I'm Donna Smith, the Regulatory Compliance Officer with Workforce QA, and one of the faculty members for this medical review officer training course. The module that I'm going to be presenting is on forensic urine collections. As I mentioned, I do work for Workforce QA, which is a third-party administrator and medical review officer firm. And in that capacity, as I mentioned, my work is in the regulatory compliance, specifically the Department of Transportation Drug and Alcohol Testing Rules arena. So without any more discussion, let's go to talking about forensic urine specimen collection procedures. Those procedures, which are detailed and specific, are found in 49 CFR Part 40, which is the procedural rule that governs all drug and alcohol testing done under DOT agency regulations. And specifically, the collection procedures are found in subparts C, D, and E of that document. The sections identify who are specimen collectors, everything necessary about the collection site, and the supplies necessary to collect a urine specimen for DOT testing. Those procedures also give the chronological steps in the collection process, which we will review. We'll also talk about what procedures are in place during the collection to ensure specimen identity, that it's correct, the security of the specimen, and the integrity of the collection process. As you know, probably, that for forensic urine testing, one of the big differences between clinical testing is that forensic urine testing requires a chain of custody, which begins with the collection of the specimen and actually goes all the way through the testing process at the laboratory, and then is a part of what you, as the medical review officer, review and affirm that the chain of custody is intact. Drug testing under federal authority, whether that be the Department of Transportation, the Nuclear Regulatory Commission, the Department of Health and Human Services, is based on principles of search and seizure, the Fourth Amendment. And that's why there are very specific things that are prohibited in the course of urine specimen collection, and also things like the chain of custody that are required. There is a DOT specimen collection guideline document, which is the source of that, is listed on this slide. It is updated frequently to provide even more specifics, some questions and answers, some examples, etc. for collectors of Department of Transportation urine specimens. So, what are the collector's responsibilities? Well, you heard me mention about the identification of the specimen, the integrity of the process, the security of the specimen, all of that, because the process begins with the collection of the specimen is a responsibility of the collector. To ensure no unauthorized access to the collection area while the collection of the urine specimen is taking place, and that, again, speaks to the integrity of the process. So, it is the collector's responsibility to initiate and document the proper chain of custody with the specimen handling, and it is the responsibility of the collector to display professional conduct at all times. The specimen collector should not be a direct supervisor of the donor, according to Department of Transportation rules, unless there is no one else available to do the collection who has the requisite training and qualifications. All specimen collectors must complete qualification training, a training course that can be a classroom course, a distance learning course, web-based course, et cetera. The training course has certain elements in it dictated by the DOT rule that it must include, and then it also has to have, rather than a written exam, it must have an initial proficiency demonstration component to the training. And the initial proficiency demonstration is often called mock collections, where the collector, in the presence of a facilitator or instructor, must complete five consecutive error-free collections. One without any problems, a couple without any problems, another one where there would be a shy bladder or the inability to provide a sufficient urine specimen for testing, another where the individual may refuse to sign or to initial the specimen bottles after the collection, those kinds of things. And then that comprises the qualification training for a urine specimen collector. They must repeat that full training, including the initial proficiency demonstration or mock collections every five years. A collector may also be required to undergo additional training called error correction training, and that is when they make an error in the collection process that requires the medical review officer or the laboratory to reject a specimen for testing in the case of the laboratory or in the case of the medical review officer to cancel the test because of a fatal flaw or other uncorrected problem with the collection. And so if that is the fault, if you will, of the collector, that error that was made, then the collector must undergo error correction training within 30 days of being notified by the medical review officer or the third-party administrator or the employer that a test was canceled by the medical review officer, either because of a fatal flaw or an uncorrected flaw in the collection process. And that error correction training consists of three mock collections and a review of the procedures that are relevant to the error that was made. Let's talk a little bit. So that's about the collector. The collection site may be a medical facility, a mobile van, a dedicated area at a work site, as long as it meets the requirements that you see on this slide. It is certainly preferred that there be a single toilet room or enclosure with a full-length privacy door and with a single entrance or exit. The area that is external to the toilet room or toilet enclosure has to have a hard surface or area where the specimen can be packaged and the custody and control form can be completed. It is allowed, as I said, a single toilet enclosed room is the preferred collection site, if you will. However, a multi-stall restroom with a partial length door can be used. The specimen is provided in the privacy of that toilet stall with the partial length door closed. The collector would secure all water sources such as sinks, urinals, other toilets that may be in that multi-stall restroom or bathroom and remain outside. Or the collector can prepare the one toilet stall that will be used for the urine specimen collection and remain outside the closed stall door but inside the restroom, the multi-stall restroom, and they would then essentially be what DOT defines as monitoring that collection. If a collector is going to serve as a monitor, meaning being inside the multi-stall restroom but stationed outside the particular stall that's being used for the collection, that monitor must be the same gender as the donor unless that monitor is a medical professional or paraprofessional such as a nurse or a PA or a certified nursing assistant, etc. The monitor does not need to meet collector qualifications. So the monitor is there, if you will, to again to deter cheating, to uphold the integrity of the process, and then if he or she is not a trained collector, the urine specimen would be handed off by the donor to the collector who would complete the paperwork. What about site security, collection site security? You have to control and restrict the access to the site and to the collection materials. Post limited access signs if it is a public area such as a multi-stall restroom or a public restroom at a worksite and it's going to be