System Maintenance software At the completion of the inspection a sticker is placed on the device 1ndlcating date of current lnspectlon date of ~ext Inspection and name of Inspector Any IV pump that does not pass its scheduled
ix
I CO1IPlalE
OAlE
inspection per manufacturer-guidelinessoftware or is ldentlfled by frontline staff or pharmacy through medication safety reporting ls tagged sequestered from dincal areas and steps will be takeh by Bto-med If there ls a repeated failure of the same type during the preventative maintenance inspection window not to exceed one year) the pump Is referred to Risk Management for further action
Actions detaled in this section are ongoing
Evenl IDVRSlmiddot1 middotI 12~42018
Page 6 of 18 Stsle-2567
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PU6LIC HEALTH
STA1EMEITT OF OEFIClCNcms (X1 I PROVIDERISVPPLIERfClA (Y2J MULTPL6 COMTRUCTON (X3) DATE SURVE IDENTFICiATON NUitU3RANO PLAH OF CORRECTION CoMrLIHEO
A-BUllOiOO
8 MNG05010_ 121071203
~fN1E OF lROVOlR OR SJPftJiR STltEET gtDOR~SS ClT(STATI iIP cooEc 61tlier Med(car Center s~cr-dffiento ~025 Capitol Avenue- Saoramonto1 CA 95116$616 SAC~A~ENTO COUNTY
(x-1)0 SUMMARY 81ATEMENT OF DEMCIENCl~S 10 flRQVIOliRS PlAlf OF COR~ECTIOH lltS) PRPFIX (EA~H DFICfENCY Ul5T BE PRtClEtJED BY FlILL PREHlt iACl1 C MlCTlVEACTION SHOULD 01 CftOSSmiddot COMPLeTE
TA~ fte0ULA10Rl OR LSC 1J5fITJFYIMG INFORMATION TAO
nurse1s noteamp 11Pt now on comfort middotcare wJfe ready for morphJnato stait Patient 3s morphine drip
was stopped on 82817 al 125 am (1 hour 26 mlnule8 taler and a subsoquent nurses notes
Indicated middotbullgtt stopped pump wllhoul any alarms bag empty
middot Review of nurses notes daled 8128117 at 125 a111 indicated Upon checking lV pump noticed morphlna gll was completely empty withIV tubing full of air IV pump still running with green light pteSent no alarms present lV states volume
-infused bull15 ml Morphine gll turned oft charge RN (Registered Nuroe] on unit and nofi1ied [charge RN] checllted pump correclly set wllh lubing fully Inserted into channol correctlyBP [blood pressure) 8552 [normal blood pressure for a healthy adJlt Is 12080]
bullReview of e document titied Default Flowsheet Data middot in Palienl ls clinical recorti nvt~d b(ooU prassum from 3 am to (l am on 81017 ranged from 8148
to 69IS7 A nurses nole dated 828117 at 357 am indicated a Ould bolus wabull ordered to support blood
pressure
Morphine carries a black box warning which Is the Strongestwai-ning the United stated Food and 0mg Administration (US FDA) can require a manufacturer to pul on the drug label Part of the bloclt bogt
warning indlmlted LlfoffThreotening- Respiratory Deproaslon-Serious life-threatening or falal
middot respiratory clep(G$Slon may occur with middotuse of Morphine sulfate lnjacton Monitor for respiratory _depres$iOn1 e~pecially during lnitalion of Morphine
I 1middot I I i
I
I I i I I
I
bull I
I I I
I I
AEFEREiNC~D TO THEAPPROPRIATI= JEFCeNCV) AIE_____- Pharmacy accountable Pharmacy Director)
middotPharmacy reviews all medication related safety lssues and determines whether a posslble errorln IV medication admlnlstratlon has occurred1 or lf any error reached the patient
1818-32918 pump evaluation process Pharmacy dally report CUI) of flow events greater than 300 seconds oo 100 of infusion pumps
Those devices with flow events greater than 300 seconds were remiddotparted to the Nursing Department and BioMed removed from
patient use tagged and referred to BloMed (eQulp for diagnostic inspection
bull Dally reports run from 1282018 to 3282018 yielded 43 flow alarm events Upun Uiag11ostic insmicroectiqri and event investigation no free-flow of fluids occurred
Current process -Manufacturer Alarms Analytic Reports CQI) are compared to Medication Administration reports and the summary is reported to the Medlcation Safety Committee
Sterile Processing Department (SP
(Accountable-SP Manager)
All IV pumps are to be sent to SPD for ltleaning and dlsnfection SPD staff were educated in March 2018 reflectlng manufacturer
Evan IDVRSl11 121412018 9 recommendations StJff were also provided--------middot-----middotmiddotmiddot--------------- a checklist to assist in visual screening of tV
Paoo 7or 18 Sllaquota-2567
CIUFORNIA HEILTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
X-3j DA1~ SURV~Y(llt1) PROVID[JSUPPlHJRCLIA ()12) MULllfLE CONSinUCTIONSTATlMENT OP 01FtCICrlCIES COMPLElEO10euroNT1ElCAflON NUMelRANO PVN OF CORRECTION
ABlJlDING
ll MNGQS0108 12m1r201s
s-rtuer AODfi~Sa CITY STATEZlf CODINAMi o PR011DEROR SUPP-IER
2625 Capitol Av1mu1r Sliclamonto middotCA ~a1e-se1s SAC~AMfNTO COUNTYSutter Medical Centrr1 Sacramonto
volutrol) will be use_d on cert-a1n high
(X~)IPmiddot SUMMARr $1ATEMCNT OF DtFICllNCIES I 10 PROVIOE~$middotPWI o= COMliCTIQr1 1lt5
PREFIX TAO
1 (MCH DEFICIENCY MUST BF PRftEiOED OY FULL RtGULATbRY Oflt LSCIOENtlFYINO mFORMAflON)
ifUFIX
rw (EACH tDAREcnVEACTION SHOUW ae (ROSSshy
REF-ER-1-mo ro iHf PPPROP~IATE oertCIENCY) COMPLEtl
OAH
pumps for potential flaw which may lead to an IV pump failure All staff demonstrated
Sulfale Injection or foHowhg a dose increase competency on the cleaning and vlsual Becaubulls of delay in maximum CNS eflect wilh I
in1ravenou~ly administered morphine (30 min) rapid inspection of lnfusion pumps
IV administration may result In overdosing The March 2018 Trainllig will continue on new
information for morphine under warnings indical~d hire and annually thereafter Hypotensiva [low blood pressure Effeclmay lnltlal training completed March 2018
cause severe hypotenslor In Eln ndividu11l wlmse ability to maintain their blood pressure has beenI Actions detaled In this section are ongoing
I compromised by depleted blood volumeMorphine must be Injected slowly rapid Intravenous RN staff f Accountable -Chief Nursing
administration rnay result in chest wall Director
rigidity lncreased Risk of Seizures in Patients wtth Staff have been educated to perform vlsual
Seiiure Disordera EltcitaHon of the central nervous inspection of pumps screening for cracks and
system resulling in convulsions [seizure activity] pump Integrity prior to use Any pumps
i may accompany high doses of morphine given identified with Issues whlch may increase the irlrnvenou$ly 1
bull risk for medication administration errors are
(Retrieved rom removed from service and sent to blo med for httpslldaitymedntrnnihgovdally111eltldruglnfoclrn diagnostic testing EdUCi3tlon was provided In aetidbull5b96eB3a-d878-4dd5-8460-83a985db4609 bull 2017 and again in 2018 and was reinforced
1official provider of FDA lnforrnatrcn [package
IInserts])
during observation audlts detaBed in following action (112)
1Review of Patient 3s vit signs (11tood pressure heart rate elc) indicated that 111s MAP (mean or 2 The High Risk Medication Policy was
middot avera-ge arterial blood pressure during a single revised Revision Include
ca1middotdlac cycle MAP of at least 60 is necessal) lo perfuse the coronary arteries that supply blood to middot the middotheart brain ancl kidneys norroal range le ~pproximatcily 70 ~ 110) was ~bove 60 before the
Smtirt pumps are to be used on all cqntinuous infusions of high lt1lert med1catlon A volume ilmitlngchamber
middot morphine infusion was sarted on 8127117 at 11 59 alert medications administered by
middot prn Review of Patient 3s MAP after the morptlne continuous 1V Infusion through the
drip was stoppcI on 82B17 al 1 25 am indiooleltI large volume pump (LVP) module per lhat it lad dmpped lo 57 al aam Review of Patient
policy3S physician orders dated 8128117 at 4 15 am When a volume limiting ch[lmber is indicated IV Dopamine (used 10 treat low blood lndlc_ated a two~hourvolume wlll be pressure 0~10 microgramkllogrsrnmlnute lo be added to the chamber Use of the
volume limittngchamber will be 12142018
Verifyon the MAR and volutrol In the comment box
EvcnlDVRSl11 documented every shft with ~Rate
Slnte-2557
CAUFOlNIA HFALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STtT~MEMT 01 d-1Cl~NCIES (Y PROVtOtRISUPPLl8RCtb (X2) MIJLrlPLE CONSTRUCTION (lt3) DATE SURVEiV AND flA~I Oi CORRECTION IDlUtfFC110N NUMBER COMfgtl[lYEO
A OlJflD1NG
050100 H WING 12107201$
NPME OF PROVJOSR Oil SUPPLIER SmEar ADDRESS CITY 9TATEZIP CODE
6utwr Medlc1atl Oentor1 Saotamonto 282S CiJpitO VQnun1Sutamcmtltgt CA 95816bullS616 SACRAMENTO COUNTY
X~ rLl PfitPlr
1AO
SUMMRY STATEMENT OF OlF1CllNC1es (ECl-1 OEf1CIENCf MUST nE PRECEeom Blt FUL 1u0ulATORYOR lSC DlNTIFYJNG l~fCJRMTlON)
titrated every 10 rnltmles far a 0081 of MAP between 60 and 65
IReview of physi9ian notes dated B28117 al 350 am indicated RN called to report 250 mg bag of morphine poeslbly given to tho patient over one haurMay use BIPAP to support breathing
Review of-the Palent 1bull Completed Medication Record Indicate( that Dopamine was started al 444 am on 8128117 for MAP less than 60
IReview of nurses ncles dale~ 828ffal 555 am lndica1ad 1New orders received ta $lop pressors middot [dopamine] anti remove BIPAP Nurses nbte dated 8128117 at 612 am indicated BIPAP removed
On 828117 al 633-am Patiertl 3 was pronounced dead The ciniral record indicated there were no orders lab res11Jls ot btood draws lo meijsure rno1microhine loXlcHy levels fonowing lhe ldenliUcaion of
the empty morphine bag Patient 3s discharge 1summe~ summary of U1e major treatments andIevents while hospilolited) doled 62B117 al 668 l am did not-address morphinG odministration
The above findingbull were aclltnowledgad by the iADHO (Mministrative Director of Hospital bullOperations) during lnle111lews on middotf24118 at 920 am and on i26118 at 15middot1 pm and with RN 8 on 112618 ot 10 am
middot During t1n inlervlew cm 12Rf18 at 258 p m bull RN 6 staled tlial on 812717 he started Patient 3bull
morphine infusion (11 69 pm per MAR) wilh tle
ID PR~F1X rG
PfJOYDEtS NAN Of COARlCTION x~
llACtt CDRRECTIW ACTlON SHOUlD ae CROSSshy COMPL~TC REFERENCEO TO fl-I AfPROfRIAT OlfCIENCf) OAre
In the event that a volume limftlng chamber Is n6t uvailabte for in indicated hgh alert medication st-aff wlll documentRate Verify (as defined in the Medication Administration policy) on the MAR every2 hours Independent double-checks The SMCS list of medications requiring an independent double-check may not match the EHR list for dual signature rnedications Alternative documentation may be employed so that SMCS staff can align their documentation with the SMCS standard (eg add a co-sign with a note lri MAR use 11given not co-signed option when a co-signature ts not required
