CASA 39/20 — Drug and Alcohol Testing by CASA under Subpart 99.C of CASR Instrument 2020

The instrument revolves around several interacting concepts: approved devices, staged testing, mandatory manufacturer compliance, sample identification and chain of custody, laboratory accreditation, and formal assignment and recordkeeping by the approving authority.

Approved devices: The instrument lists specific models approved for initial screening and, in some cases, confirmatory use. Schedule 1 Table 1 approves the Alcolizer LE5 for initial alcohol testing; Schedule 1 Table 2 approves the Drager Alcotest 9510 Aus for initial and confirmatory alcohol testing. Schedule 2 lists approved initial drug screening devices: Securetec DrugWipe 5S and Abbott SoToxa. These explicit approvals restrict the set of devices that CASA‑authorised testers may use under Subpart 99.C (s 5(1)-(2)).

Staged testing architecture: For drug testing the instrument prescribes a two‑stage screening process (Step 1 and Step 2) followed by laboratory confirmation where necessary. Schedule 3 sets detailed Step 1 procedures for DrugWipe 5S and Step 2 procedures for Abbott SoToxa. The rules define when Step 2 must follow Step 1 (for example, a Step 1 screening positive for a testable drug group triggers Step 2) and when an initial drug test is complete (for example, a Step 2 negative makes the initial drug test negative). Confirmatory testing procedures and sample preparation for laboratory submission are also set out (Schedule 3 item 2).

Mandatory manufacturer compliance and specified maintenance regimes: Multiple schedules make adherence to manufacturer instructions mandatory when storing, testing, maintaining and operating devices (Schedules 4 and 7). For some devices the instrument imposes additional constraints. For example, Abbott SoToxa requires inspection, cleaning, recalibration and other maintenance by Abbott or another approved person at least once every 12 months (Schedule 4, Table 2). The Alcolizer LE5 is to be configured with specific sampling and display parameters and includes a calibration lock that renders the device inactive if sample module recalibration has not been done within 12 months (Schedule 7, Table 1).

Sample identification and chain of custody: Schedule 5 prescribes the method for determining sample identifiers: CASA or a person authorised by CASA must approve sequences of sample identification numbers, assign sequences to approved testers, and maintain a record of assignments (Schedule 5 cl 2-4). When allocating a number to a sample, the approved tester must append the donor’s date of birth in dd/mm/yy format; the combined string constitutes the sample identifier (cl 5(2)-(3)). When a sample is split into Sample A and Sample B, the same allocated sample identification number must be placed on both tubes and each tube must be marked “Sample A” or “Sample B” (cl 6).

Laboratory accreditation: Schedule 8 declares ISO/IEC 17025‑2005 (as applied by NATA in Forensic Services on the recommendation of the Forensic Science Accreditation Advisory Committee) as another standard to which NATA may accredit a person who is to be approved by CASA to conduct confirmatory drug tests. This ties CASA’s approval of confirmatory laboratories to NATA accreditation to a specific international standard.

Institutional allocation and record obligations: The instrument centralises key administrative functions with CASA or its authorised delegate. The approving authority provides sequences of sample identification numbers, must ensure sufficient numbers are available, assigns them to approved testers, must not reassign a sequence already assigned, and must maintain a record and make it available to CASA on request (Schedule 5 cl 2-4, 7). The instrument also conditions aspects of approval on adherence to the declared standards and recordkeeping.

Together these concepts create a tightly specified operational framework for on‑site screening and laboratory confirmation within CASA’s statutory testing regime. The schedules operationalise the technical steps, the chain of custody, equipment maintenance and accreditation standards rather than creating novel substantive offences or penalties themselves.

This instrument affects several discrete groups in concrete ways: CASA as regulator and approving authority; approved testers and testing organisations; manufacturers and maintenance providers of the specified devices; accredited laboratories conducting confirmatory drug testing; donors (persons tested); and, indirectly, operators and employers who operate under CASA’s safety regime where testing is required.

CASA and its authorised persons: CASA (or a person authorised in writing by CASA) is explicitly the approving authority for assigning sample identification number sequences and for other administrative allocations (Schedule 5 cl 2-4). CASA also is the entity that approves laboratories in accordance with Part IV of the Civil Aviation Act and for which Schedule 8 declares a NATA accreditation standard. CASA therefore makes operational decisions, maintains assignment records and supervises adherence to the instrument’s requirements.

