HHS Issues Guidelines for Oral Fluid Drug Testing

​Federal agencies, contractors and industries regulated by the Department of Transportation (DOT), including trucking, airline and railroad companies, will soon have an alternative to urine testing for the first time since federal drug-testing guidelines were published in 1988.

Released Oct. 25 by the Substance Abuse and Mental Health Services Administration (SAMHSA), part of the Department of Health and Human Services (HHS), the newly endorsed use of oral fluid testing (oral fluid is more than just saliva) will allow an easier, less costly sample collection and better detection of recent drug use than urine testing.

"It's a significant change, giving employers more versatility in their drug-testing programs," said Nina French, managing partner of the Current Consulting Group in Philadelphia and a leading expert on workplace drug testing.

The guidelines, which go into effect Jan. 1, 2020, apply only to federal employees and contractors. But agencies such as the DOT and the Nuclear Regulatory Commission are required to follow the guidelines when developing drug-testing programs for their regulated industries. "It's anticipated that the Department of Transportation and Nuclear Regulatory Commission will issue their own proposed regulations aligned to the SAMHSA guidelines very soon," French said.

The SAMHSA guidelines "establish standards and technical requirements for oral fluid collection devices, including initial and confirmatory oral fluid drug test cutoff concentrations and methods, and processes for review by a medical review officer," said Kathryn Russo, an attorney in the Long Island office of Jackson Lewis and practice leader of the firm's Drug Testing and Substance Abuse Management Practice Group.

It took several years for the agency to release the final guidelines (proposed in 2015), but it has advocated for the testing method's benefits for just as long, saying that collecting samples would save time and money and would avoid the pervasive problem of urine test cheating.

"While we recognize the fairness, effectiveness and accuracy of urine tests, we also all realize that there is a tremendous cheating problem out there," said Patrice Kelly, director of the DOT's Office of Drug and Alcohol Policy and Compliance in Washington, D.C. "Oral fluids and hair offer great promise because both of them are observed collections and arguably, in many cases, are less intrusive."

A long-gestating proposal allowing hair-based drug testing is currently at the White House Office of Management and Budget for review, but it is not expected to be introduced anytime soon.

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Easier, Faster Sample Collection

The guidelines establish the preferred standard for how to conduct oral fluid testing—the employee collects while the employer observes.

"Collection is typically performed by [the subject] placing an absorbent pad in [his or her] mouth to collect an adequate quantity of sample for testing," said Jackie Pirone, program lead at OraSure Technologies, a pioneer in oral fluid drug testing based in Bethlehem, Pa.

"The sample is placed into a vial containing a preservative, sealed under chain-of-custody protocol and then sent to a lab for screening and confirmation testing."

Pirone added that the guidelines only cover and permit lab-based testing and not the use of instant drug-testing products.

The guidelines require employers to collect a specific volume of oral fluid and provide for split-specimen collections, in which samples are collected and separated into two parts in case further testing is needed.

"Collectors must be trained to collect oral fluid specimens in accordance with the guidelines," Russo said. "There are requirements for oral fluid specimen collection devices and collection procedures, including procedures to be followed when a tested individual claims that he or she cannot provide an oral fluid specimen."

Benefits of Oral Fluid Testing

Donors collect their own oral fluid samples under direct observation of a monitor, reducing the likelihood of tampering, French said. The collection process is also perceived as "less yucky," she added. "Because of that, the willingness of people at the worksite to be certified as collectors of oral fluid is anticipated to be much higher."

Samples can be collected anytime and anywhere, saving time and cost by eliminating the need for private restrooms or same-gender collectors, time away from the worksite for testing, and the incidence of "shy bladder" issues.

Maybe most importantly, the window of detection is much tighter than with urine testing.

Drugs take a couple of hours to metabolize in the body before showing up in a urine test and remain detectable by a urine test for significantly longer than that, making testing for recent impairment ineffective, French said. But an oral fluid test detects drugs starting soon after ingestion and only detects them for 24 to 48 hours after use, making the testing method ideal for a broad range of testing situations ranging from pre-employment to reasonable-suspicion to post-accident testing.

"Oral fluid testing gives the employer versatility in detection—different testing methods can be used for different situations," French said. "Regulated employers can stick with urine tests for pre-employment but will now have the option of using oral fluid for post-accident or reasonable-suspicion testing, where it's critical to pick up the most recent drug use to determine potential impairment on the job."

The SAMHSA guidelines do not require employers to choose between testing oral fluid or urine. Federally regulated drug-free workplace programs, as well as nonregulated programs, can include lab-based urine and lab-based oral fluid as part of the same drug-testing program.

Time to Prepare

Even though the effective date for the guidelines is Jan. 1, it could take 12 to 18 months for labs and service providers to adopt the changes, French said.

Organizations will also have to update their drug-testing policies and train managers on the new procedures.

"Employers will have to understand how to use the different methods and technologies and the different cutoff levels related to each method," French said. "The chain-of-custody process will remain the same, as will the requirement to use certified collection devices and laboratories, and the requirements for medical review officers will parallel what is in place for urine testing."

SAMHSA projects that 25 percent to 30 percent of all federal and federally mandated drug testing will transition to oral fluid over the next four years.

"If you are a nonregulated employer or have a portion of nonregulated employees, there's nothing to wait for—you can switch now," Pirone said. "Simply consult with your provider on how to make laboratory-based oral fluid drug testing part of your program."