Good morning again. Yesterday we spent a little bit of time, very little bit of time, talking about validity testing, specifically creatinine-specific gravity, invalid results, so today we're going into them in greater detail, as I promised you we would. Again, I'm giving credit to my mentor, Ian McDonald, who's seeing my disclosure yet again. We're going to talk about invalid results, dilute results, adulterated results, and we're going to wind up with the testing of split specimens, kind of have to talk about split specimens after we have at least gone over the validity testing piece of it. What does this mean? Validity testing is the evaluation of a specimen to determine if it's consistent with normal human urine, and if it's able to be tested, pretty much. Notice the wording here, and I'm going to want you all, in case you haven't figured this out before this, I'm going to want you all to be very, very careful about how you use words in this program. This definition is a prime example of that. Notice that it says, determine if the specimen is consistent with. It does not say that the specimen is normal human urine. What we say a whole lot in this entire program is that what we are finding is consistent with something, something, something. We are also here saying normal human urine. We are not saying it's not human urine. We are saying normal human urine. As soon as you say that a specimen fails validity testing, and that makes it not normal human urine, somebody is going to come back at you and say, what is it, dog urine? Again, please focus on the words you use and how you use them, because I promise you, you're going to have to go back and do some explanations, especially about validity testing. We are looking here to see, again, that the specimen is consistent with normal human urine. There's a timeline for validity testing on the bottom part of the slide. Ferguson's humble opinion is validity testing needs to be done on all testing specimens. It's required that it be done in DOT testing. No big deal. We know that. In my opinion, there's no reason not to do it on any testing, DOT, non-DOT, certainly on the monitoring specimens that I do for a living, but there's no reason not to do it, because we want to know, at least have a good idea of what we're testing. What does MROs review? Invalid results. You review split specimen testing options, but you cannot offer split specimen reconfirmations on invalid testing results. You do offer split specimen testing options to the donors on adulterated and substituted laboratory results, but you can't do it on invalid results, and the reason is there's no result. The laboratory is simply telling you the specimen's invalid. What does validity testing mean? It means the lab is looking for the concentration of creatinine in the specimen, a protein found in all mammalian urine. Remember the specific wording I talked about before, creatinine's in all mammalian urine, not just human urine. When the creatinine concentration is less than 20 milligrams per deciliter, specific gravity is also measured. It's not measured if the creatinine is 21 milligrams per deciliter or above. Below 20, specific gravity is always measured. The lab tests for pH, acid base, and does a general screen for oxidizing agents. The reason being, I think hopefully you've heard of that before this, is that oxidizing agents interfere with the testing for marijuana specifically, but also opiates. We want to know if they're there. Additional testing must be performed if the specimen doesn't look right. Makes sense. Abnormal physical characteristics present. If the laboratory sees a reaction that's characteristic of a specific adulterant, they should test for it, and they should do further testing anytime things just don't look right. If the presence of an interfering substance or an adulterant is suspected, but the lab can't identify it, the lab is required to call you to decide whether or not they send the specimen to a different lab. That's a requirement. I don't like that option, and we'll talk about why in a few slides, but the lab is required to get in touch with you if there's a problem with the specimen. One of the options that you can look at as the MRO is to authorize the specimen be sent to a different certified laboratory. If a laboratory identifies a new adulterant, they must complete the testing for drugs and notify HHS and DOT. You will see in your practice that very seldom, very, very seldom now do you actually report of an adulterated specimen, and we can discuss why in a few slides. Talking about invalids, the definition beyond what we talked about before with the definition of validity testing, this specifically means a drug test specimen that contains an unidentified adulterant or an unknown interfering substance. Now remember, if the substance is unknown, we really don't know if it's an adulterant that was put there on purpose or if something that is just physiologically happening in that specimen, so keep an open mind. If you see an invalid result, do not automatically think there's been some tampering going on here because we don't know that yet. Specimen can also have abnormal physical characteristics like we talked about before, and as I said, it could be a physiologically endogenous substance at an abnormal concentration that prevents the lab from obtaining a valid test result. Bottom line, no valid test results can be obtained. That's what makes a specimen invalid. Guidance, what actually does this? Creatinine less than two, but specific gravity acceptable? That should make