Implementation of ISO 15189:2012 in a regional hospital’s medical laboratory

Thesis Abstract

This study addresses the persistent challenge of aligning regional hospital medical laboratories with ISO 151892012 standards to enhance patient safety, accuracy of results, and laboratory efficiency amid limited resources and variable staff expertise. The aim is to evaluate the implementation process, assess current compliance gaps, and propose an evidence-based improvement framework for sustained accreditation readiness. Specific objectives are to (i) map existing quality management practices against ISO 151892012 requirements, (ii) identify critical barriers and facilitators to implementation, (iii) quantify improvements in key performance indicators such as turnaround time, error rates, and proficiency testing performance, (iv) develop a structured implementation roadmap tailored to resource-constrained regional settings, and (v) validate the framework through a pilot deployment in selected departments. The study employs a mixed-methods design anchored in the Kawalek Theory of Organizational Change and the Capability Morya model of quality management to examine the interplay between leadership commitment, staff competencies, and organizational culture during standard adoption. The population comprises all personnel within the regional hospital’s medical laboratory, including 28 technologists, 6 supervisors, 4 quality managers, and associated support staff. A purposive sample of 40 participants will be selected for in-depth qualitative inquiry, complemented by all 12 laboratory sections for quantitative assessment. Data collection instruments include a standardized ISO 151892012 compliance checklist, a validated laboratory quality assurance survey, proficiency testing records, and interview guides. Instrument validity will be established through expert panel review and pilot testing, while reliability will be assessed via Cronbach’s alpha (target ?0.80) for the survey and inter-rater reliability (kappa ?0.70) for audit judgments. Quantitative data will be analyzed using descriptive statistics to establish current compliance baselines and trends, and inferential statistics including paired t-tests and ANOVA to evaluate changes in key performance indicators pre- and post-intervention. Multivariate regression will explore predictors of successful implementation, with independent variables including leadership engagement, staff training hours, internal auditor frequency, and documentation quality scores. The qualitative data will be analyzed thematically using Braun and Clarke’s approach to identify recurrent themes related to change management, resource constraints, and stakeholder perceptions of ISO 151892012 processes. Triangulation will integrate qualitative insights with quantitative outcomes to derive robust conclusions about causal pathways. Expected findings include measurable improvement in document control, equipment calibration adherence, and incident/near-miss reporting following targeted interventions such as revised standard operating procedures, staff competency matrices, and an enhanced internal audit program. Proficiency testing performance is anticipated to show reduced result variances and closer alignment with peer group benchmarks. The study is expected to reveal a nuanced understanding of how organizational factors—particularly leadership support, time allocation for training, and cross-functional collaboration—mediate the effectiveness of ISO 151892012 implementation in resource-limited settings. The contribution to knowledge lies in delivering a context-specific implementation framework for regional hospital laboratories aiming for ISO 151892012 accreditation, including a practical gap-analysis tool, a staged deployment plan, and a set of indicators for ongoing monitoring and continuous improvement. The findings will extend theoretical models of quality management adoption by integrating organizational change dynamics with laboratory-specific accreditation requirements, offering transferable lessons for similar hospitals in low- to middle-income regions. The study concludes with a set of policy and practice recommendations, such as establishing dedicated quality assurance budgets, formalizing continuous professional development for technical staff, and institutionalizing continuous internal audits. Limitations include potential biases from self-reported data and the single-site scope; future research should test the framework across multiple regional hospitals and in varied laboratory subspecialties.