Welcome, this long segment is going to deal with the heart of this program, namely being an effective MRO. We will break it down into five modules. First we'll talk about receiving the results both from the laboratory and the collection site, and also the process of contacting and interviewing the donors, and we'll talk about those three-day and 10-day clocks. Secondly, we will talk about how to deal with positive results and the explanations that donors can give. Thirdly, we'll talk about other laboratory reports, substituted, adulterated, invalid, and dilutes. In the fourth module, we will put on our second MRO hat and talk about assessing workplace safety issues. And in the final module, I will give you some guidelines that will put all the pieces together. So let's start at the beginning, a day in the life of an MRO. So when I'm called into action, I need to put on my MRO hat and realize that it's a very narrowly prescribed set of responsibilities. I know that I'm a gatekeeper for the flow of information among many different parties. I know I'm responsible for reviewing and making interpretations about the custody and control forms, and if there's a fatal or non-corrected error, I have to notify the collector or the employer in order that remediation take place. If there is a non-negative, I have to offer every donor the opportunity to talk with me personally. I'll also need to review findings of certain clinical medical evaluations, such as the Chi Bladder. And finally, I'll have to report certain safety concerns that are specified under DOT. Had we covered the basics early on, I talked about these nine R's and two I's and one A, and in this module, we're going to focus on the first three, the receiving the results and the MRO interview. Under federal regulations, all laboratory results must come directly to an MRO, not going through a third-party administrator. The laboratory can report negative results electronically without a copy of the CCF, but if it's a non-negative result, there has to be a copy of the CCF signed by the laboratory certifying scientists. Laboratories can report positive or negative results, but almost uniformly, they give us quantitative results, and if they don't, we can send them a written notification, and from that point forward, they'll always send us the quantitative results. And if the laboratory did find a fatal flaw or reported an adulterated or substituted result, they will have a certain code language of comments and remarks that we will quickly get to know as an MRO. Let's start with the negatives, and then we'll turn to the positives. So for all negative results, I or my assistant must carefully review both the laboratory report and also copy to the MRO copy of the CCF. If there are no problems, we can go ahead and check a box saying that the result was negative, and if my assistant is doing the review, they will stamp my signature stamp on the form, and then they should put their initials in the margin. So if there is ever a question or a review, we'll know who actually reviewed the form. In addition, as a quality control measure, every MRO must sign 5% of all the negatives, and that would include all the problem CCFs where there were correctable flaws. So I will sign my name either on top of or above or below the signature stamp so that we know that it was my signature. Now as far as errors, Dr. Smith went through them in detail, but let's start with the minimal errors. These are so small that they do not require correcting, although you or your assistant can make corrections on the CCF, but since you're changing one copy of the form, your initials should be in the margin next to the correction. But those are what Dr. Smith called the who cares errors, and they're distinguished from the correctable errors. These are the ones where a statement of correction must be received in order for you to go forward with your MRO work, and here you see five of them. If the collector omitted their signature and their name, then that would be a fatal flaw, but if their name was there but they left out their signature, that can be corrected. Similarly, if a donor refused to sign the form, which is not required, the collector may not have made a remark to that effect. For any non-negative, the laboratory certifying scientist signature has to be on the form, and I have seen them come in without the signature. It always amazes me how quickly after calling or sending a fax to a lab for a correction, within less than five minutes, my fax is whirring and I'm receiving a corrected form. Doctors definitely want to cover their errors. If there's an outdated or non-DOT form, the certifying statement needs to say that the procedures were followed in accordance with the appropriate regulations, and if the temperature box is not checked, it should be corrected, but that's not an absolute requirement in order for you to go forward. For a non-negative result, we will have the laboratory copy copy one with the signature of the scientist, but obviously something's missing. We also need to get copy two from the collection site, because that is the one that has the name and the contact information for the donor. I can't tell you how many times I've gotten laboratory results, and then going through the non-negatives, we've had to call the employer and ask them to send us the CCF from the collection site for particular individuals. Now, if there is a non-negative at this point, you might be one of the rare MROs who's working with an employer that has a stand-down order. If that's the case, you can call the DER immediately, let them know that you have a case and that they can stand down the person from safety-sensitive work. You don't tell them the result, but you simply say that they can pull that person off of the job, and then you proceed with your interview. So let's talk about contacting and interviewing the donor. Being an MRO is obviously not a 9-to-5 job, because so many workers work evening shifts and night shifts. But we've gotten some guidance from DOT about contacting a donor. They suggest that we attempt three times to reach the donor, spaced over 24 hours. And if we're not able to reach the donor by then, then it's time to ask for help. So