Approved testers and testing personnel: Approved testers are responsible for following the detailed procedures laid down in Schedules 3, 4, 6 and 7. That includes selecting the correct approved device for a given test (for example, using Alcolizer LE5 for initial alcohol testing or Drager 9510 for confirmatory alcohol testing where appropriate), following the stepwise drug testing procedures (DrugWipe Step 1 rules and SoToxa Step 2 rules), obtaining sufficient samples, affixing tamper‑evident seals, labelling Sample A and Sample B, allocating sample identification numbers according to Schedule 5, and following mandatory maintenance and operating instructions. Approved testers are also required to maintain records of sample identification sequences and return unused numbers on expiry or termination of their approval (Schedule 5 cl 4(4) and cl 7).

Manufacturers and maintenance providers: Designated manufacturers derive concentrated benefits. Only named models are approved and, for some devices, maintenance and calibration are specified to be conducted only by the manufacturer or a person approved by it. For example, Schedule 4 requires that inspection, cleaning, recalibration and maintenance of the Abbott SoToxa be carried out by Abbott or another person approved by it at least once every 12 months, and that necessary repairs be undertaken by Abbott or such an approved person (Schedule 4 Table 2). For the Alcolizer LE5, calibration of the Sample Module is to be undertaken only by the manufacturer or an agent approved by it (Schedule 7 Table 1). The instrument therefore creates demand for manufacturer services and restricts who can undertake certain maintenance tasks.

Accredited laboratories and NATA: Laboratories seeking CASA approval to perform confirmatory drug tests must be NATA‑accredited in accordance with the declared standard (Schedule 8). That connects laboratory approval to an international standard as applied by NATA in forensic services and therefore affects laboratory accreditation, quality systems and ongoing compliance.

Donors (persons tested): The instrument places procedural duties on donors indirectly through the testers’ duties. For example, an approved tester must ask a donor about consumption in the past 15 minutes and may delay testing where consumption is reported (Schedule 6 item 1 for Alcolizer LE5). The instrument states that if a donor consumes something after the initial sample until testing is completed, it may be considered that the donor has refused to give a sample (Schedule 6 item 1). Donors are also required to initial tamper‑evident seals on confirmatory samples, and samples are labelled with donor date of birth appended to a sample identification number.

Operators, employers and safety regimes: Organisations that operate under CASA‑regulated safety schemes and must submit to drug and alcohol testing will bear indirect costs from device purchases, consumables (mouthpieces, cartridges, Quantisal kits), maintenance contracts with named manufacturers, training of testers to follow the schedules and possible downtime if device calibration is not current. The instrument therefore imposes compliance costs on those who fund testing programs and on approved testers who must ensure devices and procedures meet CASA’s prescribed standards.

Other stakeholders: National Measurement Institute verification requirements for Drager devices (Schedule 7 Table 1) implicate measurement regulators and may affect who can service and verify devices. The instrument’s explicit requirement that only mouthpieces manufactured or supplied by the particular manufacturer be used may affect supply chains for consumables.

In sum, the instrument distributes responsibilities: CASA controls approvals and number sequences; testers implement procedures and maintain chain of custody; manufacturers supply approved models and, in some cases, perform or control maintenance; NATA and accredited labs provide confirmatory analysis; donors must cooperate with specified steps and initial tamper seals; operators and employers fund compliance costs and maintain access to approved devices and consumables.

Duties prescribed by the instrument fall on CASA (and its authorised delegates), approved testers, device operators, manufacturers where specified, and laboratories seeking CASA approval. The instrument also confers procedural rights that flow from the approvals process.

Duties of CASA and approving authority

• Approve and assign sequences of sample identification numbers, ensure sufficient sequences are available, assign them to approved testers in the order approved, and maintain records of those assignments and make the record available to CASA on request (Schedule 5 cl 2-4). CASA or a person authorised in writing by CASA performs these functions (cl 2).
• Approve breathalysers and drug testing devices for specified uses under Subpart 99.C (s 5(1)-(2)).
• Declare an accreditation standard for confirmatory drug testing laboratories, namely ISO/IEC 17025‑2005 as applied by NATA in forensic services (Schedule 8).

