Date of Conferral
Doctor of Business Administration (D.B.A.)
Inadequate quality management systems (QMS) in medical laboratories result in errors, which cost the United States healthcare industry approximately $29 billion per year. Healthcare managers who fail to implement the International Organization for Standardization (ISO) 15189 QMS are at high risk of managing costs. Grounded in Lewin’s 3-step organizational change model and the force field analysis, the purpose of this qualitative multiple case study was to explore strategies healthcare managers use to design, develop, and implement an ISO 15189 QMS using a mentorship approach. The participants comprised 5 healthcare managers from the United Republic of Tanzania, East Africa, who implemented the ISO 15189 QMS up to international accreditation using a mentorship approach. Data were collected using semistructured telephone interviews and company documents and reports. Thematic analysis was used to analyze the data; 4 themes emerged to include unfreezing phase-preparation for change, changing phase-implementation of QMS, refreezing the new behavior, and maximizing the forces for change. A key recommendation is to structure mentorship programs into 4 stages, including a gap assessment, documentation of the QMS, implementation of the process, and continuous improvement activities. The implications for positive social change include the potential to promote reliance on ISO 15189 accredited medical laboratories by the people served and help the population engage in correct health-seeking behavior.
Mtotela, Wilson, "Strategies for Implementing the International Organization for Standardization 15189 for Medical Laboratories" (2020). Walden Dissertations and Doctoral Studies. 9606.