So welcome, everyone, to the May 10th meeting of our MRO faculty for our online course. My understanding is that all people who have participated in the course are sent invitations, and obviously we have a nice number tonight. There may be additional people arriving. And my assumption is that you as students will probably be more interested in studying the basics and how to prepare for the exam. And I know we got some questions from a number of you. So I think in terms of the order of things, what I'd like to do is to have us briefly introduce ourselves. I think you know most of our faculty. Then deal with the questions that came in, and there were four questions that came in. See if there are any other questions that you all have about studying for the exam or about understanding the basics of being an MRO. And then after that, this is a very timely month, because finally after years and years of waiting, the Department of Transportation has finally released their final oral fluid regulations. And although they will not take effect until three laboratories have been certified, and therefore the information that's being released will not be included in your MROCC exams, I suspect that many people will be interested in knowing what they were. So after we've covered your questions, and then have addressed any other questions about the basic course, we're going to turn our attention to the changes in oral fluid regulations. So that's the plan for the evening. Welcome Chris. Let's start with introductions and I'll begin by introducing you. So Chris Paciak is the Executive Director of the Medical Review Officer Certification Council. So her organization is sponsoring the exam that we take after completing our MRO training. And Chris is a wonderful resource. And you can ask her questions tonight about how to prepare for the exam, and any technical logistical questions. And you're a wonderful resource. Thank you for being here. Danielle Feinberg is the ACOM staff person. You're the Director of eLearning for ACOM, right? Manager of eLearning. And so you are our support person. Thank you for recording this, being here, giving up part of your evening for us. We're very grateful for you as well. I think you know, the three of us, Dr. Smith is a doctor, doctor, she's a psychologist and an educator. And she's worked in a wide variety of areas of psychology, but she got involved in drug testing early on in the military in the Department of Defense, then moved into working with the Department of Transportation, was pretty much the main driving force behind the creation of DOT's drug and later alcohol testing regulations, and has really been a major policymaker, and then left federal service, and has been working in the private sector for the subsequent 20 years. And so she will cover a wide variety of things and has questions to answer tonight. Michael Peat is a forensic toxicologist. And he's been also teaching with us for several decades. He's also a scientist. He's the editor of the Journal of Analytical Toxicology, Forensic Toxicology, and he will cover questions about substances and laboratory testing. And a number of the questions that were submitted will go his way. I'm a physician, so I'm the MD member of our team, trained in internal medicine, got into occupational medicine long ago. And part of occupational medicine is drug testing. And so I am a sort of a general utility infielder, but I do work as an MRO to keep those skills active. So we are the three principal faculty. At one point, we had seven or eight faculty, but we found it was probably easier to have fewer faculty, and each of us be able to not duplicate each other, and to work much more closely together. So we've been a team for a long time, and as time goes on, each of us will be replaced, and ACON will find new faculty as the years unfold. So tonight, we got questions submitted by a couple of people, and I'd like to just take them in the order in which they were submitted. If you can see that the first question was submitted by Yong Kang, and I think there may be another question from you in the chat, but we'll start with this. And this was a question that came in about the testing of minors. And I wondered, Donna, if you could address that, how to address drug tests for minors at both the workplace and in school? So specifically, Dr. Kang asked, is a written consent from the parents required, either for work or school? And should a drug test result for a minor be revealed to parents if they asked to have the results? Did you get the answers I already did for you written? No, I did not. I'm sorry. OK, well, let me try to bring them up, then, because I did do them. Let's see here. OK, the answer to the first question, which are minors. Do you want to share your screen, or shall I keep mine up? No, that's OK. I'm sorry. I just have to find it. I was so sure that you would have it that I don't. I have to go through here and find them. Let's see here. I'll put the question back up, then. OK, all right. So it is. It depends, in terms of drug testing of minors in an employment setting, it does depend on the state law. And it depends on the state law in terms of regarding, not necessarily the state drug testing law, but more it is related to their law on the employment of minors, and whether that is somebody considered under age 21, under age 18. What is the age of consent in the employment context for work rules and abiding by those or whatever? It has been my experience. It's certainly true in Department of Transportation testing, but it has been my experience that no separate consent is needed in the workplace. An employee who is 18 or 19 or 20 or 17 or whatever, and is subject to drug testing under the company's policy, would sign the Custody and Control Form like anyone else, and no additional consent would be needed, nor would any consent be needed of parent or guardian, unless, again, the state law is specific that a minor, typically under age 18, a parent has to consent to the work rules, if you will, the work standards, the work whatever. Now in student drug testing, that's a different issue. School testing usually does require parental consent for testing. It is based on the district, the school district, so that a district that is implementing drug testing of students is going to have in its policy that's been approved by its board, the school board, whether or not parental consent is necessary. My experience is that it is for almost all school testing programs, particularly public school testing programs, and if a parent does not consent for their child to be in a drug testing program, whether that's