The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care

Kaul, Karen L.; Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri; Benirschke, Robert; Carlow, Dean; Funke, Birgit H.; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Murata, Kazunori; Pessin, Melissa; Press, Richard D.; Thomson, Richard B.

It is an understatement to say that the medical field is rapidly changing. Technology and new genomic data developed as a result of the human genome project are leading to an explosion of knowledge applicable to individual patient care; this is the promise of precision medicine. We must continue to innovate and integrate novel diagnostic tools, genomic information, and new treatments into clinical practice. Considerable technologic advances allow clinical laboratory professionals to offer new testing that provides more information than ever before and often within a time frame that allows rapid patient care and better outcomes. Next-generation sequencing (NGS) in genetics and oncology, MALDI-TOF in the clinical microbiology laboratory, and a variety of mass spectroscopy-based methods in clinical chemistry now allow precise and rapid testing with demonstrated improvements in patient care. It is often thought that when "laboratory tests" are done to reach a diagnosis, they are done with a kit or on a machine, but in fact, most are procedures done with the direct involvement of a laboratory professional or physician. Laboratory tests are generally not fully encompassed by a "test kit" but often start with the pathologist examining the tissue section, bone marrow aspirate, or gram stain and determining what additional information is needed to provide the clinician with the best scenario so that the patient can be treated most effectively. Often, clinical laboratory professionals lead the development and optimization of these approaches to improve care and fill a clinical need, and their involvement in the process helps ensure that the highest quality standards are maintained. Ongoing development of these novel methods is critical to medicine and must be done with the highest level of safety and accuracy, yet simultaneously addressing growing demands to lower the cost of medical care in the United States.