Greetings. I'm Dr. Kent Peterson, a certified medical review officer. And the segment that we are now going to be starting is called the basics, because I want to bring everyone up to a certain basic level of understanding of drug and alcohol testing, and also to have us familiar with the basic terminology and some of the acronyms that are often used in the world of drug testing. What we will be covering in this next 45 minutes are some history about the beginnings of drug testing in a modern era. We're going to talk about what has been called the drug-free workplace program, a term that was coined by President Reagan in an executive order that began a drug testing program among federal employees. We'll talk about the purposes and types of drug testing, the standards of practice, and some acronyms that are frequently used. And we'll talk about the three basic steps, the collection of a specimen, the analysis of the specimen, and then the review and verification of the results. And we'll go into the steps, step-by-step, fairly quickly in this segment, because later I'll be going through them in much greater detail. We'll also talk about the duties and the responsibilities of the medical review officer, and tangentially, of the medical review officer assistant. So let's begin with a little history. We all know that substances have long been used throughout society, not only in the home, but in the work. We know, for example, in our archaeological digs, that if we look at the Roman fortifications throughout the very large Rome that the world that the Roman armies occupied, there were casks and bottles that contained alcohol, alcoholic beverages. We know that sailors on the ships, on the high seas, were issued grog. I used to think that was offered at the end of a long session of climbing up the ropes and hanging onto the masts and pulling and tightening the sails. But it turns out that grog was given at lunch, as well as at the end of one's job shift. So we not only are a substance-using species, but substances have been used at work and around the workplace for a long time. So how did we get into drug testing of workers? Well, one of the reasons is literally because of technology. You know, in the 1970s, a new technology emerged, which allowed rapid, inexpensive testing of urine and other specimens for the presence of substances. And this immunoassay technology made possible the testing for substances that was never possible before. At the same time, we had a problem. We had a problem in our war in the Vietnam arena, because many service people were terrified in the jungles of Vietnam. They had ready access to opiates, to marijuana, to heroin, and many, many of them came back addicted and very disabled as a result of substance use. So we had a problem with the use, prevalent use in the military, and a cheap and simple technology that allowed testing for it. And so it's not surprising that the U.S. Department of Defense was the first major government agency that began the testing of substances. That led to a great learning curve, an understanding of what a quality program needed to consist of, and it led eventually to a set of standards of practice that are now fairly rigidly in place and represent what, in my opinion, is a very, very high-quality program of drug testing in the workplace. The term drug-free workplace was coined by President Reagan in an executive order that required the Department of Health and Human Services to create guidelines for drug testing for any federal employee who worked in a safety or security-sensitive job. So the focus was on safety and security in what are now easily spoken of as safety-sensitive positions. And there were five components of a drug-free workplace program. The first was a written policy. So any company that's going to do drug testing of employees needs to make their rules very clear, very specific, written down, and communicated with the employees. The second component was supervisor training. It's important for supervisors not only to understand company policies, but part of the program was for supervisors to observe the behavior of employees and to notice if there was something that was off that might warrant mandatory drug testing. So this has been called for reasonable suspicion drug testing or shortened to for-cause drug testing. So how does a supervisor know what a reasonable suspicion is? What to look for in terms of behavior? Absenteeism on Mondays and Fridays, coming into work late, moody behavior, maybe getting into conflict with supervisor or other employees. So supervisory training was a second component of the drug-free workplace. A third component was that of educating employees about what types of drugs there are, how they're available, the problems associated with the use of drugs and what the company policies were in terms of prohibiting the use of drugs, not only at the workplace, but on nights, weekends, and on one's own time. And the fact is that not everybody knows what marijuana looks like, and so it was useful for employees, particularly those who are parents of younger children, to really have a better understanding of drugs. The fourth component of the drug-free workplace program was some form of employee assistance. Now, in the federal drug-free workplace program, that employee assistance meant the paid opportunity to visit and be interviewed by a substance abuse professional, by an employee assistance counselor, someone who is experienced with drugs and drug use, who can help determine if someone has a drug problem, can refer them to the appropriate treatment and rehabilitation, and evaluate at the end whether this person has successfully completed a rehabilitation program and is ready to be recommended to return to work. The last component of a drug-free workplace program is that of some form of substance abuse testing, some way of identifying the use of substances. Now, if that method had been the use of a trackball on a computer testing eye-hand coordination, it would have been a psychometric evaluation, and I'm not sure how much medical involvement we would have in