Standards
for Convicted Offender DNA Databasing Laboratories
Preface
Throughout its deliberation
concerning these quality standards, the DNA Advisory Board recognized
the need for a mechanism to ensure compliance with the standards.
An underlying premise for these discussions was that accreditation
would be required to demonstrate compliance with the standards and
therefore assure quality control and a quality program. Accordingly,
the Board recommends that forensic laboratories performing DNA analysis
seek such accreditation with all deliberate speed. Additionally, the
Board strongly encourages the accrediting bodies to begin positioning
themselves to accommodate the increasing demand for accreditation.
INTRODUCTION
Forensic DNA identification
analysis currently involves forensic casework and convicted offender
analyses. These complementary functions demand adherence to the highest
analytical standards possible to protect both public safety and individual
rights. Separate standards have been drafted for laboratories performing
these functions. This separation is an acknowledgment of the differences
in the nature or type of sample, the typical sample quantity and potential
for reanalysis, and specialization that may exist in a laboratory.
Standards for convicted offender laboratories, in some instances,
are less stringent than for those performing forensic casework analyses,
but in no case should the two documents be interpreted as conflicting.
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.
MECHANISM TO RECOMMEND
CHANGES TO STANDARDS
Once the Director of the
Federal Bureau of Investigation (FBI) has issued standards for quality
assurance for convicted offender DNA testing, the DNA Advisory Board
may recommend revisions to such standards to the FBI Director, as
necessary. In the event that the duration of the DNA Advisory Board
is extended beyond March 10, 2000, by the FBI Director, the Board
may continue to recommend revisions to such standards to the FBI Director.
In the event that the DNA Advisory Board is not extended by the FBI
Director after March 10, 2000, the Technical Working Group on DNA
Analysis Methods (TWGDAM) may recommend revisions to such standards
to the FBI Director, as necessary.
Effective
Date
These Quality Assurance
Standards for Convicted Offender DNA Databasing Laboratories take effect
April 1, 1999.
REFERENCES:
American Society of Crime
Laboratory Directors-Laboratory Accreditation Board (ASCLD-LAB), ASCLD-LAB
Accreditation Manual, January 1994, and January, 1997. Federal Bureau
of Investigation, Quality Assurance Standards for Forensic DNA Testing
Laboratories, (1998) 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 government laboratory which is
defined as a facility in which convicted offender DNA testing is regularly
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 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) Batch is a group of samples analyzed at the same time.
(f) 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.
(g) CODIS is the Combined DNA Index System administered by the FBI.
It houses DNA profiles from convicted offenders, forensic specimens,
population samples and other specimen types.
(h) Commercial test kit is a preassembled kit that allows the user
to conduct a specific DNA identification test.
(i) Convicted offender is an individual who is required by statute
to submit a standard sample for DNA databasing.
(j) Convicted offender database (CODIS) manager or custodian (or equivalent
role, position, or title as designated by the laboratory director)
is the person responsible for administration and security of the laboratory's
CODIS.
(k) Convicted offender standard sample is biological material collected
from an individual for DNA analysis and inclusion into CODIS. See
also database sample.
(l) Critical equipment or instruments are those requiring calibration
prior to use and periodically thereafter.
(m) Critical reagents are determined by empirical studies or routine
practice to require testing on established samples before use in order
to prevent unnecessary loss of sample.
(n) Database sample is a known blood or standard sample obtained from
an individual whose DNA profile will be included in a computerized
database and searched against other DNA profiles. (o) Examiner/analyst
(or equivalent role, position, or title as designated by the laboratory
director) is an individual who conducts and/or directs the analysis
of samples, interprets data and reaches conclusions.
(p) Known samples are biological material whose identity or type is
established.
(q) Laboratory is a government facility in which convicted offender
DNA testing is performed or a government facility who contracts with
a second entity for such testing.
(r) Laboratory support personnel (or equivalent role, position, or
title as designated by the laboratory director) are individual(s)
who perform laboratory duties and do not analyze samples.
(s) NIST is the National Institute of Standards and Technology.
(t) 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.
(u) 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.
(v) 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.
