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)