Standards for Forensic DNA Testing Labs
INTRODUCTION
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.
REFERENCES:
American Society of Crime Laboratory Directors-Laboratory
Accreditation Board (ASCLD-LAB), ASCLD-LAB Accreditation Manual,
January 1994,
and January, 1997. International Standards Organization (ISO)/International
Electrotechnical Commission (IEC), ISO/IEC Guide 25-1990, (1990)
American National Standards Institute, New York, NY. Technical Working
Group on DNA Analysis Methods, "Guidelines for a Quality Assurance
Program for DNA Analysis," Crime Laboratory Digest, April 1995,
Volume 22, Number 2, pp. 21-43. 42 Code of Federal Regulations, Chapter
IV (10-1-95 Edition), Health Care Financing Administration, Health
and Human Services.
1. SCOPE
The standards describe the quality assurance requirements that a
laboratory, which is defined as a facility in which forensic DNA
testing is performed, should follow to ensure the quality and integrity
of the data and competency of the laboratory. 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:
(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 template;
(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 classified as:
(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 body.
(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 samples.
(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.
3. QUALITY ASSURANCE PROGRAM
STANDARD 3.1
The laboratory shall establish and maintain a documented quality
system that is appropriate to the testing activities.
3.1.1 The quality manual shall address at a minimum:
(a) Goals and objectives
(b) Organization and management
(c) Personnel Qualifications and Training
(d) Facilities
(e) Evidence control
(f) Validation
(g) Analytical procedures
(h) Calibration and maintenance
(I) Proficiency testing
(j) Corrective action
(k) Reports
(l) Review
(m) Safety
(n) Audits
4. ORGANIZATION AND MANAGEMENT
STANDARDS 4.1
The laboratory shall:
(a) have a managerial staff with the authority and resources needed
to discharge their duties and meet the requirements of the standards
in this document.
(b) have a technical manager or leader who is accountable for the
technical operations.
(c) specify and document the responsibility, authority, and interrelation
of all personnel who manage, perform or verify work affecting the
validity of the DNA analysis.
5. PERSONNEL
STANDARD 5.1
Laboratory personnel shall have the education, training and experience
commensurate with the examination and testimony provided. The laboratory
shall:
5.1.1 have a written job description for personnel to include responsibilities,
duties and skills.
5.1.2 have a documented training program for qualifying all technical
laboratory personnel.
5.1.3 have a documented program to ensure technical qualifications
are maintained through continuing education.
5.1.3.1 Continuing education - the technical manager or leader and
examiner/analyst(s) must stay abreast of developments within the
field of DNA typing by reading current scientific literature and
by attending seminars, courses, professional meetings or documented
training sessions/classes in relevant subject areas at least once
a year.
5.1.4 maintain records on the relevant qualifications, training,
skills and experience of the technical personnel.
5.2 The technical manager or leader shall have the following:
5.2.1 Degree requirements: The technical manager or leader of a
laboratory shall have at a minimum a Master's degree in biology-,
chemistry- or forensic science- related area and successfully completed
a minimum of 12 semester or equivalent credit hours of a combination
of undergraduate and graduate course work covering the subject areas
of biochemistry, genetics and molecular biology (molecular genetics,
recombinant DNA technology), or other subjects which provide a basic
understanding of the foundation of forensic DNA analysis as well
as statistics and/or population genetics as it applies to forensic
DNA analysis.
5.2.1.1 The degree requirements of section 5.2.1 may be waived by
the American Society of Crime Laboratory Directors (ASCLD) or other
organization designated by the Director of the FBI in accordance
with criteria approved by the Director of the FBI. This waiver shall
be available for a period of two years from the effective date of
these standards. The waiver shall be permanent and portable. 5.2.2
Experience requirements: A technical manager or leader of a laboratory
must have a minimum of three years of forensic DNA laboratory experience.
5.2.3 Duty requirements: 5.2.3.1 General: manages the technical
operations of the laboratory. 5.2.3.2
Specific duties
(a) Is responsible for evaluating all methods used by the laboratory
and for proposing new or modified analytical procedures to be used
by examiners.
(b) Is responsible for technical problem solving of analytical methods
and for the oversight of training, quality assurance, safety and
proficiency testing in the laboratory.
