Preface
The Scientific
Working Group on Forensic Analysis of Chemical Terrorism (SWGFACT)
has developed the following quality assurance guidelines to provide
laboratories engaged in forensic analysis of chemical evidence associated
with terrorism a framework to implement a quality assurance program.
This document provides guidance to laboratories that carry out forensic
analysis to support the judicial system. Consideration may be given
to alternate methods of achieving the intent of these quality assurance
practices as outlined in these guidelines. A quality program is
always evolving, and likewise, this document should be considered
a living document.
Introduction
SWGFACT's mission
is "to develop guidelines for the forensic identification, characterization,
and attribution of evidence in planned, threatened, or actual acts
of chemical terrorism." The Quality Assurance Guidelines for
Laboratories Performing Forensic Analysis of Chemical Terrorism
may be used by laboratories to structure or enhance their quality
assurance practices in the analysis of chemical terrorism. SWGFACT
emphasizes the importance of complying with applicable international,
federal, state, and local regulations, specifically in the areas
of sample shipment, hazard containment, and personnel protection.
References
American Society
of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB),
ASCLD/LAB Accreditation Manual, July 2003.
Federal Bureau
of Investigation DNA Advisory Board. Quality assurance standards
for forensic DNA testing laboratories, July 1998, Forensic Science
Communications [Online]. (July 2000). Available: www.fbi.gov/hq/lab/fsc/backissu/july2000/codis2a.htm.
Scientific
Working Group on Microbial Genetics and Forensics. Quality assurance
guidelines for laboratories performing microbial forensic work,
Forensic Science Communications [Online]. (October 2003).
Available: www.fbi.gov/hq/lab/fsc/backissu/oct2003/2003_10_guide01.htm.
International
Organization for Standards/International Electrotechnical Commission.
ISO/IEC 17025, General Requirements for the Competence of Testing
and Calibration Laboratories. American National Standards Institute,
New York, 1999.
Suggested
Reading
SW-846
Manual: Test Methods for Evaluating Solid Waste, Physical/Chemical
Methods. U.S. Environmental Protection Agency, Washington,
DC. Available: www.epa.gov/epaoswer/hazwaste/test/sw846.htm.
Select
Agents and Toxins, Title 42 CFR Part 73, U.S. Department of
Health and Human Services, Washington, DC, 2003. Available: www.access.gpo.gov/nara/cfr/waisidx_03/42cfr73_03.html.
1. Scope
These guidelines
describe quality assurance activities that a laboratory should follow
to ensure the quality and integrity of the data and competency of
the laboratory. A laboratory, in the context of these guidelines,
is defined as a facility in which analyses associated with chemical
terrorism is performed. These guidelines do not preclude a laboratory
by itself or in collaboration with others from participating in
research and development.
2. Definitions
As used in
these guidelines, the following terms shall have the meanings specified:
Administrative review is an evaluation of examination documentation
for consistency with laboratory policies and for editorial correctness.
Analytical procedure is an orderly step-by-step instruction
designed to ensure operational uniformity and to minimize uncertainty.
Attribution is the identification of the source of a material
to the degree that it can be ascertained.
Audit is an inspection used to evaluate, confirm, or verify
activity and documentation related to quality.
Calibration is a set of operations that establish, under
specified conditions, the relationship between values provided by
a measuring instrument or measuring system and a known value.
Chain of custody is the tracking and documentation of physical
control of evidence.
Chemical terrorism is the use, or threat of use, of chemicals
to commit acts of terror or crime.
Equipment and instruments are apparatus capable of measuring
and/or having an effect on the accuracy or validity of a technical
operation used to determine one or more physical or chemical characteristics
of a given test sample (e.g., gas chromatograph, balance, carrier
gas generator, oven, thermometer, auto pipetter).
Examination documentation encompasses any documentation
generated as a result of the analysis of submitted evidence. This
may include technical notes, worksheets, charts, graphs, printouts,
spectra, photographs, and other data or records used by examiners/analysts
to support their reported conclusions.
