e) Devices for Alcohol Testing. All devices used for the testing of breath and saliva for alcohol shall meet the following requirements:

1. 1) Alcohol Screening Test Devices. Evidential Breath Testing Devices and Alcohol Screening Devices on the NHTSA conforming products lists for evidential and non-evidential devices are the only devices allowed to be used to conduct alcohol screening tests. An Alcohol Screening Device shall be used only for screening tests for alcohol and not for alcohol confirmation tests.

2. 2) Alcohol Confirmation Test Devices. An alcohol confirmation test shall be performed with an Evidential Breath Testing Device that:

   1. A) is listed on the NHTSA Conforming Products Lists for Evidential Breath Testing Devices;
   2. B) provides a printed triplicate result (or three consecutive identical copies of a result) of each breath test;
   3. C) assigns a unique number to each completed test, which the Technician and the employee can read before each test and that is printed on each copy of the result;
   4. D) prints, on each copy of the result, the manufacturer's name for the device, its serial number, and the time of the test;
   5. E) distinguishes alcohol from acetone at the 0.08 alcohol concentration level;
3. F) tests an air blank; and
4. G) performs an external calibration check.

f) Use and Care of Devices for Alcohol Testing

1. 1) Evidential Breath Testing Devices. Users of an Evidential Breath Testing Device must:

   1. A) follow the manufacturer's instructions, including performance of external calibration checks at the intervals the instructions specify.
   2. B) in conducting external calibration checks, use only calibration devices appearing on NHTSA's Conforming Products List for Calibrating Units for Breath Alcohol Tests.
   3. C) maintain records of the inspection, maintenance and calibration of Evidential Breath Testing Device for two years; and
   4. D) ensure that inspection, maintenance and calibration of the Evidential Breath Testing Device are performed by its manufacturer or a maintenance representative certified either by the manufacturer or by a state health agency or other appropriate state agency. If an Evidential Breath Testing Device fails an external check of calibration, the Evidential Breath Testing Device must be taken out of service. The Evidential Breath Testing Device may not be used again for alcohol testing until it is repaired and passes an external calibration check.
2. 2) Alcohol Screening Device.

3. A) Users of an Alcohol Screening Device must:

   1. i) follow the quality assurance plan instructions created by the manufacturer of the Alcohol Screening Device; and
   2. ii) follow all device and care requirements for Evidential Breath Testing Devices.
   3. B) An Alcohol Screening Device that does not pass the specified quality control checks or has passed its expiration date shall not be used.

g) Alcohol Screening Test Procedures

1. 1) Initial Procedures. The Breath Alcohol Technician or Screening Test Technician shall take the following steps to begin all alcohol screening tests, regardless of the type of testing device used:

   1. A) The Technician shall ensure that, when the employee enters the alcohol testing site, the alcohol testing process begins without undue delay.
   2. B) If the employee is also going to provide a urine or blood specimen, the Technician shall, to the greatest extent practicable, ensure that the alcohol test is completed before the urine or blood collection process begins.
   3. C) If the employee needs medical attention, this treatment shall not be delayed to conduct an Alcohol Screening Test.
   4. D) The employee shall provide the Technician with positive identification.
   5. E) The Technician shall explain the testing procedure to the employee.

2. 2) Evidential Breath Testing Device or Non-evidential Breath Alcohol Screening Device. For an alcohol screening test using an Evidential Breath Testing Device or non-evidential breath Alcohol Screening Device, the Technician shall execute the following procedure:

   1. A) Select, or allow the employee to select, an individually wrapped or sealed mouthpiece from the testing materials.
   2. B) Open the individually wrapped or sealed mouthpiece in view of the employee and insert it into the device in accordance with the manufacturer's instructions.
   3. C) Instruct the employee to blow steadily and forcefully into the mouthpiece for at least six seconds or until the device indicates that an adequate amount of breath has been obtained.

3. D) Show the employee the displayed test result.

   1. E) If the device is one that prints the test number, testing device name and serial number, time and result directly onto the collection form, the Technician shall ensure that the information has been printed correctly onto the collection form.
   2. F) If the device is one that prints the test number, testing device name and serial number, time and result, but on a separate printout rather than directly onto the collection form, the Technician shall affix the printout of the information to the collection form with tamper-evident tape or use a self-adhesive label that is tamper-evident.
   3. G) If the device is one that does not print the test number, testing device name and serial number, time and result, or is a device not being used with a printer, the Technician shall record this information on the collection form.

