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AS/NZS 4308:2008

AS/NZS 4308:2008

Procedures for specimen collection and the detection and quantitation of drugs of abuse in urine

Standards Australia

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Table of Contents

<toc>
<bookmarktable>
<bookmark index='0'>
<pageno>1</pageno>
<text>AS/NZS 4308:2008 PROCEDURES FOR SPECIMEN COLLECTION AND THE DETECTION AND QUANTITATION OF DRUGS OF ABUSE IN URINE</text>
<bookmark index='1'>
<pageno>4</pageno>
<text>PREFACE</text>
</bookmark>
<bookmark index='2'>
<pageno>5</pageno>
<text>CONTENTS</text>
</bookmark>
<bookmark index='3'>
<pageno>7</pageno>
<text>FOREWORD</text>
</bookmark>
<bookmark index='4'>
<pageno>9</pageno>
<text>SECTION 1 SCOPE AND GENERAL</text>
<bookmark index='5'>
<pageno>9</pageno>
<text>1.1 SCOPE</text>
</bookmark>
<bookmark index='6'>
<pageno>9</pageno>
<text>1.2 REFERENCED DOCUMENTS</text>
</bookmark>
<bookmark index='7'>
<pageno>10</pageno>
<text>1.3 DEFINITIONS</text>
<bookmark index='8'>
<pageno>10</pageno>
<text>1.3.1 Accreditation</text>
</bookmark>
<bookmark index='9'>
<pageno>10</pageno>
<text>1.3.2 Adulterant</text>
</bookmark>
<bookmark index='10'>
<pageno>10</pageno>
<text>1.3.3 Amphetamine type substances (Sympathomimetic amines)</text>
</bookmark>
<bookmark index='11'>
<pageno>10</pageno>
<text>1.3.4 Benzodiazepines</text>
</bookmark>
<bookmark index='12'>
<pageno>10</pageno>
<text>1.3.5 Blind testing</text>
</bookmark>
<bookmark index='13'>
<pageno>10</pageno>
<text>1.3.6 Calibration standard</text>
</bookmark>
<bookmark index='14'>
<pageno>10</pageno>
<text>1.3.7 Cannabinoids</text>
</bookmark>
<bookmark index='15'>
<pageno>10</pageno>
<text>1.3.8 Cannabis metabolite</text>
</bookmark>
<bookmark index='16'>
<pageno>10</pageno>
<text>1.3.9 Chain-of-custody</text>
</bookmark>
<bookmark index='17'>
<pageno>10</pageno>
<text>1.3.10 Chain-of-custody form</text>
</bookmark>
<bookmark index='18'>
<pageno>10</pageno>
<text>1.3.11 Cocaine metabolites</text>
</bookmark>
<bookmark index='19'>
<pageno>11</pageno>
<text>1.3.12 Collecting agency</text>
</bookmark>
<bookmark index='20'>
<pageno>11</pageno>
<text>1.3.13 Collecting site</text>
</bookmark>
<bookmark index='21'>
<pageno>11</pageno>
<text>1.3.14 Collector</text>
</bookmark>
<bookmark index='22'>
<pageno>11</pageno>
<text>1.3.15 Concentration</text>
</bookmark>
<bookmark index='23'>
<pageno>11</pageno>
<text>1.3.16 Confirmatory test</text>
</bookmark>
<bookmark index='24'>
<pageno>11</pageno>
<text>1.3.17 Control specimen</text>
</bookmark>
<bookmark index='25'>
<pageno>11</pageno>
<text>1.3.18 Cut-off concentration</text>
</bookmark>
<bookmark index='26'>
<pageno>11</pageno>
<text>1.3.19 Donor</text>
</bookmark>
<bookmark index='27'>
<pageno>11</pageno>
<text>1.3.20 Drug free</text>
</bookmark>
<bookmark index='28'>
<pageno>11</pageno>
<text>1.3.21 Integrity testing</text>
</bookmark>
<bookmark index='29'>
<pageno>12</pageno>
<text>1.3.22 Laboratory</text>
</bookmark>
<bookmark index='30'>
<pageno>12</pageno>
