CASA 39/20

Instrument number CASA 39/20

I, Jonathan Aleck, Executive Manager, Legal, International & Regulatory Affairs, a delegate of CASA, make this instrument under regulation 99.140 of the Civil Aviation Safety Regulations 1998.

[Signed Jonathan Aleck]

Jonathan Aleck
Executive Manager, Legal, International & Regulatory Affairs

30 July 2020

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

1 Name

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

2 Commencement

This instrument commences on the day after it is registered.

3 Repeal of instrument CASA 125/09

Instrument CASA 125/09, Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998, is repealed.

4 Legislative instrument for drug and alcohol testing

This instrument is a legislative instrument providing for certain matters under Subpart 99.C of CASR.

5 Drug and alcohol testing

(1) For paragraph 99.130 (a) of CASR, I approve the breathalysers mentioned in Schedule 1 for use in alcohol testing under Subpart 99.C of CASR.

(2) For paragraph 99.130 (b) of CASR, I approve the drug testing devices mentioned in Schedule 2 for use in initial drug testing under Subpart 99.C of CASR.

(3) For regulation 99.140 of CASR, the procedures for an approved tester to take and prepare a body sample for drug testing under Subpart 99.C of CASR are set out in Schedule 3.

(4) For subregulation 99.145 (2) of CASR, storing, testing, maintaining and operating a drug testing device approved for use in an initial drug test under Subpart 99.C of CASR must be in accordance with Schedule 4.

(5) For regulation 99.150 of CASR, the method for determining sample identifiers to be allocated to body samples that approved testers take under Subpart 99.C of CASR and send for confirmatory drug tests is specified in Schedule 5.

(6) For regulation 99.245 of CASR, the procedures for an approved tester to take body samples for alcohol testing under Subpart 99.C of CASR are set out in Schedule 6.

(7) For subregulation 99.250 (3) of CASR, storing, testing, maintaining and operating a breathalyser approved for use in an initial alcohol test under Subpart 99.C of CASR must be in accordance with Schedule 7.

(8) For paragraph 99.445 (3) (b) of CASR, another standard to which the National Association of Testing Authorities may accredit a person if the person is to be approved by CASA to conduct confirmatory drug tests for the purposes of Part IV of the Civil Aviation Act 1988 (the Act) is declared in Schedule 8.

Schedule 1 Approved breathalysers

1 Approved breathalysers — initial alcohol testing

A breathalyser mentioned in an item in Table 1 is approved for use in initial alcohol testing.

Table 1

Item	Name of manufacturer	Name and model of breathalyser
1	Lion Laboratories Limited	Lion Alcometer SD400

2 Approved breathalysers — initial and confirmatory alcohol testing

A breathalyser mentioned in an item in Table 2 is approved for use in initial and confirmatory alcohol testing.

Table 2

Item	Name of manufacturer	Name and model of breathalyser
1	Drager Safety Pacific Pty Ltd	Drager Alcotest 9510 Aus

Schedule 2 Approved drug testing device — initial drug testing

1 Approved drug testing device — initial drug testing

A drug testing device mentioned in an item in Table 1 is approved for use in initial drug testing.

Table 1

Item	Name of manufacturer	Name and model of drug testing device
1	Securetec Detektions-Systeme AG	DrugWipe 5S
2	Abbott	SoToxaTM

Schedule 3 Procedures for taking and preparing body samples for drug testing

1 Procedures

The procedures for an approved tester to take and prepare a body sample for a drug test mentioned in an item of Table 1 are set out in the item.

