Appendix A to Part 40 — DOT Standards for Urine Collection Kits

The Collection Kit Contents

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 of 32–38 °C / 90–100 °F, that is affixed or can be affixed at the 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 ensures there is no potential for contamination of the specimen.

d. Must be individually wrapped in a sealed plastic bag or shrink wrap; or must have a peelable, sealed lid or another 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.

Plastic Specimen Bottles

a. Each bottle must be large enough to hold at least 35 mL; alternatively, two distinct sizes of specimen bottles may be used, 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 provided on the CCF fit without damaging the seal when the employee initials it, and without the chance that the seal overlap would conceal printed information.

e. Must be wrapped (with caps) together in a sealed plastic bag or shrink wrap, separate from the collection container; or must be wrapped (with caps) individually in sealed plastic bags or shrink wrap; or must have a peelable, sealed lid or another easily visible tamper-evident system.

f. Plastic material must be leach-resistant.

Leak-Resistant Plastic Bag

a. Must have two sealable compartments or pouches that 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.

Absorbent Material

Each kit must contain enough absorbent material to absorb the entire contents of both specimen bottles. The absorbent material must be designed to fit inside the leak-resistant plastic bag pouch into which the specimen bottles are placed.

Shipping Container

a. Must be designed to adequately protect the specimen bottles from damage during shipment 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 the actual kit sent to collection sites.

c. A shipping container is not necessary if a laboratory courier hand-delivers the specimen bottles in the leak-proof plastic bags from the collection site to the laboratory.