5.2.3.3 The technical manager or leader shall be accessible to the
laboratory to provide onsite, telephone or electronic consultation
as needed.
5.3 Examiner/analyst shall have:
5.3.1 at a minimum a BA/BS degree or its equivalent degree in biology-,
chemistry- or forensic science- related area and must have successfully
completed college course work (graduate or undergraduate level) covering
the subject areas of biochemistry, genetics and molecular biology
(molecular genetics, recombinant DNA technology) or other subjects
which provide a basic understanding of the foundation of forensic
DNA analysis, as well as course work and/or training in statistics
and population genetics as it applies to forensic DNA analysis.
5.3.2 a minimum of six (6) months of forensic DNA laboratory experience,
including the successful analysis of a range of samples typically
encountered in forensic case work prior to independent case work
analysis using DNA technology.
5.3.3 successfully completed a qualifying test before beginning
independent casework responsibilities.
5.4 Technician shall have:
5.4.1 On the job training specific to their job function(s).
5.4.2 successfully completed a qualifying test before participating
in forensic DNA typing responsibilities.
5.5 Laboratory support personnel shall have:
5.5.1 training, education and experience commensurate with their
responsibilities as outlined in their job description.
6. FACILITIES
STANDARDS 6.1
The laboratory shall have a facility that is designed to provide
adequate security and minimize contamination. The laboratory shall
ensure that:
6.1.1 Access to the laboratory is controlled and limited.
6.1.2 Prior to PCR amplification, evidence examinations, DNA extractions,
and PCR setup are conducted at separate times or in separate spaces.
6.1.3 Amplified DNA product is generated, processed and maintained
in a room(s) separate from the evidence examination, DNA extractions
and PCR setup areas.
6.1.4 The laboratory follows written procedures for monitoring, cleaning
and decontaminating facilities and equipment.
7. EVIDENCE CONTROL
STANDARD 7.1
The laboratory shall have and follow a documented evidence control
system to ensure the integrity of physical evidence. This system
shall ensure that:
7.1.1 Evidence is marked for identification.
7.1.2 Chain of custody for all evidence is maintained.
7.1.3 The laboratory follows documented procedures that minimize
loss, contamination, and/or deleterious change of evidence.
7.1.4 The laboratory has secure areas for evidence storage.
STANDARD 7.2
Where possible, the laboratory shall retain or return a portion
of the evidence sample or extract.
7.2.1 The laboratory shall have a procedure requiring that evidence
sample/extract(s) are stored in a manner that minimizes degradation.
8. VALIDATION
STANDARD 8.1
The laboratory shall use validated methods and procedures for forensic
casework analyses.
8.1.1 Developmental validation that is conducted shall be appropriately
documented.
8.1.2 Novel forensic DNA methodologies shall undergo developmental
validation to ensure the accuracy, precision and reproducibility
of the procedure. The developmental validation shall include the
following:
8.1.2.1 Documentation exists and is available which defines and characterizes
the locus.
8.1.2.2 Species specificity, sensitivity, stability and mixture studies
are conducted.
8.1.2.3 Population distribution data are documented and available.
8.1.2.3.1 The population distribution data would include the allele
and genotype distributions for the locus or loci obtained from relevant
populations. Where appropriate, databases should be tested for independence
expectations.
8.1.3 Internal validation shall be performed and documented by the
laboratory.
8.1.3.1 The procedure shall be tested using known and non-probative
evidence samples. The laboratory shall monitor and document the reproducibility
and precision of the procedure using human DNA control(s).
8.1.3.2 The laboratory shall establish and document match criteria
based on empirical data.
8.1.3.3 Before the introduction of a procedure into forensic casework,
the analyst or examination team shall successfully complete a qualifying
test.
8.1.3.4 Material modifications made to analytical procedures shall
be documented and subject to validation testing.
8.1.4 Where methods are not specified, the laboratory shall, wherever
possible, select methods that have been published by reputable technical
organizations or in relevant scientific texts or journals, or have
been appropriately evaluated for a specific or unique application.
9. ANALYTICAL PROCEDURES
STANDARD 9.1
The laboratory shall have and follow written analytical procedures
approved by the laboratory management/technical manager.
