This is the final segment on our discussion of the DOT drug and alcohol rules. And this segment will concentrate on the MRO responsibilities as defined and outlined in Part 40. Subpart G of 49 CFR Part 40 is the area of the regulation that is specific to MRO duties, responsibilities, and requirements. Part 40 specifies the way in which medical review officers report test results to employers. Telephonic reporting to the employer is definitely authorized. However, the MRO must provide a written or a document of the test result to the designated employer representative or to the third-party administrator that has been designated by the employer. The MRO provides that documented test result either using the MRO copy of the CCF, which the MRO has signed, or using a form letter or a test result report letter that is provided to the DER or the TPA. All test results that the medical review officer reports must include the donor's name. All non-negative test results must be signed by the medical review officer. Negative tests from the laboratory that are negative can be reviewed. There's no donor interview, and an MRO staff member can sign or initial those test results for the medical review officer. The MRO or his or her staff members cannot report a test result until the copy two of the CCF, the MRO copy, has been received and has been reviewed. So even for a laboratory negative, that result cannot be transmitted to the employer or the TPA until the MRO staff or the MRO himself or herself have received the MRO copy, have reviewed it for fatal or correctable flaws, and are able to attest that it is true and accurate on its face. All non-negative test results must be reported promptly. And the Part 40 regulation says that preferably that means on the same day that the result was verified by the medical review officer. And certainly for a non-negative verified result, such as a positive test, a refusal to test adulterated, or refusal to test substituted, or for a test result where there is going to be a recollection required because the MRO has canceled the test, the DOT certainly encourages the medical review officer to make that notification telephonically as soon as possible so that the employee can be removed from duty or sent back for the recollection. So let's look now at what the MRO's determinations are in terms of verified DOT drug test results. So essentially, the MRO is going to take the information provided by the laboratory and make one of four or a combination of these verified test determinations, either negative or negative dilute, positive with the name of the drug or drugs that are verified as positive, and it can be also a positive dilute. Refusal to test requires a remark for the explanation of that test result, and we'll talk about what those remarks are in just a moment. And test canceled is the other category of an MRO verified result that is reported to the employer. Let's take a look at the negative results. First of all, under DOT, a candidate or an employee must have a negative test result reported by the MRO before they can be hired for a safety-sensitive job or for a return to duty or a follow-up test. That's when a negative result is mandatory in terms of for being able to continue. The negative dilute remark is when the laboratory must provide you, the medical review officer, the numerical creatinine value. If that creatinine value is 2 to 5 milligrams per deciliter, the medical review officer does not report that result, instead tells the employer that they must recollect a specimen under direct observation. If the negative dilute has a creatinine greater than 5 and less than 20 milligrams per deciliter, then the employer may direct the donor to submit another specimen, but no direct observation. The employer must accept the result of a second test, even though it may be, again, negative dilute. So for a creatinine of greater than 5 and less than 20 that the laboratory reports to you as the medical review officer as negative dilute, you report that to the employer as negative dilute. And the employer can choose to accept that result and hire the person or continue on with other random tests, et cetera, or they can require the individual to come back for another test, but it's not under direct observation. There is no MRO interview needed with a negative dilute, even a negative dilute where the creatinine is 2 to 5, and you are going to require a recollection under direct observation. Now let's look at positive results. So the positive test result is going to come from the laboratory. It will be signed by the certifying scientist on a copy one from the lab and identify what were the drugs or drug metabolites that were confirmed positive. You as the medical review officer then, if you are going to report this as a positive test result after interviewing the donor and finding no acceptable medical explanation for the laboratory's findings, you will report that as positive with the drugs that were detected for which there is no medical explanation. You do not provide quantitative levels to the employer or to the TPA to whom you report the test result. If a verified positive result is also dilute, you do enter that in your remark section of the MRO report. Dilute actions, of course, regarding recollection of a specimen, et cetera, do not apply because the positive finding is what determines the employer's actions. Let's take a look at the canceled test category. The MRO makes a determination of test canceled or canceled test in the following circumstances. When the laboratory has rejected the specimen for testing. So your only option then is to report a canceled test. When there is a correctable flaw identified by either the laboratory or by you or other service agent that cannot be corrected with a signed statement from the collector or other person, then you have to cancel the test as the medical review officer. Another circumstance where you will report a canceled test is where there has been a shy bladder event and no specimen went to the laboratory. The individual, the donor, was examined by a physician who found that there was a physiological condition or pre-existing psychological condition that you as the MRO accept as an acceptable medical explanation for the donor's inability to provide an adequate urine specimen. So that's then reported as test canceled. Another circumstance for a test canceled is for invalid test results that are reported by the laboratory. And in this circumstance, you must consult with a laboratory scientist before you conduct the interview with the donor and before you make your final determination. And an invalid test result, if there is not further testing that you and the certifying scientist agree to, is always going to be reported as a canceled test. The last circumstance where the MRO is going to report a canceled test is where there is a split specimen that is requested by the donor because the test result from the laboratory was verified by you as a positive