LIMS validation for new lab
“A really effective drug testing program is about deterrence”Scott Stanley, Lead at UK-EACL
Our Industry Leaders series introduces you to Scott Stanley, Director of the University of Kentucky Equine Analytical Chemistry Lab (UK-EACL) who discusses the evolution of their new lab, and future plans for equine drug testing:
Scott, please introduce yourself
I am Scott David Stanley, I have worked in equine pharmacology and toxicology for my entire career. I am now the lead at the newly formed University of Kentucky Equine Analytical Chemistry Laboratory (UK-EACL) which was formerly the drug testing laboratory for the United States Equestrian Federation, and has been commissioned as the new drug testing laboratory for the Kentucky Horse Racing Commission.
In addition to my responsibilities at UK-EACL, I am Professor and have a research laboratory at the Gluck Research Center focusing on equine toxicology and pharmacology. I am also Director of the Small Molecule Mass Spectrometry Core facility for the University of Kentucky.
UK-EACL is gearing up to become a leader in the field of anti-doping control. We are ISO 17025 accredited, as well as fully accredited by the Racing Medication and Testing Consortium (RMTC) and is at the cutting-edge of technology. To date, an investment of about 2.5 million USD has been put into the laboratory. The new laboratory conducts ultra-modern anti-doping testing and applied research, and is committed to identify new emerging threats in horseracing.
Please can you tell us more about the UK-EACL collaboration with USEF and Kentucky Horseracing Commission’s Equine Drug Research Council?
Our new UK-EACL laboratory is a reference laboratory, covered under the new federal legislation (Horseracing Integrity and Safety Authority (HISA) as well as serving the local regulatory agency. I am also one of the members of the HISA subcommittee for Anti-Doping and Medication Control, as part of the new changes from state governance to federal governance.
We acquired the new laboratory from the United States Equestrian Federation (USEF) and conduct all their testing services. The UK-EACL is responsible for testing all US Equestrian drug and medication samples as well as those from the KHRC race dates. We also undertake emerging threats research and work in collaboration with the national and international bodies to ensure future needs are anticipated and met. Going forward, with the new federal regulations due, the UK-EACL is not only gearing up to provide the best testing support to our state, but also to be ready for the new regulations when they land.
A really effective equine drug testing program is about deterrence: We want to convince people that if they use a medication that’s inappropriate that we will detect it, and you know that will result in severe penalties or violations. The percent of violations for prohibited substances is actually rather low: about 0.1%. For therapeutic substance violations, it’s closer to 1%. So, we can see that people are being deterred from taking the risk.
How would you describe your experience in building a lab to test for future needs?
This new highly invested UK-EACL service lab has been built to accommodate a change in equine testing, and we are due to move in during Spring 2022. The role of drug testing in racing and competition (covered in this podcast) means that the new lab needs a wide array of new technology. The new facility allows for expansion, and with the new technology, is more progressive. 11,000 samples are processed in the lab, and this will increase.
Because we have the luxury of building the facility from the ground-up, it has the requirements built-in to accommodate a modern 21st century lab. Our team is now focused on introducing new equipment, new technology, new approaches to answer our technical problems.
I was fortunate enough to have been involved in construction of a new laboratory in California, the UC Davis Laboratory. This allowed me to take a lot of the things that I learned during that project, and apply them here at UK-EACL too. These learnings ranged from electricity and bench space, through validating the LIMS, and ordering instrumentation. Whenever you start a new laboratory, you often have an influx of start-up funds. I was fortunate enough to convince the university to loan me money to buy equipment, and I was also able to get our partners at Kentucky Horse Racing Commission and the Equine Drug Research Council to provide us some funds to buy new equipment as well.
I was able to start with a clean slate and set up the new laboratory with power, electricity, plumbing benches, ventilation, and data transfer, to be the most efficient it needs to be. There have of course been some challenges that have emerged – for example, when shifting techniques, the new instruments create huge data files. To overcome this, we used a much faster connectivity so that we wouldn’t be backlogged with moving data in the laboratory workflow. As we begin to focus our efforts more into proteomics, looking at proteins and peptides, and move into out-of-competition testing, we will slow down our productivity if we run into bottlenecks related to moving and processing data.
Conventional equine drug testing techniques have changed because drug potency has changed, leading to demand for higher sensitivity. Where the conventional testing used to be thin layer chromatography and immunoassay-based, it is now almost exclusively gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS). These analytical techniques allow us to see our target drugs at low parts per billion, in many cases even parts per trillion.
We understand you undertook a LIMS implementation and validation for the new lab. How did you find this project?
We were substantially affected by COVID, as it hit during our start-up year. Financially, it was very challenging to get things done. Like many organisations, we were shut down for a number of months, during which time we had reduced workload, reduced income, and implemented hiring freezes.
