Instrução de trabalho para colheita, conservação e transporte de amostras de esfregaço/fluído lesão para diagnóstico de Varíola dos Macacos (Monkeypox) / Work instructions for collecting, preserving and transporting swab samples/lesion fluid for Monkeypox diagnosisWork instructions for collecting, preserving and transporting swab samples/lesion fluid for Monkeypox diagnosis

Para o diagnóstico de varíola dos macacos (Monkeypox), amostras de esfregaço e fluído da lesão são as recomendadas para diagnóstico. Amostras de esfregaço nasofaríngeo, esfregaço orofaríngeo, biopsia, sangue total e soro são amostras complementares às de esfregaço/ fluído da lesão e podem ser colhidas para aumentar a capacidade de detecção. Nesta instrução de trabalho, o foco são amostras de esfregaço/fluído da lesão...

Corruption: An Impediment to Delivering Pathology and Laboratory Services in Resource-Limited Settings.

OBJECTIVES: Corruption is a widely acknowledged problem in the health sector of low- and middle-income countries (LMICs). Yet, little is known about the types of corruption that affect the delivery of pathology and laboratory medicine (PALM) services. This review is a first step at examining corruption risks in PALM. METHODS: We performed a critical review of medical literature focused on health sector corruption in LMICs. To provide context, we categorized cases of laboratory-related fraud and abuse in the United States. RESULTS: Forms of corruption in LMICs that may affect the provision of PALM services include informal payments, absenteeism, theft and diversion, kickbacks, self-referral, and fraudulent billing. CONCLUSIONS: Corruption represents a functional reality in many LMICs and hinders the delivery of services and distribution of resources to which individuals and entities are legally entitled. Further study is needed to estimate the extent of corruption in PALM and develop appropriate anticorruption strategies.

Optimal Conflict in Team-Based Laboratory Culture.

One critical determinant of success that is not part of standardized scientific training programs is the development of the right mindset for competitive team science. Mindset has been categorized as fixed and growth. People with fixed mindset who believe that virtues such as goodness and intelligence are naturally endowed and thus fixed are reportedly less likely to succeed than people with growth mindset who believe that such abilities are malleable and scalable. People with growth mindset handle conflicts more effectively. As it stands in academic culture, mostly dominated by the education mission, conflict is a taboo. Administrators generally view conflict as something that must be avoided or resolved. Yet the American Psychological Association, among many others, recognize that good science requires good conflict. Team science efforts must recognize the perils of artificial harmony. Artificial harmony is a state wherein members of the team act as if they are getting along in a setting where serious issues remain unattended. Artificial harmony stifles open communication. Open communication within the team is essential to uphold rigor in science. The threat of conflict triggers the flight or fight response in us. Flight, motivated by conflict avoidance, favors artificial harmony. Fight, in its optimal form, empowers teammates to express their opinion leading to healthy disagreement and debate. Teams must find their own optimal conflict point. Mastering that art of identifying and achieving the optimal conflict point for any given team will return lucrative dividends in the form of competitive edge.

[Ethics and confidentiality of a patient in a medical biology laboratory]. / L'éthique et la confidentialité du patient au laboratoire de biologie médicale.

Confidentiality is based on principles of deontology and ethics, which are included in French regulations and supported by the professional orders. It contributes to the respect and dignity of the patient. If this consideration of the human person is old, it has been updated to build the framework imposed by the accreditation of medical biology laboratories. Confidentiality is thus reflected in a charter of ethics, a model of which we propose here. It reflects the commitments of healthcare professionals in the processing of biological samples from patients. Confidentiality is thus applied, in a practical way, at each phase of the laboratory's activity. In the pre-analytical phase, it organizes the reception of the patient and the taking of samples, taking into account the particular case of minors. In the analytical phase, confidentiality imposes limited access to the technical premises and the organization of the flow of personnel from outside the laboratory. Finally, in the post-analytical phase, the reporting of results is regulated, depending on the type of analyses performed and the person to whom the results are to be reported (patient or prescriber). The particular case of spermiology illustrates all these points. Finally, during these phases of sample processing, document management is also a matter of confidentiality and data protection. Confidentiality is essential to the functioning of a health care structure, but it is restrictive in its day-to-day implementation. Nevertheless, it must be combined with an awareness of all staff to address the ethical issue of human dignity.

[Reading Spallanzani today]. / Leyendo a Spallanzani hoy en día.

