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Subpart I - Problems in Drug Tests
§40.191 What is a refusal to take a DOT drug test,
and what are the consequences?
(a) As an employee, you have refused to take a drug test if you:
(1) Fail to appear for any test (except a pre-employment test)
within a reasonable time, as determined by the employer, consistent
with applicable DOT agency regulations, after being directed to
do so by the employer. This includes the failure of an employee
(including an owner-operator) to appear for a test when called
by C/TPA (see §40.61(a));
(2) Fail to remain at the testing site until the testing process
is complete; provided, that an employee who leaves the testing
site before the testing process commences (see §40.63(c))
for a pre-employment test is not deemed to have refused to test;
(3) Fail to provide a urine specimen for any drug test required
by this part or DOT agency regulations; provided, that an employee
who does not provide a urine specimen because he or she has left
the testing site before the testing process commences (see §40.63(c))
for a pre-employment test is not deemed to have refused to test;
(4) In the case of a directly observed or monitored collection
in a drug test, fail to permit the observation or monitoring of
your provision of a specimen (see §§40.67(l) and 40.69(g));
(5) Fail to provide a sufficient amount of urine when directed,
and it has been determined, through a required medical evaluation,
that there was no adequate medical explanation for the failure
(6) Fail or decline to take a second test the employer or collector
has directed you to take;
(7) Fail to undergo a medical examination or evaluation, as directed
by the MRO as part of the verification process, or as directed
by the DER under §40.193(d). In the case of a pre-employment
drug test, the employee is deemed to have refused to test on this
basis only if the pre-employment test is conducted following a
contingent offer of employment; or
(8) Fail to cooperate with any part of the testing process (e.g.,
refuse to empty pockets when so directed by the collector, behave
in a confrontational way that disrupts the collection process).
(b) As an employee, if the MRO reports that you have a verified
adulterated or substituted test result, you have refused to take
a drug test.
(c) As an employee, if you refuse to take a drug test, you incur
the consequences specified under DOT agency regulations for a
violation of those DOT agency regulations.
(d) As a collector or an MRO, when an employee refuses to participate
in the part of the testing process in which you are involved,
you must terminate the portion of the testing process in which
you are involved, document the refusal on the CCF (including,
in the case of the collector, printing the employee’s name
on Copy 2 of the CCF), immediately notify the DER by any means
(e.g., telephone or secure fax machine) that ensures that the
refusal notification is immediately received. As a referral physician
(e.g., physician evaluating a “shy bladder” condition
or a claim of a legitimate medical explanation in a validity testing
situation), you must notify the MRO, who in turn will notify the
(1) As the collector, you must note the refusal in the “Remarks”
line (Step 2), and sign and date the CCF.
(2) As the MRO, you must note the refusal by checking the “refused
to test because” box (Step 6) on Copy 2 of the CCF, and
add the reason on the “Remarks” line. You must then
sign and date the CCF.
(e) As an employee, when you refuse to take a non-DOT test or
to sign a non-DOT form, you have not refused to take a DOT test.
There are no consequences under DOT agency regulations for refusing
to take a non-DOT test.
§40.193 What happens when an employee does not provide
a sufficient amount of urine for a drug test?
(a) This section prescribes procedures for situations in which
an employee does not provide a sufficient amount of urine to permit
a drug test (i.e., 45 mL of urine).
(b) As the collector, you must do the following:
(1) Discard the insufficient specimen, except where the insufficient
specimen was out of temperature range or showed evidence of adulteration
or tampering (see §40.65(b) and (c)).
(2) Urge the employee to drink up to 40 ounces of fluid, distributed
reasonably through a period of up to three hours, or until the
individual has provided a sufficient urine specimen, whichever
occurs first. It is not a refusal to test if the employee declines
to drink. Document on the Remarks line of the CCF (Step 2), and
inform the employee of, the time at which the three-hour period
begins and ends.
(3) If the employee refuses to make the attempt to provide a new
urine specimen or leaves the collection site before the collection
process is complete, you must discontinue the collection, note
the fact on the “Remarks” line of the CCF (Step 2),
and immediately notify the DER. This is a refusal to test.