3 The Medication Administration Policy was revised Revision Include Use of the LV Pump
i Choose the appropriate age- weght- andor unlt--1nsud prmiddotorne when starting the Infusion pump
b Enter the patients M edcal Record Number (MRN) when asked for Patient ID
t The Guardrails drug lbrary rs to be used for all medications unless the particular- drug does not exist in the library
d Only those medkations with the bolus feijture built Into the pump for that drug may be bolused from the pump
1211412016Even IDVRSlI I
Page Oo 18 Sate2587
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HEAL7H AND HUMAN SEHVICES AGEHCY DEPARTMENT OF PUBLIC HEALTH
STAIEMENT OF DruCliJJCOS x1) PAOVIDEWSUPPLl~RCLIA X) MULTIPIE CONSTRUCTION ((~) FJATE SURVEY
ANO flLJJq DF CORRECl10N lDENllFICATION NUMEtf(middot COMPtllO
AllUtLDrNC3
aso1oa SWING 121072018
ilAME OF PROVfDR OR StlfPUER SWIHrflOOHms CITY STATE lP COOi
SultGr Mndi~I CGnh1t1 Sacramonto 2025 Capitol Avem1~ Sairamoneo CA 9Sa1(~SM6 SACRAMBlliO COUNTY
)(4)11) BUMMRi SlArEMCITT OF DFICiENCIES 10 PROVIDERS Pl11-l Ofl CORREOlON (lt5)
P~EFX (12ACH OlFCIENCY MUST flE PRECEEDEO av iuLL PRfHX (~ACH cORBECTIVE ACTION ~HDVLO ee CROSS- COMJLlTE tAG REPEREMCEP Ttl THE AilPR PRIArE 0euroFICJENCY1 OAflTAG RGULATORY OR LSC 108Nrl~YtIIG 1NFORMATl0N)
1----+------------------+---~~-------middotmiddot-Sio med staff~ accountable -Bto Med Director)
implemented to ensure safe adminisVation practlca 61 medlctlons tdentlfiM wilh high potential for Bio Med reports on pump maintenance devaslatlng consequences If an error occurs and evaluations andvolume of Issues resolved and
2) Medlcelions were administered per physician or number of pumps removed from servtce middotorder when Patfanl 3 wa)i adrnntstered 50 mllllgram (mg) of IV (inlravenoosly ln)ecled Uirough Sterile Processing Departrnent (SPO
i lhe vein) morphine a potent nareolic for part) over (Accountable -SPD Manager)Ione and a half hours Instead of the preoribed 1 mg per hour SPD reports on dlslnfectlon processes and
pump lflegrity escalations to Bio Med AH IV The medloalion ortor exposed Patient a to effects of pumps are sent to SPD for deaning and middot morphine overdose (166 times he precrtbed dose) disinfection including low blood pressure and subsequent death
RN staff (Accountable Chief N~rsingIFioding Director)
Review of PaUent Ds ci11ica[ record indicated he Nursing representation revlews and reports
middot was admitted to the facility on 8111117 for acule on documentation audits and concurrent
cespirnloiy failure (Inability of the lungs to maintain ntervlew audits for v1sual inspection rate n_orrnal respiratory functfon) P~Oant 3 n~ed0d high verification and volume llrnitlng chambers flow oxygen lnto lhe nose tn ensure oxygen delivery Actionsto blood and organs
I Actions taken to ensure that corrective actions i Review of Patient 3s physician orders dated
were effectivemiddot 827117 at345 pm Indicated morphine 250 mg in NaCl 09 [saline solullon] 250 ml [rnillillter) IV Drip The hospital developed corrective- actions [pronixed in tile pharmacy] CONTINUOUS
trorn the an~lyss of events1 informationconfinuousty lt1dminlstored ot the specified ral~l
obtained from the manufacturer exter-nal middot Initial dose 1 mghour [1mllhr (hour) is equal to 1 sources and subsequent internal Investigationmg of morphinehr] findings Interventions deslgned to prevent IV pump medication errors Including free flow Revlew of Patient 3s MAR (medicetion
admlnislratlon record) ndicaled the n~orphlne drip events have been added ta medication management pollltles procedures was started on 827117 at 854 pnt and slopped at
[902 prn (S minutes later)
12142018 90420MEve-nl IDVRSlI 1
Paso 5of rn Stote~2567
CALIFORNIA HEALH AND HUMAN SERVICES AGEHGY DEPARTMENT OF PUBLIC HlAJTH
STAffeM~NT 01 dfflCJENCJES ANO PlAM or CORReCTION
NMtE OF PROVIOlR OR 51JPfgtllER
(XU PROV[iRISUPlgtUERICLII (X2) MIJTJPle CONsrnucnm1 IOENltPICATION ilJMBlH
A tlUILOING
D5ofoa - e w~Q
STREET ffiDRESS (IT( $TiT ZIP CODG
X3f DAT~ SURJEV COMfl~tlO
12072018
Suitor Medical Glfrac14ntor Sacramento 2825 C~pitol Avenue Sacrnmonto CA Sml1GSG10 SACRPiMENiO COLINrr
-(X4) D SUMMIRY STATE MtNT OF OlFCIEIICES JOPREFIX EACH OEFJCll1fJCV MUST BE PRlC161)i llY FULL PREF(
TAO REGUcATOt(V OR ISC 10GHill1ilNG NFOFIMA110t~)
[ Review of Patient 3s nursing notes dated 6127117 bullindicated -At 902 pm pt [pa~enl) wih deocease In RR [respiratory rateJ oxygen saturalion down to 70s
Morphine gtt [drip Infusion tumed oft
bull At 906 pm EICU (Eleclronic Intensive Care Uni] called no rall back from PMA [Pulmonary iMedicine Altendin~] pt with sz [seizure- sudden I uncontrolled electrical diolurbance In themiddot brain] middot activity lasting about 25- secondsmiddot bull At 907 pm Dr returned page Updated on siwaian New order received lo start on BIPAP middot [bl-level posillve airway pressure is a type of device that helps with breathing] bull At 927 pm Dra bedside Discussing situation 1w1thwie l middot At 950 pm Decision made by wifewith Dr middot present lo transition to comfort care care directed al preventing or relieving suffering at end or llfeJ
During an interview on 126118 al 258 pm RN 6 middot verified Iha shorlly aner the morphine drip was lnitialed on 82717 Patient 31s respirat13ry rale and bulloxygen saturation dropped RN 6 slated he had stepped the morphine and called Resplralory
Therapy and the MD Mediltlel OoclorJ
Review of Potlent 3s physician orders dated 8127117 at 1052 prn lndlcalcd morphine 250 mg in NaCl 09 250 ml IV Drip CONTINUOUSdose 1mghour
Patient 3s MAR for 812717 Indicated the morphine drip was restarted at 11 59 pm with a comment In
PROVIDERS PLAN Of cortReCTION
IEIICH CORMCTIV~NntON StWUID BE CROSS-PlFERENCEO TOlHE APPROPRIATE DEFICJENCi)
i Bio med staff~ laccountab1e -Bic Med Director)
Education - BloMed (eQuip)
All staff demonstrate competency for diagnostic Inspection and repair per manufacturer guidelines Completed 318 100 of IV pumps were Inspected and tested per manufacturers recomrnendatlon Pump manufacturer blo techs remained n site and assisted wlth the revlew1 until completed All preventative maintenance and repairs are documented in our computerized maintenance middotmanagement system (CMMS) Bia-med comp1ete_sa scheduled at least annuaHy preventatlve maintenance inspection on all pump lnfwon pumps utilizing the Pump System Maintenance software At the completion of the inspection a sticker is placed on the device 1ndlcating date of current lnspectlon date of ~ext Inspection and name of Inspector Any IV pump that does not pass its scheduled
ix
I CO1IPlalE
OAlE
inspection per manufacturer-guidelinessoftware or is ldentlfled by frontline staff or pharmacy through medication safety reporting ls tagged sequestered from dincal areas and steps will be takeh by Bto-med If there ls a repeated failure of the same type during the preventative maintenance inspection window not to exceed one year) the pump Is referred to Risk Management for further action
Actions detaled in this section are ongoing
Evenl IDVRSlmiddot1 middotI 12~42018
Page 6 of 18 Stsle-2567
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PU6LIC HEALTH
STA1EMEITT OF OEFIClCNcms (X1 I PROVIDERISVPPLIERfClA (Y2J MULTPL6 COMTRUCTON (X3) DATE SURVE IDENTFICiATON NUitU3RANO PLAH OF CORRECTION CoMrLIHEO
A-BUllOiOO
8 MNG05010_ 121071203
~fN1E OF lROVOlR OR SJPftJiR STltEET gtDOR~SS ClT(STATI iIP cooEc 61tlier Med(car Center s~cr-dffiento ~025 Capitol Avenue- Saoramonto1 CA 95116$616 SAC~A~ENTO COUNTY
(x-1)0 SUMMARY 81ATEMENT OF DEMCIENCl~S 10 flRQVIOliRS PlAlf OF COR~ECTIOH lltS) PRPFIX (EA~H DFICfENCY Ul5T BE PRtClEtJED BY FlILL PREHlt iACl1 C MlCTlVEACTION SHOULD 01 CftOSSmiddot COMPLeTE
TA~ fte0ULA10Rl OR LSC 1J5fITJFYIMG INFORMATION TAO
nurse1s noteamp 11Pt now on comfort middotcare wJfe ready for morphJnato stait Patient 3s morphine drip
was stopped on 82817 al 125 am (1 hour 26 mlnule8 taler and a subsoquent nurses notes
Indicated middotbullgtt stopped pump wllhoul any alarms bag empty
middot Review of nurses notes daled 8128117 at 125 a111 indicated Upon checking lV pump noticed morphlna gll was completely empty withIV tubing full of air IV pump still running with green light pteSent no alarms present lV states volume
-infused bull15 ml Morphine gll turned oft charge RN (Registered Nuroe] on unit and nofi1ied [charge RN] checllted pump correclly set wllh lubing fully Inserted into channol correctlyBP [blood pressure) 8552 [normal blood pressure for a healthy adJlt Is 12080]
bullReview of e document titied Default Flowsheet Data middot in Palienl ls clinical recorti nvt~d b(ooU prassum from 3 am to (l am on 81017 ranged from 8148
to 69IS7 A nurses nole dated 828117 at 357 am indicated a Ould bolus wabull ordered to support blood
pressure
Morphine carries a black box warning which Is the Strongestwai-ning the United stated Food and 0mg Administration (US FDA) can require a manufacturer to pul on the drug label Part of the bloclt bogt
warning indlmlted LlfoffThreotening- Respiratory Deproaslon-Serious life-threatening or falal
middot respiratory clep(G$Slon may occur with middotuse of Morphine sulfate lnjacton Monitor for respiratory _depres$iOn1 e~pecially during lnitalion of Morphine
I 1middot I I i
I
I I i I I
I
bull I
I I I
I I
AEFEREiNC~D TO THEAPPROPRIATI= JEFCeNCV) AIE_____- Pharmacy accountable Pharmacy Director)
middotPharmacy reviews all medication related safety lssues and determines whether a posslble errorln IV medication admlnlstratlon has occurred1 or lf any error reached the patient
1818-32918 pump evaluation process Pharmacy dally report CUI) of flow events greater than 300 seconds oo 100 of infusion pumps
Those devices with flow events greater than 300 seconds were remiddotparted to the Nursing Department and BioMed removed from
patient use tagged and referred to BloMed (eQulp for diagnostic inspection
bull Dally reports run from 1282018 to 3282018 yielded 43 flow alarm events Upun Uiag11ostic insmicroectiqri and event investigation no free-flow of fluids occurred
Current process -Manufacturer Alarms Analytic Reports CQI) are compared to Medication Administration reports and the summary is reported to the Medlcation Safety Committee
Sterile Processing Department (SP