We remember Lazaro Spallanzani (1729-1799) mainly for his controversy with Needham over spontaneous generation, but he was a man of multiple scientific activities in the fields of biology, mineralogy, physics, mathematics and… volcanology! Called "the biologist of biologists", he developed a series of investigations about reproduction of amphibian, in one of them -Experiences in service to the history of the generation of animals and plants- we have found horrific experiments with frogs, including severe and useless mutilation of males, in order to interrupt its copulation with females, acts he describes as "barbaric", and we estimate inadmissible in the ecclesiastic man he was, even in an epoch in which animals were considered "anima vili" (something without value). A brief review of the use of animals in laboratories shows significant advances in the ethical regulations for this practice, but we believe that these achievements are not enough.

Desarrollo e implementacion de un proyecto de comunicacion efectiva de valores criticos en un laboratorio publico pediatrico / Development and implementation of an effective communication project of critical values in a pediatric public laboratory / Desenvolvimento e implementação de um projeto de comunicação efetiva de valores críticos em um laboratório público pediátrico

Los valores criticos (VC) son resultados de laboratorio que deben comunicarse inmediatamente al profesional responsable, representan una amenaza para la vida del paciente y requieren atencion clinica urgente. La deteccion y comunicacion efectiva de valores criticos (CEVC) impacta directamente en la seguridad del paciente y es responsabilidad del laboratorio. Entes acreditadores y la International Organization of Standardization (ISO- 15189:2012) incluyen los VC entre sus requisitos. En 2017 se desarrollo un proyecto para garantizar la CEVC en el Hospital Garrahan. Se reviso el proceso de CEVC documentado en 2015. Se realizaron encuestas y reuniones dentro del laboratorio que evidenciaron falta de adherencia al mismo. Los VC no se comunicaban de la forma estandarizada y frecuentemente no se registraban. Se evaluaron las causas utilizando el diagrama de Ishikawa, lo que reflejo ausencia de consenso para elaborar el documento inicial. Se realizaron encuestas y reuniones intralaboratorio y con los servicios medicos, para consensuar aspectos relacionados con la CEVC y umbrales para diferentes analitos. Se acordo un nuevo listado de VC y otro de valores de informe inmediato en los que era necesario garantizar la comunicacion efectiva, aunque no requirieran intervencion medica urgente. Se protocolizo la CEVC: informe telefonico al medico tratante registrado en un formulario estandar. Se redacto y difundio un nuevo procedimiento. Se desarrollo un sistema de monitoreo con indicadores de calidad. Promover la mejora continua y desarrollar proyectos interdisciplinarios favorece la atencion centrada en el paciente y su familia. El trabajo mancomunado de diferentes servicios permitio consensuar la lista de VC y un protocolo de comunicacion acorde a las necesidades de esta institucion pediatrica.

The critical values (CV) are laboratory results that should be reported immediately to the responsible professionals, representing a threat to the patient's life and being required for urgent clinical attention. Detection and effective communication of the critical values (ECCV) impacts directly on the patient's College of Americans Pathologists (CAP), Joint Commission on Accreditation of Health Care Organizations (JCAHO), Clinical Laboratory Improvements Amendments (CLIA) e safety and it is the laboratory's responsibility. Accrediting bodies and the International Organization of Standardization (ISO 15189:2012) include CV among their mandatory requisites. In 2017, a project was developed to guarantee the ECCV at the Hospital Garrahan. The ECCV process documented in 2015 was reviewed. Surveys and assemblies were carried out within the laboratory, finding evidence of the lack of compliance with standard procedures. The CV were neither reported according to the expected standardized rules nor registered regularly. The causes were evaluated using the Ishikawa diagram, which reflected the absence of consensus to elaborate the initial document. Surveys and intra-laboratory assemblies were performed alongside with medical Departments staff, in order to come to terms on aspects related to the ECCV as well as thresholds for different analytes. Agreement was reached on a new CV list and another list for immediate reporting, in which it is essential to guarantee effective communication, even though they do not require urgent medical intervention. The ECCV was standardized through a telephone report to the treating physician registered in standard forms. A new operation procedure was edited and shared. A monitoring system with quality indicators was developed. Promoting continuous improvements as well as developing interdisciplinary projects enhance patient and family-centred care. The joint work of different Service Departments made it possible to issue the CV list and a communication protocol according to the needs of this pediatric institution.

