CASA 125/09 - Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998 (Cth)

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CASA 125/09 — Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998 (as amended)

made under the Civil Aviation Safety Regulations 1998 (CASR 1998).

This compilation was prepared on 5 October 2017 taking into account amendments up to CASA 90/17. It is a compilation of CASA 125/09 — Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998 as amended and in force on 16 September 2017.

Prepared by the Legal Advisory, Drafting and Contracts Section, Legal Affairs, Regulatory Policy & International Strategy Branch, Civil Aviation Safety Authority, Canberra.

Compilation No. 5.

Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998

1 Commencement

This instrument commences on the day after it is registered.

2 Legislative instrument for drug and alcohol testing

This instrument is a legislative instrument providing for certain matters under Subpart 99.C of CASR 1998.

3 Drug and alcohol testing

(1) For paragraph 99.130 (a) of CASR 1998, I approve the breathalysers mentioned in Schedule 1 for use in alcohol testing under Subpart 99.C of CASR 1998.

(2) For paragraph 99.130 (b) of CASR 1998, I approve the drug testing device mentioned in Schedule 2 for use in initial drug testing under Subpart 99.C of CASR 1998.

(3) For regulation 99.140 of CASR 1998, the procedures for an approved tester to take and prepare a body sample for drug testing under Subpart 99.C of CASR 1998 are set out in Schedule 3.

(4) For subregulation 99.145 (2) of CASR 1998, storing, testing, maintaining and operating a drug testing device approved for use in an initial drug test under Subpart 99.C of CASR 1998 must be in accordance with Schedule 4.

(5) For regulation 99.150 of CASR 1998, the method for determining sample identifiers to be allocated to body samples that approved testers take under Subpart 99.C of CASR 1998 and send for confirmatory drug tests is specified in Schedule 5.

(6) For regulation 99.245 of CASR 1998, the procedures for an approved tester to take body samples for alcohol testing under Subpart 99.C of CASR 1998 are set out in Schedule 6.

(7) For subregulation 99.250 (3) of CASR 1998, storing, testing, maintaining and operating a breathalyser approved for use in an initial alcohol test under Subpart 99.C of CASR 1998 must be in accordance with Schedule 7.

(8) For paragraph 99.445 (3) (b) of CASR 1998, 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

The 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 DrugWipeÒ 5S

2 Alere^TM Alere DDS2

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 DrugWipeÒ 5S approved drug testing device in association with the Alere DDS2 approved drug testing device
Step 1 — Taking body samples with the DrugWipeÒ 5S approved testing device (the device):

Having checked that the device has not passed its expiry date, the approved tester is to separate the saliva collector (sometimes also called a “swab”) of the device from the detection element.

The approved tester is then to ask the donor to moisten the inside of his or her cheeks by rolling the tongue around the inside of the mouth.

The approved tester is then to ask the donor to hold the saliva collector in one hand and apply moderate pressure in using the saliva collector to wipe his or her tongue in a downward and circular movement, and to wipe the inside of his or her cheeks making circular movements.

Preparing body samples:

Once a saliva sample has been obtained, the approved tester is to:

•   Reattach the saliva collector to the detection element. A double click will be heard on successful reattachment.

•   Bring the device into a vertical position and by pressing with a thumb on the crosshairs marked on the ampoule unit 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 seconds.

•   Place the device horizontally on a surface for a period of not less than 7 minutes but not more than 10 minutes. After a time within this period, the display window on the device will show the red control line (CL).