Duties of approved testers and operators

• Use only devices approved under the instrument for initial screening or confirmatory testing as specified (s 5(1)-(2); Schedule 1 and Schedule 2).
• Take and prepare body samples in the manner prescribed in Schedule 3 (drug testing) and Schedule 6 (alcohol testing); follow the stepwise rules on timing, reading windows and interpretation set out in Schedule 3 (for example, the DrugWipe Step 1 reading window of between 5 and 15 minutes and the rules about faint or developing indicator lines).
• Store, test, maintain and operate approved drug testing devices and breathalysers in accordance with the relevant schedules (Schedules 4 and 7), including mandatory compliance with manufacturer instructions and any device‑specific maintenance regime (for example, Abbott SoToxa annual maintenance and Alcolizer sampling module calibration lock).
• Allocate sample identification numbers in accordance with Schedule 5: use numbers assigned by the approving authority in order, append donor date of birth in dd/mm/yy format, ensure the combination forms the sample identifier, and when samples are split into Sample A and Sample B use the same allocated number on both tubes and label them (Schedule 5 cl 5-6).
• When taking confirmatory samples using Quantisal kits, follow the detailed procedures in Schedule 3 item 2, including use of tamper‑evident seals A and B (with C as backup), asking the donor to initial the seals, placing sealed transport tubes into clip‑seal transit pouches for dispatch, and recording required information.
• Maintain test records, produce and, where required by device procedures, print results (for example, Drager prints two copies for confirmatory alcohol tests; SoToxa requires two hardcopy printouts; Alcolizer printing is not required) and ensure that devices are configured or verified as specified (Schedules 4, 6, 7).

Duties of manufacturers and maintenance providers

• The instrument makes compliance with manufacturer instructions mandatory for storing, testing, maintaining and operating devices (Schedules 4 and 7). For Abbott SoToxa, maintenance must be by Abbott or an Abbott‑approved person at least once every 12 months and necessary repairs must be undertaken by Abbott or an Abbott‑approved person (Schedule 4 Table 2).
• For Alcolizer LE5, calibration and configuration of the Sample Module is limited to the manufacturer or an approved agent (Schedule 7 Table 1).

Duties of laboratories and NATA accreditation

• Laboratories approved by CASA to conduct confirmatory drug tests must hold accreditation to the declared standard (Schedule 8), namely ISO/IEC 17025‑2005 as applied by NATA in the field of Forensic Services on the recommendation of the Forensic Science Accreditation Advisory Committee.

Rights and constraints

• Approved testers have the right to be assigned sequences of sample identification numbers by the approving authority and to use devices approved by this instrument in their official role (Schedule 5 cl 4).
• CASA holds the administrative right to assign numbers, maintain records, and authorise persons in writing to perform those allocation functions (Schedule 5 cl 2).
• Manufacturers secure the right to control certain maintenance and calibration work for their devices where the instrument prescribes manufacturer‑only activity; that produces a practical exclusivity to provide maintenance and calibration services for approved devices (Schedules 4 and 7).
• Donors have procedural protections embedded in the steps (for example, the instrumental requirement that donors are asked about consumption and the 15‑minute waiting rule for alcohol), but the instrument also makes certain donor actions relevant to testing outcomes, for example that continuing to consume after being asked to refrain may be treated as a refusal (Schedule 6 item 1).

Non‑compliance implications in the instrument

• The instrument repeatedly states that compliance with manufacturer instructions is to be regarded as mandatory. Failure to comply means the device would not have been used “in accordance with” the instrument, with implications for whether the testing conformed to CASA‑approved procedures. The instrument requires recordkeeping (Schedule 5 cl 4(4)) and returns of unused sample numbers (cl 7) upon expiry or termination of an approved tester’s approval. The instrument itself does not prescribe penalties, but it sets out operational conditions whose breach would be non‑compliance with CASA’s testing framework under Subpart 99.C (see s 4 and s 5).

In short, duty allocation is precise: CASA governs approvals and sequences, testers execute tightly specified sampling and labelling steps, manufacturers may be required to perform maintenance and calibration, and laboratories must meet a declared NATA standard to be approved for confirmatory testing.

The instrument is a legislative instrument that prescribes devices, procedures and standards for testing under Subpart 99.C of CASR. It does not itself set out criminal offences, monetary penalties or explicit enforcement powers. The instrument's role is to provide technical and procedural prescriptions that operate within the enforcement architecture of CASR and the Civil Aviation Act 1988. The opening clauses make this relationship clear: s 4 states that this instrument is a legislative instrument providing for matters under Subpart 99.C of CASR, and s 5 links its approvals and procedures directly to the CASR provisions it implements (for example, paragraph 99.130(a), 99.130(b), regulation 99.140, subregulation 99.145(2), regulation 99.245 and subregulation 99.250(3)).

Enforcement mechanics therefore operate by reference. Subpart 99.C of CASR and Part IV of the Civil Aviation Act supply the statutory framework that creates powers, offences, approvals and sanctions that CASA can exercise. This instrument feeds into that regime by determining which devices and procedures constitute compliant practice. For example, the instrument requires that storing, testing, maintaining and operating devices be “in a manner not inconsistent with the manufacturer’s instructions” and states that compliance with recommended actions is mandatory (for example Schedule 4 and Schedule 7). A failure to follow those mandatory actions would be a failure to follow an instrument that forms part of the regulatory regime, potentially exposing an approved tester or testing organisation to action under CASR or the Act for non‑compliance with statutory testing requirements. The instrument itself, however, does not define the specific statutory penalties or administrative sanctions that CASA may impose; those are located in CASR and the Act.

