AS/NZS 4308:2008

1 - AS/NZS 4308:2008 PROCEDURES FOR SPECIMEN COLLECTION AND THE DETECTION AND QUANTITATION OF DRUGS OF ABUSE IN URINE
4 - PREFACE
5 - CONTENTS
7 - FOREWORD
9 - SECTION 1 SCOPE AND GENERAL
9 - 1.1 SCOPE
9 - 1.2 REFERENCED DOCUMENTS
10 - 1.3 DEFINITIONS
10 - 1.3.1 Accreditation
10 - 1.3.2 Adulterant
10 - 1.3.3 Amphetamine type substances (Sympathomimetic amines)
10 - 1.3.4 Benzodiazepines
10 - 1.3.5 Blind testing
10 - 1.3.6 Calibration standard
10 - 1.3.7 Cannabinoids
10 - 1.3.8 Cannabis metabolite
10 - 1.3.9 Chain-of-custody
10 - 1.3.10 Chain-of-custody form
10 - 1.3.11 Cocaine metabolites
11 - 1.3.12 Collecting agency
11 - 1.3.13 Collecting site
11 - 1.3.14 Collector
11 - 1.3.15 Concentration
11 - 1.3.16 Confirmatory test
11 - 1.3.17 Control specimen
11 - 1.3.18 Cut-off concentration
11 - 1.3.19 Donor
11 - 1.3.20 Drug free
11 - 1.3.21 Integrity testing
12 - 1.3.22 Laboratory
12 - 1.3.23 On-site drug screening device
12 - 1.3.24 On-site screening
12 - 1.3.25 Opiates
12 - 1.3.26 Permanent record system
12 - 1.3.27 Proficiency testing program
12 - 1.3.28 Referee specimen
12 - 1.3.29 Reference compound
12 - 1.3.30 Requesting authority.
12 - 1.3.31 Sample
12 - 1.3.32 Screening tests
12 - 1.3.33 Specimen
12 - 1.3.34 Thermometer
13 - 1.3.35 Uncertainty of measurement
13 - 1.3.36 Verification of on-site devices
14 - SECTION 2 SPECIMEN COLLECTION, STORAGE, HANDLING AND DISPATCH
14 - 2.1 GENERAL
14 - 2.2 COLLECTING SITE
14 - 2.2.1 General
14 - 2.2.2 Privacy
14 - 2.2.3 Security
14 - 2.2.4 Chain-of-custody
14 - 2.2.5 Access
15 - 2.3 INTEGRITY AND IDENTITY OF THE COLLECTED SPECIMEN
15 - 2.3.1 General
15 - 2.3.2 Precautions
15 - 2.3.3 Collection procedure
16 - 2.4 PREPARATION FOR DISPATCH
16 - 2.5 TRANSPORTATION TO THE LABORATORY
17 - SECTION 3 GENERAL LABORATORY REQUIREMENTS
17 - 3.1 GENERAL
17 - 3.2 REAGENTS
17 - 3.3 APPARATUS
17 - 3.3.1 Volumetric glassware
17 - 3.3.2 Piston operated volumetric apparatus
17 - 3.4 LABORATORY SECURITY
18 - 3.5 SPECIMEN RECEPTION
18 - 3.6 SPECIMEN INTEGRITY TESTING
18 - 3.6.1 General
18 - 3.6.2 Creatinine concentration greater than 50 mg/L but less than 200 mg/L
18 - 3.6.3 Creatinine less than 50 mg/L
18 - 3.6.4 Other substances
18 - 3.7 RECONCILIATION OF TEST RESULTS
19 - 3.8 STORAGE OF SPECIMEN
19 - 3.8.1 Short-term storage
19 - 3.8.2 Long-term storage
20 - SECTION 4 LABORATORY SCREENING PROCEDURES
20 - 4.1 GENERAL
20 - 4.2 METHOD
20 - 4.3 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY TESTING AND STORAGE OF SPECIMENS
20 - 4.4 PERSONNEL