testing of performance or behavior for impairment. But the fact is that drug testing involved the collection and analysis of a bodily fluid. So it required collecting, in most cases, urine, testing that urine, and then since the urine can contain substances that could be prescribed, taken over the counter, or even consumed by eating foodstuffs, it required some discernment about whether the presence of drugs represented an authorized, understandable use, or it really represented unauthorized or even illegal use. And that's why we, as health professionals, got involved in drug testing. Now, I remember in, I think, 1981, the American College of Occupational Environmental Medicine sponsored a symposium. It was called Drug Testing in Industry, an Ethical Dilemma. I actually organized that symposium, and at that time, we could have divided a room down into two halves, and one half would have said, drug testing is important. It involves a disease, an illness. It involves an impairment. We need to find these people, treat them, rehabilitate them, get them back to work. Of course, this is a medical program. The other group of company medical directors, occupational health professionals, would have said, drug testing is something that management wants to do. It wants to find and fire people who are using drugs, and it will damage our credibility as health professionals if we get involved in reviewing drug test results. That ought to be contracted out. We really ought to have nothing to do with it. So there really was the belief in 1981 that there was an ethical dilemma. Now, obviously, in the 20 years that have occurred since then, the entire room has shifted to the fact that this is a medical program and that a far greater benefit to people can be had by testing, finding that there's a potential problem, getting people into care, and helping them to return to duty, because our goal is not to have a large unemployed workforce, but to have people fit and able to function in their work. But notice how quickly and how dramatically the landscape has changed. Now, what are the purposes of drug testing? Well, these are not written down in any federal regulation, but a few years ago, your faculty got together and said, well, there's about six or seven main purposes of drug testing, and the first is to reduce within a population of workers the inappropriate or illegal use of substances, particularly people in safety-sensitive positions. A second purpose of drug testing is to educate the workforce. If you know you're working for a company that could test your urine for drugs on any day at any hour, it's definitely going to get your attention. I remember having a daughter who had just graduated from college. She had had her first job, and she was thinking about getting a job to work for the airlines. I found it really interesting that my daughter, still in her late teens, was asking me, Dad, how long does marijuana stay in your system? I'm just curious, and I found it very interesting that she asked. Also, that she took a trip to West Virginia for a few days right after that, and that she did, in fact, get a job working with an airline, became a supervisor and a manager, and at one point, actually supervised the drug testing program at a whole airport. But as I say, a drug testing policy will get your attention, and it'll be the source of education. A third purpose is to identify and remove people who are using illegal drugs or drugs inappropriately from safety-sensitive positions. And I'll show you the data that shows that people in safety-sensitive positions who use drugs do have more accidents and injuries and lost time. Another very important part of drug testing is to get the people who have a drug substance abuse problem into treatment. I mean, we all know that denial is a lot more than a river in Egypt. Denial is a major component of the misuse of alcohol, tobacco, and illegal drugs. And so confronting someone with the fact that they may have a very serious health issue, encouraging them to talk with a substance abuse professional can be a very, very beneficial and therapeutic process. And finally, the nature of drug testing is such that it creates a deterrent. You know, if I know that I'm at risk of being tested, and maybe I'm only tested once every two years, but on any day there's a chance I could be called, it gets my attention, it educates me, and it creates a deterrent that may really alter my behavior on a Saturday night when I'm away from work and I'm being offered that extra highball or a chance to try some recreational drug. So we have a deterrence-based program. And Dr. Smith will talk to you later about the difference between a fitness for duty program and a deterrence-based program, which is the fundamental foundation of the Department of Transportation Regulations. Now, what are the different types of drug testing? And again, we're just going through the basics at this point. Well, the most common form of drug testing is what used to be called pre-employment, but a more accurate term would actually be pre-placement, because I may be working for an employer in a non-safety-sensitive job, and then I may shift to a safety-sensitive job, and before I am placed in the safety-sensitive job, my employer may require that I have a clean urine just to make sure that I will not endanger the health and safety of myself, other people, or the public. So the terms can also be called applicant drug testing, or as I say, pre-placement. Another form of drug testing is the post-accident. Let's say I've had an accident where I had a lost time away from work injury, or I had damage to a truck, or to goods or equipment, or to someone else. You know, most employers will have a criteria that defines what does a post-incident or post-accident test require. Maybe I'm a member of a union, and I violated a safety procedure, but that was called an incident, and therefore, I needed to be drug tested. So that's another reason why someone might be required to take a drug test. After all, we do know that substance abuse can be associated with accidents. A third form of drug