scholarly journals A Customized Tool of Incident Reporting for the Detection of Nonconformances at a Single IVF Center: Development, Application, and Efficacy

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Daria Morini ◽  
Jessica Daolio ◽  
Alessia Nicoli ◽  
Gaetano De Feo ◽  
Barbara Valli ◽  
...  
Keyword(s):  
Quality Management System ◽  
Daily Practice ◽  
Incident Reporting ◽  
Sample Treatment ◽  
Time Saving ◽  
Complex Processes ◽  
Quality Aspects ◽  
Sample Management ◽  
Analytical Phase ◽  
The Moment

In IVF centers, risk assessment applies to complex processes potentially accounting for adverse events and reactions that undergo well-established legislative oversight, and nonconformances (NCs), that lack of established tracking systems. NCs account for an integral part of the quality management system, so that their documentation is important. The study evaluated the performance of a customized tool for incident reporting (IR) to track and characterize NCs in a public IVF center. IVF operators used the IVF-customized IR tool to record NCs at the moment of detection or subsequently, and in a time-saving manner during daily practice. From February 2015 to February 2020, 635 NCs were reported leading to the implementation of 10 operative instructions and 3 procedures with corrective strategies. NCs referred to the IVF laboratory were the most numerically meaningful (454/635, 71.5%). The majority (352/454, 77.5%) accounted for NCs related to procedures of sample management; considering the analytical phase as all the procedures involving sample treatment, the intra-analytical phase (176/352, 50%) has always been more subject to NCs compared to pre- (102/352, 29%) and postanalytical (74/352, 21%) phases. Our experience showed that the IVF-customized IR tool is suitable for application in IVF with regard to NC reports and documentation, as it identifies the most vulnerable steps of treatments. It manages NCs over the time, but it requires a contextual understanding of its application in order to avoid NC underestimates that could negatively influence the safety and quality aspects of IVF treatments.

scholarly journals How to meet ISO15189:2012 pre-analytical requirements in clinical laboratories? A consensus document by the EFLM WG-PRE

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Pieter Vermeersch ◽  
Glynis Frans ◽  
Alexander von Meyer ◽  
Seán Costelloe ◽  
Giuseppe Lippi ◽  
...  
Keyword(s):  
Quality Management System ◽  
Clinical Chemistry ◽  
European Federation ◽  
Consensus Recommendation ◽  
Iso 15189 ◽  
Consensus Document ◽  
Analytical Phase ◽  
Total Testing Process ◽  
Analytical Requirements ◽  
Analytical Requirement

Abstract The International Organization for Standardization (ISO) 15189:2012 standard aims to improve quality in medical laboratories through standardization of all key elements in the total testing process, including the pre-analytical phase. It is hence essential that accreditation bodies, assessing laboratories against ISO15189:2012, pay sufficient attention to auditing pre-analytical activities. However, there are significant differences in how technical auditors interpret the pre-analytical requirements described in ISO15189:2012. In this consensus document, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Pre-analytical Phase (WG-PRE) sets out to review pre-analytical requirements contained in ISO15189:2012 and provide guidance for laboratories on how to meet these requirements. The target audience for this consensus document is laboratory professionals who wish to improve the quality of the pre-analytical phase in their laboratory. For each of the ISO requirements described in ISO15189:2012, members of EFLM WG-PRE agreed by consensus on minimal recommendations and best-in-class solutions. The minimal consensus recommendation was defined as the minimal specification which laboratories should implement in their quality management system to adequately address the pre-analytical requirement described in ISO15189:2012. The best-in-class solution describes the current state-of-the-art in fulfilling a particular pre-analytical requirement in ISO15189:2012. We fully acknowledge that not every laboratory has the means to implement these best-in-class solutions, but we hope to challenge laboratories in critically evaluating and improving their current procedures by providing this expanded guidance.

scholarly journals Reliability of Telepathology for Frozen Section Service

2000 ◽  
Vol 21 (3-4) ◽  
pp. 213-222 ◽  
Author(s):  
Uwe Wellnitz ◽  
Bernd Binder ◽  
Peter Fritz ◽  
Godehard Friedel ◽  
Peter Schwarzmann
Keyword(s):  
Diagnostic Accuracy ◽  
Technological Development ◽  
Frozen Section ◽  
False Negative ◽  
Daily Practice ◽  
Histopathological Diagnosis ◽  
Time Saving ◽  
Surgical Interventions ◽  
Average Accuracy ◽  
Frozen Section Diagnosis

