QA/QC; Technician Certification; Lab Accreditation; Federal Oversight
QA/QC Guidelines
- Established in 1989; revised in 1990, 1991, 1995 & 1998
- Can be found in your text: Appendix G (pp 233-244);
- Guidelines have several sections:
- Scope
- Definitions
- Quality Assurance Program
- Organization & Management
- Personnel
- Descriptions
- Supervisor, Technical Leader
- Examiner, Analyst
- Technician
- Qualifications
- Review, Continuing Education
- Facilities
- Evidence Control
- Validation
- Analytical Procedures
- Equipment Calibration and Maintenance
- Reports
- Review
- Proficiency Testing
- Corrective Action
- Audits
- Safety
- Subcontractor of Analytical Testing for which Validated Procedures
Exist
Additional Information can be found on the web site of the American Academy of Forensic Sciences
Laboratory Errors can lead to:
- False Exclusions - perpetrator may go free
- False Inclusions - innocent individual may be falsely convicted
- False exclusions are more common than false inclusions
- False inclusions are of greater concern in legal system because the U.S.
considers conviction of an innocent party to be a more serious problem than
allowing a guilty person to go free
Issues of Concern with STR/Microsatellite Analysis
- Correct ID of known genotype
- extraneous alleles (mixture/contamination)
- allele dropout
- No more than 2 alleles (could be only one) for any one individual at any one locus
- No fewer than 1 allele (could be two) for any one individual at any one locus
- Peak heights should be similar for both alleles of heterozygous individual
- No stutter products
- Consistent results when testing same sample (or multiple samples from same individual)
- Each common allele readily separated (distinguished) from the others
- Size standard produces predicted fragment pattern
- Matrix file used prevents dye pull-up
- Peaks sharp
- Peaks within vertical range
- Peals outside of size range for a particular locus are indicative of a problem
- Proper protocol followed - volumes/times/reagents recorded in notebook or on lab sheets
- Deviations from protocol noted for troubleshooting purposes
- Samples logged in and out
- Chain of custody maintained by proper handoffs/signoffs
Certification
- Qualifications of individual criminalist/technician
- Voluntary not Required - encouraged (highly favorable) - helps credibility
in court
- Exams administered by American
Board of Criminalistics (ABC)
- General Knowledge Exam ==> Diplomate
- Written Specialty Exam plus annual hands-on proficiency testing ==>
Fellow
- Technical Specialist - combines specialist exam plus some questions
from General Knowledge Exam - not widely accepted yet
- Failure of more than one proficiency test in a 4-year period ==>
temporary revocation of Fellow staus
- Reinstated when deficiency is remedied to satisfaction of the ABC review
committee and a successful re-test is completed
- Many laboratories employ non-certified technicians
- However, many laboratories will only allow certified technicians to
present evidence in court
- Some labs have a certified technician as a supervisor over non-certified
technicians and the certified individual must sign off on all procedures and
results
Accreditation
- Qualifications of the testing laboratory
- Voluntary & Self-Regulated
- Standards established and accreditation overseen by American Society of Crime Lab Directors/
Laboratory Acreditation Board (ASCLD/LAB)
- Accreditation also offered by the National Forensic Science and Technology
Center (NFSTC)
- Laboratory must demonstrate that they meet standards for:
- management
- operations
- personnel
- procedures
- equipment
- physical plant
- security
- health & safety
- Laboratory must also participate in a periodic proficiency testing program
- Accreditation is for 5 years providing standards are maintained
- Initial accreditation and reaccreditation require a full review of the
laboratory including an on-site inspection
SWGDAM (The Scientific Working Group on DNA Analysis Methods)
- Formerly TWGDAM (The Working Group on DNA Analysis Methods)
- Established at request of FBI
- Forensic scientists and experts from academic communities
- Forum for Forensic Laboratories to:
- discuss issues
- conduct studies
- decide on methods to be used
- exchange data
- establish laboratory guidelines
- Established
- Quality Control/Quality Assurance guidelines
- Database development guidelines
- Validation guidelines for new systems
- Consensus statements regarding:
- validity and reliability of various DNA techniques and calculations
- guidelines for statistical treatment of DNA data
- responses to DNA-testing challenges
NRC I and II (National Research Council Reports)
- The National Research Council is a part of the National Academy of
Sciences
- Prestigious body of well-respected sciences
- DNA first used in forensic casework in UK in 1985
- FBI began testing in 1988
- Questions of reliability and validity (and laboratory dependability) began
to surface
- NRC was asked, and agreed, to address the genral applicability and
appropriateness of DNA technology to forensic science
- Established the Committee on DNA Technology in Forensic Science
- First report issued in 1992 (NRC I)
- Engendered some controversy
- Second report issued in 1996 to clarify (NRC II)
- Specific recommendations from both reports are detailed in Appendix
I of your text (pp 253-262)
NRC I (DNA Technology in Forensic Science; 1992)
Recommendations in 6 Areas
- Technical considerations
- Statistical interpretation
- Laboratory standards
- Databanks & privacy
- Legal considerations
- Societal & Ethical issues
-
Controversial Areas
- Statistical interpretation - had no basis in scientific principle
- "Ceiling principle" for rare alleles was conservative but had no
scientific basis
- "Interim ceiling principle" was even more conservative
- Laboratory error rates were discussed but an error was never defined
- Acceptable vs, unacceptable risk for error was not defined
- Called for QA/QC standardization
- Argued for case-by-case admissibility
- Called for national databank with updatable technologies
- Cautioned against overselling of DNA evidence in court
- Who should render expert opinion
- Forensic scientists with knowledge of the field and of application -
well-informed but may be biased
- Molecular biologists/Geneticists - Greater general knowledge and
unbiased but no experience with forensic application ==> incomplete
knowledge
NRC II (The Evaluation of Forensic DNA Evidence; 1996)
- Refines the statistical interpretation using more meaningful
scientific/statistical principles (e.g. the product rule)
- Incorporates new data on population substructure
- Provides additional consideration of lab operations and the risk of lab
error
- Withdrew recommendation of "Ceiling Principle" and/or "Interim Ceiling
Principle" in favor of methods based on (but appropriately modified from)
population genetics
- Discouraged "adjustment of frequencies by combination with an error rate"
- Promoted raising lab standards
- Emphasized current lab practices not past performance
- Recommended saving a portion of any sample for subsequent independent
testing
- Stated that "reliability and validity of properly collected and
analyzed DNA data should not be in doubt"
Federal DNA Advisory Committee (DNA Advisory Board; DAB)
- Established by the DNA Identification Act of 1994
- Appointed by FBI from nominees submitted by National Academy of Sciences
and other organizations
- Provide guidelines on a variety of issues
- Quality Assurance Standards for Forensic DNA Testing Laboratories - 1998
- Quality Assurance Standards for Convicted Offender DNA Databsing
Laboratories - 1999
- Quality Assurance Audit for Forensic DNA and Convicted Offender DNA
Databasing Laboiratories - 2000
(to be used by Inspection Teams)
- Substantial power
- Any agency requesting federal funding for DNA development must comply
with standards set by DAB
- De facto standard for any laboratory providing DNA serevices to
courts
- Provided guidelines on "Statistical and Population Genetics Issues
Affecting the Evaluation of the Frequency of Occurrence of DNA Profiles
Calculated from Pertinent Population Database(s)" - Appendix H
(pp. 245-252)
http://www.fbi.gov/hq/lab/fsc/backissu/july2000/dnastat.htm
- DAB was Phased Out in 2000 and responsibilities assumed by
SWGDAM
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