1.3 DEFINITIONS

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

1.3.1 Accreditation: Independent attestation related to a collecting agency or laboratory conveying formal demonstration of its technical competence.

1.3.2 Adulteration: The addition of a substance in-vivo or in-vitro, excluding those integral to the on-site collection and or testing process, which may compromise the integrity of the specimen.

1.3.3 Amphetamine-type stimulants: Amphetamine-type stimulants (ATS) may include, but are not necessarily limited to, the following: amphetamine, methylamphetamine, methylenedioxymethylamphetamine (MDMA), methylenedioxyamphetamine (MDA).

1.3.4 Analyst A person with a suitable tertiary qualification who has appropriate training and experience to perform laboratory drug testing of biological fluids.

1.3.5 Calibrator: A sample matrix containing an analyte at a known concentration used to determine the response of an assay.

1.3.6 Cannabis: This Standard refers to Δ 9-tetrahydrocannabinol (THC) as the target substance.

1.3.7 Chain-of-custody: A series of procedures to account for the integrity of each oral fluid specimen by tracking its handling and storage from point of specimen collection to final disposal of the specimen.

1.3.8 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.

NOTE: Within the laboratory appropriate documentation can account for the specimen or specimen aliquots.

1.3.9 Cocaine and metabolites: Cocaine, benzoyl ecgonine and ecgonine methyl ester.

1.3.10 Collecting agency: An accredited organization to assume professional, organizational, educational and administrative responsibility for collection, initial testing if applicable, storage and dispatch of the oral fluid specimen.

1.3.11 Collection device: A device that consists of one or more components designed to collect oral fluid and incorporates an adequacy indicator.

NOTES:

1 The device may contain a fluid designed to facilitate the analysis.

2 It may include absorbent material or a tube to directly receive the oral fluid.

1.3.12 Collection site: A place at which the specimen collection occurs and where initial testing procedures may be conducted.

1.3.13 Collector: A person who has successfully completed a course of instruction in compliance with this Standard for specimen collection, storage, handling and dispatch and received a statement of attainment in accordance with the Australian Quality Training Framework.

1.3.14 Concentration: Quantity of a substance in a defined volume or mass. Concentration may be expressed in nanograms per millilitre (ng/mL). Other units may also be used as appropriate, e.g. micrograms per litre, μg/L or nanograms per gram (ng/g).

1.3.15 Confirmation: Process that unequivocally determines the presence of a specific drug or metabolite above the relevant target concentration.

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

1.3.17 Confirmed negative: A result at or below the target concentration following confirmatory testing.

1.3.18 Confirmed positive: A result above the target concentration following confirmatory testing.

1.3.19 Control specimen: An oral fluid specimen containing drugs and/or drug metabolites at known concentrations.

1.3.20 Donor: A person who provides an oral fluid specimen to be assessed for the presence of drugs.

1.3.21 Drug: A substance that has a physiological effect on the body either itself or through its metabolite(s). The term ‘drug’ refers to the drug and/or its metabolite(s) for the purpose of detecting a target drug in oral fluid.

1.3.22 Drug-free specimen: An oral fluid specimen demonstrated to be free of all drugs and drug metabolites being tested.

1.3.23 Initial testing: A valid method used to exclude the presence of a drug or class of drugs. NOTE: This is also known as a screening test.

1.3.24 Laboratory: A place at which the analytical procedures are conducted.

NOTES:

1 The laboratory could include a laboratory service with a uniform quality system under the

same administration.

2 The laboratory or laboratory service undertaking analysis according to this Standard should

be accredited to the Standard or forensic equivalent.

1.3.25 Laboratory specimen: A specimen prepared for sending to the laboratory and intended for inspection and testing.

1.3.26 Laboratory record system: A book in which identifying data on each specimen collected are permanently recorded.

NOTE: Other systems which permanently record these data may be used in place of the permanent record book.

1.3.27 Negative result: A result at or below the nominated or target concentration used for initial testing.

1.3.28 Nominated concentration: A concentration expressed in units such as ng/mL, above which the drug is deemed to be ‘unconfirmed’, and at which a manufacturer or laboratory can show that a drug or a drug metabolite can be reliably detected by the initial testing and for which performance specifications are available.

NOTE: See Clause 1.5 and Sections 4 and 5 for further information.

1.3.29 On-site: A place at which the specimen collection occurs and where initial testing procedures may be conducted.

1.3.30 Opiates: Opiates may include but are not necessarily limited to the following: morphine, codeine and 6-acetylmorphine.

1.3.31 Oral fluid specimen: Secretions in the oral cavity emanating predominantly from the major and accessory salivary glands.

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

1.3.33 Proficiency testing program (Initial testing): A series of qualitative tests to ensure that a collecting agency performing initial testing can operate at a level of proficiency in accordance with this Standard.

1.3.34 Proficiency testing program (Laboratory): A series of both qualitative and quantitative tests to ensure that a laboratory can operate at a level of proficiency in accordance with this Standard.

1.3.35 Referee specimen: A second container of the collected specimen or additional specimen collected contemporaneously which is sealed at the point of collection and subsequently transported and securely stored at the confirmatory testing laboratory for analysis in the event of a disputed analysis.

1.3.36 Requesting authority: An individual, agency or organization that requires assessment of a donor’s oral fluid for the presence of drugs and to which the result of the assessment is reported.

1.3.37 Target concentration: A concentration expressed in units such as ng/mL, that is sufficient to detect drug use by the donor.

NOTE: See Clause 1.5 and Sections 4 and 5 for further information.

1.3.38 Technician: A person who conducts on-site testing. This person has successfully completed a course of instruction in compliance with this Standard for on-site testing and received a statement of attainment in accordance with the Australian Quality Training Framework.

1.3.39 Test portion: The portion of material taken from the laboratory specimen on which the test or assay is actually carried out.

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

1.3.41 Unconfirmed result: A result that requires confirmatory testing of the specimen to unequivocally determine the presence or absence of a drug.