AS/NZS 4308:2023
Procedures for specimen collection and the detection and quantification of drugs in urine
Standard sets out procedures for urine specimen collection, storage, handling, onsite drug screening tests and, if required, dispatch to a laboratory. It also covers applicability of urine for drug testing and general issues related to drug screening onsite and drug screening or confirmation in a laboratory.
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AS/NZS 4308:2023 Procedures for specimen collection and the detection and quantification of drugs in urine
Preface
Introduction
Section 1 Scope and general
1.1 Scope
1.2 Application
1.2.1 Drug analysis
1.2.2 Transitional period
1.3 Normative references
1.4 Terms and definitions
Section 2 Collection, storage, handling and dispatch
2.1 General
2.2 Collection site
2.2.1 General
2.2.2 Privacy
2.2.3 Security
2.2.4 Informed consent
2.2.5 Chain-of-custody
2.3 Integrity and identity of the collected specimen
2.3.1 General
2.3.2 Precautions
2.3.3 Collection procedure
2.4 Preparation for dispatch
2.5 Transportation to the laboratory
Section 3 Onsite screening test procedure
3.1 General
3.2 Access to expertise
3.3 Procedure
3.3.1 General
3.3.2 Requirements for onsite screening tests
3.3.3 Requirements for quality control and proficiency testing
3.4 Reporting of results
3.4.1 General
3.4.2 Conditions for reporting
3.4.3 Test report
3.4.4 Record keeping
3.4.5 Collation and reconciliation of test results
Section 4 General laboratory requirements
4.1 General
4.2 Reagents
4.3 Apparatus
4.3.1 Volumetric glassware
4.3.2 Piston-operated volumetric apparatus
4.4 Laboratory security
4.5 Specimen reception and general acceptance criteria
4.5.1 Reception of specimens
4.5.2 General acceptance criteria
4.6 Specimen integrity testing
4.6.1 General
4.6.2 Creatinine concentration equal to or greater than 50 mg/L but less than 200 mg/L
4.6.3 Creatinine less than 50 mg/L
4.6.4 Other substances
4.7 Collation and reconciliation of test results
4.8 Storage of specimens
4.8.1 Short-term storage
4.8.2 Long-term storage
Section 5 Laboratory screening procedures
5.1 General
5.2 Method
5.3 Laboratory personnel
5.3.1 Laboratory manager
5.3.2 Laboratory supervisor
5.3.3 Laboratory analyst
5.3.4 Access to expertise
5.3.5 Acceptance of results
5.3.6 Review of results
5.4 Number of determinations
5.5 Calibration
5.6 Blank determination
5.7 Quality control
5.8 Screening test cut-off levels
5.9 Acceptance criteria
5.10 Interpretation of results
5.11 Reporting of results
5.11.1 Conditions for reporting
5.11.2 Test report
5.12 Record keeping
Section 6 Laboratory confirmatory procedures
6.1 General
6.2 Principle
6.3 Apparatus
6.4 Laboratory personnel
6.4.1 Laboratory manager
6.4.2 Laboratory supervisor
6.4.3 Laboratory analyst
6.4.4 Access to expertise
6.4.5 Acceptance of results
6.4.6 Review results
6.5 Confirmation procedures
6.6 Instrumentation
6.7 Number of determinations
6.8 Instrument setup
6.9 Blank determination
6.10 Quality control
6.11 Calculations
6.12 Interpretation of results
6.13 Acceptance criteria
6.13.1 General
6.13.2 Mass spectrometric detection
6.14 Test report
6.15 Record keeping
6.16 Disputed results
Appendix A (normative) Additional and optional testing
Appendix B (normative) Verification of performance of devices used for the collection, onsite testing, transportation and storage of urine specimens
Appendix C (informative) Recommended precautions for handling biological specimens
Appendix D (informative) Principles of operation
Appendix E (informative) Roles in facilities
Bibliography
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AS/NZS 4308:2023 Procedures for specimen collection and the detection and quantification of drugs in urine
Preface
Introduction
Section 1 Scope and general
1.1 Scope
1.2 Application
1.2.1 Drug analysis
1.2.2 Transitional period
1.3 Normative references
1.4 Terms and definitions
Section 2 Collection, storage, handling and dispatch
2.1 General
2.2 Collection site
2.2.1 General
2.2.2 Privacy
2.2.3 Security
2.2.4 Informed consent
2.2.5 Chain-of-custody
2.3 Integrity and identity of the collected specimen
2.3.1 General
2.3.2 Precautions
2.3.3 Collection procedure
2.4 Preparation for dispatch
2.5 Transportation to the laboratory
Section 3 Onsite screening test procedure
3.1 General
3.2 Access to expertise
3.3 Procedure
3.3.1 General
3.3.2 Requirements for onsite screening tests
3.3.3 Requirements for quality control and proficiency testing
3.4 Reporting of results
3.4.1 General
3.4.2 Conditions for reporting
3.4.3 Test report
3.4.4 Record keeping
3.4.5 Collation and reconciliation of test results
Section 4 General laboratory requirements
4.1 General
4.2 Reagents
4.3 Apparatus
4.3.1 Volumetric glassware
4.3.2 Piston-operated volumetric apparatus
4.4 Laboratory security
4.5 Specimen reception and general acceptance criteria
4.5.1 Reception of specimens
4.5.2 General acceptance criteria
4.6 Specimen integrity testing
4.6.1 General
4.6.2 Creatinine concentration equal to or greater than 50 mg/L but less than 200 mg/L
4.6.3 Creatinine less than 50 mg/L
4.6.4 Other substances
4.7 Collation and reconciliation of test results
4.8 Storage of specimens
4.8.1 Short-term storage
4.8.2 Long-term storage
Section 5 Laboratory screening procedures
5.1 General
5.2 Method
5.3 Laboratory personnel
5.3.1 Laboratory manager
5.3.2 Laboratory supervisor
5.3.3 Laboratory analyst
5.3.4 Access to expertise
5.3.5 Acceptance of results
5.3.6 Review of results
5.4 Number of determinations
5.5 Calibration
5.6 Blank determination
5.7 Quality control
5.8 Screening test cut-off levels
5.9 Acceptance criteria
5.10 Interpretation of results
5.11 Reporting of results
5.11.1 Conditions for reporting
5.11.2 Test report
5.12 Record keeping
Section 6 Laboratory confirmatory procedures
6.1 General
6.2 Principle
6.3 Apparatus
6.4 Laboratory personnel
6.4.1 Laboratory manager
6.4.2 Laboratory supervisor
6.4.3 Laboratory analyst
6.4.4 Access to expertise
6.4.5 Acceptance of results
6.4.6 Review results
6.5 Confirmation procedures
6.6 Instrumentation
6.7 Number of determinations
6.8 Instrument setup
6.9 Blank determination
6.10 Quality control
6.11 Calculations
6.12 Interpretation of results
6.13 Acceptance criteria
6.13.1 General
6.13.2 Mass spectrometric detection
6.14 Test report
6.15 Record keeping
6.16 Disputed results
Appendix A (normative) Additional and optional testing
Appendix B (normative) Verification of performance of devices used for the collection, onsite testing, transportation and storage of urine specimens
Appendix C (informative) Recommended precautions for handling biological specimens
Appendix D (informative) Principles of operation
Appendix E (informative) Roles in facilities
Bibliography
Previous versions
AS/NZS 4308:2023
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.