9.1.1 The laboratory shall have a standard operating protocol for
each analytical technique used.
9.1.2 The procedures shall include reagents, sample preparation,
extraction, equipment, and controls which are standard for DNA analysis
and data interpretation.
9.1.3 The laboratory shall have a procedure for differential extraction
of stains that potentially contain semen.
STANDARD 9.2
The laboratory shall use reagents that are suitable for the methods
employed.
9.2.1 The laboratory shall have written procedures for documenting
commercial supplies and for the formulation of reagents.
9.2.2 Reagents shall be labeled with the identity of the reagent,
the date of preparation or expiration, and the identity of the individual
preparing the reagent.
9.2.3 The laboratory shall identify critical reagents and evaluate
them prior to use in casework.
These critical reagents include but are not limited to:
(a) Restriction enzyme
(b) Commercial kits for performing genetic typing
(c) Agarose for analytical RFLP gels
(d) Membranes for Southern blotting
(e) K562 DNA or other human DNA controls
(f) Molecular weight markers used as RFLP sizing standards
(g) Primer sets
(h)Thermostable DNA polymerase
STANDARD 9.3
The laboratory shall have and follow a procedure for evaluating
the quantity of the human DNA in the sample where possible.
9.3.1 For casework RFLP samples, the presence of high molecular
weight DNA should be determined.
STANDARD 9.4
The laboratory shall monitor the analytical procedures using appropriate
controls and standards.
9.4.1 The following controls shall be used in RFLP casework analysis:
9.4.1.1 Quantitation standards for estimating the amount of DNA recovered
by extraction.
9.4.1.2 K562 as a human DNA control. (In monitoring sizing data,
a statistical quality control method for K562 cell line shall be
maintained.)
9.4.1.3 Molecular weight size markers to bracket known and evidence
samples.
9.4.1.4 Procedure to monitor the completeness of restriction enzyme
digestion.
9.4.2 The following controls shall be used for PCR casework analysis:
9.4.2.1 Quantitation standards which estimate the amount of human
nuclear DNA recovered by extraction.
9.4.2.2 Positive and negative amplification controls.
9.4.2.3 Reagent blanks.
9.4.2.4 Allelic ladders and/or internal size makers for variable
number tandem repeat sequence PCR based systems.
STANDARD 9.5
The laboratory shall check its DNA procedures annually or whenever
substantial changes are made to the protocol(s) against an appropriate
and available NIST standard reference material or standard traceable
to a NIST standard.
STANDARD 9.6
The laboratory shall have and follow written general guidelines
for the interpretation of data.
9.6.1 The laboratory shall verify that all control results are within
established tolerance limits.
9.6.2 Where appropriate, visual matches shall be supported by a numerical
match criterion.
9.6.3 For a given population(s) and/or hypothesis of relatedness,
the statistical interpretation shall be made following the recommendations
4.1, 4.2 or 4.3 as deemed applicable of the National Research Council
report entitled "The Evaluation of Forensic DNA Evidence" (1996)
and/or court directed method. These calculations shall be derived
from a documented population database appropriate for the calculation.
10. EQUIPMENT CALIBRATION AND MAINTENANCE
STANDARD 10.1
The laboratory shall use equipment suitable for the methods employed.
STANDARD 10.2
The laboratory shall have a documented program for calibration of
instruments and equipment.
10.2.1 Where available and appropriate, standards traceable to national
or international standards shall be used for the calibration.
10.2.1.1 Where traceability to national standards of measurement
is not applicable, the laboratory shall provide satisfactory evidence
of correlation of results.
10.2.2 The frequency of the calibration shall be documented for each
instrument requiring calibration. Such documentation shall be retained
in accordance with applicable Federal or state law.
STANDARD 10.3
The laboratory shall have and follow a documented program to ensure
that instruments and equipment are properly maintained.
10.3.1 New instruments and equipment, or instruments and equipment
that have undergone repair or maintenance, shall be calibrated before
being used in casework analysis.
10.3.2 Written records or logs shall be maintained for maintenance
service performed on instruments and equipment. Such documentation
shall be retained in accordance with applicable Federal or state
law.