testing is what I mentioned earlier, and that is reasonable suspicion. A supervisor observes the behavior of an employee, and the employee is really acting unusually compared to their usual behavior, or strange by any standard. Maybe they're skipping work, taking very long lunch hours, or coming back after break seeming a little bit out of it, or they're moody and irascible. Whatever the particular behaviors are, they need to be documented, not only by the supervisor, but by the supervisor's manager. So we have two levels of supervision, noting behavior, talking about it, writing it down, documenting it, and then deciding we are going to require this person to undergo a drug test. Now, what if they refuse? Well, if they refuse to undergo a drug test, it may be required as a condition of employment, so their job may be threatened, or they may say, okay, if you refuse to have a medical evaluation or a drug test, then you're going to be dealt with based upon the performance problem. So if you've got a performance problem, if it's due to a medical problem, you may have a chance to be treated and rehabilitated, but if you refuse to go, then you're going to have to deal with the consequences of your erratic attendance and your unstable performance. So those are the kinds of dilemmas that come up in the workplace. Another form of drug testing is random testing. So if, in fact, we have a random testing program, that means that all the employees who are in a drug testing program are put in a pool. So let's say that this plate of fruit is, in fact, the names of people who are in a pool. Then at random, on a periodic basis, names are drawn out of that pool, and they are drug tested. Now, if the drug test comes back negative, does that mean that that's put aside and then other people are taken from the pool? No. The names are put back in the same pool, so the very next week or month when another time for drug testing occurs, that person is still at equal risk of having their name drawn. Now, we all know that based upon the principles of statistics, some people's names are going to come up two times, maybe even three times in one year, and other people's names aren't going to come up for three or four years. But if you have a 50% sampling rate, that means that on average, one half of all the names in that pool will be tested in a given year. More frequent is to have a 10% or a 25% sampling rate, so one quarter of the people are actually tested, but it's based upon their names coming up on a random basis. The next two types are return to duty and follow-up, and it's important to distinguish these two. Return to duty means that I have been out from my regular job for a period of time. Now, maybe I'm a seasonal worker and I've been out for three months, but before I come back to work, my employer's policy says I have to again have a clean urine before I resume my job. More often than not, a return to duty test will mean that I have had a positive drug test. I have been out while talking with a substance abuse professional and while getting some form of treatment or education or rehabilitation, and now I'm about to return to work. It makes sense, doesn't it, that before I come back to my safety-sensitive job, I have to give another specimen and document that I have a drug-free urine. So that would be a return to duty test, but let's say that I have a negative specimen. I do, in fact, return to duty, and now I am going to be tested more frequently than the people in the random pool. I'm going to have a follow-up testing program that's going to require me to have at least six drug tests over a 12-month period. The policy will be set by my employer, but again, there are federal requirements for those in the Department of Transportation, and those are often good guidelines. So it means that I'm in a random pool of one. So I'm going to be tested more frequently, and therefore, I know that I have to be very, very meticulous in continuing to stay off of drugs. So those are the different boxes on the custody and control form that will be checked in terms of the type of drug test, and Dr. Smith will go over those in her segment on specimen collection. There's also a last form, which is called the periodic or voluntary, which means, let's say, I have a regular annual physical as part of my job, and as part of that, I'm going to, that will include a drug test. Now, you might very well ask, well, if I know I'm going to have a physical, and I know I'm going to have a drug test, and I'm scheduled two weeks in advance, why even bother? And all I can say to you is they don't call it dope for nothing. You know, every year, as a medical director of a company that does annual physicals, mobile health testing, I find people with a positive test, most often for marijuana, and I call these people up and say, you knew you were having your annual physical, why did you smoke marijuana? And we have some interesting discussions, but there's not a federal requirement, except in certain agencies, that it be scheduled. At one time, the commercial driver's license drug test was part of the driver examination, but that was separated, so now the DOT driver drug test is totally separate and independent from the DOT driver physical examination, which can include a drug test at the discretion of the examiner, but it is not an official DOT drug test, it is a clinical drug test, and it can test for any particular substances, and it does not need to follow the federal guidelines, so that's separate and distinct from the DOT driver drug test, which is no longer part of that physical examination. Now, I've already mentioned several times the word standards of practice, and when we think about drug testing, the standards or guidelines or the mandatory guidelines that came from the Department of Health and Human Services are the ones that are first thought of. So the Health and Human Services had the first set of mandatory guidelines, the Department of Transportation really created the gold standard with a very detailed set of protocols, the Department of Defense has, as I say, a more rigorous drug testing