კლინიკური ბიოქიმიის განყოფილება [L-11]

კლინიკური ბიოქიმიის განყოფილება [L-11]: ლაბორატორიული ბიოუსაფრთხოება — პათოგენების რისკ-ჯგუფებიდან კონტეინმენტის სისტემებამდე

Laboratory-acquired infections represent a preventable yet persistent occupational hazard: the WHO estimates that even in controlled settings, unsafe handling of biological agents causes hundreds of documented infection events annually, with a significant proportion resulting in severe morbidity. In Georgia and across the South Caucasus, accelerated investment in diagnostic infrastructure — driven by post-COVID-19 laboratory capacity expansion and JCI accreditation pursuits — has placed biosafety competency at the centre of institutional quality agendas. Yet biosafety is routinely treated as administrative formality rather than as the evidence-based, patient-and-staff protection system it is required to be under ISO 15189:2022 and WHO Laboratory Biosafety Manual (4th edition, 2020) standards. This course addresses that gap directly, providing clinical laboratory professionals with the structured knowledge and practical frameworks needed to operate safely across all containment levels.

The course content is grounded in the WHO Laboratory Biosafety Manual (4th edition), ISO 15189:2022 quality and competence requirements for medical laboratories, and the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL 6th edition), with contextual reference to Georgia’s National Centre for Disease Control guidelines on biological hazard management. Teaching methodology integrates case-based scenario analysis drawn from real laboratory incident reports, structured decision-tree exercises for PPE selection and decontamination sequencing, and applied planning tasks that require participants to audit and revise a model laboratory safety plan against international benchmarks.

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

• Distinguish between WHO Risk Groups 1–4 and accurately assign clinical and environmental specimens to the appropriate biosafety level (BSL-1 through BSL-4), applying the risk assessment criteria defined in the WHO Biosafety Manual (4th edition).
• Implement a systematic biological risk assessment for a clinical biochemistry or diagnostic laboratory, identifying exposure routes, agent characteristics, and procedural hazards that require mitigation under ISO 15189:2022 competence requirements.
• Select and correctly sequence personal protective equipment (PPE) — including gloves, respiratory protection, eye shields, and fluid-resistant gowns — according to the specific containment level, specimen type, and procedural aerosol risk involved.
• Apply validated decontamination and disinfection protocols, differentiating between sterilisation, high-level disinfection, and surface decontamination methods appropriate for each biosafety level and relevant pathogen category.
• Construct a compliant laboratory biosafety plan that incorporates incident reporting procedures, emergency response protocols, biological waste disposal pathways, and staff training documentation as required by national and JCI standards.
• Evaluate the adequacy of existing biosafety infrastructure within their own laboratory setting by conducting a structured gap analysis against WHO and ISO containment requirements, producing prioritised corrective action recommendations.

Who Should Attend

This course is designed for clinical laboratory scientists, medical biochemists, laboratory technicians, and laboratory managers working in hospital diagnostic departments, public health reference laboratories, and outpatient diagnostic centres across Georgia and the wider South Caucasus region. It is particularly relevant for professionals whose institutions are preparing for JCI accreditation, ISO 15189 certification, or national licensing renewal, as well as those assuming biosafety officer responsibilities for the first time or refreshing competencies in line with updated WHO 2020 guidance. Mid-career laboratory professionals transitioning into supervisory or quality assurance roles will derive substantial structured benefit from the applied planning components.

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 including scenario exercises, decontamination sequencing simulations, and the laboratory biosafety plan construction task; completion is assessed through a scored knowledge check and a structured practical submission reviewed against a standardised rubric. Successful participants receive a GMJ Academy certificate of completion carrying continuing medical education (CME) credit in accordance with the Georgian Medical Association CPD framework.