An evaluation of the present status of quality assurance program implementation in digital mammography facilities in a developing country.

Quality assurance program (QAP) implementation in mammography is a key aspect to guarantee the acquisition of -quality images and, thus, an opportune diagnosis of breast cancer. A QAP involves planned and systematic actions, such as quality control (QC) tests that will produce consistently high-quality images, while considering low radiation exposure for stakeholders. Currently, there is poor evidence of the current QAP implementation status in developing countries, particularly in Latin America. In this work, 47 Mexican digital mammography facilities were evaluated in terms of their QAP implementation's current status during the period October 2021 to April 2022. A survey of three key indicators of compliance/non-compliance with QAPs was carried out. Also, 17 QC test parameters were assessed in all mammography units according to an international framework. The Kruskal-Wallis test, McNemar test, and Spearman correlation were used to identify the significant correlation between the QC tests and QAP indicators. Statistical analysis showed a significant positive correlation between the QAP indicators and QC parameters that were evaluated, especially associated with an increase in image quality. Almost 90% of the facilities evaluated failed in some QAP indicators, and only 44.68% of the facilities had an updated and current QAP implemented. Successful QAP implementation directly impacted on the QC mammography test results, particularly in terms of image quality, thus conditioning a successful mammography acquisition chain. The results obtained in this work suggest that better regulations need to be implemented to guarantee QAP surveillance, which could mean an increase in opportune diagnosis and management of breast cancer, with improved radiological safety for patients and occupational exposure personnel.

Quality control of involved field radiotherapy in the HD 13 and HD 14 trials : Report of the radiotherapy panel of the German Hodgkin Study Group (GHSG).

INTRODUCTION: As part of the foundation of the German Hodgkin Study Group (GHSG) in 1978, a central radiotherapy (RT) reference centre was established to evaluate and to improve the quality of treatment. During the study generations, the quality assurance programs (QAP) were continued and adapted to the demands of each study. The purpose of this article is to demonstrate the results of the fifth study generation and to compare them to the previous findings. METHODS: With the start of the fourth GHSG study generation (HD10-12), a central prospective review of all diagnostic images was established to create an individual treatment plan for each early stage study patient. The quality of involved field RT was retrospectively evaluated by an expert panel of radiation oncologists. In the fifth study generation (HD13-15), the retrospective review of radiotherapy performed was refined and the results were compared with the findings of the fourth generation. RESULTS: The expert panel analyzed the RT planning and application of 1037 (28 %) patients (HD13 n = 465, HD14 n = 572). Simulation films were available in 85 % of cases and verification films in 87 %. RT was assessed as major violation in 46 % (HD13 = 38 %, HD14 = 52 %), minor violation in 9 % (HD13 = 9 %, HD14 = 9 %) and according to the protocol in 45 % (HD13 = 52 %, HD14 = 38 %). CONCLUSION: The value for QAP of RT within the GHSG trials is well known. Still there were several protocol violations. In the future, the QAP program has to be adapted to the requirements of "modern RT" in malignant lymphoma.

A comprehensive quality assurance program for four-dimensional computed tomography in radiotherapy.

This study aimed to develop and validate a comprehensive, reproducible and automatic 4DCT Quality Assurance (QA) workflow (QAMotion) that evaluates image accuracy across various regular and irregular breathing patterns. Volume and amplitude deviations, CT number accuracy, and spatial integrity were used as evaluation metrics. For repeatability tests, tolerances were respected with a mean CT number deviation < 10 HU, volume deviation < 2% and diameter and amplitude deviation < 2 mm except for irregular amplitude curves for which an amplitude deviation up to 6 mm was measured. QAMotion was able to flag image artefacts for our clinical 4DCT system.

Qualification of Hemophilia Treatment Centers to Enable Multi-Center Studies of Gene Expression Signatures in Blood Cells from Pediatric Patients.

Hemophilia A is a rare congenital bleeding disorder caused by a deficiency of functionally active coagulation factor VIII (FVIII). Most patients with the severe form of the disease require FVIII replacement therapies, which are often associated with the development of neutralizing antibodies against FVIII. Why some patients develop neutralizing antibodies while others do not is not fully understood. Previously, we could demonstrate that the analysis of FVIII-induced gene expression signatures in peripheral blood mononuclear cells (PBMC) obtained from patients exposed to FVIII replacement therapies provides novel insights into underlying immune mechanisms regulating the development of different populations of FVIII-specific antibodies. The aim of the study described in this manuscript was the development of training and qualification test procedures to enable local operators in different European and US clinical Hemophilia Treatment Centers (HTC) to produce reliable and valid data for antigen-induced gene expression signatures in PBMC obtained from small blood volumes. For this purpose, we used the model antigen Cytomegalovirus (CMV) phosphoprotein (pp) 65. We trained and qualified 39 local HTC operators from 15 clinical sites in Europe and the US, of whom 31 operators passed the qualification at first attempt, and eight operators passed at the second attempt.

