Implementation of a quality management system in public health laboratories in the Republic of Georgia
Through a cooperative agreement with the Centers for Disease Control and Prevention (CDC), the Clinical and Laboratory Standards Institute and CDC Laboratory Strengthening Department implemented quality management systems (QMS) into the two national public health laboratories in Tbilisi, Georgia. The QMS was based on CLSI's document Quality Management System: A Model for Laboratory Services; Approved Guideline and ISO 15189, Medical Laboratories - Standards for Quality and Competency. Both documents require a quality manual that covers twelve quality system essentials (QSE). The two laboratories identified in the study are linked with the Department of Defense's Defense Threat Reduction Agency (DTRA). The National Center for Disease Control and the Laboratory of Ministry of Agriculture are responsible for the detection and diagnosis of disease in human and animal populations respectively. ^ The purpose of this study was to assess the implementation of the QMS through the use of training records, laboratory quality indicators to monitor effectiveness of continuous quality improvement, and performance on internal and external assessments to measure achievement of international standards assessments based on CLSI and ISO 15189 standards to prepare the laboratories for eventual accreditation by an international accrediting agency. ^ Although several challenges were encountered along the way, the process has been slow but progressing. The NCDC laboratory had personnel changes that hindered the process but they have been able to overcome and significantly improve their documentation on the quality system essentials, most significantly in Non-Conforming Events Management and Continual Improvement. The LMA laboratory had a stellar start with the strong support of their laboratory director and completed several sections of the quality manual. Both laboratories struggled with data collection and identifying potential and useful quality indicators to monitor their progress during the implementation process. ^ While significant progress has been made in both laboratories, additional steps remain to be implemented prior to application to an accrediting agency. The next steps will be to continue working with each laboratory to complete all documents necessary to support the QSE's. The CLSI program manager recommended that it would be advantageous to have an experienced person with information technology experience to assist the personnel in developing databases to manage data and eliminate the use of paper logs. The CLSI program manager has made a recommendation for a volunteer experienced in QSE to remain in Georgia as a mentor to continue the implementation process. ^ Implementing a quality management system is never easy, but the task becomes even more challenging in an under-resourced country with significant language barriers and little to no public regulations. However, the benefit to public safety is tremendous when completed.^
Health Sciences, Public Health|Health Sciences, Health Care Management
"Implementation of a quality management system in public health laboratories in the Republic of Georgia"
(January 1, 2012).
Texas Medical Center Dissertations (via ProQuest).