program with a higher rate of sampling and with every specimen being a witness collection. So at one point, we talked about regulated drug testing and non-regulated drug testing, but we don't talk that way anymore, because almost all drug testing falls subject to some kind of regulations. For example, state laws, more than half of all the states have a law which governs drug testing, very frequently this involves workers' compensation. So let's say that I have a workplace accident or injury, it's a lost time accident, I'm missing work because of the injury and under workers' compensation, I may be able to claim pay for my lost time due to an accident. Well, many states have requirements that say if I have a drug test and if it's positive, then I will not be compensated for my lost time because of a positive drug test, because I contributed to that accident in a negligent way. So the legal term is contributory negligence and that's a way for states to save money and to put the burden back on the employee if they had a positive drug test. There are many union contracts that also govern drug testing. A decade or so ago, our MRO faculty was asked to teach a private drug testing course to physicians working for General Motors. We did it in Palm Springs, California. I'd never been to the land of Bob Hope before. It was a very interesting experience and it was a very interesting experience for two reasons. Number one, in the back of the room with all the physicians in it for their continuing medical education, there were rows of chairs filled by union members, union representatives, because union reps attended every single hour of continuing medical education because the union wanted to know what the doctors were being taught, what they were being told, and to really make sure that they were getting it right. The other thing that was interesting to us was that General Motors did not have any employee drug testing program. Now you might ask why and I asked the question myself and it was very simple. The reason they didn't have a drug testing program was because there was no drug problem. It was so clear and obvious that it was written down in the union management contract that there's no problem and there will be no drug testing and that is a negotiated part of the union contract. Now I also found it very interesting that there was an employee assistance program sponsored by the union and it did in fact deal with substance abuse problems as well as other family marital issues, domestic violence, etc. But that's an example of the power of a union contract and how that can influence drug testing. So there is no such thing as a non-regulated form of drug testing and we will see for example states like Florida requiring the drug test results be reviewed by a medical review officer and even a medical review officer who has been certified by one of the approved organizations for the state of Florida. So that's an example of a very specific state law requiring medical review officer involvement. So that's the world of standards of practice. Now I've been talking in very long terms about the Department of Health and Human Services and I'm going to stop doing that. From now on I'm going to talk about DHHS or even shorter HHS because it saves time and you'll discover that as an MRO when you're talking to one another people use a lot of funny terms. I mean we've already been talking about MRO. That's a lot shorter than saying Medical Review Officer Assistant, MROA. And so you see that there are certain government agencies and acronyms and I've put them in a different page in your syllabus but you'll need to know these acronyms. There are also some acronyms for the different modes in the Department of Transportation and some of them have fairly strange titles like the FMCSA. Actually the Federal Motor Carrier Safety Administration used to be part of the Federal Highway Administration but as health and safety issues became a bigger part of these highway administration's activities they split off a separate agency just dealing with highway safety and that involves the DOT physical exams as well as drug testing. So again we need to know the acronyms. Now you'll notice that the U.S. Coast Guard is also listed as falling under the Department of Transportation even though it has now been removed and is part of the Homeland Security Administration the drug testing provisions still are those that apply to the Department of Transportation. And finally we see acronyms for professionals. Now we're training to be MROs or to become recertified as MROs but we're going to be dealing with BATs and SAPs and DIRs. I mean if we were talking this way you'd probably begin to question our intelligence but we know that BATs are the Breath Alcohol Technicians. The SAPs, the Substance Abuse Professionals and the DIRs, we'll be talking this later about DIRs, the Designated Employer Representative, the person that we're authorized to talk with among the employer. So be familiar with acronyms as part of your acquaintance with drug testing. So let's get down to the three steps. The three parts of collection of drug testing as I said we're collecting a specimen, analyzing the specimen and then reviewing and verifying the results. So first we collect a specimen and quite frankly this is the weak link in the chain. We all have heard or know about the TV program called the weak link. Well the weakest link is the one where they're the largest number of collection sites, the largest number of people who are actually doing collection as collectors, the people who need to complete the custody and control forms and because there's so many and because their training is relatively short and the turnover is relatively rapid as an MRO, I very frequently have to take a positive drug test result and cancel it and not report it as positive to an employer because the paperwork was not correctly completed and there's no way to go back and make it right. So specimen collection is a troublesome area and we will talk about it because we need to know and understand where the problems come from. We know that the