Hi, everyone, thank you for joining us. We'll get started here in just a few minutes. So, usually we can at least see the, whatever, the participants right. Yeah, if you click on the participants tab at the bottom of your screen, you should be able to see a column, a right hand panel should appear, we have who have joined us so far. This 12. Does that include us for the 12th? We're up to 10 attendees, not counting the 4 panelists. Oh, there's Kent. Oh, fabulous. Welcome Dr. Peterson. Hello. Hello. I will be the silent one. Well, it's very nice to see you Dr. Peterson. Thank you. Let me get some of my name. Are you outside. No, but I haven't been in the basement all day. And it's cold. Normally I hate the room. It's freezing down here. Why are you down there. This is my home office I have a whole floor. Oh. Eventually, I'll be closing my real office, and this will be my office so I have a whole suite down here. So, it's got a kitchen and a bathroom and a bedroom. And of course a large wine room and media room, but we don't eat on because it's a large space. We are right at the hour and we have 14 attendees who have joined us this evening. Not sure if you would like to get started with the agenda or if you want to give them another minute or two before you begin. Donna you're the lead so why don't you make the decision. Okay, well welcome everybody as Michelle said, this is our, they're not in yet. Everyone is in. Okay. Yep. So this is our final for the year 2023 Wednesday evening session for the MRO a calm MRO online course and to have an opportunity to, to talk with and interact with the faculty. So joining us tonight is our usual our cast of usual suspects as we would say right, Dr. Pete, our toxicologist and I'm Donna Smith I generally teach the DLT rules sections of the MRO course. Our first person whom you saw briefly but who has no voice to speak tonight to speak of is, is the course director, and has been for a number of years, and then also with us is Chris Pesciak who is the executive director of the medical review officer certification and she is the person that will could answer any and all questions relative to the certification exam, and the MROC operation. And then from a comms education department is Michelle Suarez, who is with us this is the first time that Michelle has had the auspicious duties of running this webinar for us, and we welcome you Michelle, and hope that all goes smoothly. Thank you. Okay. I thought we might start tonight. And then I'll kind of turn it over just see if Dr. P has something that he would like to add but I wanted to talk about and I'll also ask Chris to shine chime in a little bit big to bring you up to date on on what we did with the education. Development Committee that met recently in terms of how things are going in that direction with regard to the MROC certification exam. So what I wanted to talk about a little bit was that I did attend the quarterly meeting of the Drug Testing Advisory Board, which is the Board of Advisors for the Substance Abuse and Mental Health Services Administration division of workplace programs, which does all things relative to establishing the scientific and technical guidelines for federally mandated drug testing. So that is the board that makes recommendations to the, the DWP the division of workplace programs with regard to revisions to the mandatory guidelines the urine testing mandatory guidelines. And now we also have the oral fluid drug testing mandatory guidelines. We have proposed guidelines for hair testing. One of the things that actually most of the session that I attended last week was dwelling on the fact that the federal government and HHS specifically is looking to add fentanyl to the drug testing panel, all of you know that you know there is a, the federal drug testing panel which applies not only to the testing under the mandatory guidelines for federal employees in testing designated positions but also to Department of Transportation mandated testing and to nuclear regulatory commission mandated testing in, in the nuclear facilities, and that panel on has grown from its inception back in the 1980s late 1980s. The federal panel now currently has five drug classes, and 14 drug analytes within those classes in the opiate opioid category, the federal panel now includes morphine encoding six monocytomorphine specific for heroin hydrocodone hydromorphone oxycodone, and oxy morphine that right I think I did that right, and I was now looking to add fentanyl, and as another analyte, if you will, a sub analyte I guess you would call it like you could explain this a little bit better, nor fentanyl. And so the discussion was about how soon the laboratories could get up to speed with the fentanyl testing, both the for urine testing and for for oral fluid testing. And the discussion was pretty lively in that there are at least some question about whether or not there are immuno assays or assays available for both fentanyl and nor fentanyl because the assays on the market now correct jump in here Mike if I guess incorrectly but the the fentanyl assays on the market now being used by drug testing laboratories are miserably cross reactive to nor fentanyl. Is that right, correct. Yeah. And so that would mean it's kind of like we had the opiates screening assay that had no reactivity for oxycodone and oxymorphone so that's why when they revise that panel, the laboratories had to have separate screening assays for oxy oxycodone in order to pick up oxycodone or oxymorphone. So that looks to be a little bit of a stumbling block there was a spirited discussion as to whether it would be