This is the second module on the Department of Transportation urine specimen collection requirements. And in this session, we will be covering the collection procedures. 49 CFR Part 40 identifies three types of urine specimen collections. The first, called a normal or privacy collection, is what we would call the typical collection. This is where the donor goes into the toilet enclosure with a full privacy door and closes the door, and the collector remains outside the room. At the conclusion of urinating into the collection container, the donor brings the specimen out of the toilet enclosure. And with the collector, they process and package the specimen for transport to the laboratory. The second type of collection is one that is not used often, but there are specific provisions in the regulation for its occurrence. This is called a monitored collection. And a monitored collection takes place in a multi-stall restroom when there is not a single toilet enclosure room with full privacy door available. The stall does have to have a partial privacy door. And the collector then prepares one toilet stall for use by removing any potential adulterants, putting blueing in the toilet water, and otherwise securing the toilet stall area for use. The collector remains outside the closed stall door, but inside the multi-stall restroom. In this type of collection, the DOT permits the monitor to be the opposite gender of the donor if he or she is a medical professional or medical paraprofessional, such as a CSA or a LPN or other medical arts professional. The third type of collection is a direct observation or witnessed collection. And this occurs in very limited circumstances. And in this circumstance, the observer must be in the toilet enclosure or the stall with the donor and observe the urination from the body into the collection container. The observer must always be the same gender as the donor, regardless of medical or other qualifications. The observer, by the way, does not have to be the collector and does not have to have collection personnel qualification training. We will discuss more about the direct observation procedures themselves later in this session. Now let's take a look at the preparation of the collection site. The collector is required to secure any and all water sources that the donor would have access to. So for example, if there is a sink in the toilet enclosure, the water faucets have to be taped off or disconnected so that there is no tap water available to the donor. If there is a tank on the toilet itself, that tank should be secured with security tape. So again, the donor does not have access to the water that would be in the toilet tank. The collector must place bluing solution into the toilet water so that, again, there is a deterrence from the individual being able to supplement their urine specimen with water that they obtained from the toilet bowl. There is a requirement that the collector remove potential adulterants from the toilet enclosure. This could be common cleaning supplies such as Tilex or disinfectants, ammonia, bleach, et cetera. And the collector must ensure that the access and exit to and from the toilet enclosure is restricted so that no one can enter or leave the toilet enclosure other than the donor and in the sight line of the collector. And lastly, the collector must ensure that there is a suitable area for completing the CCF. So there needs to be an area outside the toilet enclosure that may have a counter or a table, or if the collector needs to use a clipboard or some area where the CCF can be completed. The Priority Regulation does specify some collection prohibitions. For example, under the DOT rules, the collection site, nor the employer, nor any other service agent can require the donor to sign a consent or release form, even a HIPAA form, or something else like that. The only consent or release form that the donor is to complete is on the CCF. So it's part of the donor certification statement and the instructions that are contained on the Federal Custody and Control Form in terms of that the specimen is going to be sent to a laboratory, and those results will be released to the medical review officer and ultimately to the employer. Likewise, the rule specifies that the collection of a urine specimen for a DOT drug test cannot take place on an unconscious donor. And again, this is a logical prohibition because one of the key factors of the specimen collection procedures is that the donor must be able to witness the sealing and labeling of the urine specimen, must be asked to identify the material or the information on the Federal Custody Control Form as being correct and true, and to attest to the fact that the procedures were followed, that they did not adulterate or manipulate the specimen in any way. So if the donor is not conscious, obviously those requirements cannot be met. The DOT rules also say that a specimen cannot be collected by catheterization. Now, there are two exceptions here to this prohibition. One is if the donor normally voids via self-catheterization, the donor must provide a specimen and must have their own catheter that they use and would normally use for urination for the specimen collection. The second exception, if you will, or caveat to no collections by catheterization is that the DOT specimen collection guidelines do provide a method for collecting from a Foley catheter or an external urine bag for a post-accident test when the employee is hospitalized and the post-accident drug test must be completed. You may recall that when we were discussing the basic tenets, if you will, of urine specimen collection, one of the key principles that was involved was the donor privacy. And that was in addition to the accuracy of the identification of the specimen with the donor and with measures to ensure the security of the specimen that it had not been tampered with or where its handling was not adequately documented. So let's take a look now at the specimen collection privacy issues. So the DOT rule says that when a donor