Patrice Kelly thoughts on DOT and oral drug testing.

Given at NDASA conference.

What I’m expressing are completely in my personal capacity about oral drug testing. My views have not been subject to the review clearance or approval by DOT And I’ll be able to tell a little bit of that. Cause I’m, I’m up and I can take off my DOT hat for a lot of these discussions as I’ve been doing with you. So my views have not been subject to review, clearance or approval by the DOT and they don’t necessarily represent the views of the DOT because again, now on the industry side, I’m looking at this more from a business perspective and trying to really see more of what you see. And already so many people have been educating me as you always have. So I thank you for that. 

DOT official capacity, NOT.

And yeah, webinars, podcast presentation. Oh my, you know, most of you know that, um, in DOT we don’t like our presentations video. And the last part that is litigation. If people want to come and sue over regulation or over one of your cases, you don’t want them pulling back up the DOT said in their official capacity at a meeting that you might, might not even good at. So, you know, we stick to our slides for the most part when we’re working with the DT and, um, you just don’t do these things. But now that I’m unplug, um, so I have been doing a lot of webcasts, um, two , one consulting, uh, for consulting. I actually did podcast. I’ve only ever listened to podcasts before. So that was pretty exciting and thank you the trusting for that. Um, and those recordings are available to all of you. And the trusting one is on Spotify. So that blew my mind too. , um, is this really loud? You can hear me okay. Okay, great. Thanks. 

So I spoke with Ron Legal at the Department of Health and Human Services last week where I communicated with him and I told him I was gonna be here and I asked him if he had anything he wanted me to share with you. And um, he asked me to tell you that there’s significant interest from labs wanting to obtain certification to conduct oral fluid testing. So while they don’t have anybody in there right now, fine, they, the labs are in communication with hjs and I understand from, from the last of the other day that it could be as late as the fourth quarter of this year or the beginning of next year before they actually apply for certification. And I think you might have heard that when, um, some of the other sessions were going on at this conference. But just so you know, there is communication going on and they’re working through the details. 

HHS verifications

So HHS is working with the laboratory adding application process to make sure everything goes smoothly. Um, Ron also asked me to let you know that once they do apply, it usually takes about three, six months to apply to approve labs and um, all the documents are final for the National Laboratory Certification program, like the collection, MRO guidance manual, like the collection guidelines, mro, guidance manuals, et cetera. So I gathered this information, I ran it by Ron, I said, this is what looks like, looks like we good with this. And he said yes. So I just wanna assure you all that, even though I am not currently in full-time government job per se, my lives of communication are very open with DOT, with hhs, with the various components of DOT. And I would be remiss not to acknowledge my colleagues from DOT who are here. 

Um, Chuck, Chuck Stevenson from the FFa Patty’s son from Federal Rails, Brian Price, Devin Eats, and other post from mc csa, Patrick man from the United States Coast Guard, Lori Nta from FTA Ion Sense, her regards, she’s ill right now. Um, COVID, so we are grateful she didn’t by that. But again, um, I ion’s, um, staff is here with Lori, so that’s very exciting. And um, pipelines, Juan Moya was here. But again, our family portrait, I just want to acknowledge those folks and say that, you know, our communications are ongoing, but it’s an interesting position not into it from being a lawyer. There’s things that people tell you that are confidential and you can’t share with anybody else. So there are things that Ron Legal conveys to me, I can’t tell anybody else. So Ron says, yeah, go ahead and put this word out. Same thing with , same thing with the mos and the same thing with industry. 

There are things you’ll tell me and it is not for me to distribute to the government, it’s from for my education. Also need to help you answer a question or problem ask. So again, it’s a unique position and I can’t think of a better employer. I mean the US Department of Transportation has given me the most phenomenal career and I started off pretty well with the Supreme Court of the United States and Senator Kennedy and State Department. But I have to tell you, DOT is the best. So Urban and Legends. Um, and again, you know, I’m not just gonna go over what have a podcast. This is totally different. This is not from the webinars, this is news. So DOT says we can now implement oral, we can implement or fluid testing for, as we all know at this point, it’s been drilled into everybody, not yet, okay? If just needs to certify two labs, why? Because if we have one lab, we have a non-negative result. What happens? Somebody may ask for split, right? If they ask for the split, then there’s no split lab available under part four as well. Test mandatory guidelines, state of law. So that’s why two. So each lab will be 

Allowed to use only the oral fluid collection devices. They are certified by HHS to use. So again, that’s why it is pen ultimate for the laboratories to be able to go in with devices and status by their needs that they’re gonna be able to work with. And HS can ensure do exactly what the devices are supposed to do and are fair and accurate in all ways. So no oral fluid collectors can be qualified to perform oral fluid testing under part 40. Why? Cause there are no devices.

