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.

Recent public documents have presented examples of specific LDPs in which the clinical validity of the test, the interpretation or use by clinicians, or the reproducibility of the laboratory data was questioned, raising concern about the safety and efficacy of this category of tests. 3, 4 Enhanced regulatory oversight has been proposed to help ensure laboratories are delivering meaningful, high-quality results to patients. However, additional regulations have the potential to slow innovation and to limit and delay patient access to novel testing that impacts their clinical care, as well as add redundant reporting efforts and significant cost. Expanded oversight of laboratories through a revised CLIA process has also been proposed (http://www.cap.org/ShowProperty?nodePath=/UCMCon/Con tribution%20Folders/WebContent/pdf/2015-cap-ldt-legisla tive-proposal.pdf. Accessed April 27, 2017). 5 In an effort to illustrate the need for and positive impact of laboratorydeveloped procedures on patient care, the following series of vignettes have been assembled. In each case, timely and highquality laboratory-developed procedures filled a key clinical need. The impact on patient care has been summarized. As possible, data describing interlaboratory comparisons are provided to demonstrate the quality of these LDPs, as validated and performed in accordance with CLIA. These examples also serve to highlight the quality efforts and interlaboratory comparisons that take place before LDPs are offered by laboratories for clinical use; these activities and data are often unknown to the clinicians who utilize these testing services. Table 1 provides a guide to the examples included and summarizes the impact of each assay along with key points about its utility.