Back
The concept of quality in the healthcare field includes dimensions such as equity, equal access, ethical principles, impact on population health, and patient safety. From this point of view, we must ensure quality from both the laboratory and the laboratory group as a Health System. Chronic Kidney Disease (CKD) is a major public health issue. Since 2003, the KDOQI Guidelines established a stratification of CKD, based on the measurement of serum creatinine. A specific test that is traceable to international standards and with minimal deviation from the reference method is necessary for this to be carried out. In 2006, the International Creatinine Standardization Program was initiated to meet these requirements, allowing routine methods to be calibrated with traceability to international standards. The industry's role is crucial in transferring the development to all diagnostic products marketed in the world. This study describes the results of the Creatinine Standardization Program, which was conducted in the province of Chaco, Argentina from 2010 to 2018. Its objective was to evaluate the Total Error (TE) of the determination in the participating laboratories, as well as to identify the causes why the analytical quality requirements were not achieved.
Retrospective descriptive study in which 49 laboratories distributed throughout the province of Chaco, Argentina participated. Working conditions were surveyed, and international protocols were applied to analyze TE, Systematic Error (SE) and Random Error (RE). Conferences were held to analyze the results.
Standardized reagents and homogeneous analytical systems are readily available in Argentina. Both coexist with reagents, which are sometimes the most used, not traceable to the international standard, and used in heterogeneous systems. According to the External Quality Assessment Program, 78% of laboratories use non-standardized methods, while only 22% use standardized methods. Only 14% of the participating laboratories achieved a TE 10%. The complexity of variables that influence was exposed. Laboratories with the greatest volume of work, homogeneous systems, internal and external quality controls, and using traceable reagents were in large cities and achieved a TE of 10%. On the other hand, those laboratories that could not achieve an expected TE, presented common characteristics: lower volume of work, generally located in smaller towns, heterogeneous systems, difficulties with water quality and continuous supply of energy, and non-stability of environmental temperature. TE was greater than 10% in these labs.
The analytical requirements were dependent on multiple factors, including environmental conditions and the availability of resources that adapt to the user's needs. This highlights the inequity that exists between laboratories. The role of industry is crucial for the development of traceable reagents and the creation of homogeneous systems accessible to all laboratories. So, the industry may close the gap in analytical quality between laboratories.