(Accountable-SP Manager)
All IV pumps are to be sent to SPD for ltleaning and dlsnfection SPD staff were educated in March 2018 reflectlng manufacturer
Evan IDVRSl11 121412018 9 recommendations StJff were also provided--------middot-----middotmiddotmiddot--------------- a checklist to assist in visual screening of tV
Paoo 7or 18 Sllaquota-2567
CIUFORNIA HEILTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
X-3j DA1~ SURV~Y(llt1) PROVID[JSUPPlHJRCLIA ()12) MULllfLE CONSinUCTIONSTATlMENT OP 01FtCICrlCIES COMPLElEO10euroNT1ElCAflON NUMelRANO PVN OF CORRECTION
ABlJlDING
ll MNGQS0108 12m1r201s
s-rtuer AODfi~Sa CITY STATEZlf CODINAMi o PR011DEROR SUPP-IER
2625 Capitol Av1mu1r Sliclamonto middotCA ~a1e-se1s SAC~AMfNTO COUNTYSutter Medical Centrr1 Sacramonto
volutrol) will be use_d on cert-a1n high
(X~)IPmiddot SUMMARr $1ATEMCNT OF DtFICllNCIES I 10 PROVIOE~$middotPWI o= COMliCTIQr1 1lt5
PREFIX TAO
1 (MCH DEFICIENCY MUST BF PRftEiOED OY FULL RtGULATbRY Oflt LSCIOENtlFYINO mFORMAflON)
ifUFIX
rw (EACH tDAREcnVEACTION SHOUW ae (ROSSshy
REF-ER-1-mo ro iHf PPPROP~IATE oertCIENCY) COMPLEtl
OAH
pumps for potential flaw which may lead to an IV pump failure All staff demonstrated
Sulfale Injection or foHowhg a dose increase competency on the cleaning and vlsual Becaubulls of delay in maximum CNS eflect wilh I
in1ravenou~ly administered morphine (30 min) rapid inspection of lnfusion pumps
IV administration may result In overdosing The March 2018 Trainllig will continue on new
information for morphine under warnings indical~d hire and annually thereafter Hypotensiva [low blood pressure Effeclmay lnltlal training completed March 2018
cause severe hypotenslor In Eln ndividu11l wlmse ability to maintain their blood pressure has beenI Actions detaled In this section are ongoing
I compromised by depleted blood volumeMorphine must be Injected slowly rapid Intravenous RN staff f Accountable -Chief Nursing
administration rnay result in chest wall Director
rigidity lncreased Risk of Seizures in Patients wtth Staff have been educated to perform vlsual
Seiiure Disordera EltcitaHon of the central nervous inspection of pumps screening for cracks and
system resulling in convulsions [seizure activity] pump Integrity prior to use Any pumps
i may accompany high doses of morphine given identified with Issues whlch may increase the irlrnvenou$ly 1
bull risk for medication administration errors are
(Retrieved rom removed from service and sent to blo med for httpslldaitymedntrnnihgovdally111eltldruglnfoclrn diagnostic testing EdUCi3tlon was provided In aetidbull5b96eB3a-d878-4dd5-8460-83a985db4609 bull 2017 and again in 2018 and was reinforced
1official provider of FDA lnforrnatrcn [package
IInserts])
during observation audlts detaBed in following action (112)
1Review of Patient 3s vit signs (11tood pressure heart rate elc) indicated that 111s MAP (mean or 2 The High Risk Medication Policy was
middot avera-ge arterial blood pressure during a single revised Revision Include
ca1middotdlac cycle MAP of at least 60 is necessal) lo perfuse the coronary arteries that supply blood to middot the middotheart brain ancl kidneys norroal range le ~pproximatcily 70 ~ 110) was ~bove 60 before the
Smtirt pumps are to be used on all cqntinuous infusions of high lt1lert med1catlon A volume ilmitlngchamber
middot morphine infusion was sarted on 8127117 at 11 59 alert medications administered by
middot prn Review of Patient 3s MAP after the morptlne continuous 1V Infusion through the
drip was stoppcI on 82B17 al 1 25 am indiooleltI large volume pump (LVP) module per lhat it lad dmpped lo 57 al aam Review of Patient
policy3S physician orders dated 8128117 at 4 15 am When a volume limiting ch[lmber is indicated IV Dopamine (used 10 treat low blood lndlc_ated a two~hourvolume wlll be pressure 0~10 microgramkllogrsrnmlnute lo be added to the chamber Use of the
volume limittngchamber will be 12142018
Verifyon the MAR and volutrol In the comment box
EvcnlDVRSl11 documented every shft with ~Rate
Slnte-2557
CAUFOlNIA HFALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STtT~MEMT 01 d-1Cl~NCIES (Y PROVtOtRISUPPLl8RCtb (X2) MIJLrlPLE CONSTRUCTION (lt3) DATE SURVEiV AND flA~I Oi CORRECTION IDlUtfFC110N NUMBER COMfgtl[lYEO
A OlJflD1NG
050100 H WING 12107201$
NPME OF PROVJOSR Oil SUPPLIER SmEar ADDRESS CITY 9TATEZIP CODE
6utwr Medlc1atl Oentor1 Saotamonto 282S CiJpitO VQnun1Sutamcmtltgt CA 95816bullS616 SACRAMENTO COUNTY
X~ rLl PfitPlr
1AO
SUMMRY STATEMENT OF OlF1CllNC1es (ECl-1 OEf1CIENCf MUST nE PRECEeom Blt FUL 1u0ulATORYOR lSC DlNTIFYJNG l~fCJRMTlON)
titrated every 10 rnltmles far a 0081 of MAP between 60 and 65
IReview of physi9ian notes dated B28117 al 350 am indicated RN called to report 250 mg bag of morphine poeslbly given to tho patient over one haurMay use BIPAP to support breathing
Review of-the Palent 1bull Completed Medication Record Indicate( that Dopamine was started al 444 am on 8128117 for MAP less than 60
IReview of nurses ncles dale~ 828ffal 555 am lndica1ad 1New orders received ta $lop pressors middot [dopamine] anti remove BIPAP Nurses nbte dated 8128117 at 612 am indicated BIPAP removed
On 828117 al 633-am Patiertl 3 was pronounced dead The ciniral record indicated there were no orders lab res11Jls ot btood draws lo meijsure rno1microhine loXlcHy levels fonowing lhe ldenliUcaion of
the empty morphine bag Patient 3s discharge 1summe~ summary of U1e major treatments andIevents while hospilolited) doled 62B117 al 668 l am did not-address morphinG odministration
The above findingbull were aclltnowledgad by the iADHO (Mministrative Director of Hospital bullOperations) during lnle111lews on middotf24118 at 920 am and on i26118 at 15middot1 pm and with RN 8 on 112618 ot 10 am
middot During t1n inlervlew cm 12Rf18 at 258 p m bull RN 6 staled tlial on 812717 he started Patient 3bull
morphine infusion (11 69 pm per MAR) wilh tle
ID PR~F1X rG
PfJOYDEtS NAN Of COARlCTION x~
llACtt CDRRECTIW ACTlON SHOUlD ae CROSSshy COMPL~TC REFERENCEO TO fl-I AfPROfRIAT OlfCIENCf) OAre
In the event that a volume limftlng chamber Is n6t uvailabte for in indicated hgh alert medication st-aff wlll documentRate Verify (as defined in the Medication Administration policy) on the MAR every2 hours Independent double-checks The SMCS list of medications requiring an independent double-check may not match the EHR list for dual signature rnedications Alternative documentation may be employed so that SMCS staff can align their documentation with the SMCS standard (eg add a co-sign with a note lri MAR use 11given not co-signed option when a co-signature ts not required
3 The Medication Administration Policy was revised Revision Include Use of the LV Pump
i Choose the appropriate age- weght- andor unlt--1nsud prmiddotorne when starting the Infusion pump
b Enter the patients M edcal Record Number (MRN) when asked for Patient ID
t The Guardrails drug lbrary rs to be used for all medications unless the particular- drug does not exist in the library
d Only those medkations with the bolus feijture built Into the pump for that drug may be bolused from the pump
1211412016Even IDVRSlI I
Page Oo 18 Sate2587
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HEALH AND HUMAN SERVICES AGEHGY DEPARTMENT OF PUBLIC HlAJTH
STAffeM~NT 01 dfflCJENCJES ANO PlAM or CORReCTION
NMtE OF PROVIOlR OR 51JPfgtllER
(XU PROV[iRISUPlgtUERICLII (X2) MIJTJPle CONsrnucnm1 IOENltPICATION ilJMBlH
A tlUILOING
D5ofoa - e w~Q
STREET ffiDRESS (IT( $TiT ZIP CODG
X3f DAT~ SURJEV COMfl~tlO
12072018
Suitor Medical Glfrac14ntor Sacramento 2825 C~pitol Avenue Sacrnmonto CA Sml1GSG10 SACRPiMENiO COLINrr
-(X4) D SUMMIRY STATE MtNT OF OlFCIEIICES JOPREFIX EACH OEFJCll1fJCV MUST BE PRlC161)i llY FULL PREF(
TAO REGUcATOt(V OR ISC 10GHill1ilNG NFOFIMA110t~)
[ Review of Patient 3s nursing notes dated 6127117 bullindicated -At 902 pm pt [pa~enl) wih deocease In RR [respiratory rateJ oxygen saturalion down to 70s
Morphine gtt [drip Infusion tumed oft
bull At 906 pm EICU (Eleclronic Intensive Care Uni] called no rall back from PMA [Pulmonary iMedicine Altendin~] pt with sz [seizure- sudden I uncontrolled electrical diolurbance In themiddot brain] middot activity lasting about 25- secondsmiddot bull At 907 pm Dr returned page Updated on siwaian New order received lo start on BIPAP middot [bl-level posillve airway pressure is a type of device that helps with breathing] bull At 927 pm Dra bedside Discussing situation 1w1thwie l middot At 950 pm Decision made by wifewith Dr middot present lo transition to comfort care care directed al preventing or relieving suffering at end or llfeJ
During an interview on 126118 al 258 pm RN 6 middot verified Iha shorlly aner the morphine drip was lnitialed on 82717 Patient 31s respirat13ry rale and bulloxygen saturation dropped RN 6 slated he had stepped the morphine and called Resplralory
Therapy and the MD Mediltlel OoclorJ
Review of Potlent 3s physician orders dated 8127117 at 1052 prn lndlcalcd morphine 250 mg in NaCl 09 250 ml IV Drip CONTINUOUSdose 1mghour
Patient 3s MAR for 812717 Indicated the morphine drip was restarted at 11 59 pm with a comment In
PROVIDERS PLAN Of cortReCTION
IEIICH CORMCTIV~NntON StWUID BE CROSS-PlFERENCEO TOlHE APPROPRIATE DEFICJENCi)
i Bio med staff~ laccountab1e -Bic Med Director)
Education - BloMed (eQuip)
All staff demonstrate competency for diagnostic Inspection and repair per manufacturer guidelines Completed 318 100 of IV pumps were Inspected and tested per manufacturers recomrnendatlon Pump manufacturer blo techs remained n site and assisted wlth the revlew1 until completed All preventative maintenance and repairs are documented in our computerized maintenance middotmanagement system (CMMS) Bia-med comp1ete_sa scheduled at least annuaHy preventatlve maintenance inspection on all pump lnfwon pumps utilizing the Pump System Maintenance software At the completion of the inspection a sticker is placed on the device 1ndlcating date of current lnspectlon date of ~ext Inspection and name of Inspector Any IV pump that does not pass its scheduled
ix
I CO1IPlalE
OAlE
inspection per manufacturer-guidelinessoftware or is ldentlfled by frontline staff or pharmacy through medication safety reporting ls tagged sequestered from dincal areas and steps will be takeh by Bto-med If there ls a repeated failure of the same type during the preventative maintenance inspection window not to exceed one year) the pump Is referred to Risk Management for further action
