§ 26.109 Urine specimen quantity.
(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 at least 30 mL. 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 17200 Mar. 31, 2008]