Operational enforcement features in the instrument

• Assignment and recordkeeping obligations: The approving authority must keep records of the sequences of sample identification numbers it assigns and make that record available to CASA on request (Schedule 5 cl 4(4)). That imposes an enforceable administrative reporting duty on the approving authority and enables CASA oversight.
• Mandatory maintenance and calibration: The instrument requires maintenance and calibration to be performed in specified ways (for instance Abbott’s annual maintenance obligation in Schedule 4, and Alcolizer’s calibration lock in Schedule 7). Those requirements create technical conditions that, if not met, mean the device is not being used in accordance with the instrument.
• Accreditation linkage: Schedule 8 ties CASA’s approval of confirmatory laboratories to NATA accreditation to a specified standard. NATA accreditation is a precondition for CASA approval. If a laboratory ceases to hold the declared accreditation, CASA’s approval criteria would not be met.
• Procedural integrity: The instrument prescribes chain‑of‑custody steps (tamper‑evident seals, donor initials, Sample A/B labelling, and the requirement to return unused sample identification numbers when approval ceases). These steps are designed to preserve evidentiary integrity and to support enforcement actions that rely on test results.

Practical enforcement pathway

• CASA exercises oversight by issuing approvals, assigning sample number ranges, requiring adherence to the schedules and retaining records. Non‑compliance by approved testers or laboratories would be addressed under CASA’s regulatory powers in CASR and the Civil Aviation Act rather than by sanctions in this instrument. For example, if a device were used out of specification or a confirmatory laboratory lacked NATA accreditation to the declared standard, CASA could treat tests so performed as not conforming to its approved procedures and could take administrative action under its statutory powers, including suspension or revocation of approvals. The instrument itself does not specify those actions; it supplies the technical baseline against which CASA’s statutory enforcement operates.

In summary, enforcement and penalties are not created by this instrument but are implemented through CASA’s regulatory apparatus under CASR and the Civil Aviation Act, with the instrument supplying the technical prescriptions and recordkeeping that make enforcement administrable.

This instrument is expressly framed as an instrument made under and for the purposes of specified provisions of the Civil Aviation Safety Regulations 1998. Section 4 describes the instrument as providing for matters under Subpart 99.C of CASR. Section 5 makes specific references to paragraphs and regulations of CASR as the statutory hooks that the instrument fills: paragraph 99.130(a) (approval of breathalysers), paragraph 99.130(b) (approval of drug testing devices), regulation 99.140 (procedures for taking and preparing body samples for drug testing), subregulation 99.145(2) (storing, testing, maintaining and operating an approved device for initial drug testing), regulation 99.150 (sample identifiers), regulation 99.245 (procedures for body samples for alcohol testing), subregulation 99.250(3) (storing, testing, maintaining and operating a breathalyser for initial alcohol testing), and paragraph 99.445(3)(b) (standards for NATA accreditation of labs approved by CASA under Part IV of the Civil Aviation Act 1988) (s 5(1)-(8)).

Relationship with the Civil Aviation Act 1988 and Part IV

• The instrument attaches to Part IV of the Civil Aviation Act where approval of confirmatory drug testing laboratories is concerned. Schedule 8 declares a standard to which NATA may accredit a person if that person is to be approved by CASA to conduct confirmatory drug tests for the purposes of Part IV of the Act. Consequently, the instrument does not supplant the Act but provides the technical accreditation standard that will be applied within the Part IV approval process.

NATA accreditation and standards regime

• Schedule 8 declares ISO/IEC 17025‑2005 as another standard for NATA accreditation “as applied by the National Association of Testing Authorities in the field of Forensic Services on the recommendation of the Forensic Science Accreditation Advisory Committee.” That declaration links CASA’s laboratory approval process to the NATA accreditation regime, which is itself governed by national accreditation practice and NATA’s procedures. The declared standard is an external technical standard that becomes incorporated by reference via this instrument.

National Measurement Institute and verification standards

• Schedule 7 imposes a requirement for verification of the Drager Alcotest 9510 Aus to National Measurement Institute standard R126 so that, after verification, only time and date or location may be varied by another person. That interaction brings measurement law and verification standards into the CASA testing regime. The instrument thus cross‑references NMI verification requirements which have independent statutory and technical standing.

