Oral Fluid is now allowed for DOT testing. Click here for more information.
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Oral Fluid Testing Regulations

PART 40 FINAL RULE
DOT Summary of Changes

Rapid Testing better complies with CA Assembly Bill 2188

We are excited to inform you that with the approval of Oral Fluid/Saliva (OF) for federal testing, we can now have you take advantage of drug screening with oral fluid (OF) drug for Pre-Employment, Post Accident and Reasonable Suspicion situations. This is key with the new California law (AB 2188).

AB 2188 goes into effect January 2024 and there are other advantages as outlined below.  The law is trying to treat Marijuana like alcohol.  We realize those of you in the construction industry may be exempt but there is still tremendous value in having a tighter window of detection to not disqualify candidates using Marijuana 30 days prior to testing.

  1. For AB 2188 – OF better fits the definition of testing of a parent drug (still in the blood)
    1. OF is a filtration of the blood, versus
    2. Urine which is a metabolite. Urine is debatable in the research cited by California
  2. For AB 2188 – OF is a closer definition to law about “a bodily fluid” to show drug use at work.
    1. OF has shorter detection window – up to 0-12 hours for THC, versus
    2. Urine detection window is 8 hours to four days making a harder case for drug use on the job.
  3. For AB 2188 – OF is a better detector of impairment at the workplace usage.
    1. OF has a window of impairment of 3-10 hours, versus
    2. Urine has a window of impairment of 12 hours to 30 days

Other major benefits and why the federal government has approved it.

  1. No need to occupy or find a restroom onsite.
  2. No method to substitute someone else’s specimen. (Temp out of range, etc.)
  3. No need to pay for wait time to us or the employee because, “they just went to the bathroom.”
  4. Very low chance of stalling because the testing can start right away. They may well just quite before you have to call us out.
  5. Ability to use a single test kit for expanded panel testing, so those of you having other than a five panel do not need to purchase kits in advance, track inventory, and eat the cost of any expired kits.

Also, note that we can set you up to do your own testing and sending results out as well.

Contact to Discuss Pricing

The final rule is effective June 1, 2023.

  • Not yet!
  • DOT oral fluid testing cannot be implemented until the Department of Health and Human Services (HHS) certifies at least two laboratories (one to serve as a primary laboratory, and a second to serve as a split specimen laboratory).
  • Check here for the listing of HHS certified laboratories https://www.transportation.gov/odapc/labs.
  • Each device must be approved
  • Laboratories must be approved for each device
  • 2 laboratories must have at least one approval for the same device
  • There needs to be some sort of a collector certification process on each approved device.
  • There are further guidelines yet to be provided regarding collector training and certification
    • The What, How and Who of training and certification still needs to be ironed out
  • Laboratories need to provide pricing to employers and TPA’s.
  • Device manufacturer’s need to provide pricing to the collection sites.
  • Collection sites must make a decision to offer Oral Fluid (OF) specimen collection and determine which devices(s) to use (requires certification for each AND the cost to buy and inventory the device(s)

MOST IMPORTANTLY, AS YOU WILL SEE BELOW.  OTHER THAN SAP CHANGES AND A FEW MRO CHANGES, THERE IS NOTHING TO DO AT THIS TIME.  OUR ESTIMATION IS A ROLL OUT IN 2024.

We go into great detail below, but one of our sources sums it up best,

“DOT spent two years reviewing the HHS proposed regulations before publishing on May 2nd.  It would be a near miracle for the vendors to have their product available and laboratories accredited in 2023.  With DOT guidance out, we hope the vendors will go more quickly and the FDA approves quickly.  But promoting products through the FDA over the last few years has been quite slow.  I hope there is a lot happening behind the scenes for the vendors but they are all very silent on the success and nobody has proposed a date for all of the reagents to be available.  It appears to a 100% completion through the FDA before any release.  Perhaps the new pressure by the testing industry may move their product faster.  I certainly hope they can do this sooner than later.”

First some definition:

Neat – A pure saliva sample. Thoughts from our laboratory scieintist:

Neat oral fluids are a set of new problems.  The collection is different and current protocols will likely not pass DOT guidance for regulated samples.  Neat oral fluids are not stable and will degrade quickly due to mouth bacteria.  I am not in favor of neat samples as they are very hard to test in the lab due to foaming and volume measurement.  I have no intention of doing neat oral fluids as a regulated test.  I would still need to dilute in the lab and have FDA cleared reagents.  Although it is possible to do this, it would be too expensive to put into production.

