ASTM E2327-2010 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操作规程》.pdf

《ASTM E2327-2010 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操作规程》.pdf》由会员分享，可在线阅读，更多相关《ASTM E2327-2010 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操作规程》.pdf（5页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: E2327 10Standard 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.1. Scope1.1 This practice covers quality assurance issues in forensiclaboratories performing seized-drug analysis including evi-dence h

3、andling, 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.2. Referenced Documents2.1 ASTM Standards:2E2328 Terminology Relating to Seized-Drug Analysis

4、32.2 Other Document:Scientific Working Group for the Analysis of Seized DrugsRecommendations for: Education and Training, QualityAssurance, Methods of Analysis3. Terminology3.1 Terms that may assist in interpreting this standard arefound in Terminology E2328.4. Significance and Use4.1 These are mini

5、mum 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. Quality Management System5.1 It is the goal of

6、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, management practices, qualita-tive analysis, and report

7、ing. A documented quality manage-ment system shall be established and maintained. Personnelresponsible for this shall be clearly designated and have directaccess to the highest level of management concerning labora-tory policy.5.2 The quality management system shall cover all proce-dures and reports

8、 associated with drug analysis.6. Personnel6.1 Job DescriptionJob descriptions for all personnelshould include responsibilities, duties, and required skills.6.2 Designated Personnel and ResponsibilitiesAn indi-vidual (however titled) may be responsible for more than oneof the following duties:6.2.1

9、Quality Assurance ManagerA designated personwho is responsible for maintaining the quality managementsystem (including an annual review of the program) and whomonitors compliance with the program.6.2.2 Health and Safety ManagerA designated personwho is responsible for maintaining the Laboratory Heal

10、th 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 basic laboratory duties, but does not analyze evidence.6.2.4 Technician/Assistant AnalystA person who analyzesevidence, but does not is

11、sue 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 Independently has access to unsealed evidence inorder to remove samples from the evidence for examination;and6.2.5.3 As

12、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 technical opera-tions of the drug analysis section. Technical operations include,but are not limited to protocols, analy

13、tical methodology, andtechnical review of reports.1This 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 Dec. 15, 2010. Published January 2010. Originallyapproved in 2004. L

14、ast previous edition approved in 2004 as E2327 04. DOI:10.1520/E2327-10.2For 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 AS

15、TM website.3Withdrawn. The last approved version of this historical standard is referencedon www.astm.org.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.6.3 Qualifications/Education:6.3.1 Technical Support Personnel shall:6.3.1.1 Ha

16、ve education, skills, and abilities commensuratewith 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 tra

17、ining specific to their position.6.3.3 All new analysts shall have at least a baccalaureatedegree or equivalent (generally a three to four year post-secondary degree) in a natural/physical science. Courseworkshall include lecture and associated laboratory classes ingeneral, organic and analytical ch

18、emistry.6.3.4 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 Trainin

19、g for New AnalystsThe laboratory shall estab-lish and document a training program and qualifying procedurefor all new technical personnel. A documented training pro-gram, approved by laboratory management, should focus onthe development of the theoretical and practical knowledge,skills and abilities

20、 necessary to examine seized-drug samplesand related materials. It shall include:6.4.1 A training syllabus providing 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 Do

21、cumented standards of performance and a plan forassessing theoretical and practical competency against thesestandards, 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 casewor

22、k repre-sentative of the type they shall be required to perform; and6.4.4 A verification document demonstrating that traineeshave achieved the required competence level per specific topicarea.6.5 Maintaining Qualifications:6.5.1 Minimum annual training required for continuingprofessional development

23、 of laboratory analysts is twenty (20)hours.6.5.1.1 Training shall be relevant to the laboratorys ana-lytical mission. Professional development may include trainingrelated to ancillary duty assignments and supervision/management responsibilities.6.5.1.2 Training completed shall be documented.6.5.1.3

24、 Training can be face-to-face interaction with aninstructor, distance learning, self-directed, or computer-based.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 shall meet required health

25、and safetybuilding codes.7.1.3 Laboratories shall contain adequate space to performrequired analytical functions and prevent 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 sched

26、ule should be establishedand implemented.7.1.6 Adequate facilities shall be provided to ensure theproper safekeeping of physical evidence, standards andrecords.7.1.7 Appropriately secured storage shall be provided toprevent contamination of chemicals and reagents.8. Evidence Control8.1 Laboratories

27、shall have and follow a documented evi-dence control system to ensure the integrity of physicalevidence.8.2 Receiving and Identifying EvidenceLaboratories shallmaintain records of requests for analysis and of the respectiveitems of evidence. A unique identifier shall be assigned to eachcase file or

28、record. This file or record shall include, at least, thefollowing:8.2.1 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 o

29、f evidence described in accompanying paperworkand examination prior to analysis, shall 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 no

