Approaches to accountability in the medical laboratory sector in Ontario.

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Purpose: Greater accountability within the Ontario medical laboratory sector is a high priority and desirable. This sector provides approximately 80% of the objective data for diagnosis, monitoring and treatment. The goal of this study is to determine how accountability is defined, and the advantages and challenges of the approaches used in this sector. Methodology: A case study design based on a mix methods approach incorporating quantitative (i.e., scoping review of documents) and qualitative data (i.e., 20 semi-structured interviews) to examine the approaches to accountability in the medical laboratory sector and the implication of core independent variables on the approaches used. Key stakeholders in the medical laboratory sector were interviewed to determine views on the advantages and challenges of the possible approaches. Results The four approaches to accountability used in the medical laboratory sector are: financial incentives, regulations, information directed towards potential users, reliance on professionalism and stewardship. Regulation is the main approach to accountability in the medical laboratory sector. Ontario Laboratory Accreditation and licensing by the Ontario government is mandatory in all laboratories except those found in physicians’ offices. There were variations in the approaches to accountability based on core independent factors such as: policy goal being pursed, the governance /ownership structures and the goods and services being delivered and their production characteristics. Laboratory services are delivered by public health, hospitals, large community based laboratories and small laboratories often found in physicians’ offices. Key informants identified quality and safety as top priorities regardless of the approach that is used. Concern for costs and resources exists within the sector as a whole. Laboratory results gain much of their value by being embedded within a system of care, in which providers order tests appropriately and are aided in interpreting and acting upon their results. The pre/post analytical stages are just as important as the analytical stage in measuring performance and ensuring validity, reliability and accountability. Conclusion: While the medical laboratory sector is highly regulated, the implementation of additional mechanisms to enhance accountability in the pre/post analytical phases is needed. The importance of this is further highlighted by the advancement of point of care testing at the bedside, the pharmacy and at home which is not fully captured by the accountability mechanisms currently in place. Advances in new technologies such as molecular and genetic testing will also impact future accountability in the medical laboratory sector.
Accountability, Regulations, Laboratory licensing, Ontario Laboratory Accreditation (OLA), Total Quality Management