sufficient to simply add fentanyl to the panel as it is now and as it is tested in many labs, you know, for non federal or whether you know, HHS wanted to stick with having both analytes detective, I don't know where that's going to go because then of course they went into closed session, Mike and I both served on that board so we know what that's like in terms of now they're going to debate that in terms of what may happen, but bottom line is, if in fact they stick with the cut offs proposed and mandated testing for both fentanyl and nor fentanyl. I will have had a second birthday by the time that happens, meaning that it will be greater than a year. And of course the, the push is that it has always taken the Fed so long to add a drug that is of concern, and is, you know, whether you want to call it epidemic or crisis or whatever it takes forever I mean ecstasy was the perfect example of that MDMA. It took from the time that HHS proposed to add ecstasy at the height of kind of a rave and the ecstasy, you know, clamor. And so now I think it's very interesting that the second proposal that was a part of the D tab meeting was that HHS is now proposing to eliminate MDMA from the panel. And there was some discussion about that as to why MDMA, a lot of data presented about the number of positives for MDMA in relationship to the positives in federal testing for things like PCP, even for six monocytal morphine. You know, so I don't know where that's going to go, either, whether they will. And I'm not really sure why there was the push to drop MDMA. I suspect that it was because if they add fentanyl, they're going to have to do the economic analysis about what adding fentanyl for all of these millions of federally mandated tests would mean from a cost perspective. And maybe they felt that they could get some cost savings. But in terms of the labs by dropping MDMA Mike is it's chuckling because he knows that that's kind of a specious argument. Am I right. Yes. Economic analysis is pretty worthless. So, I don't know if you have anything to add Mike you probably talked to some folks too but I think, you know, everybody realizes the need to attack this fentanyl epidemic in some way or the other. You know, no slouch to that it understands the public reaction that's going on. But fentanyl analysis it's like one of those moving targets. I mean, there's not only the problem of the metabolite, there's an equal problem with what is actually on the street. It may not be fentanyl, very often it isn't fentanyl. And some of those immunoassay kits have less reactivity to those fentanyls and metabolites as well as norfentanyl. The second is when you come to confirmation, what are you going to require the lab to test for fentanyl itself is fairly easy to test for. It's concentrations in the fentanyl business aren't that low in both oil fluid and in urine. But once you start getting to some of the other metabolites of fentanyl or the other fentanyls, it's a whole different ballgame again because labs don't routinely do that broad spectrum of fentanyl. And the DEA probably has figures for what percentage of the seizures are actually not fentanyl, but something else. I haven't seen it. If they do have it, I haven't seen it shared. But I'm sure they do. And I'm sure I hope anyway that the Drug Testing Advisory Board has some visibility of that. Because this could quickly go the way of MDMA. It's a legal drug, number one, in some cases. And certainly in other cases, it's going to be very hard to detect some of those isomers that are kicking around. Because they can change so quickly just like anything else in this day and age. I think it's going to be interesting. MDMA is coming off the panel, I'm sure, because it's now almost legal for treatment of PTSD. So it's going to be interesting. I just don't see anything happening here quickly. The fortunate thing is that the labs can, they're all doing, most of them are doing fentanyl for some client or other. So it's not going to be a long trip for the labs to get ready for this. They're probably doing it in oral fluid and urine. But I just don't see this quickly because of the issue of what, you know, how are you going to interpret it? What are you going to do about the metabolites? What are you going to do about the analogs? I think there's a lot more than just detecting fentanyl. So that's my search here. The other item that probably is on people's minds has to do with where things are at with regard to the certification of one or more laboratories under the National Laboratory Certification Program for oral fluid testing. And I am sorry to report that each time I mentioned this topic, I have to revise my prediction from my slightly cloudy crystal ball as to when I think we will really have oral fluid testing in federally mandated programs. It looks like there has been very little progress made on getting FDA approval of a new oral fluid collection device that in fact can collect sufficient oral fluid and then be subdivided and placed into a tube A and a tube B and have any semblance of whatever, I guess you would say continuity or consistency with regard to those portions of the collection device or the pad. So until we get a collection device that is what we call a buffered, that uses a buffered solution, and then the laboratories can identify their screening assays in relationship to that device, we are set back months. And everybody that I talked to now. I mean you remember when we first thought okay maybe the last quarter of 2023 well we're certainly at the last quarter of 2023. I think last month I said maybe by the second quarter of 