Department of Transportation (DOT) Oral Fluid Drug Testing for Regulated Employees Still Delayed
Although the 49 CFR Part 40 Department of Transportation (DOT) rules were changed over nine (9) months ago to allow the use of oral fluid specimens for federal drug testing under the Procedures for Transportation Workplace Drug and Alcohol Testing Programs, no oral fluid collections may be conducted as of the publication of this newsletter (March 18, 2024). We realize that everyone in this industry is anxiously awaiting the green light to begin training collectors to conduct oral fluid collections, but the public has no idea at this point when this will happen. We continue to receive questions from customers, such as:
What are we waiting for???
Before a trained oral fluid specimen collector may begin collections using this particular bodily fluid, there must be at least two laboratories certified by the Department of Health and Human Services (HHS), and this has not occurred yet. Under the federal regulations, there must also be one laboratory to serve as a primary laboratory and a second lab to serve as a split-specimen testing laboratory.
In addition, there are currently no oral fluid collection devices approved and available that meet the DOT rule requirements. Appendix B of the Part 40 Rules requires a single oral fluid collection device that may be subdivided in the donor’s presence. Once device(s) are available that meet the Appendix B requirements, the next hurdle is that they must be approved by HHS for use by the specific laboratory that will test the specimen that was collected by this particular, approved device. As you may imagine, this is a lengthy process.
I have heard of other collection sites that have already started doing oral fluid or saliva collections for drug testing. Is this permissible?
No, this is NOT permissible currently. You must wait until all required approvals are in place before conducting oral fluid specimen collections or sending oral fluid specimens for DOT tests to a laboratory. In the meantime, trained urine specimen collectors should continue performing urine specimen collections only, as prescribed by the federal regulations.
Certified Training Solutions’ professional urine specimen collector courses are available conveniently online and by webcam at an affordable price.
It is unfortunate to hear that some collectors and collection sites have started performing oral fluid collections for DOT drug tests using non-approved devices and sending the specimens to laboratories. These folks seemed to have jumped the gun; and have obviously failed to read, understand, and verify what is currently allowed by the regulations. You should NOT be conducting these types of collections at this time. Collectors need to wait until we get the go-ahead from regulators – and until they have completed the oral fluid-specific training.
Service agents (collectors, collection sites, etc.) should be aware that they may be subjected to enforcement action, including a Public Interest Exclusion (PIE) for engaging in behaviors that constitute serious noncompliance and violate the Program’s rules. You may read more about Public Interest Exclusions here:
https://www.ecfr.gov/current/title-49/subtitle-A/part-40/subpart-R
And here: eCFR :: 46 CFR 16.109 — Public Interest Exclusion (PIE).
What can I do to prepare to become an oral fluid specimen collector at this point?
If you would like to get a head start on becoming knowledgeable about oral fluid specimen collections, Certified Training Solutions suggests that you start by reading the Part 40 rules that pertain to oral fluid specimens:
Oral fluid specimen collector training requirements: https://www.ecfr.gov/current/title-49/section-40.35
Oral fluid collection site requirements:
https://www.ecfr.gov/current/title-49/section-40.47
… Along with reading Subpart D, which outlines sites, equipment, forms, and supplies: https://www.ecfr.gov/current/title-49/part-40/subpart-D
Security and integrity of oral fluid collections:
https://www.ecfr.gov/current/title-49/section-40.48
Direct observation collections for transgender and non-binary donors and how it relates to oral fluid collections:
https://www.ecfr.gov/current/title-49/part-40#p-40.67(g)(3)
Steps the collector must take prior to an oral fluid collection: https://www.ecfr.gov/current/title-49/section-40.72
The process of conducting an oral fluid collection: https://www.ecfr.gov/current/title-49/section-40.73
Preparing oral fluid specimens for shipment to an approved laboratory:
https://www.ecfr.gov/current/title-49/section-40.74
Once both oral fluid collection devices and laboratories are approved, may I start conducting oral fluid collections immediately?
No… you must first receive separate and specific training as an Oral Fluid Specimen Collector. Even if you are currently qualified as a urine specimen collector, you are not qualified to conduct oral fluid specimen collections. You are also not qualified to conduct DOT oral fluid collections if you have been conducting non-DOT oral fluid collections or using saliva devices for drug testing in the past. The federal rules require entirely new, additional training for anyone wishing to become an Oral Fluid Specimen Collector in the DOT’s Program.
Certified Training Solutions will roll out the new Oral Fluid Specimen Collector Training Course after all government approvals are in place which allow using specific, approved oral fluid devices for DOT drug testing. Your training must include becoming proficient in both the regulations and procedures for these types of collections, along with completion of a series of error-free mock tests under the observation of a qualified monitor/instructor using the specific, approved oral fluid collection device that you will be using in the real world.
Keep checking Certified Training Solutions’ Oral Fluid Specimen Collector procedures training webpage for upcoming availability.
Certified Training Solutions offers convenient and affordable internet-based training courses and webcam classes for all our course offerings, including breath alcohol technician (BAT) training, DOT specimen collector training and certification, online supervisor reasonable suspicion training, drug-free workplace training, screening test technician (STT) training, and more.
Date of this publication: March 18, 2024 © Certified Training Solutions, LLC
The information presented here is meant to provide general information, guidance, and reflects the opinions of the author only. Information is deemed reliable but not guaranteed. Legal advice must be provided in the course of an attorney-client relationship specifically with reference to all the facts of the particular situation under consideration. Such is not the case here, and accordingly, the information presented here must not be relied on as a substitute for obtaining legal advice from a licensed attorney and/or the U.S. Department of Transportation Office of the General Counsel. When in doubt, check with your corporate legal counsel and/or the U.S. Department of Transportation Office of the General Counsel or an agent of the operating agency that covers your industry. Certified Training Solutions LLC is not responsible or liable for any loss or damage relating to the use of the information in this article. Before relying on the material in any important matter, users should carefully evaluate its accuracy, currency, completeness and relevance for their purposes, and should obtain any appropriate professional advice relevant to their particular circumstances.