This is the first of two modules on the urine specimen collection requirements under Department of Transportation regulations. In this module, we will cover the supplies that are needed to do a urine specimen collection and the federal custody and control form that is used to document the specimen collection. And the second module will actually go through the procedures for doing the urine specimen collection. The DOT urine specimen collection requirements are outlined in a lot of detail in 49 CFR Part 40. In fact, they are contained in three separate subparts, subpart C, D, and E. And in summary, those subparts include the who is it to be a specimen collector, what the collection site and supplies that are needed, does include the custody and control form documentation process, the chronological steps in the collection process. Also outlined in these subparts are the process that ensures the specimen identity, the security, and the integrity of the collection process. Because this is considered forensic testing, if you will, the DOT regulations are based upon principles of search and seizure. In other words, that the specimen itself may become evidence that an individual has violated a Department of Transportation regulation or rule. Because the federal government is the one requiring this search and seizure, that is why it essentially must be documented on a form that includes what is being obtained as evidence and that who has handled the evidence so that there is a chain of custody from the point of obtaining the evidence until a result is reported that, again, may provide evidence that an individual has violated the DOT rules. There is a DOT specimen collection manual that the Office of Drug and Alcohol Policy and Compliance updates frequently that is designed specifically for specimen collectors to give them additional information and practical hints, if you will, in being able to meet the requirements that are specified in 49 CFR Part 40. And that document is available along with other publications by ODAPC at the government's website that you see on this slide. Part 40 states that the specimen collector should not be the direct supervisor of the donor unless there is no one else available. But other than that, there are no specific professional qualifications, if you will, for who serves as a urine specimen collector. They must complete qualification training. The DOT details in Part 40 the basic components of that training course and specifies that the collector must complete successfully an initial proficiency demonstration that must be in person with the facilitator or the instructor in which they complete five consecutive error-free mock collections. And that has to include the correct completion of the custody and control form. Collectors have to repeat this same training, the core components of a didactic online or in-person course, plus the initial proficiency demonstration or skills test every five years. In addition, if a collector is identified as having made an error that caused the medical review officer to cancel a test, then that collector has to undergo error correction training within 30 days of being notified of their error. And that error correction training does have to include, again, a skills demonstration with them performing three mock collections related to the error that they committed. And those mock collections must be done in the presence of a facilitator or trainer. Collectors are required to subscribe to the Office of Drug and Alcohol Policy and Compliance list serve function. That's how they can receive updates from ODAPSI on a regular basis, particularly things that may be germane to changes in collection procedures or any other information that would be necessary for the specimen collector. The specimen collection supplies that are used for a Department of Transportation urine specimen collection are basically divided into three components. The first is what we call the specimen collection kit. And the second is the custody and control form that is used to document the collection. And then the third component of the supplies are really the things that are necessary in the collection process itself, such as a pen to fill out the custody and control form, gloves if the collector would wear to protect themselves, a bluing agent, et cetera, that may be used, again, to deter cheating. So let's take a look at the specimen collection kit. And in order to do that, I'm going to go ahead and look at some photos of a specimen collection kit. This photo of a typical specimen collection kit shows the components of that kit. Specimen collection kits are provided by the laboratories and they are shipped to the collection site or to the employer. The collection kit has the open mouth collection container that's capable of holding up to at least 150 cc's of urine. It has graduated markings on the side to help the donor and the collector know when the minimum volume of 45 ml's has been deposited into the collection container. This is the only part of the collection kit that the donor takes into the toilet enclosure with him or her and urinates directly into this container. The temperature sensing strip affixed to the bottom area of the container is graduated from 90 to 100 degrees. And as the donor urinates into the cup, the temperature sensing strip changes colors to record the actual temperature of the