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

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AS/NZS 4308:2008

Australian/New Zealand Standard™

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



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AS/NZS 4308:2008

This Joint Australian/New Zealand Standard was prepared by Joint Technical
Committee CH-036, Analysis of Body Fluids and Wastes. It was approved on behalf
of the Council of Standards Australia on 21 January 2008 and on behalf of the
Council of Standards New Zealand on 25 January 2008.
This Standard was published on 19 March 2008.


The following are represented on Committee CH-036:



Air New Zealand

Australasian Railway Association

Australasian Association of Clinical Biochemists

Australian Council of Trade Unions

Australian Institute of Medical Scientists

Institute of Environmental Science and Research, New Zealand

Institute of Medical and Veterinary Science

Medical Industry Association, New Zealand

National Association of Testing Authorities

National Drug and Alcohol Research Centre

National Institute of Forensic Science

National Measurement Institute

Path West Laboratory Medicine, WA

Pacific Laboratory Medicine Services

Queensland Health Scientific Services

Royal College of Pathologists of Australasia

Royal Prince Alfred Hospital

South Eastern Area Laboratory Services

Victorian Institute of Forensic Medicine

WorkCover New South Wales


Additonal Interests:



NSW Nurses Association

Rail, Tram and Bus Union



Keeping Standards up-to-date

Standards are living documents which reflect progress in science, technology and
systems. To maintain their currency, all Standards are periodically reviewed, and
new editions are published. Between editions, amendments may be issued.
Standards may also be withdrawn. It is important that readers assure themselves
they are using a current Standard, which should include any amendments which
may have been published since the Standard was purchased.

Detailed information about joint Australian/New Zealand Standards can be found by
visiting the Standards Web Shop at www.standards.com.au or Standards New
Zealand web site at www.standards.co.nz and looking up the relevant Standard in
the on-line catalogue.

Alternatively, both organizations publish an annual printed Catalogue with full
details of all current Standards. For more frequent listings or notification of
revisions, amendments and withdrawals, Standards Australia and Standards New
Zealand offer a number of update options. For information about these services,
users should contact their respective national Standards organization.

We also welcome suggestions for improvement in our Standards, and especially
encourage readers to notify us immediately of any apparent inaccuracies or
ambiguities. Please address your comments to the Chief Executive of either
Standards Australia or Standards New Zealand at the address shown on the back
cover.


This Standard was issued in draft form for comment as DR 07317.



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AS/NZS 4308:2008

Australian/New Zealand Standard™

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










































Originated in Australia as AS 4308—1995.
Previous edition AS/NZS 4308:2001.
Third edition 2008.

COPYRIGHT

© Standards Australia/Standards New Zealand

All rights are reserved. No part of this work may be reproduced or copied in any form or by

any means, electronic or mechanical, including photocopying, without the written

permission of the publisher.

Jointly published by Standards Australia, GPO Box 476, Sydney, NSW 2001 and Standards

New Zealand, Private Bag 2439, Wellington 6020

ISBN 0 7337 8564 6

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AS/NZS 4308:2008 2





PREFACE

This Standard was prepared by the Standards Australia/Standards New Zealand Committee

CH-036, Analysis of Body Fluids and Wastes to supersede AS/NZS 4308:2001, Procedures

for the collection, detection and quantitation of drugs of abuse in urine.

The objective of this Standard is to ensure that the detection of drugs in urine meets the

expectations for testing of specimens for medico-legal, workplace or court-directed

purposes. This Standard addresses appropriate procedures for the collection of urine, on-site

screening, handling and dispatch of specimens to the laboratory for screening and

confirmatory tests. Testing for clinical use or in sport is not covered.

This revision provides additional requirements for collection procedures, laboratory

screening procedures and quantitative laboratory confirmatory procedures. It also includes

an appendix specifying the requirements for optional on-site screening since this procedure

has become an established screening technique in a number of industries.

Statements expressed in mandatory terms in footnotes to tables are deemed to be

requirements of this Standard.

The terms ‘normative’ and ‘informative’ have been used in this Standard to define the

application of the appendix to which they apply. A ‘normative’ appendix is an integral part

of a Standard, whereas an ‘informative’ appendix is for information and guidance only.

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3 AS/NZS 4308:2008



CONTENTS

Page

FOREWORD.............................................................................................................................. 5

SECTION 1 SCOPE AND GENERAL

1.1 SCOPE ........................................................................................................................ 7

1.2 REFERENCED DOCUMENTS ................................................................................. 7

1.3 DEFINITIONS ............................................................................................................ 8

SECTION 2 SPECIMEN COLLECTION, STORAGE, HANDLING AND DISPATCH

2.1 GENERAL ................................................................................................................ 12

2.2 COLLECTING SITE................................................................................................. 12

2.3 INTEGRITY AND IDENTITY OF THE COLLECTED SPECIMEN ....................... 13

2.4 PREPARATION FOR DISPATCH ........................................................................... 14

2.5 TRANSPORTATION TO THE LABORATORY...................................................... 14

SECTION 3 GENERAL LABORATORY REQUIREMENTS

3.1 GENERAL ................................................................................................................ 15

3.2 REAGENTS .............................................................................................................. 15

3.3 APPARATUS............................................................................................................ 15

