HIWU Q and A On Lab Issues: We are investigating for “Non-Conformity Across the Laboratories”

Last week saw the Horseracing Integrity and Safety Unit (HIWU) and the University of Kentucky issue their reports into alleged misconduct and mismanagement at the university's Equine Analytical Chemistry Lab (EACL) under the leadership of former director, Scott Stanley.

The allegations levelled towards Stanley and the lab's operations include misrepresentation of its ability to test for specific substances such as erythropoietin (EPO), and the “intentional misrepresentations” of positive tests as negative.

Questions arising from operations at HIWU's fleet of contracted laboratories isn't confined just to the UK Lab, however.

At the start of September, the Racing Medication and Testing Consortium (RMTC) issued a 60-day accreditation suspension of the University of Illinois Chicago Analytical Forensic Toxicology Laboratory. At the time, the RMTC did not publicly undisclosed the reasons for the temporary accreditation suspension.

Just prior to that, HIWU said that it had granted a temporary stay of enforcement to connections in six pending total carbon dioxide (TCO2) cases, all of which are out of Pennsylvania, in order to conduct a review of TCO2 analysis at the Pennsylvania Equine Toxicology and Research Laboratory (PETRL).

More broadly, the TDN has also reported on lab variability issues arising from different facilities using different testing equipment, different testing methodologies, and different sets of staff interpreting the results.

To discuss the fallout from the UK report, the issues at the Illinois and Pennsylvania laboratories, and the topic of lab variability more generally, the TDN spoke Monday with Dr. Mary Scollay, HIWU's chief of science, and Ben Mosier, HIWU's executive director. The following has been edited for clarity and brevity.

TDN: Now the dust has settled a little into what allegedly transpired at the UK lab under the direction of Dr. Stanley, what are your main takeaways from this whole affair?

Dr. Mary Scollay: I think there's added emphasis on the verify, for the trust and verify. Harmonization is so important, and consistent performance across the laboratories is so important.

Ben Mosier: I think my takeaway from this is that we now have a system in place where you know there's one organization with more oversight over the laboratories, with the upcoming accreditation model that requires oversight and more communication and more working together.

TDN: There were so many alleged failures at the UK lab covering so many aspects of the lab's operations under Dr. Stanley that appeared to have occurred over many months. Why did it take so long to identify a problem?

MS: I think the short answer for me is that negative results are not subject to the level of scrutiny as the positive tests. Positive tests, they're subject to scrutiny through the B sample analysis, attornies will have their expert packets, and so, positives undergo tremendous scrutiny. Negative tests are pretty much accepted at face value. I think we have learned to be more rigorous with negative samples as well.

BM: Well ultimately, what triggered the investigation was just general unprofessional behavior with the lab and then some general reporting issues. They weren't requesting extensions for reporting. It was really performance based why we made the decision to move samples away from the lab. And it was after that, that we uncovered that the suspect EPO sample hadn't been analyzed. Obviously, the program had been up and running for roughly eight months before we even came to that point.

Now, the investigation itself entailed an extensive amount of data and information that had to be compiled. Ultimately, we had to go through every bit of that data to ensure that we were doing the most detailed comprehensive investigation that we possibly could have.

The sheer volume of the samples we had to go back and sort through as part of this investigation, I mean, we're talking about nearly ten-thousand samples.

TDN: Just to note, my question wasn't on why the investigation took so long. It was more about why it took so long to identify the failures in the first place. But I appreciate your answers here. Let's move onto Illinois. What specific issues led the RMTC to suspend its accreditation of the Illinois Chicago Analytical Forensic Toxicology Laboratory?

BM: We were informed of the suspension just like all the other clients of that laboratory on the same day. What they referenced to us was multiple violations of their code of standards.

We were made aware afterwards that there were several external quality assurance samples that were failed. We don't know if it was more than that–if there were other issues. Ultimately, it was left pretty vague in the reasoning.

We're working with Illinois to gather information and understand more of what we ultimately need to review and look into.

TDN: Those multiple quality assurance samples that the lab failed, by that, you mean single and double-blind proficiency tests, correct?

BM: That's correct.

