Page 24 - OHS, March 2020

DRUG TESTING
for handling specimens and completing the required paperwork
■ A secure temporary storage area to maintain specimens un-
til the specimen is transferred to an HHS-certified laboratory
■ A restricted access area where only authorized personnel
may be present during the collection
■ A restricted access area for the storage of collection supplies
■ The ability to store records securely
The federal custody and control form (CCF) must be used with
each collection in much the same way it is used currently for urine specimen collections. With few exceptions, “The OMB-approved Federal CCF must be used to document custody and control of each specimen at the collection site.”
Collectors may only use a single-use collection device designed specifically for oral fluid collections that has been cleared by the Food & Drug Administration (FDA). The device must “not sub- stantially affect the composition of drugs and/or drug metabolites in the oral fluid specimen.”
Among the requirements for FDA clearance, a device must have a built-in volume indicator and be capable of collecting a least 1 mL of “undiluted (neat) oral fluid.”
Split specimen collections are required. Serial or simultaneous collections using two collection devices constitute a split oral fluid collection. According to the OFMG:
The collector collects at least 1 mL of undiluted (neat) oral fluid in a collection device designated as ‘A’ (primary) and at least 1 mL of undiluted (neat) oral fluid in a collection de- vice designated as ‘B’ (split) either simultaneously or serially (i.e., using two devices or using one device and subdividing the specimen).
What Must Laboratories Know?
The easy answer to this question is “a lot.” While not all labora- tories will choose to offer OFMG-compliant oral fluid drug testing, those that do must become certified by successfully going through a very similar and equally rigorous process required of labs that offer urine drug testing. In other words, the certification process is not a proverbial “walk in the park.” And that’s good news for em- ployers and drug testing providers who have come to trust and rely on the SAMHSA-lab certification as a quasi “good housekeeping” seal of approval.
Laboratories certified to conduct oral fluid tests must test for marijuana and cocaine, and they are authorized to test for opi- oids, amphetamines, and phencyclidine. On a case-by-case basis, when certain requirements are met (typically involving reason- able suspicion or post-accident testing), a specimen may be tested for any drugs listed in Schedule I or II of the Controlled Sub- stances Act (CSA).
Also, laboratories will use SAMHSA-approved cut-off levels de- signed to show the presence of drugs in a manner similar to urine cut-off levels. The cut-off level for THC was a topic of much dis- cussion prior to the issuance of the final guidelines. According to the OFMG, the initial screen cut-off level for marijuana is 4 ng/mL and 2 ng/mL for confirmation tests. Remember, oral fluid tests with labs detect the parent drug (the drug itself), whereas urine labs typ- ically detect a metabolite of the drug. A metabolite is a substance formed when the body breaks down food, drugs or chemicals, or its own tissue as part of its metabolism.2
Because of this, urine tests have the ability to detect “recent use” with oral fluids.
It is probably a safe prediction to say that the day is not far dis- tant when using a SAMHSA-certified laboratory to conduct oral fluid testing will be considered by many to be the preferred meth- od, in much the same way that using a certified lab to test for urine has been the preferred way for three decades.
What Must MROs Know?
When reading the OFMG, it is clear that protecting the integrity of the testing process and ensuring the accuracy of reported re- sults were of paramount importance to SAMHSA during the de- velopment of the guidelines. As is the case with urine drug testing, MROs play a critical role in the OFMG.
In some ways, not a lot has changed for MROs except for the fact that they will be verifying results from a completely different drug testing method. So, there is much in the way of added respon- sibilities. As such, MROs must learn the details of the OFMG and everything related to reviewing and verifying oral fluid test results.
For employers and providers who may still be on the fence re- garding lab-based oral fluid drug testing, consider the following regarding the role of MROs:
The OFMG require that MROs: (1) Review the information on the MRO copy of the Federal CCF that was received from the collector and the report received from the HHS-certified laboratory or HHS-certified IITF; (2) Interview the donor when required; (3) Make a determination regarding the test result; and (4) Report the verified result to the federal agency.
Getting Ready
The Oral Fluid Mandatory Guidelines will initially only apply to federal workplaces. DOT has stated its intention to have its own oral fluid testing regulations in place by the time SAMHSA com- pletes its 12- to 18-month implementation period.
The OFMG are an official endorsement of lab-based oral fluid testing by the federal government, and the guidelines provide a new “gold” standard for how to best utilize the technology. Many employers will consider this a green light to implement oral fluid testing either in place of, or in combination with, urine drug test- ing (lab-based oral fluid testing has historically been permitted in 47 states).
For the professionals who ensure the integrity of each drug test, such as collectors, labs, and MROs, the OFMG will become the “gold” standard for oral fluid drug testing. For employers, the OFMG will provide a level of comfort when utilizing lab-based oral fluid drug testing. For both groups, service providers and end users of their services, now is the time to prepare.
Jackie Pirone is the Program Leader for OraSure Technologies’ Substance Abuse Testing Division
REFERENCES
1. https://www.federalregister.gov/documents/2019/10/25/2019-22684/ mandatory-guidelines-for-federal-workplace-drug-testing-programs-oralfluid
2. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/ metabolite
18 Occupational Health & Safety | MARCH 2020
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