(a) Administrative review
is an evaluation of the report and supporting documentation for consistency
with laboratory policies and for editorial correctness.
(b) Amplification blank
control consists of only amplification reagents without the addition
of sample DNA. This control is used to detect DNA contamination of
the amplification reagents.
(c) Analytical procedure
is an orderly step by step procedure designed to ensure operational
uniformity and to minimize analytical drift.
(d) Audit is an inspection
used to evaluate, confirm, or verify activity related to quality.
(e) 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.
(f) Critical reagents are
determined by empirical studies or routine practice to require testing
on established samples before use on evidentiary samples in order
to prevent unnecessary loss of sample.
(g) Commercial test kit
is a pre-assembled kit that allows the user to conduct a specific
forensic DNA test.
(h) Examiner/analyst is
an individual who conducts and/or directs the analysis of forensic
casework samples, interprets data and reaches conclusions.
(I) Forensic DNA testing
is the identification and evaluation of biological evidence in criminal
matters using DNA technologies.
(j) Known samples are biological
material whose identity or type is established.
(k) Laboratory is a facility
in which forensic DNA testing is performed.
(l) Laboratory support
personnel are individual(s) who perform laboratory duties and do not
analyze evidence samples.
(m) NIST is the National
Institute of Standards and Technology.
(n) Polymerase Chain Reaction
(PCR) is an enzymatic process by which a specific region of DNA is
replicated during repetitive cycles which consist of
(1) denaturation of the
(2) annealing of primers to complementary sequences at an empirically
determined temperature; and
(3) extension of the bound primers by a DNA polymerase.
(o) Proficiency test sample
is biological material whose DNA type has been previously characterized
and which is used to monitor the quality performance of a laboratory
or an individual.
(p) Proficiency testing
is a quality assurance measure used to monitor performance and identify
areas in which improvement may be needed. Proficiency tests may be
(1) Internal proficiency
test is one prepared and administered by the laboratory.
(2) External proficiency test, which may be open or blind, is one
which is obtained from a second agency.
(q) Qualifying test measures
proficiency in both technical skills and knowledge.
(r) Quality assurance includes
the systematic actions necessary to demonstrate that a product or
service meets specified requirements for quality.
(s) Quality manual is
a document stating the quality policy, quality system and quality
practices of an organization.
(t) Quality system is the
organizational structure, responsibilities, procedures, processes
and resources for implementing quality management.
(u) Reagent blank control
consists of all reagents used in the test process without any sample.
This is to be used to detect DNA contamination of the analytical reagents.
(v) Reference material
(certified or standard) is a material for which values are certified
by a technically valid procedure and accompanied by or traceable to
a certificate or other documentation which is issued by a certifying
(w) Restriction Fragment
Length Polymorphism (RFLP) is generated by cleavage by a specific
restriction enzyme and the variation is due to restriction site polymorphism
and/or the number of different repeats contained within the fragments.
(x) Review is an evaluation
of documentation to check for consistency, accuracy, and completeness.
(y) Second agency is an
entity or organization external to and independent of the laboratory
and which performs forensic DNA analysis.
(z) Secure area is a locked
space (for example, cabinet, vault or room) with access restricted
to authorized personnel.
(aa) Subcontractor is an
individual or entity having a transactional relationship with a laboratory.
(bb) Technical manager
or leader (or equivalent position or title as designated by the laboratory
system) is the individual who is accountable for the technical operations
of the laboratory.
(cc) Technical review is
an evaluation of reports, notes, data, and other documents to ensure
an appropriate and sufficient basis for the scientific conclusions.
This review is conducted by a second qualified individual.
(dd) Technician is an individual
who performs analytical techniques on evidence samples under the supervision
of a qualified examiner/analyst and/or performs DNA analysis on samples
for inclusion in a database. Technicians do not evaluate or reach
conclusions on typing results or prepare final reports.
(ee) Traceability is the
property of a result of a measurement whereby it can be related to
appropriate standards, generally international or national standards,
through an unbroken chain of comparisons.
(ff) Validation is a process
by which a procedure is evaluated to determine its efficacy and reliability
for forensic casework analysis and includes:
(1) 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
(2) Internal validation is an accumulation of test data within the
laboratory to demonstrate that established methods and procedures
perform as expected in the laboratory.