All right, thank you. Hi, everyone, and welcome to tonight's MRO discussion. We are so glad that you could make it here to join us this evening. We are joined by Dr. Kent Peterson, Dr. Donna Smith, Dr. Michael Peet, and Christine Paciak. I hope I said that right. From MROC, and I will turn it over to doctors. Excuse me, Dr. Peterson now. Well, good day. Good evening, everybody. This month, we are changing from the usual technical format to a different one, and this may be a temporary change. So we cannot see all of your faces, but I think you can see the five of us. Danielle, do you want to describe the nature of the change and what you think will happen going forward? Sure, I can do that. Just to introduce myself, my name is Danielle Feinberg, and I am the manager for e-learning with ACOM. So ACOM recently had a new system integration, and the system integration is. For all intents and purposes, fabulous, but we are finding some small bugs and one of the small bugs is it doesn't like when you notify a lot of people about a meeting or a webinar, and it does not send out the notifications. It just kind of holds on to them forever and then it duplicates them sometimes. So if you received multiple notifications of it, that would be why. And I do apologize for that. I tried to find a workaround. So for this month and possibly next month, but at least for this month, what we will do is a Zoom webinar. So it's essentially the same platform. But what you received was an email directly from Zoom notifying you of the webinar and then you received a reminder email. So that's just kind of a workaround for this month. I'm hoping that we'll go back to the old way and then we can have everything scheduled out. But I really appreciate everyone's flexibility. We'll still record this. We'll still post it to the MRO course. So you'll be able to review the archives. And we're excited to have everyone here with us tonight. Thank you. Good. I do have a question, and that is, how can participants tonight submit questions to the faculty during this conversation? Is there a chat that they can type into or a way that they can submit questions tonight? There are two different options. We do have the chat capability or the chat function enabled, excuse me, or you can submit it through the Q&A box. You're more than welcome to use either one, and I will monitor both. All of our panelists should be able to see the chat as well as the Q&A. So please feel free to post your questions into either one of those. And then we can share the questions there. Wonderful. Another announcement is that although you are subscribed to the MRO online program, ACOM has made a decision to hold a live MRO fast track course that will be held on October the 28th and 29th in Elk Grove, Illinois, at the ACOM Learning Center. And those of us that you see here, Dr. Smith, Dr. Pete and myself and Dr. and Christine Paciak will all be there at the Learning Center. And so if some people who prefer a live faculty as opposed to an online course are interested, you should be aware that that will be be held. And then there'll be another live course in Orlando next April at the Occupational Health Conference. There are some changes within MROC, and I wanted to ask you, Chris, if you would just indicate that there have been recent elections and the change of officers and any other announcements that you might want to make from MROC. Sure, at our recent board meeting, we did have a couple important changes that came about, you know. Firstly, thank you to our our past officers, including Dr. Peterson, for the great job they've done. But we are transitioning with a new set of officers. Dr. Ben Gerson is taking over as chair. Dr. Ken Lincoln is taking over as vice chair. And Dr. Doug Martin will be taking over as vice chair. Dr. Doug Martin will be taking over as secretary treasurer. Another big item that came out of that meeting is that we are no longer going to offer CME credit for the quarterly newsletter. So we are going to open it up to the public for free. There will be no cost for the newsletter any longer. And if anyone is interested in getting access to the newsletter, you know, please just send me an email. Danielle has my contact information and I'm happy to get you into the newsletter. I think that's it. Good, thank thank you and thank you, Chris, for being here. Dr. Smith, I know we talked at some length last month about the specifics of the final rules that were published by the DOT about oral fluid and other changes. But can you just give us sort of a brief announcement and summary of that, because we've been waiting for years. And this is a very significant publication. Right. Well, the DOT did a rule, a final rule and revisions to its part 40 procedures that are effective June one this past week so that oral fluid drug testing can be used in addition to urine drug testing in place of urine drug testing or in combination for DOT regulated employers who are required to do drug and alcohol testing. The oral fluid testing is lab based. It is not point of collection or rapid testing. It mirrors in almost 60% of the procedures. What is it? What has been in place for 30 some years for urine drug testing? And that is also something that right there. I need to stop and say that it mirrors the fact that there must be laboratory certified by the National Laboratory Certification Program and the Department of Health and Human Services specifically to conduct oral fluid drug testing. Currently, there are no laboratories certified. And best estimates from folks in the industry are that it will be three to six months before we the National Laboratory Certification Program is able to approve and certify laboratories for oral fluid testing. So you're not going to be reviewing your first DOT oral fluid drug test this month or next. Do not worry. In fact, the oral fluid drug testing, which again is the employer's choice as to whether they are going to use oral fluid drug testing or stay with urine testing, or as I mentioned, do some combination of the two. The employers are not permitted to implement any oral fluid testing until there are at least two drug testing laboratories are certified. Why is that? Again, the parallel to the urine drug testing program, which there must be a split specimen collection and every donor who has a verified positive or adulterated or substituted result is entitled to have the bottle B or the