An Extensive Quality Control and Quality Assurance (QC/QA) Program Significantly Improves Inter-Laboratory Concordance Rates of Flow-Cytometric Minimal Residual Disease Assessment in Acute Lymphoblastic Leukemia: An I-BFM-FLOW-Network Report

Monitoring of minimal residual disease (MRD) by flow cytometry (FCM) is a powerful prognostic tool for predicting outcomes in acute lymphoblastic leukemia (ALL). To apply FCM-MRD in large, collaborative trials, dedicated laboratory staff must be educated to concordantly high levels of expertise and their performance quality should be continuously monitored. We sought to install a unique and comprehensive training and quality control (QC) program involving a large number of reference laboratories within the international Berlin-Frankfurt-Münster (I-BFM) consortium, in order to complement the standardization of the methodology with an educational component and persistent quality control measures. Our QC and quality assurance (QA) program is based on four major cornerstones: (i) a twinning maturation program, (ii) obligatory participation in external QA programs (spiked sample send around, United Kingdom National External Quality Assessment Service (UK NEQAS)), (iii) regular participation in list-mode-data (LMD) file ring trials (FCM data file send arounds), and (iv) surveys of independent data derived from trial results. We demonstrate that the training of laboratories using experienced twinning partners, along with continuous educational feedback significantly improves the performance of laboratories in detecting and quantifying MRD in pediatric ALL patients. Overall, our extensive education and quality control program improved inter-laboratory concordance rates of FCM-MRD assessments and ultimately led to a very high conformity of risk estimates in independent patient cohorts.

An Application for Measuring and Analyzing the Level of Performance Accuracy for Health Services Quality Indicators by Using Six-Sigma: A Study Case of Government Hospitals in Khartoum State

The study aimed at acknowledging the Six Sigma methodology and the existence of the essential components for the application, as well as reducing the time for completing the operations, reducing the error rate to the lowest possible level, and improving the quality of operations. For this objective, the analytical descriptive methodology was used on a sample consisted of 300 administrative and medical staff from Khartoum State Hospitals (Khartoum, Omdurman, Bahri). To this end, a questionnaire was used for collecting data and for analyzing it and achieving the results of the study by using the statistical analysis package (SPSS). The study deduced a number of results, the most important of which are that the items of commitment and supreme command support for the senior leadership and the methods of abundant human resources on quality control, and the application of the Six Sigma methodology in government hospitals in Khartoum state achieved a satisfactory level, while continuous improvement paragraphs, processes, and systems on quality control and the application of Six Sigma methodology achieved high quality. There is a significant effect on the extent of commitment and support of the higher leadership on quality control and the application of the Six Sigma methodology. Similarly, there is a statistically significant effect on the application of continuous improvement methods on quality control and Six Sigma methodology. Also, there is a statistically significant effect on the application of the abundance of human resources methods variable on quality control and the application of Six Sigma methodology in governmental hospitals in Khartoum state. The study recommended to take interest in the Six Sigma methodology and assure the possibility of using it in Khartoum State’s hospitals because of its scientific and practical importance in improving the quality of services and provided processes, and the need to provide qualified financial and human resources for using and developing Six Sigma methodology in hospitals, as well as great attention in training and providing departments heads with full knowledge of Six Sigma methodology and the fundamentals on which Six Sigma methodology, is based on its importance for hospitals. The study also recommended associating the promotions system in government hospitals in Khartoum state with the quality control program.

Short term intensified training temporarily impairs mitochondrial respiratory capacity in elite endurance athletes

Aim: The maintenance of healthy and functional mitochondria is the result of a complex mitochondrial turnover and herein quality-control program which includes both mitochondrial biogenesis and autophagy of mitochondria. The aim of this study was to examine the effect of an intensified training load on skeletal muscle mitochondrial quality control in relation to changes in mitochondrial oxidative capacity, maximal oxygen consumption and performance in highly trained endurance athletes. Methods: 27 elite endurance athletes performed high intensity interval exercise followed by moderate intensity continuous exercise 3 days per week for 4 weeks in addition to their usual volume of training. Mitochondrial oxidative capacity, abundance of mitochondrial proteins, markers of autophagy and antioxidant capacity of skeletal muscle were assessed in skeletal muscle biopsies before and after the intensified training period. Results: The intensified training period increased several autophagy markers suggesting an increased turnover of mitochondrial and cytosolic proteins. In permeabilized muscle fibers, mitochondrial respiration was ~20 % lower after training although some markers of mitochondrial density increased by 5-50%, indicative of a reduced mitochondrial quality by the intensified training intervention. The antioxidative proteins UCP3, ANT1, and SOD2 were increased after training, whereas we found an inactivation of aconitase. In agreement with the lower aconitase activity, the amount of mitochondrial LON protease that selectively degrades oxidized aconitase, was doubled. Conclusion: Together, this suggests that mitochondrial respiratory function is impaired during the initial recovery from a period of intensified endurance training while mitochondrial quality control is slightly activated in highly trained skeletal muscle.

