§ 26.117 Preparing urine specimens for storage and shipping.
(a) Both the donor and the collector shall keep the donor's urine specimen(s) in view at all times before the specimen(s) are sealed and labeled. If any specimen or aliquot is transferred to another container, the collector shall ask the donor to observe the transfer and sealing of the container with a tamper-evident seal.
(b) Both the collector and the donor shall be present (at the same time) during the procedures outlined in this section.
(c) The collector shall place an identification label securely on each container. The label must contain the date, the donor's specimen number, and any other identifying information provided or required by the FFD program. The collector shall also apply a tamper-evident seal on each container if it is separate from the label. The specimen bottle must be securely sealed to prevent undetected tampering.
(d) The donor shall initial the identification label(s) on the specimen bottle(s) for the purpose of certifying that the specimen was collected from him or her. The collector shall also ask the donor to read and sign a statement on the custody-and-control form certifying that the specimen(s) identified as having been collected from the donor is, in fact, the specimen(s) that he or she provided.
(e) The collector shall complete the custody-and-control form(s) and shall certify proper completion of the collection.
(f) The specimens and chain-of-custody forms must be packaged for transfer to the HHS-certified laboratory or the licensee's testing facility. If the specimens are not immediately prepared for transfer, they must be appropriately safeguarded during temporary storage.
(g) While any part of the chain-of-custody procedures is being performed, the specimens and custody documents must be under the control of the involved collector. The collector may not leave the collection site during the interval between presentation of the specimen by the donor and securing of the specimens with identifying labels bearing the donor's specimen identification numbers and seals initialed by the donor. If the involved collector momentarily leaves his or her workstation, the sealed specimens and custody-and-control forms must be secured or taken with him or her. If the collector is leaving for an extended period of time, the specimens must be packaged for transfer to the HHS-certified laboratory or the licensee testing facility and secured before the collector leaves the collection site.
(h) The specimen(s) sealed in a shipping container must be immediately transferred, appropriately safeguarded during temporary storage, or kept under the personal control of an authorized individual until transferred. These minimum procedures apply to the transfer of specimens to licensee testing facilities from collection sites (except where co-located) as well as to the shipping of specimens to HHS-certified laboratories. As an option, licensees and other entities may ship several specimens via courier in a locked or sealed shipping container.
(i) Collection site personnel shall ensure that a custody-and-control form is packaged with its associated urine specimen bottle. Unless a collection site and a licensee testing facility are co-located, the sealed and labeled specimen bottles, with their associated custody-and-control forms that are being transferred from the collection site to the drug testing laboratory must be placed in a second, tamper-evident shipping container. The second container must be designed to minimize the possibility of damage to the specimen during shipment (e.g., specimen boxes, shipping bags, padded mailers, or bulk insulated shipping containers with that capability), so that the contents of the shipping containers are no longer accessible without breaking a tamper-evident seal.
(j) Collection site personnel shall arrange to transfer the collected specimens to the HHS-certified laboratory or the licensee testing facility. Licensees and other entities shall take appropriate and prudent actions to minimize false negative results from specimen degradation. Specimens that have not been shipped to the HHS-certified laboratory or the licensee testing facility within 24 hours of collection and any specimen that is suspected of having been substituted, adulterated, or tampered with in any way must be maintained cooled to not more than 6°C (42.8 °F) until they are shipped to the HHS-certified laboratory. Specimens must be shipped from the collection site to the HHS-certified laboratory or the licensee testing facility as soon as reasonably practical but, except under unusual circumstances, the time between specimen shipment and receipt of the specimen at the licensee testing facility or HHS-certified laboratory should not exceed 2 business days.
(k) Couriers, express carriers, and postal service personnel do not have direct access to the custody-and-control forms or the specimen bottles. Therefore, there is no requirement that such personnel document chain of custody on the custody-and-control forms during transit. Custody accountability of the shipping containers during shipment must be maintained by a tracking system provided by the courier, express carrier, or postal service.
[73 FR 17201 Mar. 31, 2008]