used for drug test collections, urine collections, it would need to be posted that there's no access to the restroom right now. Similar, quite frankly, to like an out-of-order sign but in this case it would be a sign that says that, you know, no access testing taking place or whatever. Security areas where items could be concealed and certainly the DOT has been notorious, I guess, for maybe taking this to quite an extreme where they actually encourage collectors to make sure that there could be nothing placed in the in ceiling tiles that are removable or accessible in the toilet enclosure, making certain that any soap or other materials are removed from the toilet enclosure, taping the toilet tank if that has water in it, securing all other sources of water to make it unavailable, putting bluing in the toilet water so that the person cannot use the water from the toilet to augment or to replace their urine, removing, as I mentioned, any kind of other supplies or things that would be in the toilet enclosure, and to recheck all of that above after each collection. So even a trash receptacle that's there needs to be empty and not have any materials in it for each collection. All right, what is the standard urine collection kit? It consists of a graduated collection container with a wide mouth opening, two specimen container bottles with leak-proof caps that accept seals, leak-resistant plastic bag with absorbent material or desiccant in two sealable compartments of that bag, hard-sided or padded shipping container if the specimens are going to be transported by express carrier or mail to the laboratory, if they are being picked up by a laboratory courier service, then they can certainly be in the plastic bags or in any other type of soft-sided packaging. Temperature sensing strip is a requirement for the collection kit. I believe today every urine collection kit that I have seen has that temperature sensing strip already attached to the collection container, the wide mouth container that the individual is going to use to urinate in, and so that once the temperature of the urine is put into that collection container, the temperature sensing strip does change colors in terms of the dots indicating that it is the temperature of the specimen within an identified range of 90 to 100 degrees Fahrenheit. Let's see, the Federal Custody and Control Form, there's a paper version of that form that's been around forever, since the 1990s, and it is a five-part form and only one copy, that is the original, goes with the specimen to the laboratory, and there is no donor information on that copy. That's why the specimen ID number and why other information that is on the bottles and the form are essential to the identity of the individual. The Federal CCF is used only for collections performed under federally mandated testing programs. Again, that would be testing under DOT, the Department of Transportation, whether that be the Federal Motor Carrier Safety Administration or the Federal Aviation Administration. The federal form is also used for Department of Health and Human Services mandated testing, which applies to federal employees who are in testing designated positions within the federal government, in the executive branch. That means probably close to about 1.2, 1.5 million federal employees who are in such positions. Lastly, the Nuclear Regulatory Commission requires testing and it's federally mandated testing for all nuclear NRC licensed facilities and the employees who have access within the gates of those facilities. If an incorrect federal or non-federal CCF is used for a federally regulated specimen, then the collector has to provide a written statement of correction documenting that the correct procedures were used. The MRO, by the way, must cancel a test if the corrective statement is not received. You probably have heard of circumstances where an employer does both federal testing and non-federal testing and an incorrect federal or a non-federal form is used for a particular collection. Then the employer wants you, the medical review officer, or as a staff member for the third party administrator to redesignate that test. In other words, to take it from being a non-federal to a federal test or DOT test or vice versa. Again, that does require a written statement of correction documenting that the correct collection procedures were used. I should mention this last bullet because it is important in 2020, the current version of the custody and control form was released by the Department of Health and Human Services and the Office of Management and Budget. It did allow for the collection of either a urine specimen for federal testing or an oral fluid specimen for federal testing. To date, however, there is no implementation of oral fluid testing under either the Health and Human Services, the Nuclear Regulatory Commission, or the DOT rules. We are still awaiting approval of the laboratories to do oral fluid testing. We are still awaiting approval of the collection devices, the collection kit, if you will, to conduct oral fluid testing. So while the current CCF can be used for either oral fluid or for urine testing, it is only for urine testing right now. What we're going to cover in the presentation today is the use of the form for a urine specimen collection because that is what, again, is authorized and implemented right now. I'll point out where there would be a requirement for you to note for specific that this is a urine specimen collection. There is also an electronic format of the custody and control form, the federal custody and control form. Those were first approved a number of years ago now, and each system that a laboratory is going to use to bring in specimens using an electronic or digital CCF has to be approved by the National Laboratory Certification Program. Currently, it is a paperless and combination system that are authorized at the laboratories. Will we move entirely to paperless soon? Everybody is hoping so, but right now it is still, while there is an electronic version and there is software at the collection site that the collector or the collection sites can use, there is still a requirement to actually print a copy of the CCF to accompany the specimen to the laboratory. Electronic signatures or digitized signatures are allowed using these eCCF systems, but again, as I mentioned, there is a requirement that an image of that be printed once those signatures are attached. Going back to the federal CCF in terms of the paper version, the specimen bottle or tamper evidence seals are on the bottom of the CCF. The seals now on the 2020 and current version of the federal CCF are designed to accommodate either the specimen bottle that we, the bottles that we described in one of the first slides, or to accommodate sealing or labeling, if you will, a much smaller container, usually called a tube or a vial for oral fluid testing. There are the two seals, if you will, on the bottom of each form, an A or B, reflecting that whether it is a urine collection or an oral fluid collection, there will be a split specimen option available for DOT testing. There is a pre-printed unique specimen ID number on the CCF that matches the number on each of those bottle or tube seals. The CCFs are usually supplied by the laboratory and we expect that to continue even with oral fluid testing. The CCFs may include client account numbers, billing codes, pre-printed employer MRO and collector names, addresses, telephone numbers, fax numbers, etc. The employer and MRO information is found in Step 1a and