One of the most promising applications of telepathology (pathology at a distance by electronic transmission of images in pathology) is frozen section diagnosis, especially because by means of this tool operations requiring an intraoperative histopathological diagnosis are feasible at hospitals without a pathologist on‐site. For the introduction of this diagnostic tool into pathologist's daily practice the evidence of its diagnostic accuracy comparable to that of the conventional frozen section diagnosis is crucial.For this purpose the literature on the diagnostic accuracy of telepathological frozen section diagnosis was reviewed. In a metaanalysis these studies and reports, in which a total of more than 1290 cases had been examined, showed a slightly lower overall diagnostic accuracy (of the telepathological frozen section diagnosis) of about 0.91 than the conventional frozen section diagnosis with an average accuracy of about 0.98 found in an analysis of several studies (on frozen section diagnosis of different organs). This difference is at least predominantly caused by a higher rate of deferred and false negative frozen section diagnoses in the telepathological method, while the specificity of both methods, each more than 0.99 was not significantly different.In conclusion, the introduction of a telepathological frozen section diagnosis for hospitals without an acceptable access to a pathologist is justifiable already at the current state of the technological development especially when considering the advantages (time saving, reduction in costs) compared to the alternative of surgical interventions without access to an intraoperative diagnosis.

scholarly journals Testing the FAIR metrics on data catalogs

2018 ◽  
Author(s):  
Jarno A A van Erp ◽  
Carolyn D Langen ◽  
Anca Boon ◽  
Kees van Bochove
Keyword(s):  
Scientific Community ◽  
Daily Practice ◽  
Open Science ◽  
White Paper ◽  
Scientific Data ◽  
Open Source Data ◽  
Starting Point ◽  
Important Solution ◽  
Public Money ◽  
The Moment

The introduction of the FAIR –Findable, Accessible, Interoperable, Reusable– principles has caused quite an uproar within the scientific community. Principles which, if everyone adheres to them, could result in new, revolutionary ways of performing research and fulfill the promise of open science. Furthermore, it allows for concepts such as personalized medicine and personal health monitoring to -finally- become implemented in daily practice. However, to bring about these changes, data users need to rethink the way they treat scientific data. Just passing a dataset along, without extensive metadata will not suffice anymore. Such new ways of executing research require a significantly different approach from the entire scientific community or, for that matter, anyone who wants to reap the benefits from going FAIR. Yet, how do you initiate behavioral change? One important solution is by changing the software scientists use and requiring data owners, or data stewards, to FAIRify their dataset. Data catalogs are a great starting point for FAIRifying data as the software already intends to make data Findable and Accessible, while the metadata is Interoperable and relying on users to provide sufficient metadata to ensure Reusability. In this paper we analyse how well the FAIR principles are implemented in several data catalogs. To determine how FAIR a catalog is, the FAIR metrics were created by the GO-FAIR initiative. These metrics help determine to what extend data can be considered FAIR. However, the metrics were only recently developed, being first released at the end of 2017. At the moment software does not come standard with a FAIR metrics review. Still, this insight is highly desired by the scientific community. How else can they be sure that (public) money is spend in a FAIR way? The Hyve has tested/evaluated three popular open source data catalogs based on the FAIR metrics: CKAN, Dataverse, and Invenio. Most data stewards will be familiar with at least one of these. Within this white paper we provide answers to the following questions: Which of the three data catalogs performs best in making data FAIR? Which data catalog utilizes FAIR datasets the most? Which one creates the most FAIR metadata? Which catalog has the highest potential to increase its FAIRness, and how? Which data catalog facilitates the FAIRifying process the best?

scholarly journals Application of UV-cured resin as embedding/mounting media for practical, time-saving otolith specimen preparation

2018 ◽  
Author(s):  
Carlos Augusto Strüssmann ◽  
Kaho Miyoshi ◽  
Shota Mitsui
Keyword(s):  
Cross Sections ◽  
Epoxy Resins ◽  
Specimen Preparation ◽  
Otolith Growth ◽  
Time Saving ◽  
Demographic Traits ◽  
Sound Detection ◽  
Otolith Core ◽  
The Moment ◽  
Microstructural Examination

AbstractOtoliths are calcified structures located in the inner ears of fish, as in most vertebrates, that are responsible primarily for the perception of gravity, balance and movement, and secondarily of sound detection. Microstructural and chemical analyzes of the inner otolith growth layers, called increments, constitute powerful tools to estimate fish age and elucidate many life history and demographic traits of fish populations. Otolith analyzes often require the production of a thin cross section that includes in the same plane of view the otolith core and all microscopic layers formed from birth until the moment of collection (otolith edge). Here we report on the usefulness of UV-cured resins that have become recently popular among nail artists and hobbyists for otolith specimen preparation. We show that single-component UV-cured resins can replace successfully and advantageously the commonly used two-component Epoxy resins to obtain otolith cross sections suitable for both microstructural examination and chemical analysis by electron probe microanalysis. UV-cured resins provide on-demand, extremely rapid (minute-order) hardening and high transparency, while providing similar adhesion and mechanical support for the otoliths during processing and analysis as Epoxy resins. UV-cured resins may revolutionize otolith specimen preparation practically- and time-wise, and may be particularly useful in teaching and workshop situations in which time for otolith embedding is a constraint.

