Management at the service of research: ReOmicS, a quality management system for omics sciences

AbstractManagement and research represent a binomial almost unknown, whose potentialities and requirements have not yet been fully exploited even if, recently, the scientific and social communities have felt the burden of producing results and data requiring at the same time reproducibility, reliability, safety and efficacy of the discoveries, as well as a profitable use of resources. A Quality Management System (QMS) could represent a valid tool for these purposes, improving the quality of the research. The research community could ask whether and how it is possible to apply this approach in a research laboratory without hindering their creativity, and what the possible benefits might be. On the other hand, an international standard for a quality management system appropriate for a research laboratory is yet to come. The choice, the design and the application of a QMS, inspired by the Good Laboratory Practices, in a research laboratory specialized on "omics" sciences, is fully described in this paper. Its application has already shown good outcomes as testified by specific metric of efficiency and effectiveness. The approach is innovative as there is no obvious requirement for research laboratories to develop and define quality objectives. The paper highlights how the QMS approach enhances the relationship with public and private sectors by increasing customer confidence and loyalty, as well as improving the overall performance of the laboratory in terms of throughput and value of research. These results encourage proposing it as a QMS model providing a new and scalable operational strategy to be applied in a research environment with the same target and even in a generic research laboratory

A failure mode and effect analysis (FMEA)-based approach for risk assessment of scientific processes in non-regulated research laboratories

AbstractNowadays, Quality Management tools such as failure mode and effect analysis (FMEA) are widely used throughout the aeronautical, automotive, software, food services, health care and many other industries to sustain and improve quality and safety. The increasing complexity of scientific research makes it more difficult to maintain all activities under control, in order to guarantee validity and reproducibility of results. Even in non-regulated research, scientists need to be supported with management tools that maximize study performance and outcomes, while facilitating the research process. Frequently, steps that involve human intervention are the weak links in the process. Risk analysis therefore gives considerable benefit to analytical validation, assessing and avoiding failures due to human error, potential imprecision in applying protocols, uncertainty in equipment function and imperfect control of materials. This paper describes in detail how FMEA methodology can be applied as a performance improvement tool in the field of non-regulated research, specifically on a basic Life Sciences research process. We chose as "pilot process" the selection of oligonucleotide aptamers for therapeutic purposes, as an example of a complex and multi-step process, suitable for technology transfer. We applied FMEA methodology, seeking every opportunity for error and its impact on process output, and then, a set of improvement actions was generated covering most aspects of laboratory practice, such as equipment management and staff training. We also propose a useful tool supporting the risk assessment of research processes and its outputs and that we named "FMEA strip worksheet." These tools can help scientists working in non-regulated research to approach Quality Management and to perform risk evaluation of key scientific procedures and processes with the final aim to increase and better control efficiency and efficacy of their research

Influenza vaccination coverage among medical residents: An Italian multicenter survey

Although influenza vaccination is recognized to be safe and effective, recent studies have confirmed that immunization coverage among health care workers remain generally low, especially among medical residents (MRs). Aim of the present multicenter study was to investigate attitudes and determinants associated with acceptance of influenza vaccination among Italian MRs. A survey was performed in 2012 on MRs attending post-graduate schools of 18 Italian Universities. Each participant was interviewed via an anonymous, self-administered, web-based questionnaire including questions on attitudes regarding influenza vaccination. A total of 2506 MRs were recruited in the survey and 299 (11.9%) of these stated they had accepted influenza vaccination in 2011-2012 season. Vaccinated MRs were older (P = 0.006), working in clinical settings (P = 0.048), and vaccinated in the 2 previous seasons (P < 0.001 in both seasons). Moreover, MRs who had recommended influenza vaccination to their patients were significantly more compliant with influenza vaccination uptake in 2011-2012 season (P < 0.001). "To avoid spreading influenza among patients" was recognized as the main reason for accepting vaccination by less than 15% of vaccinated MRs. Italian MRs seem to have a very low compliance with influenza vaccination and they seem to accept influenza vaccination as a habit that is unrelated to professional and ethical responsibility. Otherwise, residents who refuse vaccination in the previous seasons usually maintain their behaviors. Promoting correct attitudes and good practice in order to improve the influenza immunization rates of MRs could represent a decisive goal for increasing immunization coverage among health care workers of the future. © 2014 Landes Bioscience

How chief risk officers (CROs) can have meaningful and productive dealings with insurance agencies: a leading example

AbstractIn broad terms, risk management (RM) covers four conventional actions in addressing operational risks (OpRisks), i.e., actions to mitigate, eliminate, accept, and transfer operational risks. In relation to transferring OpRisks to external third parties, this study aids chief risk officers (CROs) in addressing issues related to the reduction of economic exposure to OpRisk. In this respect, the economic handling of OpRisks and their coverage through specific insurance programs are among the major challenges that CROs face within their roles. The aim of this paper is to provide CROs with an analytical pathway to addressing these challenges by applying the total cost of risk (TCoR) method tailored to their purposes. Through a leading example, this paper demonstrates that the TCoR approach meaningfully and productively supports CROs' decisions when striving to deal with OpRisk. In fact, the TCoR approach implementation, together with the application of Monte Carlo simulation as a computational tool, drives TCoR value optimization when OpRisk is transferred to insurance agencies. In addition, by applying a TCoR framework, CROs can find the correct and cost-effective balance between the company's retention level—consistent with the company's risk appetite—and the premiums paid to insurance agencies. In conclusion, this paper provides CROs with a methodological approach for efficiently building relationships with insurance agencies by consistently addressing TCoR-based dealings

Curcumin as a Therapeutic Agent in Dementia: A Mini Systematic Review of Human Studies

Dementia is a leading health problem worldwide, with Alzheimer’s disease (AD) representing up to 60% of all dementia cases. A growing interest has recently risen on the potential use of natural molecules in this condition. Curcumin is a polyphenolic compound traditionally used in Indian medicine. Several in vitro and in vivo studies have found a protective effect of curcumin in AD. In the present systematic review we aimed to evaluate the state-of-the-art of clinical trials of curcumin in AD. We retrieved three published studies, while there are several ongoing clinical trials. To date there is insufficient evidence to suggest the use of curcumin in dementia patients. Of note, short-term use of curcumin appears to be safe. Several reasons could be responsible for the discrepancy between in vitro and in vivo findings and human trials, such as low bioavailability and poor study design