Further to this, we were mid-LIMS validation when COVID closed us down. We had just commenced the validation process on the LIMS when we had to send everybody home. Nothing in our project management plan allowed for this! So, we needed to change our approaches completely. This involved how we trained our teams, how we implemented new systems, and how we got our technology up and running to accommodate those shutdowns.
For a period of time, we ran half-staff because of social distancing requirements, as social distancing requirements meant we did not have the space to accommodate everyone on site at the same time. So, we ended up having to do the validation remotely with people off-site.
We were lucky to have already selected and invested in state-of-the-art equipment, which was definitely beneficial to us. Of course, data is at the heart of what we do, because we work in such a data-rich environment. This also leads to challenges such as where to store the data, how to process it, interpret it, and then make decisions based on.
Our LIMS implementation and validation was supported by Scimcon, our colleagues for 25 years or thereabouts. As the team is uniquely made up of individuals with laboratory backgrounds, it is easier to communicate our needs than it would be with someone that comes from a strict IT background. For example, If I talk about test-tubes, labels and barcodes, samples and aliquoting samples: they know what that means. It is not new to them as they understand the challenges of operating within a laboratory, and how critical it is that we are able to remain productive.
I’ve learned that working with outside consultants like Scimcon is incredibly valuable for us to get the end result. Realistically, if you think you can do everything yourself, you’re fooling yourself. There are certain things you just have to outsource. I need our suppliers to help us configure and implement our LIMS, whereas my internal resources need to be able to maintain the system, and keep it current and tested. These two skillsets are different, and I need both, at different times. I do not need to keep implementation skills on our team, but I do need to keep maintenance and upkeep skills as permanent fixtures.
Scimcon are problem-solvers, and that is all you can ask for, offering good support and consulting help. They can give us technical people when we need them, and management people when we need them. They can help us select and pick a LIMS product that is right for the now and the future. There are not many entities that bring that diversity and depth of industry experience.
I don’t know that many people would have even attempted to try and validate a LIMS computer system remotely. It was daunting and a lot of work on both sides – for us at UK-EACL and Scimcon – to make that happen. But we had some strict deadlines that we were working towards, and their ability and desire to help us meet those deadlines made that happen.
Can you tell us more about the plans for the Equine Biological Passport?
Looking forward, one of the plans on the horizon for UK-EACL is to supervise the introduction of the equine biological passport. The EBP project (Equine Biological Passport project) has been written into federal legislation, and sees the equine biological passport as a reflection on a human athlete’s biological passport which is used by the World Anti-Doping Agency in order to address medication and doping problems. The plan is to introduce a similar passport for horses within the horse racing world. The EBP is a biological test panel and not a physical booklet like a travel document.
The EBP program has been developing over the past several years as part of the racing industry’s effort to renew public awareness of equine safety, integrity and transparency. The project and aims to identify specific biomarkers that can detect drug use, and monitors those biomarkers over time. This allows us to detect drug abuse that occurs anytime in the horse’s development or during their performance career.
The program goals are aligned with both industry initiatives and stakeholder expectations, enabling distinctive separation for future drug violation versus inadvertent medication exposures. This program also aims to differentiate contaminations from human and non-human contacts, which don’t affect performance, and as a tool, it will enable us to rapidly identify new drugs and measure/monitor the physiological effect on the equine athlete. These data will be critical in differentiating between intentional doping and accidental contaminants, which can smear the industry reputation and damage the persona of the horse, the trainer, and the owner.
The focus of the (initial) equine biological passport project in 2019 was the investigation of the concept of protein biomarkers as an indicator of prohibited substance abuse. One benefit of this research program being moved to central Kentucky is the access to samples. In 2019, a large cohort of “baseline” samples, 196 specifically, were collected. Serum samples were collected from 67 yearlings from a thoroughbred farm in central Kentucky, and known to be untreated with any prohibited substances. In addition to these samples, another 480 samples were collected in 2020 and 2021 with the same parameters. A large cohort sampling has been pivotal, allowing us to establish a normal population distribution range, and providing data that will be used to generate the baseline for the Equine Biological Passport project.
How does this affect your plans for the future?
The EBP is one of the reasons we are doing so much work in the laboratory, and specifically the LIMS. We pull together our list of ‘should do’s’, and one of these is remote login.
The ideal situation for us is to be able to track the sample from cradle to grave completely, so we’d like that incorporated into our computer databases and LIMS system. Being able to provide a complete chain-of-custody is critical for us to be able to effectively prosecute any findings. This would track the sample from the moment it’s collected, combining remote, paper, and electronic logins once the sample arrives at the laboratory. It will enable us to expand the number of sites and locations that testing can occur at, not just at-competition testing.
So, the new lab at UK-EACL is at the heart of current equine testing, and mapping out the future of equine anti-doping analysis, as it evolves.
Scimcon is proud to support industry leaders like Scott Stanley in building a new lab and succeeding in implementation projects. Stay tuned for more content from our discussion with Scott, and contact us for more information about our services.