ASTM E2327-2015 Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis《执行没收药品分析的实验室质量保证的标准实施规程》.pdf

1、Designation: E2327 10E2327 15Standard Practice forQuality Assurance of Laboratories Performing Seized-DrugAnalysis1This standard is issued under the fixed designation E2327; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year

2、of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice covers quality assurance issues in forensic laboratories performing seized-drug analysis including ev

3、idencehandling, analytical procedures, report writing, method validation, documentation, proficiency testing, audits, and health andsafety.1.2 This practice is meant to apply only to qualitative seized-drug analysis.1.3 This practice does not replace knowledge, skill, ability, experience, education,

4、 or training and should be used in conjunctionwith professional judgment.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety and health practices and determine

5、the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E620 Practice for Reporting Opinions of Scientific or Technical ExpertsE2328E1732 Terminology Relating to Seized-Drug AnalysisForensic Science (Withdrawn 2005)E1459 Guide for Physical Evidence Labeling

6、 and Related DocumentationE1492 Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science LaboratoryE2326 Practice for Education and Training of Seized-Drug AnalystsE2329 Practice for Identification of Seized DrugsE2548 Guide for Sampling Seized Drugs for Qualitativ

7、e and Quantitative AnalysisE2549 Practice for Validation of Seized-Drug Analytical MethodsE2764 Practice for Uncertainty Assessment in the Context of Seized-Drug Analysis2.2 Other Document:Documents:ISO Guide 34 General Requirements for the Competence of Reference Material Producers3ISO/IEC 17025 Ge

8、neral Requirements for the Competence of Testing and Calibration Laboratories3Scientific Working Group for the Analysis of Seized Drugs for the Analysis of Seized Drugs Recommendations for: Educationand Training, Quality Assurance, Methods of Analysis43. Terminology3.1 Terms that may assist in inter

9、preting this standard are found in Terminology E2328E1732.4. Significance and Use4.1 These are minimum standards of quality assurance applicable to laboratories where analysis of seized-drug submissions isperformed.1 This practice is under the jurisdiction of ASTM Committee E30 on Forensic Sciences

10、and is the direct responsibility of Subcommittee E30.01 on Criminalistics.Current edition approved Dec. 15, 2010May 1, 2015. Published January 2010June 2015. Originally approved in 2004. Last previous edition approved in 20042010 asE2327 04.E2327 10. DOI: 10.1520/E2327-10.10.1520/E2327-15.2 For refe

11、rencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3 The last approved version of this historical standard is referenced o

12、n www.astm.org.Available from International Organization for Standardization (ISO), ISO CentralSecretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland, http:/www.iso.org.4 Available from Scientific Working Group for the Analysis of Seized Drugs, http:/www.swgdrug.org.

13、This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior edi

14、tions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.2 This practice is to be used by forensic anal

15、ysts performing seized-drug analysis and promoted/supported by laboratorymanagement.5. Quality Management System5.1 It is the goal of a laboratorys drug analysis program to provide customers of the laboratorys services access to quality druganalysis. It is the goal of this standard to provide a fram

16、ework of quality in the processing of drug evidence, including evidencehandling, management practices, qualitative and quantitative analysis, and reporting. A documented quality management systemshall be established and maintained. Personnel responsible for this shall be clearly designated and have

17、direct access to the highestlevel of management concerning laboratory policy.5.2 The quality management system shall cover all procedures and reports associated with drug analysis.6. Personnel6.1 Job DescriptionJob descriptions for all personnel should include responsibilities, duties, and required

18、skills.6.2 Designated Personnel and ResponsibilitiesAn individual (however titled) may be responsible for more than one of thefollowing duties:6.2.1 Quality Assurance ManagerA designated person who is responsible for maintaining the quality management system(including an annual review of the program

19、) and who monitors compliance with the program.6.2.2 Health and Safety ManagerA designated person who is responsible for maintaining the Laboratory Health and Safetyprogram (including an annual review of the program) and who monitors compliance with the program.6.2.3 Personnel Technical SupportSuppo