sense. We're going to talk about dilute specimens, creatinine, and specific gravity in greater details in the next section of this lecture, but I said already that these are both measures of specimen concentration, therefore, it would be logical to assume that measures of specimen concentration work in parallel. Creatinine goes down, you'd expect specific gravity would go down as well. You're seeing from the first two bullet points here disparate creatinine and specific gravity result. One is high, one is low. That makes no sense. That's obvious. Sadly, you're going to have to remember those numbers for the test. After the test, the laboratory will tell you the numbers and you don't have to remember them anymore unless you get asked about them a lot. Abnormal pH, okay, the low end of the pH in blue in the bullet point here is a change. Abnormal pH to be considered an invalid specimen must be between four and 4.5. You'll find in the adulterant section that below four constitutes an adulterated specimen. The gray area or invalid results are above four, but less than 4.5 and above nine and less than 11. The laboratory sees reactions in the specimen that resemble oxidants, halogens, aldehydes, surfactants like soap, anything, then also you will get a report of an invalid specimen. If there's something in there that interferes with immunoassay, Dr. Sample went over the process and the chemistry of immunoassays. Something in there is blocking some of that assay reading, then that is going to get you an invalid result from the laboratory. Immunoassay interference, the laboratory will tell you that's the cause of the invalid report. There can also be interference with the confirmation processes. The immunoassay had a presumptively positive specimen that went to confirmation, but for some reason, the laboratory couldn't confirm it, the report will be invalid. You're not going to know what went to confirmation because that would potentially bias your review of the case. Those are two different causes of invalid specimens. Again, the specimen looks funny, or if bottle A and bottle B look different, they both come from the same void, it's a split specimen, so they ought to be pretty similar. There's got to be some settling, perhaps some sediment issues in different bottles, but they should look pretty similar because they're the same void. If they don't, you'll get a report of an invalid specimen. Then specimens with the same abnormal color in bottles A and B may be tested by the laboratory or may not be tested by the laboratory. This is a judgment call on the part of the accessioner and the certified scientist laboratory. If that happens, if the laboratory does not tell you the specimen is an invalid specimen but sends you a result, they're not going to tell you about abnormal colors. That's the reason if you have suspicions here, for example, if the donor told you they were taking an azo medication that you expect to turn specimen colors, you might want to call the lab and check because if the test process continues as it normally would, the lab's not going to tell you about the color. Okay, always, always, always check with a certifying scientist and try to get all of your questions answered before you talk to donors. HHS requires a certifying scientist to call you in some cases. Frankly, that's awkward because it almost always goes to voicemail. I would much rather call the laboratory if I can. Most especially large laboratories have toxicologists on call that are available to pick up the phone and talk to you. But regardless, the bottom line, the important thing is that before you continue with the review of an invalid specimen from the laboratory, talk to the certifying scientist at the laboratory and find out all you can find out about that specimen. Immunoassay interference can be caused by prescription medications. Non-steroidal anti-inflammatories can do it. Certain antibiotics, quinolones, metronidazole can do it. It's also possible that synthetic urine is looked at and reported by the laboratory as having immunoassay interference. It's important to talk to a certifying scientist because all of these reasons create somewhat identifiable, if not forensically defensible patterns. And the verbal discussion that you're having with the certifying scientist is not written down, it's offline, but you will get a sense of what is going on with that specimen. It's really good for you to know if the interference looks like it's medication interference, like an NSAID or an antibiotic. Then when you do the interview with the donor, you can ask about prescriptions. So this is important. The last bullet point is on the slide for completion. Really you don't have to ask the lab about their abilities to perform an alternate screening assay. They all do it automatically nowadays. If there is an available different screening assay, it's going to be done. You can ask, but it's going to be done. So if they can't do any more testing and the immunoassay interference looks like the report you're going to get, you have the option to order the specimen to be transferred to another HHS lab and see if they can screen it. You have this option. We have to show you this for completion. I don't like it. I don't do it, and I won't start, and I won't recommend you do it either. The reasons are, I think, obvious. Sending a specimen elsewhere takes a lot of time. We talked already in previous sessions about the importance of turnaround time. You may have to ask permission with a designated employer representative about who's going to pay