(w) A Qualifying test measures proficiency in both technical skills
and knowledge.
(x) Quality assurance includes the systematic actions necessary to
demonstrate that a product or service meets specified requirements
for quality.
(y) A quality manual is a document stating the quality policy, quality
system and quality practices of an organization.
(z) Quality system is the organizational structure, responsibilities,
procedures, processes and resources for implementing quality management.
(aa) 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.
(bb) 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.
(cc) 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.
(dd) Review is an evaluation of documentation to check for consistency,
accuracy, and completeness.
(ee) Second agency is an entity or organization external to and independent
of the laboratory and which performs DNA identification analysis.
(ff) Secure area is a locked space (for example, cabinet, vault or
room) with access restricted to authorized personnel.
(gg) Subcontractor is an individual or entity having a transactional
relationship with a laboratory.
(hh) Technical manager or leader (or equivalent position or title
as designated by the laboratory director) is the individual who is
accountable for the technical operations of the laboratory.
(ii) 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.
(jj) Technician (or equivalent role, position, or title as designated
by the laboratory director) is an individual who performs analytical
techniques on samples under the supervision of a qualified examiner/analyst
and/or performs DNA analysis on samples for inclusion in a database.
(kk) 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.
(ll) Validation is a process by which a procedure is evaluated to
determine its efficacy and reliability for DNA 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 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) Sample control
(f) Validation
(g) Analytical procedures
(h) Calibration and maintenance
(i) Proficiency testing
(j) Corrective action
(k) Documentation
(l) Review
(m) Safety
(n) Audits
4. ORGANIZATION AND MANAGEMENT
STANDARD 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) have a CODIS manager or custodian who is accountable for CODIS
operations.
(d) 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, CODIS manager or custodian, 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.
STANDARD 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 organizations 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 the standards. The waiver
shall be permanent and portable.
5.2.2 Experience requirements: A technical manager or leader of
a laboratory shall have a minimum of three years of relevant problem
solving or related analytical 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
on-site, telephone or electronic consultation as needed.
STANDARD 5.3
CODIS manager or custodian
shall have the following:
5.3.1 Degree requirements:
A CODIS manager or custodian shall have, at a minimum, a Bachelor's
degree in a natural science or computer science.
5.3.2 Experience requirements: A CODIS manager or custodian shall
have a working knowledge of computers, computer networks, and computer
database management, with an understanding of DNA profile interpretation.
5.3.3 Duty requirements:
(a) Is the system administrator
of the laboratory's CODIS network and is responsible for the security
of DNA profile data stored in CODIS.
(b) Is responsible for oversight of CODIS computer training and
quality assurance of data.
(c) Has the authority to terminate the laboratory's participation
in CODIS in the event of a problem until the reliability of the
computer data can be assured. The state CODIS manager or custodian
has this authority over all CODIS sites under his/her jurisdiction.
STANDARD 5.4
Examiner/analyst shall have
the following:
5.4.1 Degree requirements:
An examiner/analyst shall have, at a minimum, a Bachelors 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.
5.4.2 Experience requirements: An examiner/analyst shall have a minimum
of six (6) months of DNA laboratory experience, including the successful
analysis of a range of samples typically encountered in convicted
offender analysis prior to independent work using DNA technology.
5.4.3 An examiner/analyst shall have successfully completed a qualifying
test before beginning independent work responsibilities.
STANDARD 5.5
Technician shall have:
5.5.1 on-the-job training
specific to their job function(s).
5.5.2 successfully completed a qualifying test before participating
in DNA typing responsibilities.
STANDARD 5.6
Laboratory support personnel
shall have:
5.6.1 training, education
and experience commensurate with their responsibilities as outlined
in their job description.
6. FACILITIES
STANDARD 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, liquid sample
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, liquid blood
examinations, DNA extractions and PCR setup areas.
6.1.4 A robotic work station may be used to carry out DNA extraction
and amplification in a single room, provided it can be demonstrated
that contamination is minimized and equivalent to that when performed
manually in separate rooms.
6.1.5 The laboratory follows written procedures for monitoring, cleaning
and decontaminating facilities and equipment.