split specimen tested at a certified laboratory different from the laboratory that did the initial analysis, including the confirmatory testing. So that would necessitate in order for that to be available, that right or that option available, that there has to be at least two laboratories that are certified. The collection procedures, the training for collectors is, again, mirrors the urine specimen collected collector qualifications and procedures, et cetera. The one difference is that the collection device is, in fact, a device that must be FDA cleared. It must be HHS approved and it must meet the DOT specifications. The collection device, which the ones that are being used now in workplace oral fluid testing, is typically some type of an absorbent pad on the end of a plastic stick. The donor in the presence of a collector or monitor, whatever you want to call them, puts that device into their mouth between the cheek and the gum and waits for enough oral fluid to be collected. The ones that have been in use for the past. Oh, I don't know, Michael, at least 10 years, right? Or 15 years. Yeah. And longer if you count the life insurance business. Right. Those particular devices do not meet the DOT requirement that the device has to be able to collect the the oral fluid onto the pad or onto whatever it is, some type of a way to collect the oral fluid. And then it has to subdivide it in the presence of the person. So you can't use two separate devices and call one specimen A and one specimen B. So it will be a while. And then I'll let Mike chime in here real quickly, because the other facet that is so different from urine specimen collection, a urine cup is a urine cup. You can send it off to any laboratory, you know, excuse me, a specimen bottle for urine. Bottle A and bottle B is the same and can go to any laboratory. Any laboratory can accession that specimen and test it. But with the the oral fluid specimen collection device, the device itself, the buffer solution that is used to preserve and stabilize the drug that has been collected onto the pad has to be has to be FDA cleared in terms of the reagents that will be used to test that specimen. I probably didn't say that well, Michael, but you can maybe clean it up and explain why we are dependent on waiting for the manufacturer and approval of these devices. Yeah, essentially the collection device and the screening procedure that's used in the lab is a kit. And the two come together. You can't have the screening, the collection device work with a screening technology that's not been approved by the FDA to work with that collection device. And some of the adsorbent solutions can impact various kits. So they've all been all the kit manufacturers have approved internally to the kit manufacturers have approved their kits to work with a collection device. And maybe as time progresses, two or three collection devices. But right now, they'll only work with one collection device. And that partnership has to be approved by the FDA. And so therefore, again, Mike and I have talked with people in the industry, et cetera. It appears that it will be again several several months before we have the manufacturer of this device that is FDA cleared in terms of the reagent kit, plus is able to subdivide a specimen while in while collecting the specimen in the oral cavity and the mouth. The other specification that has to be a part of this collection device is a volume indicator. So that the that the the volume indicators like we had a temperature indicator on the collection cup for urine. We have to have a volume indicator on the collection device to determine when there is sufficient oral fluid collected that would be insufficient quantity for analysis with both a an A and a B specimen, a subdivided specimen. So that's really, you know, oral fluid testing, as I said. Yes, employers are starting to look at, do we want to use it? Do we want to use it for preemployment? Do we want to use it for random? Do we want to use it only for reasonable suspicion or post-accident? Those are all decisions that all each employers can make. Employers can use it for any of the reasons for testing. They can use it only in certain circumstances where a urine collection is problematic, such as a, quote, shy bladder or where a urine specimen has been provided that is suspect because of it being out of temperature range or color or odor that would necessitate a second collection immediately. And that second collection has to be under direct observation. So an employer can choose the circumstances that they wish to incorporate oral fluid testing. As far as the MRO, there really is very little difference in the procedures for the medical review officer receipt of oral fluid results. They will come from the laboratory, from the certified laboratory, just like urine test results come now at the laboratory. They will be subjected to the same panel of drugs that urine testing is under the federal programs. The cutoff levels are established by the HHS guidelines as they are for urine. They are much smaller quantitation for determining a positive versus a negative because of the deposition of drugs in the oral fluid in much smaller quantities than is true in urine. So the MRO will receive the oral fluid result. Will again, it will be a specimen that has been above the cutoff level on both the screening technology and and the confirmatory technology, which is some form of mass spectrometry. And then you will interview the donor just as you had before. The same circumstances apply in terms of what are acceptable medical explanations for an oral fluid positive test, as is true for a urine positive test. There is no specimen validity testing. Currently for oral fluids. So one thing that will potentially be different is that you will certainly not be getting the number of invalid laboratory results that you currently get with urine drug testing. Who knows what will happen in the future? But, you know, right now, at least that's that's where that stands. So the MRO review, there is still a bifurcated system for oral fluid, positive coding and morph and or morphine results to make an allowance for the possibility of poppy seed ingestion as an explanation for a relatively low level coding and or low level morphine positive result. We may see some change in that down the line, not only for oral fluid drug testing, but also for urine drug testing in terms of what