<text>1.3.23 On-site drug screening device</text>
</bookmark>
<bookmark index='31'>
<pageno>12</pageno>
<text>1.3.24 On-site screening</text>
</bookmark>
<bookmark index='32'>
<pageno>12</pageno>
<text>1.3.25 Opiates</text>
</bookmark>
<bookmark index='33'>
<pageno>12</pageno>
<text>1.3.26 Permanent record system</text>
</bookmark>
<bookmark index='34'>
<pageno>12</pageno>
<text>1.3.27 Proficiency testing program</text>
</bookmark>
<bookmark index='35'>
<pageno>12</pageno>
<text>1.3.28 Referee specimen</text>
</bookmark>
<bookmark index='36'>
<pageno>12</pageno>
<text>1.3.29 Reference compound</text>
</bookmark>
<bookmark index='37'>
<pageno>12</pageno>
<text>1.3.30 Requesting authority.</text>
</bookmark>
<bookmark index='38'>
<pageno>12</pageno>
<text>1.3.31 Sample</text>
</bookmark>
<bookmark index='39'>
<pageno>12</pageno>
<text>1.3.32 Screening tests</text>
</bookmark>
<bookmark index='40'>
<pageno>12</pageno>
<text>1.3.33 Specimen</text>
</bookmark>
<bookmark index='41'>
<pageno>12</pageno>
<text>1.3.34 Thermometer</text>
</bookmark>
<bookmark index='42'>
<pageno>13</pageno>
<text>1.3.35 Uncertainty of measurement</text>
</bookmark>
<bookmark index='43'>
<pageno>13</pageno>
<text>1.3.36 Verification of on-site devices</text>
</bookmark>
</bookmark>
</bookmark>
<bookmark index='44'>
<pageno>14</pageno>
<text>SECTION 2 SPECIMEN COLLECTION, STORAGE, HANDLING AND DISPATCH</text>
<bookmark index='45'>
<pageno>14</pageno>
<text>2.1 GENERAL</text>
</bookmark>
<bookmark index='46'>
<pageno>14</pageno>
<text>2.2 COLLECTING SITE</text>
<bookmark index='47'>
<pageno>14</pageno>
<text>2.2.1 General</text>
</bookmark>
<bookmark index='48'>
<pageno>14</pageno>
<text>2.2.2 Privacy</text>
</bookmark>
<bookmark index='49'>
<pageno>14</pageno>
<text>2.2.3 Security</text>
</bookmark>
<bookmark index='50'>
<pageno>14</pageno>
<text>2.2.4 Chain-of-custody</text>
</bookmark>
<bookmark index='51'>
<pageno>14</pageno>
<text>2.2.5 Access</text>
</bookmark>
</bookmark>
<bookmark index='52'>
<pageno>15</pageno>
<text>2.3 INTEGRITY AND IDENTITY OF THE COLLECTED SPECIMEN</text>
<bookmark index='53'>
<pageno>15</pageno>
<text>2.3.1 General</text>
</bookmark>
<bookmark index='54'>
<pageno>15</pageno>
<text>2.3.2 Precautions</text>
</bookmark>
<bookmark index='55'>
<pageno>15</pageno>
<text>2.3.3 Collection procedure</text>
</bookmark>
</bookmark>
<bookmark index='56'>
<pageno>16</pageno>
<text>2.4 PREPARATION FOR DISPATCH</text>
</bookmark>
<bookmark index='57'>
<pageno>16</pageno>
<text>2.5 TRANSPORTATION TO THE LABORATORY</text>
</bookmark>
</bookmark>
<bookmark index='58'>
<pageno>17</pageno>
<text>SECTION 3 GENERAL LABORATORY REQUIREMENTS</text>
<bookmark index='59'>
<pageno>17</pageno>
<text>3.1 GENERAL</text>
</bookmark>
<bookmark index='60'>
<pageno>17</pageno>
<text>3.2 REAGENTS</text>
</bookmark>
<bookmark index='61'>
<pageno>17</pageno>
<text>3.3 APPARATUS</text>
<bookmark index='62'>
<pageno>17</pageno>
<text>3.3.1 Volumetric glassware</text>
</bookmark>
<bookmark index='63'>
<pageno>17</pageno>
<text>3.3.2 Piston operated volumetric apparatus</text>