•   After a further time, but still within the 10 minute period mentioned above, if another 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 10 minutes have elapsed. But do not ignore any line or part of a line that first appears BEFORE 10 minutes have elapsed EVEN IF it goes on developing until 12 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, after the further time but still within the 10 minute period as 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 10 minutes have elapsed, may go on developing until 12 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 DrugWipe® 5S approved drug testing device in association with the Alere DDS2 approved drug testing device
Step 2 – Taking body samples with the Alere DDS2 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 Alere 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 DDS2 device

·   the approved tester is to remove a new test cartridge from the foil wrapper

·   the approved tester is to 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

·   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 ask the donor to remove the Alere DDS2 Oral Fluid Collection Device 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 Alere DDS2 Oral Fluid Collection Device around the gums, tongue and inside the cheeks of the donor, then leave the swab under the tongue until the sample presence indicator turns completely blue to indicate that a sufficient sample has been obtained

·   insert the Alere DDS2 Oral Fluid Collection Device 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 device has been inserted, the analyser should be kept in a horizontal plane remaining as still as possible throughout testing. If the analyser is tilted beyond the acceptable range, a warning symbol will appear on the screen. Correct the orientation of the analyser immediately to prevent disruption to the test

·   when the Alere DDS2 Oral Fluid Collection Device has been inserted into test cartridge in the analyser, the screen will display “test in progress” and a countdown timer appear

·   when the analyser has finished processing the test, a results screen will be displayed showing either positive or negative for each drug group and 2 hardcopy printouts are also 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

·   the result of the initial drug test is, therefore, not a positive test result and 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:

(a)   for each testable drug group which returned a positive result under Step 1; and

(b)     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 Step 2:

testable drug group means the pharmacological grouping into which particular testable drugs fall, namely, the amphetamine and methamphetamine group, the cannabis group, the cocaine group, and the opiates group.

2

For the conduct of a confirmatory test on a further body sample taken under subregulation 99.170 (1), where the result of an initial drug test using the Alere DDS2 approved drug testing device on an earlier body sample is a positive result

Taking body samples:

The approved tester is to ask the donor to:

·   remove the swab of a Alere Certus Oral Fluid Collection Device from the packaging, ensuring the donor holds the plastic stem of the swab

·   place the cotton end in the donor’s mouth, actively moving the swab around the gums and tongue and inside the donor’s cheeks

·   leave the swab under the donor’s tongue until the sample presence indicator on the swab turns completely blue to indicate that a sufficient sample has been obtained

·   remove the swab from the donor’s mouth and give it to the approved tester by holding the plastic stem.

The approved tester may require the donor to replace the swab in the donor’s mouth until the swab turns blue.

Preparing body samples:

Once a sufficient sample has been obtained, the approved tester is to:

·   remove the cap from the longer collection tube containing buffer solution and insert the swab into the tube, cotton end first

·   firmly screw the cap onto the longer tube with the swab in it and gently shake for not less than 30 seconds to create the sample for testing

·   remove the caps from the shorter, empty tubes

·   remove the cap from the longer tube containing the sample and pour at least 1 ml (using guides on the tubes) of the buffer solution into each of the 2 shorter tubes, dividing the sample approximately evenly between the 2 shorter tubes

·   firmly screw the caps onto the shorter tubes

·   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 with the CASA Transmission of sample to approved laboratory form

·   invite the donor to initial the tamper-evident seals — the donor may choose to do so

·   fix the tamper-evident seal “A” across the top of the cap and down the sides of 1 of the shorter 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 remaining shorter 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 the 2 sealed, shorter tubes into the front pocket of the transit bag, ensuring the gauze pad (if supplied) is in the same pocket, for dispatch to the approved laboratory for confirmatory testing.