20、rt PersonnelA person who performs basic laboratory duties, but does not analyzeevidence.6.2.4 Technician/Assistant AnalystA person who analyzes evidence, but does not issue reports for court purposes.6.2.5 AnalystA designated person who:6.2.5.1 Examines and analyzes seized drugs or related materials

21、, or directs such examinations to be done;6.2.5.2 Independently has access to unsealed evidence in order to remove samples from the evidence for examination; and6.2.5.3 As a consequence of such examinations, signs reports for court or other purposes.6.2.6 Supervisory AnalystAdesignated person who ha

22、s the overall responsibility and authority for the technical operations ofthe drug analysis section. Technical operations include, but are not limited to, protocols, analytical methodology, and technicalreview of reports.6.3 Qualifications/Education:6.3.1 Technical Support Personnel shall:6.3.1.1 Ha

23、ve education, skills, and abilities commensurate with their responsibilities; and6.3.1.2 Have on-the-job training specific to their position.6.3.2 Technicians/Assistant Analysts shall:6.3.2.1 Have education, skills, and abilities commensurate with their responsibilities; and6.3.2.2 Have on-the-job t

24、raining specific to their position.6.3.3 All new analystsAnalysts shall have at least a baccalaureatebachelors degree or equivalent (generally(generally, a threeto four year post-secondary degree) in a natural/physical science. Coursework shall include The individual shall have successfullycompleted

25、 lecture and associated laboratory classes in general, organic, and analytical chemistry.chemistry (see Practice E2326).6.3.4 New Supervisory Analysts shall:6.3.4.1 Meet all the requirements of analyst (6.3.3),6.3.4.2 Have a minimum of two (2) years of experience as an analyst in the forensic analys

26、is of drug evidence, and6.3.4.3 Exhibit knowledge necessary to evaluate analytical results and conclusions.6.4 Training for New AnalystsThe laboratory shall establish and document a training program and qualifying procedure forall new technical personnel. A documentedpersonnel (see Practice E2326tra

27、ining program, approved by laboratory management,should focus on the development of the theoretical and practical knowledge, skills and abilities necessary to examine seized-drugsamples and related materials. It shall include:).6.4.1 Atraining syllabus providing descriptions of the knowledge and ski

28、lls in which analysts are to be trained for specific topicareas, milestones of achievement, and methods of testing or evaluating competency;6.4.2 Documented standards of performance and a plan for assessing theoretical and practical competency against thesestandards, for example, written and oral ex

29、aminations, critical reviews, analysis of unknown samples, mock casework, etc. perspecific topic area;6.4.3 A period of documented, supervised casework representative of the type they shall be required to perform; and6.4.4 A verification document demonstrating that trainees have achieved the require

30、d competence level per specific topic area.6.5 Maintaining Qualifications: Qualifications6.5.1 Minimum annual training required for continuing professional development of laboratory analysts is twenty (20) hours.E2327 1526.5.1.1 Training shall be relevant to the laboratorys analytical mission. Profe

31、ssional development may include training relatedto ancillary duty assignments and supervision/management responsibilities.6.5.1.2 Training completed shall be documented.6.5.1.3 Training can be face-to-face interaction with an instructor, distance learning, self-directed, or computer-based.Allforensi

32、c scientists have an ongoing responsibility to remain current in their field (see Practice E2326).7. Physical Plant7.1 Physical Plant Requirements:7.1.1 Laboratories shall provide adequate safety and security for personnel and operations.7.1.2 Laboratories shall meet required health and safety build

33、ing codes.7.1.3 Laboratories shall contain adequate space to perform required analytical functions and prevent contamination.7.1.4 Chemical fume hoods shall be provided. They shall be properly maintained and monitored according to an establishedschedule.7.1.5 A laboratory-cleaning schedule should be

34、 established and implemented.7.1.6 Adequate facilities shall be provided to ensure the proper safekeeping of physical evidence, standards and records.7.1.7 Appropriately secured storage shall be provided to prevent contamination of chemicals and reagents.8. Evidence Control8.1 Laboratories shall hav

