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.