Optimizing the delivery of genetic and advanced diagnostic testing in the province of Ontario: challenges and implications for laboratory technology assessment and management in decentralized healthcare systems.

AIMS: The Canadian province of Ontario provides full coverage for its residents (pop.14.8 M) for hospital-based diagnostic testing. Historical governance of the healthcare system and a legacy scheme of health technology assessment (HTA) and financing has led to a suboptimal approach of adopting advanced diagnostic technology (i.e. protein expression, cytogenetic, and molecular/genetic) for guiding therapeutic decisions. The aim of this research is to explore systemic barriers and provide guidance to improve patient and care provider experiences by reducing delays and inequity of access to testing, while benefitting laboratory innovators and maximizing system efficiency. MATERIALS AND METHODS: A mixed-methods approach including literature review, semi-structured interviews, and a multi-stakeholder forum involving patient representatives (n = 1), laboratory leaders (n = 6), physicians (n = 5), Ministry personnel (n = 4), administrators (n = 3), extra-provincial experts, and researchers (n = 7), as well as pharmaceutical (n = 5) and diagnostic companies (n = 2). The forum considered evidence of good practices in adoption, implementation, and financing laboratory services and identified barriers as well as feasible options for improving advanced diagnostic testing in Ontario. RESULTS: Overarching challenges identified included: barriers to define what is needed; need for a clear approach to adoption; and the need for more oversight and coordination. Recommendations to address these included a shift to an anticipatory system of test adoption, creating a fit-for-purpose system of health technology management that consolidates existing evaluation processes, and modernizing the governance and financing of testing so that it is managed at a care-delivery level. CONCLUSIONS: The proposals for change in Ontario highlight the role that HTA, governance, and financing of health technology play along the continuum of a health technology life cycle within a healthcare system where decision-making is highly decentralized. Resource availability and capacity were not a concern - instead, solutions require higher levels of coordination and system integration along with innovative approaches to HTA.

Teaching and assessing intra-operative consultations in competency-based medical education: development of a workplace-based assessment instrument.

Competency-based medical education (CBME) is being implemented worldwide. In CMBE, residency training is designed around competencies required for unsupervised practice and use entrustable professional activities (EPAs) as workplace "units of assessment". Well-designed workplace-based assessment (WBA) tools are required to document competence of trainees in authentic clinical environments. In this study, we developed a WBA instrument to assess residents' performance of intra-operative pathology consultations and conducted a validity investigation. The entrustment-aligned pathology assessment instrument for intra-operative consultations (EPA-IC) was developed through a national iterative consultation and used clinical supervisors to assess residents' performance at an anatomical pathology program. Psychometric analyses and focus groups were conducted to explore the sources of evidence using modern validity theory: content, response process, internal structure, relations to other variables, and consequences of assessment. The content was considered appropriate, the assessment was feasible and acceptable by residents and supervisors, and it had a positive educational impact by improving performance of intra-operative consultations and feedback to learners. The results had low reliability, which seemed to be related to assessment biases, and supervisors were reluctant to fully entrust trainees due to cultural issues. With CBME implementation, new workplace-based assessment tools are needed in pathology. In this study, we showcased the development of the first instrument for assessing resident's performance of a prototypical entrustable professional activity in pathology using modern education principles and validity theory.