Control of Clinical Laboratory Errors by FMEA Model

Patient safety is an aim for clinical applications and is a fundamental principle of healthcare and quality management. The main global health organizations have incorporated patient safety in their review of work practices. The data provided by the medical laboratories have a direct impact on patient safety and a fault in any of processes such as strategic, operational and support, could affect it. To provide appreciate and reliable data to the physicians, it is important to emphasize the need to design risk management plan in the laboratory. Failure Mode and Effect Analysis (FMEA) is an efficient technique for error detection and reduction. Technical Committee of the International Organization for Standardization (ISO) licensed a technical specification for medical laboratories suggesting FMEA as a method for prospective risk analysis of high-risk processes. FMEA model helps to identify quality failures, their effects and risks with their reduction/elimination, which depends on severity, probability and detection. Applying FMEA in clinical approaches can lead to a significant reduction of the risk priority number (RPN).

“Havens of mercy”: health, medical research, and the governance of the movement of dogs in twentieth-century America

This article argues that the movement of dogs from pounds to medical laboratories played a critically important role in debates over the use of animals in science and medicine in the United States in the twentieth century, not least by drawing the scientific community into every greater engagement with bureaucratic political governance. If we are to understand the unique characteristics of the American federal legislation that emerges in the 1960s, we need to understand the long and protracted debate over the use of pound animals at the local municipal and state level between antivivisectionists, humane activists, and scientific and medical researchers. We argue that the Laboratory Animal Care Act of 1966 reflects the slow evolution of a strategy that proved most successful in local conflicts, and which would characterize a “new humanitarianism”: not the regulation of experimental practices but of the care and transportation of the animals being provided to the laboratory. Our analysis is consistent with, and draws upon, scholarship which has established the productive power of public agencies and civil society on the periphery of the American state.

Externalities of Lean Implementation in Medical Laboratories. Process Optimization vs. Adaptation and Flexibility for the Future

Important in testing services in medical laboratories is the creation of a flexible balance between quality-response time and minimizing the cost of the service. Beyond the different Lean methods implemented so far in the medical sector, each company can adapt the model according to its needs, each company has its own specifics and organizational culture, and Lean implementation will have a unique approach. Therefore, this paper aims to identify the concerns of specialists and laboratory medical services sector initiatives in optimizing medical services by implementing the Lean Six Sigma method in its various variants: a comparative analysis of the implemented models, with emphasis on measuring externalities and delimiting trends in reforming/modernizing the method, a comprehensive approach to the impact of this method implementation, and an analysis of available databases in order to underline the deficit and information asymmetry. The results highlighted that in the case of clinical laboratories, the Lean Six Sigma method is conducive to a reduction of cases of diagnostic errors and saves time but also faces challenges and employees’ resistance in implementation.

Seroprevalence of anti-SARS-CoV-2 IgG at the first epidemic peak in French Guiana, July 2020

Background While Latin America has been heavily affected by the pandemic, only a few seroprevalence studies have been conducted there during the first epidemic wave in the first half of 2020. Methodology/Principal findings A cross-sectional survey was performed between 15 July 2020 and 23 July 2020 among individuals who visited 4 medical laboratories or 5 health centers for routine screening or clinical management, with the exception of symptomatic suggestive cases of covid-19. Samples were screened for the presence of anti-SARS-CoV-2 IgG directed against domain S1 of the SARS-CoV-2 spike protein using the anti-SARS-CoV-2 enzyme-linked immunosorbent assay (ELISA) from Euroimmun. Conclusions/Significance The overall seroprevalence was 15.4% [9.3%-24.4%] among 480 participants, ranging from 4.0% to 25.5% across the different municipalities. The seroprevalence did not differ according to gender (p = 0.19) or age (p = 0.51). Among SARS-CoV-2 positive individuals, we found that 24.6% [11.5%-45.2%] reported symptoms consistent with COVID-19. Our findings revealed high levels of infection across the territory but a low number of resulting deaths, which can be explained by French Guiana’s young population structure.

Survey of Human Gait Analysis and Recognition for Different Sensor Modalities

Gait is a behavioural biometric which sometimes changes due to diseases but it is still a strong identification metric that is widely used in forensic works, state biometric preserve sectors, and medical laboratories. Gait analysis sometimes helps to identify person’s present mental state which reflects on physiological therapy for improved biological system. There are various gait measurement forms which expand the research area from crime detection to medical enhancement. Many research works have been done so far for gait recognition. Many researchers focused on skeleton image of people to extract gait features and many worked on stride length. Various sensors have been used to detect gait in various light forms. This paper is a brief survey of works on gait recognition, collected from various sources of science and technology literature. We have discussed few efficient models that worked best as well as we have discussed about few data sets available.

Immunoglobulin D Multiple Myeloma with a “Hidden” Lambda Light Chain

Introduction/Objective In rare cases, the conventional immunofixation gel electrophoresis technique fails to detect the light chain of an M-protein. We report a case of immunoglobulin (Ig) D multiple myeloma with a hidden lambda (λ) light chain. Methods/Case Report Capillary electrophoresis (CE) (Sebia CAPILLARYS 2) was used to detect and quantify M- proteins in serum specimens. Immunosubtraction (IS) on the CAPILLARYS 2 systems was used to identify the classes of M-proteins. Conventional gel immunofixation electrophoresis (IFE) was performed, using monospecific antisera for IgD, IgE, kappa (κ) or λ in the Sebia HYDRASYS system, and IgG, IgA, IgM, κ or λ in the Helena SPIFE3000 system. Beta-mercaptoethanol (BME) with Fluidil were used as reduction agents. Results (if a Case Study enter NA) Results of serum CE showed two abnormal peaks in beta 2 and gamma regions, suspected to be positive for M-proteins. IS results showed subtraction for λ light chain only in both peaks, suggesting two monoclonal λ light chains. In contrary, no monoclonal λ light chain was detected in gamma region by IFE (Sebia). Epitope masking in the folded monoclonal protein was suspected to cause the “hidden λ light chain” and was further investigated by two laboratory approaches. IFE performed on the Helena SPIFE3000 system found two λ bands in beta 2 and gamma regions, which was consistent with the results from IS. The treatment of BME with Fluidil helped unmasking the hidden epitope and revealed the λ band in gamma region on IFE (Sebia). Conclusion The medical laboratories should be aware of the described scenario. The failure to detect light chains of certain intact M-proteins is most likely due to the structurally inaccessibility of light chains. It is recommended that treatment with reduction agents or use of an alternative methodology or IS might be helpful for investigating suspected heavy chain only cases, due to the limitation of conventional methodology.