Laboratory Quality Management System and Quality Indicators Implementation Status as Perceived by Laboratory Professionals in Preparation for the Accreditation Process from Selected Government Hospitals of Ethiopia.

BACKGROUND: The aim was to produce quality results that clinical laboratories need to implement and maintain continuous quality improvement systems. In recent years, health organizations have increasingly prioritized the quality of laboratory services by implementing quality management systems (QMSs) and building quality improvement activities. Efforts to strengthen laboratory systems in the African region have received increased attention in recent years. Assessing the implementation levels of laboratory quality management system components is important to identify the gaps that need further improvements. METHODS: A cross-sectional study design was used between March and May 2017 in selected government hospitals of Ethiopia, and sample size was determined using a finite population formula, and a proportional sampling technique was employed; a sample size of 184 (62%) was calculated from 295 laboratory professionals. RESULTS: All respondents were informed about the laboratory's experience in the quality management system implementation; of those, only 138 (79%) engaged in the implementation process. From the 18 selected laboratory quality management components, 5 were observed to have the list implementation status, which are: (1) Performance of internal quality control for all tests, (2) Development and communication of a quality manual for all tests, (3) Adequacy of storage space for the supplies, (4) Development of an action plan based on internal audit, and (5) monitoring of environmental conditions. Running quality controls for all types of tests became a headache in almost all laboratories. From 12 selected quality indicators studied in this research, the 5 indicators with either poor or very poor performance outcome were: control of documents 136 (77.7%), control of records 123 (70.3%), development of manuals and policies 122 (69.7%), development of process and procedures 120 (68.6%), and internal communication 114 (65.1%). CONCLUSIONS: This research indicated the top 3 LQMS components with either poor or very poor implementation status: (1) Performance of internal quality controls for all tests, (2) Development and communication of quality manuals for all tests, (3) Adequacy of storage space for the supplies. Of the quality indicators studied, control of documents was perceived to have poor performance outcome by 136 (77.7%) of study participants.