Department Of Forensic Science

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Department of Forensic ScienceCOPYRIGHT 01 FB PM QA ProgramIssued by Biology Program ManagerIssue Date: 24-September-2020UNCONTROLLEDCOPYQualtrax ID: 4041Qualtrax Revision 11Page 1 of 60

Table of ContentsTABLE OF CONTENTS1234Quality Assurance 1.141.151.161.171.18Goals and ObjectivesOrganization and Management StructurePersonnel Qualifications and TrainingFacilitiesEvidence ControlValidationAnalytical ProceduresCalibration and MaintenanceProficiency TestingCorrective ActionReportsReviewSafetyAuditsOutsourcingDocument RetentionCase File Documentation and Storage of Electronic DataRedaction of Data Bank Information From Case File Documentation Released to Outside Parties3.13.23.33.43.53.63.73.8PCR-Based System KitsPunchSolution KitAmpliTaq Gold DNA PolymerasePlexor HY KitsStandard Reference Material (SRM) Kitp30 ABACARD GeneScan 600 LIZ Size StandardWEN Internal Lane Standard 500VIRGINIAEquipment, Reagents and SuppliesDEPARTMENT2.1 Instruments and Equipment2.2 Reagents, Chemicals and SuppliesOFQuality Control of Critical Reagents and SuppliesFORENSIC SCIENCEValidation of PCR-Based Analytical Procedures4.14.25Developmental ValidationInternal Validation of Established ProceduresInternal Controls and Standards – Polymerase Chain Reaction (PCR) Procedures5.15.25.35.45.56COPYRIGHT 2020Reagent BlanksRandom Sample (Used During Analysis of Convicted Offender and Arrestee Samples)Procedures for Estimating DNA recoveryNegative Amplification Control (Negative Control)Positive Amplification Control (Positive Control)Dedicated Work Areas6.16.26.3DNA Extraction Work AreaPCR Setup Work AreaAmplified DNA Work Area210-D2001 FB PM QA ProgramIssued by Biology Program ManagerIssue Date: 24-September-2020UNCONTROLLEDCOPYQualtrax ID: 4041Qualtrax Revision 11Page 2 of 60

Table of ContentsAppendix AAutoclave Quality ControlAppendix BCalibration of the Biomek NXP Automation WorkstationAppendix CCentrifuge Speed Check by TachometerAppendix DCare and Maintenance of PipettesAppendix EPerforming the Stratagene MX3005P Instrument Qualification TestAppendix FThermometer Temperature CalibrationAppendix GThermal Cycler 9700 Temperature Calibration, Temperature Non-Uniformity, and SystemPerformance Diagnostic TestsAppendix HMaintenance of the Casework 3500xl Genetic AnalyzersAppendix IPreparing NIST Traceable SamplesAppendix JGuide for Review of Autosomal DNA DataAppendix KGuide for Review of Y-STR DNA DataCOPYRIGHT 2020VIRGINIADEPARTMENTOFFORENSIC SCIENCE210-D2001 FB PM QA ProgramIssued by Biology Program ManagerIssue Date: 24-September-2020UNCONTROLLEDCOPYQualtrax ID: 4041Qualtrax Revision 11Page 3 of 60

1 Quality Assurance Program11.1Goals and Objectives1.1.1Goals 1.1.2To support criminal justice agencies in the Commonwealth with DNA analysis of selected biologicalmaterials associated with criminal and missing persons investigations using polymerase chainreaction (PCR) based testing.To maintain a DNA Data Bank of convicted offenders and arrestees.To ensure the quality, integrity, and accuracy of the analytical data through the implementation of adetailed quality control program.Objectives 1.2QUALITY ASSURANCE PROGRAMEstablish and monitor quality requirements for reagents, supplies, equipment, and analyticalprocedures.Ensure that DNA analytical procedures are operating within the established performance criteria andthat the quality and validity of the analytical data is maintained.Ensure that problems are noted and that the appropriate corrective action is taken and documented ina Memorandum of Record or case file documentation for the affected case file(s) and, if necessary,for the Quality Control records.COPYRIGHT 2020VIRGINIAOrganization and Management StructureDEPARTMENTThe organization and management of the Virginia Department of Forensic Science is addressed in the DepartmentQuality Manual.OFThe management structure for the Department is set forth in the Department Organizational Chart.FORENSIC SCIENCEThe contingency plan for a vacated Technical Leader position is detailed in the Department Quality Manual.If at any time the number of qualified Forensic Biology analysts statewide falls below two full-time employeeswho are qualified analysts, casework in the affected discipline or sub-discipline or Data Bank sample processing,as applicable, will be halted. The Biology Program Manager (Technical Leader) will then determine theappropriate next steps in reinstating the discipline, sub-discipline, or Data Bank sample processing.1.3Personnel Qualifications and TrainingThe procedure for the qualification and training of personnel is addressed in the Department Quality Manual.The policy that addresses attending meetings and seminars is addressed in the Department Quality Manual,Continuing Education and Training, and associated documentation is considered part of the overall training recordfor document retention purposes.Each laboratory will maintain the training record for each assigned person.All analyst(s), the technical leader and casework CODIS administrator(s) must receive 8 hours of continuingeducation on a yearly basis. The technical leader shall approve the continuing education program which will bedocumented in Qualtrax.A review of scientific literature will be conducted through the use of a reading list. The technical leader willapprove the articles on the list. Documentation of the completion of the required reading shall be maintained bythe section supervisor or their designee(s).210-D2001 FB PM QA ProgramIssued by Biology Program ManagerIssue Date: 24-September-2020UNCONTROLLEDCOPYQualtrax ID: 4041Qualtrax Revision 11Page 4 of 60