Table 1

Item	Drug test	Procedures
1(a)	For the conduct of Step 1 of an initial drug test using the DrugWipe 5S approved drug testing device	Step 1 — Taking body samples with the DrugWipe 5S approved testing device (the device): Having checked that the device has not passed its expiry date, the approved tester is to open the packaging and separate the saliva collector (with sampling pads) of the device from the test cassette. The approved tester is then to ask the donor to moisten the inside of their cheeks by rolling the tongue around the inside of their mouth. The approved tester is then to ask the donor to hold the saliva collector and apply moderate pressure in using the saliva collector to wipe their tongue in a downward movement, or the interior of their cheek, ensuring the sampling pads are in in contact with the tongue or cheek. The approved tester is to check sampling pads to confirm sufficient saliva has been collected. Preparing body samples: Once a saliva sample has been obtained, the approved tester is to: Reattach the saliva collector to the test cassette. A double click will be heard on successful reattachment. Bring the device into a vertical position with the ampoule at the bottom, press with a thumb on the word PRESS marked on the ampoule section to open the ampoule. A snap will be heard on the successful opening of the ampoule. After this snap is heard, hold the device vertically for a further 10 to 15 seconds. Place the device horizontally on a surface for a period of not less than 8 minutes but not more than 15 minutes. After a time within this period, the display window on the device will show the red control line (CL). If a red control line does not appear on all 3 CL strips, the test result is not valid and device must be discarded. Within the time period mentioned above, if a red line, or part of a red line, does not appear in any of the segments containing an abbreviation code for a testable drug group, the test has resulted in a Step 1 screening negative. Ignore any line or part of a line that FIRST appears after 15 minutes have elapsed. But do not ignore any line or part of a line that first appears BEFORE 8 minutes have elapsed EVEN IF it goes on developing until 15 minutes have elapsed. If the test has resulted in a Step 1 screening negative, testing is complete at that point and Step 2 is not required. However, if, during the time period mentioned above, another red line or part of a red line DOES appear in any of the segments containing an abbreviation code for a testable drug group, the test has resulted in a Step 1 screening positive. Step 2 of the initial drug test is then to commence. Definitions For the purpose of preparing body samples for Step 1: part of a red line includes a red line that is faint, interrupted or irregular. Note This is the kind of line that having appeared in some form BEFORE 8 minutes have elapsed, may go on developing until 15 minutes have elapsed. testable drug group means the pharmacological grouping into which particular testable drugs fall, namely, the amphetamine group, the cannabis group, the cocaine group, and the opiates group.
1(b)	For the conduct of Step 2 of an initial drug test using the Abbott SoToxaTM approved drug testing device	Step 2 – Taking body samples with the Abbott SoToxaTM testing device (the device): turn device on allow the device to perform start-up checks during the start-up process to make sure device is in good operating condition. During this testing, the screen will display the Abbott logo Note Device will not be able to run start-up checks if a test cartridge is already inserted. Remove cartridge before turning on. when the device is ready to begin a test, the screen will display “Insert cartridge to start new test” with a picture of a cartridge being inserted into a SoToxa device show the donor that a new and unopened DDS-2 or SoToxa test cartridge is being used and is opened in view of the donor the approved tester is to remove a new test cartridge from the foil wrapper and check the silica gel pack colour the test cartridge can be used if the silica gel pack is yellow or orange in colour, slight discolouration of the silica beads is normal. When the majority of the beads within the pack are green, the test cartridge should not be used as the performance of the product may have been compromised. If the silica gel pack has burst, do not use the test cartridge the approved tester is to insert the test cartridge into the cartridge slot on the front of the device if a QC test has not been conducted within the defined time interval, the QC lockout symbol and “Insert PQC Cartridge to start test” will be displayed on the screen when a test cartridge is inserted. Remove test cartridge and conduct QC test before continuing with test check on the screen that the device has identified the cartridge and verify it is within its expiry date. This is shown by the text “Cartridge valid” with the cartridge number and a green tick on the screen. Do not use cartridge if it has expired. Preparing body samples: the approved tester is to open a DDS-2 or SoToxa Oral Fluid Collection swab packaging and ask the donor to remove the DDS-2 or SoToxa Oral Fluid Collection swab from the packaging, ensuring they hold the plastic stem of the collection device, and then place it in their mouth the donor must actively swab the bud-end of the DDS-2 or SoToxa Oral Fluid Collection swab around the gums, tongue and inside the cheeks of the donor, then leave the swab under the tongue until the sample presence indicator starts to turn blue to indicate that a sufficient sample has been obtained (any blue colouring is regarded as a sufficient sample) insert the DDS-2 or SoToxa Oral Fluid Collection swab into the test cartridge currently located in the device. Gently push the collection device all the way into the test cartridge to the stop position once the sample collection swab has been inserted, the device should be kept in a horizontal plane remaining as still as possible throughout testing. If the device is tilted beyond the acceptable range, a warning symbol will appear on the screen and a beeping sound. Correct the orientation of the device immediately to prevent disruption to the test. If the device is not corrected in the required time this may result in a testing error when the DDS-2 or SoToxa Oral Fluid Collection swab has been inserted into test cartridge in the device, the screen will display “test in progress” and a countdown timer will appear when the device has finished processing the test, a results screen will be displayed showing either positive or negative for each drug group record the result select “OK” using the right select key to move to the next screen to print results, select YES using the left select key. After printing is complete, the print option screen will be displayed again for additional copies of results, select YES again for another copy. Two hardcopy printouts are to be produced if the result of the analysis is negative for all testable drug groups, the test has resulted in a Step 2 screening negative and, therefore, a negative initial drug test result, testing is complete at that point however, if the result of the analysis is positive for any testable drug group, the test has resulted in a Step 2 screening positive for that testable drug group the result of the initial drug test is, therefore, a positive test result: – for each testable drug group which returned a positive result under Step 1; and – each testable drug group which returned a positive result under Step 2; the tester is to proceed to the procedures in item 2 as the case may be. Definition For the purpose of preparing body samples for confirmatory drug testing testable drug group means the pharmacological grouping into which particular testable drugs fall, namely, the amphetamine group, the cannabis group, the cocaine group, and the opiates group.
2	For the conduct of a con-firmatory test on a further body sample taken under subregulation 99.170 (1), where the result of an initial drug test using the Abbott SoToxaTM approved drug testing device on an earlier body sample is a positive result	Taking body samples: ensure all parts of the Quantisal® Oral Fluid Collection kit which contains 2 oral fluid collection swabs and 2 sealed collection tubes containing the buffer solution, enclosed in a sealed clip seal transit pouch, are within expiry dates by checking the labels on the Quantisal collection tubes and oral fluid collection swabs in the presence of the donor, with gloves on, open the sealed Quantisal® Oral Fluid Collection kit and open both Quantisal® Oral Fluid Collection Device with Volume Adequacy Indicator (swabs) packaging. The approved tester is to ask the donor to: remove both collectors of the Quantisal® Oral Fluid Collection Device with Volume Adequacy Indicator from their packaging, by holding the plastic stems that is fixed to the cellulose pad (swab) of each collector move the donor’s tongue within their mouth to accumulate saliva have the donor actively move the swabs around their gums, tongue and inside their cheeks, then leaving the swabs in their mouth under their tongue ensure both collectors remain under the donor’s tongue until the indicator on each collector turns blue to indicate a sufficient sample of oral fluid has been obtained or 10 minutes has elapsed remove both collectors from the donor’s mouth by holding the plastic stem. If an indicator on a collector has not turned blue within 10 minutes, the approved tester may require the donor to place 2 new collectors in the donor’s mouth until the indicator of each collector turns blue. Preparing body samples: Once a sufficient sample has been obtained, the approved tester must: remove the cap from both specimen tubes (transport tubes) containing buffer liquid and have the donor insert 1 collector into each tube, swab end first place the cap over the top of the stem of the collector in each transport tube and forcefully push the cap downward until cap snaps flush with top of tube mix the saturated swab of the collector with the buffer liquid in each transport tube by gently shaking the tube write the donor’s date of birth and the approved tester’s initials on a tamper‑evident seal marked “A” and on a tamper-evident seal marked “B” provided in the CASA Transmission of sample to approved laboratory form, as existing from time to time request that the donor initial the tamper‑evident seals Note See subregulation 99.180 (7) of CASR for what to do if the donor refuses the request. fix the tamper-evident seal “A” across the top of the cap and down the sides of 1 of the transport tubes, ensuring that the centre oval with the letter “A” in the middle is placed over the top of the cap on the tube fix the tamper-evident seal “B” across the top of the cap and down the sides of the other transport tube, ensuring that the centre oval with the letter “B” in the middle is placed over the top of the cap on the tube place both sealed transport tubes back into the clip seal transit pouch, for dispatch to the approved laboratory for confirmatory testing of the fluid collected.