</bookmark>
</bookmark>
<bookmark index='64'>
<pageno>17</pageno>
<text>3.4 LABORATORY SECURITY</text>
</bookmark>
<bookmark index='65'>
<pageno>18</pageno>
<text>3.5 SPECIMEN RECEPTION</text>
</bookmark>
<bookmark index='66'>
<pageno>18</pageno>
<text>3.6 SPECIMEN INTEGRITY TESTING</text>
<bookmark index='67'>
<pageno>18</pageno>
<text>3.6.1 General</text>
</bookmark>
<bookmark index='68'>
<pageno>18</pageno>
<text>3.6.2 Creatinine concentration greater than 50 mg/L but less than 200 mg/L</text>
</bookmark>
<bookmark index='69'>
<pageno>18</pageno>
<text>3.6.3 Creatinine less than 50 mg/L</text>
</bookmark>
<bookmark index='70'>
<pageno>18</pageno>
<text>3.6.4 Other substances</text>
</bookmark>
</bookmark>
<bookmark index='71'>
<pageno>18</pageno>
<text>3.7 RECONCILIATION OF TEST RESULTS</text>
</bookmark>
<bookmark index='72'>
<pageno>19</pageno>
<text>3.8 STORAGE OF SPECIMEN</text>
<bookmark index='73'>
<pageno>19</pageno>
<text>3.8.1 Short-term storage</text>
</bookmark>
<bookmark index='74'>
<pageno>19</pageno>
<text>3.8.2 Long-term storage</text>
</bookmark>
</bookmark>
</bookmark>
<bookmark index='75'>
<pageno>20</pageno>
<text>SECTION 4 LABORATORY SCREENING PROCEDURES</text>
<bookmark index='76'>
<pageno>20</pageno>
<text>4.1 GENERAL</text>
</bookmark>
<bookmark index='77'>
<pageno>20</pageno>
<text>4.2 METHOD</text>
</bookmark>
<bookmark index='78'>
<pageno>20</pageno>
<text>4.3 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY TESTING AND STORAGE OF SPECIMENS</text>
</bookmark>
<bookmark index='79'>
<pageno>20</pageno>
<text>4.4 PERSONNEL</text>
<bookmark index='80'>
<pageno>20</pageno>
<text>4.4.1 Laboratory supervisor</text>
</bookmark>
<bookmark index='81'>
<pageno>21</pageno>
<text>4.4.2 Screening analyst</text>
</bookmark>
<bookmark index='82'>
<pageno>21</pageno>
<text>4.4.3 Access to expertise</text>
</bookmark>
<bookmark index='83'>
<pageno>21</pageno>
<text>4.4.4 Acceptance of results</text>
</bookmark>
<bookmark index='84'>
<pageno>21</pageno>
<text>4.4.5 Accreditation</text>
</bookmark>
</bookmark>
<bookmark index='85'>
<pageno>21</pageno>
<text>4.5 NUMBER OF DETERMINATIONS</text>
</bookmark>
<bookmark index='86'>
<pageno>21</pageno>
<text>4.6 BLANK DETERMINATION</text>
</bookmark>
<bookmark index='87'>
<pageno>21</pageno>
<text>4.7 QUALITY CONTROL</text>
</bookmark>
<bookmark index='88'>
<pageno>21</pageno>
<text>4.8 SCREENING TEST CUT-OFF LEVELS</text>
</bookmark>
<bookmark index='89'>
<pageno>21</pageno>
<text>4.9 ACCEPTANCE CRITERIA</text>
</bookmark>
<bookmark index='90'>
<pageno>22</pageno>
<text>4.10 CONFIRMATORY TESTING</text>
</bookmark>
<bookmark index='91'>
<pageno>22</pageno>
<text>4.11 REPORTING OF RESULTS</text>
<bookmark index='92'>
<pageno>22</pageno>
<text>4.11.1 Conditions for reporting</text>
</bookmark>
<bookmark index='93'>
<pageno>22</pageno>
<text>4.11.2 Test report</text>
</bookmark>
</bookmark>
<bookmark index='94'>
<pageno>23</pageno>
<text>4.12 RECORD KEEPING</text>
</bookmark>
</bookmark>
<bookmark index='95'>
<pageno>24</pageno>
