| Next >>
Subpart D - Collection Sites, Forms, Equipment and Supplies
Used in DOT Urine Collections
§40.41 Where does a urine collection for a DOT
drug test take place?
(a) A urine collection for a DOT drug test must take place in
a collection site meeting the requirements of this section.
(b) If you are operating a collection site, you must ensure that
it meets the security requirements of §40.43.
(c) If you are operating a collection site, you must have all
necessary personnel, materials, equipment, facilities and supervision
to provide for the collection, temporary storage, and shipping
of urine specimens to a laboratory, and a suitable clean surface
(d) Your collection site must include a facility for urination
described in either paragraph (e) or paragraph (f) of this section.
(e) The first, and preferred, type of facility for urination that
a collection site may include is a single-toilet room, having
a full-length privacy door, within which urination can occur.
(1) No one but the employee may be present in the room during
the collection, except for the observer in the event of a directly
(2) You must have a source of water for washing hands, that, if
practicable, should be external to the closed room where urination
occurs. If an external source is not available, you may meet this
requirement by securing all sources of water and other substances
that could be used for adulteration and substitution (e.g., water
faucets, soap dispensers) and providing moist towelettes outside
the closed room.
(f) The second type of facility for urination that a collection
site may include is a multistall restroom.
(1) Such a site must provide substantial visual privacy (e.g.,
a toilet stall with a partial-length door) and meet all other
applicable requirements of this section.
(2) If you use a multi-stall restroom, you must either --
(i) Secure all sources of water and other substances that could
be used for adulteration and substitution (e.g., water faucets,
soap dispensers) and place bluing agent in all toilets or secure
the toilets to prevent access; or
(ii) Conduct all collections in the facility as monitored collections
(see §40.69 for procedures). This is the only circumstance
in which you may conduct a monitored collection.
(3) No one but the employee may be present in the multistall restroom
during the collection, except for the monitor in the event of
a monitored collection or the observer in the event of a directly
(g) A collection site may be in a medical facility, a mobile facility
(e.g., a van), a dedicated collection facility, or any other location
meeting the requirements of this section.
§40.43 What steps must operators of collection sites
take to protect the security and integrity of urine collections?
(a) Collectors and operators of collection sites must take the
steps listed in this section to prevent unauthorized access that
could compromise the integrity of collections.
(b) As a collector, you must do the following before each collection
to deter tampering with specimens:
(1) Secure any water sources or otherwise make them unavailable
to employees (e.g., turn off water inlet, tape handles to prevent
(2) Ensure that the water in the toilet is blue;
(3) Ensure that no soap, disinfectants, cleaning agents, or other
possible adulterants are present;
(4) Inspect the site to ensure that no foreign or unauthorized
substances are present;
(5) Tape or otherwise secure shut any movable toilet tank top,
or put bluing in the tank;
(6) Ensure that undetected access (e.g., through a door not in
your view) is not possible;
(7) Secure areas and items (e.g., ledges, trash receptacles, paper
towel holders, under-sink areas) that appear suitable for concealing
(8) Recheck items in paragraphs (b)(1) through (7) of this section
following each collection to ensure the site’s continued
(c) If the collection site uses a facility normally used for other
purposes, like a public rest room or hospital examining room,
you must, as a collector, also ensure before the collection that:
(1) Access to collection materials and specimens is effectively
(2) The facility is secured against access during the procedure
to ensure privacy to the employee and prevent distraction of the
collector. Limited-access signs must be posted.
(d) As a collector, you must take the following additional steps
to ensure security during the collection process:
(1) To avoid distraction that could compromise security, you are
limited to conducting a collection for only one employee at a
time. However, during the time one employee is in the period for
drinking fluids in a "shy bladder" situation (see §40.193(b)),
you may conduct a collection for another employee.
(2) To the greatest extent you can, keep an employee’s collection
container within view of both you and the employee between the
time the employee has urinated and the specimen is sealed.
(3) Ensure you are the only person in addition to the employee
who handles the specimen before it is poured into the bottles
and sealed with tamper-evident seals.
(4) In the time between when the employee gives you the specimen
and when you seal the specimen, remain within the collection site.
(5) Maintain personal control over each specimen and CCF throughout
the collection process.
