Expert DataCareIntelligent cord blood gas analysis - provides an objective measure of perinatal outcome.

• Protectionfromobstetriclitigation

• Audittoolforlabourmanagement

• Expertinterpretationofcordbloodgasanalysis

• Diagnosticsoftwareforvalidaationofpairedcordsamples

• Permanentdatabaseofresults

• Permanentdatabaseofcalibrations

Dedicated to Quality in Maternity Care

Our vision has been tobringmidwives,doctorsandtechnologists together todevelop innovativesolutionsto improve maternity carefor clinicians, mothers andtheirbabies.

K2 Medical Systems havedeveloped a portfolio ofproducts that togetherform a powerful strategyto improve patient care inmaternityandchildbirth.

Why cord blood gas analysis?

Assessment of the acid-base statusof umbilical cord blood at birthprovides an objective measure ofthefetalresponsetolabourandwasrecommended in1993by the26thStudy Group on Intrapartum FetalSurveillanceoftheRoyalCollegeofObstetricians and Gynaecologists1.An international consensusstatement in 1999 also regardedthisasanessentialrequirement forassessing the outcome of labour2.In May 2001 the Royal College ofObstetricians and GynaecologistsEvidence-based Clinical GuidelineNo.8on‘TheUseofElectronicFetalMonitoring’ has recommended thatumbilical artery acid-base statusbeused as an intermediate outcomemeasure of fetal hypoxia in allhospitals3. These recommendationshavebeenendorsedbytheNationalInstituteforClinicalExcellence4.

• Cord blood gas analysisprovides an objective measureof neonatal condition at birth,asopposedtotheApgarscorewhich is subjective, usuallyassigned retrospectively andis influenced by many factorsother than hypoxia duringlabour.

• The presence of an arterialmetabolic acidosis will identify

those fetuses who haveexperienced significant oxygendeficit prior to delivery, andwho therefore may be at riskof neonatal problems such ashypoglycaemia.

• Normal blood gases areessential to defend litigationand acidotic blood gases anessential requirement for adiagnosis of hypoxic ischaemicencephalopathy.

• It encourages a physiological-basedapproach to intrapartumfetal assessment and helpsclinicians to retrospectivelyreviewandlearnfromthefetalheartratetraceduringlabour.

• It isuseful information tohavewhen counselling parents ofbabieswhoencounterproblemsintheneonatalperiod.

• Itprovidesanobjectivetoolforthe audit of intrapartum careand for risk management.Theincidenceofmetabolic acidosiscanbeusedasaqualitymeasureofthestandardofcare.

Why do we need an objective measure of perinatal outcome?TheNationalAuditOfficereported(May2001)thatmedicalmalpracticeclaims against the NHS amount to£4 billion5. 80% is attributable tocerebral palsy and the majority ofclaim is therefore against obstetric

care aroundlabour. Individualcases of cerebralpalsy attributedto perceivedmis-managementduring labourroutinely receivesettlements of theorderof£3million.

These figures are disproportionateandareexacerbatedby the lackofan objective measure of perinataloutcome. All too often a case isdecided on a subjective argumentbetween two sets of experts. It isperhaps not surprising, given thesubjectivity and a brain damagedinfant, that a Court often finds fortheplaintive.

An outcome measure is neededthat can reliably reflect theconditionof the infantatbirthandprovide an indication of the levelof oxygen deprivation actuallysustained during labour. Thisobjective knowledge, can betterestablish the timingof the cerebralinjury (antepartum, intrapartum orpostpartum).

Why do we need Expert DataCare?The NICE and RCOG Guidelinesrecommend that umbilical acidbasestatusneedstobeassessedbycollection of paired samples fromthecordarteryandvein.

The Quality of Data without DataCareHowever, the artery can be quitedifficult to sample. If there is nomechanism to check the results atthetimeofsamplingthenoftentwoveinsamplesareobtainedinsteadofan artery and a vein pair6.A singlesample has little clinical value andvirtuallynovalueinacourtoflaw.

