Directly observed collections must be performed in the following situations:
- The Medical Review Officer (MRO) reported that a donor's specimen was a negative-dilute with a creatinine concentration of greater than or equal to 2mg/dL but less than or equal to 5mg/dL.
- The testing facility reported that a donor had an invalid specimen and the MRO indicated that there was no valid medical explanation for the result.
- A split specimen test could not be performed because the split sample was lost or there was inadequate volume.
- The donor's specimen is required for a return-to-duty or follow-up test.
- The collector observed materials brought to the collection site by the donor, or the donor's conduct clearly indicated an attempt to, in some manner, tamper with the specimen to be tested.
- The temperature of the original specimen was out of range or the specimen appeared to be tampered with.