In an observed collection, the observer must be the same gender as the donor. If an observed collection must be made, and the collector is not the same gender as the donor, it is the responsibility of the collector to locate someone who is the same gender as the donor to act as the observer. If the collector is not the observer, the donor can not hand the specimen to the observer. It is, however, the responsibility of the observer to make sure the donor directly hands the specimen to the collector.

In an observed collection, the donor must raise and lower clothing and turn around to permit the observer to determine if a prosthetic or other device is present. The observer must physically watch the donor urinate into the collection container.

The collector must mark on the CCF that the collection was observed and state why in the Remarks section.

If the collector learns that a directly observed collection should have taken place, but did not, the collector must inform the employer that the donor must be directed to return for an immediate recollection under direct observation.