§ 26.115 Collecting a urine specimen under direct observation.
(a) Procedures for collecting urine specimens must provide for the donor's privacy unless directed by this subpart or the MRO or FFD program manager determines that a directly observed collection is warranted. The following circumstances constitute the exclusive grounds for performing a directly observed collection:
(1) The donor has presented, at this or a previous collection, a urine specimen that the HHS-certified laboratory reported as being substituted, adulterated, or invalid to the MRO and the MRO reported to the licensee or other entity that there is no adequate
medical explanation for the result;
(2) The donor has presented, at this collection, a urine specimen that falls outside the required temperature range;
(3) The collector, or the hydration monitor if one is used as permitted in § 26.109(b)(1), observes conduct by the donor indicating an attempt to subvert the testing process;
(4) A directly observed collection is required under § 26.69; or
(5) The donor requests a retest and either Bottle B or the single specimen is not available due to circumstances outside of the donor's control, as described in § 26.165(f)(2).
(b) Before collecting a urine specimen under direct observation, the collector shall obtain the agreement of the FFD program manager or MRO to obtain a urine specimen under direct observation. After obtaining agreement, the collector shall ensure that a
specimen is collected under direct observation as soon as reasonably practicable.
(c) The collector shall explain to the donor the reason for direct observation of the collection under paragraph (a) of this section.
(d) The collector shall complete a new Federal CCF for the specimen that is obtained from the directly observed collection. The collector shall record that the collection was observed and the reason(s) for the directly observed collection on the form.
(e) The collector shall ensure that the observer is the same gender as the donor. A person of the opposite gender may not act as the observer under any conditions. The observer may be a different person from the collector and
need not be a qualified collector. If the observer is not a qualified collector, the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) of this section before proceeding with the directly observed collection.
(f) The individual who observes the collection shall follow these procedures:
(1) The observer shall instruct the
donor to adjust his or her clothing to
ensure that the area of the donor's body
between the waist and knees is exposed;
(2) The observer shall watch the
donor urinate into the collection
container. Specifically, the observer
shall watch the urine go from the
donor's body into the collection
container. A reflective mirror may be
used to assist in observing the provision
of the specimen only if the physical
configuration of the room, stall, or
private area used for urination is not
sufficient to meet this direct observation
requirement; the use of a video camera
to assist in the observation process is
not permitted;
(3) If the observer is not the collector,
the observer may not touch or handle
the collection container but shall
maintain visual contact with the
specimen until the donor hands the
collection container to the collector; and
(4) If the observer is not the collector, the collector shall record the observer's name on the Federal CCF.
(g) If a donor declines to allow a
directly observed collection that is
required or permitted under this
section, the donor's refusal constitutes
an act to subvert the testing process, and
the collector shall follow the procedures
in § 26.107(d).
(h) If a collector learns that a directly observed collection should have been performed but was not, the collector shall inform the FFD program manager, or his or her designee. The FFD program manager or designee shall ensure that a directly observed collection is immediately performed.
[73 FR 17201 Mar. 31, 2008; 87 FR 71458, Nov. 22, 2022]
Page Last Reviewed/Updated Thursday, December 22, 2022