Os valores críticos (VC) são resultados laboratoriais que devem ser imediatamente comunicados ao profissional responsável, representam uma ameaça para a vida do paciente e requerem atenção clínica urgente. A detecção e comunicação efetiva de valores críticos (CEVC) é de responsabilidade do laboratório e impacta diretamente na segurança do paciente. Organismos de acreditação e a Organização Internacional de Padronização (ISO-15189: 2012) incluem os VC entre seus requisitos. Em 2017, um projeto foi desenvolvido para garantir a CEVC no Hospital Garrahan. O processo do CEVC documentado em 2015 foi revisado. Pesquisas e reuniões foram realizadas dentro do laboratório, evidenciando a falta de adesão a ele. VC não se comunicavam de maneira padronizada e frequentemente não se registravam. As causas foram avaliadas, usando o diagrama de Ishikawa, refletindo a ausência de consenso para preparar o documento inicial. Pesquisas e reuniões foram realizadas dentro do laboratório e com os serviços médicos, para acordar aspectos relacionados à CEVC e limiares para diferentes analitos. Uma nova listagem de VC foi acordada e outra de valores de relatório imediato nas quais era necessário garantir a comunicação efetiva, mesmo que não exijissem intervenção médica urgente. O CEVC foi registrado: relatório telefônico para o médico responsável pelo tratamento registrado em um formulário padrão. Um novo procedimento foi escrito e divulgado. Um sistema de monitoramento com indicadores de qualidade foi desenvolvido. Promover a melhoria contínua e desenvolver projetos interdisciplinares favorece o cuidado centrado no paciente e sua família. O trabalho conjunto de diferentes serviços permitiu chegar a um consenso sobre a lista de VC e um protocolo de comunicação de acordo com as necessidades dessa instituição pediátrica.

Leyendo a Spallanzani hoy en día / Reading Spallanzani today

Resumen Recordamos al abate Lázaro Spallanzani (1729-1799) fundamentalmente por su victoriosa contienda con Needham sobre la generación espontánea, pero fue un hombre de múltiples intereses en distintos campos de la ciencia, desde la biología a la volcanología. Se lo llamó el "biólogo de los biólogos", desarrollando una serie de investigaciones sobre la reproducción de los anfibios, en una de las cuales - "Experiencias al servicio de la historia de la generación de animales y plantas" - el lector moderno se estremece de horror ante las crueles mutilaciones que infligiera a los sapos machos tratando de interrumpir su copulación con las hembras. Él mismo las califica de "bárbaras" estas torturas, inadmisibles en un hombre que detentaba una jerarquía eclesiástica, aún en una época como la suya, en que se calificaba a los animales como "anima vili" (cosa sin valor). Mucho se ha avanzado hoy en día en resguardo de nuestros "hermanos menores", como los llamara San Francisco, pero aún falta mucho que hacer en la regulación de la experimentación científica que los utiliza.

Abstract We remember Lazaro Spallanzani (1729-1799) mainly for his controversy with Needham over spontaneous generation, but he was a man of multiple scientific activities in the fields of biology, mineralogy, physics, mathematics and… volcanology! Called "the biologist of biologists", he developed a series of investigations about reproduction of amphibian, in one of them -Experiences in service to the history of the generation of animals and plants- we have found horrific experiments with frogs, including severe and useless mutilation of males, in order to interrupt its copulation with females, acts he describes as "barbaric", and we estimate inadmissible in the ecclesiastic man he was, even in an epoch in which animals were considered "anima vili" (something without value). A brief review of the use of animals in laboratories shows significant advances in the ethical regulations for this practice, but we believe that these achievements are not enough.

Not Just a Specimen: A Qualitative Study of Emotion, Morality, and Professionalism in One Medical School Gross Anatomy Laboratory.

Medical schools are increasingly integrating professionalism training into their gross anatomy courses, teaching ethical behavior and humanistic attitudes through the dissection experience. However, many schools continue to take a traditional, technical approach to anatomical education while teaching professionalism in separate courses. This interview-based study explored how students viewed the body donor and the professional lessons they learned through dissection at one such medical school. All students oscillated involuntarily between seeing the cadaver as a specimen for learning and seeing the cadaver as a person, with some students intentionally cultivating one of these ways of seeing over the other. These views shaped students' emotional and moral responses to the experiences of dissection. The "specimen" view facilitated a technical, detached approach to dissection, while the "person" view made students engage emotionally. Further, students who intentionally cultivated a "specimen" view generally felt less moral distress about dissection than students who intentionally cultivated a "person" view. The concept of respect gave students permission to perform dissections, but "person-minded" students developed more complex rules around what constituted respectful behavior. Both groups of students connected the gross anatomy experience to their professional development, but in different ways. "Specimen-minded" students intentionally objectified the body to learn the emotional control physicians need, while "person-minded" students humanized the body donor to promote the emotional engagement required of physicians. These findings support efforts to integrate professionalism teaching into gross anatomy courses, particularly content, addressing the balance between professional detachment and concern.