are the what is that bifurcated cut off for medical review officers in terms of considering the what I call the poppy seed defense and quote. Otherwise, your reporting and your review and everything else is exactly like the like it has been. I'd like to mention two things that don't relate to oral fluid specimens. Specifically, but other changes that are effective January, June one for MROs, and that is that for the first time, medical review officers have an option available to them to uncancel a drug test that they have canceled. Again, it's limited in scope. You can uncancel a test that you have canceled when you canceled it because of an uncorrected correctable flaw, specifically that you had to cancel a test because you could not obtain a copy of the CCF that was the MRO copy or an equivalent copy. The collector had moved to Moose Breath, whatever, Siberia and was not contactable. There was no way to get any other copy of the copy too and under DOT rules, you had to cancel that result. Now, if that, a copy of the CCF is obtained within 60 days after you had canceled the test and you can, in fact, review it and it is whole and satisfies the requirements for the review of that drug test result, you can uncancel it and you can report the laboratory results or the verified result. If it's after 60 days that you are able to obtain the missing paperwork, then you have to go to ODAPC, the DOT Office of Drug and Alcohol Policy and Compliance, and ask for permission to go ahead and uncancel or overturn your canceled result and go forth with that action. That's one change that was made that's effective June 1. So it applies obviously to urine testing now and would apply in the future to oral fluid testing. The other change that was made, and it's not really a change per se, but a reminder, I guess you would say, and that is that when you report a DOT negative result with a safety concern or a safety notice, that information cannot be included on the MRO copy of the CCF, which you provide to the employer. Instead, that has to be on a separate MRO report, a separate MRO safety notice or safety concern. In that safety concern, you must tell the employer what it is that you are concerned about in terms of safety. Is it a medication that you are concerned about in terms of the person's ability to safely perform their safety-sensitive duties? Is it a medical diagnosis that you are concerned about that may again possibly make that individual unsafe to do the tasks associated with their DOT covered position? Or thirdly, is it a medical condition or medication that would mean the person may be medically unqualified based on DOT medical qualification standards? Now, the only positions that have DOT medical qualification standards are commercial drivers, CDL holders, and airline pilots, first officers, et cetera, cockpit crew. Those are the only two that have medical standards. There can be an argument made that for the locomotive engineers, there are also some medical standards associated with that. And I think that if you're doing railroad work, you would be pretty familiar with the circumstance where you may want to address that with the railroad. So those are the only changes really in the MRO process that are taking effect now. Good, thank you for a brief summary of what I know will be a very comprehensive set of changes. The good news for you students who are preparing to take the MROCC exam is that none of these changes will be on the exam that you will be taking. There has not yet been an opportunity for the Examination Development Committee to meet, to develop new questions. And so what we're talking about are the cutting edge. And I know what we're here tonight to discuss is the basics. So what I'd like to do first is to cover two questions that were submitted in writing prior to this evening. And then we have seven or eight questions that have come in in the chat, in the Q&A. And Michael, many of those questions as you are seeing are gonna be directed toward you. But let me share my screen and just show the first questions that came in. So the first question that came in, came in from an MRO in Shanghai, China. And he is a student of the course. And as we have said many times, there are no foolish questions and questions are intended to help us learn. So I'm gonna read his question and then I'm going to give you a sort of a step-by-step answer. So the question has to do with the interpretation of a positive test according to the DOT part 40, section 137. And the MRO correctly stated that section. So the question is that the regulation states that if you determine that there's a legitimate medical explanation, you must verify the test result as negative. Otherwise you must verify the test result is positive. And that is correct and that makes sense. Then he says, as far as I remember, marijuana belongs to schedule one substances. And even if there is a legitimate medical explanation, the MRO shall assess it as a verified positive result. So let me stop right there. I'm going to stop sharing and I'm gonna show you another page, which is the list of control substances. So this is in your syllabus. It's in tab one, the very first tab. It shows you schedules one through five and it does confirm. And I bolded this in the syllabus and you see it here, some examples. It's not comprehensive, but examples of schedule one substances are heroin, marijuana, and it's cannabinoids, MDMA, and then a list of other drugs that are not covered under the panel. So those are schedule one drugs. Now, I also then want to go down to schedule three and show you that under schedule three, some examples of schedule three drugs are dronabinol or the trade name Marinol. And that is a commercial version of tetrahydrocannabinol. So that is also a cannabinoid, but it is a synthetic cannabinoid. While we're here, I will also point out that under schedule two, one of the schedule two substances, which I've bolded is that of phencyclidine or PCP. So you have schedule one drugs, which are marijuana and it's cannabinoids. You have a schedule two substance, which is PCP and you have schedule three substance, which is dronabinol. So now let's go back to the question that was submitted and we'll discuss it. So the questioner says, as far as I remember, marijuana belongs to schedule one substances. That is correct. And even if there's a legitimate medical explanation, the MRO shall assess it as a