A higher standard
As our name suggests, we’re interested in continually leveling up. We see ourselves as catalysts — status quo isn’t for us. One ongoing push for our lab is through the National Laboratory Certification Program, the top-tier certification in the world of toxicology and drug testing. The NLCP represents a higher operational standard for clinical labs, and it will allow us to expand our capabilities and increase our impact.
Many folks who know the clinical lab space have heard of accreditations like CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists). CLIA is akin to a baseline requirement for any lab to perform toxicology testing. CAP accreditation comes with more stringent requirements for testing and results. It’s not a required credential but represents a step up from CLIA. The certification from NLCP is something like ten steps above that. It’s the highest level and a complex path to certification.
NLCP-certified labs are few and far between. There is currently only one in Oregon and 20 total across the country. They mean business. RTI International is an independent nonprofit research institute that manages the certification. From the RTI website: the goal of the NLCP is protecting the integrity of drug test results for federally regulated workplace programs through proficiency testing, inspection, and accreditation of forensic drug testing laboratories.
These laboratories are known as the “gold standard” in the drug testing industry.www.rti.org
How do they do that? In a nutshell, the process involves early audits of lab processes and documentation followed by a lot of back and forth with the accrediting body. They assess what we have in place and what needs to change to meet their strict requirements. That’s before we can even submit an application. The application submission is followed by proficiency testing and in-person walkthroughs. In the simplest terms, they want to ensure we can produce consistent, accurate results, and they want to see the documentation that demonstrates a repeatable process for achieving those results.
NLCP at Rize
This certification is in line with our value to walk the talk. As much as we already have our bases covered and could continue to operate with the same level of effectiveness, it’s just not our style. We bill ourselves as innovators and experts, and that’s more than just chatter.
In short, we’re building the lab to be better. We’re getting more specific about standardizing procedures that can help guarantee results within a certain range. This involves new protocols, better controls to prevent errors or re-tests, additional documentation and document control, and improvements to the testing methodologies themselves.
One tangible example of becoming a better lab is the addition of a new screening instrument. We added this instrument to help meet some of the requirements for the certification, but the benefits are providing immediate value. Screening is much quicker than confirmation testing and requires less complicated equipment. Depending on the substance, the new instrument can run 70–150 tests per hour. Compare that to 100 tests per day on our confirmation instruments — higher volume and a simpler machine.
This instrument is also capable of testing for substances in the blood, opening up the potential for new assays beyond what we’ve been performing with saliva and urinalysis. We’ve looked into adding more testing options in the past but didn’t have the bandwidth to achieve acceptable results in a timely manner and had to abandon our attempts. The push for NLCP has led to improvements in lab infrastructure and new expertise that put new types of testing within reach.
Opportunities all around
One of the most exciting opportunities is for our team. Pushing beyond what we already know requires some pretty advanced chemistry knowledge. By adding new team members with this expertise, we’re upping our collective capability and creating a place where everyone can share in the knowledge transfer. We think it’s especially exciting for new graduates and those earlier in their careers to have the chance to work in such a high-level atmosphere.
Along with the advanced knowledge comes a huge opportunity to expand our toxicology offerings. In addition to improving the tests we already run, we’re also able to develop new assays and even branch out into new areas beyond toxicology. Genetic testing, anyone? That’s just one possibility we’ve kicked around. We’re thinking bigger about what Rize Lab is capable of.
We’re becoming a better overall lab now even if we never apply for the certification — smarter, faster, more innovative.Silas Walker-Tjepkes, Chief Operating Officer — Rize Lab
Of course, perhaps the most important opportunity — and the reason we’re here in the first place — is the ability to better serve our community. We can offer better service to customers, more streamlined testing with more consistent and accurate results in less time. Even if we didn’t expand into new markets or achieve the official certification, Rize is still a better lab for having walked the talk so far. We’re already meeting new targets and surpassing specific requirements. We’ve gotten a taste of what we’re capable of and we’re turning up the heat from here.
Realistically, we’re looking at September or October 2022 before we’ll submit our application and likely an entire year after the submission before achieving the certification. We’re working with some fantastic, third-party consultants now to help prep for the application, and we still have a lot of learning ahead of us.
That hasn’t tempered our enthusiasm for the potential we see. As we dig deeper into technical documentation, we’re able to see more clearly why we’re getting certain results. How are specific inputs impacting the results, and how might we shift our own proprietary methodologies to account for these subtle shifts? The improved understanding translates to the ability to develop new tests faster and expand what types of testing we can offer.
We’ve been excited about the potential for a while, but the work we’re putting in now constitutes our official step into the realm of research and development. We added a toxicology-specific R&D role in 2021, and our advanced chemistry hire will add to this effort. Working towards the NLCP certification has stretched us in more ways than we expected. Though we’re still not ready to apply, we’ve already gained so much tangential knowledge. The more we learn, the more potential we start to see.