As of November 5, 2024, there are no currently qualified oral fluid collectors per § 40.35(c)(2) who meet the additional qualifications at § 40.35(c)(2)(i), (ii) or (iii) to monitor and evaluate the trainee’s mock collections; therefore, no one can be a qualified oral fluid collector at this time. IS THIS CHANGING? YES!
Previously, the Department of Transportation made confusing rules around qualified DOT oral fluid collectors and their training. But they are aiming to fix this.
DOT published a final rule in the Federal Register today to provide temporary qualification requirements for mock oral fluid monitors.
This final rule, effective on December 5, 2024, will also:
- provide for consistent requirements by identifying which individuals may be present during an oral fluid collection, and
- clarify how collectors are to document that a sufficient volume of oral fluid was collected.
Let’s take a close look at what qualified oral fluid collector training requirements look like and what this clarification means for 2025.
DOT saliva drug testing is nearly here… but when?
For an employer to implement oral fluid testing under DOT’s regulation, the U.S. Department of Health and Human Services (HHS) will need to certify at least two laboratories for oral fluid testing, which has not yet been done.
Either LabCorp or Quest are expected to be certified in Q1 2025, according to HHS. So, will this be enough to start DOT oral saliva drug testing?
No, there must be a different HHS-certified laboratory to conduct the split specimen drug testing on the secondary specimen if the employee requests split specimen testing for a non-negative result.
In other words, oral fluid testing under part 40 cannot be fully implemented until HHS certifies at least two laboratories. But we also need to get qualified oral fluid collectors.
The following is a link to HHS-certified laboratories: https://www.samhsa.gov/workplace/drug-testing-resources/certified-lab-list
DOT oral fluid collector training requirements
As stated earlier, there are no currently qualified oral fluid collectors per part 40.
While the training and qualification requirements for urine collectors and oral fluid collectors in Part 40 are similar, they are also unique because of the differences in the collection site, collection equipment and supplies used, and the collection process for urine and oral fluid specimens.
Understanding this, what kind of training should oral fluid collectors receive?
The May 2023 final rule established these requirements, mirroring the existing urine collector qualifications in § 40.33 as closely as possible:
- Basic Information
- Qualification Training
- Initial Proficiency Demonstration
- Refresher Training
- Error Correction Training, and
- Documentation
Additionally, there are provisions in each section that are unique and tailored specifically to oral fluid specimen collection:
- Training on ‘‘dry mouth’’ collections for oral fluid in § 40.35(b)(4);
- Completion of an oral fluid mock collection*** for a scenario in which the employee has something in the employee’s mouth that might interfere with the collection in § 40.35(c)(1))
Per § 40.35(c)(2)(i), (ii), and (iii), the qualified collector that will serve as the monitor for the mock collections is additionally required to have demonstrated knowledge, skills, and abilities by
- ‘‘Regularly conducting DOT drug test collections for a period of at least one year’’; or
- ‘‘Conducting collector training under Part 40 for at least one year’’; or
- ‘‘Successfully completing a ‘train the trainer’ course’’
DOT acknowledged in its June 2024 DFR that it had inadvertently created a factual impossibility given the current language of § 40.35.
To address the issues, DOT published a direct final rule (DFR) on June 21, 2024. DOT received adverse comments to each of the provisions in the DFR and NPRM, and DOT published a notice withdrawing the DFR in the Federal Register on August 1, 2024 (89 FR 62665).
This current final rule is hoping to clarify this impossibility by authorizing individuals to monitor mock oral fluid collections without meeting the requirement of being a qualified oral fluid collector, specified in § 40.35 as proposed in the NPRM.
They propose that this regulatory flexibility would apply only to those individuals meeting the knowledge, skills, and abilities in § 40.35(c)(2)(ii) or (iii) to waive the requirement that individuals conducting oral fluid collector training have at least one year of experience conducting collector training.
The course content must meet the requirements in § 40.35(b), and individuals conducting training should maintain good records (for example, the course content for the instructor and student, the duration of the training, the dates the course was taught, who attended the course, and any certificate of successful completion provided to students, etc.) to demonstrate that they conducted the training.
Individuals conducting this training would be eligible to observe oral fluid mock collections during the period of regulatory relief, which will sunset one year after HHS published a Federal Register notice that it certified the first oral fluid drug testing laboratory.
In its comments, NDASA stated that it alone has trained ‘‘several hundred’’ trainers through its train-the-trainer course since the issuance of DOT’s oral fluid rule in May 2023.
This—coupled with the regulatory flexibility established in this rule—will ensure that there are enough qualified oral fluid collectors within the first year of laboratories being certified without the need for an extended sunset date.
CNS Occupational Medicine can help with oral testing and customized policy development
Drug testing policies can be complicated and should consider:
- Purpose of the Policy
- Specimen Types
- Testing Procedures
- Prescription Drug Disclosure
- Federal Regulations (DOT)
- State Drug Testing Laws and Marijuana Laws
- Workers’ Compensation
- ADA
- Prohibited Conduct
- Consequences
At CNS, we also offer a comprehensive Drug and Alcohol Consortium Service and are a certified consortium and third-party administrator (C/TPA).
Our experts ensure that all DOT rules and regulations are followed, including the implementation of random drug tests for you and your drivers, updating your company drug testing policies, record retention and document purge management. Join our consortium today!
For more information, contact us at 800.551.9816 or info@cnsoccmed.com.
