Compliance With Standards Governing
Convicted Offender DNA Sample
Backlog Reduction Program Activities
ReliaGene Technologies, Inc.
New Orleans, Louisiana
September 19, 2001
Office of the Inspector General
The Office of the Inspector General, Audit Division, is conducting an audit of the Convicted Offender DNA Sample Backlog Reduction Program (Program), administered by the National Institute of Justice (NIJ). In conjunction with that effort, we have completed an audit of ReliaGene Technologies, Inc. (ReliaGene), a private laboratory providing contracted DNA analysis services for Program grantees, for compliance with standards that govern those services.
Scope and Methodology
We conducted our audit in accordance with Government Auditing Standards and included such tests as were considered necessary to accomplish the audit objective. Our audit of ReliaGene generally covered the 2-year period preceding our fieldwork conducted in August 2001. See Appendix I for a detailed description of our audit scope and methodology.
The overall objective of the audit was to assess ReliaGene's compliance with standards governing their DNA analysis contracts with Program grantees, namely the Quality Assurance Standards for Convicted Offender DNA Databasing Laboratories (Offender QAS), effective April 1, 1999. See Appendix II for further details concerning our audit criteria.
Findings and Recommendations
We considered 130 elements 1 of the Offender QAS. We found that ReliaGene complied with the Offender QAS except for one area of noncompliance described on the following page.
Offender Standard 10.2 states that a laboratory shall identify critical equipment and shall have a documented program for calibration of instruments and equipment. Although ReliaGene complied with this standard by identifying critical equipment and by having a documented calibration program, ReliaGene staff did not comply with their own calibration program for 1 of the 10 equipment items reviewed. ReliaGene's calibration program requires that the Omega Temperature Verification System be calibrated annually. Documents reviewed indicated that the system was placed into service on July 22, 1999. However, no calibrations subsequent to the initial calibration were performed until August 22, 2001, the date our audit revealed the deficiency. This was a span of 25 months.
ReliaGene management stated that the missing calibrations were due to oversight and immediately calibrated the instrument while we were on site. No problems were found and the instrument was within acceptable ranges when compared with a National Institute of Standards and Technology thermometer.
We recommend that the Director of the National Institute of Justice, through the Program grantees contracting with ReliaGene, ensure that:
OTHER REPORTABLE MATTER
Offender Standard 5.1.3 states that a laboratory shall have a documented program to ensure technical qualifications are maintained through continuing education. Offender Standard 126.96.36.199 clarifies that continuing education includes staying abreast of developments within the field of DNA typing by reading current scientific literature and by attending seminars, courses, etc., in relevant subject areas at least once a year.
In compliance with Offender Standard 5.1.3, ReliaGene did have a continuing education program. However, the program did not address the requirement for reading of scientific literature.
ReliaGene management stated that the staff understand that reading scientific literature is part of their required continuing education. For evidence of this, they pointed to scientific periodicals available to staff in the library/conference room and to the fact that the Laboratory Director identifies important current journal articles which are routed throughout the laboratory for all the analysts and the technical manager to read. Further, ReliaGene management stated that there is an informal, unwritten policy for technical personnel to document their reading in their qualifications notebook.
All staff interviewed were aware of this informal policy. However, only one of the six analysts that were hired prior to the current year documented their reading in the manner prescribed by the informal policy. Therefore, although alternative documentation was produced to fully document that staff are reading scientific literature, ReliaGene could, in our judgment, better ensure that staff are complying with continuing education requirements by formally including the reading of scientific literature in their written continuing education program. We encourage ReliaGene management to specify, as part of the written policy, the manner in which analysts are expected to document their reading and ensure that staff are complying with this requirement.
VIEWS OF RESPONSIBLE OFFICIALS
During the audit and at the exit conference, we solicited comments on our audit finding, the recommendation, and the other reportable matter from ReliaGene management. Their comments have been incorporated in the preceding details of these sections.
SCOPE AND METHODOLOGY
We conducted our audit in accordance with Government Auditing Standards and included such tests as were considered necessary to accomplish the audit objective. Our audit generally covered the period between August 1999 and August 2001, with certain issues of compliance applicable only to the time period during which ReliaGene was contracting with Program clients (beginning approximately August 2000). Also, our audit was limited to sections of ReliaGene involved in the analysis of Combined DNA Index System (CODIS) DNA samples for Program clients. To accomplish the audit objective, we:
For the purposes of this audit, we limited our review to ReliaGene's compliance with the QAS. As such, we only tested the issues of compliance and internal controls directly related to the QAS. Accordingly, we did not attach a separate Statement of Compliance with Laws and Regulations or a Statement on Management Controls to this report.
The key source of criteria for our audit is the QAS, recommended by the DNA Advisory Board and formally instituted by the Director of the FBI (see Appendix III for a description of these organizations' roles). Although two sets of standards have been instituted, only the set specific to the analysis of convicted offender samples applies to this audit: the Quality Assurance Standards for Convicted Offender DNA Databasing Laboratories effective April 1, 1999 (Offender QAS).