Schedule 4 Procedures – approved drug testing device for use in initial drug testing – storing, testing, maintaining and operating the device

1 Procedures

Storing, testing, maintaining and operating a drug testing device approved for use in an initial drug test must be in accordance with Table 1 and Table 2.

Table 1 DrugWipe 5S

Activity	Procedures
Storing	In a manner not inconsistent with the manufacturer’s instructions for storing the device, provided that compliance with any action recommended in those instructions is to be regarded as mandatory.
Testing	In a manner not inconsistent with the manufacturer’s instructions for testing the device, provided that compliance with any action recommended in those instructions is to be regarded as mandatory.
Maintaining	Maintenance is not required as the device is a one-use only device and is disposed of after use.
Operating	In a manner not inconsistent with the manufacturer’s instructions for operating the device.

Table 2 Abbott SoToxaTM

Activity	Procedures
Storing	In a manner not inconsistent with the manufacturer’s instructions for storing the device, provided that compliance with any action recommended in those instructions is to be regarded as mandatory.
Testing	In a manner not inconsistent with the manufacturer’s instructions for testing the device, provided that compliance with any action recommended in those instructions is to be regarded as mandatory.
Maintaining	In a manner not inconsistent with the manufacturer’s instructions for maintaining the device, provided that: compliance with any action recommended in those instructions is to be regarded as mandatory inspection, cleaning, recalibration and other maintenance is to be carried out by Abbott, or another person approved by it, at least once every 12 months any necessary repairs are to be undertaken by Abbott or another person approved by it.
Operating	In a manner not inconsistent with the manufacturer’s instructions for operating the device, provided that: compliance with any action recommended in those instructions is to be regarded as mandatory Alere DDS-2 or Abbott SoToxaTM Test Kit is to be used each test result is to be printed out.