20 - 4.4.1 Laboratory supervisor
21 - 4.4.2 Screening analyst
21 - 4.4.3 Access to expertise
21 - 4.4.4 Acceptance of results
21 - 4.4.5 Accreditation
21 - 4.5 NUMBER OF DETERMINATIONS
21 - 4.6 BLANK DETERMINATION
21 - 4.7 QUALITY CONTROL
21 - 4.8 SCREENING TEST CUT-OFF LEVELS
21 - 4.9 ACCEPTANCE CRITERIA
22 - 4.10 CONFIRMATORY TESTING
22 - 4.11 REPORTING OF RESULTS
22 - 4.11.1 Conditions for reporting
22 - 4.11.2 Test report
23 - 4.12 RECORD KEEPING
24 - SECTION 5 LABORATORY CONFIRMATORY PROCEDURES
24 - 5.1 GENERAL
24 - 5.2 PRINCIPLE
24 - 5.3 APPARATUS
24 - 5.3.1 Gas chromatograph/mass spectrometer
24 - 5.3.2 Liquid chromatograph/mass spectrometer
24 - 5.3.3 Tandem mass spectrometry
24 - 5.4 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY TESTING AND STORAGE OF SPECIMENS
24 - 5.5 PERSONNEL
24 - 5.5.1 Laboratory management
24 - 5.5.2 Laboratory supervisor
25 - 5.5.3 Analyst
25 - 5.5.4 Review results
25 - 5.5.5 Accreditation
25 - 5.6 CONFIRMATION CRITERIA
25 - 5.7 INSTRUMENTATION
25 - 5.8 NUMBER OF DETERMINATIONS
26 - 5.9 BLANK DETERMINATION
26 - 5.10 INSTRUMENT SETUP
26 - 5.11 QUALITY CONTROL
26 - 5.12 CALCULATIONS
26 - 5.13 ACCEPTANCE CRITERIA
27 - 5.14 UNCERTAINTY OF MEASUREMENT
28 - 5.15 TEST REPORT
29 - 5.16 RECORD KEEPING
29 - 5.17 DISPUTED RESULTS
30 - APPENDIX A - ON-SITE SCREENING PROCEDURE
30 - A1 GENERAL
30 - A2 PERSONNEL
30 - A3 PROCEDURE
30 - A3.1 General
30 - A3.2 Requirements for on-site screening
31 - A3.3 Acceptance of results
31 - A4 REPORTING OF RESULTS
31 - A4.1 Test report
32 - A4.2 Record keeping
32 - A4.3 RECONCILIATION OF TEST RESULTS
33 - APPENDIX B - VERIFICATION OF PERFORMANCE OF ON-SITE DEVICES AROUND THE CUT-OFF
34 - APPENDIX C - CHAIN-OF-CUSTODY FORM
35 - APPENDIX D - RECOMMENDED PRECAUTIONS FOR HANDLING BIOLOGICAL SPECIMENS
35 - D1 GENERAL RECOMMENDATIONS
35 - D2 DISINFECTION OF SPILLS
36 - D3 DISINFECTION OF EQUIPMENT
36 - D4 WASTE DISPOSAL
36 - D5 BIBLIOGRAPHY
37 - APPENDIX E - PRINCIPLES OF OPERATION
37 - E1 GAS CHROMATOGRAPHY
37 - E2 GAS CHROMATOGRAPHY/MASS SPECTROMETRY
37 - E3 HIGH PRESSURE LIQUID CHROMATOGRAPHY
37 - E4 IMMUNOASSAY
38 - E5 LIQUID CHROMATOGRAPHY/MASS SPECTROMETRY
38 - E6 TANDEM MASS SPECTROMETRY(GC/MS/MS, LC/MS/MS)

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.

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.

First published as AS 4308-1995.Jointly revised and designated as AS/NZS 4308:2001.Third edition 2008. Originated in Australia as AS 4308-1995. Previous edition AS/NZS 4308:2001. Third edition 2008.