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Analyst Training > QAS Defintions > Flashcards

QAS Defintions Flashcards

1
Q

accreditation

A

the formal recognition that a laboratory meets or exceeds a list of standards, including the FBI Director’s Quality Assurance Standards, to perform specific tests. it is dministered 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 or subsequent laws

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2
Q

administrative review

A

an evaluation of the report and supporting documentation for consistency with laboratory policies and for editorial correctness

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3
Q

analyst

A

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 can conduct and/or direct the analysis of forensic samples, interpret data, reach conclusions, and generate reports

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4
Q

analytical control

A

a sample used to demonstrate that a method works correctly and to ensure the data are valid

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5
Q

analytical documentation

A

the documentation of procedural notes, 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.

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6
Q

analytical procedure

A

an orderly, step-by-step process designed to ensure operational uniformity and to minimize analytical drift

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7
Q

analytical threshold

A

the minimum height requirement, determined through validation testing, at or above which detected peaks/signal can be reliably distinguished from background noise; peaks/signal at or above this threshold are generally not considered noise and are either artifacts or true alleles

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8
Q

audit

A

an on-site inspection used to evaluate, confirm, and/or determine the extent to which specified requirements are fulfilled

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9
Q

audit team

A

one or more individuals, including at least one auditor, that performs an inspection of a laboratory. At least one audit team member shall be or have been an analyst previously qualified in the laboratory’s current DNA technologies and platforms.

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10
Q

auditor

A

an individual who has successfully completed the FBI’s DNA auditor training course

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11
Q

binary method

A

an approach for which there are only two values (possible or not possible) for each decision

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12
Q

biochemistry

A

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

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13
Q

casework CODIS administrator

A

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. An alternate casework CODIS administrator must be designated by the laboratory as required by the NDIS operational procedures.

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14
Q

casework reference samples

A

biological material (e.g., buccal swab, fingerprick, or blood draw) obtained directly from a known individual and used for purposes of comparison to forensic samples

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15
Q

certified reference material

A

material for which values are obtained by a technically valid procedure and accompanied by, or traceable to, a certificate or other documentation which is issued by a certifying body (e.g., NIST)

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16
Q

CODIS

A

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

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17
Q

CODIS user

A

an employee or contract employee who has login access to the CODIS (i.e., State or Local) system and is authorized to read, add, modify and/or delete DNA records in CODIS

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18
Q

competency testing

A

a test or series of tests (practical, written, and/or oral) designed to establish that an individual has demonstrated achievement of technical skills and met minimum standards of knowledge necessary to perform forensic DNA analysis

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19
Q

competency

A

the demonstration of technical skills and knowledge necessary to perform forensic DNA analysis successfully

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20
Q

contamination

A

the unintentional introduction of exogenous DNA into a sample or analytical control during DNA testing

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21
Q

corrective action plan

A

evaluates and remediates a nonconformity with the goal to identify, correct, and/or prevent reoccurrence of the nonconformity, when possible

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22
Q

critical equipment or instruments

A

equipment/instruments whose accurate functionality directly affects the results of the analysis and requires calibration, certification, or performance check prior to use and periodically thereafter

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23
Q

critical reagents

A

those whose performance is vital to the success of the DNA testing and require testing on known samples before use on forensic or casework reference samples

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24
Q

differential amplification

A

the unequal amplification of one target region or locus over another during the polymerase chain reaction

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25
Q

disposition of evidence

A

the documentation of the retention, return, or consumption of the evidence item(s) upon completion of DNA testing

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26
Q

DNA record

A

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

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27
Q

DNA type

A

the genetic constitution of an individual at one or more defined locations (also known as loci) in the DNA.
1) A DNA type derived from nuclear DNA typically consists of one or two alleles at several loci (e.g., short tandem repeat loci).
2) 2) The DNA type derived from mitochondrial DNA is a specific sequence of nucleotides at a given mitochondrial region(s). In human DNA typing, the DNA type derived from mitochondrial DNA is described in relation to the revised

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28
Q

electrophoresis detection system

A

a platform that allows for the size separation of DNA molecules through a fluid or a gel under the influence of an electric field and the subsequent detection of the separated molecules by fluorescence or other means

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29
Q

evidence

A

an item submitted for DNA testing and/or a derivative of an item as defined by the laboratory that is subject to a chain of custody

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30
Q

expert system

A

a software program or set of software programs designed to interpret single source DNA data in accordance with laboratory defined quality assurance rules and identify DNA data not satisfying laboratory defined quality assurance rules, without human intervention.

