IMPLEMENTATION AND FURTHER DEVELOPNIENTOF QUALITY MANAGEMENT SYSTEMACCORDING TO ISO 9001:2000STANDARD AT THE DEPARTMENTOF CARDIAC SURGERY.DUBRAVA UNIVERSITY HOSPITAL Barii, Dt., Brkii, Kr., Sutlid,Zt., Nikid, N{., Grubisii, NIs'& Deviid-}eras,A6. U D K / U D C :6 1 6 I. 2 - 8 9 : 0 0 6 . 3ts0( 0 ) I S O I E L :I " znanstvenirad paper/Izr,'orni Orginalscienti{rc Primljeno:.[anuar Receivedi ,v20,2007I 20.sijectrja2007. za trsak:Nlarch19,2007I 19.ozuika2007. Acceptedfor publishing/Prihvaieno Summary Theneedforquality tnonagementsystem(()MS) nt t:ardiacsurgerydepnrtrnerthas pi'clcr/r of all processts beenrecognized for sonrctime. QNISshouldhelpin rnonugement ()Lttcorne analysis.Cornprehensive organizationalmistakesand provide a tool for unbiased process analysisof surgicaltreatmentof cardiacpatient httsbeencarriedout. Recluirements of the ISO 9001:2000standard:quality managementslsteil, manogementresponsibility, product realization,measurenlentonalysisond improventertt,t'ere resourcemanagement, customizedto specifcsof cardiacltatient trealment. All docuntentationn'ds n,ritten in plttin languageto seryeas practicemctnual.QfutSernphosisis routine investigationo.fall adyerseeventsand stotisticalanalysisof trendsin treiltnrclil.After 22 months,QIIS has beencerliJiedaccordingto 1SO 9001:2000standord.ior scopeof cardiacsurger)',curdiLtc intensiyecoreand perfusion.The implementcrl Q-rl{Shos ensuredcortsistency ttrraesthesia, antl improvementof workingpractice,which in turn provided bettercontrolover achievetl nrcdicslresultsand higherpnLiettsatisfnction. ISO 9001:2000'scope' Key words: cluality managementsystem,cardiac sLffger)t, trnprovement.
L Davortsarii,dr. med.,generalsurgen'specialist,surgeon,Dcpartrnentoi(-ar.liacSurgerr',Dubrava Unirersitv Hospital. I N{r. sc. Kristipa Brkii, medical biocheniist,junior researche'r, lJcPrrtrtlent of Cardiac Surgerr',f)ubriu'u Universitl'Hospitarl. Prof. Ph.D.,Zeljko Sutlii, cardiacsurgeon,Departmentof CardiacSurgerv.DubravaUniversitv Hospital. ' NaclaNikit, dr. med. alesthesiologrst, Clinic of Anesthesiologl.ReaninratoloqvirtrdIntensiveCarc, L)ubrlva Universitl'Hospita[. , N,iilkaGrubiSii,head ntirse,l)epartn]entof cardiac Surgerl"Dubrara Unilersitv Hospital. ' r\na Devtit leras,chemicalengineer,consultant,l)ubrava Uuilersitr Hospitirl. '
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BR.I I (2OOi) GOD. ZA6REB, IIVR5NO5I PO5LOVNA
I. l. l
D, le' tv i i c J e r al m s ,pAl:e m e n t a t i 0 n b ii ti i<t& E a r i ( , 0 , , B r k i ( , K . , 5 u t l i ( ,G2r. u, N i, cM
INTRODUCTION Qualityinmedicine
as achlcvetnentand nlaitltetlauceof Quality in medicine is usually defined healthcare'Indicatorsirnd standarcls and acceptedstandardsof treatment iuternatircnally are measurablefactslvithin are the basicterms relatedto quality in medicine.Indicators procedure,illciclence operative the processof treatment,e.g.moriality of a particular treatr.nent'Patient of of particuiar complications,incidence of unsatisfactorl'results categor)'; subjective is-a lengtli of hospital stal',or cost per da,v.Satisf'action satisl'action, are S/rrnrlttrds and scaies. lrorvever,it can be exactlymelsured by use of questionnaires pr'iblished experience 'alues set for indicators,mostly based on agreementor others' standardsare also Accepted treatment fbr guidelines as or literature iu professional controlin medicineinclude knorvnasGood CiinicalPractice.The main modesof qualitv clfcauses' signals'ar.ralysis continuousrecordingof indicators,identificationof trenclsancl e e a s u r eIsI l . a n d u s eo f c o r r e c t i v m 1.2' ISO 9001:2000and its requirements The InternationalOrganizationfor Standardization(ISO) is a nou goYernmental federationof ntitio'al organizationestablishedin lSqZrvhich presentstodav a rvorldrvide l*,2006) (on August the [2] Its original 157 countries standardsbodiesfiom rnorethan