CLIA Inspection: A highly anticipated day

As many of you know, we received our CLIA designation back in March of this year for our first CLIA test, the Clinical Exome Test. While this is not a catchy name with a clever acronym, it does a pretty good job of conveying exactly what the test is, I believe. What you may not know is that you do not get inspected by State regulators before you receive your CLIA and State certificates, you get audited afterwards. So, while highly confident in our data submission package for CLIA application, until you get audited, there is still a bit of doubt as to whether you are truly good enough. Similar to asking someone to marry you, when proposing, generally you are pretty confident in the response. But there is always that little bit of doubt…

So the day arrived for our audit and there was anxious anticipation regarding the process and what the final outcome would be. There would be a tour of the facility, interviews with key employees and then a review of our documentation and processes. First up, a tour of our facility. We are very proud of our facility. A lot of thought and preparation went into the design, architecture, and build-out and we believe it is a world-class facility for DNA sequencing. While leading the tour, I begin to wax nostalgic about how we got into the business, why we designed our facility the way we did, speak glowingly of our staff, and so on. Here is where we get our first detour from our plan. The inspector starts to ask about procedures and we think it best to bring in one of our technical personnel to explain the particular process. Let me say that this particular person did an amazing job with the inspector, who, as you might imagine, is not particularly well-versed in next-generation sequencing processes. Our technician took the time to explain the process, offer different scenarios, and patiently answer all of the questions posed by the inspector. This process took over an hour, which was not at all anticipated by us.

One of the biggest areas of discussion was around our LIMS system. Our partner for LIMS is GenoLogics and we did a great case study with them a few months ago. In essence, our inspector came away rather impressed with the amount of information contained in the LIMS and certainly our ability to track a sample completely through the CLIA process. Michael Ball is the CEO over at GenoLogics, and he and his team have been fantastic partners through the CLIA process, helping tailor their product to our needs. If you are in the market for a LIMS system for your lab, I would highly recommend giving Michael a call.

Once the lab tour and interviews were over, the inspector reviewed our paperwork and had a few questions for us before wrapping up for the day. Ten short business days later we had our inspection report, in which we were cited for only one deficiency which was rectified within a week and submitted to our State agency. We have been told anecdotally that almost all labs get cited for something during inspection, and the fact that we were only cited for one thing is remarkable. So thank you to everyone at Edge who worked long and hard to obtain our CLIA certification. For our customers, you can feel very safe and secure when you send your CLIA samples to Edge that they are going to a world-class facility with some of the best professionals in the business.