4. 3) Procedure for an Alcohol Screening Test using a Saliva Alcohol Screening Device or a Breath Tube Alcohol Screening Device. The Technician shall execute the following procedure when using the saliva Alcohol Screening Device:

   1. A) Check the expiration date on the device or on the package containing the device and show it to the employee. The device shall not be used after its expiration date.
   2. B) Open an individually wrapped or sealed package containing the device in the presence of the employee.
   3. C) Offer the employee the opportunity to use the device. If the employee uses it, the Technician shall instruct the employee to insert it into his or her mouth and use it in a manner described by the device's manufacturer.
   4. D) 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, the Technician shall insert the device into the employee's mouth and gather saliva in the manner described by the device's manufacturer. The Technician shall wear single-use examination or similar gloves while doing so and change them following each test.
   5. E) When the device is removed from the employee's mouth, the Technician shall follow the manufacturer's instructions regarding necessary next steps in ensuring that the device has activated.
   6. F) If the Technician is unable to successfully follow these procedures, he or she shall discard the device and conduct a new test using a new device. The new device must be one that has been under the control of the Technician. The Technician shall note on the remarks section of the collection form the reason for the new test. The Technician shall offer the employee the choice of using the device or having the Technician use it unless the employee was responsible for the new test needing to be conducted.
   7. G) If the Technician is unable to successfully follow the required procedures on the new test, he or she shall end the collection and include an explanation on the remarks section of the collection form. The Technician shall then direct the employee to take a new test immediately, using an Evidential Breath Testing Device for the screening test.
   8. H) If the Technician is able to successfully follow the procedures, but the device does not activate, he or she shall discard the device and conduct a new test. In this case, the Technician shall place the device into the employee's mouth to collect saliva for the new test.
   9. I) The Technician shall 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 after the test. The Technician shall then show the device and its reading to the employee and enter the result on the collection form.
   10. J) The Technician shall not re-use devices, swabs, gloves or other materials used in saliva testing.

5. 4) Procedure for Breath Tube Alcohol Screening Device. The Technician shall execute the following procedure when using the breath tube Alcohol Screening Device:

   1. A) 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. The Technician shall not use the device or the analyzer after its expiration date. The Technician shall not use an analyzer that is not specifically pre-calibrated for the device being used in the collection.
   2. B) 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.

6. C) Break the tube's ampoule in the presence of the employee.

   1. D) Offer the employee the opportunity to use the device. If the employee chooses to use the device, instruct the employee to blow forcefully and steadily into the blowing end of device until the inflation bag fills with air.
   2. E) If the employee chooses not to hold the device, the Technician shall hold the device.
   3. F) When the employee completes the breath process, take the device from the employee, remove the inflation bag, and prepare the device to be read by the analyzer in accordance with the manufacturer's directions.
   4. G) If the Technician was unable to successfully complete these procedures, he or she shall discard the device and conduct a new test using a new one. The new device must be one that has been under the control of the Technician before the test. The Technician shall note on the remarks section of the collection form the reason for the new test.
   5. H) The Technician shall offer the employee the choice of holding the device or having the Technician hold it, unless the employee was responsible for the new test needing to be conducted.
   6. I) If the Technician is unable to successfully follow the required procedures on the new test, he or she shall end the collection and put an explanation in the remarks section of the collection form.
   7. J) The Technician shall then direct the employee to take a new test immediately, using another type of Alcohol Screening Device or an Evidential Breath Testing Device.
   8. K) If the Technician was able to successfully follow the required procedures, and after having waited the required amount of time directed by the manufacturer for the detector device to incubate, the Technician shall place the device in the analyzer in accordance with the manufacturer's directions. The result must be read from the analyzer no earlier than the required incubation time of the device. In all cases, the result shall be read within 15 minutes after the test.
   9. L) The Technician shall follow the manufacturer's instructions for determining the result of the test. He or she shall show the analyzer result to the employee and record it on the collection form.
   10. M) The Technician shall 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.

