90-DayStatusReportFollowingtheLangReview
oftheMotheriskDrugTestingLaboratory(MDTL)
OnDecember17,2015,theHonourableSusanLangreleasedtheReportoftheMotheriskHair
AnalysisIndependentReview.Thereportconcludedhair-stranddrugandalcoholtestingused
bytheMotheriskDrugTestingLaboratory(MDTL)between2005and2015wasinadequateand
unreliableforuseinchildprotectionandcriminalproceedingsandthelaboratorydidnotmeet
internationallyrecognizedforensicstandards.
JusticeLangfoundthatSickKidsfailedtoexercisemeaningfuloversightoverMDTL;shealso
concludedshewasconfidentthatSickKidswouldreflectdeeplyonwhatwentwrongatMDTL
andinthebroaderinstitution.SickKidshasandcontinuestoreflectonwhathasbeenlearned,
andhastakenandwillcontinuetotakeappropriateactiontoensurethatthehospitalandits
staffmeetthehigheststandardswheninteractingwiththejusticesystem.
ThissummaryhighlightsthechangesSickKidshasimplemented,asaresultofJusticeLang’s
reportandSickKids’owninternalreview,toenhanceouroversightstructureandmechanisms
aswellasqualitycontrolsystemsacrosstheorganization,topreventsimilareventsfrom
everoccurringatSickKidsagain.
Understandinginteractionswiththejudicialsystem
InteractionsbetweenSickKidsphysicians,staffandthelegalsystemareinevitableandoccurin
anumberofsettings,astheydowithstaffinmostchildren’shospitals.Suchinteractionsoccur
whenstaffareaskedundersubpoenatoprovidetestimonyaboutcaredeliveryandwhenthey
voluntarilyprovideexperttestimony.Theymayparticipateincivilorcriminalproceedings
includingchildprotectionproceedings.Staffmembershaveaprofessionalresponsibilityto
provideimpartialtestimonythatreflectscurrentmedicalscienceincludinganylimitationor
uncertainty.
Thehospitalhasconsideredwhichprogramsarelikelytoprovide‘forensic’testimonyor
evidence.Giventhenatureofhighlyspecializedchildren’shospitalslikeSickKids,manyclinical
programsandserviceshavethepotentialtointeractwiththejudicialsysteminanumberof
ways.Toensurethatstaffarewellawareoftheirprofessionalresponsibilities,andtotrack
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interactionsinordertoenablebetteroversight,wehaveimplementedanewpolicy.Thispolicy
allowsinteractionswiththelegalsystemtobemonitored,andmandateseducationforstaff
whoprovidetestimonyforlegalproceedings.
1. Monitoringinteractionswiththelegalsystem
Allstaffinteractingwiththelegalsystemwillberequiredtonotifytheorganization.In
mostcircumstances,thehospitalrecognizesthatitcannotrestrictstaffandphysiciansfrom
interactingwiththelegalsystemandcannotpreventstafffromfulfillingrequirements
undersummonsorsubpoena.Wedonotintendtorestrictactivitiesbutrathertobeable
tomonitorthetypesandfrequencyofinteractionswiththelegalsystemandtoensurethat
staffareproperlytrainedtofulfilltheirprofessionalobligations.
Byadoptinganewpolicy,SickKidsnowrequiresallstaffandphysicianswhoacceptservice
ofasummonsorsubpoenatoregisteracopyofthesummonsorsubpoenawithSickKids’
legaldepartment.Additionally,allstaffandphysiciansactingasanexpertwitnessinlegal
proceedingsorwhoprovidewrittenopinionformedical/legalmattersmustnotifytheir
supervisor,andprovideabriefexplanationofthecircumstancestoSickKids’legal
department.Thisnotificationtriggersmandatoryeducationandtraining.
2. Trainingforstaffthatinteractwiththelegalsystem
SickKidshasimplementedmandatorytrainingforstaffandphysicianspriortotestifyingor
submittingopinionstothelegalsystem.Uponcompletionofthetraining,staffmust
providewrittenaffirmationthattheyunderstandtheirroleandresponsibilities.Priorto
decidingwhethertoprovideexperttestimony,staffmembersareencouragedtoseek
advicefromSickKids’legaldepartmentand/ortheCanadianMedicalProtectiveAssociation
sothattheyfullyunderstandtheirproposedrole.
