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 CLIA provide for oversight of clinical laboratories by defining all aspects of laboratory operation, including the quality programs required for clinical tests, personnel requirements, and the validation requirements for LDPs. The CLIA certification of laboratories can be accomplished through several deemed agencies such as the College of American Pathologists (CAP) or the New York State Department of Health (NYS-DOH). These organizations provide operational guidelines and perform on-site inspections based upon checklists developed via consensus of laboratory experts, which include hundreds of pages of requirements and data points. Compliance with CLIA has been built into clinical laboratory operations, mechanisms for data collection, training, proficiency testing (PT), and test implementation. Laboratories are subject to unannounced inspections and must demonstrate satisfactory performance characteristics for any test offered to ensure that results are accurate. For testing not reviewed by the FDA, such as LDPs, laboratories must go through a rigorous validation process before offering the test for clinical use. Under CLIA, the validation data collected by these laboratories are subject to ongoing peer review. In particular, organizations with deemed status overseeing laboratories (such as CAP and NYSDOH) conduct rigorous peer-inspection using detailed criteria developed specifically for molecular pathology. Laboratories also participate in required PT to demonstrate assay quality, with interlaboratory data sharing and assessment (most often led by the CAP) that leads to ongoing broad improvement in LDPs.