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Standards for Convicted Offender
Labs
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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