Actions detaled in this section are ongoing
Evenl IDVRSlmiddot1 middotI 12~42018
Page 6 of 18 Stsle-2567
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PU6LIC HEALTH
STA1EMEITT OF OEFIClCNcms (X1 I PROVIDERISVPPLIERfClA (Y2J MULTPL6 COMTRUCTON (X3) DATE SURVE IDENTFICiATON NUitU3RANO PLAH OF CORRECTION CoMrLIHEO
A-BUllOiOO
8 MNG05010_ 121071203
~fN1E OF lROVOlR OR SJPftJiR STltEET gtDOR~SS ClT(STATI iIP cooEc 61tlier Med(car Center s~cr-dffiento ~025 Capitol Avenue- Saoramonto1 CA 95116$616 SAC~A~ENTO COUNTY
(x-1)0 SUMMARY 81ATEMENT OF DEMCIENCl~S 10 flRQVIOliRS PlAlf OF COR~ECTIOH lltS) PRPFIX (EA~H DFICfENCY Ul5T BE PRtClEtJED BY FlILL PREHlt iACl1 C MlCTlVEACTION SHOULD 01 CftOSSmiddot COMPLeTE
TA~ fte0ULA10Rl OR LSC 1J5fITJFYIMG INFORMATION TAO
nurse1s noteamp 11Pt now on comfort middotcare wJfe ready for morphJnato stait Patient 3s morphine drip
was stopped on 82817 al 125 am (1 hour 26 mlnule8 taler and a subsoquent nurses notes
Indicated middotbullgtt stopped pump wllhoul any alarms bag empty
middot Review of nurses notes daled 8128117 at 125 a111 indicated Upon checking lV pump noticed morphlna gll was completely empty withIV tubing full of air IV pump still running with green light pteSent no alarms present lV states volume
-infused bull15 ml Morphine gll turned oft charge RN (Registered Nuroe] on unit and nofi1ied [charge RN] checllted pump correclly set wllh lubing fully Inserted into channol correctlyBP [blood pressure) 8552 [normal blood pressure for a healthy adJlt Is 12080]
bullReview of e document titied Default Flowsheet Data middot in Palienl ls clinical recorti nvt~d b(ooU prassum from 3 am to (l am on 81017 ranged from 8148
to 69IS7 A nurses nole dated 828117 at 357 am indicated a Ould bolus wabull ordered to support blood
pressure
Morphine carries a black box warning which Is the Strongestwai-ning the United stated Food and 0mg Administration (US FDA) can require a manufacturer to pul on the drug label Part of the bloclt bogt
warning indlmlted LlfoffThreotening- Respiratory Deproaslon-Serious life-threatening or falal
middot respiratory clep(G$Slon may occur with middotuse of Morphine sulfate lnjacton Monitor for respiratory _depres$iOn1 e~pecially during lnitalion of Morphine
I 1middot I I i
I
I I i I I
I
bull I
I I I
I I
AEFEREiNC~D TO THEAPPROPRIATI= JEFCeNCV) AIE_____- Pharmacy accountable Pharmacy Director)
middotPharmacy reviews all medication related safety lssues and determines whether a posslble errorln IV medication admlnlstratlon has occurred1 or lf any error reached the patient
1818-32918 pump evaluation process Pharmacy dally report CUI) of flow events greater than 300 seconds oo 100 of infusion pumps
Those devices with flow events greater than 300 seconds were remiddotparted to the Nursing Department and BioMed removed from
patient use tagged and referred to BloMed (eQulp for diagnostic inspection
bull Dally reports run from 1282018 to 3282018 yielded 43 flow alarm events Upun Uiag11ostic insmicroectiqri and event investigation no free-flow of fluids occurred
Current process -Manufacturer Alarms Analytic Reports CQI) are compared to Medication Administration reports and the summary is reported to the Medlcation Safety Committee
Sterile Processing Department (SP
(Accountable-SP Manager)
All IV pumps are to be sent to SPD for ltleaning and dlsnfection SPD staff were educated in March 2018 reflectlng manufacturer
Evan IDVRSl11 121412018 9 recommendations StJff were also provided--------middot-----middotmiddotmiddot--------------- a checklist to assist in visual screening of tV
Paoo 7or 18 Sllaquota-2567
CIUFORNIA HEILTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
X-3j DA1~ SURV~Y(llt1) PROVID[JSUPPlHJRCLIA ()12) MULllfLE CONSinUCTIONSTATlMENT OP 01FtCICrlCIES COMPLElEO10euroNT1ElCAflON NUMelRANO PVN OF CORRECTION
ABlJlDING
ll MNGQS0108 12m1r201s
s-rtuer AODfi~Sa CITY STATEZlf CODINAMi o PR011DEROR SUPP-IER
2625 Capitol Av1mu1r Sliclamonto middotCA ~a1e-se1s SAC~AMfNTO COUNTYSutter Medical Centrr1 Sacramonto
volutrol) will be use_d on cert-a1n high
(X~)IPmiddot SUMMARr $1ATEMCNT OF DtFICllNCIES I 10 PROVIOE~$middotPWI o= COMliCTIQr1 1lt5
PREFIX TAO
1 (MCH DEFICIENCY MUST BF PRftEiOED OY FULL RtGULATbRY Oflt LSCIOENtlFYINO mFORMAflON)
ifUFIX
rw (EACH tDAREcnVEACTION SHOUW ae (ROSSshy
REF-ER-1-mo ro iHf PPPROP~IATE oertCIENCY) COMPLEtl
OAH
pumps for potential flaw which may lead to an IV pump failure All staff demonstrated
Sulfale Injection or foHowhg a dose increase competency on the cleaning and vlsual Becaubulls of delay in maximum CNS eflect wilh I
in1ravenou~ly administered morphine (30 min) rapid inspection of lnfusion pumps
IV administration may result In overdosing The March 2018 Trainllig will continue on new
information for morphine under warnings indical~d hire and annually thereafter Hypotensiva [low blood pressure Effeclmay lnltlal training completed March 2018
cause severe hypotenslor In Eln ndividu11l wlmse ability to maintain their blood pressure has beenI Actions detaled In this section are ongoing
I compromised by depleted blood volumeMorphine must be Injected slowly rapid Intravenous RN staff f Accountable -Chief Nursing
administration rnay result in chest wall Director
rigidity lncreased Risk of Seizures in Patients wtth Staff have been educated to perform vlsual
Seiiure Disordera EltcitaHon of the central nervous inspection of pumps screening for cracks and
system resulling in convulsions [seizure activity] pump Integrity prior to use Any pumps
i may accompany high doses of morphine given identified with Issues whlch may increase the irlrnvenou$ly 1
bull risk for medication administration errors are
(Retrieved rom removed from service and sent to blo med for httpslldaitymedntrnnihgovdally111eltldruglnfoclrn diagnostic testing EdUCi3tlon was provided In aetidbull5b96eB3a-d878-4dd5-8460-83a985db4609 bull 2017 and again in 2018 and was reinforced
1official provider of FDA lnforrnatrcn [package
IInserts])
during observation audlts detaBed in following action (112)
1Review of Patient 3s vit signs (11tood pressure heart rate elc) indicated that 111s MAP (mean or 2 The High Risk Medication Policy was
middot avera-ge arterial blood pressure during a single revised Revision Include
ca1middotdlac cycle MAP of at least 60 is necessal) lo perfuse the coronary arteries that supply blood to middot the middotheart brain ancl kidneys norroal range le ~pproximatcily 70 ~ 110) was ~bove 60 before the
Smtirt pumps are to be used on all cqntinuous infusions of high lt1lert med1catlon A volume ilmitlngchamber
middot morphine infusion was sarted on 8127117 at 11 59 alert medications administered by
middot prn Review of Patient 3s MAP after the morptlne continuous 1V Infusion through the
drip was stoppcI on 82B17 al 1 25 am indiooleltI large volume pump (LVP) module per lhat it lad dmpped lo 57 al aam Review of Patient
policy3S physician orders dated 8128117 at 4 15 am When a volume limiting ch[lmber is indicated IV Dopamine (used 10 treat low blood lndlc_ated a two~hourvolume wlll be pressure 0~10 microgramkllogrsrnmlnute lo be added to the chamber Use of the
volume limittngchamber will be 12142018
Verifyon the MAR and volutrol In the comment box
EvcnlDVRSl11 documented every shft with ~Rate
Slnte-2557
CAUFOlNIA HFALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STtT~MEMT 01 d-1Cl~NCIES (Y PROVtOtRISUPPLl8RCtb (X2) MIJLrlPLE CONSTRUCTION (lt3) DATE SURVEiV AND flA~I Oi CORRECTION IDlUtfFC110N NUMBER COMfgtl[lYEO
A OlJflD1NG
050100 H WING 12107201$
NPME OF PROVJOSR Oil SUPPLIER SmEar ADDRESS CITY 9TATEZIP CODE
6utwr Medlc1atl Oentor1 Saotamonto 282S CiJpitO VQnun1Sutamcmtltgt CA 95816bullS616 SACRAMENTO COUNTY
X~ rLl PfitPlr
1AO
SUMMRY STATEMENT OF OlF1CllNC1es (ECl-1 OEf1CIENCf MUST nE PRECEeom Blt FUL 1u0ulATORYOR lSC DlNTIFYJNG l~fCJRMTlON)
titrated every 10 rnltmles far a 0081 of MAP between 60 and 65
IReview of physi9ian notes dated B28117 al 350 am indicated RN called to report 250 mg bag of morphine poeslbly given to tho patient over one haurMay use BIPAP to support breathing
Review of-the Palent 1bull Completed Medication Record Indicate( that Dopamine was started al 444 am on 8128117 for MAP less than 60
IReview of nurses ncles dale~ 828ffal 555 am lndica1ad 1New orders received ta $lop pressors middot [dopamine] anti remove BIPAP Nurses nbte dated 8128117 at 612 am indicated BIPAP removed
On 828117 al 633-am Patiertl 3 was pronounced dead The ciniral record indicated there were no orders lab res11Jls ot btood draws lo meijsure rno1microhine loXlcHy levels fonowing lhe ldenliUcaion of
the empty morphine bag Patient 3s discharge 1summe~ summary of U1e major treatments andIevents while hospilolited) doled 62B117 al 668 l am did not-address morphinG odministration
The above findingbull were aclltnowledgad by the iADHO (Mministrative Director of Hospital bullOperations) during lnle111lews on middotf24118 at 920 am and on i26118 at 15middot1 pm and with RN 8 on 112618 ot 10 am
middot During t1n inlervlew cm 12Rf18 at 258 p m bull RN 6 staled tlial on 812717 he started Patient 3bull
morphine infusion (11 69 pm per MAR) wilh tle
ID PR~F1X rG
PfJOYDEtS NAN Of COARlCTION x~
llACtt CDRRECTIW ACTlON SHOUlD ae CROSSshy COMPL~TC REFERENCEO TO fl-I AfPROfRIAT OlfCIENCf) OAre
In the event that a volume limftlng chamber Is n6t uvailabte for in indicated hgh alert medication st-aff wlll documentRate Verify (as defined in the Medication Administration policy) on the MAR every2 hours Independent double-checks The SMCS list of medications requiring an independent double-check may not match the EHR list for dual signature rnedications Alternative documentation may be employed so that SMCS staff can align their documentation with the SMCS standard (eg add a co-sign with a note lri MAR use 11given not co-signed option when a co-signature ts not required
3 The Medication Administration Policy was revised Revision Include Use of the LV Pump
i Choose the appropriate age- weght- andor unlt--1nsud prmiddotorne when starting the Infusion pump
b Enter the patients M edcal Record Number (MRN) when asked for Patient ID
t The Guardrails drug lbrary rs to be used for all medications unless the particular- drug does not exist in the library
