Now that we've covered review of positive test results, let's look at the review of four different kinds of reports we can get from laboratories. The first is an adulterated specimen, and here's a definition straight out of DOT's Part 40. So, if it's adulterated, it contains a substance that's not supposed to be present in urine or at a level that is so high that it's not consistent. In order to report a specimen as adulterated, a laboratory has done a very good job, because they will have not only identified it with a screening technology, but they will have confirmed it by a different method. So, they will have identified a substance put into the urine, and they'll have to state exactly what it is, that is, it was too acidic, too basic, or there was a particular substance like chromium or peroxide or a halogen. The specific quantitative results that you need to know as MROs are the level of nitrite, which has to be at or above 500 micrograms, not nanograms, but micrograms, and also an extremely low or an extremely high pH. So, remember these numbers. A substituted specimen is an entirely different animal. I usually think of them as incompatible with human life. And in order to report them, a laboratory has to have had two separate criteria met. And as an MRO, I put up both of my hands and I think they both have to be met to be substituted. The first, of course, has to do with specific gravity. It has to be so extremely dilute that it is equal to or less than 1.0010, or so highly concentrated that it is equal to or greater to 1.0200. And the second criterion is an extraordinarily low creatinine level of less than 2 milligrams per deciliter. If both of these criteria are met, this will be a rare and unusual day for you. However, more often than not, only one of the two criteria are met. And in this case, the laboratories say this is inconsistent. The two results are not consistent, and they will report it as an invalid specimen. Adulterated and substituted specimens are treated the same way by MROs. That is, you need to interview the donor. You must explain the findings to the donor and answer their technical questions. You must offer them a split sample. And finally, you give them the opportunity to present what is called a legitimate medical explanation for these very, very rare and unusual findings. So what would a legitimate explanation be that would allow you to publish your results, even in the New England Journal of Medicine? Well, a donor has the burden of proof to be able to show that the adulterant occurs naturally in their urine. Perhaps they are from Transylvania and have a rare and unique family metabolic history. Or in the case of a extremely low specific gravity and creatinine for substituted specimens, they have to document that they are physiologically able to produce those results on a consistent basis. So when you hear this kind of a story from a donor, you then have to use your best professional judgment to see whether that is a potentially legitimate explanation. If you don't buy their story, then you are simply going to go ahead and report it as a refusal to test. That is, the person refused to comply with the drug testing regulations by either putting something into the urine or by substituting something instead of urine. In the extremely rare situation where the donor's explanation might possibly provide a reasonable basis for the results, then you must follow a very detailed set of steps that are outlined in Section 145 of Part 40. A couple of points, though. Neither the MRO nor the employer is responsible for the costs associated with getting any additional medical testing. The burden of proof is on the donor to show that they were able to produce these results. After getting a written report from another examining physician, you then are obligated to review the results and decide if that was an acceptable explanation. If it is, you will call it a canceled test because it doesn't follow the usual protocol, and it will be so rare that you will write a report to ODAPC at DOT. Otherwise, you will then report it, as we showed in the previous slide, as a refusal to test. The third and more common distinctive laboratory report will be that of an invalid specimen. Now, what does that mean? Well, you see here a definition from Part 40, but basically it means that the laboratory was unable to perform their usual drug tests because something interfered with the testing process. It was either an unidentified adulterant, that's certainly most often the case, or an unidentified interfering substance. And in that case, the laboratory could not give you a result, and they will call it invalid. So what do I do as an MRO with an invalid? Well, just as we talked about the two criteria for a substituted specimen, I again put my hands up, both hands, and say, I am now going to be making two telephone calls. The first is to the laboratory scientist, because I'm going to ask them, what the heck is going on? What do you think this is? And the second one is going to be a call to the donor to ask them what could explain this result. When you talk with the laboratory scientist, what you will hear usually is that the laboratory suspected it was an adulterant. That is, they had done a screening test which identified an adulterant, but they did not take the time or go to the expense to confirm it by a second method. Instead, they sort of lazed out and called it invalid. The other thing is that there may have been an interfering substance, and you see here three medications that historically did interfere with the immunoassay initial test. And that was Cipro, an antibiotic, Flagyl, which is an antihelminthic drug, or Tolectin, which was one very specific non-steroidal anti-inflammatory agent. Now I said this is historical because today's immunoassay tests have gotten around that problem and this is not usually a problem again. The most important thing to know about an invalid specimen is that an MRO, you are always going to report it as a canceled test. But there's two different forms of cancellation. First is with a medical explanation. So the person was taking a medication that explained it, and therefore they will not need to have additional testing. However, if there's an invalid specimen and there's no explanation, you will report it as without medical explanation, unexplained, invalid result, and the result is that the urine will have to be recollected, this time under direct observation. If the second specimen comes back from the lab also as an invalid specimen for the same laboratory reasons, then this does not mean that the employer needs to keep going on collecting a third or more specimens. As an MRO, you will report it as a canceled test, but you'll say that it was without an explanation. Interestingly, however, if the second specimen turns out to be invalid for a different laboratory reason, then a third specimen must be collected under direct observation. And again, if it comes back as invalid for the same reason, the railroad stops and there will no longer be any additional collections. The last thing we'll talk about here are dilute specimens. And I think by now you're fully familiar with and understand and remember the two criteria, both of which must be met. First, there's a specific gravity criteria. So on the low end, it has to be greater than 1.0010, because if it were less than that, it would be a criterion for being substituted. And secondly, the creatinine is at or above 2 milligrams, because if it were below 2 milligrams, that also would be a substitution criteria. On the high end, you see that it has to be up to 1.0030. And the creatinine has to be less than 20 milligrams. So these are the definitions of diluted, and this is what you will report. Now that we've defined dilute specimens, let's make things a little more complicated. Because there's something called an extremely dilute or a highly dilute urine. And that is one where the creatinine is between 2 and 5 milligrams. And under DOT, that will be reported as a negative dilute, but you must notify your employer that a recollection is required under direct observation. So this is clearly a highly suspicious dilute specimen. Otherwise, if the creatinine is greater than 5 but less than 20, you'll call it a negative dilute. And the reason why that is significant is that employers can require people who come back with a negative dilute to have a second collection, but not under direct observation. And if they do that, then that policy must apply equally to all of the employees within a particular job class. Otherwise, they might be accused of discriminating. And the employer must accept the result of a second test. They can't go on and do a third or fourth test. Because this can seem somewhat confusing, we've been asked by our students if we could summarize it in a simple chart. And that's what Dr. Smith and I did painstakingly. So you see on the left-hand column, we show the creatinines going from less than 2 all the way up to less than 20. Also, you have a specific gravity and shows the different possibilities. And how you can interpret that and specifically what action you should take. So I recommend that you study that until you feel totally comfortable with it.

laboratory reports

adulterated specimens

substituted specimens

invalid specimens

dilute specimens