TDN: How many is multiple?

MS: I don't think that was disclosed to us. it was mentioned elsewhere in the trades–I think three–but can't confirm that because that wasn't shared directly with us.

TDN: Do you know what the substances involved were?

MS: No. If we knew that, we'd know how many.

TDN: Okay, so what can you tell us about the sorts of substances employed in these quality assurance tests?

MS: They can be controlled medication and banned substances. There is a list of candidate analytics and that expanded tremendously this year as we prepare for HEAL accreditation.

TDN: What are you doing to ensure that the samples processed through the Illinois lab were handled correctly? Are you currently conducting an audit of the samples that have been processed by the Illinois lab, for example, like you did for the UK lab?

BM: The first step is to gather as much information as we can from the laboratory in terms of overall inventory of the samples that they have still retained, start potentially gathering instrument data, other types of information from the lab when they're assessing samples.

It's important to know, as Mary described earlier, that the adverse findings coming out of that laboratory have been under extreme scrutiny already, just because of normal process of adverse findings, right? There are legal teams, both the defense and on our side, that are looking at very detailed lab data packets both for A sample and B sample analysis.

It doesn't mean we might not go ahead and re-check some of those adverse findings, just out of fairness for the horsemen. If there are failed quality assurance samples, that's indicative of the need to look into failed negative samples conducted at that laboratory.

TDN: Are there similar personnel issues plaguing the Illinois lab? More pointedly, are you satisfied that lab director Brendan Heffron is capable and qualified to do the job?

BM: We have no indication of personnel issues. We've not had any personal challenges with behavior. Our working relationship with Brendan has been very professional.

TDN: The FTC recently overturned trainer Chris Hartman's case for an acepromazine positive after the labs the A and B samples were processed by both lost their RMTC accreditation (Hartman was originally suspended 15 days and fined $1,000). Do you expect, and are you prepared for, a number of other lawsuits challenging the findings of samples processed by either the UK lab of the Illinois lab, or both?

BM: I don't think we're expecting any new lawsuits–I mean, we've certainly been in communication with the cases coming out of those laboratories. I think all I can say to that is we're working closely with those cases and interested parties in those cases.

TDN: This is a question for Mary Scollay. When the RMTC's Horserace Testing Laboratory Committee (HTLC) voted whether or not to approve suspending the lab's accreditation, you abstained? Why?

MS: Because we are a client and I felt that a vote I cast in either direction could be perceived as having some bias, rather than simply an assessment of the scientific information in front of the committee.

TDN: What's the status of the pause in enforcement of the TCO2 tests processed by the Pennsylvania Equine Toxicology and Research Laboratory?

MS: I understand the horsemen are involved with investigating matters on their end. Likewise, we are investigating and undertaking some experiments on our end across the laboratories to determine if there is non-conformity across the laboratories, what the significance of it is, and to the extent that it might exist, how to remedy it.

TDN: What instrument was Pennsylvania using to conduct TCO2 tests?

MS: They are currently using a radiometer. And they are in the process of validating a method on a gas chromatography-mass spectrometry (GC/MS) Headspace.

TDN: What will you do if you find that covered persons were suspended through a flawed TCO2 test processed by the HIWU lab?

BM: I think we would have to work with HISA on what could be rectified through the situation. There's no other way around it.

I think it's important to say here, we have already conducted a review and an investigation, if you will, on questioning the TCO2 testing at the Pennsylvania laboratory. And we're comfortable with what they have provided us in terms of their own lab.

The exercise we're conducting now, which we think is the right thing to do and fair for the program, is to ensure uniformity and that deep samples would result in the same level, or have the same result, at all of the other laboratories

We are very comfortable with what the laboratory has been able to do thus far–we're just taking it an extra step to ensure fairness.

MS: To be clear, the data packets from the laboratory has been reviewed with no evidence for error, aberration or inconsistent analytical approach.

TDN: Would the lab packets show if there was a problem with the instrument itself?

MS: A component of performing the analysis is using internal calibrators at known concentrations. And so, if the result of one of those internal calibrators doesn't meet criteria, then you know that you do have a problem with the Instrument.

