შიდა ხარისხის კონტროლი, Westgard-ის წესები და EQA [L-07]

შიდა ხარისხის კონტროლი, Westgard-ის წესები და EQA [L-07]

Laboratory error is not a rare event: studies published in peer-reviewed literature consistently estimate that 0.1–0.5% of clinical laboratory results contain clinically significant inaccuracies, and the majority of these originate in the analytical phase where inadequate quality control is the proximate cause. For Georgian and South Caucasus laboratories pursuing or maintaining ISO 15189 accreditation — a process now actively supported by the Accreditation Centre of Georgia — the ability to design, execute, and interpret an internal quality control (IQC) programme is a mandatory professional competency, not an administrative formality. Failures in IQC translate directly into misdiagnosis, inappropriate therapy, and patient harm, making this domain one of the highest-stakes intersections between laboratory science and clinical outcomes.

This course is grounded in the statistical and operational frameworks codified by ISO 15189:2022, the CLSI EP23-A guideline on laboratory quality control design, and the Westgard multirule system as described in the peer-reviewed work of James O. Westgard and colleagues. Teaching methodology integrates worked quantitative examples, pattern-recognition exercises using realistic control charts, and structured decision-tree scenarios that mirror the conditions encountered during routine analytical runs and external quality assessment (EQA) cycles. Participants engage with authentic documentation templates that reflect the audit expectations of accreditation bodies operating under ISO/IEC 17025 and ISO 15189 frameworks.

By the end of this course, participants will be able to:

• Distinguish between random and systematic analytical error using Levey-Jennings charts and correctly classify each error type according to its probable source within the analytical system.
• Apply the full Westgard multirule algorithm — including 1₂s, 1₃s, 2₂s, R₄s, 4₁s, and 10x rules — to interpret control data and determine whether an analytical run should be accepted, rejected, or subjected to further investigation.
• Implement a statistically valid IQC strategy for a clinical chemistry, haematology, or immunoassay platform, specifying appropriate control levels, target means, and acceptable standard deviation intervals based on method verification data.
• Evaluate EQA results from recognised external schemes, identify systematic bias relative to peer-group performance, and initiate a structured root-cause analysis when performance falls outside acceptable limits.
• Construct corrective and preventive action (CAPA) records that satisfy the documentary requirements of ISO 15189:2022 Clause 7.7, including clear linkage between observed nonconformity, root cause, corrective measure, and verification of effectiveness.
• Design a shift-handover quality control briefing protocol that ensures continuity of QC decision-making across multiple analytical sessions, consistent with the operational demands of a high-throughput Georgian referral laboratory or hospital core laboratory.

Who Should Attend

This course is designed for clinical laboratory specialists, biomedical scientists, and laboratory technicians working in hospital core laboratories, polyclinic diagnostic units, or independent reference laboratories across Georgia and the wider South Caucasus region. It is equally relevant for laboratory heads and quality managers responsible for maintaining ISO 15189 accreditation, as well as for professionals preparing for their first accreditation assessment and seeking to establish robust, audit-ready QC documentation systems. Participants at all post-graduate career stages — from newly qualified laboratory scientists to experienced analytical chemists transitioning into quality roles — will find the content directly applicable to their daily practice.

Course Structure

The course is delivered entirely online through the GMJ Academy platform as a self-paced module with an estimated study commitment of four to five hours, comprising video-based instruction, interactive control-chart exercises, and a summative multiple-choice and case-based assessment requiring a minimum pass mark of 75%. Successful completion awards CME/CPD credits recognised within the Georgian continuing medical education framework administered by the National Center for Disease Control and Public Health.