Forensic Pathology Service and ISO 17020
Forensic Pathology Service and ISO 17020
Forensic Pathology Service and ISO 17020
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Content Quality Assurance• Why ?ooPrinciples of forensic investigationThe role of <strong>Forensic</strong> <strong>Pathology</strong>• Which system ?oo<strong>ISO</strong> 1702OAccreditation• How ?22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 2
<strong>Forensic</strong> Sciences• Application of sciences inthe search for the truth• AimsoReconstruction of theevento Evidence• Used tooooReveal the truthIdentify the perpetrator(s)Prevent new event(s)22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 4
Goals of forensic investigation• Analysis of the facts (service to the community)ooreconstruction of events• determination the manner: accident-suicide-homicide-natural• determination of responsibilities• prevention (e.g. accidents, catastrophes…)data gathering• documentation <strong>and</strong> explanation of phenomena (e.g. criminology)• data linking forensic intelligence• Crime investigationooooodetection of crimedetermination of type of crimereconstruction of the crimeidentification of the perpetrator(s)furnishing of proof or forensic evidence to deliver burden of proof22/5/13_CADIZQA & <strong>ISO</strong> <strong>17020</strong> 5
Fundamental law of forensics• Locard’s Exchange Principle (Edmond Locard,1877-1966)• transfer• imprint22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 6
VICTIMblunt open headtraumahair & bloodTime of deathno alibimotiveBlood onhusb<strong>and</strong>clothesOBJECTiron rodFingerprints& DNASUSPECThusb<strong>and</strong>22/5/13_CADIZQA & <strong>ISO</strong> <strong>17020</strong> 7
Judging evidence in court• Judge’s /Jury’s decision is based on• <strong>Forensic</strong> evidence• Testimonial evidence• Circumstantial (not eye-witnessed) evidence• Chain of custody• From detection until the courtroom• Crime scene related evidence is not equal to crime relatedevidence!• Quality of investigation/evidence• Quality of expert opinion22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 8
Quality assessment• Methodology (‘st<strong>and</strong>ards’ Frye <strong>and</strong> Daubert criteria)ooooreproducebility‘peer reviewed’validation (e.g. false negatives <strong>and</strong> positives)generally accepted methods• Qualification of the expertooocontinuous education, formation <strong>and</strong> training ‘forensic laws’!deontology & ethics (independency <strong>and</strong> honesty)skills• rational, critical <strong>and</strong> analytic thinking• communication• Maintenance of chain of custody(e.g. <strong>ISO</strong> <strong>17020</strong>/17025)22/5/13_CADIZQA & <strong>ISO</strong> <strong>17020</strong> 9
Sir Arthur Conan Doyle“It is a capital mistake to theorize before onehas data. Insensibly one begins to twistfacts to suit theories instead of theories tosuit facts.”dixit Sherlock Holmes“When the evidence is inconsistent with ahypothesis, the hypothesis must be changed tofit the evidence” (R.F. Becker, A.W. Dutelle, CriminalInvestigation, 2013)22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 10
<strong>Forensic</strong> pathology <strong>and</strong>evidence22/5/13_CADIZQA & <strong>ISO</strong> <strong>17020</strong> 11
fibers <strong>and</strong> hairs (1:1 taping)22/5/13_CADIZQA & <strong>ISO</strong> <strong>17020</strong> 12
manual strangulationrape22/5/13_CADIZQA & <strong>ISO</strong> <strong>17020</strong> 13
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>14
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Autopsy findings22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 16
Acid phosphatasevaginalanalGenetics: Complete DNA-profile of perpetrator+ DNA of victim on penis of perpetrator22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>17
double swab method (DNA)22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 18
Transfer from skin to skin• “hard” contact (e.g. friction) > gentle contact• moist > dry traceRutty G.N. (2002) An investigation into the transference <strong>and</strong> survivability of human DNA following simulated manual strangulation with consideration of theproblem of third party contamination. International Journal ofLegal Medicine 116:170-3 (2002)19 22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>
LS 04-410 & ON 04-360Unknown male killed by 2 gunshots in the thorax& 1 gunshot in the head22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>20
Wipe pattern of a dragged body22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>21
Investigations• Identification: dactyloscopy• Stomach content placeof last contact with 3suspects (french fries)• DNA fingerprints on the leftankle of 1 out of 3suspectsQA & <strong>ISO</strong> <strong>17020</strong>2222/5/13_CADIZ
Why accreditation ?• <strong>Forensic</strong> medicine = application of medical knowledge forlegal issues both depending on the analysis of medicolegalfindings <strong>and</strong> on (biological) evidence that form anintegrated whole together with other evidence forensicevidence to solve & prove the case chain of custody• St<strong>and</strong>ardisation of methods / methodology (international) quality st<strong>and</strong>ards• Proof of correct (= qualified) application of forensicmedicine quality assessment22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>23
