The U.S. Department of Transportation announced updates to its drug and alcohol testing standards. This final rule, set to take effect on December 5, 2024, builds on the initial May 2023 rule with modifications that clarify critical components of the oral fluid collection process, specifically focusing on temporary qualification training standards for collection monitors, enhanced privacy guidelines, and documentation protocols for sample volume verification.
Key Revisions in the Final Rule
Temporary Qualification Standards for Oral Fluid Monitors:
To address the current shortage of fully qualified oral fluid monitors, DOT is allowing individuals who meet specific training requirements to oversee mock collections on a temporary basis. This measure will expire one year after the Department of Health and Human Services (HHS) certifies the first DOT-approved laboratory for oral fluid testing. Those eligible include individuals conducting oral fluid collector training or who have completed a “Train the Trainer” course. The usual experience requirements are temporarily waived, enabling faster onboarding of collection monitors.
Mock Collection Training:
The final rule allows organizations to begin mock collection training for oral fluid collectors effective December 5, 2024. However, it is important to note that the oral fluid device used in training may differ from the certified device required by HHS, which could necessitate additional training with a DOT-compliant system.
Requirements for Oral Fluid Testing:
DOT-regulated oral fluid testing cannot commence until two (2) HHS-certified laboratories are available. Currently, there are no approved laboratories. At least one (1) DOT-compliant oral fluid collection device, approved by HHS, must be utilized in the testing process. Currently, there are no approved devices.
Privacy Protocols:
The revised rule clarifies that only the collector, the employee being tested, and a DOT agency representative may be present during oral fluid collections, aligning these procedures with current alcohol testing standards to protect employee privacy.
Clarified Documentation Requirements:
To ensure consistency across collections, collectors must document the collection of a sufficient specimen volume by checking the “Volume Indicator(s) Observed” box in Step 2 of the Custody and Control Form (CCF). This standardizes the process, improving accuracy and record-keeping for oral fluid tests.
What does this mean for Collectors, Trainers, C/TPAs, and Employers?
Collectors
- Temporary Qualification for Monitoring:
- Collectors meeting specific training standards can monitor mock collections, even if they do not fully meet experience requirements, until HHS certified laboratories are in place.
- Documentation Consistency:
- Collectors are responsible for verifying and documenting the specimen volume In Step 2 of the CCF.
Trainers
- Training Flexibility:
- Trainers can now conduct mock collection training without full qualification prerequisites, facilitating quicker readiness for the anticipated demand in oral fluid testing.
- Device Training Risks:
- Trainers can use non-certified devices for training, but there’s a risk: the device might not ultimately be an HHS approved device, meaning it might not be usable for official collections and retraining may be required to comply with the regulations.
- Emphasis on Privacy Compliance:
- Trainers should reinforce the updated privacy protocols, ensuring trainees understand that only designated personnel are permitted during collections.
Consortium/Third-Party Administrators (C/TPAs)
- Policy Updates:
- C/TPAs should adjust protocols to reflect temporary qualification changes and privacy standards and should assist clients in implementing these regulatory adjustments.
- Device Certification Awareness:
- C/TPAs need to stay informed about HHS-certified devices and laboratory certifications to ensure compliance readiness when oral fluid testing begins.
Employers
- Privacy Standards at Collection Sites:
- Employers must confirm that all testing site locations meet DOT’s revised privacy requirements.
- It may be necessary to conduct a site inspection to verify compliance.
- Collaboration for Training:
- Employers are encouraged to coordinate with C/TPAs to ensure timely and appropriate training for staff to meet the latest DOT standards.
These regulatory updates are intended to streamline DOT’s drug and alcohol testing program while supporting worker privacy and compliance. For further details, visit the official Federal Register announcement.