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Quality Assurance Audit for Forensic DNA and Convicted Offender DNA Databasing Labs 12.20.2007.pdf

Quality Assurance Audit for Forensic DNA and Convicted Offender DNA Databasing Labs 12.20.2007.pdf

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k._,
i
QUALITYASSURANCEAUDITFORFORENSICDNAANDCONVICTEDOFFENDER
-
-_
..
-
-----------,._.-
-----~--
--~---~~--------
--
_DNADATABASING
LABO'RArORIES
INACCORDANCEWITHTHEQUALITYASSURANCESTANDARDS
FOR
FORENSICDNATESTINGLABORATORIESANDCONVICTEDOFFENDERDNADATABASINGLA,BORATORJESISSUEDBYTHEFBIDIRECTOR
AnAuditofSouthwesternInstituteofForensicSciencesDatesofAudit
12/20";31/2007
Auditor(s)
Timothy
J.
Sliter,
Ph.D.
(Name)
Stacy
McDonald,
Ph.D.
(Name)
(Signature)
Name)
FBIDNAQualityAssuranceAuditDocumentIssueDate
07/04
(Rev.
#
6)
•'&~•
 
.1
TableofContents
Introduction3References,6Defini1ions:7
---~---.Standard
-l;
QualityAssurance.l?.roH'gr""'~,....m...__
Standard4:OrganizationandManagement:12Standard5:Personnel_
>
14
Standard6:Facilities..24Standard7:EvidenceorSampleControl..:.26·Standard8:Validation"28Standard9:AnalyticalProcedures::31Standard10:EquipmentCalibrationandMaintenance36Standard11:Reports37Standard12:Review::..39
.'
.
Standard13:ProficiencyTesting:
41
Standard
14:
CorrectiveAction::.'44·.-Standard15:Audits~45Standard16:Safety,::
47
Standard17:SubcontractorsofAnalyticalTestingforWhichValidated:.,.48Appendix
A:
FindingsandResponses:50
FBIDNAQualityAssurance
Audit
DocumentIssueDate
07/04
,(Rev.#6)
 
