§ 26.109 - Urine specimen quantity.

§ 26.109 Urine specimen quantity.

Cross Reference

Link to an amendment published at 87 FR 71458, Nov. 22, 2022.

(a) Licensees and other entities who are subject to this subpart shall establish a predetermined quantity of urine that donors are requested to provide when submitting a specimen. At a minimum, the predetermined quantity must include 30 milliliters (mL) to ensure that a sufficient quantity of urine is available for initial and confirmatory validity and drug tests at an HHS-certified laboratory, and for retesting of an aliquot of the specimen if requested by the donor under § 26.165(b). The licensee's or other entity's predetermined quantity may include more than 30 mL, if the testing program follows split specimen procedures, tests for additional drugs, or performs initial testing at a licensee testing facility. Where collected specimens are to be split under the provisions of this subpart, the predetermined quantity must include an additional 15 mL.

(b) If the quantity of urine in the first specimen provided by the donor is less than 30 mL, the collector shall take the following steps:

(1) The collector shall encourage the donor to drink a reasonable amount of liquid (normally, 8 ounces of water every 30 minutes, but not to exceed a maximum of 40 ounces over 3 hours) until the donor provides a specimen containing of at least 30 mL. Alternatively, as specified in the licensee's or other entity's FFD program procedures, the collector may assign responsibility for monitoring a donor during the hydration process to another collector who meets the requirements in § 26.85(a) or to a hydration monitor. If another collector or hydration monitor is used, the collector:

(i) Shall explain the hydration process and acceptable donor behavior to the hydration monitor;

(ii) Shall record the name of the other collector or hydration monitor on the Federal CCF; and

(iii) May perform other collections while the donor is in the hydration process;

(2) The collector shall provide the donor with a separate collection container for each successive specimen

;

(2) . Once the donor provides a specimen of at least 30 mL, the collection must end. If the specimen quantity is at least 30 mL but is less than the licensee's or other entity's predetermined quantity, the licensee or other entity may not require the donor to provide additional specimens and may not impose any sanctions on the donor. If the donor provides a specimen of 30 mL or more, but the specimen quantity is less than the predetermined quantity, the collector shall forward the specimen to the HHS-certified laboratory for testing. If the donor provides a specimen of at least the predetermined quantity, the specimen may be processed under the FFD program's usual testing procedures;

(3) If the donor has not provided a specimen of at least 30 mL within 3 hours of the first unsuccessful attempt to provide a specimen of the predetermined quantity, the collector shall discontinue the collection and notify the FFD program manager or MRO to initiate the “shy bladder” procedures in § 26.119; and

(4) Neither the donor nor the collector may combine specimens. The collector shall discard specimens of less than 30 mL, except if there is reason to believe that the donor has diluted, adulterated, substituted, or otherwise tampered with the specimen, based on the collector's observations of the donor's behavior during the collection process or the specimen's characteristics, as specified in § 26.111. If the collector has a reason to believe that a specimen that is 15 mL or more, but less than 30 mL, has been diluted, adulterated, substituted, or altered, the collector shall prepare the suspect specimen for shipping to the HHS-certified laboratory and contact FFD program management to determine whether a directly observed collection is required, as described in § 26.115.

[73 FR 17176, Mar. 31, 2008, as amended at 87 FR 71458, Nov. 22, 2022]