Instrument number CASA 125/09
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 (CASR 1998).
[Signed John F. McCormick]
John F. McCormick
Director of Aviation Safety and
Chief Executive Officer
25 March 2009
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
Lion Laboratories Limited
Lion Intoxilyzer 8000
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
Cozart plc
Cozart DDS
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
For the conduct of an initial drug test using the Cozart DDS approved drug testing device
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
• ensure that the Cozart DDS device is ready to begin a new test
• open the lid of the sample buffer bottle
• hold the bottle vertically and, using a sterile pipette, apply 4 drops of fluid from the sample buffer bottle on to the sample well of the Cozart DDS test cartridge to be used with the Cozart DDS device
• close the lid of the sample buffer bottle
• as soon as the fluid appears on each of the 4 white membrane strips of the Cozart DDS cartridge (this will take between 2 and 30 seconds), insert the cartridge into the Cozart DDS device with the arrow facing upwards; and
• initiate a new test.
2
For the conduct of a confirmatory test on the same body sample as that which has been subject to an initial drug test using the Cozart DDS approved drug testing device
Preparing body samples:
In the presence of the donor, the approved tester is to:
• open the lid of the sample buffer bottle
• using a sterile pipette, divide the remaining content 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 seal 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; and
• place the specimen tubes in suitable packaging for dispatch to the approved laboratory for confirmatory testing.
3
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 Cozart DDS 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 content 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 seal 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; and
• place the specimen tubes in suitable packaging 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
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.
TABLE 1
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 Cozart plc, or another person approved by it, at least once every 12 months; and
• any necessary repairs are to be undertaken by Cozart plc 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
• Cozart DDS801 drug testing cartridges are to be used; and
• 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 they have had anything to eat or drink in the preceding 10 minutes.
If the donor advises that he or she has had something to eat or drink in the preceding 10 minutes, the approved tester must request the donor to remain in the tester’s presence and not eat or drink anything further until the testing, including confirmatory testing if necessary, is completed.
If the donor has advised the approved tester that he or she has had something to eat or drink in the preceding 10 minutes, the approved tester must wait until at least 10 minutes have elapsed since the person had eaten or drank.
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 had anything to eat or drink 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 Lion Intoxilyzer 8000 (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.
The approved tester must first ask the donor if they have had anything to eat or drink in the preceding 10 minutes.
If the donor advises that he or she has had something to eat or drink in the preceding 10 minutes, the approved tester must request the donor to remain in the tester’s presence and not eat or drink anything further until the confirmatory testing is completed.
If the donor has advised the approved tester that he or she has had something to eat or drink in the preceding 10 minutes, the approved tester must wait until at least 10 minutes have elapsed since the person had eaten or drank.
Before taking the breath sample, the following must occur:
• the unit must be allowed to warm up (this is initiated by switching the unit on and can take up to 10 minutes)
• following the warm up, the approved tester must press the “Start Test” button on the front panel of the unit; the words “Ready to Analyse” will be displayed on the screen, followed by the time and date
• the approved tester must then press the “Start Test” button again to initialise testing; the unit will then automatically go through a self-calibration check
• when this self-calibration check is completed, the approved tester must type the following details into the unit, pressing the enter button after each item, namely, his or her:
– operator ID number
– surname; and
– first name
• the date and time will be displayed on the screen and “Analysis Location” will then flash on the screen of the unit. If this is correct, press YES; if not, press NO and enter the correct location and press enter
• unless already entered, the approved tester must then enter the following donor’s details into the unit, pressing enter after each entry, namely, surname, given name, date of birth, gender and the ID number (sample identification number); to change gender, press space bar
• the unit will perform another self-calibration check
Note For clarity, self-calibration check X.
• when the unit is ready the approved tester must attach a new mouthpiece to the breath hose and ask the donor to remove the protective cellophane packaging
• provided that the donor has not had anything to eat or drink in the preceding 10 minutes, the approved tester must then ask the donor to place the end of the mouth piece into the donor’s mouth and to seal his or her lips around it; the donor is then to be requested to blow steadily and continuously through the mouth piece until a double beep is heard, when they must be requested to stop blowing.
If the breath specimen is accepted, “Specimen Accepted” will appear on the screen of the unit
If the breath specimen is not accepted, a descriptive comment will appear on the screen of the unit explaining why the specimen has been rejected. The approved tester must inform the donor that a repeat test is necessary; the unit is to be reset by entering “Y” when the unit screen displays “Repeat Test? Y/N”; and each step taken after the previous self-calibration check (referred to as X in the Note above) is to be repeated.
On the successful provision of a sample, the unit will then do more self-calibration checks and will show the “Subject’s Result”. Two hard-copies of the result docket will be printed out by the unit.
Schedule 7 Procedures — approved breathalyser for use in initial 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 0.022 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
– Data is to be down-loaded every 6 months at the time of recalibration.
• 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
Lion Intoxilyzer 8000
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 Lion Laboratories Limited 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.
