ASTM E2327-04

Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis

SIGNIFICANCE AND USE
These are minimum standards of quality assurance applicable to laboratories where analysis of seized-drug submissions is performed.
The standards are to be practiced by forensic analysts performing seized-drug analysis and promoted/supported by laboratory management.
SCOPE
1.1 This standard covers quality assurance issues in forensic laboratories performing seized-drug analysis including evidence handling, analytical procedures, report writing, method validation, documentation, proficiency testing, audits, and health and safety.
1.2 Standards are meant to apply only to the practice of qualitative seized-drug analysis.

General Information

• Status: Historical
• Publication Date: 30-Sep-2004
• ICS: 71.040.01 - Analytical chemistry in general
• Technical Committee: E30 - Forensic Sciences
• Drafting Committee: E30.01 - Criminalistics

Relations

• Replaced By: ASTM E2327-10 - Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis
• Effective Date: 15-Dec-2010
• Referred By: ASTM E2882-19 - Standard Guide for Analysis of Clandestine Drug Laboratory Evidence
• Effective Date: 01-Oct-2004
• Referred By: ASTM E2329-17 - Standard Practice for Identification of Seized Drugs
• Effective Date: 01-Oct-2004

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E2327–04
Standard Practice for
Quality Assurance of Laboratories Performing Seized-Drug
Analysis
This standard is issued under the fixed designation E2327; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope framework of quality in the processing of drug evidence,
including evidence handling, management practices, qualita-
1.1 This standard covers quality assurance issues in forensic
tive analysis, and reporting. A documented quality manage-
laboratories performing seized-drug analysis including evi-
ment system must be established and maintained. Personnel
dence handling, analytical procedures, report writing, method
responsible for this must be clearly designated and have direct
validation, documentation, proficiency testing, audits, and
access to the highest level of management concerning labora-
health and safety.
tory policy.
1.2 Standards are meant to apply only to the practice of
5.2 The quality management system must cover all proce-
qualitative seized-drug analysis.
dures and reports associated with drug analysis.
2. Referenced Documents
6. Personnel
2.1 ASTM Standards:
6.1 Job Description—Job descriptions for all personnel
E2328 Terminology Relating to Seized-Drug Analysis
should include responsibilities, duties and required skills.
2.2 Other Document:
6.2 Designated Personnel and Responsibilities—An indi-
Scientific Working Group for the Analysis of Seized Drugs
vidual (however titled) may be responsible for more than one
Recommendations for: Education and Training, Quality
of the following duties:
Assurance, Methods of Analysis
6.2.1 Quality Assurance Manager—A designated person
3. Terminology
who is responsible for maintaining the quality management
system (including an annual review of the program) and who
3.1 Terms that may assist in interpreting this standard are
monitors compliance with the program.
found in Terminology E2328.
6.2.2 Health and Safety Manager—A designated person
4. Significance and Use
who is responsible for maintaining the Laboratory Health and
Safety program (including an annual review of the program)
4.1 These are minimum standards of quality assurance
and who monitors compliance with the program.
applicable to laboratories where analysis of seized-drug sub-
6.2.3 Personnel Technical Support—A person who per-
missions is performed.
forms basic laboratory duties, but does not analyze evidence.
4.2 The standards are to be practiced by forensic analysts
6.2.4 Technician/Assistant Analyst—Aperson who analyzes
performing seized-drug analysis and promoted/supported by
evidence, but does not issue reports for court purposes.
laboratory management.
6.2.5 Analyst—A designated person who:
5. Quality Management System
6.2.5.1 Examines and analyzes seized drugs or related
materials, or directs such examinations to be done,
5.1 It is the goal of a laboratory’s drug analysis program to
6.2.5.2 Independently has access to unsealed evidence in
providecustomersofthelaboratory’sservicesaccesstoquality
order to remove samples from the evidence for examination,
drug analysis. It is the goal of this standard to provide a
and
6.2.5.3 As a consequence of such examinations, signs re-
This practice is under the jurisdiction of ASTM Committee E30 on Forensic
ports for court or other purposes.
Sciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.
6.2.6 Supervisory Analyst—A designated person who has
Current edition approved Oct. 1, 2004. Published January 2005. DOI: 10.1520/
E2327-04. the overall responsibility and authority for the technical opera-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
tionsofthedruganalysissection.Technicaloperationsinclude,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
but are not limited to protocols, analytical methodology, and
Standards volume information, refer to the standard’s Document Summary page on
technical review of reports.
the ASTM website.
Withdrawn. The last approved version of this historical standard is referenced
on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2327–04
6.3 Qualifications/Education: 7.1.2 Laboratories must meet required health and safety
6.3.1 Technical Support Personnel will: building codes.
6.3.1.1 Have education, skills and abilities commensurate
7.1.3 Laboratories must contain adequate space to perform
with their responsibilities, and
required analytical functions and prevent contamination.
6.3.1.2 Have on-the-job training specific to their position.
