This fourth module is going to zero in on something we've been alluding to throughout this course, namely, how do you assess and how do you report potential workplace safety concerns? The MRO or MRO assistant must review the MRO copy, copy two of the CCF before reporting any results to the DOT. But let's differentiate between negative and non negatives. If it's a negative result, you know, you don't have to personally sign that form and the results can actually be transmitted electronically. However, for non negatives, the MRO must personally review the CCF and must have their signature. And if you're verifying a non negative, such as a positive, this means that time is of the essence. So you must call or report on the same day for the next business day and you have to submit a written a written form. Now, if the employer is using a third party administrator, you can notify the TPA and not the employer. And as far as what you reported on, you can use a CCF or you can use your own letterhead or any other form as long as it has the same information in the test results. To help pull everything together, I've created several pages of summary reports. I'm not going to go through them in detail, but let me just show you that on the left is what the laboratory reports and on the right are the possible reports that an MRO could make. So let's just look at the second item down as an example. A laboratory negative dilute, as we've just covered, could be a negative dilute and therefore the employer might have the authority to recollect if they do it for all of the same groups of workers. Or if it was an extremely or highly dilute with the creatinine between two and five, you would call it negative dilute, but you would say that the employer must do a recollection under direct observation. The third possibility is that you would report a negative dilute as a canceled if there was a major flaw in the custom control form, such as an uncorrected error. Here, I've made the same kind of summary for adulterated, substituted, and invalid specimens from the lab. And looking on the bottom right, you see that an invalid result could be reported as a refusal to test if during the interview, the donor admitted to perhaps putting an adulterant in the urine. Otherwise, as we said, invalids are always canceled. And the question is, would it be with or without a medical explanation? MROs can sometimes get confused about the reporting of split results. The most important thing is that the laboratory confirmation is not going to be positive for this drug or a substituted, etc. But you're going to be reporting only whether the initial laboratory's findings were reconfirmed at the second laboratory or rarely where they failed to reconfirm. So, in the case of reconfirmed, you would report it as a positive, or you would report it again as a refusal to test. If the specimen failed to reconfirm, there would be two possible explanations. First of all, Bottle B might not be available. Perhaps it was lost in transit, or it leaked, or the laboratory simply couldn't find it. And in that case, you will notify the employer that both tests are canceled and why that was true. And then there will need to be an immediate recollection under direct observation. The very rare instance that occurs is where a drug was not detected at the level of detection for a positive, or the original adulteration or substitution criteria were not met. And in this case, a very rare situation, you would report it to the DER, and again, both test results would be canceled. All failures to reconfirm are so rare that they're treated as an emergency, and therefore, MROs are obligated to report them to ADAPC within DOT. And there's actually a format in Part 40 for doing that. The last page of my chart, again, summarizes what the laboratory could tell you in terms of reconfirmed or failure to reconfirm and how you would report it. So again, I recommend you study this and understand it fully. A new feature instituted last year for commercial motor vehicle drivers is what is called the FMCSA Clearinghouse. If you're doing an MRO review for a driver, you must register, first of all, at the clearinghouse, and your assistant can also register and therefore do the reporting for you. Then you would report all non-negatives, that is positives, adulterated, substituted, and even shy bladder refusal to test, and you must do so within two days. If there's a change in your findings, you need to report those within one business day. Now, the clearinghouse was instituted last year. It went down because of some technical problems. It's recently been reinstituted, so I'm not sure at this moment when you're hearing this whether it will be up or down. One of the notable things is that in order to complete the information in this report, you may need to contact the employer because the CCF will not have information on the driver's CDL number, necessarily their date of birth or their state. So this is a little bit beyond the usual reporting requirements. Remember, only an MRO can cancel a test, and I've summarized here five different reasons why a test could be canceled. So perhaps a specimen was rejected by the laboratory because of a fatal flaw, or it was reported as invalid, or there was a failure to reconfirm a split, or there was a shy bladder with a medical explanation for why the person could not produce an adequate specimen, or there was a correctable flaw but no statement of correction was able to be obtained. It's important to realize that there's no fault or flaw in changing a verified result with the DER, and only that can be done by an MRO. So here are some examples of situations where that might occur. Perhaps the donor was not interviewed because they couldn't be reached, and later they contacted you, and they did, in fact, have a valid explanation, or a split specimen did not reconfirm at the second laboratory, or perhaps an error was discovered after you reported your initial result, and as a result, you're changing it. And finally, within 60 days, you get new information that might have changed the results of your verification process. These would be examples of why an MRO might change a verified result. I briefly mentioned MRO recordkeeping in the basics presentation, but let's