The second segment of our discussion on the Department of Transportation Drug and Alcohol Testing Rules will cover 49 CFR Part 40 and really review the general requirements that Part 40 enumerates for employers who must implement drug and alcohol testing programs under their DOT agency rules. It is in Part 40 that the program components for DOT drug and alcohol testing rules are laid out, and those include things other than just a testing program, such as that the employers must have a written substance abuse policy, that there does have to be drug and alcohol testing in conformance to those DOT agency rules, that there must be education of employees and supervisors, and what that education and supervisory training should include. Each program or each employer's policy has to include sanctions for violations, in other words the removal from safety-sensitive duty, the referral or information for the substance abuse professional on return to duty process, and any additional disciplinary actions that the employer may impose. There must be some identification of the confidentiality of test results and of test records, and there has to be some information about how the records are kept and what the reporting requirements and what will be reported to whom or to what entity. And lastly, of course, the major component of the DOT drug and alcohol testing and drug-free workplace programs and policies includes the return to duty process. The DOT agency rules in Part 40 are very clear in stating that the employer is the entity that is responsible for compliance with the DOT rules. And it goes on to specifically also indicate that when and if the employer uses a variety of service agents, such as laboratories, medical review officers, collection sites, third-party administrators to administer or conduct part or all of their drug and alcohol testing requirements, the employer is responsible for the actions of those service agents. Part 40 states that the Department of Transportation drug tests and alcohol tests, for that matter, must be completely separate from any testing that the employer does under its own independent authority. That really means, for example, that the federal custody and control form for urine drug testing can only be used for DOT tests. It can't be used for tests that are done based on the employer's drug-free workplace policy. Likewise, the same thing is true for alcohol testing. The DOT alcohol testing form can be used only when that test is required or authorized by the Department of Transportation regulations. So, another aspect of that, sometimes people say, well, if an employer wants to do a random test under DOT, because they're in the random pool, but they also want to do a random test under their own authority, perhaps for additional drugs or under some other circumstance, can the same specimen be used? So, that part of the specimen would be for the DOT random test, and part of the urine specimen would then be used for the company authority random test. And the answer to that is no. They do have to be entirely separate processes. A unique feature of Part 40 that has to do with an employer's actual implementation, if you will, of its drug testing program has to do with what is referred to as a stand-down waiver. And in Part 40, this is identified as the practice of removing an employee from performing DOT-covered safety-sensitive functions upon notice of a laboratory report of a positive adulterated or substituted drug test prior to the MRO's verification of that result. Without a stand-down waiver, an employer can take no action and have no information about a laboratory non-negative result until the employer's designated medical review officer has completed the test verification process. So, the stand-down waiver is granted in writing by the DOT agency that regulates the employer that is seeking the stand-down waiver so that they can take action to temporarily or immediately remove a person from safety-sensitive duties pending the MRO's verification decision. There have been very few waivers granted over the 20 years that this regulation has been in effect. And you, as a medical review officer, if an employer says, I want to know when you get that laboratory result, and then I will wait however long it takes you to do the verification decision, but in the meantime, I'm going to stand the employee down. You have to say to that employer that unless they can show you that they have an approved stand-down waiver from the DOT agency, such as the FAA or the FMCSA, that you cannot engage in that practice. The DOT agency may impose conditions and they may suspend or revoke a waiver that they have granted to an employer. In review and repetition of what we have discussed previously, remember that an employer is responsible, not the medical review officer, but the employer, for an employer action when there is a verified positive adulterated or substituted result. The employer must immediately remove that individual from safety-sensitive duties. They cannot defer the removal until they get a written test result from you. Or until a split specimen test result is reported. Likewise, they have to, at the same time that they have immediately removed that person from safety-sensitive duties, they must provide them with contact information for a qualified substance abuse professional. What this really means is a list of local substance abuse professionals, including their names and telephone numbers. The employer is under no obligation to pay for the substance abuse professional evaluation. They are under no obligation to arrange for it or to make a specific referral to a specific SAP. But