This module will review the duties and the responsibilities of the MRO. We'll be going through this once over lightly, and then later we'll be going in much more detail. The Department of Transportation has often called the MRO that of a gatekeeper. That is, we're right in the middle of a number of different actors, which we'll see in a moment. The key function, the key decision that we make as an MRO is what is called a verification decision. That is, after receiving and reviewing and interpreting all the available information, we come down to a verification decision. So we receive from the laboratory a confirmed positive result. That is, the laboratory has done an initial test and then a second confirmatory test, and so they report it as a confirmed positive. After we have verified that, we will then make a decision, which could go back to the employer as a negative, a positive, a canceled, or a refusal to test. Here are all the actors that we're involved with as an MRO. As you can see, the employer notifies the donor that they need to provide a specimen. The donor goes to the collection site. The collection site then sends the specimen and the custody and control form to the lab, and they send a copy of the custody and control form to the MRO. The laboratory then sends us their test results, and then we communicate with many other actors. The usual party that we're dealing with is the designated employer representative, or the DER. Now, this cannot be done alone. It's very inefficient for a physician MRO to do all the administrative work, so we usually have a nurse or an assistant who's trained to work with us, and they help us as a team partner. And there are actual training programs and certification programs to be an MRO assistant. As MROs, we wear two very different hats. The classic role for the MRO deals strictly with the drug test results. That is, we receive, we review, we interview, we interpret the results, we contact the donor. If they're on prescription medication, we document that, and we ultimately make our verification decision as to whether the prescription was authorized or not. However, a second hat that we need to wear is a constant vigilance about workplace safety and fitness for duty. To do that, we need to know something about the duties of the donor. In the process of talking about them with their medications, we may discover that there are certain medications that cause us concern about workplace safety. We need to assess those safety risks and report those concerns to the employer. That's an option for MROs under certain circumstances. It's a requirement that we report our concerns. Let's review in a little more detail the specific responsibilities of the MRO. Jokingly, we sometimes refer them as the nine R's, the two I's, and we've recently added an A. So the MRO receives the results from the laboratory. We review those results, and then we investigate, including talking with the donor by interview. We record our findings in our documented record. We often get to revel in the things that people say, and we deal with the reanalysis of a single specimen, sometimes the opportunity to do a recollection and another analysis. To finish out our list, we see that an MRO sometimes has to refer a donor for a medical evaluation. For example, somebody who has needle tracks that might indicate injection or a shy bladder or a shy lung. We ultimately make our verification decision and interpret all the data. We report that to the employer. Sometimes we have to release medical information. We keep our records, and now we have the second hat responsibility to assess safety risks and fitness for duty. Let's review each of these now in a little more detail. In receiving results from a laboratory, they can come in by a secured fax or other electronic means, but results can never be reported by telephone. For the negatives, laboratories can use any written format that they wish. However, for what we call a non-negative specimen, an actual copy of the custody and control form needs to be sent to us, signed by the laboratory's certifying scientists. So we will be receiving results from the laboratory as well as a slightly different form from the collection site. And the difference is that the one from the collection site actually contains the name and contact information of the donor. After receiving the results, it's then time to review them and make sure that they represent a valid test. The way this is done is by carefully looking at the custody and control form. Our MRO assistant or team partner can do an administrative review of the negative results, but the MRO him or herself must personally review every non-negative specimen. I just mentioned that term before. That includes the positives and what may be adulterated, reported as substituted, or invalid by the laboratory. Now, the laboratory can identify a flaw in the custody and control form, but it is our responsibility to decide its significance. Any omissions or flaws on the custody and control form can be divided into three categories. There are what are called fatal flaws, which invalidate the entire drug test. There are correctable flaws, which can be corrected. And then there are often a number of minor errors or de minimis errors. As far as fatal flaws, an example would be that there was no seal over the bottle when it was received at the laboratory. Or that the identification number on the bottle did not match the identification number on the custody and control form. If these are true, there's no way that they can be corrected, so the MRO is going to cancel that test as an invalid test. The correctable flaws, though, are ones where corrections can be made. For example, a collector might have not written down that the donor refused to sign their copy of the custody and control form, and they can go back and do that later. There's no particular method for correcting a custody and control form. If it's a minor or de minimis error, the MRO can ignore those and simply put in the correct box and write their initials. But if there's a significant correctable error, there needs