comes for a DOT drug test, a urine specimen collection, the donor cannot be required to undress and to don a hospital gown, for example, as they might be if they are presenting for a physical examination or for other medical or clinical treatment. It does say that the donor is required to remove their outerwear, meaning coats, hats, jackets, et cetera. The rule also specifies that the collector is required to search, if you will, the pockets that the person may have on clothing that they are not going to remove. So that might be pants, or skirt, or dress, or shirt pockets, et cetera. And by pocket searches, what the rule specifies is that the collector is to ask the donor to remove anything that's in any of their pockets and display it for the collector. If anything in the pockets could possibly be used to alter or manipulate the test results, such as even a packet of salt, or some medications, or something like that, the donor is required to leave those out of their pockets and leave them outside the toilet enclosure with the collector. The DOT rules also specify that the collector cannot ask, or record, or document any medications that the donor is taking. So any medications that the donor is taking that the donor believes may impact the drug test results, the collector instructs the donor to make a note of those after the collection is complete and have them ready for discussion with the medical review officer if and when their test result is non-negative, and the MRO is going to contact them to determine whether there may be a medical explanation for the laboratory result. The collector can also indicate that the donor can write those on the back or the bottom of the donor copy of the custody and control form and retain that document, again, for use when and if they have an interview with the medical review officer. Another privacy issue, of course, is that there has to be a private enclosure for urination. So we talked about the fact that the donor goes into this toilet enclosure and closes a full privacy door. The collector does not keep the door ajar, nor do they stand right inside the toilet enclosure, et cetera. Now, the privacy is somewhat diminished in a monitored collection, as we mentioned. But again, there, the monitor or collector remains outside the closed stall door, even though the stall door may not be a full privacy door but would afford some measure of auditory and visual privacy. And lastly, in terms of collection privacy issues, the DOT makes a note that the donor may retain his or her wallet or money clip, which, by the way, the collector can inspect prior to allowing the donor to take that into the toilet enclosure with him or her. They must instruct the collector that any other handheld items must be left outside the toilet enclosure area. So this would include things like cell phones, notepads, a fanny pack, anything that has personal contents in it other than their actual money or credit cards, wallet, et cetera must be left outside the toilet enclosure. Moving on to another core principle of DOT urine specimen collection procedures are the specimen security issues. So when the collection kit, which we discussed in a previous module, is presented to the donor, it must be wrapped. The collection container itself is either shrink-wrapped or, as I showed you earlier, it is oftentimes a sealed kit with the specimen containers inside the collection container along with the plastic specimen bag. And then that collection container kit, if you will, is sealed with an aluminum covering or some other type of seal. The specimen bottles themselves also have to be secured separately from, if you will, just being a part of the collection kit. In most instances, this is accomplished with a plastic flange that shows that the specimen bottle has not been opened since its manufacture. And that flange then, when the collector removes the lid or the cap, the flange will separate. And that's the way that you know that that specimen container, excuse me, that specimen bottle was not previously used. The specimen is always kept in the donor site. So when the donor comes out of the toilet enclosure and presents a specimen to the collector, the collector, in full view of the donor, continues with the process and the packaging, meaning subdividing the specimen, applying the bottle seals and labels, presenting the specimen bottles or specimen containers to the donor for their initials, et cetera. And also, the donor should remain there while the collector puts the sealed specimen bottles and the custody and control form into the plastic specimen container bag and applies the pressure-activated seal to seal that packaging. The donor's signature on the CCF and the donor's initials on the seals of the bottles are obtained after those seals are placed on the specimen bottle. There is sometimes a tendency for the collector to make sure that they get all of that done. And so they have the donor fill out step five before they even go into the toilet enclosure to provide their specimen. And they will go ahead and have them initial the seals while they are still attached to the copy one of the CCF. This is not in accordance with the procedures because the whole purpose of having the donor sign that statement and initial the seals is to have them attest to the fact that the specimen was labeled and sealed in his or her presence. The specimen bottles and the CCF then are secured in the plastic transport bag, as we talked about. There is no need for the collector or for the donor to initial the bag or to sign the bag. The bag itself does not have an individual or unique specimen ID number on it. And no identifying information about the donor is contained on the bag. The actual collection process is a multi-step chronological process that has very specific detailed procedures that are to occur in a certain order. The standard joke is that only the Department of Transportation could write regulations that would require 22 steps to collect the perfect urine specimen. But at any rate, let's kind of go