Strengthening the regulatory system through the implementation and use of a quality management system.

Quality management systems (QMS), based on ISO 9001 requirements, are applicable to government service organizations such as Health Canada's Biologics and Genetic Therapies Directorate (BGTD). This communication presents the process that the BGTD followed since the early 2000s to implement a quality management system and describes how the regulatory system was improved as a result of this project. BGTD undertook the implementation of a quality management system based on ISO 9001 and containing aspects of ISO 17025 with the goal of strengthening the regulatory system through improvements in the people, processes, and services of the organization. We discuss the strategy used by BGTD to implement the QMS and the benefits that were realized from the various stages of implementation. The eight quality principals upon which the QMS standards of the ISO 9000 series are based were used by senior management as a framework to guide QMS implementation.

Strengthening the regulatory system through the implementation and use of a quality management system / Fortalecimiento del sistema de reglamentación mediante la aplicación y el uso de un sistema de gestión de la calidad

Quality management systems (QMS), based on ISO 9001 requirements, are applicable to government service organizations such as Health Canada’s Biologics and Genetic Therapies Directorate (BGTD). This communication presents the process that the BGTD followed since the early 2000s to implement a quality management system and describes how the regulatory system was improved as a result of this project. BGTD undertook the implementation of a quality management system based on ISO 9001 and containing aspects of ISO 17025 with the goal of strengthening the regulatory system through improvements in the people, processes, and services of the organization. We discuss the strategy used by BGTD to implement the QMS and the benefits that were realized from the various stages of implementation. The eight quality principals upon which the QMS standards of the ISO 9000 series are based were used by senior management as a framework to guide QMS implementation.

De acuerdo con las normas ISO 9001, los sistemas de gestión de la calidad (SGC) son aplicables a las entidades de la administración pública, como la Dirección de Insumos Biológicos y Terapias Genéticas de Salud Canadá (BGTD por su sigla en inglés). En esta comunicación se describe el proceso que siguió la BGTD desde principios del siglo XXI para instituir un sistema de gestión de la calidad y las mejoras incorporadas como resultado de este proyecto. La BGTD se propuso instaurar un sistema de gestión de la calidad conforme a la norma ISO 9001 y algunos aspectos de la ISO 17025 con el propósito de fortalecer el sistema de reglamentación mejorando los recursos humanos, los procesos y los servicios de la entidad. En esta comunicación, describimos la estrategia empleada por la BGTD para aplicar el SGC y los beneficios logrados en las diversas etapas de su aplicación. A modo de guía en la aplicación del SGC, el personal directivo superior utilizó como marco los ocho principios de gestión de la calidad en los que se basa la serie de normas ISO 9000.

Strengthening the regulatory system through the implementation and use of a quality management system / Fortalecimiento del sistema de reglamentación mediante la aplicación y el uso de un sistema de gestión de la calidad

ABSTRACT Quality management systems (QMS), based on ISO 9001 requirements, are applicable to government service organizations such as Health Canada's Biologics and Genetic Therapies Directorate (BGTD). This communication presents the process that the BGTD followed since the early 2000s to implement a quality management system and describes how the regulatory system was improved as a result of this project. BGTD undertook the implementation of a quality management system based on ISO 9001 and containing aspects of ISO 17025 with the goal of strengthening the regulatory system through improvements in the people, processes, and services of the organization. We discuss the strategy used by BGTD to implement the QMS and the benefits that were realized from the various stages of implementation. The eight quality principals upon which the QMS standards of the ISO 9000 series are based were used by senior management as a framework to guide QMS implementation.(AU)

RESUMEN De acuerdo con las normas ISO 9001, los sistemas de gestión de la calidad (SGC) son aplicables a las entidades de la administración pública, como la Dirección de Insumos Biológicos y Terapias Genéticas de Salud Canadá (BGTD por su sigla en inglés). En esta comunicación se describe el proceso que siguió la BGTD desde principios del siglo XXI para instituir un sistema de gestión de la calidad y las mejoras incorporadas como resultado de este proyecto. La BGTD se propuso instaurar un sistema de gestión de la calidad conforme a la norma ISO 9001 y algunos aspectos de la ISO 17025 con el propósito de fortalecer el sistema de reglamentación mejorando los recursos humanos, los procesos y los servicios de la entidad. En esta comunicación, describimos la estrategia empleada por la BGTD para aplicar el SGC y los beneficios logrados en las diversas etapas de su aplicación. A modo de guía en la aplicación del SGC, el personal directivo superior utilizó como marco los ocho principios de gestión de la calidad en los que se basa la serie de normas ISO 9000.(AU)

Incidence of Renal Failure Requiring Hemodialysis Following Transcatheter Aortic Valve Replacement.