for this. It's going to cost extra money. It's going to take extra time. Most certified laboratories in this country now do the same things. The odds of you getting a different immunoassay result from a different laboratory is not good. It was significantly different 20 years ago, but this day, today, it's just not very good. This is pretty much, I think, a waste of time and a waste of money. One thing that's not on this slide that I think is really important about this is, if whatever was in that specimen that interfered with the testing, if that was put there on purpose by the donor to hide something, remember the detection times in urine that we've talked about from previous lectures. By the time you go through this entire process, that detection time has passed. Whatever the donor might have been trying to hide is now metabolized away, is gone, and will test negative. Even if the donor was not doing this on purpose, bottom line is the detection period is still over. My advice to you is, if you get this report from the lab, expedite your review. If you are going to collect another specimen, get it done as soon as is humanly possible to avoid that as much as you possibly can to avoid that detection time issue. If the interference is consistent with prescription medication, verify the prescription just like you would if it was codeine or an amphetamine. When you get invalid results from the laboratory and you see no confirmed positives, the report that you give to the designated employer representative is test canceled. You tell them why the test was canceled. Then you have to make a decision about whether or not you are going to require the doer to recollect another specimen under direct observation, to recollect another specimen not under direct observation, or possibly not recollect another specimen at all. Remember those three reasons we needed negatives. Regardless of the outcome of this review, if you need a negative, you have to get another specimen. The question then becomes, do you do it under observation or not? If you have verified a prescription for ciprofloxacin, for example, then you have a medical explanation that's consistent with the findings of the laboratory. If you need another collection, it's not going to be observed. No reason to observe that. You've explained the interference in immunoassay. If you need another collection, you do it. If you don't need a negative in that situation, you may not do another collection. If a negative test result is required and the medical explanation concerns a situation in which the employee has a permanent or long-term condition that precludes the provision of a valid specimen, then you're going to have a consultant physician involved, just like we did before with shy bladder. That consultant physician, they're not going to be looking, obviously, for explanations for a shy bladder, but the examination will focus on whether there is clinical evidence that the individual has used drugs illicitly or not. As the MRO, it is your job to determine if that clinical evidence exists, if that clinical evidence shows the individual is currently using drugs illicitly. You always have to relate the findings of a physical examination, regardless of the cause of the physical examination, to the actual collection process, the actual collection event. If there are, as I said yesterday, if there are healed track lines that look more like historical track lines than current use, that doesn't qualify. You have to relate the findings of the exam to the collection event. You can do the exam yourself if you want to. If you're in the clinic, you can certainly do it. If not, you have to have the exam done. If that exam doesn't show anything, there's no clinical evidence of drug use, then as the MRO, you are allowed to report this as a negative test result in those three circumstances where you need a negative result. You want notations there regarding the exam of course but the result is negative. So the report should also state why the exam was required and that's a little bit different but it has to be put in there so that the basis for the determination was that a permanent long-term medical condition does exist. There's another case which we're going to talk about in a few slides about a recollection under direct observation which resulted in another invalid result for the same reason. We're going to review that in a few slides coming up. Okay if the examination reveals no signs no symptoms of current drug use you can report the result as negative but if the evaluation does reveal clinical evidence of the use you do not report the test as positive you report the test as canceled. The reason you don't report the test as positive is because we do not have laboratory confirmation of a drug. We have a clinical evaluation that shows signs and symptoms but we cannot name a drug. Remember this is a forensically defensible process which means we have to be able to name and quantitate a drug at confirmation. We can't do it. The test is canceled. Remember though that there's no action based on a canceled result. So if this is a situation where a negative result is required then still the donor cannot be hired but cannot be put back to duty because canceled tests don't work as negatives. We've said that already. Now there is an issue with the upper end of the pH range that you will see I promise you you will see this a lot especially in the summer. So when you conduct an interview for an invalid result that has a pH in the nine to nine and a half range remember what happens when