(e) If you are operating a collection site, you must implement
a policy and procedures to prevent unauthorized personnel from
entering any part of the site in which urine specimens are collected
(1) Only employees being tested, collectors and other collection
site workers, DERs, employee and employer representatives authorized
by the employer (e.g., employer policy, collective bargaining
agreement), and DOT agency representatives are authorized persons
for purposes of this paragraph (e).
(2) Except for the observer in a directly observed collection
or the monitor in the case of a monitored collection, you must
not permit anyone to enter the urination facility in which employees
(3) You must ensure that all authorized persons are under the
supervision of a collector at all times when permitted into the
(4) You or the collector may remove any person who obstructs,
interferes with, or causes a delay in the collection process.
(f) If you are operating a collection site, you must minimize
the number of persons handling specimens.
§40.45 What form is used to document a DOT urine
(a) The Federal Drug Testing Custody and Control Form (CCF) must
be used to document every urine collection required by the DOT
drug testing program. The CCF must be a five-part carbonless manifold
form. You may view this form on the Department's web site (http://www.dot.gov/ost/dapc/)
or the HHS web site (http://www.health.org/samhsa.gov).
(b) You must not use a non-Federal form or an expired Federal
form to conduct a DOT urine collection. As a laboratory, C/TPA
or other party that provides CCFs to employers, collection sites,
or other customers, you must not provide copies of an expired
Federal form to these participants. You must also affirmatively
notify these participants that they must not use an expired Federal
form (e.g., that beginning August 1, 2001, they may not use the
old 7-part Federal CCF for DOT urine collections).
(c) As a participant in the DOT drug testing program, you are
not permitted to modify or revise the CCF except as follows:
(1) You may include, in the area outside the border of the form,
other information needed for billing or other purposes necessary
to the collection process.
(2) The CCF must include the names, addresses, telephone numbers
and fax numbers of the employer and the MRO, which may be preprinted,
typed, or handwritten. The MRO information must include the specific
physician’s name and address, as opposed to only a generic
clinic, health care organization, or company name. This information
is required, and it is prohibited for an employer, collector,
service agent or any other party to omit it. In addition, a C/TPA’s
name, address, fax number, and telephone number may be included,
but is not required. The employer may use a C/TPA’s address
in place of its own, but must continue to include its name, telephone
number, and fax number.
(3) As an employer, you may add the name of the DOT agency under
whose authority the test occurred as part of the employer information.
(4) As a collector, you may use a CCF with your name, address,
telephone number, and fax number preprinted, but under no circumstances
may you sign the form before the collection event.
(d) Under no circumstances may the CCF transmit personal identifying
information about an employee (other than a social security number
(SSN) or other employee identification (ID) number) to a laboratory.
(e) As an employer, you may use an equivalent foreign-language
version of the CCF approved by ODAPC. You may use such a non-English
language form only in a situation where both the employee and
collector understand and can use the form in that language.
§40.47 May employers use the CCF for non-DOT collections
or non-Federal forms for DOT collections?
(a) No, as an employer, you are prohibited from using the CCF
for non-DOT urine collections. You are also prohibited from using
non-Federal forms for DOT urine collections. Doing either subjects
you to enforcement action under DOT agency regulations.
(b) (1) In the rare case where the collector, either by mistake
or as the only means to conduct a test under difficult circumstances
(e.g., post-accident or reasonable suspicion test with insufficient
time to obtain the CCF), uses a non-Federal form for a DOT collection,
the use of a non-Federal form does not present a reason for the
laboratory to reject the specimen for testing or for an MRO to
cancel the result.
(2) The use of the non-DOT form is a “correctable flaw.”
As an MRO, to correct the problem you must follow the procedures
§40.49 What materials are used to collect urine
For each DOT drug test, you must use a collection kit meeting
the requirements of Appendix A of this part.
§40.51 What materials are used to send urine specimens
to the laboratory?
(a) Except as provided in paragraph (b) of this section, you must
use a shipping container that adequately protects the specimen
bottles from shipment damage in the transport of specimens from
the collection site to the laboratory.
(b) You are not required to use a shipping container if a laboratory
courier hand-delivers the specimens from the collection site to
| Next >>