<text>SECTION 5 LABORATORY CONFIRMATORY PROCEDURES</text>
<bookmark index='96'>
<pageno>24</pageno>
<text>5.1 GENERAL</text>
</bookmark>
<bookmark index='97'>
<pageno>24</pageno>
<text>5.2 PRINCIPLE</text>
</bookmark>
<bookmark index='98'>
<pageno>24</pageno>
<text>5.3 APPARATUS</text>
<bookmark index='99'>
<pageno>24</pageno>
<text>5.3.1 Gas chromatograph/mass spectrometer</text>
</bookmark>
<bookmark index='100'>
<pageno>24</pageno>
<text>5.3.2 Liquid chromatograph/mass spectrometer</text>
</bookmark>
<bookmark index='101'>
<pageno>24</pageno>
<text>5.3.3 Tandem mass spectrometry</text>
</bookmark>
</bookmark>
<bookmark index='102'>
<pageno>24</pageno>
<text>5.4 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY TESTING AND STORAGE OF SPECIMENS</text>
</bookmark>
<bookmark index='103'>
<pageno>24</pageno>
<text>5.5 PERSONNEL</text>
<bookmark index='104'>
<pageno>24</pageno>
<text>5.5.1 Laboratory management</text>
</bookmark>
<bookmark index='105'>
<pageno>24</pageno>
<text>5.5.2 Laboratory supervisor</text>
</bookmark>
<bookmark index='106'>
<pageno>25</pageno>
<text>5.5.3 Analyst</text>
</bookmark>
<bookmark index='107'>
<pageno>25</pageno>
<text>5.5.4 Review results</text>
</bookmark>
<bookmark index='108'>
<pageno>25</pageno>
<text>5.5.5 Accreditation</text>
</bookmark>
</bookmark>
<bookmark index='109'>
<pageno>25</pageno>
<text>5.6 CONFIRMATION CRITERIA</text>
</bookmark>
<bookmark index='110'>
<pageno>25</pageno>
<text>5.7 INSTRUMENTATION</text>
</bookmark>
<bookmark index='111'>
<pageno>25</pageno>
<text>5.8 NUMBER OF DETERMINATIONS</text>
</bookmark>
<bookmark index='112'>
<pageno>26</pageno>
<text>5.9 BLANK DETERMINATION</text>
</bookmark>
<bookmark index='113'>
<pageno>26</pageno>
<text>5.10 INSTRUMENT SETUP</text>
</bookmark>
<bookmark index='114'>
<pageno>26</pageno>
<text>5.11 QUALITY CONTROL</text>
</bookmark>
<bookmark index='115'>
<pageno>26</pageno>
<text>5.12 CALCULATIONS</text>
</bookmark>
<bookmark index='116'>
<pageno>26</pageno>
<text>5.13 ACCEPTANCE CRITERIA</text>
</bookmark>
<bookmark index='117'>
<pageno>27</pageno>
<text>5.14 UNCERTAINTY OF MEASUREMENT</text>
</bookmark>
<bookmark index='118'>
<pageno>28</pageno>
<text>5.15 TEST REPORT</text>
</bookmark>
<bookmark index='119'>
<pageno>29</pageno>
<text>5.16 RECORD KEEPING</text>
</bookmark>
<bookmark index='120'>
<pageno>29</pageno>
<text>5.17 DISPUTED RESULTS</text>
</bookmark>
</bookmark>
<bookmark index='121'>
<pageno>30</pageno>
<text>APPENDIX A - ON-SITE SCREENING PROCEDURE</text>
<bookmark index='122'>
<pageno>30</pageno>
<text>A1 GENERAL</text>
</bookmark>
<bookmark index='123'>
<pageno>30</pageno>
<text>A2 PERSONNEL</text>
</bookmark>
<bookmark index='124'>
<pageno>30</pageno>
<text>A3 PROCEDURE</text>
<bookmark index='125'>
<pageno>30</pageno>
<text>A3.1 General</text>
</bookmark>
<bookmark index='126'>
<pageno>30</pageno>
<text>A3.2 Requirements for on-site screening</text>
</bookmark>
<bookmark index='127'>
<pageno>31</pageno>
<text>A3.3 Acceptance of results</text>
</bookmark>
</bookmark>
<bookmark index='128'>
