Health Impact Assessment and the Role of Accredited Clinical Laboratory on ISO 15189:2007 International Standard

Background: Health impact assessment (HIA) is a multidisciplinary process within which a range of evidence about the health effects of a proposal is considered in a structured framework. HIA is used to evaluate objectively the potential health effects of a project or policy before it is built or implemented. It draws on diverse methodologies and tries to balance qualitative and quantitative evidence. There are five sequential core steps in HIA, as follows: screening, scoping, appraisal of the potential health effects/impacts, decision-making, monitoring and evaluation. Medical laboratory services are essentials to patient care. However, little is known about the relationship between HIA and clinical laboratory, especially with respect to the accreditation process according to the International Standard ISO 15189:2007 (Medical laboratories- particular requirements for quality and competence). Here we would like to show our experience in this way. Methods: After a rapid appraisal, when a quality commitment was clearly defined in a stakeholder economy, we defined the scope. We spent a four-year period to prepare our unit for the standard, making changes in: personnel policies, staffing levels and competencies, laboratory information system, laboratory equipment, reporting of results, documentation, quality management system, quality and technical records, physical infrastructure, environmental conditions, coordination to existing regional and provincial-level health programs, etc. A set of quality indicators was defined for monitoring and evaluating the laboratory's contribution to patients care. Results: A continual improvement circle is working and our laboratory has been transformed to fulfil with the standard. Identification and control of nonconformities is a key point. Conclusion: HIA is a rapidly emerging practice that can help planners and clinicians to consider the health consequences of their decisions. More work is needed to document its value in laboratory-related decision-making processes. ISO 15189 is a good way to improve quality and performance in a medical laboratory.