When a donor has not provided a specimen of at least 30 mL within the 3 hours permitted for urine collection, FFD program personnel shall direct the donor to obtain, within 5 business days, an evaluation from a licensed physician who is acceptable to the MRO and has expertise in the medical issues raised by the donor's failure to provide a sufficient specimen. The MRO may perform this evaluation if the MRO has the appropriate expertise.

If another physician will perform the evaluation, the MRO shall provide the other physician with the following information and instructions:

The donor was required to take a drug test, but was unable to provide a sufficient quantity of urine to complete the test;

The potential consequences of refusing to take the required drug test; and

The physician must agree to follow the requirements of paragraphs (c) through (f) of this section.

The physician who conducts this evaluation shall make one of the following determinations:

A medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficient amount of urine; or

There is an inadequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficient quantity of urine.

For purposes of this section, a medical condition includes an ascertainable physiological condition (e.g., a urinary system dysfunction) or a medically documented pre-existing psychological disorder, but does not include unsupported assertions of “situational anxiety” or dehydration.

The physician who conducts this evaluation shall provide a written statement of his or her determination and the basis for it to the MRO. This statement may not include detailed information on the donor's medical condition beyond what is necessary to explain the determination.

If the physician who conducts this evaluation determines that the donor's medical condition is a serious and permanent or long-term disability that is highly likely to prevent the donor from providing a sufficient amount of urine for a very long or indefinite period of time, the physician shall set forth this determination and the reasons for it in the written statement to the MRO.

The MRO shall seriously consider and assess the information provided by the physician in deciding whether the donor has a medical condition that has, or with a high degree of probability could have, precluded the donor from providing a sufficient amount of urine, as follows:

If the MRO concurs with the physician's determination, then the MRO shall declare that the donor has not violated the FFD policy and the licensee or other entity shall take no further action with respect to the donor;

If the MRO determines that the medical condition has not, or with a high degree of probability could not have, precluded the donor from providing a sufficient amount of urine, then the MRO shall declare that there has been a refusal to test; or

If the MRO determines that the medical condition is highly likely to prevent the donor from providing a sufficient amount of urine for a very long or indefinite period of time, then the MRO shall authorize an alternative evaluation process, tailored to the individual case, for drug testing.