Oral Fluid Industry Update

DISA Global Solutions’ annual Day with DISA event features a number of industry-leading professionals who present on a variety of important issues, including the latest on drug and alcohol testing trends and news. Jackie Pirone, Program Leader, Risk Assessment/Substance Abuse Testing and Brian Feeley, Director of Sales, Risk Assessment/Substance Abuse Testing at OraSure Technologies together presented “Oral Fluid Industry Update,” giving attendees a closer look at new SAMHSA guidelines the industry changes COVID-19 has brought, and how they impact employers.

If you didn’t get the opportunity to attend the Day with DISA conference, or if you would like to review this presentation again, you can download or watch it using the link below.

What Is Oral Fluid Testing?

Oral fluid testing, or “saliva” testing, collects a sample from the donor using an oral swab, detecting drugs and metabolites sometimes within 15 minutes. Unlike other forms of drug testing, oral fluid is fully observed and features a short detection window, detecting current usage and up to two days following the initial use. Currently, there is no means of detecting impairment, but with the extremely shortened drug detection window for oral fluid, employers can detect if the drug use was recent, similar to blood testing but easier and less invasive. Oral fluid testing panels can vary by laboratory, but commonly tested drugs include:

· Marijuana

· Cocaine

· Opiates

· Amphetamine

· Methamphetamine, including MDMA (Ecstasy)

· Phencyclidine (PCP)

· Barbiturates

· Benzodiazepines

· Methadone

· Oxycodone

· Spice/K2

· Buprenorphine

· Fentanyl

· Cotinine (tobacco)

Since oral fluid testing is observed, it makes it more difficult to subvert, adulterate, substitute, and dilute a sample when that’s not always the case for urine. Accuracy and performance like this have convinced the HHS to add laboratory-based oral fluid testing to the SAMHSA federal guidelines.

SAMHSA OFMG Guidelines

SAMHSA guidelines have two separate mandatory guidelines; one for urine and one for oral fluid. Proposed guidelines for hair testing are still pending and are for only random and pre-employment testing. At this time, the guidelines are for federal employees only. On the other hand, oral fluid and urine testing can be used for pre-employment, random, reasonable suspicion, post-accident, return-to-duty, and follow-up testing. SAMHSA guidelines require the following:

• Initial drug tests can be immunoassay or alternate technology
• Confirmatory drug tests must use “mass spectrometric identification”
• POCT/rapid/instant testing is not permitted
• FDA-cleared single-use collection devices are required
• All collections are required to be split specimens
• Collections can occur simultaneously or serially

- If occurring serially, it must occur with two separate devices

- Each collection tube must contain at least 1mL of oral fluid

HHS-certified laboratories are required

Devices must:

- Have an indicator showing how much oral fluid has been collected (1 mL required)

- Be sealable and non-leaking

- Maintain specimen integrity

- Have components ensuring drug and drug metabolite stability

- Not substantially impact the composition of drugs/drug metabolites

Guidelines were effective as of January 1, 2020, but with a standard 12-18-month implementation period where federal agencies will be able to choose lab-based oral fluid testing as an alternative to, or add it to, a traditional urine testing program. As of October 1, 2020, there are currently no HHS certified labs approved for oral fluid testing, but they are still within the implementation period, allowing them time to become certified into next year.

DOT Versus Non-Regulated Testing

The DOT will engage in a full rulemaking process, beginning with the Proposed Rulemaking (NPRM) to revise 49 CFR Part 40 to include oral fluid drug testing for DOT-mandated programs. The rulemaking process consists of the NRPM, public comment period, economic impact analysis, review of comments received, final rule publication, and implementation period and typically takes at least 12 months. Additionally, OMB, DOJ, and other relevant federal agency approval are required. Once Part 40 is amended to include oral fluid testing procedures, each of the DOT agency drug and alcohol testing rules will have to make revisions.

Many employers who were hesitant about oral fluid testing are now considering it in combination with urine drug testing, thanks to the OFMG serving as an official endorsement by the federal government. Now that the government gives it the green light, employers can better understand that it is scientifically sound and has many advantages. Combining testing methodologies, such as urinalysis with oral fluid, helps cover a more comprehensive detection window as oral fluid detects shorter, recent usage that closer aligns to impairment, while urine shows a longer detection window. By randomizing testing methods, donors are kept on their toes. Lab-based oral fluid testing is permitted in 48 states.

Drug Testing During COVID-19

One of the benefits of oral fluid testing is that it adheres to CDC social distancing guidelines by allowing the donor to administer the test themselves so that the collector can remain touch-free. The collector can place the product out for the donor to grab and explain how to swab, observing throughout the entire process. Once the donor finishes their swab, they can place it in the collection tube. This allows the collector and the donor to remain six feet apart from one another, maintaining social distancing standards.

Due to COVID-19, many collection facilities are closed, have reduced hours of operation, or do not offer urine collections at this time. To navigate these issues, oral fluid testing does not require the use of an off-site collection facility or a secured restroom, reducing sanitization concerns. Some oral fluid collections are being done virtually through Skype, Zoom, etc. The employee is sent an oral fluid kit, and the observer/collector walks them through the collection process

DISA Global Solutions-owned collection sites have also implemented new safety measures and have spent significant time and effort reworking collection site processes to further protect customers and employees.

DISA service centers:

• Have enhanced cleaning procedures
• Require an initial risk survey when donors enter the facility
• Minimize overcrowded waiting rooms
• Allow donors to wait in their car
• Do NOT test for COVID-19

DISA can help! Get answers directly from DISA’s subject matter experts with ‘Ask DISA’

Visit www.askdisa.com to ask your questions today.

Founded in 1986, DISA is the industry-leading provider of employee screening and compliance services. Headquartered in Houston, with more than 35 offices throughout the U.S. and Canada, DISA’s comprehensive scope of services includes drug and alcohol testing, background check, occupational health, and transportation compliance. DISA assists employers in making informed staffing decisions while building a culture of safety in their workplace.