1 Quality Assurance Program1.4FacilitiesThe Facilities of the Department are addressed in the Department Quality Manual.1.5Evidence ControlThe procedure for the assignment of laboratory numbers to submission of physical evidence, and item [sub-item]numbers to evidence contained in the submission of physical evidence is addressed in the Department QualityManual.The procedure for the handling of physical evidence is addressed in the Department Quality Manual. Workproduct is defined as the material that is generated by the laboratory as a function of analysis that is not subject toa chain of custody and includes amplified product and amplification tubes or plates.1.5.1All DNA extracts and cuttings to be returned to the submitting agency (refer to FB PM Extraction ofDNA) for possible future testing are securely maintained in the Forensic Biology laboratory in whichthey were created during the normal workflow process until they are placed into the applicable associatedcontainer for return.COPYRIGHT 20201.5.1.11.5.2Exceptions are specifically addressed in 1.5.2.3.VIRGINIACreation of a sub-itemin the LIMS is not typically required.DEPARTMENTThe chain of custody will be documented in the case notes and will minimally include:OF Date of creation and initials of the creatorSCIENCE FORENSICDate placed into the applicableassociated container for return to the submittingA chain of custody will be maintained for DNA extracts and/or cuttings that will be returned to thesubmitting agency for possible future testing.1.5.2.11.5.2.2agency and initials of person performing this task1.5.2.2.1Movement within the Forensic Biology laboratory during the normal workflowprocess (e.g., storage after robotic extraction and normalization, reamplificationof an extract, drying down of extracts, storage after drying, etc.) occurs in acontrolled access environment and need not be documented.1.5.2.2.2The creation of a cutting can be captured in the case file notes (i.e., the date andinitials for the notes page will suffice) and is defined as: the placement of a cutting taken directly from an item of evidence intoa tube for possible extractionOR 1.5.2.2.3or the placement of a cutting from a swabbing taken directly from anitem of evidence into a tube for possible extractionThe creation of an extract is the placement of the first extraction reagent into thetube in which the extraction is to take place.1.5.2.2.3.1210-D2001 FB PM QA ProgramIssued by Biology Program ManagerIssue Date: 24-September-2020For a batch composed of samples from more than oneexaminer, handwritten initials of each person performing eachtype of extraction next to the date of extraction alreadydocumented on the batch paperwork will suffice.UNCONTROLLEDCOPYQualtrax ID: 4041Qualtrax Revision 11Page 5 of 60

