Quality assurance program for molecular medicine laboratories.

BACKGROUND: Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. METHODS: We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. RESULTS: Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. CONCLUSION: Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level.

Challenges of implementing Iranian national laboratory standards.

After four years of publishing the Iranian National Laboratory Standard and following a strategic plan to implement its requirements, it was decided to review the taken actions, evaluating the achievements and the failures, as well as analyzing the gaps and planning the interventional activities to resolve the problems. A thorough evaluation revealed that the progress of implementation process varies considerably in different provinces, as well as in laboratories in different public and private sectors. Diversity and heterogeneousity of laboratories throughout the country is one of unresolvable problems. Although we encounter shortage of resources in the country, improper allocation or distribution of resources and budgets make the problems more complicated. Inadequacy of academic training in laboratory sciences has resulted in necessity of holding comprehensive post-graduate training courses. Revising academic curriculum of laboratory sciences could be mostly helpful, moreover there should be organized, training courses with pre-determined practical topics. providing specific technical guidelines, to clarify the required technical details could temporarily fill the training gaps of laboratory staff. Inadequate number of competent auditors was one of the difficulties in universities. Another important challenge returns to laboratory equipment, developing the national controlling system to manage the laboratory equipment in terms of quality and accessibility has been planned in RHL. At last cultural problems and resistance to change are main obstacles that have reduced the pace of standardization, it needs to rationalize the necessity of establishing laboratory standards for all stakeholders.