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31
Q

FBI

A

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).

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32
Q

forensic DNA analysis

A

the process of isolation, detection, identification, and evaluation of biological evidence in criminal matters using DNA technologies.

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33
Q

forensic sample

A

a biological sample originating from and associated with evidence from a crime scene. A sample associated with evidence from a crime scene may include a sample that has been carried away from the crime scene.

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34
Q

fuctional testing

A

a process to confirm that a software performs the tasks as expected.

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35
Q

genetics

A

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

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36
Q

guidelines

A

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

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37
Q

inconclusive

A

a determination that no inclusion or exclusion can be drawn from the comparison of a casework reference sample to a forensic sample. This could result from statistical analyses that fail to provide sufficient support for an inclusion or exclusion. An inconclusive conclusion could be due to uninterpretable data or data determined by the laboratory as not suitable for comparisons.

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38
Q

integral component

A

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

39
Q

interpretation software

A

a tool to assist the analyst in assessing the analyzed data by applying quality assurance rules, performing mixture deconvolution, and/or evaluating comparisons. Interpretation software may include probabilistic genotyping software or expert systems.

40
Q

intimate sample

A

a biological sample from an evidence item that is obtained directly from an individual’s body; it is not unexpected to detect that individual’s allele(s) in the DNA typing results.

41
Q

known samples

A

biological material whose identity or DNA type is established.

42
Q

laboratory

A

a facility
1) Employing at least two full-time employees who are qualified analysts; and
2) Having and maintaining the capability to perform the DNA analysis of forensic samples and/or casework reference samples at that facility.

43
Q

laboratory support personnel

A

employees or contract employees who perform laboratory support duties exclusive of analytical procedures on forensic or casework reference samples.

44
Q

method

A

a combination of procedural steps used to perform a specific technical process. The method includes the validated steps, reagents, and critical instruments needed to perform the process or portion of a process. The same method may be conducted using different equipment (automated vs manual) when appropriately validated.

45
Q

methodology

A

the categories of methods used to perform a stage of a DNA typing technology or technologies. For example, methodologies for STR technology can include extraction, quantification, amplification, and detection

46
Q

modified rapid DNA analysis

A

the semi-automated (hands-free) process of developing a CODIS acceptable STR profile from a casework reference sample. The “swab in – profile out” process consists of automated extraction, amplification, separation, and detection without human intervention but requires an analyst to perform manual interpretation and technical review

47
Q

molecular biology

A

the study of the theories, methods, and techniques used in the study and analysis of gene structure, organization, and function

48
Q

multi-laboratory system

A

used to describe an organization that has more than one laboratory performing forensic DNA analysis

49
Q

negative amplification control

A

an analytical control that is used to detect DNA contamination of the amplification reagents. This analytical control consists of only amplification reagents without the intentional addition of template DNA

50
Q

negative sample control

A

an analytical control that is used to detect DNA contamination in Rapid DNA reagents and consumables

51
Q

negative sequencing control

A

an analytical control that is used to detect DNA contamination of the sequencing reagents. This analytical control consists of only sequencing reagents without the intentional addition of template DNA. The negative amplification control can be used as the negative sequencing control.

52
Q

NIST

A

the National Institute of Standards and Technology.

53
Q

nonconformity

A

not meeting, implementing, maintaining, or complying with one or more of the requirements of these standards or a laboratory’s procedures, policies, or other quality system documents.

