As you have learned, urine drug testing under Department of Transportation and other federal regulations is essentially a three-step process. It's the process, first, of collecting and processing the urine specimen and sending it for the analytical procedures that will be done at a drug testing laboratory. And then those results are reported and communicated to a medical review officer, a specially trained physician who will review, interpret, and report those results to the employer. So this is the first kind of those three processes. And we'll cover in detail the urine specimen collection procedures as they are outlined in the DOT drug testing regulation known as 49 CFR Part 40. And the urine specimen collection procedures are detailed in excruciating minutiae, quite frankly, in subparts C, D, and E of that regulation. So we will cover the collector, the urine specimen collector, the collection site, if you will, or location, the supplies that are used in the collection of a urine specimen for DOT drug testing. We will talk about the chronological steps in the collection process. We will talk about what undergirds the regulation for these procedures that ensure the specimen identity, that it is identified with the individual who has provided the urine specimen, what provisions there are for the security of that specimen against tampering, essentially that will follow to some extent the rules of evidence, and the integrity of the process, what are the procedures and the processes that are in place to deter people from cheating or defrauding the drug testing procedures. Urine drug specimen collection for federal testing is of necessity based on the principles of search and seizure. Who knows why, but drug testing has now for decades been interpreted, quite frankly, as a search and seizure conducted by the federal government because the federal government requires certain employees in safety-sensitive transportation occupations, for example, to provide a urine specimen that will be searched for, prohibited substances, and that ultimately can be used as evidence of misconduct or evidence of engaging in conduct or behavior that is prohibited by federal regulation. So much of what we talk about in this segment is in fact related then to that whole process that the test result and the urine specimen that began that process may in fact be evidence that the person has violated a federal regulation or a federal rule. Custody and control form is the term that is used to describe the documentation that is going to track this urine specimen, this potential evidence of misconduct, through the process. And it starts at the collection, it continues while the specimen is at the laboratory, and then the medical review officer, in reporting the result, will make a notation on that same document, essentially attesting to the process of the chain of custody of this test and its result from the beginning. There is a DOT specimen collection manual that is issued by the Department of Transportation that serves as an additional guidance document for urine specimen collectors, for employers, and even also for medical review officers, in terms of how this regulation is in fact to be implemented and what are the special circumstances, if you will, for, and offers guidance to the collectors in how to handle those. And that document, along with many other publications by the Department of Transportation concerning its drug testing procedures, is found on the DOT website identified on this slide, which is the Office of Drug and Alcohol Policy and Compliance, or DAPC, and that is the proponent office in the Secretary of Transportation's department, if you will, for the Part 40 regulation. So collector's personnel, collection personnel, who can be a specimen collector? I'm not sure that that is a career goal for children when they are eight or nine, but there aren't a lot of specific academic requirements in terms of who can serve as a urine specimen collector under DOT procedures. The only thing that the rule says in terms of relationships, if you will, is that the collector of a urine specimen for a DOT drug test should not be the direct supervisor of the donor unless no one else is available to, who is qualified, to perform those duties. The collector, while there is no requirement that they have any medical training or that they have any medical technician training, that there is any specific type of academic requirement, but there is a requirement that those persons who wish to serve as urine specimen collectors under this program do have to complete qualification training. There is a training course, the components of which are specified in the DOT regulation. It can be a classroom setting. It can be a web-based or distance learning type program. But in addition to the didactic regulatory material in the basic curriculum for a urine specimen collector, there is also the added requirement for what is called a proficiency demonstration. In other words, that person, in order to be qualified, must conduct some mock specimen collections, including completing the custody and control form, packaging the specimen, doing all of that kind of thing in the presence of a trained collector or instructor or facilitator in order to be qualified. There is no requirement that collectors, like medical review officers, must complete any type of a written examination, per se. The proficiency demonstration is the skill demonstration portion of the qualification training for urine specimen collectors. Collectors must repeat this qualification training requirement, including the didactic portion, as well as the proficiency demonstration, every five years. And if they make a mistake along the way that results in you, the medical review officer, canceling a test because of an error that they made, then they must undergo error correction training. And error correction training also includes a review and remediation of the procedures or the process that they did incorrectly, and again, performing some mock collections in front of a qualified instructor or facilitator to show that they know how to do that particular type of collection correctly. What are the supplies that a collector uses in a DOT collection? Well, basically these are in two parts, if you will, what's called the specimen collection kit, and that consists of two specimen containers or bottles, they're often referred to, that do have caps or lids that can be sealed or secured on to prevent leakage. A collection container, which is an open, no lid, wide mouth container that the person urinates directly into. There also must be a specimen bag or a polyurethane bag, almost looks like a Ziploc bag, et cetera, that has two compartments, one where the specimen containers will be placed after the urine has been poured into them and they have been sealed, and one container or one pouch, if you will, where a copy of the custody and control form. That bag then is sealed with a tamper evident seal, and it is then ready for shipment to the drug testing laboratory. I should mention here that federal drug testing at this moment requires that all testing of the specimen take place at a certified laboratory. There is no screening, or rapid tests, or instant tests, or any type of testing of the specimen that occurs at the site or location where the specimen is collected. So everything, the collection is done, it is forensically packaged, if you will, and then any analysis or any action on the specimen itself takes place at the laboratory. There must be in this collection kit also a temperature sensing device. Usually this is affixed to the side of that collection container. The purpose of this is that this is one of those specimen integrity checks, so that the temperature of the specimen itself as recorded on this temperature sensing device has to be within a range of 90 to 100 degrees to ensure that, again, the specimen is freshly boarded, coming from the body, not something that has been carried in or smuggled in or whatever external to the body, and therefore would not meet that temperature criteria range. And the last part of the specimen collection kit is a shipping container. Because the specimens are typically going to a drug testing laboratory that is located some geographic distance from where the specimen has been collected, they are generally taken either by express carrier of some type, such as FedEx or UPS, et cetera, or they may be going through a courier system where they are picked up by one of the laboratories, such as Quest Diagnostics or LabCorp, et cetera, and then taken to one of the certified drug testing laboratory locations. When they are entered into the common carrier system, such as FedEx or UPS or other express shipping, they have to be in a hard-sided or protected padded mailer to protect the specimen while being shipped. And so the shipping container then is a required part of the processing and packaging and transmission of the specimen if a local courier service is not used. So in addition to the collection kit, and of course, being a federal agency, the Department of Transportation has a whole appendix in Part 40 that specifies the details, the specifications, you know, how big does the bottle have to be, what is the circumference, what material can it be made out of, and all that kind of thing. In addition to the specimen collection kit, then, there is the custody and control form, or CCF. This is a five-ply document. It has a standard format. And both the specimen collection kit and the custody and control form are generally supplied by the drug testing laboratory that is going to receive the specimen, do the analysis, and report the results to the medical review center. Here is a photo of the specimen collection kit, the standard kit. You will note that beginning a number of years ago, the Department of Transportation specified that all urine specimen collected for a DOT drug test would use the split specimen collection method, which means that the person urinates into the collection container that you see here, and then the collector subdivides or pours off that urine volume of a minimum of 45 milliliters into the two specimen bottles that your containers that you see pictured here, both of which are sitting on the polyurethane bag or plastic bag that I mentioned earlier. The custody and control form has several unique, if