specimen as it is placed into the cup. The two specimen bottles or specimen containers are also a part of the kit. And they are each capable of holding up to 45 ml's of urine. They have to have a cap or a lid that can be secured and that will prevent leakage while the specimen is in transit. All of the components of the kit are made out of polyurethane plastic. The plastic bag then, which is the specimen bag, has two compartments. One contains a desiccant that will absorb any urine that has leaked during transit. And that's where the two specimen containers are placed once they are labeled and sealed. And then the second compartment is where the copy of the custody and control form, the laboratory copy one, is folded in place. You can see that there is a flap on the top of the specimen bag that has a pressure sensitive seal, which that pressure sensitive seal is peeled back and then the flap is folded down. And that essentially secures the copy of the CCF and the specimen containers into the plastic bag. Let's go on to the second component of the specimen collection supplies, which is the federal custody and control form. The federal custody and control form can be either an all paper form or it can be an electronic form that is kind of a combination, if you will, of starting out as an electronic form that then a copy or copies of it are printed once they are completed. The custody and control form has five copies, if you will. And it also has a pre-printed unique specimen ID number on the top of the form. The form itself, the paper form or the electronic format also has a paper component that has the bottle seals or bottle labels that are attached. And the bottle labels or bottle seals are designed so that there are two of them. They also have the same pre-printed specimen ID number as the form does. And those bottle seals then are placed on the specimen bottle once the urine is placed in the specimen bottle for processing and packaging. The custody and control form does require both the donor's signature and the collector's signature. And the form must also have the information as to what employer this DOT drug test is being conducted for. And it also has to have the name and information of the medical review officer that the laboratory must report the test result to. So let's just take a look at the federal custody and control form. The federal urine drug testing custody and control form is used to document urine specimen collections performed for federal employees under the HHS mandatory guidelines for Department of Transportation regulated employees and for Nuclear Regulatory Commission employees in NRC licensed nuclear facilities. The current version of the federal CCF was approved by the Office of Management and Budget in 2017 and expires in August of 2020. There is a proposed new federal CCF that would be used for urine specimen collections as have all previous versions of the federal CCF. But this one also can be used for oral fluid specimen collections if and when the oral fluid specimen collection procedures and laboratory procedures are approved for all federal testing. The custody and control form is available in both paper, five copy or five plies, and electronic formats. As mentioned earlier, federal CCF is used only for collections performed for federally mandated testing programs. Any other testing that is done under an employer's independent authority cannot use the federal CCF. There are five copies of the paper form and five printable images of the electronic CCF. One copy, which is copy one, is sent with the specimen to the laboratory. Copy two, which is the MRO copy, and copy four, which is the employer's copy, are faxed or scanned and emailed to the medical review officer and the employer representative by the collector at the completion of the specimen collection. The MRO must receive copy two of the CCF before he or she can report any test results to the employer. The CCF is completed and signed by the collector and is also signed by the donor who completes a donor certification section as part of the CCF. These next two slides provide a mock-up of the federal custody and control form that is currently in use for federal drug testing, including DOT drug testing. You will note this is copy one, and as mentioned earlier, the copy one is the copy that does contain the specimen bottle labels and seals at the bottom. You will note, again, that at the top of the form is the unique specimen ID number. It appears both in a barcode and in an alphanumeric signature. And at the bottom, that same specimen ID number is imprinted on each of the bottle seals. Remember that Department of Transportation and all federal drug testing currently requires that a urine specimen be subdivided when it is collected into two specimen bottles. So that is called a split specimen collection, and that's why we have two bottle seals on the form, because each of those bottles then has to be labeled and sealed with the specimen ID number initialed by the donor, and the collector places a date of the collection on that seal. So copy one, then, is the one that is going, once the seals have been peeled off of the bottom and placed onto each of the specimen bottles, that is the copy that will accompany the specimen to the laboratory. Now taking a look at copy two, or the MRO copy of the Federal Custody and Control form, you can see at a glance a