verified positive result. That I would say is not correct because under US federal regulation, there is no legitimate medical explanation for the positive test result of tetrahydrocannabinol except for prescription medication. And that would be schedule three and that could be verified as a negative. So in federal testing, a schedule one substance that is a positive for THC will be reported by the MRO as a positive. Now we know that in non-federally regulated testing, some states have legalized marijuana and therefore for employers who are having you test under non-federal regulations as an MRO, you're gonna have to follow the guidance of your employer. If they want you to verify marijuana as having had a marijuana authorization or marijuana recommendation, that is up to the employer and they can give you that guidance. But under a federal regulation, you would never call a schedule one substance that is you would never call marijuana positive as a legitimate medical explanation. Now, then the last part of this question says additionally, although PCP belongs to schedule two substances, it is treated similar as schedule one substances, which means the MRO will verify PCP as positive even if there is a legitimate medical proof. And again, I want to stop and comment. At one time, phencyclidine did have legitimate uses as a veterinary medication. So it was legitimate and used in veterinary medicine, but in this day and age, there is no legitimate explanation for PCP. And therefore I would say there is not legitimate medical proof. Now, I suppose I could ask you, Dr. Pete, why is phencyclidine still listed as a schedule two and why hasn't FDA moved it to a schedule one? Any comments there? I think they've left well alone without opening Pandora's box because there are drugs similar to PCP in their pharmacological activity that are used therapeutically today. So I think they've just left it well being. PCP has no approved medical use. It's not used off label, quote unquote. There's no reason for a donor to have been given PCP. One of the things that I could add is that several years ago, discussions at HHS and at FDA, et cetera, that one of the reasons that they did not move it from schedule two to schedule one is that when that happens, it does make it so much more difficult to obtain the drug and use it for research purposes. Yeah, and that's correct. Yeah, and so that was really the primary motivator at that time. I'm going back 10 years or so, Mike. So I don't know whether that still would hold today. I think it probably would hold today because of the therapeutic uses being identified for ketamine. Yeah. Which is a very, very similar drug pharmacologically. And I think they'd be, they're wiser to leave it where it is because there is no approved therapeutic use for PCP. Mike. Okay, well, I'm grateful to the MRO for asking the question. You can see that you got most of your question correctly. However, under federal regulation, there would not be a legitimate medical explanation for THC or for cannabinoid. And certainly for fencyclidine, again, there would not be an acceptable medical explanation. So I think I'm gonna now jump to the Q and A's. And since I am hoarse, I wonder Danielle, if you can read the first of the Q and A's and Dr. Pete will be the one who can answer this. Absolutely. So our first question is, is it true that benzo initial screens can be false positive for all SSRIs, not just Sertraline? Sertraline, yeah. Thank you, sorry. I believe I had one with citalopram. Yeah. Urine test was unfortunately lost and not sent to a lab and will be repeated on the client's usual meds. The issue of benzodiazepine detection is extremely complicated because there are so many benzodiazepines and there are seven, eight, or maybe even more benzodiazepine kits, immunoacid kits, that have different cross-reactivities to not only the SSRIs, but also the benzodiazepines. There are some SRIs and other drugs, so lazepine being one, that will cross-react to some of the benzodiazepine kits to give a quote-unquote false positive on an initial test, hence the reason for confirmation of that benzodiazepine. The other complication in benzodiazepine testing is that labs have a variety of menus for the confirmation. Some labs simply do oxazepam, nordazepam, temazepam, which are really valium metabolites, or in some cases, the parent drug. Other labs will do alpha-hydroxy alprazolam. Some will do clonazepam and immunoclonazepam. So there's a wide, wide variety of benzodiazepines. So the fact that the lab gets a false positive on the immunoassay screen could really be they've detected a benzodiazepine, but they don't confirm it, not that there's an SSRI present in it. So, you know, it's a really mixed field, and I just continue to advocate that labs complete their benzodiazepine confirmation panel and that all initial screen positives go to that panel in that lab. This picture is complicated because there are increasing examples of designer benzodiazepines. As are designer opiates, et cetera. There's now designer benzodiazepines, and some of them may well give you a positive immunoassay, but would be confirmed as a negative. So this is really a field or part of the testing outside of DOT where the lab needs to confirm their screen positive to make sure that if there's no, there is or is not a benzodiazepine present. Thank you, Dr. Peete. Danielle, can you read the next of the submitted questions? The next question, is there any difference between a test by a forensic versus a clinical lab test regarding a substance not in the DOT panel? Absolutely. Yes. Thank you, Donna. I mean, I have really been struggling with this because of some work that I do, and Michael helps me along occasionally with professional health monitoring programs that, again, want to use very robust panels. I mean, that include many, many substances, and they are at much lower cutoff levels, often at seriously LOD or LOQ, right, for detecting a particular analyte. And the laboratories that do not have any kind of forensic procedures in place, and are handling these as clinical tests, they are missing what I think is essential for you as a medical review officer in terms of being able to have confidence that that test is accurate, that it is precise, and that it is reproducible or replicable. And there are, for example, in any kind of forensic lab, and I'm not talking just about HHS certified drug testing