SAMHSA Seeks Comments on Oral Fluid Testing

This could be big news for testing companies and for employers covered by the mandatory testing regulations. The agency wants comments by Aug. 9.

Drug testing companies and the Drug & Alcohol Testing Industry Association have long expected the U.S. Department of Health and Human Services to accept oral fluid testing in the Mandatory Guidelines for Federal Workplace Drug Testing Programs. The Substance Abuse and Mental Health Services Administration, an HHS agency, signaled that this change is coming in a June 10 request for comments published in the Federal Register.

SAMHSA asked for comments by Aug. 9 to answer these questions:

  • Analytes/Cutoffs: What analytes should be measured in oral fluid for the initial and confirmatory tests? What initial and confirmation cutoffs should be used for the oral fluid drug tests? Should the oral fluid drug testing panel be expanded to include schedule II prescription medications?
  • Specimen Validity: Are bio-markers needed to validate the oral fluid specimen? Are there appropriate bio-markers or tests for the oral fluid specimen that would reveal adulteration, substitution, and/or dilution?
  • Collection: How should an oral fluid specimen be collected? For an oral fluid split specimen collection, how should the collection of the two specimens be performed? As a donor, would you prefer to provide an oral fluid or a urine specimen?
  • Collection Devices: What should be the technical requirements for an oral fluid specimen collection device?
  • Testing: What technologies are available to perform initial and confirmatory testing on oral fluid specimens?

In the notice, SAMHSA said its chartered CSAP Drug Testing Advisory Board "will be the vehicle to provide recommendations for including alternative specimens (oral fluid) in the Mandatory Guidelines for Federal Workplace Drug Testing Programs. The overall intent of this effort will be publication of the proposed revisions to the Mandatory Guidelines in the Federal Register for public comment and the development of the Final Notice. To assist the DTAB, we are soliciting written comments and statements from the general public and industry stakeholders regarding a variety of issues related to oral fluid specimen drug testing, including analytes, cutoffs, specimen validity, collection, collection devices, and testing."

Comments may be mailed to Substance Abuse and Mental Health Services Administration, Attention: Division of Workplace Programs, 1 Choke Cherry Road, Room 2-1049, Rockville, MD 20857, or sent by express or overnight mail to Substance Abuse and Mental Health Services Administration, Attention: Division of Workplace Programs, 1 Choke Cherry Road, Room 2-1049, Rockville, MD 20850.

For more information, contact LT Eugene Hayes in the Division of Workplace Programs at 240-276-1459 or eugene.hayes@samhsa.hhs.gov.

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