to be what is called a written statement of correction that is received from the collector. Sometimes collectors will notarize an affidavit because it looks better, but as long as there's a written statement of correction, that is all that is required. Once the custody and control form has been received and reviewed, it's time for the MRO team to go at work and do some investigation. The MRO assistant can handle the paperwork. However, the MRO, him or herself, has to personally look at the custody and control form of every non-negative. In addition, everyone with a non-negative test result must be given the opportunity to talk directly with an MRO before the verification decision is made. This could be done face-to-face with an in-house MRO program, but usually it's done by telephone, and the interviews are relatively quick and they're relatively practical. When you're talking with the donor, it's important to keep very diligent records of what you have discovered. So I always have a checklist in front of me and keep notes when I'm talking with a donor, and there's a copy of that that we'll go through later on. It documents that we follow a consistent standard operating procedure, so if somebody questions our interpretation decision, we can show that this is the way we always operate. Every time we attempt to contact a donor and leave a message, that should be written down on the form, and we especially need to document the day and the time because there are two clocks that we'll need to be able to understand and master called a three-day clock and a 10-day clock. If a person says that they have a prescription which explains the test result, we need to verify to validate that with a practicing physician or with a pharmacist. So when talking with a donor who has a positive test result, we often get to revel in the things that people tell us. For example, I live in Virginia, and every year we have our hunting season, and people will come in with a positive marijuana test result. I'll ask them about it, and they say, oh, yes, I was out there with my buds, and we were hunting, and we bagged ourselves a buck, and here we are cleaning up that rascal, and you know that meat is so tasty that we're just eating a little bit of that sushi. And you know them deer, they go out in the woods, and they eat that shit, and that's why it was positive for marijuana. That's what we call the Bambi defense. Or we also have from our town a famous musician named Dave Matthews who puts on rock concerts, and people may say, well, I was going to a Dave Matthews concert. While I was in the auditorium, there was this sweet smell that was flowing through the auditorium, and of course, I didn't want to give up my tickets, but that's why it's positive. So you might as well expect now to hear many stories because the donors will try to pull the wool over you. I love this depiction of some of the many masquerades that donors can try to pull on an MRO. I particularly like the picture of the blind farmer at Thanksgiving who's going out to harvest turkeys, and you can see that there's a lot of turkeys around him saying moo. Well, I can promise you as an MRO, you're going to be mooed at quite frequently. When we talk with a donor, they will often say, doc, there's just no way that that result could be positive. There's got to be some mistake. Surely you can give me a retest, and we can explain to the donor, yes, we can reanalyze the specimen that you provided, and we can do it by sending a split specimen to a second laboratory, and you even have some choice over where that specimen goes. But that is not the same thing as a recollection of a new specimen. So this is a decision the MRO needs to make. They can order the lab to send a split to a second lab or even retest the initial specimen at their lab. This split specimen is usually called a Bottle B. So under the federal program, a single void is collected in a specimen container, and then it is poured into two bottles. The first bottle, Bottle A, is under the discretion of the MRO. The second bottle is called Bottle B, and that's really analyzed only at the request of the donor, and often the donor has to pay for that analysis as well. Occasionally, an MRO will refer a donor for further medical evaluation, and these will be clinical evaluations. An example might be what we call a shy bladder or a shy lung. That is, the donor was unable to provide an adequate specimen of urine or to be able to blow into a breath analyzer. The employer might also want to have people with positive opiate results evaluated clinically for signs of needle tracks or opiate abuse. And finally, if a laboratory reports a substituted or adulterated specimen, a donor might say that they have a rare family medical condition that can explain that results. And if so, we would refer that person for a medical evaluation. Now, as an MRO, we have a very narrowly prescribed role. However, if we want to take off our MRO hat and put on our clinician hat, it's possible for us to do clinical evaluations. We can do the evaluation of a shy lung or a shy mouth in the case of oral fluids. But we're doing it as a clinician, and we have to write a report then that goes back formally to the MRO. As MROs, we must ultimately make our big verification decision. That means we take all the data that we have received, including the confirmed result from the laboratory, the results of talking with a donor, with a pharmacist, or with a treating physician, and our decision is going to boil down to one of the four following results, which we report. It could be a negative. Now, as far as negatives, we could have a confirmed laboratory positive, but if a person has a prescription that's been verified, then we could call it a negative. That doesn't mean that the drug test result was negative from the lab. It means that it was negative in that the donor did not violate company policy of not being able to have unauthorized use. The result could be a positive, a confirmed positive, which we have verified as a positive. In that case, we need to tell the employer the name of the drug, but