Buffered– Incorporates a buffer preservative solution

  • Specimen must be able to be subdivided into an “A” and “B”.  It must be obtained at the same time, from same collection, not sequentially (one after another).
  • Since buffered is preferred, the configuration for the device must be Single or Dual joined pads placed in the same region of the mouth, then subdivided into two separate containers.
  • You, not the employee, choose the collection methodology for the test reason (e.g., randoms will start with urine; follow-ups will use oral fluid).
  • You, not the employee, choose the collection methodology for the subsequent collection following a shy bladder, dry mouth, or other test that requires a directly observed collection.
  • ​​​​Ensure you have business relationships with the oral fluid collectors and labs, whether directly or through your service agents.
  • It is a best business practice to have a standing order in place with each of your collection sites, so they know what kind of collection you want performed (i.e., urine or oral fluid) and when.
  • Designated Employer Representatives have always been required to be available to the collectors 24/7, but that is even more important now.
    • Ensure your phone number is correct on the CCF so the collector can reach you.
    • You need to be available to the collector to discuss if there are problem collections.
    • You should always be available to discuss standing orders on what type of test you want administered if problem collection scenarios arise (e.g., if an employee does not provide a sufficient urine specimen, do you want the collector to switch to an oral fluid collection?).
      • You can start with a urine drug screen and stay with urine or choose to move to oral fluid; or start with oral fluid and stay with oral fluid or move to urine.
      • We suggest oral first and if dry mouth, then switch to urine
    • If there are no standing orders AND collector cannot contact the DER, the collector makes the call on which type of specimen to collect
  • It is the employer’s duty to determine whether a refusal has occurred at the collection site. Employers have never been able to delegate this duty. So, a collector can tell you something appears to be a refusal, but the final determination is yours.

Remember, if an employee does not appear for a pre-employment drug test or leaves the collection site before receiving a cup (for a urine collection) or unwrapping the device (for an oral fluid collection) it is not a refusal.
  • You could be subject to either an oral fluid collection or a urine collection for any DOT-regulated test [i.e., pre-employment, random, reasonable suspicion/ cause, post-accident (other than FRA [1]), return-to-duty, or follow-up].
    • If there is a reason a second collection is needed during the testing event, (e.g., initial temperature out-of-range urine specimen, or insufficient quantity for either an oral fluid or a urine specimen), the employer may choose to change to the other type of collection to finish the testing event.
  • The choice of whether to conduct an oral fluid or a urine test is up to the employer.
  • Substance Abuse Professional (SAP) evaluations may be conducted remotely (additional detail under the SAP section below).
  • For an oral fluid collection, if you receive an expired device, you must reject the specimen for testing.
  • For an oral fluid collection, if the collector failed to enter the expiration date or was entered incorrectly in Step 4 of the CCF, the laboratory must reject the specimen unless the laboratory is able to determine the expiration date by inspecting Bottles A and B.  The laboratory will note the correct date and proceed with the testing process.
  • Labs must bi-annually provide DOT data that is categorized by DOT operating administration (FRA, FTA, FAA, PHMSA, FMCSA), test reason (pre-employment, random, return-to-duty, follow-up, post-accident, reasonable suspicion/cause) and specimen type (urine, oral fluid).
  • HHS requires use of FDA cleared collection devices when the device contains a buffered solution.

From Our Laboratory Q&A Session

Yes, we must have a combination of device and reagent approved.  It only works as a set and approved as a set (device and screen reagents).

Yes, it appears that this may not be an issue for a while though.  It appears only one vendor is close to having a product available and approved by the FDA

Our current device (Intercept) does not meet FDA requirements.  No vendor has an approved device and reagents at the approved cutoffs.  Every vendor must be FDA approved and for a panel of drugs which could be a multi-year process.  Fortunately, this has been underway for at least two years already.  Once we have the reagents and devices, the lab must recertify the collection device at each lab to validate even though the FDA has already done this.  It will take additional weeks to accomplish as there are specific rules for drug stability as well.

CRL has been confirming Immunalysis, Oral-Eze, and POCT devices for years.  I am not sure that other labs will do the same.  But this is for non-regulated testing which only requires CAP accreditation of the testing process.

