The U.S. Department of Health and Human Services (“DHHS”) proposed new guidelines in the Federal Register on May 15, 2015 that would revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs in two significant ways: (1) to permit the testing of oral fluid specimens for drugs; and (2) to include drug testing for certain synthetic opiates – hydrocodone, oxycodone, hydromorphone and oxymorphone.
Oral Fluid Testing. The proposed guidelines will allow employers regulated by the Mandatory Guidelines for Federal Workplace Drug Testing Programs to include oral fluid testing as part of their drug testing programs. The guidelines establish standards and technical requirements for oral fluid collection devices including cut-off concentrations for initial and confirmatory tests, testing methods, review by a Medical Review Officer, and requirements for federal agency actions. Oral fluid cut-off concentrations will be much lower than urine cut-off concentrations because drug analyte concentrations in oral fluid are much lower than urine concentrations. Split specimen testing will be required either by requiring two specimens to be obtained from the donor, either concurrently or serially, using separate collection devices or a single collection device that can be split into two separate specimens.
The benefits of oral fluid testing (instead of urine testing) include a reduction in time of the collection process; an observed collection method leading to reductions in rejected, invalid, substituted and adulterated specimens; and a more effective tool in post-accident testing. In addition, since oral fluid collection does not have the same privacy concerns as urine collection, on-site collections are likely, thereby reducing the time an employee is away from the worksite.
Synthetic Opiate Testing. The proposed guidelines will require drug testing for oxycodone, hydrocodone, hydromorphone and oxymorphone. Oxycodone and hydrocodone – more commonly known as OxyContin and Vicodin — were included because they top the list of narcotic pain relievers causing visits to hospital emergency rooms due to non-medical use, and are among the top ten drugs seized in law enforcement operations. Hydromorphone and oxymorphone were included because they are available commercially as analgesics, are more potent than hydrocodone and oxycodone and are highly addictive.
The proposed guidelines address additional issues including reducing the pH level needed to establish an adulterated urine specimen and training requirements for Medical Review Officers, among other things.
DHHS is accepting comments on the proposed rules until July 14, 2015. Comments may be submitted online at http://www.regulations.gov.