to the worksite … Te Department estimates the time savings to be more than 2 hours. Using OPM’s estimate for the average annual salary of Federal employees converted to an hourly wage, the savings generated for the Federal Government would be roughly $400,000 to $1.2 million a year, or $38 to $114 per test.
In the Federal Register announcement, SAMHSA stated:
Te scientific basis for the use of oral fluid as an alternative specimen for drug testing has now been broadly established and the advances in the use of oral fluid in detecting drugs have made it possible for this alternative specimen to be used in federal programs with the same level of confidence that has been applied to the use of urine. (emphasis added)
SAMHSA added:
Te OFMG provide the same scientific and forensic supportability of drug test results as the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG). (emphasis added)
Tat’s quite an acknowledgement.
And terms like “scientific basis… has been broadly established,” and “the same scientific and forensic supportability” as urine testing will likely have a powerful impact on employers, mandated or not, who are considering lab-based oral fluid testing. It will force many service providers from a passive marketing position of simply making oral fluid testing available to clients to more aggressive and outward efforts to not only offer this alternative testing method but to differentiate themselves from their competition. For the typical buyer, as well as many
sellers of drug testing, it’s more about authorization than it is about science—“If
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it’s good enough for the government, it must be good enough for me.” Tat may be a gross oversimplification of an otherwise complex issue, but it applies, generally. Some people must now, at the very least, become knowledgeable about lab-based oral fluid testing, while others, such as lab professionals, collectors, certain employees at companies that conduct drug testing, and medical review officers (MROs), must become experts, at least in the specific duties they will be responsible for in an OFMG-compliant testing program. SAMHSA is allowing a 12–18-month
implementation period to give employers and service provides ample time to learn the regulations, get trained in how to fulfill their responsibilities per the guidelines, and in some cases, such as with laboratories, become certified. Fortunately, the OFMG are written in the same concise, easy-to-understand style as the mandatory guidelines for urine testing, which is a good thing because there’s a lot to know going forward. Following are just a few highlights of the OFMG.
What Must
Collectors Know? Collectors are significantly affected by the OFMG. First, with oral fluid collections employees, in addition to professional technicians, can conduct the collection. Tere are two key parts to collector training—the OFMG and the specific collection device being used. Te OFMG define a collector as someone “who has been trained to collect oral fluid specimens in accordance with these Guidelines and the manufacturer’s procedures for the collection device.” Second, collections can take place at
the workplace in addition to an approved off-site facility. Te site being used may be a permanent or a temporary facility if the site meets all the requirements of an approved collection site. SAMHSA
anticipates that many employers will choose to collect oral fluid samples at the work site in order to save time and boost productivity. Collectors, including employees who conduct collections, will be responsible to ensure the portion of a worksite being used for collections qualifies according to the OFMG. Citing Subpart E of the guidelines, collection site requirements include: (a) Provisions to ensure donor privacy during the collection;
(b) A suitable and clean surface area that is not accessible to the donor for handling the specimens and completing the required paperwork;
(c) A secure temporary storage area to maintain specimens until the specimen is transferred to an HHS- certified laboratory;
(d) A restricted access area where only authorized personnel may be present during the collection;
(e) A restricted access area for the storage of collection supplies; and
(f) Te ability to store records securely. Te federal custody & 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, “Te 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 substantially 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.”
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