traded in products for specifications oftechnical purposewasto provide standardization highly are iSO standards of majoritv vast the the internationalmarketplace[31.Today, have that standards the Hor'veYer, process. specificto a particular product, material, or as are knolvn reputation worldrvide earned the ISO 9000 anci iSO 14000 families a "genericmanagementsystemstandards"[2]' late 1980s The ISO conceptrvasfirst brought by the automobileindustry in the manufactures' automobile by used of suppliers becauseof a neecito qualify the thousands qualit,vfiamervork This effortwasa concreteexampleof competitorsrvorkingto developa ideahasel'olyecl this years, the over However, customers. that would servethem and theii management quality generic of concept broader to a fron.rspecifictechnicalspecilications svstemsstandards[4]. The ISO 9001:2000is ir generic standard,rvhich means that all standard of its type, size, requirementsare generaland can apply to any organizationirrespecti\re product or serviceit oflers.It should be noted that a partictiar prlcessis being certihed requirements rather than a particularproduct or service.The ISO 9001:2000standard of quality system to the approach process of principles are basedon the fundamental of the father Deniing, Edlvards w. by issued principles the to management,according following: the on based is standard The (QMS) [5]' quality management,yit.,r-t .
determinationof all processesrelevantfor quality lnanagement'
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determinationof the courseand interactionof the processes,
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P05I0\/NA lz\/RsNOsT ZAGREB, | (2007) BR.1 G0D.
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lnrplementaion Bari(,D.,Brkic,K.,5utlic,l.,l'llkii,N.,Grubiiic,[4.&Devcic]era
tor verificationof the process determinationof the criteriaand rr.rethods eflicier-rc1',
pr'cesses' :
-"-.--:::::il:::
.
continuingprocessimprol'ement.
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An organizationseekingcertificationaccordingto lSO 9001:2000nonn nlust describeand implement quality nanagement system requirementsinto their process. This involveswriting a quality policl', quality manual and quality objectivesaccordingto the officialnorm (HR EN ISO 9001in Croatia)[6]. the conventionalISO sayingis that )rou: .
rvhatyou do"), Documentwhat you do ("Sa,v
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Establisha processfbr the service,
.
Perfortnto your documentation('Do rvhat1'ousav"),
.
Providethe servicebasedon the process,
.
Recordthe resultsof your work ("Recordinfbrmation"),
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Appropriatelymaintenanceall recordedinfbrmation,
.
("Audit eflectiveness"), for effectiveness Audit the docurnentatior.r
.
Audit using the processapproach.
1. 3.
Purposeofarticle
The aim of this article is to describeour experiencein the developmentand implementation of a QMS at a hospital department ar.rdthe processof certificatiorr standard. accordingto ISO 9001:2000 l. 4. Department of Cardiac Surgery The Departrnent of Cardiac Surgery is a part of Dubrava University Hospital, of rvhich is one of set'eralstatehospitaisin Zagreb,Croatia. The Department cor.rsists a ward with an intermediatecare unit rvith total of 3 i beds. It is closelvreiateclto the Departmentof Cardiac Ar.resthesia with 5 beds in intensivecare unit (lCU) and to the stuffof about50 healthrvorkers operatingblock rvith 2 operatingtheatres.Highly educatecl anesthetists, cioselyinvolvedin surgicaltreatmentofcardiacpatients,includesurgeons, and perfusionists,OR nurses,ICU nurses,ward nurses,physiotherapists,acln.rinistrator supporting stuff. Over 450 surgicalprocedureson open heart are performed annually in two operatingtheatres.Structureof departmentis presentedas organizationchart in F i s u r e1 .
