No device is perfect; otherwise, we would all be using the same instrumentation! Every test can fail, and it will, if subjected to the right conditions. As laboratorians, we must define the testing process, identify weak points in the process that could lead to error, and take steps to detect and prevent errors before they can affect the patient.
This presentation will describe the new Clinical and Laboratory Standards Institutes EP23 Guideline, Laboratory Quality Control Based on Risk Management. We will describe risk management and discuss sources of error as well as quality control processes to detect and prevent errors. Together, we will develop a quality control plan using a simple, CLIA moderate-complexity device, fetal fibronectin. Learn how to better define your testing processes, look for potential sources of error, and learn to be proactive in mitigating risk in your laboratory.
After attending this session, participants will be able to:
- Define risk management.
- Examine common sources of error in the testing process.
- Identify the CLSI EP23 Guideline as a resource for risk management in the clinical laboratory.
- Develop a quality control plan based on risk management for a simple, CLIA moderate complexity device.
James H. Nichols, PhD, DABCC, FACB
Director of Clinical Chemistry
Vanderbilt University School of Medicine
Nashville, TN
Professor of Pathology, Microbiology, and Immunology
Vanderbilt University School of Medicine
Nashville, TN
Practicing Pathologists, Residents, Doctoral Scientists, Laboratory Managers, Bench Supervisors, Bench Technologists & Technicians, Point of Care Testing Coordinators and Nursing Managers, Students
