The procedures for oral fluid drug testing for federally mandated drug testing are found in the Department of Health and Human Services Mandatory Guidelines for Oral Fluid Testing in Federal Workplace Programs. As of 2020, the Department of Transportation has not yet issued regulations or procedures or authorization for DOT-regulated employers to use oral fluid drug testing. The collection procedures that I'll review in this module are the ones that are based on the HHS Mandatory Guidelines. The HHS Oral Fluid Mandatory Guidelines do contain information about the specimen collector for oral fluid drug testing. In many ways, there are parallels to the requirements for urine specimen collectors. One of the chief differences, however, is that oral fluid testing, and particularly the collection itself, is always directly observed. And the role of the oral fluid specimen collector is much less more of an observer than anything else. Nevertheless, the oral fluid specimen collector must be trained in accordance with the Oral Fluid Mandatory Guidelines and the manufacturer's procedures for the specific collection device that they will be using. Different from urine specimen collection, where the collection kit is not specific to a manufacturer or not specific to a laboratory, the oral fluid collection devices are specific to a manufacturer and the laboratory that will be doing the analysis of the specimen. So there are training requirements that mirror the urine specimen collector, including that they must take a course that includes key components, and they must successfully complete five mock collections of oral fluid. And they have to undergo refresher training every five years. There is, however, no requirement in the Mandatory Guidelines for error correction training with regard to an oral fluid specimen collection. There is a statement in the Oral Fluid Mandatory Guidelines that the immediate supervisor or the hiring official of an applicant who is undergoing an oral fluid pre-employment drug test should only be used as the specimen collector when there is no other collector available. The requirements for an oral fluid specimen collection site or area and the supplies that are used are, again, detailed in the HHS Mandatory Guidelines. An oral fluid specimen for federal workplace drug testing can take place at the work site or at an off-site location, such as a clinic or other facility. There are the same requirements for donor privacy. There has to be a suitable space to complete the custody and control form. There has to be restricted access to the collection area. And there are certain supplies that are necessary for the collection of an oral fluid specimen. The collection itself is documented on an Office of Management and Budget-approved federal custody and control form. Currently, there is a proposed form, federal form, that would be used for either urine specimen collection or oral fluid specimen collection that is expected to be issued in August of 2020. The collection device itself must be an FDA-cleared single-use collection device that is intended for the purpose of collecting oral fluid specimens that will be shipped to a laboratory for analysis. The device has to be capable of maintaining the integrity of the specimen during its storage and transport so that the specimen can then be tested at an HHS-certified laboratory for the presence of drugs or for their metabolites. This slide shows a mock-up of the proposed new federal custody and control form that would be used for either urine specimen collections or oral fluid specimen collections for federally mandated drug testing. It resembles to a large extent the previous versions of the urine specimen collection custody and control form. It does obviously have places to identify whether it is an oral fluid specimen or a urine specimen that is being transmitted to the laboratory with a copy of the form. There are seals at the bottom of the form that could be used for either sealing and labeling a urine specimen container or an oral fluid collection device container. The mandatory guidelines state that the oral fluid specimen collection device has to have a volume indicator, which will change color, essentially, when at least one milliliter of oral fluid has been collected by the device. The requirement is for one milliliter of neat oral fluid. If a diluent is used, then the volume of oral fluid collected should be at least one milliliter plus or minus 10%. And the volume of diluent in the device should be within plus or minus 2.5% of the diluent target value. It is a sealable, non-leaking container that maintains the integrity of the specimen during storage and transport that is used for sending the specimen to the laboratory. The components of the oral fluid collection device have to ensure pre-analytical drug and drug metabolite stability. And they have to make sure that the components of the device do not substantially affect the composition of drugs and or drug metabolites in the oral fluid specimen. This slide shows some photos of current oral fluid specimen collection devices that are on the market today. There will probably be additional ones that will be FDA approved and that will come to market for the use in oral fluid testing for federal workplaces. However, at the present time, I don't believe that any of the ones on the market have been FDA cleared for the volume indicator