35、e and follow a documented evidence control system to ensure the integrity of physical evidence.8.2 Receiving and Identifying EvidenceLaboratories shall maintain records of requests for analysis and of the respective itemsof evidence.Auniqueevidence (see Practice E1492identifier shall be assigned to

36、each case file or record. ). This file or record shallinclude, at least, the following:8.2.1 Submission documents or copies,8.2.2 Identity of party requesting analysis and date of request,8.2.3 Description of items of evidence submitted for analysis,8.2.3.1 Any significant irregularities identified,

37、 during a comparison of evidence described in accompanying paperwork andexamination prior to analysis, shall be documented and included in case file or record.8.2.4 Unique case identifier,8.2.5 Chain of custody record, and8.2.6 Identity of person who actually submits evidence, along with date of sub

38、mission. For evidence not delivered in person,descriptive information regarding mode of delivery and tracking information shall be included.8.3 Integrity of EvidenceEvidence shall be properly secured and sealed. Appropriate storage conditions shall ensure that,insofar as possible, the composition of

39、 seized material is not altered. All items shall be safeguarded against loss or contamination.Any alteration of the evidence (for example, repackaging) shall be documented. Procedures shall be implemented to assure thatsamples are properly labeled throughout the analytical process.process (see Guide

40、 E1459).8.4 Storage of EvidenceAccess to the evidence storage area shall be controlled, it being granted only to authorized personnel.A system shall be established to document a chain of custody for evidence in laboratory custody.8.5 Disposition of EvidenceRecords shall be kept regarding the disposi

41、tion of all items of evidence.8.6 Security of Analytical Documentation Associated with EvidenceAll laboratory records such as analytical results,measurements, notes, calibrations, chromatograms, spectra, and reports shall be retained in a secure fashion.9. Analytical Procedures9.1 Analytical Procedu

42、res for Drug Analysis:9.1.1 Laboratories shall have and follow documented analytical procedures.9.1.2 Laboratories shall have in place protocols for the sampling of evidence.evidence (see Practice E2548).9.1.3 Work practices shall be established to prevent contamination of evidence during analysis.9

43、.1.4 Laboratories shall have and follow documented guidelines for the acceptance and interpretation of data.9.1.5 Laboratories shall monitor analytical processes using appropriate blanks, controls and traceable standards.referencematerials.9.1.6 Laboratories shall have and follow documented guidelin

44、es for the acceptance and interpretation of data. Referencematerials and reference data are critical to demonstrating the validity of quantitative and qualitative test results. A positive testresult shall meet the acceptance criteria defined in the method validation and operating protocol. In descen

45、ding order of preference,the acceptance criteria should be based on:9.1.6.1 Comparison to data obtained from a suitable drug reference material analyzed under the same analytical conditions asthe test/case sample. The reference material may be analyzed:(1) Contemporaneously with test/case sample;E23

46、27 153(2) As part of routine quality control (for example, daily check solutions); or(3) At a previous date (for example, method validation, in-house library).9.1.6.2 Comparisons to external reference data may be used where a reference material is unavailable. External reference datashall be shown t

47、o be fit for purpose. The veracity of the data shall be considered and assessed. Factors include:(1) Origin of the data,(2) Validation of the data,(3) Peer review of the data, and(4) Comparability of analytical conditions.The use of external reference data rather than a reference material shall be d

48、ocumented and where applicable the limitationexpressed within the report.9.1.6.3 When neither reference materials nor external reference data are available, structural elucidation techniques may beemployed providing the analyst has the appropriate skills for their interpretation. Such interpretation

49、s shall be made only byanalysts competent in structural elucidation interpretation. The absence of a reference material and external data shall bedocumented and the impact on the interpretation of reported results assessed.9.1.7 Analytical procedures shall be validated in compliance with SectionPractice 14E2549.9.1.8 Analysts shall take measures to be assured that identifications are correct and relate to the right submission. Thisissubmission (see Practice E2329best established by the use of at least two appropriate techniques based on different principl