11. REPORTS
STANDARD 11.1
The laboratory shall have and follow written procedures for taking
and maintaining case notes to support the conclusions drawn in laboratory
reports.
11.1.1 The laboratory shall maintain, in a case record, all documentation
generated by examiners related to case analyses.
11.1.2 Reports according to written guidelines shall include:
(a) Case identifier
(b) Description of evidence examined
(c) A description of the methodology
(d) Locus
(e) Results and/or conclusions
(f) An interpretative statement (either quantitative or qualitative)
(g) Date issued
(h) Disposition of evidence
(I) A signature and title, or equivalent identification, of the person(s)
accepting responsibility for the content of the report.
11.1.3 The laboratory shall have written procedures for the release
of case report information.
12. REVIEW
STANDARD 12.1
The laboratory shall conduct administrative and technical reviews
of all case files and reports to ensure conclusions and supporting
data are reasonable and within the constraints of scientific knowledge.
12.1.1 The laboratory shall have a mechanism in place to address
unresolved discrepant conclusions between analysts and reviewer(s).
STANDARD 12.2
The laboratory shall have and follow a program that documents the
annual monitoring of the testimony of each examiner.
13. PROFICIENCY TESTING
STANDARD 13.1
Examiners and other personnel designated by the technical manager
or leader who are actively engaged in DNA analysis shall undergo,
at regular intervals of not to exceed 180 days, external proficiency
testing in accordance with these standards. Such external proficiency
testing shall be an open proficiency testing program.
13.1.1 The laboratory shall maintain the following records for proficiency
tests:
(a) The test set identifier.
(b) Identity of the examiner.
(c) Date of analysis and completion.
(d) Copies of all data and notes supporting the conclusions.
(e) The proficiency test results.
(f) Any discrepancies noted.
(g) Corrective actions taken. Such documentation shall be retained
in accordance with applicable Federal or state law.
13.1.2 The laboratory shall establish at a minimum the following
criteria for evaluation of proficiency tests:
(a) All reported inclusions are correct or incorrect.
(b) All reported exclusions are correct or incorrect.
(c) All reported genotypes and/or phenotypes are correct or incorrect
according to consensus genotypes/phenotypes or within established
empirically determined ranges.
(d) All results reported as inconclusive or uninterpretable are consistent
with written laboratory guidelines. The basis for inconclusive interpretations
in proficiency tests must be documented.
(e) All discrepancies/errors and subsequent corrective actions must
be documented.
(f) All final reports are graded as satisfactory or unsatisfactory.
A satisfactory grade is attained when there are no analytical errors
for the DNA profile typing data. Administrative errors shall be documented
and corrective actions taken to minimize the error in the future.
(g) All proficiency test participants shall be informed of the final
test results.
14. CORRECTIVE ACTION
STANDARD 14.1
The laboratory shall establish and follow procedures for corrective
action whenever proficiency testing discrepancies and/or casework
errors are detected.
14.1.1 The laboratory shall maintain documentation for the corrective
action. Such documentation shall be retained in accordance with
applicable Federal or state law. 15. AUDITS
STANDARD 15.1
The laboratory shall conduct audits annually in accordance with
the standards outlined herein.
15.1.1 Audit procedures shall address at a minimum:
(a) Quality assurance program
(b) Organization and management
(c) Personnel
(d) Facilities
(e) Evidence control
(f) Validation
(g) Analytical procedures
(h) Calibration and maintenance
(I) Proficiency testing
(j) Corrective action
(k) Reports
(l) Review
(m) Safety
(n) Previous audits
15.1.2 The laboratory shall retain all documentation pertaining
to audits in accordance with relevant legal and agency requirements.
STANDARD 15.2
Once every two years, a second agency shall participate in the annual
audit.
16. SAFETY
STANDARD 16.1
The laboratory shall have and follow a documented environmental
health and safety program.
17. SUBCONTRACTOR OF ANALYTICAL TESTING FOR WHICH VALIDATED PROCEDURES
EXIST
STANDARD 17.1
A laboratory operating under the scope of these standards will require
certification of compliance with these standards when a subcontractor
performs forensic DNA analyses for the laboratory.
17.1.1
The laboratory will establish and use appropriate review procedures
to verify the integrity of the data received from the subcontractor.
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