Examiner or analyst (or equivalent role, position, or title
as designated by the laboratory director) is a person who conducts
and/or directs the analysis of samples, interprets data, and reaches
conclusions and may eventually testify to those findings or conclusions.
Laboratory is a facility in which chemical forensic testing is performed.
Laboratory support personnel (or equivalent role, position,
or title as designated by the laboratory director) are people who
perform supportive laboratory duties but are not involved in the
analysis of evidence.
Proficiency test samples are materials whose identity,
type, or values are previously characterized and used to assess
the performance of a laboratory or a person.
Proficiency testing is a quality assurance measure used
to monitor individual or laboratory performance and identify areas
in which improvement may be needed. A determination of proficiency
can only be obtained when the expected results are not known by
the test participant during the test administration.
Proficiency tests may be classified as
- Internal-A proficiency test that is prepared in the laboratory
being tested.
- External-A proficiency test that is prepared by an external
agency.
Quality
assurance includes monitoring activities that are intended
to verify whether practices and test results are providing reliable
information.
Quality control includes laboratory activities intended
to verify whether analytical procedures are performed appropriately
to yield reproducible results (e.g., blind samples, negative and
positive controls).
The quality manager is the person designated by top management
who, irrespective of other responsibilities, has the defined authority
and obligation to ensure that the requirements of the quality system
are implemented and maintained.
A quality manual is a document stating the quality policy,
quality system, and quality practices of an organization.
Quality system is the organizational structure, responsibilities,
procedures, processes, and resources for implementing quality.
A qualifying test measures proficiency in technical skills
and knowledge and is administered prior to a person assuming independent
work responsibility. It may also be referred to as a competency
test.
Reagent is a substance used in an analytical procedure
because of its chemical, biological, or physical properties.
Reference material (certified or standard) is a material
for which identities, types, or values are certified by technically
valid procedures and is accompanied by or traceable to, a certificate
or other documentation that is issued by a certifying body.
A sample is the subject of an analytical procedure (e.g.,
evidence).
Secondary evidence is an evidentiary item separated by
a physical or chemical means from the original piece of evidence
(e.g., powder residue on clothing).
A secure area is a locked space (e.g., cabinet, vault,
room) with access restricted to authorized personnel.
Subcontractor is a person or entity having a transactional
relationship with a laboratory.
Technical manager (or equivalent position or title as designated
by the laboratory director) is the person who is accountable for
the technical operations of the laboratory.
Technical review is an evaluation of reports, notes, data,
and other documents to ensure an appropriate and sufficient basis
exists for the reported scientific conclusions. A technically qualified
person other than the person who prepared the reports, notes, data,
and other documents under review conducts this review.
Technician (or equivalent role, position, or title as designated
by the laboratory director) is a person who performs analytical
techniques on evidentiary items under the supervision of a qualified
examiner or analyst.
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.
Uncertainty is the amount of variance in a stated measurement
or result.
Validation is a process by which a procedure is evaluated
to determine its efficacy and reliability for analysis.
3.
Quality Assurance Program
3.1 The laboratory should establish and maintain a documented quality
system that is appropriate to the testing activities.
3.1.1 The quality system should address at a minimum the following:
3.2 The laboratory should identify a person as the quality manager.
4. Organization and Management
4.1 A laboratory should have the following:
- A managerial staff with the authority and resources needed
to discharge their duties and meet the criteria of the guidelines
in this document.
- A technical manager.
- Documentation specifying the responsibilities, authority,
and interrelationships of all personnel who manage, perform,
or verify work affecting the validity of forensic chemical analysis.
- A statement of the goals and objectives of the laboratory's
quality system.
5. Technical Personnel and Training
5.1 Laboratory personnel should have the education, training, and
experience necessary to perform examinations and provide testimony.
The laboratory should have the following:
5.1.1 Written job description(s) for personnel that includes responsibilities,
duties, and skills.
5.1.2 A documented training program for assuring the competence
of all technical laboratory personnel.
5.1.3 Records maintained on the relevant qualifications, training,
skills, and experience of the technical personnel.
5.1.4 Records maintained of security clearances, when appropriate,
for laboratory personnel when evidence/information must be secure
and protected.