d Only those medkations with the bolus feijture built Into the pump for that drug may be bolused from the pump
1211412016Even IDVRSlI I
Page Oo 18 Sate2587
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PU6LIC HEALTH
STA1EMEITT OF OEFIClCNcms (X1 I PROVIDERISVPPLIERfClA (Y2J MULTPL6 COMTRUCTON (X3) DATE SURVE IDENTFICiATON NUitU3RANO PLAH OF CORRECTION CoMrLIHEO
A-BUllOiOO
8 MNG05010_ 121071203
~fN1E OF lROVOlR OR SJPftJiR STltEET gtDOR~SS ClT(STATI iIP cooEc 61tlier Med(car Center s~cr-dffiento ~025 Capitol Avenue- Saoramonto1 CA 95116$616 SAC~A~ENTO COUNTY
(x-1)0 SUMMARY 81ATEMENT OF DEMCIENCl~S 10 flRQVIOliRS PlAlf OF COR~ECTIOH lltS) PRPFIX (EA~H DFICfENCY Ul5T BE PRtClEtJED BY FlILL PREHlt iACl1 C MlCTlVEACTION SHOULD 01 CftOSSmiddot COMPLeTE
TA~ fte0ULA10Rl OR LSC 1J5fITJFYIMG INFORMATION TAO
nurse1s noteamp 11Pt now on comfort middotcare wJfe ready for morphJnato stait Patient 3s morphine drip
was stopped on 82817 al 125 am (1 hour 26 mlnule8 taler and a subsoquent nurses notes
Indicated middotbullgtt stopped pump wllhoul any alarms bag empty
middot Review of nurses notes daled 8128117 at 125 a111 indicated Upon checking lV pump noticed morphlna gll was completely empty withIV tubing full of air IV pump still running with green light pteSent no alarms present lV states volume
-infused bull15 ml Morphine gll turned oft charge RN (Registered Nuroe] on unit and nofi1ied [charge RN] checllted pump correclly set wllh lubing fully Inserted into channol correctlyBP [blood pressure) 8552 [normal blood pressure for a healthy adJlt Is 12080]
bullReview of e document titied Default Flowsheet Data middot in Palienl ls clinical recorti nvt~d b(ooU prassum from 3 am to (l am on 81017 ranged from 8148
to 69IS7 A nurses nole dated 828117 at 357 am indicated a Ould bolus wabull ordered to support blood
pressure
Morphine carries a black box warning which Is the Strongestwai-ning the United stated Food and 0mg Administration (US FDA) can require a manufacturer to pul on the drug label Part of the bloclt bogt
warning indlmlted LlfoffThreotening- Respiratory Deproaslon-Serious life-threatening or falal
middot respiratory clep(G$Slon may occur with middotuse of Morphine sulfate lnjacton Monitor for respiratory _depres$iOn1 e~pecially during lnitalion of Morphine
I 1middot I I i
I
I I i I I
I
bull I
I I I
I I
AEFEREiNC~D TO THEAPPROPRIATI= JEFCeNCV) AIE_____- Pharmacy accountable Pharmacy Director)
middotPharmacy reviews all medication related safety lssues and determines whether a posslble errorln IV medication admlnlstratlon has occurred1 or lf any error reached the patient
1818-32918 pump evaluation process Pharmacy dally report CUI) of flow events greater than 300 seconds oo 100 of infusion pumps
Those devices with flow events greater than 300 seconds were remiddotparted to the Nursing Department and BioMed removed from
patient use tagged and referred to BloMed (eQulp for diagnostic inspection
bull Dally reports run from 1282018 to 3282018 yielded 43 flow alarm events Upun Uiag11ostic insmicroectiqri and event investigation no free-flow of fluids occurred
Current process -Manufacturer Alarms Analytic Reports CQI) are compared to Medication Administration reports and the summary is reported to the Medlcation Safety Committee
Sterile Processing Department (SP
(Accountable-SP Manager)
All IV pumps are to be sent to SPD for ltleaning and dlsnfection SPD staff were educated in March 2018 reflectlng manufacturer
Evan IDVRSl11 121412018 9 recommendations StJff were also provided--------middot-----middotmiddotmiddot--------------- a checklist to assist in visual screening of tV
Paoo 7or 18 Sllaquota-2567
CIUFORNIA HEILTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
X-3j DA1~ SURV~Y(llt1) PROVID[JSUPPlHJRCLIA ()12) MULllfLE CONSinUCTIONSTATlMENT OP 01FtCICrlCIES COMPLElEO10euroNT1ElCAflON NUMelRANO PVN OF CORRECTION
ABlJlDING
ll MNGQS0108 12m1r201s
s-rtuer AODfi~Sa CITY STATEZlf CODINAMi o PR011DEROR SUPP-IER
2625 Capitol Av1mu1r Sliclamonto middotCA ~a1e-se1s SAC~AMfNTO COUNTYSutter Medical Centrr1 Sacramonto
volutrol) will be use_d on cert-a1n high
(X~)IPmiddot SUMMARr $1ATEMCNT OF DtFICllNCIES I 10 PROVIOE~$middotPWI o= COMliCTIQr1 1lt5
PREFIX TAO
1 (MCH DEFICIENCY MUST BF PRftEiOED OY FULL RtGULATbRY Oflt LSCIOENtlFYINO mFORMAflON)
ifUFIX
rw (EACH tDAREcnVEACTION SHOUW ae (ROSSshy
REF-ER-1-mo ro iHf PPPROP~IATE oertCIENCY) COMPLEtl
OAH
pumps for potential flaw which may lead to an IV pump failure All staff demonstrated
Sulfale Injection or foHowhg a dose increase competency on the cleaning and vlsual Becaubulls of delay in maximum CNS eflect wilh I
in1ravenou~ly administered morphine (30 min) rapid inspection of lnfusion pumps
IV administration may result In overdosing The March 2018 Trainllig will continue on new
information for morphine under warnings indical~d hire and annually thereafter Hypotensiva [low blood pressure Effeclmay lnltlal training completed March 2018
cause severe hypotenslor In Eln ndividu11l wlmse ability to maintain their blood pressure has beenI Actions detaled In this section are ongoing
I compromised by depleted blood volumeMorphine must be Injected slowly rapid Intravenous RN staff f Accountable -Chief Nursing
administration rnay result in chest wall Director
rigidity lncreased Risk of Seizures in Patients wtth Staff have been educated to perform vlsual
Seiiure Disordera EltcitaHon of the central nervous inspection of pumps screening for cracks and
system resulling in convulsions [seizure activity] pump Integrity prior to use Any pumps
i may accompany high doses of morphine given identified with Issues whlch may increase the irlrnvenou$ly 1
bull risk for medication administration errors are
(Retrieved rom removed from service and sent to blo med for httpslldaitymedntrnnihgovdally111eltldruglnfoclrn diagnostic testing EdUCi3tlon was provided In aetidbull5b96eB3a-d878-4dd5-8460-83a985db4609 bull 2017 and again in 2018 and was reinforced
1official provider of FDA lnforrnatrcn [package
IInserts])
during observation audlts detaBed in following action (112)
1Review of Patient 3s vit signs (11tood pressure heart rate elc) indicated that 111s MAP (mean or 2 The High Risk Medication Policy was
middot avera-ge arterial blood pressure during a single revised Revision Include
ca1middotdlac cycle MAP of at least 60 is necessal) lo perfuse the coronary arteries that supply blood to middot the middotheart brain ancl kidneys norroal range le ~pproximatcily 70 ~ 110) was ~bove 60 before the
Smtirt pumps are to be used on all cqntinuous infusions of high lt1lert med1catlon A volume ilmitlngchamber
middot morphine infusion was sarted on 8127117 at 11 59 alert medications administered by
middot prn Review of Patient 3s MAP after the morptlne continuous 1V Infusion through the
drip was stoppcI on 82B17 al 1 25 am indiooleltI large volume pump (LVP) module per lhat it lad dmpped lo 57 al aam Review of Patient
policy3S physician orders dated 8128117 at 4 15 am When a volume limiting ch[lmber is indicated IV Dopamine (used 10 treat low blood lndlc_ated a two~hourvolume wlll be pressure 0~10 microgramkllogrsrnmlnute lo be added to the chamber Use of the
volume limittngchamber will be 12142018
Verifyon the MAR and volutrol In the comment box
EvcnlDVRSl11 documented every shft with ~Rate
Slnte-2557
CAUFOlNIA HFALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STtT~MEMT 01 d-1Cl~NCIES (Y PROVtOtRISUPPLl8RCtb (X2) MIJLrlPLE CONSTRUCTION (lt3) DATE SURVEiV AND flA~I Oi CORRECTION IDlUtfFC110N NUMBER COMfgtl[lYEO
A OlJflD1NG
050100 H WING 12107201$
NPME OF PROVJOSR Oil SUPPLIER SmEar ADDRESS CITY 9TATEZIP CODE
6utwr Medlc1atl Oentor1 Saotamonto 282S CiJpitO VQnun1Sutamcmtltgt CA 95816bullS616 SACRAMENTO COUNTY
X~ rLl PfitPlr
1AO
SUMMRY STATEMENT OF OlF1CllNC1es (ECl-1 OEf1CIENCf MUST nE PRECEeom Blt FUL 1u0ulATORYOR lSC DlNTIFYJNG l~fCJRMTlON)
titrated every 10 rnltmles far a 0081 of MAP between 60 and 65
IReview of physi9ian notes dated B28117 al 350 am indicated RN called to report 250 mg bag of morphine poeslbly given to tho patient over one haurMay use BIPAP to support breathing
Review of-the Palent 1bull Completed Medication Record Indicate( that Dopamine was started al 444 am on 8128117 for MAP less than 60
IReview of nurses ncles dale~ 828ffal 555 am lndica1ad 1New orders received ta $lop pressors middot [dopamine] anti remove BIPAP Nurses nbte dated 8128117 at 612 am indicated BIPAP removed
On 828117 al 633-am Patiertl 3 was pronounced dead The ciniral record indicated there were no orders lab res11Jls ot btood draws lo meijsure rno1microhine loXlcHy levels fonowing lhe ldenliUcaion of
the empty morphine bag Patient 3s discharge 1summe~ summary of U1e major treatments andIevents while hospilolited) doled 62B117 al 668 l am did not-address morphinG odministration
The above findingbull were aclltnowledgad by the iADHO (Mministrative Director of Hospital bullOperations) during lnle111lews on middotf24118 at 920 am and on i26118 at 15middot1 pm and with RN 8 on 112618 ot 10 am
middot During t1n inlervlew cm 12Rf18 at 258 p m bull RN 6 staled tlial on 812717 he started Patient 3bull
morphine infusion (11 69 pm per MAR) wilh tle
ID PR~F1X rG
PfJOYDEtS NAN Of COARlCTION x~
llACtt CDRRECTIW ACTlON SHOUlD ae CROSSshy COMPL~TC REFERENCEO TO fl-I AfPROfRIAT OlfCIENCf) OAre
In the event that a volume limftlng chamber Is n6t uvailabte for in indicated hgh alert medication st-aff wlll documentRate Verify (as defined in the Medication Administration policy) on the MAR every2 hours Independent double-checks The SMCS list of medications requiring an independent double-check may not match the EHR list for dual signature rnedications Alternative documentation may be employed so that SMCS staff can align their documentation with the SMCS standard (eg add a co-sign with a note lri MAR use 11given not co-signed option when a co-signature ts not required
3 The Medication Administration Policy was revised Revision Include Use of the LV Pump
i Choose the appropriate age- weght- andor unlt--1nsud prmiddotorne when starting the Infusion pump
b Enter the patients M edcal Record Number (MRN) when asked for Patient ID
t The Guardrails drug lbrary rs to be used for all medications unless the particular- drug does not exist in the library
d Only those medkations with the bolus feijture built Into the pump for that drug may be bolused from the pump
1211412016Even IDVRSlI I
