ASTM E2327-2004 Standard Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis《进行没收药品分析的实验室的质量保证的标准实施规程》.pdf

1、Designation: E 2327 04Standard Practice forQuality Assurance of Laboratories Performing Seized-DrugAnalysis1This standard is issued under the fixed designation E 2327; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of las

2、t revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This standard covers quality assurance issues in forensiclaboratories performing seized-drug analysis including evi-denc

3、e handling, analytical procedures, report writing, methodvalidation, documentation, proficiency testing, audits, andhealth and safety.1.2 Standards are meant to apply only to the practice ofqualitative seized-drug analysis.2. Referenced Documents2.1 ASTM Standards:2E 2326 Practice for Education and

4、Training of Seized-DrugAnalystsE 2328 Terminology Relating to Seized-Drug AnalysisE 2329 Practice for Identification of Seized Drugs2.2 Other Document:Scientific Working Group for the Analysis of Seized DrugsRecommendations for: Education and Training, QualityAssurance, Methods of Analysis3. Termino

5、logy3.1 Terms that may assist in interpreting this standard arefound in Terminology E 2328.4. Significance and Use4.1 These are minimum standards of quality assuranceapplicable to laboratories where analysis of seized-drug sub-missions is performed.4.2 The standards are to be practiced by forensic a

6、nalystsperforming seized-drug analysis and promoted/supported bylaboratory management.5. 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 afram

7、ework of quality in the processing of drug evidence,including evidence handling, management practices, qualita-tive analysis, and reporting. A documented quality manage-ment system must be established and maintained. Personnelresponsible for this must be clearly designated and have directaccess to t

8、he highest level of management concerning labora-tory policy.5.2 The quality management system must 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 Designa

9、ted Personnel 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

10、compliance 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 Personnel Technical SupportA person who per-forms bas

11、ic laboratory 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 d

12、one,6.2.5.2 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 author

13、ity for the 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:1This practice is under the jurisdiction of ASTM Committee E30 on ForensicSciences and is

14、 the direct responsibility of Subcommittee E30.01 on Criminalistics.Current edition approved Oct. 1, 2004. Published January 2005.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume informat

15、ion, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6.3.1 Technical Support Personnel will:6.3.1.1 Have education, skills and abilities commensuratewith their responsib

16、ilities, and6.3.1.2 Have on-the-job training specific to their position.6.3.2 Technicians/Assistant Analysts will: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 Analysts will:6.3.3.1 Have a mi

17、nimum of a bachelors degree or equiva-lent in a natural science or applied science, including crimi-nalistics or forensic science, which shall include lecture andassociated laboratory classes in general, organic, and analyticalchemistry, or6.3.3.2 By January 1, 2005, have a minimum of five (5)years

18、practical experience in the area of seized-drug analysis,and have demonstrated competency following the completionof a formal, documented training program and post trainingcompetency assessment.6.3.4 Supervisory Analysts will:6.3.4.1 Meet all the requirements of analyst (6.3.3),6.3.4.2 Have a minimu

19、m 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 for New AnalystsThe laboratory must estab-lish and document a training program and qualifying procedurefor all ne

20、w technical personnel. A documented training pro-gram, approved by laboratory management, should focus onthe development of the theoretical and practical knowledge,skills and abilities necessary to examine seized-drug samplesand related materials. It must include:6.4.1 A training syllabus providing

21、descriptions of theknowledge and skills in which analysts are to be trained forspecific topic areas, milestones of achievement, and methods oftesting or evaluating competency,6.4.2 Documented standards of performance and a plan forassessing theoretical and practical competency against thesestandards

22、; for example, written and oral examinations, criticalreviews, analysis of unknown samples, mock casework, etc.per specific topic area,6.4.3 A period of documented, supervised casework repre-sentative of the type they will be required to perform, and6.4.4 A verification document demonstrating that t

23、raineeshave achieved the required competence level per specific topicarea.6.5 Maintaining Qualifications:6.5.1 Minimum annual training required for continuingprofessional development of laboratory analysts is twenty (20)contact hours.6.5.1.1 Training must be relevant to the laboratorys ana-lytical m

24、ission.6.5.1.2 Training completed must be documented.7. Physical Plant7.1 Physical Plant Requirements:7.1.1 Laboratories shall provide adequate safety and secu-rity for personnel and operations.7.1.2 Laboratories must meet required health and safetybuilding codes.7.1.3 Laboratories must contain adeq

25、uate space to performrequired analytical functions and prevent contamination.7.1.4 Chemical fume hoods must be provided. They must beproperly maintained and monitored according to an establishedschedule.7.1.5 A laboratory-cleaning schedule should be establishedand implemented.7.1.6 Adequate faciliti

26、es must be provided to ensure theproper safekeeping of physical evidence, standards andrecords.7.1.7 Appropriately secured storage must be provided toprevent contamination of chemicals and reagents.8. Evidence Control8.1 Laboratories shall have and follow a documented evi-dence control system to ens

27、ure the integrity of physicalevidence.8.2 Receiving and Identifying EvidenceLaboratories mustmaintain records of requests for analysis and of the respectiveitems of evidence. A unique identifier must be assigned to eachcase file or record. This file or record must include, at least, thefollowing:8.2

28、.1 Submission documents or copies,8.2.2 Identity of party requesting analysis and date ofrequest,8.2.3 Description of items of evidence submitted for analy-sis,8.2.3.1 Any significant irregularities identified, during acomparison of evidence described in accompanying paperworkand examination prior t