Introduction
The
DNAIdentificationActof
1~94requiredtheformationofapaneLof.distingiShedprofessionals'fromthepublicandprivatesectorstoaddressissuesrelevanttoforensicDNAapplications.Thispanel;titledtheDNAAdvisoryBoard,firstconvenedin1995.AnearlymissionoftheDNAAdvisoryBoardwastodevelopandimplementqualityassurancestandardsforusebyforensicPNAtestinglaboratories.The.scopewas'quicklyexpandedtoincludeforensicDNAdatabasinglaboratories.Th~DNAAdvisoryBoardfulfillethisrote,recommendingseparatedocumentsdetailingqualityassurancestandardsforbothapplications.The
QualityAssuranceStandardsforForensicDNATestingLaboratories
andtheQua/ity
Assarenc«
Standards'forConvictedOffenderDNADatabasingLaboratories
wereissuedbythe·Directoroftl:IeFegeralBureauof
_.lrrles.tigatiQ.l1.in
October1,998and}...Q.riI1999,r~~ctively.Bothdocumentshavebecom~benchmarksforassessingthequalitypracticesandperformancesofDNA
Iaboratcrtssjhrouqnout
thecountry.----The
DNAIdentificationAct
of1994alsorequiredtheFBILaboratory-toe!lsurethatallDNAlaboraforiesthatarefederallyoperated,receivefederalfunds,oremploysoftwarepreparedfortheCombinedDNAIndexSystem(COOlS)demonstratecompliance
with
thestandardsissuedbytheFBI:Addition<:I"J'..programs,suchastheNationalDNAIndexSystem,addedfurtherrequirementsfarDNAlaboratoriest1iatwishtoenterdataintothenationalDNAdatabasealsodemonstratecompliancewithsuchstandards..Typically,documentationofalaboratory'scompliancewithastatedstandardhasbeenmeasu~d,through'anauditprocess.Suchauditshavebeenperformedbyforensicscientists,eitherinternal.orexternaltothelaboratory,andservetoidentifycompliancewithestablishedstandards..Sincetheissuanceofbothqualityassurancedocuments,ccnfusionregardingtheintentand-subsequentinterpretationforvariousstandardshasexistedintheforensicsciencecommunity-Thelackofa.defined,uniforminterpretationguideforsuchstandardshaspresentedapotential'problemamonglaboratoriesandauditorsattemptingtodeterminelevelsofcompliance,Inaneffo(t.tosatisfytheresponslbilitiesassiqned.throughthe
DNAIdentificationActof
1994andattempttominimizeinterpretationvariability,theFBILaboratoryhasdevelopedanauditdocumentforassessingco~pliance.withtherequiredstandardspfbothdocuments.Recognizingthebroadapplicationofsuchan.undertaking,theFBILaboratoryhassolicitedinputfrommanyforensicDNAlaboratoriesoverthepastyear.toassistinthedocument'sdesign.Thishasincludedcollaboratingwithmembersfrom
two
prominentjntemational·insp.ectionlaccreditationentitles,theAmericanSocietyofCrimeLaboratoryDfrectors/LahoratoryAccreditationBoard(ASCLD/LAB)andtheNationa[ForensicScienceTechnologyCenter.Tothis.eoo,theauditdocumenthasbeencreatedbytheFBIlaboratorywiththeinput,guidance,andconsensusfromtheabove-mentionedgr.D;ups.The..,document.definesandinterpretseachstandard,withaddeddiscussion.pointsclarifyingthe'criteria..necessaryforcompliance.Additionally,thedocumentisstructuredsuchthat·c.~teria:which'overlap..'..betweentheFB[-issuedstandardsandthecorrespondingASClD/LAS.elements,-sharea
consistent.
interpretativeview.-....RegiJrdingtheformatoftheauditdocument,eachstandardis'list~numerically,comblnlnqthe.qualltystandardsoftheforensicDNAlaboratoriesandtheconvictedoffender"DNAdatabasinglaboratories:intoonedocumentStandardsthatapplyexclusivelytooneapplication.areiderytifiedassuch,with
ftl_e.:
deSignationofeitherFOorCO,parentheticallyadjacenttothestandard,T~~absenceof-agesign~tionidentifiesasharedapplication.'Instancesinwhichthewordingofa.standardlsthesameforboth.appleatlons(FOand'CO),butthecorrespondlnqnumberofth8..standardQJ~ers~.theFO'numb:er.
~iIl
beparentheticallyadjacenttothe'standard,ar1dtheCOdesignatici.n,.wi~h.ts'corresponding
number;
'willfollowthenarrativeofthestandard.Theratingsystemforassessingthelaboratorywithea¢hstandardislisted.
by
thechoicesofYes,No,orNotApplicable
(N/A).
Asindicated'earlier,discussionsectionsfoII
ow
.standards,asappropriate.aridservetoclarifytheinterpretationnecessaryfcrcompllance,Specificpassagesareboldtoaddemphasistotheintentassociatedwithastandard.Acornrnentsecfion
J$
alsopro.videdfO'lIowingthediscussionareas,affordingaudjtorstheopportunjtytoreferencelnformationthatmayhaveyalue·in.thauditprocess(suchaslistingthereasonfor~Yes,Nq,?r
N/A).."..
Finally,inAppendixA,thefindingsassociatedwiththeaudit
will'
bedetailedand'summaFize'dby-the'auditor,withanareaavailableforresponsetosuchfindings
by
thelaboratory.Notesorcomments,includingobservationsandrecommendationsarebettersuitedtobementionedduringtheexitb~iefl(1gwith
..
FBIDNAQualityAssuranceAuditDocument
IssueDate07!04(Rev.
#6)
3
'.

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