2015 AACC

Using CLSI EP19-A for Assuring Quality Throughout the Life of a Clinical Assay: From Conception and Validation to Verification and Maintenance-72216 (Room Georgia World Congress Center - B310)

27 Jul 15
2:30 PM - 5:00 PM

Tracks: Evidence-based Medicine, Government/Regulatory, Guidelines, Lab Management, Quality Assurance

Speaker(s): Curtis Parvin, Manager, Bio-Rad Laboratories; Paula Ladwig, Mayo Clinic; Luann Ochs, Clinical and Laboratory Standards Institute

Moderator(s): J. Rex Astles, Centers for Disease Control and Prevention;

After this session, attendees will be able to: 1) describe the various steps that occur during “establishment” and “implementation” stages of a test method’s life cycle; 2) describe the critical elements of an assay validation; 3) explain how the same CLSI protocols that are used by commerical industry to produce reliable test methods are useful to clinical laboratories that develop them; 4) explain how checklists provided in EP19-A can help users to document how they demonstrate acceptable evaluations during each step of establishment and implementation; 5) explain the importance of following FDA's Quality System Regulation for LDT's and the relevant new tool available from CLSI; and 6) define opportunities for new approaches for statistical QC for maintaining quality of assays once implemented.