title: Quality assurance program for molecular medicine laboratories.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Hajia
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: N
authors.initials: N
authors.lastname: Safadel
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: S Mirab
authors.initials: SM
authors.lastname: Samiee
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: P
authors.initials: P
authors.lastname: Dahim
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: S
authors.initials: S
authors.lastname: Anjarani
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: N
authors.initials: N
authors.lastname: Nafisi
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: Amir
authors.initials: A
authors.lastname: Sohrabi
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: M
authors.initials: M
authors.lastname: Rafiee
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: F
authors.initials: F
authors.lastname: Sabzavi
authors.affiliation: Health Reference Laboratory of Iran, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: B
authors.initials: B
authors.lastname: Entekhabi
keywords: Accreditation; Iran; Molecular Laboratory; Quality Assurance