Development of quality assurance program for digital pathology by the Korean Society of Pathologists.

BACKGROUND: Digital pathology (DP) using whole slide imaging is a recently emerging game changer technology that can fundamentally change the way of working in pathology. The Digital Pathology Study Group (DPSG) of the Korean Society of Pathologists (KSP) published a consensus report on the recommendations for pathologic practice using DP. Accordingly, the need for the development and implementation of a quality assurance program (QAP) for DP has been raised. METHODS: To provide a standard baseline reference for internal and external QAP for DP, the members of the Committee of Quality Assurance of the KSP developed a checklist for the Redbook and a QAP trial for DP based on the prior DPSG consensus report. Four leading institutes participated in the QAP trial in the first year, and we gathered feedback from these institutes afterwards. RESULTS: The newly developed checklists of QAP for DP contain 39 items (216 score): eight items for quality control of DP systems; three for DP personnel; nine for hardware and software requirements for DP systems; 15 for validation, operation, and management of DP systems; and four for data security and personal information protection. Most participants in the QAP trial replied that continuous education on unfamiliar terminology and more practical experience is demanding. CONCLUSIONS: The QAP for DP is essential for the safe implementation of DP in pathologic practice. Each laboratory should prepare an institutional QAP according to this checklist, and consecutive revision of the checklist with feedback from the QAP trial for DP needs to follow.

Effect of an Integrated, Multidisciplinary Nationwide Approach to Type 1 Diabetes Care on Metabolic Outcomes: An Observational Real-World Study.

Objective: Achieving good metabolic control in people with type 1 diabetes (T1D) remains a challenge, despite the evolutions in diabetes technologies over the past decade. Here we investigate the evolution of metabolic control in people with T1D, where care is provided by specialized centers with access to technology, diabetes education, and regular follow-up. Methods: Data were cross-sectionally collected between 2010 and 2018 from more than 100 centers in Belgium. The evolutions over time of hemoglobin A1C (HbA1c), low-density lipoprotein (LDL) cholesterol, and systolic blood pressure (SBP) were investigated, together with the evolutions of use of insulin pump (continuous subcutaneous insulin infusion [CSII]), continuous glucose monitoring (CGM), and lipid-lowering and antihypertensive drugs. Association of HbA1c with gender, age, diabetes duration, and technology use was analyzed on the most recent cohort. Results: The study population contained data from 89,834 people with T1D (age 1-80 years). Mean HbA1c decreased from 65 mmol/mol (8.1%) in 2010-2011 to 61 mmol/mol (7.7%) in 2017-2018 (P < 0.0001, adjusted for gender, age, diabetes duration, and technology use). Respectively, mean LDL cholesterol decreased from 2.45 mmol/L (94.6 mg/dL) to 2.29 mmol/L (88.5 mg/dL) (P < 0.0001, adjusted for gender, age, and diabetes duration), and mean SBP remained stable. CGM usage increased, whereas the use of CSII and lipid-lowering and antihypertensive drugs remained stable. Gender, age, diabetes duration, and technology use were independently associated with HbA1c. Conclusions: Our real-world data show that metabolic and lipid control improved over time in a system where T1D care is organized through specialized multidisciplinary centers with emphasis on linking education to provision of technology, and its quality is monitored.

Improving quality of care in endoscopy of inflammatory bowel disease: can we do better?

INTRODUCTION: Endoscopy plays a key role in the management of inflammatory bowel disease (IBD). There is an increased need for quality assurance programs that evaluate the quality, safety and patient experiences of endoscopy, by assessing procedural and clinical outcomes. AREAS COVERED: This review aims to summarize the most important quality indicators of endoscopy in IBD patients and could serve as the basis to improve quality endoscopic procedures and patients' perception of endoscopy in the future. However, further studies and consensus reports are necessary to standardize the quality of care in the endoscopy unit of all IBD centers. EXPERT COMMENTARY: Developing an understanding of the patient-reported perception is important for both clinicians and patients, as it facilitates patient engagement with their care. Moreover, implementing education in reporting is crucial f and the use of verifiable databases, generated from electronic reporting systems, should be encouraged rather than unverified self-reporting, to have greater validity for documenting and to formally evaluate endoscopic practice data with audits. The use of artificial intelligence may improve the quality of endoscopy, by increasing the adenoma detection rate and helping endoscopists in the challenging differentiation between inflammatory and neoplastic lesions.