1 Quality Assurance Program1.5.2.31.5.2.2.3.2For a batch composed of samples from a single examiner, thehandwritten initials at the top of the page required for allcasework documentation will suffice.1.5.2.2.3.3Sperm and non-sperm fractions are considered to have beencreated on the date on which the extraction begins, even if thetube is incubated overnight at 37ºC prior to transfer of thenon-sperm portion into a separate tube.Internal transfers of DNA extracts and/or cuttings outside of their applicable associatedcontainer to a member of another section, to a different examiner of the same section for thepurposes of performing a type of testing in which the originating examiner is not qualified, orto another VA DFS laboratory via lockbox will be documented in the LIMS.1.5.2.3.1This type of transfer will require that the affected extracts and/or cuttings besub-itemized in the LIMS and the transfers tracked electronically.COPYRIGHT by a2020A DNA extract is createdmitochondrial DNA examiner who is notEXAMPLES:qualified to perform Y-STR analysis. The extract is later referred for YSTR analysis. This extract must be sub-itemized in the LIMS and theassociated transfers to and from the nuclear DNA section/examiner and themitochondrial DNA examiner tracked electronically.VIRGINIAA DNA extract is created by a nuclear DNA examiner in the CentralLaboratory who is not qualified to perform Y-STR analysis. The extract isDEPARTMENTlater referred for Y-STR analysis and transferred to a different examiner inthe Central Laboratory for the Y-STR analysis. This extract must be subOFitemized in the LIMS and the associated transfers to and from the nuclearDNA section/examiners tracked electronically.FORENSIC SCIENCEA DNA extract is created by a nuclear DNA examiner in the WesternLaboratory. The extract is later referred to an examiner in the CentralLaboratory for Y-STR analysis. This extract must be sub-itemized in theLIMS and the associated transfers to and from the Western DNAsection/examiner and the Central DNA section/examiner trackedelectronically.A DNA extract is created by a nuclear DNA examiner in the CentralLaboratory. This extract is amplified as a part of the normal workflow of abatch of samples from multiple examiners. The amplification positivecontrol fails and requires a reamplification of the entire batch of samples.One examiner with samples in the batch offers to reamplifiy the entire batchmanually. This is defined as movement during the normal workflowprocess that will be documented through the use of the manualamplification set up worksheet. Therefore, it need not be documented in thenotes or in the LIMS.1.5.2.41.5.3Once placed into the applicable associated container for return to the submitting agency, thechain of custody of the parent container encompasses the chain of custody of the extract(s)and/or cutting(s). Any transfers after this point do not require sub-itemization of an affectedextract and/or cutting that was not previously sub-itemized.A chain of custody will be maintained for all microscope slides created in the laboratory that will bereturned to the submitting agency for possible future testing (e.g., 3µL spots of sperm fractions that arenot discarded due to no spermatozoa having been observed, positive slides created from stains onbedding, etc.).210-D2001 FB PM QA ProgramIssued by Biology Program ManagerIssue Date: 24-September-2020UNCONTROLLEDCOPYQualtrax ID: 4041Qualtrax Revision 11Page 6 of 60

1 Quality Assurance Program1.5.3.1Creation of a sub-item in the LIMS is not required.1.5.3.2The chain of custody will be documented in the case notes and will minimally include: 1.5.3.31.6Date of creation and initials of the creator – the date and initials for the notes pagewill suffice.Date placed into the applicable associated container for return to the submittingagency and initials of person performing this task – if conducted and documented onthe same day and on the same original notes page as the creation, the date and initialsfor the notes page will suffice.Once placed into the applicable associated container for return to the submitting agency, thechain of custody of the parent container encompasses the chain of custody of these laboratorycreated microscope slide(s).ValidationCOPYRIGHT 2020The validation of new DNA technologies/methodologies by the Forensic Biology Section is addressed in thismanual. In addition, a summary of each validation study is maintained with the data. The summary and data aremaintained by the Biology Program Manager as directed by the Department Quality Manual.VIRGINIAThe analytical procedures used by the Section are set forth in the Forensic Biology Procedures Manuals and theDEPARTMENTMitochondrial DNA Section ProceduresManual. Establishment of these procedures is guided by the DepartmentQuality Manual.OF1.7.1Estimation of the uncertainty of measurement: no critical measurements are taken during the analyticalprocess in the Section; therefore, no estimation of uncertainty of measurement is necessary.FORENSIC SCIENCE1.7Analytical Procedures1.8Calibration and MaintenanceProcedures for the calibration and maintenance of laboratory equipment are set forth in this manual. Establishmentof these procedures is guided by the Department Quality Manual.1.9Proficiency TestingThe proficiency testing program for the Department is referenced in the Department Quality Manual.1.10 Corrective ActionThe procedure for corrective action is set forth in the Department Quality Manual.1.11 ReportsThe procedure for generating a Certificate of Analysis is addressed in the Department Quality Manual.The procedure for the preparation, storage and disposition of case file records is addressed in the DepartmentQuality Manual.The procedure for the expungement of records is addressed in the Department Quality Manual.1.12 ReviewThe Department procedure for the administrative and technical review of case files is addressed in the DepartmentQuality Manual. To aid the Section examiner during the review of the documentation found in the case file, the“Guide for Review of Autosomal DNA Data” found in Appendix J and the “Guide for Review of Y-STR DNA210-D2001 FB PM QA ProgramIssued by Biology Program ManagerIssue Date: 24-September-2020UNCONTROLLEDCOPYQualtrax ID: 4041Qualtrax Revision 11Page 7 of 60