Schedule 5 Method — determining sample identifiers to be allocated to body samples

1 Method

The method for determining sample identifiers to be allocated to body samples that approved testers take under Subpart 99.C of CASR and send for confirmatory drug tests, is specified in this Schedule.

2 Provision of sample identification numbers by approving authority

CASA, or a person authorised in writing by CASA (the approving authority), must, from time to time, approve a group of sequences of sample identification numbers for each approved tester to use in accordance with this Schedule.

3 Provision of further sample identification numbers by approving authority

The approving authority must ensure that sufficient approved groups of sequences of sample identification numbers are available to ensure that each approved tester is assigned sufficient numbers to enable the approved tester to allocate a number to a body sample in accordance with clause 5 or 6.

4 Assignment of sample identification numbers to approved testers

(1) The approving authority must, from time to time, assign to an approved tester sample identification numbers from the group of sequences approved and in the order in which they were so approved.

(2) The approving authority must assign sufficient numbers to enable the approved tester to cover the number of confirmatory tests that may arise from the volume of initial drug tests anticipated to be undertaken by the approved tester during a period agreed between the approving authority and the approved tester.

(3) No sequence of numbers assigned by an approving authority to an approved tester may later be assigned by the approving authority to any other approved tester.

(4) The approving authority must maintain a record of each sequence of numbers assigned by it, and of the approved tester to whom it is assigned, and make that record available to CASA on request.

5 Allocation of sample identification numbers by approved tester

(1) When an approved tester conducts an initial drug test for which a positive result is recorded, the approved tester is to allocate to the body sample that is to be sent for a confirmatory drug test a sample identification number chosen from, and in the order in which it appears in, a sequence of numbers assigned by the approving authority to the approved tester.

(2) The approved tester is to add to the number so allocated the date of birth of the donor of the sample, expressed in the form “dd/mm/yy”, where “dd’ is a 2-digit designation of the day, “mm” is a 2-digit designation of the month, and “yy” is a 2-digit designation of the year.

(3) The combination of the allocated sample identification number and the donor’s date of birth constitutes the sample identifier mentioned in Subpart 99.C of CASR.

(4) Except for the purposes of clause 6, an approved tester is not to allocate the same sample identification number to more than 1 body sample.

6 Allocation of sample identification numbers to Sample A and Sample B

(1) When a body sample is divided by an approved tester into a Sample A and a Sample B, the same sample identification number is to be allocated to each of Sample A and Sample B when the samples are placed into separate specimen tubes.

(2) The allocated sample identification number (together with the donor’s date of birth) is to be placed on each such tube. The approved tester must ensure that 1 such tube is marked “Sample A” and the second such tube is marked “Sample B”.

7 Return of unused sample identification numbers

(1) When the approval of a person as an approved tester expires or is otherwise terminated, any sample identification numbers assigned to the tester and not allocated in accordance with clause 5 or 6 is to be returned to the approving authority that assigned them to the tester.

(2) The approving authority must note the return of assigned numbers in the record mentioned in subclause 4 (4).

Schedule 6 Procedures for taking body samples for alcohol testing

1 Procedures

The procedures for an approved tester to take body samples for alcohol testing using an approved breathalyser mentioned in an item in Table 1 are set out in the same item.

