მოწყობილობა, კალიბრაცია, მოვლა და გარემო [L-05]

მოწყობილობა, კალიბრაცია, მოვლა და გარემო [L-05]

Every diagnostic decision rests ultimately on the trustworthiness of the instrument that generated the result. Across clinical laboratories in Georgia and the broader South Caucasus region, equipment-related measurement error remains a principal contributor to pre-analytical and analytical non-conformities — a pattern consistent with findings documented in WHO’s global laboratory quality assessments and reflected in recurring deficiencies identified during Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) evaluations. ISO 15189:2022, the international standard governing medical laboratory quality and competence, is explicit in its requirements: laboratories must maintain documented programmes for equipment selection, installation verification, calibration, and ongoing performance monitoring, with full traceability to national or international measurement standards where applicable. Failure to meet these requirements does not merely jeopardise accreditation status — it introduces systematic bias into patient results, with direct consequences for clinical management and patient safety.

This course is grounded in the normative requirements of ISO 15189:2022, CLSI guidelines on method verification and calibration (EP series), and WHO’s Laboratory Quality Management System (LQMS) framework, synthesising these authoritative sources into practical, operationally actionable content. Instruction draws on authentic laboratory scenarios, structured case analysis of equipment failure events, and guided application of calibration scheduling matrices and maintenance log templates that participants can immediately adapt to their own institutional settings. The teaching approach emphasises procedural reasoning — equipping participants not only to follow established protocols but to evaluate the adequacy of existing practices and design improvements where gaps are identified.

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

• Distinguish between the concepts of calibration, verification, and quality control, and articulate the specific role each plays in ensuring metrological traceability under ISO 15189:2022 requirements.
• Design a risk-stratified equipment calibration schedule that accounts for instrument type, frequency of use, manufacturer specifications, and applicable regulatory or accreditation timelines.
• Implement a preventive maintenance programme, including the construction of standardised maintenance records that satisfy documentary requirements for both internal audits and external accreditation assessments.
• Evaluate environmental monitoring data — including temperature, humidity, and electrical supply stability — to determine whether laboratory conditions fall within acceptable ranges and to identify corrective action thresholds.
• Apply a structured out-of-service and return-to-service protocol when equipment fails or produces suspect results, in accordance with ISO 15189 non-conforming work requirements.
• Analyze equipment performance trends using calibration and maintenance records to detect early indicators of instrument degradation before they produce clinically significant measurement error.

Who Should Attend

This course is designed primarily for medical laboratory specialists, laboratory technicians, and quality managers working in hospital-based, outpatient diagnostic, or reference laboratory settings at all career stages — from practitioners preparing their laboratories for initial ISO 15189 accreditation to experienced professionals seeking to strengthen existing quality systems. It is equally relevant to laboratory directors, chief medical officers with oversight responsibility for diagnostic services, and biomedical engineers involved in equipment procurement and technical validation within Georgian health facilities or regional referral centres across the South Caucasus.

Course Structure

The course is delivered fully online through the GMJ Academy platform, comprising approximately five to six hours of self-paced study including instructional modules, applied exercises, and downloadable working tools; participants complete a structured knowledge assessment upon conclusion, and successful completion yields a GMJ Academy certificate of achievement eligible for recognition toward continuing professional development requirements.