Quality in Forensic Bio & DNA
Page 1: Introduction to Quality in Forensic Bio & DNA
Overview of importance of quality in forensic biology and DNA practices.
Page 2: Quality Assurance vs. Quality Control
Quality Assurance (QA)
Standards used to evaluate the quality system.
Methods to correct or improve product/service quality (e.g., DNA casework).
Policies and procedures to ensure the provision of quality work.
Quality Control (QC)
Following standards and controls to achieve a quality product.
Ensuring adherence to documented and tested analytical procedures.
Day-to-day actions that comply with established policies.
Page 3: Quality Assurance vs. Quality Control (Continued)
Daily Operations in QC
Emphasis on consistent application of standards to ensure quality output.
Page 4: A Quality Training Program
Training conducted by court-recognized experts.
Criteria for passing through training and corrective actions.
Competency testing including oral, written, and practical assessments.
Mock and supervised casework to ensure hands-on experience.
Page 5: Proficiency Testing
Requirement of 2 external tests per year by QAS standards.
Analysts treat external tests as real case analyses following lab procedures.
Results must be returned and verified for compliance.
Page 6: QA Methods
Various QA methods to ensure laboratory standards, including:
Random reanalysis
Case file reviews
Administrative (self) reviews
Peer reviews
Technical reviews
Quality audits/on-site visits.
Page 7: ISO 17025
ISO standard applicable to all testing laboratories, tailored for forensic labs.
Examines personnel, training, equipment maintenance, and lab testing.
Audits conducted by independent agencies for compliance.
ANAB (ANSI-ASQ National Accreditation Board).
Page 8: Quality Assurance Standards for Forensic DNA Laboratories
Overview of specific QA standards designed for DNA labs.
Page 9: DNA Identification Act of 1994
Established DNA Advisory Board (DAB).
Developed CODIS for law enforcement information exchange.
FBI laboratories must comply with national standards for accreditation.
Page 10: DNA Advisory Board (DAB)
Initial meeting in 1995 leveraging TWGDAM Guidelines.
Recommended quality assurance standards for DNA testing labs.
Sought to combine guidelines with contemporary issues for best practices.
Page 11: FBI Laboratory Standards
FBI incorporated DAB recommendations into binding standards by October 1998.
Standards now mandatory for forensic DNA testing and convicted offender labs.
Page 12: Significance of DNA Quality Assurance Standards
Raises expectations for DNA testing laboratories from voluntary to mandatory.
Ensures lab's analytical data quality, integrity of results, technical personnel qualification, and overall competency.
Page 13: SWGDAM (Scientific Working Group on DNA Analysis Methods)
Membership is by invitation, limited to three years.
Comprises technical leaders from various laboratories and select experts.
Responsible for making best practice recommendations in DNA analysis.
Page 14: SWGDAM Subcommittees
Focused on various aspects of DNA analysis, including:
Quality Assurance
Expert Systems
Rapid DNA
Next Generation Sequencing and more.
Page 15: Updates to the QAS
Recommendations from SWGDAM processed and approved by the FBI.
Most recent update effective from July 1, 2020; includes 17 total recommendations and a guidance document for clarity.
Page 16: QAS Overview
1. Scope & Applicability
Applies to all labs with access to CODIS and associated vendor labs.
Establishes professional standards for DNA analysis at extraction.
2. Definitions
Clear definitions of key terms relevant to QA and DNA processes.
3. Quality Assurance System
Requirement to have a structured system including goals, personnel, documentation, and outsourcing protocol.
Page 17: QAS Standards
4. Organization and Management
Defines the roles of personnel involved in DNA analysis:
Analysts with a BS/BA in natural sciences.
Technical leaders overseeing laboratory aspects.
5. Personnel
Analyst roles require specific educational backgrounds including coursework in biochemistry, molecular biology, genetics, and statistics.
Page 18: QAS Standards Continued
6. Training
Newly updated training protocols effective from 2020.
7. Facilities & Evidence Control
Guidelines for maintaining integrity in facilities handling forensic evidence.
8. Validations
All methods must undergo thorough validation processes involving developmental and internal assessments.
Page 19: QAS Standards Continued
9. Analytical Procedures
Laboratories must follow established procedures with proper validations in place including:
Data interpretations
Statistical analyses
Requirement to quantify human DNA in evidence samples.
10. Equipment
Appropriate maintenance and calibration of laboratory equipment required.
Page 20: QAS Standards Continued
11. Reports
Establishment of a standardized report system detailing analytical components while ensuring case information remains confidential.
12. Peer Review
Mandatory review of data for accuracy by proficient examiners.
Page 21: QAS Standards Continued
13. Proficiency Testing
Requirement for analysts to undergo proficiency testing biannually.
Ensures all staff involved in casework meet testing standards.
14. Corrective Action
Procedures for addressing non-compliance or errors established and documented.
15. Audits
Annual audits to verify compliance with established standards; external audits every other year.
Page 22: QAS Standards Continued
16. Professional Development
Ongoing education is essential for analysts to stay current with advancements in the field.
17. Outsourcing
Vendor labs must comply with QAS; CODIS laboratories must review data for accuracy before entry into the system.