Appendix A to Part 40 - DOT Standards for Urine Collection Kits
49:1.0.1.1.30.20.43.1.28 : Appendix A
Appendix A to Part 40 - DOT Standards for Urine Collection Kits The
Collection Kit Contents
1. Collection Container
a. Single-use container, made of plastic, large enough to easily
catch and hold at least 55 mL of urine voided from the body.
b. Must have graduated volume markings clearly noting levels of
45 mL and above.
c. Must have a temperature strip providing graduated temperature
readings 32-38 °C/90-100 °F, that is affixed or can be affixed at a
proper level on the outside of the collection container. Other
methodologies (e.g., temperature device built into the wall
of the container) are acceptable provided the temperature
measurement is accurate and such that there is no potential for
contamination of the specimen.
d. Must be individually wrapped in a sealed plastic bag or
shrink wrapping; or must have a peelable, sealed lid or other
easily visible tamper-evident system.
e. May be made available separately at collection sites to
address shy bladder situations when several voids may be required
to complete the testing process.
2. Plastic Specimen Bottles
a. Each bottle must be large enough to hold at least 35 mL; or
alternatively, they may be two distinct sizes of specimen bottles
provided that the bottle designed to hold the primary specimen
holds at least 35 mL of urine and the bottle designed to hold the
split specimen holds at least 20 mL.
b. Must have screw-on or snap-on caps that prevent seepage of
the urine from the bottles during shipment.
c. Must have markings clearly indicating the appropriate levels
(30 mL for the primary specimen and 15 mL for the split) of urine
that must be poured into the bottles.
d. Must be designed so that the required tamper-evident bottle
seals made available on the CCF fit with no damage to the seal when
the employee initials it nor with the chance that the seal overlap
would conceal printed information.
e. Must be wrapped (with caps) together in a sealed plastic bag
or shrink wrapping separate from the collection container; or must
be wrapped (with cap) individually in sealed plastic bags or shrink
wrapping; or must have peelable, sealed lid or other easily visible
tamper-evident system.
f. Plastic material must be leach resistant.
3. Leak-Resistant Plastic Bag
a. Must have two sealable compartments or pouches which are
leak-resistant; one large enough to hold two specimen bottles and
the other large enough to hold the CCF paperwork.
b. The sealing methodology must be such that once the
compartments are sealed, any tampering or attempts to open either
compartment will be evident.
4. Absorbent material
Each kit must contain enough absorbent material to absorb the
entire contents of both specimen bottles. Absorbent material must
be designed to fit inside the leak-resistant plastic bag pouch into
which the specimen bottles are placed.
5. Shipping Container
a. Must be designed to adequately protect the specimen bottles
from shipment damage in the transport of specimens from the
collection site to the laboratory (e.g., standard courier
box, small cardboard box, plastic container).
b. May be made available separately at collection sites rather
than being part of an actual kit sent to collection sites.
c. A shipping container is not necessary if a laboratory courier
hand-delivers the specimen bottles in the plastic leak-proof bags
from the collection site to the laboratory.