OBJECTIVE: Studies have shown that iodinated radiocontrast use is associated with acute renal failure especially in the presence of chronic kidney disease and multiple factors modulate this risk. The purpose of this meta-analysis is to compare the incidence of renal failure requiring hemodialysis between transfemoral (TF) and transapical (TA) transcatheter aortic valve replacement using the Edwards valve. METHODS: The PubMed database was searched from January 2000 through December 2014. A total of 10 studies (n = 2,459) comparing TF (n = 1,268) and TA (n = 1,191) TAVR procedures using the Edwards valve were included. Variables of interest were baseline logistic EuroSCORE, prevalence of diabetes mellitus, hypertension, peripheral arterial disease, chronic kidney disease and amount of contrast used. The primary endpoint was incidence of renal failure requiring hemodialysis. The odds ratio and 95% CI were computed and P < 0.05 was considered as the level of significance. RESULTS: The logistic EuroSCORE was significantly higher in TA compared to TF (P = 0.001) TAVR. The amount of contrast (mL) used was significantly higher in the TF group compared to the TA group (mean difference: 36.9, CI: 25.7-48.1, P < 0.001). The incidence of hemodialysis following the procedure was significantly higher in the TA group compared to TF group (odds ratio = 4.3, CI: 2.4-7.8, P < 0.00001). CONCLUSIONS: This meta-analysis suggests that despite the lower amount of contrast used in TA-TAVR, the incidence of renal failure requiring hemodialysis was higher with the Edwards valve. This suggests that the incidence of renal failure requiring hemodialysis after TAVR is associated with baseline comorbidities in the TA-TAVR group rather than the volume of contrast used.

Hydroxyurea decreases hospitalizations in pediatric patients with Hb SC and Hb SB+ thalassemia.

PURPOSE: Patients with hemoglobin SC (Hb SC) and hemoglobin SB+ (Hb SB+) thalassemia suffer from frequent hospitalizations yet strong evidence of a clinical benefit of hydroxyurea (HU) in this population is lacking. Patients with recurrent hospitalizations for pain crisis are offered HU at our institution based on small cohort data and anecdotal benefit. This study identifies outcomes from a large cohort of patients with Hb SC and SB+ thalassemia who were treated with HU for 2 years. MATERIALS AND METHODS: A retrospective review was conducted of 32 patients with Hb SC and SB+ thalassemia who were treated with HU. We reviewed the number, and reasons for hospitalization in the 2 years prior to, and 2 years post-HU treatment as well as laboratory changes from baseline, over 1 year. RESULTS: Patients with Hb SC and SB+ thalassemia started on HU for frequent pain, had a significant reduction in hospitalizations over 2 years as compared to the 2 years prior to HU initiation (mean total hospitalizations/year: pre-HU: 1.6 vs post-HU 0.4 hospitalizations, P<0.001; mean pain hospitalizations/year: pre-HU 1.5 vs post-HU 0.3 hospitalizations, P<0.001). Patients demonstrated hematologic changes including an increase in percent fetal hemoglobin (%HbF) pre-post HU (4.5% to 7.7%, P=0.002), mean corpuscular volume (74 to 86 fL, P<0,0001), and decrease in absolute neutrophil count (5.0 to 3.2×10(9)/L, P=0.007). Patients with higher doses of HU demonstrated the greatest reduction in hospitalizations but this was unrelated to absolute neutrophil count. CONCLUSION: This cohort of patients with Hb SC and SB+ thalassemia provides additional support for using HU in patients with recurrent hospitalizations for pain. A large randomized multicenter trial of HU to reduce pain admissions should be conducted to confirm these data and provide much needed evidence based recommendations for this population.