couple of differences between the first ply. Probably the most significant two parts of this form, obviously, are that it is only on this copy, and not on the copy that goes to the laboratory, but only on copy two and the subsequent copies, where the donor-specific information is provided. This is where the donor signs the affirmation statement that this is my specimen, it was labeled and sealed in my presence, et cetera. And also, this is where the donor provides telephone numbers that the medical review officer can use to contact the donor, should that be necessary for an MRO interview. It also provides the donor's printed name and the donor's date of birth. In addition, the MRO copy is unique in that it has the MRO's test result reporting section, or verification section, where the medical review officer is going to make their determination of how the specimen is going to be verified. And so you can see that the MRO will be able to check whether the final verification decision is negative or positive, whether it is an MRO-determined refusal to test, and if so, various comments. This is the section of the form, then, that the medical review officer will sign and date once he has completed the review process. Also contained on this copy, at the very bottom, is the section if the medical review officer is going to need to review and report any results of a split-specimen reconfirmation. And we'll talk a little bit about that in other segments of the training. Step one of the Federal Custody and Control Form is completed by the collector. Many portions of it may be pre-printed with employer information, with medical review officer information, with collection site information, et cetera. So the sections, if you will, of step one include the employer information, the medical review officer information, which must have a physician's name, address, and phone or fax numbers, the donor ID number, which is usually either the Social Security number or other employer-issued identification number. For tests that are done under the Federal Motor Carrier Safety Administration, the employee ID number must be the driver's commercial driver's license number, along with the two-letter acronym for the state in which it was issued. Another section of step one is the collector checks what the reason for test is, whether it's a pre-employment test, a random test, et cetera. There is a box for other, and that's only used in DOT testing for a US Coast Guard periodic drug test that is done as part of a Siemens application or renewal of a Coast Guard license. The drug test four is the drug test panel. And for DOT testing, that is always the five drug panel, which is abbreviated on the form as THC for marijuana, THC metabolite, COC for cocaine, and metabolite benzoethylene, amphetamine, AMP for amphetamines and methamphetamines, and designer or analog amphetamines such as MDMA. OPI is the class of drugs tested for opiates. That includes morphine and codeine, 6-monoacetylmorphine. And most recently, starting in 2018, it also includes the semisynthetics or the opioids, oxycodone, oxymorphone, hydrocodone, and hydromorphone. And lastly, PCP or fincyclidine. So that is the standard panel for federal testing, including for all DOT testing. Collection site information, as I said, can be pre-printed, but it must include the physical location where the collection is taking place and the phone and fax numbers of the collector. Step two on the form is completed by the collector also, but this is done now after the donor has come out of the toilet enclosure with their specimen in the collection container. And so the collector then has to record the temperature of the specimen as identified on that temperature sensing strip within four minutes of when the donor presents the specimen to the collector. And they simply check yes if it's within 90 to 100 degrees, or they check no. And if it is not within that degree, then they enter a remark. And that remark is going to include that a second collection will need to be done under direct observation. The collector also identifies that there is sufficient volume in the specimen to process a split specimen, which is required for all federal testing. They would only check single specimen if, again, the specimen was suspect because the temperature was out of range or there were other indications of possible manipulation or adulteration. And even though there may not be enough to process a split specimen, it would be processed as a single. And then lastly, that box is only checked by the collector if the individual has not provided any specimen. They either have left the collection site, which will be a refusal to test determination by the employer, or they have exhausted the time and the protocol for a shy bladder. And then lastly, if the specimen was directly observed, then the collector would check that box. And if the observer was a different person from the collector, the collector would write the observer's name in the remarks section of step two. And now for step three, there is no CCF entry required. This is really simply the reminder, if you will, for the collector as to what he or she is to do now. Now that he or she has the collection container with the urine in it, has filled out the appropriate things on step two. And so now the collector is going to affix the bottle seals to the bottle. The collector is going to date