random or reasonable suspicion only, or at the start of a particular sports program, or when they are applying for a permit to park on school grounds, then the student is not permitted to continue with that activity. Almost all public school testing is based on extracurricular or privileges that a student may have, such as participating in a sports team. It's not ever generally done of all students. So that's really what determines that consent piece. As far as, again, it would be based on the school district's program for student drug testing as to whether a medical review officer gets those test results from the laboratory, who the MRO reports the result to, is it to the school, either to the principal or to an administrator of the student drug testing program. There are, I know, two or three school testing programs that I've been involved with. The school district protocol or policy called for the parent to be present, if you will, during the MRO interview of a student with a positive test. By present, that would be on the phone, unless, again, there was the medical review officer, for whatever reason, may have been doing the interviews of the student in an office or at the school or whatever. But as far as an obligation to report the test result to the parent, no. That would all be determined by the school district's policy. So if you're going to be serving as an MRO for a student drug testing program, it's absolutely imperative that you get a copy of what that district's program, what it is, what the protocol is, what the procedures are, what the rights and responsibilities are. Good. Thank you. And Chris, I'm assuming that this is an interesting question, but it's not one that would be, there would be any test questions in the MROCC exam about. Is that correct? That is correct. There won't be anything that is that tricky or that, you know, that most people aren't dealing with in a normal setting. So it's something on drug testing minors isn't going to be covered. Good. So thank you, Dr. Kang, for your question. And thank you, Donna, for your answer. The next question was submitted by Jessica Chuang, and it has to do with new legislation in California. So again, I think this is an interesting question, but it's not one that we're going to need to know in order to pass the MROCC exam. However, states are continuing to pass state laws. And as Donna has repeatedly said, as an MRO, we really need to be familiar with the laws in the states where we are functioning as an MRO. So the question says that starting in January of 2024 in California, there's legislation, and I presume this means it has passed, prohibiting employers from testing inactive metabolites of marijuana. My understanding is that currently these are what the laboratories test for. I'd like to ask, and this really is you, Dr. Peete, whether you anticipate laboratories to test specifically for marijuana active metabolites, what things should employers or labs look out for as well? Well, let me assume in the question that we're talking about urine, at least in that question, because there's another question of fluid. None of the labs that I'm aware of in the regulated program or in workplace drug testing actually test in urine for THC or 11-hydroxy-THC, which are the only active metabolites that are present in body fluids to any significant degree. THC is hardly excreted at all in urine, probably less than 1% of the dose is excreted in urine, and 11-hydroxy would even be less than that, because it has a very short half-life. So I know of no labs that are testing for active metabolites of marijuana, and not necessarily that they can't do so, although testing for THC in urine would be different than testing for the THC metabolite that's included in the regulated programs. But there's probably no need to, because it's not there in any significant degree. So I'm a little puzzled by this. When I read it, I was a little puzzled by this regulation, but I don't imagine the labs are going to change their policies here, because for DOT and the vast majority of non-regulated testing, the detection of the THC metabolite is proof of THC use, and that's what people are interested in. So this would not affect the federally regulated testing. Do you think that it would then, Mike, affect the non-regulated testing, and would it essentially eliminate testing for THC in the non-regulated testing? No, I don't think so, because I think that, and Donna had a news release or whatever it was you sent this afternoon, Donna, on what this is meaning in employee-employer law or relations or regulations. I don't anticipate any lab changing to detect these active metabolites. Right. And again, I think we have to be, I did try to include, Kent, on what I sent you, the actual language from AB 2188 in California. And again, and this is very important for MROs to know. Yes, it's important for MROs to know what the state laws are or whatever, but all of the restrictions or the prohibitions on what can be done with regard to a marijuana test result fall on the employer, not on the MRO and not on the laboratory. So AB 2188 doesn't prohibit a laboratory from conducting a test for non, whatever they use, whether they use non-psychoactive cannabis metabolites. What this says to an employer is, and this again is outside the regulated industry, okay, it says that as an employer, you can't refuse to hire, you cannot terminate or take any adverse action based on an employee's use of cannabis off the job and away from the workplace or upon an employer required drug screening test that has found the person to have non-psychoactive cannabis metabolites. And it does specify in their hair, in blood, in urine or other body fluids. So I think it's an important distinction to make. And in this, not only is the federal carve out, but this is kind of interesting in terms of how legislatures are dealing with this now, fueled, absolutely fueled and powered by the marijuana industry, okay? That employees in the building and the construction trades and any applicant or employees in positions that require a federal background investigation or background check or any kind of a clearance of a federal clearance are accepted. So in other words, testing and be able to take adverse action for any type of marijuana use or for a test or whatever is allowed there. So I think the devil is in the detail and all of these state things that are being passed. There's no question that what states are trying to do is to prohibit employers from taking any kind of action, not hiring or firing or whatever people for marijuana use. And why is that? Because quite frankly, those states