Legislation Act 2003 and administrative form

• The table of amendments shows that certain provisions were repealed with reference to the Legislation Act 2003 (see table of amendments: s 2 rep. Legislation Act 2003 s 48D; s 3 rep. Legislation Act 2003 s 48C). That indicates the instrument’s form and notes have been adjusted to reflect broader Commonwealth legislative drafting and publishing rules.

Admissibility, evidentiary effect and procedural consequence

• While the instrument does not itself define evidentiary rules, by prescribing precise devices, procedural steps, lab accreditation standards and chain‑of‑custody safeguards (tamper‑evident seals, sample identification rules), it creates a compliance baseline against which courts, tribunals or administrative processes may evaluate the reliability and admissibility of test results obtained under CASA’s Subpart 99.C regime. The instrument’s detailed technical requirements will therefore interact functionally with evidentiary and administrative law even though it does not alter substantive criminal or disciplinary offences.

Operational compliance with other statutory regimes

• The instrument’s prescriptions (for example, manufacturer‑only maintenance for certain devices and NATA accreditation for confirmatory labs) affect how testing organisations comply with procurement, contract and occupational safety obligations. The requirement that certain consumables and mouthpieces only be those manufactured or supplied by the device manufacturer has implications for procurement law and supply chain compliance.

In short, this instrument operates as a detailed technical adjunct to the statutory powers and duties in CASR and the Civil Aviation Act, and it deliberately imports and references other national technical regimes (NATA accreditation to ISO/IEC 17025‑2005, NMI verification standard R126) so that CASA’s testing framework interoperates with national measurement and accreditation law.

This compilation was prepared on 3 July 2025 and takes into account amendments up to CASA 29/25, see the compilation notice at the head of the instrument. The instrument as originally registered was CASA 39/20 , Drug and Alcohol Testing by CASA under Subpart 99.C of CASR Instrument 2020, registered 3 August 2020 and commencing 4 August 2020 (Table of instruments). Subsequent amendment instruments recorded in the compilation are:

• CASA 69/24 , CASA 39/20 (Drug and Alcohol Testing by CASA under Subpart 99.C of CASR) Amendment Instrument 2024, registered 10 December 2024, commencing 11 December 2024.
• CASA 29/25 , CASA 39/20 (Drug and Alcohol Testing by CASA under Subpart 99.C of CASR) Amendment Instrument 2025, registered 2 July 2025, commencing 3 July 2025.

The embedded table of amendments in the compilation identifies specific provisions affected by the amendment instruments. The compilation’s amendment table records the following changes (as described in that table):

• s 2 rep. Legislation Act 2003, s 48D (repeal noted).
• s 3 rep. Legislation Act 2003, s 48C (repeal noted).
• Schedule 1, Table 1: rs. F2025L00822 (repealed and substituted by the 2025 instrument).
• Schedule 3, Table 1: am. F2024L01627, rs. F2025L00822 (amended in 2024 and repealed and substituted in 2025).
• Schedule 4, Table 2: am. F2025L00822 (amended 2025).
• Schedule 6, Table 1: am. F2025L00822 (amended 2025).
• Schedule 7, Table 1: am. F2025L00822 (amended 2025).

The compilation also shows that certain tables and items were changed across the 2024 and 2025 amendments. For example, Schedule 3 was amended in 2024 and then repealed and substituted in 2025 (see the table). Schedule 1, Table 1 was repealed and substituted by the 2025 amendment. The exact textual replacements are contained in the revised schedules of the 2025 instrument as reflected in this compilation.

The compilation includes its own internal editorial notes and the FRLI registration details for the original instrument and the two amendment instruments. The instrument’s structure and content as presented in this compilation therefore reflect those amendments up to and including CASA 29/25 (registered 2 July 2025, commencing 3 July 2025). The compilation does not include any amendment beyond CASA 29/25.

For a practitioner assessing a historical trajectory or compliance obligations, these amendment records show that the instrument has been actively maintained and that device approvals, procedural steps and maintenance requirements have been the subject of recent change. The compilation itself is the authoritative text incorporating those changes as at 3 July 2025.

The instrument as compiled does not cite or record any litigation history. It does not name any decisions or judicial consideration of the instrument’s provisions. The text contains no references to cases, judicial interpretations or litigation outcomes.

Practically, this means that there is no adjudicated body of case law set out within the instrument to guide interpretation of its technical provisions. Any disputes that might arise about compliance with the instrument (for example, whether a tester followed the specified reading window for a DrugWipe device, whether a sample identifier was correctly allocated, or whether a laboratory held the requisite NATA accreditation) would have to be resolved through the usual administrative and judicial channels under CASR, the Civil Aviation Act, or more generally through courts or tribunals with jurisdiction over administrative or evidentiary issues. The instrument’s detailed procedural prescriptions will function as primary source material in such disputes, but the compilation itself contains no report of decisions applying those rules.

