By Dan Ross
It has been two months since the Horseracing Integrity and Welfare Unit (HIWU) stopped sending samples to the University of Kentucky's Equine Analytical Chemistry Laboratory due to “concerns with the performance” of the facility.
Prior to that, the laboratory had been one of six drug testing facilities used under The Horseracing Integrity and Safety Authority's (HISA) drug testing program.
Since then, several key developments have unfurled amid limited public explanations.
HISA and HIWU announced that they have opened an investigation into the UK Laboratory's performance, alongside the university's own investigation into the matter.
In the same statement, the agencies announced that the university was conducting “an ongoing personnel investigation relating to Dr. Scott Stanley, the director of the UK Lab, and Dr. Stanley was not permitted to be in direct communication with the other staff at the laboratory.”
Stanley had told the TDN that he had stepped down as the UK Lab's director at the beginning of March and has been reassigned within the university.
The Racing Medication and Testing Consortium (RMTC) subsequently announced that it had suspended its accreditation of the UK Lab. RMTC accreditation is a necessity if a laboratory is to be among HIWU's stable of drug testing facilities.
When asked why the RMTC had suspended its accreditation, executive director Michael Hardy pointed to a code of standards which lists 10 possible considerations that might prompt the organization to take such an action.
The University of Kentucky then announced that it had hired Cynthia Cole as the interim lab director. Cole previously served as an associate clinical professor and director of The Racing Laboratory at the University of Florida from 2002-2006, then again from 2018-2023 when the laboratory closed.
The TDN spoke this week with Cole about these recent developments at the UK Laboratory, and about her role as the lab's acting director. The following has been edited for brevity.
TDN: What details can you share about HISA, HIWU and the university's investigations into the UK Lab's performance?
Cynthia Cole: I'm afraid very little other than I do know both are ongoing and both organizations are working very collaboratively, as are the laboratory personnel in the process of the investigations.
TDN: And what can you tell us about the HR-related investigation also in progress?
Cole: That I have even less information on because it's not really pertinent to my role. I don't know the status of it and have not had it confirmed that there is one ongoing.
TDN: Outside of HIWU and HISA, have other organizations stopped using the UK Lab to process samples?
Cole: Yes. The U.S. Equestrian Federation (USEF) has also stopped sending samples to UK.
TDN: What can you share about their decision to stop using the lab?
Cole: My understanding is they were briefed on the concerns that HISA had, and that was part of it. There were also issues with not meeting turnaround times and so the decision was made to use another laboratory.
One of my primary goals is to get the system back up and running and address any concerns that any of our clients had, including USEF, so that we can get them back to using the laboratory.
TDN: Do any of these developments call into question the legitimacy of any HISA/ HIWU related samples that were processed by the lab?
Cole: I think that it's possible that that will come into question. I think that is one of the main goals of the investigations, to determine if there is any reason to be concerned about any of the results returned to HISA and HIWU.
TDN: Do you know when light might be shed on that one way or another?
Cole: Just in discussing what we're providing to both of the investigation groups, I think it's going to be a couple of months before they are complete in their investigations.
TDN: What can you share about the RMTC's decision to suspend accreditation?
Cole: They provided the university with a letter of deficiencies and concerns that RMTC had with the laboratory. We have 60 days to reply to try to address those issues.
Currently, I am in the process of working with the university to address as many of those deficiencies as possible and hope to get an extension to that because some of them are rather extensive requests in terms of adding personnel, which of course in a university setting is not a quick process. But we are addressing each and every one of those concerns and hope to maintain accreditation with the organization.
TDN: What happens if you can't achieve the necessary fixes within the stipulated timeframes?
Cole: They proceed to full revocation of the accreditation. If that were to [happen], we would have to start very much from scratch and that can be a very laborious and time-consuming process. So, we really want to try as best we can to maintain accreditation so that we can focus on moving forward.
TDN: How hopeful are you that you will avoid revocation?
Cole: I am an optimist, so I'm going to say we will be able to achieve this. I think we've made tremendous advances in already meeting some of their requests and their concerns.
Some of them are simply a little bit more time consuming. So, I believe with an extension we can address almost all of their [RMTCs] concerns.
For example, I don't think it would make sense to repeat an external audit process until we finish overhauling our quality management system. And that's probably not going to be completed until the summer.
Hopefully they will appreciate that we're not trying to do it quick, we're trying to do it well. And that can take a little more time.
TDN: What have been your primary responsibilities since you've taken over as interim director?
Cole: We did have samples that we were processing for some organizations, the U.S. Equestrian Federation as well as the National Reining Horse Association. And so, the first goal was to try to make sure that those samples were finished and confirmations were done and that the clients were provided with those results.
The next really important goal of mine was to really help the laboratory address the requests by the UK audit, as well as the HIWU and HISA investigators, and make it very clear that whatever we can do to assist we needed to do.
Obviously, there are certain things within the laboratory information management system–which is the program that among other things tracks the chain of custody, sample analysis and results–that we can't change or alter until the investigations are complete. But we can work on improving and validating some of our screening methods and other processes once we get the go ahead.
TDN: Have your responsibilities also included firing and/or hiring personnel at the lab?
Cole: Yes, although the staff is the same as when I accepted the interim role. So, we have not let anyone go and nor has anyone left since I joined.
We are in the process of hiring a quality manager. [As] part of that new role, that individual will report, not to me, but to an external individual at a higher level within the university system so that we have that independence, in terms of any concerns that a quality manager may have in the process.
It can be obviously a conflict of interest for them if they have to report to the person who supervises them. So, in this case, we will remove that issue and have that person report to an external faculty member or university leadership.
TDN: Does that mean there was no quality assurance manager?
Cole: There had been, [but] that individual left and they had been unable to fill the role. [Though] I believe they did search several times.
TDN: What other key changes have you made or you seek to make that you're able to talk about?
Cole: I think one of the most important aspects is the quality program. And so, the external hire of a Quality Manager and instituting a quality management system was my first goal. And that very much aligns with what RMTC has requested of us.
TDN: In terms of things potentially not being done appropriately, are you able to elaborate?
Cole: No, I'm afraid I can't. That's part of the investigations that are ongoing.
TDN: If the UK Lab regains its RMTC accreditation, is it a given that it'll once again re-join HIWU's stable of labs?
Cole: I would not say that it's a given. I think that there has been a breach of trust for HIWU and HISA, and it will take some effort on our part to convince them that we are going to meet or exceed all of their quality expectations. We think that relationship is something that has to be earned and we don't take it for granted.
TDN: Will the university's own investigation yield a report that will be made available to the public at the end?
Cole: That's a good question. I don't know the answer to that.
TDN: Do you have any other comments that you think is important for the industry to know that I haven't asked about?
Cole: No, I would just reiterate that I agreed to take on this role as an interim director. I'm very committed to it. I don't want anyone to think that because it's interim, it isn't taken very serious by me. It's just not something that I want to go back and do full time.
I've been really impressed by the laboratory staff. They are extremely talented. They are extremely dedicated. The laboratory itself is incredibly well equipped and the university is very dedicated to rebuilding and establishing a trust within the industry, for the laboratory.
There is no reason that at some period of time-and I don't know exactly what that time period is-we should be a laboratory that will be state-of-the-art, second-to-none in the world.
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