donor has the right to privacy and so there are monitored collections where someone is monitoring the collection by preparing the room and following I think 21 steps in going through the specimen collection procedure but they're not directly observing the collection. There are also I think seven or eight circumstances now where one is authorized to directly observe the urine coming from the meatus in order to make certain that a person is not cheating on the drug test and Dr. Smith will go through those in piddling detail with you later. There's a chain of custody form which is a federal form and the chain of custody is the section where I literally sign that I have received the specimen, it's in my presence and under my safekeeping, I then sign that I am turning it over to someone else, they sign that they're receiving it and then it is passed on so there's literally a chain of direct custody of that urine specimen within a collection site more often from a collector to a courier and then from a courier to a laboratory and within the laboratory to different sections of the laboratory. So there's a temperature recording strip, we need to make sure that the temperature is within a range and also there needs to be a tamper evidence seal so if someone's been trying to take the seal off and change the urine that will become instantly obvious and that will be an invalid specimen collection and that also will be an example of a test that is called canceled and there will need to be another collection in this case under direct observation. The second part of the process is the laboratory analysis. So the laboratory analysis is probably the most accurate part of the process and I would say with a high degree of comfort that we have about a 99.99 something percent accuracy, very rigorous procedures created by the Substance Abuse and Mental Health Services Administration, a national laboratory certification program where a drug testing laboratory must be certified under very expensive and rigorous standards. Every specimen must be analyzed by two distinct and separate methods. Initially in the early world of drug testing simply using the inexpensive rapid immunoassay test was considered sufficient but we in fact found that there were some false positives due to that. As a result, a second method, a much different and more detailed and more expensive analytical method is required, right now that's the gas chromatograph GC-MS, grass chromatography mass spectrometry and there are some other technologies which are now becoming acceptable that are even more accurate. So we have two different methods, what's called the initial or screening examination and then a second or a confirmatory test and when you get the results back from the laboratory, the words will be very specific saying, you have a confirmed positive, a laboratory confirmed positive is a test that has been confirmed by a second analytical technique. We then come to the third part of the process and that is us, that is the medical review officer, the medical review officer assistant and the people working under our authorization. In order to be an MRO, you have to be a licensed physician, that is an MD or a doctor of osteopathy, you cannot do it as a forensic toxicologist, as a nurse practitioner, as a chiropractor the way you can do a DOT physical exam, you have to be a licensed physician. And interestingly, you have to be licensed, actively licensed to practice somewhere within North America. The NAFTA regulation meant that physicians in Canada, physicians in Mexico can also act as MROs, so there's a business opportunity for enterprising people south of the border. One license is required, one active license and we have to have basic knowledge in the subjects that we are covering in the ACOMM MRO course. In addition to going through what is called qualification training, which is a one and a half or a two-day course of instruction on collection procedures, reporting, record keeping, interpreting drug and validity test results, et cetera. In addition to the qualification training, MROs must, according to the Department of Transportation, pass a nationally recognized certifying examination. So the MROCC MRO test is one of three forms of acceptable certification. If you're a certified addiction medicine specialist by the American Society of Addiction Medicine and you've also passed their examination, passed an examination, taken a course, usually pass the exam offered by MROCC, that's another acceptable route. And there's a third organization, the American Association of Medical Review Officers. Now note that prior to October of 2010, you also as an MRO needed to engage in continuing medical education that was relevant to the drug testing arena. You had to have 12 hours of relevant CME every three years. That requirement has now been dropped. As of October 1st, 2010, now an MRO must go through re-qualification training, that is take the same day and a half or two day course, the full course, and then go through a re-examination process, that is pass again the MRO certification exam and do that every five years. So this is a change. Again in the elevator today, someone asked me, does that mean I don't have to have continuing education? And the answer is yes, but you have to five years after you've completed your adequate amount of CME, five years after that date, you then have to go through re-qualification training and pass a new certifying exam. So that's something that is in transition, so we're all somewhere in that transitional state. Now as an MRO, we are in the middle of a dynamic of a lot of information flowing from one source to another. So you see on the left of this slide, the information coming to us, and on the right-hand side, the various groups that we may need to be in communication with. And this is very often where our assistants are the ones talking with the collection site or with the laboratory, et cetera. So there's a lot of information, and as I mentioned the MRO assistant, I can say as an MRO, we really can't do this alone. There's a lot of communication, there's a lot of