What steps must operators of collection sites and collectors take to protect the security and integrity of oral fluid collections?

§ 40.48 What steps must operators of collection sites and collectors take to protect the security and integrity of oral fluid collections? (a) Collectors and operators of collection sites must take the steps listed in this section to prevent unauthorized access that could compromise the integrity of collections. (b) As a collector, you must do the following before each collection to deter tampering with specimens: (1) Ensure that access to collection materials and specimens is effectively restricted; (2) Ensure that undetected access ( e.g., through a door not in your view) is not possible; and (3) Ensure the security of the facility during the collection process to maintain privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted. (c) As a collector, you must take the following additional steps to ensure security during the collection process: (1) To avoid distraction that could compromise security, you are limited to conducting a collection for only one employee at a time. However, during the time one employee is in the period for drinking fluids in a “dry mouth” situation ( see § 40.72(b)(1)), you may conduct a collection for another employee as long as the employee with “dry mouth” remains supervised. (2) To the greatest extent practicable, keep an employee's collection container within view of both you and the employee between the time the employee has provided the oral fluid specimen and the specimen is sealed. (3) Ensure you are the only person in addition to the employee who handles the specimen before it is sealed with tamper-evident seals. (4) In the time between when the employee gives you the specimen and when you seal the specimen, remain within the collection site. (5) Maintain personal control over each specimen and CCF throughout the collection process. (d) If you are operating a collection site, you must implement a policy and procedures to prevent unauthorized personnel from entering any part of the site in which oral fluid specimens are collected or stored. (1) Only employees being tested, collectors and other collection site workers, DERs, employee and employer representatives authorized by the employer ( e.g., employer policy, collective bargaining agreement), and DOT agency representatives are authorized persons for purposes of this paragraph (d). (2) You must ensure that all authorized persons are under the supervision of a collector at all times when permitted into the site. (3) You or the collector may remove any person who obstructs, interferes with, or causes a delay in the collection process. (e) If you are operating a collection site, you must minimize the number of persons handling specimens. [88 FR 27640, May 2, 2023]