review it again in more detail. So you know that the MRO copy 2 of the CCF comes to you, and if it's not available, you need to have a reasonable facsimile, such as the employer's copy or the collection site copy. And you need to keep this with your signature, with your assistant's signature, with the initials, if your assistant did it. The negatives are kept for a minimum of one year, and the non-negatives must be kept for five years. In addition to the CCF, for all non-negatives, you need to keep your documentation, which is usually your written notes on an MRO checklist, or however you keep your records. It's important to recognize that drug test results did not come from a clinical doctor-patient encounter, so they should not be commingled with regular patient medical records. If a patient says, I'm going to move, or I want to change doctors, and I want you to send all of my medical records to another physician, that's perfectly fine. But the drug test results are different, and they should be handled under the authority of the employer. So you can transfer the records to a new MRO as well. You don't have to permanently keep records if your employer decides to get another MRO. The second half of this module is going to zero in on MRO safety concerns. So in the basics presentation, I described the two different roles and the two different hats that an MRO wears. Much of our effort has been focused on the classic MRO of dealing with the laboratory results and the interview and the documentation and verification process. But in addition, as we mentioned, an MRO is always concerned about workplace safety. To do that, you really need to have an understanding of the workplace, the types of jobs that people are doing. You'll be in your interview learning about medications, and from that, you can assess safety risks. And there are absolute obligations to report these concerns, and we're going to go into that in detail now. When the semi-synthetic opioids were added to the federal drug panel, it dramatically increased the number of positive tests on federally regulated drug testing. And it also brings MROs into the current opioid dependency crisis in this country, which I think is part of a much larger addiction crisis, as we've seen by the rising rates of many different types of drug use. And the opioids really highlight the important issue of workplace safety and fitness for duty. How are the strengths of the various opioid drugs determined? Well, the way that it's done is to compare their strength to morphine as a baseline. So you need to be familiar with two different terms, morphine equivalent dose, or MED, and also morphine milligram equivalent, or MME. So you'll find tables in which you can make the calculations of the equivalent strength to morphine. Among the most commonly prescribed of the opioids, you'll notice that fentanyl is the most potent, 70 to 100 times more potent than morphine. And the next most potent of these drugs are the hydromorphone and oxymorphone. Also notice that a opioid naive patient is more sensitive to the same dose. When my wife had a knee replacement, she was given a low dose of oxycodone for pain, but she found that it made her extremely lightheaded and spacey, and she broke her pill in half. So this is a good example of how a naive patient can be more sensitive and also more impaired. Let's look at a couple of sets of guidelines. First, the Washington State Interagency Guidelines. In 2007, the expert panel of physicians said there's a very high risk of overdose in chronic opioid users, and they raised a yellow flag for an MED of 120 milligrams a day, saying that these people should be referred to a pain specialist. A few years later, in 2015, they reviewed the literature, and at that point they said there is no completely safe dose, and there's a dose-response relationship, or a dose-risk relationship. So the risk is twice as much at an MED of 20 to 49, and nine times higher at a hundred. So they said opioids should not be used for chronic conditions such as low back pain or fibromyalgia. Because of what is called a national epidemic of opioid abuse and opioid deaths, the Centers for Disease Control issued some guidelines in 2016, and the guidelines pertain to when to initiate or to continue opioids, the selection and duration and follow-up, and assessing the risks. They also issued a checklist for prescribing opioids, and some additional material is in your syllabus. ACOM has become well known for issuing a detailed set of evidence-based practice guidelines, and these have been adopted by many states. In 2014, they issued one on the use of opioids, and they came down much harder. They said acute or chronic opioid use is not recommended for workers who perform safety-sensitive jobs, and they went on to define safety-sensitive jobs very specifically. Operating motor vehicles, other modes of transportation, using forklifts, overhead cranes, heavy equipment, sharps work, and tasks involving high levels of cognitive function and impairment. So the writers of these guidelines included in safety-sensitive jobs those that require high levels of cognitive function and judgment. So consider that when evaluating the safety risks of someone who's taking opioids. They looked at the strength of the evidence, and they called it a moderate level of confidence. Specifically, the crash risk for people taking opioids was twice as high as those who were not, and they found a distinctive dose-response relationship, and their recommendation was that the maximum for an opioid-naive acute pain treatment is 50 milligrams MED. So with these guidelines in mind, let's look at the MRO reporting of safety concerns, and you'll find that there are two very, very different approaches that have been issued by the Department of Health and Human Services as opposed to the Department of Transportation. The HHS mandatory guidelines say that if an MRO identifies a safety or fitness for duty concern, they may report them, but that's the choice of the MRO. It's not required by the authority of federal agencies. DOT on the other hand has come down very strongly and said that the MRO has not only the option to report, but that they have a duty. They have a mandate to identify safety concerns, and they have come up