«QUALITY ASSURANCE STANDARDS FOR DNA DATABASING LABORATORIES INTRODUCTION These Standards are applicable to databasing laboratories performing DNA ...»
QUALITY ASSURANCE STANDARDS FOR DNA
These Standards are applicable to databasing laboratories performing DNA analyses on DNA
samples obtained from identified subject(s) for purposes of entering the resulting DNA profile or
DNA record into a DNA database. If, in addition, the databasing laboratory is performing DNA
analyses on known or casework reference samples considered evidence by that laboratory, the
databasing laboratory shall:
(1) Follow the Quality Assurance Standards for Forensic DNA Testing Laboratories for the known or casework reference samples; or (2) Follow these Standards including the additional requirements for known and casework reference samples in 184.108.40.206.1 and 220.127.116.11.
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 September 1, 2011.
Federal Bureau of Investigation, “Quality Assurance Standards for Forensic DNA Testing Laboratories” and “Quality Assurance Standards for Convicted Offender DNA Databasing Laboratories,” Forensic Science Communications, July 2000, Volume 2, Number 3.
1. SCOPE These Standards describe the quality assurance requirements that laboratories performing DNA testing on database, known or casework reference samples for inclusion in 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 DNA testing on database, known or casework reference samples 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:
Draft Quality Assurance Standards for DNA Databasing Laboratories 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 science community in accordance with the provisions of the Federal DNA Identification Act (42 U.S.C. §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/or 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 or contract employee that has successfully completed the laboratory’s training requirements for database, known or casework reference 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 database, known or casework reference samples and interprets the resulting data from these samples.
Analytical documentation is the documentation of procedures, standards, controls and instruments used, observations made, results of tests performed, 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.
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.
Calibration is the set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material, and the corresponding known values of a measurement.
Casework reference sample is biological material obtained from a known individual and collected for purposes of comparison to forensic samples.
CODIS is the COmbined DNA Index System administered by the FBI. CODIS links DNA evidence obtained from crime scenes, thereby identifying serial criminals. CODIS also compares crime scene evidence to DNA profiles obtained from offenders, thereby Quality Assurance Standards for DNA Databasing Laboratories 2 Effective September 1, 2011 providing investigators with the identity of the putative perpetrator. In addition, CODIS contains profiles from missing persons, unidentified human remains and relatives of missing persons. There are three levels of CODIS: the Local DNA Index System (LDIS), used by individual laboratories; the State DNA Index System (SDIS), used at the state level to serve as a state’s DNA database containing DNA profiles from LDIS labs; and the National DNA Index System (NDIS), managed by the FBI as the nation’s DNA database containing all DNA profiles uploaded by participating states.
CODIS administrator (or equivalent role, position, or title as designated by the Laboratory Director) is an employee of the laboratory responsible for administration and security of the laboratory’s CODIS at a laboratory that owns the database and/or known samples.
Competency test(s) is a written, oral and/or practical test or series of tests designed to establish that an individual has demonstrated achievement of technical skills and met minimum standards of knowledge necessary to perform database DNA analysis.
Competency is the demonstration of technical skills and knowledge necessary to perform database DNA analysis successfully.
Contamination is the unintentional introduction of exogenous DNA into a DNA sample or PCR reaction.
Continuing education is an educational activity (such as a class, lecture series, conference, seminar, or short course) that is offered by a recognized organization or individual that brings a participant up to date in his/her relevant area of knowledge.
Contract employee is an individual that provides DNA typing and/or analytical support services to the NDIS participating laboratory. The person performing these services must meet the relevant qualifications for the equivalent position in the NDIS participating laboratory. A contract employee cannot serve as CODIS Administrator or technical leader and cannot be counted as a full-time qualified DNA analyst for purposes of satisfying the definition of a laboratory. Employment of a contract employee by multiple NDIS participating and/or vendor laboratories shall be disclosed and shall only be permitted subject to approval by the technical leader of the NDIS participating laboratory for which the contract employee is performing DNA typing and/or analytical services.
Coursework is an academic class officially recognized and taught through a college or university program in which the participating student successfully completed and received one or more credit hours for the class.
Critical equipment or instruments are those requiring calibration or a performance check prior to use and periodically thereafter.
Quality Assurance Standards for DNA Databasing Laboratories 3 Effective September 1, 2011 Critical reagents are determined by empirical studies or routine practice to require testing on established samples before use on database or known samples.
Database or databasing refers to the DNA analysis of database samples for entry into CODIS and, if eligible, for upload to the National DNA Index System (NDIS).