Page Oo 18 Sate2587
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CIUFORNIA HEILTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
X-3j DA1~ SURV~Y(llt1) PROVID[JSUPPlHJRCLIA ()12) MULllfLE CONSinUCTIONSTATlMENT OP 01FtCICrlCIES COMPLElEO10euroNT1ElCAflON NUMelRANO PVN OF CORRECTION
ABlJlDING
ll MNGQS0108 12m1r201s
s-rtuer AODfi~Sa CITY STATEZlf CODINAMi o PR011DEROR SUPP-IER
2625 Capitol Av1mu1r Sliclamonto middotCA ~a1e-se1s SAC~AMfNTO COUNTYSutter Medical Centrr1 Sacramonto
volutrol) will be use_d on cert-a1n high
(X~)IPmiddot SUMMARr $1ATEMCNT OF DtFICllNCIES I 10 PROVIOE~$middotPWI o= COMliCTIQr1 1lt5
PREFIX TAO
1 (MCH DEFICIENCY MUST BF PRftEiOED OY FULL RtGULATbRY Oflt LSCIOENtlFYINO mFORMAflON)
ifUFIX
rw (EACH tDAREcnVEACTION SHOUW ae (ROSSshy
REF-ER-1-mo ro iHf PPPROP~IATE oertCIENCY) COMPLEtl
OAH
pumps for potential flaw which may lead to an IV pump failure All staff demonstrated
Sulfale Injection or foHowhg a dose increase competency on the cleaning and vlsual Becaubulls of delay in maximum CNS eflect wilh I
in1ravenou~ly administered morphine (30 min) rapid inspection of lnfusion pumps
IV administration may result In overdosing The March 2018 Trainllig will continue on new
information for morphine under warnings indical~d hire and annually thereafter Hypotensiva [low blood pressure Effeclmay lnltlal training completed March 2018
cause severe hypotenslor In Eln ndividu11l wlmse ability to maintain their blood pressure has beenI Actions detaled In this section are ongoing
I compromised by depleted blood volumeMorphine must be Injected slowly rapid Intravenous RN staff f Accountable -Chief Nursing
administration rnay result in chest wall Director
rigidity lncreased Risk of Seizures in Patients wtth Staff have been educated to perform vlsual
Seiiure Disordera EltcitaHon of the central nervous inspection of pumps screening for cracks and
system resulling in convulsions [seizure activity] pump Integrity prior to use Any pumps
i may accompany high doses of morphine given identified with Issues whlch may increase the irlrnvenou$ly 1
bull risk for medication administration errors are
(Retrieved rom removed from service and sent to blo med for httpslldaitymedntrnnihgovdally111eltldruglnfoclrn diagnostic testing EdUCi3tlon was provided In aetidbull5b96eB3a-d878-4dd5-8460-83a985db4609 bull 2017 and again in 2018 and was reinforced
1official provider of FDA lnforrnatrcn [package
IInserts])
during observation audlts detaBed in following action (112)
1Review of Patient 3s vit signs (11tood pressure heart rate elc) indicated that 111s MAP (mean or 2 The High Risk Medication Policy was
middot avera-ge arterial blood pressure during a single revised Revision Include
ca1middotdlac cycle MAP of at least 60 is necessal) lo perfuse the coronary arteries that supply blood to middot the middotheart brain ancl kidneys norroal range le ~pproximatcily 70 ~ 110) was ~bove 60 before the
Smtirt pumps are to be used on all cqntinuous infusions of high lt1lert med1catlon A volume ilmitlngchamber
middot morphine infusion was sarted on 8127117 at 11 59 alert medications administered by
middot prn Review of Patient 3s MAP after the morptlne continuous 1V Infusion through the
drip was stoppcI on 82B17 al 1 25 am indiooleltI large volume pump (LVP) module per lhat it lad dmpped lo 57 al aam Review of Patient
policy3S physician orders dated 8128117 at 4 15 am When a volume limiting ch[lmber is indicated IV Dopamine (used 10 treat low blood lndlc_ated a two~hourvolume wlll be pressure 0~10 microgramkllogrsrnmlnute lo be added to the chamber Use of the
volume limittngchamber will be 12142018
Verifyon the MAR and volutrol In the comment box
EvcnlDVRSl11 documented every shft with ~Rate
Slnte-2557
CAUFOlNIA HFALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STtT~MEMT 01 d-1Cl~NCIES (Y PROVtOtRISUPPLl8RCtb (X2) MIJLrlPLE CONSTRUCTION (lt3) DATE SURVEiV AND flA~I Oi CORRECTION IDlUtfFC110N NUMBER COMfgtl[lYEO
A OlJflD1NG
050100 H WING 12107201$
NPME OF PROVJOSR Oil SUPPLIER SmEar ADDRESS CITY 9TATEZIP CODE
6utwr Medlc1atl Oentor1 Saotamonto 282S CiJpitO VQnun1Sutamcmtltgt CA 95816bullS616 SACRAMENTO COUNTY
X~ rLl PfitPlr
1AO
SUMMRY STATEMENT OF OlF1CllNC1es (ECl-1 OEf1CIENCf MUST nE PRECEeom Blt FUL 1u0ulATORYOR lSC DlNTIFYJNG l~fCJRMTlON)
titrated every 10 rnltmles far a 0081 of MAP between 60 and 65
IReview of physi9ian notes dated B28117 al 350 am indicated RN called to report 250 mg bag of morphine poeslbly given to tho patient over one haurMay use BIPAP to support breathing
Review of-the Palent 1bull Completed Medication Record Indicate( that Dopamine was started al 444 am on 8128117 for MAP less than 60
IReview of nurses ncles dale~ 828ffal 555 am lndica1ad 1New orders received ta $lop pressors middot [dopamine] anti remove BIPAP Nurses nbte dated 8128117 at 612 am indicated BIPAP removed
On 828117 al 633-am Patiertl 3 was pronounced dead The ciniral record indicated there were no orders lab res11Jls ot btood draws lo meijsure rno1microhine loXlcHy levels fonowing lhe ldenliUcaion of
the empty morphine bag Patient 3s discharge 1summe~ summary of U1e major treatments andIevents while hospilolited) doled 62B117 al 668 l am did not-address morphinG odministration
The above findingbull were aclltnowledgad by the iADHO (Mministrative Director of Hospital bullOperations) during lnle111lews on middotf24118 at 920 am and on i26118 at 15middot1 pm and with RN 8 on 112618 ot 10 am
middot During t1n inlervlew cm 12Rf18 at 258 p m bull RN 6 staled tlial on 812717 he started Patient 3bull
morphine infusion (11 69 pm per MAR) wilh tle
ID PR~F1X rG
PfJOYDEtS NAN Of COARlCTION x~
llACtt CDRRECTIW ACTlON SHOUlD ae CROSSshy COMPL~TC REFERENCEO TO fl-I AfPROfRIAT OlfCIENCf) OAre
In the event that a volume limftlng chamber Is n6t uvailabte for in indicated hgh alert medication st-aff wlll documentRate Verify (as defined in the Medication Administration policy) on the MAR every2 hours Independent double-checks The SMCS list of medications requiring an independent double-check may not match the EHR list for dual signature rnedications Alternative documentation may be employed so that SMCS staff can align their documentation with the SMCS standard (eg add a co-sign with a note lri MAR use 11given not co-signed option when a co-signature ts not required
3 The Medication Administration Policy was revised Revision Include Use of the LV Pump
i Choose the appropriate age- weght- andor unlt--1nsud prmiddotorne when starting the Infusion pump
b Enter the patients M edcal Record Number (MRN) when asked for Patient ID
t The Guardrails drug lbrary rs to be used for all medications unless the particular- drug does not exist in the library
d Only those medkations with the bolus feijture built Into the pump for that drug may be bolused from the pump
1211412016Even IDVRSlI I
Page Oo 18 Sate2587
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CAUFOlNIA HFALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLIC HEALTH
STtT~MEMT 01 d-1Cl~NCIES (Y PROVtOtRISUPPLl8RCtb (X2) MIJLrlPLE CONSTRUCTION (lt3) DATE SURVEiV AND flA~I Oi CORRECTION IDlUtfFC110N NUMBER COMfgtl[lYEO
A OlJflD1NG
050100 H WING 12107201$
NPME OF PROVJOSR Oil SUPPLIER SmEar ADDRESS CITY 9TATEZIP CODE
6utwr Medlc1atl Oentor1 Saotamonto 282S CiJpitO VQnun1Sutamcmtltgt CA 95816bullS616 SACRAMENTO COUNTY
X~ rLl PfitPlr
1AO
SUMMRY STATEMENT OF OlF1CllNC1es (ECl-1 OEf1CIENCf MUST nE PRECEeom Blt FUL 1u0ulATORYOR lSC DlNTIFYJNG l~fCJRMTlON)
titrated every 10 rnltmles far a 0081 of MAP between 60 and 65
IReview of physi9ian notes dated B28117 al 350 am indicated RN called to report 250 mg bag of morphine poeslbly given to tho patient over one haurMay use BIPAP to support breathing
Review of-the Palent 1bull Completed Medication Record Indicate( that Dopamine was started al 444 am on 8128117 for MAP less than 60
IReview of nurses ncles dale~ 828ffal 555 am lndica1ad 1New orders received ta $lop pressors middot [dopamine] anti remove BIPAP Nurses nbte dated 8128117 at 612 am indicated BIPAP removed
On 828117 al 633-am Patiertl 3 was pronounced dead The ciniral record indicated there were no orders lab res11Jls ot btood draws lo meijsure rno1microhine loXlcHy levels fonowing lhe ldenliUcaion of
the empty morphine bag Patient 3s discharge 1summe~ summary of U1e major treatments andIevents while hospilolited) doled 62B117 al 668 l am did not-address morphinG odministration
The above findingbull were aclltnowledgad by the iADHO (Mministrative Director of Hospital bullOperations) during lnle111lews on middotf24118 at 920 am and on i26118 at 15middot1 pm and with RN 8 on 112618 ot 10 am
middot During t1n inlervlew cm 12Rf18 at 258 p m bull RN 6 staled tlial on 812717 he started Patient 3bull
morphine infusion (11 69 pm per MAR) wilh tle
ID PR~F1X rG
PfJOYDEtS NAN Of COARlCTION x~
llACtt CDRRECTIW ACTlON SHOUlD ae CROSSshy COMPL~TC REFERENCEO TO fl-I AfPROfRIAT OlfCIENCf) OAre
In the event that a volume limftlng chamber Is n6t uvailabte for in indicated hgh alert medication st-aff wlll documentRate Verify (as defined in the Medication Administration policy) on the MAR every2 hours Independent double-checks The SMCS list of medications requiring an independent double-check may not match the EHR list for dual signature rnedications Alternative documentation may be employed so that SMCS staff can align their documentation with the SMCS standard (eg add a co-sign with a note lri MAR use 11given not co-signed option when a co-signature ts not required
3 The Medication Administration Policy was revised Revision Include Use of the LV Pump
i Choose the appropriate age- weght- andor unlt--1nsud prmiddotorne when starting the Infusion pump
b Enter the patients M edcal Record Number (MRN) when asked for Patient ID
t The Guardrails drug lbrary rs to be used for all medications unless the particular- drug does not exist in the library
d Only those medkations with the bolus feijture built Into the pump for that drug may be bolused from the pump
1211412016Even IDVRSlI I
Page Oo 18 Sate2587
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORMIA HEILTH IND HUMAN SERVICES AGENCY DEPARlMENT Of PUBLIC HEALTM
(gt-1) PROVIDEFIJSUPPLIERCtl ()a) fJiULtlP-U COtlSTRUCTIOM8TITfMENT0f DEF1CGNCli$ X3 lllTE SllRVEY
AMO FLAN Oi- (iORRECTJO~I 10~iTIFICAilON MUfBR COMPllillD
A BULOING
BWNG05010~ 1Z0712016