(4) If the employee has not provided a sufficient specimen within
three hours of the first unsuccessful attempt to provide the specimen,
you must discontinue the collection, note the fact on the “Remarks”
line of the CCF (Step 2), and immediately notify the DER.
(5) Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You
must send or fax these copies to the MRO and DER within 24 hours
or the next business day.
(c) As the DER, when the collector informs you that the employee
has not provided a sufficient amount of urine (see paragraph (b)(4)
of this section), you must, after consulting with the MRO, direct
the employee to obtain, within five days, an evaluation from a
licensed physician, acceptable to the MRO, who has expertise in
the medical issues raised by the employee’s failure to provide
a sufficient specimen. (The MRO may perform this evaluation if
the MRO has appropriate expertise.)
(1) As the MRO, if another physician will perform the evaluation,
you must provide the other physician with the following information
(i) That the employee was required to take a DOT drug test, but
was unable to provide a sufficient amount of urine to complete
(ii) The consequences of the appropriate DOT agency regulation
for refusing to take the required drug test;
(iii) That the referral physician must agree to follow the requirements
of paragraphs (d) through (g) of this section.
(d) As the referral physician conducting this evaluation, you
must recommend that the MRO make one of the following determinations:
(1) A medical condition has, or with a high degree of probability
could have, precluded the employee from providing a sufficient
amount of urine. As the MRO, if you accept this recommendation,
(i) Check “Test Cancelled” (Step 6) on the CCF; and
(ii) Sign and date the CCF.
(2) There is not an adequate basis for determining that a medical
condition has, or with a high degree of probability could have,
precluded the employee from providing a sufficient amount of urine.
As the MRO, if you accept this recommendation, you must:
(i) Check “Refusal to test because” (Step 6) on the
CCF and enter reason in the remarks line; and
(ii) Sign and date the CCF.
(e) For purposes of this paragraph, 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.
(f) As the referral physician making the evaluation, after completing
your evaluation, you must provide a written statement of your
recommendations and the basis for them to the MRO. You must not
include in this statement detailed information on the employee's
medical condition beyond what is necessary to explain your conclusion.
(g) If, as the referral physician making this evaluation in the
case of a pre-employment test, you determine that the employee’s
medical condition is a serious and permanent or long-term disability
that is highly likely to prevent the employee from providing a
sufficient amount of urine for a very long or indefinite period
of time, you must set forth your determination and the reasons
for it in your written statement to the MRO. As the MRO, upon
receiving such a report, you must follow the requirements of §40.195,
(h) As the MRO, you must seriously consider and assess the referral
physician’s recommendations in making your determination
about whether the employee has a medical condition that has, or
with a high degree of probability could have, precluded the employee
from providing a sufficient amount of urine. You must report your
determination to the DER in writing as soon as you make it.
(i) As the employer, when you receive a report from the MRO indicating
that a test is cancelled as provided in paragraph (d)(1) of this
section, you take no further action with respect to the employee.
The employee remains in the random testing pool.
§40.195 What happens when an individual is unable
to provide a sufficient amount of urine for a pre-employment or
return-to-duty test because of a permanent or long-term medical
(a) This section concerns a situation in which an employee has
a medical condition that precludes him or her from providing a
sufficient specimen for a pre-employment, follow-up or return-to-duty
test and the condition involves a permanent or long-term disability.
As the MRO in this situation, you must do the following:
(1) You must determine if there is clinical evidence that the
individual is an illicit drug user. You must make this determination
by personally conducting, or causing to be conducted, a medical
evaluation and through consultation with the employee’s
physician and/or the physician who conducted the evaluation under
(2) If you do not personally conduct the medical evaluation, you
must ensure that one is conducted by a licensed physician acceptable
(3) For purposes of this section, the MRO or the physician conducting
the evaluation may conduct an alternative test (e.g., blood) as
part of the medically appropriate procedures in determining clinical
evidence of drug use.
