INFORMED CONSENT IN CROATIAN CLINICAL LABORATORY PRACTICE - CURRENT ISSUES AND FUTURE PERSPECTIVES.

This paper deliberates on the place and role of informed consent in everyday clinical laboratory practice. Taking into account international ethical guidelines such as the UNESCO Universal Declaration on Bioethics and Human Rights, the Declaration of Helsinki of the World Medical Association, and Croatian national laws and codes such as the Act on the Protection of Patients' Rights, the Act on Medical Biochemistry, the Code of Ethics of Medical Biochemists and Medical Deontology, the Act on Healthcare Services, and the Code of Ethics of the Croatian Chamber of Healthcare Workers, an overview is given on the actual implementation of the aforementioned recommendations and regulations. A distinction between consent to a medical procedure and consent to enrolment in a research protocol is strongly stressed out. Special emphasis is placed on the role of specialists in laboratory medicine and masters of medical biochemistry in the process of obtaining informed consent. The design of an 'informed consent interview' is to be taken into consideration. Additional deliberation is needed on the option of 'broad consent'. It is concluded that informed consent should represent an important and routine activity within Croatian clinical laboratories.

Error Disclosure in Pathology and Laboratory Medicine: A Review of the Literature.

Since the 1990s, the fields of anatomic and clinical pathology have made strong commitments to improving patient safety, including the creation of formal and informal guidelines for assessing and reporting quality lapses. Unfortunately, some medical errors are inevitable. Patient safety experts advocate full and complete disclosure of all serious medical errors in an effort to preserve the patient-physician relationship and minimize the risk of harm to patients. While evidence suggests that most pathologists disclose serious medical errors, many do not disclose such errors to patients. A literature review of articles published on diagnostic error disclosure in pathology and laboratory medicine suggests that there are in fact persistent barriers to the disclosure of diagnostic errors that are specific to pathology. A number of these barriers are considered here, followed by recommendations for improving patient safety in pathology.

Grado de implantación de especificaciones de la calidad analítica en España / Level of implementation of analytical quality specifications in Spain

Objetivos: Este trabajo pretende conocer el grado de implantación de las especificaciones de la calidad en los laboratorios clínicos de España y concretamente de las especificaciones mínimas de la calidad analítica consensuadas por el Comité de Expertos Interdisciplinar sobre Especificaciones de la Calidad (CEIEC) en el Laboratorio Clínico, así como la opinión del sector respecto a la necesidad del establecimiento de valores preceptivos de requisitos de la calidad analítica: Material y método: Se diseñó una encuesta que constaba de 22 preguntas, 4 de ellas de tipo descriptivo, 16 retrospectivas y 2 prospectivas. El periodo de recogida de respuestas fue de septiembre a noviembre de 2012. Como requisito de los encuestados solo se consideró que participasen en algún programa de intercomparación de las sociedades científicas españolas representadas en el citado comité. El número de encuestas remitidas fue de 1.738. Resultados: Se recibieron 340 respuestas (19,6% del total). El 59% de los que respondieron tiene implantado un sistema de reconocimiento formal de la calidad. El 83% comprueba si cumplen o no con las especificaciones, el 68% dispone de un compromiso documental de cumplirlas y el 64% ha elaborado el listado con los valores concretos de especificaciones. El 55% conoce la existencia de unas especificaciones mínimas de la calidad consensuadas por el CEIEC. El 49% estaría de acuerdo en que estas especificaciones fueran preceptivas, mientras que el 33% no se define (AU)

Objectives: This work aims to determine the level of implementation of analytical quality specifications in Spanish clinical laboratories and, in particular, the minimum analytical quality specifications obtained by consensus of the Interdisciplinary Expert Committee on Quality Specifications (CEIEC) in the Clinical Laboratory, as well as to determine the opinions of the professionals as regards establishing mandatory analytical quality specifications.. Material and method: A questionnaire was designed including 4 descriptive, 16 retrospective, and 2 prospective questions. The responses were collected during September to November 2012. The requirement for participating was to be involved in an intercomparison program of any of the 4 Spanish scientific societies represented on the abovementioned committee. A total of 1,738 questionnaires were sent. Results: A total of 340 responses (19.6% over the total) were received. The results showed that 59% of respondents have a formally recognized quality system. The attainment of predefined specifications was checked by 83%, with 68% having a commitment for documented quality specifications, and 64% had made a list with specification values. A majority (55%) is aware of the existence of the consensus minimum quality specifications of the CEIEC, and 49% would agree that these specifications should become mandatory, while 33% did not declare a clear position on this subject (AU)

El diagnóstico en medicina tropical en países con pocos recursos / Medical diagnosis in resource-poor tropical countries

Cuando se trabaja en centros sanitarios de países en vías de desarrollo, ante la limitación de recursos diagnósticos, las habilidades clínicas resultan de gran importancia. En este trabajo se presentan las herramientas diagnósticas disponibles en zonas de bajos recursos. La anamnesis y exploración son claves para alcanzar un diagnóstico correcto. En el laboratorio se dispone de hemograma, bioquímica sanguínea básica y uroanálisis elemental. Las pruebas microbiológicas básicas disponibles son el estudio en fresco de las heces, frotis para malaria, baciloscopia de esputo y tinción de Gram de exudados clínicos. Las radiografías elementales de tórax, abdomen, huesos y partes blandas son de gran ayuda, pero tampoco están disponibles en todos los centros. La ecografía puede resultar de gran utilidad por su sencillez y versatilidad. El diagnóstico en condiciones de bajos recursos debe agudizar nuestras habilidades clínicas y debe apoyarse en el uso de pruebas complementarias elementales (AU)