Every lab will need to be certified by the NLCP to test federal samples.  Each device will need to certified to test and report for regulated samples

  • MROs are not required to undergo recertification training, but it is strongly suggested that MROs seek supplemental information about oral fluid testing by the time HHS certifies at least two laboratories to conduct oral fluid testing.
  • MRO staff (not just an MRO) may contact a pharmacy to verify a prescription that an employee has cited as a potential legitimate medical explanation for a laboratory-confirmed positive test.
  • MROs are permitted to un-cancel a test that had been previously cancelled by the MRO due to un-corrected flaws (e.g. the MRO did not receive a copy of the CCF, but later receives a copy of the CCF).
  • In the rare circumstance when an employee is not able to provide a sufficient oral fluid specimen after an insufficient urine specimen or vice a versa (shy bladder/shy lung), the employee would only be required to have a referral physician evaluation for the second specimen type attempted.
  • Remember, it is the employer’s duty to determine whether a refusal has occurred at the collection site.  Employers have never been able to delegate this duty.
  • Clarification of “Safety Concerns”
    • Cannot be recorded on MRO copy of CCF
    • Report must state specific nature of the MRO concern, such as “medications may have an adverse effect on the performance of safety-sensitive duties”
  • SAPs may conduct evaluations either in-person or remotely, with criteria for remote evaluations as follows:
    • Technology used must permit real-time two-way audio and visual interaction between the SAP and the employee.
    • Quality of the technology must be sufficient to allow the SAP to gather all the visual and audible information the SAP would normally observe in a face-to-face in-person interaction.
    • Technology must incorporate sufficiently robust security to protect the confidentiality of the conversation.
  • If you are an otherwise qualified SAP, you must abide by the geographic limitations applicable to your credential when performing remote evaluations.  You must not conduct an evaluation that exceeds your geographic limitations.
  • If you are administering a program for an employer (to include C/TPAs administering a program for FMCSA-regulated owner operators) in accordance with the employer’s decision about the testing methodologies to be used, you need to make sure there are agreements in place for both oral fluid and urine collections and laboratory testing.
    • While the employer may opt for only one methodology, oral fluid testing must be available for directly observed collections for transgender and nonbinary individuals.
  • Ideally, ensure there are standing orders from the employer and that the collectors know what specimen they need to collect for regular collections and for direct observation, shy bladder, and dry mouth collections.
  • Ensure you know the employer’s preferences and standing orders for regular and problem collections.
  • Designated Employer Representatives have always been required to be available to the collectors 24/7, but that is even more important now.
    • Ensure their phone number is correct on the CCF so the collector can reach you.
    • They need to be available to the collector to discuss if there are problem collections.
    • They should always be available to discuss standing orders on what type of test you want administered if problem collection scenarios arise (e.g., if an employee does not provide a sufficient urine specimen, do you want the collector to switch to an oral fluid collection?).
      • Can start with a urine drug test and stay with urine, or move to oral fluid drug test; or start with oral fluid drug test and stay with oral fluid, or move to urine.
      • We suggest oral first and if dry mouth, then switch to urine
      • Regardless, if the collector switches to the other specimen types in a dry mouth or shy bladder, they must use a new CCF for that specimen type, enter remarks from first attempt onto second CCF and destroy 1st attempt CCF.
    • If there are no standing orders AND collector cannot contact the DER, the collector makes the call on which specimen to use.
  • You must ensure the DER information is current or pen and ink changes.
  • Ensure that the collector’s phone number provided on the Federal Drug Testing Custody Control Form (CCF) in Step 1.G. connects directly to the collector and/or the collector’s supervisor, and not a general call center.
  • Employee ID on the CCF can be the individual’s actual Social Security Number, a unique identifier issued by the employer, a State-issued identification card number, a State-issued driver’s license number (including a CDL number) or any other State-issued or federally-issued identification number (must be CDL number and State for drivers regulated by FMCSA).
  • Acceptable to used expired ID issued by state, local or federal government as long as it has not expired for more than one year.
  • Since either a urine or an oral fluid collection may be required, ensure that either you or a coworker is qualified to collect either specimen type. If no one is qualified to conduct the alternate collection, contact the employer so the employer can make arrangements to have the employee tested at another collection site.
  • You must obtain training to proficiency in the operation of the particular oral fluid collection device you will be using; if you will be using more than one device, then you need to prove initial proficiency on each device.
  • Ensure that you complete the correct line on Step 2 of the CCF – ORAL FLUID.
    • “Subdivided” And Exp Date and Volume Indicator Observed boxes.
  • You must:
    • check the expiration date on the device or on the package containing the device and show it to the employee,
    • not use the device after its expiration date (this would be a “fatal flaw” and you will need to complete error correction training),
    • check “Each Device Within Expiration Date?” in Step 2 of the CCF after ensuring the device is within its expiration date, and
    • enter the Split Specimen Device Expiration Date in Step 4 of the CCF.
    • Need to do steps 1,2,4 (only device exp date) then 3,5 and the rest of Step 4
      • Expiration date is entered under “Received at Lab or IITF” under “Split Specimen Device Expiration Date”
      • Collector must keep copy one separate when writing expiration date or it will bleed through Donor info on Copies 2-4
      • Cannot cover expiration date on vials with seals
*** We know today that current labels will not work, so the collection vials must be bigger or the labels much smaller***
    • Training and certification will be  similar to Breath Alcohol Technician
      • Online on CFR procedures
        • May be stand alone or part of a Combo UDS/Oral Fluid cert
        • Need training and certification by device manufacturer
        • Must perform five mocks FOR EACH DEVICE used
  • For CFR Part 40 Training, we are trying to get our partner, Lifeloc to create a Combo Urine/Oral Fluid course and if not, we will find and offer one from another qualified source.
  • In the past, such device training was a simple online program provided by the manufacturer. If it is some other way, we will see if we can be certified to provide device training.
  • For observation of mock collections, we will complete an approved “Train the Trainer program.” No one will have been doing federal OF drug specimen collections for the required one year. All those we trained will be able to observe the mock collections after one year.