1 Quality Assurance ProgramData” found in Appendix K may each be used as a guide and are not intended to supercede or replace the officialtechnical review form addressed in the Department Quality Manual.Although the technical and administrative reviews are conducted as a combined review in accordance with theDepartment Quality Manual, the completion of these reviews will be documented separately with the reviewer’shandwritten initials or signature and date of each review on a Department technical review form (TRF) to bemaintained in each case file. The same TRF may be used to document a nonconformity, its resolution, and thecompletion of the technical and administrative reviews, as applicable. Only TRFs used to document anonconformity must be forwarded to the examiner’s supervisor and subsequently the Laboratory Director forreview, as detailed in the Department Quality Manual.Forensic Biology casework combined technical and administrative review will include: a review of all case notes, all worksheets, and the electronic data (or printouts of such data) supportingthe results and/or conclusions.a review of all analytical controls, internal size standards, and allelic ladders used for sizing to verify thatthe expected results are obtained.a review of the raw data for reagent blanks and negative controls to ensure amplification product wasindeed loaded into the plate for the Genetic Analyzer.o A review of the raw data associated with evidence samples or known reference samples forwhich no typing results are obtained may be indicated if the quantitation value for the sampleindicated a profile should have been obtained.a review of all DNA types to verify that they are supported by the raw or analyzed data(electropherograms or images).a review of all data to verify conclusions (i.e., inclusions, exclusions, inconclusive) are in compliancewith laboratory guidelines.a review of statistical analyses, if applicable.a review of the case file and final report’s content to verify compliance with QAS Standard 11.2 and thatthe results and/or conclusions are supported by the data.verification that all profiles entered into CODIS are eligible, have the correct DNA types, and are enteredinto the correct specimen category.a review of the case file and final report for clerical accuracy.a review of the chain of custody and disposition of the evidence.o The chain of custody review includes the written chain of custody on the RFLE and theelectronic chain information maintained in FA.COPYRIGHT 2020VIRGINIADEPARTMENTOFFORENSIC SCIENCEOn occasion, there can be initial disparities between the conclusions drawn by qualified examiners in the technicalreview process. The first step towards achieving a unified scientific conclusion should be a discussion between theexaminer and technical reviewer. In this discussion, each party should provide details supporting the basis ofhis/her conclusions. If consensus cannot be achieved, a supervisor should be consulted. The Biology ProgramManager (Technical Leader) or Assistant Technical Leader can be contacted for further technical discussionsbetween the examiner and technical reviewer/supervisor or examiners in other laboratories, if necessary. Aninconclusive result should be reported in the rare instance where a scientific consensus cannot be reached.Data Bank combined technical and administrative review will include: a review of all notes, all worksheets, and the electronic data (or printouts of such data) supporting theresults and/or conclusions.A review of all analytical controls, internal size standards, and allelic ladders used for sizing to verifythat the expected results are obtained, except if using an NIDS approved and internally validated ExpertSystem.a review of all DNA types to verify that they are supported by the raw or analyzed data(electropherograms or images), except if using an NDIS approved and internally validated ExpertSystem.210-D2001 FB PM QA ProgramIssued by Biology Program ManagerIssue Date: 24-September-2020UNCONTROLLEDCOPYQualtrax ID: 4041Qualtrax Revision 11Page 8 of 60

1 Quality Assurance ProgramAn additional documented annual review of Forensic Biology case files independent of the required combinedtechnical and administrative review process and of any external audit conducted in accordance with the FBIQuality Assurance Standards shall be conducted. The scope and plan for this annual review will be determinedprior to its start each applicable year and will include a representative sample of cases worked, as determined andapproved by the Biology Program Manager (Technical Leader).An additional documented annual review of Data Bank sample processing records independent of any externalaudit conducted in accordance with the FBI Quality Assurance Standards shall be conducted. The scope and planfor this annual review will be determined prior to its start each applicable year and will be representative of thesamples tested, as determined and approved by the Biology Program Manager (Technical Leader).The procedure for the moni

the Central Laboratory for the Y-STR analysis. This extract must be sub-itemized in the LIMS and the associated transfers to and from the nuclear DNA section/examiners tracked electronically. A DNA extract is created by a nuclear DNA examiner in the Western Laboratory. The extract is later referred to an examiner in the Central

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