specimens age. You might want to see how long it took the specimen to get from the collection type to the laboratory. You might want to figure out what time of year and what part of the country the collection and the transportation actually happened in. As specimens age especially when there's heat the pH goes up. So that may be the actual explanation for a pH in the nine to nine and a half range. Simple time and transit. You are authorized by DOT to consider the following. Temperature conditions are likely to have caused that and as such that you may use that consideration to explain medically why you received the invalid report from the laboratory. If in your opinion time and temperature possibly caused the elevation of pH into that invalid range then you cancel the test and you don't have to have a directly observed recollection. If you determine that time and temperature could not have been responsible for that then in fact you still cancel the test but you have to have that directly observed recollection that we talked about. So remember when we're talking about canceled tests and you are talking to the employer your main job is to make a decision about whether there's likely medical explanation or not. Regardless of the reason for test if there is no likely medical explanation in your opinion you always get a directly observed recollection. If you have a likely medical explanation you do not need a directly observed recollection. Okay when you do the interview you can ask did you mess with the test? And believe it or not I've actually had people say yeah. I said yeah you caught me. Most the time obviously that's not going to happen but it's okay to ask that question during your interview. So the donor denies it of course. Test canceled, invalid result, direct observation recollection is required. That's if you don't think there's a good medical explanation for this. No notice observed recollection. That's how you report it to the doer. If the adulteration is admitted like I said it happens believe it or not not very often. You put refusal to test but under the remarks you have to put adulterated with by interview. You have to put the comment that that shows the doer what the donor told you during the interview if the donor admits it. Then of course you sign that statement. So that's only if adulteration is admitted. Don't expect that to happen a lot. Okay so if we get that recollection that we're talking about and if you require that second collection to be observed and you get another invalid result for the same reason what do you do? Remember Ferguson said the myth of the observed collection. You've heard about what it takes to do a properly observed collection from Donna Smith. So it's not the most fun thing for anybody to do collector or donor. So I call some of them the myth of the observed collection. So I want you to check with the collector and find out exactly what happened at that second collection. Was it properly observed? Okay if it wasn't don't interview the donor just send them back and get a better observer to do the next recollection. But if the second collection was properly observed and was invalid for the same reason the test is canceled and no further action as less the negative was needed like we talked about before. Now if it's invalid for something else for a different reason you do another observed recollection but that's only if it's invalid for a different reasons. You can only have four different ways to report the outcome of this whole set of events. See then it'd be negative or negative dilute positive or positive dilute. Test canceled that's the most likely one. Test canceled give the remarks we talked about or refusal to test because. Those are the options the only options coming from an invalid report from the lab. We've given you a chart here to hopefully aid you in your studying. DNR means do not report in the last column. This chart simply gives you those options and tells you which collection becomes the result of record. Okay notice in most cases it's going to be the second collection. Okay we are moving now to more consideration of creatinine and specific gravity values. Specifically and we we've seen a lot of agreement between HHS and DOT. Well herein is one major area of disagreement. The HHS guidelines only recognize one category of dilute specimens. In other words it's either dilute or it's not. If it's not dilute its concentration is within the acceptable range creatinine above 20 or is substituted. DOT doesn't buy that. There's a historical reason for this we don't have time to go into that here but DOT gives two categories of dilute. When creatinine is greater than 5 milligrams per deciliter but less than 20 we are going to call that normal regular dilute if you will. That's the standard range for dilute specimen but if the creatinine is between 2 and 5 it's greater than or equal to 2 less than or equal to 5 that's a special DOT category called hyper dilute ultra dilute whatever you want to call it there's no official name for it. You have to do a different action if you're reviewing a DOT result in that range. Substituted meaning the creatinine is so low it could not have come from a mammal substituted is less than 2 milligrams per deciliter. So as I said for HHS you see the substituted dilute or normal. For DOT you see a substituted hyper dilute dilute or normal. It's a little bit confusing just remember the differences when we talked about setting up non-regulated testing with your client you want to maybe discuss this with your client about how they