April 9, 2001
Mr. Kenneth Edgell
Acting Director
Office of Drug and Alcohol Policy and Compliance
U.S. Dept. of Transportation
400 Seventh St., S.W.
Washington, DC 20590
Dear Ken:
Since the Department of Transportation (DOT) has indicated that they will be issuing technical amendments to its CFR 49 Part 40 regulations to become effective August 1, 2001, I’d like to pose some important questions to you that I have encountered during DATIA’s training sessions on the new regulations. These questions continue to surface and seem to be causing much confusion within the industry, as well as concern given that the Public Interest Exclusion is in effect. I believe that they can be properly addressed in the amendments, which will ensure that the CFR 49 Part 40 regulations are properly executed.
1. The first issue addresses collector proficiency demonstrations. The required training and proficiency demonstrations are outlined in 40.33 along with the requirements for the monitor of the proficiency demonstrations in 40.33 (c) (2). There is confusion as to whether the monitor needs to perform the required proficiency demonstrations as well, and if so who is to monitor the monitor? The consensus that DATIA has received is that if the monitor also performs collections and meets the requirements that DOT has set forth to be able to determine if other collectors are performing collections in accordance with the regulations, then they should not also have to perform the proficiency demonstrations.
2. The regulations in 40.45 (b) (2) require that the employer’s phone and fax are included on the custody and control form (CCF), however, the CCF does not indicate this. Will the CCF be amended to indicate that this information is required? To ensure that all information required to be included on the CCF is actually included, DATIA suggests that the CCF be modified to include denoted spaces for the employer’s fax and phone number.
3. If the C/TPA is to receive the test results from the MRO, how is this indicated on the CCF? Can the CCF list the employer’s name and the C/TPA’s address, phone, and fax or must the MRO remember that the information is not to be sent to the employer’s
address/fax on the CCF but rather to the C/TPA? The most logical solution would be for the address and contact information on the CCF to be the actual entity that the MRO will need to contact with the test results. For record keeping purposes, the CCF should list the C/TPA name, the Employer name, and the C/TPA’s contact information.
4. The regulations indicate that one collector must handle a collection from start to finish. If a collector starts a collection that turns out to be a shy bladder situation, can the collector turn the collection over to another collector if no specimen has yet to be provided? In this instance, the specimen itself would still be handled by only one collector and should be allowed by the regulations.
5. Since Error Correction Training is required when a test is canceled, who is responsible for notifying the collection site of the canceled test since only collection sites that also operate as C/TPAs may receive test results? Should the MRO notify collection sites of canceled tests, or should this responsibility lie with the employer or C/TPA? Since the C/TPA/Employer would most likely be the ones to contract with a collection site, this information would be beneficial for the C/TPA/Employer to have to ensure that they are working with qualified service agents as required.
6. Who qualifies as a medical professional? This needs to be established as it is now an arbitrary term. Must a medical professional be state licensed, certified, or registered? Can it simply be a person that works in a medical office that has contact with patients or do they need to be recognized as a medical professional from a state or national agency? DATIA recommends that a definition for medical personnel be included in the regulations to state that a medical professional is one who is licensed, registered, or certified by a state medical board or agency.
7. In 40.355 (a) service agents are prohibited from requiring employees to sign a waiver of liability, consent, release, or indemnification agreement with respect to any part of the drug and alcohol testing process. Does this prohibition also apply to employers, or are they allowed to require employees to sign such documents?
8. For a refusal to test where no specimen is provided, 40.191 (d) (1) directs the collector to sign the collector certification on the CCF. For a shy bladder situation where no specimen is collected, 40.193 (b) (4) does not direct the collector to sign the collector certification on the CCF. Since both of these scenarios involve a situation where no specimen is collected, shouldn’t both either require the collector to sign the certification statement or not sign the certification statement? Since no specimen is collected in either instance, DATIA suggests that the collector does not sign the certification statement since no specimen is collected. Instead, the collector should only print his/her name and contact information on the CCF. In any type of dispute regarding a “refusal to test” a signed certification statement attesting that the collector “collected, labeled, sealed and released to the delivery service” a specimen could bring the “refusal” into question.
