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გამოკვლევა: პროცესი და უსაფრთხოება [LAB-07]

Laboratories seeking accreditation frequently struggle to align examination workflows with rigorous safety and process standards, resulting in costly findings. This ... Show more
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Examination: Process & Safety

გამოკვლევა: პროცესი და უსაფრთხოება [LAB-07]

Laboratory examination processes sit at the intersection of patient safety and diagnostic accuracy: errors introduced during pre-analytical, analytical, or post-analytical phases account for up to 70% of all laboratory-related adverse events, according to published estimates aligned with WHO Laboratory Quality Management System guidance. In Georgia and the broader South Caucasus region, the accelerating rollout of Accreditation Service for Facilities (ASF) standards has placed unprecedented pressure on laboratory teams to demonstrate rigorous procedural compliance—yet many institutions lack structured training that bridges regulatory requirements with daily operational practice. Deficiencies identified during accreditation surveys carry direct consequences: delayed diagnoses, corrective-action costs, and, most critically, preventable harm to patients. This course addresses that gap with the precision and depth that healthcare professionals require to lead sustained improvement in their institutions.

The course content is grounded in internationally recognised frameworks, including ISO 15189:2022 (Medical Laboratories — Requirements for Quality and Competence), WHO Laboratory Biosafety Manual (4th Edition), and Joint Commission International (JCI) laboratory standards, adapted specifically to the ASF examination requirements applicable in Georgia. Instruction follows a competency-based methodology: clinical case scenarios, procedural walkthroughs, and audit-simulation exercises replace passive content delivery, ensuring that participants develop transferable skills rather than rote familiarity. Each module is cross-referenced with current ASF inspection criteria so that learners can immediately map acquired knowledge to real accreditation findings.

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

  • Distinguish between pre-analytical, analytical, and post-analytical error categories and identify the ASF examination requirements that govern each phase of the laboratory workflow;
  • Implement standardised specimen collection, handling, transport, and storage protocols consistent with ISO 15189:2022 and ASF examination criteria;
  • Apply biosafety risk-assessment principles drawn from the WHO Laboratory Biosafety Manual to classify hazards and select appropriate personal protective equipment and containment measures for each examination type;
  • Evaluate existing laboratory safety documentation—including standard operating procedures, incident logs, and corrective-action records—against ASF compliance benchmarks and identify specific gaps requiring remediation;
  • Design a traceable internal audit pathway for examination processes that satisfies ASF requirements for documented quality oversight and continuous improvement;
  • Demonstrate correct procedural responses to critical examination findings, including result verification, clinician notification timelines, and documentation obligations as specified in national and international quality standards.

Who Should Attend

This course is designed for laboratory managers, chief medical laboratory scientists, quality officers, and senior laboratory technicians working in hospital-based, polyclinic, or independent diagnostic laboratory settings that are pursuing or maintaining ASF accreditation. Clinicians—including internists, pathologists, and family medicine physicians—who bear institutional responsibility for examination quality or who interpret laboratory outputs in patient-care decisions will also derive substantial benefit. The content is equally suited to professionals at mid-career who are transitioning into quality or compliance roles and require a structured, standards-referenced foundation.

Course Structure

The course is delivered entirely online through the GMJ Academy platform in an asynchronous format, comprising six structured modules with an estimated total study time of eight to ten hours; completion is assessed through scenario-based knowledge checks and a cumulative case audit exercise that must be passed at 75% or above to qualify for certification. Upon successful completion, participants receive a GMJ Academy certificate of completion eligible for Continuing Medical Education (CME) credit recognition under Georgia’s current professional development framework.

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