I'll go over this in just a minute. There's got to be employer name and address. One of the things that has been stressed most recently in the DOT regulation is that the custody and control form has to have the DER, the designated employer representative's name and phone number, in step 1A of the form. The employer address can be the address of their agent, their third party administrator. The TPA name can be included in step 1A. But for sure, it's got to be the name of the employer, JW Trucking, Inc., or whatever that may be. And it has to have the name of who is the designated employer representative for JW Trucking and that individual's phone number. The collector may cross out incorrect or preprinted information and write inapplicable names or phone numbers, et cetera, on the CCF. That's always a little risky because things get very confused in terms of account numbers and everything else. But it is possible, based on the regulation, to do that. The DOT rule requires employers or TPAs to provide the collector with all the info that's required for step 1 of the CCF. So here are the CCF requirements in step 1, the employer information, which we talked about, the medical review officer information, which is in step 1B. And that does have to have a physician's name, a qualified physician's, well, an MRO qualified physician's name. It does have to have a street address of the MRO's business. And it has to have a medical review officer's phone number where he or she can be reached by the donor, by the collector, by the employer, the DER, et cetera. So that information all has to be in step 1B. The donor ID number is in step 1C. For a test that is being done under the Federal Motor Carrier Safety Administration Authority, which is testing for commercial driver's licensed personnel, either applicants or incumbent drivers, those CCFs where FMCSA is marked as the DOT agency under whose authority the test is being done, they must have the donor CDL number and the two-letter designation for the state it was issued in as the donor ID number. For all other federal tests, including other DOT agency tests, the donor ID number can be anything. I mean, it can be anything. It can be the Social Security number. It can be other ID provided by the employer, passport number. It can be literally any ID number that the donor presents to the collector or that the DER or the TPA has provided to the collector to use as the donor ID. Step 1D is the testing authority. And basically, remember, there are three federal authorities, the Department of Health and Human Services, the Nuclear Regulatory Commission, and then a DOT agency. For the DOT testing, you must identify which of the six DOT agencies this test is being done. Again, quick review here, Federal Motor Carrier Safety Administration, that's going to be a test for a commercial driver's license, and it will have the CDL as the donor ID. If it is a test of aviation personnel, an aviation company, then it would be marked, the box would be marked as FAA. And likewise, for a Federal Railroad Administration test, for a Federal Transit Administration, which is public transit agencies and systems, for the Pipeline and Hazardous Material Safety Administration, whose regulations apply to all oil and gas operators and their contractors. And lastly, the U.S. Coast Guard also requires testing, again, utilizing Part 40 procedures, and that would be for all commercial maritime events, excuse me, activities, specifically the personnel on U.S. flag ships in commercial maritime activities that are involved in vessel navigation, vessel operation, and emergency response on the vessel. So those are the DOT agencies. And one of those needs to be checked if it is going to be a DOT test. Otherwise, it would be marked as an HHS test of a federal employee in a federal agency, such as the Department of Commerce, the Department of Interior, the Department of Labor, whatever, or it is marked as an NRC test. The reason for tests, we often refer to this as the type of test, but in correct nomenclature, it's the reason for tests. And you check a box, whether that is pre-employment, random, et cetera. There is a box for other, for DOT testing, that is only used when it is a U.S. Coast Guard required test for a mariner or a seaman who is renewing his or her Coast Guard credential to operate a vessel. So otherwise, for DOT testing, it's got to be pre-employment, random, reasonable suspicion, reasonable cause, post-accident return to duty or follow-up. Other is only used for the Coast Guard periodic test. The drugs that are tested for, as in step 1F, these are usually pre-printed. The panel is usually pre-printed with a panel number by the laboratory that has provided the form. It is always for DOT testing, one panel and one panel only. And that will be true, by the way, even when oral fluid testing is an option, it will be the same federal panel in terms of the five drug classes, if you will, which you see marked here, for marijuana, metabolite, THC, cocaine, amphetamines to include methamphetamine, amphetamine and analog amphetamines. Opiates is the fourth class, and that now includes for federal testing, morphine, codeine, the heroin, metabolite, 6M, as well as oxycodone, oxymorphone, hydrocodone and hydromorphone. And then lastly, still on the panel from the very beginning of DOT testing back in 1990, is then cyclodine or PCP. So it's always a five drug panel, even though there are 14 analytes that are ultimately tested for and targeted for federal testing. And the collection site info must include the physical location and the phone and the fax numbers of the collector. We have tried to kind of move forward with each iteration of this form to getting rid of the fax number since very few people use faxes anymore. And going to email or other communication actions. However, the form still does require, and if a collection site doesn't have a fax or an MRO doesn't have a fax, then you simply mark that as not available. So here's a representation of the federal CCF in step one that we've just gone over. And now let's look at step two and we've gone ahead and put the visual of the image of step two. This is where the collector checks for the DOT urine specimen collection, checks urine as you can see to start off. By the way, even when our fluid testing is going to be implemented, an employer cannot collect both an oral fluid and a urine specimen to begin a DOT test. So they have to decide. If it's a random test, we're going to do urine. If it is a pre-employment test, we're going to do oral fluid. And so they would have to start out with a choice. Now, there may be circumstances where if they begin with a urine test, they ultimately go to an oral fluid test and that those might be circumstances where the person has a shy bladder, for example. So once oral fluid testing is available, the employer can provide a standing protocol that says if a person is unable to urinate the required 45 cc's on the first urination attempt, then rather than go into the shy bladder protocol, which can take up to three hours, the employer says go ahead and collect an oral fluid specimen. So that would be an example. However, you would never collect both specimens on one CCF. So again, if the change was made from the urine test and then that was a shy bladder, that form would be completed with that information. And then a new custody and control form needs to be initiated for the oral fluid collection. You must check on, and again, we're going back now to the urine test, okay? So you have checked urine and