1st INTERNATIONAL DNA USER’S CONFERENCE
24th - 26th November 1999 in Lyons
Papers - Quality assurance and training

The United States DNA Advisory Board and its Role in Setting Quality Assurance Standards
Arthur J, Eisenberg. University of North Texas Health Science Center, Fort Worth, Texas, USA

The DNA Advisory Board (Board) was established by the Director of the Federal Bureau of investigation under the DNA Identification Act of 1994 (Act) as a separate and distinct advisory board administered by the FBI. The Act provided funding for forensic laboratory’s to improve the quality and availability of DNA analyses, and to the FBI to establish the national Combined DNA Index System (CODIS). Congress authorized the Director of the FBI to develop standards for quality assurance, including standards for testing the proficiency of forensic laboratories, and forensic analysts performing DNA analyses. The legislature specified that access to federal funding provided under the DNA Identification Act is contingent upon a laboratories strict adherence to these standards. In accordance with the DNA Identification Act, the quality assurance guidelines adopted by the Technical Working Group on DNA Analysis Methods (TWGDAM) were deemed the FBI Director’s interim standards.

Members of the Board were appointed by the Director of the FBI from nominations proposed by the National Academy of Sciences and professional societies of crime laboratory officials. The Act specified that members of the Board include scientists from state, local, and private forensic laboratories; molecular geneticists and population geneticists not affiliated with a forensic laboratory; a representative from the National Institute of Standards and Technology (NIST); the chair of Technical Working Group on DNA Analysis Methods (TWGDAM); and a judge. The initial Board consisted of 16 members, including the chair (former noble prize winner Dr. Joshua Lederberg, a voting member); two voting members in a representational capacity (from NIST and TWGDAM); ten general voting members; and three non-voting members. The three non-voting members appointed by the FBI Director included an executive secretary, a quality control/quality assurance specialist, and a medical/legal ethicist. In addition, pursuant to the Federal Advisory Committee Act, the Director of the FBI appointed a designated Federal employee to perform the functions set forth by law.

The Director of the FBI, in accordance with the DNA Identification Act of 1994, specified that the Board’s scope of activity was:

• To develop, and if appropriate, periodically revise, recommend standards for quality assurance, including standards for testing the proficiency of forensic laboratories, and forensic analysts, in conducting analysis of DNA.
• To recommend standards which specify criteria for quality assurance and proficiency tests to be applied to the various types of DNA analyses used by forensic laboratories, including statistical and population genetics issues affecting the evaluation of the frequency or occurrence of DNA profiles calculated from pertinent population database(s).
• To recommend standards for acceptance of DNA profiles in the FBI’s Combined DNA Index System (CODIS) which take account of relevant privacy, law enforcement and technical tissues.
• To make recommendations for a system for grading proficiency testing performance to determine whether a laboratory is performing acceptably.

Throughout its deliberation concerning these quality standards, the DNA Advisory Board recognized the need for a mechanism to ensure compliance with the standards. An underlying premise for these discussions was that accreditation would be required to demonstrate compliance with the standards and therefore assure quality control and a quality program. The Board recommended that forensic laboratories performing DNA analysis seek such accreditation with all deliberate speed. The Board strongly encouraged the accrediting bodies to begin positioning themselves to accommodate the increasing demand for accreditation. In accordance with the DNA Identification Act, the Board forwarded to the Director of the FBI its recommendations for standards. After careful review, the Director’s "Quality Assurance Standards for Forensic DNA Testing Laboratories" took effect on October 1, 1998. These national standards have now superseded the TWGDAM Guidelines for purposes of certifications required for the receipt of Federal funding as well as participation in the National DNA Index System.

