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.

The science of laboratory medicine has advanced dramatically in the almost 3 decades since CLIA was enacted, and updates and expansions to CLIA regulations could be useful. Additional resources, such as reference materials, and consensus practice guidelines would extend the quality framework that all laboratories and manufacturers utilize. For example, consensus guidelines that include such details as the target for percent allele frequency detectable, requirements for percent tumor cell content, what mutations and variants should be included, and sample types to be tested would be useful as a guide for assay validation as well as in standardization of the practice. Professional expert groups are already generating assay and practice guidelines. 69, 73, [172] [173] [174] [175] Ideally, clinical laboratories and kit manufacturers would utilize appropriate reference materials to help standardize the results obtained for any particular analyte regardless of technology platform or laboratory setting.