This presentation is on oral fluid specimen collections. I'm Donna Smith, and I work for the third-party administrator Workforce QA, LLC. I am the regulatory compliance officer and advisor for that entity. So the oral fluid specimen collection procedures, much like the urine specimen collection procedures, are found in various subparts of 49 CFR Part 40. And in fact, they are very well organized in the same manner in those sections of Part 40 in terms of talking about specimen collectors, the steps in the oral fluid collection process, the use of the federal custody and control form in either a paper or an electronic version, and the current federal CCF, or custody and control form, is used for oral fluid specimens as well as for urine specimen collections. It is important to know that an employer cannot collect or a collector cannot collect both a urine and an oral fluid specimen using a single CCF. If there's a circumstance where they are going to be collecting a urine specimen, and then they move to an oral fluid specimen, they have to fill out and document both collections using separate federal CCFs. There will be Department of Transportation oral fluid specimen collection guidelines developed and issued by the Office of the Drug and Alcohol Program and Compliance Office. So let's talk a little bit about the oral fluid specimen collector. Essentially, it's the same criteria and qualification training requirements as for urine specimen collectors. Must complete qualification training, a training course, have to complete refresher training every five years, and must undergo error correction training. All of that is exactly the same as for urine specimen collection. But one difference here is that on the mock demonstrations or the mock collections, the oral fluid specimen collector does have to complete mock collections using the specific oral fluid collection device that they will use for all collections. So if there are two different oral fluid specimen collection devices that are eventually approved by the Department of Transportation and the FDA, then the collector, if she or he intends to use both of those oral fluid collection devices for doing collections for employers, they would have to complete successful mock collections using each of the devices. An oral fluid collection site is exactly the same in terms of the initial requirements, auditory and visual privacy for the person who is being tested, preventing unauthorized access to where the oral fluid specimen is being collected. But of course, it's much simpler than for urine specimen collection, where we have to have a toilet enclosure and all the preparation steps in order to collect a urine specimen. But for an oral fluid specimen, there are essentially minimum requirements for the area in which or the room in which the oral fluid specimen is collected. One of the significant differences in oral fluid specimen collection from urine specimen collection that I already alluded to is the specimen collection device. It does have to meet both DOT specifications for a split specimen collection using a single collection device. It must use a collection device that has been approved for the specific laboratory that the oral fluid specimen is being sent to. And the device, of course, as the oral fluid collector begins the process, has to be sealed and wrapped in packaging that contains that collection device that has two vials or tubes that the collection device, once the oral fluid has been collected on the device, are put into those two vials, an A and a B. And those vials have to have caps that they can be secured against leakage, et cetera. It's important to note that one of the reasons for an oral fluid collection device having to have approval and being specific to a laboratory is because of the buffer solution that is contained in the vial that stabilizes the drug and that stabilizes the oral fluid as it is shipped to the laboratory. So that's why, again, there has to be a cap on that vial that will prevent leakage of the specimen and specifically the buffer solution. You use a federal custody and control form, as I mentioned. Same federal custody and control form. It has the option, as we will see, for collecting an oral fluid specimen or for collecting a urine specimen. And of course, they will need a shipping container or packaging to protect the two vials that are being sent off to the laboratory by an express or other common carrier. So let's take a look at the custody and control form requirements. And let's look at step 1. It's the same as for urine specimen collection. So there's no difference at all in what is done in step 1. In step 2 and step 3, the collector does have to now identify that this is an oral fluid collection. And so the oral fluid box has to be checked in step 2. It has to be marked a split specimen because, again, DOT requires always a split oral fluid specimen collection using the device. So it's going to automatically, essentially, be a split specimen collection. And for the oral fluid, they have to check that it is a subdivided box, check the expiration date on the device. And if it is not past the expiration date, then you check yes. It's important that this expiration date information be put on the form because the laboratory will need to identify that the device is not expired and can then be processed at the lab. Also check the volume indicator observed box because it is an observed collection. The remarks are required in step 2 as for any atypical collection circumstances, which we'll get to briefly later. Step 3, there is no entry required. Step 4 is exactly the same as is done for a urine specimen collection. The one difference here is that in the very bottom right hand section of step 4, the collector must put for an oral fluid collection the split specimen device expiration date. And you see that there is a space there for the month, the day, and the year for the expiration date of the collection device. And steps 5A and B, which are completed not at the time of collection of the oral fluid specimen, but by the laboratory, are exactly the same as for urine specimen collection. So there will be no different in how the laboratory completes