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Subpart E – Urine Specimen Collections
§40.61 What are the preliminary steps in the collection
As the collector, you must take the following steps before actually
beginning a collection:
(a) When a specific time for an employee's test has been scheduled,
or the collection site is at the employee’s work site, and
the employee does not appear at the collection site at the scheduled
time, contact the DER to determine the appropriate interval within
which the DER has determined the employee is authorized to arrive.
If the employee's arrival is delayed beyond that time, you must
notify the DER that the employee has not reported for testing.
In a situation where a C/TPA has notified an owner/operator or
other individual employee to report for testing and the employee
does not appear, the C/TPA must notify the employee that he or
she has refused to test (see §40.191(a)(1)).
(b) Ensure that, when the employee enters the collection site,
you begin the testing process without undue delay. For example,
you must not wait because the employee says he or she is not ready
or is unable to urinate or because an authorized employer or employee
representative is delayed in arriving.
(1) If the employee is also going to take a DOT alcohol test,
you must, to the greatest extent practicable, ensure that the
alcohol test is completed before the urine collection process
Example to Paragraph (b)(1): An employee enters the test site
for both a drug and an alcohol test. Normally, the collector would
wait until the BAT had completed the alcohol test process before
beginning the drug test process. However, there are some situations
in which an exception to this normal practice would be reasonable.
One such situation might be if several people were waiting for
the BAT to conduct alcohol tests, but a drug testing collector
in the same facility were free. Someone waiting might be able
to complete a drug test without unduly delaying his or her alcohol
test. Collectors and BATs should work together, however, to ensure
that post-accident and reasonable suspicion alcohol tests happen
as soon as possible (e.g., by moving the employee to the head
of the line for alcohol tests).
(2) If the employee needs medical attention (e.g., an injured
employee in an emergency medical facility who is required to have
a post-accident test), do not delay this treatment to collect
(3) You must not collect, by catheterization or other means, urine
from an unconscious employee to conduct a drug test under this
part. Nor may you catheterize a conscious employee. However, you
must inform an employee who normally voids through self-catheterization
that the employee is required to provide a specimen in that manner.
(4) If, as an employee, you normally void through self-catheterization,
and decline to do so, this constitutes a refusal to test.
(c) Require the employee to provide positive identification. You
must see a photo ID issued by the employer (other than in the
case of an owner-operator or other self-employed individual) or
a Federal, state, or local government (e.g., a driver’s
license). You may not accept faxes or photocopies of identification.
Positive identification by an employer representative (not a co-worker
or another employee being tested) is also acceptable. If the employee
cannot produce positive identification, you must contact a DER
to verify the identity of the employee.
(d) If the employee asks, provide your identification to the employee.
Your identification must include your name and your employer’s
name, but does not have to include your picture, address, or telephone
(e) Explain the basic collection procedure to the employee, including
showing the employee the instructions on the back of the CCF.
(f) Direct the employee to remove outer clothing (e.g., coveralls,
jacket, coat, hat) that could be used to conceal items or substances
that could be used to tamper with a specimen. You must also direct
the employee to leave these garments and any briefcase, purse,
or other personal belongings with you or in a mutually agreeable
location. You must advise the employee that failure to comply
with your directions constitutes a refusal to test.
(1) If the employee asks for a receipt for any belongings left
with you, you must provide one.
(2) You must allow the employee to keep his or her wallet.
(3) You must not ask the employee to remove other clothing (e.g.,
shirts, pants, dresses, underwear), to remove all clothing, or
to change into a hospital or examination gown (unless the urine
collection is being accomplished simultaneously with a DOT agency-authorized
(4) You must direct the employee to empty his or her pockets and
display the items in them to ensure that no items are present
which could be used to adulterate the specimen. If nothing is
there that can be used to adulterate a specimen, the employee
can place the items back into his or her pockets. As the employee,
you must allow the collector to make this observation.
(5) If, in your duties under paragraph (f)(4) of this section,
you find any material that could be used to tamper with a specimen,
(i) Determine if the material appears to be brought to the collection
site with the intent to alter the specimen, and, if it is, conduct
a directly observed collection using direct observation procedures
(see §40.67); or
(ii) Determine if the material appears to be inadvertently brought
to the collection site (e.g., eye drops), secure and maintain
it until the collection process is completed and conduct a normal
(i.e., unobserved) collection.