then you have to either check split or you would check non-provided. Why would you check non-provided? This would be a circumstance where, again, the individual was unable to provide an adequate specimen, the three hours has elapsed, and the collection has been discontinued. You might also be checking non-provided when there's a situation that the person leaves the collection site before the process has completed, and therefore there is no specimen that is going to be sent to the laboratory in that instance. Then if you have to identify with urine collecting the temperature of the specimen, the collector needs to read that specimen temperature sensing device within four minutes of the donor presenting the urine to the collector. And they have to mark them, what's the temperature between the acceptable range of 90 to 100? You mark yes, or if no, enter a remark. Obviously, if it is no, then the specimen is going to be held until a second collection is done immediately, and that second collection is going to be done under direct observation. There is a new CCF that needs to be initiated again here for the second urine collection under direct observation. Remarks are required for any atypical collection circumstance. And then step three on the form is really there's no entry on the form required, no documentation on the form. That is simply the instructions to the collector for sealing, initialing, and dating the bottle seals. Step four is the collector's printed name and signature, the date and time of collection. The time of collection is when the collection is successfully concluded. The specimen shipping information goes in step four, so that the name of the shipping, excuse me, the shipping entity, such as FedEx, UPS, Quest Laboratory, Courier, CRL, Courier, whatever it may be, there is not necessary, nor is it advisable, to have an individual's name in that particular box. So there's no chain of custody entry by the person who picks up the specimen, the FedEx person or the UPS person, et cetera. So it simply is what is the delivery or the transit service being used. Okay, the other step four, the other part of step four that you see here at the bottom is what is going to be used at the laboratory. And that's essentially going to continue, if you will, the custody and control chain of custody documentation at the laboratory. So you can see that that's going to pick up with the accessioning person at the laboratory, who's going to say, yes, I got this specimen, did I, they'll check and see, it came in by Fed, it was marked FedEx, did it come in by FedEx? Yes, okay. Was the primary specimen seal intact? Yes or no. And then beginning the internal tracking or internal chain of custody, who the accessioner releases the bottles to once they have been entered into the laboratory system. So step five, A and B on copy one, these sections are completed at the testing laboratory and a copy is provided to the MRO. They are not completed at the time of testing, obviously, because our collection, excuse me, because the DOT doesn't authorize any kind of point of collection or rapid result kind of testing at all. Everything is sealed and sent off to the laboratory. So these are the primary specimen report completed by the testing facility, by the testing laboratory. The certified scientist checks the confirmed positive drug test and must sign step five, A, and identify what drug it was confirmed positive for and provide the quantitative levels. That's why this copy, remember, only goes to you. It does not go to the designated employer representative or the employer, but only to you as the medical review officer. And then the step five, B, would be filled out again by the laboratory that is doing the bottle B analysis, if and when, that is requested by the employee, by the donor, and that testing is accomplished. Now, step five does not appear on the original copy of the CCF. It is only on copies two through five of the five-ply form that we discussed earlier. The donor completes their printed name, signature, date of birth, their email address was added in the last couple iterations of the form, and a daytime telephone contact numbers, daytime and evening, and then also the date that the specimen was collected as well as their date of birth. The, it's uncommon today that you will necessarily get a donor to provide all three of those contact information, but oftentimes you do. So, and the purpose of that is for you as the medical review officer to have as great an opportunity as possible to contact this person if they have a confirmed positive or confirmed adulterated, substituted, or an invalid test that requires you to conduct an interview with them. And so that's why this information is on your copy of the CCF, copy two, which is what the collector will provide to you immediately after, or as soon as possible after the collection is done. So here's the distribution of the copies, the five copies of the CCF. Copy one to the laboratory with the specimens in the plastic bag. Copy two is your copy as the medical review officer that should be faxed, emailed, imaged, however, to you as the MRO. How does the collector know which MRO to send it to? Well, because that information is in step 1B of the custody and control form. And so that should be sent within 24 hours so that you have that form at the ready to review and the information if necessary to contact the person once the laboratory result is sent to you. Because again, the laboratory result is going to come directly to you, not to the third party administrator or the employer's agent or to the employer, but to you. So you are the one that needs to marry up then the custody and control form with the result from the laboratory. Copy three, the collector is going to retain that copy for 30 days in case, for example, that your copy two goes awry and you need a copy of the custody and control form in order to review and verify a case, a test. So you could use the collector copy or a copy of the collector's copy. Copy four is going from a collector to the employer, designated employer representative. And again, hopefully that was going to get to the designated employer representative within 24 hours of when the collection has taken place. Copy five is the donor's copy that's given to the donor at the completion of a collection process. Okay, DOT versus non-DOT tests. Remember, they have to be kept separate in all respect. DOT collection must be completed and the urine discarded before a non-DOT collection is started. There is one exception here, and that is there may be some of you who serve as medical examiners for doing commercial driver's physical examinations. And you know that the urine specimen there is used for some clinical purposes. And so if that, at the same time that you are doing this driver physical, the employer has ordered a DOT pre-employment, for example, pre-employment drug test, you can get the pre-employment drug test done, and then you can use any leftover urine for the clinical test for the medical examination. You may not use a federal CCF for non-DOT collections and vice versa, talked about that before. It causes all kinds of problems in terms of being able to re-designate it to the correct type of test. So the pre-collection process, the collector prepares that toilet room and the stall. We talked about the bluing and the removal of potential adulterants or items that could be used to manipulate or to cheat on the test. The beginning, then, is that the collector obtains a photo ID of the donor. There is no photo ID of the