NOTE THAT DOT ORAL FLUID (OF) Collection Guidelines are not yet available.  We do know that it will not be combined with Urine Collection Guidelines.

  • Only one donor at a time
  • Pre-employment process does not begin until device is unwrapped (for point of refusal)
    • Switching to the other specimen after the first specimen does not allow for a new point of refusal
  • Visual inspection of mouth before Oral Fluid (OF) collection
    • Flashlight recommended
    • Offer employee to cleanse their hands prior to inspection
    • Ask to lift their tongue and separate their cheek from gum
    • Remove anything from mouth
      • If anything is in mouth or donor claims “dry mouth, “offer  donor to rinse (may swallow) 8 oz water.
    • 10-minute monitored wait time before OF collection
      • Collector provides/Donor selects a sealed /packaged OF collection kit
      • Review instructions with the donor for collecting the specimen
      • Show employee device expiration date,
        • Open the first page so as not to print through rest of CCF
        • Record date at bottom left of Step 4 of CCF under section, “RECEIVED AT LAB OR IITF”.
        • If expired, do not collect and follow outlined procedure for guidance from DER. They may have you do a Urine collection.
          • If you cannot contact the DER move to Urine collection unless
            • If employee identifies as non-binary or transgender, do not conduct a Urine collection, then stop the process document the case on remarks and dismiss the employee
          • Complete Step 2: Check “Oral Fluid”, “Subdivided”, and “Within Expiration Date” boxes
          • Employee inserts device into mouth
          • Collector instructs employee to remove when volume indicator shows adequate specimen
            • Allow 15 minutes to produce an adequate specimen once the collection device is inserted into the mouth
            • Insufficient OF specimen procedures and a decision was made to try another OF specimen instead of Urine.

*****NOTE OUR PRACTICE IS TO IMMEDIATELY SWITCH TO URINE, IF ABLE TO ********

  • Offer 8 oz water
  • Wait 10 minutes
  • Up to one hour wait time from end of 10-minute period to produce an adequate specimen
  • Employee must be monitored, but not by a collector
  • OR If employer standing order, switch to urine
    • Note that same process is to be followed if starting urine and switching to saliva
  • OF Dry mouth or Urine Shy bladder only based on second specimen attempt to be collected
    • If switching specimen type, only use and send in second specimen CCF and note in remarks the reason form change to another specimen type.
  • Suspect specimens – both specimen types go to the lab, even if different labs. Cross reference with LAB and Specimen ID in remarks.
  • For directly observed collections, if the same gender collector cannot be found:
    • If the employer has a standing order to allow oral fluid testing in such situations, the collector will follow that order.
    • If there is no standing order from the employer, the collector must contact the DER and either conduct an oral fluid test if the collection site is able to do so or send the employee to a collection site acceptable to the employer for the oral fluid test.
  • For direct observation collections involving transgender or nonbinary individuals, an oral fluid collection must be conducted.
  • Beginning with Subpart C of Part 40, new sections have been added and numerous sections have been redesignated (i.e., renumbered and reordered), including the Appendices, to provide a more easily followed flow for users of the regulatory provisions specific to oral fluid drug testing (see the Table provided in the “Background” section of the final rule).

You can view the final rule on ODAPC’s web site.

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