you will, characteristics, meaning that it has to be standard on all copies of the federal custody and control form. That is the pre-printed specimen ID number, which is a number that is assigned to the custody and control form by whoever prints them or the laboratory. It's not an account number. It's not identified with a specific donor or a specific employer in any way. It is really like a clinical rec number for a clinical test that you may be ordering for the laboratory. It is pre-printed on the custody and control form. There are five copies or plies of the form. The bottle seals or bottle labels are attached to the first ply of the form at the bottom, and I think we have a picture of this. Yes, you can see the tamper evidence seals across the bottom of the custody and control form, and those bear the specimen ID number. In this case, it's a 000 plus 1, and that number appears on the custody and control form, all five copies, as well as on the bottle labels. The CCF also requires the donors and the collectors' signatures. The collector's signature is on the first copy, and of course, because all plies are carbonless manifolds of each other, then it appears on all five copies of the form. The donor's signature, however, is only on copy two through five, because the DOT in the very beginning decided that they did not want donor-identifying information, such as the donor's name, signature, date of birth, contact numbers, to be known to the laboratory. In other words, they wanted the specimen really only to be identified by the specimen ID number and not know who the donor was. The custody and control form must also include both the employer, so for DOT testing, all tests are ordered by or done under the authority of an employer, whether that is a prospective employer for someone who is applying for a position for which a DOT drug test, pre-employment drug test is required, or is currently working in a safety-sensitive position. In addition, the form must also have who the medical review officer is, so that the laboratory knows to whom to send the results of this drug test. The medical review officer's name, as well as business address, as well as phone and fax number are required on the CCF. They can be pre-printed there for the CCFs that are supplied for a particular employer or to a particular collection site that is going to be doing the testing. A pen, rubber gloves, or latex gloves of some type or whatever, protective gloves, bluing agent and tape, or other supplies that are commonly associated with collecting the urine specimen. So the Federal Urine Drug Testing CCF then, there was a new version that was released by the federal government and cleared through the Office of Management and Budget, effective October 1st of 2010. The federal custody and control form is to be used only for that drug testing that is mandated by federal law or regulation. And today, drug testing is mandated by the Department of Transportation for safety-sensitive employees and applicants for safety-sensitive positions in the transportation industries. It is also mandated by the Department of Health and Human Service for all federal employees who are in testing-designated positions and exclusive of members of Congress or the legislative branch or the judicial branch. And it is also mandated by the Nuclear Regulatory Commission for employees who work in licensed nuclear energy facilities. Federal testing then, the use of that form for any testing that is mandated by those statutes or by those regulations or rules, is identified on the form as of October 2010 as the testing authority. This is a new addition to the standard form. Before, a federal form was a federal form and there was no need to identify whether the test was being done under the Department of Transportation's rules, the Department of Health and Human Service regulation or the Nuclear Regulatory Commission. That has now changed. And so the collector, based on the information from the employer who has ordered the test, must mark on the form whether it is a DOT test, an NRC test, Nuclear Regulatory Commission or a Department of Health and Human Services test, meaning for a federal employee in the Department of Defense, Department of Energy, Department of Interior, Department of Commerce, etc. For a DOT test, the federal regulators indicated that the federal form must specify one of the DOT agencies, the six agencies that require testing under the DOT statute and regulations. So, in addition to marking DOT as the authority, the collector must have the information from the employer, is this person applying for or working in a position that is regulated by the Federal Aviation Administration, by the Federal Motor Carrier Safety Administration, for example, because they hold a CDL, or by the Federal Transit Administration because they are a worker in public transit. There is still the types of tests, if you will, are often referred to as the reasons for tests on the CCF, and that is where, again, the collector, based on what the employer has told the collector, is going to mark why is this test being done. Is it a pre-employment test? Is it a random test? Is it a post-accident test, etc.? There is a space for other on the form. For DOT testing, if the DOT authority box is marked, the other box can only be used if it is a test being done under U.S. Coast Guard rules for the periodic test required every time a Coast Guard licensed captain or crew member is having their license reinstated or renewed. The drugs tested for are often known as the drug test panel. For DOT testing, of course, you always check the five-drug panel because that is all that is authorized for DOT testing or for any federal testing today. It is true that some people thought when changes were made to the regulation in late 2010 that the DOT had expanded to a, quote, seven-drug panel, but that is not the case. What the DOT stayed with was the five basic drug classifications, but they added the analog amphetamine drugs to the amphetamines category, and they added a requirement that 6-acetylmorphine, or the marker for heroin, would be done as a part of the opiate class screening or immunoassay process. So it is still a five-drug or five-drug class panel that can be used for federal testing. I frequently get the question, and it's not a different answer any year that I've been teaching this course, and that is, when will DOT testing expand to test for other Schedule 2 or Schedule 3 drugs that are a risk to public safety, particularly with the data that we have had in the past two to three, maybe five years now, where prescription drug abuse, misuse, or dependency, particularly on narcotic opioid drugs, is perhaps more of a threat to transportation safety in particular than some of the other illicit drug use. And I stand here today to tell you that there has been no specific movement to include drugs such as oxycodone or some of the benzodiazepines or other more frequently abused drugs in the federal panel. But I can also tell you that there is a substantial amount of data being collected through non-DOT testing, which does often include testing for those drugs, about the incidence and prevalence of those circumstances. And that's being triggered primarily through the Office of National Drug Control Policy as well as the Department of Health and Human Services. So I guess my comment is to stay tuned in terms of whether we will have other drug testing panel options for the federal drug testing program in the near future. So of the five copies of the custody and control form, one copy, the original, if you will, is sent with the specimen containers to the laboratory. Copy two, which is the medical review officer copy, and copy four, which is the employer's copy, are to be sent by the collector to the medical review officer and the employer representative as quickly as possible. It is encouraged by the regulation that the copies of these forms be sent respectively to the medical review officer and the employer designated representative via fax or scanning or some basically very quick electronic transmission, although the regulation does allow for them to be mailed. And so consequently, in some instances where there is not electronic transmission of the images of these documents to the MRO in particular and also to the employer, it may be several days before the copy of the form is delivered or arrives at the medical review officer or the DER location. Because in many circumstances, the collections of urine specimens, as you will see, are done a great distance from where the medical review officer is. They're often, in many instances, done at multiple locations, even in multiple states for a given employer. And so that means that from a standpoint of collecting the paperwork in one central place, if you will, for both the medical review officer process and for the employer's process, it does mean that there's got to be some way of getting this documentation. The other question that's often associated with this portion of the seminar is when will the Department of Transportation allow the use of an electronic form so that, you know, you can press the button, so to speak, and at the point of collection, the various copies or images can go to where they need to go and we can kind of get away from this cumbersome five-ply form and mailing and separating and all of that kind of thing. And on that score, I can tell you that the Office of Management and Budget, in approving this latest form that the Department of Health and Human Services issued in October of 2010, or effective October 2010, did say that they would not approve a subsequent version of a paper form unless the Department of Health and Human Services could show that they had thoroughly exhausted any possibility of a paperless or electronic system. So I think that HHS and DOT and the rest of the federal agencies that are proponents for the drug testing program are going to be under considerable pressure and guidance to see if there cannot be a paperless or electronic solution for the CCF and the chain of custody documentation for this program within the next couple of years. Now, because the new form was issued effective in October of 2010, as is the custom for DOT's drug testing program when certain regulatory changes are made and certainly when new copies of the forms or forms associated with