donor available. Then the employer has to provide adequate ID of the person so that the collector knows that they are collecting urine from the person that is identified on the form. The donor is to have a DOT alcohol test done. The preferred procedure is to do the alcohol test first. Remember, DOT testing, alcohol testing, is not done with the urine specimen, not done on the urine specimen. When I briefly went over those five drug classes, you didn't hear alcohol mentioned. That's because alcohol testing under DOT is a totally separate testing process. It uses a, primarily, it uses an evidential breath testing methodology. So if the person is scheduled for a random DOT drug and a random DOT alcohol test, then the alcohol breath test should be done first, and then the urine test done after that. If the donor is having both of those tests done and there are circumstances where you need to switch the order of those because of the availability of a technician or whatever that is perfectly acceptable, you should still do both tests. The collector initiates the CCF, completing step one, as we talked about, some of which may be pre-printed, but other of which may need to be filled out at the time prior to the collection. The collector explains the collection procedures and shows the instructions. The instructions on the back of the form, now, again, this has kind of changed a little bit. And so it is advisable that if you are doing collections in your office or at the clinic where you're working or whatever or at the company where you're serving as the medical review officer, that they should have the DOT collection procedures available to show to the individual, whether that's on a laminated sheet or whether that's on a small poster, anything, and certainly offering the donor the opportunity, do you need to review the collection procedures or have you done this before, that kind of thing. You want to try to make sure, to the best extent possible, that the collector does explain the collection procedures to those individuals who need or want to have a review of or to go over what is going to occur in terms of the collection process. Outer clothing, briefcases, or backpacks, or fanny packs, whatever, purses, other belongings must stay with the collector. The person is entitled to take their money, their cash, or credit cards in a wallet or other kind of clip into the toilet enclosure. But other than that, those items must stay outside the toilet enclosure room. And the person may be given a receipt or an itemization, a checkoff thing of what items were left outside. If you have available, if a collector has available, a drawer that could be locked or a little cabinet that could be locked where the individual's belongings are kept while they are in the toilet enclosure, that's ideal, but not absolutely necessary. There is no further removal of clothing, if you will, that is authorized for DOT collections. So having a person remove their socks or their shoes, having them disrobe and put on a hospital or medical examination gown, et cetera, is not authorized for the DOT testing. Pockets have to be emptied looking for suspicious material. Determine the possible intent to adulterate or not. If suspicious, conduct immediately observed collection. If inadvertent, in terms of maybe the person had packets of salt, for example, in their pockets. OK, well, salt could be used to attempt to adulterate a urine specimen. No question about that. But could it also have just been inadvertently the person had it in their pocket because of using it for a meal or whatever? Yes. So that's the collector's determination. My, again, my best practice kind of thing is that if it is suspicious because it looks like fake urine, like a product that's labeled as test clean or test clear or something that's going to be used to manipulate the testing process, then conduct an immediate observed collection. If it's inadvertent, that's something that would ordinarily be in a person's pocket, simply have them remove it, secure it, and maintain and then proceed with a normal collection. The donor is required to wash their hands. If they do not want to wash their hands at this point, it is a refusal to test. So the hand washing prior to providing the specimen is a mandatory part of the process. The person selects the, the donor selects the kit. And, or again, if it does not, that is not an essential part that, oh, I have to have five kits to choose from. The key thing is that the donor is given a sealed kit that has not been opened or used prior. And the donor takes only the collection container. The collector opens that kit. Most of them have a peel back foil top as a seal and takes the collection container into the toilet enclosure. Specimen bottles, plastic bag remain with the collector. Donor provides the specimen within a reasonable time. What is that? Generally speaking, it should be within three to four minutes max. The donor was instructed not to flush the toilet and brings the specimen to the collector. Again, inspects for the sufficient volume first, which is 45 mLs in that container, inspects for the temperature that is within range and any signs of tampering, such as that it's foaming and uncharacteristically it is, smells overwhelmingly of bleach. It's a blue-green color that would indicate that perhaps water from the blueing in the toilet bowl was added to the specimen. Anything that there's a sign of tampering. So those are the inspections, the visual, if you will, inspections that the collector does. Collector completes CCF step two that we talked about. The collector, not the donor, pours the urine, subdividing into two specimen bottles and applies the bottle seals. The split specimen is required for all DOT tests, at least 30 mLs needs to go in bottle A in one bottle and then 15 mLs needs to go in the second bottle. Any remaining urine is discarded. The collector then completes step four of the CCF and dates each bottle seal. So the collector is going to date each bottle seal, going to instruct the donor then to initial each bottle seal and to complete step five on the CCF that we reviewed earlier, which is on copy two through five of the five-ply form. Okay, so monitor collection procedure is done when there's a multi-stall restroom. I'm not going to spend a lot of time on this slide because A, it's not as common a practice anymore as it may have once been. Plus, we talked about the essential things before are that either one of the stalls is fully prepared and then a monitor or a collector stays in the restroom, the multi-stall restroom, to protect or prevent from being able to have access to water or adulterants or other things throughout the restroom area. Or if all of the water has been shut off, if all of the toilets, et cetera, and stalls have been inspected and any potential adulterants or tampering agents removed, then the collector can stay outside the multi-stall restroom. Okay, so that's, again, there's no direct observation. There does have to be a partial stall door. DOT does not authorize the collecting of a specimen from a urinal, so it's got to be a partial stall door. Shipping container must have adequate damage protection. It has to have the absorbent material inside and use an express shipping company boxes or padded mailers, bin packs, or whatever. If it is being transported directly by the laboratory courier service, then the specimens can be shipped or can be transported in the plastic bags. Okay, we need to finish up with some special situations. That was kind of taking you through a