Quality control is performed daily in every clinical flow cytometry laboratory, yet routine instrument and reagent checks may not address the pre-analytic and analytic variables that influence patient results. Regulatory expectations for monitoring the complete analytic process are frequently misunderstood.

This continuing education webinar reviews the regulatory and consensus-standard framework governing full-process quality control in United States clinical flow cytometry laboratories. The session outlines the relationship between CMS oversight, CLIA regulations (42 CFR Part 493), and CAP accreditation. It then examines the CLIA requirement to monitor “the accuracy and precision of the complete analytic process,” the corresponding CAP Flow Cytometry Checklist items evaluated during inspection, and how CLSI H62 translates these requirements into documented laboratory practice. Common gaps between routine QC activity and full-process monitoring are described. Regulatory citations are provided throughout so participants can review primary source language directly.

Learning Objectives

At the conclusion of this webinar, participants will be able to:

• Describe the respective roles of CMS, CLIA, FDA, and CAP accreditation in establishing quality control requirements for US clinical flow cytometry laboratories.
• Differentiate full-process quality control from instrument-only analytical QC and from laboratory-developed test (LDT) validation in terms of which steps of the testing workflow each does and does not challenge.
• Explain the CLIA requirement at 42 CFR 493.1256 to monitor “the accuracy and precision of the complete analytic process,” including the individualized quality control plan (IQCP) alternative.
• Identify the CAP Flow Cytometry Checklist requirements for daily full-process controls in qualitative and quantitative assays, and how CLSI H62 guidance addresses them.
• Compare the strengths and limitations of patient-sample, in-house cell-line, and commercially available assayed process controls relative to the requirements discussed.

Register for "Full-Process Quality Control in Clinical Flow Cytometry: Regulatory Requirements and Practical Implementation" here