TDN: Do you have any concerns with any other areas of the Pennsylvania lab's set-up? For example, you've both talked publicly about how different labs are equipped with different testing instruments, some older, some newer. Are the instruments the Pennsylvania lab uses to test either the blood or the urine as technically advanced as, say, the Maddy Lab at UC Davis?

MS: If you're asking if I've done a one-on-one comparison across the laboratories with respect to instrumentation, the answer is no I haven't. But the lab has a strong research division. They're on the cutting edge of a number of fields, and they have the instrumentation to support that. So, I have every confidence that their instrumentation meets the requirements of the industry.

TDN: Has the Pennsylvania lab ever failed single or double-blind proficiency tests since the advent of the ADMC program?

BM: Not we've been made aware.

MS: Off the top of my head, I don't recall. The lab is required to disclose to us [if they've failed such a proficiency test]. I don't have those results in front of me.

TDN: You've stated that HISA's new Equine Analytical Laboratory (“HEAL”) accreditation begins early next year. How will that program differ from the RMTC's accreditation program?

MS: I think what we've learned is to put more emphasis on negative samples. The passed sample exchange–and that has already been expanded per HIWU's request to the RMTC-but the passed sample or negative sample exchange occurs every month where the labs are assigned a certain number of samples to send to another laboratory. This lab screened a negative, and they're being sent to another laboratory to undergo screening.

This is one of the ways that we can double check on our negative samples. It allows us to see if we have inconsistent sensitivity at screening for certain analytes. That's being done on a monthly basis.

In the past, it was not a component of the RMTC accreditation program. Labs did it between themselves without disclosing results to their clients. And because we are directing it, we can instruct which laboratories are sharing which samples with each other. So, it can certainly be a round-robin way of checking all of the labs in a systematic manner.

TDN: Will the RMTC still have a role in the accreditation process?

MS: They'll administer the external quality insurance program under our direction. We will select the analytes and they will handle the mechanics of procuring external quality assurance samples, circulating them, and receiving the information from the laboratories when they report.

All of that information then will come to us, we will perform the assessment, and our lab expert group will establish the criteria for acceptable corrective action plans if there's a deficiency. This will also allow us to identify not just deficiencies but best practices, so, if we see someone who has more efficient approach to a specific analyte, we can require all the labs to adopt it.

TDN: If you could start the ADMC over from scratch, would you do anything differently when it comes to your selection of laboratories, and what you've required of them?

BM: If I think of individual laboratories, it's hard to speculate any different. We were certainly in a position where we were working closely with Dr. Scott Stanley. He was on the ADMC committee. As we worked towards May 22, 2023, we had every reason to believe that that lab was going to be a great laboratory under the program.

All of the other labs were very compliant that we ended up signing agreements with, have been able to handle the volumes we send them. Now, just more extensive quality assurance measures has uncovered some deficiencies it sounds like at the Illinois laboratory specifically. But the Kentucky lab situation was less about that and more about deceitful behavior.

So no, I'm not sure much could have been done differently. We approached it to the best of our ability, and put a very thoughtful strategy into how we selected the labs.

TDN: Final question, if cost was not an option, what would your ideal set-up be for American racing? One primarily focused on a single centralized laboratory?

MS: Last year, I was in Hong Kong for the international conference of racing analysts and veterinarians. One of the talks was on a laboratory in Australia and they discussed the design of a new building holding their thirty six—thirty six—liquid chromatography mass spectrometry (LC-MS) units.

I sat in the audience and I wondered how many of our labs do we have to put together to come up with thirty LC-MS or GC-MS units.

The international community has got so much more money to apply to research and innovative testing and exploring specific samples that show elevated concentrations of testosterone.

Money is no object? That's not achievable. The industry is going to need to recognize that to combat the doping which is I think the largest concern within the industry, a lot more resources are going to have to be directed to the laboratories.

The fact now that we have laboratories cooperating and collaborating means that we can establish centers of excellence so different labs are working on different areas of research interest, that we're not getting redundant efforts, and instead we can really dive into and solve some of those problems that we believe are out there–ones we have not yet had the resources or the opportunity to address.