ISO 15189 standard in the pre-analytical phase of the microbiology area of the Ecuadorian Institute of Social Security Jipijapa

Abstract

The preanalytical phase is an important part of clinical laboratories, where different procedures can affect the results of patient tissue or body fluid samples. The objective of the study was to evaluate the ISO 15189 standard in the preanalytical phase of the microbiology area of the Ecuadorian Social Security Institute. The methodology applied was observational descriptive with a cross-sectional study, in addition to a prospective risk-free study. This study did not consider the use of a population or sample, as it focused on evaluating the degree of application of the international ISO 15189 standard. The results revealed that out of thirteen questions, five were met; regarding the instructions for sample collection, two questions were not met, and similarly, in the sample transport section, three questions were not met. The continuous improvement plan was based on the non-conformities determined from the self-assessment questionnaire of the Ecuadorian accreditation system criteria according to the ISO 15189 standard: 2012. Essential elements were applied in the pre-analytical phase in the area of microbiology, which guaranteed an evaluation of quality and reliability. It was concluded that the initial diagnosis regarding compliance with ISO 15189 standards in the pre-analytical phase shows a notable deficiency in various areas. The importance of ongoing education and training of personnel in pre-analytical variables is highlighted. It points out that ISO 15189 and ISO 9001 standards are key to the regulation and documentation of microbiological procedures.