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.
When I graduated from college, I didn’t know exactly what I wanted to do, but the idea of helping patients and being part of health care were of great interest to me. Mayo Clinic has a great reputation, of course, and I knew I wanted to work here, but I didn’t have a job lined up. My wife and I took a leap of faith, moved to Rochester, and I started applying. In the interim, I worked for a temp agency. As luck would have it, I got placed in the Clinical Microbiology Lab doing data entry. It was an eight-hour shift, and it only took me about an hour to do the data entry, so I was really bored. I sent an email to the supervisors to let them know I had a microbiology degree, and I could do other things to help out if they wanted me to. They asked if I wanted a full-time job. I said okay, and that’s how I started at Mayo Clinic. I’ve been here for 22 years.
I’ve had a number of roles within DLMP (Department of Laboratory Medicine and Pathology). First, I was a bench tech in the Clinical Microbiology and Toxicology labs. There reached a point where I thought I wanted to get into supervision, and an assistant supervisor position opened, but I didn’t even get an interview. I was pretty disappointed. A brand-new position had been created, though, called a quality specialist. Frankly, I thought it sounded dull, but my supervisor encouraged me to apply. I did, I got the job, and I’ve been in a quality role ever since. Obviously, my supervisor was right, and this was a good place for me.
Another new position was created a few years later called the division quality coordinator, and I was the first quality coordinator for the Division of Clinical Biochemistry and Immunology. After that, one of the Immunology labs split, and I decided to apply for the supervisor position of the new lab, the Cellular and Molecular Immunology Lab. Several years later, I applied for the quality supervisor position in Anatomic Pathology and was in that role for a number of years. Then the department created a new quality manager position due to continued interest by the FDA for a more direct role in regulating clinical laboratories. DLMP, in an effort to get ahead of that, created the quality manager position to be in charge of that area. I applied for and got the position. Since then, it’s had a name change to director of Regulatory Affairs. And that’s where I am today.
My core responsibility revolves around regulatory surveillance, keeping an eye on new requirements, and regulatory interpretation, as well as making sure we’re in compliance. I also handle the department’s regulatory strategy. My team does all submissions to regulatory bodies for our lab tests. What you submit, how you submit it, how you frame things, that’s a big part of the job. It’s one of the things I really enjoy — figuring out the best way to make these things work for our laboratories.
I do external outreach, too. For example, I work closely with the American Clinical Laboratory Association and, when it comes to pending legislation, I talk with people in Congress, at the FDA, and other industry partners. So a big chunk of my job is working with people outside of Mayo Clinic to try to influence significant policy that may impact us.
Mayo Clinic’s reputation is built on quality care. I help ensure that our clinical laboratories operate at the highest level of quality and regulatory compliance, that we are the best of the best, and we have the paperwork to show it. Even though I’m the director of Regulatory Affairs, I also co-manage Quality Management Services, so I still am very involved in the quality side of things, as well.
I think the thing people might be most surprised about with a regulatory affairs job is that it’s actually interesting. Ten years ago, if you told me I’d be working in Regulatory Affairs, I would have told you that was crazy because it sounds really boring. But it’s not. There’s a lot of strategy involved, and I get a lot of satisfaction in my job identifying win-win solutions, where our approach works well for the laboratory and accomplishes our goals.
The most challenging for me is when decisions need to be made, figuring out who we need to get approval from to make it happen. Mayo Clinic isn’t just a matrix organization, it’s a matrix of matrix organizations. Within all of the committees and subcommittees, keeping track of who needs to be involved in the decision-making process can be difficult.
When people ask what I do, I usually say that I’m a professional troubleshooter. I like doing that and fulfilling that role. But the other thing that brings me joy is that I work with an amazing team of people. We’re small but mighty; I have nine direct reports. I joke that my role is chief cheerleading officer. I encourage and enable this dedicated and talented group of experts I work with and then get out of their way. It’s fulfilling for me to see all they accomplish.
As director of Regulatory Affairs for the Department of Laboratory Medicine and Pathology, Shannon Bennett helps safeguard Mayo Clinic’s reputation for quality care by ensuring that its clinical laboratories operate at the highest level of regulatory compliance.
As a clinical laboratory technologist, Daniel Kronemann enjoys going beyond his day-to-day work as he explores new ways to enhance processes and systems in Bacteriology.