through a few of those and so you get a sense for the actual process. So first, the collector checks the donor's photo ID. And that photo ID has to be a government or an employer issued ID and explains the collection process to the donor. If the donor is fairly familiar with the DOT collection process and has had other specimens collected previously, the collector can simply refer the donor to the back of the paper CCF copy 5 has all of the collection procedures printed on that copy. The donor is then instructed to remove outdoor clothing, such as, again, jackets, coats, hats, gloves, anything that would be considered outer clothing. The collector then checks the person's pockets that remain on the clothing that they will have on to go into the toilet enclosure to provide the urine specimen. And the donor must leave all hand carried items outside that toilet enclosure. So once those couple of things have been done, the collector then completes step one of the CCF. And as we reviewed, step one is all of the actually demographic and other basic information about this urine specimen collection. Has the medical review officer on it, the employer under whose authority this test is being required. Has the donor's ID number, what might be a commercial driver's license or a social security number, a passport number, an employee ID number, et cetera. After completing step one, the collector then presents a collection kit to the employee. Probably the best practice here is for the collector to have multiple collection kits and allow the donor to choose the one that they want to use for their collection. It's not a mandate by the regulation, but it is a best practice. The next step in the collection process is for the collector to instruct the donor to wash their hands. Should be a sink or hand sanitizer, soap and water, et cetera, available for the donor to wash their hands prior to giving the specimen. The purpose of this step is to make certain that the donor does not have any crystals or powders or other kind of potential adulterants under their fingernails or on their hands that could be introduced into the urine while they are in the toilet enclosure. If the donor refuses to wash their hands, the collector would stop the collection process and inform the donor that that is a refusal to test. That is a mandatory part of the collection process. The collector then unwraps the collection kit or the collection container and provides it to the donor, instructing the donor to enter the toilet enclosure, close the door, and provide at least 45 mLs of urine into the collection container. The donor does not take the specimen bottles or the plastic bag or any other part of the collection kit into the toilet enclosure with him or her, only the collection container. The donor then comes out of the toilet enclosure and presents the specimen to the collector. The collector now is going to perform what are called specimen integrity checks, if you will. They're going to look at that temperature-sensing device that was affixed to the collection container and make sure that the specimen temperature has recorded between 90 and 100 degrees Fahrenheit, which is the acceptable temperature range. And they must do this check within four minutes of when the donor provides the specimen to the collector. The collector then checks the physical appearance of the specimen to determine whether there is something atypical or unusual or even suspicious about it. Does it have excess foaming? Does it smell like bleach? Is it blue-green in color, indicating that the donor may have introduced some of the blue toilet water into the urine specimen container? Once they have done that, the collector then identifies if there is adequate volume of specimen. So that would be 45 mLs. The donor is not permitted to waive their right to a split specimen and present the specimen of less than 45 mLs for processing to the laboratory. The collector then completes step two of the CCF. Remember, that's, again, those specimen integrity checks with temperature and volume that it is a split specimen. There is sufficient for a split specimen. And then any discrepancies or atypical characteristics must be noted in the remarks section of step two. The collector is now ready to process the specimen, if you will, for packaging and transmission to the laboratory. So at this point, the collector unwraps or opens those specimen bottles, which, remember, are secured with either a shrink wrap around the cap or a plastic flange. And it is the collector who pours the specimen from the collection container into the two specimen bottles. The collector then closes and secures those bottle caps and applies the bottle seals or labels. And the collector dates each seal once it is on the bottle. The collector then presents the sealed specimen bottles to the donor and asks the donor to initial each seal. It is at this point that the donor may wash his or her hands after the collection, but that is not a requirement. In other words, the donor doesn't have to wash their hands again after the collection, but this is the point at which they are permitted to do so. Once they have washed their hands, if they choose to, then the collector instructs the donor to complete step five. And remember, the collector has to turn to page two or ply two of the CCF, because that is where the donor information section, step five, is printed. The collector, after the donor has completed step five, then the collector completes step four, which is their certification statement, printing their name, signing it, putting the date and the time that the collection was complete, as well as the courier or the express service, which will transport the specimen to the laboratory. The collector then puts the CCF, copy one, laboratory copy, and the specimen bottles into the plastic bag in their appropriate compartment and seals the bag with the pressure-sensitive seal on the top. The collector then gives copy five of the CCF to the donor, and the collection is then complete. The collector