• Internationalisation of law enforcement / forensicinvestigation [EU: e.g. Treaty of Prüm (2005)]: crossbordercooperation in the exchange of evidence <strong>and</strong>information…• Existing obligation for forensic DNA-labs• Guarantee of• overall quality according to international st<strong>and</strong>ards• chain of custody22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 24
<strong>Forensic</strong> genetics<strong>Forensic</strong> pathologyAnalytical testsFunctional tests22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>25
Fundamentals of quality system (<strong>ISO</strong>-st<strong>and</strong>ards)• Quality st<strong>and</strong>ards for certifyingo personnel / staff qualification, training, supervision, evaluationooinfrastructurelab techniqueso procedures• Documentation <strong>and</strong> registration of activitiesvalidation methodology, calibration, inventory <strong>and</strong> maintenance ofequipmentQuality assessment <strong>and</strong> management system (h<strong>and</strong>book)St<strong>and</strong>ards of Operation (SOP’s) working procedures22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>26
<strong>ISO</strong> <strong>17020</strong>:• Identification of the Organisationoolegal, financial, deontologic…aspectspersonnel, infrastructure, equipment• Type material corpse• Type inspection forensic autopsy• Inspection mode SOP’soooregistration of• the corpse (identification, h<strong>and</strong>ling, conservation…)• those attending the autopsyexternal <strong>and</strong> internal examination• imaging• dissection methods22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 27accreditation by• sampling (<strong>and</strong> preparation) for further investigations (histopathology, toxicology, genetics,microbiology <strong>and</strong>/or biochemistry …)• registration <strong>and</strong> preservation of samplesreporting, administration<strong>Forensic</strong> Medicine
Guidance for st<strong>and</strong>ardsPublished in <strong>Forensic</strong> Science International, 2000, 111, 5-2922/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 28
egistration22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>29
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 30registration
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 31
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 32
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 33registration
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 34
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 35
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 36Chain of custody ! - archive
egistrationDisclaimer / <strong>Service</strong>LevelAgreement22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 37
Principle VI – Autopsy report22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 38
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 39
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 40
<strong>ISO</strong> <strong>17020</strong> in ourDEPARTMENT-our principles in post mortemexamination-consequences of accreditation
Medicolegal autopsy - goals• Identification• Documenting health status• Documenting all traumatic lesions• Determining cause of deathooimmediate <strong>and</strong> underlying/primary causecontributing factors• Determining mechanism of death• Determining time of death• Collecting evidence, i.e. biological evidence (sperm, bitelesions…)22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 42
Minimal requirements SOP’S• External examinationoooPost mortem changesBody inspection:• special attention at petechiae, neck, back,wounds• body measurementsSampling of (biological) evidence• Internal examination (always three body compartments)oooThorax – Abdomen - SkullRegistration of amount of fluid contents/organ weightsDissection all organs (heart!) + biopsiesoNeck dissection (cave artefactual Prinsloo Gordon haemorrhages)• Sampling for ancillary investigations… (preserving at – 30 C)22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 43
Additional investigations• Special dissectionsooooPostmortem coronarographyNeuropathologyBack <strong>and</strong> limbsFacial skull• Post mortem imaging (virtual autopsy – total body CT)• Histology (m<strong>and</strong>atory)ooLungs, liver, heart, kidney, lesions…Wounds (histologic estimation of age of injuries)• Toxicology (routinely)• Biochemistry, microbiology, genetics• Odontology, osteology, …22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 44
IN PRACTICE – quality management• Procedures concerning personnelooooojob description ( organogram)qualilficationsduty of secrecyfollow up performance, (continuous) education…back up• Procedures concerning administrationoooregistrations (assignements, corpses, visitors, samples…)management of computers, instruments, material, machines, archives…communication (internal <strong>and</strong> external contacts)• Procedures concerning infrastructure / equipmentoovalidation, callibrationcontrol, registration performance parameters…22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 45
Paradigm: paper work …Initial administrative burden:ooTechnical process: process written dawn in SOP’s SOPproposal reviews (QM) final SOP• Autopsy (in- + external, imaging, safety,… st<strong>and</strong>ardreports, documents• Morgue equipment• Products (urine tests,…)QH (soft elements):• Organizational structure• Personnel management• Integrity, confidence• Competence, qualifications• Identification of records, safety• …22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>47
