We Are Officially in the New Lab
Back in 2015, we started designing and developing our new laboratory. After repeated trial and error in the old lab, we knew EXACTLY what we were looking for. There was plenty of space, but the layout and instrumentation needed to be strategically planned. We wanted to expand our base hormone panel but needed a more sensitive LCMS/MS, so we set out to find the best one money could buy, using data instead of emotion to make our final decision. We then took these instruments for a test drive, using real patient samples and our own preparation method. First, we split urine samples into several plates, performed our own sample preparation method, and sent them out to all the big vendors. Then, we sat back and let the results compete with each other. We then purchased two Sciex 6500+ LCMS/MS instruments, an additional Thermo Scientific Vantage LCMS/MS, three liquid handling Tecans, and more. We even installed an in-house nitrogen generator system that supplies enough nitrogen for every instrument and process required in the lab, with additional built-in expansion (and we even have a backup tank for that!). We now have built-in automation and redundancy in every area of the new lab. Literally, every piece of equipment and every process in this laboratory has a back-up, which is used for clinical operations only. In fact, we have an entire lab dedicated to Research and Development that could serve as a back-up!
Unfortunately, we had to learn the hard way that Clinical Operations and Research and Development couldn’t coexist without dedicated instrumentation and staff. When it came down to making a decision on whether to use the instruments for R&D or clinical ops, clinical would win 100% of the time. R&D would make a little progress, but then Operations would need the instruments. R&D would then have to throw their work away and start over when they became available again. This vicious cycle went on for too long before we finally realized that we needed to split the two up, so we built the new lab with the intent of keeping everything in the old lab and turning it into Research and Development. We also decided to keep the CLIA license there and apply for another CLIA license in the new building, creating the added benefit of a fully equipped, licensed back-up lab should our current lab’s license ever become compromised. With the rapidly-evolving LCMS industry, regulatory compliance became very difficult to keep up with. For this reason, we have contracted a team of consultants to come in and perform mock inspections on a quarterly basis. These are former inspectors who specialize in this area and keep us informed of any changes that we may not be aware of. This also keeps us on our toes and ensures that we are always “inspection ready”. Having two complete, CLIA-licensed labs made the process of moving the operation a lot easier. The idea of shutting down the lab for a week to move simply wasn’t realistic, so we kept running in the old lab while building out, testing, validating, and correlating the instruments in the new lab. Finally, in February, we passed regulatory inspection and obtained our new CLIA license. We then started moving one process at a time, with the option of reverting back to the old lab if need be.
As of October 1st, we are fully operational in the new lab. Not only are we excited to be utilizing our new, state-of-the-art equipment, but we’re happy to be reunited with the rest of our Physicians Lab family! Beyond that, we’re already prepared for further expansion!