For the last 30 years, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) confined federal drug testing programs to laboratory-based urine tests. No other types of tests, including oral fluid tests, were permissible.

In early 2020, with the release of its new guidelines for oral fluid testing, that all changed. These guidelines, known as The Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG), will allow federal agencies to collect and test oral fluid as part of their drug testing programs. As a result of these changes, SAMHSA expects that oral fluid testing will account for 25% to 30% of federal agency drug testing within the next four years. If that predicted increase is also echoed by non-federal agency drug tests, who frequently elect to follow federal guidelines, it will mean millions of oral fluid tests.

For now, the OFMG will only apply to federal workplaces. The Department of Transportation (DOT) has indicated that it will release its own regulations, probably by the spring or summer of 2021.

If you are considering implementing oral fluid tests at your workplace, here is what you need to know about SAMHSA's new guidelines.

What is Oral Fluid Drug Testing?

Oral fluid testing uses a swab to gather saliva to test for drug use. The test is quick and straightforward. It can easily be performed at a workplace and is considered less invasive and more respectful of personal privacy. The speed of the test and the reduction in worker time off the job can result in significant cost savings for the employer. The oral test detects drugs, and there is some indication that oral testing results in higher positivity rates than urine testing, especially for cannabis. It is also highly unlikely that a worker can cheat on an oral fluid test.

Oral fluid testing detects the actual drug in the user's system, unlike urine tests, which detect metabolites produced as the body breaks down a drug. This means that one drawback for this type of testing is that it has a limited detection window and can usually only identify drug use within the previous few days. The individuals administering the test also have to be especially careful not to contaminate the sample before transferring it to the laboratory.

Not all states have welcomed oral fluid drug testing. Laboratory-based oral fluid testing is still not permitted in Maine, Vermont, Hawaii and Puerto Rico, although that could eventually change.

Implementation Period

SAMHSA is allowing a 12-18-month implementation period to let employers get up to speed on oral fluid testing and to enable laboratories to become certified if necessary.

Collection

Within the new guidelines, there are some significant changes in collection processes, which may make oral fluid testing more appealing to employers. Employers can elect to use either employees or professional technicians to collect samples, although both must be trained in the process. Employers can also choose to have the collection occur either at their worksite or at an approved permanent or temporary collection site. If they elect to have onsite collection, the collectors will be responsible for ensuring that the selected area meets collection site guidelines.

Additionally, collectors must use the federal custody and control form (CCF) with each collection and use a Food and Drug Administration (FDA) approved single-use device for collection of the sample.

The Collection Process

FDA-approved collection devices for oral fluid testing must have a capacity of at least 1 mL of fluid and must also have a built-in volume indicator. The guidelines also require split specimen collections via either serial or simultaneous collection. If a donor is unable to provide a saliva sample, employers will have the option of collecting a urine sample. If they first require a urine sample and the donor is unable to provide one, they will now have the option of requesting a saliva sample.

The Collection Site

If you decide to host the collection site at your workplace, SAMSHA has precise requirements in Part E of its guidelines. These require employers to ensure:

• Donor privacy during the collection
• A clean surface area not accessible to donors for specimens and paperwork
• A secure storage area for samples and the ability to securely store records
• Restricted areas for both storage of collection supplies and authorized personnel

Laboratories

Regardless of where you choose to have the sample taken, it must be tested by a laboratory. Although quick oral swab testing kits are available, they are not acceptable for use under the SAMHSA guidelines. Department of Health and Human Services (HHS) will certify laboratories testing oral fluids. According to the new guidelines, these labs may opt to test for opioids, amphetamines and phencyclidine but must test for both marijuana and cocaine. Under exceptional circumstances, including reasonable suspicion testing or post-incident testing, they can also test for any other Schedule 1 or Schedule II drug. Cut-off levels are similar to those already in place for urine tests.

The Medical Review Officer Role (MRO)

Not much has changed concerning the role of the MRO. All of the duties of the MRO with respect to oversight and follow-up remain in place with the new oral fluid guidelines. However, MROs do need to become familiar with the guidelines and a completely new method of testing, which will be time-consuming.

Next Steps

Implementation of the oral fluid testing guidelines, including certification of labs, is expected to take between 12 and 18 months. If you are considering implementing oral fluid testing at your workplace, here are a few things you can do to prepare.

Start by discussing the logistics of adding oral fluid testing to your drug testing program with your supervisors, managers and Designated Employee Representative (DER) if you have one. If you do decide to proceed with oral fluid testing:

• Ensure the MRO and DER are informed early and can secure the necessary training
• Train supervisory personnel on the guidelines
• Select your collection site, either in-house or at a certified laboratory
• Secure your supply chain of vendors and collection supplies and find an accredited laboratory to perform the tests
• Hire or appoint collectors if you are collecting onsite and ensure they are trained
• Find a suitable location if the collection is happening onsite and ensure it is approved by your collector(s)
• Inform all employees of your intention to start an oral fluid testing program