Multi-site comparison of factors influencing progress of African insecticide testing facilities towards an international Quality Management System certification.

BACKGROUND: Insecticidal mosquito vector control products are vital components of malaria control programmes. Test facilities are key in assessing the effectiveness of vector control products against local mosquito populations, in environments where they will be used. Data from these test facilities must be of a high quality to be accepted by regulatory authorities, including the WHO Prequalification Team for vector control products. In 2013-4, seven insecticide testing facilities across sub-Saharan Africa, with technical and financial support from Innovative Vector Control Consortium (IVCC), began development and implementation of quality management system compliant with the principles of Good Laboratory Practice (GLP) to improve data quality and reliability. METHODS AND PRINCIPLE FINDINGS: We conducted semi-structured interviews, emails, and video-call interviews with individuals at five test facilities engaged in the IVCC-supported programme and working towards or having achieved GLP. We used framework analysis to identify and describe factors affeting progress towards GLP. We found that eight factors were instrumental in progress, and that test facilities had varying levels of control over these factors. They had high control over the training programme, project planning, and senior leadership support; medium control over infrastructure development, staff structure, and procurement; and low control over funding the availability and accessibility of relevant expertise. Collaboration with IVCC and other partners was key to overcoming the challenges associated with low and medium control factors. CONCLUSION: For partnership and consortia models of research capacity strengthening, test facilities can use their own internal resources to address identified high-control factors. Project plans should allow additional time for interaction with external agencies to address medium-control factors, and partners with access to expertise and funding should concentrate their efforts on supporting institutions to address low-control factors. In practice, this includes planning for financial sustainability at the outset, and acting to strengthen national and regional training capacity.

Pearls and Pitfalls of the Virtual Interview: Perspectives From Both Sides of the Camera.

As the SARS-COV-2 pandemic created the need for social distancing and the implementation of nonessential travel bans, residency and fellowship programs have moved toward a web-based virtual process for applicant interviews. As part of the Society of Asian Academic Surgeons 5th Annual Meeting, an expert panel was convened to provide guidance for prospective applicants who are new to the process. This article provides perspectives from applicants who have successfully navigated the surgical subspecialty fellowship process, as well as program leadership who have held virtual interviews.

Strategic Deployment of Cardiology Fellows in Training Using the Accreditation Council for Graduate Medical Education Coronavirus Disease 2019 Framework.

Coronavirus disease 2019 is a global pandemic affecting >3 million people in >170 countries, resulting in >200 000 deaths; 35% to 40% of patients and deaths are in the United States. The coronavirus disease 2019 crisis is placing an enormous burden on health care in the United States, including residency and fellowship training programs. The balance between mitigation, training and education, and patient care is the ultimate determinant of the role of cardiology fellows in training during the coronavirus disease 2019 crisis. On March 24, 2020, the Accreditation Council for Graduate Medical Education issued a formal response to the pandemic crisis and described a framework for operation of graduate medical education programs. Guidance for deployment of cardiology fellows in training during the coronavirus disease 2019 crisis is based on the principles of a medical mission, and adherence to preparation, protection, and support of our fellows in training. The purpose of this review is to describe our departmental strategic deployment of cardiology fellows in training using the Accreditation Council for Graduate Medical Education framework for pandemic preparedness.

MOCA-Peds: Development of a New Assessment of Medical Knowledge for Continuing Certification.

The American Board of Pediatrics (ABP) certifies that general and subspecialty pediatricians meet standards of excellence established by their peers. Certification helps demonstrate that a general pediatrician or pediatric subspecialist has successfully completed accredited training and fulfills continuous certification requirements (Maintenance of Certification [MOC]). One current component of the MOC program is a closed-book examination administered at a secure testing center (ie, the MOC Part 3 examination). In this article, we describe the development of an alternative to this examination termed the "Maintenance of Certification Assessment for Pediatrics" (MOCA-Peds) during 2015-2016. MOCA-Peds was conceptualized as an online, summative (ie, pass/fail), continuous assessment of a pediatrician's knowledge that would also promote learning. The system would consist of a set number of multiple-choice questions delivered each quarter, with immediate feedback on questions, rationales clarifying correct and incorrect answers, references for further learning, and peer benchmarking. Questions would be delivered quarterly and taken at any time within the quarter in a setting with Internet connectivity and on any device. As part of the development process in 2015-2016, the ABP actively recruited pediatricians to serve as members of a yearlong user panel or single-session focus groups. Refinements to MOCA-Peds were made on the basis of their feedback. MOCA-Peds is being actively piloted with pediatricians in 2017-2018. The ABP anticipates an expected launch in January 2019 of MOCA-Peds for General Pediatrics, Pediatric Gastroenterology, Child Abuse, and Pediatric Infectious Diseases with launch dates for the remaining pediatric subspecialties between 2020 and 2022.