(b) If the medical evaluation reveals no clinical evidence of
drug use, as the MRO, you must report the result to the employer
as a negative test with written notations regarding results of
both the evaluation conducted under §40.193(d) and any further
medical examination. This report must state the basis for the
determination that a permanent or long-term medical condition
exists, making provision of a sufficient urine specimen impossible,
and for the determination that no signs and symptoms of drug use
(1) Check “Negative” (Step 6) on the CCF.
(2) Sign and date the CCF.
(c) If the medical evaluation reveals clinical evidence of drug
use, as the MRO, you must report the result to the employer as
a cancelled test with written notations regarding results of both
the evaluation conducted under §40.193(d) and any further
medical examination. This report must state that a permanent or
long-term medical condition exists, making provision of a sufficient
urine specimen impossible, and state the reason for the determination
that signs and symptoms of drug use exist. Because this is a cancelled
test, it does not serve the purposes of a negative test (i.e.,
the employer is not authorized to allow the employee to begin
or resume performing safety-sensitive functions, because a negative
test is needed for that purpose).
(d) For purposes of this section, permanent or long-term medical
conditions are those physiological, anatomic, or psychological
abnormalities documented as being present prior to the attempted
collection, and considered not amenable to correction or cure
for an extended period of time, if ever.
(1) Examples would include destruction (any cause) of the glomerular
filtration system leading to renal failure; unrepaired traumatic
disruption of the urinary tract; or a severe psychiatric disorder
focused on genito-urinary matters.
(2) Acute or temporary medical conditions, such as cystitis, urethritis
or prostatitis, though they might interfere with collection for
a limited period of time, cannot receive the same exceptional
consideration as the permanent or long-term conditions discussed
in paragraph (d)(1) of this section.
§40.197 What happens when an employer receives a
report of a dilute specimen?
(a) As the employer, if the MRO informs you that a positive drug
test was dilute, you simply treat the test as a verified positive
test. You must not direct the employee to take another test based
on the fact that the specimen was dilute.
(b) If the MRO informs you that a negative drug test was dilute,
you may, but are not required to, direct the employee to take
another test immediately. Such recollections must not be collected
under direct observation, unless there is another basis for use
of direct observation (see §40.67(b) and (c)).
(c) You must treat all employees the same for this purpose. For
example, you must not retest some employees and not others. You
may, however, establish different policies for different types
of tests (e.g., conduct retests in pre-employment test situations,
but not in random test situations). You must inform your employees
in advance of your decisions on these matters.
(d) If you direct the employee to take another test, you must
ensure that the employee is given the minimum possible advance
notice that he or she must go to the collection site.
(e) If you direct the employee to take another test, the result
of the second test – not that of the original test –
becomes the test of record, on which you rely for purposes of
(f) If you require employees to take another test, and the second
test is also negative and dilute, you are not permitted to make
the employee take a third test because the second test was dilute.
(g) If you direct the employee to take another test and the employee
declines to do so, the employee has refused the test for purpose
of this part and DOT agency regulations.
§40.199 What problems always cause a drug test to
(a) As the MRO, when the laboratory discovers a "fatal flaw"
during its processing of incoming specimens (see §40.83),
the laboratory will report to you that the specimen has been "Rejected
for Testing” (with the reason stated). You must always cancel
such a test.
(b) The following are "fatal flaws":
(1) There is no printed collector's name and no collector's signature;
(2) The specimen ID numbers on the specimen bottle and the CCF
do not match;
(3) The specimen bottle seal is broken or shows evidence of tampering
(and a split specimen cannot be redesignated, see §40.83(g));
(4) Because of leakage or other causes, there is an insufficient
amount of urine in the primary specimen bottle for analysis and
the specimens cannot be redesignated (see §40.83(g)).
(c ) You must report the result as provided in §40.161 .
§40.201 What problems always cause a drug test to
be cancelled and may result in a requirement for another collection?
As the MRO, you must cancel a drug test when a laboratory reports
that any of the following problems have occurred. You must inform
the DER that the test was cancelled. You must also direct the
DER to ensure that an additional collection occurs immediately,
if required by the applicable procedures specified in paragraphs
(a) through (e) of this section.
(a) The laboratory reports an “Invalid Result.” You
must follow applicable procedures in §40.159 (recollection
under direct observation may be required).