laboratories, forensic laboratories are used in a variety of settings, but there are three key things that you don't find on the clinical side. First of all, you have always have a double review process, if you will, in terms of certification of the batch of specimens, whether that's on the initial testing, whether that's on the mass spec, whether that's on a second confirmation procedure. You don't find that on the clinical side. Number two, you often do not have any kind of quality control, what's the right word for it, Mike, in each of the batches, standards or whatever? Yeah, there are very different, in a lot of clinical labs, there are very different QC protocols, the tests that are done clinically, quote unquote, and those that are done forensically. The clinical QC can happen once a day, and in some cases, maybe less than that, even once a week, given what the lab knows about stability of the instrument and the test. In a forensic situation, you have to have QC in every batch. So that batch could be 10 specimens, it could be 100, it could be one, but you still have to have QC in that batch. And that QC is designed to challenge the cutoff being used for that drug. And then the final one is chain of custody on the original bottles and on the aliquots thereof. So they're very, very different tests. But I equally well know that there are employees who use simple clinical tests in lab to do pre-employment testing. So it's out there, it's not probably the best thing to do. It certainly isn't the best thing to do if it's post-accident or random or something of that nature that might be challenged. But there are labs that do that for certain employers, but there are great differences between what they do and what a forensic lab would do. Thank you. Our next question. Next question. I have seen specific interpretations, quantities, and time from a PETH test by MROs. Is this something MROs should avoid? Donna, do you want to take that one? Sure. PETH testing, which is a blood test, either a blood draw or a blood spot, is not typically, nor is it appropriate for any kind of workplace testing. It is an alco biomarker. It is designed to identify whether or not a person remains totally abstinent from alcohol intake. PETH testing, does it have an MRO review if you're working for a professional health monitoring program? Yes, you will, as a medical review officer, be asked to review a PETH result. As far as what our MROs and the company that I work for that does review drug and alcohol testing results for about 37 professional health monitoring programs, one of the things that the MRO is often asked is, well, does a PETH of 272 nanograms mean that the person drank three drinks, four drinks, 10 drinks, and did they drink them yesterday, a week ago, or two weeks ago? No matter how many times we try to be very professional and very whatever to tell them, you cannot do that. Is there some dose correlation or alcohol intake correlation to a PETH quantitation? I mean, even that stretching it, the word correlation, wouldn't you think, Mike? Yes, I would think. I mean, there's certainly not, you cannot say that there is a dose relationship to quantitation of PETH. A couple of things that we can say as a medical review officer on these kinds of things is that at least to the extent of the published research and published data, a person is not going to have a positive PETH test above the standard cutoff, which is generally 20 nanograms per deciliter of blood, from any kind of incidental or unknown ingestion or exposure to alcohol, such as through mouthwash, through hand sanitizer use, through incidental alcohol in food products, et cetera. That generally speaking, that a positive PETH means that there was significant alcohol consumption that would be equivalent to four or more standard drinks of alcohol, i.e. 50 grams of alcohol. Mike, you want to go ahead? No, I think that's covered it. I mean, it's a test that's gained popularity in the last five years or so. I think it's a useful test when it's used and done correctly and interpreted correctly. But as with any blood or urine test or fluid test, some people just jump to conclusions, and that's a caution with the PETH test without question. So, Chris, I think that from an MRO examination certification point of view, the PETH test will not be covered on the exam. Is that correct? So this is an advanced discussion and not a basic that you'll need to know as an MRO. But I think that the next questions will bring us closer to the MRO basics. Can you read the next one, Danielle? Excuse me, question. A urine drug screen was declared invalid because of an elevated PH of 9.3, and the donor had no reasonable medical explanation. The MRO canceled the test and stated that recollection under observation is required. The donor is a minor. Does the parental guardian consent have to specify observed collection? Can the parent be present in the bathroom during the collection, or should someone else be present as a monitor for the protection of both the donor and the observer? We keep getting tough questions. So, Donna, do you want to start with that? Well, certainly with DOT, if it's a DOT test, the fact that the person is a minor, whether you're defining that as under 18 or under 21 or whatever, and they are subject to testing, there is no parental consent. There is no exceptions made to how the person must abide by the testing procedure. So if a direct observation urine specimen is required, that would be done on the 19 or 20-year-old or whatever under DOT rules. That is generally true. And again, I'm not an expert on all of the state laws that talk about workplace testing in relationship to minors. There are some state laws that talk about testing of minors in schools, but that's not workplace testing. That is testing that's done in schools as a part of under school board decision for students that are participating in extracurricular activities, sports, and that kind of thing. And in many of those states that have some type of statute or regulation about the testing of students in an education environment, in a public school environment, yes, there may be a requirement for, there's always a requirement even for parental consent for the student to be tested. That starts with it. And I'm sure that there may be some additional things that would talk about the circumstance that you mentioned with a direct observation being ordered by