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ბიოუსაფრთხოება, PPE, გადასხმა, სასხლეტი ნივთები, ნარჩენები, ხანძარი [L-09]

Non-conformities that go uncorrected become recurring failures. Apply ISO 15189 root-cause analysis, corrective and preventive action, and verification steps that ... Show more
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ბიოუსაფრთხოება, PPE, გადასხმა, სასხლეტი ნივთები, ნარჩენები, ხანძარი [L-09]

Laboratory safety failures — including sharps injuries, improper transfusion handling, healthcare waste mismanagement, and fire hazards — remain among the most preventable yet consequential risks in clinical and diagnostic settings. The WHO estimates that unsafe injection and sharps practices cause millions of needlestick injuries annually worldwide, contributing to transmission of bloodborne pathogens including hepatitis B, hepatitis C, and HIV. In Georgia and across the South Caucasus, accelerating accreditation cycles under ISO 15189 and Joint Commission International standards have placed renewed scrutiny on how laboratories identify non-conformities, investigate their root causes, and verify that corrective actions are durable. This course addresses precisely that gap: transforming isolated safety incidents into systematic, evidence-based quality improvements that do not recur.

The course is grounded in ISO 15189:2022 requirements for nonconformity control, corrective action, and management review, integrated with WHO Laboratory Biosafety Manual (4th edition) guidance on containment, personal protective equipment selection, and waste segregation hierarchies. Teaching methodology employs case-based scenario analysis drawn from real-world laboratory incident typologies, structured root-cause analysis frameworks including fishbone (Ishikawa) diagrams and the “5 Whys” technique, and stepwise corrective and preventive action (CAPA) workflows aligned with international quality management system principles. Participants engage with verification checklists and audit simulation exercises that mirror the documentation standards expected during external accreditation assessments.

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

  • Distinguish between biosafety risk levels and select appropriate personal protective equipment for each containment scenario in accordance with WHO Laboratory Biosafety Manual criteria and ISO 15189 risk assessment requirements.
  • Implement a structured root-cause analysis protocol for laboratory safety non-conformities — including sharps injuries, transfusion handling deviations, and hazardous waste incidents — using validated investigative tools such as fishbone diagrams and the “5 Whys” methodology.
  • Design corrective and preventive action (CAPA) plans that address systemic causes rather than isolated events, specifying responsible personnel, timelines, resource requirements, and measurable success criteria.
  • Apply ISO 15189:2022 documentation standards to record non-conformities, investigation findings, corrective measures, and verification outcomes in a format auditable by accreditation bodies.
  • Evaluate the effectiveness of implemented corrective actions through prospective monitoring indicators and re-audit cycles, confirming that identified failure modes have been durably eliminated.
  • Analyze fire safety protocols, healthcare waste segregation procedures, and sharps disposal compliance within their own laboratory or clinical environment, identifying gaps against WHO and national Georgian regulatory benchmarks.

Who Should Attend

This course is designed for clinical laboratory specialists, medical laboratory technologists, infection prevention and control practitioners, and quality managers working in hospital-based or reference laboratories, blood transfusion services, and diagnostic centers in Georgia and the wider South Caucasus region. It is equally relevant to laboratory directors preparing facilities for ISO 15189 initial accreditation or surveillance audits, and to biosafety officers responsible for maintaining occupational health compliance. Early- to mid-career professionals who have direct responsibility for incident reporting, non-conformity documentation, or safety protocol implementation will derive the greatest operational benefit.

Course Structure

This course is delivered entirely online through the GMJ Academy platform in an asynchronous, self-paced format, requiring an estimated four to five hours of study time inclusive of video lectures, interactive case scenarios, and a competency-based post-assessment requiring a minimum passing score of 80%. Successful completion awards verified CME/CPD credit recognized within Georgia’s continuing professional development framework for licensed healthcare professionals.

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Course details
Duration 45 minutes
Lectures 9
Quizzes 9
Level Beginner
Certificate awarded on passing Certification Test at 80% or above. 1 CPD credit.
365 days
Desktop, Laptop, Tablet, Smartphone
Basic info
  • ISO 15189:2022 requirements — L-09.
Course requirements
L-01 recommended.
Intended audience
Laboratory scientists and quality professionals
ბიოუსაფრთხოება, PPE, გადასხმა, სასხლეტი ნივთები, ნარჩენები, ხანძარი [L-09]
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