La norma UNE 179007: Sistemas de Gestión de la Calidad para Laboratorios de Reproducción Asistida, ¿obsoleta o vigente? / Une 179007: Quality management system applied to IVF laboratories, outdated or current

Los Laboratorios de Reproducción Humana Asistida (LRHA) deben tener implementado un Sistema de Gestión de Calidad (SGC) que favorezca el seguimiento de los procesos y técnicas realizadas en los mismos, así como la obtención de un servicio de alta calidad y fiabilidad para los pacientes. Con el fin de disponer de una certificación de calidad aplicada específicamente a los LRHA, en 2013 se publica la UNE 179007, otorgada por AENOR y basada en la norma de Sistema de Gestión de la Calidad de la Organización Internacional de Normalización (ISO) vigente en ese momento, es decir la ISO 9001:2008.En 2015 se publicó la 4ª versión de la ISO 9001 que incorporaba cambios de contenido y de formato, adaptándose a la estructura establecida por el Anexo SL, (elaborado con el fin de unificar estructuras en los estándares ISO). Ante esta nueva edición, como la UNE 179007 está basada en su versión ante-rior, surge la cuestión de si debido a estos cambios, la norma específica para los LRHA ha quedado obsoleta.En el presente trabajo se realizó una revisión a fondo de las estructuras y contenidos de las diferentes publicaciones para determinar hasta qué punto puede haber afectado a la vigencia de la UNE 179007. (AU)

Assisted reproductive laboratories have to provide a Quality Management System (QMS) to help the monitoring of the processes and techniques performed in them, as well as obtaining a high quality and reliable service for their patients. In order to have a quality certification specifically applied to IVF laboratories, it was published in 2013 UNE 179007 granted by AENOR and based on the Quality Management System of the International Organization for Standardization (ISO) in force in that year, ISO 9001:2008.The 4th version of ISO 9001 was published in 2015 including content and format changes tailoring to the structure fixed by Annex SL, which was prepared in order to unify structures in ISO standards. Faced to this new edition, as UNE 179007 is based in its previous version, these changes force us to consider if the specific standard for LRHA has become obsolete or is it still valid?In the present work, a thorough review of the structures and contents of the different publications was carried out to determine to what extent it may have affected the validity of UNE 179007. Once this exhaustive analysis was performed, we concluded that future updates should take into account the changes contemplated in ISO 9001:2015, which are more structural than content-related, as well as the evolution of the techniques used in the IVF laboratories. However, we believe that it cannot be consi-dered obsolete because it is still the only specific rule for the implementation of a QMS in assisted reproductive laboratories. (AU)

Application of a sperm survival test: Results from an external quality control programme.

OBJECTIVE: The study aim is to determine which type of material - pipette tips or culture medium - is more appropriate for use in a cytotoxicity external quality control programme (CT-EQC). STUDY DESIGN: The results of the participating laboratories in Spanish CT-EQC programme for human reproduction laboratories during the period 2013-2016 were analyzed. Per year, laboratories receiving three pipette tips and three aliquots of culture medium. All laboratories used the human sperm survival test to perform the bioassay. On average 48 laboratories took part in the programme each year. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and overall accuracy were calculated, with the corresponding 95% confidence intervals. RESULTS: Overall, for both products, sensitivity was higher than specificity, and NPV was higher than PPV. For laboratories participating for the first time in the CT-EQC, lower results were obtained in sensitivity and specificity in culture media than in pipette tips. However, in subsequent years, these differences disappeared. The PPV obtained for pipette tips was higher than that obtained for culture media (0.82 (0.77-0.87) vs 0.71 (0.66-0.76)). No relationship was recorded between the laboratories' accuracy in culture media and pipette tips (r = 0.026). CONCLUSIONS: From a logistical standpoint, pipette tips are more appropriate than culture medium for use in a CT-EQC programme.

Critical appraisal of the Vienna consensus: performance indicators for assisted reproductive technology laboratories.