the MRO. And I would like to point out a little bit here about the invalid test with an elevated pH. I'm somewhat surprised, quite frankly, that the medical review officer would not have considered this elevated pH as certainly being within the realm of possibility of ambient temperature exposure, which we know can elevate pH post-collection. To me, again, especially in the summer months, and when you've got a pH of 9.1, 9.2, 9.3, certainly the DOT rule says to an MRO, you can't accept exposure and post-collection elevation of the pH in that range as a legitimate explanation for the invalidity. And you can simply have the person come back for another collection without the additional measure of direct observation. So I'm curious. I mean, I don't know the circumstance in this particular test, but that's something I would have asked. And, you know, let's also talk about, if this is non-regulated, let's talk about the invalid, and Mike can speak to this too. I know we think of this whole thing that, okay, if it's got a pH outside of 9, okay, or less than 4.5, is it now? Yeah, 4, whatever. Yeah, 4.5 is whatever, that that means that they cannot test the specimen. And that's really not very true. Now, again, for DOT, they say that you would declare that it's invalid, but it's not like this is an adulterated specimen, et cetera, and that it's going to mask or it's going to get rid of all of the drugs in a person's system. The real thing is having to do with the reagents on the screening test. Some of them do not do well with a higher pH, and some of them do not perform as well, optimally, at a lower pH, meaning at the 4.5 and below range. Do you want to add something to that, Mike, about pH and urine testing? Yeah, I would first second, you know, in the summer months, I mean, it's 103 today in Texas, and the humidity is approaching 100%. So, you know, as conditions like that occur, you know, the risk of alkali buildup, ammonia buildup in a urine specimen, it can be considerable, particularly if that specimen is not protected in any way from that heat. So, I'm with Donna, I think a 9.1, a 9.2, a 9.3 is probably maybe an invalid specimen, whatever that requirement is, but that could be the worst. I would not as an MRO call that a positive. That would be very difficult for me to do. I think the range of acidity and the range of alkalinity that impacts immunoassay kits, they're a lot more rugged today than they were many years ago. And they very well may operate at a pH of 4 and a pH of 9 without any decrement in performance. And I would say as part of a lab's validation of their immunoassay procedures, they test those kits at a range of pH in case samples of the type Donna and I are describing are occasionally submitted for analysis. So, you may get an abnormal pH, but if the lab verifies it or confirms it as a positive drug test, you're going to go ahead and proceed and treat it as a positive test. Yes. Okay. The next question asks you to look into a crystal ball, but I'll go ahead and read it anyway. And that is the question, is the DOT considering not testing for THC because of widespread use of cannabis? Any thoughts about that, Donna? I know there is no official answer, but do you have any indication that that's been considered by DOT? Yeah, certainly DOT and HHS have lots of folks working on contingency plans of what they do with regard to if FDA does reclassify marijuana as a Schedule 2 drug or a Schedule 3 drug rather than a Schedule 1 drug. Certainly, they have ongoing discussions about whether or not, and continue to look at the research with regard to performing safety-sensitive functions while using or with the use of marijuana. I do not, quite frankly, see a day, and I could be wrong, but I think that there is now over the past seven years, in fact, more and more data that does show that marijuana use has an impact on safety. If you just look at the drug driving, excuse me, the statistics, Dr. Peete just did an article about, again, the rise in positive tests for marijuana as it has become more acceptable, if you will, in society and in workplace testing. Interestingly enough, what a corresponding jump in post-accident tests that are positive. I mean, it's triple, isn't it, Michael? That's amazing. Now, is it because the person used marijuana that they had the accident? Can we prove that they were impaired? No, but again, we're getting a lot closer, I think, to saying that there is still some correlation between marijuana use and the impact on safety. DOT programs are safety programs. There's no question about that. It's not, do I think that the day will come and am I seeing it already in non-safety sensitive occupations and in our clients that do testing, pre-employment testing, they've taken marijuana off the panel when they're testing in retail environment, when they're testing in other non-safety sensitive environment. The people that aren't taking it off are construction industries. Even though they're not DOT regulated, they do not want to hire people who are using marijuana for their construction jobs, operating crane, climbing scaffolding, whatever. I don't think, of course, I don't have a lot of lifetime left, so I guess I shouldn't say in my lifetime, but I really do not think it within the next decade that we will see DOT indicate that safety sensitive individuals, pilots, locomotive engineers, commercial drivers can use marijuana regardless of its legal status. I agree with Donna. I think that in the last 10 years, it's become increasingly obvious. Maybe it's because of the increase of THC in the marijuana and hashish that's consumed today. It's become increasingly obvious that there's impairing effects. If you're in a safety conscious position, in my view, it would be hard to defend the use of THC in those environments. They may make some changes in how they test for THC. By that, I mean, for example, with going to oral fluid testing, one of the significant things that they did is that the testing is going to be for THC, not for tetrahydrocannabinol, THCA, acid. Now, what does that give you? THC is the psychoactive metabolite, right? The psychoactive constituent, yes. I'm sorry, yes. Whereas THCA is considered non-psychoactive. So might there be an overall change that says that you can only test for and take action for whatever body fluid it is for the psychoactive constituent? I can see that happening, Mike. Yeah, I could see that change