Iris Hasibra1, Artan Bego1, Shpetim Qyra1, Silva Bino1,2, Albana Fico1,2
1 Institute of Public Health, Tirana, Albania;
2 Faculty of Medicine, University of Medicine, Tirana, Albania.
Aim: Since 2019 Albania is a member of the WHO Laboratory Task Force to preparedness and response to High Threat Pathogens. As part of this network we are supported to strengthening country core laboratory capacities, with focus on national reference microbiological laboratories, as laboratory services are key to adequate clinical and public health responses to infectious hazards. One important component in this regard is the implementation and monitoring of the quality management system. The aim of this initiative is to reach the final goal of having all the IPH microbiological laboratories accredited by the accredited bodies by the ISO 15189:2012 standard.
Methodology: In October 2019 a country assessment was based on a checklist generated by the ISO 15189:2012 involving but not only the main areas for the implementation of quality management like: Infrastructure, Bio-safety and Bio-security, Human Resources, Procurement, sample collection storage and transport, lab diagnostics etc. A report with clear recommendation on strengths and gaps is delivered and as a follow up we have started the mentoring programme with the support of WHO. In December 2019 a mentor (licensed quality manager ISO 15189) visited our microbiology laboratories and an action plan with defined deliverables and deadlines is provided. This action plan will prepare all the documents and processes related to the pre-analytical phase of the implementation process.
Results: Overall, quality and biosafety management are weak. Participation to proficiency testing is not the case for all diseases diagnosed by IPH. Equipment preventive maintenance in IPH is not applicable for all the equipment. Lack of a primary reception room for all the types of samples received in the IPH.
Conclusion: The appointment of a team with assigned duties to conduct this work based on ISO 15189:2012 is officially created which will be integrated in the IPH structure in a latter phase. WHO High Threat Pathogens teams is supporting our country in setting up a national laboratory working group to elaborate a national laboratory policy and strategic plan which can be integrated in the new national health strategy.
Keyword: biosafety management, strategic plan.