Table 1

Item	Alcohol test	Procedures
1	For the conduct of an initial alcohol test on a person using the Lion Alcometer SD400 (in this item, the device)	Taking body samples: The approved tester must first ask the donor if the donor has consumed anything containing alcohol in the preceding 10 minutes. If the donor advises that the donor has consumed something containing alcohol in the preceding 10 minutes, the approved tester must request the donor not consume anything further (except water) until the testing, including confirmatory testing if necessary, is completed. The approved tester must inform the donor that if the donor consumes anything further (except water) until the testing, including confirmatory testing if necessary, is completed, it may be considered that the donor has refused, or failed to give a body sample. If the donor has advised the approved tester that the donor has consumed something containing alcohol in the preceding 10 minutes, the approved tester must wait until at least 10 minutes have elapsed since the tester first asked the donor if the donor had consumed anything containing alcohol. Having turned on the device by pressing the red button below the display, the display will initially show a Lion Alcometer emblem, the time and date, then “please wait”. The device conducts a self-check, the approved tester must ensure that the device has completed the self-check and “Provide sample” appears on the display. The approved tester must then attach an approved mouthpiece to the device’s sampling port by, partially opening the cellophane packaging, ensuring that the tester does not touch the lipped end and that the protective cellophane packaging remains in place until the donor removes it. The approved tester must then ask the donor to remove the protective cellophane packaging and provide a sample of the donor’s breath. The donor must be asked to take a deep breath, hold it, and then place the lipped end of the mouthpiece in their mouth, sealing their lips around it. The donor must then be asked to blow steadily and continuously until requested to stop blowing by the approved tester. As the donor commences to provide a sample, “Subject blowing” will be displayed and a continuous audible tone will be emitted. A sufficient sample is necessary for the sample to be analysed. On the provision of a sufficient sample, an audible click is heard from the device. At this time, the donor is to be requested to stop blowing. On the completion of the analysis of the sample, indicated by “please wait” ceasing to appear on the display screen, and a reading will appear of either “NEG” or “POS” indicating either a NEGATIVE or POSITIVE result.
2	For the conduct of a confirmatory test on a further body sample of the person using the Drager Alcotest 9510 Aus (in this item, the device)	Taking body samples: The approved tester must take a further breath sample for a confirmatory alcohol test as soon as practicable, but not sooner than 15 minutes from the time that the initial alcohol test sample was taken. If the approved tester has reason to believe that the donor may have consumed something containing alcohol since giving the initial sample, the tester must wait until at least 10 minutes have elapsed since the tester formed that view. The approved tester must then proceed to take a further breath test. When taking the breath sample, the approved tester must ensure that the following procedure is followed: the device must be connected to the appropriate power supply, depending on whether the device is being used from 240V mains power or 12V DC power the power switch must be pressed to on if using 240V mains power supply, the toggle switch must be turned to “I” on the 12V DC cable near the connector plug to the device an external keyboard may be connected through the USB ports, if desired a printer test must be performed and the printer paper must be changed, if required the device must be allowed to warm up (this is initiated by switching the device on and can take up to 10 minutes) Note During the warm-up period, the device will conduct a series of internal system checks. After all tests have been conducted and the complete system is verified, the device will begin to warm up and indicate on the screen “WARMING UP” the device must be set at the correct time and date of the location at which the test is occurring following the warm-up, the device is ready to perform a breath measurement by indicating “READY” on the screen — the green button under the front screen on the device must then be pressed the personal details of the donor (surname, given names, date of birth), location and the approved tester performing the test must be entered into the device the “Save” button must be pressed to initialise testing; the device will then automatically go through an internal diagnostic check. when the internal diagnostic check is completed, the device will display “PLEASE BLOW” on the screen a new mouthpiece must be attached to the breath hose the donor must be asked to remove the protective cellophane packaging from the mouthpiece the donor must be instructed to place the end of the mouthpiece into the donor’s mouth and to seal their lips around it when blowing Note After a period of 2 minutes of a beeping alert tone to provide breath, if a breath sample is not obtained, the device displays “READINESS TO BLOW EXPIRED” and the device will re-set to “PLEASE BLOW”. The device will re-set 3 times before the test will be discontinued. Each unsuccessful attempt is recorded on the certificate with “TEST DISCONTINUED” printed at the bottom of the certificate. the donor must be asked to inhale calmly and then blow evenly and continuously through the mouthpiece for as long as possible when a sufficient volume of breath sample is achieved, the frame around the bottom bar graph becomes bold to indicate that the sample has been collected; the procedure under A. below must then be followed if the breath flow falls below the minimum flow at any time during the breath sample delivery, the display will indicate “STOP BLOWING” and the delivery of the breath sample must be stopped immediately so as to avoid the donor attempting to re-blow; the procedure under B. below must then be followed. Sufficient volume of breath given: the mouthpiece must be removed when the device indicates to do so the device will conduct more internal diagnostic checks, complete the sample analysis and display, under a heading “Subject’s Result”, the result of the test on the device screen 2 copies of the result will be printed by the device if the device detects alcohol in the mouth of the donor, the device will display “ALCOHOL IN MOUTH”. The approved tester must wait a further 10 minutes and then repeat the process above to take a breath sample. The approved tester may warn the donor not to further consume alcohol and may refer to offences for failing to provide a body sample or interfering with a sample. the approved tester must allow at least 3 attempts to provide a testable body sample but may discontinue the test if the donor fails to provide an adequate sample after 3 attempts. If the test is discontinued without a valid result, the donor must be advised they can no longer perform SSAA until notified to the contrary by CASA. Note CASA will consider and advise the donor of the legal implications of the failure to provide a sample. B. Sufficient volume of breath not given: the donor must be informed that a repeat test is necessary remove the mouthpiece when the device indicates to do so on its screen — the device will then automatically perform an internal diagnostic check each step is to be repeated by the approved tester and the donor, after the previous internal diagnostic check Note Device will conduct 3 unsuccessful tests before cancelling the entire testing and returning to the ready screen. Each unsuccessful attempt is recorded on the certificate with “TEST DISCONTINUED” printed at the bottom of the certificate. the approved tester must allow at least 3 attempts to provide a testable body sample but may discontinue the test if the donor fails to provide an adequate sample after 3 attempts. If the test is discontinued without a valid result, the donor must be advised they can no longer perform SSAA until notified to the contrary by CASA. Note CASA will consider and advise the donor of the legal implications of the failure to provide a sample