our assistant can contact the designated employer representative and have them try to reach the donor. Now the DER may say, oh, you got a positive? And of course, we cannot tell them that result. All we can say is we're working on a case and we need their help. So the DER may have additional phone numbers or additional information, such as the person may be on leave or on travel status. And if they're able to reach the donor, they need to tell them that it's vitally important that they contact you, the MRO, within three days. They also need to let you know exactly when they told the donor to call you, because it begins what's called a three-day clock. And if after three days the donor has not called you, you can go ahead and proceed to verify the laboratory results without actually having an interview. If the DER was unsuccessful in reaching the donor, they also need to let you know, because then that will begin a 10-day clock. Nobody can reach the donor. The donor has essentially vaporized. And after 10 days, without any further information, you can go ahead and complete your MRO review and report your verified result. When would that likely happen? Well, that would probably be with a pre-employment examination, where the applicant gets a call from the MRO saying, I'm a doctor and I need to talk with you about your test results. They don't think that's going to be good news. Then they get a call from the company saying, you need to call the doctor, and they figure this is not going to be a very long or successful career. So they just don't call. We used to call those the stragglers, and the reports would pile up on a pile in my desk. But after 10 days, we can now report them as positive. So all of this can contact and can be done by my MRO assistant. But once the donor is on the phone, then I personally have to be the one to talk with the donor. So to review, here are situations where you can go ahead and complete your verification without talking with the donor. The first one, of course, is if the donor says, I don't want to talk with you. Go to hell, doc. I don't have any reason to talk to you. The second is the three-day clock, where the DER did contact the donor, but the donor never called you. And the third is the 10-day clock, where nobody could get a hold of the donor. Now, if after 10 days, the donor comes back from a hospitalization or a long vacation or some other absence, you can still reopen the case as long as it's done within 60 days. And every time you attempt to make a contact with the donor, you should be logging that into a checklist that we'll go through a little bit later. So let's assume you have the donor on the telephone. You're about to conduct your interview. You're putting on your MRO hat. And here are the things you need to remind yourself. You know, you're not in a clinical doctor-patient relationship. You're acting as an agent for the employer. You're not trying to be the nice guy and win a popularity contest. This is not a way to recruit people to join your practice. And you're also not on a personal crusade to stamp out all drug abuse in the workplace. You know, you're an agent, but you're not a tool of the employer. You're really representing the attempt to have a fair and valid process that reaches the truth. You're also not an SAP. so you're not going to be doing a substance professional evaluation. I always carry in my calendar at least one copy of an MRO interview schedule, and I use this as a standard checklist, and there is a sample form within this segment of your syllabus. Initially, I begin by identifying myself. I'm Kent W. Peterson. I'm a physician, and I'm calling as a medical review officer for the XYZ company, and I want to make sure I'm talking with the right person. Is this Joe Jones? And it's important then to confirm the identity, so you might say, I have your social security number as 1-2-3-4-5. Can you let me know this next four digits of your social security number? There's nothing more embarrassing than telling somebody that they have a positive test for cocaine, and then having the person say, well, excuse me, this is Joe Jones senior. I think you want to talk to my son, Joe Jones junior. We can inquire about collection procedures, and that is entirely optional, because we weren't there at the collection. There's no recording or video of the collection, so if the donor tells you that there were all kinds of problems, you're not going to be in a position to adjudicate what really happened, but you may want to ask about it and just sort of go through. So you provided a specimen. You were given a package which had a urine collection device. Once you provided the urine, it was poured into two separate bottles, and at that point, you signed the form, and then you also had labels put over the bottles, etc., etc., so it may be helpful to go through that, but that is entirely at your option. Then at this point, you let the donor know the test result, but you notice I skipped one very important thing, and that is informally called the medical Miranda warning. Now what is that? You remember your old dragnet TV shows where the investigator finally catches up with a crook, and they say, I've got you. You have the right to remain silent, and anything you say may be used against you. That's the medical Miranda. Section 135 of the DOT Part 40 is quite specific about the MRO interview, and so I just want to go through their language in some detail. The reason I'm speaking to you, Joe Jones, personally, is to discuss the results of your drug test. There's a few things that are important for you to know. First, if any further medical evaluation is needed, you must comply with the request, and if you don't do that, it's the same as refusing to discuss the result. Secondly, I may be required to report to third parties without your consent, drug test results or medical information that I learned that affects performance of safety-sensitive duties. You have the option of not discussing the matter with me if you choose. Do you have any questions at this point? So this is the heart of the medical Miranda. Anything you say can be used against you, and I may have to release this information without your consent. And then I keep going, and listen carefully to this next part. The results of your drug tests have been received, and it is a positive. 