We've talked about collection, we've talked about lab, we've talked about updated DOT regulations, and now we're going to get to what may be the meat of the course and talk about all of the federally mandated rules that govern what we do as MROs. My disclosure has not changed from the introduction that we did. Here is my email address and phone number. I encourage you to ask questions either by phone, by voicemail, if I don't pick up, or by email. We still get questions from past courses and I enjoy the feedback, good and bad, but as long as it's productive, that's the best thing, and please don't hesitate to follow up as you need to do. So the reason we are redoing this is because the old presentations are in fact old and there have been changes. Some of the changes are no longer recent, which is why I put recent in quotes, because they've been out for a while. I think most of us are aware of them, but for those of you that might be looking to follow up this with an exam, I have, as I did in the previous presentations, left the changed thing, the changed content in blue font. So if you're reviewing for an exam and you don't want to read the black stuff that has been around for at least a decade, many of the black content slides have not changed in longer than a decade, you can just scroll through and look for blue. The blue is the new stuff, and the new stuff is, as this slide says, from 2017 on. I hope that helps you with the exam. SAMHSA, remember, puts out their mandatory guidelines, which apply only to federal employees subject to the Federal Employee Testing Program. And once that happens, if DOT wants to, well, not if they want to, DOT has to conform to the SAMHSA guidelines within certain limits. DOT can take its time issuing conforming regulations and frequently does. It's one of the reasons we have not seen oral fluid come out until recently. Until recently. But the DOT testing program is required to conform with the SAMHSA guidelines. So DOT took no time in conforming with the 2017 updates to include the opioids. As of yet, though, the opioids do not include fentanyl. More recent changes, we're not going to dwell on these. No blind specimens. At that point, in 2017, urine was the only authorized specimen. As you know from the previous slides, that's not the case anymore. We're going to go with that. Still can't do DNA testing. If you are not subscribed to the ODAPC list, sir, please do, especially if you want to do federal testing. Prescription information is not out there. THCV, add-on testing, we will discuss as we go down. Remember, you can use your own logos, but you can't use any federal logos on your official brand. Okay. Oral fluid testing. SAMHSA issued the first guidelines in 2019. They were effective the first of the year, 2020. DOT took until last May to issue their conforming regulations, and they did in a final rule that took effect on June 1st. So what? Nobody's doing it, right? And why aren't they doing it? Because there are no FDA-cleared devices, and there are no oral fluid laboratories that are certified by the National Laboratory Certification Program. Yes, there's lots of labs doing oral fluid. We all know that. We've been doing it for years. But that doesn't mean that their processes are yet certified by the National Laboratory Certification Program. We are recording this in July 2023. It is my best guess that oral fluid testing will not be rolled out before January 2024 at the absolute earliest, probably later than that. That's one of the reasons we're doing different color formats, because if you're taking this before the turn of the year from 2023 to 2024, the eyes are going to want to come back and review some of this. Hopefully, we're making that easier. Throughout, there's a lot of changes that you hear from Dr. Sample and Dr. Smith in terms of collection specifications, laboratory things. As far as MRO work, not a whole lot has changed. There's a few oral fluid-specific things that we're going to focus on a little more in these presentations than we did before. And there's a few other fairly significant changes, but not very many of them, to the parts of Part 40 that require the MROs to perform functions in accordance with what the DOT wants them to. We'll talk about them, and they will be, like I said, in blue. If you want to see what the SAMHSA proposed care mandatory guidelines are, here's a link for you. They are still not out. This is the only slide you're going to see on them for a while. The proposed guidelines are still, at this point, in July of 2023, in the Office of Management and Budget, awaiting presentation. The proposed care mandatory guidelines are going to say things that are essentially the same as already are out there. Urine and oral fluid specimens must be collected simultaneously. Hair specimen confirms positive. This is not, like I say, these are just in the guidelines, just for your information. Don't focus too much on the specifics of this slide. Here we go, black slides. This slide has been around since probably 1995. You have to be licensed in any one state, province, or Canada. You have to have a knowledge of substance abuse disorders, plus an undefined term called clinical experience. We don't know what that means. As I've told you before, I'm an addiction doc. Many of the people involved in this are family doctors, happily, occupational medicine doctors. In my humble opinion, it's really hard to be in any field of medicine nowadays that doesn't touch on addiction medicine in some way. We are all involved in that. We all need to be aware of that, and