Clinical OMICs - Volume 3, Issue 9 - 30

(continued from previous page) The most important language in a technical environment is critical thinking and the context of the process (or procedure) in which it is used. Is it any wonder that the technical realm of testing has been exploding and exploiting the realm of software and digital technology to increase the sensitivity of the testing environment? (It's worth noting that CLIA does not address software, despite the fact that the majority of modern LDT's rely on sophisticated software to interpret test results.) This environment has been an attack on the elimination of human factors in the detection levels of genetic structure, as well as the esoteric factors that are causal to "bad" tests at the macro- (my term) or nontraditional-testing level. In this macro world, we must control such factors by being aware of and sensitive to their risks! This is done by applying critical thinking, the discipline of continuous critical reflection based on the sound science of thinking inside of the processes, methods, and procedures we create. In the quality world, critical thinking includes the following four activities: * Issue characterization and refinement based on risk (e.g., timing, urgency and impact); * Root cause analysis for verifiable cause(s) and validation of action(s) to be implemented; * Risk-based decision making, which is criteria-driven and based on the sound objective(s) to be implemented; and 30 Clinical OMICs September 2016 Figure 1. The white spaces in the systematic operations of an operation. * Risk analysis of (project) planning to identify critical areas of concern with risk factors identified in order to plan the right type of actions to eliminate, avoid, contain and mitigate risk/ consequences. Use Critical Thinking to Manage "White Spaces" and Improve Process Performance Incorporating these activities into your QC efforts is the first step toward gaining control of the "white spaces" in quality processes/procedures that are not controlled by a method validation, or a quality control sample, but rather by an IQCP. LDTs are the design components of such a regimen. Risk and probable thinking must work innovatively in a controlled manner to deal with quality events and design out the pitfalls of risk. Specifically, the risks brought on by the constraints, restraints, regulation, and requirements characterized by a method, procedure or process. Simply put, implementing a quality management process that's compliant with FDA quality system requirements (QSR) is essential to the success of test method development. Good laboratory practices (GLPs) and good manufacturing practices (GMP) deploy processes designed to consider what affects the white spaces; this is lacking in CLIA QC requirements. In a laboratory in the Greater New York area, I met with the CEO to discuss how to bring his R&D side in sync with his testing side regarding quality and regulatory considerations. He stated that his chairman and owner, a CLIA-phite, wouldn't allow it. He believes that the innovative character of the R&D group should not be impeded by the strucwww.clinicalomics.com http://www.clinicalomics.com

Table of Contents for the Digital Edition of Clinical OMICs - Volume 3, Issue 9