10 seconds, the longest 10 seconds in the history of the world. There you are with your checklist in front of you, your pen poised, and you know that the person is going to say something like, oh, blank, and it's likely to be a four-letter word. You got me. You got to be kidding. There's got to be some mistake. They guaranteed it was clean urine. So people will say the most amazing things. So then you continue with your interview. The purpose of this interview is to let you know, have an opportunity to voluntarily share information with me that might explain your result, such as something from your medical history, prescriptions you might be taking, recent medical treatment, something in your diet. Based on this information, I can make the best final determination of the result. So here you are basically at the heart of your role as an MRO. If they refuse to talk to you, there are going to be adverse consequences. But if they do talk to you, they may well have a legitimate medical explanation. And even if they confess or if you do report it as a positive, they're very likely then to have a chance to see an SAP and get treatment and rehabilitation. As an MRO, you may or may not want to discuss with the donor the results of their test. I will often say, so you have a positive test for marijuana. When's the last time you used marijuana? And depending upon the way you approach the person, they might say, well, that's got to be a mistake. I never use marijuana. Or you might say, well, let me ask you this. Have you ever used marijuana? Well, yes, Doc, but that was a long time ago. Well, let me ask you this. Were you recently around somebody else who might have been smoking marijuana? Well, Doc, now that you mentioned it, yes, I was. Well, why that was happening. Did you possibly just take a little, a little toke of marijuana? Gosh, Doc, I guess to be honest, yes, I did. So why would you even bother to talk with the donor? Well, you were the first potential step in the process of helping this person to recognize there may be a need for treatment. So this is up to you as an MRO. But I find it interesting to talk with people about their drug use. And I always feel more reassured when they admit that they were taking it. Then depending upon the nature of the positive, you would inquire, of course, about prescription medication, medical care, surgical procedures, etc. But I find it absolutely amazing that in that moment of shock, after being told the result of a drug test, donors are just totally nonplussed. They say, I didn't hear anything. I didn't say anything. I didn't do anything. I have no idea what's going on. And that's what the three monkeys represent. But it's also interesting that 10 minutes later, since they have my phone number that I called them from, I often get a call back. And at that point, they're full of information, and they definitely have gotten over their shock. If a split sample was collected, it's also your duty to offer that as an option to the donor. Bottle A, of course, belongs to you, and you can order reanalysis of that however you wish. Bottle B really is under the jurisdiction of the donor, and you can approach them very different ways. You might say, for example, so another bottle was collected. If you want to pay the $100 that your employer is going to require, you can have it analyzed at a different lab. But I have to be honest and tell you that never, in my experience, has one of these ever been overturned. So I'm assuming you don't want that to be done. If that's the case, you're probably going to get a no. On the other hand, if you say to the donor, well, you know, when you were giving your specimen, a second bottle was sent to the lab. I don't know whether it actually got to the lab and whether the lab has it, but that's under your control, and you have a perfect right to have that sent to a different laboratory and reanalyzed and see if it confirms the first result. And, you know, there's a chance that the specimen might not be in existence or that the numbers might have dropped a little bit, and this might be your one out. Well, guess what the person's going to say. So your demeanor as an MRO will have a lot to do with how people respond to the split specimen. You also, depending upon the drug and the medications need at this point to assess safety concerns, this might be a good time to ask the person, so tell me about your work. What are the major things that you do? Are there particular hazards or risks in your job? And finally, you will answer any technical questions, and donors often may still be stunned during the first interview, but they will not infrequently call you back and have a lot of questions later on. For laboratory reports of an adulterated or a substituted specimen, you would also offer the donor the opportunity to have a split specimen test, so it would be just the way you do it for a confirmed positive. That is not true for an invalid test, because if the laboratory was unable to get an accurate result on the first specimen, why would they think that it would be any different for the second? As far as who pays for this, this is really not something that the MRO is in the middle of. You would never not send a split specimen off because of financial issues, so that's up to the employer policy, and they're the ones who have to collect the money from the donor. In the case of an adulterated or substituted specimen, the laboratory is going to use the same exact criteria to validate a substituted or adulterated specimen. But as you have been told, for a positive specimen, the original cutoff values do not apply, and the second laboratory is simply looking for any positive at or above the threshold level. So make sure that you review in your syllabus the sample MRO donor contact record that I put together. You're welcome to use it or adapt it however you wish, but you will definitely want to have some kind of a checklist when you're conducting your interviews. you

Medical Review Officer

laboratory results

workplace safety issues

federal regulations

interview process

split specimen testing