Comment on “Upgrading the Iranian National Laboratory Standard to Conform to ISO 15189:2012”

Dear Editor,

In a recent issue of the Accreditation and Quality Assurance journal, Safadel et al. [1] announced that Reference Health Laboratory of Iran is going to upgrade the national laboratory standard to make it more compatible with ISO 15189:2012. They have been assuming that the majority of laboratories have a standard infrastructural, since they believe most laboratories have implemented the main requirements of this issue.

Let us take a brief look at published literature [1], secretary of health decided to establish a department called Reference Health Laboratory of Iran (RHL) in 2006. This new structural was established by integration the “Directorate of General Affairs and Laboratory department of CDC” and “Reference Laboratories of Iran” [2]. RHL has been highlighted the main goal as “Quality Improvement of Medical Laboratory Network”. It was based on “policies of Ministry of Health and Medical Education, and “development goals and requirements of International Health Regulations” (IHR). They have been trying to achieve a certain level of quality among thousands of diagnostic laboratories. Therefore, three phases considered : training, implementation and accreditation. Safadel et al. [3], have been reported of some unsolved problems throughout the country such as cultural problems and resistance to change that they have mentioned as the main obstacles of reduced the pace of standardization. It would seem most of these difficulties remain in majority of clinical laboratory exposures, but there is no independent scientific study for evaluation of the main designed goals. External quality assessment and proficiency testing have been applying as an integral part of laboratory quality assurance. This process establishes harmonizing and standardizing at all laboratory processes [4]. It is the best practice for laboratory tests, and allows assessing diagnosis quality and accuracy. This program can indeed identify systematic errors in methodology that may not be revealed by internal QA (Quality assurance) processes. Two independent organizations have been determined to perform external QA annually throughout the country. However, laboratories staff are not allowed to access the details of launched results and no scientific result has reported yet. One the other hand, “Laboratory Affairs` Offices” has the responsibility for auditing the laboratories at each province of Iran. Unfortunately, they are performing in wide range flexibility and without sufficient similarity in their auditing despite of full training. The main reasons are existence of more than 6000 laboratories in Iran, lack of sufficient auditors and frequently changing of laboratory staff and auditors leads to individual experiences are not transferred correctly. We are still facing with frequently reports on unreliability results [4, 5]. It seems all influential parameters must be carefully evaluated through independent studies and scientific investigations. At first, establishing appropriate penalties must be defined for laboratories that have nonconformities reports and do not meet the standards. Revising the auditing process and its method, and having the true evaluation of current running EQA are the initially steps before moving toward ISO 15189:2012.

To sum up, some of the main highlighted points of current issue are scientific investigation on all processes with establish expert committees, publishing regular progress reports, reducing the long bureaucratic procedures on evaluation at each step, merging those small clinical laboratories in each province, utilization of other laboratories stockholders and having an organized proficiency testing that to be enable to overcome difficulties and limitations of ISO 15189:2012 implementation in Iran.

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Conflict of interest

The authors declare that they have no conflicts of interest.