test, an adulterated test, or a substituted test. And when you process the donor's request for the split specimen, the laboratory informs you that it is unavailable for reconfirmation analysis, meaning that it was lost in transit, there was not sufficient urine in the bottle B or the split specimen container, etc. But for whatever reason, the split specimen is not available to be reconfirmed at a second laboratory. So then you are going to cancel your originally reported positive or originally reported refusal to test. Some information about the MRO's determination of reporting a test canceled is identified on this slide. The test canceled always requires you as a medical review officer to make a remark on your written test result report or on the CCF copy 2 that you are signing and providing to the DER or the TPA, explaining why the test was canceled. A canceled test cannot be repeated unless a negative test is needed for pre-employment, return to duty, or follow-up. So if it was a random test that you canceled, then the employee cannot be sent back in for another random test. Or a canceled test would only be repeated, meaning another specimen collected, and the specimen collected if the employer is required by you, the medical review officer, to do an immediate recollection under direct observation. Those are the only circumstances where the test canceled report is going to lead to another specimen collection and another test. It's important to remember that a canceled test that you report cannot be treated as a violation of the DOT rules. And remember that only the medical review officer cancels a test. An employer or a third-party administrator or a collector cannot cancel a test. Only you, the medical review officer, can do that. You cannot order another collection when you have canceled a test unless it was an invalid result for which you found no acceptable medical explanation, if it was a failure to reconfirm where the split specimen was not available, or where there was a negative test result needed on a pre-employment, return to duty, or follow-up test. And what you have reported is a canceled test. So obviously, then another specimen can be collected, another test done in a different specimen can be collected, another test done in order to get a negative test. The employer cannot count a canceled random test toward its compliance with the random testing required for that year. So if there are 10 random tests done in a particular quarter and two of them you end up canceling, that employer can only be able to count that they did eight random tests toward their 50% or 25% annual test requirement. And a canceled test cannot be the basis for requiring a test under company policy. So they can't use a DOT canceled test to say, well, I'm going to do a test under my own authority for reasonable suspicion or as another random test or whatever it may be. So we've gone over MRO negative tests, MRO positive tests, MRO canceled tests. Now let's take a look at the category of MRO refusals to test. So a refusal to test determination always requires the MRO to have explanatory remarks. And there are basically only four circumstances where you make a refusal to test determination that you report to the employer. One of those is where the specimen is adulterated and you must specify on your report the adulterant or the adulterant criteria, such as pH greater than 11, that led to your determination of refusal to test. Specimen substituted. Again, you must specify in your remarks the substitution criteria that this test met that it was a substituted specimen, meaning the creatinine was less than two and the specific gravity was less than 1.001 or greater than 1.020. The other circumstance is the outcome for a shy bladder event and a shy bladder evaluation. So that if the examination done by a physician to determine whether there was a physiological or pre-existing psychological condition that precluded the individual from providing an adequate specimen is not found by that examining physician or the report that you receive from that examining physician, in your opinion, does not adequately provide an existing physiological and or psychological condition, then you are going to report that test result as a refusal to test. And the fourth circumstance where you, the medical review officer, would be making a refusal to test determination is when the donor admits to you that they have attempted to or have, in fact, adulterated or substituted their urine specimen. Realistically, this generally will occur when you are doing an interview with someone for an invalid specimen and trying to determine if there is a medical explanation for the specimen being found invalid by the laboratory and the person will kind of blurt out that, well, I don't understand why it was invalid. I used this thing I was supposed to drink or this thing that I put in the urine specimen that was supposed to make sure that it would be negative. That's an admission of attempting to or having adulterated a specimen. So these are the only refusals, remember, that you as a medical review officer report. Any other refusals to test. And remember, we went over 13 different reasons that a DOT specimen is deemed a refusal to test. Those other nine circumstances, if you will, that determination of refusal to test is made by the employer, by the designated employer representative, oftentimes in consultation with a collector or other person that maybe had been involved with the testing circumstance. We know that split specimens are required for DOT drug testing and it's also required for other federal drug testing programs. And so what is your role as a medical review officer in processing split specimens? We talked early on about the collector's duties of how to collect a split specimen and documented. We talked about in terms of Part 40 stating that the split specimen request has to go to a second laboratory, etc. So let's talk now about your role in the processing and receipt and report of split specimen results. So you inform the donor of the opportunity to have a split specimen analyzed on a verified positive adulterated or substituted test. You should do that informing of the donor at the conclusion of your interview with the person. You do not offer a split specimen reconfirmation for an invalid specimen result, only if you are going to verify the result as positive, adulterated, or substituted. You process the request for split analysis in terms of a 72-hour window for the donor to decide and to inform you. So the donor doesn't have to make the decision right at the end of the donor interview, but you need to tell them that they have up to 72 hours to inform you that they do want the split specimen reconfirmed. It's up to the MRO whether you take that request for split specimen analysis verbally or whether you require an email or other written request from the donor. But once you have the donor's request to do the split specimen analysis, and by the way, only