Beginning the process for establishing a clinical lab or POL can be an exciting time and it’s easy to start looking toward the future and what it promises. And there is nothing wrong with that. However, at Quasar, having experienced many lab installations, we recognize that our value, in part, is in moderating the euphoria of opening a lab. We value our relationship with our customers above all else and a large part of that value is to not misguide expectations. Therefore, we would like for you to read the following pages regarding our view of the reality of setting up a lab.
Your lab is called a high complexity lab for a reason and the process is a very complex one. It requires a significant amount of time, money and patience. From start to finish, this is not a process that can be completed in a few weeks or even a couple of months. In addition, there will inevitably be hiccups at one point or another. It is crucial to maintain realistic expectations and know that while you may get anxious at times along the way, once the lab is validated and running it will be worth it.
It should be noted that the development of a High Complexity Laboratory, initiating its own Laboratory Developed Test methodology, requires significant amounts of communication and coordination.
The real “complexity” of your new lab and the complexity of bringing it up is created by the fact that you are undertaking a “laboratory developed test”. The LC-MS is a scientific bundle of equipment rather than a clinical bundle. Therefore, utilizing this equipment in your lab requires you to demonstrate suitability for its intended purpose.
UDT definitive/confirmatory testing operates with some elements that are well-developed science and technology and some elements that appear to be almost alchemy rather than chemistry. For example, the master mixes created in the lab are necessarily imprecise. A 3% error tolerance for pipetting liquids in small quantities is generally considered excellent, but random errors are additive and 35 analytes becomes an issue. A 70 analyte panel is worse. A 100 analyte panel is, well, quite likely to produce some issues that will prove difficult.
There are at least two mechanisms available to mitigate problems in this arena: (1) work with multiple but smaller panels of analytes. This makes human error less likely; (2) automation/robotics can be utilized to maintain more consistent/accurate pipetting. This can make sense for some higher volume labs.
On a different plane there are issues of chemical interactions and detection ability. There are quite literally hundreds of drug compounds and their metabolites from which you will choose to test. Some WILL interfere with the ability to detect others. And while method developers typically have a fair idea of which compounds are more or less stable over time and which compounds tend to be known to interfere with others, there are literally 2^100 or 1,267,650,600,000,000,000,000,000,000,000 different combinations of only 100 compounds that could potentially interact in some way with each other.
Nope. No method developer can anticipate what any given unique array of analytes is going to do in terms of interactions. Happily, most of chemistry “plays well together.” Most of the time preliminary developmental runs will point to where issues are lurking. However, your lab will be truly developing its own test method when compounds are being put together by you and your Lab Director; method development is not a totally smooth process, nor can anyone guarantee that all of your desired analytes can be accomplished in a single method run.
As a point of possible interest, Quasar, if selected as your method developer, can often begin preliminary development work on your desired panel of compounds/analytes at our own facility in Colorado Springs on the same devices and using the same procedures that will ultimately exist in your lab. This will save some development time, but will not obviate the need for development time at your own facility with your own equipment.
If you are presently operating a laboratory at your practice, note that your experiences are most likely going to be different from the laboratory type you are now considering. Most physicians who already operate a lab are familiar with Chemical Analyzers. These devices are 510K FDA certified and require significantly less in the way of sample preparation or the actual running of the apparatus. For this new confirmatory lab component, your lab tech will be required to exercise substantially increased amounts of attention to detail and note keeping.
There is, nonetheless, a substantial element of good news in all of this:
The good news is that while it is generally true that 80-90% of new products and new enterprises fail, yours will almost assuredly succeed. It likely won’t happen quite as fast as one might like (not in just a few weeks) and it probably won’t happen without some of those hiccups and frustrations along the way. But, the LC-MS/MS system does work. Analytes can and will be detected. Outcomes can be reviewed and analyzed and your patients’ treatments can be initiated and altered as appropriate. Generally, these outcomes can take place more quickly and certainly with you having the ability to exercise greater control over your practice.