29、o analysis, must be documented andincluded 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 submission. For evidence not delivered inperson, descriptive information regarding mode of delive

30、ry andtracking information must be included.8.3 Integrity of EvidenceEvidence must be properly se-cured and sealed. Appropriate storage conditions shall ensurethat, insofar as possible, the composition of seized material isnot altered. All items must be safeguarded against loss orcontamination. Any

31、alteration of the evidence (for example,repackaging) must be documented. Procedures should beimplemented to assure that samples are properly labeledthroughout the analytical process.8.4 Storage of EvidenceAccess to the evidence storagearea must be controlled, it being granted only to authorizedperso

32、nnel.Asystem shall be established to document a chain ofcustody for evidence in laboratory custody.8.5 Disposition of EvidenceRecords must be kept regard-ing the disposition of all items of evidence.8.6 Security of Analytical Documentation Associated withEvidenceAll laboratory records such as analyt

33、ical results,measurements, notes, calibrations, chromatograms, spectra andreports shall be retained in a secure fashion.E23270429. 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

34、 in place protocols for thesampling of evidence.9.1.3 Work practices shall be established to prevent con-tamination of evidence during analysis.9.1.4 Laboratories shall monitor analytical processes usingappropriate controls and traceable standards.9.1.5 Laboratories shall have and follow documented

35、guide-lines for the acceptance and interpretation of data.9.1.6 Analytical procedures must be validated in compli-ance with Section 14.9.1.7 Analysts shall take measures to be assured that iden-tifications are correct and relate to the right submission. This isbest established by the use of at least

36、 two appropriate tech-niques based on different principles and two independentsamplings.9.2 Verification of Drug Reference Materials:9.2.1 The identity of certified reference materials must beverified prior to their first use.9.2.2 The identity of uncertified reference materials must beverified prio

37、r to use by methods such as mixed melting pointdetermination, Mass Spectrometry, Infrared Spectroscopy, orNuclear Magnetic Resonance Spectrometry.9.2.3 Verification must be performed on each new lot ofreference material.9.2.4 All verification testing must be documented and in-clude the name of the i

38、ndividual who performed the identifi-cation, date of verification, verification test data, and referenceidentification.10. Instrument/Equipment Performance10.1 Instrument PerformanceInstruments must be rou-tinely monitored to ensure that proper performance is main-tained.10.1.1 Monitoring must inclu

39、de, at least, the use of refer-ence standards, test mixtures, calibration standards, or blanks.10.1.2 Instrument performance monitoring must be docu-mented.10.2 EquipmentUse of unsuitable or improperly operatingequipment is discouraged. Equipment performance parametersshould be routinely monitored a

40、nd documented.10.2.1 The manufacturers operation manual and other rel-evant documentation for each piece of equipment should bereadily available.11. Chemicals and Reagents11.1 Chemicals and reagents used in drug testing must be ofthe appropriate grade for the test performed.11.2 There must be docume

41、nted procedures for the formu-lation of all chemical reagents produced within the laboratory.11.2.1 Documentation for reagents prepared within thelaboratory must include identity, concentration (when appro-priate), date of preparation, identity of the individual preparingthe reagents and the expirat

42、ion date (if appropriate).11.3 The efficacy of all test reagents must be checked priorto their use in casework. Results of these tests should bedocumented.11.4 Chemical and reagent containers should be dated andinitialed when received and when first opened.12. Casework Documentation, Report Writing

43、andReview12.1 Casework Documentation:12.1.1 Documentation must contain sufficient informationto allow a peer to evaluate the notes and interpret data.12.1.2 Evidence handling documentation should includechain of custody, the initial weight/count of evidence to beexamined (upon receipt by the analyst

44、), information regardingpackaging of evidence upon receipt, a description of evidenceand communications regarding the case.12.1.3 Analytical documentation should include procedures,standards, blanks, observations, test results, and supportingdocumentation including charts, graphs, and spectra genera

45、tedduring analysis.12.1.4 Casework documentation must be preserved accord-ing to documented laboratory policy.12.2 Report Writing:12.2.1 Reports issued by laboratories must meet require-ments of the jurisdictions served. Reports may include:12.2.1.1 Identity of testing laboratory,12.2.1.2 Case ident

46、ifier,12.2.1.3 Identity of contributor,12.2.1.4 Date of receipt,12.2.1.5 Date of report,12.2.1.6 Descriptive list of submitted evidence,12.2.1.7 Identity of analyst,12.2.1.8 Analytical techniques employed, and12.2.1.9 Results/Conclusions.12.3 Case Review:12.3.1 Laboratories must have a documented po

47、licy estab-lishing protocols for technical and administrative case review.12.3.2 Laboratories must have a documented policy forresolving instances where analyst and reviewer disagree.13. Proficiency and Competency Testing13.1 Each laboratory should participate in, at least, anannual inter-laboratory

48、 proficiency-testing program and shouldhave documented protocols for testing the proficiency andcompetency of its analysts.13.2 Proficiency Testing:13.2.1 Laboratories shall perform proficiency testing inorder to verify the laboratorys performance in comparison toother laboratories. The frequency of

49、 proficiency testing shouldbe at least annually and at least one of these proficiency testsshould be from a recognized proficiency-test provider externalto the laboratory.13.2.2 Proficiency-test samples should be representative ofthe laboratorys normal casework.13.2.3 Methodology required to perform proficiency testsshould be in concert with that normally practiced in thelaboratory.13.3 Competency Testing:E232704313.3.1 Laboratories will test the competency of their ana-lysts prior to assigning them independent casework responsi-bilities.13.3.2 Competency-test sa