Pumping Up Profitability In Your Toxicology Lab
Dr. Daniel Sappington holds a Ph.D. in cancer biology from the University of Arkansas for Medical Sciences, and is currently a Toxicology Consultant, Lab Director, and Technical Supervisor for multiple laboratories. He assists labs that process a few thousand samples up to to as many as 40,000 samples a month.
We sat down with Dr. Sappington to learn more about the unique needs of toxicology labs, and how consultants like Dr. Sappington help these labs improve profitability, quality, and efficiency.
What is something that those of us not involved in toxicology testing might no understand about this area?
First of all, I find that those not involved in toxicology are always surprised at how prevalent it is.There are easily several hundred toxicology labs just in Texas! There’s a high clinical demand for this testing, most notably to help physicians monitor medication adherence as well as maintain drug levels within the therapeutic window (therapeutic drug monitoring).
Secondly, labs just getting started in this space consistently underestimate the difficulty of method development, designing quality control and assurance plans, troubleshooting, validation & compliance, and, surprisingly, profitability planning. Since this testing can be quite high-volume, profitability planning and a robust assessment of operations may provide significant benefit to the lab’s financial health.
Lastly, toxicology testing is high complexity testing, so it’s important that the technicians are specially trained and that the lab is prepared for inspections by the relevant accreditation bodies: CAP, CLIA and COLA.
What technologies are important in toxicology and how are they evolving?
Toxicology testing is based upon LC-MS, or liquid chromatography–mass spectrometry, which is a chemistry technique that combines the physical separation capabilities of liquid chromatography with the analysis capabilities of mass spectrometry. This application is already quite complex in and of itself. Adding to this complexity, there are several vendors in this space, each one with its own nuances in software, instrumentation, and data reporting. I’ve mostly worked with Agilent, Sciex, and Waters, all of which are fairly common platforms.
Over the past 30 years in LCMS assay development there have been dramatic improvements within the triad of essential performance metrics–sensitivity, specificity, and throughput. It’s hard to forecast exactly where the application is going, but one thing is clear, this space is evolving at a rapid clip and keeping pace will require Laboratory Directors to support their staff with updated training on new developments.
Why are you so passionate about toxicology and laboratory medicine?
Patients deserve impeccable data. They rely on the laboratory to provide trustworthy answers and we have to rise to that challenge. My roles in operations and toxicology consulting often push me to assist in method development, to troubleshoot LC-MS assays, or even to evaluate an assay’s profitability for the laboratory, but what ultimately gets me going each day is my part in patient care and safety.
What kind of advising are you doing on Clinical Lab Advisor?
Let me say first that I’m really excited about this new platform! From my vantage point, it accomplishes several important things for the laboratory community:
(1) There are, sadly, a lot of so-called “consultants” out there that have never even worked in a lab. A great thing about ClinicalLabAdvisor.com is that they’re interviewing candidates, verifying credentials, and, best of all, allowing labs who work with advisors to post reviews. All of this will lead to a more transparent environment for labs requiring help and advice.
(2) They’re making the process of getting quick access to experts a reality. Most labs simply cannot afford having in-house experts for all their platforms or functions, so I see ClinicalLabAdvisor.com really empowering these labs to up their game on their limited budgets.
(3) Lastly, it enables the most technically savvy laboratorians, those employed and practicing their skills full-time, to start earning a side income from consulting other laboratories.
The lab industry is changing in many ways, but new software and technology like ClinicalLabAdvisor.com has the potential to make us more efficient as an industry.
As for me, I’ll be advising labs on starting a toxicology lab, laboratory cost reduction strategies, LC-MS method development, QC/QA process development, LC-MS assay troubleshooting, validation and compliance, and CLIA / COLA inspection preparation. This is where the majority of my training and experience has been.
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Toxicology Consultant, Lab Director, and Technical Supervisor for multiple laboratories