**Subpart G - Medical Review Officers and the Verification Process**

**§ 40.145   On what basis does the MRO verify test results involving
adulteration or substitution?**

\(a\) As an MRO, when you receive a laboratory report that a specimen is
adulterated or substituted, you must treat that report in the same way
you treat the laboratory\'s report of a confirmed positive test for a
drug or drug metabolite.

\(b\) You must follow the same procedures used for verification of a
confirmed positive test for a drug or drug metabolite (see
§§40.129--40.135, 40.141, 40.151), except as otherwise provided in this
section.

\(c\) In the verification interview, you must explain the laboratory
findings to the employee and address technical questions or issues the
employee may raise.

\(d\) You must offer the employee the opportunity to present a
legitimate medical explanation for the laboratory findings with respect
to presence of the adulterant in, or the creatinine and specific gravity
findings for, the specimen.

\(e\) The employee has the burden of proof that there is a legitimate
medical explanation.

\(1\) To meet this burden in the case of an adulterated specimen, the
employee must demonstrate that the adulterant found by the laboratory
entered the specimen through physiological means.

\(2\) To meet this burden in the case of a substituted specimen, the
employee must demonstrate that he or she did produce or could have
produced urine through physiological means, meeting the creatinine
concentration criterion of less than 2 mg/dL and the specific gravity of
less than or equal to 1.0010 or greater than or equal to 1.0200 (see
§40.93(b)).

\(3\) The employee must present information meeting this burden at the
time of the verification interview. As the MRO, you have discretion to
extend the time available to the employee for this purpose for up to
five days before verifying the specimen, if you determine that there is
a reasonable basis to believe that the employee will be able to produce
relevant evidence supporting a legitimate medical explanation within
that time.

\(f\) As the MRO or the employer, you are not responsible for arranging,
conducting, or paying for any studies, examinations or analyses to
determine whether a legitimate medical explanation exists.

\(g\) As the MRO, you must exercise your best professional judgment in
deciding whether the employee has established a legitimate medical
explanation.

\(1\) If you determine that the employee\'s explanation does not present
a reasonable basis for concluding that there may be a legitimate medical
explanation, you must report the test to the DER as a verified refusal
to test because of adulteration or substitution, as applicable.

\(2\) If you believe that the employee\'s explanation may present a
reasonable basis for concluding that there is a legitimate medical
explanation, you must direct the employee to obtain, within the five-day
period set forth in paragraph (e)(3) of this section, a further medical
evaluation. This evaluation must be performed by a licensed physician
(the "referral physician"), acceptable to you, with expertise in the
medical issues raised by the employee\'s explanation. (The MRO may
perform this evaluation if the MRO has appropriate expertise.)

\(i\) As the MRO or employer, you are not responsible for finding or
paying a referral physician. However, on request of the employee, you
must provide reasonable assistance to the employee\'s efforts to find
such a physician. The final choice of the referral physician is the
employee\'s, as long as the physician is acceptable to you.

\(ii\) As the MRO, you must consult with the referral physician,
providing guidance to him or her concerning his or her responsibilities
under this section. As part of this consultation, you must provide the
following information to the referral physician:

\(A\) That the employee was required to take a DOT drug test, but the
laboratory reported that the specimen was adulterated or substituted,
which is treated as a refusal to test;

\(B\) The consequences of the appropriate DOT agency regulation for
refusing to take the required drug test;

\(C\) That the referral physician must agree to follow the requirements
of paragraphs (g)(3) through (g)(4) of this section; and

\(D\) That the referral physician must provide you with a signed
statement of his or her recommendations.

\(3\) As the referral physician, you must evaluate the employee and
consider any evidence the employee presents concerning the employee\'s
medical explanation. You may conduct additional tests to determine
whether there is a legitimate medical explanation. Any additional urine
tests must be performed in an HHS-certified laboratory.

\(4\) As the referral physician, you must then make a written
recommendation to the MRO about whether the MRO should determine that
there is a legitimate medical explanation. As the MRO, you must
seriously consider and assess the referral physician\'s recommendation
in deciding whether there is a legitimate medical explanation.

\(5\) As the MRO, if you determine that there is a legitimate medical
explanation, you must cancel the test and inform ODAPC in writing of the
determination and the basis for it (e.g., referral physician\'s
findings, evidence produced by the employee).

\(6\) As the MRO, if you determine that there is not a legitimate
medical explanation, you must report the test to the DER as a verified
refusal to test because of adulteration or substitution.

\(h\) The following are examples of types of evidence an employee could
present to support an assertion of a legitimate medical explanation for
a substituted result.

\(1\) Medically valid evidence demonstrating that the employee is
capable of physiologically producing urine meeting the creatinine and
specific gravity criteria of §40.93(b) .

\(i\) To be regarded as medically valid, the evidence must have been
gathered using appropriate methodology and controls to ensure its
accuracy and reliability.

\(ii\) Assertion by the employee that his or her personal
characteristics (e.g., with respect to race, gender, weight, diet,
working conditions) are responsible for the substituted result does not,
in itself, constitute a legitimate medical explanation. To make a case
that there is a legitimate medical explanation, the employee must
present evidence showing that the cited personal characteristics
actually result in the physiological production of urine meeting the
creatinine and specific gravity criteria of §40.93(b) .

\(2\) Information from a medical evaluation under paragraph (g) of this
section that the individual has a medical condition that has been
demonstrated to cause the employee to physiologically produce urine
meeting the creatinine and specific gravity criteria of §40.93(b) .

\(i\) A finding or diagnosis by the physician that an employee has a
medical condition, in itself, does not constitute a legitimate medical
explanation.

\(ii\) To establish there is a legitimate medical explanation, the
employee must demonstrate that the cited medical condition actually
results in the physiological production of urine meeting the creatinine
and specific gravity criteria of §40.93(b) .

\[65 FR 79526, Dec. 19, 2000, as amended at 68 FR 31626, May 28, 2003;
69 FR 64867, Nov.9, 2004\]