Item

Alcohol test

Procedures

For the conduct of an initial alcohol test on a person using the Lion Alcometer SD400 (in this item, the device)

Taking body samples:

The approved tester must first ask the donor if the donor has consumed anything containing alcohol in the preceding 10 minutes.

If the donor advises that the donor has consumed something containing alcohol in the preceding 10 minutes, the approved tester must request the donor not consume anything further (except water) until the testing, including confirmatory testing if necessary, is completed. The approved tester must inform the donor that if the donor consumes anything further (except water) until the testing, including confirmatory testing if necessary, is completed, it may be considered that the donor has refused, or failed to give a body sample.

If the donor has advised the approved tester that the donor has consumed something containing alcohol in the preceding 10 minutes, the approved tester must wait until at least 10 minutes have elapsed since the tester first asked the donor if the donor had consumed anything containing alcohol.

Having turned on the device by pressing the red button below the display, the display will initially show a Lion Alcometer emblem, the time and date, then “please wait”. The device conducts a self-check, the approved tester must ensure that the device has completed the self-check and “Provide sample” appears on the display.

The approved tester must then attach an approved mouthpiece to the device’s sampling port by, partially opening the cellophane packaging, ensuring that the tester does not touch the lipped end and that the protective cellophane packaging remains in place until the donor removes it.

The approved tester must then ask the donor to remove the protective cellophane packaging and provide a sample of the donor’s breath.

The donor must be asked to take a deep breath, hold it, and then place the lipped end of the mouthpiece in their mouth, sealing their lips around it. The donor must then be asked to blow steadily and continuously until requested to stop blowing by the approved tester.

As the donor commences to provide a sample, “Subject blowing” will be displayed and a continuous audible tone will be emitted. A sufficient sample is necessary for the sample to be analysed. On the provision of a sufficient sample, an audible click is heard from the device. At this time, the donor is to be requested to stop blowing.

On the completion of the analysis of the sample, indicated by “please wait” ceasing to appear on the display screen, and a reading will appear of either “NEG” or “POS” indicating either a NEGATIVE or POSITIVE result.

For the conduct of a confirmatory test on a further body sample of the person using the Drager Alcotest 9510 Aus (in this item, the device)

Taking body samples:

The approved tester must take a further breath sample for a confirmatory alcohol test as soon as practicable, but not sooner than 15 minutes from the time that the initial alcohol test sample was taken.

If the approved tester has reason to believe that the donor may have consumed something containing alcohol since giving the initial sample, the tester must wait until at least 10 minutes have elapsed since the tester formed that view. The approved tester must then proceed to take a further breath test.

When taking the breath sample, the approved tester must ensure that the following procedure is followed:

the device must be connected to the appropriate power supply, depending on whether the device is being used from 240V mains power or 12V DC power
the power switch must be pressed to on if using 240V mains power supply, the toggle switch must be turned to “I” on the 12V DC cable near the connector plug to the device

an external keyboard may be connected through the USB ports, if desired
a printer test must be performed and the printer paper must be changed, if required
the device must be allowed to warm up (this is initiated by switching the device on and can take up to 10 minutes)

Note During the warm-up period, the device will conduct a series of internal system checks. After all tests have been conducted and the complete system is verified, the device will begin to warm up and indicate on the screen “WARMING UP”

the device must be set at the correct time and date of the location at which the test is occurring
following the warm-up, the device is ready to perform a breath measurement by indicating “READY” on the screen — the green button under the front screen on the device must then be pressed
the personal details of the donor (surname, given names, date of birth), location and the approved tester performing the test must be entered into the device
the “Save” button must be pressed to initialise testing; the device will then automatically go through an internal diagnostic check.

when the internal diagnostic check is completed, the device will display “PLEASE BLOW” on the screen
a new mouthpiece must be attached to the breath hose
the donor must be asked to remove the protective cellophane packaging from the mouthpiece
the donor must be instructed to place the end of the mouthpiece into the donor’s mouth and to seal their lips around it when blowing

