1.3 DEFINITIONS

For the purpose of this Standard, the definitions below apply.

1.3.1 Accreditation: Assessment by a recognized body of the technical competence of a laboratory conducting

specific analysis as laid down in the Standard, or a collecting agency where both collection

procedures and on-site screenings are performed.

1.3.2 Adulterant: A substance used to compromise, or attempt to compromise, the integrity of a urine specimen.

1.3.3 Amphetamine type substances (Sympathomimetic amines): Amphetamine, benzylpiperazine, ephedrine, methylamphetamine,

methylenedioxyamphetamine (MDA), methylenedioxymethylamphetamine (MDMA), phentermine and pseudoephedrine.

1.3.4 Benzodiazepines: Alprazolam, clonazepam, diazepam, flunitrazepam, nitrazepam, oxazepam, temazepam and/or their metabolites.

1.3.5 Blind testing: Testing where the true result is unknown to the operator at the time of the analysis.

1.3.6 Calibration standard: A drug-free urine to which has been added a reference compound at a known concentration

for the purpose of defining the calibration and linearity of the analytical method.

1.3.7 Cannabinoids: Any number of urinary metabolites of tetrahydrocannabinol.

1.3.8 Cannabis metabolite: 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic acid.

1.3.9 Chain-of-custody: A series of procedures to account for the integrity of each specimen by tracking its handling

and storage from point of specimen collection to final disposal of the urine.

1.3.10 Chain-of-custody form: A form to be used from time of collection of the specimen to its receipt by the laboratory as

well as dispatch between laboratories. Thereafter, appropriate documentation accounts for the urine or aliquots within the laboratory.

1.3.11 Cocaine metabolites: Benzoyl ecgonine and ecgonine methyl ester.

1.3.12 Collecting agency: An organization assuming professional, organizational, educational and administrative

responsibility for collection, on-site screening (if applicable), storage and dispatch of the urine specimen.

NOTES:

1 Responsibility for on-site screening is dependent on accreditation.

2 The requesting authority also may operate as a collecting agency.

3 Medical advisors such as a Medical Review Officer (MRO) may be used to provide advice.

1.3.13 Collecting site: A place where a donor provides a specimen of his/her urine.

NOTE: On-site screening may be conducted at the collecting site.

1.3.14 Collector: A person who has successfully completed a course of instruction for specimen collection and on-site screening (if applicable), handling, storage and dispatch of specimens and who has received a statement of attainment in accordance with The Australian Quality Training Framework or New Zealand Qualification Authority.

1.3.15 Concentration: Mass of a substance in a defined volume. Concentration may be expressed in micrograms per litre (μg/L). Where concentration is very low, the mass may be expressed as nanograms, or similar units as appropriate. One microgram per litre (μg/L) is equivalent to one nanogram per millilitre (ng/mL).

1.3.16 Confirmatory test: An analytical procedure that uses mass spectrometry to unequivocally identify the presence of a specific drug and/or metabolite.

NOTE: This should be carried out on a fresh aliquot taken from the original specimen.

1.3.17 Control specimen: A specimen containing drugs or drug metabolites at a recognized concentration and

prepared wherever possible from a different source to the calibration standard for the purpose of evaluating the acceptability of a test result.

1.3.18 Cut-off concentration: A value at or above which the drug/metabolite is deemed to be ‘detected’ and below which

the drug/metabolite is deemed to be ‘not detected’.

NOTE: In some contexts the words positive and negative are used respectively for detected and

not detected.

1.3.19 Donor: A person who provides a urine specimen to be assessed for the presence of drugs and/or metabolites.

1.3.20 Drug free: A urine specimen demonstrated to be free of all drugs and/or metabolites as related to this Standard.

1.3.21 Integrity testing: Tests for substances that affect the detection or quantitation of drugs or metabolites in the specimen.

1.3.22 Laboratory: A testing facility accredited against AS/NZS 4308 at which the analytical procedures are carried out to screen for and/or confirm the presence of a specific drug or metabolite.

NOTE: The above definition excludes a collecting agency that performs on-site screening only.

1.3.23 On-site drug screening device: An immunoassay device used to exclude the presence of drugs and/or metabolites in urine

at the site of specimen collection and which has been verified in accordance with Appendix B.

1.3.24 On-site screening: A screening test carried out at the point of collection.

1.3.25 Opiates: 6-acetylmorphine, codeine, morphine.

1.3.26 Permanent record system: A system in which identifying data on each specimen collected at the collecting site are permanently recorded in the sequence of collection.

1.3.27 Proficiency testing program: A series of tests to ensure that a laboratory or organizations conducting on-site screening can operate at a level of proficiency in accordance with this Standard.

1.3.28 Referee specimen: An aliquot of the original specimen that has been decanted into a separate container which is to be sealed at the point of collection and subsequently transported and securely stored at the laboratory for analysis in the event of any disputed result(s).

1.3.29 Reference compound: Primary material of certified purity or secondary material traceable to a primary standard.

1.3.30 Requesting authority: An individual, agency or organization that requests and ensures that collection and testing of a donor’s urine for the presence of drugs and the reporting of results are in compliance with this Standard.

NOTE: In some organizations medical advisors such as a Medical Review Officer (MRO) may be used to review test results.

1.3.31 Sample: A portion or aliquot taken from the specimen, on which the test or assay is actually carried out.

1.3.32 Screening tests: Methods used to exclude the presence of a drug or class of drugs and to identify whether specimen integrity is compromised.

1.3.33 Specimen: Urine collected from the donor.

1.3.34 Thermometer: A device used to determine the temperature of the collected specimen without contaminating it.

1.3.35 Uncertainty of measurement: A parameter associated with the result of a measurement that characterizes the dispersion of the values of analyte concentration that could reasonably be attributed to the analytical procedure.