5.2 The technical manager is the designated person who is responsible
for the technical operations of the laboratory. This person is responsible
for the following:
5.2.1 Evaluating and approving all analytical procedures used
by the laboratory.
5.2.2 Technical problem solving of analytical procedures and the
oversight of training, quality assurance, safety, and proficiency
testing in the laboratory.
5.2.3 Suspending laboratory operations, when appropriate.
5.3 Examiner or Analyst.
5.3.1 An examiner or analyst is responsible for the content of
a laboratory report released under his/her name and provides expert
courtroom testimony, if required.
5.3.2 An examiner or analyst should have successfully completed
a documented training program and qualifying test before assuming
independent forensic casework responsibilities. The training program
should include an understanding of forensic operations.
5.4 Technician.
5.4.1 A technician should have on-the-job training specific to
the job function(s).
5.4.2 A technician should have successfully completed a qualifying
test before participating in forensic casework responsibilities.
6. Facilities and Security
6.1 The laboratory should have a facility designed to provide appropriate
levels of security, safety, and contamination control. Laboratory
management should ensure the following:
6.1.1 Access to the laboratory is controlled and limited.
6.1.2 Evidence is appropriately secured and stored when not under
examination.
6.1.3 The laboratory follows written procedures for monitoring
equipment and instrumentation for cross contamination.
6.1.4 Appropriate protocols and records should be maintained when
regulatory requirements apply for sample receipt, storage, containment,
and protection.
6.2 A laboratory should document waste-management requirements to
ensure that appropriate decontamination and disposal measures are
in place and that compliance with relevant laws is being accomplished.
6.3 A laboratory should consider appropriate measures to address
the following:
6.3.1 Backup-power sources for power outages to protect evidence
and equipment.
6.3.2 Computer security for case-documentation records.
7. Evidence Control
7.1 The laboratory should have and follow a documented evidence
control system. This system should ensure the following:
7.1.1 Items are marked with unique identifiers.
7.1.2 Documentation of evidence identity, receipt, storage, and
disposition is maintained.
7.1.3 The laboratory follows documented procedures that minimize
loss, contamination, and/or deleterious change to evidence.
7.1.4 The laboratory has secure areas for evidence storage including
environmental control(s) consistent with the form or nature of
the item.
7.2 The laboratory should have available guidelines for sample collection.
7.3 Laboratories should request the following information from the
submitter of samples, when possible:
7.3.1 Sample collected from a location.
- Type of sample.
- Environmental conditions.
- Sampling tool or technique.
- Date and time collected.
- Who collected sample.
- Sampling location.
- Screening tests and the results of the screening.
7.3.2 Physiological sample collected from a person.
- Name or identifier.
- Type of sample.
- Age.
- Gender.
- Population affinity.
- Weight.
- Body temperature.
- Current medications.
- Symptomatology.
- Who collected sample.
7.4 The laboratory should maintain a chain of custody for evidence
from the time of receipt in the laboratory. Individual items should
be tracked. Time and date of transfers should be documented. Secondary
evidence should be tracked.
7.5 When the laboratory completely consumes tested samples, that
fact should be recorded in the examination documentation.
7.6 A laboratory should document and provide appropriate guidelines
for sample submission, packaging, and return. Items should be shipped
in accordance with federal requirements.
7.7 A laboratory should document a policy for long-term sample storage,
retention, disposal, and/or return.
8. Validation
8.1 Documented validation studies for forensic analytical procedures
being performed by laboratory personnel should be available. SWGFACT
will publish a validation guidance document.
9. Analytical Procedures
9.1 The laboratory should have and follow current written analytical
procedures approved by the technical manager.
9.1.1 The procedures should, when applicable, include or reference
a list of equipment and reagents, step-by-step instructions, quality
controls, test calculations, limitations, interpretation criteria,
measurement uncertainty, and literature references. Procedures
for measuring uncertainty should be included.
9.1.2 The laboratory should have a written policy whereby a deviation
from an analytical procedure is documented and approved.
9.1.3 The laboratory should have a documented approach for testing
general unknowns.