the program are issued, there is a one-year phase-in period. So collectors, laboratories, employers, et cetera, can continue to use the older version of the CCF for one year after the new CCF became effective. So up through September of 2011, DOT drug tests can be done on the expired or the former version of the form without there being a requirement for a memorandum of correction or for canceling a test or for doing anything differently about the form. Of course, once that September 30th phase-in or grace period expires this year, then in order for a DOT test to be reported to an employer as a valid result, then a statement of correction is needed that says why the old form was used and since the old form was used were all of the new procedures followed and, for example, what is the DOT testing authority and those kinds of things in terms of the form, the older form, making sure that the information that is required on the new form is appropriately documented. This is a screenshot of the current federal custody and control form implemented and effective in October of 2001. This is the MRO copy. Again, I believe you may have full page copies of this in your syllabus at the end of this PowerPoint presentation so that you can more clearly identify the segments and sections of the form. So going through the form now, because it is an essential part of what the medical review officer and or the medical review officer staff members must do in the review process for every DOT test, drug test, is to review the form, make sure that it is complete, whole, and accurate on its face before reporting out any kind of a test result. Let's go through that form and what are the things that must be there. So step one, of course, has the identifying information that is necessary. It has the employer information, including the telephone and fax number of the employer's designated representative. It must have the MRO information, who the laboratory is to report the results to, and that has to have, by the way, a physician's name. So, for example, the name of the company that provides MRO services that I work for is called First Lab Inc. It's an MRO, third-party administrator company. We have four physicians who serve as medical review officers. So we can't just put First Lab MROs up there. We have to have the name of the senior or the chief or the designated, if you will, medical review officer who has met the qualification training requirements. So it would say, for example, Dr. Natalie Hartenbaum, and then give the First Lab address and the phone and fax number where Dr. Hartenbaum or her staff can be reached if there are questions by the laboratory or the collection personnel. The testing authority box must be checked. DOT, obviously, for a DOT test, and you can see that the testing authority box is right under where the donor's SSN or donor employee ID number is, and that is not pre-printed on the form, the donor's information, nor, generally speaking, nor is the DOT testing authority. The donor ID number has become less and less important in the collection process and the documentation over the years. It started out that it was a Social Security number that was required on the form for every individual who was undergoing a DOT drug test. As you know, in the last decade, there has been increasing concern about the use of a Social Security number on any document or on any reports that would include a person's name as well as their Social Security number because of identity theft and confidentiality, privacy issues, etc. So probably today, there are more and more circumstances where employers and employees choose not to use a Social Security number as part of the drug testing collection process. They will use employer-issued ID numbers or driver's license numbers or passport numbers or other numbers that are associated with their photo ID that they present at the time of coming for a collection. The collection site information is also a part of step one. You see that in the bottom box, essentially, in letter G, and that is, where was this specimen collected? Was it collected at the employer's work site by a mobile or on-site collector? Was it collected at a clinic, at a laboratory patient service center, or a variety of places where specimen collections can take place? It does have to have the collector's phone number off to the right as well as the collector's fax number, again, so that if either the laboratory or the medical review officer or his or her staff needs to contact the collector about a part of the form that is not legible or a question about remarks or any other thing that needs to be cleared up about the form prior to reviewing and releasing a DOT drug test result can be accomplished. Step two is completed by the collector, as you can see. Now, step one, remember, large portions of that may be pre-printed at the time that the laboratory sets up an account for a particular employer's DOT drug testing program, then much of that information at the top can be pre-printed, such as, obviously, the employer and the MRO information. In many instances, obviously, it's a five-drug panel, so that can be pre-checked or pre-printed onto the form. In some instances, even, if all of the collections, for example, are done at the employer's work site, that information can be pre-printed on the form. Step two, however, is not pre-printed at all. The collector must complete this step at the time of the collection, and basically, this is information about the collection and as a, to some extent, it is a checklist that the collector is following the procedures or process that is outlined in the DOT regulation. So one of the first things that the collector does when the individual presents the specimen to the collector in the collection container is to check that temperature-sensing strip and to make a notation then about the specimen's temperature. So is it, was it read within four minutes of being presented by the donor to the collector is the first thing. And then the second thing that they have to essentially answer is, was the specimen between 90 and 100 degrees? Yes. And if it was not between 90 and 100 degrees on this LED kind of readout or LCD readout, then what, then you enter a remark. Was the, was the temperature cold? Was it less than 90 degrees? Was it greater than 100 degrees? And a remark that indicates that this will be followed, this particular specimen collection will be followed by another collection of urine from the person, and this time it will be a directly observed or witnessed collection. And I'll go into that in more detail later. The second thing that the collector checks about the specimen is, was it a split specimen? Did the collector subdivide it and put it into the two specimen containers? As I mentioned, for DOT testing, it's mandatory that there be a divided specimen. If there is less than 45 milliliters of urine collected, the collector must pour it out and have the person try to urinate again. That's the minimum volume. The collector is instructed to put 30 mLs into one collection container and 15 or any remaining residual urine into the second container. The only time that the single collection should be checked on a DOT specimen collection custody and control form is when the individual has come out of the bathroom, an unobserved collection, presented a specimen that is, say, 30 mLs or 20 mLs, but it is a suspect specimen, in the opinion of the collector. What does that mean? It was blue, which means they dipped it in the blueing agent in the toilet, okay? Or it smelled overwhelmingly like bleach, or it was frothing and bubbling like an eighth grade chemistry set, or any number of things in terms of the specimen looks like it was manipulated, adulterated, etc. And then they are going to package that as a single specimen with the appropriate notation and send it off to the lab for analysis, obviously primarily for specimen validity testing to determine how was this specimen manipulated or adulterated. None provided must be checked on the form when the person has what was coined 20 years ago as a shy bladder event. Now I have to say that Mr. Ashby, the attorney who collaborated with me and others in writing the original DOT procedures, kind of came up with that term, much to the chagrin of Dr. Peterson and every other physician who said, where is that in the PDR? Where is that in the diagnostic manual? Where did you come up with this term? And it was just that. It was a DOT term. Feds love to invent words. We're coiners of phrases. And so the shy bladder event is one in which the person is afforded an ample opportunity of time and ample amount of fluid to reasonably hydrate themselves. And at the end of that process, which is defined as three hours maximum and up to 40 ounces of water or other fluid offered, then if they are still not able to produce at least 45 milliliters of urine in a single void, then the collector discontinues the process, makes notes on the remarks line that you see here in step two and enters that no specimen was provided. Now this becomes, as Dr. Peterson and others will discuss with you in subsequent sections today, that the MRO is the one now that is going to make the final determination. When there is no test result to report because there was no specimen, it will be the MRO based on other medical information that is obtained that will determine that this person was incapable of providing a urine specimen or that this person was capable physiologically and psychologically but simply refused to do so. And then it would be a refusal to test. The last part on step two of the custody and control form is the observed box. And that would only be checked when, in fact, the person was not given the specimen container and told to go into a toilet facility and close the door and pee in the cup, but when the collector or another individual from the collection site accompanies that person into the toilet facility and watches them or observes them urinate. Now DOT specifies that direct observation can only be done in certain circumstances, very specifically prescribed as to procedures and when, and I will go over those later in this lecture. Step three is that essentially instructions to the collector as to what to do next. And that is that the collector puts the bottle seals or the container, specimen container seals onto the