Of Discomfort and Disagreement: Unclaimed Bodies in Anatomy Laboratories at United States Medical Schools.

Use of unclaimed bodies for anatomy teaching in undergraduate medical education continues, but is ethically controversial. The purposes of this study were to estimate the proportion of United States (US) medical schools using unclaimed bodies in first-year anatomy laboratories, to determine whether schools inform students of this use, and to explore anatomy course leaders' attitudes toward unclaimed body use. Anatomy course leaders from 146 US medical schools that had independent preclinical programs including anatomy were surveyed. Survey results were analyzed with descriptive statistics and statistical tests of association. Free text responses were analyzed using a thematic editing style of qualitative content analysis. Of 89 responses (response rate, 61.0%), 11 schools (12.4%) reported possible use of unclaimed bodies. Course leaders from these schools reported greater comfort with using unclaimed bodies compared to leaders from other schools (P < 0.01). Although most course leaders (49/76, or 64.5%) believed it was important or very important to inform students about use of unclaimed bodies, respondents from schools where unclaimed bodies could be used were more neutral (P < 0.01). Qualitative findings revealed deep disagreement and contradictory views about how unclaimed body use relates to ethical principles of respect for persons and justice. Continued use of unclaimed bodies, varying levels of comfort with their use, and disagreement about the practices' underlying morality suggest a need for greater ethical reflection about the permissibility of unclaimed body use in clinical anatomy and for educational interventions that teach students about its history, ethics, and contemporary practice.

Animal ethics and welfare education in wet-lab training can foster residents' ethical values toward life.

Live animals are used in surgical skills training in wet lab, which has undeniable effectiveness for the development of future surgeons. However, where such training is provided, animal welfare is a major consideration. Increasingly, institutions that offer wet-lab training are incorporating animal ethics and welfare-related content into their training courses, but the effectiveness of such animal ethics education has yet to be evaluated quantitatively. We investigated whether the animal ethics content of a training course affected trainees by measuring increase in ethical awareness using visual analog scale questionnaires before and after training. Our results demonstrated a significant and positive increase in awareness of animal ethics (significance level of 5%; 0.0380≤P≤0.0016).

A survey of current practices for genomic sequencing test interpretation and reporting processes in US laboratories.

PURPOSE: While the diagnostic success of genomic sequencing expands, the complexity of this testing should not be overlooked. Numerous laboratory processes are required to support the identification, interpretation, and reporting of clinically significant variants. This study aimed to examine the workflow and reporting procedures among US laboratories to highlight shared practices and identify areas in need of standardization. METHODS: Surveys and follow-up interviews were conducted with laboratories offering exome and/or genome sequencing to support a research program or for routine clinical services. The 73-item survey elicited multiple choice and free-text responses that were later clarified with phone interviews. RESULTS: Twenty-one laboratories participated. Practices highly concordant across all groups included consent documentation, multiperson case review, and enabling patient opt-out of incidental or secondary findings analysis. Noted divergence included use of phenotypic data to inform case analysis and interpretation and reporting of case-specific quality metrics and methods. Few laboratory policies detailed procedures for data reanalysis, data sharing, or patient access to data. CONCLUSION: This study provides an overview of practices and policies of experienced exome and genome sequencing laboratories. The results enable broader consideration of which practices are becoming standard approaches, where divergence remains, and areas of development in best practice guidelines that may be helpful.Genet Med advance online publication 03 Novemeber 2016.

Ebola Virus Preparedness: Emerging Viruses and Ethics in Laboratory Medicine.

