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)