La gestión de la calidad y la acreditación ISO 15189 en los laboratorios clínicos de Latinoamérica / Quality management and ISO 15189 accreditation in clinical laboratories in Latin America / Gestão da qualidade e acreditação ISO 15189 nos laboratórios clínicos da América Latina

Resumen El presente trabajo fue realizado por el Grupo de Trabajo Gestión de Acreditación de la Confederación Latinoamericana de Bioquímica Clínica (COLABIOCLI) con el objetivo de conocer el estado de los Laboratorios Clínicos (LC) con respecto a la gestión de la calidad y el estatus de la acreditación ISO 15189 en Latinoamérica. La investigación fue de tipo observacional, transversal y descriptiva; se utilizó como herramienta la encuesta y como instrumento el cuestionario. Los resultados se expresaron en frecuencias simples y porcentajes y se analizaron por estadística descriptiva. En las 253 encuestas aceptadas participaron LC de 15 de 16 países integrantes de COLABIOCLI. El 80% de los LC tenían procedimientos de la fase preanalítica y posanalítica. Más del 85% contaba con registros de gestión de la calidad y participaban en programas de evaluación externa de la calidad (PEEC), principalmente en las disciplinas de química clínica (mayor del 80%) y hematología (mayor del 70%). El 7,51% estaban acreditados por ISO 15189 y 10,27% certificados por ISO 9001. La gestión de la calidad y los PEEC presentan un importante avance en los LC de Latinoamérica; sin embargo, es deseable que todas las partes interesadas armonicen intereses, para que este proceso sea introducido paulatinamente y como parte de las normativas y/o regulaciones obligatorias respectivas, lo que podrá contribuir a que más LC se acrediten en base a ISO 15189 en la región.

Abstract The present work was carried out by the Accreditation Management Working Group of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI) with the aim of knowing the status of Clinical Laboratories (LC, for its acronym in Spanish) with respect to quality management and the status of the ISO 15189 accreditation in Latin America. The research was observational, cross-sectional, and descriptive, using the survey as a tool and the questionnaire as an instrument. The results were expressed in simple frequencies and percentages and analysed by descriptive statistics. LCs from 15 of the 16 member countries of COLABIOCLI participated in the 253 surveys accepted. Eighty percent of LCs had pre-analytical and post-analytic procedures, and more than 85% had quality management records and participated in external quality assessment services (EQAS), mainly in the disciplines of clinical chemistry (greater than 80%) and hematology (greater than 70%); 7.51% were ISO 15189 accredited and 10.27% ISO 9001 certified. Although quality management and EQAS represent an important advance in LCs in Latin America, it is desirable that all stakeholders harmonise interests, so that this process is introduced gradually and as part of the respective mandatory standards and/or regulations, thus contributing to more LCs being accredited based on ISO 15189 in the region.

Resumo O presente trabalho foi realizado pelo Grupo de Trabalho de Gestão de Acreditação da Confederação Latino-Americana de Bioquímica Clínica (COLABIOCLI) com o objetivo de conhecer o status dos Laboratórios Clínicos (LC) com relação à gestão da qualidade e o status da acreditação ISO 15189 na América Latina. A pesquisa foi observacional, transversal e descritiva, utilizando a enquete como ferramenta e o questionário como instrumento. Os resultados foram expressos em frequências simples e porcentagens e analisados por estatística descritiva. LCs de 15 dos 16 países membros do COLABIOCLI participaram das 253 pesquisas aceitas; 80% dos LCs tinham procedimentos da fase pré-analítica e pós-analítica, e mais de 85% tinham registros de gestão da qualidade e participavam de programas de avaliação externa da qualidade (PEEC), principalmente nas disciplinas de química clínica (maior de 80%) e hematologia (maior de 70%); 7,51% estavam acreditados pela ISO 15189 e 10,27% certificados pela ISO 9001. Embora a gestão da qualidade e os PEECs apresentem um importante avanço nos LCs da América Latina, é desejável que todas as partes interessadas harmonizem interesses, para que esse processo seja introduzido gradualmente e como parte das respectivas normas e/ou regulações obrigatórias, o que poderá contribuir para que mais LCs sejam acreditados com base na ISO 15189 na região.

Active Surveillance of Antimicrobial Resistance and Carbapenemase-Encoding Genes According to Sites of Care and Age Groups in Mexico: Results from the INVIFAR Network.

We analyzed the antimicrobial resistance (AMR) data of 6519 clinical isolates of Escherichia coli (n = 3985), Klebsiella pneumoniae (n = 775), Acinetobacter baumannii (n = 163), Pseudomonas aeruginosa (n = 781), Enterococcus faecium (n = 124), and Staphylococcus aureus (n = 691) from 43 centers in Mexico. AMR assays were performed using commercial microdilution systems (37/43) and the disk diffusion susceptibility method (6/43). The presence of carbapenemase-encoding genes was assessed using PCR. Data from centers regarding site of care, patient age, and clinical specimen were collected. According to the site of care, the highest AMR was observed in E. coli, K. pneumoniae, and P. aeruginosa isolates from ICU patients. In contrast, in A. baumannii, higher AMR was observed in isolates from hospitalized non-ICU patients. According to age group, the highest AMR was observed in the ≥60 years age group for E. coli, E. faecium, and S. aureus, and in the 19-59 years age group for A. baumannii and P. aeruginosa. According to clinical specimen type, a higher AMR was observed in E. coli, K. pneumoniae, and P. aeruginosa isolates from blood specimens. The most frequently detected carbapenemase-encoding gene in E. coli was blaNDM (84%).

Increment Antimicrobial Resistance During the COVID-19 Pandemic: Results from the Invifar Network.

Aim: This study aims to assess the changes in antimicrobial resistance among some critical and high-priority microorganisms collected previously and during the coronavirus disease 2019 (COVID-19) pandemic in Mexico. Methods: We collected antimicrobial susceptibility data for critical and high-priority microorganisms from blood, urine, respiratory samples, and from all specimens, in which the pathogen may be considered a causative agent. Data were stratified and compared for two periods: 2019 versus 2020 and second semester 2019 (prepandemic) versus the second semester 2020 (pandemic). Results: In the analysis of second semester 2019 versus the second semester 2020, in blood samples, increased resistance to oxacillin (15.2% vs. 36.9%), erythromycin (25.7% vs. 42.8%), and clindamycin (24.8% vs. 43.3%) (p ≤ 0.01) was detected for Staphylococcus aureus, to imipenem (13% vs. 23.4%) and meropenem (11.2% vs. 21.4) (p ≤ 0.01), for Klebsiella pneumoniae. In all specimens, increased ampicillin and tetracycline resistance was detected for Enterococcus faecium (p ≤ 0.01). In cefepime, meropenem, levofloxacin, and gentamicin (p ≤ 0.01), resistance was detected for Escherichia coli; and in piperacillin-tazobactam, cefepime, imipenem, meropenem, ciprofloxacin, levofloxacin, and gentamicin (p ≤ 0.01), resistance was detected for Pseudomonas aeruginosa. Conclusion: Antimicrobial resistance increased in Mexico during the COVID-19 pandemic. The increase in oxacillin resistance for S. aureus and carbapenem resistance for K. pneumoniae recovered from blood specimens deserves special attention. In addition, an increase in erythromycin resistance in S. aureus was detected, which may be associated with high azithromycin use. In general, for Acinetobacter baumannii and P. aeruginosa, increasing resistance rates were detected.