(g) You must instruct the employee not to list medications that
he or she is currently taking on the CCF. (The employee may make
notes of medications on the back of the employee copy of the form
for his or her own convenience, but these notes must not be transmitted
to anyone else.)
§40.63 What steps does the collector take in the
collection process before the employee provides a urine specimen?
As the collector, you must take the following steps before the
employee provides the urine specimen:
(a) Complete Step 1 of the CCF.
(b) Instruct the employee to wash and dry his or her hands at
this time. You must tell the employee not to wash his or her hands
again until after delivering the specimen to you. You must not
give the employee any further access to water or other materials
that could be used to adulterate or dilute a specimen.
(c) Select, or allow the employee to select, an individually wrapped
or sealed collection container from collection kit materials.
Either you or the employee, with both of you present, must unwrap
or break the seal of the collection container. You must not unwrap
or break the seal on any specimen bottle at this time. You must
not allow the employee to take anything from the collection kit
into the room used for urination except the collection container.
(d) Direct the employee to go into the room used for urination,
provide a specimen of at least 45 mL, not flush the toilet, and
return to you with the specimen as soon as the employee has completed
(1) Except in the case of an observed or a monitored collection
(see §§40.67 and 40.69), neither you nor anyone else
may go into the room with the employee.
(2) As the collector, you may set a reasonable time limit for
(e) You must pay careful attention to the employee during the
entire collection process to note any conduct that clearly indicates
an attempt to tamper with a specimen (e.g., substitute urine in
plain view or an attempt to bring into the collection site an
adulterant or urine substitute). If you detect such conduct, you
must require that a collection take place immediately under direct
observation (see §40.67) and note the conduct and the fact
that the collection was observed in the “Remarks”
line of the CCF (Step 2). You must also, as soon as possible,
inform the DER and collection site supervisor that a collection
took place under direct observation and the reason for doing so.
§40.65 What does the collector check for when the
employee presents a specimen?
As a collector, you must check the following when the employee
gives the collection container to you:
(a) Sufficiency of specimen. You must check to ensure that the
specimen contains at least 45 mL of urine.
(1) If it does not, you must follow “shy bladder”
procedures (see §40.193(b)).
(2) When you follow “shy bladder” procedures, you
must discard the original specimen, unless another problem (i.e.,
temperature out of range, signs of tampering) also exists.
(3) You are never permitted to combine urine collected from separate
voids to create a specimen.
(4) You must discard any excess urine.
(b) Temperature. You must check the temperature of the specimen
no later than four minutes after the employee has given you the
(1) The acceptable temperature range is 32-38 º C / 90-100
(2) You must determine the temperature of the specimen by reading
the temperature strip attached to the collection container.
(3) If the specimen temperature is within the acceptable range,
you must mark the “Yes” box on the CCF (Step 2).
(4) If the specimen temperature is outside the acceptable range,
you must mark the “No” box and enter in the “Remarks”
line (Step 2) your findings about the temperature.
(5) If the specimen temperature is outside the acceptable range,
you must immediately conduct a new collection using direct observation
procedures (see §40.67).
(6) In a case where a specimen is collected under direct observation
because of the temperature being out of range, you must process
both the original specimen and the specimen collected using direct
observation and send the two sets of specimens to the laboratory.
This is true even in a case in which the original specimen has
insufficient volume but the temperature is out of range. You must
also, as soon as possible, inform the DER and collection site
supervisor that a collection took place under direct observation
and the reason for doing so.
(7) In a case where the employee refuses to provide another specimen
(see §40.191(a)(3)) or refuses to provide another specimen
under direct observation (see §40.191(a)(4)), you must notify
the DER. As soon as you have notified the DER, you must discard
any specimen the employee has provided previously during the collection
(c) Signs of tampering. You must inspect the specimen for unusual
color, presence of foreign objects or material, or other signs
of tampering (e.g., if you notice any unusual odor).
(1) If it is apparent from this inspection that the employee has
tampered with the specimen (e.g., blue dye in the specimen, excessive
foaming when shaken, smell of bleach), you must immediately conduct
a new collection using direct observation procedures (see §40.67).