9. If a C/TPA administrator is hired by an employer as an “independent” safety consultant, can he/she perform the duties of the Designated Employer Representative if the employer has contracted with him/her to execute all aspects of the company’s safety and drug and alcohol testing program?
10. Regarding Medical Review Officer continuing education, 40.121 (d) states that "During each three-year period from the date on which you satisfactorily complete the examination under paragraph (c)(2) of this section, you must complete continuing education of at least 12 professional development hour relevant to performing MRO functions." Does the three-year time period date from the time the MRO was last certified even if this date is before August 1, 2001? For example, an MRO certified in 1997 would be past his/her three-year time limit for continuing education on August 1, 2001, but having already received the qualification training and taking the examination in 1997 would exempt the MRO from needing to meet these requirements again. DATIA suggests that those MROs who have been certified before August 1, 2001 have three years after the regulations go into effect to complete the continuing education requirements.
11. The next issue concerns the change in the regulations with respect to the donor being able to have his/her split sample tested when the primary is adulterated. The first problem already experienced in implementing these procedures is that there are some adulterants on the market that dissipate within 24 to 48 hours, therefore, the primary specimen may show the adulterant, but the split specimen will have no traces of it. Secondly, when you pour a solution into two vials the concentration levels in each vial will be at different levels unless the solution is thoroughly mixed. Once donors get wind of this tactic, they will always have the split tested. Many laboratories have had several cases of these scenarios already since January and a lot more are sure to come. Possible solutions may be to reconsider the pH levels at which a sample is considered to be adulterated, testing the split not only to confirm the adulterant but also for the presence of drugs, or requiring a shorter reporting time and time for requesting a split test for samples reported as adulterated/substituted. To properly address this issue, surveying the laboratories to determine what percentage of adulterated specimens do not confirm when the split is tested may be very helpful and/or necessary.
12. Another important issue of interest to our members, that may take more time in addressing, is the issue of safety sensitive employees who work for more than one DOT regulated transportation company, such as freelancers, independent contractors, temporary or part-time staff. This type of employment is typical in the trucking and marine industries. Under DOT rules, if the employee tests positive for company A, he will be removed from safety sensitive duty for that employer, but will not be removed from safety sensitive duty for companies B and C (who are prohibited from receiving test information from company A without a specific written authorization for that single test result from that employee who tests positive). This means that the employee can continue to work for companies B and C in safety sensitive positions despite the positive drug or alcohol test, and that is the usual outcome in our members’ experience. In addition, the employee, in almost all cases terminates employment with company A following a positive test and is then free to move on to any new employer without going through the required follow-up process. Since the employee can still use company B and C as his employment history and selectively “omit” company A, the positive test result for company A will not “follow” him when a new employer researches his previous 2 year’s of DOT drug and alcohol test results.
The situation described above is a common situation for some DOT modes, and has major safety concerns, as the effect of the DOT rule allows a person with more than one employer to continue in safety sensitive positions following a positive test. It is also clearly an example where the principle of confidentiality conflicts with safety. We are not recommending a “solution” at this time, but we do believe that the entire thrust of the DOT rules and their support in the courts, has been to hold safety as a higher principle than confidentiality. If DOT agrees that safety is the highest principle, it would seem appropriate to allow test results to be shared with employer B and C in the example above. But we understand the concern about confidentiality also. Regardless, the confidentiality-safety issue needs more careful consideration and we would appreciate any additional input on this issue.
Ken, I have presented many questions and issues for DOT’s review, and would like to make myself available to discuss these matters further. DATIA has trained hundreds of professionals on the new regulations over the past two months and these issues are continually raised. The industry would definitely benefit from receiving guidance/clarification from DOT and the most appropriate forum would be as amendments to CFR 49 Part 40. Please contact me directly at 703.519.9846 or lauranorfolk@datia.org to discuss these items or set up a time to devote to working on them. I look forward to hearing from you.
Sincerely,
Laura E. Norfolk
Executive Director