[Reporting and information system for significant events related to radiation exposures in medicine: Structure, responsibilities and reporting criteria]. / Melde- und Informationssystem für bedeutsame Vorkommnisse bei Strahlenanwendungen in der Medizin: Struktur, Zuständigkeiten und Meldekriterien.

The increasing frequency and complexity of medical radiation exposures to humans inevitably result in higher risks of harmful unintended or accidental radiation exposures. To ensure a high level of protection and its continuous improvement, the Directive 2013/59/Euratom thus requires to systematically record and analyze both events and near-miss events as well as, in the case of their significance, to disseminate information regarding lessons learned from these events promptly and nationwide to improve radiation protection in medicine. These requirements have been transposed into German legislation by the new radiation protection law and radiation protection ordinance that entered into force simultaneously on December 31th, 2018. The reporting and information system as provided by these regulations as well as the tasks, duties and powers of the parties involved are presented in the first part of this review article. In the second part, the established application-specified criteria for the significance - and thus the notification requirement - of (near-miss) events are itemized and explicated.

Quality Indicators for the Total Testing Process.

ISO 15189:2012 requires the use of quality indicators (QIs) to monitor and evaluate all steps of the total testing process, but several difficulties dissuade laboratories from effective and continuous use of QIs in routine practice. An International Federation of Clinical Chemistry and Laboratory Medicine working group addressed this problem and implemented a project to develop a model of QIs to be used in clinical laboratories worldwide to monitor and evaluate all steps of the total testing process, and decrease error rates and improve patient services in laboratory testing. All laboratories are invited, at no cost, to enroll in the project and contribute to harmonized management at the international level.

National External Quality Assurance Program Pakistan (NEQAPP) -A Milestone in Proficiency Testing in Pakistan.

OBJECTIVE: The objective of this study was to highlight current status and importance of National External Quality Assurance Program Pakistan (NEQAPP). Study Design: Cross sectional study. PLACE AND DURATION OF STUDY: Department of Chemical Pathology and Endocrinology, Armed Forces Institute of Pathology (AFIP) from August to October 2015. METHODS: The study data was extracted from electronic NEQAPP database. Results from 2014-2015 were evaluated for clinical chemistry, hematology, microbiology, and immunoassay programs. Frequencies of unsatisfactory results of individual analytes as well as of all the participating laboratories were calculated. RESULTS: Failure rate of newly enrolled laboratories were more as compared to those which were participating for the last two years. The percentages of unsatisfactory results of all laboratories were 19% and 15% in 2014 and 2015, respectively. Fifteen analytes were selected according to their increasing percentage of participation. Failure rate was highest for alkaline phosphatase (35%) followed by creatinine (22%) and urea (20%) in two years analysis. Performance of laboratories in each quarter was evaluated depending upon number of analytes in which they fail to pass. The major failures were due to clerical and technical errors as determined during data compilation of results. CONCLUSION: There is an increase in trend of participating in NEQAPP by health care laboratories which is a step towards laboratory quality management system in Pakistan. Nonetheless, there is a need for improving quality of laboratory results.

The Newborn Screening Quality Assurance Program at the Centers for Disease Control and Prevention: Thirty-five Year Experience Assuring Newborn Screening Laboratory Quality.

Newborn screening is the largest genetic testing effort in the United States and is considered one of the ten great public health achievements during the first 10 years of the 21st century. For over 35 years, the Newborn Screening Quality Assurance Program (NSQAP) at the US Centers for Disease Control and Prevention has helped NBS laboratories ensure that their testing does not delay diagnosis, minimizes false-positive reports, and sustains high-quality testing performance. It is a multi-component program that provides comprehensive quality assurance services for dried blood spot testing. The NSQAP, the Biochemical Mass Spectrometry Laboratory (BMSL), the Molecular Quality Improvement Program (MQIP) and the Newborn Screening Translation Research Initiative (NSTRI), aid screening laboratories achieve technical proficiency and maintain confidence in their performance while processing large volumes of specimens daily. The accuracy of screening tests could be the difference between life and death for many babies; in other instances, identifying newborns with a disorder means that they can be treated and thus avoid life-long disability or severe cognitive impairment. Thousands of newborns and their families have benefited from reliable and accurate testing that has been accomplished by a network of screening laboratories and the NSQAP, BMSL, MQIP and NSTRI.

An assessment of 25-hydroxyvitamin D measurements in comparability studies conducted by the Vitamin D Metabolites Quality Assurance Program.

