§ 26.159 Assuring specimen security, chain of custody, and preservation.
(a) The HHS-certified laboratories performing services for licensees and other entities under this part shall be secure at all times. Each laboratory shall have in place sufficient security measures to control access to the premises and to ensure that no unauthorized personnel handle specimens or gain access to the laboratory processes or areas where records are stored. Access to these secured areas must be limited to specially authorized individuals whose authorization is documented. All authorized visitors, and maintenance and service personnel, shall be escorted at all times in the laboratory, except personnel who are authorized to conduct inspections and audits on behalf of licensees, other entities, the NRC, or the HHS Secretary, and emergency personnel (including but not limited to firefighters and medical rescue teams).
(b) When a shipment of specimens is received, laboratory personnel shall inspect each package for evidence of possible tampering and shall compare information on specimen bottles within each package to the information on the accompanying custody-and-control forms.
(1) Any direct evidence of tampering or discrepancies in the information on the specimen bottles and the custody-and-control forms attached to the shipment must be reported to the licensee or other entity within 24 hours of the discovery and must be noted on the custody-and-control forms for each specimen contained in the package. When notified, the licensee or other entity shall ensure that an investigation is initiated to determine whether tampering has occurred.
(i) If the investigation determines that tampering has occurred, the licensee or other entity shall ensure that corrective actions are taken.
(ii) If the licensee or other entity has reason to question the integrity and identity of the specimens, the specimens may not be tested and the licensee or other entity shall ensure that another collection occurs as soon as reasonably practical, except if a split specimen collection was performed, either the Bottle A or Bottle B seal remains intact, and the intact specimen contains at least 15 mL of urine. In this instance, if the licensee testing facility has retained the specimen in Bottle B, the licensee testing facility shall forward the intact specimen for testing to the HHS-certified laboratory and may not conduct any testing at the licensee testing facility.
(2) The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen:
(i) The custody-and-control form does not contain information to identify the specimen collector and the collection site cannot provide conclusive evidence of the collector's identity;
(ii) The identification numbers on the specimen bottle seal(s) do not match the identification numbers on the custody-and-control form;
(iii) A specimen bottle seal is broken or shows evidence of tampering and an intact specimen, as specified in paragraph (b)(1)(ii) of this section, does not exist;
(iv) The specimen appears to have leaked out of its sealed bottle and there is less than 15 mL remaining, and an intact specimen, as specified in paragraph (b)(1)(ii) of this section, does not exist; or
(v) As required under § 26.165(f)(2).
(c) The HHS-certified laboratory shall retain specimen bottles within the laboratory's accession area until all analyses have been completed. Laboratory personnel shall use aliquots and laboratory internal custody-and-control forms when conducting initial and confirmatory tests. The original specimen and the original custody-and-control form must remain in secure storage.
(d) The laboratory's internal custody-and-control form must allow for identification of the donor, and documentation of the testing process and transfers of custody of the specimen.
(e) Each time a specimen is handled or transferred within the laboratory, laboratory personnel shall document the date and purpose on the custody-and-control form and every individual in the chain shall be identified. Authorized technicians are responsible for each urine specimen or aliquot in their possession and shall sign and complete custody-and-control forms for those specimens or aliquots as they are received.
(f) If a specimen is to be transferred to a second HHS-certified laboratory, laboratory personnel shall ensure that a copy of the custody-and-control form is packaged with the aliquot of a single specimen or Bottle B of a split specimen, as appropriate. Sealed and labeled specimen bottles and aliquots, with their associated custody-and-control forms, being transferred from one laboratory to another must be placed in a second, tamper-evident shipping container designed to minimize the possibility of damage to the specimen during shipment (e.g., specimen boxes, padded mailers, or bulk insulated shipping containers with that capability) so that the contents of the shipping containers are inaccessible without breaking a tamper-evident seal.
(g) Couriers, express carriers, and postal service personnel do not have direct access to the custody-and-control forms or the specimen bottles. Therefore, such personnel are not required to 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.
(h) Specimens that do not receive an initial test within 7 days of arrival at the laboratory must be placed in secure refrigeration units for short-term storage. Temperatures may not exceed 6 °C (42.8 °F). The laboratory shall ensure proper storage conditions in the event of a prolonged power failure.
(i) Long-term frozen storage at a temperature of –20 °C (–68 °F) or less ensures that positive, adulterated, substituted, and invalid urine specimens and Bottle B of a split specimen will be available for any necessary retests. Unless otherwise authorized in writing by the licensee or other entity, laboratories shall retain and place in properly secured long-term frozen storage all specimens reported as positive, adulterated, substituted, or invalid. At a minimum, such specimens must be stored for 1 year. Within this 1-year period, a licensee, other entity, or the NRC may ask the laboratory to retain the specimen for an additional period of time. If no retention request is received, the laboratory may discard the specimen after the end of 1 year. However, the laboratory shall retain any specimens under review or legal challenge until they are no longer needed.
(j) The laboratory shall discard a valid specimen that tests negative on initial or confirmatory drug tests or may pool such specimens for use in the laboratory's internal quality control program after certifying that the specimens are negative and valid. The laboratory may not retain any information linking donors to specimens that are pooled for use in the internal quality control program.
[73 FR 17210 Mar. 31, 2008]