(a) HHS-certified laboratories shall develop, implement, and maintain clear and well-documented procedures for accession, receipt, shipment, and testing of urine specimens.
(b) Written chain-of-custody procedures must describe the methods to be used to maintain control and accountability of specimens from receipt through completion of testing and reporting of results, during storage and shipping to another HHS-certified laboratory, if required, and continuing until final disposition of specimens.
(c) HHS-certified laboratories shall develop, implement, and maintain a written manual of standard operating procedures for each assay performed for licensees and other entities for drug and specimen validity testing. The procedures must include, but are not limited to, detailed descriptions of -
(1) The principles of each test;
(2) Preparation of reagents, standards, and controls;
(3) Calibration procedures;
(4) Derivation of results;
(5) Linearity of methods;
(6) Sensitivity of the methods;
(7) Cutoff values;
(8) Mechanisms for reporting results;
(9) Controls;
(10) Criteria for unacceptable specimens and results;
(11) Reagents and expiration dates; and
(12) References.
(d) HHS-certified laboratories shall develop, implement, and maintain written procedures for instrument setup and normal operation, including the following:
(1) A schedule for checking critical operating characteristics for all instruments;
(2) Tolerance limits for acceptable function checks; and
(3) Instructions for major troubleshooting and repair.
(e) HHS-certified laboratories shall develop, implement, and maintain written procedures for remedial actions to be taken when errors are detected or systems are out of acceptable limits.
The laboratory shall maintain documentation that its personnel follow these procedures and take all necessary corrective actions. In addition, the laboratory shall have systems in place to verify all stages of testing and reporting and to document the verification.