2025 Medical Review Officer Online Course with Live Discussion (Includes Digital Syllabus)-Tab 12: Oral Fluid Testing (Alternative Specimens)

Tab 12: Oral Fluid Testing (Alternative Specimens)

Pdf Summary

This document summarizes key procedures and requirements for oral fluid (OF) specimen collection and laboratory testing under the HHS/DOT regulations, as presented by Donna R. Smith, Ph.D., and Michael A. Peat, Ph.D.<br /><br />Specimen Collection:<br />OF specimen collectors must be specially trained per the Oral Fluid Mandatory Guidelines (OF MG), 49 CFR Part 40, and device manufacturers' instructions, including five error-free practice collections and refresher training every five years. Collection sites may be work-based or off-site, ensuring donor privacy and controlled access. Collections use FDA-cleared, single-use devices capable of maintaining specimen integrity and subdividing samples into primary and split specimens for DOT testing. The 2020 Federal Custody and Control Form (CCF) documents collections.<br /><br />Collection involves removing interfering items from the donor's mouth, visually inspecting the oral cavity, and a 10-minute observation period before specimen collection using a device inserted between gum and cheek. For split specimens, either two devices are used simultaneously or one device subdivides the sample. Donors must initial tamper-evident seals, and specimens are sealed and sent to an HHS-certified lab within 24 hours. “Dry mouth” procedures allow donors to rinse and attempt collection again; if unsuccessful, a urine test or medical review may follow.<br /><br />Laboratory Testing:<br />Laboratories follow similar testing protocols as urine, using immunoassay screening followed by confirmatory mass spectrometry methods. Specimen validity testing is not required. Cut-offs for screening and confirmation are defined for various drugs, including THC (marijuana) at 4 ng/ml screening and 2 ng/ml confirmation levels. THC detection primarily reflects recent use, as THC and its acid form (THCA) are protein-bound and less present in oral fluid. Passive exposure is unlikely to exceed cut-offs.<br /><br />Oral fluid pharmacology explains how drugs diffuse passively from blood into saliva, influenced by pH and protein binding, with drug presence also possible from oral use or inhalation routes. <br /><br />Overall, the document outlines detailed OF collection standards, device requirements, donor handling, and analytical cut-offs to ensure accurate drug testing compliance for federal and transportation agencies.

Keywords

Oral Fluid Specimen Collection

HHS/DOT Regulations

Oral Fluid Mandatory Guidelines

FDA-cleared Collection Devices

Federal Custody and Control Form

Donor Privacy and Observation

Split Specimen Testing

Laboratory Immunoassay Screening

Confirmatory Mass Spectrometry

THC Detection Cut-offs