want these handled which set of rules or guidelines would your client like to follow. You can certainly make your own recommendations. Okay here is agreement from DOT and HHS dilute creatinine less than 20 but greater than or equal to 2 and specific gravity is less than 1.0010 greater than 1.0010 but less than 1.0030. DOT and HHS agree on that range and substituted is when creatinine is less than 2 but remember you need a second test you also need specific gravity as the confirmation test here if you will. Specific gravity needs to be less than or equal to 1.0010 or really at the other end of the spectrum greater than or equal to 1.02. You need both measures in those abnormal ranges to call dilute or to call a specimen substitute. A laboratory is going to report that to you they're going to give you the values the good news is you have to remember the numbers for the test after that the laboratory will tell you the numbers. The specimen is substituted it's going to come to you with that word substituted with with remarks and then remarks are going to give you the creatinine and the specific gravity. They may not actually give you a creatinine level if they can't detect creatinine they'll just tell you they can't detect creatinine. Okay for dilute specimens you don't interview the donor there's no reason to interview a donor for a dilute specimen period. So you report it as negative dilute if it's positive of course you do the interview and still report it as positive dilute as we talked about before. Remember the employer option for recollection of a negative dilute that we talked about yesterday. Inform the employer that they have that option also remember that that option can only be done once the second collection is the result of record. If the specimen is substituted in other words the creatinine is less than two and the specific gravity is less than or equal to 1.0010 or really high greater than or equal to 1.0200 then you have to do an interview. And when the donor decides they can't explain this you report it as a refusal to test because specimen substituted. Believe it or not you can also sometimes find positive drugs in those specimens they just donor did not dilute it down far enough and the drug still confirmed positive. You report both you report refusal to test and positive for whatever the drug was confirmed. And when remember we talked about those two values now right they're both measures of concentration so they should parallel but if they don't the specimen is invalid. It's not substituted it's invalid if creatinine and specific gravity are discrepant. They don't parallel they don't look like they should the specimen is invalid. Either the creatinine is almost non-existent but the specific gravity is fine or vice versa. The creatinine is okay but the specific gravity isn't. So you do an interview when they can't explain it which is likely. Sometimes there can be some types of explanation you can look at but most of the time no. Test cancelled invalid specimen. If the explanation that you heard from that donor does not make sense you get an observed recollection. For hyper dilute for DOT only now this is DOT only no MRO interview. Remember I said for just simple dilutes you'd never do an interview. For hyper dilutes no interview but there is an immediate observed recollection required by DOT not by HHS by DOT. If the drugs positive report the positive obviously and you don't do a recollection. You only do the observed recollection this should make sense. You only do the observed recollection for a negative hyper dilute specimen. But again do not do the interview unless there is a drug confirmed positive. For your study aid we have given you a chart. This is a confusing chart Donna Smith and I spent a long time working on this. It's right I hope it helps you. Moving out of the invalid substituted dilute ranges we're going to talk about adulterated specimen. Now you have to look at adulterants the same way you look at drugs. For the laboratory to report to you an adulterated specimen they have to confirm an adulterant. Just like when they report a positive they have to confirm positive drug. So an adulterant is a substance that isn't expected to be there. A substance that might be expected to be there but is way out of whack in terms of concentration. Or that the physical characteristics of the specimen are not what you expect from human urine. In other words it's suds like soap. Here's the definition of adulterated specimens. pH less than 4, greater than or equal to 11. That's a change at the lower end. The 4 is a change. Nitrites greater than 500 micrograms per mil. Chromium. I'm sorry again you're gonna have to remember these numbers for the exam. Halogens all those kind of things do not come in human urine. Now if a laboratory is able to identify any other adulterant they should confirm and report that adulterant to you as well. Remember the testing for confirmation of adulterants is done at the laboratory the same way that testing for presumptively positive drugs is conducted. Separate aliquots, same bottle. The laboratory will report the values to you with quant levels just like it does for drug quant levels. The quantitative values that you see must be reported all the time. You should not ever have to call the lab and get quantitative values. This is how you're gonna do copy 2 when you write the report. Oh but this is copy 1. Never mind this is how the laboratory will sign copy 1 and send to you. This is what you have to have remember before you do DOT reviews. You have to have a