ASTM E2327-2015e1 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 151Standard 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 of last

2、 revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTE9.2.7.1 was corrected editorially in December 2015.1. Scope1.1 This practice covers quality assurance issues in forensiclaborator

3、ies performing seized-drug analysis including evi-dence handling, analytical procedures, report writing, methodvalidation, documentation, proficiency testing, audits, andhealth and safety.1.2 This practice is meant to apply only to qualitativeseized-drug analysis.1.3 This practice does not replace k

4、nowledge, skill, ability,experience, education, or training and should be used inconjunction with professional judgment.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-pr

5、iate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E620 Practice for Reporting Opinions of Scientific or Tech-nical ExpertsE1732 Terminology Relating to Forensic ScienceE1459 Guide for Physical Evidence

6、Labeling and RelatedDocumentationE1492 Practice for Receiving, Documenting, Storing, andRetrieving Evidence in a Forensic Science LaboratoryE2326 Practice for Education and Training of Seized-DrugAnalystsE2329 Practice for Identification of Seized DrugsE2548 Guide for Sampling Seized Drugs for Quali

7、tative andQuantitative AnalysisE2549 Practice for Validation of Seized-Drug AnalyticalMethodsE2764 Practice for UncertaintyAssessment in the Context ofSeized-Drug Analysis2.2 Other Documents:ISO Guide 34 General Requirements for the Competence ofReference Material Producers3ISO/IEC 17025 General Req

8、uirements for the Competenceof Testing and Calibration Laboratories3Scientific Working Group for the Analysis of SeizedDrugs Recommendations for: Education and Training,Quality Assurance, Methods of Analysis43. Terminology3.1 Terms that may assist in interpreting this standard arefound in Terminolog

9、y E1732.4. Significance and Use4.1 These are minimum standards of quality assuranceapplicable to laboratories where analysis of seized-drug sub-missions is performed.4.2 This practice is to be used by forensic analysts perform-ing seized-drug analysis and promoted/supported by laboratorymanagement.5

10、. Quality Management System5.1 It is the goal of a laboratorys drug analysis program toprovide customers of the laboratorys services access to qualitydrug analysis. It is the goal of this standard to provide aframework of quality in the processing of drug evidence,including evidence handling, manage

11、ment practices, qualita-tive and quantitative analysis, and reporting. A documentedquality management system shall be established and main-tained. Personnel responsible for this shall be clearly desig-nated and have direct access to the highest level of manage-ment concerning laboratory policy.1This

12、 practice is under the jurisdiction of ASTM Committee E30 on ForensicSciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.Current edition approved May 1, 2015. Published June 2015. Originallyapproved in 2004. Last previous edition approved in 2010 as E2327 10. DOI:10.15

13、20/E2327-15E012For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from International Organization for

14、Standardization (ISO), ISOCentral Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.4Available from Scientific Working Group for the Analysis of Seized Drugs,http:/www.swgdrug.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700

15、, West Conshohocken, PA 19428-2959. United States15.2 The quality management system shall cover all proce-dures and reports associated with drug analysis.6. Personnel6.1 Job DescriptionJob descriptions for all personnelshould include responsibilities, duties, and required skills.6.2 Designated Perso

16、nnel and ResponsibilitiesAn indi-vidual (however titled) may be responsible for more than oneof the following duties:6.2.1 Quality Assurance ManagerA designated personwho is responsible for maintaining the quality managementsystem (including an annual review of the program) and whomonitors complianc

17、e with the program.6.2.2 Health and Safety ManagerA designated personwho is responsible for maintaining the Laboratory Health andSafety program (including an annual review of the program)and who monitors compliance with the program.6.2.3 Technical Support PersonnelAperson who performsbasic laborator

18、y duties, but does not analyze evidence.6.2.4 Technician/Assistant AnalystA person who analyzesevidence, 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 relatedmaterials, or directs such examinations to be done;6.2.5.2