paperwork, there's a lot of detail, a lot of documentation and communication, so every one of us needs to have someone on our staff that we can trust, work closely with, and whom we are responsible for in terms of their actions. So our role, according to the Department of Transportation, is to function as a gatekeeper. We're a gatekeeper where we are keeping track of the flow of information, and it's our job basically to assure that this is a valid and legitimate process. I mentioned earlier that if the seal over a bottle of urine was tampered with and it was clear that someone had tried to replace the urine, that is an example of a situation where the laboratory and the MRO would cancel the test. It's our job as an MRO to cancel tests and to tell the employer that's a non-test. It doesn't count toward the necessary number of tests in your random pool. You're going to have to have someone else do a test in order to make those numbers, but since there was a particular problem with this particular urine, we're now going to ask that you have that person tested immediately under direct observation of the specimen collection. So we act as a gatekeeper, and our principal job is to come to a conclusion which is called a verification decision. So we get from the laboratory a confirmed positive. The laboratory has confirmed the specimen by two different methods. When we finish, we are going to verify that result. So the terms confirmed and verified are often confused. When it leaves our shop, it has been verified. Now this may seem a bit confusing, and in fact it is. The only way to work your way through this complex maze is to walk every single corridor to understand every possible combination and permutation of laboratory test results that you can get from the laboratory and every possible way that you could explain it and either justify it that there was a legitimate medical explanation or to verify this as a confirmed positive and now a verified positive. And we will be walking through those in a later section of our course. So what are our duties and responsibilities? Well, the basics basically summarizes it to say that there are nine R's and two I's. And we will walk through them very, very quickly in the next few minutes and then we'll walk through them in more detail later on. So the first of the R's is that we receive the results. We get the results from two sources. We get the results from a laboratory that sends us their laboratory test results. We cannot get the results by telephone. It must be done electronically by fax or by printer or by mail. And we get the results of a non-negative, that is a test that is positive or adulterated or substituted by getting the laboratory copy of the custody and control form. We also need to get a different copy of the custody and control form and that's the one from the collection site. There's an MRO copy and there's a collection site copy. We need to get one of those because there's certain information on that form that does not go to the laboratory. What is that information? The name of the donor and the telephone number of the donor. So a laboratory gets a specimen. It doesn't know whether it's a blind specimen for quality assurance testing or a live specimen from a real donor. So the donor's name is not known to the laboratory. We have to get the name and contact information of the donor from a different copy of the custody and control form. So we get the laboratory results from one source, the information on the donor from another, then we can put them together and go into action. So what do we do? Well, the second step is we review the results and this is where our MRO assistants are extremely helpful looking at the laboratory result, looking at the custody and control form, and specifically doing an administrative review of negatives. If the paperwork was absolutely perfectly completed, the results are intact, no issues, our assistants can stamp our name on a report, initial it with their initials, and it will be considered an acceptable negative. Our name, the initial of the person who did that administrative review. However, if there's a flaw, then we have to decide how to interpret that flaw. And you'll notice that there's actually three different kinds of flaws. The first two are what are called the fatal and the correctable flaws. A fatal flaw is a flaw in the paperwork that is so egregious that it can never be corrected. Dr. Smith will go through all of the fatal flaws, but one example would be if the number on the form, on the custody and control form, and the number on the bottle that went to the laboratory didn't match. Maybe it was the wrong urine. That's an example of a fatal flaw. Or the seal on the urine looked like it had been tampered with, another example. Now, a correctable flaw is one where there's a mistake. Everything is not correct, but it can be corrected. One example would be if the donor did not sign the custody and control form. We get that information in the MRO office. Our assistant looks at it and says, wait a second. There's no signature of the donor. That can't fly. That'll have to be canceled unless we get a statement of correction. The MRO assistant will call the laboratory, talk with the collector, and if the collector says, oh, yes, I forgot to write a note on the custody and control form saying that the donor refused to sign their signature, but I will send you a written statement attesting to the fact that the donor refused to sign their signature, then that would be a statement of correction, and that would be acceptable to correct what otherwise would have been a fatal flaw. Make sense? Another example would be that the donor did sign the paper, but the collector, their name was written down, but they forgot to sign it. There was a name, but not a signature. Now, if there was neither the name nor the signature of the collector, that's a fatal flaw. That can never be corrected. But if the name is there, but the signature is missing, then the collector can, again, give a statement of correction. Now, you'll notice I said there were three kinds of flaws. We've