9.2 The laboratory should use reagents including commercial supplies
that are suitable for the analytical procedures employed and should
maintain documentation verifying suitability. Reagent containers
should be labeled with the identity of the reagent, the date of
preparation and expiration, the identity of the person preparing
the reagent, and relevant storage instructions.
10. Equipment Calibrations and Maintenance
10.1 The laboratory should use equipment suitable for the analytical
procedures employed.
10.2 The laboratory should have an inventory of its equipment and
should have a documented program for calibration of instruments
and equipment.
10.2.1 When available and appropriate, reference standards traceable
to national or international standards should be used for calibration.
When traceability to national standards of measurement is not
applicable, the laboratory should provide satisfactory evidence
of the quality of the reference standard.
10.2.2 The frequency of the calibration should be documented for
each instrument requiring calibration. Calibration documentation
should be retained in accordance with laboratory policy.
10.3 The laboratory should 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, should be calibrated
or validated before use.
10.3.2 Written records or logs should be maintained for maintenance
service performed on instruments and equipment. Such documentation
should be retained in accordance with laboratory policy.
10.3.3 Commercial instrument software may be considered validated.
If the laboratory modifies the software, it should demonstrate
the software has been validated. Internally developed software
should be validated.
11. Reports and Supporting Documentation
11.1 The laboratory should have and follow written procedures for
generating and maintaining documentation for tested samples.
11.1.1 The laboratory should have written procedures for the release
of laboratory reports and examination results.
11.1.2 A laboratory report should include the following:
- Name of submitting agency.
- Date the sample(s) was received in the laboratory.
- Brief description of all examined evidence, including the
indicated source of the sample, when available (e.g., lungs,
water source, debris).
- Statement to address the specific request made of the laboratory.
- General description of analytical procedure(s) used.
- Analytical results and interpretive statement to provide
clarity of result.
- Statement of recommended additional testing, when appropriate.
- Laboratory location (city, state).
- Identity of the person responsible for the technical conclusions
of the laboratory report.
- Identification of all components of the analysis completed
using subcontractors.
11.2 The laboratory should maintain, at a minimum, the following
examination-related information:
- Analyst- and technician-generated notes including the identity
of the person generating the notes.
- List of instrumentation used (by specific identifier, when
available).
- All charts, graphs, photographs, and other examination-related
records.
- Chain of custody.
- Description of evidence.
- Date of analysis.
- Any deviations from analytical procedures.
- Statement regarding any consumption or disposition of evidence.
- The identity of the people performing technical and administrative
reviews of the report.
- Case communication documentation.
12. Review of Reports
12.1 The laboratory should have and follow written procedures for
technically reviewing all examination documentation. All reports
should be administratively reviewed.
12.2 The laboratory should have a documented mechanism in place
to address conflicting interpretations or conclusions between analysts
and reviewer(s) and a mechanism to address unresolved conclusions
or interpretations.
12.3 The laboratory should have a practice in place to review and
address reports of noncompliance (e.g. findings resulting from audit
reports, contamination logs, controls not functioning properly).
13. Proficiency Testing
13.1 Examiners and other personnel designated by the technical manager
who are actively engaged in forensic analysis should undergo annual
proficiency testing. The test samples should be processed and analyzed
in the same manner as casework. Successful completion of annual
proficiency testing should be required to continue casework. Quality
control samples should not be considered proficiency tests.
13.1.1 The laboratory should maintain the following proficiency
test documentation:
- Source of test (internal or external).
- Test set identifier.
- Identity of the test participant(s).
- Distribution date and due date.
- Date of analysis and completion.
- All data and notes supporting the conclusions.
- Proficiency test results.
- Any discrepancies noted.
- Corrective actions taken.
- Retention, if possible, of a portion of each proficiency
test for reanalysis and comparison, if circumstances dictate.
13.1.2 Records for each person tested should be maintained, including
all notes, records, reports, and evaluations.
13.2 The following proficiency test information should be documented
for tests prepared in the laboratory:
- Identity of person(s) who prepared the test samples.
- Date test samples were prepared.