7. SAMPLE CONTROL
STANDARD 7.1
The laboratory shall have
and follow a documented sample inventory control system. This system
shall ensure that:
7.1.1 Offender samples
are marked for identification.
7.1.2 Documentation of sample identity, collection, receipt, storage,
and disposition is maintained.
7.1.3 The laboratory follows documented procedures that minimize sample
loss, contamination, and/or deleterious change.
7.1.4 The laboratory has secure areas for sample storage including
environmental control consistent with the form or nature of the sample.
8. VALIDATION
STANDARD 8.1
The laboratory shall use
validated methods and procedures for DNA analyses.
8.1.1 Developmental validation
that is conducted shall be appropriately documented.
8.1.2 Novel database DNA methodologies shall undergo developmental
validation to ensure the accuracy, precision and reproducibility of
the procedure.
8.1.2.1 Documentation shall be available which defines and characterizes
the locus.
8.1.3 Internal validation shall be performed and documented by the
laboratory. 8.1.3.1 The procedure shall be tested using known samples.
The laboratory shall monitor and document the reproducibility and
precision of the procedure using human DNA control(s).
8.1.3.2 Before the introduction of a procedure into database sample
analysis, the analyst or examination team shall successfully complete
a qualifying test. 8.1.3.3 Material modifications made to analytical
procedures shall be documented and subject to validation testing.
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.
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 and expiration, and the identity of the individual
preparing the reagent.
9.2.3 The laboratory shall identify critical reagents, if any, and
evaluate them prior to use.
STANDARD 9.3
The laboratory shall monitor
the analytical procedures using appropriate controls and standards.
9.3.1 The following controls
shall be used in RFLP analysis:
9.3.1.1 When required by the analytical procedure, standards for estimating
the amount of DNA recovered by extraction shall be used.
9.3.1.2 K562 as a human DNA control.
9.3.1.3 Molecular weight size markers to bracket samples on an analytical
gel. No more than five lanes shall exist between marker lanes.
9.3.1.4 A procedure shall be available to monitor the completeness
of restriction enzyme digestion. Interpretation of the autorad/lumigraph
is the ultimate method of assessment but a test gel or other method
may be used as necessary.
9.3.2 The following controls shall be used for PCR database analysis:
9.3.2.1 When required by the analytical procedure, standards which
estimate the amount of human nuclear DNA recovered by extraction shall
be used. 9.3.2.2 Positive and negative amplification controls.
9.3.2.3 Contamination controls.
9.3.2.3.1 Samples extracted prior to the effective date of these standards
without reagent blanks are acceptable as long as other samples analyzed
in the batch do not demonstrate contamination.
9.3.2.4 Allelic ladders for variable number tandem repeat sequence
PCR-based systems.
STANDARD 9.4
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 9.5
The laboratory shall have
and follow written general guidelines for the interpretation of data.
9.5.1 The laboratory shall
verify that all control results are within established tolerance limits.
10. EQUIPMENT CALIBRATION
AND MAINTENANCE
STANDARD 10.1
The laboratory shall use
equipment suitable for the methods employed.
STANDARD 10.2
The laboratory shall identify
critical equipment and 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 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 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 critical instruments
and equipment, or critical instruments and equipment that have undergone
repair or maintenance, shall be calibrated before use.
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 federal or state law.
11. REPORTS
STANDARD 11.1
The laboratory shall have and follow written procedures for generating
and maintaining documentation for database samples.
11.1.1 The laboratory shall
have written procedures for the release of database sample information.
12. REVIEW
STANDARD 12.1
The laboratory shall have
and follow written procedures for reviewing database sample information,
results, and matches.
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 laboratory personnel.
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 analytical errors are detected.
14.1.1 The laboratory shall
maintain documentation for the corrective action. Such documentation
shall be retained in accordance with 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) Sample control
(f) Validation
(g) Analytical procedures
(h) Calibration and maintenance
(i) Proficiency testing
(j) Corrective action
(k) Documentation
(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 convicted offender
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 including but not limited
to:
(a) Random reanalysis
of samples.
(b) Visual inspection and evaluation of results/data.
(c) Inclusion of QC samples.
(d) On-site visits.
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