(a)As the STT or BAT, you must take the following steps when using the saliva ASD:
(1)Check the expiration date on the device or on the package containing the device and show it to the employee. You may not use the device after its expiration date.
(2)Open an individually wrapped or sealed package containing the device in the presence of the employee.
(3)Offer the employee the opportunity to use the device. If the employee uses it, you must instruct the employee to insert it into his or her mouth and use it in a manner described by the device's manufacturer.
(4)If the employee chooses not to use the device, or in all cases in which a new test is necessary because the device did not activate (see paragraph (a)(7) of this section), you must insert the device into the employee's mouth and gather saliva in the manner described by the device's manufacturer. You must wear single-use examination or similar gloves while doing so and change them following each test.
(5)When the device is removed from the employee's mouth, you must follow the manufacturer's instructions regarding necessary next steps in ensuring that the device has activated.
(6)(i) If you were unable to successfully follow the procedures of paragraphs (a)(3) through (a)(5) of this section ( e.g., the device breaks, you drop the device on the floor), you must discard the device and conduct a new test using a new device.
(ii)The new device you use must be one that has been under your control or that of the employer before the test.
(iii)You must note on the “Remarks” line of the ATF the reason for the new test. (Note: You may continue using the same ATF with which you began the test.)
(iv)You must offer the employee the choice of using the device or having you use it unless the employee, in the opinion of the STT or BAT, was responsible ( e.g., the employee dropped the device) for the new test needing to be conducted.
(v)If you are unable to successfully follow the procedures of paragraphs (a)(3) through (a)(5) of this section on the new test, you must end the collection and put an explanation on the “Remarks” line of the ATF.
(vi)You must then direct the employee to take a new test immediately, using an EBT for the screening test.
(7)If you are able to successfully follow the procedures of paragraphs (a)(3)-(a)(5) of this section, but the device does not activate, you must discard the device and conduct a new test, in the same manner as provided in paragraph (a)(6) of this section. In this case, you must place the device into the employee's mouth to collect saliva for the new test.
(8)You must read the result displayed on the device no sooner than the device's manufacturer instructs. In all cases the result displayed must be read within 15 minutes of the test. You must then show the device and it's reading to the employee and enter the result on the ATF.
(9)You must never re-use devices, swabs, gloves or other materials used in saliva testing.
(10)You must note the fact that you used a saliva ASD in Step 3 of the ATF.
(b)As the STT or BAT, you must take the following steps when using the breath tube ASD:
(1)Check the expiration date on the detector device and the electronic analyzer or on the package containing the device and the analyzer and show it to the employee. You must not use the device or the analyzer after their expiration date. You must not use an analyzer which is not specifically pre-calibrated for the device being used in the collection.
(2)Remove the device from the package and secure an inflation bag onto the appropriate end of the device, as directed by the manufacturer on the device's instructions.
(3)Break the tube's ampoule in the presence of the employee.
(4)Offer the employee the opportunity to use the device. If the employee chooses to use ( e.g. hold) the device, instruct the employee to blow forcefully and steadily into the blowing end of device until the inflation bag fills with air (approximately 12 seconds).
(5)If the employee chooses not to hold the device, you must hold it and provide the use instructions in paragraph (b)(4) of this section.
(6)When the employee completes the breath process, take the device from the employee (or if you were holding it, remove it from the employee's mouth), remove the inflation bag, and prepare the device to be read by the analyzer in accordance with the manufacturer's directions.
(7)(i) If you were unable to successfully follow the procedures of paragraphs (b)(4) through (b)(6) of this section ( e.g., the device breaks apart, the employee did not fill the inflation bag), you must discard the device and conduct a new test using a new one.
(ii)The new device you use must be one that has been under your control or that of the employer before the test.
(iii)You must note on the “Remarks” line of the ATF the reason for the new test. (Note: You may continue using the same ATF with which you began the test.)
(iv)You must offer the employee the choice of holding the device or having you hold it unless the employee, in the your opinion, was responsible ( e.g., the employee failed to fill the inflation bag) for the new test needing to be conducted.
(v)If you are unable to successfully follow the procedures of paragraphs (b)(4) through (b)(6) of this section on the new test, you must end the collection and put an explanation on the “Remarks” line of the ATF.
(vi)You must then direct the employee to take a new test immediately, using another type of ASD ( e.g., saliva device) or an EBT.
(8)If you were able to successfully follow the procedures of paragraphs (b)(4) through (b)(6) of this section and after having waited the required amount of time directed by the manufacturer for the detector device to incubate, you must place the device in the analyzer in accordance with the manufacturer's directions. The result must be read from the analyzer no earlier then the required incubation time of the device. In all cases, the result must be read within 15 minutes of the test.
(9)You must follow the manufacturer's instructions for determining the result of the test. You must show the analyzer result to the employee and record the result on Step 3 of the ATF.
(10)You must never re-use detector devices or any gloves used in breath tube testing. The inflation bag must be voided of air following removal from a device. Inflation bags and electronic analyzers may be re-used but only in accordance with the manufacturer's directions.
(11)You must note the fact that you used a breath tube device in Step 3 of the ATF.