instead, they must provide the individual with information about how to accomplish the SAP referral assessment and return to duty process. It is in Part 40, actually in Section 40.25, that the Department of Transportation places a requirement on all employers to do a prior test results check when they are hiring a person into a safety-sensitive position. So, they must get the candidate to sign a release form and they must then send that release form to any of the employee's previous employers in the past two years where the employee was subject to DOT testing to see whether or not they had a DOT test violation. For motor carriers, the DOT regulation expands that period of time for doing the prior results check to three years. The FMCSA, as we mentioned earlier, put in place in January of 2020 a national database, a federal clearinghouse. And so, once that is up and running for three years, then this mechanism for contacting the previous employers for a candidate for a CDL position will go away and the requirement for the employers to query the database for every candidate for a CDL driving position will replace this prior results check. So, while the prior results check may be eliminated in terms of the procedure for FMCSA employers in 2023, it will remain in effect for all other DOT-regulated employers. And so, if violations are reported by previous employers, the employer must then obtain the substance abuse professional return to duty and follow-up test information on that individual in order to consider hiring them for the DOT-regulated position. They must have this information from the previous employer or employers within 30 days of the employee performing safety-sensitive functions, or they have to have documented that they made a good-faith effort to comply and to obtain the information. The information about prior drug and alcohol violations must – the request to previous employers must be in writing and they must receive that information from the prior employers in writing so that the documentation can be maintained. The regulation also specifies that they have to provide the candidate signed release to the previous employers. And now, if the candidate says, I'm not going to sign a release for you to contact my previous employer, then the employer cannot consider that candidate for a DOT position. Part 40 includes some record-keeping requirements for employers who are obligated to conduct testing under the DOT rules, and particularly Part 40. And it's broken out on this slide in terms of the types of records and for what period of time the employers must retain those records. The DOT has opined that the records may be maintained electronically, if you will, but they have to be scanned or other copies of the documentation so that they can be printed to show the actual document, such as a custody and control form or a test result report, et cetera. So, you see here that the test records related to verified positive drug tests, alcohol tests of 0.04 or greater, test refusals, SAP reports and follow-up testing schedule and test results must be maintained for five years. And so that's the longest record-keeping requirement under the Part 40 regulation. In our specimen collection module, we discussed that the DOT regulation, along with all other federal drug testing actually, meaning HHS and Nuclear Regulatory Commission, does require a split specimen. The split specimen must be retained by the laboratory for one year on all non-negative results. Reconfirmation for drugs in that split specimen is based on limit of detection, not on the confirmation cutoff levels. And reconfirmation for adulterants or substitution criteria must meet the original parameter so that if a specimen was identified as adulterated because the pH was greater than 11, if the donor requests the split specimen be reconfirmed so it's sent to another laboratory, the second laboratory there must determine that the pH is in fact greater than 11 in order to reconfirm that this is an adulterated specimen. Payment for the split specimen analysis is an employer responsibility. However, the employer can, under the provisions of the rule, get reimbursement from the donor. But the medical review officer, for example, cannot refuse or delay the employee's request to have the split specimen tested pending receiving any kind of payment from either the employer or from the employee. The Part 40 regulation does have very specific information about confidentiality and release of information, especially as it relates to test results and employee test records. So the test information or test results and other documentation cannot be released to a third party without the donor's consent. That's the general statement. However, there are obviously exceptions. Any and all of that information can be released to the employer and it can be released to the substance abuse professional, to any DOT agency, and to the third party administrator. Obviously, the medical review officer gets that information from the laboratory and that is included as a part of authorization that the donor signs on the custody and control form. The employer can release information in a legal proceeding initiated by the employee or when the employee's performance of safety-sensitive duties is the issue. So this might be, for example, an employee is contesting unemployment insurance being denied. And so there is a legal proceeding then to determine whether the employer's termination of the employee will be upheld. And in that case, the employer can release to the adjudicating officer in that proceeding test result information, et cetera. The MRO or the TPA must release information to