Where judicial or administrative review occurs, parties and decision‑makers will need to reconcile the instrument’s precise technical steps, mandatory manufacturer‑compliance language and documentation requirements against the statutory powers, rights and obligations in CASR and the Civil Aviation Act. In the absence of an existing litigation record in the instrument, practitioners should expect that contested matters may focus on factual compliance with the detailed steps (timing windows, tamper seals, sample identifiers, device configuration and maintenance logs), on the integrity of chain of custody, and on whether confirmatory laboratories retained current NATA accreditation to the declared standard.

Because the instrument ties laboratory approval to NATA accreditation as applied in forensic services (Schedule 8) and requires specific maintenance and verification standards for equipment (Schedules 4 and 7), disputes are likely to implicate technical evidence and expert testimony about device operation, calibration validity and laboratory quality assurance. The instrument itself offers no adjudicative guidance; therefore administrative records, device logs, maintenance certificates and NATA accreditation certificates will be central evidentiary materials in any enforcement or dispute resolution process.

The instrument contains many precise, technical rules that create a range of practical traps for the unwary. Key “gotchas” drawn directly from the schedules are set out below.

Device exclusivity and maintenance dependency

• For certain devices maintenance, recalibration and repairs are required to be undertaken only by the manufacturer or a person approved by the manufacturer. For Abbott SoToxa, inspection, cleaning, recalibration and other maintenance must be carried out by Abbott or an Abbott‑approved person at least once every 12 months, and necessary repairs must likewise be by Abbott or an Abbott‑approved person (Schedule 4 Table 2). For the Alcolizer LE5, calibration and configuration of the Sample Module is to be undertaken only by the manufacturer or an agent approved by it (Schedule 7 Table 1). This creates operational dependency on manufacturer service networks and can produce downtime if service agreements are not in place.

Calibration lock and verification constraints

• The Alcolizer LE5 has a calibration lock that renders the device inactive if the Sample Module recalibration has not been undertaken in the last 12 months (Schedule 7 Table 1). If a testing organisation does not track calibration dates, devices may become inactive at inopportune times.
• The Drager Alcotest 9510 Aus must be verified to National Measurement Institute standard R126 such that after verification only time, date and location may be varied by another person (Schedule 7 Table 1). This restricts who may verify or authorise certain changes and may limit workshop flexibility.

Strict reading windows and interpretation rules for drug screens

• DrugWipe Step 1 (Schedule 3 item 1(a)) requires readings between 5 and 15 minutes after breaking the ampoule. Any indicator line or part of an indicator line that appears before 5 minutes must not be ignored even if it subsequently develops further before 15 minutes; conversely, any line appearing after 15 minutes must be ignored. “Part of an indicator line” includes faint, interrupted or irregular lines. These fine timing and reading rules are technical and could be decisive in challenging the result’s proper interpretation if not rigorously followed.

Two‑step and confirmatory sequencing

• The instrument requires Step 2 (SoToxa) only where Step 1 (DrugWipe) is screening positive for a testable drug group. If Step 2 returns a positive result for any testable drug group, the initial drug test is positive for each group that was positive at Step 1 or Step 2 (Schedule 3 item 1(b)). Misordering or failing to carry out Step 2 where required could render an initial test non‑compliant with the instrument.

Sample identification pitfalls

• Sample identifiers are the combination of the allocated sample identification number and the donor’s date of birth in dd/mm/yy form (Schedule 5 cl 5(2)-(3)). This exact format is mandatory. Approved testers must not allocate the same sample identification number to more than one body sample except when splitting a sample into Sample A and Sample B , in that case the same allocated number is used on both tubes and each tube must be marked Sample A or Sample B (cl 6). Failures in formatting, duplications, or mislabelling can invalidate chain‑of‑custody integrity under the instrument.

Tamper‑evident seal procedure for confirmatory samples

• Quantisal confirmatory sample preparation requires two tamper‑evident seals marked “A” and “B”, donor initials on those seals, and placement of sealed transport tubes into a clip‑seal transit pouch for dispatch (Schedule 3 item 2). If a tamper‑evident seal is damaged while fixing, the instrument requires the use of tamper‑evident seal C as a replacement. Omitting donor initials or failing to fix seals correctly are procedural errors specified in the instrument.

Consumables and mouthpiece restrictions

• The instrument requires that only mouthpieces manufactured or supplied by the device manufacturer be used for certain devices (for example Alcolizer LE5 and Drager 9510 Aus , Schedule 7 Table 1; Alcolizer Schedule 7 Table 1 also states only mouthpieces manufactured or supplied by Alcolizer Pty Ltd are to be used). Using third‑party consumables may be non‑compliant.