not the quantitative level. We can cancel a test, and we'll later go through all the reasons why an MRO could cancel a test, but one of them, as I said, would be that there was a fatal flaw that was not a valid drug test result, and so it goes back as a canceled test. The fourth finding that we would report to an employer requires a little explanation. We don't call it a positive or a negative. We call it a refusal to test. That is, somebody may have adulterated their urine by putting some other substance in it or substituted water or Mountain Dew in exchange for urine. The consequences of a refusal to test, though, can be much more dire than a positive. A positive may mean that a person is referred for treatment and rehabilitation, but somebody who interfered with the drug testing process by refusing to test probably is not going to have a very long and successful employment career with this employer. So, in essence, our job as the gatekeeper is to simplify the complex. We need to take all of the data that we've received and translate it into very simple, easy to interpret report that we send to the employer. Once we've made our verification decision, we then report that to the employer, and it always has to be done within 24 hours of completing our verification decision. The regulations recommend that we make an immediate telephone call and that we follow that with a written report. It can be a copy of the custom control form, but it can also be in any written form that we wish. As I said, if the drug test was positive, we tell the employer the name of the drug, but we're not allowed to provide quantitative results because human resources personnel are very tempted to play doctor and to make interpretations of what the quantitative result would mean. And if a urine test was reported as adulterated or substituted, then we need to provide additional details. It's important not only to tell this result to the employer, but to also notify and let the donor know what we're going to be telling the employer. And if they have an authorized designee, perhaps a union representative or an attorney, we need to report those results to them as well. Occasionally, we are required to report our drug test results to a court of law, particularly if there's been a questioning or a challenge of the drug test result. And under rare conditions, we would report the results to the Department of Health and Human Services or DOT. An example of that might be that if a split specimen that was initially positive failed to reconfirm as a positive at a second laboratory, that would be considered an extremely rare and urgent situation, and DOT would want to investigate that situation. In addition to notifying the employer and the donor, we sometimes must release medical information to third parties without the donor's consent. And here are two situations. The first is that the information is likely to result in the employee being medically unqualified under an applicable DOT regulation. An example might be that a donor reported having epilepsy and that they're taking medication for seizures. Well, that is not allowed for a commercial driver, and therefore, as an MRO, you would need to notify the employer what you learned. A second condition is very carefully worded, that is, if continued performance in safety-sensitive functions is likely to pose a significant safety risk. And here's where we're concerned about workplace safety and fitness for duty, and we will talk much more about that later on. So when we're releasing information, we sometimes have to report it not only to the employer, but to a healthcare provider that's determining a medical qualification, such as a commercial driver examiner or to a DOT agency. We need to keep our drug test results carefully. We're required to keep negative results for one year and positives and non-negatives for five years. One tip that is sometimes surprising to new MROs is the drug test results are really not part of the clinical patient record, because as an MRO, our role was not as a clinician, but as an agent for the employer. So drug test results should not be combined in patient charts. They should be kept separately. So if, for example, a patient decides to move to another town or change providers and they want copies of their medical reports to go to the new provider, everything can be copied, but the drug test results should not. That's often something doctors are not aware of, and it's often an aha moment when they've become MROs. Finally, as an MRO, we have to put our second hat on and look at workplace safety and security. In order to do that, it is helpful if we know the job duties, and since you as an MRO are working for an employer, it's useful to know what kind of work their workers do and have that in your back pocket. When you review the medications that a person is on, even if there's a valid prescription, you need to think about potential adverse effects, particularly as an example, how opioids could affect workplace safety. You need to assess safety risks, and knowing the safety sensitive functions will be helpful to you. And finally, you must report your concerns. A DOT requires that MROs report their concerns, so if there's a fitness for duty issue, that has to be reported immediately. If your concern is about a medication, you are required to allow up to five days for the treating physician to change the prescription. This is complex, and we'll have a whole module on this later on in this course. So to close out this segment, I just want to point out a couple of additional resources. I mentioned that the MROCC has written a detailed set of MRO competencies, and they are totally consistent with the duties and responsibilities that I've covered. But because they are used as the basis for the MRO certification exam, you may want to review them carefully. And finally, as I said, when we come to segment 10 of our program, we will go through in much more detail all the things that I've covered here. Thank you.

MRO

drug testing programs

verification decision

employer communication

actors involved

documentation