that have quote legalized marijuana, that have recreational marijuana, what's the driving force for states to do that? It's tax revenue. They want the sales of marijuana to continue. And so in order to buy your marijuana from your state sponsored store, you probably got to have a job, right? Hey, the other question from Dr. Chuang is a much easier one to address. And this is a simple one for you, Michael. And that is, what is the window of detection for marijuana metabolites and marijuana in oral fluid testing? There's nothing simple about marijuana. Exactly. So I'll try to do this. Let's step back to what a urine positive THC metabolite means in terms of time of use or frequency of use or whatever it is. It essentially means nothing because nobody can take a urine concentration of THC metabolite and tell you how often that person used it, how much they used it, how long they used it or anything, because THC metabolite can stay in the urine specimen for weeks, if not months, after somebody ceases use of that particular drug, THC. So we got a situation in similar concept in oral fluid. In oral fluid, the compound that's detected is THC itself, the psychoactive constituent of THC. And certainly after sort of normal use, if I can call it that, like taking or using marijuana on a Friday night, you might be able to detect THC in oral fluid for 12, 16 hours. But obviously the more frequently that individual uses THC, because THC itself is stored in the buccal cavity and the lipid cells of the buccal cavity, the longer that detection window is going to be. And there are some reports of 24, 36 hours for detection of THC in oral fluid. So we have no data as we sometimes suspect we have data for urine samples where the user has used it for months, if not years, and then ceases use of marijuana. We have no data that I'm aware of that's been published to show that THC in oral fluid lasts for weeks or months, but certainly one would suspect it would last for days and possibly weeks simply because of the lipid solubility that is stored in the buccal cavity cells. So, you know, it's a work in the details and the more we learn about marijuana, the less we know about marijuana. I mean, that's a simple way to put it. Thank you. Thank you. Okay, our last question comes from a regular attendee, although it's late his time, Dr. Sparring in Sweden. And he wrote just today and said, talked, wrote about the refusal to sign the signature by the donor on the custody and control form. So he says, if the donor refuses to sign the CCF, I understand that the collector shall proceed with the collection and note that the donor refused to sign the form. And I believe that is correct, at least under the federal program. No, no, no. I think that's one of the things I said initially is that don't forget in urine drug testing under the federal programs, the donor is not asked to sign the custody and control form until after he has already provided the specimen. Uh-huh, correct. Okay. So now the next part of the question is, should the MRO inform the DER of a positive drug test if the donor refused to sign and the collector made a note? So I'm assuming that means that the laboratory confirmed it as a positive, or should the refusal to sign be considered as a refusal to test? And that's where he said in the Switinsky Manual that appears to be the case with oral fluid, with breath testing. So can you explain that, Donna? All right, well, let me try to explain all three kind of together. First of all, let's talk about DOT rules with regard to alcohol testing and when the donor has to sign. In alcohol testing, the donor must sign the alcohol testing form prior to submitting to the breath test. So essentially in those procedures, the donor is acknowledging that they are undergoing a test mandated by Department of Transportation regulations. Refusal to sign that at the start of the process is a refusal to test. So now let's go to, now again, I guess I should probably add, there is another point at which the donor or the employee may be asked to sign the alcohol testing form. And that is after the breath test result has been, after the breath test result has been given and the result is 0.02 or greater, on the last step on the alcohol testing form, it asks the donor to sign that and acknowledge that they had a breath alcohol result of greater than 0.02. They should not drive a vehicle, they should not do this, and they will be suspended from, you know, they cannot return to safety sensitive duty. If the donor, once he's got his test result of greater than 0.02, refuses to sign that in the final step on the alcohol testing form, that is not a refusal to test because he's already taken the test and the breath alcohol technician would simply note in the remarks section that the donor did not sign, I think it's step four, I can't remember now whether it's step four or step five, but at any rate, that final step. So that's how donor signature and refusal to test versus it doesn't matter, okay, is for DOT alcohol testing. For DOT drug testing, the donor signature is not asked for until after they have provided their specimen to the collector. And if they refuse to sign, we obviously don't know what the result is because it hasn't even gone to the lab yet. If they refuse to sign the custody and control form, the collector makes a note on the custody and control form in the remarks section, donor refused to sign the form. If you get a result, whether it's a negative or a positive or whatever it is, you have no obligation to inform the employer, you report the result as you would any other result. With a donor signature or whatever, because again, the collector has noted that the donor did not sign the form, which is his right under the DOT rules, doesn't have to sign the form at the end, has to provide the specimen, but does not have to sign the form. Now, by the way, obviously the donor, excuse me, the employer is going to know this because the employer has a copy of that custody and control form. And that custody and control form is going to have that note by the collector that the donor did not sign or refused to sign or did not sign. Let's see, what else? Would there be any reason to consider that a refusal to test? And again, the answer is no. I think that covers it. Okay, so we are now ready to open the floor. I see that there's some questions in chat. Let me start with the first one from Dr. Kang. A urine drug test was positive for marijuana. The CCF was mistakenly marked as a DOT Federal Motor Carrier Safety Administration test. The employer made it clear that it should be marked as a non-DOT test. How can we