Clinicalandresearchlaboratoryoversight
Asaninnovative,academicteachinghospitalwithaworld-renownedResearchInstitute,we
recognizethatmanydiscoveriesinourresearchlaboratoriesaretranslatedtoclinical
application.Manynewclinicaltestsoriginateinresearchlaboratoriesaspartofclinicalresearch
studies.Whennewtestsarefoundtobeuseful,theyareoftenadoptedforclinicaluseand
possiblyforensicuse.Astestsbecomeusedforclinicaldecision-making,itisimportantthatthe
laboratoriesperformingthosetestsareincompliancewithLaboratoryandSpecimenCollection
CentreLicensingAct(“theAct”).
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Inanefforttostrengthenclinicallaboratoryoversight,andtoensurethatresearchlabsthat
developusefultestsandthenwishtotransitionthosetestsfromresearchtoclinicalsettingsare
compliantwiththeAct,SickKidsimplementedanewpolicyinDecember2015.Thispolicy
requiresthatanylaboratoryatSickKidsthatmeetsthedefinitionofaclinicallaboratorymust
identifytheassociatedtestingontheDepartmentofPaediatricLaboratoryMedicine(DPLM)
laboratorylicenseandarrangefortestingtobeplacedundertheclinical,operationaland
qualitymanagementcontrolofDPLM.
SickKidsdoesnotcurrentlyperformteststhatarepredominatelyusedforforensicpurposes
anddoesnotoperatealaboratorythatisaccreditedasaforensiclaboratory.Werecognizethat
resultsfromourclinicallaboratorycouldbeadmittedasevidenceorotherwisebeusedinlegal
proceedings.BytheendofMarch2016,morethan95%ofourlaboratoryreportswillbe
modifiedwithadisclaimertoensurethatresultsarenotmis-representedascomingfroma
forensiclaboratory.Theremainderofthereportswillbemodifiedasnewinformationsystems
go-liveinthenext2-3months.
Conflictofinterestmanagement
SickKidshasreflecteddeeplyonconcernsraisedaboutperceptionsofconflictsofinterest
arisingfromresearchfundingbyprivateindustryorbyderivingrevenuefromotheractivities.
Webelievethatrelationshipswithindustryincludingfinancialsupportofresearcharevitalto
aneffectiveandproductiveacademicresearchenvironment.However,weacknowledgethat
whenfundingisreceivedbyahospitalorscientistfromprivateindustry,disclosuresmustoccur
andthepotentialforconflictofinterestand/orbiasmustbemanaged.
Concernsaboutconflictsofinterestariseinmanywalksoflifewheneveraperson’sself-interest
canbeperceivedtobeatoddswiththoseinwhosebestintereststheyaresupposedtoacting.
Forexample,whenascientist’sinterestsinpreservingfundingisatoddswiththeir
responsibilitytoactscientificallyinawaythatbestservesthepublic’sinterests.Ethical
behaviouristhefirstlineofdefenseinensuringpotentialconflictsdoesn’tbiasanindividual’s
actions.Whilepotentialconflictsmaybeinevitable,thehospitalmusttakeamoreactiverolein
ensuringthatconflictsdon’tinfluencephysicians,scientists,orotherstaffandthatthepublic
understandswhenconflictsmightexist.SickKidshaslonghadapolicyrequiringstafftodisclose
potentialconflictstotheirsupervisor.However,toallowthehospitaltoevaluateandbetter
managepotentialconflicts,wehaveestablishedaConflictofInterestCommitteetoevaluate
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potentialconflictsandtoprescribeappropriatemanagementstrategiesincluding,when
necessary,avoidingconflictsaltogether.Thecommitteeiscurrentlyworkingonharmonizing
conflictofinterestpoliciesacrossSickKids,andwilldevelopastandardprocessformanaging
conflictsofinterestacrossSickKids.Acomplianceofficerwillbehiredtoprovideleadershipto
supporttheConflictofInterestCommittee.
Ongoingclinicalresearchoversight
SickKidsiscommittedtoensuringthatallclinicalresearchmeetsquality,regulatory,and
researchethicsstandards.Overthepasttwoyears,SickKidshasdevelopededucational
workshopsonGoodClinicalPracticeforresearchersandtheirteamsontopicssuchasstaff
training,studydocumentation,medicaloversight,andadverseeventreporting.Inaddition,a
mandatoryprocesswasimplementedforallnewinvestigator-initiated/sponsoredclinicaltrials
thatmustbecompletedpriortostartinganynewstudytoensurethatallrelevantprocesses,
training,andoversightmechanismsareinplace.
Accesstodataonelectronicsystemsisgovernedbyprivacylegislationaswellasbyresearch
ethics.Allresearchstaffmustcompletemandatoryonlinelearningmodulesthatteach
regulationsandexpectationsregardingprivacyandconfidentiality.Inaddition,theChiefof
ResearchandtheChairoftheResearchEthicsBoardhavecommunicatedtoallresearchstaff
that,inaccordancewithexistingpolicies,anyelectronicsystemwithpersonalhealth
informationmusthaveappropriatecontrolsandanyresearchuseofthedatamustbefully
authorizedbytheResearchEthicsBoard.Anannualprivacyauditplan,includingself-auditby
researchteams,hasbeenimplementedtomonitorandensureresearchcompliancewith
privacystandardsandlegislation.