Note After a period of 2 minutes of a beeping alert tone to provide breath, if a breath sample is not obtained, the device displays “READINESS TO BLOW EXPIRED” and the device will re-set to “PLEASE BLOW”. The device will re-set 3 times before the test will be discontinued. Each unsuccessful attempt is recorded on the certificate with “TEST DISCONTINUED” printed at the bottom of the certificate.

the donor must be asked to inhale calmly and then blow evenly and continuously through the mouthpiece for as long as possible
when a sufficient volume of breath sample is achieved, the frame around the bottom bar graph becomes bold to indicate that the sample has been collected; the procedure under A. below must then be followed
if the breath flow falls below the minimum flow at any time during the breath sample delivery, the display will indicate “STOP BLOWING” and the delivery of the breath sample must be stopped immediately so as to avoid the donor attempting to re-blow; the procedure under B. below must then be followed.

Sufficient volume of breath given:

the mouthpiece must be removed when the device indicates to do so
the device will conduct more internal diagnostic checks, complete the sample analysis and display, under a heading “Subject’s Result”, the result of the test on the device screen
2 copies of the result will be printed by the device
if the device detects alcohol in the mouth of the donor, the device will display “ALCOHOL IN MOUTH”. The approved tester must wait a further 10 minutes and then repeat the process above to take a breath sample. The approved tester may warn the donor not to further consume alcohol and may refer to offences for failing to provide a body sample or interfering with a sample.
the approved tester must allow at least 3 attempts to provide a testable body sample but may discontinue the test if the donor fails to provide an adequate sample after 3 attempts. If the test is discontinued without a valid result, the donor must be advised they can no longer perform SSAA until notified to the contrary by CASA.

Note CASA will consider and advise the donor of the legal implications of the failure to provide a sample.

B. Sufficient volume of breath not given:

the donor must be informed that a repeat test is necessary
remove the mouthpiece when the device indicates to do so on its screen — the device will then automatically perform an internal diagnostic check
each step is to be repeated by the approved tester and the donor, after the previous internal diagnostic check

Note Device will conduct 3 unsuccessful tests before cancelling the entire testing and returning to the ready screen. Each unsuccessful attempt is recorded on the certificate with “TEST DISCONTINUED” printed at the bottom of the certificate.

the approved tester must allow at least 3 attempts to provide a testable body sample but may discontinue the test if the donor fails to provide an adequate sample after 3 attempts. If the test is discontinued without a valid result, the donor must be advised they can no longer perform SSAA until notified to the contrary by CASA.

Note CASA will consider and advise the donor of the legal implications of the failure to provide a sample

Schedule 7 Procedures – approved breathalyser for use in initial or confirmatory alcohol testing – storing, testing, maintaining and operating the breathalyser

1 Procedures

Storing, testing, maintaining and operating a breathalyser approved for use in an initial alcohol test must be in accordance with Table 1.

Table 1

Item	Approved breathalyser	Procedures
1	Lion Alcometer SD400	Storing: The device is to be stored in clean and dry conditions and not exposed to extreme weather conditions. Testing: The device is to be tested in a manner not inconsistent with the manufacturer’s instructions provided that compliance with any action recommended by the manufacturer in the instructions is mandatory. Maintaining: The device is to be maintained in a manner not inconsistent with the manufacturer’s instructions for use of the device, provided that compliance with any action recommended in those instructions is to be regarded as mandatory. The device is to be cleaned only with a slightly damp cloth and not exposed to cleaning products that contain solvents. Operating: The device is to be operated in a manner not inconsistent with the manufacturer’s instructions for use of the device, provided that: calibration and configuration of the device is to be undertaken only by the manufacturer or an agent approved by it the device is to be configured so that: – Test Mode is set to Active Sampling – Digital Display Mode is set to Reveal – Display Format is set to Positive or Negative – Measurement ratio is set to 2100:1 – Display Mask is set to declare a result at or below 0.009 as Negative – Breath Sampling Parameters are set to be:  for discard volume parameter — between 1 and 5 litres  for drop or flow rate parameter – between 20 and 50 litres/minute – Display Reset Time is set to 10 seconds – Calibration Lock is to render the device inactive if recalibration has not been undertaken within the last 6 months – Device Firmware is dongle protected and accessible only by the manufacturer or an agent approved by it the following optional functions are not to be activated: – Passive Test Mode – Hide Digital Display Mode – Actual Alcohol Units Display – Timed Sample Capture – Precursory Mode – Manual Sampling the device is only to be used in Analyse Mode the device is to be used only with one‑use‑only mouthpieces and not with the reusable sampling cup a clean unused mouthpiece is to be used for every test only mouthpieces manufactured or supplied by Lion Laboratories Limited are to be used the device is not to be used with “online‑400” PC software printing of test results is not required.
2	Drager Alcotest 9510 Aus	Storing: The device is to be stored in its travel case in clean and dry conditions and not exposed to extreme weather conditions. Testing: The device is to be verified to National Measurement Institute standard R126 so that after verification only the time and date may be varied, or the location of testing inserted, by another person. The verification is to be conducted in a manner not inconsistent with the manufacturer’s instructions provided that compliance with any action recommended in those instructions is to be regarded as mandatory. Maintaining: The device is to be maintained in a manner not inconsistent with the manufacturer’s instructions for use of the device, provided that compliance with any action recommended in those instructions is to be regarded as mandatory. The device is to be cleaned only with a slightly damp cloth and not exposed to cleaning products that contain solvents. Operating: The device is to be operated in a manner not inconsistent with the manufacturer’s instructions for use of the device, provided that: compliance with any action recommended in those instructions is to be regarded as mandatory results are to be printed using a thermal printer connection to another printer or to a PC or modem is not required a clean unused mouthpiece is to be used for every test only mouthpieces manufactured or supplied by Drager Safety Pacific Pty Ltd are to be used.

