49 CFR §40.199

1. (a)As the MRO, when the laboratory discovers a “fatal flaw” during its processing of incoming specimens (see § 40.83), the laboratory will report to you that the specimen has been “Rejected for Testing” (with the reason stated). You must always cancel such a test.
2. (b)The following are “fatal flaws”:
   1. (1)There is no CCF;
   2. (2)In cases where a specimen has been collected, there is no specimen submitted with the CCF;
   3. (3)There is no printed collector's name and no collector's signature;
   4. (4)Two separate collections are performed using one CCF;
   5. (5)The specimen ID numbers on the specimen bottle and the CCF do not match;
   6. (6)The specimen bottle seal is broken or shows evidence of tampering (and a split specimen cannot be re-designated, see § 40.83(h)); or
   7. (7)Because of leakage or other causes, there is an insufficient amount of specimen in the primary specimen bottle for analysis and the specimens cannot be re-designated (see § 40.83(h)).
   8. (8)For an oral fluid collection, the collector used an expired device at the time of collection.
   9. (9)For an oral fluid collection, the collector failed to enter the expiration date in Step 4 of the CCF and the laboratory confirmed that the device was expired.
3. (c)You must report the result as provided in § 40.161.