step 5 and or step 5B if a split specimen is ultimately tested at a second laboratory. And step 5 on copies 2 through 5, which is called the donor information section, again, identical to what would be done for a urine specimen collection with the signature of the donor, the donor's name, and contact information. The pre-collection process for an oral fluid specimen has a few more things, but actually is less complicated than for a urine specimen collection. So the collector instructs the donor to open his or her mouth, and the collector visually checks for any items in the mouth, such as gum, food, candy, tobacco, et cetera. The employee has to remove any items from his or her mouth. If the donor had items in their mouth, such as gum or lozenger or whatever, the donor is then provided up to 10 ounces of water and instructed to rinse his or her mouth. Failure to permit checking the mouth for foreign objects essentially is a refusal to test, and the process will be discontinued. This is similar to in the urine specimen collection. If the donor refuses to wash their hands prior to the urine specimen collection, it's considered a refusal to test, and the collection is discontinued and reported to the employer's designated representative. There is, in addition to after this checking of the oral cavity, if you will, the mouth, there's a 10-minute observed supervised wait period before providing the collection device to the donor. If the donor says, look, I don't think I'm going to be able to produce any saliva, I have a dry mouth, I have whatever, whatever the reason may be, the collector can provide up to 8 ounces of water for the donor to drink. And then if once that is done, then again, there's a 10-minute wait period after the rinsing or drinking of the water. Steps one and two of the CCFR completed during this 10-minute wait, recollection wait period, the donor is instructed to wash and dry their hands. The collector provides the wrapped sealed collection device to the donor and checks and records the expiration date. The oral fluid collection process continues then with the collector unwrapping the collection device package, and in accordance with the device manufacturer's instructions, directs the employee to position the collection device into his or her mouth. And the device may talk about between the cheek and the gum. It may be in the front of the mouth. What the specific manufacturer's device instructions will say to the collector in order to facilitate and optimize collecting an adequate oral fluid specimen. When each device will have a volume indicator on it, and when sufficient volume is obtained on the pad or on the device, then the employee, not the collector, removes that device from his or her mouth. The device is a pad. Generally speaking, it is a pad, an absorbent pad on the end of a thin plastic or polyurethane stick that looks like a very small straw or like a coffee stirrer, if you will. The collector then places the divided specimen into the two tubes in accordance with the device manufacturer's instructions and caps and seals and labels each tube, one as, again, specimen A and the other as B, using the seals that are provided at the bottom of the CCF. The CCF, again, remember, can be used for a urine specimen collection or for an oral fluid specimen collection, and therefore the seals are exactly the same. You don't have separate seals for the urine specimen bottle and separate set of seals for the oral fluid collection tube or vial. The seals are intended to be used for either type of collection. The collector then dates each tube and seal, if you will, and or label, if you want to call it that, and then directs the employee to initial each tube or container label. The collector then tells the employee, just like in urine specimen collection, to complete step five on copy two of the CCF. If the employee says, no, I'm not going to put all this information in, then the collector has to note this on the remarks line and simply print the employee's name in step five of the donor information section. The collector then completes and signs step four of the CCF, providing the date of collection, the time it was completed, the method of the shipment of the specimen to the laboratory, and don't forget that the expiration date of the collection device also has to be recorded in the very bottom of step four. The collector then puts step copy one, excuse me, places copy one and both specimen tubes in the plastic bag. Again, it's a bag very similar to what we are used to from urine specimen collection, seals the bag, and we're ready to go. The collector then provides copy five to the employee and distributes copy two to the medical review officer and copy four to the employer, just like it's done in urine specimen collection. We don't have a, quote, shy bladder procedure involving the providing of fluids and the, you know, the three hours time, but we do have a specific circumstance for, we do have a specific circumstance for a circumstance, an event where the individual is not able to complete an adequate oral fluid specimen collection. So I mentioned that if they make a claim about dry mouth at the very beginning, difficulty salivating, et cetera, at the start of the collection process, the collector may provide the eight ounces of water right up front before they even attempt to get the oral fluid collection in process. The employee can rinse with that or, and if they drink it, that's fine too. And then again, remember there's a 10 minute wait period after this water has been given to the employee. So let's say that that's not the case. You've started the collection and if the volume indicator on the device does not indicate a sufficient specimen after 15 minutes, so you have to allow up to 15 minutes for the device to collect a sufficient volume. And by the way, the regulation states that we're going to need at least a total of two mils of oral fluid to be collected on the pad. One mil is going to be used for the specimen A and one mil will be used for the split specimen or the specimen B. So if the volume indicator does not change color or show that there is sufficient specimen after 15 minutes, the employee then removes