happening. Then it would become a safety test, quote unquote. And that was the decision that was made in Australia by the equivalent of the Federal Aviation Administration. They decided a number of years ago to test not for urine, but to test for oral fluids. So I think that was their rationale. They did not want a long lingering metabolite to be detected. They were really more concerned about the active psychoactive chemical. I wanna change gears and do a follow-up to last month's discussion. I will try to remember the details, but as I recall, there was a commercial driver examination but it was not a DOT commercial driver. It was a driver exam, but the specimen was submitted on a DOT form and it came back positive, but it was really not a commercial driver exam. And so it had been reported to the clearinghouse. And the question was how to change it from a DOT exam to a non-DOT exam. And Donna, your advice was to write to DOT and to get the clearinghouse to change the result. And so you see that Dr. Young says that he submitted that request to downgrade the classification a month ago, still no response from FMCSA. What's the next step? Any advice? All right, now I'm looking at his question. It looks to me like he's requesting to downgrade a DOT positive to a non-DOT. And he has to go through the FMCSA Office of Drug Control Substance Use, et cetera, not the clearinghouse. And I can't remember the name of the person who is now at FMCSA in that capacity, but if it was to the FMCSA Drug and Alcohol Branch and it's a month, that's probably about normal, to be honest with you, because they have a very small staff and it takes forever. I would suggest that to send a reminder email to that same person in the FMCSA office and ask them the status of their determination of re-designation is the word you wanna use, not downgrading, re-designation of a DOT test to a non-DOT test. And if that does not work, if you do not get any response, then I would suggest that you call the office in Washington, DC directly. Good, thank you. I thought the clearinghouse was involved as well. Can you change something that once it's been submitted to the clearinghouse or is that a whole other kettle of fish? No, you can do that yourself. Okay, thank you. But what he has to get first is he has to get from, if he reported to the clearinghouse as a DOT violation, if he did that, okay, the MRO, and now he's trying, he's saying, oh my gosh, this is not a DOT violation. First of all, if it wasn't a driver, okay, I don't know how he would have reported it to the clearinghouse because that person would not be in the clearinghouse. Is that making sense? Now, if this was a driver, but the test was done as a DOT test, say as a DOT post-accident test and came back positive for marijuana, and then it was found that the criteria were not met for it being a DOT post-accident, but rather a post-accident under the company's policy. So now he's going to try to get that changed. It will be unlikely that FMCSA will approve that because they're basically saying that driver had a prohibited substance in their system. Okay, Donna, we've just gotten further information that they did not send it to the, report it to the clearinghouse. Okay, yeah. Okay, so Mike, let's go back to a question that has come up before, and that is about the other metabolites or the other forms of cannabinoids. For THC testing, would the oral testing detect Delta-8, Delta-9, Delta-10 versions? Isn't there one currently not detected in urine testing? Well, let's deal with the oral fluid tests. I don't know the cross-reactivity of the immunoassays to those particular isomers of Delta-9, but nevertheless, if they were detectable on the immunoassay, I can certainly get that for you, but if there was detectable on the immunoassay, all labs should be able to separate those isomers by any of the mass spectrometry technologies in place today. That should be part of their validation for that procedure. And when the NLCP visits for an inspection, they're asked to see that data. That should be available, and it's not that difficult for them to separate those isomers. Right. Good. All right, we have a couple more questions. We skipped over one that has to do with compensation, and we can't give you an official answer, but maybe some informal information. Could you read that, Danielle? If there's time, I'm hoping the faculty could share some insight on the typical compensation rates for working as an MRO for a lab or TPA on a contract or part-time basis. I've come across a couple of opportunities that look great, but the pay is much, much lower than I would expect for a position that requires a medical degree, medical license, and special certification. Thank you. I know in the early days of being an MRO, there were not many MROs, and MROs started by charging $100 or sometimes even $200 per case to function as an MRO. As the field has matured, the prices have dropped substantially, and in your syllabus, you saw some data that came from the MRO handbook that Robert Switinsky wrote, and we did include that information in your syllabus, but that is some years out of date, and I would suspect that the prices or the rates for compensating MROs are going down even lower. Do you have any idea what the reasonable range is now, Donna? Well, I do think it depends on how it's structured. I do work for a large TPA that employs six physicians certified as medical review officers. Two of them are full-time on staff, and so they have a commensurate package or whatever that is certainly equivalent. It's in a six-figure salary range, okay? It's a salaried position. As a full-time medical review officer, it includes other kinds of administrative requirements. Now, the other MROs that work for this TPA are contract, if you will, and they are part-time, et cetera. Two of them, it is on a case basis. In other words, they are reviewing cases. They could be an invalid. It could be a positive. It could be an adulterated or whatever. They're doing no negative case reviews at all. The rate per case on that ranges from $50 to $75 per case. Then there is also, I think, two more. One of our contract MROs who are essentially on a part-time, what do I wanna say, schedule, where they are working, for example, two days a week. Let's say it's a Monday and a Wednesday, and on those particular days, again, they are being fed the calls that come in, or the MRO staff is making