30、t delivered inperson, descriptive information regarding mode of delivery andtracking information shall be included.8.3 Integrity of EvidenceEvidence shall be properly se-cured and sealed. Appropriate storage conditions shall ensurethat, insofar as possible, the composition of seized material isnot a

31、ltered. All items shall be safeguarded against loss orcontamination. Any alteration of the evidence (for example,repackaging) shall be documented. Procedures shall be imple-mented to assure that samples are properly labeled throughoutthe analytical process.8.4 Storage of EvidenceAccess to the eviden

32、ce storagearea shall be controlled, it being granted only to authorizedpersonnel.Asystem shall be established to document a chain ofcustody 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 Analytic

33、al Documentation Associated withEvidenceAll laboratory records such as analytical results,measurements, notes, calibrations, chromatograms, spectra andreports shall be retained in a secure fashion.E2327 1029. Analytical Procedures9.1 Analytical Procedures for Drug Analysis:9.1.1 Laboratories shall h

34、ave and follow documented ana-lytical procedures.9.1.2 Laboratories shall have 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 control

35、s and traceable standards.9.1.5 Laboratories shall have and follow documented guide-lines for the acceptance and interpretation of data.9.1.6 Analytical procedures shall be validated in compli-ance with Section 14.9.1.7 Analysts shall take measures to be assured that iden-tifications are correct and

36、 relate to the right submission. This isbest established by the use of at least 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 shall beverified prior to their firs

37、t use.9.2.2 The identity of uncertified reference materials shall beverified prior to use by methods such as mixed melting pointdetermination, Mass Spectrometry, Infrared Spectroscopy, orNuclear Magnetic Resonance Spectroscopy.9.2.3 Verification shall be performed on each new lot ofreference materia

38、l.9.2.4 All verification testing shall be documented and in-clude the name of the individual who performed the identifi-cation, date of verification, verification test data, and referenceidentification.10. Instrument/Equipment Performance10.1 Instrument PerformanceInstruments shall be rou-tinely mon

39、itored to ensure that proper performance is main-tained.10.1.1 Monitoring shall include, at least, the use of refer-ence materials, test mixtures, calibration standards, or blanks.10.1.2 Instrument performance monitoring shall be docu-mented.10.2 EquipmentUse of unsuitable or improperly operatingequ

40、ipment is discouraged. Equipment performance parametersshould be routinely monitored and 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 te

41、sting shall be ofthe appropriate grade for the test performed.11.2 There shall be documented procedures for the formu-lation of all chemical reagents produced within the laboratory.11.2.1 Documentation for reagents prepared within thelaboratory shall include identity, concentration (when appro-priat

42、e), date of preparation, identity of the individual preparingthe reagents, storage conditions (if appropriate), and theexpiration date (if appropriate).11.3 The efficacy of all test reagents shall be checked priorto their use in casework. Results of these tests shall bedocumented.11.4 Chemical and r

43、eagent containers should be dated andinitialed when received and when first opened.11.5 Chemical and reagent containers shall be labeled as totheir contents.12. Casework Documentation, Report Writing andReview12.1 Casework Documentation:12.1.1 Documentation shall contain sufficient information toall

44、ow a peer to evaluate the notes and interpret data.12.1.2 Evidence handling documentation shall includechain of custody, information regarding packaging of evidenceupon receipt, the initial weight/count of evidence to be exam-ined (upon opening), a description of evidence, and commu-nications regard

45、ing the case.12.1.3 Analytical documentation should include procedures,standards, blanks, observations, test results, and supportingdocumentation including charts, graphs, and spectra generatedduring analysis.12.1.4 Casework documentation shall be preserved accord-ing to documented laboratory policy

46、.12.2 Report Writing:12.2.1 Reports issued by laboratories shall be accurate,clear, objective, and meet the requirements of the jurisdictionsserved. Reports may include:12.2.1.1 Identity of testing laboratory,12.2.1.2 Case identifier,12.2.1.3 Identity of contributor,12.2.1.4 Date of receipt,12.2.1.5

47、 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,12.2.1.9 Results,12.2.1.10 Conclusions,12.2.1.11 Sampling, and12.2.1.12 Uncertainty.12.3 Case Review:12.3.1 Laboratories shall have a documented policy estab-lishing p

48、rotocols for technical and administrative case review.12.3.2 Laboratories shall have a documented policy forresolving instances where analyst and reviewer disagree.13. Proficiency and Competency Testing13.1 Each laboratory shall establish a written competencytesting and proficiency testing program.

49、Each laboratory shallhave documented protocols for monitoring the competency andproficiency 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 proficiency testing shall beat least annually and at least one of these proficiency testsshould be from a recognized proficiency-test provider externalto the laboratory.E2327 10313.2.2 Proficiency-test samples should be representative ofthe laboratorys normal casework.13.2.3 Met