post-collection, actually, then faxes or emails the CCF copies two, which is the MRO copy, and the CCF four, which is the employer copy, to the medical review officer and to the designated employer representative, respectively. The procedures for a witnessed or directly observed specimen urine collection are very detailed in 49 CFR part 40. First of all, the observation must always be by a same gender individual as the donor. It doesn't matter whether they are medically trained, a physician or a nurse or whatever. They have to have the same sex or same gender as the donor. The direct observation must be noted in step two by checking the observe box, and it must be explained, why is this a direct observed specimen collection? Thirdly, the donor must be told the reason for this being a direct observed collection, and it is limited to six special circumstances, and I'll go over those in just a moment. The observer does not have to be a trained collector. So a collector may be opposite gender from the donor, and then there is a need for a direct observation, and they can use that same gender person to be the observer, even though they do not become the collector, do not sign the custody and control form, and are not required to have any collector qualification training requirements. The observer then instructs the donor to position their clothing. The observer, by the way, accompanies the donor into the toilet enclosure and closes the door. And the observer then instructs the donor to position their clothing so that the observer can view the donor's body, front and back, from the chest to the mid-thighs to inspect for a specimen substitution or adulteration device. There are six circumstances where a direct observation or witness collection is required under the DOT rules. Two of these are determined by the collector. Three of them are determined by the medical review officer, and one of them is determined by the employer. So let's look at the first two. These are the two circumstances in where the collector is going to make a decision to collect a directly observed specimen. In all cases, this is a second specimen that is being collected after the first collection was done with a normal or privacy collection. So if that first specimen, the temperature was out of range, meaning out of 90 to 100 degrees Fahrenheit, then the collector informs the donor that they will do an immediate second collection, and that will be a directly observed collection. The collector uses a new CCF and a new specimen collection kit for the witness recollection, records on the CCF as collection two of two, and states the reason for the direct observation. The collector, in this instance, will send both a temp out of range specimen that was collected under the privacy collection, as well as the specimen that is obtained under direct observation to the laboratory. The first specimen, there is a notation in the remarks section of step two that this is collection one of two. So you have two CCFs, one of two, and two of two, and two separate specimen collections. The second circumstance is very similar, but rather than the specimen being temperature out of range, it is where the collector has identified an attempt to tamper with or manipulate the specimen. So there is donor conduct, or the qualities of the specimen, the physical properties of the specimen, which make it suspect to having been manipulated or adulterated or tampered with. Again, the same procedure that we just went over. And the collector is going to send a suspect specimen to the laboratory, record that on the CCF as collection one of two, use a new CCF and kit for witness recollection, and record that collection on the CCF step two as collection two of two, stating the reason for the direct observation. There's a note on the bottom of this slide that is very important, and that is that if the second specimen, the one being collected under direct observation, is not obtained. In other words, the donor refuses, they leave the collection site, or they have a shy bladder and cannot produce the directly observed specimen given the three hours and the 40 ounces of fluid to hydrate, then the specimen one is discarded and no specimen is sent to the laboratory. The CCF two that was initiated for the direct observed collection becomes the CCF of record for that collection event, and the collector identifies why no direct observation specimen was collected. Well, the first two circumstances for a directly observed collection occur at the collection site, and they are in immediate succession to a privacy collection in which there was a suspect specimen provided. The MRO is going to direct a recollection or another collection under direct observation that will occur at a time subsequent to when a specific type of test result has been received by the medical review officer. And here are those three circumstances, where the MRO is going to cancel a previous test as an invalid result, where there is no medical explanation for the specimen's invalidity. Next, where the previous test result had to be canceled by the MRO because the split was not available to reconfirm a positive adulterated or substituted result. And number three, a previous test was reported negative dilute with a creatinine of 2 to 5 milligrams per deciliter. So this is really a very or hyper dilute, very suspicious result. A negative dilute that has a creatinine between 5 and 20 and a specific gravity of less than 1.002, but greater than 1.001 is going to be considered a dilute, negative dilute, and does not require recollection under direct observation. So for these circumstances then, the medical review officer notifies the DER that they have canceled the test and that the recollection under direct observation as soon as practical is required. The reason for the test of this directly observed collection is going to be the same reason for test as the specimen that the MRO canceled. So if it was a random test, the directly observed collection will be identified also as a random test. The final circumstance where