with detailed protocols for that which we will cover. Here are the details of the HHS fit-for-duty guidance that came from a 2018 update of their MRO manual, and they clearly say that an MRO decision to contact the employer and to discuss safety or fitness for duty issues is not required. You know, it's entirely up to the MRO's voluntary choice and whatever arrangements they have with their employing agency. In contrast, many years ago, DOT issued a set of safety requirements. They specifically said MROs must disclose disqualifications or safety risks to the employer representative, and they had two very specific situations. First, that an MRO believes the donor is medically unqualified for a DOT safety sensitive position. So an example of that might be in the MRO interview, the MRO learns that the donor has epilepsy and is taking seizure medication, or that they're diabetic and they're using insulin. Well, under DOT regulations, those people would be medically unqualified. The second is a more general expression, and that is that the MRO believes there's a safety risk associated with the donor's performance of safety sensitive duties. So this was initially, by DOT, authorized for disclosure. Later, they tightened the regulations that said that it was a requirement. Notice that this information is confidential. It can only be released to the employer representative, to the donor, or the substance abuse professional, but certainly not to a union or to a supervisor. Now that raises some ethical concerns on our part, because the ACOM Code of Ethical Contact strongly opposes the release of medical diagnoses, findings, or treatments. So I'll show you the language that I wrote to be able to deal with the DOT requirement and still maintain confidentiality. What I tell employers is that based on the information that I have learned in the course of being an MRO about a donor's history, test results, diagnosis, or treatment, so I don't give them specific information, but based on that, I have a reasonable concern about their ability to safely perform essential job functions. This is the language that comes from the Americans with Disabilities Act. I strongly urge you, the employer, to have the donor undergo a fitness for duty evaluation by a qualified clinician. So that means I'm not in a doctor-patient relationship. I have very little information, but a clinical evaluation seems indicated to determine fitness for duty. And finally, I will release pertinent information to the examining health professional. Under the most recent DOT guidance, timing becomes very, very important. During your MRO interview, you've got to let the donor know if you have safety concerns about prescription medication that they may be taking. Furthermore, you must give the donor the option to have their treating physician contact you within five business days to discuss whether an alternative treatment would alleviate your concerns. Then you have to wait. You cannot report your safety issue for five days, so you'll send the employer a negative report as soon as you have verified that there's a valid prescription. This five-day pause raises some real safety concerns on the part of MROs, and some people have called it the five-day horrid pause. However, DOT is clear that if the concern is about one's fitness for duty, one's qualification to perform a DOT role, then you may notify the employer immediately. But if your concern is about medication, then you have got to wait up to five business days for the prescribing physician to contact you and see if the medication can be changed. So of course, the donor may say, I'm not about to have my doctor contact you, and if that's what they say, then you can go ahead and report your safety concern immediately. But if the donor says, that's probably a good idea. Before you tell my employer, let me get a hold of my doctor, then you have to help the donor facilitate the discussion between the doctor and the MRO. This could get fairly complicated. So if the doctor does not contact you within five days, then you can go ahead and notify the employer of the safety concern. It's not your duty to make sure that the prescribing physician contacts you. However, if they do talk with you, and they do change the drug, then you have the option of not notifying the employer of your safety concern. And if the physician does not contact you within the five days, and you've gone ahead and reported your safety concern, and then they contact you and change the drug, then you must contact the employer and remove your safety concern. Sometimes doctors will disagree. So if the prescribing physician refuses to change the drug and says they believe it's safe, then you've got to use your reasonable medical judgment about your safety concern. And if your judgment says there is a safety concern, I know more about the workplace, I know more about the role that this person plays, I'm going to go ahead and report it, then you are free to do that. It's important to have discussed this in advance with your employers, because they're going to need to know how to interpret your safety concern and make sure that they have a pathway for having fitness for duty evaluations. You're also not supposed to question the prescribing physician about whether they should or should not have prescribed the medication, but you can, as I say, disagree with their judgment. Strong concerns were raised about this five-day wait by Robert Swietczynski, the editor of the MRO Update newsletter, and he pointed out that MROs may be less inclined to flag and report safety concerns if they're going to have to go through a five-day hassle. They also may forget in the course of day-to-day work that five days has passed and it's now time for them to report their concern. It's also, of course, going to be a challenge for the employer, because if they're hiring an applicant, are they going to wait? They won't even know that there's a safety concern for five days, so they may have hired somebody and then have to get a safety warning and not quite know what to do. And there's also the liability. What if an accident occurs when the MRO knew about a safety concern but had not reported it to the employer?

workplace safety concerns

MRO

CCF

DOT

opioids

fitness for duty