Item

Approved breathalyser

Procedures

Lion Alcometer SD400

Storing:

The device is to be stored in clean and dry conditions and not exposed to extreme weather conditions.

Testing:

The device is to be tested in a manner not inconsistent with the manufacturer’s instructions provided that compliance with any action recommended by the manufacturer in the instructions is mandatory.

Maintaining:

The device is to be maintained in a manner not inconsistent with the manufacturer’s instructions for use of the device, provided that compliance with any action recommended in those instructions is to be regarded as mandatory.

The device is to be cleaned only with a slightly damp cloth and not exposed to cleaning products that contain solvents.

Operating:

The device is to be operated in a manner not inconsistent with the manufacturer’s instructions for use of the device, provided that:

calibration and configuration of the device is to be undertaken only by the manufacturer or an agent approved by it
the device is to be configured so that:

– Test Mode is set to Active Sampling

– Digital Display Mode is set to Reveal

– Display Format is set to Positive or Negative

– Measurement ratio is set to 2100:1

– Display Mask is set to declare a result at or below 0.009 as Negative

– Breath Sampling Parameters are set to be:

 for discard volume parameter — between 1 and 5 litres

 for drop or flow rate parameter – between 20 and 50 litres/minute

– Display Reset Time is set to 10 seconds

– Calibration Lock is to render the device inactive if recalibration has not been undertaken within the last 6 months

– Device Firmware is dongle protected and accessible only by the manufacturer or an agent approved by it

the following optional functions are not to be activated:

– Passive Test Mode

– Hide Digital Display Mode

– Actual Alcohol Units Display

– Timed Sample Capture

– Precursory Mode

– Manual Sampling

the device is only to be used in Analyse Mode
the device is to be used only with one‑use‑only mouthpieces and not with the reusable sampling cup
a clean unused mouthpiece is to be used for every test
only mouthpieces manufactured or supplied by Lion Laboratories Limited are to be used
the device is not to be used with “online‑400” PC software
printing of test results is not required.

Drager Alcotest 9510 Aus

Storing:

The device is to be stored in its travel case in clean and dry conditions and not exposed to extreme weather conditions.

Testing:

The device is to be verified to National Measurement Institute standard R126 so that after verification only the time and date may be varied, or the location of testing inserted, by another person. The verification is to be conducted in a manner not inconsistent with the manufacturer’s instructions provided that compliance with any action recommended in those instructions is to be regarded as mandatory.

Maintaining:

The device is to be cleaned only with a slightly damp cloth and not exposed to cleaning products that contain solvents.

Operating:

The device is to be operated in a manner not inconsistent with the manufacturer’s instructions for use of the device, provided that:

compliance with any action recommended in those instructions is to be regarded as mandatory
results are to be printed using a thermal printer
connection to another printer or to a PC or modem is not required
a clean unused mouthpiece is to be used for every test
only mouthpieces manufactured or supplied by Drager Safety Pacific Pty Ltd are to be used.

Schedule 8 Another standard – National Association of Testing Authorities accreditation – confirmatory drug tests

1 Another standard for confirmatory drug test accreditation

(1) Another standard to which the National Association of Testing Authorities may accredit a person if the person is to be approved by CASA to conduct confirmatory drug tests for the purposes of Part IV of the Act, is declared in subclause (2).

(2) ISO/IEC 17025-2005, General requirements for the competence of testing and calibration laboratories, being the international standard so numbered as in force from time to time and published jointly by the International Organisation for Standardization and the International Electrotechnical Commission, 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.