19、Independently has access to unsealed evidence inorder to remove samples from the evidence for examination;and6.2.5.3 As a consequence of such examinations, signs re-ports for court or other purposes.6.2.6 Supervisory AnalystA designated person who hasthe overall responsibility and authority for the

20、technical opera-tions of the drug analysis section. Technical operations include,but are not limited to, protocols, analytical methodology, andtechnical review of reports.6.3 Qualifications/Education:6.3.1 Technical Support Personnel shall:6.3.1.1 Have education, skills, and abilities commensuratewi

21、th 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 commensuratewith their responsibilities; and6.3.2.2 Have on-the-job training specific to their position.6.3.3 All new Ana

22、lysts shall have at least a bachelorsdegree or equivalent (generally, a three to four year post-secondary degree) in a natural/physical science. The individualshall have successfully completed lecture and associated labo-ratory classes in general, organic, and analytical chemistry (seePractice E2326

23、).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 asan analyst in the forensic analysis of drug evidence, and6.3.4.3 Exhibit knowledge necessary to evaluate analyticalresults and conclusions.6.4 Training

24、for New AnalystsThe laboratory shall estab-lish and document a training program and qualifying procedurefor all new technical personnel (see Practice E2326).6.5 Maintaining QualificationsAll forensic scientists havean ongoing responsibility to remain current in their field (seePractice E2326).7. Phy

25、sical Plant7.1 Physical Plant Requirements:7.1.1 Laboratories shall provide adequate safety and secu-rity for personnel and operations.7.1.2 Laboratories shall meet required health and safetybuilding codes.7.1.3 Laboratories shall contain adequate space to performrequired analytical functions and pr

26、event contamination.7.1.4 Chemical fume hoods shall be provided. They shall beproperly maintained and monitored according to an establishedschedule.7.1.5 A laboratory-cleaning schedule should be establishedand implemented.7.1.6 Adequate facilities shall be provided to ensure theproper safekeeping of

27、 physical evidence, standards and re-cords.7.1.7 Appropriately secured storage shall be provided toprevent contamination of chemicals and reagents.8. Evidence Control8.1 Laboratories shall have and follow a documented evi-dence control system to ensure the integrity of physicalevidence.8.2 Receiving

28、 and Identifying EvidenceLaboratories shallmaintain records of requests for analysis and of the respectiveitems of evidence (see Practice E1492). 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 ofrequ

29、est,8.2.3 Description of items of evidence submitted foranalysis,8.2.3.1 Any significant irregularities identified, during acomparison of evidence described in accompanying paperworkand examination prior to analysis, shall be documented andincluded in case file or record.8.2.4 Unique case identifier

30、,8.2.5 Chain of custody record, and8.2.6 Identity of person who actually submits evidence,along with date of submission. For evidence not delivered inperson, descriptive information regarding mode of delivery andtracking information shall be included.8.3 Integrity of EvidenceEvidence shall be proper

31、ly se-cured and sealed. Appropriate storage conditions shall ensurethat, insofar as possible, the composition of seized material isnot altered. All items shall be safeguarded against loss orcontamination. Any alteration of the evidence (for example,repackaging) shall be documented. Procedures shall

32、be imple-mented to assure that samples are properly labeled throughoutthe analytical process (see Guide E1459).E2327 15128.4 Storage of EvidenceAccess to the evidence storagearea shall be controlled, it being granted only to authorizedpersonnel.Asystem shall be established to document a chain ofcust

33、ody for evidence in laboratory custody.8.5 Disposition of EvidenceRecords shall be kept regard-ing the disposition of all items of evidence.8.6 Security of Analytical Documentation Associated withEvidenceAll laboratory records such as analytical results,measurements, notes, calibrations, chromatogra

34、ms, spectra,and reports shall be retained in a secure fashion.9. Analytical Procedures9.1 Analytical Procedures for Drug Analysis:9.1.1 Laboratories shall have and follow documented ana-lytical procedures.9.1.2 Laboratories shall have in place protocols for thesampling of evidence (see Practice E254

