Abstract
Objective:The quality medical laboratory services play a vital role in healthcare systems. Iran has set national standards based on the international standard ISO15189. These standards came into force in September 2007. Given the important role of both laboratories professional and assessors in the standardization, this study aims to compare and analyze medical laboratory directors’ and assessors’ opinions about this process, its challenges and relevant solutions.Methods:This qualitative study was conducted on two populations in 2013. The first survey population consisted of 150 assessors. The second group consisted of directors working in medical laboratory settings. From all universities of medical sciences, 258 medical laboratories were randomly selected. Data were gathered using two open-ended questionnaires and analyzed using the thematic analysis.Results:Challenges and relevant solutions regarding the standardization and standards, the assessment process and assessor, laboratories, external entities and contextual factors across laboratories directors and assessors were derived and compared. Both groups had a positive attitude towards the standardization process. However, they expressed some concerns regarding the process and accordingly proposed solutions to overcome the challenges.Conclusion:This study provides insights into the challenges and solutions of the standardization from two professional groups’ viewpoint. These two factors are closely related and should be considered when implementing standards since a positive perception of them increases the likelihood of successful standardization. Similarities and divergences regarding challenges and solutions of the standardization, in turn, can provide insights into how this process can be improved and deserve policy makers’ attention to continue the progress.
Highlights
Medical laboratory services play a vital role in healthcare systems; (Spitzenberger & Edelhäuser, 2006) high-quality and reliable laboratory services are necessary for effective and well-functioning health systems (Cobbina, Agbezudor, Amuzu, & Gyampomah, 2012)
These two factors are closely related and should be considered when implementing standards since a positive perception of them increases the likelihood of successful standardization
The ISO standards used by the Reference Health Laboratory (RHL) as source documents in drafting national standards came into force in September 2007 and all medical laboratories were required to apply these standards (Dahim et al, 2009; Anjarani, 2013)
Summary
Medical laboratory services play a vital role in healthcare systems; (Spitzenberger & Edelhäuser, 2006) high-quality and reliable laboratory services are necessary for effective and well-functioning health systems (Cobbina, Agbezudor, Amuzu, & Gyampomah, 2012). Many national and international quality standards exist for laboratory practices. These standards are lists of requirements that need to be met in order to ensure quality practice (Datema, Oskam, & Klatser, 2011). Many countries have adopted internationally accepted standards such as ISO17025 and/or ISO15189 (Nkengasong, 2010). Other countries, such as Iran, have developed their own standards based on the country-specific circumstances. The ISO standards used by the Reference Health Laboratory (RHL) as source documents in drafting national standards came into force in September 2007 and all medical laboratories were required to apply these standards (Dahim et al, 2009; Anjarani, 2013). The General Directorate of Laboratory Affairs (GDLA) in each medical www.ccsenet.org/gjhs
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