Mayo Clinic Labs @Work
Thousands of people in hundreds of different roles work at Mayo Clinic Laboratories. Mayo Clinic Labs @Work offers a glimpse behind the scenes into this busy reference laboratory, featuring staff from throughout the organization talking about what they do and why they do it.
I was a technologist in the cytogenetics laboratory at another health care organization. I was looking to advance in my career, and a friend suggested Mayo Clinic. I was fortunate to be offered a job working in Cytogenetics in the FISH Lab in 2010. My family and I then relocated to Rochester, Minnesota. I eventually went from a technologist into a quality specialist role.
At that point, I had been in a lab for 17 years and decided I wanted to switch to a business role. I then moved into an associate project manager role in Mayo Clinic BioPharma Diagnostics. In 2019, I transitioned into my current role as the quality and regulatory coordinator. In mid-November, I will have the opportunity to keep advancing my career as I transition to a project manager within BioPharma Diagnostics.
I don’t have a typical day. It varies a lot. I triage issues that affect the BioPharma team, including troubleshooting sample processing concerns, and providing support to resolve queries with the laboratories or other internal groups. I also work with our clients quite a bit. Many of the companies we work with have to qualify Mayo Clinic Laboratories as a vendor. So one of my primary roles is to work with clients to get their vendor management team the access they need to make that happen. I meet with them to review all the quality systems that Mayo’s Department of Laboratory Medicine and Pathology has, including information technology systems, how equipment is validated, and provide an overview of our test lifecycle process. In the past, we would typically have clients come on-site to do that. Right now, it’s all virtual, which is much more complicated. When the pandemic started, I had to create the virtual program from the ground up, which has been very successful. We have been able to virtually showcase our high-quality standards and systems.
BioPharma Diagnostics provides services that many other organizations are not able to. This includes project management, supporting research and clinical trial sample testing within Mayo Clinic Laboratories, and regulatory support. BioPharma Diagnostics, along with support from Mayo Clinic’s Department of Laboratory Medicine and Pathology and research core laboratories, provides services for clients that span both the clinical and research labs. For instance, we recently were able to support time sensitive testing where the sample started in the clinical lab and then completed testing in a research lab. This coordination between departments has opened more doors for our clients. Our team is also working to help bridge new diagnostics and therapies to patients.
I’m not sure many people understand that I have to be able to translate CAP (College of American Pathologists) and CLIA (Clinical Laboratory Improvement Amendments) regulations and how they compare to the pharma and clinical trial regulations. There are similarities, but they aren’t exactly the same. It’s important that I’m able to get pharma clients or researchers to see that the CAP guidelines do overlap with Good Clinical and Laboratory Practice guidelines. That’s sometimes challenging to get across, but it’s important for the work we do in BioPharma Diagnostics.
Overall, BioPharma Diagnostics has 500-plus projects in process at any one time, so prioritizing can be a real challenge. My role is to support the Quality program, however, I still am the project manager for a few of our complex testing projects. I also work with our Legal Department on regulations or privacy requirements that differ from the U.S. clinical trials. Samples coming from the European Union, for example, have different regulatory requirements. The review of these requirements is another step we have to take to work with our clients. We need to understand where samples are coming from to ensure that there is no downstream affect when processing samples at Mayo Clinic Laboratories. Those are the kind of logistics that have to happen for us to be successful, but most people have no idea how and where they get taken care of. In this case, I’m the one behind the scenes taking care of those things. Fortunately, I’m very detail oriented. That helps.
Representing Mayo Clinic and Mayo Clinic Laboratories is humbling and I always keep in mind that behind each sample, there is a patient. These patients are typically part of a clinical trial or involved in some type of research because they can’t get treatment anyplace else. Knowing that we need to do the best we can with each sample from each of those patients means a lot to me. I think sometimes people think of our department as just testing old research samples, which we do support, but this is a very small portion of our projects. We are working on a regular basis with pharmaceutical companies and clinical research organizations in an effort to advance new therapies for patients, who many times are very ill, to make a difference for them. Knowing that I’m helping to make the process run smoothly is rewarding, and I really like what I do.
As a national accounts executive for Mayo Clinic Laboratories, Paul Schneider helps to improve and advance diagnostic patient care by bringing Mayo Clinic Laboratories testing to many of the nation’s top health care systems.
As a national accounts executive for Mayo Clinic Laboratories, Kimberly Knight helps clients see and understand the importance of laboratory testing and how partnering with Mayo Clinic Laboratories on that testing can help them and their patients.