to donors, and their compensation is based on an eight-hour day, if you will, or whatever period of time it is, and that's based on an hourly compensation that is in the neighborhood of, I shouldn't probably guess on this because I'm really not sure about that, but I don't think it is much more than $150 an hour, maybe close to $1,000 a day. So clearly, there are different ways that MROs can charge for their services. I charge based on my time that I spend on complicated cases, and that allows me to take on some legal cases, and I simply base it on the amount of time that I spend. So working for a half day or for a full day or full time, that's an easy way to negotiate a salary. I think where it gets complicated is if you're paid on a per-case basis. Generally, some MROs will charge for reviewing or overseeing negative cases, but that may only be a few dollars per case, and they will charge higher amounts for a positive or a non-negative, but in general, those are bundled together, and there's generally a single fee per case for MROs who are in private practice on their own. Yeah, I would suggest, Kent, that what you're describing is generally what's negotiated between a medical review officer and an employer and a company, not working for a TPA or a laboratory MRO section, if that's making sense. Okay, so that's about the best that we can tell you there. We had one other question that was submitted in writing. I won't show the question, but I will raise the issue. We're talking about a person who has a shy bladder. That is, they are unable to provide an initial specimen of sufficient quantity, and therefore, they're in that three-hour window. During that three-hour window, they're allowed, as you know, to consume up to 40 ounces of food. They're not required to, but they are allowed to, and during that time, if they do need to go to the bathroom, they will either produce an adequate amount of urine, like 45 cc's or more, or they may, again, provide less than 45 cc's, in which case, that urine must be poured out. The collector cannot save little bits of urine from one void and add that to another void, so that has to be thrown out, and it's essentially started all over again. If a person, during that three-hour period, needs to go to the bathroom and do more than just urinate, if they can collect urine at the same time, and it meets the criteria of 45 cc's, they're home free, but if they're not able to produce enough urine, they're basically starting all over. Do you have any additional comments to make, Donna? Because I know this is a concept that's a little hard for new MROs to grasp. Well, I mean, I think one of the things, just two things I can say. If the person is in a shy bladder protocol, meaning they have provided an inadequate specimen or were unable to urinate, and the three-hour clock has started, and they have been offered up to 40 ounces of fluid, and then at some point, I don't care whether that's 30 minutes later or an hour and a half later, and they say, I need to go to the bathroom, but I don't have to urinate, I just have to defecate. The question is, can the person be allowed, now, again, this is under direct observation according to the question that was originally asked, can the person be allowed to go into the bathroom and defecate and not have the direct observer go with them? And the answer to that is no, because again, you don't have any assurance, if you will, that in fact, they are also going to urinate, and therefore, okay, prolong the circumstance for not being able to provide a specimen. So I don't know that there's an easy way to do this, but again, I think that under DOT rules, you would say to the person, the observer will go in with you. Hopefully, you will be able to urinate first into the cup, if you will, and then finish whatever else needs to be done, but I don't see a way to separate it out, to separate out one circumstance from the other, that you can allow the person an opportunity to go back into the toilet enclosure for something other than attempting to give another specimen. Now, again, this is my hope and my dream, is that when oral fluid testing is allowed, I am going to strongly encourage 99.9% of the clients that I work with, from airlines to trucking companies, to oil and gas operators, that you want to stay with urine testing, that's fine, because it's cheaper and you're used to it, but for goodness sake, put into your policy that when a person goes in for a urine collection and they cannot urinate a full specimen, an adequate specimen on the first try, say, that's just fine, open your mouth and we'll take an oral fluid specimen. Everything is done and I don't have to worry. I don't have to have, you don't have to have collectors sitting there for three hours, you don't have to have multiple attempts, you don't have to do a shy bladder examination with a referral physician, and then you as the MRO have to determine whether or not that referral physician's examination supports a determination that yes, there was an existing medical condition at that time that precluded the individual from providing 45 mLs of urine or no, there was not, and therefore it's gonna be a refusal to test and you have a 50% chance of ending up in court. So I too dream of the day when the shy bladder is a historical reference. And that oral fluid has taken over in its place. So I think those are the questions for tonight. This was a webinar, perhaps by next month, we'll be back to our other format, but I think this worked well, even though we couldn't see you, the participants. Danielle, thank you so much for joining our team. Now that Heather Hodge has passed on, you are the person we rely on, we depend on, we're enormously grateful to you. It's a pleasure to work with you and thank you so much. Thank you, Dr. Peterson. And just a quick note, and we'll make sure to send out the invitations. The next MRO discussion will take place on Wednesday, July 12th. So kind of be on the lookout for calendar, meeting invites, things like that. Otherwise, thank you very much, everyone. Have a great night, drive safe if you're traveling. Otherwise, have a wonderful evening. Bye. Thank you. Bye. Thank you, everyone.

MRO

Medical Review Officer

benzodiazepine initial screens

SSRIs

comprehensive benzodiazepine confirmation panel

forensic lab tests

clinical lab tests

PETH testing

alcohol consumption

marijuana reclassification

DOT testing