We have touted the advantages of oral fluid drug testing over urine drug testing many times in the past. Now those statements have been validated by the US Federal Government. We have listed below what we believe are important points. Each statement is followed by the page number of the actual document. You can read the entire document by DHHS Proposes Rules Permitting Oral Fluid Drug Testing and Synthetic Opiate Testing clicking here. Call us if you wish to discuss implementing oral fluid drug testing in your organization.
DHHS Proposes Rules Permitting Oral Fluid Drug Testing and Synthetic Opiate Testing
Summary of Mandatory Guidelines for Federal Workplace Drug Testing Programs; Notice dated May 15, 2015
This notice of proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) will allow federal executive branch agencies to collect and test an oral fluid specimen as part of their drug testing programs (Page 2)
Since oral fluid collection does not have the same privacy concerns as urine collection, onsite collections are likely, thereby reducing the time a donor is away from the worksite. The Department estimates the time savings to be between 1 and 3 hours. The Department believes the cost reduction as outlined in this Preamble will benefit the federal agencies and drug free workplace program.
The federal agencies choosing to use oral fluid in their drug testing program may see many benefits including a reduction in time of the collection process; an observed collection method leading to reductions in rejected, invalid, substituted, and adulterated specimens; and an effective tool in post- accident testing identifying the parent or active drug. Productivity for federal agencies related to the drug free workplace program is expected to improve. For example, administrative data indicates it takes, on average, about 4 hours from the start of the notification of the drug test to the actual time a donor reports back to the worksite. Since oral fluid collection does not have the same privacy concerns as urine collection, onsite collections are likely, thereby reducing the time a donor is away from the worksite. The Department estimates the time savings to be between 1 and 3 hours. The Department believes the cost reduction as outlined in this Preamble will benefit the federal agencies and drug free workplace program. (Page 3)
The scientific basis for use of oral fluid as an alternative specimen for drug testing has been broadly established. Corresponding developments have proceeded in analytical technologies that provide the needed sensitivity and accuracy for testing oral fluid specimens. Oral fluid and urine test results have been shown to be substantially similar, and oral fluid may have some inherent advantages as a drug test specimen.
Oral fluid collection will occur under observation, which should substantially lessen the risk of specimen substitution and adulteration and, unlike direct observed urine collections; the collector need not be the same gender as the donor. (Page 5)
COMPARABILITY OF POSITIVITY RATES
In the absence of paired specimen collections (i.e., urine and oral fluid from the same donor) in workplaces, the positivity rates of urine and oral fluid tests can be used to infer the relative effectiveness of these two specimen types. The workplace positivity rates for drugs in oral fluid appear to be generally comparable to corresponding rates reported for urine. The 2013 Drug Testing Index (DTI) by Quest Diagnostics for drugs in the general workforce indicated positivity rates for oral fluid as 0.59 percent amphetamines (combined percentages of amphetamine and methamphetamine), 0.31 percent cocaine, 4.0 percent marijuana, 0.88 percent opiates, and 0.02 percent PCP and, for urine, as 0.87 percent amphetamines, 0.21 percent cocaine, 2.0 percent marijuana, 0.44 percent opiates and 0.01 percent PCP.39 The overall drug positivity rate for oral fluid was 5.5 percent compared to 4.1 percent for urine. An earlier study of 77,218 oral fluid specimens reported similar trends in the positive prevalence rates compared to the DTI for urine specimens collected during the same period.40 In that study, the overall combined positivity rate for oral fluid was 5.06 percent compared to 4.46 percent for urine. Both sets of data compared positivity rates in two separate workplace populations over a comparable time period. The higher positivity rates for oral fluid are most likely due to the fact that oral fluid collections are performed under observation, reducing the ability of donors to substitute or adulterate the specimen. (Page 6)
DIRECT OBSERVATION DECREASES INVALID TESTS
Oral fluid collections will occur under observation, which should substantially lessen the risks of specimen substitution and adulteration that has been associated with urine specimen collections, most of which are unobserved. All oral fluid specimens will be tested for either albumin or immunoglobulin G (IgG) to identify invalid specimens. (Page 17)
Oral fluid collection can require less time than urine collection, reducing employee time away from the workplace and, therefore, reducing costs to the federal agency employer. Oral fluid collection does not require a facility that provides visual privacy during the collection. It is expected that many oral fluid collections will occur at or near the workplace, and not at a dedicated collection site, thereby reducing the amount of time away from the workplace. The collector is allowed to be in the vicinity of the donor, reducing the loss of productive time. (Page 17)
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. (Page 17)
VERSATILITY IN DETECTION
The time course of drugs and metabolites differs between oral fluid and urine, resulting in some differences in analytes and detection times. Oral fluid tests generally are positive as soon as the drug is absorbed into the body. In contrast, urine tests that are based solely on detection of a metabolite are dependent upon the rate and extent of metabolite formation. Thus, oral fluid may permit more interpretative insight into recent drug use drug-induced effects that may be present shortly before or at the time the specimen is collected. A federal agency may select the specimen type for collection based on the circumstances of the test. For example, in situations where drug use at the work-site is suspected, the testing of oral fluid may show the presence of an active drug, which may indicate recent administration of the drug and be advantageous when assessing whether the drug contributed to an observed behavior. (Page 17 & 18)
ADVANCES IN ORAL FLUID DRUG TESTING
Urine was the only permitted specimen for forensic workplace drug testing. However, some issues that previously deterred the use of oral fluid for drug testing have been resolved. The scientific basis for the use of oral fluid as an alternative specimen for drug testing has now been broadly established. For example, oral fluid collection devices and procedures have been developed that protect against biohazards, maintain the stability of analytes, and provide sufficient oral fluid for testing. In addition, OFMG analyte cutoff concentrations are much lower than those specified for urine in the Guidelines. Additionally, specimen volume is also much lower, saving time in collection and transport cost. Developments in analytical technologies have allowed their use as efficient and cost-effective methods that provide the needed analytical sensitivity and accuracy for testing oral fluid specimens. (Page 18)