Training

Guys, please don’t start training collectors. Please don’t do that. It’s not time yet. If you train somebody and then you can’t do their mocks for six months. Six months, what does, how does that reflect back on you for training them? And what if they go ahead and they start practicing and they say, well, they’ll train me. 

What does that do for bill’s liability ultimately? So yet we hold up a little bit. Train the trainer is potentially okay, that’s why you started the trainer training a lot fit. Um, but at any rate, so remember DOT is not gonna allow most of the devices that are on the market today for oral fluid collection. Why? Because that 20 little transportation Employee Testing Act 1999 says we have to have single device that subdivided in the presence of the donor or a single specimen subdivided in the presence of the donor. Most devices can’t do that today except for the need collection, which may or may not pose additional scientific issues. I’ve heard of the scientific community on that. Okay, Ms. There will no longer be urine directly observed collections. Whoa, I don’t know what I said in the webinars. Cause lot of people get unhinged on this. 

Okay? No, no, no, no, no. There will still be urine directly observed collections under, I don’t know what I said, but obviously I misled people or there was a liable bit of maybe selective hearing. But some people thought that we had eliminated in this final rule, direct observed collections. We did not, we added to section 40.67, but we did not remove that. The only situation where this would arise is the very, very, very rare circumstance where somebody is identified as transgender or non-binary. And some people have said, yeah, but what if they identify and they’re not really, and go ahead and give them an or fluid test. Well, if not really you gave them a test, you successfully completed the testing process, right? So again, for the few people who are gonna try to fake us out by saying that they are transgender and non-binary and aren’t, it’s worth giving them the oral fluid test to protect those individuals whose civil rights were on the line. ‘=

Oral drug testing and the DOT

Um, and actually I was truly grateful that, um, Admiral had, has said the other day that he noticed that provision and he saw the civil rights aspects of that. And as I cleared that provisions through the Department of Transportation, I talked to several offices specifically about that. And, um, oh, you know what I wanna ask in this room? How many people commented from. DOT on the oral fluid that proposed rulemaking? Keep your hands up for a second and then the agencies, can you all just raise your hands and Coast Guard kind of get a hand up and then I want people to look around the room. Please, all of you contributed to this rule. You can put your hands down now. Thank you. But all of you did. We listened to what you said. 417 comments. 

Of you with 17 pages, some of you with fewer. Um, but thank you for doing that. Do you see the differences? Do you see why I wrote a 200 page preamble? You gave us a lot of good stuff to chew on and we made changes. Said that Hey dt, you got this wrong dmt, where have you been? We paid for collection devices. Dmt, this is what you think that a oral blood test cost. Because that what Hs pull us at a cost. Well HHS and DOT doing the testing that you are doing. So again, when we go out, we ask you about costs, we ask you about frequency on things, we ask you if we’ve got something right or wrong. We love those comments coming back. 

Environmental medicine US a lot of insight of the team. So it was really, really helpful to have that public input. So I am really honored and humbled by being the lead author, but I am not the sole author And the people in this room who raised your hands, you either gave us food for thought, you helped us make changes or you reviewed it and said yay or nay. And those were the kinds of differences that people make that really bring it all together. We don’t work in the vacuum. So oral fluid collections, uh, this is also under urban Miss and legends. Oral fluid collections will be brought in half by employers and external collectors will no longer be needed. How many people in this room are DERs? 

Thank you. So we have a few of you. Are you doing collections inhouse? Are you doing breath alcohol inhouse?

Employers liability

I’ve got a lot of education from employers in the comment period and they said, I don’t want the liability. I don’t want HR involved in administer the test. And then on the other end of a lawsuit cause somebody claims to be discriminated cause we didn’t hire this person or that this HR person was involved in terminating our employee who had a non-negative result and the person from HR was also the collector. So a lot of employers brought up very interesting points, but there is somewhat of a panic going on out there that there will no longer be a need for external collectors. In some situations, an employer makes excuse to bring these inhouse. Well, for the same reason that they’re not already doing urine and breath collections inhouse. 

Post accident oral testing.