the employer for the above purpose. So when you ordinarily cannot give, for example, quantitative levels or some other information to the employer, that was a part of the test result verification process. If there is a legal action or legal proceeding surrounding that test result, you then are permitted to provide that information to the employer. The donor, of course, is always entitled to information concerning his or her test result and you as the medical review officer must provide that information to the donor within 10 days of the employee's written request. The role of the consortia and third-party administrator, often using the acronym C-TPA, is specific to DOT drug testing. And the definition that is provided of a consortia third-party administrator is a service agent that provides or coordinates the provision of a variety of drug and alcohol testing services to employers. This slide provides some of the very common functions that a TPA does perform on behalf of its employer, clients, or customers. Operating random testing programs, assisting with arrangements for other types of testing such as post-accident testing, pre-employment testing for candidates, etc. They can certainly actually do the random selection and run random pools for employers. They may assist in follow-up testing plans so that they can assist the employer in scheduling the follow-up testing that has been ordered by the substance abuse professional. They may receive and maintain drug and alcohol test records for the employer, including individual test results. So you as a medical review officer may be reporting verified test results to an employer's TPA rather than directly to the employer's designated employer representative. Let's take a moment to look at the principles for medical review officer and third-party administrator interaction or relationships. A TPA may provide MRO services for its clients. They can do that through MROs that are on their staff, that are employees of the third-party administrator entity, or through contract. This is different from the relationship between the medical review officer and the laboratory where there are specific prohibitions in both the HHS guidelines and the DOT regulation that says that a laboratory cannot provide MRO services for its clients. And there cannot be any kind of a financial or other operational relationship between a medical review officer and the laboratory. The MRO must perform their duties independently and confidentially if they are an employee of the TPA or if they are contracted to the TPA. There must be physical and operational separation of the MRO functions of a TPA and the TPA functions, such as customer service, setting up accounts, identifying collection sites, random selections, et cetera. The staff who are under the direct supervision of the medical review officer are the ones that must perform any work for the MRO functions, such as receiving the test results from the laboratory, reviewing the custody and control form, assembling the information for the medical review officer to conduct the interview with a non-negative test donor. And only the MRO, of course, can interview the donor and can make the verification determination. Even in terms of asking for prescription drug information, all of that that's a part of the MRO interview must be done by the physician MRO and cannot be delegated to staff members either on the TPA side of the house, so to speak, or to non-physician staff members under the MRO's supervision. And finally, let's take a look at another provision in Part 40 called the public interest exclusion. And the purpose of the public interest exclusion, or PI as the acronym is known, is to protect public interest from serious non-compliance with DOT rules by its service agents. So again, this is to make sure that there is a mechanism that if a service agent, such as a collection site, a medical review officer, a third party administrator, is not conforming to the Part 40 requirements in drug and alcohol testing that's mandated by DOT, then those entities can be identified so that employers do not use them for those services. A PI is initiated and investigated by a DOT agency so that if there is a complaint, for example, about a collection site that's not doing DOT collections for truck drivers or for oil and gas workers, etc., then the DOT agency will take up and investigate that complaint against that collection site. The ultimate public interest exclusion is issued by ODAFC by the Office of the Secretary of Transportation. And the first step is really where a notice of proposed exclusion is sent to the offending entity. And if they are given an opportunity to remediate their errors, to come into conformance or compliance with the Part 40 procedures, and if that does not occur, then the NOAP, or the Notice of Proposed Exclusion, becomes a PI. The service agent presents their defense, of course, to the ODAFC director, and then the ODAFC makes a decision. They will provide a written notice and the basis for the PI, the name of the service agent that is listed then on the DOT website and in a Federal Register Notice. Service agents must, when they have been issued a PI, a public interest exclusion, they must notify all of their DOT regulated clients or customers about the PI, and the employers must stop using the service agents within 90 days of the PI being issued. The PI can be issued for one year up to five years. However, ODAFC can adjust the duration based on the service agent remediation. Thank you. you you

Department of Transportation

DOT

Drug and Alcohol Testing Rules

49 CFR Part 40

substance abuse policy

return to duty process