მეთოდის ვერიფიკაცია, ვალიდაცია და გაზომვის განუზღვრელობა [L-06]

მეთოდის ვერიფიკაცია, ვალიდაცია და გაზომვის განუზღვრელობა [L-06]

Pre-analytical errors represent the single largest source of laboratory inaccuracy, accounting for 46–68% of all diagnostic mistakes according to peer-reviewed analyses published in Clinical Chemistry and Laboratory Medicine and corroborated by WHO global laboratory quality assessments. These errors — arising from improper specimen collection, inadequate labelling, suboptimal transport conditions, and inappropriate storage — directly compromise patient safety, delay clinical decision-making, and inflate healthcare costs. In the South Caucasus region, where laboratory accreditation under ISO 15189 remains an evolving priority and where referral networks often extend across challenging geographic terrain, the risk of specimen degradation is compounded by logistical complexity. Acquiring rigorous, evidence-aligned competency in pre-analytical quality assurance is therefore not merely a professional standard — it is a patient safety imperative.

This course is grounded in the normative frameworks of ISO 15189:2022 (Medical Laboratories — Requirements for Quality and Competence), CLSI guidelines GP44 and H18, and WHO Laboratory Quality Stepwise Implementation (LQSI) tools, ensuring that all procedural standards presented reflect current international consensus. Instructional content is structured around authentic case scenarios drawn from clinical laboratory practice, enabling participants to move beyond theoretical recall toward applied judgement. A layered pedagogical approach — combining guided reading, structured reflection, and scenario-based self-assessment — supports durable knowledge transfer for busy clinical professionals.

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

• Distinguish the principal categories of pre-analytical error — including haemolysis, lipaemia, icterus, and clot formation — and explain the specific analyte groups most vulnerable to each type of interference.
• Implement correct venepuncture and capillary collection procedures in accordance with CLSI H03 and H04 standards, including appropriate tube order, fill volumes, and mixing protocols for anticoagulated specimens.
• Apply validated labelling and chain-of-custody requirements to ensure unambiguous specimen-to-patient traceability from the point of collection through result reporting.
• Evaluate transport and storage conditions — including temperature ranges, permissible transit times, and centrifugation parameters — for a defined panel of routine and specialist analytes.
• Construct and justify specimen rejection criteria appropriate to the testing menu and patient population of a defined laboratory setting, aligning thresholds with ISO 15189 quality indicator requirements.
• Analyze real or simulated pre-analytical failure events using root-cause analysis methodology, and formulate corrective and preventive actions consistent with a laboratory quality management system.

Who Should Attend

This course is designed for medical laboratory scientists, clinical biochemists, and laboratory technicians working in hospital, polyclinic, or reference laboratory settings at any career stage, from early-practice graduates to experienced professionals preparing for ISO 15189 accreditation audits. It is equally relevant to clinicians and nurses who bear direct responsibility for specimen collection in ward, emergency, or primary care environments, and to laboratory managers seeking to strengthen their institution’s pre-analytical quality indicators. Professionals in Georgian healthcare facilities undergoing accreditation through the Levan Samkharauli National Forensics Bureau framework or Joint Commission International standards will find the content directly applicable to their compliance requirements.

Course Structure

The course is delivered entirely online through the GMJ Academy platform in a self-paced format, with an estimated study commitment of four to five hours inclusive of reading, case analysis, and formative exercises; completion is assessed via a proctored multiple-choice examination requiring a minimum passing score of 75%. Successful participants receive a GMJ Academy certificate of completion carrying continuing medical education credit recognised under Georgian CME/CPD requirements, supporting documentation for professional re-licensure and quality management portfolios.