In the world of medicine, and especially laboratory medicine, new technologies with new and usually improved capabilities are arising far faster than we can keep up with them. Those new technologies sometimes revolutionize not only the field they spring up in, but also other, originally unrelated fields. Tandem mass spectrometry is a good example of this type of revolutionizing technology. Originally an instrument and test system considered a research tool, it’s capabilities have led the way to improving and standardizing newborn screening across the US (1). Because new technology can change the way we practice, we must always be ready and willing to learn about the newest technology. However, sometimes it’s difficult to walk that fine line between leaping ahead too fast and not moving ahead at all.
In the medical field in general, and especially in laboratory medicine, there are a lot of checks and balances in place. Many of these are instituted by national agencies and are in the form of the regulations and controls we love to hate so much. It makes sense that if an assay has the potential for putting a person’s health, well-being or even life in danger, the level of checks and balances in place to prevent harm becomes totally understandable and even necessary. However, we must be careful not to refuse to see new technology because it doesn’t fit the mold of our current regulatory environment. Sometimes in order to move forward, we must re-invent the regulations as well as the technology. A good example of this was learning to deal with and regulate electronic or equivalent quality control when instruments like the I-STAT (handheld blood analyzer) were introduced to the field. Regulations concerning equivalent quality control (EQC) continue to evolve with the advent of the newest guideline, EP-23 (2).
Occasionally there is an incredibly fine line between stifling innovation and having necessary and appropriate controls in place. The regulatory agencies walk this line routinely and often bear the brunt of laboratory ire for new regulations as they try to keep the public safe. It takes an astute eye and keen insight and understanding of not only the new technology, but also the purpose and design of the regulations to walk this line. It’s not good enough to blindly follow the letter of the regulation. We should also ask ourselves: What was the intent of this rule? Why is this regulation important and is there a way to make sure the new technology meets the regulation and/or the regulation can be re-invented to make sure the new technology does follow the intent of having that regulation in place? Next generation sequencing has been struggling to perform this balancing act since its inception, not only in the technical assay itself, but in the handling of the big data that it generates (3,4). We in laboratory medicine do not wish to sacrifice our ability to create and innovate, nor our need for safety and ‘do no harm’. When an innovation enters the clinical laboratory, how can we make sure both it and the regulations which monitor its performance are “ready for prime time”?
1. Jones PM, Bennett MJ. The changing face of newborn screening: diagnosis of inborn errors of metabolism by tandem mass spectrometry. Clin Chim Acta. 2002 324:121-128. PMID: 12204433
2. Malone B. A new approach to quality control. Clinical Laboratory News. November 2011. 37(11)
3. Editorial: Knocking on the clinic door. High-throughput sequencing for clinical purposes faces technical and quality challenges, but it’s worth it. Nature biotechnology 2012 30(11):1009
4. Gargis AS, Kalman L, Berry MW, et al. Assuring the quality of next-generation sequencing in clinical laboratory practice. Nature Biotechnology 2012 30(11):1033-36