Inherent within the standards is the intent to upgrade the educational background and experience of forensic scientists. The board spent a considerable amount of time discussing the qualifications for the Technical manager or leader (or equivalent position or title as designated by the laboratory system). This is the individual who is accountable for the technical operations of the laboratory. The Board strongly believed that this position required an individual with a minimum of a Masters degree in biology, chemistry, or a forensic science related area. In addition, they must have successfully completed a minimum of 12 semester or equivalent credit hours in course work covering biochemistry, genetics and molecular biology, or other subjects which provide a basic understanding of the foundations of forensic DNA analysis as well as statistics and/or population genetics as it applies to forensic DNA analysis. A technical manager/leader of a laboratory must have a minimum of three years of forensic DNA laboratory experience. The Board recognized that there are individuals who have been serving in the capacity of technical manager/leader who do not meet the educational requirements specified by the standards. The standards included a provision for the waiver of the degree requirements for the Technical manager or leader. The waiver is only for the educational requirement and not for the minimum of three years of forensic DNA laboratory experience. ASCLD in conjunction with ASCLD/LAB, has established a credentials review committee to grant waivers to current technical leader/managers who do not fully meet the DAB educational standards for the DNA technical leader/manager, but who qualify as technical leaders based upon their knowledge and experience. The wavier is available for a period of two years from the effective date of the standards (October 1, 1998). In addition, the wavier is permanent and portable.

Forensic DNA identification analysis currently involves forensic casework and convicted offender analyses for inclusion in CODIS. Separate standards have been drafted for laboratories performing the analysis of convicted offender samples. The separation was an acknowledgement of the differences in the nature or type of sample, the quantity and potential for reanalysis, and specialization that may exist in a laboratory. Standards for convicted offender laboratories, in some instances, are less stringent than for those performing forensic casework analyses, but in no case should the two documents be interpreted as conflicting. The Board forwarded its recommendations to the Director of the FBI, and after review issued his "Quality Assurance Standards For Convicted Offender DNA Databasing Laboratories". These standards became effective on April1,1999.

Pursuant to Section 210303 of the DNA Identification Act of 1994, the DNA Advisory Board was tasked with recommending standards for testing the proficiency of forensic laboratories that conduct analyses of DNA. The Act required that the National Institute of Justice (NIJ) review the availability and feasibility of blind external proficiency testing for forensic DNA analysis. A grant was awarded by NIJ, and after an extensive evaluation and review, the project concluded that by defining "feasible" as possible and practicable in terms of costs and logistics….a national blind proficiency testing program employing….blind proficiency tests via law enforcement agencies, conduit laboratories and/or blind analyst models, is not feasible at this time. Three recommendations were provided in their report: "1. The accreditation system and associated quality assurance guidelines of the DNA Advisory Board need to be given the opportunity to take hold, 2. It is recommended that the DNA Advisory Board generate guidelines for more stringent external case audits for use by ASCLD-LAB, or another relevant accrediting body, as part of the accreditation process. The external case audits should be conducted regularly and serve as a measure of how well accreditation and its associated requirements are working in a quality assurance context, and 3. In the extreme, blind proficiency testing is possible, but fraught with problems (including costs), and it is recommended that a blind proficiency testing program, be deferred for now until it is more clear how well implementation of the first two recommendations are serving the same purposes as blind proficiency testing". After a review of the NIJ project, the Board on April 23, 1999 issued the following resolution on blind external proficiency testing: "The DNA Advisory Board accepts and adopts the finding of the NIJ Project that a blind DNA proficiency testing program is not feasible at this time. While the DNA Advisory Board is supportive of the recommendations proposed in the Final Report, the Board suggests that ASCLD/LAB is in a better position to address the second recommendation".

In compliance with the DNA Identification Act, the Board provided the Director of the FBI with a recommendation for a system for grading proficiency testing performance to determine whether a laboratory is performing acceptably: "All proficiency tests are graded as satisfactory or unsatisfactory. A satisfactory grade is attained when there are no analytical errors for the DNA profile typing data. Administrative errors shall be documented and corrective actions taken to minimize the error in the future".

According to the requirements of the DNA Identification Act, the Board will terminate on March 9, 2000, unless the Board’s term is extended by the Director of the FBI. The Board is currently evaluating, and will make recommendations concerning statistical and population genetic issues related to calculations involving source attribution, sample mixtures, relatives, and CODIS database searches.