May 5th, 2021 | Sterling

On the Horizon: New Federal CCF & Oral Fluid Testing

In August 2020, the U.S. Department of Health & Human Services (HHS) published guidance for use of a new chain-of-custody/control form (CCF) for federally-mandated drug testing programs. Shortly thereafter, the U.S. Department of Transportation (DOT) also published guidance.

With the announcement of the new CCF, the current version (revised January 2017) was also authorized for continued use through August 29, 2021. Use of the new CCF, however, will be mandated beginning August 30, 2021.

Overview of New CCF Changes

Perhaps the most impactful change of the new CCF is the inclusion of laboratory-based oral fluid testing for use in federally-mandated programs, in addition to traditional laboratory-based urine testing. While the DOT has not yet formally authorized oral fluid testing for DOT-regulated programs, authorization is expected towards the end of 2021 or early next year. Until such time, urine testing will continue to be the only permissible testing method for DOT-regulated programs.

Other noteworthy changes in the new CCF include:

• New notation for recording the donor’s commercial driver’s license (CDL) number and state of issuance in the donor identification line in Step 1 of the CCF:
  • For FMCSA-regulated testing (Federal Motor Carrier Safety Administration), the CDL number and state is to be used in lieu of the social security number or employer ID on the new CCF, as this information will assist the MRO (Medical Review Officer) with reporting drug testing violations promptly to the FMCSA Clearinghouse.
  • Note that the donor’s CDL number and state can still be recorded on the current CCF, and employers who currently direct job candidates and employees for FMCSA-regulated testing should record this information on the current CCF as the donor’s identifier.
• New notation for recording the donor’s email address in Step 5 of the paper CCF (copies 2–5), which will assist the MRO with outreach to the donor when needed.

Oral Fluid Testing

The ability to use oral fluid for federally-mandated drug testing has been long-awaited by many in the drug-free workplace industry, and federally-regulated employers as well. Though inclusion of oral fluid in the new CCF certainly points to its inevitability, a long process is first needed to ensure a thorough end-to-end structure is firmly in place, from point of specimen collection, to laboratory specimen handling and analysis, and through medical review of the reported lab result. More than three decades earlier a similar process was undertaken when lab-based urine was established for federally-mandated testing.

Key steps in the overall process includes HHS establishing laboratory protocol and test device requirements, after which approval by the Federal Drug Administration (FDA) is necessary before laboratories can be formally certified by the Substance Abuse & Mental Health Services Administration of HHS (SAMHSA) to begin testing. Certification of individual laboratory facilities is the primary step that remains open at this time.

Once lab-based oral fluid drug testing is authorized for all federally-mandated programs (DOT, NRC, etc.), SAMHSA projects about 7% of all federally-mandated testing would transition to oral fluid from urine by the end of the first year, and more than 25% by the end of four years*. This transition is also expected to increase lab-based oral fluid use for employer policy drug testing (not federally mandated).

There are several reasons why oral fluid testing has been so long-awaited for federally mandated programs:

• Unlike a urine collection where the donor is afforded privacy in a bathroom to provide a specimen, collection of an oral fluid specimen is performed in the presence of the collector, thereby significantly decreasing potential for specimen adulteration or substitution by the donor. In fact, cheating would be near impossible (according to SAMHSA, as much as 3% of unobserved urine collections may be found to be substituted or adulterated*).
• Overall time currently required by an employee to visit a third-party collection site for testing would be eliminated as specimen collection could be performed at an employer’s work location by trained staff. In turn, this would significantly reduce employer cost for lost time the employee is away from work (according to SAMHSA, 2 – 4 hours are typically needed by an employee to travel to a collection site to provide a urine specimen and return to the job*). In most instances, less than 10 minutes would be needed for an oral fluid specimen to be collected.
• Recollection of a specimen that is sometimes necessary due to a donor’s inability to provide a sufficient amount of urine will be eliminated. This will also reduce need to coordinate for a medical evaluation of a donor (as specified by DOT regulation) to determine if a valid medical condition exists that inhibited the donor from providing a sufficient urine specimen.

What Federally Regulated Employers Need to Know

• While some laboratories have updated their CCFs to comply with the new CCF format, many are still in the process of doing so. All laboratory CCFs are, however, expected to be in compliance before the end of June.
• In preparation for the August 30 mandate, DOT-regulated employers are encouraged to first deplete paper supplies of the current CCF and, to the extent possible, refrain from ordering new supplies until June:
  • If supplies must be ordered prior to June, employers should avoid ordering more than what would be necessary to support paper CCF testing roughly up to the middle of July.
  • Once supplies of the new CCF are received, all supplies of the current CCF should be destroyed to prevent use following the August 30 mandate.
  • Employers should be aware that ordering paper CCF supplies during the summer months may result in delay in receiving new supplies, as laboratories will be replenishing for other DOT-regulated employers during this time as well. Ordering 3 – 4 weeks in advance of need should be strongly considered. Still, an overall 2–3 month preparation period is expected to provide ample time for DOT-regulated employers to meet the August 30 mandate.
• Prior to August 30, paper supplies of the new CCF should be in hand. At this time, all supplies of the previous paper CCF should be destroyed (if the previous CCF is used after August 31, 2021, the laboratory will be required to obtain a memorandum of correction from the collector, thereby delaying the testing and reporting of the final result to the employer).
• Employers who are not yet leveraging eCCF (electronic chain-of-custody/control form) can avoid replenishing paper supplies altogether by electronically registering their job candidates and employees for DOT drug testing online. Not only does this make sense in that paper supplies would no longer be needed, but eCCF would help eliminate current challenges associated with use of paper CCFs, such as illegible handwriting, missing information, and other factors that oftentimes lead to delayed turnaround of test results or cancelled testing.
• In preparation for the new CCF, the changeover period can also be used by employers to ensure up-to-date Designated Employer Representative (DER) and MRO information is properly recorded for the employer’s laboratory account(s) and captured on the new CCF.

*https://www.federalregister.gov/documents/2019/10/25/2019-22684/mandatory-guidelines-for-federal-workplace-drug-testing-programs-oralfluid

Sterling is not a law firm. This publication is for informational purposes only and nothing contained in it should be construed as legal advice. We expressly disclaim any warranty or responsibility for damages arising out this information. We encourage you to consult with legal counsel regarding your specific needs. We do not undertake any duty to update previously posted materials.