bottle, placing them over the caps and forming a tamper evidence seal, if you will. The collector is then, that seal of course has the same specimen ID number as is on the custody and control form. The collector then dates that seal showing that she has applied it or he has applied it and then presents it to the donor who is still standing there, who has not finished with the process yet and asks the donor to initial the bottle seal. And again, this is all in preparation for the donor signing a certification statement that says this is a urine specimen identified by the specimen ID number on this form and on the specimen seals that is my urine. I presented it to the collector. It was labeled and sealed in my presence and I have not adulterated or manipulated it in any way. And that becomes the certification statement that the donor signs. So once the donor has initialed the seals or if the donor says I'm not going to initial the seals, that's fine. It's not a refusal to test. The collector simply makes a notation in that remark section that donor refused to initial seals and goes on to the next step, which is step five, that is on copy two of the custody and control form. Remember the donor information and donor signature isn't on that first copy because that goes where? To the laboratory and the laboratory cannot have what? The donor identification information in terms of name, date of birth, contact information, etc. Okay. Now step four is back on the original ply on copy one and this is the collector certification statement. Very similar in wording to what the donor has signed, but this time the collector is essentially attesting that this is the urine specimen identified by the specimen ID number that she has received from this donor, who is identified in step five of the custody and control form, and that she has followed the applicable DOT or federal collection procedures, and that it was labeled and sealed, and that she or he is then releasing it to the delivery service that is noted on the right. So the collector is going to sign that, print his or her name, identify the time that the collection was completed, and the date, the date here obviously should match the date on the bottle seals, right? And then the collector is going to identify the delivery service that is going to transmit or that is going to transport the urine specimen to the drug testing laboratory. There is no need for her to identify the specific FedEx carrier who is going to, or I should say employee, driver, who is, you know, it doesn't have to say Jack Frost from FedEx, it just would say FedEx. But it does have to have the specific delivery service. So if that is FedEx, it should say FedEx. If it's UPS, it should say UPS. If it is LabCorp courier, it should say LabCorp courier, or MedTox courier, or Quest courier. It should not just say delivery boy, okay? Or it should not just say lab courier, because it should specifically identify which courier service the specimen has been released to. And then the additional part of step four that you see here is where we are continuing, if you will, this chain of custody. So now the next notation that will be made on this form, which is going to become this record throughout the process, right, is going to be made by the accessioning person at the laboratory, who is going to say that I'm the person that has received the specimen, this is the day that I got it, and I am going to certify that the specimen bottles, the primary specimen bottle seal was intact, yes. If no, there's going to be a remark. Oftentimes if the primary specimen seal has been torn or is not applied properly and has come loose, or that specimen has leaked and destroyed or deteriorated the seal, et cetera, then the laboratory can redesignate if the split specimen has sufficient volume in it for testing, and where that seal is intact. So there would be a variety of possibilities that the accession person would have to note specifically if there was a problem with the primary specimen bottle seal. And then, of course, the accession person is going to identify who it is released to. In these laboratories, as Dr. Peet will explain to you, very, very segmented tasks and sections separated by all kinds of security doors and codes, et cetera. So the actual testing of the specimen, the opening of the specimen, the aliquoting of the specimen, et cetera, is going to take place in a different location. So the accessioner, once the form has been reviewed and the specimen ID number and various other tracking numbers through barcoding and the alphanumerics have been entered into the laboratory system, whether that's the LIMS system or some other system, then the accessioning person is going to indicate the person to whom it has been released for further processing. Step five, again, that is on, remember, that is on the second copy and goes through then on the carbonless manifold to copies three, four, and five. Contains the donor information, the printed name of the donor, the donor's signature, the donor's date of birth, which is used for MRO identification purposes only. Dr. Peterson will mention that in his subsequent talks with you. The telephone contact numbers, again, the purpose of that, not for the employer, but just for you, the medical review officer. So for any non-negative laboratory result, you have an obligation to contact the donor by telephone. And that is where you get that information as to where to contact the donor, how to contact the donor. And then, of course, the date of collection. And this has, again, a similar certification statement as I mentioned earlier. If the donor refuses to sign and complete step five, one might think the DOT would say this is a failure to cooperate with the process and is a refusal to test. Is that what the rule says? No. The rule says, again, to some extent I think counterintuitively, that it says that all the federal government can require the person to do is pee in the cup. And if they don't do the rest of the stuff, initialing the seals or signing the form, that's okay. And so then the collector is simply going to note that in the collector section, okay, that the donor refused to sign the form. And the collector is going to print the donor's name in the section. Not sign for the donor, not complete any other information, but simply to print the donor's name. Okay. So now we have completed steps one through five potentially on the CCF. There are additional steps on the CCF, as you note, but these are ones that will be completed by certifying scientists at the laboratory, by you as the medical review officer, and perhaps by a certifying scientist at a second laboratory if a split specimen reconfirmation or reanalysis has been requested and obtained on this particular test. So copy one is going to go to the laboratory, remember, with the specimen containers in the plastic bag. Copy two, as we mentioned, is the MRO copy. The collector has the third copy. Now we're getting down to where these are almost probably not readable at all, okay, because people don't press hard enough for the information to go through. That would be another great advantage, quite frankly, if we could get an electronic custody and control form system for federal testing. But copy three is the collector copy. Does anybody, oh, it says right here, you have to retain the collector copy for how long? Thirty days. That's correct. And copy four is the employer's copy. That is for the designated employer representative. Again, if they are audited, that gives them proof that they did send this person for a random test, that they did do a post-accident collection within the number of hours after an accident where a post-accident collection was required, et cetera. Copy five, of course, is the donor's copy given to the donor by the collector. That's the point at which the collection process is completed and the donor can leave the collection site. There's nothing in the rule about how long the collector, the donor has to retain their form. One time I was going to do an office pool for how long we think donors hang on to those forms. Probably what, you think it's past the second trash can on the way out or what? But at any rate, that's probably the copy that is not going to be retained by anybody for any length of time. Okay, I mentioned that one of the tasks of both the laboratory accessioning person and the medical review officer or medical review officer assistant or staff member is the review of the custody and control form or the review of the condition of the specimen itself in terms of the laboratory to determine whether there are fatal flaws, whether there is an error that is apparent here that is not salvageable, that we're not going to be able to test the specimen and report out a result that we can in any way hope to legally or forensically support as being a test result identified with this donor. So the fatal flaws are listed here and there aren't a lot of them for as much paperwork and as many procedures as there are, there really are very few errors or omissions that constitute an irrevocably flawed test collection. One of them is that if the specimen ID number on the CCF, which is the custody and control form, it's pre-printed there, does not match the specimen ID number that is on the bottle seals. Occasionally we find this has happened when a collector has gotten almost through the collection process, put the seals on, et cetera, somebody dumps their coffee onto the form, obliterates it, so they grab a new form, fill it all out, and the seals that are on the bottle, of course, have what number on them? The one the coffee ate or the one the dog ate or whatever, right? The form that is not going to be used. Sometimes we had a rash of them, I think, a number of years ago where it was a printing error. Seriously. Because at that time it was a two-stage printing to print the specimen ID number at the top of the form and then to also print them on these tamper evident labels that are affixed with a special adhesive on the bottom of the form, and it got one off. Who knows how? But that, you know, so there was a whole hundreds of forms that the specimen ID number pre-printed on the top of the form was one digit off from the specimen ID number that was printed on the labels. So that made for a real havoc for a number of collections. Okay, the other fatal error