that counts as clinical experience. You have to know things about drug testing. That's what we're here talking about today. You have to be certified by a nationally recognized MRO certification board. There are two, MROC and AMRO. Recertification is still required every five years, although that was waived during the pandemic. We are past pandemic, he said happily, optimistically. You have to recertify every five years now. Those extensions have expired. Drug testing knowledge, this is not just what the laboratory does. This is the regs. As we've said before, when you take the exam, the regs are important as they apply to collection, as they apply to lab, and as they apply to us. You have to know collection chain of custody procedures. You have to be able to interpret the specifics of drug and validity tests as they are mandated in the federal testing program. For those of us that do work outside of the federal program, sometimes the interpretation can be different. What counts on the exam and what counts for the feds is that we know what they are doing and know it very well. In all drug testing programs, I think you have to know how to interact with everybody else that's in that program. Designated employer representatives, substance abuse professionals, laboratory toxicologists, collectors, everybody. The OTMRO guidelines are very important for you to know, not just for the test, but for your daily practice doing federal work, as well as a background for any non-federal drug testing that you might be doing, because forensic testing, gold standard, is always federal regulations. Qualifications, you have to meet the DOT training requirements, just like we said. You can be an MRO, but you can't review federal tests, DOT tests, until you have met the qualifications. SAMHSA requirements are the standard. You have to have them before you do any federal tests, even for SAMHSA or for DOT. The good news is that the new rules that are out doesn't impose new training requirements, but the DOT oral fluid rule says it expects MRO trainings to be updated. That's what we're doing. That's why we're hopefully making it easier for you. Continuing education, these have not changed. Qualification training required every five years, like we said. Requalification every five years and certification boards. Each one, MROC and AMRO, have their own certification requirements attached to this slide deck, are the requirements for the MROC board. The training has to address all the things you would expect it to address. Regulations, guidance, collection procedures for urine and oral fluid specimens, chain of custody handling, reporting, record keeping, interpretation of drug validity tests, the roles that you follow, and importantly, any federal regulation, the roles that you can't follow. How to interact with other participants and how you interact with the other participants in the program, including employers. Documentation. You have to maintain documentation. If you didn't write it down, likely it didn't happen. This is forensic testing. We'll talk more about the definition of forensic testing as we go on. Bottom line, if you don't document something, you're going to have a very hard time testifying that it actually happens. You also have to have a record. Give people, like authorized DOT representatives, when they ask. Employers and third-party administrators can be in various negotiations, union negotiations, contract negotiations, as well as being audited by the appropriate federal agencies, and they're going to need to show the documentation, so you have to have it. You are not a medical provider. You are an independent, impartial gatekeeper to the federal program. You are the quality control step, QC. You advocate for the accuracy and, most importantly, integrity of the process. You are encouraged in that role to consult with anybody you feel like you need to. You should not feel like once you take this virtual course, you're on an island, all by yourself, out in orbit somewhere else, without any ability to consult, ask questions, and have backups. Please don't feel like you're alone out there. Ask us. Ask DOT. Talk to the laboratories. Do not hesitate to do that, and if you see problems you can correct, do it. You look for legitimate, acceptable medical explanations for what the laboratories found. Again, consult where you need to. Remember, you are looking for legitimate medical explanations, and we are going to define the word legitimate as we go ahead because legitimate has to be defined in accordance with the guidelines from SAMHSA and the rules of the DOT under which you're functioning. In addition to that, you have to have a timely flow of test results. As I don't have to tell you, probably the employers want them all yesterday. Sometimes you can't do that. It is much more important to get it right than it is to get it out fast. Sometimes that's easy for me to say, very hard to do. Trust me, you got to do it right or it's going to come back to haunt you. Okay, way back when we were all teenagers, ODAFC put out guidance, and this guidance is still in place. You cannot hide. You have to have your name addressed, business address, phone numbers, and if you still use fax numbers, email addresses on the CCF. They have to be there. Your information, if you are employed by a third-party administrator, it has to be address, phone number, contact information of the MRO, not the non-MRO part of the TPA. It must be a street address and not a post office box. Believe it or not, I used to argue that. It didn't work. Laboratory drug test