<pageno>31</pageno>
<text>A4 REPORTING OF RESULTS</text>
<bookmark index='129'>
<pageno>31</pageno>
<text>A4.1 Test report</text>
</bookmark>
<bookmark index='130'>
<pageno>32</pageno>
<text>A4.2 Record keeping</text>
</bookmark>
<bookmark index='131'>
<pageno>32</pageno>
<text>A4.3 RECONCILIATION OF TEST RESULTS</text>
</bookmark>
</bookmark>
</bookmark>
<bookmark index='132'>
<pageno>33</pageno>
<text>APPENDIX B - VERIFICATION OF PERFORMANCE OF ON-SITE DEVICES AROUND THE CUT-OFF</text>
</bookmark>
<bookmark index='133'>
<pageno>34</pageno>
<text>APPENDIX C - CHAIN-OF-CUSTODY FORM</text>
</bookmark>
<bookmark index='134'>
<pageno>35</pageno>
<text>APPENDIX D - RECOMMENDED PRECAUTIONS FOR HANDLING BIOLOGICAL SPECIMENS</text>
<bookmark index='135'>
<pageno>35</pageno>
<text>D1 GENERAL RECOMMENDATIONS</text>
</bookmark>
<bookmark index='136'>
<pageno>35</pageno>
<text>D2 DISINFECTION OF SPILLS</text>
</bookmark>
<bookmark index='137'>
<pageno>36</pageno>
<text>D3 DISINFECTION OF EQUIPMENT</text>
</bookmark>
<bookmark index='138'>
<pageno>36</pageno>
<text>D4 WASTE DISPOSAL</text>
</bookmark>
<bookmark index='139'>
<pageno>36</pageno>
<text>D5 BIBLIOGRAPHY</text>
</bookmark>
</bookmark>
<bookmark index='140'>
<pageno>37</pageno>
<text>APPENDIX E - PRINCIPLES OF OPERATION</text>
<bookmark index='141'>
<pageno>37</pageno>
<text>E1 GAS CHROMATOGRAPHY</text>
</bookmark>
<bookmark index='142'>
<pageno>37</pageno>
<text>E2 GAS CHROMATOGRAPHY/MASS SPECTROMETRY</text>
</bookmark>
<bookmark index='143'>
<pageno>37</pageno>
<text>E3 HIGH PRESSURE LIQUID CHROMATOGRAPHY</text>
</bookmark>
<bookmark index='144'>
<pageno>37</pageno>
<text>E4 IMMUNOASSAY</text>
</bookmark>
<bookmark index='145'>
<pageno>38</pageno>
<text>E5 LIQUID CHROMATOGRAPHY/MASS SPECTROMETRY</text>
</bookmark>
<bookmark index='146'>
<pageno>38</pageno>
<text>E6 TANDEM MASS SPECTROMETRY(GC/MS/MS, LC/MS/MS)</text>
</bookmark>
</bookmark>
</bookmark>
</bookmarktable>
</toc>

Abstract

Sets out procedures for specimen collection, screening, confirmation, quantitation and reporting of drugs in human urine as well as integrity testing of the specimen. This edition introduces the option of on-site screening.

Scope

This Standard sets out procedures for specimen collection, screening, confirmation, quantitation and reporting of drugs in human urine as well as integrity testing of the specimen. The procedures are intended for but not limited to medico-legal, workplace, correctional services or court directed testing of any or all of the following classes of drugs:
(a) Amphetamine type substances.
(b) Benzodiazepines.
(c) Cannabis metabolites.
(d) Cocaine metabolites.
(e) Opiates.
NOTES:
1 The detection and reporting of drugs other than those listed in Table 2 is not precluded.
2 This Standard has no relevance to the issue of impairment.

General Product Information

Document Type Standard
Status Current
Publisher Standards Australia
Committee CH-036
Supersedes
  • AS/NZS 4308:2001
  • DR 07317 CP

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