BACKGROUND: The National Institute of Standards and Technology (NIST), in collaboration with the National Institutes of Health Office of Dietary Supplements, established the first accuracy-based program for improving the comparability of vitamin D metabolite measurements, the Vitamin D Metabolites Quality Assurance Program. METHODS: The study samples were human serum or plasma Standard Reference Materials (SRMs) with 25-hydroxyvitamin D values that were determined at NIST. Participants evaluated the materials using immunoassay (IA), liquid chromatography (LC) with mass spectrometric detection, and LC with ultraviolet absorbance detection. NIST evaluated the results for concordance within the participant community as well as trueness relative to the NIST value. RESULTS: For the study materials that contain mostly 25-hydroxyvitamin D3 (25(OH)D3),the coefficient of variation (CV) for the participant results was consistently in the range from 7% to 19%, and the median values were biased high relative to the NIST values. However, for materials that contain significant concentrations of both 25-hydroxyvitamin D2 (25(OH)D2) and 25(OH)D3, the median IA results were biased lower than both the LC and the NIST values, and the CV was as high as 28%. The first interlaboratory comparison results for SRM 972a Vitamin D Metabolites in Human Serum are also reported. CONCLUSIONS: Relatively large within-lab and between-lab variability hinders conclusive assessments of bias and accuracy.

Precision Parameters for the FDA Shellfish Laboratory Quality Assurance Program for 1973-1989.

Precision parameters from four microbiological analytical methods (coliform most probable number [MPN], fecal coliform MPN, Staphylococcus aureus plate count and standard plate count) were computed for the Shellfish Quality Assurance Program of the U.S. Food and Drug Administration (FDA). The pooled reproducibility variance (SR2) for the four methods from 1973 to 1989 were 0.0778, 0.1181, 0.0137, and 0.0087, respectively.

Círculos de calidad como, estrategia de un programa de garantía de calidad de la atención médica, en el instituto nacional de perinatología / Quality circles as strategy of a quality assurance program of medical attention in national institute od perinatology

El presente artículo muestra la metodología de implantación de un porgrama de garantía de calidad de la atención médica mediante círculos de calidad en el Instituto Nacional de Perinatología, y sus resultados. Entre ellos destacan: efectos en la estructura organizacional, en la optimización de recursos, en el porpio porceso de la atención, en la satisfacción de los pacientes y en el aprendizaje implicado en la adaptación de esta tecnología al ámbito hospitalario y a las características de una cultura diferente de la cual surgió esa tecnología. El poryecto, concebido como investigación-acción, fue asesorado por el Centro de Investigaciones en Salud Pública, y fue creado con el porpósito de asegurar que las condiciones organizacionales bajo las cuales se porporciona la atención médica fue sen aquélas que permitieran elevar la calidad tanto en la dimensión interpersonal como en la técnica, mediante la participación del personal directamente responsable de la prestación de los servicios. Ello condujo a la utilización de los círculos de calidad como técnica participativa de control de calidad y como eje de un porgrama de garantía de calidad de la atención médica. Pueden identificarse siete etapas en la implantación del porgrama de garantía de calidad mediante la utilización de círculos de calidad: 1) elaboración del documento porpositivo y portocolo de trabajo; 2) negociación; 3) diseño de una guía para la elaboración de un manual de garantía de calidad; 4) selección del punto de inicio; 5) elaboración del Manual de Garantía de Calidad por servicios; 6) operacionalización de los círculos de calidad; 7) evaluación del porgrama. Esta experiencia ha demostrado la factibilidad de utilizar los círculos de calidad como componentes fundamentales de un porgrama de garantía de calidad de la atención médica y permite asegurar que, en general, es posible utilizar esta tecnología en los servicios de salud

The present article shows the methodology of implantation of a quality guarantee program of medical attention through quality circles at the National Institute of Perinatology and it's results. Among them emphasize the following: organization's structure effects. The optimus on resources in it's own process of attention on the satisfaction of the patients and in the learning implicated in the adaptation of the technology to the hospital enviroment and the characteristics of a different culture from which that technology emerged. The proyect, conceived as investigation-action, was advised by Public Health Investigation Center and was created with the purpose to secure that the organized conditions under which the medical attention are given were those permitting to raise the quality as much in the among personal dimention as in the technical, through the participation of the personnel directly resposible of the services given. This led to the use of quality ,circles as participant technical of quality control and as main quality guarantee program of medical attention. Seven stages can be identified in the implantation of the quality assurance program using the quality circles: 1) to elaborate the proposal document and work protocol; 2) negotiation; 3) drawing of a guide for the elaboration of a quality guarantee manual; 4) selection the point of starting; 5) elaboration of the quality guarantee manual by service; 6) to operate the quality circles; 7) evaluation of the program. This experience has demostrated it's feasible using the quality circles as fundamental components of a quality guaranty program of medical attention and permits to secure that, in general, it is possible to use this technology in the health services.