On May 2, 2023, the Department of Transportation (DOT) announced a change in its alternative drug testing methodology. The DOT has authorized oral fluid as an alternative testing methodology, harmonizing with the Health and Human Services (HHS) Mandatory Guidelines that were made effective January 1, 2020. Although they have yet to amend the rules, they anticipate they will.
Faye Caldwell, legal advisor and litigator at Caldwell Everson LLC, recently presented a webinar for DISA covering the approval of oral fluid testing and everything else that you need to know.
Here’s a quick summary of everything she discussed.
Certified Laboratories Required
As of June 1, 2023, employers may not use oral fluid testing until at least two laboratories certified by the HHS to perform this testing exist. At this point, no laboratory holds such a certification. The topic of lab certifications requirements being met by two branches of the same organization is one that comes up often. According to the National Laboratory Certification Program, every lab stands alone. So, for example, it could be two Quest Labs, two LabCorps, or two labs from different lab-certified organizations.
Combining Testing Methodologies
Employers will now have the freedom to choose between oral fluid and urine testing for DOT drug testing. They can use oral fluid for all required tests, except for FRA post-accident testing, during direct observation requirements, or when a second specimen collection is needed. Clear circumstances must be defined if an employer runs a combined program, specifying when each testing method will be used. You can’t use both at the same time as the first step, but you can use it in combination if direct observation is required. This is especially used if there isn’t a same-sex observer available. Oral fluid must be available for directly observed collections for non-binary/transgender individuals.
What Employers/TPAs Need to Know
When administering testing, following the drug policies and procedures is crucial to avoid any mistakes. You must choose the type of collection you will issue initially, as you cannot collect both. This helps maintain consistency throughout subsequent collections within the same event. Oral fluid and urine laboratories need to be designated separately as not all labs have certifications for both specimen types. Some labs only have certifications to collect oral, while others only have certifications to collect urine.
It's also essential to communicate any changes in testing policies to employees, even if a specific date is unavailable. Ensuring employees are informed about upcoming changes helps for a smooth transition, and it is important to set up accounts and notify employees accordingly.
When selecting a lab for testing, it's best practice to have a standing order with collection sites. This ensures that collection personnel know the type of collection required and when it should be performed. The DER should always be available to address any concerns related to standing orders during the collection process in case any problems arise.
If there needs to be a pivot to another specimen type during a collection event, they need to do that while the donor is there, following collection rules before concluding the process. It's vital to avoid terminating the collection and resume the next day, as it may compromise the accuracy of the results. Ensure that accurate contact information is pre-printed on the forms to facilitate effective communication. Lastly, have skilled collectors in place to perform the specimen collection accurately.
Collectors
Collectors are tasked with using the oral fluid collection device specific to the laboratory, meeting FDA, HHS, and DOT requirements. They must complete DOT Oral Fluid qualification training, including mock collections, and be proficient in using the oral fluid collection device. Your certification as a collector depends on the device. If you have clients who use multiple devices, you must be certified in each device.
Additionally, collectors are unable to be the supervisors of the donors tested unless there’s no trained collector available. Once available, there will be many organizations providing training. The collector must document the expiration date on the chain of custody; expired devices will be canceled by the laboratory. Collectors must ensure they are using the current CCF to fill out the proper oral fluids, not the 2017 CCF. The DOT has not issued the guidelines for oral fluid yet but is expected to do so soon.
MROs
MROs are also affected by this change. Although they are not required to undergo recertification training for oral fluid, it's recommended that they review supplemental information about oral fluid testing. Additional changes not specific to oral fluid involve permitting un-canceling of results, validating prescription information, and reporting safety concerns.
As with any change, there might be some uncertainty, such as whether oral fluid is eligible for use with ECCF or if there will be restrictions like with DOT alcohol. The expectation is that EECF will be part of the current ECCF program. The certification for ECCF requires each lab to have IT certification, which is also expected to be part of the process.
Conclusion
The Department of Transportation's authorization of oral fluid as an alternative drug testing methodology is a major change for workplace testing. The DOT's commitment to updating drug testing practices reflects its dedication to safer workplaces and a more efficient testing system overall.
DOT oral fluid testing is expected to apply to PHMSA. The rule hasn’t been amended yet, but there’s strong anticipation of it happening soon. Homeland Security has also indicated that they’ll also be amending the rules to allow the use of oral fluid.
This change to the permitted drug testing methodologies will affect many in the industry, including employers, employees, TPAs, collectors, and others. It is likely that there will be more updates that you will need to stay on top of. DISA is here to help you stay up to date with this information and with the latest in industry news, laws, and regulations. Be sure to stay ahead so you don’t get left behind!
Related Articles:
- Cannabis and Workplace Drug Testing – Common Misconceptions
- DOT Approves Oral Fluid Testing for Covered Employees
- Should We Remove Marijuana from Drug Test Panels?
- How to Get Started Using ECCFs
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