CONTEXT: Emerging pathogens have affected, and will continue to affect, the health care system in diverse ways. Clinical laboratories face ethical challenges in responding to emerging pathogens. We use the 2014-2015 outbreak of Ebola virus disease as a model to explore some of the ethical issues in laboratory medicine related to emerging infectious disease. OBJECTIVE: To describe the major ethical concerns raised in the clinical laboratory environment by emerging infections. DATA SOURCES: We assessed current guidelines and practices in the Ebola outbreak in developed-world clinical laboratories, reviewed risk assessment practices and the role of the clinical laboratory in providing care for patients with potential or confirmed Ebola, and reviewed the relevant literature on duty to provide care in the laboratory context. CONCLUSIONS: Clinical laboratories in developed countries have to rely more on expert guidelines and theoretical risk assessments than on practice in less-developed areas. Risk minimization for clinical laboratory workers is essential but may conflict with the laboratory's duty to provide standard of care. Patients can be put at risk not only from loss of laboratory services from restriction of testing but also from impairment of laboratory services in cases of spills or accidents. Significant discrepancies in guidelines from professional and governmental sources exacerbate the difficulty and confusion inherent in dealing with a dynamic, emerging infectious disease crisis. The duty to provide care for laboratory workers is ill-defined. Balancing risks to patients and laboratory workers and benefits to patients presents challenges to laboratory professionals at all levels.

The Central Importance of Laboratories for Reducing Waste in Biomedical Research.

The global biomedical research enterprise is driving substantial advances in medicine and healthcare. Yet it appears that the enterprise is rather wasteful, falling short of its true innovative potential. Suggested reasons are manifold and involve various stakeholders, such that there is no single remedy. In the present paper, I will argue that laboratories are the basic working units of the biomedical research enterprise and an important site of action for corrective intervention. Keeping laboratories relatively small will enable better training and mentoring of individual scientists, which in turn will yield better performance of the scientific workforce. The key premise of this argument is that people are at the heart of the successes and failures of biomedical research, yet the human dimension of science has been unduly neglected in practice. Renewed focus on the importance of laboratories and their constituent scientists is one promising approach to reducing waste and increasing efficiency within the biomedical research enterprise.

[23 and Me: how to make (a lot of) money out of your customers]. / 23andMe ou comment (très bien) valoriser ses clients - Chroniques génomiques.

The announcement of several deals between the DTC genetics firm 23 and Me and Genentech, Pfizer and other corporations reveals the real business model of the company: selling access to sets of characterized patients for targeted drug development. This may be a useful strategy, but it raises a number of questions concerning the privacy of the company's customers and also of adequate compensation when they become valuable currency.

Medication monitoring and drug testing ethics project.

In 2012, Duke University initiated a research project, funded by an unrestricted research grant from Millennium Laboratories, a drug testing company. The project focused on assessing the frequency and nature of questionable, unethical, and illegal business practices in the clinical drug testing industry and assessing the potential for establishing a business code of ethics. Laboratory leaders, clinicians, industry attorneys, ethicists, and consultants participated in the survey, were interviewed, and attended two face-to-face meetings to discuss a way forward. The study demonstrated broad acknowledgment of variations in the legal and regulatory environment, resulting in inconsistent enforcement of industry practices. Study participants expressed agreement that overtly illegal practices sometimes exist, particularly when laboratory representatives and clinicians discuss reimbursement, extent of testing, and potential business incentives with medical practitioners. Most respondents reported directly observing probable violations involving marketing materials, contracts, or, in the case of some individuals, directly soliciting people with offers of clinical supplies and other "freebies." While many study respondents were skeptical that voluntary standards alone would eliminate questionable business practices, most viewed ethics codes and credentialing as an important first step that could potentially mitigate uneven enforcement, while improving quality of care and facilitating preferred payment options for credentialed parties. Many were willing to participate in future discussions and industry-wide initiatives to improve the environment.

Ethics in the minutiae: examining the role of the physical laboratory environment in ethical discourse.

Responsibility within life science research is a highly scrutinised field. Increasingly, scientists are presented with a range of duties and expectations regarding their conduct within the research setting. In many cases, these duties are presented deontologically, forgoing extensive discussion on how these are practically implemented into the minutiae of daily research practices. This de-contextualized duty has proven problematic when it comes to practical issues of compliance, however it is not often considered as a fundamental aspect of building ethics discourse. This paper examines this issue in detail, particularly focusing on how differences in the contrasts between the ideal and real physical research environments cause conceptual problems for scientists and retard ethical engagement. Such issues are particularly pertinent in low- and middle-income countries. This paper combines theoretical and empirical analyses using the concept of "dual-use" as a focalizing topic. The data show that the research environment acts as an intimate component in the interpretation and implementation of ethical actions.

El Laboratorio Clínico en Atención Sanitaria, ¿proceso clave o de apoyo? / The clinical laboratory in the health care system: a key or a support process?

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