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.

To address the needs for reference materials to facilitate assay result standardization, a multistakeholder initiative, the Diagnostic Quality Assurance Pilot, has been launched to design, develop, and evaluate traceable reference sample materials (referred to as reference materials) to better provide molecular pathology laboratories with the means to demonstrate equivalent performance of LDPs and companion diagnostic IVDs for targeted cancer therapy. This Quality Pilot emerged from the Sustainable Predictive Oncology Therapeutics and Diagnostics working group, launched in 2013 by Tapestry Networks (Waltham, Massachusetts), which was composed of diverse stakeholders (oncologists, pathologists, patient advocates, third party payers, and regulators) for the purpose of designing a quality pilot to advance these goals (http://www.ta pestrynetworks.com/initiatives/healthcare/oncology-therapeu tics-and-diagnostics/diagnostic-quality-assurance-pilot.cfm. Accessed April 27, 2017). 176 The Tapestry pilot proposes that laboratories would be allowed to utilize assays that best serve the needs of their patients based upon performance, quality, clinical needs, and the test menus and volumes of that particular laboratory. It is not critical that laboratories all use the identical assay or test platform, provided that all are able to get the correct answer.