Are Toilet “Hats” Mandatory for DOT Urine Specimen Collections?

Toilet “hats” are collection devices which aid the donor in providing a urine specimen for testing. They fit on the rim of the toilet and most provide pre-printed measuring lines to aid the donor in determining whether she has provided a sufficient specimen for testing. Individuals with limited range of motion and those who are considered medically obese benefit the most from these devices. In some of these circumstances, some argue that a toilet hat may be the only method available to obtain a sufficient specimen. With that argument in mind, federally regulated employers and their service agents should be asking the following questions:

Am I obligated or required to have such devices on-hand?

The supplies a collection site needs to have in order to conduct a urine specimen collection under DOT protocols are discussed in 49 CFR Part 40.43 and 40.49 (which references Appendix A, an exhaustive list of the supplies necessary for urine collection). Neither of these parts nor their corresponding “Questions and Answers” reference the need for the collection site to provide a “hat” or another type of assistive device. We reached out to the Office of Drug and Alcohol Policy and Compliance (ODAPC) to determine what their official position is regarding “hats” and whether they have issued any other interpretive guidance on the subject. In a phone interview, Bob Ashby, Deputy Assistant General Counsel for Regulation and Enforcement at ODAPC indicated that there was not official guidance nor an opinion letter issued, but he did indicate the following:

  • Though not specifically addressed in the regulations, collectors may use hats if they are single-use and come in sterile containers.
  • Though not required, it would seem to make sense to have at least a few hats on-hand at all times. If an employer is aware that one or more of her employees will need a hat to provide a specimen, she should have them available.
  • If a donor arrives at the site and it becomes apparent that a hat will be necessary for a fair test, the reason for testing should inform the collector and Designated Employer Representative’s subsequent action:
    • Pre-Employment & Return to Duty: Since these tests are not as time-sensitive, if an employee arrives at the collection site and will require a hat to provide a sufficient specimen, the collection site/employer may arrange for the acquisition of a hat if one is not readily available.
    • Post-Accident/Follow-Up: These testing scenarios are more time-sensitive than Pre-Employment and Return to Duty, but the regulations do provide a few hours to complete the collection, so collectors or employers should make a reasonable effort to acquire a hat for an employee who needs one.
    • Random, Reasonable Suspicion: These are the tough scenarios. These tests should be completed as soon as practicable without delay. This means that there would not be much of a choice for the employer or collector without immediate access to a hat except making the attempt without one. If, after the allotted time period, the donor is unable to provide a specimen, then the collector should note on the CCF that the individual was, for medical/anatomical reasons, unable to provide a specimen. The effect would essentially be a canceled test and would need to be rescheduled for a time as soon as a hat could become available.

Ashby also discussed the role of a Medical Review Officer (MRO) in the process and whether it should be the MRO’s responsibility to determine the medical necessity of the hat. The first issue is that the MRO won’t be involved unless there is an insufficient specimen provided. Even then, the issue is that the MRO’s role with respect to insufficient specimens is to determine whether there was a valid medical explanation for the donor’s inability to produce a specimen during the collection process rather than her inability to provide a specimen in the collection cup. When the question is framed around the donor’s inability to produce a specimen, the MRO will inevitably indicate that there was not a valid medical explanation. This means that the MRO can’t currently be relied upon for assistance with determining the need for hats or whether you should make a refusal determination if the donor is unable to provide one.

Even with guidance from ODAPC, the answer still isn’t exactly cut and dry. For example, if not the MRO, who should make the determination of whether the employee has a legitimate medical need for a hat or whether the donor is simply using the unavailability of hats at a collection site as a means to delay her test? The collector is not trained to decide the medical or anatomical necessity for a toilet hat and neither is the employer. Either the employer or the collector can certainly use the facts available to them in order to make an educated guess as to the need for a hat, but an incorrect guess could result in either a wrongful termination/discrimination suit for failure to provide accommodation for a medical condition or a failure to detect an employee with a substance issue as a result of a delay in testing. Ideally, the employer would discover the necessity for a hat during a pre-employment test and ensure that hats be available for subsequent use. This may address several scenarios, but it is still probable that the need for a hat may arise at some point after the pre-employment test and during the course of employment.

The cost is another issue. Who should bear the burden of the cost to supply the hat? If the regulations don’t require the collector to have hats on hand, why would the collection site pay for them? Does this mean the employer should bear an additional cost for employees who need this kind of accommodation? Bob Ashby indicated that this is something that should be negotiated between the collection site and the employer.

Is it an employee’s right to have a toilet hat?

Based on the regulations alone, an employee would not have a “right” to an assistive hat device. However, 49 CFR Part 40.209 provides that an employee has a right to a fair and accurate test. If truly necessary, the lack of a hat would result in a refusal for an employee. As a result, there may be an argument that the employee’s right to a fair and accurate test would be violated. Refusals have severe adverse consequences for covered employees often including termination without the opportunity for rehire and being reported to the FMCSA Clearinghouse, making new job prospects even harder. However, there appears to be no major case law indicating how the court would rule in such a challenge. A company policy or collective bargaining agreement could also provide for an employee’s right to a toilet hat, though this kind of provision would be an extreme rarity.

If I had some “hats” to provide if asked for one, do they have to be sterile?

The regulations don’t explicitly require or prohibit the use of a hat, so the main question about its use is whether it affects the collector’s ability to maintain chain of custody and specimen integrity? When introducing any material that may come into contact with the specimen before it is sent to the lab the collector must be certain that there is no possible way it could adulterate or be said to have adulterated the specimen. This should include acquiring and utilizing sterile materials. This is likely why Bob Ashby at ODAPC has indicated that employers and collectors may use single-use hats that come in sterile containers.

A good rule to follow for employers and collectors is to stick as close as possible to what the regulations state and try not to deviate from them at all. However, this is a scenario that would lend itself to deviation. Though not explicitly required, providing single-use, sterile hats would not create liability that would potentially outweigh the risk of not using them. If an employer or collector does choose to provide a hat, they should treat the use of it as they would a collection kit from the laboratory. Have the donor wash her hands before coming into contact with it, have her select it from at least three to choose from, and have her verify that it is sealed before opening it for use.



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