3.4 LABORATORY SECURITY .................................................................................... 15

3.5 SPECIMEN RECEPTION ......................................................................................... 16

3.6 SPECIMEN INTEGRITY TESTING ........................................................................ 16

3.7 RECONCILIATION OF TEST RESULTS................................................................ 16

3.8 STORAGE OF SPECIMENS .................................................................................... 16

SECTION 4 LABORATORY SCREENING PROCEDURES

4.1 GENERAL ................................................................................................................ 18

4.2 METHOD.................................................................................................................. 18

4.3 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY

TESTING AND STORAGE OF SPECIMENS.......................................................... 18

4.4 PERSONNEL ............................................................................................................ 18

4.5 NUMBER OF DETERMINATIONS......................................................................... 19

4.6 BLANK DETERMINATION .................................................................................... 19

4.7 QUALITY CONTROL.............................................................................................. 19

4.8 SCREENING TEST CUT-OFF LEVELS.................................................................. 19

4.9 ACCEPTANCE CRITERIA ...................................................................................... 19

4.10 CONFIRMATORY TESTING .................................................................................. 20

4.11 REPORTING OF RESULTS..................................................................................... 20

4.12 RECORD KEEPING ................................................................................................. 21

SECTION 5 LABORATORY CONFIRMATORY PROCEDURES

5.1 GENERAL ................................................................................................................ 22

5.2 PRINCIPLE............................................................................................................... 22

5.3 APPARATUS............................................................................................................ 22

5.4 LABORATORY SECURITY, SPECIMEN RECEPTION, SPECIMEN INTEGRITY

TESTING AND STORAGE OF SPECIMENS.......................................................... 22

5.5 PERSONNEL ............................................................................................................ 22

5.6 CONFIRMATION CRITERIA.................................................................................. 23

5.7 INSTRUMENTATION ............................................................................................. 23

5.8 NUMBER OF DETERMINATIONS......................................................................... 23

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AS/NZS 4308:2008 4





Page


5.9 BLANK DETERMINATION .................................................................................... 24

5.10 INSTRUMENT SETUP............................................................................................. 24

5.11 QUALITY CONTROL.............................................................................................. 24

5.12 CALCULATIONS..................................................................................................... 24

5.13 ACCEPTANCE CRITERIA ...................................................................................... 24

5.14 UNCERTAINTY OF MEASUREMENT................................................................... 25

5.15 TEST REPORT ......................................................................................................... 26

5.16 RECORD KEEPING ................................................................................................. 27

5.17 DISPUTED RESULTS.............................................................................................. 27

APPENDICES

A ON-SITE SCREENING PROCEDURE..................................................................... 28

B VERIFICATION OF PERFORMANCE OF ON-SITE DEVICES AROUND THE

CUT-OFF .................................................................................................................. 31

C CHAIN-OF-CUSTODY FORM ................................................................................ 32

D RECOMMENDED PRECAUTIONS FOR HANDLING

BIOLOGICAL SPECIMENS .................................................................................... 33

E PRINCIPLES OF OPERATION................................................................................ 35

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5 AS/NZS 4308:2008



FOREWORD

This Standard sets out the procedures for specimen collection, packaging and transportation

to a laboratory and the detection and quantitation of drugs in urine. This edition of the

Standard introduces the option of on-site screening.

After collection of the specimen, the Standard allows for either screening at the collecting

site or at a laboratory using the cut-off levels as specified in the Standard. If all test results

for drugs are negative and specimen integrity is not a question, then a final report is issued

at this stage.

As the results of screening are used for evidentiary purposes, it is necessary to ensure that

on-site and laboratory screenings are substantially equivalent.

For on-site screening, this necessitates the implementation of procedures such as quality

controls, proficiency testing, verification of testing devices, competency based training and

accreditation.

These procedures have been a requirement for laboratory testing in this Standard since its

inception and provide confidence in the quality of results obtained.

Any unconfirmed result requires laboratory confirmatory testing using mass spectrometry.

Figure 1 provides a flowchart showing the steps involved in specimen collection, screening,

confirmation and reporting results.



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AS/NZS 4308:2008 6







FIGURE 1 FLOWCHART T
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7 AS/NZS 4308:2008

COPYRIGHT

STANDARDS AUSTRALIA/STANDARDS NEW ZEALAND


Australian/New Zealand Standard

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




S E C T I O N 1 S C O P E A N D G E N E R A L

1.1 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.

1.2 REFERENCED DOCUMENTS

The following documents are referred to in this Standard.

AS

2162 Verification and use of volumetric apparatus

2162.1 Part 1: General—Volumetric glassware

2162.2 Part 2: Guide to the use of piston-operated volumetric apparatus (POVA)

2164 Laboratory glassware—One-mark volumetric flasks

2166 Laboratory glassware—One-mark pipettes

2167 Graduated straight pipettes

4633 Medical laboratories—Particular requirements for quality and competence

AS ISO/IEC

17025 General requirements for the competence of testing and calibration

laboratories

AS/NZS

2243 Safety in laboratories

2243.1 Part 1: Planning and operational aspects

2243.2 Part 2: Chemical aspects

2243.3 Part 3: Microbiological aspects and containment facilities

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