is that both the collector's signature and the collector's printed name are missing. In other words, we have no idea who collected this, right? We don't know. We have an address that it was collected at such and such a clinic, maybe, or at a particular worksite location, and maybe we even got that it went by FedEx Courier, but we have no idea who the collector was. And we can't, we therefore do not have any way to establish that chain of custody starting, okay, with that collector's certification statement. If the bottle seal, of course, is broken, absence, or shows evidence of tampering on the specimen that needs to be used as the primary specimen, then that is a fatal flaw. And if neither the primary, and this is probably not worded correctly, but I'm hoping I can explain this, you've got to have at least one bottle with the seal intact that has close to 30 mLs in it. Now, how close does that have to be? Well, the regulation actually allows the laboratory to determine what is their minimum volume. So if the bottle seal that they can, based on their, you know, technology, on their methodology, that they have to have to do the five panel immunoassay, including the new requirement for the analog amphetamines MDMA, MDEA, and MDA, and the 6M analysis, as well as then having sufficient urine specimen to do confirmation for one or more drugs that may have screened positive. And for most laboratories, that's going to be somewhere in the 20 mL range. Most laboratories don't need a lot more than that today. So that's set by the laboratory as to what is the minimum volume below which they will reject the specimen as an insufficient quantity. Now, if a specimen comes in and it's got 25 mLs in the bottle that is marked B, or split specimen, and it's got, you know, 15 in the bottle that is marked A, can they redesignate that and go forward with the testing? And the answer is yes. And Dr. Peet will explain that process in terms of the accession decisions that are made at the laboratory. Okay. So these fatal flaws, you can see, it's really the laboratory that's got the first crack at those. So it's rare, but it may happen, that the laboratory may have missed one of these fatal flaws and the MRO staff member or the medical review officer in reviewing the form picks it up. Now, again, of course, the mismatched ID number, the bottle seal's broken, or the insufficient volume arriving at the laboratory are only things that the laboratory can tell. The only one possibly that the MRO or MRO staff member might identify that the laboratory missed would have been the absence of a collector's signature and collector printed name. Then the regulation goes on to identify not fatal flaws that are going to require the laboratory to reject the specimen and for the MRO to cancel the test, but flaws that are considered correctable. And these correctable flaws, in all instances except for one, require a signed statement of correction from the individual who committed the error or made the omission, and the MRO must cancel the test result if it is negative, positive, adulterated, or whatever, if the flaw is not corrected and is acceptable to the medical review officer based on the documentation provided by the individual making the error. What are the correctable flaws? If the collector's signature is missing but the printed name is there, then either the laboratory or the medical review officer or MRO staff member who identifies that can go to that collector based on the printed name and the collection information, the fax and the phone number, and get a statement from that collector that yes, I did this collection for this individual on this date, I inadvertently did not sign the form at the completion of the collection, and then have them sign a statement that is essentially the same as that taken from Step 4 on the CCF. Another possible correctable flaw is that there is no donor signature and there is no remark explaining the failure to sign. And again, this is something that can only be discovered by the MRO or the MRO staff member. The laboratory doesn't have any access to look at Step 5, so that becomes your responsibility. You cannot report out even a negative result unless you have a copy of the CCF, preferably the MRO copy, that has the donor's signature, or that you have obtained a memorandum of understanding, or a memorandum of correction, excuse me, from the collector who did the collection that states that the donor refused to sign it, but I forgot to mark that down. The donor left the facility when I discovered that I hadn't had them do Section 5, or I simply forgot that yes, I did follow all the procedures, I checked over the form, but I did not remember to have the donor sign Step 5. If the certifying scientist's signature is missing for a non-negative result, again, this is something that an MRO or MRO staff member would be the one who would identify this. Remember for DOT testing, there is no requirement for a certifying scientist's signature or even any requirement for you to have from the laboratory that laboratory copy one of the CCF. That's not required on negatives or negative dilutes, but that is required on any non-negative laboratory result. So for any positive, for any adulterated, for any rejected for testing, state of law, for any invalid, for any substituted result, you must have the laboratory copy of the CCF, a copy of it or an image of it, and it has to have a certifying scientist's signature stating what was the reported outcome to you the MRO. Was it rejected for testing, was it invalid, was it positive, et cetera. The other correctable flaw, and this is one that probably takes in many instances the most hassle, creates the most hassle for MRO staff members, MROs, collectors, and laboratories alike, and that is where a non-federal form, CCF, is used for what should be a DOT drug test. And the employer has had a qualifying accident, for example, accidents seem to occur with semis or with trains or whatever in the middle of the night or the morning, so they end up going to a hospital or other 24-hour facility that doesn't normally do their specimen collections, may not even normally do many DOT specimen collections, and the form that is used is a non-federal custody and control form. And yet the employer needs this to be a DOT drug test and needs to be able to report it on their statistical report and on their information in the case, for example, to the FRA for their post-accident tests that have been done. So that is a correctable flaw, but it does require a substantial amount of documentation. For you as a medical review officer to report out that result as a DOT result, you have to have a statement from the collector as to why they used the wrong form, and even though they used the wrong form, did they follow the DOT procedures in doing the collection? But then here's the harder one. You have to get a statement from the laboratory or have the laboratory retest the specimen and then certify it out that it was tested for the five drug classifications for DOT, using the DOT cutoff levels for screen and confirmation, and that it adhered to all other DOT procedures with regard to the analytical process, such as the quality control, the blinds, and the opens that Dr. Peet will explain in his next presentation. And then finally there is the old form, okay? I mentioned that in my earlier remarks, so I think that we don't have to cover that again. There is one more correctable flaw, but it's in its own category because it's correctable, but kind of the DOT rule says we really don't care a lot about this one, okay? So this is a correctable flaw that the laboratory or the MRO staff member or MRO should seek a statement of correction for. However, if the collector can't remember, if the collector never responds, or they aren't able to correct this particular flaw, we can go ahead and report the result anyway. You talk about a schizophrenic approach to documentation, but remember, this is a federal rule, right? Okay, so if the temperature box, remember that temperature box in step two, right? I read the specimen temperature within four minutes, and it was yes within range, or no, and if it was no, there was a remark. If that is blank, and there is no remark that indicates anything about the specimen temperature, then you are supposed to get a statement of correction. But if the collector can't remember, if they don't respond to the request for a statement of correction from the laboratory, the laboratory goes ahead and tests the specimen, reports the result to the MRO, and you as the MRO, after making another attempt to get a statement or correction of did you take the temperature and what was it, from the collector, you still report it out without canceling the test. Another category of flaws or errors or omissions, whatever you want to call them, in terms of the collection process, or specifically the documentation on the CCF, are called de minimis, or I call them de minimis or minimal flaws. They do not rise to the level of you as a medical review officer being authorized to cancel a test. In the DOT's opinion, you would not cancel a test if any of this information is incorrect or omitted because it does not compromise the forensic or legal defensibility of the test result, and it does not represent that a donor's rights to a fair and just and accurate test result were compromised. So things like if the address or phone number errors in the donor, the employee, the collector section, et cetera, those are not considered significant errors. If the donor's social security number or ID number is incorrect, you call up the donor on a test result and say, this is Dr. So-and-so, I'd like to discuss with you a test that you took for employer XYZ on such and such a date. To make sure that I have the correct person, is your date of birth, and then you would read that off of the form, and then I'm going to have a donor ID number where the last four digits are 7-8-9-9. Well, no, that must not be me. First of all, I was born on the 2nd of January, not the 1st of February. And secondly, my social security number is, or the last four of my social security number is 7-9-8-8, not 7-8-9-9. Now what do you do? These are de minimis errors. Don't forget, who filled out that section? The donor filled out the date of birth. Does the collector have any way of knowing whether that was