What must be done if a direct observed collection is required?

When a direct observed collection is required, it is essential for the collector to properly document the process to maintain adherence to the required protocols. Checking the "Observed" box indicates that an observation was carried out during the collection process. Entering a reason in the remarks line serves as an important clarification for regulatory compliance and record-keeping. Documenting these details ensures that there is a clear understanding of why the observation took place, thus enhancing the integrity of the testing process and providing transparency.

This practice not only solidifies the validity of the collection but also helps in cases where the results might be challenged. It provides a clear audit trail for any future inquiries into how the collection was handled. Therefore, both checking the "Observed" box and entering a reason in the remarks are critical components of the procedure when a direct observed collection is mandated.