Cartridge and silica gel checks for SoToxa

• The SoToxa Step 2 procedure requires visual checks of the silica gel pack colour. If the majority of beads are green, the cartridge must not be used as its performance may have been compromised (Schedule 3 item 1(b)). Cartridges with a burst silica gel pack must not be used. Missing or incorrect cartridge checks risk invalidation of the test procedure.

QC lockout and PQC tests for SoToxa

• If a QC test has not been conducted within the defined time interval, the device will display a QC lockout and require a PQC cartridge test before further testing (Schedule 3 item 1(b)). Testing organisations must maintain QC schedules and supplies of PQC cartridges to avoid lockout interruptions.

Time rules for alcohol testing

• For initial alcohol testing with Alcolizer LE5 the approved tester must first ask the donor if they consumed anything in the preceding 15 minutes and, if so, wait until at least 15 minutes have elapsed since the query before conducting the test (Schedule 6 item 1). If the donor then consumes anything further (except water) until testing, testing may be considered refused. These tight time rules may interact with donor conduct and operational realities (for example, where multiple donors are tested sequentially).

Printing and record capture differences

• Devices differ in print and record obligations. SoToxa requires two hardcopy printouts of results for each test (Schedule 3 item 1(b)). Drager prints two copies for confirmatory alcohol tests (Schedule 6 item 2). Alcolizer does not require printing (Schedule 7 Table 1 states printing is not required). Inconsistent record capture across devices may produce evidentiary gaps if personnel assume a uniform printing obligation.

Allocation and return of unused sample numbers

• When an approved tester’s approval expires or is otherwise terminated, any assigned but unused sample identification numbers must be returned to the assigning approving authority and the authority must note the return in its record (Schedule 5 cl 7). Failing to return unused numbers or to keep records may create administrative non‑compliance.

In practice these technical rules impose multiple small operational steps that, taken together, create substantial compliance complexity. Testing organisations must build checklists, supply chains, manufacturer service contracts, device QC timetables and recordkeeping systems to avoid operational errors that the instrument itself declares mandatory to follow.

Compliance requires operationalising the instrument’s device approvals, procedural steps, maintenance obligations, sample identification rules and recordkeeping requirements. The following practical checklist and procedural roadmap follows the instrument’s prescriptions and cites the relevant schedules and clauses.

1. Device selection and approvals

• Use only devices approved in the instrument for the specified task. For initial alcohol testing, use Alcolizer LE5 (Schedule 1 Table 1) or the Drager Alcotest 9510 Aus which is approved for initial and confirmatory alcohol testing (Schedule 1 Table 2). For initial drug screening, use Securetec DrugWipe 5S or Abbott SoToxa (Schedule 2 Table 1). Do not substitute unapproved models.

2. Device storage, maintenance and operating procedures

• Store, test, maintain and operate each device strictly in accordance with the manufacturer’s instructions as incorporated by the schedules. Compliance with recommended manufacturer actions is “to be regarded as mandatory” (Schedule 4 Table 1 and Table 2; Schedule 7 Table 1).
• Enter contractual maintenance arrangements with manufacturers or manufacturer‑approved agents where the instrument mandates manufacturer maintenance. For Abbott SoToxa, ensure inspection, cleaning, recalibration and other maintenance are performed by Abbott or an Abbott‑approved person at least once every 12 months (Schedule 4 Table 2). For Alcolizer LE5, ensure Sample Module recalibration by the manufacturer or an approved agent before the 12‑month calibration lock expiry (Schedule 7 Table 1).

3. Training and procedure checklists for testers

• Train approved testers on the stepwise procedures in Schedule 3 (drug testing) and Schedule 6 (alcohol testing). Provide written checklists that replicate the timing, reading windows and QC checks required by the instrument:
  • DrugWipe Step 1: check expiry date, do not touch sampling pads, instruct donor to moisten cheeks, collect saliva by wiping, confirm sufficient saliva, reattach sample collector, break ampoule, hold vertically for 10 seconds after breaking ampoule, place horizontally and read between 5 and 15 minutes. If no control lines appear, discard device. If indicator lines appear in drug group segments before 5 minutes do not ignore them; ignore any indicator line that first appears after 15 minutes (Schedule 3 item 1(a)).
  • SoToxa Step 2: perform start‑up checks, show donor cartridge is new, check silica gel colour, insert cartridge, ensure QC test performed if required by QC lockout, collect oral fluid swab until indicator turns blue, insert swab into cartridge and keep device horizontal while test runs, print two hardcopy printouts and record results (Schedule 3 item 1(b)).
  • Quantisal confirmatory: use sealed kits within expiry, open in donor presence with gloves, collect two swabs until indicators turn blue, insert swabs into transport tubes, apply tamper‑evident seals A and B, have donor initial seals, label one tube Sample A and the other Sample B, place into clip‑seal transit pouch and dispatch to approved lab (Schedule 3 item 2).