certifying scientist signed copy of copy 1. Again we talked about the laboratory results with the remarks. Just a list of the same things we've talked about. Don't forget you can see multiple results. It's an interesting interview okay. When you have a positive and invalid for example you will be asked but how can you have a positive result if the specimen is invalid? You'll have to explain that. The two different processes at the laboratory and those words refer to the outcomes of those two different processes but it's not necessarily an easy explanation for you. Your actions are a standard verification process. Gotta get copy 1, gotta get copy 2, do the donor interview. You notify the donor that the split specimen is available for reconfirmation at another certified laboratory for adulterated and substituted specimens but also remember not for invalids just for adulterated and substituted specimens. Like with drugs the burden proof is on the donor. As with drugs you can extend the time for the donor to prove that they can physiologically produce an adulterated or a substituted specimen for up to five days and when that process is undertaken by the donors okay then they must demonstrate that an adulterant entered the specimen physiologically. Same way with substitution. They must prove to you that they are physiologically capable of diluting a urine specimen into the substituted range of creatinine and specific gravity values. Good luck. If you believe that their medical explanation may be reasonable then you have to direct the donor to obtain an evaluation by a licensed physician just like those other physician consults we've talked about before for shy bladders or for the inability to produce a specimen. For invalid results, same kind of consultation with a physician. You get approval of the consultant physician. The physician has to be acceptable to you. In this case, unlike the evaluations we talked about before, I would suggest that the consultant physician be a specialist, urologist, nephrologist, something. The donor has to pay for this. The company's not going to pay for this. So the donor is responsible for setting up, paying and conducting the interview or the evaluation exam. So if the expert physician is used just like before, you have to provide that physician with guidance on what's going to be expected. You have to explain what's going on, DOT test results and the consequences those results carry with them. The referral physician can do anything the referral physician wants to do in terms of additional testing. Can be clinical tests, can be drug tests, can even be a hair test if it's being done as a part of a consultant exam. Obviously, as in the DOT program, as of yet, hair testing is not allowed. But for this type of specialist consultation, the specialist can do any kind of test they wanna do. And when they're done with their evaluation, you will need a written consultation and recommendation about that exam. But always remember that for any of these exams, for any of these outside exams, you as the MRO have the final decision. It's up to you. You can either agree or disagree with the examining physician. So it's not enough when that exam is going on to just make a diagnosis by the consultant. The medical condition that is diagnosed has to show that it caused the problem at the drug test collection. You have to relate the diagnosis to the collection event. If that doesn't work, then the diagnosis doesn't count. It has to relate to the collection event. Your options, again, you've only got four options, just like before. Negative, negative, dilute, positive, positive, dilute, canceled with reasons, refusal to test because. And remember, if specimen substituted, that's the end of the report. But if the specimen is adulterated, you have to name the adulterant. In our world today, you hardly ever see a certified laboratory confirm an adulterant. It just doesn't happen. There are historical reasons for that. We don't have time to go into them here. It's just very, very uncommon for you to get an adulterated report now. When you write up the form, you check refusal to test because specimen adulterated, and in the remarks section, you put the confirmed adulterant. If you believe there is a legitimate medical explanation, the test is canceled and reported to the DER as a canceled test, it's not gonna be easy, is then you have to notify ODAPSI in writing. Why do you think that? You have to explain to ODAPSI, why do you think there's a medical explanation for an adulterated or a substituted specimen? I've never had to do that. I doubt that conversation would go easily. If there isn't a legitimate medical explanation, the report that you give to the employer is refusal to test because specimen adulterated with or because specimen substituted. Okay, so the refusal to test report applies to any donor who refuses to appear, to remain when they're supposed to remain, to provide a required specimen, or to permit a directly observed specimen when required. Relative to the first bullet point about the appearance for the test, please make sure that the reason they did not appear is not explainable before you saddle that donor with a refusal to test, which has some pretty draconian options in the DOT testing world. Maybe they did not appear for the test because they had a flat tire on the way to the testing site. So at least check it out before you automatically assume that the non-appearance was a refusal to test. So refusal to test also applies to any refusal to provide a sufficient specimen without a