results have to go directly to you. Laboratory cannot release a confirmed result to the third-party administrator and then have that entity release it to you. That is not according to any federal guideline or rule. You have to set it up that way so that you directly get the results from the laboratory. You have staff that you must be able to supervise in a meaningful fashion. A lot of us work remote. We're even doing these courses remote now. You still have to have a structure that is meaningful supervision of the staff that you work with. You have to have hiring and firing authority over that staff. In other words, they really have to be your staff even if administratively they're being paid by a third-party administrator. You have to be able to show this on a DOT audit. The staff needs to be yours because you are the quality control staff. You are the gatekeeper. You cannot have a relationship with a laboratory that creates or gives the appearance of a conflict of interest because you may have to effectively turn that laboratory into a federal regulator to the National Laboratory Certification Program if you think that there's been something inappropriate or wrong going on at that laboratory. You can't have a relationship that forms a conflict of interest with that. Here's some examples. You cannot be employed, contracted, or retained by the laboratory. Your TPA can set up contracts in terms of laboratory function and TPA relationship. You as the MRO cannot have a contract with a laboratory. You can't get an incentive from the laboratory to function as their MRO. You cannot give a client an incentive to use a specific laboratory. You can't have your office in the laboratory. Other than in very large mutual funds, you can't have a financial interest in the laboratory. Now we're going to get down a little bit more to the meat of what we do. We have to have a little bit of a baseline. We have to understand that all drug tests are not created equal. The most important thing to realize is that drug tests are answers to a question. What question you are asking determines the answer. Are you in a detection program where you need to detect every single use of drug or any contact with a drug? Or are you in a deterrence program where your main program function is to deter the use of drugs in the workplace? Or in a period of time before the participant comes to work so that the likelihood of performance at the job is not going to be affected by the use of drugs? In a detection program, if your goal is to detect everything, what's the worst thing that can happen? The false negatives. In a detection program, the worst thing that can happen is you miss something. That's called a false negative. But in a deterrence program where the vast majority of people being tested are not drug using inappropriately, a false positive, in other words, a false accusation is the worst thing that can happen in a deterrence program. Because of what I just said, deterrence programs are mainly focused on workplace populations, which are low user populations. Detection programs are not. They're substance abuse monitoring programs. They're incarcerated individual programs. They're programs that treatment centers use in admissions and post-treatment care and monitoring. They're entirely different testing programs. Because of that, the protections for the people being tested in a deterrence program are much higher, much more forensically defensible than in a purely detection program. Okay. Medical review in a true deterrence program is required, and the main reason for medical review is the QC step we just talked about, but also to avoid the possibility of false positives. In a detection program, a positive is a positive is a positive. Sometimes medical review can be helpful, but it's not required. We also have to differentiate programs that are primarily clinically based versus forensic programs, and I don't probably have to tell you the main differentiator. Clinical programs need to have a medical benefit. You're doing them with a doctor-patient relationship to gain information that helps you in the treatment and diagnosis and treatment of your patient. Forensic programs need to be so rigid that they can stand up in court. You importantly have no doctor-patient relationship with the donors of drug test specimens in a forensic program. Forensic drug test specimens are not medical specimens. They do not belong to the donors. They belong to the person or the entity that is establishing the program. In the federal program, effectively, DOT owns the drug test results in their program, so it's a forensic program, not a clinical program. For clinical information, maybe sometimes all you need is a quick screen when a collection. That doesn't work in forensic programs. Like I said, in forensic programs, the results have to stand up in court, so it has to be established, certified laboratory procedures, every specimen. Screening versus confirmed. Point-of-collection testing is all screening. Dr. Sample is going to talk to you more specifically about that. As an MRO, I want to really emphasize, you should never, ever conduct an MRO review on a screening-only result, because of all the things that Dr. Sample talked about in his talk about the lab, screening results are sensitive, but they're not specific. MRO reviews require confirmed, specific laboratory results, and I cannot emphasize that enough. Medical review, again, just in the previous bullets, medical review is required in a forensic program. Again, as I said, drug test results are answers to questions. What