4. Sample identification numbering and recordkeeping

• Obtain sequences of sample identification numbers from CASA or a person authorised by CASA (the approving authority) and ensure assigned sequences are used in the order approved (Schedule 5 cl 2-5).
• Allocate numbers sequentially from the assigned sequence and append the donor’s date of birth in dd/mm/yy form. Record the combination as the sample identifier (Schedule 5 cl 5(2)-(3)).
• When splitting a sample into Sample A and Sample B, apply the same allocated sample identification number to both tubes and label them accordingly (Schedule 5 cl 6).
• Maintain a log of numbers assigned, numbers used and unused numbers, and return any unused numbers to the approving authority when the tester’s approval expires or is terminated (Schedule 5 cl 7). Ensure the approving authority maintains and can produce the assignment record to CASA on request (cl 4(4)).

5. Chain of custody, tamper seals and donor involvement

• During confirmatory sample preparation use tamper‑evident seals A and B and request donor initials on those seals. If a seal is damaged while fixing, use the tamper‑evident seal C as backup (Schedule 3 item 2).
• Retain the clip‑seal transit pouch containing the sealed transport tubes and forward to the approved laboratory as directed by CASA procedures.

6. Laboratory accreditation

• Send confirmatory samples only to laboratories that hold NATA accreditation in accordance with the declared standard in Schedule 8, ISO/IEC 17025‑2005 as applied by NATA in Forensic Services. Confirm the laboratory’s current accreditation status before dispatch.

7. Device QC, consumables and cartridge checks

• Maintain stock of required consumables (manufacturer mouthpieces, SoToxa cartridges, PQC cartridges). Only use mouthpieces manufactured or supplied by the device manufacturer where the schedule requires it (Schedules 4 and 7).
• For SoToxa cartridges, check the silica gel pack colour and do not use cartridges if the majority of beads are green or if the silica gel pack is burst (Schedule 3 item 1(b)).
• Maintain QC testing schedules to avoid PQC lockouts on SoToxa devices. If a PQC or QC test is required, perform it in accordance with the device instructions before resuming testing.

8. Printing and results handling

• Where device procedures require printed outputs, produce the required hardcopy printouts and retain them in the testing record. SoToxa requires two hardcopy printouts for Step 2; Drager prints two copies for confirmatory alcohol testing; Alcolizer printing is not required but ensure device logs are captured where practicable (Schedules 3 and 6).

9. Operational contingencies and service agreements

• Establish service agreements with manufacturers or approved agents for annual maintenance and calibration, and document service and calibration dates to avoid calibration lockouts or verification lapses. Maintain spare devices or arrangements for access to the Drager device where confirmatory capability is needed, since Alcolizer is approved for initial testing only in Schedule 1 Table 1 and Drager is approved for both initial and confirmatory testing (Schedule 1 Tables 1 and 2).
• Keep records of maintenance, recalibration, verification certificates (for Drager to NMI R126) and NATA accreditation certificates for laboratories.

10. Administrative compliance and audit readiness

• Ensure the approving authority’s record of assigned sequences is accessible to CASA on request (Schedule 5 cl 4(4)). Maintain internal audit trails of sample allocation, donor DOB formatting, tamper seal application and donor initials, dispatch logs for confirmatory samples and device maintenance logs.

11. Staff training and SOPs

• Implement written standard operating procedures (SOPs) that mirror the relevant schedule language and timing rules exactly. Train staff to follow the SOPs and to document any deviations along with remedial actions and notifications to CASA where required by CASR.

12. Legal and advisory steps

• Where a test is discontinued due to a donor failing to provide an adequate sample after the permitted number of attempts (for example, the Drager 9510 Aus permits at least three attempts) the instrument indicates CASA will consider and advise the donor of the legal implications (Schedule 6 item 2). Have a process that records the discontinuation and provides for CASA notification or referral, consistent with the statutory framework in CASR.

By implementing these steps, a testing organisation will align operational practice with the instrument’s approvals and procedures. The core compliance principle is strict adherence to the schedules’ procedural and timing rules, preservation of chain of custody, up‑to‑date device maintenance and calibration records, and using only approved devices and accredited laboratories as specified by CASA.