35、8).9.1.3 Work practices shall be established to prevent con-tamination of evidence during analysis.9.1.4 Laboratories shall have and follow documented guide-lines for the acceptance and interpretation of data.9.1.5 Laboratories shall monitor analytical processes usingappropriate blanks, controls and

36、 reference materials.9.1.6 Reference materials and reference data are critical todemonstrating the validity of quantitative and qualitative testresults. A positive test result shall meet the acceptance criteriadefined in the method validation and operating protocol. Indescending order of preference,

37、 the acceptance criteria shouldbe based on:9.1.6.1 Comparison to data obtained from a suitable drugreference material analyzed under the same analytical condi-tions as the test/case sample. The reference material may beanalyzed:(1) Contemporaneously with test/case sample;(2) As part of routine quali

38、ty control (for example, dailycheck 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 usedwhere a reference material is unavailable. External referencedata shall be shown to be fit for purpose. The veracity of

39、 thedata 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 referencematerial shall be documented and where applicable the limi

40、ta-tion expressed within the report.9.1.6.3 When neither reference materials nor external refer-ence data are available, structural elucidation techniques maybe employed providing the analyst has the appropriate skills fortheir interpretation. Such interpretations shall be made only byanalysts compe

41、tent in structural elucidation interpretation. Theabsence of a reference material and external data shall bedocumented and the impact on the interpretation of reportedresults assessed.9.1.7 Analytical procedures shall be validated in compli-ance with Practice E2549.9.1.8 Analysts shall take measures

42、 to be assured that iden-tifications are correct and relate to the right submission (seePractice E2329).9.2 Assessment of Drug Reference Materials:9.2.1 Laboratories shall have a process for assessing thatreference materials are fit for purpose.9.2.1.1 The assessment and purpose of a reference mater

43、ialshall be documented. The documentation shall include thename of the individual who performed the assessment, the dateof the assessment, verification test data, and details of allreference materials and reference data used.9.2.2 To be fit for purpose, the reference material must meetthe minimum sp

44、ecification defined in the validation process(see Practice E2549).9.2.2.1 The assessment shall be done on each lot of refer-ence material.9.2.2.2 This assessment shall be completed prior to oralongside casework analysis as appropriate.9.2.2.3 Reference materials shall only be used for thepurpose def

45、ined by the laboratory. For example a referencematerial may be deemed suitable for qualitative but notquantitative determinations.9.2.3 Fit for purpose for qualitative work requires an assess-ment of chemical identity.9.2.4 Fit for purpose for quantitative work requires anassessment of purity or con

46、centration, or both, as appropriate tothe application and its associated uncertainty of measurementin addition to 9.2.3.9.2.4.1 For quantitative determinations, different sources ofreference material should be used for calibration and qualitycontrol. Where this is not feasible, two different lots of

47、 thesame source may be used or lastly a single source of referencematerial can be sub-divided and each part assigned a specificpurpose.9.2.5 These parameters in 9.2.3 and 9.2.4 may be describedin a certificate, statement of analysis, data sheet or labelsupplied with the material or may be determined

48、 by in-houseanalysis or reference to published literature.9.2.6 The laboratory shall assess the reliability of theinformation supplied with a reference material even if thematerial meets the definition of a certified reference material.9.2.6.1 For reference materials obtained from a provideraccredit

49、ed under ISO Guide 34, the information contained inthe accompanying certificate is considered reliable and can beaccepted as correct if the material is stored and used inaccordance with the manufacturers instructions. In thesecircumstances the assessment need not include analysis.9.2.6.2 For reference materials obtained from a provider notaccredited under ISO Guide 34 the identity of the referencematerial shall be verified by analysis. If the reference materialwill be used for quantitative analyses the purity and/orconcentration, as appropriate to the applic