Joe was recruited to assist in a DOT direct observation urine specimen collection by the collector, Sally. She told Joe that he was supposed to “watch the urine leave the patient’s male anatomy.” However, during the process, Bill, the employee was belligerent and difficult. When Bill and Joe were alone in the bathroom, Bill filled the cup to the line and handed the cup to Joe so he could pull his pants up. Later, Bill said that Joe and Sally didn’t follow protocol because the cup was supposed to be held by the donor the entire time. Did Joe and Sally breach protocol by holding the cup for the donor while still in the restroom?
For those unfamiliar with observed collections, this scenario is referencing the procedure outlined in 49 CFR Part 40.67(k) which states, “[a]s the observer but not the collector, you must not take the collection container from the employee, but you must observe the specimen as the employee takes it to the collector.” The protocol is that the observer, if not the collector, does not come into contact with the specimen directly.
Before getting to the answer to the question, it is important to address ways to help prevent this situation from occurring in the first place. If the donor was being belligerent in any other step of the process, the first step would be for the collector, Sally, to warn Bill, the donor, that ignoring instructions and being belligerent will be considered a refusal and that she will have to stop the test if he continues to maintain non-compliance. This warning is expressly discussed in 49 CFR Part 40.191(a)(8) wherein employees are deemed to have refused if they “[f]ail to cooperate with any part of the testing process (e.g., refuse to empty pockets when directed by the collector, behave in a confrontational way that disrupts the collection process, fail to wash hands after being directed to do so by the collector).” This was also explained in the July, 2006 Frequently Asked Questions update from ODAPC; they recommend “[w]hen the issue is a problem with refusing to following instructions – for example, refusing to empty pockets or refusing to wash hands – or if there is a confrontation, the collector should warn the employee of potential consequences of a failure to cooperate; and if practical, seek assistance from the DER or supervisor to ensure that the employee understands the ramifications.”
In addition, 40.191(a)(9) speaks directly to direct observation refusals indicating a refusal when employees, “fail to follow the observer’s instructions to raise your clothing above the waist, lower clothing, and underpants, and to turn around to permit the observer to determine if [they] have any type of prosthetic or other devices that could be used to interfere with the collection process.”
Following these recommendations would have put Bill, the employee, on notice of the possible refusal and the resulting consequences.
The second step would be for the collector to ensure that Joe, as the observer, was properly trained on the procedure and to ensure that nothing he did or didn’t do could interfere with the test. The facts indicate that Joe may not have been properly trained if all the collector told him to do was “watch the urine leave the patient’s male anatomy.” However, even if Joe were properly trained as discussed in this course, there is still a chance that the donor would have given him no choice but to grab the cup to avoid spilling it. Had there been a proper explanation to both Bill and Joe regarding the rules for a direct observation, then this kind of behavior could be immediately considered a refusal.
Under these facts, Bill would be right in stating that Sally and Joe didn’t follow protocol. The regulations clearly state that the observer must not take the collection container from the employee. The real question is, is the violation the kind that will result in a canceled test? There are no facts to suggest that the specimen was ever out of the donor’s sight or that the observer had an opportunity to adulterate the specimen. If there was, the issue would likely have been raised immediately. In this scenario, the facts only state that Bill made his allegations “later” meaning likely that the donor didn’t raise the issue until after the collection was complete and the results were reported.
The next question is: how much do ODAPC and the DOT care about this particular type of flaw? It isn’t listed under the problems that cause a drug test to be canceled in 49 CFR Part 40.199, 40.201, or 40.203. This leaves us to look for guidance under 49 CFR part 40.209(a) which states, “[a]s a collector . . . or other person administering the drug testing process, you must document any errors in the testing process of which you become aware, even if they are not considered problems that will cause a test to be cancelled as listed in this subpart. Decisions about the ultimate impact of these errors will be determined by other administrative or legal proceedings, subject to the limitations of paragraph (b) of this section.”
Since this particular error is not listed in any other section of the 49 CFR Part 40, it would be up to Joe and Sally to document the error. The donor may raise the error in a complaint to the DOT which may, or likely may not, initiate administrative proceedings against them. 49 CFR Part 40(b) goes on to limit the consequences for minor mistakes that don’t affect an employee’s right to a fair test, “[n]o person concerned with the testing process may declare a test canceled based on an error that does not have a significant adverse effect on the right of the employee to have a fair and accurate test.” If the specimen was not adulterated and had no opportunity to be switched, or broke chain of custody in any other way, then there could not have been a significant adverse effect on Bill’s right to a fair and accurate test.
Based on the facts provided, there was certainly an error in the process, but it didn’t affect the employee’s right to a fair and accurate test so the test could not be canceled as a result. However, there is still a possibility that the donor could report the issue to the DOT and that they could initiate administrative proceedings against Joe and Sally. Though the likelihood of an administrative proceeding is extremely slim.