we do with them is more important than the result itself. Drug-free workplace testing is fitness for duty only in the two instances cited here. The Nuclear Regulatory Commission has a fitness for duty program, and the DOT alcohol testing program is a fitness for duty program. Those are the only places where the testing that we do can be considered fitness for duty. Just because somebody might pass your drug test, that doesn't mean they're fit for duty. It means they pass the drug test. They're fit for duty after they pass their examinations and meet all the other requirements that the DOT entities require to function under that DOT-specific umbrella. Our programs are deterrence programs. Not detection programs. No matter how hard we work, especially in a deterrence program, or how right we are, the dragon's going to win sometimes. I like that slide. Administrative responsibilities. You get all the laboratory results, like I said. You get negatives, negative dilutes, positive, positive dilutes. All of these possibilities come directly to you from the lab. Just keep in mind, there's a lot of different types of results that you can get. You can get combinations. In other words, a negative is a negative, but it can also be a negative dilute. You can, this is really confusing sometimes, we'll have to talk about it more coming slides. You can get a positive and an invalid. You can get adulterated and positive. All sorts of combinations of things that we'll have to dissect as we go along. Again, they go only to you, any kind of secure format that works nowadays, hardly anybody uses faxes, as Donna said. These results are not considered to be official by whatever means you get them. However, at this point in July of 2023, they are not considered official until you get a hard copy of copy one signed by the certifying scientist. That may change coming forward. It has not changed in July of 2023. If you get reports electronically, they must effectively include everything on the custody and control form. I'm not going to read all these happily, but those are the things that have to be in the electronic reports from the laboratory. Laboratories have to certify the results, and that is why you have to get copy one, because that is the certification of the result and it needs to be signed by the certifying scientist with the result of the test check, the check mark. As I said before, you can get multiple results. If the lab finds the cocaine metabolite, but for some reason cannot complete testing for the marijuana metabolite, think for a minute and tell me what that report is going to say. It will say positive for the cocaine metabolite and an invalid specimen with the remarks from the laboratory. That will complicate your interview with the donor and may complicate your discussion with your employer representative when you do the report. We will discuss a way to handle that as we move forward. But look at that. This is in black. I told you we didn't color it especially, so this is not an update. This is something that's been in effect since 2008. You will get always quantitative levels from the laboratory for every result. Those levels are there. They can only be released to the donor and the substance abuse professional upon the request. You may not release them to the employer unless it's part of a litigation package that is part of a legal proceeding that's going on. You can't do it. Also, the reason for that should be obvious. As we have already mentioned and we'll talk about as the course goes on, quantitative levels are there just to show that the testing actually happened. It's not like you can be a little pregnant. You're not a little positive. You're either positive or you're not, regardless of what the level is. Remember, we have periods of detection that go along with all of the specimens that we are using. Urine is three to five days in most cases. We don't know where in that detection window the specimen was collected. We don't know if that level is going up or going down. We cannot use that level to say to a donor, an employer, or a SAP. We cannot use the level to say that person is only a little positive because we don't know that. We don't have that information in the two-dimensional snapshot that is a drug test result. You have to review with your staff all custody and control forms. You have to look at written comments about temperature ranges. Signatures have to be there. Most important, you have to verify that all of the numbers match up. As Dr. Smith said during the collection lecture, the most important numbers are not necessarily the donor ID number. You'll get a lot of questions about that if they don't match up. The most important numbers that have to match are the specimen ID numbers and the accession numbers. Those have to match between the results that you get and a copy of the custody control form that you get. The good news is the vast majority of the results you get are going to be negative. You can have your staff help you with the review of those CCFs. Somebody's got to review them. Staff's got to do it. You still have to review 5% of all the negative CCFs up to 500 per quarter. You have to review those that have errors. You can't get out of that even though your staff can review the administrative negatives and release them. Of all those ones your staff reviewed, you have to have to take 5% and review them yourself. Keep that 5% available for audits. I'm only going to rush through this because it's confusing. Every course we teach, stand down reporting is effectively not a player in any of