correct it? So that's a question, Donna, for you. So that's a question, Donna, for you. If it's a positive test, then the employer has to go to the DOT agency and explain why this should not be considered a federal drug testing violation. If the test was done on a DOT-regulated employee, the chances that the DOT is going to say, okay, you don't have to treat this as a DOT violation are slim to none. If the test was done on a non-regulated employee, not in a safety-sensitive position, but the collector or the employer mistakenly used the federal form, then it can be essentially redesignated as a non-DOT test and would be dealt with by the employer under their policy for a positive test. Okay. Well, hi, my name is Yun Kang. And Dr. Peterson, thank you for answering this question earlier, I think probably at least probably a week ago. And I brought up this question to want to get more clarification because this is a case that I met recently. So this employee was tested positive for marijuana and the collector, for whatever reason, marked as a DOT test, but it is not. The employee working is just a material-handling guy. He has no commercial drive license, does not drive any commercial vehicle. It's not a safety-sensitive position. So after I got this and looks like I did some research, I read the medical review officer manual book said you have to submit some documentation to the FMCSA to downgrade. But also my question is, since this is not a real DOT regulated, can we just do it ourself without submitting any documentation to the FMCSA? Well, but I think the point is that it was done on a federal form and it was tested at the laboratory as a DOT. And so if you're saying that it should not have been, because again, this is even more critical now that we have the clearinghouse, because if in fact this was an FMCSA mandated employee on an individual with a CDL, then it would be reported to the clearinghouse. But because this is a test that was erroneously done on a person that is not subject to DOT testing, right? Okay. Correct. You have to get the downgrade or the redesignation from FMCSA. Okay. So you're talking about this is the same person, but this time the test is not a DOT test. Even if he has a commercial driver license? I'm not sure I understand now, Kent. Do you know, what am I missing? You said this was not a commercial driver. This was not a DOT test. It was done, it was put on the form by mistake. Right. And Donna is saying that because the federal form was used, you need to go to the federal agency and get them to downgrade it because the results should not be put on the clearinghouse. You can still report it to the employer as a positive and they can take whatever action their policy calls for. But if I have to report it, if I can just downgrade it myself, if it's a possibility, I don't feel it's fair to report to the clearinghouse. No, you cannot downgrade it yourself, sir. You don't have that authority. Oh. You cannot. That has to come from FMCSA, or if this was an FAA test, it has to come from the FAA. Just because you use the wrong form? Yes. Okay. Well, that's a little complicated. It is complicated. It was a mistake that was made by the collector and the employer's responsible, and they're gonna have to go through that process. You know, okay, at this point, probably who made a mistake doesn't matter. Actually, I think that somehow it's the registration from our lab made a mistake. And it clearly should be a non-DOT, just regular testing, no DOT test, but it's marked as DOT. So you're saying I have to send the documentation to the FMCSA to downgrade. Yes. That's what I'm saying. All right, let me go to another question. And there are two questions for you, Chris. The first is, is there any question bank for the MRO exam to practice? There are a few sample questions on our website. If you go to the Get Certified page under exam preparation, there's a few sample questions. There is also a section on navigating the online exam so that you can see what a question looks like, what buttons you're going to be using, which is worth doing ahead of time because you don't have a lot of time on the exam. But those are the only sample questions that we have. I'm not aware of any other question bank except for the Q and A's that we have included with this course. And there's more than 100 of those, but I don't think there is another source. Another question for you, Chris, is the exam an open book? Can you explain the online exam and how it is and is not an open book? The online exam is an open book exam. You can use really any resources other than other people, but one thing I do always like to point out is that there are only three hours and you have 110 questions. So although it's an open book exam, you do not have a lot of time to look things up. You're going to want to make a reference sheet with anything you think might be on there, your confirmation levels, et cetera. And you're going to want to have all of your reference materials readily available so that you can find things quickly if you do need to look them up. Okay, and Danielle, we have a question even for you. How can I get a hard copy of the course I've already bought and finish the online course? Can you talk about the availability for additional funds of getting a hard copy of the syllabus and all of the written material as opposed to having it online? So you can submit a request to purchase the syllabus for the course. There's an additional fee. If you only purchased the digital version, we can, if you send an email to educationinfo, and I'll type that into the chat box, if you send a request there, what we can do is let me know your name, obviously, and that you would like to request a hard copy of the syllabus. And we can send you an invoice. And once that invoice is paid, we'll submit a request to get that syllabus sent to you. So. I definitely recommend to our students that you get the syllabus. I know it's a long document. But I use it as an MRO on a regular basis because that's where I go for the tables and the charts on specific gravity and creatinine and the cutoff levels for the initial test and the confirmation test. And I have questions that come up. And when they do, I always feel more comfortable if I've gone to the syllabus for my answers. You do not need to do that. Certainly, the book published by Dr. Swietynski is another excellent reference book. But those are the two places that I would go for hard copies. Absolutely. Sometimes being able to make the notes, Chris noted having a resource sheet, that syllabus can really become helpful as you're going through making notes. And