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

Item	Drug test	Procedures
1(a)	For the conduct of Step 1 of an initial drug test using the DrugWipeÒ 5S approved drug testing device in association with the Alere DDS2 approved drug testing device	Step 1 — Taking body samples with the DrugWipeÒ 5S approved testing device (the *device): Having checked that the device has not passed its expiry date, the approved tester is to separate the saliva collector (sometimes also called a “swab”) of the device from the detection element. The approved tester is then to ask the donor to moisten the inside of his or her cheeks by rolling the tongue around the inside of the mouth. The approved tester is then to ask the donor to hold the saliva collector in one hand and apply moderate pressure in using the saliva collector to wipe his or her tongue in a downward and circular movement, and to wipe the inside of his or her cheeks making circular movements. Preparing body samples: Once a saliva sample has been obtained, the approved tester is to: • Reattach the saliva collector to the detection element. A double click will be heard on successful reattachment. • Bring the device into a vertical position and by pressing with a thumb on the crosshairs marked on the ampoule unit 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 seconds. • Place the device horizontally on a surface for a period of not less than 7 minutes but not more than 10 minutes. After a time within this period, the display window on the device will show the red control line (CL). • After a further time, but still within the 10 minute period mentioned above, if another 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 10 minutes have elapsed. But do not ignore any line or part of a line that first appears BEFORE 10 minutes have elapsed EVEN IF it goes on developing until 12 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, after the further time but still within the 10 minute period as 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 10 minutes have elapsed, may go on developing until 12 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 DrugWipe® 5S approved drug testing device in association with the Alere DDS2 approved drug testing device	Step 2 – Taking body samples with the Alere DDS2 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 Alere 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 DDS2 device · the approved tester is to remove a new test cartridge from the foil wrapper · the approved tester is to 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 · 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 ask the donor to remove the Alere DDS2 Oral Fluid Collection Device 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 Alere DDS2 Oral Fluid Collection Device around the gums, tongue and inside the cheeks of the donor, then leave the swab under the tongue until the sample presence indicator turns completely blue to indicate that a sufficient sample has been obtained · insert the Alere DDS2 Oral Fluid Collection Device 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 device has been inserted, the analyser should be kept in a horizontal plane remaining as still as possible throughout testing. If the analyser is tilted beyond the acceptable range, a warning symbol will appear on the screen. Correct the orientation of the analyser immediately to prevent disruption to the test · when the Alere DDS2 Oral Fluid Collection Device has been inserted into test cartridge in the analyser, the screen will display “test in progress” and a countdown timer appear · when the analyser has finished processing the test, a results screen will be displayed showing either positive or negative for each drug group and 2 hardcopy printouts are also 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 · the result of the initial drug test is, therefore, not a positive test result and 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: (a) for each testable drug group which returned a positive result under Step 1; and (b) 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 Step 2: *testable drug group* means the pharmacological grouping into which particular testable drugs fall, namely, the amphetamine and methamphetamine group, the cannabis group, the cocaine group, and the opiates group.
2	For the conduct of a confirmatory test on a further body sample taken under subregulation 99.170 (1), where the result of an initial drug test using the Alere DDS2 approved drug testing device on an earlier body sample is a positive result	Taking body samples: The approved tester is to ask the donor to: · remove the swab of a Alere Certus Oral Fluid Collection Device from the packaging, ensuring the donor holds the plastic stem of the swab · place the cotton end in the donor’s mouth, actively moving the swab around the gums and tongue and inside the donor’s cheeks · leave the swab under the donor’s tongue until the sample presence indicator on the swab turns completely blue to indicate that a sufficient sample has been obtained · remove the swab from the donor’s mouth and give it to the approved tester by holding the plastic stem. The approved tester may require the donor to replace the swab in the donor’s mouth until the swab turns blue. Preparing body samples: Once a sufficient sample has been obtained, the approved tester is to: · remove the cap from the longer collection tube containing buffer solution and insert the swab into the tube, cotton end first · firmly screw the cap onto the longer tube with the swab in it and gently shake for not less than 30 seconds to create the sample for testing · remove the caps from the shorter, empty tubes · remove the cap from the longer tube containing the sample and pour at least 1 ml (using guides on the tubes) of the buffer solution into each of the 2 shorter tubes, dividing the sample approximately evenly between the 2 shorter tubes · firmly screw the caps onto the shorter tubes · 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 with the CASA Transmission of sample to approved laboratory form · invite the donor to initial the tamper-evident seals — the donor may choose to do so · fix the tamper-evident seal “A” across the top of the cap and down the sides of 1 of the shorter 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 remaining shorter 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 the 2 sealed, shorter tubes into the front pocket of the transit bag, ensuring the gauze pad (if supplied) is in the same pocket, for dispatch to the approved laboratory for confirmatory testing.