our scenarios. If you teach enough of these courses, sooner or later we're going to have somebody taking it that actually has a client that's been granted a stand down waiver but it's very, very rare. The employer's responsibility is to tell you, the MRO, that there is a stand down waiver in place. Just to protect yourself as the MRO, you're going to want to see documentation about the stand down waiver. What that means is that every time you get a confirmed positive from the laboratory, you have to tell the employer that you have a confirmed positive that's under review. The employer can take whatever action the waiver authorizes that employer to take. Unless you have documentation of an existing stand down waiver, you are never, ever allowed to tell the employer that you have gotten a confirmed positive result from the laboratory and are beginning your review. You can't do it. You have to see documentation of that waiver to do it. Making contact with the donor. As we talked about before, you're going to need copies one and two. Copy one has to be signed. Copy two has to be signed. Dr. Smith talked to you about the errors of missing signatures on the copies. Copy two should contain for you a way to contact the donor. At a minimum, you got to make three attempts. Now, you can stretch that three attempts out somehow over 24 hour periods. You cannot call, get a voicemail, hang up, call, get another voicemail, hang up, call, get a third one in a space of five minutes and call that three attempts that are consistent with DOT regulations. That's not going to fly a whole lot of people. Try that, doesn't work. So, spread it out. Morning, noon, evening, early evening, last of the days. They come in late in the day, do a couple that day and or a couple the next day, but make three attempts spread out a little bit. Don't want to make the calls too late because after you make these calls, obviously, you've got to be accessible to the callbacks because hopefully they come. So, time them in accordance with your daily schedule so that you can be accessible. There's no contact after a reasonable amount of time after the third call. If you still haven't gotten a return call from the donor, you have to call the designated employer rep and ask them to contact the donor and have the donor call you. Now, that does not violate the stand down prohibition. You're not going to give the DER any test information. You're just going to say you need to have this guy call me, this lady call me. When you do that, again, we're back to documentation, document, document, document. Now, once you do that, the DER has to contact the donor immediately, just like you tried to do. Maybe the DER will have better ways to do it, hopefully, but the DER must contact the donor immediately and tell the donor they need to call you. The DER tells the donor that if the donor doesn't call you, in case the donor was screening calls and didn't want to talk to you, the donor, the DER has to inform that person there's consequences of not calling you. Those consequences are not that that person will absolutely fail the drug test because the person may not fail the drug test. The consequences the DER must tell the donor is that if you don't call the MRO, you don't get an interview. The MRO will report the result without an interview. Again, you've got to be accessible to that. Again, the DER has to make three attempts, just like you do. If there's no success after the three attempts, then the DER leaves a message. At that point, and only at that point, the DER may place the employee on temporary medical leave pending the MRO's contact with that donor. Again, document everything. What happens if the person never calls? For positives, invalids, and refusals to test, there are three types of verifications without donor interviews. If you have the donor on the phone and you know you're talking to the right person, verify the identity. The donor says, nope, don't want to interview, go bye. You can report it immediately after that, donor refusing the interview. You can report it in 72 hours after the DER put that person on medical leave, but the DER has got to tell you they did that. 72 hours after you know that happened, the donor hasn't called you, you can report the positive to the DER. Beyond that, 10 days. Now, that's the DOT world. In the federal world, that's not a realistic timeline outside of the DOT umbrella, but the 10 days have to be waited, and you cannot report a positive result for that period of time if you can't contact the donor. The 10 day starts when you get the downloaded lab result, not the confirmed copy of copy one. When you first get the result is when that 10 day period starts. Use of your staff. Your staff can do everything for negative functions, except they cannot cancel a test. That's really not a negative function. Your staff is limited to all negative functions, including for positives, they can make initial contact and schedule an MRO interview. That's how you do things. The staff may also, just like the DER, the staff may notify of consequences if the donor declines the interview. The staff may not discuss lab findings, and most importantly, folks, the staff may not ask the donor if they want to speak to you. Federal regs require you to talk to any donor with a non-negative laboratory result. So, the staff must tell them that, the staff cannot ask, do you want to speak to the MRO that doesn't fly? This is in blue. It's a major change, and we've been waiting for years for this to happen. It's a really good thing. The staff may now call the pharmacy