(b) The laboratory reports the result as “Rejected for Testing.”
You must follow applicable procedures in §40.161 ( a recollection
may be required).
(c) The laboratory’s test of the primary specimen is positive
and the split specimen is reported by the laboratory as “Failure
to Reconfirm: Drug(s)/Drug Metabolite(s) Not Detected.”
You must follow applicable procedures in §40.187(b) (no recollection
is required in this case).
(d) The laboratory's test result for the primary specimen is adulterated
or substituted and the split specimen is reported by the laboratory
as “Adulterant not found within criteria,” or “
specimen not consistent with substitution criteria, as applicable.
You must follow applicable procedures in §40.187(c) (no recollection
is required in this case).
(e) The laboratory's test of the primary specimen is positive,
adulterated, or substituted and the split specimen is unavailable
for testing. You must follow applicable procedures in §40.187(d)
(recollection under direct observation is required in this case).
(f) The examining physician has determined that there is an acceptable
medical explanation of the employee’s failure to provide
a sufficient amount of urine. You must follow applicable procedures
in §40.193(d)(1) (no recollection is required in this case).
§40.203 What problems cause a drug test to be cancelled
unless they are corrected?
(a) As the MRO, when a laboratory discovers a "correctable
flaw" during its processing of incoming specimens (see §40.83),
the laboratory will attempt to correct it. If the laboratory is
unsuccessful in this attempt, it will report to you that the specimen
has been "Rejected for Testing" (with the reason stated).
(b) The following is a "correctable flaw" that laboratories
must attempt to correct: The collector's signature is omitted
on the certification statement on the CCF.
(c) As the MRO, when you discover a "correctable flaw"
during your review of the CCF, you must cancel the test unless
the flaw is corrected.
(d) The following are correctable flaws that you must attempt
(1) The employee's signature is omitted from the certification
statement, unless the employee's failure or refusal to sign is
noted on the “Remarks” line of the CCF.
(2) The certifying scientist's signature is omitted on the laboratory
copy of the CCF for a positive, adulterated, substituted, or invalid
(3) The collector uses a non-Federal form or an expired Federal
form for the test. This flaw may be corrected through the procedure
set forth in §40.205(b)(2), provided that the collection
testing process has been conducted in accordance with the procedures
of this part in an HHS-certified laboratory. During the period
August 1 – October 31, 2001, you are not required to cancel
a test because of the use of an expired Federal form. Beginning
November 1, 2001, if the problem is not corrected, you must cancel
§40.205 How are drug test problems corrected?
(a) As a collector, you have the responsibility of trying to successfully
complete a collection procedure for each employee.
(1) If, during or shortly after the collection process, you become
aware of any event that prevents the completion of a valid test
or collection (e.g., a procedural or paperwork error), you must
try to correct the problem promptly, if doing so is practicable.
You may conduct another collection as part of this effort.
(2) If another collection is necessary, you must begin the new
collection procedure as soon as possible, using a new CCF and
a new collection kit.
(b) If, as a collector, laboratory, MRO, employer, or other person
implementing these drug testing regulations, you become aware
of a problem that can be corrected (see §40.203), but which
has not already been corrected under paragraph (a) of this section,
you must take all practicable action to correct the problem so
that the test is not cancelled.
(1) If the problem resulted from the omission of required information,
you must, as the person responsible for providing that information,
supply in writing the missing information and a statement that
it is true and accurate. For example, suppose you are a collector,
and you forgot to make a notation on the “Remarks”
line of the CCF that the employee did not sign the certification.
You would, when the problem is called to your attention, supply
a signed statement that the employee failed or refused to sign
the certification and that your statement is true and accurate.
You must supply this information on the same business day on which
you are notified of the problem, transmitting it by fax or courier.
(2) If the problem is the use of a non-Federal form or an expired
Federal form, you must provide a signed statement (i.e., a memorandum
for the record). It must state that the incorrect form contains
all the information needed for a valid DOT drug test, and that
the incorrect form was used inadvertently or as the only means
of conducting a test, in circumstances beyond your control. The
statement must also list the steps you have taken to prevent future
use of non-Federal forms or expired Federal forms for DOT tests.