Asian Care Certificate (ACC): a care quality assurance framework.

Purpose Quality assuring elderly care through a viable and feasible standard framework is a major challenge for Asian governments. Although several attempts have been made to tackle foreign care worker (FCW) shortage, assuring the quality of the care they provide has been overlooked. The original framework allowed a better control over service quality to assure the elderly about their care according to the agreed standards. The paper aims to discuss these issues. Design/methodology/approach Through several Japanese Governmental meetings, a new Asian Care Certificate (ACC) program is discussed based on the Japanese Care Certificate (JCC). The governments' representatives adopted the JCC to form the ACC, which enables the ACC board to evaluate care workers and to intervene whenever the desired quality level is not achieved. Findings The author describes a new program. The findings of this paper will be confirmed when the ACC is implemented. Practical implications Using the ACC framework, the challenge in providing a high-quality care service using FCWs across Asia would be partly resolved. FCWs' quality of life might also gradually improve especially regarding to their human rights. Originality/value The ACC provides a new framework. Its value is recognized if one considers that many Asian populations are rapidly aging and many governments compromise quality by employing overseas workers to solve care worker shortages.

[In search of a travel guide-results from a survey of E­health startup companies]. / Reiseführer gesucht ­ Ergebnisse einer Umfrage bei E­Health-Start-ups.

As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e. V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.

Grundvoraussetzungen herzchirurgischer Einheiten zur Behandlung von Patienten mit angeborenen Herzfehlern.

This document defines fundamental structures of congenital cardiac surgery departments in Germany. It has been developed by the executive boards of the German Society for Thoracic and Cardiovascular Surgery (GSTCVS) and the German Society of Pediatric Cardiology (GSPC) in collaboration with the working group for Congenital and Pediatric Heart Surgery of the GSTCVS.This updated consensus paper is based on a previous publication of the European Association for Cardiothoracic Surgery (EACTS) and is a refinement and adaptation of its initial version published by the GSTCVS in 2005. In Germany, pediatric cardiology and cardiac surgery facilities caring for patients with congenital cardiac defects are subject to certain regulations. For example, in 2010 the Federal Joint Committee implemented the resolution on Quality Assurance Measures in the Provision of Cardiac Surgical Care for Children and Adolescents (directive congenital cardiac surgery) which regulates structural and process quality compulsorily. To date, fundamental and considerable differences of the respective departments persist.Congenital cardiac surgery departments have to provide the whole spectrum of the cardiac surgical therapy from the neonate to the adult with congenital cardiac defects (with the exception of heart transplantation) continuously and with the appropriate experience. Furthermore, the departments have to prove their constant scientific activity and ensure that they facilitate education and training for the specialty certification in cardiac surgery. The responsible surgeons of all congenital cardiac surgery departments commit to participate in the currently voluntary national quality assurance for congenital cardiac defects of the GSTCVS and the GSPC and perform an individual surgical outcome assessment and risk stratification. This is supplemented by the willingness for external certification specific to the individual and the facilitation of peer review procedures for quality assurance purposes. Additional measures, such as collaboration in clinical research and ongoing interdisciplinary education and training, are preferable.

The cardiovascular in-training examination: development, implementation, results, and future directions.