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 DrugWipeÒ 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 Alere DDS2

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 Alere, or another person approved by it, at least once every 12 months · any necessary repairs are to be undertaken by Alere 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 DDS2 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 1998 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 1998.

(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 he or she has consumed anything containing alcohol in the preceding 10 minutes.

If the donor advises that he or she 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 he or she consumes anything further (except water) until the testing, including confirmatory testing if necessary, is completed, it may be considered that he or she has refused, or failed to give a body sample.

If the donor has advised the approved tester that he or she 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 he or she had consumed anything containing alcohol.

Having turned on the device by pressing the large button marked “I-O”, the approved tester must then ensure that the device has completed the self-check (RED light) and that the GREEN “ready” light is illuminated.

The approved tester must then attach an approved mouthpiece to the device, ensuring that he or she does not touch the lipped end and that the protective cellophane packaging remains in place until the donor removes it.

Provided that the donor has not consumed anything containing alcohol in the preceding 10 minutes, 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 his or her 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, the YELLOW flow light will be illuminated. A sufficient sample is necessary for the sample to be analysed. On the provision of a sufficient sample, the AMBER analysis light will be illuminated, and 2 beeps will sound. At this time, the donor is to be requested to stop blowing.

On the completion of the analysis of the sample, indicated by the AMBER analysis light ceasing to be illuminated, a reading will appear on the display screen of either NEGATIVE or POSITIVE.

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 unit)

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 unit must be connected to the appropriate power supply, depending on whether the unit 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

·   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 unit must be allowed to warm up (this is initiated by switching the unit 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 unit must be set at the correct time and date of the location at which the test is occurring

•   following the warm up, the unit is ready to perform a breath measurement by indicating “READY” on the screen — the green button under the front screen on the unit 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 unit

•   the “Save” button must be pressed to initialise testing; the unit will then automatically go through an internal diagnostic check

•   when the internal diagnostic check is completed, the unit 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 mouth piece into the donor’s mouth and to seal their lips around it when blowing

•   the donor must be asked to inhale calmly and then blow evenly and continuously through the mouth piece 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 reblow; the procedure under B. below must then be followed.

A. Sufficient volume of breath given:

·   the mouthpiece must be removed when the unit indicates to do so

·   the unit 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 unit

·   if the unit detects alcohol in the mouth of the donor, the unit 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 unit indicates to do so on its screen — the unit will then automatically perform an internal diagnostic check

·   each step to be taken by the approved tester and the donor after the previous internal diagnostic check must be repeated

Note   Unit 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 alcohol testing — storing, testing, maintaining and operating the breathalyser

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 he or she has consumed anything containing alcohol in the preceding 10 minutes. If the donor advises that he or she 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 he or she consumes anything further (except water) until the testing, including confirmatory testing if necessary, is completed, it may be considered that he or she has refused, or failed to give a body sample. If the donor has advised the approved tester that he or she 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 he or she had consumed anything containing alcohol. Having turned on the device by pressing the large button marked “I-O”, the approved tester must then ensure that the device has completed the self-check (RED light) and that the GREEN “ready” light is illuminated. The approved tester must then attach an approved mouthpiece to the device, ensuring that he or she does not touch the lipped end and that the protective cellophane packaging remains in place until the donor removes it. Provided that the donor has not consumed anything containing alcohol in the preceding 10 minutes, 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 his or her 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, the YELLOW flow light will be illuminated. A sufficient sample is necessary for the sample to be analysed. On the provision of a sufficient sample, the AMBER analysis light will be illuminated, and 2 beeps will sound. At this time, the donor is to be requested to stop blowing. On the completion of the analysis of the sample, indicated by the AMBER analysis light ceasing to be illuminated, a reading will appear on the display screen of either NEGATIVE or POSITIVE.
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 *unit*)	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 unit must be connected to the appropriate power supply, depending on whether the unit 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 · 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 unit must be allowed to warm up (this is initiated by switching the unit 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 unit must be set at the correct time and date of the location at which the test is occurring • following the warm up, the unit is ready to perform a breath measurement by indicating “READY” on the screen — the green button under the front screen on the unit 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 unit • the “Save” button must be pressed to initialise testing; the unit will then automatically go through an internal diagnostic check • when the internal diagnostic check is completed, the unit 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 mouth piece into the donor’s mouth and to seal their lips around it when blowing • the donor must be asked to inhale calmly and then blow evenly and continuously through the mouth piece 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 reblow; the procedure under B. below must then be followed. A. Sufficient volume of breath given: · the mouthpiece must be removed when the unit indicates to do so · the unit 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 unit · if the unit detects alcohol in the mouth of the donor, the unit 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 unit indicates to do so on its screen — the unit will then automatically perform an internal diagnostic check · each step to be taken by the approved tester and the donor after the previous internal diagnostic check must be repeated Note Unit 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.