legitimate medical explanation that we've just talked about. To cooperate with any part of the testing process, that's a refusal to test. If a second test is required and the donor refuses, that's a refusal to test. The donor refuses to undergo a medical examination that you require for after a shied ladder, that's a refusal. And verified adulterated or substituted reports as we've just talked about also applies. Understand that with some of these refusals, you as the MRO are not necessarily involved. The second bullet point here, if the donor refuses to cooperate with the collection process, or refuses to take a second test that the collector requires because of a temperature out of range or something like that, you're not involved as the MRO, okay? The only time you issue a MRO verified report is when you have specifically done the review yourself, interviewed the donor and followed all the protocol that we've spent, you know, past couple hours talking about. So be careful if the donor, as I just said, if the donor doesn't appear, be careful about, find out the reasons for the lack of appearance. Most commonly, they walk out of the collection site. That again, is the collector refusal to test, not the MRO refusal to test. Provide the required specimen or permit the observation. So if there is no legitimate explanation, then as we said before, these are the refusal to test reason, remember that you're not always involved with these, okay? But this is a serious result. There is a draconian action in the DOT testing world for a refusal to test. In many cases, it's considered to be worse than a MRO verified positive test. So immediate notification of the DER is required. Telephone, don't leave a voicemail, just like we've talked about. Okay, split specimens. We have, as I said early, early on, there's just no reason for forensic drug testing to be done in this day and age without a split specimen. The collection kits don't cost anymore, there's just no reason to do it. But it's certainly for all federal tests, it's mandatory. As Dr. Smith told you, 45 mils total collection, 30 in the bottle A, 15 in bottle B. Collected in a single container and then split with the donor watching. And non-DOT programs without split, first of all, as the MRO advise your clients, they shouldn't be doing splits. If they insist, then sometimes a reconfirmation can be done on a separate aliquot of a single specimen if a reconfirmation is necessary. Okay, the bottle A is non-negative. Remember the words non-negative, positive, invalid, adulterated, substituted. If bottle A is non-negative, B is kept frozen in the freezer for a year at the laboratory. It can be discarded after a year unless you file with the laboratory a request to hold that specimen, which you will do if there's a litigation or anything unusual going on around that event. If bottle B is not available, then the lab will analyze bottle A and report the results of bottle A to you. They may not tell you that bottle B is not available. That's sad, but they may not. If only bottle B has the required volume, say bottle A leaked in transit, then the lab has the ability to redesignate bottle B as bottle A. Again, they may not tell you that. Sometimes they will, they're not supposed to because the reason is that if you have to do an MRO review of the laboratory non-negative result, and if you as the MRO know there is no bottle B available, there is no split specimen available, that has the potential to bias your interview. So the laboratory is not supposed to tell you whether or not B is available. And if you need to do an MRO review of a laboratory report, then you do it as you normally would. If a donor requests a split specimen, that's when you find out that it's not available. And that's when you know as the MRO, you have to cancel the test because the split's not available. That, again, would be the explanation for the potential of bias on the part of you doing an interview, and that is why the lab's not supposed to tell you about bottle B issues. The bottle B split specimen reconfirmation testing only be ordered by the employee through you. The only reason for testing bottle B is to reconfirm bottle A's, positive adulterated or substituted results. We talked yesterday about the 72-hour rule, and remember you may extend that. Bottle A reanalysis is a different thing. It can be ordered by a federal agency. It can be ordered by you. For example, if you don't have a methamphetamine chiral separation already set up at the lab and you want it done, you can order that on bottle A. You can't do it on bottle B, though. If you want to do THCV, same thing. The employee, through the MRO, when bottle B fails to reconfirm, if there's an issue with the split specimen at lab B, then the employee, through you, can order more testing on bottle A. Now, we're going to talk about that a little bit in a few slides, but under that very unusual circumstance, the employee can, through you, request more testing on bottle A, and remember the oversight agency, HHS or DOT, can also order more testing on bottle A. When a split specimen is ordered, you send a request to the lab, to lab A, to send the following items to lab B. The original bottle B with the seal intact. The seal has to be intact, just like on the bottle A when it first gets to the lab. Written request, remember DOT, still everything is done in writing. Copy one of the CCF. No employee name, same as usual. Lab B on bottle B only does confirmation testing, and they do not use a cutoff. They test the specimen at the laboratory's limited