and other specific components. I will now review rather quickly the oral fluid collection procedures as they are detailed in the HHS mandatory guidelines for oral fluid drug testing. And again, there are a lot of parallels to how the urine specimen collection procedures are detailed in the mandatory guidelines for urine drug testing in federal programs. So the collector essentially has the donor open their mouth and remove any items that may interfere with the collection. That would be gum or candy, food, tobacco, anything that would be in the person's mouth. The collector then visually inspects the oral cavity. They may provide up to four ounces of water for the donor to rinse their mouth. If the donor additionally says, look, I really have a dry mouth, I have difficulty producing saliva, the collector may provide four ounces of water that they can drink, if they wish, in addition to just rinsing with the water. The collector observes the donor during a 10-minute wait period before actually collecting the specimen. And then the collector explains the collection procedures and completes step one of the CCF. The donor is provided a sealed wrapped collection device, very similar again to urine drug testing where they are provided the sealed collection kit. That sealed wrapped collection device is opened in the donor's presence. The donor positions the collection device between the gum and cheek in the mouth, and the collector observes the donor as this is taking place. When the volume indicator demonstrates that there's been collection of a sufficient oral fluid specimen, the donor, not the collector, but the donor removes the collection device from the mouth and places it in the specimen vial or tube. It is important to note that the HHS guidelines call for a split specimen collection procedure for oral fluid drug testing, just as they mandate a split specimen collection process for urine specimen collections. And in this case, there are two options, if you will, for collecting a split specimen. And one of those is either using two separate collection devices simultaneously, one in each side of the mouth, or using a second collection device immediately following the completion of the first specimen collection. And so whichever way that is done, essentially simultaneously or sequentially, then two separate specimens, if you will, are packaged and sent to the laboratory. In the presence of the donor, then, the collector places a tamper evident label or seal from the federal CCF over the cap of each specimen tube. The collector records the date of the collection on the tamper evident label and seal, then asks the donor to initial the label or seal on each specimen tube. The collector then completes the information on the CCF and the subsequent steps. The donor reads the certification statement on the CCF and signs and dates the CCF. And the collector then signs and prints their name on the CCF. The collector seals the specimens in a package, meaning in a transportation or transport package, and within 24 hours or during the next business day, makes certain that they are transported to the HHS-certified laboratory by common express carrier or by a laboratory courier system. So this really is the summary of what we have on oral fluid specimen collection procedures right now. Again, I want to reiterate that the Department of Transportation has not yet issued either proposed or final procedures for oral fluid specimen collections for use in Department of Transportation-mandated drug testing programs. Likewise, you noted the discussion about using an HHS-certified laboratory for oral fluid testing. And again, to date, the HHS has not approved or certified laboratories for oral fluid testing. They are in the process of completing that task using the National Laboratory Certification Programs protocols. The HHS mandatory guidelines for oral fluid testing do have some procedures that the collector is to follow when the donor is unable to provide an oral fluid specimen of adequate volume to be shipped to the laboratory. So the way in which this, quote, dry mouth event is documented is that the donor is to have the collection device in their mouth for up to 15 minutes. And if there is insufficient volume or no oral fluid is collected using the device at that point, then the collector starts the process, if you will, for dry mouth procedures. If the donor states that they believe they could provide a specimen after drinking some fluids, the collector does give the donor a drink of water up to 8 ounces and waits an additional 10 minutes before beginning the specimen collection again using a new sealed collection device package. A period of one hour must be provided or until the donor has provided a sufficient oral fluid specimen. If the federal agency has authorized, a urine specimen may be collected when a donor cannot produce an oral fluid specimen. If there is no authorization for a urine specimen collection, then the same procedures that are used for a shy bladder are followed, meaning that the donor would be sent for a medical examination to a physician with then that physician's findings being submitted to the medical review officer for a final determination about that test being made by the MRO.

oral fluid drug testing

federally mandated drug testing programs

collector training

split specimen collection

certified laboratories for oral fluid testing