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p05LOVNA BR.l | (2007) G0D, ZA6REB, |Z\/RSNOST
Figure
'l:
m.p&lD em B a r i i . D . , B r k i i , K . , 5 ! t l i ( , i , N i k i i , N . , 6 r u b i < i t , [ l' 1 e vei n i ct]aetri o an s'A:
organizationchart The l)e;'artnlentof CardiacSurgerr':
: ::..t;:
Research activities
Patient irteatment
Education activities
QualitY assuranceand informatics
ofMedicine School ofZagreb University
Labaratory Surgical o{Biomedical Research
of Medicine School ol SPlit University
Administration
Quality assurance Medical results
1S09001:2000
Computer systems Library
0Rnurses lor CIinic cardiac surgery
Perfusion
Cliniclor heart transplatation
1.5. IrnPlementationof QMS of tl.re Theprocessof the implementationof the QN{Stook 22 months' Introduction at Department' (Figure formed rvas 2) force task a rvhen QMS rvasinitiated in Ma,v2003, Traini.g and support in QMS developmentrvasprovided b,vconsultzrntwith previtlus norm waschosensince TheEN ISO 9001:2000 certification. in ISO 9001:2000 experience (asin our crse)'The organization cornplex in departrlents it enablescertiticationof single the purposeand present to emplo,vees all for sessior.rs consultantdeliveredseveraliraining asa supporting accept emp1o1'ees that QIVIS importance structureof a QMS.It wasof utmost j threat' a not as atld ob everyday their of irameivorkto be usedin intprovement
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BR.1 I (2007) POsLOVNA IZVRSNOST ZAGRIB, 6OD.
em B a r i i , D . , B r l i r , K . , 5 u t l i i , 7 . , N i k i t , N . , G r u b i i i i ,llm ' . 4p.l& D evnitlat itei or ans. ., A . :
of CardiacSLtr-getr at DePartrnent Figure 2: Taskforcefor intplementingISO 9001:2000
ISO9001:2000 CONSULTANT
During the lirst yearof QMS development,taskforceleadersidentifiedanclthorougDue to its complexitr.,all hly analyzedmain processof treatmentofcardiacsurgerypatients. employees wereactivelyengagedin productionofa seriesofstandardoperatingprocedurcs (SOP),eachdefinedby its purpose,responsibility, generaldescription,resources(persor.rnel, qualification,tools,hard- and software,infrastructure)and documentationrequirements. All generallyacknowledgedstandardsfor dilTerentproceduresin cardiacsurgery,cardiac anesthesia, intensivecare,perfusionand nursing,aslvell asexistingprotocolsof Dubrava University Hospital were registered,evaluatedregardingtheir applicabilityand, hnali,r', incorporatedin our QMS. Severaladditionalformsrveredevelopedand includedin patient medicaldocumentation,thus rnaking routine job easier.