STRfcEr ADDRESS CITY STATcZIP CODENN1~ Of 11ROVIOR OR SUPPLIER
~15 C11pltol Avenue1 Sacramutilo CA 96-816-5616 sACRANIENTD COUNTYSutte-r Medlnl Cenlnr Sacfamento
(~4110 SUMMARY 6TATICMENT ~ oeFIClfNCES ID j PR011DER9 PlAN OF COMGCTION ()(5) riREFX (EACH OEFClttCY MU$T Bli pmCEEDEO BY FULL PREFIX (EACH CORRECitVt AClOr-i st-lCULD e1 CROSS- COMP~Tt
TAG REGUtATOIW OR ISC IOENllFYl~G lr-lFDRMATION) TAG ftlflRENCEO TO fHSAPPROPPJATE DEFC1euroNCY) DATE
If-------middot-bull----+---------~---------j e For ALL medications lnfuslng
through the large volurne pump I I smart purrip by nrs1 checking that the tubing was In
I
(LVP) module on the-pump staff he correct place c~ssette was tn the chamber
will document Rate Verify In themiddotcorrectly the Infusion was programmed correclly
MAR
Iand verified It with anolllar nurse RN 8 slated that RateVerlfyw111 be documented at _he checked Patient 3s vital signs including his the folowing Intervals Iblood pressure and rospiratmy rate and they 1 Atthestartofanynewlooked good RN 6 said he was in and out of continuous V infusion New
Patient 3s room after starting tho infusion RN 6 Bag documentation is slated that at 125 am on 82817 when he equivalent to Rate Verify for returned lo Patient abulls room Patient 3s wife pointed new IV infu~ion) lo the morphine bag Indicating it looked ompw RN 2 If the pump module door is 6 verified that the bag was empty bul no ~larrrn I opened or any manipulation
were sounding R~l 6 notified another nurse -ind of the cassette middotcalled the physician RN 6 staled he chected the 3 At shift change adn1lsson or floor and the bad lo ea ~ any of the morphine trpnsfers from other units or
bull solution had leaked out but was unable to Ond procedural areas When documenting Rate Verify
staff attest to bull1 anyhing wet
Facility policy H)gh Alert Medications 1 Visual check of cassette Managenient of tlaled 6130116 classlfied IV loaded appropri~tely
2 Visual check of IV flowing1 Infusions of morphine as a 11igl1 a[ert nedicallon appropriately In drip
drc1gs that bear a heighlenefj risk of causing The policy indicatud 1High alert medications are
chamber for set rate 3 Visual check of rate of
Although mislakes may or may not be more significant paliont harm when they aroused in error
Infusion on pump rnodule middot _common with thesa drugs the consequences of an - ertor are clearly morn devpound1stt1Ung to patients- RN education ta the revisions and
expectations of the High Alert Medication and IA group interview was held on 112l18 at 906 am Medication Admln1stration policies was with the Director of Pt1armacy (DOP) Director of completed in May 2018 and repeated Q4 2018
middot Education (DOE) Assistant Administrator of Integrated Quality Services (AAOS) Chief Nurse IExecutive (CNE) ADHO Admln1strator ior Wornens and Childrens Center (AAWC) BIOM (Bin Met SlafQ 1 and BIOM 2 The CNEmiddotslated that the ________________________________________________---____
Evel) IDVRSl11 2I14120U 90420AM
Page 10 ol rn Slate-2567
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HEl~rH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBIIC HEALTImiddotI
STATEMtNl OF Dlrtlt1NCIES (Xt) [=IROYIOERISUPPUtROLII X2j h11JLrune CONSTRUCTION tXJ DATE JUlCVFY MID PLAN Ofl CORRECTIOfl 1 EMTiflCATI01gt1 IUMOER COMPLBlO
ABJllOlNG
lWING050100 12072018
------------------------~------lt During the initial education period the cllnlcal
rAME OF PRCillDER OR $UPtlER
Sutler Medical Crtriter Sacrame-nlo STfmT ADDRESS CctYSlAW ZIP CODl
2825 Capitol Avonuc-1 Sacranu111to CA- 95816-5616 SAC~AM5NTO COUNTY
())[~ PR~Fllt ma
SUMMARY STATfMlNT OF OiFll~NCIES iACH DliffCE)lCY WJ8T fF flftllCflOD BY FULL REGULATORY OR ISC IOENT1fiYlNG INF()RMAtlON)
ID
PtlErlX TAG
PROVlDERS PLAH OF CORlt1CCTil)N IFAilmiddot rtdegRAr-imiddot~ ~~1(~fmiddotSHNJLO cm CRDSSshy
1bullbullmiddot tf1 1 IHmiddotAfrbull11bull)fbull11o_j1 OiiJ(Cl~ICV
(Y5) cm-WLETI
DATI
1 l nursing leaders conducted daily concurrent bull racllily ooulo nol come up with what happened io 11 Interviews audits at the bedside The Patient s case The CNE strited th~i the physician purpose of the interviews were to ensure that
did not feel Patient 3 could have received the full 250 the RNs could accurately demonstrate the expectations of visual lnspectlons rate
middot mg of morphine based on his vital sign~ Themiddot verificatlon and use of Infusion pump was token lo the Blomed (Biomedical
volume limftlng chamber The return middotengineering Is the applloalion cf tha principles and demonstration audits Initiated 218 98 of problbullrn-solvlng technlques of engineering to biology active staff were Interviewed in Feb through and medicine) deparlmenl who ran a detailed report March of 2018 The Pump audit continued on the pump and no problem Wa5 identified The thrnugh 201g After the initial audit an DOP staled they looked fer any diver3ion average of 200 audits were completed per (medlcalian diverted to oomeone o11er than the month The audit concluded 122018
patient for whom ii was intended) irdicaors but were uoablo to find any The CNE slated that U1ere An addt1onal monthly Punip Documentation was no coronera report received at present The Audit of 150-900 MRs conducted startingI111QS slated that the ewnl was no classified as a S18 and Is rigolng This audmiddot1t is to confirm sentiiet (unanlicpaled event In a healthcare selling compliance to documeotatlomiddotn requirements rasulli11g mdeath or serious physical or per policies
psychological injury lo a patient not related to Iha natural courne- of the patients Illness) event but a 4 To provide cl_ear direction to facility quality analysis was done pump users of expectations for pumpmiddotuse
th~ hospital has provided 100 of RN Staff In the group interview BIOM 2 staled that they education detaling that the IV-pump may
received the purnp1 and using the manufacturer free flow without an audlble alarm and the software they tested it did a vfsual inspection and Importance of flow verification and
were not able lo replicate the error 80M 2 staled documentation expectations This Information has been added to a badge
pressed on the Infusion pump DOP slated that this buddy de~igned to assists RNs In mntinual
was no dono for this pump understanding of expect~tions for IV pump
middot hat ph~rmacy normally check what butlona bull user
use Review of the Biomed produced detailed report (COi Cornmunicatlon Education was Implemented
report) of Iha smart pump actlVily lmJiriteo an anlry 22618 and completed 31418 on B2817 at 1202 am Indicating lnrusion started and on B128117 11 23 am Indicating loluslan S If an RN eltperiences an lssue or
almmed free now (when infusion can be Injected concern whlle using an Infusion pump_ tile
lnlo tM palient at an uncontrolled rate) alarm 4857 pump Is removed from patient use when safe to do so_ tagged ond referred to BfoMed
121142018 9 (eQ_uip) for diagnostic lnspection event tDVRSl11 ---------middot
PaGe11or1a
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HEAlH ANO HUMlt-1 SERVIC1poundS AGENCY OPARTMfNr or- PUBLIC HEAl n-1
lTIITEIAINl (Jf DlJCltNCS fl(I) l~OV10ERISIAfIIERICIJA POlPAT6 SURVllf AOO PIM 01 CO RRFClIOM IOlNTIFICAflON NUMBER COliPLETeo
OL~~DINO
050100 8 YANG 12072018
STREIIT AODRl55 OW S1ArE iIP CODEltlllf OF PROlllEI 01 SIJPPLlfR
825 Capllo l Avemo 9acentramcnto CA 96816--6616 $ACRflMENTO COUNIYSul~r ModlcI CentiIr Shc nme-nto
(X~)IO SUMUgtllV STJTl~Nr OF UFf1CIENCIE6 ID PR()ViOERSPlJIN OP CO~llllCrtON (iWgtI coru1~Cil1(E AC1ro~~ SHOVIO oe CROSSbull PflYf( liCW DliflCIEMCV IUST BIi PA~C5(U)liO SY fULL PREflK
TAG REOUIATORYOA 10C IOGHTr-YUIGtlfOUVTIONJ TAG RSERlllCllD TO lHi IPPRCgtAAlTf DEFICIENCY) middotI
seconds (1 hour ~1 m1not~s which coitlclded wih lhc time be1w11en Pallent ls morfhine lnfuiion I rastartlng and diGCOvarlng ihti morphine lgtag ernJgtly) SIOM 1 and BfOM 2 were unable to axptain lhe bullrree itow alflrm par1 of the COl report They tndlc11ted lhoy wlll ch~ck with manufactulEw
Review cgtf manufacturer oornmunicalon wilh lhe
Ihosph~f d0leltl l 24118 indiraled Fre~-Flow alam1 is seen in lhe CQI dalamp ii Iha pump door is open and the saiety damp ll open whRe the infusion set i3
primed Manufacturer lodicatod he pump should I
alarm lf Iha saiely clomp Is open wih lhe door open I I
The document lndlcated free flow OJJld happen wilh I
1the PUMP door ooocd in rare cacUll The 1locomentIiruli=aletl If you llelieva tho dovcc$ w~rcnt working as oxpocted or Ir them was a JJlllient event in which ii Is suspected th11 an actuot r1ee ftowov~r Infusion occurred CustoInar Advocacy can complete an jinvostlgatlon with tle ttJbng Pump module and pc iUrit (sic~ the main pLmp companenl Illa allows Icostoml1ilior1 of Infusions The facility blorned ideparlment had ampequester(ld (isolated lhr pullll hut middot ii hacl not been senl lo lhe maoulaciurer
During Iha group lnlerview lho MQS staled lhal lhls informatlon abo~ a free flow alarm fOI 4057 6econds wis not diicussed during lhe
l facility
quillty lnveslgalion of the event Jhe- group waa middotunaware lhal ~ free now eam was indicated en the cletail eltl inrlfsion pump roporl MQS cortflrmeltf hat no audits were coducted fo look atdf111iled infusion ))Ump rapo1~1 lo check rorlree llow fssu~1
Event 10VRSI 11 12HJQ18 o0420M
Pl(1o 12or 1e
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
(
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMENT OF PUBLlC HEALTH
I
I
Sl IITEllElff 011iflCIENCIES MD Pi OF COnlltCflON
(X11 1110l101P-ISUlllJERiCUA IUlHlIFlCATION llUMBER
(Xll tllTE SUIWEI COMllTlP
OGOt08 A11JllQING
B YIING 1207l011$
WJll OF PROVIDER OR SUFllSR STRllT AOORESS CITY STATE i1r tODE
Suitor Medical Conter Sacramento 21326 C11itol Avenue $acr11moll11 CA 95S1amp-SG16 SACRAMENTO COUNT(
(X1)il PAeuroAX
TIIG
SUMM~RV SfATUl~NT OF OEf1C11NC1cS (iilCH OOFICIFlCYlllli 111 lREllFOrn BY ffJl RlGJLATORV M LSC IDElflrvlIG ~O~MATIONI
Reviclw of a facility documen daled 82616 indicated a high pri0rlly alert from the smurl PJlllP manufacturer ind~atrng tlamased Ooor
ICon1ponenls May fail to Engllge A11tibullFree Flow middotMechanism Pctenlwlly lcocling to Gravity Flow
II
l 1 1
PROVIDERS PIJN OF CORlEC1101J lEACn connecrNS ACTION SHOULD Ile CROSSmiddot REFFHFflCFDTO THll APlMPRlllii DEflctllJCY)
l
Everii IDVRS111 12412018
Pige 13 iir 1aStllle-2007
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
(