A review of supposed paired cordblood gas data from a multicentretrial intheUKandEuropewithoutExpert DataCare, found thatboth artery and vein had onlybeen obtained in 40% of cases.The remainder had duplicate veinsamples. A success rate this lowquestionsthevalueoftheprocedure.

In units where ExpertDataCare isused, the success rate in obtainingtrue paired results can be greater

0003-9-0005

How does Expert DataCare work?

Recognition of sampling errorsExpert DataCare has in-built expert knowledge to enable it torecognise when an erroneous sample has been obtained. Sampleerrorsareflaggedatthetimeofsamplingtoenableanopportunitytoobtainabetterqualitysample.Physiologicalerrorrangeshavebeenidentifiedbasedonourexperienceofusingcordbloodgasesinmanythousandsofcases6.

Physiological errors cannot bedetectedby the blood gas analysertheycanonlybedetectedbyExpertDataCare.

Expert interpretation of resultsAcid-base balance is a difficult area and this is particularly sofor umbilical cord acid-base measurements.The system uses theexperience and knowledge of physiologists, obstetricians andpaediatriciansto interprettheresultsand identify infantswhomayexperienceproblemsintheneonatalperiod.

Thevalidatedresultsare interpretedusingadatabaseofrulesandclassifiedintooneof36groupsrangingfrom‘Allresultsnormal’to‘Severearterialandvenousmetabolicacidosis’.Afullandsummarisedexplanationoftheresultsisgiven.

What is Expert DataCare?ExpertDataCareisaPCsoftwarepackagethatconnectstomostbloodgasanalysers(Bayer,Chiron,Radiometer,InstrumentationLaboratory,AVL)andcanbeconfiguredforothers.

Expert SystemExpertDataCarehasin-builtexpertknowledgetointerpretthecordbloodgasresults.Itidentifieswhetherbothanarterialandvenoussamplehavebeenobtained.Thecordarteryisthemoredifficulttosample.Iftwovenoussamplesweremistakenlyobtainedthentheuserisgiventheopportunitytoresamplethearterybeforethecordisdisposedof.Thisensuresthatdataisconsistentlycollectedandvalidatedtotheappropriatestandard.

Expert InterpretationAdetailedinterpretationoftheresultsisdisplayedonscreenandabriefsummarycommentisprintedalongwiththeresultsontostickylabelsforinclusionintothemother’sandbaby’snotes.Theclinicianthereforehasanimmediatefeedback.

Expert DataCare adjusts blood gas analyser results to make them applicable for the fetus rather than the adult.Most blood gas analysers calculate BaseDeficitofthebloodcompartmentwhichiscorrectfortheadultbutnotforthenewborn.ExpertDataCarecalculatesBaseDeficitoftheextra-cellularfluidcompartmentwhichisthecorrectcompartmentfortheneonate.

DatabaseExpert DataCare stores all results (cordblood gas data, fetal blood samples,miscellaneous samples and calibration andqualitycontrolsamples)toadatabase.Thisallowsapermanentrecordtobekeptwhichcan be linked to patient information forauditpurposesandisusefultobiochemistsformaintainingcalibration.

Defence against LitigationMost casesof cerebral palsy nowbecome the subject of litigation but it iswidelyacceptedthatonlyabout10%areattributableto intrapartumevents.Anormalvalidatedpairedsample(arteryandvein)isanextremelypowerfuldefence against litigation for clinical negligence during labour. Single vesselsamplesorpairedsampleswhicharesubsequentlybothfoundtobevenousareofnogreatvalue.

Graph of pH

vs pCO2

Example of printed label

TrainingWe will provide all unitswith 1 day’s training onthe software and on theoperational aspects ofadopting routine cordblood gas analysis intoyourunit.

Software updatesAll software updates andupdates to the expertsystem knowledgewill beprovided free as part ofthemaintenance contract.

