ISO 15189 ACCREDITATION PROJECTS AND PERFORMANCE OF MEDICAL LABORATORIES IN NAIROBI CITY COUNTY, KENYA
Ngeno Kibet Leonard - Master of Business Administration (Project Management), Kenyatta University, Kenya
Dr. Franklin Kinoti - Department of Management Science, Kenyatta University, Kenya
ABSTRACT
Many medical laboratories have successfully completed ISO 15189 accreditation projects and achieved accreditation recognition certificate according to Kenya National Accreditation service department in the ministry of industrialization in-charge of accreditation in Kenya. Ministry of Health in the year 2010 begun process of accreditation of national and county referral public laboratories to ISO 15189 standard with donor support while private firms channel their resources following Ministry of health recommendations. Both sectors implemented ISO 15189 accreditation three key projects. These projects are quality Management System, Process control, and resource management system. However, not all laboratories who initiated the projects have attained ISO 15189 accreditation by December 2015 according to KENAS. Thus the need for research to be done to analyze the effects of accreditation projects on the performance of medical laboratories within Nairobi City County, Kenya so as to inform a new approach to accreditation projects for laboratories that have not completed the projects in the entire country. The purpose of the study was to assess the effects of accreditation projects specifically on the performance of accredited medical laboratories in relation to Productivity, Quality of service delivery and Cost of services. The organizational theory advanced by Berle and Means in 1932 and scientific management Theory by Taylor of 1909 guided this study. Descriptive research design was used in the study with focus on all levels of management in the laboratories as respondents; Stratified sampling techniques was utilized to group different laboratory management levels (Top Management, Middle level, Operations Level and Technical personnel) and simple random sampling was used from each stratum so as to obtained varied perception views from all levels of management. The target population was seven accredited medical laboratories in Nairobi City County with measurement unit of 225 laboratory personnel with a target sample size of 141 respondents; primary data was collected using structure questionnaire. The study found out that quality management system project (β=0.312, p=0.000<0.05) has a positive and significant effect on performance of medical laboratories. Process control project (β=0.243, p=0.002<0.05) has a positive and significant effect on performance of medical laboratories. Resource management system project (β=0.318, p=0.000<0.05) has a positive and significant effect on performance of medical laboratories. The study concludes that ISO 15189 accreditation projects have a positive effect on performance of medical laboratories. The study recommends that the management of all medical laboratories in Kenya should increase the implementation and adoption of quality management system project in order to positively influence performance of their organizations. The management of all medical laboratories in Kenya need to improve on the process control projects in order to positively influence performance of their organizations. All medical laboratories should improve on their resource management system projects for positive improvement in performance.