that device from his or her mouth and it is discarded. The employee is then offered up to eight ounces of water and one hour to successfully complete the collection process. So you can see the parallel here with urine specimen collection, shy bladder, where it's up to 40 ounces of fluid to hydrate and up to three hours. This is much, much less in terms of both the fluid that is offered to the employee and the amount of time that they have to successfully complete the process. There has to be a 10 minute wait period before beginning another collection attempt after drinking the water or after the first unsuccessful attempt where the indicator did not show sufficient specimen. Again, the same CCF is used with appropriate remarks to document each attempt and the times. If the donor is unsuccessful at the end of the hour, the collection is discontinued, the employer representative is contacted, the DER then is responsible for arranging a physical examination by a physician to determine if there is a legitimate medical explanation for the employee's inability to provide an adequate oral fluid specimen. The employer can adopt procedures or have a standing order, if you will, with the collection site or with the oral fluid collector that says that if the individual is unable to produce an adequate oral fluid specimen, rather than go to the one hour wait or offering more fluids, that we can switch immediately to a urine collection. That's a feature of the new DOT rule that will be in place for both a shy bladder urine collection, they can go immediately after the first unsuccessful attempt to an oral fluid collection, or in the case of an oral fluid collection, to begin the testing event, and it's unsuccessful at the first attempt, they can move to a urine specimen collection, if that is what the employer has identified as their protocol. Certainly, if that is the case, if you're moving to a urine specimen collection in lieu of completing an oral fluid collection, then you would initiate a new CCF and indicate in the remarks that a urine specimen collection is required because of a dry mouth event with an oral fluid collection and proceed with completing that collection as a urine specimen collection. There are a bunch of fatal flaws that are essentially the same as we have in place for a urine specimen. These apply exactly the same, if you will, to a urine specimen or to an oral fluid specimen. For example, that the specimen ID numbers on the specimen bottle or the specimen vial or tube and the CCF do not match. That's an example. There are two at the bottom of this slide that are specific to an oral fluid collection that are fatal flaws. Again, I alluded to these at the very beginning when we were talking about the completion of the custody and control form for an oral fluid specimen collection. If a collector used an expired device at the time of the collection, yes, it was expired, but they went ahead and did the collection, then that is going to be a fatal flaw. The laboratory is going to reject that specimen for testing and it will be reported as a rejected specimen, a fatal flaw to you, the medical review officer. Likewise, if the collector failed to enter the expiration date in step four, and the laboratory confirmed the device was expired. Now, how will the laboratory know that? Because the expiration date of the device has to be printed and available on the device itself. When the laboratory gets the specimens, even if the collector did not put the date on the form on the CCF, the laboratory is able to see what the expiration date is of the device. There are correctable flaws, again, very much the same as we had with urine collection. There is really essentially no different here. The medical review officer, you would identify potentially the following correctable flaws. The employee's signature is missing from step five. There is no remark indicating that the individual declined to complete step five or to sign the certification statement. If the other correctable flaw is the certifying scientist's signature is omitted on copy one of the CCF, remember in step 5A that we discussed briefly, for a positive or an adulterated, substituted, or for an invalid oral fluid test result. The laboratory and or the MRO will identify the following correctable flaw, and that is that the collector used a non-federal CCF or an expired CCF. Fortunately, the current CCF I think has been approved for at least another three years, if not even five. We shouldn't have a lot of circumstances where an expired federal custody and control form is used for oral fluid testing. Those are the correctable flaws. The correction of a correctable flaw is exactly the same as for a urine specimen collection correctable flaw, where the party, whether that is the collector or in the case of the employee's signature being admitted, you may get a statement from the employee. Once those corrections are received, then the oral fluid test can go ahead and be considered valid. Okay, that would be everything we need to know about oral fluid collection for now. This module was put together in late 2023, and as of this date, we do not have any authorization for oral fluid testing to be done in the DOT-mandated arena. We are still awaiting while we have the procedures and we have the regulation, we are still awaiting the certification of at least two laboratories to conduct oral fluid testing, and most importantly, from an oral fluid collection standpoint, we are waiting for the approval of the oral fluid specimen collection device that meets DOT requirements for collecting a split specimen that is subdivided at the time of the collection in the presence of the employee. Many of you may be familiar with doing oral fluid collections in the non-regulated arena, and there are oral fluid specimen collection devices that are used for that testing. However, none of them meet the requirements for DOT testing under this final rule in 2023, so we are awaiting the development of and approval of specimen collection devices for DOT oral fluid drug testing. That's it.

oral fluid collection

specimen procedures

49 CFR Part 40

training requirements

custody and control form

DOT testing approvals