(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 observes conduct clearly and unequivocally indicating an attempt to dilute, substitute, or adulterate the specimen; and

(4) A directly observed collection is required under §26.69.

(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 custody-and-control form 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 individual. 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.

(f) If someone other than the collector is to observe the collection, the collector shall instruct the observer to follow the procedures in this paragraph. 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;

(3) If the observer is not the collector, the observer may not take the collection container from the donor, but shall observe the specimen as the donor takes it to the collector; and

(4) If the observer is not the collector, the collector shall record the observer's name on the custody-and-control form.

(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.

(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.