scholarly journals Practical Guidance for Clinical Microbiology Laboratories: Implementing a Quality Management System in the Medical Microbiology Laboratory

2018 ◽  
Vol 31 (3) ◽  
Author(s):  
Roberta B. Carey ◽  
Sanjib Bhattacharyya ◽  
Sue C. Kehl ◽  
Larissa M. Matukas ◽  
Michael A. Pentella ◽  
...  
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Daily Practice ◽  
Microbiology Laboratory ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Roles And Responsibilities ◽  
Technical Requirements ◽  
Total Testing Process

SUMMARY This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages “systems thinking” by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum.

Great Trek and Long Walk: Readings of a Biblical Symbol

1999 ◽  
Vol 7 (3) ◽  
pp. 272-300
Author(s):  
Barbara Green
Keyword(s):  
South African ◽  
Meaning Making ◽  
Methodological Issues ◽  
Black South African ◽  
Complex Processes ◽  
Critical Approaches ◽  
The Moment ◽  
Desmond Tutu ◽  
Fresh Insight ◽  
Insight Into

AbstractDiverse South African readings of "the exodus" offer convenient access to the complex processes of "meaning-making" which are currently under scrutiny in many disciplines. This essay investigates several diverse appropriations of the biblical text in order to read the classic journey story-particularly the moment of encountering the Canaanites-and to sort some of the methodological issues. First, a pair of opposite versions: white South African (Boer) and black South African (represented by Archbishop Desmond Tutu); second, a triad of critical approaches, but with different emphases (historical-critical, text-centered, reader-focused); and third, my own construal of Nelson Mandela's autobiography, Long Walk to Freedom, as yet another appropriation of liberation texts. In each case, the valuable questions to ask are how the interpreter has proceded and what has been the result, both for the understanding of texts and for the methodological discussion. The allegorical approach (Boer and Tutu) seems totally inadequate. The scholarly critical readings, with their behind-, within-, and before-the-text emphases are illuminating. But Mandela's construal, or at least my version of it, offers additional and fresh insight into the dynamics of liberation.

scholarly journals Testing the FAIR metrics on data catalogs

2018 ◽  
Author(s):  
Jarno A A van Erp ◽  
Carolyn D Langen ◽  
Anca Boon ◽  
Kees van Bochove
Keyword(s):  
Scientific Community ◽  
Daily Practice ◽  
Open Science ◽  
White Paper ◽  
Scientific Data ◽  
Open Source Data ◽  
Starting Point ◽  
Important Solution ◽  
Public Money ◽  
The Moment

The introduction of the FAIR –Findable, Accessible, Interoperable, Reusable– principles has caused quite an uproar within the scientific community. Principles which, if everyone adheres to them, could result in new, revolutionary ways of performing research and fulfill the promise of open science. Furthermore, it allows for concepts such as personalized medicine and personal health monitoring to -finally- become implemented in daily practice. However, to bring about these changes, data users need to rethink the way they treat scientific data. Just passing a dataset along, without extensive metadata will not suffice anymore. Such new ways of executing research require a significantly different approach from the entire scientific community or, for that matter, anyone who wants to reap the benefits from going FAIR. Yet, how do you initiate behavioral change? One important solution is by changing the software scientists use and requiring data owners, or data stewards, to FAIRify their dataset. Data catalogs are a great starting point for FAIRifying data as the software already intends to make data Findable and Accessible, while the metadata is Interoperable and relying on users to provide sufficient metadata to ensure Reusability. In this paper we analyse how well the FAIR principles are implemented in several data catalogs. To determine how FAIR a catalog is, the FAIR metrics were created by the GO-FAIR initiative. These metrics help determine to what extend data can be considered FAIR. However, the metrics were only recently developed, being first released at the end of 2017. At the moment software does not come standard with a FAIR metrics review. Still, this insight is highly desired by the scientific community. How else can they be sure that (public) money is spend in a FAIR way? The Hyve has tested/evaluated three popular open source data catalogs based on the FAIR metrics: CKAN, Dataverse, and Invenio. Most data stewards will be familiar with at least one of these. Within this white paper we provide answers to the following questions: Which of the three data catalogs performs best in making data FAIR? Which data catalog utilizes FAIR datasets the most? Which one creates the most FAIR metadata? Which catalog has the highest potential to increase its FAIRness, and how? Which data catalog facilitates the FAIRifying process the best?

