Abstract
Implementation research aims to link research and practice to carry out interventions, tools or treatments that have been shown to be effective in controlled conditions and make them available to those who need them in the real world, ensuring their sustainability overtime. It is known that in low-income countries, the implementation challenges are greater. The province of Chaco (Argentina), where more than one million inhabitants lives, is one of the poorest in the country. In it, a Creatinine Standardization Program was implemented in clinical laboratories in the year 2000, a program that still is running. 2010. The objective of this presentation is to describe the barriers encountered in the implementation of the mentioned program, and to show the application of the Clinical and Laboratory Standard Institute (CLSI) EP5-A as an implementation strategy to determine precision and to guarantee sustainability. The program was divided into three phases: a baseline survey, the implementation of the standardization program, and an end-line survey. During this process, three laboratory controls were completed. The systematic approach began with the collaboration of the multidisciplinary research team with biochemists that covered primary health care throughout the province. Public and private clinical laboratories participated in the discussion of the barriers that arise during the implementation of the program. Of 49 participating laboratories, 36 (73.5%) remain active; 5 (14%) with Total Error (TE) <10% sustained over time; 7 (19%) Random Error (RE) within expected limits with TE> 10%; 16 (45%) remain with difficulties in both RE and Sistematic error (SE); 8 (22%) did not present stable results in the RE and / or SE. The barriers to effective implementation and ensuring sustainability were: heterogeneity of reagents and calibrators; need for continuous training to interpret the results of external evaluations; non-homogeneous equipment (equipment from one manufacturer and reagents from another); reuse of disposable material; frequent power outages and water quality; high ambient temperatures; maintenance of the cold chain, since the samples must be frozen at -70ºC; long distances to travel in areas with lack of pavement; non-automatic equipment; persistence of the Jaffe method and lack of traceable reagents in the country. The implementation of creatinine standardization is not an easy task, especially in underdeveloped regions. The multidisciplinary team has to solve implementation problems rather than the eventual results of creatinine standardization per se. During the running of the program, the fidelity of the laboratories was high but still persist the need for adaptation in order to achieve the desired standards.
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