then, obviously, all of these discussions on a monthly basis, we do record them and archive them. So you can go back to previous discussions. Good. Thank you very much. We have a question from Khaled about a non-regulated employer can handle a negative dilute pre-placement result for a candidate who has a medical reason for having a diluted urine. So we're not talking about a substituted urine. We're talking about a negative dilute. What actions may constitute a violation of the ADA? So Donna, could you begin by reviewing how negative dilutes are handled and under the conditions under which a second specimen might be collected? And then we can talk about whether any of this having medical conditions might violate ADA. But let's start with the negative dilutes. Well, under DOT, there is no provision for determining whether a negative dilute is because of a medical condition, because the person drinks eight bottles of water a day, is on some type of a detox type of regimen, a dietary. A negative dilute is a negative dilute. And under DOT, the only option that the employer has is they can accept it as a negative and hire the person. You're talking pre-employment here. Or they can require the applicant to come back for another test, not under direct observation, just another urine test, urine pre-employment test. And if that one is also dilute, they must accept that as a negative. And the person has met the eligibility requirements for hire. On a non-DOT, I suppose that you could have a policy that says that we are going to require another collection, even under direct observation. Or we're going to require another collection if there is no medical explanation. I think the latter would perhaps place the employer into a greater problem. Because then you are saying that, OK, a person that has a medical condition, as in what, a UTI for which they're taking Pyridia? I don't know what that might be. Or that they are on a diuretic, for example. But that you'll accept that as a negative dilute and you'll hire the person. But the person who simply drinks a lot of water, you're not going to hire them. Or you're not going to treat them in the same way. I think that's a little bit more dangerous. Refusing to hire somebody because of a negative dilute urine, whether there is a medical condition or whether there is not, in my mind, does subject the individual, does subject the employer to challenge by the individual for failure or whatever, for discrimination in hiring. I am aware of several private employers, not under the federal regulated system, who did require that people provide a concentrated urine. And if their specific gravity was dilute, they would make them give another urine specimen. And they gave them, I think, three chances. I'm specifically thinking, Donna, of Caterpillar. But that was some years ago. But it was a policy that was consistent for all people giving urine specimens. And so it was not discriminatory against any one individual. I mean, I've worked with Caterpillar for 10 years. I'm not aware of that. That would be, if it was applied across the board, yes. I don't see a problem. And in terms of saying that you have to produce, the question is, by the time that they have their third thing or whatever, and they still do not produce a concentrated enough specimen that Caterpillar likes, if the person is on a diuretic, would they say, well, you have to stop taking it so that you can produce a concentrated urine? Then I think you've got real problems. So I can't imagine that Caterpillar's legal staff, as I know them, would have taken that kind of risk. May I ask a clarifying question? This is Khaled. Please do. In my situation, I was consulted on a case with the two negative dilute. And the employer has actually a policy where it states everybody has to pass a negative test, concentrated urine. And if they have one negative dilute, they have to produce another negative dilute. After that, the job offer will be rescinded. The candidate provided a letter from her oncologist stating that she is taking a medication that cannot be stopped for any reason. And it is a diuretic. It's one of the hormone replacement, hormone modulator for breast cancer. I kind of challenged the HR to not rescind that. And we are to rescind the offer. And they give her another chance. So I feel there is a risk for ADA discrimination there. I just wanted to run it by you guys and see what's your opinion on that. Because I would like to help them rewrite the policy and offer some kind of, I don't know, leeway. But I see what Donna said about if you don't run it across the board, then you're going to be at risk of being sued for discrimination. So I don't know which side we should go with. Well, there's one other approach. And that is that if they have a policy that you have to produce a concentrated urine, and if this one individual for medical reasons is not able to do that, they could request a reasonable accommodation. And I think it would be a reasonable request. And I would think that if the employer did not do that, that they would be liable to a claim for discrimination. Thank you. Dr. Peterson, could you repeat the name of the book that you had noted when referring to the syllabus? We had a question about what the name of the book was that you mentioned as well. All right. Let me get that while Dr. Pete answers a question that Suma would like to ask you. I don't know what the question is. So please go ahead. And I'll get the book in the meantime. Hi there. My name is Suma. I'm a fairly new MRO, maybe for the past year and a half. I successfully took this course and passed it on my first go. So thank you so much for all your wisdom. I like to just come and listen to these discussions because I'm always learning something from everyone. So thank you very much. I might probably know the answer to this question, but I just wanted to do my due diligence and ask because I don't know any other local MROs around here. And so I kind of get all my information from here. But I'm a MRO for our local hospital system. Marijuana is not legal in the state that I live in. And so for our pre-employment drug screens, marijuana is on there. And so if they're positive for marijuana, we don't hire these new hires, right? Recently, our executive committee is looking into removing pre-employment marijuana testing, thinking just because in the news it's getting so rampant. Again, it's not legal in our state. So we're having a lot of discussions around this. My question is, I know what the legal limits are in terms of drug testing, but is there any minimum amount of marijuana in your system that constitutes