(2) In a case where a specimen is collected under direct observation
because of showing signs of tampering, you must process both the
original specimen and the specimen collected using direct observation
and send the two sets of specimens to the laboratory. This is
true even in a case in which the original specimen has insufficient
volume but it shows signs of tampering. You must also, as soon
as possible, inform the DER and collection site supervisor that
a collection took place under direct observation and the reason
for doing so.
(3) In a case where the employee refuses to provide a specimen
under direct observation (see §40.191(a)(4)), you must discard
any specimen the employee provided previously during the collection
procedure. Then you must notify the DER as soon as practicable.
§40.67 When and how is a directly observed collection
(a) As an employer you must direct an immediate collection under
direct observation with no advance notice to the employee, if:
(1) The laboratory reported to the MRO that a specimen is invalid,
and the MRO reported to you that there was not an adequate medical
explanation for the result; or
(2) The MRO reported to you that the original positive, adulterated,
or substituted test result had to be cancelled because the test
of the split specimen could not be performed.
(b) As an employer, you may direct a collection under direct observation
of an employee if the drug test is a return-to-duty test or a
(c) As a collector, you must immediately conduct a collection
under direct observation if:
(1) You are directed by the DER to do so (see paragraphs (a) and
(b) of this section); or
(2) You observed materials brought to the collection site or the
employee's conduct clearly indicates an attempt to tamper with
a specimen (see §§40.61(f)(5)(i) and 40.63(e)); or
(3) The temperature on the original specimen was out of range
(see §40.65(b)(5)); or
(4) The original specimen appeared to have been tampered with
(d) (1) As the employer, you must explain to the employee the
reason for a directly observed collection under paragraph (a)
or (b) of this section.
(2) As the collector, you must explain to the employee the reason,
if known, under this part for a directly observed collection under
paragraphs (c)(1) through (3) of this section.
(e) As the collector, you must complete a new CCF for the directly
(1) You must mark the “reason for test” block (Step
1) the same as for the first collection.
(2) You must check the “Observed, (Enter Remark)”
box and enter the reason (see §40.67(b)) in the “Remarks”
line (Step 2).
(f) In a case where two sets of specimens are being sent to the
laboratory because of suspected tampering with the specimen at
the collection site, enter on the “Remarks” line of
the CCF (Step 2) for each specimen a notation to this effect (e.g.,
collection 1 of 2, or 2 of 2) and the specimen ID number of the
(g) As the collector, you must ensure that the observer is the
same gender as the employee. You must never permit an opposite
gender person to act as the observer. The observer can be a different
person from the collector and need not be a qualified collector.
(h) As the collector, if someone else is to observe the collection
(e.g., in order to ensure a same gender observer), you must verbally
instruct that person to follow procedures at paragraphs (i) and
(j) of this section. If you, the collector, are the observer,
you too must follow these procedures.
(i) As the observer, you must watch the employee urinate into
the collection container. Specifically, you are to watch the urine
go from the employee’s body into the collection container.
(j) As the observer but not the collector, you must not take the
collection container from the employee, but you must observe the
specimen as the employee takes it to the collector.
(k) As the collector, when someone else has acted as the observer,
you must include the observer’s name in the “Remarks”
line of the CCF (Step 2).
(l) As the employee, if you decline to allow a directly observed
collection required or permitted under this section to occur,
this is a refusal to test.
(m) As the collector, when you learn that a directly observed
collection should have been collected but was not, you must inform
the employer that it must direct the employee to have an immediate
recollection under direct observation.
§40.69 How is a monitored collection conducted?
(a) As the collector, you must secure the room being used for
the monitored collection so that no one except the employee and
the monitor can enter it until after the collection has been completed.
(b) As the collector, you must ensure that the monitor is the
same gender as the employee, unless the monitor is a medical professional
(e.g., nurse, doctor, physician’s assistant, technologist,
or technician licensed or certified to practice in the jurisdiction
in which the collection takes place). The monitor can be a different
person from the collector and need not be a qualified collector.
(c) As the collector, if someone else is to monitor the collection
(e.g., in order to ensure a same-gender monitor), you must verbally
instruct that person to follow procedures at paragraphs (d) and
(e) of this section. If you, the collector, are the monitor, you
must follow these procedures.