During the secondyear,the taskforcewasfocusedor-rthe resourcesmanagement:all used locations,infrastructure,surgicalequipment,medicalinstrumentsand otherresources and system:rtically entered in in the processof treatmentof cardiacpatientslveredescribed custom-madedatabases. Complexrelationsrvith other units and servicesof DubravaUniversityHospitalwere analyzedand formal protocolsof comnrunicationsn'ereagreed. and distributed At the end,comprehensivedocumentation(Figure3) rvasfir.rished in ,rvrittenand electronicforms.Standardoperatingprocedureson eachparticularsegment
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A: lmplemenlatr0n i\'1. &DevciGJeras' N.,6rirbiii(, K.,Sutlii,7 , Nikit, Bari(. D.,Brkii,
and clocttt.tlellof the processof treatment arrear,ailableto eachemplol'ee"I'erminology to iacilitate used rvas language friendl,v and but a plain werestandardized, tation s-vstem routineusage. and suiPlannedinternal auclitsrverestartedto confirm the correctperformance b1'quality management tabilitl, of the reviseclprocesses[ 1] . Theseauditswere performed and their conseq Results rvhole the QN{S covered ancl of theiepartment representatives m:rnual' management qualitv .,"..". are reporteclin the
l.6.Measurementofthequalityoftreatmentofcardiacsurgerypatients of questionnaIn additionto usualmor.ritoringof the patientssatistactionbv means analysisof objectii'e i'e' result, ires,our QMS includescontinuousmeasurementof medical methods' statistical and treatmentoutcomes.Theprocessof outcomeanalysisusesdatabase clata, extert]al rvith and consistsof data collection,risk adjustmentof data, comparison is the rnortalitf feedbackupon the processoftreatment.Perioperative and consequential o'erirll of fbllolr'-up ntajor quality i'clicator in cardiac.,r.g..y. QIVISincludescontinuous Theresultsobtainedare mortaliiy anclmortality accordingto particulartypesof operation' a model of preoperatiYe with the expecteclmortality accordingto EuToSCORE, cot.r-rpared that has found wiclestapplicationall over Europe [7]. Besidesmortalitr', risk assessment urgent reoperationor otl.rertreatmentcomplicationssuchasthe rate of infection,needof analvsisof treatrller]t the rvith Along monitored. regularly repeatsternalclosureare also and discussedat presented regularly are analysis trencls,all casesof unfbvorabl. ,r.,t.o-. Departmentstaffmeetings.
l. 7' Researchactivities of Department of Cardiac Surgery Good Researchactivitiesin our Departmentarebasedon the follorvingstandards: t'f Dechration LaboratoryPractice[8] and Good clinical Practice[9], togetherrvith the colleroutine Helsinki 1i01.flere are two tJpesof researchactivities:clinical research and science surger)'; in cardiac topics various concerning clata cting ancianalysisofclinical (SLBR). The idea of Research Biomedicai for Laboratory ..r."a..h performedin Surgical in line 2003' of beginning at tl.re launched was Department a researchlaboratoryat our "cardiothoracic at laboratory" research so-called establishing lvith the worldwide trend of (http://rvrvt't ' Foundation (Cleveland Clinic departrnents ma.r,vrenownedcardiacsurgery (http://u'rvrv'bumc' Campus Nledical University Boston clevclanclclinic.org/heartcenter/), bu.edu),MedizinischeHochschuleHannover (http://r'vrvrv.mh-hannover.deiklinikeruthgi lebao/index.html).
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BR.1 I (2007) PO5LOVNA IZVRSNO5I ZAGREB, GOD.
.. N.,6rubiiii, lV.&DeviiiJeras, 4..lmpementation 2,,Nikic, K.,5utlic, Barit, 0.,Brki(,
Figure 3: Schernaticdiagram of documentationin our Ql\lS
Vision,mission and quality policy Qualitygoals
O K K _ Z D2 QUALITYMANAGMENT SYSTEM
PSKPSKPSKPSK-
management 1 Documentation 2 Internalauditand correctivemeasures measures 3 Preventive management 4 Discrepancy
PSK- 1 Treatmentof cardiacsurgerypatient PSK- 2 Work organization
OKK_ZD3 QUALITYBOOKOF PROCEDURES
PSK- 3 Reasurcemanagement PSK- 4 Scientificresearchwork PSK- 5 Surgiocallaboratoryfor biomedicalresearch
OKK_ZO 4 OUALITYBACKGROUNDAND QUALITYRECORDSSUSTAVUKVALITETE
OKK-ZD4-KBD OKK-ZD4-NN AND REGULATIONS LAWS,NORMSAND FOR REGULATIONS DOCUMENTATION DUBRAVAUNIVERSITY HOSPITAL
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BR.1 60D.I (2007) ZAGREB, IZVRSNOST POStOVNA
A':lmplementali0n M &Devti(-Jetas' N,,Gr|lbiii( Niki(, K.,5utlii,2,, D.,Brki(, Baric
is to grow lnto Laboratoryis the hrst of that type in croatia. Its main objective laboratoryiorappliedmolecularbiology.insurgerfin the research the leadingbiomeclical includesthe follorving:tearching RepublicJf Croatioand neigirboringregio'. The mission make them in appliei,.,role."uloibiologyand researchmethodologyto rhe surgeons-to-be and solr'ingclinical problems full,vcJmpetentand iirdependentphysicians-scientists, ph,vsiologyand patholog,vof basic encounteredin cardiac,ury..y ovhli. comprehencling the evaiuationof the results' to idea tl.reissues.Thewhole p.o..i., irom the main research and presentedin cross-functionalflowchart lveredefir.red -Ihis
unit in the to our research requirernents we haveimplementedthe ISo 9001:2000 Nlal'2006,accordingto the stepsdescribedin section2 2'
2.