Weanticipatethistobeatleastonceperannum.

Customer SupportWe have midwivesworking with K2 MedicalSystems to provide youwith quality customersupport. They have in-depth product knowledgeof Expert DataCare andmuchpracticalexperienceofcordbloodsampling.

Clinical AuditK2MS will provide aconfidential annual reportof your units’ cord bloodgas data. Every 6 monthswe will provide you witha clinical audit reportthat can be used totrack changes in clinicalperformance. You cancompare your unit’sperformance with theprevious year andwewillalsoprovideyouwithdatafrom a comparable unit

K2 Medical Systems Ltd7ResearchWay,TamarScienceParkPlymouth,Devon.UK.PL68BTT:+44(0)1752397800F:+44(0)1752764899E:enquiries@k2ms.com

www.k2ms.com

References1. Recommendationsarisingfromthe 26thROGstudygroup.In‘Intrapartum FetalSurveillance’.EdsSpencerJADand WardRHT.RCOGPress.19932. MacLennanA,fortheInternational CerebralPalsyTaskForce.Atemplate fordefiningacausalrelationbetween acuteintrapartumeventsandcerebral palsy:internationalconsensusstatement. BMJ1999;319October16,1054-1059.3. TheUseofElectronicFetalMonitoring. RoyalCollegeofObstetriciansand Gynaecologists.May20014. TheUseofElectronicFetalMonitoring. NationalInstituteforClinicalExcellence. May20015. HandlingClinicalNegligenceClaimsin England.NationalAuditOffice3rd May20016. WestgateJ,GaribaldiJ,GreeneKR. Umbilicalcordbloodgasanalysisat delivery:atimeforqualitydata.BrJ Obstet&Gynaecol,1994101:1054-63

Which vessel should we sample?Both. Without both artery and veinsamplesyoucannotbesurethatyouhavetheartery.Itisthearterythatreflectsfetalacid-base balance but ismore difficult toget.Asinglesamplecannotbeguaranteedtohavecomefromthearteryandsoisoflittlevalueforauditorinacourtoflaw.

Which deliveries should get cord blood sampling?Ideallyalldeliveries. Ifyoudocordbloodgas analysis for audit purposes then youclearly need to know about your wholepopulationofbirths,notjustasub-group.Ifyoudocordbloodgasanalysisfordefenceagainstsubsequentlitigationthenagain,youneedtodoallbirthsbecausethere isnowayoftellingwhichcasesmightbringabouta future claim. Some have suggested justdoingsamplingoncaseswithApgarscoresless than 7 at five minutes.The problemhere is thatApgarsaresosubjective thatthey are easily challenged in a court.Theonly way to exclude intrapartum eventsas a cause of cerebral palsy and blocklitigationistohavethecordbloodgasdatafromavalidatedpairedsample.

Who should do cord blood gas analysis?Anyonecanbetrainedtogetreliablecordbloodgasresults.InPlymouththenursingauxiliariestakealmostallsamplesafterthecordhasbeenclampedbythemidwife.Wehavemeasuredtheirperformanceandhavefoundthattheyconsistentlyachievehighersuccessratesforvalidatedpairedsamplesthan either midwives or doctors. Theimportant factor is theprovisionofgoodquality training so that staff are awareofthepotentialpitfallsincordbloodsampling.

Is routine cord blood gas analysis difficult to implement?Itiscertainlynoteasyunlesscliniciansareprovidedwith feedback.ExpertDataCaredoesthis.Itisourexperiencethataroutinesamplingpolicyestablishesamorereliablequalitysystemthanselectivesampling.Wehaveawealthofexperiencethatcanhelpyouestablishaprocessinyourhospitaltoallow you to realise the full potential ofcordbloodgasanalysis.Thekeytosuccessis a good workable system and goodtrainingwithfeedback.

What is included in the Service Contract?

Frequently asked questions