Instrument number CASA 165/13
I, John francis mcCORMICK, Director of Aviation Safety, on behalf of CASA, make this instrument 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.
[Signed John F. McCormick]
John F. McCormick
Director of Aviation Safety
20 August 2013
Amendment of instrument CASA 125/09 — Drug and alcohol testing by CASA under Subpart 99.C of CASR 1998
1          Commencement
                 This instrument commences on the day after registration.
2          Amendment of instrument CASA 125/09
                 Instrument CASA 125/09 is amended as set out in Schedule 1.
Schedule 1          Amendments
[1]        Schedule 2, clause 1, Table 1, item 2
substitute
2
AlereTM
Alere DDS2
[2]        Schedule 3, clause 1, Table 1, item 1(a)
omit
Cozart DDS
insert
Alere DDS2
[3]        Schedule 3, clause 1, Table 1, item 1(b)
substitute
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.

            [4]       Schedule 3, clause 1, Table 1, item 2
substitute
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 hold and actively swab the bud-end of a Cozart Oral Swab around the gums and tongue and inside the cheeks of the donor, then leave the swab under the tongue until the sample presence indicator on the swab turns completely blue to indicate that a sufficient sample has been obtained.
·      Preparing body samples:
·      Once a sufficient sample has been obtained, the approved tester is to:
·      remove the lid from a sample buffer bottle and place the Cozart Oral Swab into the bottle, bud-end first
·      snap the stem of the Cozart Oral Swab by gently bending it at the scored break-point
·      replace the lid on the sample buffer bottle and tighten it
·      mix the contents of the sample buffer bottle by gently but repeatedly inverting it for 30 seconds
·      open the lid of the sample buffer bottle
·      using a sterile pipette, divide the contents of the sample buffer bottle approximately evenly between 2 specimen tubes that have not previously been used
·      close each of the specimen tubes
·      endorse 2 tamper-evident seals with the tester’s initials; ensure the sample identifier is marked on each seal; and ensure 1 seal is marked “Sample A” and the other is marked “Sample B”
·      ask the donor to initial each tamper evident seal
·      apply one of these endorsed tamper-evident seals across the lid of each of the 2 specimen tubes
·      place the specimen tubes in suitable packaging for dispatch to the approved laboratory for confirmatory testing.
            [5]       Schedule 3, clause 1, Table 1, item 3
omit
            [6]       Schedule 4, clause 1, Table 2
substitute
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.