typical collection, if you will, one in which the person's able to urinate enough specimen, the 45 mLs, where there are no indications of tampering or adulteration, and where there is, again, packaging for a split specimen and everybody signs the correct part of the custody and control form. So let's take a look now at what happens when there are some problems in one or more of those parts of the process. So direct observation urine collections are used in DOT testing in only very specific circumstances. The collector can't just decide, well, I'm going to do a direct observation collection here. The employer can't just say, well, you know what? I think there's been cheating going on. I've heard rumors, da, da, da, da. I'm going to do all my collections directly observed. But rather, the DOT rule specifies specifics where the employer and or the medical review officer will order that a urine collection is observed. In the first ones here, the laboratory, these are where there is a second collection at a later time taking place, meaning that there has been a test, a urine test, a collection done. A urine test was done. It was reported to the MRO. And it is based on that laboratory report or actions that occur at that point that the donor is going to be subject to a recollection, to another collection event. So, and that event is going to require that the urine specimen be a directly observed collection. The laboratory reports an invalid test. And the MRO reports the canceled test without a medical reason. That's going to require a not, so he's canceled the test. And the remarks by you, the medical review officer, are going to say recollect the specimen under direct observation. If there was a positive adulterated or substituted specimen result that you had to cancel because the split either was not available for testing and the donor had requested it, or the split testing, the reconfirmation testing was reported to you as invalid, then you must cancel that verified positive or refusal to test and require another collection. And this one under direct observation. If the laboratory reports to you, the medical review officer, a dilute specimen with creatinine value between two and five, which is at the very low end, if you will, of acceptable creatinine, then you must require a recollection under direct observation. And lastly, any DOT return to duty or follow-up test must be a directly observed urine collection. So, and that is for the return to duty test and then the follow-up test, which are determined by the substance abuse professional, every one of those must be a directly observed collection. And if they aren't, and you as the medical review officer get a follow-up test and it's negative, for example, but it was not observed, it wasn't marked observed and your staff or you contact the collection site and they say, well, no, we didn't even know we had to observe it. There was no suspicion. And you say, well, it was, was it a follow-up test? Yes, it was. Okay. So then you need to cancel that negative and you need to have the person come back for another test that is done under direct observation. Okay. Required by the collector, observe an action indicating an attempt to tamper, observe material and indicating an intent to tamper. We talked about those two. The specimen appears to have been tampered with and some other characteristic of visual or even smelling like bleach, that kind of thing. The temperature taken within four minutes was outside the temperature range. All of these are going to require an immediate collection, not a week later, not the next day, whatever, but an immediate collection under direct observation. Here's the circumstance for documenting on the CCF. When there is a immediate observed collection using a new CCF and the notation on both CCFs, the first one should be noted as one of two. The other CCF has two of two. The observed box should be checked on the two of two and the reason for the direct observation noted. Both specimens are sent to the laboratory. This is with a temperature out of range suspect specimen. If the donor refuses the direct observation, then you discard the specimen and notify the DER of refusal to test. No requirement to seek concurrence from a supervisor or from the DER prior to an observed collection. This is, again, a standard part of the rule. It's not the DER's choice. Well, forget about it. We don't need to do a direct observation in that circumstance. Okay, so the reason for tests, by the way, on the second collection, on the second CCF, is the same. It was a random test. Yes, it was a reasonable suspicion test. Same reason for test. The observed box is checked. Observer always is the same gender as the donor. The observer is not required to be a trained collector and the observer who is not the collector does not handle the urine specimen, doesn't sign the CCF, et cetera. Of note here, in terms of the whole gender identification process currently for under DOT guidance, the, if the individual, it is the gender identity that the donor provides that determines the gender of the observer. So if the donor says that they identify as male or if the donor says they identify as female, then that is the gender of the observer. There is provision now with the oral fluid rule that will hopefully be implemented by the beginning of next year that the, for non-binary donors, for other trans circumstances, that certainly we will go and use the oral fluid collection rather than trying to sort out the issues relative to gender identity for an observer for those individuals. But we're not quite there yet in terms of being able to implement the oral fluid testing. The observer must enter the toilet enclosure with the donor. The donor has to reposition their clothing so that the observer can see if they have some type of an apparatus or paraphernalia or whatever that is attached to their body and trying to substitute or otherwise manipulate the testing process. If no adulteration or substitution device is found, then the donor may reposition their clothing. And the repositioning of the clothing is by taking the shirt or whatever up toward the mid chest line so that the observer can see bare skin on the front and on the back of the person, and then also repositioning the lower clothing from the waist down to mid thigh to include underwear and street clothing. So again, so that the observer can view both front and back of the body without clothing from the waist down to the mid thigh. The observer then remains in the toilet enclosure and watches the donor urinate into the collection container. If the donor refuses observed collection, then the collection process is discontinued. If the observer finds adulteration or substituted products, substitution products or devices on the donor, then the collection process is discontinued. The collector will, those are both going to be refusal to test determinations made by the employer. The collector takes the following actions for the employer to determine that's a refusal to test, immediately notifies the DER, does not send the first specimen. If there is one prior to this attempt at collecting the second specimen under direct observation, records the incident on the CCF and signs and dates step two on the copy one, and prints the employee's name in step five on copy five. Okay, sorry, on copy two. All right, urge the donor to drink up to 40 ounces. This is for the shy bladder procedure. Again, this hasn't changed since 1990. We have been dealing with for all these years circumstances where people are unable