They’re probably not gonna do these inhouse. There may be exceptions for post-accident testing, but employers are gonna have to decide do they want to get their collector trained? Do they want to keep devices that have expiration dates on their shelf and make sure that the tests they’re administering, they’re administering with the device that’s not expired? Do they want to go through those details in order to be able to administer one test hopefully every year in their post-accident scenario? So again, it’s food for thought, but that is, this is your opportunity for those of you who are service agents to go out there to educate the folks who are your clients. Educate everybody right now. 

So first time in history, we’ve got two different methodologies, okay? And as I said, the change mindset is what I’m asking you for. I want you to start thinking about the fact that even if somebody wants to do urine only, they need to express that in writing. Am I saying every d r should write down a full policy all by themselves? Well, do you write your employer policies contract or do you somebody if your C do you help people with that empathy? And this is your business opportunity. This is your business opportunity. And I want you to think about it in terms of educate yourself. Work with your laboratories to understand what the benefits and drawbacks are of what they’re offering. You. Create the bundles that you want somebody to buy it. You want them doing oral fluid for post-accident and reasonable suspicion. But you want all of your clients to be doing urine for pre-employment. 

Put it in writing. Have the employer sign off on it. And then that way, you know, whenever a question comes in from a collection site or whenever a collection site gets one of your clients, everybody’s on the same page. Don’t you understand this is your opportunity to write that page And this has never been that way before. So this is choices for laboratory, yes, existing or future. Your clients are awaiting the word from you who offer oral protesting. No advice are you gonna use it or not. And that’s something that laboratories are exploring now. I went around to the exhibitor hall and I hope everybody here goes at every conference through entire exhibitor hall because for those of you who’ve known me for years, you know I even go to the folks who don’t do do testing cause I wanna learn. It is even how I learned about oral fluid. So go around and ask the question. See what the laboratories are going to do. When the laboratories decide what they want to do, then they’ll be able to explain it to you. Will they turn separately through the devices or include them in the cost of each oral fluid test? When they apply to the N L C P program, will they let the clients know that the testing is 

On the Verizon or just wait until it’s approved? Again, mindset choices. Think about it. And so what’s the gonna be used? That’s the big question for all of us. For collections, for labs, for collective training, et cetera. Have you started thinking back your standing order, AKA instructions to your collectors? You’ll need to instruct your collection size directly or through the cpta and what type of protect you want. You what kind situations? Again, your employers, even if you’ll know up my methodology, he needs to be clear about that. Cause you don’t want a collection flip to an oral fluid test cause that’s what they’re used to doing. And you don’t want oral fluid or vice versa. You don’t want your, are you interested in implementing your oral fluid testing for your employees? Think about it.

Oral drug testing why or why not.

Why or why not? Because people are gonna start asking you and you want to know the answer to the ER as to what your thoughts are. Are you working with the C TPA or do you directly contact with the lab for urine testing? Then talk to the lab about the possibility of your decisions and your choices. Choices. Do you wanna use external collectors to perform fluid collections or do you want train your staff as we discuss liability issues? Perhaps are you doing it right now or you already set up to do it? And again, I know I’m time. 

Sure like a minutes down. Two minutes. Two minutes. Okay, so I’m gonna zip through the rest of this. Um, but again, I wanted to approach this more from the business end, especially third parties administrator. This is a business and marketing opportunity like you’ve seen never before in the last 32 years. When did you stop and really talk about hey, we need to discuss drug testing, your drug testing, and what products I have for you think for all of your clients at the same time? You’re welcome. So start now before the post, before the post certification probably begins, talk to them now, say, I dunno what last we’re gonna be using, but these are the pluses and minuses. Start to design your sample standing orders. Put yourself in the driver’s seat, thank you for my cover. Uh, put yourself in the driver’s seat and make sure that you’re telling your clients what you think is that for marketing your clients, what you recommend for each test head, what you recommend for the broad or collection, developing your standing orders in a way that lowers costs and maximize efficiency. Again, you know, funneling, if you’re selling only this type of testing for pre-employment, you’re probably doing a better pricing and try to probably get better pricing available to your Clients.

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So again, thoughts, food for thought. We are going lead an employer policy to describe what’s going on. And once labs are certified, you can establish contacts and business to marketing opportunity. Collect your trainings, how are you gonna, um, best the business choices for trader. How are you gonna prepare for this? Well, in essence, you can’t qualify your collectors until we’ve got the devices. Do you want to offer or fluid? If not, then it needs to be clear. That needs to be expressed to the collectors. And again, 3, 2, 1. Um, so I want thank you all over time. I’ve been dying to talk to you and thank you so.

The screenshots of the presentation.