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 0.022 as Negative

     – Breath Sampling Parameters are set to be:

n for discard volume parameter – between 1 and 5 litres

n 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 recalibra-tion has not been undertaken within the last 6 months

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

•   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; and

     – 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; and

•   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 instruct-tions 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; and

•   only mouthpieces manufactured or supplied by Drager Safety Pacific Pty Ltd to be used.

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

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 0.022 as Negative – Breath Sampling Parameters are set to be: n for discard volume parameter – between 1 and 5 litres n 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 recalibra-tion has not been undertaken within the last 6 months – Unit Firmware is dongle protected and accessible only by the manufacturer or an agent approved by it; and. • 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; and – 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; and • 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 instruct-tions 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; and • only mouthpieces manufactured or supplied by Drager Safety Pacific Pty Ltd to be used.

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.

Note to CASA 125/09 — Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998

Note 1

CASA 125/09 — Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998 (in force under regulations 99.130 and 99.140, subregulation 99.145 (2), regulations 99.150 and 99.245, subregulation 99.250 (3) and paragraph 99.445 (3) (b) of the Civil Aviation Safety Regulations 1998) as shown in this compilation is amended as indicated in the tables below.

Table of instruments

Title	Date of FRLI registration	Date of commencement	Application, saving or transitional provisions
CASA 125/09 Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998	31 March 2009 (see F2009L01203)	01 April 2009	—
CASA 263/09 Amendment of instrument CASA 125/09	19 June 2009 (see F2009L02447)	20 June 2009	—
CASA 151/12 Amendment of instrument CASA 125/09	22 May 2012 (see F2012L01057)	23 May 2012	—
CASA 165/13 Amendment of instrument CASA 125/09	23 August 2013 (see F2013L01616)	24 August 2013	—
CASA 23/17 Amendment of instrument CASA 125/09	7 March 2017 (see F2017L00196)	8 March 2017	—
CASA 90/17 Amendment of instrument CASA 125/09	15 September 2017 (see F2017L01192)	16 September 2017	—

Table of amendments

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected	How affected
Schedule 1, Approved breathalysers	am. CASA 90/17
Schedule 2, Approved drug testing device — initial drug testing	am. CASA 263/09, CASA 151/12, CASA 165/13
Schedule 3, Procedures for taking and preparing body samples for drug testing	am. CASA 263/09, CASA 151/12, CASA 165/13, CASA 23/17
Schedule 4, Procedures — approved drug testing device for use in initial drug testing — storing, testing, maintaining and operating the device	am. CASA 263/09 rs. CASA 151/12 am. CASA 165/13
Schedule 6, Procedures for taking body samples for alcohol testing	am. CASA 263/09, CASA 90/17
Schedule 7, Procedures — approved breathalyser for use in initial alcohol testing — storing, testing, maintaining and operating the breathalyser	am. CASA 90/17

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Citations

CASA 125/09 - Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998 (Cth)

Cases Citing This Decision

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Cases Cited

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Statutory Material Cited

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

Item	Name of manufacturer	Name and model of drug testing device
1	Securetec Detektions-Systeme AG	DrugWipeÒ 5S
2	Alere^TM	Alere DDS2