RESUITS
2. L.
Certification of the QMS
completedirl lr'larch lhe implementationof the quality managementsvstem\vas veritas (DN\r) (http:ri 2005, r,vhenthe international certification company Det Norske audit, and confrrmed $,rvw.dnv.org)performed clocumentationreview and certification (cardiacsurger)',cardiacant'sthesia ih. pro..r, of ir.ut-.r1t .f cardiacsurgery patients set by the ISO ar.rdintensivetreatment,perfusion) to iompletely rneetthe reqtiirements systemhasbeenset g00l:2000standard.It shouldbe notedthat our qualitymanagement applicable' as a flexiblesystem,thus modificationsof proceduresbeing readily 2.2.
Extensionof QMS scoPe
norm requiresnot onll'effectiveimplemenAs alreadymentioned,ISO 9001:2000 In May 2006 lve tation and maintenanceof the QNIS,but also continual impro'n'ement' Todaysscope extendedthe scopeofcertificationto the field ofdesignand deYelopment' and intensive anesthesia is: treatmentof cardiacsurgerypatients:cardiacsurger)',cardiac research. treatment,perfusion;and reseaichwith Surgicallaborator,vof biomedical 2.3.
QMS benefits
and The benefitsfiom all quality managementsystemsgenerall,vare long-term compa-of The majority becorneevidentonly after severalyearsof their implenlentation. higher satisfactionof nies and organizationsobserveimproved productivity and success, systemhasjust management their usersand employees,and cosi reduction.As the qualit,v onl,vbe ableto rvill its ber.refits beenfully implementedat Departmentof CardiacSurgerl', during obvious assessin a certainlapseof time. Yet, some benefitshal'e alreadybecome of standardization the introduction and initial implementationof the system,as follorvs: and deviations procedures- existenceof working instructions;mechanismof iderltiff ing andunderstandcommunication problems);better prlsent (unspoken but theircorrection medical ing of the entireprocess;bettermaintenanceand calibratingof the equipment; of continuous obligation imposed and kept; properly and is complete clocumentation resultmonitoring. lfJ
1 BR. POStOVNA IZVRSNOST ZA6REB, 6OD, I (2007)
3.
N.,Grubiji(, A.:lmplementati0n Niki(, M.&DeviiiJeras, Erki(, K.,5utli(,2., 8arit,0,,
CONCTUSION
Effectivequality managementsystemsare raritv in our troubled health system and there are no consultantsrvith necessarycombination of basic medical knorvledge and experiencein field of quality assurance.Developmentof a QMS is both costly and time-consumingprocess.Bearingall that in mind, we havestartedpioneeringjob of Ql\{S implementationin a single departmentof highly specializedmedical field inside a huge statehospital.The successof our job was proven by certification accordingto ISO 9001:2000norm in 2005and by the extensionofcertificationscopein 2006.Finally,we can concludethat implementedQMS has ensuredconsistencyand improvement of lvorking practice,which in turn provided bettercontrol over achievedmedical resultsand higher patient satisfaction.