2024. I think there's a really good chance that I will be either retired or dead before we see this happen. Well we hope it's the form Madonna. I think we are at least 12 months away I mean, if FDA approved it tomorrow, and the reagent manufacturers you know got the reagents etc and a lot, I mean, and then into production, and the two labs going through the certification process because they. One thing that was mentioned is that NL NLCP and HHS has has said that you know they'll, they're, they're going to kind of lower the entry fees in terms of the thousands of dollars that laboratories have to pay for initial certification. In order to encourage people to apply but I mean I think that's a specious argument again, you know, because that's really not good. That's, that's, that is not what is holding things up there are not laboratories and nobody is going to apply for certification for oral fluid until they are certain as to what is going to happen with dot testing, and of course dot testing cannot go forward without an FDA approved split specimen collection device. So I guess testing could go forward, you know, using sequential or serial use of a single specimen collection device in the mouth, you know, one side and the other side or do one, get that done, and then immediately do the second one for to be available for reconfirmation. I don't think there's going to be many labs Mike you were in the lab business that are going to sign up to get reagents and everything in place that they would would test the hundred and some. I don't know how many federal tests are done a year it's not even 100,000 is it anymore. No, it's far less than that. Yeah, yeah. I think the labs that are going to wait, and, you know, they've got their market and all fluid today in non regulated testing. It's much simpler to do than what the dot want to do. The other counter the all the other thing that's an economic unknown is the cost of the kits are the cost of the collection kits more correctly. And it has to be a lifetime to them somehow. And, you know, how many will actually be used and who will be liable for the cost of those unused kits, it's going to be the labs, obviously. So, I'm, I'm hesitant to say that this is going to be next, next, next year fourth quarter could be ambitious. I mean it's a shame because we've been arguing for all fluid testing for over a decade. Yes, and it's now become so complicated that it will not be an option. It's, it's sad to see that. One of the things that, again, the DOT approval is not necessarily, well, yes, I guess not necessarily a factor here, but I have been working this way pretty extensively with a lot of workforce QA clients who do testing in the states of California and Washington. And both of those states enacted legislation that kicks in January 1st of 2024, that indicates that an employer cannot take an adverse action, meaning refusing to hire someone or terminating or firing or other disciplinary action on the basis of a test to detect marijuana use that tests for the non-psychoactive metabolite. And of course, urine testing and hair testing, both the results that are reported, the confirmation is for THCA, which is considered a non-psychoactive metabolite. THC, tetrahydrocannabinol is the, it's considered a psychoactive metabolite. So employers in California and Washington could continue to test for marijuana on their employment drug tests and use them for adverse employment actions if they used oral fluid testing. I'm not sure that's what the legislators intended, but nonetheless, that's how the law is, the laws are specifically addressed. So again, oral fluid testing is an option then. And now again, those state laws do not apply to DOT testing, but we have a lot of clients that do testing that, and they wanna continue to test for marijuana in those states. And so their only choice really, if they want to use those results for screening applicants, not hiring them or taking other adverse action in terms of their upholding their drug-free workplace policy is that they would need to move to oral fluid testing. Do we have some questions in there, Michelle? We do. I wasn't sure if you wanted to open up the Q&A or if you wanted me to read those aloud. I think that we can go ahead and read the ones that are in there. Let's see here. Why don't you read rather than me trying to do it? Did you have anything else you wanted? Oh, Chris, do you wanna talk about the MROC exam at all or anything right now before we go in and answering these questions? Sure, I can go through that real quickly. Okay. There has been some question on the MROC certification exam and the regulation changes that came out in June of 2023. It takes about a full year to get the exam updated with new information when these types of changes came out. So the first step was to review the current exam and update it so anything that conflicted with the changes was removed from the exam, so a new version went out. And then we had to meet with our committee of experts, Don is on the committee, to go over any questionable items and to review new items on the new changes. So that just happened two weeks ago. We just had that meeting. So the next step will be to get it incorporated into the exam. Can I tell you exactly when that will happen, but it will be sometime in the first six months of 2024. And it will definitely be prior to the AOHC exam. And are we in April or May this year? But it will be prior to that. There is nothing on the exam. If you're scheduled to take the exam soon, there's nothing on there where you're going to say, well, is this the old regulations or the