ინფ. უსაფ., LIS-ის გათ., backup, მონ. დაც. [L-10]

Information Security, LIS Integration, Backup Protocols, and Data Protection in the Clinical Laboratory [L-10]

Laboratory information systems (LIS) are the operational backbone of modern clinical diagnostics, yet their failure — whether through cyberattack, hardware malfunction, or uncontrolled data migration — can directly compromise patient safety by corrupting results, disrupting reporting chains, or rendering audit trails irretrievable. ISO 15189:2022 explicitly mandates that laboratories establish structured risk management frameworks governing information integrity, system access controls, and continuity planning as non-negotiable components of quality management. In the South Caucasus region, where laboratory networks are undergoing accelerated digitisation under national health system reform programmes, the gap between deployed LIS infrastructure and the risk governance competencies needed to protect it represents a measurable and urgent patient safety liability. This course addresses that gap with the specificity and rigour that international accreditation bodies require.

The course is grounded in the risk management methodology of ISO 15189:2022 (clauses 8.5 and 4.1), harmonised with IEC 80001-1 principles governing the safety of health software in networked environments, and informed by WHO guidance on health information system resilience. Participants are guided through Failure Mode and Effects Analysis (FMEA) and formal risk register construction as applied specifically to LIS-dependent laboratory workflows, using authentic case scenarios drawn from accreditation reviews and documented sentinel events. Instructional design follows a structured competency-based model, progressing from conceptual frameworks to hands-on analytical exercises that produce directly transferable artefacts.

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

• Distinguish between information security threats, data integrity failures, and system availability risks in LIS environments, and explain the distinct patient safety consequences of each failure category.
• Construct a compliant risk register for a clinical laboratory’s information management system, incorporating probability, severity, and detectability scoring consistent with ISO 15189:2022 requirements.
• Apply FMEA methodology to identify and prioritise critical failure modes across LIS data entry, result transmission, backup execution, and external interface points with hospital information systems.
• Design a laboratory backup and data recovery protocol that satisfies ISO 15189:2022 continuity provisions, specifying recovery time objectives, backup frequency, storage segregation, and verification procedures.
• Evaluate existing access control policies against recognised information security standards, identifying non-conformities related to user authentication, audit log maintenance, and role-based permission structures.
• Implement a structured mitigation and monitoring plan for ranked LIS risks, including defined review intervals, responsible personnel assignments, and measurable indicators of control effectiveness.

Who Should Attend

This course is designed for clinical laboratory managers, quality managers, and LIS administrators responsible for maintaining ISO 15189 accreditation or preparing for initial accreditation review in hospital, reference, or public health laboratory settings. It is equally relevant to laboratory physicians, senior biomedical scientists, and health informatics professionals involved in LIS procurement, implementation, or governance at institutional or national programme level. Participants at mid-career and senior stages who carry direct accountability for laboratory quality management systems will derive the most immediate operational benefit.

Course Structure

This course is delivered entirely online through the GMJ Academy platform in a self-paced format, with an estimated study commitment of seven to nine hours inclusive of video instruction, guided risk register exercises, and a structured competency assessment requiring demonstration of applied FMEA and risk documentation skills. Successful completion qualifies for Category 1 CME/CPD credits recognised by the Scientific-Practical Center for Laboratory Medicine of Georgia, in accordance with the national continuing professional development framework.