scholarly journals Assessing value of biomedical digital repositories

2017 ◽  
Author(s):  
Chun-Nan Hsu ◽  
Anita Bandrowski ◽  
Jeffery S Grethe ◽  
Maryann Martone
Keyword(s):  
Digital Repository ◽  
Digital Repositories ◽  
Quality Metric ◽  
Data Citation ◽  
Funding Agencies ◽  
Quality Aspects ◽  
Resource Identification ◽  
The Difference ◽  
The Moment ◽  
Information Framework

Digital repositories bring direct impacts and influence to the research community and society but at the moment it is challenging to objectively measure their value. We distinguished the difference between impacts and influence and discussed measures and mentions as the basis of a quality metric of a digital repository. It is challenging to define a single perfect metric that covers all quality aspects. We argue that these challenges may potentially be overcome through the introduction of standard resource identification and data citation practices. We briefly summarized our research and experience in the Neuroscience Information Framework, the BD2K BioCaddie project on data citation, and the Resource Identification Initiative. We outline our accomplishments and challenges ahead. Full implementation of these standards will depend on cooperation from all stakeholders --- digital repositories, authors, publishers, and funding agencies, for which we have been gaining support with endorsements and resource investments.

scholarly journals Electronic Diabetes Management System Replaces Paper Insulin Chart: Improved Quality in Diabetes Inpatient Care Processes Due to Digitalization

2020 ◽  
pp. 193229682095704
Author(s):  
Julia Kopanz ◽  
Katharina M. Lichtenegger ◽  
Constanze Koenig ◽  
Angela Libiseller ◽  
Julia K. Mader ◽  
...  
Keyword(s):  
User Interface ◽  
Management System ◽  
Diabetes Management ◽  
Point Of Care ◽  
Work Processes ◽  
Time Saving ◽  
Documentation Quality ◽  
Paper Chart ◽  
Quality Aspects ◽  
Inpatient Diabetes Management

Background: GlucoTab, an electronic diabetes management system (eDMS), supports healthcare professionals (HCPs) in inpatient blood glucose (BG) management at point-of-care and was implemented for the first time under routine conditions in a regional hospital to replace the paper insulin chart. Method: To investigate quality of the eDMS for inpatients with type 2 diabetes mellitus a monocentric retrospective before-after evaluation was conducted. We compared documentation possibilities by assessing a blank paper chart vs the eDMS user interface. Further quality aspects were compared by assessing filled-in paper charts ( n = 106) vs filled-in eDMS documentation ( n = 241). HCPs ( n = 59) were interviewed regarding eDMS satisfaction. Results: The eDMS represented an improvement of documentation possibilities by offering a more structured and comprehensive user interface compared to the blank paper chart. The number of good diabetes days averaged to a median value of four days in both groups (paper chart: 4.38 [0-7] vs eDMS: 4.38 [0-7] days). Median daily BG was 170 (117-297) mg/dL vs 168 (86-286) mg/dL and median fasting BG was 152 (95-285) mg/dL vs 145 (69-333) mg/dL, and 0.1% vs 0.4% BG values <54 mg/dL were documented. Diabetes documentation quality improved when using eDMS, for example, documentation of ordered BG measurement frequency (1% vs 100%) and ordered BG targets (0% vs 100%). HCPs stated that by using eDMS errors could be prevented (74%), and digital support of work processes was completed (77%). Time saving was noted by 8 out of 11 HCPs and estimated at 10-15 minutes per patient day by two HCPs. Conclusions: The eDMS completely replaced the paper chart, showed comparable glycemic control, was positively accepted by HCPs, and is suitable for inpatient diabetes management.

scholarly journals Pre prosthetic crown lengthening: an esthetic and functional procedure. A case report

2017 ◽  
Vol 18 (2) ◽  
pp. 23-26
Author(s):  
Carlos Bernardo Aguelo ◽  
Juan Manuel Rico ◽  
Pablo Emilio Molano
Keyword(s):  
Case Report ◽  
Surgical Procedure ◽  
Clinical Case ◽  
Surgical Techniques ◽  
Daily Practice ◽  
Great Frequency ◽  
The Moment ◽  
Crown Lengthening

Crown lengthening is a procedure widely used in periodontal practice, for esthetic procedures and also for pre-prosthetic ones; situation that is present with great frequency in the daily practice in periodontics. It is very important the knowledge of the anatomic structures of the periodontal anatomy in order to do a proper surgical procedure, preceded by a deep clinical and radiological exam and a pertinent treatment prosthetic plan. It is also important that the clinician knows all the surgical techniques, because not all the procedures need the same approach and there are certain anatomic and surgical characteristics that must be taken in concern at the moment of planning a surgical crown lengthening. In this article we present a clinical case where it is integrated the periodontal and prosthetic discipline.

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