if you've been told that there's a prescription effect, and that's the cause of the laboratory result. The MRO staff may gather pharmacy prescription information for you. This is the first time that DOT has allowed that. A lot of us have been advocating for that for years. I think, personally, my staff is better at that than I am. So, in this rule that came into effect on June 1st, the staff may now do it, but this is another reason, if you use a staff for this function, you must really have good control over them and a good working relationship with them, and you must be able to oversee function of the staff contacting the pharmacy. Give them a script. Tell them what to say and how to say it. Occasionally, monitor calls if you can. Use any method that you can to show that you are, in fact, doing appropriate oversight of your staff. Even though the staff can gather that information, there are things you cannot delegate. You cannot delegate the donor interview. You cannot delegate the discussion of legitimate medical explanations, i.e. prescriptions. You cannot delegate the cancellation of a test. You cannot delegate the verification of the test, and most importantly, even if the staff gathers prescription information, you have to verify that that's the right prescription, that that really is the cause of the confirmed positive. That's up to you, not your staff. The MRO team can collect, but you have to verify. You still, as much as I hate to say it, have to review five percent of the negatives. You can't delegate. Okay, we're going to do a quick interview synopsis right now. Before you start, you should think, okay, is this the right specimen for the right donor? Is the chain of custody as it should be? Does the laboratory report tell you everything you need to know. What would be legitimate medical explanations for this result I'm looking at? What would the donor have to tell me that I would believe is a legitimate medical explanation for this result? As we move into the MRO interview, I want you to realize that very little of that has changed for oral fluid. There are some changes and we're gonna talk about them, but the interview outline, if you will, has not changed with the beginning of the ability to test oral fluid. This checklist has been and still is in effect. So I'm giving you a checklist rather than a form. Everybody's got their own way of doing things. Just whatever form you develop that is most comfortable for you, stick by it. Just make sure it has all these steps in it, okay? Especially the order of the steps. And nowadays it's probably not true that the donor doesn't know why you're calling, but you have to assume that they may not. So you have to identify the donor and you as who you are, why you are calling, explain what you're doing, and before you do anything else, you give them an advisory statement, which we've called since the beginning of this program, drug testing Miranda, and we will talk about that. So follow this order in whatever way is comfortable to you as you're doing your interviews. Okay, identify. Is this Joe Jones? I'm Dr. Ferguson. I'm calling on behalf of whoever the employer is, discuss the results of the drug testing. Give them a date. Say as much as you can possibly say here so that the donor knows you're legit. And then you have to, and actually this is appreciated. Okay, when you take the time to do these proper identification steps, it is appreciated by donors, employers, everybody involved in this program. You have to get the identification number. Hopefully that most people aren't using full social security numbers anymore. If they do, just get the last four digits. The donor, whatever number they pick, I think Dr. Smith told us this, whatever number they pick, all they have to do is be able to regurgitate that number back to you when you ask for it. It doesn't have to be a social security number, a driver's license number, a CDL number, anything. You just have to be able to tell you that is the number. And obviously it's gotta be something the employer wants them to do. This is your opportunity to offer any information you may want that may help me find a legitimate medical explanation. That's why we're talking. This is your opportunity to tell me what's going on. Now, this is a tough one. This slide and the next three contain the full donor advisory statement, sometimes lovingly called the Moran. Most of us don't read all these slides. One of the reasons I haven't given you a form is you need to read these slides on your own, consolidate the information, say it in the way that is most comfortable to you that goes along with the flow of your interview, but make sure you get the information to the donor that they understand, number one, that there's no doctor-patient relationship, most importantly, that anything that is said in this interview is not private information. It can be passed on to employers, to DOT representatives, or anybody who's in a need-to-know situation. Beyond that, of course, it is private, but it's not private between you and the person you're talking to on the phone. As a part of the process of verifying the laboratory result, I'm interviewing you. I'm required to pass along information to third parties about the test result that will make you medically unqualified, or that I believe could cause a significant safety. The information may include information about your medication, other substances that may come up that may affect the performance of safety-sensitive duties. Read that if somebody admits that they're taking high doses of diphenhydramine