the seal's donor and ask the donor to initial the seals and then have the donor complete step five, which is on copy two, which is the MRO copy of the form. Remember, step five does not appear on the copy one, which is the laboratory copy. We're now moving on to step four on the CCF. And this is the collector's portion of the form and very important from a standpoint of really initiating the chain of custody to document the handling of the specimen. So step four, the collector's printed name, full name, is required, and the collector's signature, along with the date and the time of collection. The time of collection is the time that the collection was successfully concluded. The form also in step four is completed after the donor has completed step five on copy two of the CCF. You will recall on our previous slide we talked about in step three that it directs the collector after affixing the bottle labels and seals and initially having the donor initial them and the collector dates them. It then says to have direct the donor to complete step five, which is on copy two, not on copy one of the CCF. So once the collector has had the donor complete step five, then they come back to copy one of the form and they are going to complete step four. The collector is also going to identify the shipping service that the specimen is going to, how it's going to get to the laboratory. So again, it doesn't have to have a person's name. It doesn't have to have the FedEx driver or the laboratory courier person, but rather the entity, if you will, the shipping entity. So if it's a common express carrier, that might be FedEx or UPS. If it is a laboratory courier system, it may be LabCorp Courier, Quest Diagnostics Courier, et cetera, or other local courier service. And so here's step five of the CCF, which is a very important step for the medical review officer as part of the MRO's duties in reviewing and verifying laboratory test results. So step five, the donor prints their name, puts signs, their name, their signature, provides their date of birth, and provides telephone contact numbers as well as a date of collection. It is important to note that if the donor refuses to sign and complete step five, remember this is done after they have presented their specimen to the collector and it has been subdivided and put into bottles A and B, and the labels and seals have been affixed to the specimen bottle. If the donor refuses to complete and sign step five, that is not a refusal to test. And the collector will simply note this in the remarks section on step two, which is again on copy one. And in the paper form of the custody and control form, it would be on all copies. The remarks would be on all copies of the form that the donor has refused to sign step five. The collector then prints the donor's name in step five but does not sign on their behalf. Steps five, six, and seven on the CCF are completed by people other than the collector or the donor. Step five A and B, which is on copy one of the CCF, are completed by the laboratory scientist. Step five A is completed by the scientist for any non-negative laboratory results that's being reported. That would be a positive, an adulterated, a substituted, a rejected for testing, or an invalid result. Step five B is completed by the laboratory that does the split specimen reconfirmation test. Remember that step five, which is on copy two of the CCF, is the donor's information and certification section. Step six, which appears on copies two through five of the CCF, is completed and signed by the medical review officer. For laboratory negative results, this section and this step can be completed and signed by an MRO staff member. For non-negative results, this must be completed and signed by the medical review officer himself or herself. Step seven is also an MRO section, and that is completed by the MRO for split specimen reconfirmation verification. And again, that does have to be signed by the medical review officer. This slide simply reiterates what I've mentioned throughout this module in terms of the various copies of the CCF and how they are distributed. In copy one to the lab, we talked about copy two as the MRO copy. Copy three is the collector's copy. The collector is required under DOT regulations to retain the copy of the CCF or any DOT test that they did for at least 30 days. Copy four, of course, is for the employer. And the employer has to retain that copy depending on the DOT agency rule. Usually, at least for one year. It may be for longer depending on the DOT agency rules. Copy five, remember, is the one that is given to the donor after the CCF is complete and the bottles are packaged and ready to go to the laboratory. In other words, at the end of the collection process. The fatal flaws are identified by the laboratory, and the specimen is rejected for testing. And that report is sent to the medical review officer. Here are the criteria that the laboratory must use when rejecting a specimen for testing because of a fatal flaw. If the specimen ID numbers on the CCF and the bottle do not match, if the collector signature and collector's printed name are missing so that there's no identification of the collector possible from the form, if the bottle seal is broken, absent, or shows evidence of tampering, if neither this primary nor the split specimen has at least 30 mLs of urine to accomplish