(a)As an employer, you must direct an immediate collection under direct observation with no advance notice to the employee, if:
(1)The laboratory reported to the MRO that a specimen is invalid, and the MRO reported to you that there was not an adequate medical explanation for the result;
(2)The MRO reported to you that the original positive, adulterated, or substituted result had to be cancelled because the test of the split specimen could not be performed; or
(3)The laboratory reported to the MRO that the specimen was negative-dilute with a creatinine concentration greater than or equal to 2 mg/dL but less than or equal to 5 mg/dL, and the MRO reported the specimen to you as negative-dilute and that a second collection must take place under direct observation (see § 40.197(b)(1)).
(4)You realize a collection under direct observation was required but was not conducted or the service agent informs you that a direct observation should have been collected but was not ( see paragraph (n) of this section).
(b)As an employer, you must direct a collection under direct observation of an employee if the drug test is a return-to-duty test or a follow-up test.
(c)As a collector, you must immediately conduct a collection under direct observation if:
(1)You are directed by the DER to do so (see paragraph (a) of this section); or
(2)You observed materials brought to the collection site or the employee's conduct clearly indicates an attempt to tamper with a specimen (see §§ 40.61(f)(5)(i) and 40.63(e)); or
(3)The temperature on the original specimen was out of range ( see § 40.65(b)(5));
(4)The original specimen appeared to have been tampered with ( see § 40.65(c)(1)); or
(5)The test reason is return-to-duty or follow-up.
(1)As the employer, you must explain to the employee the reason for a directly observed collection under paragraph (a) or (b) of this section.
(2)As the collector, you must explain to the employee the reason, if known, under this part for a directly observed collection.
(e)As the collector, you must complete a new CCF for the directly observed collection.
(1)You must mark the “reason for test” block (Step 1) the same as for the first collection.
(2)You must check the “Observed, (Enter Remark)” box and enter the reason (see paragraphs (c)(2) through (4) of this section) in the “Remarks” line (Step 2).
(f)In a case where two sets of specimens are being sent to the laboratory because of suspected tampering with the specimen at the collection site, enter on the “Remarks” line of the CCF (Step 2) for each specimen a notation to this effect ( e.g., collection 1 of 2, or 2 of 2) and the specimen ID number of the other specimen.
(g)As the collector, you must ensure that the observer is the same sex ( i.e., male or female) as the employee.
(1)You must never permit a person of the opposite sex to act as the observer.
(2)The observer can be a different person from the collector and need not be a qualified collector.
(3)If oral fluid testing is not yet available (see paragraph (g)(5) of this section) and a same sex observer is not present at the collection site, the collector must contact the DER. The DER will either arrange for a same sex observer to be present at the time of the collection or send the employee to a collection site acceptable to the employer for a directly observed urine collection as required in this section.
(4)Once oral fluid testing is available (see paragraph (g)(5) of this section), and a same sex observer cannot be found for a directly observed urine collection:
(i)If the employer has a standing order to allow oral fluid testing in such situations, the collector will follow that order.
(ii)If there is no standing order from the employer, the collector must contact the DER, and the DER will direct the collector to either conduct an oral fluid test if the collection site is able to do so or send the employee to a collection site acceptable to the employer for the oral fluid test.
(5)For an employer to use oral fluid testing, there must be at least two HHS-certified oral fluid drug testing laboratories. For employers subject to FAA regulations at 14 CFR 120.123(a), the two certified laboratories must be located in the United States. In addition, both a qualified oral fluid collector and a conforming oral fluid collection device are available at a collection site.
(6)Once HHS gives notification of a second HHS-certified oral fluid drug testing laboratory, there will be an 18-month grace period to allow employers to continue to conduct directly observed urine collections (see paragraph 3 of this section) until the employer is set up to conduct oral fluid testing (see paragraphs 4 and 5). If during the 18-month grace period the employer has decided to use oral fluid drug testing and the employer is ready to conduct oral fluid drug testing, the employer must do so. ODAPC will publish a Federal Register notice to let employers and collectors know when the 18-month period begins and ends.
(h)As the collector, if someone else is to observe the collection ( e.g., in order to ensure a same sex observer), you must verbally instruct that person to follow procedures at paragraphs (i) and (j) of this section. If you, the collector, are the observer, you too must follow these procedures.
(i)As the observer, you must request the employee to raise his or her shirt, blouse, or dress/skirt, as appropriate, above the waist; and lower clothing and underpants to show you, by turning around, that they do not have a prosthetic device. After you have determined that the employee does not have such a device, you may permit the employee to return clothing to its proper position for observed urination.
(j)As the observer, you must watch the employee urinate into the collection container. Specifically, you are to watch the urine go from the employee's body into the collection container.
(k)As the observer but not the collector, you must not take the collection container from the employee, but you must observe the specimen as the employee takes it to the collector.
(l)As the collector, when someone else has acted as the observer, you must include the observer's name in the “Remarks” line of the CCF (Step 2).
(m)As the employee, if you decline to allow a directly observed collection required or permitted under this section to occur, this is a refusal to test.
(n)As a service agent, when you learn that a directly observed collection should have been collected but was not, you must inform the employer that it must direct the employee to have an immediate recollection under direct observation.