Last updated: July 26, 2021
The urine test will no longer be the only approved testing method for safety-sensitive and other federal employees. The HSS Oral Fluid Testing Guidelines will be released tomorrow.
It’s the end of a long road for those who’ve been waiting for oral fluid testing to become a federally approved employee drug testing method. Health and Human Services (HSS) proposed guidelines for oral fluid drug testing back in May 2015. They gathered comments for sixty days and began reviewing them. The finalized version is good to go and becomes effective on January 1, 2020.
It allows federal executive branch agencies to drug test using an oral fluid test. It also requires the DOT and like agencies to develop drug-testing programs including the mouth swab test for all regulated agencies. Moreover, the Nuclear Regulatory Commission (NRC) will use the Guidelines for drug testing programs where regulated to do so.
Regulations pertaining to collectors explicitly list who may not collect specimens. For instance, even though immediate supervisors of federal employees or the hiring official of a federal agency may be trained for collection procedures, they can’t actually administer the test unless there is no other collector available. This regulation can ward off unwanted conflicts of interest.
Third-Party Administrators (TPA) trained to collect fluid samples in accordance with the new guidelines, as well as the manufacturer’s collection instructions for the testing device should administer the test if at all possible.
Allowing them to do so protects employers from a disgruntled employee’s attempt to bring an HR lawsuit against the company at some point in the future.
The Drug and Alcohol Testing Industry Association (DATIA) shared an advanced copy and, in turn, we’re ready to hit the highlights.
An alternative to urine
The Oral Fluid Mandatory Guidelines (OFMG) provide employers with an alternative to the urine drug test.
The fact that the urine test was the only approved drug testing method for federally regulated employees has officially been disputed since the regulation was put in place back in 1988. Complaints of possible adulteration being the main concern. Since then, advances in technology coupled with the, now, broadly established scientific basis have made it possible to accept the mouth swab test as an alternative.
Thus, the OFMG will provide the same scientific and forensic supportability of the drug test results as the Mandatory Guidelines for Federal Workplace Drug Testing Programs using urine.
Nothing changes as far as the types of drug tests required. The oral fluids gained approval for all federally regulated drug tests.
It takes two
Each oral fluid specimen is collected as a split specimen. This means that the collector uses two separate collection devices in the case of mouth swab testing. If collecting actual saliva, one device may be used, but 2 mL of fluid must be collected.
The oral fluids test
The drugs included in the test panels remain the same. Oral fluid drug tests must identify amphetamines, marijuana, cocaine, opioids, and PCP (phencyclidine). The DOT extended the opiate panel to include hydrocodone, hydromorphone, oxymorphone, and oxycodone. Moreover, if a federal agency is conducting the collection for reasonable suspicion or post-accident testing, they may test for additional drugs. This, however, is on a case by case basis.
A second test confirms an immunoassay (IA) test that’s positive.
If the testing process identifies adulterants, the HHS-certified lab reports it to the MRO.
Criteria used to deem a test as invalid are:
- Interference occurs on the initial drug tests.
- Something interferes with drug confirmation on both tests and the lab can’t identify the cause.
- Physical appearance causes concern in regard to it possibly damaging testing equipment.
- Test results on test A and test B specimens are clearly different.
- The biomarker isn’t consistent with that of human fluid for either test.
As mentioned above only trained collectors may administer the oral fluids drug test. And even though HR personnel or a staff supervisor qualifies through training, they should only administer the test if there is no alternative.
In addition, those that can’t administer the test include:
- An employee who is qualified to test may not collect for co-workers in the same testing pool, or who work together each day.
- An applicant or employee may not collect their own specimen.
- An employee working for an HHS-certified lab can’t collect if they can link the donor’s identity to the drug test result.
- Collectors may not be related to or a close personal friend of the test subject.
Ensure that your C/TPA has qualified personnel which includes both the test collector and your MRO. They should have staff trained specifically to handle oral fluid testing in compliance with the Guideline regulations on all fronts.
The guidelines for the collection site remain in place. It can be either a permanent or temporary facility as long as it’s clean, affords privacy, contains an area for handling specimens that is not accessible to the donor, contains a proper specimen storage area, and has the ability to store records appropriately.
Maintaining Custody and Control
Use the OMB-approved Federal Custody and Control Form (CCF) for documentation. If for some reason collectors use a non-federal form or an expired CCF, it won’t necessarily mean the test gets rejected. Subsequently, the collector merely documents that they submitted a federally regulated specimen and why they used the incorrect form. Based on the information provided, the HSS certified laboratory must test the specimen.
The test devices must adequately collect 1 ml of undiluted oral fluid. You’ll find the particulars of the device requirements in Section 7.3 of the Guidelines.
Unlike the urine test, the oral fluid test doesn’t require that a collector of the same gender be on-site. In regard to privacy, regulations allow for only the donor and authorized personnel in the area where the collection takes place.
If the donor is late, the collector follows company policy. If they haven’t received instruction as to what that entails, they contact the employer to obtain guidance.
The collection process begins immediately upon the donor’s arrival. The collector follows the identification guidelines before asking the donor to open his mouth for a visual inspection looking for items that would tamper with the test. If the collector finds something, of course, they halt the process immediately and document the incident as a refusal to test.
In the case of “dry mouth,” the collector offers something to drink and waits 10 minutes before beginning the collection. Afterward, the collector readies the specimen for transport. The employee completes any documentation and is free to go.
If the employee is unable to provide an oral sample and agrees to the alternative, the collector submits an alternative method request. Upon receiving authorization, the collector may implement the urine test. Refusing the authorization request equates to a refusal to test.
HHS SAMHSA Approved
Laboratories that conduct federally regulated employee drug testing must be HHS certified. To qualify, they pass rigorous and routine inspections on the property and lab equipment. SAMHSA (Substance Abuse and Mental Health Services Administration) demands that laboratories meet the strictest of standards. Failure to remain in compliance results in decertification.
Consequently, if a laboratory is notified in writing that it’s failed to follow Guidelines and doesn’t respond with a request in writing asking for an informal review within 30 days, certification is revoked.
During the comment process, several commenters voiced disagreements with the proposed number of blind samples required. It was set at between 3% and a 400 sample maximum in the proposal. It was suggested that only the 3% requirement be used.
The Department concluded there was no need for change.
In addition, the department clarified responsibility. It’s the employers’ responsibility to ensure the blind samples get sent to the labs. However, the collectors assume responsibility for getting them there.
Instrumented Initial Test Facilities aren’t considered practical at this time. Therefore, HSS prohibits using them.
However, they noted they would revisit the possibility in the future.
Guidelines pertaining to Medical Review Officers largely mirror those Guidelines set on October 1, 2010.
Subsequently, those physicians acting as MROs will have been properly trained and meet existing “knowledge of” criteria.
Rejecting a specimen
There’s been an addition to the fatal flaws that cause immediate rejection of a specimen. The Department has revised this section to allow laboratories to reject a specimen when they identify a flaw that either prevents testing or compromises the forensic defensibility of the drug test.
Subpart O, Section 15 deals with the particulars of what does and doesn’t cause rejection in regard to missing information or reporting errors.
The New Year rings in change for the better
The new year is setting up to wage war on drugs from a whole new perspective.
The HSS Oral Fluid Testing Guidelines take effect on January 1st giving employers an alternative drug testing method that is able to detect current and recent drug use. Then, the FMCSA Clearinghouse program rolls out on January 6th. The database tracks drivers with drug or alcohol violations until they are resolved.
En garde, drugs! We have a battle plan!
And, it involves a lot more than “Just say no.”