OrganizationalOversightandAccountability
Toensurethatkeylearningsareappliedbroadlyacrosstheorganizationandthatpeople
leadersfullyunderstandtheirresponsibilitiestoprovideappropriateoversight,SickKids
PresidentandCEODr.MichaelApkonandtheexecutiveteamhaveconductedaseriesof
mandatorymeetingswithallclinicalandresearchleadersintheorganizationtointroducethese
newpolicies.Leaderswillcontinuetobeheldaccountableforbeingfamiliarwithactivitiesof
theirteamsandforrelevantregulationsgoverningthoseactivities.
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JusticeJudithBeamanCommission
OnJanuary15,2016theProvinceofOntariolaunchedanindependentcommissiontoassist
familieswhomayhavebeenaffectedbyresultsgeneratedbytheMDTL.CommissionerJudith
C.BeamanisleadingthereviewandwillprovidesupporttoindividualsinOntariowhosecases
involvedtheuseofMDTLhairtestsbetween1990and2015.
SickKidswillcooperatefullywithCommissionerBeamanduringherteam’sreview.Atthistime,
itisourunderstandingthatthisreviewwillonlyconsidercasesthatinvolvedtheOntariolegal
system.ThehospitalhassentletterstootherprovincesandterritoriesthatusedMDTLresults
tocalltheirattentiontothefindingsintheLangreviewandtonotifythemthatthereareclients
whousedtheMDTLservicesintheirprovince.Wehaveofferedtoworkcollaborativelywith
themtoensuretheyhavewhateverinformationtheyneedfromthehospital.
Summary
SickKidsdeeplyregretsthatitfellshortintermsoversightandresponsibilityoftheMDTL.We
areresolvedtolearnfromtheseeventsandarecommittedtoapplyinglessonslearnedbroadly
withsafe,highqualityandeffectivepracticesbeingourhighestpriority.InthewakeoftheLang
reviewandSickKids’owninternalreview,wehaveamplifiedandreinforcedourcommitmentto
robustoversight.
Inparticular,wehaveintroducednewpoliciesandstructuresregarding:
•
•
•
Defininginteractionsofstaffandphysicianswiththejudicialsystem
o Formalnotificationtoleadershipwhensuchinteractionsoccur
o Formaltraininginrolesandresponsibilitiesofgivinglegaltestimony
Clinicalandresearchlaboratoryoversighttoensurecompliance
Conflictofinterestmanagementtofacilitatedisclosureandenhancemanagementof
conflicts
o COIpolicy
o Oversightcommittee
Overthepasttwoyears,SickKidshasbeenworkingtomoredeeplyadoptprinciplesand
behavioursassociatedwithhighreliabilityorganizations.Werecognizethat,withinallsystems,
failuremaybeultimatelyinevitable.However,highperformingorganizationsseektolearnfrom
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theirfailuresaswellastoworktoensurethatsuchfailuresareincreasinglylesslikelyandmore
easilyintercepted.
Asahighreliabilityorganization,wearealsocommittedtoresilience–tobeingabletorecover
fromerrorsthathaveoccurredandlearnfromthemasquicklyaspossible.Wealsorecognize
thatallSickKidsleadershaveasharedresponsibilitytonurtureanexceptionalcommunitywith
well-definedoversightandaccountability.Ourintentisnottostifleinnovationorprevent
societyfrombenefitingfromnewtestsdevelopedbyourtalentedstaffortheirexpertise.
Ratherwewishtopromotehighqualityandsafepracticesthroughoutourorganization.Wewill
continuetoexamineourpracticesandtocultivateandadheretoprinciplesofhighreliability.
WeareconfidentthatweareaddressingtherecommendationcontainedinJusticeLang’s
reportwhileimplementingappropriateandeffectivemeasurestopreventtheneedforanother
revieworinquiryintohowSickKids,itsprofessionalstaff,oritsprogramsinteractwiththe
justicesystem.Themajorityofthesemeasureshavebeenimplemented.Itisourintentionto
provideasubsequentreportlaterinthefalltoprovideanupdateonourprogressandensure
thatourlearningsasanorganizationaresharedbroadly.
Onceagain,wedeeplyregrettheeventsthathaveoccurredinthisparticularlaboratoryandthe
impactsthatchildrenandtheirfamiliesmayhaveexperienced.
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