impairment as such? I didn't think it was. I mean, I don't know if it's a minimum or maximum. It doesn't constitute impairment necessarily. There are states that have passed DUI laws that do have levels of impairment, but they're purely administrative. There's no scientific proof behind those levels of impairment. There's no question that marijuana impairs ability to drive. I mean, that's fairly open now at this point, but doesn't relate to a blood concentration and certainly not to a urine concentration. I didn't think it did, but I just wanted to ask. I think with our laboratories, the initial testing cutoff is 50 and then the confirmation through mass spectrometry is 15. Does that sound- 50 and 15? Correct. For the THC metabolite. Correct. Which obviously by itself is not pharmacologically active. Correct. Wouldn't expect that to impair, but no, there's no per se law like there is with alcohol for THC itself. I didn't think there was. It's just really sad because they lose out. We have a fair amount of positive marijuanas and most of them, hey, I went to the drug store or the gas station and bought the Delta-8 products. And so they're minimal amounts in their system. It still constitutes a positive, but we're losing good employees that may be, and I know it's, this is kind of a, it's difficult conversation to have, but we can't move forward with their employment because- Wait a minute, wait a minute. They're not getting Delta-8 and getting positive for THC at 16 or 20 or 28. You're right. This is what they claim. Sorry, I shouldn't mention it. This is what they say. So, I mean, you can't really know what they're thinking, right? Yeah, I mean, they're getting marijuana or cannabis. Again, we deal with this all the time. It's only from CBD. Well, that's just, certainly not from illegal CBD in terms of less than 3% THC, but- Am I right to just tell them that, a lot of these products are not very well regulated and there's varying amounts in each product, which who knows- Buyer beware, at your own risk. Yeah, and I would also, you may want to have a little chat with the lab director just to make sure that his THC metabolite procedure or her THC metabolite procedure differentiates Delta-8 from Delta-9. No, that's a good question. Okay. Because that is, most labs should be doing that and be able to do that. Not that you'd report Delta-8, I mean, because that's not on the panel, Delta-9 is, but just to make sure you couldn't get a false positive from Delta-8. Okay. I would hope not. I mean, they're all regulated laboratories, right? I mean, they all pretty much work the same, right? Theory. All right. There's always some, some people take a non-regulated specimen, which would be your medical program. It's not regulated by the federal government. And they run those a different manner than the federal government specimens. I would just double check that's the case. Our hospital does follow like DOT protocols in terms of collection and the resulting, so. Yeah, but what Mike is saying, what Dr. Pete is saying, and this relates to what the question earlier from Dr. King, that when that specimen, when your specimen comes in on a non-federal form, okay, all right, for drug testing, even though that's to a HHS certified laboratory, they have no requirement, if you will, and probably don't test that exactly the same as they would a federal specimen, okay? In terms of the quality control batches, in terms of a number of things. That's what he's alluding to. Yeah. The big labs, the labs that, you know, the question the lab calls everybody of that size, they always put things through the same process. And it's the process that DOT specimens get tested for. Small labs, because there's more requirements on the quality control, et cetera, for the DOT specimens may not run everything through the DOT standards. We use Quest, so they're pretty standard. In that case, then you're okay. But I've got to put on record, I was an employee of Quest at one point, so. Well, that's a good point. I wasn't aware of that, so I learned something there. You should be fine. If the Quest lab your specimens go to is one of those that are certified by HHS, you should be fine. I believe they are. All right. So the question earlier was to clarify what the alternative book was to the MRO syllabus. And I will unblur myself so you can see it, but we posted it in the chat and Chris Paciak put a link to the website. So that is the textbook that is a compliment, I will say, to the MRO syllabus. So if there are not any other questions, I'm going to ask if you can briefly, Donna, summarize the revelation that DOT actually finalized their oral fluid specimen regulations. I know they're effective in June, but they will not really be effective because there are not three certified laboratories for doing oral fluid. But can you summarize if there were any surprises, any significant differences from what you and Dr. Peet teach in the oral fluid segment of this course? There are not any real surprises other than the fact that there's a specific difference. There's really very little difference for MROs. Let me first mention that. For oral fluid testing and for urine drug testing in terms of the review of results, the reporting of results, et cetera, that's very much the same. The difference is that the collection device that is used is linked specifically to the laboratory's screening analysis procedures. So it has to be FDA cleared with the reagents that are used. It has to be HHS and DOT approved. Currently, based on the specifications by HHS, the FDA clearance that's out there now, there is only one oral fluid collection device that meets the specifications. And even that one, Mike, according to what I learned this week, that's an immunoanalysis manufactured device and it's called Quantisal 2, but it doesn't even have the reagent approval, the FDA reagent approval for several of the target analytes that would be tested for in oral fluid. And as Mike has said before, the cutoff levels that are used for oral fluid detection are very different from what are used for urine. So the laboratory really has to, the reagents, excuse me, the reagents have to have FDA clearance for oral fluid testing for those drugs, even though they may already have FDA clearance for those reagents used in urine testing. Do you want to elaborate on that, Mike? It becomes very complicated and convoluted. That's the problem here with all fluid. I mean, the concentrations, the cutoff points are much lower. The ability to run controls 25% and 25% below the cutoff is more difficult once you get down to those concentrations. And as I understand it with the