Quality Assurance Standards for Forensic DNA Testing Laboratories
Quality Assurance Program
Organization and Management
Equipment Calibration and Maintenance
This document consists of definitions and standards. The standards are quality assurance measures that place specific requirements on the laboratory. Equivalent measures not outlined in this document may also meet the standard if determined sufficient through an accreditation process.
These standards shall take effect July 1, 2009.
DNA Advisory Board. Quality assurance standards for forensic DNA testing laboratories July 1998, Forensic Science Communications [Online]. (July 2000). Available: http://www.fbi.gov/hq/ lab/fsc/backissu/july2000/codis2a.htm.
DNA Advisory Board. Quality assurance standards for convicted offender DNA databasing laboratories April 1999, Forensic Science Communications [Online]. (July 2000). Available: http://www.fbi.gov/hq/lab/fsc/backissu/july2000/codis1a.htm.
The standards describe the quality assurance requirements that laboratories performing forensic DNA testing or utilizing the Combined DNA Index System (CODIS) shall follow to ensure the quality and integrity of the data generated by the laboratory. These standards also apply to vendor laboratories that perform forensic DNA testing in accordance with Standard 17. These standards do not preclude the participation of a laboratory, by itself or in collaboration with others, in research and development on procedures that have not yet been validated.
As used in these standards, the following terms shall have the meanings specified:
Accredited laboratory is a DNA laboratory that has received formal recognition that it meets or exceeds a list of standards, including the FBI Director's Quality Assurance Standards, to perform specific tests, by a nonprofit professional association of persons actively involved in forensic science that is nationally recognized within the forensic community in accordance with the provisions of the Federal DNA Identification Act (42 U.S.C. [section] 14132) or subsequent laws.
Accuracy is the degree of conformity of a measured quantity to its actual (true) value.
Administrative review is an evaluation of the report and supporting documentation for consistency with laboratory policies and for editorial correctness.
Analyst (or equivalent role, position, or title as designated by the Laboratory Director) is an employee that has successfully completed the laboratory's training requirements for casework sample analysis, passed a competency test, and has entered into a proficiency testing program according to these Standards. This individual conducts and/or directs the analysis of forensic samples, interprets data, and reaches conclusions.
Analytical documentation is the documentation of procedures, standards, controls, and instruments used; observations made; results of tests performed; and charts, graphs, photos, and other documentation generated which are used to support the analyst's conclusions.
Analytical procedure is an orderly, step-by-step process designed to ensure operational uniformity and to minimize analytical drift.
Annual is once per calendar year.
Audit is an inspection used to evaluate, confirm, or verify activity related to quality.
Biochemistry is the study of the nature of biologically important molecules in living systems, DNA replication and protein synthesis, and the quantitative and qualitative aspects of cellular metabolism. …