Cold chain: Validation of an instrument for Evaluation

Author(s): Maila Martins de Oliveira

The cold chain of immunobiological conservation is a strategic activity of the National Immunization Program (NIP) to maintain the quality of these inputs. Despite its undeniable relevance, research studies carried out in several countries detected shortcomings such as: storage temperatures outside the recommended, lack of devices for monitoring this temperature, absence of electrical generators, inadequate reception of immunobiologicals at various levels of the cold chain, lack of conformity in the ambiance of the coils of reusable ice, putting immunobiologicals at risk of exposure to freezing temperatures, among others, which endanger the effectiveness of immunobiologicals and the NIP (1- 8). To develop and to test the validity of content and layout of a multidimensional tool to evaluate maintenance of the cold chain for immunobiological conservation. A methodological study carried out in three steps: integrative review; development of theoretical and logical model for the develop¬ment of the tool (figure 1); implementation of the Delphi Technique to test the validity of content and layout. The Content Validity Index (CVI) and Content Validity Ratio (CVR) were calculated considering appropriate those values greater than or equal to 75% and 0.4, respectively. The instrument consisted of 7 questions about structure and 20 about process, subdivided into three components: Transportation/Recep¬tion; Storage/Handling; Supervision/Permanent education. The CVI value was 87.4%, with values equal to 85.7% and 89% in the structure and process dimensions, respectively. The process compo¬nents obtained CVI values equal to 88.9, 88.9 and 89.2%, respectively. The CVR was 0.8, with values equal to 0.7 and 0.8 in the structure and process dimensions. As for the layout valida¬tion, the questionnaire was consid¬ered intelligible. The study provides an instrument with validity of content and layout for health professionals in charge of the supervision of activi¬ties of immunobiological conserva-tion, ensuring the maintenance of the immunogenic quality of the products offered to the population.