- Test identifier.
- Sufficient information to duplicate test preparation.
- Expected results, including criteria for acceptable limits
(if appropriate).
13.3 A laboratory may choose to employ a revolving matrix (food/water/air)
in order to encompass the possible areas for which casework may
be performed.
14. Corrective Action
14.1 The laboratory should establish and follow procedures for corrective
action when analytical errors and/or proficiency testing discrepancies
are detected. The laboratory should maintain documentation for the
corrective action and monitor its effectiveness. The documentation
should be retained in accordance with laboratory policy.
15. Audits
15.1 The laboratory should conduct audits annually in accordance
with the guidelines outlined herein.
15.1.1 Audit procedures should address at a minimum the following:
- Goals and objectives.
- Organization and management.
- Technical personnel and training.
- Facilities and security.
- Evidence control.
- Validation.
- Analytical procedures.
- Equipment calibration and maintenance.
- Proficiency testing.
- Corrective action.
- Reports and supporting documentation.
- Review of reports.
- Audits.
- Safety.
- Previous audits.
The laboratory should retain all documentation pertaining to audits
in accordance with laboratory policy.
15.2 When a laboratory uses a subcontractor, documented audits of
the subcontractor should be submitted to the laboratory for retention.
15.3 Laboratories are encouraged to have external agencies perform
the audits.
16. Safety
16.1 The laboratory should have and follow a documented environmental
health and safety program. This program should include a documented
on-going safety-training program for laboratory personnel and should
be in accordance with federal and state laws.
16.2 The laboratory should identify a person as the safety officer
and ensure he/she has or receives appropriate training.
17. Subcontracting
17.1 The laboratory should notify and gain the approval from the
submitting agency of any use of subcontracting laboratories.
17.2 A laboratory operating under the scope of these guidelines
should require certification of compliance with those portions of
these guidelines appropriate to the analysis when a subcontractor
performs analyses for the laboratory and may choose to require documentation
of this before submitting samples for analysis.
17.2.1 The laboratory should establish and use appropriate review
procedures based on the type of work being provided by the subcontracting
laboratory. This is to verify the integrity of the data received
from the subcontractor. The review should include but is not limited
to the following:
- Inspection and evaluation of all results and/or data.
- Inclusion of quality control samples.
- Annual on-site visits.
17.3 The contracting laboratory should define a policy for notification
of applicable technical personnel changes by the subcontracting
laboratory.
Contributors
The following
SWGFACT members contributed to this document:
Marc A. LeBeau
Anja R. Einseln
Dean D. Fetterolf
Federal Bureau of Investigation
Laboratory
Quantico, Virginia
Armando Alcaraz
Lawrence Livermore National Laboratory
Forensic Science Center
Livermore, California
Shauna Darby
Battelle
Arlington, Virginia
Mary Drummond
Research, Development and Engineering Command
Forensic Analytical Center
Aberdeen Proving Ground, Maryland
Martin Harper
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
Health Effects Laboratory Division
Morgantown, West Virginia
Charles Hooper
U.S. Environmental Protection Agency
Athens, Georgia
Eugene Kennedy
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
Chemical Exposure and Monitoring Branch
Cincinnati, Ohio |
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Mathew Magnuson
U.S. Environmental Protection Agency
National Risk Management Research Laboratory
Cincinnati, Ohio
Madeline A. Montgomery
Federal Bureau of Investigation
Laboratory
Quantico, Virginia
Eric Nottingham
U.S. Environmental Protection Agency
National Enforcement Investigations Center
Denver, Colorado
James Peterson
Batelle
Aberdeen Proving Ground, Maryland
Charles F. Quenzer
Federal Bureau of Investigation
Laboratory
Quantico, Virginia
R. Duane Satzger
U.S. Food and Drug Administration
Forensic Chemistry Center
Cincinnati, Ohio
James Seidel
U.S. Environmental Protection Agency
Office of Criminal Enforcement
Forensics and Training
Denver, Colorado
Karen Wolnik
U.S. Food and Drug Administration
Forensic Chemistry Center
Cincinnati, Ohio |
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