(5 minutes) Welcome and Introduction (Grace Williams)
Dr. Williams will welcome participants, introduce faculty, and provide an overview of the course agenda to set expectations and orient participants to the interactive components.
(15 minutes) Regulatory aspects of quality assurance (Grace Williams)
Dr. Williams will present an overview of key regulatory requirements relevant to quality assurance in the clinical laboratory. This section will review applicable CAP requirements, CLSI recommendations, and foundational principles of quality assurance in production environments. Knowledge checks using audience polling will be incorporated throughout to reinforce learning and assess understanding.
- CAP regulatory requirements
- CLSI recommendations
- Quality assurance in production
(30 minutes) Calibration and QC introduction (Grace Williams)
Dr. Williams will continue with a presentation focused on calibration and QC fundamentals. Topics will include the importance of calibrators, traceability, handling new reagent lots, calibration frequency, setting acceptance criteria, and documentation requirements. The session will also introduce best practices for selecting quality control materials, determining appropriate QC scheduling, and monitoring performance using Levey–Jennings charts.
- Calibrators including traceability, handling new lots, calibration frequency, setting acceptance criteria, and documentation
- Selecting QC material, scheduling QC runs, and monitoring performance
Case-based practical applications
(10 minutes) Break
(50 minutes) QC monitoring, troubleshooting, and recovering from out-of-control events (Aaron Geno)
Dr. Geno will provide an overview of quality control rules and practical approaches to QC monitoring across multiple analyzers. Through case-based learning and group discussion, participants will explore strategies for troubleshooting common QC issues, including zebra stripe patterns, drifts, lot-to-lot shifts, and supply chain disruptions. This section will also guide participants through conducting root cause analyses for nonconforming events, with an emphasis on practical application in clinical laboratory settings.
- Practical approaches to QC monitoring across analyzers
- Troubleshooting QC issues
- Zebra stripe pattern
- Drifts
- Root cause analysis on a non-conforming event
(10 minutes) Break
(50 minutes) Overview of quality assurance techniques (Jacqueline Hubbard)
Dr. Hubbard will present an overview of quality assurance (QA) techniques used throughout the clinical laboratory, including proficiency testing, instrument comparisons, linearity studies, delta checks, patient-based quality control approaches, and laboratory information system (LIS) rules. Participants will engage in case-based learning to identify quality issues and participate in group discussions focused on effective resolution strategies.
- QA techniques
- Proficiency testing
- Instrument comparisons
- Linearities
- Delta checks
- Patient-based approaches
- LIS rules
- Case-based scenarios on identifying quality issues
- Small group discussions on issue resolution
(10 minutes) Closing and Q&A (All)
The course will conclude with a facilitated question-and-answer session. Faculty will summarize key concepts, address outstanding questions, and reinforce practical take‑home messages for application in daily laboratory practice.
