Current Situation of Molecular Diagnostic Assay in Iran: Is it Necessary to Revise of Health Surveillance System at Laboratory Level?

Dear Editor,

Molecular diagnostic assays have a critical role in clinical decision making throughout the world. All diagnostic methods have been performing by different laboratories and at different times on the same specimens. Laboratories must have been interoperated by reliability and consistency procedures. However, unfortunately, we are involved with the number of unreliable laboratory results. The importance of standardization is due to its ability to minimize uncertainty from the pre-analytical phase up to the preparation of final reports [1]. Therefore, the quality of laboratory results must be extended by enhancing clinician and patient requests and their satisfaction.

Laboratory mistakes have been reported all over the world and can sometimes cause permanent harm or even death of patients [2]. Molecular techniques are one of tests that help clinicians in making the final decision and hence require strict supervision on various aspects. In a laboratory that has been certified for their technical qualification, there are some other impacting factors that are not under the control of the laboratory [3]. These include the use of validated equipment, approved laboratory kits and, ultimately, a competent technical authority to monitor the process and results of tests performed. We are going to have a brief review of those parameters that are not under the control of diagnostic laboratories.

One of the pitfalls that is not directly associated with performance of clinical laboratory and needs to have correct and active governmental policies that is a duty under medical devices department. This office is a governmental body of Health Ministry that has the main role in approving and selecting required laboratory procedures and devices such as instruments, reference materials, consumables, reagents and analytical systems. The adverse effects of these pitfalls could be mitigated by having correct and active governmental reports [3]. Besides, these long bureaucratic time-consuming processes may cause and encourage the laboratories to use home brew diagnostic kits without having full validation which also require clearing clinical trial experiments since they have a much lower cost than those approved ones. These protocols have obviously lower sensitivity, specificity and repeatability than the internationally approved protocols. Our periodical inspection reveals that a lot of equipment used for the patient’s specimen still exist at the diagnostic laboratories that have not been approved yet. Another issue affecting the quality of any laboratory is being audited, especially the regular external audit. These authorities are responsible under the duty of the Laboratory Affairs Offices (LAO) of each university throughout the country in Iran. These offices are located under treatment deputy of each medical university. They are involved in surveillance for all clinical laboratories and arrange for their regular auditing [3, 4]. Unfortunately, this duty is not currently efficiently performing in correct way since most of their staff don’t have the required knowledge, and are continuously substituted. Besides, they are not arranging for regular audits since they have to cover hundreds of laboratories. Obviously, we need to revise the auditing procedure [5]. Another matter, and the most important one, is laboratory performance. Periodical inspections have revealed that some common systematic errors still exist in the routine works of clinical laboratories, even in the laboratories that tend to apply all validation criteria. Undoubtedly, technical authorities of each diagnostic laboratory have the most important role in checking the validity of the whole diagnosis processes. Non-harmonization of analytical issues is an important effecting parameter that may cause misinterpretation of the results or might lead to some other problems [3].

External quality assessment (EQA) and proficiency testing have been and should remain an integral part of laboratory quality assurance. EQA is defined by the World Health Organization (WHO) as ‘a system of objectively checking laboratory results by an external agency to establish inter-laboratory consistency’. The process establishes, harmonizes and standardizes best practices for laboratory tests, and allows an accurate assessment of the diagnosis quality. This program can indeed identify systematic errors in methodology that may not be revealed by internal QA processes. The responsibility of performing EQA schemes was decided to be transferred to two non-governmental organizations that are independent bodies “Pishgam Iranian Group©” and “Iranian Association of Clinical Laboratory Doctors” since 2008. No scientific report has been released on their success in reducing nonconformities within the laboratories yet. It seems the procedures selected by both organizations are not able to upgrade the laboratory performance and to reveal their weaknesses [2].

Briefly, overviewing all the discussed issues has revealed that the Iranian clinical diagnostic centers are faced with several barriers. These might be raised from two possibilities issues. Firstly, there is no clear view on the importance of standardization in laboratories’ performance, either by clinical diagnostic centers or by all authority bodies and offices. Secondly, it seems that there is not any active supervision or required penalties for any laboratories with various non-conformities that affect the results. Therefore, laboratories have not been encouraged to pay enough attention to this concern. This uncertainty would not be solved in the recent future, unless some basic revisions are applied in all of the involved authority bodies and guidelines.

Abbreviations

RHL

Reference health laboratory

MOHME

Ministry of health and medical education

LAO

Laboratory affairs offices

QA

Quality assurance

EQA

External quality assurance

Compliance with ethical standards

Conflict of interest

The authors declare that there is no conflict of interest.