detection or the limit of quantitation, and it's usually the LOD, LOQs are the same, not always. Since, as I told you before, laboratories have to confirm quantitative levels. Normally, the lab B will test at the limit of quantitation, but they will not tell you the quant levels. Bottle B testing is qualitative only. You don't get levels, because the levels are hardly ever gonna be the same. Even though the specimen's been frozen, there's degradation that happens, all sorts of things happen, so you will not get quant levels on split specimen bottle B testing. Likewise, the 100 nanogram per mil amphetamine requirement for methamphetamine is gone for bottle B split specimen retesting. So, lab B gives you a qualitative result only, but tells you what their LOD slash LOQ is. If it does, this bottle B does not reconfirm, lab performs validity tests on the split specimen. If the lab is not able to identify the reason for the failure to reconfirm, they may send a specimen to another lab to conduct another test. This actually might happen in real life, okay? You'll be involved in this decision, but that is an option for lab B. Now, unlike the LOD, LOQ requirement for positive drugs, if the split is being reconfirmed for reports of adulterated or substituted specimens, then the levels tested at laboratory B in bottle B are the same as the levels used for bottle A to establish the adulterated or substituted result. In other words, those same quant levels for nitrites at 500 that you all memorized for the test have to be found, the specimen in bottle B has to be found above those levels, just as it was for bottle A for the original test result. Okay? You only again test for the substance that was found in bottle A, but just remember for the test and for the future that when you are reconfirming adulterated or substituted specimens in bottle B, the levels lab B finds must be the same as the levels you memorized for bottle A. That's different than drugs. Drugs are tested at the laboratory's LOD. Split specimens reports, either reconfirmed or it's not. If it's not reconfirmed, you have to have the reason. A report, again, only comes to you, just like all of the other results, and this is how you sign off on copy two. It's either got to be reconfirmed or it's not going to be reconfirmed. This is from the laboratory, the report on the laboratory copy of copy one, copy two. You report reconfirmed and adulterated with or substituted. Remember, adulterated, substituted results are refusals to test. You again call the donor and notify the DER of the split specimen reconfirmation result. We just talked about what the lab will tell you. Failed to reconfirm, it has to give you a reason if it doesn't reconfirm. It also has to tell you that it did validity testing if it does not reconfirm. Now, what do you do for failures to reconfirm? So if the laboratory has a bottle B that fails and the validity testing is done, the laboratory will tell you, you must notify the worker that the result of both tests are canceled. Now, here's what we don't get a lot of times in teaching these courses and on the exam. If bottle B needs to be looked at as the donor's right to due process, for a scientific result to be valid, it has to be attainable in more than one situation by more than one tester. If bottle B is a valid specimen and goes to lab B, but lab B doesn't find the same thing that lab A found, no reconfirmation is possible. The donor's right to due process has been done. Both test results are canceled. If bottle B is a valid specimen, then both tests are canceled and there is recollection. The testing is over. Within the result is a cancellation. Now, this happens in the DOT testing program very, very rarely. And you must report that to ADAPC. They'll report it to HHS. Auditors will descend on the lab. But rare, but just keep in mind that if all of these steps have worked, the due process has been accomplished and no reconfirmation happens, the test is canceled. Now, what happens if all the steps don't work? So what happens if the split specimen is not available or is not sufficient? What happens if the split specimen results are invalid? You still then have to cancel both tests, but due process has not been completed. In other words, bottle B was unable to be tested. So we don't know if it was gonna reconfirm or not because it could not be tested. You have to have an immediate observed recollection in that case. Again, you report the case to ADAPC. Please keep that in mind. If you have questions, we will be through the chat function addressing them today. So I know this is confusing, but just remember, look at it as due process evaluation. Okay, you notify ADAPC on split analysis when GLAD-B makes any of these reports. Failures to reconfirm, drug metabolites not detected, criteria for adulteration substitution not met, unavailable for testing, any of those, you notify ADAPC. Any problem in the process. Okay, mandatory recollection only happens when the split specimen is unavailable for testing or when the split specimen was invalid and because it was invalid, it failed to reconfirm. When split specimen fails to reconfirm substituted and creatinine values that are different than the original one, mandatory recollection. And that is it. Please ask questions in the chat function if you have them. I know this is confusing and I really appreciate your attention.

urine drug testing

validity testing

invalid specimens

dilute specimens

adulterated specimens

creatinine levels

specific gravity

split specimen testing

medical review officers