correct or not? Probably not, right? The collector probably asked the individual for their social security number or their employee ID number or something else, or perhaps they did take it from a license or other document, but you don't know whether they have taken, for example, the first eight numbers of a 14-digit driver's license number or the last, you know, five. So those kinds of things are considered minimal or de minimis information. If the testing authority box is not checked, even though the federal government wants to be able to track how many tests are DOT and how many are NRC and how many are federal employee tests, that is not a reason that you would cancel the test. If the drug panel is not checked or is checked incorrectly, as long as you have identified that the laboratory did test it for the federal panel at its cutoff levels, et cetera, that is not, that's a de minimis flaw on the CCF and does not require you to cancel the test or require a memorandum of correction. If the collector's name is illegible or missing, remember all you have to have is the signature. You don't have to have the printed name. The split specimen box is not checked, again, that is not a problem that you as the medical review officer or reason that you would not, that you would cancel the test. The laboratory is going to identify in the accessioning process whether or not a split specimen was received or only a single specimen was received. And by the way, even for a DOT testing, they can certainly go forward with the testing even if only one specimen is received. And again, Dr. Peet will talk about, and Dr. Peterson, the reasons why that is a decision that the DOT has made for its testing program. Okay, let's talk about the steps now, this chronological process with regard to collecting the urine specimen. We talked about the custody and control form, the documentation, the chain of evidence, if you will, the chain of custody for the potential evidence. Now let's talk about how we ensure the other processes that we have mentioned or the other objectives of the collection process such as protecting the specimen, the testing, integrity of the testing process, the security of the specimen itself, and the proper identification of the specimen with the individual. So the collector then is required prior to the donor starting the collection process to make sure that any water, sources of water in the room or the toilet enclosure where the person is going to urinate have been secured so that they cannot add warm water or other water to their own urine or to, for example, take warm water and add it to dehydrated urine pellets or nuggets that are sold on the Internet as a way to beat a test. So securing the water sources, putting blueing in the toilet or any water sources that cannot be secured or blocked off so that if the person does attempt to use that water as part of their specimen, the color would be an indication of that form of adulteration or manipulation. Restricting potential adulterants from the toilet enclosure, things like Tilex, like disinfectants, like soap, et cetera. Interestingly enough, if only a couple of drops of those things are added to a urine specimen, they can interfere significantly with the testing process or can mask certain types of drug response, of responses to certain types of drugs on the screening assay. Having access and exit to the facility, you do not want to have the donor all checked in. You give them the collection kit and then you tell them to go down the hall three doors to the left, go into the bathroom and provide the specimen when they can have their best buddy or friend coming in, right, to pee in the cup for them because of other access to that area where the collection is being done. Choosing a suitable area, obviously, for completing the CCF, which is done again jointly by the collector and the donor. So the DOT then, in its description of this wonderful process of collecting a forensically correct urine specimen, says that there are basically three types of collections. There's the normal or the privacy collection. Donor does all this and the collector does all this preparation. Collector goes into the toilet enclosure with the full privacy door, like a bathroom that you would have at home, et cetera. Usually it should be a single toilet facility, again, where other sources of water have been secured or blocked, closes the door, urinates into the cup. The collector remains outside that facility, the door is closed, and the donor then emerges from that facility, that toilet facility, and hands the collection container to the collector. The second type of collector, which is permitted under DOT rules, is what's called a monitored collection. And this is a collection that is to be done, or a procedure, when there is not a single toilet facility available. Let's say you're at a work site where all there is is an employee restroom that has two stalls and three urinals, or whatever. So the DOT says that, yes, can DOT drug test urinary collections be done in that kind of an environment? And the answer is yes. The collector then is considered to do a monitored collection. It will be done in a stall, not at a urinal, and the collector will prepare that one stall with the toilet by making sure it's blued and that there's no access within that stall to potential adulterants, disinfectants, materials, et cetera, and that there is no access to water. And then the collector goes into that stall, and, excuse me, the donor goes into that stall, closes the door. The collector, however, remains in the restroom so that the employee can't go out to other sinks or to other areas of that restroom to get around the specimen integrity checks. And for DOT purposes, obviously, for a normal collection, there is no requirement that the collector be the same gender or sex as the donor. For a monitored collection where the collector is going to be in the multi-stall restroom while the donor is in a stall, the collector can be the opposite gender or sex of the donor if that collector is a medical professional, medical paraprofessional, a medical technician, or otherwise licensed in the medical arts in some way. If they are not, then the monitor who stands in there has to be the same gender as the donor. And lastly is the direct observation or witnessed collection. The witnessed collection or the direct observation is permitted under limited circumstances, which I will review. The observer must be in the toilet enclosure, whether that is the stall or this individual toilet facility, with the donor and must observe the person urinate. The observer, under DOT rules, must always be the same gender or sex as the donor. Doesn't matter whether that is a physician, a nurse, or other medically licensed professional, always has to be the same gender or sex as the donor. The observer, however, does not have to be a trained collector. So you could have a male person stand in and do the observation with the collector who is trained and qualified, who is a female, right, outside the door. The donor comes out after being observed by the male observer and hands the specimen container to the collector. What are some of the prohibitions, and they have to do with donors' rights and donors' privacy, that are imposed in a DOT urine specimen collection scenario? One is, and this creates a lot of concern and consternation, certainly for collection facilities, for clinics, physicians' offices, hospital and other medical facilities that do DOT urine collections. Many of them want automatically for donors to have to sign HIPAA releases, other forms of consent or indemnification, permissions to treat, or whatever. The DOT has been very, very specific, even after the enactment of HIPAA, that a collection site, nor an employer, nor a medical review officer, can require an employee for a DOT to sign any kind of consent form, any kind of HIPAA, any kind of authorization with regard to release of information, with the exception of the signing of the custody and control form, which already indicates that the specimens are going to be transferred to the lab, tested at the lab, and reported to the medical review officer. Also, the DOT rules do prohibit the collection of a specimen from an unconscious donor, whether by catheterization or by whatever. And so if a person cannot sign the form, cannot initial the bottles, cannot witness that the specimen has been obtained from them, and sealed and labeled in their presence, even for a post-accident test, you cannot do that under DOT rules. You cannot collect urine by catheterization, even if the person has been there two hours, has drunk 40 ounces of fluids, and you're closing in 15 minutes. Now, I'm not saying you couldn't display a large catheter, but you cannot use a catheter. If the person, however, normally voids via self-catheterization, he or she must provide the specimen. There are special provisions on a conscious patient to be able to collect a DOT test from a Foley catheter for a post-accident test only. But for a random test or for some other type of test, DOT does not authorize the use of a collection with even an external cath or a Foley catheter bag, etc. Some of the privacy issues for specimen collection under DOT rules. If I were to come to your office or to your clinic to have a specimen collection done, I could not be required to disrobe and put on an examination gown, for example. I could only be required to remove what is considered outer clothing. So you could require me to take off my jacket, which I'm not going to do because I'm all mic'd up here, but you could require me to take off my jacket. If I had any pockets remaining in my trousers or slacks or other clothing that I have on that I'm going to go into the collection toilet facility with, you would require me to empty those pockets and display the contents. You would require me to leave any hand-carried item and any outer clothing to include hats, coats, scarves, etc., outside the toilet enclosure while I provide the specimen. So that would include even things like cell phones, etc. The only thing hand-carried or in my pockets that I would be allowed to take into the toilet enclosure is my wallet or money clip, money or credit cards. And if I insist on taking my wallet in with me, then the collector has the right to inspect my wallet to see if I have any