The Department of Transportation (DOT) issued a summary of changes earlier this month regarding a final rule on Part 40, which will take effect on December 5, 2024, concerning oral fluid testing and certification. This rule clarifies that being a DOT-certified collector for urine specimens does not automatically qualify you for DOT oral fluid collections. The certifications for collecting urine and oral fluid specimens are distinct; therefore, your testing provider must hold both certifications – a DOT urine collector certification and a DOT oral fluid collector certification – in order to collect both types of specimens.
To best facilitate the timely training of oral fluid collectors, the final rule permits an individual who is not a qualified oral fluid collector to serve as the monitor for oral fluid mock collections ONLY if:
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- The individual successfully completes an oral fluid “train the trainer” course (§ 40.35(c)(2)(iii)); OR
- The individual conducts oral fluid collector training (§ 40.35(c)(2)(ii)).
- DOT is waiving the requirement that an individual have at least 1 year experience conducting oral fluid collector training.
- The individual conducting the oral fluid collector training should (1) have a thorough understanding of Part 40, (2) be well versed in the course content they are teaching, and (3) maintain records to demonstrate that the training was conducted. The course content must meet the requirements specified in § 40.35(b).
This temporary modification to the rule will expire one year after the Department of Health and Human Services (HHS) publishes a notice in the Federal Register announcing the certification of the first oral fluid drug testing laboratory. After that one-year period, all individuals conducting mock test observations will be required to comply with the requirements outlined in § 40.35(c)(2).
The rule states that collectors may use an oral fluid collection device to conduct their mock tests before the devices are certified by HHS. However, it is important to note that this means they may be using a device that could ultimately be different from the one that is approved for DOT testing. As a result, once HHS approves specific devices, another mock test will be required using those approved devices.
As is stated in § 40.35 (c)Following your completion of qualification training under paragraph (b) of this section, you must demonstrate proficiency in collections under this part by completing five consecutive error-free mock collections for each device you will use.
The update specifies who is permitted to be present during an oral fluid collection. Only the collector, the employee, or a representative from the Department of Transportation (DOT) may witness the testing procedure. Additionally, the rule requires the collector to confirm that an appropriate volume has been collected using their collection device. This confirmation must be documented by checking the “Volume Indicator(s) Observed” box in Step 2 of the Federal Custody and Control Form (CCF).