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.
[Org. Part 40, Nov. 21, 1988 as amended by Amdt. 40-1, 54 FR 49854, Dec. 1, 1989; Amdt. 40-2, 59 FR 7340, Feb. 15, 1994; Amdt. 40-10, 65 FR 79462, Dec. 19, 2000]