the donor can request this, not the employer, not you as the medical review officer, or not a service agent, you then provide a written request, your request to the laboratory to send the split specimen to another HHS-certified laboratory for reconfirmation analysis must be in writing. You have to include the specimen ID number, the drug or drugs that you want reconfirmed, and or the adulterant or substitution findings that are to be reconfirmed. You do not delay reporting of that verified result pending split specimen decision by the employee or waiting to get the split specimen result if the employee has requested split specimen reconfirmation analysis. The MRO, as I mentioned earlier, cannot require upfront payment for split specimen analysis from the donor or from the employer. Once you get the request, you must process the request with the laboratory to send the specimen to a second laboratory for reconfirmation analysis. And lastly, I'm going to cover perhaps one of the more controversial aspects, if you will, of the Part 40 language concerning a medical review officer's duty to disclose medical information that he or she obtains as a part of the donor interview and the test result verification process. So Part 40 says that the medical review officer must, not can or not is permitted to, but must report medical information learned in the verification process in the following circumstances. Number one, that that information that you have received or obtained, in your best judgment, you believe the employee could be medically unqualified under a DOT regulation. Now remember, not all safety sensitive physicians that are subject to DOT regulations have medical standards. For example, flight attendants do not. Pilots do. Commercial driver licensed employees do have medical standards imposed by the FMCSA. The railroad does not have medical standards imposed for railroad engineers. So that first, that's what you have to know. You really need to know whether or not the donor, the employee, does have DOT regulatory imposed medical qualification standards. Second circumstance is where you believe that continued performance of safety sensitive duties by the individual, by the donor, is likely to pose a significant safety risk. Now the DOT rule does not elucidate or further define what is a significant safety risk. It doesn't define likely pose. So this is really a judgment factor for you, the medical review officer. So if the person has told you that they have a prescription for oxycodone, for example, and that explains why their laboratory result was positive for oxycodone and oxymorphone, you're going to report the result as negative. Under this paragraph, you have to determine whether you believe that continued performance of safety sensitive duties by that employee who has a oxycodone prescription is likely to pose a significant safety risk. And if it is, then you must disclose that medical information. It's not going to change if the test is negative. It's not going to change it to a positive, but it will require disclosure of medical information. The parties to whom you as the medical review officer may release this medical information include the employer, the physician, for example, the medical examiner or the aviation medical examiner who has qualified the individual for their DOT under their DOT qualifications. You can release that information to the SAP, although I'm not sure why you would. You can release it to a DOT agency or to a state safety agency. And certainly in the case of a post-accident test where you may be contacted concerning a post-accident test outcome, you may be required to provide that information to the NTSB. In 2018, when the DOT testing panel was expanded to include the opioid drugs, oxycodone, oxymorphone, hydrocodone, and hydromorphone, the DOT's final regulation in late 2017 included some pretty significant changes to this whole arena or area in Part 40 of the MRO's responsibility regarding disclosure of medical information and assessment, if you will, of safety and the impact of medications on safety. So the DOT regulation reiterated, but stressed more strongly that the MRO must continue to evaluate the potential for adverse impact of medication use on safety as part of the employee verification interview. So now Part 40 says that if you as the MRO believe that there is a significant safety risk associated with the employee's continued use of the medication, you then have to instruct the employee, the donor, to have his or her prescribing healthcare practitioner contact you to discuss a possible change to or discontinuance of the medication. So this is a gate through which the medical review officer must now pass in terms of making a determination and reporting medical or medication information to an employer. If the prescribing healthcare practitioner does not contact the medical review officer within five days, the MRO then can report the medication information or the safety concern and the medical information to the employer or to other authorized third party. If the prescribing healthcare practitioner discontinues the medication or changes the medication to one that does not present a safety risk, then the MRO does not report the medical information or the medication information. It is only the negative test. If the prescribing healthcare practitioner contacts the MRO and states that the medication is not being changed or discontinued, but you and the prescribing healthcare practitioner does not believe that it presents any kind of risk or associated fitness for duty issue, you as the medical review officer still have the right, based on your best professional judgment, to report a safety concern and the medication or medical information to the employer. And usually that report will have as its accompaniment a recommendation from you that the employer have the employee undergo a fitness for duty evaluation to essentially assess this issue of the medication's impact on the ability of the employee to safely perform their duties. So the DOT rule, which this is found in section 40.135, now specifies that the medical review officer must report the negative result when there is a prescription that medically explains the laboratory result. And they must report that to the employer in a timely manner. They cannot hold that negative report waiting to resolve the issue about the person's medication and whether or not the medication and the medical information is going to be disclosed to the employer. So what that means now is that the MRO may report a negative result on an employee today. And then three days later, after the healthcare practitioner has said, I'm not changing the medication, the MRO would then report to the employer, essentially an amended report that includes a safety concern or safety notice or medication and medical information disclosure.

Medical Review Officer

DOT drug and alcohol regulations

Part 40 of 49 CFR

test results

Custody and Control Form

split specimens