7. 5) Procedures Following an Alcohol Screening Test Result

   1. A) The Breath Alcohol Technician or the Screening Test Technician shall complete and sign the collection form.
   2. B) If the test result is an alcohol concentration of less than 0.08, the Technician, must complete the collection form and transmit the result to the DER in a confidential manner.
   3. C) If the test result is an alcohol concentration of 0.08 or higher, the Technician shall direct the employee to take an Alcohol Confirmation Test.
   4. D) If the test result is any other result, the Technician shall note this result in the remarks section of the collection form.

h) Alcohol Confirmation Test Procedures

1. 1) Initial Procedures. Before starting the Alcohol Confirmation Test, the Breath Alcohol Technician shall execute the following procedure:

   1. A) Ensure that the employee waits at least 15 minutes before taking an alcohol confirmation test, starting with the completion of the Alcohol Screening Test. After the waiting period has elapsed, the Breath Alcohol Technician shall begin the Alcohol Confirmation Test as soon as possible, but not more than 30 minutes after the completion of the Alcohol Screening Test.
   2. B) The Breath Alcohol Technician shall observe the employee during the waiting period.

   3. C) The employee shall be given the following instructions before beginning the waiting period:

      1. i) Not to eat, drink, put anything, such as a cigarette or chewing gum, into his or her mouth, or belch;
      2. ii) That the reason for the waiting period is to prevent inaccurate reading;
      3. iii) That following the instructions concerning the waiting period is to the employee's benefit; and
      4. iv) That the confirmation test will be conducted at the end of the waiting period, even if the instructions have not been followed.
   4. D) If the Breath Alcohol Technician is aware that the employee has not followed the instructions, this should be noted in the remarks section of the collection form.
   5. E) If the Breath Alcohol Technician did not conduct the Alcohol Screening Test for the employee, the Breath Alcohol Technician performing the Alcohol Confirmation Test shall require positive identification of the employee, explain the confirmation procedures, and use a new collection form. The Breath Alcohol Technician performing the Alcohol Confirmation Test must note on the remarks section of the collection form that a different Breath Alcohol Technician or Screening Test Technician conducted the Alcohol Screening Test.
   6. F) Even if more than 30 minutes have passed since the screening test result was obtained, the Breath Alcohol Technician shall begin the Alcohol Confirmation Test, not another Alcohol Screening Test.
   7. G) The Breath Alcohol Technician performing the Alcohol Confirmation Test shall note in the remarks section of the collection form the time that elapsed between the two events and, if the Alcohol Confirmation Test could not begin within 30 minutes after the screening test, the reason why.

2. 2) Alcohol Confirmation Test Procedures. The Breath Alcohol Technician conducting the Alcohol Confirmation Test must execute the following procedures to complete the Alcohol Confirmation Test process:

   1. A) In the presence of the employee, conduct an air blank on the Evidential Breath Testing Device to be used for the Alcohol Confirmation Test before beginning the confirmation test and show the reading to the employee.

      1. i) If the reading is 0.00, the test may proceed. If the reading is greater than 0.00, another air blank shall be conducted.
      2. ii) If the reading on the second air blank is 0.00, the test may proceed. If the reading is greater than 0.00, the Breath Alcohol Technician must take the Evidential Breath Testing Device out of service. If the Evidential Breath Testing Device is taken out of service for an air blank reading greater than 0.00, the Evidential Breath Testing Device shall not be used until it is found to be within tolerance limits on an external check of calibration.
   2. B) Open a new individually wrapped or sealed mouthpiece in view of the employee and insert it into the device in accordance with the manufacturer's instructions.
   3. C) The Breath Alcohol Technician and the employee shall both read the unique test number displayed on the Evidential Breath Testing Device.
   4. D) Instruct the employee to blow steadily and forcefully into the mouthpiece for at least six seconds or until the device indicates that an adequate amount of breath has been obtained.
   5. E) Show the employee the result displayed on the Evidential Breath Testing Device.
   6. F) Show the employee the result and unique test number that the Evidential Breath Testing Device prints out.
   7. G) If the Evidential Breath Testing Device provides a separate printout of the result, attach the printout to the collection form with tamper-evident tape, or use a self-adhesive label that is tamper-evident.

3. 3) Procedures Following an Alcohol Confirmation Test Result. After the Evidential Breath Testing Device has printed the result of an alcohol confirmation test, the Breath Alcohol Technician shall execute the following procedures:

   1. A) Indicate the alcohol reading from the Evidential Breath Testing Device on the collection form and sign the collection form.
   2. B) If the test produces any other results, indicate these results in the remarks section of the collection form.
   3. C) Immediately transmit the collection form with the reported result directly to the DER and the employee in a confidential manner.