The 5 page federal CCF must always be used: (b) (1) In the rare case where the collector, either by mistake or as the only means to conduct a test under difficult circumstances (e.g., post-accident or reasonable suspicion test with insufficient time to obtain the CCF), uses a non-Federal form for a DOT collection, the use of a non-Federal form does not present a reason for the laboratory to reject the specimen for testing or for an MRO to cancel the result. (2) The use of the non-Federal form is a “correctable flaw.” As an MRO, to correct the problem you must follow the procedures of §40.205(b)(2).
Explanation
Washing hands AFTER the collection has nothing to do with the integrity of the process
The "suspicious" specimen with temperature out-of-range needs to be sent to the lab and noted accordiingly
Refusing to wash hands before providing specimen is considered a refusal to test.
If you make a mistake in the collection process that causes a test to be cancelled (i.e., a fatal or uncorrected flaw), you must undergo error correction training. This training must occur within 30 days of the date you are notified of the error that led to the need for retraining.
When the temp is out of range, both specimens are sent to the lab- both the temp-out-of-range specimen and the second observed collection.
For "monitored" collections, it is acceptable for a medical professional to be of different gender. For "direct observation" collections, the observer MUST be of the same gender without exception.
The donor must give the specimen to the collector. The third party must not handle the specimen.
If collector only forgets printed name OR signature it is correctable...if both then it is fatal flaw.
If the donor refuses to initial the seal, it must be noted in the remarks section, but it is not a refusal to test.
Refusing to sign COC or to initial specimen vials does not constitute a refusal to test...but this must be notated on the chain of custody remarks
Collectors must maintain documentation that they currently meet the training requirements, but they are not required to have this documentation on their person. They must be able to produce this documentation to DOT officials in a reasonable amount of time.
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