The long-awaited release of the federal government’s Oral Fluid Mandatory Guidelines (OFMG) on October 25, 2019, by the Substance Abuse and Mental Health Services Administration’s (SAMHSA), represents a major change in the drug testing industry and will, over time, have a significant impact on how employers conduct drug testing.
While the OFMG have an implementation date of January 1, 2020, their effective date is March 1, 2020. With this short, 60-day implementation period, not all industry professionals are expected to be prepared to offer lab-based oral fluid testing in accordance with the guidelines as of March 1. However, that will likely not tamp down the growing level of interest in lab-based oral fluid drug testing among many employers. (SAMHSA projects that 25-30% of all federal and federally-mandated drug testing will transition to oral fluid over the next four years.)*
Oral Fluid Mandatory Guidelines General Overview
If you’re an employer who conducts drug testing, what should you do first? Take a deep breath and relax. Initially, the OFMG will only apply to federal drug-free workplace programs. The Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) must engage in separate rule-making activities before their regulations can include lab-based oral fluid testing, though it is anticipated that both agencies will move in that direction.
There are severalimportant things for employers to keep in mind:
1. Currently, there are only three states (Maine, Vermont, and Hawaii, as well as the U.S. Territory of Puerto Rico) that do not permit the use of lab-based oral fluid drug testing. Outside of those three states with a handful of exceptions, 47 states permit lab-based oral fluid testing.
2. Nevertheless, the OFMG will have a direct impact on certain state drug testing laws. For instance, there are 17 states that defer to the SAMHSA or DOT regulations for their required drug testing procedures. These include several states with workers’ compensation denial and/or unemployment compensation denial laws that offer incentives to encourage companies to conduct drug testing, as well as industry-specific laws such as the mining industry in Kentucky or public works contractors in Illinois. With the addition of lab-based oral fluid testing to the federal guidelines, employers in these states may have the option of using lab-based oral fluid testing.
3. Similar to the existing mandatory guidelines for urine testing, the OFMG establish a preferred standard for how to conduct lab-based oral fluid testing. This should give employers, whether mandated to conduct drug testing or not, a green light to consider using lab-based oral fluid testing in place of or in combination with urine drug testing. (Note: The OFMG do not require a complete replacement of lab-based urine testing, nor do they require a choice to be made between lab-based oral fluid and lab-based urine testing. Federally regulated drug-free workplace programs, as well as non-mandated programs, can include both lab-based urine and lab-based oral fluid as part of the same drug testing program or policy.)
4. Another very important note is that, while instant-result or POCT oral fluid testing can be a valuable testing method, the OFMG only refer to and permit lab-based oral fluid drug testing.
Why Did SAMHSA Decide to Permit the Use of Lab-based Oral Fluid Drug Testing?
It took many years from the time SAMHSA first issued a Notice of Proposed Rulemaking (NPRM) until the release of the final regulations (OFMG). But long before the NPRM was issued, SAMHSA had already concluded that lab-based oral fluid testing represented potentially valuable attributes, which made it worth going through the enormous effort to create regulations. The agency’s justification centered on reducing the expense in time and money needed to maintain a drug testing program, as well as eliminating the pervasive problem of drug testing cheating.
But perhaps more than anything else, it came down to the science behind lab-based oral fluid drug testing. Using SAMHSA's own words:
“The scientific basis for the use of oral fluid as an alternative specimen for drug testing has now been broadly established. For example, oral fluid collection devices and procedures have been developed that protect against biohazards, maintain the stability of analytes, and provide sufficient oral fluid for testing. In addition, OFMG analyte cutoff concentrations are much lower than those specified for urine in the Guidelines. Additionally, specimen volume is also much lower, saving time in collection and transport costs. Developments in analytical technologies have allowed their use as efficient and cost-effective methods that provide the needed analytical sensitivity and accuracy for testing oral fluid specimens.”
As an Employer, What Should I Do Next?
Use the implementation period to prepare. Many changes are required to be compliant with the guidelines. If you are a non-regulated employer that would like to begin conducting oral fluid testing, there are several things you will want to consider:
- Identify your drug-testing objectives and applications for testing.
- Update your policy to include oral fluid testing.
- Determine how you would like oral fluid samples collected (on-site or at a collection facility).
- Train supervisors/managers on the new policy and procedures.
- Ensure that vendors such as labs and third-party administrators are set up.
- Inform your Medical Review Officer (MRO) that you have added oral fluid testing.
Announce the program to all employees.
* https://www.federalregister.gov/documents/2019/10/25/2019-22684/mandatory-guidelines-for- federal-workplace-drug-testing-programs-oralfluid
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