Licensee testing facilities shall develop, implement, and maintain clear and well-documented procedures for accession, shipment, and testing of urine specimens.

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 the HHS-certified laboratory, and continuing until final disposition of the specimens.

Licensee testing facilities shall develop, implement, and maintain written standard operating procedures for each assay performed for drug and specimen validity testing. If a licensee testing facility performs validity screening tests, the licensee testing facility shall develop, implement, and maintain written standard operating procedures for each test. The procedures must include, but are not limited to, detailed descriptions of—

The principles of each test;

Preparation of reagents, standards, and controls;

Calibration procedures;

Derivation of results;

Linearity of the methods;

Sensitivity of the methods;

Cutoff values;

Mechanisms for reporting results;

Controls;

Criteria for unacceptable specimens and results;

Reagents and expiration dates; and

References.

Licensee testing facilities shall develop, implement, and maintain written procedures for instrument and test setup and normal operation, including the following:

A schedule for checking critical operating characteristics for all instruments and validity screening tests;

Tolerance limits for acceptable function checks; and

Instructions for major troubleshooting and repair.

Licensee testing facilities shall develop, implement, and maintain written procedures for remedial actions to be taken when systems, and instrumented and non-instrumented tests are out of acceptable limits or errors are detected. Each facility shall maintain documentation that these procedures are followed and that all necessary corrective actions are taken. In addition, each facility shall have systems in place to verify all stages of testing and reporting and to document the verification.