immune analysis, you know, when they first went to the FDA for their reagent approval, 501k didn't have all the drugs that eventually became included in the SAMHSA panel in that 501k. And they're trying to go back to clarify the 501k, whatever they call it. But the difficulty for the labs in this new set of, and we've talked about it in the past, new set of requirements is the collection device. The ability to collect and separate to routine with urine, but it's not as straightforward with oral fluid. And that's what I, as I understand it, that's what's up, you know, slowing down the process of having the collection device FDA approved and the immunoassay FDA approved. Because the reagent companies would like to have them paired obviously for economic reasons, right? They could, then they can sell collection devices and kits. And today they can sell a collection device, which is a urine container. And they, you can get, labs can get the kits from anywhere. I mean, that's. So in a nutshell, what DOT has done with this final rule is that they are presenting to DOT regulated employers. You can choose, you can choose whether you want to have your continue with urine drug testing. You can choose whether you want to switch to oral fluid drug testing, again, same panels we talked about, et cetera, or you can use a combination of both. You can differentiate that by reasons for tests. You can do all pre-employment drug tests using urine specimens, and you can do all other types of tests while using oral fluid specimens, you can differentiate that by circumstances. For example, you may want to do problem urine collections with an oral fluid test. Once again, once you can implement oral fluid testing with having the approved devices and the approved laboratories to test them or oral fluid laboratories. But, so for example, if you're going to stay with urine testing, but you have a shy bladder circumstance, you can, under these new rules, after the person gives an insufficient urine specimen can say, okay, we're not going to sit here for three hours and give you up to 40 ounces of water and yada, yada, yada, and go through a shy bladder examination. We're going to do an oral fluid test. So that's an example. The other issue with DOT drug testing has always been the circumstances where a directly observed collection is required. Like on a second collection, when the first urine specimen given was suspect, temperature out of range, overwhelming odor of bleach or whatever, then the next test that needs to be done right then and there, if you will, another urine test, but it has to be directly observed. And that direct observation has to be by an observer who has the same gender as the donor, regardless of whether they're a medical person or not. So finding that person and having that person available has often been problematic. DOT a number of years ago said that all return to duty tests and all follow-up tests after completing the return to duty process and treatment, all of those have to be directly observed. So now with the flexibility in this rule, an employer, anytime a directly observed specimen is required, they can go immediately and do an oral fluid collection rather than an observed urine collection. So those are examples of how the program, the employer can, quote, mix and match the two specimen matrices for their DOT mandated program. There is one exception, which was kind of a little surprise in the final rule, because they made a big deal about it, is that if a direct observation is required on a non-binary transgender employee, then they must do an oral fluid collection. They cannot do an observed urine collection. That's for the non-binary transgender employee. Um, let me just go real quickly to some other things that have nothing to do really with oral fluid testing, but the other provisions of the changes in Part 40 that do take effect on June 2nd. And I will specifically talk to the changes that the MRO needs to know. Um, let me just back up one more time. For once oral fluid drug testing is, um, can be implemented by DOT regulated employers, do medical review officers have to take another MRO training course? Do they have to take another certification exam? Do they have to be requalified or recertified within that five-year window of when they were last certified in the end in order to review and report DOT oral fluid drug test results? And the answer is no. There is no requirement that you would have to be, quote, recertified or certified specifically on oral fluid testing in order to review those results. There is an expectation by the DOT that, uh, MROs will between now and the time that they may be reviewing DOT oral fluid drug test results that they would, uh, become familiar with the rules that they would take some other type of training, uh, you know, uh, a training module or whatever that is specific to, uh, issues related to the oral fluid, uh, uh, testing, but no recertification is required. Uh, so let's talk about what else changes, again, irrespective of whether it's an oral fluid test or a urine test. Uh, MROs can now uncancel a canceled drug test so that if you cancel the DOT drug test because of a, uh, an uncorrected flaw in the process, uh, let's say, for example, you were never able to get the copy two, the MRO copy two, which you have to have and have to review before you can report a result to the employer. And if you could not get that or could not get a substitute copy of the CCF, meaning the employer copy or the collector copy or the donor's copy, then you had to cancel the test. Uh, let's say that you're happy go lucky collector that, uh, you know, uh, you contacted to try to get a collector copy because you never got the MRO copy, uh, returns from their, uh, four month vacation in Bali, uh, and, uh, is now available to give you that copy of the CCF, then you can uncancel that test. If you have that corrective statement or that, uh, the, the document that you need within 60 days of when you canceled the test, if it's greater than 60 days after you have canceled the test, then you have to go to ADAPC to the office of drug and alcohol policy and compliance and get their approval to uncancel the test, uh, more than 60 days after you did report a canceled test. So that's a major change because before, once a test was canceled, it was all, it remained canceled and that was the end of the story. But now for, this does not apply for rejected for testing specimens or fatal flaw specimens, which can never be recovered, but for un, uh, unrecovered or uncorrected correctable flaws, you can do that. The second thing that is in this part 40 rule is that