adulterant materials or anything else that I am taking into the collection site with me. Okay, there is not permitted under DOT on that custody and control form, or on a separate form for that matter, to have a donor list the medications that they are taking. And in fact, some donors are so concerned about this that they'll come with a boatload of their meds with them, and they'll say, here, I want you to write down and let the lab know I'm taking these 27 drugs. Or I want to fill out a form so that I know. Or I come here as a patient, can you put a copy of my medical records for the meds that I'm on? Or here's my pharmacy printout. And the collector's response to that has to be that I cannot take any medication information from you at the time of the collection. If you want to keep that pharmacy printout or that copy you've got here, or if you want to make a jot down the meds you've been taking this week on the back of your copy of the form, that's fine. Because the only person that you are going to provide that information to is whom? The medical review officer. Not to the laboratory, not to the employer, DER, etc., but to the MRO. Okay, specimen security issues. We had the privacy issues, the protection issues, etc. What about the security issues? When that collection kit, remember that you saw in that photograph, is presented to the donor, it should be what? Wrapped or sealed. Most of those collection kits actually come from the laboratory with the two specimen containers snugly fitting inside the collection container. And this baggie all rolled up and crumpled in. It's amazing to me how they do it. And that is stuffed also into the collection cup or container. And then over the top of this is what? Usually a foil thing like on your yogurt or your orange juice, or some type of a shrink-wrapped material that shows that the kit has not been opened, it's not been used, and therefore it is viable for this particular collection. So that's one of the first security issues. The specimen bottles themselves then, when we take this kit, the collector takes this kit, and oftentimes the collector, probably one of the best practices is they've got a drawer full or a box full of these kits and says, pick one, right? Pick the one you want, I don't care. And then opens that kit in front of them, dumps out the bottles and the bag, because you're not going to give the bottles, or the specimen containers, to the employee, to the donor. You give only the collection container. And those specimen containers, those two bottles like, those also have to be sealed. So that once the donor comes back out, you can unseal those in their presence to show that there's no possibility that you dipped a little cocaine, right, into their bottle, or you put somebody else's contaminated pee, right, into that bottle, and that that's what is confounding their test. So again, most of those specimen containers that you receive as a part of the collection kit are going to have either a seal, like a wax seal around them, or more commonly, like a plastic flange that, you know, when you open it, the flange breaks off so that you can see that that specimen bottle has not been opened prior to that moment. Specimen, of course, is kept always in the donor's site. Signatures and initials are obtained after the seals are placed on the specimen bottles. That's the purpose. Again, very detail-oriented, A-plus type personalities, obsessive-compulsive collectors, right, say, oh, I want to get this all done. So they say to the donor, sign right here, right, don't want to forget to flip to page two, and while you're at it, initial the seal, and there we've got it all done. Well, hello? They're not supposed to sign the statement until they say, I have given this urine specimen to you, right? I have watched it labeled and sealed in my presence. So by having them do all that beforehand, it really and truly negates. Now you would think, well, it's going to be the collector's word against the donor's word. Not so fast, right? Because if the individual has been asked to initial the seals while they are still on the form, before they have been placed on the bottle, what are you going to see probably on the MRO copy? Those initials are going to come through, right, on the bottom. Because it's what? A carbonless manifold paper. So when you see that, you've got to think to yourself, hmm, all right. Now, I know collectors do it for a lot of reasons. They do it because it's easier to initial it when it's not on the bottle and there's ridges and it's wet and it's yucky or whatever. I understand all of that. But remember, we're talking about a forensic process here in terms of can we go to court if we have to and say this is how this occurred. Okay. Specimen bottles in the CCF are secured in the plastic transport bag. There is no requirement now for initialing that seal or for a separate tracking number or anything else to be placed on that bag. It's not exactly a Ziploc bag, but in fact it has a flap that there is a pressure sensitive seal system. You remove, like on some envelopes or whatever, you remove the strip, press down on it, and then it forms a seal that is very difficult to open without tearing the bag or showing that it has been entered. But the key thing, of course, in terms of the security of the specimen is that tamper of a bottle seal itself. So I mentioned that the DOT rules then go on to identify the chronological process, the steps. Checking the donor ID, explaining the process, removing outer clothing, et cetera. Depending on how you count them, there are probably 22 steps to collecting the perfect urine specimen. How do we come up with that? Well, I can tell you that a number of years ago when we were putting this together, we did a short videotape and a poster of how to collect a perfect urine specimen. I brought that short videotape and that poster home to my 16 and 17-year-old boys at the time, made them sit down and take the collector course. When it was finished, I said to Matthew, my youngest, what did you think, Matthew? And he says, mother, only the federal government could take 22 steps to pee in a cup. Probably true, right? There may be a little bit of overkill here. In terms of the process or the steps. But it goes through, again, you see, the protections and linked with all of the underlying objectives of the process for urine specimen collection. So, again, it's intertwined, obviously, for the places at which the CCF is completed and the donor and the collector's process as we go through this. Okay, I had promised you that I would talk about some of the specific collection circumstances. And I want to talk with you about direct observation. And I want to talk with you about the shy bladder process, if you will, in particular. So, direct observation, we know, must be done by the same gender individual who must serve as the observer. Again, the observer can be the same person as the collector, but doesn't have to be the same person as the collector. The observer does not have to meet the qualification requirements, the proficiency demonstration, and all of that that is required for the collector. The direct observation must be noted in step two and explained in the remarks section. In other words, why are we doing this as a direct observation? Because the first specimen was temperature out of range, or the first specimen was blue, or the first specimen reeked of bleach. Or maybe it's observed because previous specimen was invalid, canceled, MRO required recollection under direct observation. So it might say something like, MRO ordered. That's the reason that we're doing this as a direct observation. It is limited to six circumstances under DOT rules. And the new procedures that the DOT enacted over a year ago, for which they were sued, by the way, went to a federal district court and the Department of Transportation prevailed. The DOT did two things almost simultaneously. The first thing was that they said that there was such a proliferation of devices to cheat on a drug test that were available in head shops and over the internet, et cetera. Things from the urinator to the wizinator to the butt wedge to the, I won't even go into the more descriptive terms, OK? And these were ways that people were cheating on a drug test by essentially getting clean urine, either purchasing it or synthetic or human urine, reconstituting it, or getting urine, clean urine, from a friend. And they were putting it in various devices with tubes and heated pouches and whatever. Just use your imagination, OK? And the wizinator, of course, was an upgrade from the urinator, which was just tubes and plastic. The wizinator came in lifelike skin tones. Do I need to say any more? OK? So that even just observing a male, you could not necessarily tell the wizinator from the real thing unless they had chosen the wrong skin tone. Which, believe me, has happened. They do not call it dope for nothing, OK? So the DOT, with this proliferation of this kind of thing, came out and said, we're going to make sure that the observer does inspect for such devices. We're not going to do body cavity searches, et cetera. But what we are going to do is to require the individual to take their clothing, including underclothing, in the presence of the observer, raise it to chest height, front and back, to see if there are tubes or things attached, and to take their clothing, including underwear, from the waist to the mid-thigh to expose the genital and the buttocks area to, again, see if there are butt wedges or other apparatus that are attached that should not be there. Then, after putting that in, which many people felt was very onerous and a huge invasion of privacy, then the DOT said, you know what? And in addition to that, we're going to make all return to duty and follow-up tests directly observed. And the unions went ballistic. And they sued. And they lost. The court decided that in a actually unanimous opinion, which is the first time we've probably had a unanimous opinion in the history of federal drug testing, that the risk to public safety and the fact that there were all of these devices and ways to cheat on the drug test warranted the invasion of privacy. And the only people that were being subject to the more onerous procedures were those who had provided a specimen that was suspect or those individuals who had already violated the