or something. That's not on the drug test, but if it comes out in the interview, then if you think it may affect safety, you have to release the information. And there's a list of the people there to whom you can release the information. Remember, that information has to go to somebody who's in a need-to-know basis, but it still can be released once that basis is agreed upon. And I will make my determination based upon the information you provide during this interview. If I require you to get something else, you must obtain it. If you fail to do what I tell you to do, then effectively you are declining to discuss your test result. Okay, that's a lot of stuff. Can you say anything that we say may be passed on if it affects safety to the employer and other representatives? Sure. Again, figure out what is the most comfortable way for you to say this in your interview that gets the meeting across. That's what counts. In a major change from earlier rules, this was the 2017 and 2012 changes that they're still in effect. That's why it's in black. DOT requires you to report drug test result information learned during your interview if you think it's gonna affect safety-sensitive duties. It could be if it's a rule violation or if you think it will affect safety-sensitive duties. We will talk about this in more detail as we go on, but this is now not a may, this is a must. This is a requirement, which is why you have to be careful about how you phrase the Miranda warning. If you hear anything that in your medical opinion that may affect performance, you are required to report it. And if you learn one of those things, if you learn that he's taken a medication that you think could be unsafe in their safety-sensitive job, you must tell the donor that with consent, not without donor consent here, that if the donor consents, you can ask the donor to have the prescribing physician call you, has to be within five days, to have a discussion about whether the medication can be changed. Again, this has been asked since around 2012. Very seldom does it happen, but you must tell the donor this, okay? It sometimes can be a very difficult conversation to have with the prescribing physician, but if you hear of someone taking a medicine that in your opinion might pose a safety risk, you have to, right there during the interview, tell the donor that with their consent, the donor can ask their prescribing physician to call you. Clearly, you can't call the prescribing physician without that physician having a medical release from the donor. So it's easier to have the donor have the physician call you. If they're hesitant to do that, you could always go the release route if you wanted to. Big blue slide. 2018 DOT safety notification changes. We are talking about it. You must notify the donor of the safety concerns we just talked about. You must give the donor the option within five days to have the physician contact you. We just talked about that. Additionally, you must give the employer a negative report if you verify a prescription, whether you think that prescription is consistent with a safety hazard or not. This is controversial. We'll see that in a few slides. This is the role. As soon as you verify a prescription, you give the employer a negative drug test report, okay? If you think there's a safety hazard in here, you still have the five-day wait going on. Now, if your concern is about a medical diagnosis or a condition that is not about a specific prescription, then you can report it right away with a verified negative result. But if it's a prescription question, you have to tell the donor about the five-day period to have their doctor contact you. You have to hold that information from the employer for that five-day period, or unless the donor refuses to do that. Five-day pause. I gotta emphasize this again, it's very important. Even though the negative is reported, if your concern is about medication, you allow the five days. If the donor does not accept that option, then you can report the safety concern right away. But you have to hear and remember, document from the donor that they are turning down that option. If the donor accepts the option, you can do anything you can to get it done, to help with the contact with the doctor. I've heard this from previous courses, and it is not true that MROs cannot assist donors in doing the things that the MROs are asking them to do. Why wouldn't we be allowed to help? Just we are facilitating, we are making the program much more efficient by helping. It's not like we're helping them pass a test that they shouldn't. We're helping them get to the right result. So if you do not hear from the prescribing physician, or if the physician does not want to change the medication, then you must notify the employer of the safety concern. So if you don't hear from the prescribing doc, or if the prescribing doc contacts you, and does not change the drug, you report the safety concern. If the prescribing physician does contact you, then you still have the option of taking away the safety concern, unless something else comes up. I don't wanna speculate about all the things that might come up, this is kind of a place for medical judgment. If the prescribing physician agrees to change the medication, it's still up to you whether you want to elect, whether you want to notify the employer of the safety concern or not. But I would just encourage you to have a really good reason if you don't remove the safety concern. And in doing that, we have this again, term in quotes, reasonable medical judgment. You have to