CALIFORNIA HEAL1HAND HUMM SERllCSS AGENCY DEPARTMENT OF PIJBllC 1-11ALtH
IXlr DAllUltRllI COIIPlEllD
(l()J MUITIPL5 COHSlRJCTION1x11 PrtOIIOmlSUfrtllICllS1ATM~tff Of IJiflCIENCfES IOeNtlllCATION NIMFt
APUl~DNO
)50108
(NO ftlN OF CORRl-ClOtl
B WIG 12072018
STflEIT iOORES$ CITY stre 21P OOIX
Suttet Medical Center Saoll$1t1e11to
l1lfl Of PROllOER OR SUPPIER
2026 CQpltol Avenue lfflcramonlo CA 9816-5616 SACRAMENTO COUNTY
(Xt) IIJ SJMMMY SYIITEMElfT OF ClPIC~N()IM ll PROVIO~li flAN OF COIIIUCTIOH EQ- OFFICtEUC1 MUST llE PHliCfEOED IY FU~L RFIX (EJCH COAAlCfllA(lllON SMOUID BlCllfJSSshyPREFIX
11G REClllilORV OR lSC IOCilFVING lfllORNATfON) TACI RFFfR2HClU TO TH lflROlRIATE 01iflCENCYI
IReview of hamp faolllty qualtly analysis document addressing PaUenl ls morphine 111edicatlon error [dated 95117 lndlcateltl pump design rriay allow for llow or IV 0~1lds withotn 8larm if 11bing is no middot properly place ti or door Ll no1 proper~ dosed
i Review of lh~ facility training document which was provided to (jtertt after the 82Sf17 lncldiml iwolvlfll PaUent 3 had very slmUflf h1forrmillon lo the prevlous roinlng The mining dociments did nol indtcote thal rreeflobulllI could happen and he pump will nPt alarm
During -an interview on 12618 at 253 pm RN 5 iwho started Patient h morphine lnrusion on 812717 l at 158 staled that he was given training on the iinfusion purnp inbull2016 ancl again In 2017 Me staledIhal he did noi leam anything new in th~ seltMd
Itrabling
middot During a group metJllng on i24111 at 630 pm the AAQS t0nfitmed Iha faclllly polloiel and procedurl)s did not a~dress tho iflfiilion pwop free
flow Ploztenlla TM MQS staled that no documentotlon was re(luired by nursing staff to
visuFJli~o the drip chombar to ensure no free How was 19~109 place a Her starling an Infusion The AAQS slaletl that the racllly was nol lracklngany middot data regarding monitoring of stiff compliance oi ftM llowilldicalors 011 infusion puinp reports Review of lhe srnart pump manufltrturar llocumP-nl dated 10117 indicated lttal A Free FkYv Alarm was a
1J1 ~1016 90420AMEyeot IDVRS11
Page M of18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HEAiTH AND HUMAN SERVICES AGoNCY DEPARTMENT OF PUBLIC HlALTH
S1Al1liNf OP DlaPICEl~ClfS (XI) PROVlDGWSlPPUERIGIA X3) OATE SURVEY AMDPIANOI COHRECTiON IDENTIFIClriON NUMeEn COMPliTEO
A BUIDl~G
050108 El WMO 12072018
tIM1E OF PMVIOlR OR SLIPFLIEI SfREeT ADORfSS CIT STATE ZIP CODE
Suttor Me-deal Con~nr Sacram~nto 2325 Camppitof Avenue Sacramorito CA 95fH6-SG1G SACRAMSWTO COLINTY
(Xd)IO SUMMARY STAriMENT Of OEFICIENCLES ID Pl10VIOPR$ PlAN- OF CORRECTION (XS) PFUiFIY tEACH 1JEF1c1tMCY MUST B~ rfUCEEDFO BY fULL PREFIX (lACH CORRECTIVE ACT10N SrOULD BE CROSS COMrtETE
TAO R~lULJTORf OR 18C IDeuroNf1FYING IUFOR~IA1lOH) TAB REf-ERENCEO 10 THE APPfOPRIATe OEflCUNCY) Orn
j reporabla alarm to lha manufacturer I Review of facility policy Medication Adminislralior1
1(Adult ond Pediatric) dated 101I 4 did not reneci 1 any or the above training
[ Review ol focilily pollcy Patient Safely Reports ligh Risk Event and Unusual Occurrences
middot Reporlingand Managemenr dated 8817 j Indicated All activitles of the RCA [Root Cause Analysis-facility quality lt1naysls of an ovent] will be presented by members of tho team ta tho Quality Council and Patient Safety Cornmiltee Relevant recommendations 11nd actlons wm be revlewad by appropriate committees (Medical Steff Commitlees
Council on Patient Carn Standards etc) Findings 1end lecentommendations from lh_e root cause ana~ysls or slgnificanVnaver event analysiswllt be reported lo the appropnate Msdlesl staffCommillee Quality and Patient Safely Committee Medical Eecutive
Committee and he Mediral Potk) CommlUee
I I
I i i Review of the aclliy quality analysis document
] addressing Patient i5 morphine medication error I
1da1ed 915117 indicated lligh Impact Acquire lo-eking devices for narcotic drlps anticipatcd 1st l quarter 2018 During an inteNew on 1125118 al 930 middot am with CNE and AAQS they indicated that lhe analysis w~s scheduled lo go lo Council Care middot Standards Quality and Modica( Executve Committees but had not been done
bullIn an Interview on 1126118 al 945 am lhe CNE ard AAQS slated that the hospital owned 3500 lnlusion ~ pLImpa lhe same type of pump Involved In the over
event IDVRSl1 t 12(1412018 90420AM
Pssei5ofi8StalEJbull2567
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HENTH lNO HUMAN SERVICES AGENCY DEPARTMENT OF PUSIIC HEALTH
liT111ELllNT OF OEl-1ciENC11~ (XII PlI0bull11bEP$UPPl8rVCW ft)middot IIULtllgtU COl 9TRJCTION (X3) DME SUlltVEY AI-IOPlAN OF COIECTION IOEHWlCATION NUlac~ CO~IPLIED
A DUILOIJgtlG
06D108 OVING 12072018
N11i( o PR0110R OR $tJIFUen SYlIEET OORl33 CllSTATI 211 COlll
SultorMecllcal Ce(lte~ Sacritnonto B29 Cnptiol Avenue Saccramonto CA OS816-6616 SACRAMENTO COUNTY
(X4) to 5JMt11RI STAllMEllT OiltDEFIClNCV~ K) PROlltOiJlS llrl-1 OFCORrUtrnOH (l(~J PlfFlX (lNH O~FlCIENCY MUSr ell IIREC1WEO IIY eUU PRCRX (EICK COl1poundCTIVE ACt tOM SHOUtP SE c~ss CCtFlElE
TIIO RGULITORVOR ~SC IO[NYJ-YIMO l)J1bull0~ATIOlI) TAG RF FIHUNCEOTO n u APPROPRlllTE DEFICllNltV) DATE
middot odmints1auo11 (f~ flltM) o1 morphine to Patient 3lThay 1llated (hat ll any gi11on day 350 lo 500 were being used I 11laquo an interview on 126118 al 230 pm the Chief
i Executive omcer (CEO) Indicated Ltiat the conclusions of the facility qi1alHy analysln or Patlan I 3s dealh potenlluly related to a medication error
j Included the po5~ibility of free now but no one wa I certain that it Qccured Tho lnvestigalors ooMlderod ftee flow machlno fuilure dosign failure dlverfion
1 and potenlial human orror middotnio tiospttal leaders
I judged that addlllonal nuruo itainlng With re tum demonstroton was sufficient 10 address thamp human MM The 81omed techniciom and manufacturer did not oonllrm devke failum co thampy asslAled free flow
1bullhad nol occurred They could not prove ltllvers911
iwas condlJltied that free flo~ did not occur in Patlent i 3 Remedies for lhe other Incidents whtch occurred a l the other faciilie6 were also dkecloo 111 human l en-or and mtrairllng nurses bul not posGihle I middot equipmool failure No kntlw corrective acliom were I undecloken Hospital toadori WGre awore IhaI middot additional steps uaing ~ llmlled v-01ume device (voMrol) could add prolaelion tom recurrence of
pump free now howe 11ar thore waa a shOttampsamp of volulrol equipmonl for all the corporate hosplllls to
lnilltute such a correcllve acllon jhe CEO acfrac14navledged Iha during the Dapelttrnent suNay
this week LhG team idenOijO a prinlo11t of Palienl i 3s Infusion pump thal showed ovet 4000 seconds of free now whch had nol been tdenllflnd oy the I
Evltnt IDVRSl11 121142016 90420Ml
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CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
(
CALIFORNIA HEAJTH ANO 11UMAN SERVICES MENCY DEPAATMEm 01 PUSLIC HEALTH
()(raquoDATE S1JWEI (XI) PROVIOOIISUPP~UarvclflST111~ltMl 011 OfftCleuroNCIE$ COMlLETEObull fOtlTIFICITIOH NIJlleERAfIO LAN OF COlIACClIOtl
110UILDNG
050f02 BIANG 1207121118
ITRelT AOOOlSS CITY SlAl E ZJP cooe
825 Cepllol A1111nu1J Sacramento CA D5111SSG1G SACRAMENTO COUNTY lIMIE CIF PROVIDER OR WPPUER
SuttnrM1dilt11I Ct1nlor Sacrnmanto
IP PROvlllsR3 PlAll 01 CORRWION IXI) CO~PLETE
11(4)10 BlNMARY STATiHJENf Of 1)1lICJENltlr$
PRSIX (EAC1-1 OEPICIE~Y MUST ae Pfl~C6EDEO llt PULL PREfllC EACH CORRliCTIIElCYlOlf SHOVLO I) CROSSmiddot RllERHICfO TO TEAPPR0PfWil 0atOlNC(J CATEneGUtATORYOR ISC IDl~tnE~ ll$0R1AtlON) lAOTAG
he CEO t1lso altknOVledged that
middot I
l yostcrday (112618) lhe ltounty Coroner verba1y I amplated that Patienl 3 r~wed a slgrnfiiant amllunl
of morphine confirming actual adminlstraUon of middot exce$siva morphifie prior to gealh Thti CEO t1cki0Wledged thal wtttl ttie additional evidence
1 lenrned this week pump failure was more likely and
eddiUonal seps tuae of vo[ulrol for high risk jmiddot mediralkms) wa needPd lo minimize rik mtd I
1recurrenceg i I I Review of the document tilled Sacramento bounty Certificale oroealh indicated ihe allowing Cause of o~athMorphlne OverdoseTlrna lnt31Val betweigtn Onset end OeahHoura
middot Therefore the Dcpartmort determined the facility failed lo administer a medication as pr11scrtbad by
tiie physlclan or In accordance with facility pollcy l he lacility failed tQ ensure that i) Toe facility pot1cy and ptocedure for Manag~ment ol High Alefl Medicatlor~ was devel11ped and lrt1pllmenled to ensure safs admlnlslratlon practice
121W2018 90l2DAMEvent IDVR$11 middotI
Paae 17 of 10
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18
CALIFORNIA HEALTH AND HUMAN SERVICES AGENCY DEPARTMEfrr 01 PUBLIC HEALTH
GTA1M~NT OF OEFICleMCIES lt1middot1) fROVIOERISvfPlltRCLIA (XZ MULTIPLE CONSTRUCTION CJ) DAT SIJRYFY AND PlAM or CORRECTIO-l IDFNflFICATON NUMBER COttPLETO
A 8ttlDINO
050100 9ltt-1G 1210712016
lHRfET AOOR~SS cmmiddot STATE Zifgt CODEt-JAJtE or PROVlOER QR ~UfPUER
2826 Capitol AYMUa1 $qcCra1nento1 CA J5816bull1iG16 SACRAMCNTO COUNTYSuthumiddot Medkml Catllet Sactntttarrto
10 PROVIU~RS LAN Ol C0RREGT10N I X5)(Xbulll110 SUMMARY SlJHMENT Of DtPfCliNC-ESmiddot PREFIX ) (EACH co1mecnVE AClIOH SHOUlO BE CRQSSshy [ COMPLETEPREflX jlACM DEFfCIENCf MU5Tl3E PJEcCEEDEO V FUlt
rnG REPERENClD TO 11E AP~RDPRIATE OifllC16NCY) DATETM RSGULTORY OR LSC 106NTliYl~l INPORMA 110N) I I
Ior maoicatlons identified wah high potential for devastatng consequences If an err~r occurs anlti 2) Medlcallons were admlnlstarad per physician order when Piitiem 3 was administered 250
milligram (mg) of IV (intravenousy injected through i the vein) morphine (a potent narwUc for paln) over one ~ud a half hours in~tead of the prescribed 1 mg per hour
middot The medicalion error exposed Pallant 3 io effects of morphine overdose (166 limes the prescribed dose) ILicludlng row blood pressure and subsequent d9ath
i i I I L [ i
middot Those failures jointly separatily1 or in any combination resulted in nonscomplance wUh one or
more rnquirements af lic1msure and caused or was m~ely to cau~e serlous inJUry or death
This facility railed to prevent the deficlency(ies) as described above that caused or Is likely to calSe
middot$eltious injury or death to the patient and therefore constitutes an Immediate jeopa~dy wllhin the meann~ of Health and Safely Coda SecUon -12803(g)
1
1
middot1middot
I
I
i
middot
Cvenl IDVRSt11 WW2018 90420AM
P~go1Sof18