the testing process, if the specimen was received at the laboratory without a CCF, or if a CCF was received without any accompanying specimen bottles, and lastly, if the collector performed two separate collections, such as an initial collection where the temperature was out of range on the specimen or the specimen was otherwise suspect of adulteration or substitution, and then a second collection was done under direct observation, if the collector only completed one CCF for sending in both of those specimen collections, then that is also a fatal flaw. And this laboratory rejects all specimens for testing and reports that to the medical review officer. The correctable flaws identified in Part 40 are errors or omissions in the completion of the custody and control form or in the collection process that can be corrected by the collector or some other entity. And if so, if the correction is documented, then the medical review officer can evaluate and interpret the test result and report it out. So they do require this signed statement of correction. And here are the correctable flaws as identified in Part 40. If the collector's signature is omitted, remember fatal flaw was collector's signature and printed collector name both missing. In this case, the printed name is there. We know who the collector was, but there is no collector's signature in the appropriate box. If there is no donor's signature in Step 5 on the MRO copy and no remark explaining the failure to sign, then that is a correctable flaw. If the certifying scientist's signature is missing on the Copy 1 that is provided on a laboratory non-negative result, that is also a correctable flaw that must have a statement from the certifying scientist attesting to the test result. If the form that is used for a DOT pre-employment test, for example, is a non-federal form, not a federal CCF, then there has to be a statement of correction from both the collector and the laboratory that the DOT procedures were used in collecting and analyzing the specimen in order for the MRO to report this as a DOT test result. And lastly, if the collector uses an expired version of the federal CCF, there has to be a signed statement from the collector that the current procedures were used and that the expired form was inadvertently used because there was no availability of the current version of the OMB-approved federal CCF. There is one other flaw that is identified as a correctable flaw, and that is where the specimen temperature box, remember that in step 2, was not checked and there was no remark. In other words, it's not marked as yes or it's not marked as no, and there is no explanation as to why. That is considered a correctable flaw. However, when the laboratory sees that that step 2 box is not marked, it will request a statement of correction from the collector. Do you remember? Was this a specimen that was in temperature range or was this one that was out of temperature range? And once the collector identifies that, then the laboratory can go ahead and analyze and report the specimen result. For the other correctable flaws, in the absence of a statement from the collector or the individual, such as a laboratory certifying scientist who did not complete the required form, the MRO has to cancel the test. In the last correctable flaw, even if the collector cannot remember about that particular specimen and the specimen temperature or doesn't respond to the laboratory's request, the laboratory can still analyze the specimen and report it to the medical review officer. And it is not grounds for the MRO to have to cancel the test result. Part 40 also identifies some other types of errors, whether those are incompletions on the CCF or other misinformation on the CCF. And they indicate that these errors do not compromise the integrity of the testing process, the correct identification of the specimen with the donor, or any of the donor's rights. And so they are considered minimal flaws or de minimis errors that do not require correction or do not require the medical review officer to cancel the test or the laboratory to reject the specimen for testing. Examples of these minimal or de minimis flaws are the address or phone number is incorrect, either for the donor, the employee, the MRO, or the employer. The donor SSN or ID number is incorrect or is even omitted from step one of the CCF. The testing authority box, in terms of whether it is an HHS test or a FAA test, is not checked. The reason for the test is not checked. Was this a pre-employment or was this a return to duty test? Drug test to be performed, that panel is not checked. Again, for a federal test, it is always default analysis takes place for the five-drug panel. If the collector's name is illegible or missing, we're talking about the printed name here being illegible or missing. As long as there is a collector's signature, then there is no requirement for a memorandum or a statement of correction. And if the split specimen box is not checked, that is not a correctable or certainly not a fatal error. So these are the de minimis flaws, and they do not allow the cancellation of a test by the medical review officer for a DOT test based solely on these types of minimis errors.

urine specimen collection

Department of Transportation regulations

DOT regulations

49 CFR Part 40

specimen collector

custody and control form

collection process