მართვის მოთხოვნები ლაბორატორიის აკრედიტაციისთვის [LAB-02]

მართვის მოთხოვნები ლაბორატორიის აკრედიტაციისთვის [LAB-02]

Laboratory errors contribute to an estimated 70% of clinical decisions, yet a substantial proportion of those errors originate not at the analytical bench but in failures of management systems — inadequate document control, unresolved nonconformities, and poorly defined personnel responsibilities. In Georgia and across the South Caucasus, the accelerating adoption of ISO 15189:2022 and Joint Commission International standards has created an urgent competency gap: laboratory professionals are expected to translate complex normative requirements into auditable, day-to-day practice with limited formal training in quality management systems. The consequences extend beyond regulatory non-compliance; they affect diagnostic accuracy, patient safety, and the credibility of national public health data. This course addresses that gap directly, providing laboratory teams with the operational knowledge and practical frameworks required to achieve and sustain accreditation under internationally recognised standards.

The course is grounded in the requirements of ISO 15189:2022, WHO Laboratory Quality Management System (LQMS) guidance, and the Clinical and Laboratory Standards Institute (CLSI) EP23-A framework for laboratory risk management. Content is structured around the four-phase Plan-Do-Check-Act cycle, enabling participants to connect normative clauses to concrete workplace actions rather than abstract compliance checklists. Teaching employs scenario-based case studies drawn from accreditation survey findings in Eastern European and Georgian laboratory settings, supported by structured document templates and self-assessment tools developed in alignment with WHO AFRO and EURO regional laboratory strengthening initiatives.

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

• Distinguish between management requirements and technical requirements within ISO 15189:2022, correctly mapping each clause to the responsible role in their laboratory’s organisational structure.
• Construct a document control system — including policy hierarchy, version management, and controlled-distribution procedures — that satisfies assessor scrutiny under Georgian accreditation body (GNAB) and JCI standards.
• Implement a nonconformity and corrective action workflow that captures root-cause evidence, assigns accountable owners, and closes findings within defined timeframes.
• Design a laboratory risk register using ISO 22367 principles, prioritising pre-analytical and post-analytical vulnerabilities identified as the most frequent sources of patient harm in peer-reviewed quality-error studies.
• Evaluate internal audit findings against normative criteria, differentiating major from minor nonconformities and selecting proportionate corrective versus preventive actions.
• Apply competency assessment and continuing education frameworks to personnel management records in a manner that meets both ISO 15189 Clause 6.2 requirements and national Georgian healthcare workforce regulations.

Who Should Attend

This course is designed for laboratory managers, quality officers, and senior medical laboratory scientists working in hospital, reference, or public health laboratories who are preparing for initial accreditation, surveillance assessment, or re-accreditation. It is equally relevant for clinical directors and hospital quality assurance coordinators who bear institutional responsibility for laboratory governance. Professionals at mid-career stage who are transitioning into quality management roles or leading accreditation readiness teams will derive the most immediate benefit.

Course Structure

LAB-02 is delivered as a self-paced, fully online programme on the GMJ Academy platform, requiring approximately 8–10 hours of study time inclusive of video modules, case-based exercises, and document-drafting activities; completion of the summative assessment with a passing score of 80% or higher awards 8 CME/CPD credits recognised under the continuous medical education framework of the National Center for Disease Control and Public Health of Georgia.