a direct observation urine specimen collection is required under DOT regulations is for return to duty and follow-up tests. The return to duty and follow-up testing is only authorized when it is being done because an individual has completed the SAP return to duty process and is eligible to resume the performance of safety-sensitive functions. So again, all return to duty tests and all follow-up tests that are a part of an individual's return to duty process must be collected under direct observation. Let's move now to very briefly reviewing the shy bladder collection procedures when a donor is unable to present a urine specimen of at least 45 mLs after they have gone into the toilet enclosure and attempted to urinate. So what the collector then does is to explain to the donor that there will be shy bladder procedures in place, and they will be provided up to 40 ounces of fluids at the collection site over a period of time not to exceed three hours. And the collector will record the number of attempts and the time they make those attempts on the CCF in the remarks section. The collector is not permitted to combine partial specimens. So if the donor provides 30 mLs on one urination and then drinks a little bit of water, goes back in, and 30 minutes later comes out and has 25, the collector cannot combine the urine from the first collection with the urine from this attempt to make the requisite minimum 45 mL volume. The collector discontinues the collection after three hours and checks none provided, and then reports to the employer, preferably by phone, and again, the DER's information is provided in step one of the CCF that the collection event has ended in a shy bladder. The collector signs step four but lines through the certification statement since there is no specimen that they have received, and they did not label or seal it, et cetera, and the donor is present. They complete steps one and two of the CCF with the requisite notes in the remarks section, print the donor name in step five of the CCF, and distribute the CCF copies accordingly. Of course, they would destroy copy one since there is no specimen going to the laboratory. There may be circumstances where an individual has a shy bladder collection attempt and the subsequent evaluation of why that donor was unable to produce an adequate urine specimen given the opportunity to hydrate with up to 40 ounces of fluid and up to three hours to provide 45 mLs of urine, and in that circumstance, if the medical examination done by a physician finds that there is a bona fide physiologic or a preexisting psychological condition that precludes them from being able to give a urine specimen on demand, then there are provisions in the regulation for a pre-employment, return to duty, or follow-up test where the individual must have a negative result in order to be hired for the safety-sensitive job or to return to duty in a safety-sensitive job capacity. In that circumstance, the medical review officer, of course, is going to review the documentation provided by the examining physician, and then the individual is going to also have to have an evaluation by a physician to determine if there are any clinical signs of drug use. And it is in that examination for clinical signs of drug use, drug abuse, et cetera, that the individual can undergo something other than a urine drug test. And so that examining physician may use an oral fluid test, a hair test, a blood test, et cetera, as a means of determining whether or not the individual has any prohibited drugs in their system. They provide that result to the MRO as part of their exam findings, stating that there were no drugs detected in the person's system using an alternative specimen. If it is all clear, then the MRO reports a negative test result to the employer so that then that individual can be hired or can return to duty. If there is evidence of drug use found, such as a positive hair test or a positive oral fluid test or other findings from the clinical exam that the referring physician has provided, then the medical review officer reports the test as canceled. So a canceled test for pre-employment or return to duty or follow-up means that the person cannot perform safety-sensitive duties. They must have a negative in order to perform safety-sensitive duties. And finally, I want to present what are the circumstances, if you will, that constitute a refusal to test that have to do with the collection process. And these are determinations that will be made by the employer, by the designated employer representative, after consultation and documentation in many circumstances from the collector. So the refusal to test determination would include things like failing to remain at the collection site until the collection process is complete, failing to provide a urine specimen for any drug test required by DOT regulations, failing to permit the direct observation of a specimen when required, failure to cooperate with any part of the testing process, for example, failure to empty your pockets or to wash your hands prior to the collection beginning. For an observed collection, if the donor fails to follow the observer's instructions to reposition their clothing and to permit the observer to watch the urine come from the body into the collection container, if the donor during the direct observation collection process is found to be wearing a prosthetic or other device that could be used to interfere with the collection process or to substitute a urine specimen, and if the individual admits specimen adulteration or substitution to the collector, that is also a refusal to test. There are some other refusals to test that are determined by the medical review officer that we will go over later on in the course. But these are the refusals to test determined by the collector and the DER as a part of the collection process. Thank you.

Department of Transportation

DOT

urine specimen collection requirements

drug testing

49 CFR Part 40

normal collection

monitored collection

direct observation collection