Guidance Document for drafting CEN/TC 158 Standards

There are various opportunities and challenges in the delivery of care to those diagnosed with chronic oedema/lymphoedema. Service provision is not consistent within the UK, and non-specialist nurses and other health professionals may be called on to fill the gaps in this area. The latest best practice guidance on chronic oedema is directed at community services that care for people within their own homes in primary care. This guide was developed in order to increase awareness, knowledge and access to an evidence base. Those involved in its creation cross specialist fields (lymphoedema and tissue viability), resulting in the document covering a number of areas, including an explanation of chronic oedema, its assessment and management and the association between chronic oedema and wet legs. The document complements existing frameworks on the condition and its management and also increases the available tools within chronic oedema management in the community. The present article provides an overview of the guidance document and discusses its salient features.

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The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2020-1384 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Paul C. D. Bank ◽

Leo H. J. Jacobs ◽

Sjoerd A. A. van den Berg ◽

Hanneke W. M. van Deutekom ◽

Dörte Hamann ◽

...

Keyword(s):

Clinical Practice ◽

The Netherlands ◽

Medical Devices ◽

Task Force ◽

Large Impact ◽

Guidance Document ◽

Scientific Societies ◽

Clinical Laboratories ◽

The Impact

AbstractThe in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.

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Proportionality in Refugee Exclusion

Journal of International Criminal Justice ◽

10.1093/jicj/mqaa056 ◽

2020 ◽

Author(s):

Elif Gökşen

Keyword(s):

International Criminal ◽

Criminal Responsibility ◽

War Crimes ◽

International Criminal Law ◽

Guidance Document ◽

Refugee Status ◽

High Commissioner ◽

State Practice ◽

Proportionality Test ◽

Individual Criminal Responsibility

Abstract In the increased discussions about international security and terrorism, the application of the exclusion clauses in Article 1 F of the 1951 Refugee Convention has become a topical and controversial issue. The United Nations High Commissioner for Refugees (UNHCR) advises states to apply a proportionality test to weigh the gravity of the crime against the consequences of exclusion for cases concerning serious non-political crimes and war crimes. However, there is no uniform approach in state practice. Also, the concept of ‘gravity of the crime’ is not clarified in any guidance document of the UNHCR. Relying on the different applications of Article 1 F of the 1951 Convention, this article questions whether the proportionality analysis is actually necessary for determining the exclusion, and how should the gravity of the crime be interpreted in such cases. First, the present article argues that the proportionality analysis is compatible with the overriding humanitarian aims of the 1951 Convention and that this analysis should be applicable to all the crimes listed in Article 1 F. Secondly, it demonstrates that the concept of ‘gravity of the crime’ should be interpreted by referring to the relevant concepts developed in international criminal law, and by considering the extent of the person’s individual criminal responsibility. This article asserts that exclusion from refugee status causes serious consequences, which sometimes might be heavier than criminal punishment. Therefore, Article 1 F should be applied with the utmost attention and sensitivity.

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Outpatient Management of COVID-19 Disease: A Holistic Patient-Centered Proposal Based on the Greek Experience

Journal of Personalized Medicine ◽

10.3390/jpm11080709 ◽

2021 ◽

Vol 11 (8) ◽

pp. 709

Author(s):

Adamantia Liapikou ◽

Eleni Tzortzaki ◽

Georgios Hillas ◽

Miltiadis Markatos ◽

Ilias C. Papanikolaou ◽

...

Keyword(s):

Preventive Measures ◽

Severe Disease ◽

Hospital Setting ◽

Guidance Document ◽

Outpatient Management ◽

Patient Centered ◽

Mild Disease ◽

Novel Coronavirus ◽

Second Wave ◽

Close Contacts

Novel coronavirus disease 2019 (COVID-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become a worldwide pandemic and affected more than 227 countries or territories, resulting in more than 179 million cases with over 3.890.00 deaths, as of June 25, 2021. The Hellenic Thoracic Society (HTS) during the second wave of COVID-19 pandemic released a guidance document for the management of patients with COVID-19 in the community and in hospital setting. In this review, with guidance the HTS document, we are discussing the outpatient management of COVID-19 patients, including the preventive measures, the patients’ isolation and quarantine criteria of close contacts, the severity and risk stratification, including the decisions for advanced hospitalization, and the disease management at home in patients with mild disease and after hospital discharge for those with more severe disease.

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Entrustable Professional Activities in Hematopathology Pathology Fellowship Training: Consensus Design and Proposal

Academic Pathology ◽

10.1177/2374289521990823 ◽

2021 ◽

Vol 8 ◽

pp. 237428952199082

Author(s):

Kristie White ◽

Julianne Qualtieri ◽

Elizabeth L. Courville ◽

Rose C. Beck ◽

Bachir Alobeid ◽

...

Keyword(s):

Medical Education ◽

Graduate Medical Education ◽

Fellowship Training ◽

Entrustable Professional Activities ◽

Guidance Document ◽

Accreditation Council ◽

Graduate Medical ◽

Professional Activities ◽

Constructive Feedback ◽

Delphi Approach

Hematopathology fellowship education has grown in complexity as patient-centered treatment plans have come to depend on integration of clinical, morphologic, immunophenotypic, molecular, and cytogenetic variables. This complexity is in competition with the need for timely hematopathology care with stewardship of patient, laboratory, and societal resources. Accreditation Council for Graduate Medical Education Milestones provide a guidance document for hematopathology training, but fellows and their educators are in need of a simple framework that allows assessment and feedback of growth toward independent hematopathology practice. Entrustable professional activities provide one such framework, and herein, we provide proposed Hematopathology Fellowship Entrustable Professional Activities based on review of pertinent guidelines and literature, with multiple rounds of expert and stakeholder input utilizing a modified mini-Delphi approach. Ten core entrustable professional activities deemed essential for graduating hematopathology fellows were developed together with skills and knowledge statements, example scenarios, and corresponding Accreditation Council for Graduate Medical Education Milestones. Application of these entrustable professional activities in program design, fellow evaluation, and decisions regarding level of supervision is discussed with consideration of benefits and barriers to implementation. These entrustable professional activities may be used by hematopathology fellowship directors and faculty to provide fellows with timely constructive feedback, determine entrustment decisions, provide the Clinical Competency Committee with granular data to support Milestone evaluations, and provide insight into areas of potential improvement in fellowship training. Fellows will benefit from a clear roadmap to independent hematopathology practice with concrete and timely feedback.

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