rules, been removed from duty, and been through treatment or rehabilitation, and therefore had a higher risk associated with relapsing, using drugs or alcohol, and contravening the federal rule, and therefore trying to cover it up by cheating on their follow-up and return to duty tests. So now we have the direct observation procedures with take your pick of the terms, nipples to knees, or whatever you want to call it. And we also have an added circumstance where it is mandatory. So what are the six circumstances? I think we have mentioned all of them. First specimen, temperature out of range, tempering attempt identified by the collection site. And then there are three circumstances which you, the MRO, are required to require a recollection of another specimen, and it must be under direct observation. So you are the one that is putting the additional requirement on for DOT tests in these circumstances. You have an invalid test result that you evaluated. You did an interview. You talked with a certifying scientist. There was no medical explanation for the specimen being invalid. So you canceled the test. And therefore, a recollection is necessary, and it must be under direct observation. You canceled a previous positive adulterated or substituted verified result because the donor asked for the split reconfirmation. And lo and behold, when you made that request of the laboratory to send that specimen to a second laboratory for split reconfirmation, the laboratory says to you what split, or we lost it, or we mistakenly dumped that, or that one leaked in transit. So if the split specimen, where it has been requested by the donor for a verified, positive, adulterated, or substituted result is unavailable for reconfirmation analysis, you must cancel your already reported adulterated, substituted, or positive result and direct the employer to send the individual immediately for another collection under direct observation. The last category is what we call a bridge category. It is neither a dilute, truly, nor is it a substituted, but it sure is questionable. It is a specimen that has a creatinine between 2 and 5. Now, you'll hear the words creatinine from Dr. Peterson and Dr. Peet ad nauseum in our subsequent sessions. So I'm not going to go into that in a lot of detail. But suffice it is to say that if you have a specimen where the creatinine is between 2 and 5, you must require a recollection of that person's specimen under direct observation, because it is highly suspected of some type of manipulation of the specimen at the time of collection. And then lastly, the last one now is that for all DOT return to duty and follow-up tests, it must be a direct observation from the beginning. Moving along to our other atypical or not normal collection scenario is the shy bladder. Or they took the word shy bladder out of the rule after I left the Department of Transportation. And they, of course, have replaced it with the inability to provide a sufficient urine specimen upon demand. Didn't you like shy bladder better? Come on, be honest. Anyway, so now the inability to provide a sufficient urine specimen, again, the procedure hasn't changed at all, even though the language or the word has changed. You provide up to 40 ounces of fluid at the collection site. You provide up to three hours on the clock to provide the specimen. The individual may make multiple attempts during that time, has to make at least one attempt to provide the specimen. The collector records the number of attempts, the times that those attempts occur, and that it was a quantity not sufficient, or a QNS, or a no specimen, an NS on each attempt. And that is recorded in the remarks section of the CCF. Again, DOT rules do not permit, unlike some athletic testing or like the USADA regulations for Olympic testing, that do permit the combining of urine specimens, partial specimens, to provide one drug test specimen. DOT does not permit that. The collection has to be discontinued after three hours, even if the individual is not successful. You then check none provided on the form, report the employer, the collector does, reports the discontinuance of the collection to the DER, the Designated Employer Representative, and then the collector completes the copies of the CCF, obviously not having the donor sign that they have provided a specimen, right? Because they haven't. There's no use of the seals or anything like that. So they line through the certification statement, sign the form showing that they have, that the remarks and the shy bladder process was followed, and then they print the donor's name in step five so that the MRO is going to know that they will get a medical evaluation report on this individual in order to make a final test result determination. There has been a lot of discussion over time, and I'm not going to go into the MRO process because I'm talking about the collection, but Dr. Peterson will review the MRO process now associated with that shy bladder determination and test result determination. But there has often been a lot of discussion about, well, what do you do with the individual who cannot urinate, who has been documented that they're on dialysis or that they have a preexisting psychological condition such as an extreme phobic reaction or whatever, okay? And you have to have a test result. In other words, it's a return to duty test. You have to have a negative before they can come back to work. You have to have a pre-employment negative test in order for them to take a job in a DOT safety sensitive position. And so there is what is called the pre-employment or return to duty exception. And that is that once the bona fide permanent or long-term existing condition, preexisting psychological or documented physiological condition has been documented, then the employee goes to another examining physician, this time an individual who is going to determine whether there is any clinical evidence of drug use or abuse. And in that exam, and only in that exam, can the practitioner, the physician, elect to use an alternative specimen as part of that clinical determination of is this person a drug user or can I send a report to the MRO that I find no evidence that they are a drug user or abuser? That is the only circumstance under which DOT currently allows the use of a hair specimen to test for drugs, a blood specimen to test for drugs, or a saliva specimen to test for drugs. Those are the major three that would be used in this context. Those results, however, are not DOT tests and they do not come to you the MRO. They come back to that examining physician, right? As part of his report that he's going to send to you that yes, there is evidence, clinical evidence of drug use as supported by a hair test or supported by the fact that I found fresh track marks, right, on their arms or between their toes or whatever. And then the MRO is going to use that written report in terms of giving a final determination on the pre-employment or the return to duty test. Okay, refusal to test. I do want to just briefly identify for you that there are a number of behaviors or circumstances that occur during the collection process that will constitute a refusal to test. The first one on this chart, on this slide, is probably the most common circumstance where the collector is going to notify the DER that there has been a refusal to test. And that is where the donor refuses to remain at the site until the testing process is complete. What we typically have, person gets there, they've waited a while, they go back, they bring out a specimen and it's 40 mLs and the collector says, sorry, that's not enough. Dumps it out. And the person says, now what? Well, you need to sit here and I'm going to keep an eye on you right here over in this section and you'll be given some water and when you think you can urinate again, then we'll proceed. Well, I got to pick up my kid, I got to meet the guys for poker, I got to stop off and get the whatever, I can't sit here. And at that point, the collector needs to notify that person if you leave the collection site, it is a refusal to test. And when they do it, they have to notify the DER, put that on the form, that that's the reason. The other thing where this often happens is the person gives a specimen and the collector says, this specimen is suspect, you see the temperature range or you see the color and we're going to have to get another specimen, you're going to have to stay here. I'm not staying here, I've been here for an hour already, this is ridiculous, I'm out of here. Or conversely, says you got to stay here for another specimen, yeah, okay. And by the way, we're going to have somebody go into the bathroom with you and watch you. Oh, nobody watches me, I have to go through that TSA screening, I'm not doing this, right, whatever, okay. And they leave. So those are most likely the circumstances where you're going to have a refusal to test that occurs at the collection site that the collector is going to document on the CCF and then notify the DER. So again, some of the times we do have, I have collectors that will occasionally call me that I had one a few weeks ago, you got to wonder whether it's the collector or the donor you need to test, but anyway, the collector called me and said that they had done these two collections this day and on the one person they had found a Wisinator. And so they made him take it off and throw it in the trash and then proceeded to do a test. No, no, no, you find the Wisinator, you find the butt wedge, it's what? Refusal to test, automatic, out of here, right? So those kinds of things in terms of what is a refusal to test. And again, if the person admits to the collector that they have substituted, that they have adulterated or substituted the specimen, and then again, the collector documents that, contacts the DER, that's on the form and that's a refusal to test. Now, in those circumstances, however, it's always a good idea to make sure that the collector has documented this on the form because later, months later, when this comes up, if it's not been documented on the CCF, if they decide not to fill out a CCF because the collection was discontinued, then there's gonna be all kinds of questions and he said, she said. So it is important to have a custody and control form documentation.

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