it had always been DOT's opinion, although I didn't think it was stated in the rule, but, uh, the people at, uh, ODAPC claimed that in validating a prescription with the pharmacy to ensure that the pharmacy had dispensed this medication, uh, to this individual, that discussion with the pharmacist had to be done by the MRO, the physician MRO, the physicians, the MRO staff member could not have that conversation or could not accomplish that validation with the pharmacy by talking with the pharmacist or with a pharmacy tech. Now this rule allows the MRO non-physician staff member to, uh, validate a prescription dispensed by a pharmacy. Thank goodness. And, and the last thing is that, um, they made a change, uh, actually I should say, they put additional clarification on the circumstances where a medical review officer for a DOT test is going to report it as negative, but they have a safety concern and the MRO has a safety concern either because of a, a medication that the person may be on in their, uh, in their, uh, opinion may have adverse effects on the individual's ability to perform in their safety sensitive position or two, that there is an underlying medical condition that may, um, preclude the individual from safely performing their DOT, um, safety sensitive position, or third, there may be medication or a medical condition that may mean the individual is medically unqualified under existing DOT agency medical qualification rules. There are medical qualification standards, as most of you are well aware, for commercial drivers, licensed individuals. There are medical qualification standards, uh, for pilots, uh, in commercial aviation as part of their aviation medical examination and their certification under FAA as a part 67 certificate holder. There are some medical qualification standards also for railroad engineers. So if, uh, again, those are the three circumstances that you as a medical review officer must report to the employer, uh, that there is a safety concern, you cannot do so on, based on this new, this final rule on the MRO copy of the CCS, that statement about the medical concern or the medical, uh, excuse me, the safety concern must be on a separate document, either an MRO report on your letterhead, a letter or an encrypted email to the designated employer representative. In that safety concern notice, you are to indicate whether it is medication that you are concerned about, whether it is an underlying or a medical condition that you are concerned about, or if it is a potentially medically disqualifying medication or medical condition. So those are the three things that, um, you know, most impact what you would do as an MRO starting on June 2nd for the MRO review process for any DOT test, which on June 2nd, it's still going to be just urine drug tests. You won't be reviewing oral fluid drug tests, trust me, by June 2nd. Um, one other thing I wanted to mention, because oftentimes MROs in the force have, have asked this, another change that was made to this part 40 rule is to allow the substance abuse professional assessments and, uh, evaluations to be done virtually. Um, so that as a medical review officer, if you wished to become a qualified substance abuse professional, which simply means taking a substance abuse professional force, that's been approved by the DOT and taking a substance abuse professional or SAP certification exam, you could perform the SAP assessments and, uh, evaluations that are identified and laid out in subpart O of part 40 in the DOT return to duty process. Uh, before it was not really feasible for MROs to function as SAPs because, uh, it had to be face-to-face in an office one-on-one. Well, now it doesn't, it's much more, uh, akin to what you do as an MRO with your telephone interview. However, the virtual interview can't just be telephonic, it must be essentially like a Zoom interview. It has to be real-time audio, uh, uh, audiovisual. Yeah. Okay, Kent, that's about, I think, what we have time for, and that gives you at least some idea. Good. So, a few of these provisions will be effective, uh, very soon, but the oral fluid part is still going to be months or years away. Yeah, I wouldn't say years. I mean, every, everybody I've talked to in terms of preparing for giving the webinars I've had to give, I've did three of them today, if you can believe it, on this rule, and, and one yesterday, so I, like, feel like I say this thing in my sleep, but in talking with laboratory people, in talking with contacts at HHS, in talking with a couple of people at the National Laboratory Certification Program, uh, there at least is some optimism that there may be two laboratories and the attendant, if you will, uh, qualified collection devices by the, uh, end of the fourth quarter of this year. Knowing what I know, Michael, about the FDA clearance process, what you know, what you've taught me, I think that's extremely optimistic, but that's what the word is out there. It depends how much work they have to do on the FDA validation. I mean, right, if it's simply, you know, a 501k alteration style, but they just amend the original 501k, then it could be fourth quarter, but if they've got to start from scratch, there's no way it's going to be fourth quarter. Yeah. Oh, hi, my name is Yong Kang again. Can you ask a quick follow-up question on my previous question? Sure. So, uh, my question is, okay, um, can we cancel this test and do a recollection instead of downgrade from FMCSA? No. Okay. Okay. That was a quick, that was a quick answer. I know you're trying, I understand that, but you're, you're kind of, you're locked in because it's a positive. Now, if the, if the result was negative, that's a whole different issue, right? But because it's a positive, because it is a positive, the FMCSA or the FAA or the FRA wants to review all of that data and make certain that that individual is not subject to DOT testing. Okay. Just because we use the wrong form. What can I say? Okay. Got it. Okay. You know, there's some parts of DOT that don't make sense, right? That's a part of it. Sure. All right. Thank you. Thank you. All right. So our May 10th faculty session is over. Thank you, Danielle, for hanging in there with us. Thank you, Chris, for being here. You had questions to answer. Thank you, Donna and Mike and all of you students. We will meet again in June and we wish you well in the meantime as students and as MROs. Good night, everyone. Bye-bye. Thank you.

MRO faculty

online course

introductions

student questions

oral fluid regulations

Department of Transportation

faculty members

MRO exam

time management

oral fluid testing

implementation