The Vienna consensus, based on the recommendations of an expert panel, has identified 19 performance indicators for assisted reproductive technology (ART) laboratories. Two levels of reference values are established for these performance indicators: competence and benchmark. For over 10 years, the Spanish embryology association (ASEBIR) has participated in the definition and design of ART performance indicators, seeking to establish specific guidelines for ART laboratories to enhance quality, safety and patient welfare. Four years ago, ASEBIR took part in an initiative by AENOR, the Spanish Association for Standardization and Certification, to develop a national standard in this field (UNE 17900:2013 System of quality management for assisted reproduction laboratories), extending the former requirements, based on ISO 9001, to include performance indicators. Considering the experience acquired, we discuss various aspects of the Vienna consensus and consider certain discrepancies in performance indicators between the consensus and UNE 179007:2013, and analyse the definitions, methodology and reference values used.

Reliability and agreement on embryo assessment: 5 years of an external quality control programme.

An external quality-control programme for morphology-based embryo quality assessment, incorporating a standardized embryo grading scheme, was evaluated over a period of 5 years to determine levels of inter-observer reliability and agreement between practising clinical embryologists at IVF centres and the opinions of a panel of experts. Following Guidelines for Reporting Reliability and Agreement Studies, the Gwet index and proportion of positive (Ppos) and negative agreement were calculated. For embryo morphology assessment, a substantial degree of reliability was measured between the centres and the panel of experts (Gwet index: 0.76; 95% CI 0.70 to 0.84). The agreement was higher for good- versus poor-quality embryos. When multinucleation or vacuoles were observed, low levels of reliability were obtained (Ppos: 0.56 and 0.43, respectively). In blastocysts, the characteristic that presented the largest discrepancy was that related to the inner cell mass. In decisions about the final disposition of the embryo, reliability between centre and the panel of experts was moderate (Gwet index: 0.51; 95% CI 0.41 to 0.60). In conclusion, the ability of clinical embryologists to evaluate the presence of multinucleation and vacuoles in the early cleavage embryo, and to determine the category of the inner cell mass in blastocysts, needs to be improved.

Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse.

The aim of this study is to determine inter-laboratory variability on embryo assessment using time-lapse platform and conventional morphological assessment. This study compares the data obtained from a pilot study of external quality control (EQC) of time lapse, performed in 2014, with the classical EQC of the Spanish Society for the Study of Reproductive Biology (ASEBIR) performed in 2013 and 2014. In total, 24 laboratories (8 using EmbryoScope™, 15 using Primo Vision™ and one with both platforms) took part in the pilot study. The clinics that used EmbryoScope™ analysed 31 embryos and those using Primo Vision™ analysed 35. The classical EQC was implemented by 39 clinics, based on an analysis of 25 embryos per year. Both groups were required to evaluate various qualitative morphological variables (cell fragmentation, the presence of vacuoles, blastomere asymmetry and multinucleation), to classify the embryos in accordance with ASEBIR criteria and to stipulate the clinical decision taken. In the EQC time-lapse pilot study, the groups were asked to determine, as well as the above characteristics, the embryo development times, the number, opposition and size of pronuclei, the direct division of 1 into 3 cells and/or of 3 into 5 cells and false divisions. The degree of agreement was determined by calculating the intra-class correlation coefficients and the coefficient of variation for the quantitative variables and the Gwet index for the qualitative variables. For both EmbryoScope™ and Primo Vision™, two periods of greater inter-laboratory variability were observed in the times of embryo development events. One peak of variability was recorded among the laboratories addressing the first embryo events (extrusion of the second polar body and the appearance of pronuclei); the second peak took place between the times corresponding to the 8-cell and morula stages. In most of the qualitative variables analysed regarding embryo development, there was almost-perfect inter-laboratory agreement among conventional morphological assessment (CMA), EmbryoScope™ and Primo Vision™, except for false divisions, vacuoles and asymmetry (users of all methods) and multinucleation (users of Primo Vision™), where the degree of agreement was lower. The inter-laboratory agreement on embryo classification according to the ASEBIR criteria was moderate-substantial (Gwet 0.41-0.80) for the laboratories using CMA and EmbryoScope™, and fair-moderate (Gwet 0.21-0.60) for those using Primo Vision™. The inter-laboratory agreement for clinical decision was moderate (Gwet 0.41-0.60) on day 5 for CMA users and almost perfect (Gwet 0.81-1) for time-lapse users. In conclusion, time-lapse technology does not improve inter-laboratory agreement on embryo classification or the analysis of each morphological variable. Moreover, depending on the time-lapse platform used, inter-laboratory agreement may be lower than that obtained by CMA. However, inter-laboratory agreement on clinical decisions is improved with the use of time lapse, regardless of the platform used.