new? You're always going to be working with the new regulations and anything that conflicts will not be on the exam at all at this point. So that isn't anything you need to worry about. Okay. All right, so Michelle, can you read one of the chat questions or a couple of them or whatever, or the Q&A? Yep, we have two in the Q&A so far. So our first question, a CDL holder was involved in a no-driving work-related accident. Which drug test should be conducted, DOT or NDOT? Yeah, it's a non-DOT test. And whatever the company's policy specifies for injury or post-incident testing is to be done. And the result, if it is positive, even if it's a urine test for the same drugs that would be on a DOT test, cannot, and this is an important thing, cannot be reported to the clearinghouse. You can only report to the clearinghouse as a medical review officer, a positive test that is a DOT test. In fact, a test that is done under the Federal Motor Carrier Safety Administration's authority. Thank you. Next one. In my experience, most fentanyl users are polysubstance users, particularly methamphetamine in my geographic region. Fentanyl is often mixed with or contaminated with multiple substances. I would think that the use of the usual screening panel would detect most illicit drug users, even without a specific fentanyl test, unless someone is on chronic pain medication via fentanyl patch for cancer, et cetera. Well, let me adjust, and there may be somebody participating here that's in the professional health monitoring field, which is a little bit different animal, but let me simply address it from what I heard presented from HHS and the Division of Workplace Program. It is true that fentanyl is being used, or it is drugs like Xanax or other benzodiazepines that are on the street, are contaminated with fentanyl, but don't forget the federal panel doesn't test for any benzodiazepines, right? And it's also being, now it's true that we do test for marijuana. And so that if a person is using marijuana that has been quote, laced with fentanyl, but again, in the non-DOT testing programs that have put fentanyl on their panel, it is probably close to a half of the fentanyl positives did not pick up another drug on the panel. I don't know why, but they didn't. They didn't pick up marijuana. They did not pick up oxycodone. They did not pick up morphine or heroin, 6M, et cetera. So that was some of the data that was given in terms of testing for fentanyl. Now, a lot of that testing is for fentanyl and norefentanyl. I don't know whether that makes any difference. I personally have not seen, maybe I've seen a few, but rarely do I see a urine positive test for norefentanyl that does not have fentanyl in it. I have another- Let Mike add onto that. No, I think this question from Dr. Saunders, it's a regional-based question because there's a lot of the areas of the country where she's correct. Methamphetamine is so high in incidence that it's probably mixed on the street with the fentanyls, but you're talking, I mean, I think everybody sort of looks at the fentanyl as being a problem on the streets and in the kids and all this sort of stuff. But there is no data that I know of to show that what the problem is in the DOT truck driver. I mean, some of these drugs that are really hot and heavy in young kids and on the streets are not present in a 57-year-old truck driver. So I'm not sure we've actually determined the incidence to do testing and make it worthwhile in the DOT population. I mean, we remember early on MDMA. I mean, there was no MDMAs because it was restricted to student use and rave parties, and it was hardly ever saw it in the DOT population. Right, in fact, yeah, it's interesting in terms of taking it off now in the regulated arena, the percentage of MDMA positives now is really unchanged from what it was 10 years ago. It's not different in the regulated population. Right, and the regulated population is an isolated population. It's not everybody in the population. So I think the public outcry about not having this DOT population, not testing for fentanyls has become, I suspect, a political issue more than a scientific one. There is a public outcry for it because there is, so. We have another question in the Q&A. Hello, I am in Florida and we have an online database for controlled prescriptions called e-Force that prescribers are mandated to check before prescribing controlled drugs. Is it acceptable for an MRO to use this database to confirm that a medication was prescribed? Unfortunately, no, it's too bad that Dr. Peterson doesn't have his voice. He's giving you the big no, and we have looked at this over and over again in terms of whether an MRO can access that database in the role of a medical review officer. And all of the states, in Florida included, the parameters for the use of that are that it is for a prescribing doctor, a doctor-patient relationship. And of course, from the very beginning, the underpinnings of the MRO role has always been that there is no doctor-patient relationship. I probably did not say that as eloquently as you, but maybe you can croak out a few things that I missed. Well, it's one of the most common questions we get, and it makes perfect sense that an MRO would want to take advantage of something that they have to be registered for, but it's only intended for people in a clinical doctor-patient relationship. It's not allowed for any kind of administrative use, and that's what this would be called. So no state has allowed that, and many have been questioned. Okay, now where else do we have? Is there something in the chat, Michelle, that we should pay