(d) As the monitor, you must not watch the employee urinate into
the collection container. If you hear sounds or make other observations
indicating an attempt to tamper with a specimen, there must be
an additional collection under direct observation (see §§40.63(e),
40.65(c), and 40.67(b)).
(e) As the monitor, you must ensure that the employee takes the
collection container directly to the collector as soon as the
employee has exited the enclosure.
(f) As the collector, when someone else has acted as the monitor,
you must note that person’s name in the “Remarks”
line of the CCF (Step 2).
(g) As the employee being tested, if you decline to permit a collection
authorized under this section to be monitored, it is a refusal
§40.71 How does the collector prepare the specimens?
(a) All collections under DOT agency drug testing regulations
must be split specimen collections.
(b) As the collector, you must take the following steps, in order,
after the employee brings the urine specimen to you. You must
take these steps in the presence of the employee.
(1) Check the box on the CCF (Step 2) indicating that this was
a split specimen collection.
(2) You, not the employee, must first pour at least 30 mL of urine
from the collection container into one specimen bottle, to be
used for the primary specimen.
(3) You, not the employee, must then pour at least 15 mL of urine
from the collection container into the second specimen bottle
to be used for the split specimen.
(4) You, not the employee, must place and secure (i.e., tighten
or snap) the lids/caps on the bottles.
(5) You, not the employee, must seal the bottles by placing the
tamper-evident bottle seals over the bottle caps/lids and down
the sides of the bottles.
(6) You, not the employee, must then write the date on the tamper-evident
(7) You must then ensure that the employee initials the tamper-evident
bottle seals for the purpose of certifying that the bottles contain
the specimens he or she provided. If the employee fails or refuses
to do so, you must note this in the “Remarks” line
of the CCF (Step 2) and complete the collection process.
(8) You must discard any urine left over in the collection container
after both specimen bottles have been appropriately filled and
sealed. There is one exception to this requirement: you may use
excess urine to conduct clinical tests (e.g., protein, glucose)
if the collection was conducted in conjunction with a physical
examination required by a DOT agency regulation. Neither you nor
anyone else may conduct further testing (such as adulteration
testing) on this excess urine and the employee has no legal right
to demand that the excess urine be turned over to the employee.
§40.73 How is the collection process completed?
(a) As the collector, you must do the following things to complete
the collection process. You must complete the steps called for
in paragraphs (a)(1) through (a)(7) of this section in the employee’s
(1) Direct the employee to read and sign the certification statement
on Copy 2 (Step 5) of the CCF and provide date of birth, printed
name, and day and evening contact telephone numbers. If the employee
refuses to sign the CCF or to provide date of birth, printed name,
or telephone numbers, you must note this in the “Remarks”
line (Step 2) of the CCF, and complete the collection. If the
employee refuses to fill out any information, you must, as a minimum,
print the employee’s name in the appropriate place.
(2) Complete the chain of custody on the CCF (Step 5) by printing
your name (note: you may pre-print your name), recording the time
and date of the collection, signing the statement, and entering
the name of the delivery service transferring the specimen to
(3) Ensure that all copies of the CCF are legible and complete.
(4) Remove Copy 5 of the CCF and give it to the employee.
(5) Place the specimen bottles and Copy 1 of the CCF in the appropriate
pouches of the plastic bag.
(6) Secure both pouches of the plastic bag.
(7) Advise the employee that he or she may leave the collection
(8) To prepare the sealed plastic bag containing the specimens
and CCF for shipment you must:
(i) Place the sealed plastic bag in a shipping container (e.g.,
standard courier box) designed to minimize the possibility of
damage during shipment. (More than one sealed plastic bag can
be placed into a single shipping container if you are doing multiple
(ii) Seal the container as appropriate.
(iii) If a laboratory courier hand-delivers the specimens from
the collection site to the laboratory, prepare the sealed plastic
bag for shipment as directed by the courier service.
(9) Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You
must fax or otherwise transmit these copies to the MRO and DER
within 24 hours or during the next business day. Keep Copy 3 for
at least 30 days, unless otherwise specified by applicable DOT
(b) As a collector or collection site, you must ensure that each
specimen you collect is shipped to a laboratory as quickly as
possible, but in any case within 24 hours or during the next business
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