54
Q

on-site visit

A

a scheduled or unscheduled visit to the vendor laboratory work site by one or more representatives of an NDIS participating laboratory.

55
Q

outsourcing

A

the utilization of a vendor laboratory to provide DNA services in which the NDIS participating laboratory takes or retains ownership of the DNA data. Outsourcing does not require the existence of a contractual agreement or the exchange of funds.

56
Q

ownership

A

the process by which the responsibility for the products of forensic DNA analyses provided by a vendor laboratory may pass to an NDIS participating laboratory. It applies if any of the following will occur:
1) The NDIS participating laboratory will use any samples, extracts or materials from the vendor laboratory for the purposes of forensic DNA testing (e.g., a vendor laboratory prepares an extract that will be analyzed by the NDIS laboratory)
2) The NDIS participating laboratory will interpret the DNA data generated by the vendor laboratory;
3) The NDIS participating laboratory will issue a report describing or drawing conclusions on the results of the DNA analysis performed by the vendor laboratory; or
4) The NDIS participating laboratory will enter or search a DNA profile in CODIS from data generated by the vendor laboratory.

57
Q

ownership review

A

the technical review of outsourced DNA data required. This review is to be distinguished from the technical and administrative reviews. For outsourced DNA data, the vendor laboratory is responsible for conducting the technical and administrative reviews.

58
Q

performance check

A

a quality assurance measure to assess the functionality of laboratory critical equipment and instruments.

59
Q

platform

A

the type of analytical system utilized to generate DNA profiles, such as capillary electrophoresis, real-time gel and end-point gel instruments or systems.

60
Q

polymerase chain reaction (PCR)

A

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.

61
Q

positive amplification control

A

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

62
Q

positive sample control

A

an analytical control that is used to determine if the Rapid DNA instrument/System is performing all steps of the process properly. This control consists of a known DNA sample.

63
Q

positive sequencing control

A

an analytical control that is used to determine if the sequencing performed properly. This control consists of the sequencing reagents and a known DNA sample. The positive amplification control can be used as the positive sequencing control.

64
Q

perferential amplification

A

the unequal amplification of the two alleles present in a heterozygous locus during the polymerase chain reaction.

65
Q

procedure

A

a series of instructions to be followed in performing a specified task or under specific circumstances.

66
Q

proficiency testing

A

a quality assurance measure used to monitor performance and identify areas in which improvement may be needed. Proficiency tests may be classified as:
1) An internal proficiency test, which is produced by the agency undergoing the test.
2) An external proficiency test, which is a test obtained from a proficiency test provider accredited to the current applicable standard of the International Organization for Standardization and the applicable test is included on the proficiency test provider’s scope of accreditation.

67
Q

qualitative statement

A

a description of the evidence (e.g., partial profile, mixture profile) or a conclusion of any comparisons that were performed without a statistical significance provided (e.g., source attribution, consistent with an intimate sample).

68
Q

quality system

A

the organizational structure, responsibilities, procedures, policies, and resources for implementing quality management.

69
Q

quantitative PCR

A

a method of determining the concentration of DNA in a sample by use of the polymerase chain reaction.

70
Q

quantitative statement

A

a conclusion that provides a statistical measure of the DNA profile (e.g., random match probability) or comparison performed (e.g., likelihood ratio).

71
Q

rapid DNA analysis

A

the fully automated (hands-free) process of developing a CODIS acceptable STR profile from a casework reference sample. The “swab in – profile out” process consists of automated extraction, amplification, separation, detection and allele calling without human intervention.

72
Q

rapid DNA cartridge

A

a preassembled set of reagents and other analytical components (such as typing test kit) designed for use in a Rapid DNA instrument/System for the extraction, amplification and/or separation of DNA samples.

73
Q

rapid DNA instrument

A

an automated device that carries out Rapid DNA analysis or modified Rapid DNA analysis used to develop a CODIS acceptable STR profile from a casework reference sample.