got the fatal flaw, the correctable flaw, and then there's some other what we'll call minimal or de minimis flaws, which are so insignificant that your MRO assistant or you can sign those, can check that box, put your initials. So, if the purpose of the test was not checked or the temperature box was not checked, those are examples of lesser flaws that do not absolutely require a statement of correction. So, we received the results. We're reviewing the results. And now, if we have a live specimen, a specimen that is not negative, now we have to go into the investigation or inquiry phase. How do we do that? Well, the staff can do the paperwork, but an MRO must now pay personal, hands-on attention to all of these non-negatives. So, here's a fundamental principle. In the world of federal and, in most cases, non-federally regulated drug testing, the donor with a positive test must be given an opportunity to provide a reasonable medical explanation. Sure, I have a positive drug test. Why wouldn't I? I'm taking prescription medication. You want to see? And the MRO or their assistant will say, yes, I would like to see. I'd like to know. I'd like, in fact, to have you have your doctor or your pharmacist send to me verification that this was a prescription medication. Now, in the past, many MRO assistants were busy calling a pharmacy, calling the doctor's office, talking with the donor about their drugs. The DOT has made it very, very clear that all of those activities must be done by the MRO, him or herself. So, we've got to call and talk with the pharmacist. We talk with the doctor. We get involved in the verification of the details, although our assistants can help with the paperwork. So, there's a change, and it's important to be very clear about that. The other thing is, then, that we must offer the donor the opportunity to have an interview. It does not have to be a face-to-face interview. It's almost always a very brief telephone interview, and the donor can say, doc, I'm not interested in talking to you, I know where this is headed. The donor can decline to have the interview. That's okay, but we have to offer the opportunity for that person to give their side of the story, to explain why they had a positive drug, and then, to document that that, in fact, is plausible. In the process of going through this process, it's important to document and to record what is said. We'll go through, later, a punch list where you actually write down what the donor says, you write down what you did, documenting that you followed your standard protocol, including reading the donor their Miranda rights, that is, the right to remain silent, and we'll talk about that in more detail, later. So, having a punch list or a checklist is very important, and we'll go through that, later. As an MRO, I get to revel in the things that people tell me. Like most of you, you probably live in a state where there is a hunting season for deer. Not that it's been particularly helpful, in terms of the overpopulation of deer in this country, but I can tell you, during hunting season, some employers expect only half the employees to show up for work on the first day of hunting season. So, in Virginia, I have occasionally encountered someone who had a positive marijuana, and I talk with them about it and they say, yeah, doc, I gotta tell you, me and my buds, we were out hunting and we were really lucky, we bagged ourselves a really big buck, and you know, we're dressing down that deer, and we're getting kind of hungry, and you know how sushi is getting popular, so we just sort of decided to take a little of that fresh, sweet, raw deer meat and eat that sushi, and man, it was good, and you know them deer, they're out in that woods, and them eating that shit, and eating bushes and branches, and who knows what they're eating, and that's why it was positive for marijuana. Now, we call that the Bambi defense. Another example is that my little town of Charlottesville is where Dave Matthews came from. Dave Matthews of the Dave Matthews Band, and every once in a while, Dave will come back to Charlottesville, rent the entire Coliseum to have a benefit concert, and there are too many people in town for one concert, so it usually is two-night stand, so you know, you're in that concert, looking at your local folk hero, and you're enjoying the music, and glad you brought your earplugs, because it is kind of loud, and there's that funny smell wafting up in the rafters, and you know, you really paid for those tickets, and you don't want to give up the music, and that smell is getting stronger and stronger, and you know, darned if two days later, you don't get tested, and you're positive for marijuana, and so you say, well, really, I don't use marijuana, but it was being at that rock concert, and that's why it's positive. Well, now there's a good question. Is that an acceptable explanation? Well, Dr. Pete will tell us what the very, very best scientific evidence is, so we will have that one answered, and I'll tell you in advance, the answer is no. You know, you cannot get, from recreational smoke, enough marijuana on board to cause a positive test at the level that we are now finding, but that is certainly one of the things that people tell us in their explanations, and there are many disguises. You know, as I said, denial is very prominent among users of drugs, so people all have their stories, and it's interesting to hear them. Now, of course, when the donor is caught red-handed, what they're going to want is a retest, right? Doc, there must be a problem. I'm sure it'll all be straightened out if I get a retest. So, of course, what do they mean by retest? They mean, give me another chance to give another specimen of urine, and, of course, what do you mean by retest? You say, sure, we can do a retest. We'll test that same specimen that you gave us, and we'll do another test. In fact, we did a split specimen. We poured off from the original bottle two different tubes, bottle A and bottle B, and we'll take the bottle B, and we'll send it to a different laboratory, and we'll retest it. We're going to do