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«QUALITY ASSURANCE STANDARDS FOR FORENSIC DNA TESTING LABORATORIES This document consists of definitions and standards. The standards are quality ...»

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QUALITY ASSURANCE STANDARDS FOR FORENSIC

DNA TESTING LABORATORIES

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.

EFFECTIVE DATE:

These standards shall take effect September 1, 2011.

REFERENCES: 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 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.

2. DEFINITIONS

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. § 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 or contract 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, 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.

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 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 performing DNA analysis on forensic and casework reference samples.

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 from offenders, thereby 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 laboratories; 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.

Quality Assurance Standards for Forensic DNA Testing Laboratories Effective September 1, 2011 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 forensic DNA analysis.

Competency is the demonstration of technical skills and knowledge necessary to perform forensic 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 participants up to date in their 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 a casework 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.

Critical reagents are determined by empirical studies or routine practice to require testing on established samples before use on evidentiary or casework reference samples.

Developmental validation is the acquisition of test data and determination of conditions and limitations of a new or novel DNA methodology for use on forensic and/or casework reference samples.

Differential amplification is the selection of one target region or locus over another during the polymerase chain reaction. Differential amplification can also arise between two alleles within a single locus if one of the alleles has a mutation within a PCR primer binding site causing this allele to be copied less efficiently because of the primertemplate mismatch.

Quality Assurance Standards for Forensic DNA Testing Laboratories Effective September 1, 2011 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 the 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.

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 DNA testing laboratories and to establish and administer the National DNA Index System (NDIS).

Forensic DNA analysis is the process of identification and evaluation of biological evidence in criminal matters using DNA technologies.

Forensic sample is a biological sample originating from and associated with a crime scene. For example, a sample associated with a crime scene may include a sample that has been carried away from the crime scene.

Genetics is the study of inherited traits, genotype/phenotype relationships, and population/species differences in allele and genotype frequencies.

Guidelines are a set of general principles used to provide direction and parameters for decision making.

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 samples are biological material whose identity or type is established.

Quality Assurance Standards for Forensic DNA Testing Laboratories Effective September 1, 2011 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 of forensic and/or casework reference 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 forensic or database samples.

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 forensic 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.

NIST is the National Institute of Standards and Technology.

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 casework.

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.

Ownership occurs when any of the following criteria are applicable:

(1) the originating laboratory will use any samples, extracts or any materials from the vendor laboratory for the purposes of forensic testing (i.e. a vendor laboratory prepares an extract that will be analyzed by the originating laboratory);

(2) the originating laboratory will interpret the data generated by the vendor laboratory;

(3) the originating laboratory will issue a report on the results of the analysis; or Quality Assurance Standards for Forensic DNA Testing Laboratories Effective September 1, 2011 (4) the originating laboratory will enter or search a DNA profile in CODIS from data generated by the vendor laboratory.

Performance check is a quality assurance measure to assess the functionality of laboratory instruments and equipment that affect the accuracy and/or validity of forensic 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.

Polymerase Chain Reaction (PCR) is an enzymatic process by which a specific region of

DNA is replicated during repetitive cycles which consist of the following:

(1) denaturation of the template;

(2) annealing of primers to complementary sequences at an empirically determined temperature; and (3) extension of the bound primers by a DNA polymerase.

Positive amplification control is an analytical control sample that is used to determine if the PCR performed properly. This control consists of the amplification reagents and a known DNA sample.

Precision characterizes the degree of mutual agreement among a series of individual measurements, values, and/or results.



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