The Offender QAS contains 130 elements organized under 14 headings applicable to our audit. We considered all 130 elements in the completion of our audit. However, not all 130 elements were ultimately applicable to ReliaGene or to the specific time period we audited. For example, some elements pertained to a different analysis method than is in use at ReliaGene on offender samples, some elements did not apply to the scope of the work ReliaGene is performing for the Program clients, and some elements pertained to issues not occurring during our audit scope.
Not included in the tally of 130 elements count is one heading containing six elements applicable only to the state and local laboratories that contract out the analysis of their samples, and not the actual contractor. The section, number 17, is titled "Subcontractor of Analytical Testing for which Validated Procedures Exist." The remaining headings include standards on such issues as: the laboratory's quality assurance program and what it contains; roles, duties, and documentation for laboratory organization, management and personnel; care and security of facilities, equipment, and samples; validation of and analytical procedures for analysis processes used by the laboratory; policies on reports, reviews and safety; and documentation of proficiency testing, corrective action, and audits.
We did not review ReliaGene against provisions unique to each of its Program client contracts, as that will be done during the review of selected state laboratories as part of the overall audit of the Program.
Combined DNA Index System
CODIS, as the system is commonly called, allows law enforcement agencies to compare DNA specimen information with that of other law enforcement agencies around the country, with the goal of matching case evidence to other previously unrelated cases or to persons already convicted of other violent or sexual crimes. Laboratories that participate in CODIS perform DNA analysis on specimens from convicted offenders or crime-scene evidence. These laboratories use special software, provided free of charge by the FBI, to organize and manage the DNA profiles and related information. The software also compares DNA profiles from participating laboratories and notifies the appropriate laboratories when two or more DNA profiles match.
CODIS was first described and authorized by the DNA Identification Act (Act) of 1994. The Act authorized the FBI to establish and maintain a national CODIS database and also contained guidelines for the inclusion of DNA profiles, the participation of state and local laboratories, and the penalty 2 for failure to comply with the guidelines.
The Act also established the DNA Advisory Board-an entity commissioned by the FBI to compose standards for quality assurance with which CODIS-participating laboratories are to comply. The Board, comprised of representatives from the FBI as well as state and local laboratories, completed this task by recommending for issuance the QAS that were subsequently issued by the Director of the FBI. All CODIS laboratories are responsible for complying with the Act, including the QAS and disclosure and proficiency testing requirements, as well as ensuring that any contractors they use for the analysis of CODIS profiles do the same.
Offender Backlog Reduction Program
The Convicted Offender DNA Sample Backlog Reduction Program provides funding to state DNA laboratories for outsourcing to private labs the analysis of large quantities of backlogged convicted offender samples for expedited entry into the national CODIS database.
A total of $14.4 million was dispersed through grants to 21 state laboratories in the first year of the program (FY 2000). Funds were provided to the state laboratories based upon the number of samples those laboratories had awaiting analysis multiplied by an estimated cost for analysis of $50 per offender sample. Based on these calculations, NIJ management has estimated that approximately 290,000 samples will be added to CODIS as a result of the Program's first year grants. A planned second round of grants is expected to be announced at the end of FY 2001.
RELIAGENE TECHNOLOGIES, INC.
ReliaGene Technologies, Inc., is an independent, privately-held corporation specializing in convicted offender databasing, forensic casework analysis, paternity testing, molecular diagnostics, and product development. ReliaGene's stated mission is to provide accurate DNA results for use in both civil and criminal courts of law. According to laboratory management, ReliaGene has a staff of approximately 60 administrative, technical, and managerial personnel.
ReliaGene has received contracts for services from a variety of state and local entities, as well as from international agencies. Since ReliaGene performs a variety of services, it has sought and obtained certification or accreditation from the following entities:
In addition, the laboratory has obtained a Clinical Laboratory Improvement Act license for interstate transport of specimens.
ReliaGene started in 1990 and immediately became involved in performing forensic casework testing for law enforcement agencies. Contracts for casework analysis were initially performed using Restriction Fragment Length Polymorphism (RFLP) and Polymerase Chain Reaction (PCR) analysis methods, but in 1994 ReliaGene began using Short Tandem Repeat (STR) analysis. According to laboratory management, ReliaGene has validated and is able to analyze over 15 STR loci (including the 13 loci required for CODIS purposes). In addition, ReliaGene started performing mitochondrial DNA analysis in 1999. According to laboratory management, ReliaGene has processed in excess of 300,000 casework samples from a variety of evidence sources, including blood and other bodily fluids, teeth, tissue, bones, cigarette butts, stamps, hair shafts, and nail scrapings.
ReliaGene added convicted offender sample analysis to its services in June 1998. According to laboratory management, in the last three years ReliaGene has analyzed approximately 40,000 offender samples for its clients. ReliaGene has completed or is in the process of completing offender analysis contracts with state agencies in Oklahoma, Nebraska, Washington, Mississippi, and Delaware.
ReliaGene has also been involved in novel research in the field of forensic analysis in the form of their development and commercialization of a new STR analysis kit (the Y-Plex™6 amplification kit), which, according to laboratory management, could further investigations of sexual crimes and the analysis of evidence containing a mixture of DNA profiles.