Database sample is a sample obtained from an individual who is legally required to provide a DNA sample for databasing purposes and whose identity is established at the time of collection of the sample.
Developmental validation is the acquisition of test data and determination of conditions and limitations of a new or novel DNA methodology for use on database and known samples.
DNA record is a database record that includes the DNA profile as well as data required to manage and operate NDIS; i.e., the Originating Agency Identifier which serves to identify the submitting agency; the Specimen Identification Number; and DNA personnel associated with the DNA profile analyses.
DNA type (also known as a DNA profile) is the genetic constitution of an individual at defined locations (also known as loci) in the DNA. A DNA type derived from nuclear DNA typically consists of one or two alleles at several loci (e.g., short tandem repeat loci). The DNA type derived from mitochondrial DNA is described in relation to the revised Cambridge Reference Sequence (Nature Genetics 1999, 23, 147).
Employee is a person: (1) in the service of the applicable federal, state or local government, subject to the terms, conditions and rules of federal/state/local employment and eligible for the federal/state/local benefits of service; or (2) formerly in the service of a federal, state or local government who returns to service in that agency on a part-time or temporary basis. For purposes of a vendor laboratory, an employee is a person in the service of a vendor laboratory and subject to the applicable terms, conditions and rules of employment of the vendor laboratory.
Expert System is a software program or set of software programs that interprets the data generated from a DNA analysis instrument platform in accordance with laboratory defined quality assurance rules and accurately identifies the data that does and does not satisfy such rules.
FBI is the Federal Bureau of Investigation, the Federal agency authorized by the DNA Identification Act of 1994 to issue quality assurance standards governing forensic testing and DNA databasing laboratories and to establish and administer the National DNA Index System (NDIS).
Genetics is the study of inherited traits, genotype/phenotype relationships, and population/species differences in allele and genotype frequencies.
Integral component is that portion of an academic course that is so significant and necessary to the understanding of the subject matter as a whole, that the course would be considered incomplete without it.
Internal validation is the accumulation of test data within the laboratory to demonstrate that established methods and procedures perform as expected in the laboratory.
Known sample is biological material whose identity or type is established. An example of a known sample is a sample contributed by the close biological relative of a missing person.
Laboratory is a facility: (1) employing at least two full time employees who are qualified DNA analysts; and (2) having and maintaining the capability to perform the DNA analysis on database and/or known samples at that facility.
Laboratory support personnel (or equivalent role, position, or title as designated by the Laboratory Director) are employees or contract employees who perform laboratory duties exclusive of analytical techniques on database and/or known samples.
LDIS is the Local DNA Index System; please see definition of CODIS.
Methodology is used to describe the analytical processes and procedures used to support a DNA typing technology: for example, extraction methods (manual vs. automated);
quantitation methods (slot blot, fluorometry, real-time); typing test kit; and platform (capillary electrophoresis, real-time gel and end-point gel systems).
Molecular biology is the study of the theories, methods, and techniques used in the study and analysis of gene structure, organization, and function.
Multi-laboratory system is used to describe an organization that has more than one laboratory performing database DNA analysis.
Multiplex system is a test providing for simultaneous amplification of multiple loci that is either prepared commercially or by a laboratory.
Negative amplification control is used to detect DNA contamination of the amplification reagents. This control consists of only amplification reagents without the addition of template DNA.
NDIS is the National DNA Index System. NDIS is one component of CODIS – the national and highest level index containing the DNA records contributed from participating federal, state and local laboratories.
Offender is an individual who is required by statute to submit a sample for DNA analysis and databasing. The term “offender” includes individuals who are convicted of or arrested for a crime or juveniles adjudicated delinquent for an offense and required by state or federal law to provide a DNA sample for analysis and databasing.
On-site visit is a scheduled or unscheduled visit to the vendor laboratory work site by one or more representatives of an NDIS participating laboratory who is (are) a qualified or previously qualified DNA analyst(s) in the technology, platform and typing amplification test kit used to generate the DNA data, or designated FBI employee(s), to assess and document the vendor laboratory’s ability to perform analysis on outsourced database, known or casework reference samples.
Outsourcing is the utilization of a vendor laboratory to provide DNA services in which the NDIS participating laboratory takes or retains ownership of the DNA data for entry into CODIS, when applicable. Outsourcing does not require the existence of a contractual agreement or the exchange of funds.
Performance check is a quality assurance measure to assess the functionality of laboratory instruments and equipment that affect the accuracy and/or validity of database, known or casework reference sample analysis.
Platform is the type of analytical system utilized to generate DNA profiles such as capillary electrophoresis, real-time gel, and end-point gel instruments or systems.