be able to defend what you do in this program. This is a very safe program, MROs very seldom get sued, but they do. The times they get sued, they're even less often found to be culpable or liable, but protect yourself. Good protection is one way to keep that percentage low. You have to use reasonable medical judgment, which in my opinion, means you have to be able to defend your decision with data. So the prescribing physician refuses to change the drug, even though that physician is insisting it's safe. If you don't believe it and you can defend your position, you go with your reasonable medical judgment. Collaborate with your clients about protocols for following this new regulations. It's tough on an employer to get a pre-employment drug test that's undergoing a five-day wait, especially when you can't tell them it's undergoing a five-day wait. So it's very important for you and your clients to be on the same page about this. You have to communicate with it. At least now it's been in effect for about six years. So it's a little bit more familiar than it was when we first did this presentation, but it is still something that I want you to talk to your clients about and make sure that you are doing things that you're both in agreement with. The last thing about this slide that's important is even if you think that the medication has been inappropriately prescribed, that's not your position to argue with the prescribing physician. Remember, we're doing a forensic practice. Regardless of whether it's medically dumb or off-label or whatever, that's between the physician and the patient. The donor is not your patient, so don't go there. Don't question the prescribing physician, but that might make you more inclined to leave a safety concern on in cases like where it comes up. Okay. Now, this is from an older episode of the MRO update from Robert Swatinski. These are concerns. I include them here only for your information and maybe as a template for you to have discussions about the five-day wait with your clients. Okay. Checklist four. Does the donor have a CDL? Does the donor have a Part 67 license? FMCSA test result, now you need to have that CDL. That has to be on there. Why? Because of the clearinghouse. Because you have to report it to the FAA. If a Part 67 holder has an MRO verified positive, you have to report it to the flight surgeon. So you have to ask these questions. These are questions now in checklist four that you don't have to ask. And we used to kind of advocate for these 30 years ago when we started teaching this course. Just like science evolves, MRO practice evolves. And I strongly encourage not going there with these kind of collection questions because in my opinion, in my experience, they become a Pandora's box. If you ask a donor for the positive result, if there's a collection concern, they're going to find one. In most cases where there is a seriously, a serious effect collection concern that is real, you will be told about it. It will come up in the interview. You don't have to go solicit it. So you can, if you want to ask these, make sure you document them if you do. But my opinion is don't. If you don't hear about it, it didn't happen. You've got the signed copy of the CCF. That's what counts. Checklist five, tell them what they tested positive for. Tell them what happens. Record what they say exactly. Does anybody use anything but a hands-free phone nowadays? I don't think so. But I didn't want to change that just because this slide's probably 30 years old. Drug specific queries. We will go over the specific queries as we get there. We'll talk about the drug. Each one involves different queries. I do not like, again, Ferguson's humble opinion. I do not ask questions that are remotely confrontational if I can avoid it. I do not ask, have you used any illicit drugs? Do you use any street drugs? How long have you been doing cocaine? I don't ask any of those questions. I know some do. I don't like them. They're confrontational. Somebody has a cocaine positive. I ask, can you explain it? Then I ask the specific medical questions that we're going to talk about when we get to the cocaine slides, but I don't want to confront these folks. And I'm kind of calling this the art of the interview. I think we all need to respect and listen to the donors and avoid confrontation. These donors are not our patients. As I said in the introduction, I think it was 1995, Robert DuPont, one of the icons of addiction medicine, did a study and said that people that tested positive on a workplace testing way back in 1995 had a 93% chance of having a substance use disorder. One thing about being an addiction physician in the role of an MRO is that this is not a diagnosis, but it is maybe an indicator. And maybe someone who needs treatment can go through this whole process and obtain treatment as the end result. In that case, everybody benefits. If you avoid confrontation and you respect and discuss with respect the conversation you're having with the donor, that will help that. Open-minded question, open-ended questions. Do not lead. What can you tell me about where the drug came from? Or what can you tell me about where the cocaine came from, the marijuana? Do you have a prescription? We'll go through the prescriptions that you need to ask about. Have you been around anyone doing this? You have ingested some. Don't confront, ask open-ended questions. And now we're going to take a little break. And when we come back, we will go into the specifics of the interview.

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