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REFERENCES ]. B e h o l z , S . , K o c h , c . , K o r . r e r t z , w . , ( 2 0 0 3 ) , Q u a l i t y N [ o n a g e m e r r t s y s t e m o J a U n i v e r s i t l ' 1SO 9001:2000'Thorac cardiov CardiacSurgeryDepartment Accordingto DII'{ El{ Surg,51.167-173
2 . http://wwrv.iso.org outlook quality management West, J., Cianfrani, C. A., Tsiakals,J' J'' Standards February2000 Progress, principles:foundation of ISo 9000:2000family. Quality systemin a multispecialt'v 4 . Levett,|. M., Implementingan ISO 9001qualitymanagement 3l(6):46-51 Nov-Dec; clinic.PhysicianExec.,2005,
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Gabor,Andrea,(1992),TlteManWhoDiscoveredQuality:HowW'EdwardsDeming Broughtthe Quality Revolutionto America' Pengurn (15O 9001:2000'El{ lSO 9001:2000)' 6. Quality monogementsystem recluirements (2002),CroatianStandardInstitute
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7 . http://www.euroscore.org 87/18/EEC,Directive88/320/ 8 . OECD Principlesof Good laboratorypr acttce.Directive EEC g.EuropeanAgencyfortheEvaluationofMedicina]Products.ICHtopicE6.Guidelines lbr Good Clinical Practice. 1996 URL: http:// wwrv.wmanet/ 10.World Medical Association. Declaration of Helsinki. elpolicy/I 7c.Pdf'2000
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A,:lmplementat on Nikic, N.,6rubiir(, l\4.&OevciCJeras, K.,5utlit,2., Brkit, Baric,0,,
IMPLEMENTACIJAI DALJNI RAZVOJUPRAVL}AN'A KVALITETEPREMANORMI ISO9001:2000 SUSTAVOM NA ODJELUZA KARDIJALNUKIRURGIJU EOTNICEDUBRAVA SVEUEITISNE Barit, D7.,Brkit, K., Sutlit, Ze., Niki6, N10.,Grubiii', Mtt. & Devtii-leras, At2.
SaZetak Potreba za sustavomupravljanja kvalitetom na Odjelu za kardijalnu kirurgiiu je postojala neko vrijeme. Sustayupravljanja kvalitetom.ie iskoriiten da bi pontogao u upravljanju procesimai sprjeiavanju organizacijskihpogreiaka te kao sredstvt:tztt nepristranu analizu rezultata. l{apravljena je sveobuhvatnaanaliza procesa kirurike obradepacijenatana Odjeluza kardijalnukirurgiju. Zahtjevi norme ISO 9001:2000:sttstav upravljanja kvalitetom, odgovornostupravljanja, upravljanje sredstvima,ostvarivanje lijetenjapaci.iettttto proizvoda,analizamjerenjatepoboljianjasuprilagodeniposebnostima sa srtanim tegobama.Svaje dokumentacijanapisanajednostavnimjezikom kako bi sluiilo kao praktitni prirutnik. Naglasakna sustovuupravljanja kvalitetomukljutuje rutinsko istra\ivanjesvih nepovoljnihdogadajai statistiikih analiza trendovau lijetenju. Nakon22 mjeseca,sustavupravljanjakvalitetomje certifciran prema normi ISO 9001:2000tako dtt intenzivnu njegu te perJuziju. obuhvaia kardijalnu kirurgiju, kardijalnu anesteziologiju, Uvedenisustav upravljanja kvalitetomje osiguraodosljednosti poboljianje prakse, ito je zauzvrat osiguralobolju kontrolu nad postignutim medicinskimrezultatima te vete zadottoljstvop acijenata. Kljuine rijeii: sustavupravljanjakvalitetom,kardijalna kirurgija, ISO 9001:2000, opseg,poboljianje
i
Davor Barii, dr. med., specijalistopce kirurgije, kirurg, Odjel za karclijalnukirurgiju, Kliniika bolnica Dubrtiva, Zagreb. I NIr. sc. Kristina Brkii, medicinski biokemidar,znanst\.eninovak, Ocljel za kardijalnu kirulgiju, Klinicka bolnica Dubrava,Zagreb. ' Prof. dr. sc. Zeljko Sutlii, kardijalni kirurg, Odjel za kardijalnu kirurgiju, Kliniika bolnica Dubrava,Zagreb. '0 Nada Nikii, clr. rned., anesteziolog,Zat'od za anesteziju,reanimatologijui intenzivno lijeienje, Kliniika bolnica Dubrava,7.tgreb. r1 Nlilka GrubiSii, vms, glavnascstra,Odjel za kardijalnu kirurgiju, Kliniika bolnica Dubrava,Zagreb. 'r Ana Deviit feras,dipl. ing. kemrje,vanjskikonzultant,Kliniika bolnica l)ubrava,Zagreb.
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