to produce an adequate urine specimen, certainly on the first try, and maybe subsequently on other tries to produce an, the DOT has never allowed and does not to this day allow you to combine a urine specimen so that if the person goes into the bathroom and to the toilet enclosure, urinates 30 mls, comes out and drinks a little bit of water and says, I think I can urinate some more and goes in and does 20 into the cup. Can you combine the 20 with the 30 that you have from the first? And the answer is no. When there is an inadequate amount, insufficient amount, I should say, urinated into the cup, if it is not, if it is not suspect in terms of suspected of tampering or adultering, then it is discarded immediately and waiting for the individual to make another attempt at producing a sufficient volume. During this time, the donor can be provided up to 40 ounces of water to drink to help hydrate. And that is, they should be encouraged to spread that reasonably over time rather than trying to guzzle all 40 ounces, you know, five minutes after they have failed to produce a sufficient volume. And the donor should be told that they cannot leave the collection site. They have to remain under supervised circumstance so that they, until they are ready to try to urinate again. The donor, each time that the donor says, I think I can try, they are given a new collection container, all right, that has been sealed and opened in their presence. They take that into the toilet enclosure and attempt to provide a specimen. Each time, there's no limit on the number of attempts they can make. There's a limit on the time, the three hours, the time at which they can make multiple attempts. And there's a limit on the amount of fluid that they can be provided. If they refuse to drink any of the fluid offered, that is not a refusal to test. The best practice is to record each attempt and the time on step two of the remarks, along with identifying when and the amount of fluid that they were given to hydrate. All of this provides a record of what occurred. So if the person ultimately is unsuccessful in providing an adequate specimen, that documentation will be going to the referral physician, who's going to try to make a determination of was there a reason, a medical reason, that this individual could not produce 45 cc's of urine in three hours, given the opportunity or actually having consumed a significant amount of water to hydrate. So recording what happened is important in terms of on the remark section of the CCF for the shy bladder, even if there is no specimen that ultimately is collected to go to the laboratory. So if at the end of the three hours, there's not been a sufficient quantity provided, then the collector is going to check none provided, notify the DER immediately, and to transmit the CCF copies to the employer and the MRO as normal, if you will. Okay, so that's the shy bladder collection procedures. Now let's move to the final category of the fatal and the correctable flaws. It seems like this list keeps growing. Every time I see a new version of part 40, we have a couple more fatal flaws that have been added. Some of these, the first four, ones that we've had since the very beginning. If there is no printed collector's name and no collector's signature on the CCF, then that's going to be a fatal flaw. And this specimen is going to be rejected at the laboratory and you as the medical review officer must cancel it. We can't correct that. If the specimen ID on the bottle, specimen ID, remember, not donor ID, the specimen ID number on the bottle label and or seal and the CCF do not match, then that is going to be a fatal flaw. This happens most of the time when a, let's say that a collector is putting a bottle seal on and she tears it or the ink smudges or something else and she goes, oh gosh, I've got to get another seal. So rather than getting a new CCF, filling that out and taking the seals from the bottom of that, they'll just grab another CCF, take the seals from the bottom and put them on the bottle, all nice, neat and pretty. But guess what? That pre-printed specimen ID number on that new nice seal doesn't match the CCF number, the specimen ID number on the CCF. So that's when you find that happening, usually. Fatal flaw, cannot correct it. The specimen seal is broken or shows signs of tampering and bottle B cannot be redesignated so that you have to have a bottle with sufficient urine in it to do the testing that arrives at the laboratory where the seal is not broken or shows any signs of tampering. If there is an insufficient quantity of specimen, so if it has leaked during transit or if the collector simply did not collect enough urine, you've got to have at least one bottle with the seal intact that has close to 30 mLs. Otherwise, it's going to be rejected for testing as insufficient quantity. Now, if the collector inadvertently put the bottle B seal on the bottle that had, you know, that 30 mLs in it and put the A label, bottle A label, on the bottle that had only 15 mLs in it, can the laboratory redesignate that to have A to B, B to A? Yes, they can without any problem. But if neither of the bottles with seals intact has the requisite 30 mLs to do the primary bottle testing, then it's going to be rejected for testing and you are going to have to cancel the result. If no CCF is submitted with the specimen, so we get a specimen in, it's got ID numbers on it, it's got labels on it, it looks very nice, but there's no CCF along with it, then that is obviously, I mean, the lab wouldn't even have any idea who this belongs to, who the MRO is, who the employer is, et cetera. So that's going to be a fatal flaw if there was a CCF that comes in, but there is no specimen. So again, that's going to be a fatal flaw and there will be no, obviously no testing done because we don't have the urine with the urine bottles that came in with the CCF. If two separate collections were performed using one CCF, so again, we have a nice, neat CCF with lots of writing on step two. And then what we find is that, again, all this writing, one of two and two of two and direct observation, and there's four bottles and they all have labels on them. And now here we've got a problem, don't we? Because where did you get the other two labels? Okay, they had to come from another CCF. I don't know any CCF that has four labels on it. So again, there are going to be problems. And so that's going to be essentially a fatal flaw for any of the testing on any of that urine. Okay, so we have correctable flaws as well as fatal flaws. The correctable flaws have a chance here that we can correct them. And therefore we can, as a medical review officer, provide a verified determination that we have confidence in the accuracy of the result and that the individual's rights were protected in the process. So we are sure about the identity, the security and the integrity of the testing process. The laboratory is usually going to identify these correctable flaws, where there is no collector signature on the CCF, but there is a printed name. Remember, it's only a fatal flaw if both the collector's printed name and the collector's signature are missing. But if there is a printed name of the collector, but he or she simply forgot to sign the signature line, that can be corrected. If it is an incorrect version of the federal CCF used, for example, if it's an expired federal CCF, the last CCF before the 2020, I think was either 2007, I think it was 2017. Actually, they did extend with all of the COVID business and the supply chain business, they