Failure to Observe: Resolving Unobserved Follow Up Plan DOT Urine Collections

You have a DOT employee who has been part of a follow-up testing program mandated by the Substance Abuse Professional (SAP) for several months and all seems to be going fine, the results are coming back negative and the employee appears to be on track in recovery. However, one day you discover that the four collections that you have done so far were not conducted under direct observation as mandated by the regulations, and many of them were conducted by collectors of the opposite gender. What do you do? Are these tests canceled and/or invalid? Do you have to redo all of these tests?

Employee Right to Fair Tests and Cancellation

First and most importantly, the test results are not invalidated just because of a failure to conduct them under direct observation. Take note that 49 CFR Part 40.209(b) provides that “[m]atters that do not result in the cancellation of a test include, but are not limited to, the following: . . . [t]he failure to directly observe or monitor a collection that the rule requires or permits to be directly observed or monitored, or the unauthorized use of direct observation or monitoring for a collection. . . .”[1] Though these tests are not canceled, the employer and its service agents now must subsequently complete the directly observed collections per the follow-up testing plan schedule.[2] Those tests, absent other errors, are still valid, but not for the follow-up testing plan, and have not counted toward meeting the requirements of the SAP plan.[3]

You and the employer may yet have a problem with a DOT agency auditor/inspector for having failed to properly complete this procedure, but the regulations are clear that this kind of failure in training/communication should not adversely affect the employee’s right to fair tests,[4] as he has otherwise complied with everything that was asked of him. If they were indeed conducted under direct observation by a person of the opposite gender, there would appear to be an invasion of privacy issue,[5] but it would still not invalidate the test for the employee. The United States Department of Transportation was clear that they did not want the employee to have to suffer for the errors of the employer/service agent in these situations.[6]

The Role of the MRO and Service Agents

Most errors on the Federal Custody and Control Form (CCF) can be discovered by the MRO or the MRO team member[7] in a cursory review.[8] For example, if “Follow Up” is checked as the reason for testing on Step 1 of the form, but “Observed” is not checked in Step 2. Though it is a responsibility of the MRO under Part 40.127 to “Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require [the MRO] to initiate corrective action or to cancel the test (see §§40.199 and 40.203),”[9] the MRO doesn’t always catch everything and at the very least needs to have some indication that something is amiss to identify an error. For example, if the collection was marked “Random” but was supposed to be marked as a “Follow Up” test, there is no method for the MRO to know there was any error whatsoever. This becomes a challenge when there is an apparent gender mismatch for what should be a directly observed test. In such an instance, in order to identify the applicable errors, the MRO must extrapolate the following:

1. The MRO must note that “follow up” was checked;
2. The MRO must note that, though “observed” was not checked, the collection should have been observed based on the reason, but may not have been;[10]
3. The MRO must would then need to investigate whether the observer was the same gender as the Donor.[11] There is nothing to indicate the collector’s gender on the form except the name in Step 4, so the MRO must rely on any remarks provided in the “Remarks” section of Step 2[12] and whether the name appears to be masculine or feminine in order to match the Donor’s gender–a challenge which is often riddled with ambiguity. If there is a question of whether the genders match and this is the only issue found on the form, in my experience, a little more than half of the MROs will assume the collector did the right thing and not require further clarification as there is no technically discovered error. For example, the collector is named “Alex” which could imply male or female genders and the form is otherwise accurate, (meaning no cognizable error is on the form to justify an affidavit or clarification from the collector), then the MRO would not take any further action; however, if the Donor’s name is Geoff and the collector’s name is Cynthia, without any additional remarks indicating a male observer, the MRO will have enough reason to believe a flaw may have occurred and will contact the collector to investigate further).[13]