St<strong>and</strong>ard sampling procedure- vitreous humour (centrifuged)-≥ 2 peripheral blood samples (sodiumfluoride)- EDTA blood sample (genetics)- urine- stomach content- bile- 2 samples of hairs- biopsies (formalin): heart, lung, liver, kidneys, adrenals,spleen, pancreas, brain, lesionsSuspicious / violent deathbiologic samples: vaginal, oral, anal, nails, cutaneousswabs (neck, ankles, wrists)Optional- organ fragments for toxicology (always kidney in absence ofurine)- intestinal content (in case of suspected food poisoning)- cerebrospinal fluid- microbiology (i.e. SIDS…)Registration of each sample unique numberPreservation at -20/25°C22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>48
Buttons to generatetemplatesRegistrationstage ofreportingRegistration data+Searching fields
Easy ?• Paradigm administrative conversion = ‘DAFOR’ :electronic databank systemo registration: tracking – libraryo automation:• generation of reports, documents, schema’s, accounts, …• labeling• Uncover old habits – change ‘corporate culture’ooSt<strong>and</strong>ardized proceduresQA/QS teaching (different ≠ bad)22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 50
Time consuming ?• Total time investment: 1 day/week during 1,5 y• Actual time investment: 2 h/w• Time investment after accreditation:ooooAutopsy unchangedSample registration ↑ (morgue employees)Archiving <strong>and</strong> tracking: ↓ ↓Preliminary results + final rapport: TAT ↓ ↓22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>51
Improvements• Process control <strong>and</strong> tractability: ‘chain of custody’• Nett (time) gain automation administrative tasks• Empowerment of the people involved• Simplify :oRegistration <strong>and</strong> tracking, follow-up files,…o Management :• Training• Evaluations• Troubleshooting22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>52
Disadvantages• Administrative burden (~ automation)• ↑ costs:oostaffing need of QMInternal <strong>and</strong> external (3800€!) audits• Actually gratuitous effort• Change ‘corporate culture’22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>53
Conclusion of the responsible pathologist• The improvements on every level can’t match the relativeincrease in administration• The accreditation of forensic autopsies is a paper tiger, itseems hazardous <strong>and</strong> awful but it isn’t…22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>54
Benefits in managing of educational institute• Registration ofoooshortcomingsnon-conformitiescomplaints• Development of database <strong>and</strong> administrative automation• SOP’s helpfull in training ofoopersonnelstaff22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 55
Final remarks• It is more than worthwile because ofooooostimulated awareness of (need of) quality <strong>and</strong> qualitymanagementverifiable formal working <strong>and</strong> management proceduresreinforcing the organisation of departementincreased possibility of detecting defaults in an earlystage‘airtight’ system preserving chain of custody(external) appreciation of quality22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 56
Advices…• Accreditation is a necessity for st<strong>and</strong>ardizedqualitative forensic work but is no guarrantee for thequality of the expert opinion !• The start up is a difficult, personnel- <strong>and</strong> timeconsumingprocess that needs excellent guidance ofa quality expert.• Be critical about current procedures <strong>and</strong> acceptnecessary changes.22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 57
• Use it to simplify, automatize <strong>and</strong> organize your work<strong>and</strong> organisation where ever <strong>and</strong> as much aspossible.• Avoid bureaucracy <strong>and</strong> do not accept that‘formalisation’ st<strong>and</strong>s in the way of good performance.• Utilize quality management to improve continuously22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 58
Crime scene - 61-y22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 59ASSISEN ANTWERPEN 13/09/2012
22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 60
DefenceSaw toothed knife22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 61
35,11°C25,16°COmst<strong>and</strong>igheden: geopende deuren, gelegen op tegelvloer correctiefactor:Meting: 03.07.09 om 12.35 u Gewicht: 86,9 kg Correctiefactor: 1,1 = 96 kgPost mortale verschijnselen: partiële lijkstijfheid, verplaatsbare lijkvlekken, geconflueerdPMI vlgs Henssge: 6.5 ± 2,8 (3) = 3,5 tot 9,5 uren voor de meting overlijden op 02.07.09 tussen 03.05 – 09.05† 03:35 – 09:05 u.22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 62
Combinated method• Livors : displacable (< 12 h)• Rigor : partial (3-8 h)• Mechanic muscular reactivity: < 8 h (max. 13 h)Arnold, Oxford,2002• Blood-serum separation : ≥ 30 min• Toxicology: caffeïne in stomach, blood negative22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 63
Police 09:42 amFP 11:59 am22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 64
Breakfast-coffee07:30Suspect to post office08:5509:20police 09:34 42CSI12:35X†5 - 30 min/manipulatie PD?characterics blood06:0509:12Henssge22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 65
No alibi…but not for the defence22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong> 66
Accreditation,the unmost sexy topic?“you can prove you are working using internationally accepted <strong>and</strong>verified methods, <strong>and</strong> procedures with qualified personnel, respectingrecognized quality st<strong>and</strong>ards”22/5/13_CADIZ QA & <strong>ISO</strong> <strong>17020</strong>67
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