74
Q

rapid DNA system

A

the collection of components that together performs a Rapid DNA analysis consisting of a Rapid DNA instrument, the PCR STR typing test kit/Rapid DNA cartridge, and an integrated Expert System used to develop a CODIS acceptable STR profile from a casework reference sample.

75
Q

reagent

A

a substance or mixture of substances used in the analysis process to detect, measure, produce, or interact with other substances.

76
Q

reagent blank control

A

an analytical control that is used to monitor contamination from extraction to DNA typing results and contains no intentionally added template DNA

77
Q

regression testing

A

the process of testing an updated software program to confirm that modifications or new functionality do not unacceptably alter or terminate a desired functionality that behaved correctly before the change was implemented.

78
Q

reinterpretation

A

the reassessment of legacy data that may change the previously documented results. This may be due to a reevaluation of any of the allele calls or genotype calls [to include potential allelic drop-out], removal of alleles (or entire loci) from statistical estimates, or a change in the assumptions.

79
Q

reliability testing

A

the process of testing a software program beyond its functional aspects to ensure it works appropriately in the laboratory environment. This may include testing multi-user or multi-site scenarios, direct-access and network/server-access scenarios, and interaction with other software programs.

80
Q

sesnitivity studies

A

used to assess the ability to obtain reliable results from a range of DNA quantities, to include the upper and lower limits of the assay or to assess the ability of the system to reliably determine the presence of a contributor’s DNA over a broad variety of evidentiary typing results (to include mixtures and low-level DNA quantities).

81
Q

specificity studies

A

used to assess the ability to detect genetic information from non-targeted species (e.g., detection of microbial DNA in a human assay). The detection of genetic information from non-targeted species does not necessarily invalidate the use of the assay, but may help define the limits of the assay. They are also used to evaluate the ability of the system to provide reliable results over a broad variety of evidentiary typing results (to include mixtures and low-level DNA quantities).

82
Q

stochastic threshold

A

the peak height or signal magnitude value, determined through validation studies, below which it is reasonable to assume that, at a given locus, allelic dropout of a sister allele in a heterozygous pair may have occurred.

83
Q

techinal leader

A

an employee who is accountable for the technical operations of the laboratory and who is authorized to initiate, suspend, and resume laboratory operations.

84
Q

technical review

A

an evaluation of reports, notes, data, and other documents to ensure there is an appropriate and sufficient basis for the scientific conclusions.

85
Q

technical reviewer

A

an employee or contract employee who is a current or previously qualified analyst that performs a technical review of, and is not an author of, the applicable report or its contents.

86
Q

technician

A

an employee or contract employee who performs analytical procedures on forensic samples or casework reference samples under the direction of a qualified analyst. Technicians do not interpret data to reach conclusions on typing results or prepare final reports.

87
Q

test kit

A

a preassembled set of reagents (or laboratory assembled equivalent) that allows the user to conduct a specific DNA extraction, quantification, or amplification method. A laboratory assembled equivalent may be referred to as a test system.

88
Q

typing test kit

A

a preassembled set of reagents (or laboratory assembled equivalent) that is used to generate a DNA type

89
Q

underlying scientific principle

A

a rule concerning a natural phenomenon or function that is a part of the basis used to proceed to more detailed scientific functions.

90
Q

uninterpretable

A

a determination that DNA data cannot be interpreted (e.g., due to poor or limited data quality, data that fail to meet laboratory quality requirements). Uninterpretable data may result in an inconclusive conclusion.

91
Q

validation

A

a process by which a method is evaluated to determine its efficacy and reliability for forensic casework analysis and includes the following:
1) Developmental validation, which is the acquisition of test data and determination of conditions and limitations of a new or novel DNA method for use on forensic samples.
2) Internal validation, which is an accumulation of test data within the laboratory to demonstrate that established methods and procedures perform as expected in the laboratory.

92
Q

vendor laboratory

A

a governmental or private laboratory that provides DNA analysis services to another laboratory or agency and does not take ownership of the DNA data for purposes of entry into CODIS.

93
Q

work product

A

the material that is generated as a function of analysis that is not subject to a chain of custody.

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