7.1.4 Chemicalfumehoodsmustbeprovided.Theymustbe
6.3.2 Technicians/Assistant Analysts will:
properly maintained and monitored according to an established
6.3.2.1 Have education, skills and abilities commensurate
schedule.
with their responsibilities, and
7.1.5 A laboratory-cleaning schedule should be established
6.3.2.2 Have on-the-job training specific to their position.
and implemented.
6.3.3 Analysts will:
7.1.6 Adequate facilities must be provided to ensure the
6.3.3.1 Have a minimum of a bachelor’s degree or equiva-
proper safekeeping of physical evidence, standards and
lent in a natural science or applied science, including crimi-
records.
nalistics or forensic science, which shall include lecture and
7.1.7 Appropriately secured storage must be provided to
associated laboratory classes in general, organic, and analytical
prevent contamination of chemicals and reagents.
chemistry, or
6.3.3.2 By January 1, 2005, have a minimum of five (5)
8. Evidence Control
years practical experience in the area of seized-drug analysis,
8.1 Laboratories shall have and follow a documented evi-
and have demonstrated competency following the completion
dence control system to ensure the integrity of physical
of a formal, documented training program and post training
evidence.
competency assessment.
8.2 Receiving and Identifying Evidence—Laboratories must
6.3.4 Supervisory Analysts will:
maintain records of requests for analysis and of the respective
6.3.4.1 Meet all the requirements of analyst (6.3.3),
items of evidence.Aunique identifier must be assigned to each
6.3.4.2 Have a minimum of two (2) years of experience as
case file or record.This file or record must include, at least, the
an analyst in the forensic analysis of drug evidence, and
following:
6.3.4.3 Exhibit knowledge necessary to evaluate analytical
results and conclusions. 8.2.1 Submission documents or copies,
6.4 Training for New Analysts—The laboratory must estab- 8.2.2 Identity of party requesting analysis and date of
lishanddocumentatrainingprogramandqualifyingprocedure
request,
for all new technical personnel. A documented training pro-
8.2.3 Description of items of evidence submitted for analy-
gram, approved by laboratory management, should focus on
sis,
the development of the theoretical and practical knowledge,
8.2.3.1 Any significant irregularities identified, during a
skills and abilities necessary to examine seized-drug samples
comparison of evidence described in accompanying paperwork
and related materials. It must include:
and examination prior to analysis, must be documented and
6.4.1 A training syllabus providing descriptions of the
included in case file or record.
knowledge and skills in which analysts are to be trained for
8.2.4 Unique case identifier,
specifictopicareas,milestonesofachievement,andmethodsof
8.2.5 Chain of custody record, and
testing or evaluating competency,
8.2.6 Identity of person who actually submits evidence,
6.4.2 Documented standards of performance and a plan for
along with date of submission. For evidence not delivered in
assessing theoretical and practical competency against these
person,descriptiveinformationregardingmodeofdeliveryand
standards; for example, written and oral examinations, critical
tracking information must be included.
reviews, analysis of unknown samples, mock casework, etc.
8.3 Integrity of Evidence—Evidence must be properly se-
per specific topic area,
cured and sealed. Appropriate storage conditions shall ensure
6.4.3 A period of documented, supervised casework repre-
that, insofar as possible, the composition of seized material is
sentative of the type they will be required to perform, and
not altered. All items must be safeguarded against loss or
6.4.4 A verification document demonstrating that trainees
contamination. Any alteration of the evidence (for example,
have achieved the required competence level per specific topic
repackaging) must be documented. Procedures should be
area.
implemented to assure that samples are properly labeled
6.5 Maintaining Qualifications:
throughout the analytical process.
6.5.1 Minimum annual training required for continuing
8.4 Storage of Evidence—Access to the evidence storage
professional development of laboratory analysts is twenty (20)
area must be controlled, it being granted only to authorized
contact hours.
personnel.Asystemshallbeestablishedtodocumentachainof
6.5.1.1 Training must be relevant to the laboratory’s ana-
custody for evidence in laboratory custody.
lytical mission.
8.5 Disposition of Evidence—Records must be kept regard-
6.5.1.2 Training completed must be documented.
ing the disposition of all items of evidence.
7. Physical Plant
8.6 Security of Analytical Documentation Associated with
7.1 Physical Plant Requirements: Evidence—All laboratory records such as analytical results,
7.1.1 Laboratories shall provide adequate safety and secu- measurements, notes, calibrations, chromatograms, spectra and
rity for personnel and operations. reports shall be retained in a secure fashion.
E2327–04
9. Analytical Procedures 11.3 The efficacy of all test reagents must be checked prior
to their use in casework. Results of these tests should be
9.1 Analytical Procedures for Drug Analysis:
documented.
9.1.1 Laboratories shall have and follow documented ana-
11.4 Chemical and reagent containers should be dated and
lytical procedures.
initialed when received and when first opened.
9.1.2 Laboratories shall have in place protocols for the
sampling of evidence.
12. Casework Documentation, Report Writing and
9.1.3 Work practices shall be established to prevent con-
Review
tamination of evidence during analysis.
12.1 Casework Documentation:
9.
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