what's called confirmation testing, and we'll make sure that there's still the presence of that drug in the urine. So, it's important, again, for terminology's sake to be clear that a retest is different than a reanalysis, and those are very different than a recollection, which is very much what the donor would like for us to do. And, of course, in many cases, we the MRO will tell the employer, this person must have a recollection, and it must be under direct observation. We also sometimes have to refer our donor for a medical evaluation. So, I'll tell you right up front, the relationship that we have with a donor in our telephone interview is not a doctor-patient relationship. The donor did not sign the usual consent form when they gave their specimen. They didn't say, I give permission, because they didn't do this voluntarily. They're signing a form, but it's not a consent form, and you do not have a doctor-patient relationship. You are an agent of the employer. You are acting on the employer's behalf, and you are talking with the person about a work-related phenomenon. But let's say that the person was unable to produce a specimen of urine, even after waiting for three hours and drinking 40 cc's of fluid. That's what, in its wisdom, DOT once called the shy bladder, and it was a pretty good term, and it has stuck. So, if a person really couldn't produce urine, then that's the reason to have that person have a shy bladder evaluation. Now, that is a clinical evaluation. There, you are gonna get into doctor-patient things, like what conditions do you have, and what drugs are you taking, and let me examine your abdomen, and let me look at your test results. So, that's a clinical evaluation. We will refer that person for a clinical evaluation. Now, that immediately raises a question. Can the MRO also do the shy bladder evaluation? The answer is yes, but you'll do it with your clinician's hat on. You'll put on a clinician hat. You will write a report based upon that evaluation, and you will send that to yourself as the MRO. So, as an MRO, you refer the person for the evaluation. You then get the written report, and then you review the results of that referral evaluation. Same is true for a physical examination for someone who had positive opiates, and the employer is being tough on opiates, and they want everyone with a positive opiate to have a physical evaluation. Ultimately, though, as an MRO, we got one job, and that is to verify our result by interpreting all the data that comes in and coming to a bottom line conclusion. So, we don't give long written reports to employers. We simplify it down to four basic possibilities. Either it was negative, or it was positive, and we give the name of the drug, or it was a substituted, it was an adulterated specimen. An adulterated specimen, which we're gonna report as a refusal to test. The person put something in the urine, or they substituted something for urine, like Mountain Dew, and we're gonna call that a refusal to test because they did not comply with the testing protocols. So, it's either negative, positive, a refusal to test, or there was a flaw, a fatal flaw, and we're gonna call it a canceled, so that is not a legitimate test, and so something else will need to happen. That's what we simplify it down to. So, our job is to simplify the complex and to get it down to simple terms that an employer and the designated employer representative will know and understand. In the process, we have to report our results, and if we have a non-negative result, once we have made our verification decision, we must report that within the same business day by telephone. So, a positive result is a matter of workplace safety concern. Time is of the essence. We have a duty to report it verbally to the DER in the same business day, and then to follow up by sending a written report within the next 24 or 48 hours. Sometimes, under certain conditions, we have to report the results to the Department of Health and Human Services or the DOT, and Dr. Smith will go into that in much more detail. Also, under certain circumstances, we have to release medical information. Most of the information that I get from a donor, I consider private and confidential. I tell the employer the name of the drug. I will not give the quantitative results. That is not something that the employer is entitled to have, but under certain conditions, I will release information, and that is a situation where in the course of being an MRO, I have learned something that makes me concerned about workplace safety. I've learned that a commercial driver is taking methadone for pain. Well, methadone is not allowed to be taken by commercial drivers or somebody who has epilepsy, and they're taking drugs for their epilepsy. That's not permitted. So in that situation, if I believe the person is not qualified for a safety-sensitive job, then I will not give all the detailed information, but I will tell to the employer, employer, I got a safety concern. Based on that, I think you need to have this person referred to a clinician for a clinical evaluation to determine their fitness for duty. So that was authorized early on by DOT, and now they have said not only is it authorized, but there's a requirement to notify of an employer if you, the MRO, have a concern for safety in the workplace. And again, we'll talk about that in more detail later on. We need to keep records. We keep all of our records for one year, and for the non-negatives, we keep them for five years. This is the requirement for employers in terms of record-keeping, and by default, we, the MROs, follow the same period. So that is the basics. We've now covered the basics. We've been over it once very lightly, and you've been very patient not to ask questions. As we now go deeper and further into this, we'll have a lot of dialogue, but thank you for letting us cover the basics.

drug and alcohol testing

history of drug testing

drug-free workplace program

types of drug testing

medical review officer

positive test

MRO responsibilities

medical evaluations

reporting results

accuracy in drug testing