For this flaw to be corrected, the test of the specimen must have
occurred at a HHS-certified laboratory where it was tested consistent
with the requirements of this part. You must supply this information
on the same business day on which you are notified of the problem,
transmitting it by fax or courier.
(3) You must maintain the written documentation of a correction
with the CCF.
(4) You must mark the CCF in such a way (e.g., stamp noting correction)
as to make it obvious on the face of the CCF that you corrected
(c) If the correction does not take place, as the MRO you must
cancel the test.
§40.207 What is the effect of a cancelled drug test?
(a) A cancelled drug test is neither positive nor negative.
(1) As an employer, you must not attach to a cancelled test the
consequences of a positive test or other violation of a DOT drug
testing regulation (e.g., removal from a safety-sensitive position).
(2) As an employer, you must not use a cancelled test for the
purposes of a negative test to authorize the employee to perform
safety-sensitive functions (i.e., in the case of a pre-employment,
return-to-duty, or follow-up test).
(3) However, as an employer, you must not direct a recollection
for an employee because a test has been cancelled, except in the
situations cited in paragraph (a)(2) of this section or other
provisions of this part that require another test to be conducted
(e.g., §§40.159(a)(5) and 40.187(b)).
(b) A cancelled test does not count toward compliance with DOT
requirements (e.g., being applied toward the number of tests needed
to meet the employer’s minimum random testing rate).
(c) A cancelled DOT test does not provide a valid basis for an
employer to conduct a non-DOT test (i.e., a test under company
§40.208 What problem requires corrective action
but does not result in the cancellation of a test?
(a) If, as a laboratory, collector, employer, or other person
implementing the DOT drug testing program, you become aware that
the specimen temperature on the CCF was not checked and the “Remarks”
line did not contain an entry regarding the temperature being
out of range, you must take corrective action, including securing
a memorandum for the record explaining the problem and taking
appropriate action to ensure that the problem does not recur.
(b) This error does not result in the cancellation of the test.
(c) As an employer or service agent, this error, even though not
sufficient to cancel a drug test result, may subject you to enforcement
action under DOT agency regulations or Subpart R of this part.
§40.209 What procedural problems do not result in
the cancellation of a test and do not require correction?
(a) As a collector, laboratory, MRO, employer or other person
administering the drug testing process, you must document any
errors in the testing process of which you become aware, even
if they are not considered problems that will cause a test to
be cancelled as listed in this subpart. Decisions about the ultimate
impact of these errors will be determined by other administrative
or legal proceedings, subject to the limitations of paragraph
(b) of this section.
(b) No person concerned with the testing process may declare a
test cancelled based on an error that does not have a significant
adverse effect on the right of the employee to have a fair and
accurate test. Matters that do not result in the cancellation
of a test include, but are not limited to, the following:
(1) A minor administrative mistake (e.g., the omission of the
employee's middle initial, a transposition of numbers in the employee's
social security number);
(2) An error that does not affect employee protections under this
part (e.g., the collector's failure to add bluing agent to the
toilet bowl, which adversely affects only the ability of the collector
to detect tampering with the specimen by the employee);
(3) The collection of a specimen by a collector who is required
to have been trained (see §40.33 ), but who has not met this
(4) A delay in the collection process (see §40.61(a));
(5) Verification of a test result by an MRO who has the basic
credentials to be qualified as an MRO (see §40.121(a) through
(b)) but who has not met training and/or documentation requirements
(see §40.121(c) through (e));
(6) The failure to directly observe or monitor a collection that
the rule requires or permits to be directly observed or monitored,
or the unauthorized use of direct observation or monitoring for
(7) The fact that a test was conducted in a facility that does
not meet the requirements of §40.41 ;
(8) If the specific name of the courier on the CCF is omitted
(9) Personal identifying information is inadvertently contained
on the CCF (e.g., the employee signs his or her name on the laboratory
(10) Claims that the employee was improperly selected for testing.
(c) As an employer or service agent, these types of errors, even
though not sufficient to cancel a drug test result, may subject
you to enforcement action under DOT agency regulations or actions
under Subpart R of this part.
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