attention to? No, nothing has come through the chat. Okay. Oh, we're getting some more questions in the Q&A. Does anyone pick up a significant use of PCP? No, when you look at the Quest Diagnostic Laboratories Drug Testing Index, it does not show literally any bump, if you will, in positive tests, both in the regulated or in the general workforce for MDMA, or excuse me, for PCP. PCP, at least in laboratory data, has always been very regional. Kind of getting back to Dr. Sauer's question, right? Mike always saw it around the Philadelphia, Washington, D.C., and that whole corridor, and then other times, pockets of it out in the far West, in New Mexico, Arizona, whatever. But no, I have not seen anything that would indicate. In fact, the positive rate for PCP is actually less than the positive rate for MDMA. And then, piggybacking on that question, can we reconfirm meds with the pharmacist? I missed it, because my dog was whining. What? They said, to piggyback on that last question, can they confirm meds with the pharmacist, reconfirm meds with the pharmacist? Oh, yes, certainly, yes. Yeah, and that's an expectation, that as a medical review officer, you would speak with the pharmacist, or you would get a pharmacy printout of what medications have been dispensed, yes. Yes. Then, any news about the Genotox lab? I understand that this lab may fold, which may eliminate the UDS DNA testing options. Hmm, Mike, what do I say about this? I have been involved recently, yes, with some discussions. I think the rumor or the information about the demise of Genotox's DNA urine testing program were somewhat premature and overblown. My understanding is what Genotox is closing is its clinical side on the pain management and the Medicare reimbursable activity. That's my understanding, that that is the part of the business that they are going to get out of. And without saying something that's going to get me in a lot of trouble, that kind of makes sense, because Genotox had some legal problems relative to that a number of years ago. I don't know, how long ago was that, Mike? I know you and I talked about that, and we saw those- Well, that was four or five years ago. Yes, right, so I, you know- And it was a reimbursement issue. Yes, so that's what I understand. That is the business aspect that they are going to discontinue. But as far as I know, their DNA testing for workplace, professional health monitoring programs, DNA urine testing, drug testing, excuse me, they are going to continue to do at their laboratory in Austin. Another question, meaning, can we call the pharmacy to verify medication use? That's a follow-up to the last question about- Maybe I'm not understanding what that question is. Can you unmute that person, Mike, and make it explain it? I'm not sure what- Let me see if we can do that. Yes, I have allowed that person mic privileges. So if you would like to go ahead and unmute. Hi, can you hear me? Yes. Hi, I got my question answered. Thank you so much. Oh, okay, great. Okay. Perfect. Okay, and then do you have info on EDTA preserving the DNA, preventing degradation? I'll take it if you want. Okay. I'm not sure what the question is, but there's no evidence that EDTA has any impact on DNA preservation. I mean, all EDTA does is it's historical impact on blood that it's known for. There's no evidence that it supports, well, no evidence that it favors DNA keeping or non-keeping, it just has no impact on it. That was our last question in our Q&A currently. Oh my goodness, Dr. Peterson's gonna fire both Mike and I, this will be the shortest session ever, right? Everybody's ready to go Christmas shopping, that's what's gonna happen. Right, right. Okay, with that then, I guess we will conclude and wish everybody a very happy holidays and especially to our friend and colleague, Kent Peterson, may the rest of your holidays go as well as so far and that your treatments continue to be tremendously successful. And by January, what's our next one? Ruth, I don't have a calendar in front of me. January three. Didn't you wanna announce that they're gonna switch to Tuesdays? Oh, that's right, we are going to Tuesday, aren't we? So it'll be the second Tuesday or the third Tuesday, which is it? Michelle, do you remember the email? Second Tuesday. All right, so I know that January 1st is a Monday, so that would mean the first Tuesday is January 2nd. So that would bring our faculty discussion to January the 9th, correct? Yep. And you can all take a minute right now to wish me a happy birthday because my birthday is on January 1st, okay? So when I see you on the 9th, okay, I will be another year older. We'll give you a Christmas privilege and take you down to another year younger. How's that? There we go. I'm definitely counting back. So I won't be able to see you when I'm in Houston, Mike, because you'll be in Prague, right? No, we're coming back on the 26th. Oh, okay, well, then I will get to see you. Okay, anything else? Well, happy holidays to everyone, enjoy. If you do have a question you gotta get answered, just email to, does it go to you, Michelle, now, or to Chris, or whoever gets, then we'll get them to Mike or me or somebody else. How does that work now? I will have to check to see what email address they were previously sent to. It was Danielle. Okay, I have access to Danielle's inbox. Okay, so just keep sending them in to Danielle, that would be fine. And then Michelle will get them to Mike and I, to get you an answer if you need one before January 9th. Okay, everybody. Enjoy the holidays. Have a wonderful holidays. Bye-bye.

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