by Bill Current

This information is provided for educational purposes only. Reader retains full responsibility for the use of the information contained herein. 

This is an exciting time to be either a provider or user of drug testing. Consider the following:  

• On February 28th, the Department of Transportation (DOT) issued a Notice of Proposed Rulemaking (NPRM) for oral fluid drug testing, essentially endorsing a drug testing method other than urine for the first time in 30+ years. 
• The industry is finding innovative ways to address and overcome its biggest threat in three decades—marijuana legalization. It turns out, testing for marijuana is still legal in virtually every state. 
• New collection methods such as telehealth apps are making it possible for employers to get specimens collected even when traditional methods are unavailable. 
• And there are some new and intriguing screening methods, including fitness-for-duty testing, that could someday change how both providers and employers address substance abuse in the workplace.  

During my 30+ years in the industry, I have witnessed countless companies introduce new drug and alcohol testing technologies, always with the promise of being the next “big” thing. Rarely does the hype match the reality, but sometimes it proves to be real. If you consider lab-based urine drug testing as “square one” for drug testing technology and everything else as the next big thing, some products that were once new to the industry are now commonplace. For instance, rapid-result devices for both urine and oral fluid were once on the proverbial “cutting edge” and today they are cutting into traditional testing’s market share. Hair testing was once hailed as the next big thing and today it’s the real thing. 

Without a doubt, the biggest winner is lab-based oral fluid testing. Today it is the only recent-use detection screening method endorsed by the federal government. DOT’s recent NPRM for lab-based oral fluid testing is by far the most significant development in drug testing since the enactment of the Omnibus Transportation Employee Testing Act of 1991. 

There are many things that can make or break a new testing methodology. Chief among these factors is what state drug testing laws say. Most state drug testing laws were enacted long before today’s newest testing methods were even imagined. Drug testing providers and employers can apply a simple six-question test with a nod to state drug testing laws (as well as federal government regulations) to determine if a new product is a legitimate contender or just another pretender.  

1. Does the product actually exist? This seems obvious, but a lot of new products appear on the scene as little more than a concept. And as great as a concept may sound, all 50 states require employers to use legitimate, existing products to screen applicants and employees. 
2. Does the product actually work? State laws only permit the use of drug testing methods that work and have a proven track record of success. So, once you confirm that a product exists, make sure it can do what its seller claims it can do. Ask to see all claims in writing. Never solely rely on the manufacturer’s marketing materials, check it out for yourself. If the product is real, they will have no problem offering you a pilot program with no obligation to buy. State laws only allow employers to test applicants and employees with the highest possible quality processes and methodologies. 
3. Does the product have approval from the federal government?  Whether lab-based or rapid-result testing, many state drug testing laws specifically refer to federal government approved methods and processes. For instance, many states only permit the use of FDA-cleared collection and testing devices as well as assays. Many states also require the use of laboratories that are certified by SAMHSA or another legitimately recognized certifying organization such as the College of American Pathologists (CAP). Currently, SAMHSA only allows laboratories to be certified for urine and oral fluid testing (and oral fluid testing is still in the developmental stages). This is an important distinction if you are considering using a method that will either be screened or confirmed at a laboratory. How will you know what procedures a lab uses if there is no SAMHSA-approved method that the lab must follow? Also, when a manufacturer says their product meets all the qualifications for FDA clearance it usually means their product does not yet have FDA clearance. 
4. Is the specimen legal to use for workplace drug testing? The only drug testing methods specifically mentioned in and permitted by most state drug testing laws are urine, oral fluid, and hair. There are some state laws that refer very broadly to “bodily specimens” but at the same time require employers to only use a SAMHSA-certified lab or to adhere to drug testing procedures from either SAMHSA or DOT (which are based on 49 CFR Part 40). The only specimens currently covered by Part 40 are urine and oral fluid. But even if a state drug testing law does not specifically stipulate which specimens can be used, the highest level of legal defensibility is to follow the federal government’s gold standard—49 CFR Part 40.
5. Are there satisfied customers already using the product? Can a new product already have customers? Maybe not, but there should be pilot programs in place in industries with the same needs and challenges as yours. No state drug testing law makes this a requirement, but many state business organizations and trade associations, as well as local unions will provide guidance to their members to help them make smart business decisions, and that advice almost always errs on the side of caution when wandering too far from the requirements of applicable state drug testing laws.
6. Is it practical? When you familiarize yourself with all the requirements of applicable state drug testing laws you will quickly realize that the “how” of drug testing is almost always dictated in great detail by states. For instance, many state laws require employers to follow very specific processes for collecting a specimen. Can the original specimen be split into two specimens to accommodate confirmatory retests? Can the original sample be confirmed at a laboratory if a rapid-result test is positive? Are there national proficiency standards for collectors who will deal directly with donors?   

 Outside of state laws, other practical things to look for are the cost of the test and how it compares to existing testing methods, the time it takes to collect a sample (which may affect downtime and productivity), the type of result the product renders (qualitative vs. quantitative), and whether a positive result can be used in a court of law to defend an employment decision your company made based on the test result.  

49 CFR Part 40 

The gold standard of drug testing is the federal government’s 49 CFR Part 40. All employers mandated to conduct workplace drug testing, including government agencies, must comply with Part 40. It contains very detailed guidance on how to do everything from collecting a sample to verifying a result to how to store drug test results. Even in non-government-mandated situations, Part 40 can serve as a guide to help employers develop the most legally defensible program possible. 

A number of states with either mandatory or voluntary drug testing laws defer to Part 40 and require employers to follow those regulations when conducting drug testing in their states. And many aspects of Part 40 can be applied to non-government endorsed testing methods such as point-of-collection/rapid-result testing, which is currently not permitted by DOT, for example. 

Drug testing is necessary for many reasons. Drug testing the right way is critical. To the extent possible, employers should employ as much of Part 40 as practical when designing their program.   

Final Point 

In the end, you must do your own research. There is too much riding on each drug test to rely wholly on what someone else says. Here’s a quick three-question test you can apply to help you decide about using any new technology: 

1. Is SAMHSA likely to issue guidelines for using this technology, thus making it part of 49 CFR Part 40, in the next 5 years?  
2. Is DOT likely to allow covered employers to use this technology sometime in the next 10 years? 
3. Are existing state drug testing laws likely to be rewritten to specifically allow the use of this new technology? 

The answers to these three questions help form a perspective for how the new technology may be used and the scope it might offer the industry.  Is it easier? better? cheaper? Or is the return on investment so overwhelming that it makes sense because of the help it provides?     

This is a unique time in the history of the drug testing industry. There is so much to look forward to for both providers and employers. The old adage, “look before you leap” is good advice for these times… but be ready to leap. Oral fluid testing, telehealth collection apps, and fitness-for-duty screening may be just the beginning of a brave new world for employee screening. 

© 2010-2022 The Current Consulting Group, LLC – No portion of this article may be reproduced, retransmitted, posted on a website, or used in any manner without the written consent of the Current Consulting Group, LLC. When permission is granted to reproduce this article in any way, full attribution to the author and copyright holder is required.