When working in healthcare centers in developing countries where diagnostic resources are limited, clinical skills are of considerable importance. This study presents the diagnostic tools available in resource-poor areas. Anamnesis and physical examination are key components for reaching a correct diagnosis. The laboratory has at its disposal hemograms, basic blood chemistry and urinalysis. The available basic microbiological tests are the study of fresh feces, smears for malaria, direct smears for bacilli in sputum and Gram staining of clinical exudates. Basic radiography of the chest, abdomen, bones and soft tissues are of considerable usefulness but are not available in all centers. Ultrasonography can be of considerable usefulness due to its simplicity and versatility. The diagnosis in low resource conditions should sharpen our clinical skills and should be supported by the use of additional basic tests (AU)

Points to consider for prioritizing clinical genetic testing services: a European consensus process oriented at accountability for reasonableness.

Given the cost constraints of the European health-care systems, criteria are needed to decide which genetic services to fund from the public budgets, if not all can be covered. To ensure that high-priority services are available equitably within and across the European countries, a shared set of prioritization criteria would be desirable. A decision process following the accountability for reasonableness framework was undertaken, including a multidisciplinary EuroGentest/PPPC-ESHG workshop to develop shared prioritization criteria. Resources are currently too limited to fund all the beneficial genetic testing services available in the next decade. Ethically and economically reflected prioritization criteria are needed. Prioritization should be based on considerations of medical benefit, health need and costs. Medical benefit includes evidence of benefit in terms of clinical benefit, benefit of information for important life decisions, benefit for other people apart from the person tested and the patient-specific likelihood of being affected by the condition tested for. It may be subject to a finite time window. Health need includes the severity of the condition tested for and its progression at the time of testing. Further discussion and better evidence is needed before clearly defined recommendations can be made or a prioritization algorithm proposed. To our knowledge, this is the first time a clinical society has initiated a decision process about health-care prioritization on a European level, following the principles of accountability for reasonableness. We provide points to consider to stimulate this debate across the EU and to serve as a reference for improving patient management.

Para el análisis tiene usted que venir en ayunas / You must fast for the analysis

Objetivos. Estudiar la cumplimentación del ayuno correcto previo a la realización del análisis de sangre y averiguar si los profesionales sanitarios aconsejan el ayuno de 12 horas. Sujetos y métodos: Se pasó una encuesta a todos los adultos que se realizaron una analítica de sangre en un centro de salud rural (CSR) y en un laboratorio hospitalario (LH) durante periodos de dos y una semanas respectivamente. Se recogieron los datos de: sexo, edad, si comieron después de las 20 horas del día previo, si sabían que debían guardar ayuno y si algún profesional sanitario les advirtió de mantener un ayuno de 12 horas. Resultados: En el CSR se recogieron 202 encuestas, el 58,1% eran mujeres y la edad media de 53,7 ± 18,7. Conocían la importancia del ayuno el 95,3% y comieron después de las 20 horas del día previo el 66,5%. Al 86,6% nadie les dijo que debían guardar ayuno de 12 horas. En el LH se recogieron 243 encuestas, el 54% eran hombres y la edad media, de 54,1 ± 18,7. Conocían la importancia del ayuno el 96,5% y comieron después de las 20 horas el 78,2%. Al 90,2% nadie les dijo que debían guardar ayuno de 12 horas. Conclusiones: La mayoría de la población conoce la importancia del ayuno. El porcentaje de observancia del ayuno de 12 horas es muy bajo, aunque algo mayor en la población rural. Los sanitarios no informamos adecuadamente a nuestros pacientes (AU)

Objetives: 1. Study correct fasting compliance prior to the performance of the blood analysis. 2. Discover if the health care professionals have recommended 12-hour fasting. Subjects and methods: All the adults who underwent a blood test in a rural health care center (RHCS) and in a hospital laboratory (HL) during a two week and one week period, respectively, were surveyed. The survey collected: gender, age, if the subject had eaten after 8 p.m. on the day before the test, if they had known they had to fast and if any health care professional had told them to maintain a 12-hour fast. Results: In the RHCS, 202 surveys were collected (58.1% women). Mean age was 53.7 ± 18.7. A total of 95.3% had known the importance of fasting, and 66.5% had eaten after 8 p.m. the day before the test. A total of 86.6% had not been informed they had to fast for 12 hours. In the HL, 243 surveys were collected, 54% men. Mean age 54.1 ± 18.7. A total of 96.5% knew about the importance of fasting, and 78.2 had eaten after 8 p.m. the day before. A total of 90.2% had not been informed of the need to follow a 12- fasting period. Conclusions: Most of the population knows the importance of fasting. However, observance of a 12-hour fasting period is low, somewhat greater in the rural population. The health care professionals do not adequately inform their patients (AU)