Controlled deterioration test to evaluate the physiological potential of sweet corn seeds

The evaluation of the physiological potential of sweet corn seeds is essential in a quality control program and the choice of vigor tests using an adequate analysis methodology is essential to obtain reliable results. In this sense, this study aimed to standardize the methodology of the controlled deterioration test through combinations between time and temperature to evaluate the vigor of sweet corn seeds. Six lots of sweet corn seeds were characterized by the degree of moisture and the initial physiological potential through the following tests: germination, first germination count, cold test, electrical conductivity, accelerated aging, length and dry mass of normal seedlings, seedling emergence in sand, and emergence rate index. Subsequently, these lots had their initial water content adjusted to 20% using the wet substrate method. The seeds from the six lots were subjected to the controlled deterioration test under two temperatures for four periods, obtaining a completely randomized design in an 8 × 6 factorial scheme with eight combinations of time/temperature and six lots. Germination and the first germination count were evaluated after the deterioration test. The data were subjected to analysis of variance with a comparison of means by the Tukey test at a 5% significance. The results of the first count and germination tests after deterioration were subjected to a simple linear correlation study together with the initial characterization data. The combinations 8 h – 40 °C and 8 h – 45 °C in the controlled deterioration test were efficient in distinguishing the vigor of seed lots. The shorter exposure period and the first germination count after deterioration are more suitable for evaluating the vigor of sweet corn seeds.

Glycated Hemoglobin Measurement: Comparison of Three Methods Versus High Performance Liquid Chromatography

Background: HbA1c result provide information on metabolic control in diabetes mellitus (DM) and could also be used for its diagnosis. For its determination, the laboratory must be certified by the National Glycohemoglobin Standardization Program (NGSP) or the International Federation of Clinical Chemistry (IFCC) and comply with a strict quality control program. Aims: To determine the correlation and agreement between HbA1c results measured by three analytical methods (enzymatic, turbidimetric, and capillary electrophoresis) versus HPLC. Methods: Method comparison—1245 samples from equal number of subjects at 45 Association of High Complexity Laboratories (Asociación de Laboratorios de Alta Complejidad—ALAC) centers, centralizing sample processing and operator. Statistical analysis—analysis of variance (ANOVA) and nonparametric Friedman ANOVA test for related samples, means, and medians. Correlation and concordance—Pearson’s correlation and linear regression, intraclass correlation coefficient (Passing and Bablock and Bland and Altman). Results: The comparison of mean values obtained by the four methods showed statistically significant, but clinically irrelevant, differences: HbA1c by HPLC versus Electrophoresis 0.06% (0.42 mmol/mol) P = .000 (± 1.96 DS -0.070 -0.047), Enzymatic 0.087% (1 mmol/mol) P = .000 (± 1.96 DS 0.077 0.098), Turbidimetric 0.056% (0.38 mmol/mol) P = 0.000 (± 1.96 DS -0.067 -0.044). Their concordance showed intraclass correlation of single measures of 0.982 P < .001 (95% CI 0.987 - 0.9838). Conclusions: The three methods present low variability and high correlation versus the HPLC.

Quality testing of veterinary antimicrobial products used for livestock in Vietnam, 2018–2019

Access to quality veterinary antimicrobial products contributes to efficient treatment of diseases in Vietnamese livestock and to reducing antimicrobial resistance (AMR). Poor quality antimicrobial drugs can lead to treatment failure, potentially influencing the inappropriate use of antimicrobials products, including increasing the dose, combining drugs, or changing to a broader spectrum antimicrobial. The objective of the study was to determine the actual concentration of antimicrobial active ingredient (AAI) in commercially available veterinary antimicrobial products as an indicator of their quality. A total of 144 veterinary antimicrobial products were purchased from randomly selected veterinary drug stores in 34 districts in eight provinces. For the qualitative analysis, we observed criteria linked to form, colour, and labelling information according to the Department of Animal Health regulations. For the quantitative analysis, high-performance liquid chromatography was used to determine the actual concentration of AAI in each sample. Of the 144 samples, 131 (91%) met the national standard of quality of being within ±10% of the labelled concentration. Ten antimicrobials (6.9%) contained less than half of the labelled content concentrations. Veterinary antimicrobial product quality control is an important part of addressing AMR. To support the national action plan to lower AMR, a veterinary drug quality control program should be implemented at all stages of the supply chain to assure high quality drugs and effective treatment of sick animals.

The Path to Implementation of A Clinical Laboratory System in A Developing Country

Background An effective laboratory system is an essential component of a public health system caring for patients with communicable and non-communicable diseases. Unfortunately, in developing countries this system is often sub-optimal, which negatively impacts health care. This paper describes the current situation of the clinical laboratory sector in Haiti and highlights challenges that exist in Haiti and other developing countries as they try to establish a clinical laboratory system. Method A cross-sectional survey was conducted in 30 laboratories across Haiti from January 19 to February 4, 2016. The laboratories surveyed were public or mixed public-private sector facilities belonging to different levels of the healthcare hierarchy. Labs were visited and directors of the health care institutions, lab managers, and members of their teams were interviewed and National Public Health Laboratory documents and information about the legal framework of the laboratory system was reviewed. Results The National Laboratory of Public Health is the reference lab for the national lab network and plays a key role in epidemiologic surveillance. Investigators felt that that the general conditions in the nation’s labs (83%) are good, but numerous deficiencies are identified. Electricity is often limited and 86% of facilities have mixed energy system. Bacterial cultures and susceptibilities are not performed. Most of the lab technologists (88.2%) have received only 2 two-year training certificates, while only the remainder (11.8%) had completed three-year programs training. Few continuing education opportunities are available. Equipment repair is available in more facilities (83%) than routine maintenance (63%) and is complicated by the diversity of brands employed. A total of 93% of the labs participate in the quality control program run by the National Lab. Conclusion The establishment of an effective national laboratory system requires coordination and input from many areas, including regulation of the sector, training of the technicians, sound infrastructure (including a stable supply of electricity) and dependable communications. Achieving this in developing countries will only be possible if different actors, national and international, coordinate their efforts.