On October 12, 2023, the Substance Abuse and Mental Health Services Administration (SAMHSA) announced updates to the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) and the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) via the Federal Register. Each document received a number of updates, including updates to how the annual drug testing panel is published, revisions to definitions, information on an authorized biomarker testing panel, updates to collection procedures, revisions to the Medical Review Officer (MRO) process, and more.
Mandatory Urine Guideline Updates
The following updates were made to the UrMG:
- The announcement of the publication of an authorized biomarker testing panel via an annual Federal Register notification (see Subpart C section 3.4).
- Requiring MROs performing medical review services for federal agencies to submit semiannual reports each January and July detailing all federal agency specimens that were reported as positive by the laboratory but verified negative by the MRO, along with the reason for the negative verification (see Subpart M section 13.11).
- An addition that donors are not required to remove any items that may be worn for faithbased reasons (see subpart H section 8.3).
- Clarification that MROs must receive training on revisions to drug and biomarker testing panels, which is to be given by approved MRO certification entities (see Subpart M section 13.3(b)).
- Revisions to clarify that passive exposure to drugs, not just marijuana, and/or the ingestion of food products containing a drug, not just marijuana, cannot be used as acceptable explanations for a positive drug test (See Subpart M section 13.5(d)(2)).
- A reordering of Subpart M sections 13.8 and 13.9.
Mandatory Oral Fluid Guideline Updates
The following updates were made to the OFMG:
- The announcement of the publication of an authorized biomarker testing panel via an annual Federal Register notification (see Subpart C section 3.4).
- Requiring MROs performing medical review services for federal agencies to submit semiannual reports each January and July detailing all federal agency specimens that were reported as positive by the laboratory but verified negative by the MRO, along with the reason for the negative verification (see Subpart M section 13.11).
- Requiring oral fluid collection devices to be “sufficiently transparent to enable a visual assessment of the contents without opening the tube (e.g., translucent)” (see Subpart G section 7.2(b)(2)).
- Additional guidance to laboratories pertaining to the expiration date on the specimen collection tube, specifically that if the expiration date is not visible upon receipt of the tube but the device lot number is, the lab can use the lot number to recover the expiration date (see Subpart G section 7.2(b)(3)).
- An addition that donors are not required to remove any items that may be worn for faithbased reasons (see Subpart H section 8.3(e)).
- Instruction that the oral fluid collection device must be within the manufacturer’s expiration date and that the collector must verify that the device is within the expiration date and document that action on the Federal Custody and Control Form (CCF) (see Subpart H sections 8.4(b) and 8.4(c)).
- Clarification that MROs must receive training on revisions to drug and biomarker testing panels, which is to be given by approved MRO certification entities (see Subpart M section 13.3).
- Revisions to clarify that passive exposure to drugs, not just marijuana, and/or the ingestion of food products containing a drug, not just marijuana, cannot be used as acceptable explanations for a positive drug test (see Subpart M section 13.5(c)(2)).
- A reordering of Subpart M sections 13.8 and 13.9.
- A specification that a laboratory must reject a specimen if the collector failed to document observation of the volume indicator at collection time (see Subpart O section 15.1.(e)).
Key Takeaways
- Updates were made to both the urine and oral fluid mandatory guidelines.
- Updates to the urine Mandatory Guidelines are effective February 1, 2024.
- Updates to the oral fluid Mandatory Guidelines are effective as of October 10, 2023.
Next Steps
Employers required to comply with the UrMG should review and update their workplace policies prior to February 1, 2024. Employers looking to use oral fluid once laboratories have been approved by SAMHSA should review the OFMG updates and plan accordingly.
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The UrMG notice can be viewed in its entirety at the following link: https://www.govinfo.gov/content/pkg/FR-2023-10-12/pdf/2023-21734.pdf
The OFMG notice can be viewed in its entirety at the following link: https://www.govinfo.gov/content/pkg/FR-2023-10-12/pdf/2023-21735.pdf