did extend the use of that until August of 2023. But now if a previous version of the federal CCF comes in, the laboratory is going to have to set that aside and get a statement from the collector that they used an expired federal form, but they did use the current collection procedures and that they have taken measures that they will only use the current form from this point on. So if those two flaws are, excuse me, those correctable flaws are not corrected, the lab reports it as rejected for testing and the MRO must cancel the test. If the specimen temperature box is not checked and there's no entry on the remarks line regarding the temperature being outside of normal range, the lab will seek a statement of correction. However, testing will continue. And after five days, if they haven't heard back from the collector that, yes, I just forgot to check it, I took the temperature, it would have been within range. If it had not been within range, then I would have marked that no and I would have proceeded with a direct observation. Therefore, I'm willing to sign a statement that it was in range. So if they don't receive anything from the collector within five days, they still will report out the result with just simply a note that there was no indication of the specimen temperature box being checked. What are the correctable flaws that you as the medical review officer have to pay attention to? Well, one of them is that if you get the CCF and there is the MRO copy and there is no donor signature in step five, and there was no remarks on the line that the individual left before signing it or refused to sign the CCF. So that you have to get a corrected statement from a collector. What happened? Can you get a statement from the donor? Yes, you can. Usually easier to get the corrective statement from the collector. The other correctable flaw is that the certifying scientist signature is admitted for a non-negative result. Remember, you need that copy of the copy one from the certifying scientist whenever it is a positive, a confirmed positive, an adult confirmed adulterated, confirmed substituted specimen, or an invalid specimen. Those all have to have a copy one along with perhaps the electronic laboratory report that you're going to get that is signed, the copy one is signed by the certifying scientist. So if you get one that you do not have a copy one, you or your staff need to go back to the lab and say for this specimen number, such and such, this lab report, I need the certifying scientist signature on the federal CCF. Most times that is easily recoverable in my experience. The test is canceled if unable to correct in terms of these correctable flaws. The employer identifies the following correctable flaws. Usually it is the MRO though that has to follow through and attempt to get them corrected. And this is the use of a non-federal CCF, may be corrected with a statement from the collector that the DOT collection procedures were followed. And if the test was done at an HHS certified lab, you would need a statement from the laboratory that the specimen was analyzed consistent with the DOT requirements in terms of cutoff levels, quality control, reporting review, et cetera. So that would be necessary in order to change that result from a non-DOT test to a DOT test. But the only way you're going to know that that is needed is if the employer tells you, this was supposed to be a DOT pre-employment test so that I can put this driver on the road, but the collector pulled the non-federal form. I have a negative result. I need it to count as the DOT pre-employment test. It was tested for the same panel of drugs. It's negative, dah, dah, dah, dah, dah. So that is where you come in with having to help with that type of correction for a correctable flaw. These are a bunch of minor flaws that you may think, do I have to cancel a test for these? The answer is no. Even if the DER says, well, I don't think I can go to court on this or whatever, you hold fast that you can cite the regulation, that the part 40, that these are not considered to affect the proper identification, the security, the donor's right to a fair and accurate test. And therefore would not cause a test result that you have verified out to be overturned or to be changed. Minor administrative mistakes all the way through that the collection facility didn't meet the requirements. Well, you may have even heard donors when you talk with them in their interview, that they will say all kinds of little things about the collection process. Well, I didn't see any bluing in the toilet. Well, guess what? It doesn't matter because that didn't affect your right to a fair and accurate result. If anything, that was there to protect against cheating. And maybe if it wasn't there, fine, but that does not impact the outcome of your result of your test. So those are a list. Probably the one that people ask the most is that where the donor ID is not correct, if you will, that donor ID number. And the person will say, well, that number isn't my, that's not my social security number, or that's not my passport number, or that's not my driver's license number. Again, doesn't matter. You signed the form that the information on this form was true and correct. That's the ID number that you gave to the collector at the time of the collection. And so there is no reason the specimen ID number, not the donor ID number, is what connects you to this particular test result. So the collector does have the responsibility. We talked about the responsibilities at the beginning in the pre-collection process. They do have the responsibility to make every attempt to complete the collection process, correcting any problems as they arise. They can certainly do, if the urine, coming out of the bathroom and the person spills the urine, does the collector say, oh, well, that's the end of that, can't do this DOT test? No, they will continue to attempt to collect and complete the collection event. So they would use a new kit and have the individual provide another specimen. The collector must supply a written statement on the same business day that he or she is notified that an error has been committed, and the lab retains the specimen for five days. Okay, these next slides, I'm certainly not going to read through. I'm sure you're tired of concentrating on this and listening to me, but I do want you to know that they are here. These are essentially a schemata, a picture of what we have gone through in terms of the DOT urine collection protocol. So this is, again, starting from the very beginning, the donor arrives, collector checks a time of arrival that notifies the DER, et cetera. And then going to the pre-collection process that we went over, washing hands, emptying pockets, all of that, right? And then you can see on here, there is a shy bladder protocol that may come into effect. And here are the steps that we just went over with the temp out of range or other evidence of tampering. And that should do it. Thanks very much. It's a complicated process in terms of the forensic urine collection, but the key things again are those three words, the integrity of the process, the proper identification and security of the specimen and the linking of the specimen to the donor. Thank you.

Regulatory Compliance

Forensic Urine Collections

Medical Review Officer

Department of Transportation

49 CFR Part 40

Drug and Alcohol Testing

Chain of Custody

Specimen Integrity

Collector Training

Collection Site Requirements

Error Correction Training

Federal Drug Testing Protocols