BACKGROUND: The American College of Cardiology (ACC), in collaboration with the National Board of Medical Examiners (NBME), developed the first standardized in-training examination (ITE) for cardiovascular disease fellows-in-training (FITs). In addition to testing knowledge, this examination uses the newly developed ACC Curricular Milestones to provide specific, competency-based feedback to program directors and FITs. The ACC ITE has been administered more than 5,000 times since 2011. OBJECTIVES: This analysis sought to report the initial experience with the ITE, including feasibility and reliability of test development and implementation, as well as the ability of this process to provide useful feedback in key content areas. METHODS: The annual ACC ITE has been available to cardiovascular disease fellowship programs in the United States since 2011. Questions for this Web-based, secure, multiple-choice examination were developed by a group of cardiovascular disease specialists and each question was analyzed by the NBME to ensure quality. Scores were equated and standardized to allow for comparability. Trainees and program directors were provided detailed feedback, including a list of the curricular competencies tested by those questions answered incorrectly. RESULTS: The ITE was administered 5,118 times. In 2013, the examination was taken by 1,969 fellows, representing 194 training programs. Among the 3 training years, there was consistency in the examination scores. Total test scores and scores within each of the content areas increased with each FIT year (there was a statistically significant difference in each cohort's average scale score across administration years). There was also significant improvement in examination scores across the fellowship years. CONCLUSIONS: The ACC ITE is a powerful tool available to all training programs to assess medical knowledge. This examination also delivers robust and timely feedback addressing individual knowledge gaps, and thus, may serve as a basis for improving training curricula.

Certifying achievement in the control of Chagas disease native vectors: what is a viable scenario?

As an evaluation scheme, we propose certifying for "control", as alternative to "interruption", of Chagas disease transmission by native vectors, to project a more achievable and measurable goal and sharing good practices through an "open online platform" rather than "formal certification" to make the key knowledge more accumulable and accessible.

Certifying achievement in the control of Chagas disease native vectors: what is a viable scenario?

As an evaluation scheme, we propose certifying for “control”, as alternative to “interruption”, of Chagas disease transmission by native vectors, to project a more achievable and measurable goal and sharing good practices through an “open online platform” rather than “formal certification” to make the key knowledge more accumulable and accessible.

The methodology for defining the European standards for the certification of Haemophilia Centres in Europe.

INTRODUCTION: Work Package 4 Development of the standardisation criteria of the European Haemophilia Network project has the main objective of implementing a common and shared European strategy for a certification system for two levels of Haemophilia Centres: European Haemophilia Treatment Centres and European Haemophilia Comprehensive Care Centres in the Member States of the European Union. MATERIALS AND METHODS: An inclusive and participatory process for developing shared standards and criteria for the management of patients with inherited bleeding disorders has been carried out. The process has been implemented through four different consultation events involving the entire European community of stakeholders that significantly contributed in the drafting of the European Guidelines for the certification of Haemophilia Centres. RESULTS: The Guidelines set the standards for the designation of centres that provide specialised and multidisciplinary care (Haemophilia Comprehensive Care Centres) as well as local routine care (Haemophilia Treatment Centres). Standards cover several issues such as: general requirements; patient care; advisory services; laboratory; networking of clinical and specialised services. CONCLUSIONS: The drafting of the European Guidelines for the certification of Haemophilia Centres was performed adopting a rigorous methodological approach. In order to build the widest possible consensus to the quality standards, the main institutional and scientific stakeholders have been involved. The resulting document will significantly contribute in promoting standardisation in the quality of diagnosis and treatment in European Haemophilia Centres.

Pain medicine: The case for an independent medical specialty and training programs.

Over the last 30 years, pain has become one of the most dynamic areas of medicine and a public health issue. According to a recent Institute of Medicine report, pain affects approximately 100 million Americans at an estimated annual economic cost of $560 to $635 billion and is poorly treated overall. The American Board of Medical Specialties (ABMS) recognizes a pain subspecialty, but pain care delivery has struggled with increasing demand and developed in an inconsistent and uncoordinated fashion. Pain education is insufficient and highly variable. Multiple pain professional organizations have led to fragmentation of the field and lack of interdisciplinary agreement, resulting in confusion regarding who speaks for pain medicine. In this Perspective, the authors argue that ABMS recognition of pain medicine as an independent medical specialty would provide much needed structure and oversight for the field and would generate credibility for the specialty and its providers among medical peers, payers, regulatory and legislative agencies, and the public at large. The existing system, managed by three ABMS boards, largely excludes other specialties that contribute to pain care, fails to provide leadership from a single professional organization, provides suboptimal training exposure to pain medicine, and lengthens training, which results in inefficient use of time and educational resources. The creation of a primary ABMS conjoint board in pain medicine with its own residency programs and departments would provide better coordinated training, ensure the highest degree of competence of pain medicine specialists, and improve the quality of pain care and patient safety.