ABSTRACT
La tinta del documento está bastante opaca. DRACES [Departamento de Regulación, Acreditación y Control de Establecimientos de Salud] Este documento tiene como objeto: "la regulación, autorización y control de los laboratorios de diagnóstico clínico y/o de vigilancia epidemiológica, en concordancia con el Reglamento para la Regulación, Autorización, Acreditación y Control de Establecimientos de Atención para la Salud, Acuerdo Gubernativo 376-2007." Es de carácter obligatorio, por lo que se aplica tanto al sector público, privado, social o subsector de la seguridad social, en todo el territorio nacional. Contiene además, las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada clínica, incluidos el equipo y recurso humano y técnico. En el capítulo II, incluye una clasificación del nivel de laboratorios, describiendo sus características, servicios, horarios, materiales técnicos y equipos.
Subject(s)
Humans , Male , Female , Clinical Laboratory Techniques/classification , Clinical Laboratory Services/organization & administration , Laboratories/legislation & jurisprudence , Medical Laboratory Personnel/standards , Medical Laboratory Personnel/organization & administration , Containment of Biohazards/standards , Clinical Laboratory Techniques/instrumentation , Clinical Laboratory Services/standards , Guatemala , Laboratories/organization & administrationABSTRACT
Background: A growing number of drug development studies that include pharmacokinetic evaluations are conducted in regions lacking a specialised pharmacology laboratory. This necessitated the development of an International Pharmacology Specialty Laboratory (IPSL) in Zimbabwe.Objectives: The aim of this article is to describe the development of an IPSL in Zimbabwe.Methods: The IPSL was developed collaboratively by the University of Zimbabwe and the University at Buffalo Center for Integrated Global Biomedical Sciences. Key stages included infrastructure development, establishment of quality management systems and collaborative mentorship in clinical pharmacology study design and chromatographic assay development and validation.Results: Two high performance liquid chromatography instruments were donated by an instrument manufacturer and a contract research organisation. Laboratory space was acquired through association with the Zimbabwe national drug regulatory authority. Operational policies, standard operating procedures and a document control system were established. Scientists and technicians were trained in aspects relevant to IPSL operations. A high performance liquid chromatography method for nevirapine was developed with the guidance of the Clinical Pharmacology Quality Assurance programme and approved by the assay method review programme. The University of Zimbabwe IPSL is engaged with the United States National Institute of Allergy and Infectious Diseases Division of AIDS research networks and is poised to begin drug assays and pharmacokinetic analyses.Conclusions: An IPSL has been successfully established in a resource-limited setting through the efforts of an external partnership providing technical guidance and motivated internal faculty and staff. Strategic partnerships were beneficial in navigating challenges leading to laboratory development and training new investigators. The IPSL is now engaged in clinical pharmacology research
Subject(s)
Chromatography , Drug Monitoring , Laboratories/legislation & jurisprudence , Pharmacology/organization & administration , ZimbabweABSTRACT
Los lineamientos de la Política Económica y Social del Partido y la Revolución son la base para el reordenamiento económico, las transformaciones del sector de la salud constituye un punto de partida en este propósito.Objetivo: realizar una propuesta metodológica para el control de los laboratorios de los Centros de Higiene y Epidemiología.Método: se realizó una investigación de desarrollo para el diseño de una metodología para el control de los laboratorios de los Centros de Higiene y Epidemiología. Para el diseño de la propuesta se realizó una revisión bibliográfica y documental. En la selección y validación de las dimensiones a incluir en la metodología se realizó en consulta con siete expertos de la Escuela Nacional de Salud Pública. En su selección se tuvo en cuenta los siguientes criterios: competencia (efectividad de la actividad profesional del experto), creatividad, disposición a participar, conformidad, capacidad de análisis, espíritu colectivista y autocrítico, efectividad de su actividad profesional.Resultados: los expertos consideraron para el diseño de la propuesta cuatro pasos, primero: obtención de la información, segundo: definición de las dimensiones, tercero: definición de los elementos que componen las dimensiones propuestas, cuarto: aplicación de la propuesta, quinto: evaluación de la propuesta.Conclusiones: la propuesta metodológica para el control de la gestión de los laboratorios de los Centros Provinciales de Higiene Epidemiología, es una herramienta útil dentro de las transformaciones del sector salud para los que se desempeñan en estos procesos, se fundamenta de normativas, documentos legales, resoluciones, artículos científicos y la praxis en la actividad...
The guidelines of the Economic and Social Politics of the Cuban Party and the Revolution are the base for the economic reorganization; changes in the health sector are a starting point to get this purpose. Objective: to make a methodology proposal for the control of the Hygiene and Epidemiology Centers laboratories.Method: a developmental research for the design of a methodology for the control of the Hygiene and Epidemiology Centers laboratories was made. A bibliographic, documentary review was made for the design of the proposal. In the selection and validation of the dimensions to be included in the methodology were made by consulting seven experts from the National School of Public Health. The following criteria were taken into account for the selection: competence (efficiency of the professional activity of the expert), creativity, disposition to participate, consent, analysis ability, spirit of collectivism and self-criticism, efficiency of the professional activity.Results: the experts considered five steps for the design of the proposal: first, the obtaining of the information; second, the definition of the dimensions; third, the definition of the elements that constitute the proposed dimensions; fourth, the application of the proposal; fifth, the assessment of the proposal.Conclusions: the methodology proposal for the control of the Provincial Hygiene and Epidemiology Centers laboratories is a useful tool among the changes in the health sector for those who carry out these processes. Besides, it is based on regulations, legal documents, resolutions, scientific articles, and the praxis in the activity...
Subject(s)
Humans , Epidemiologic Research Design , Validation Study , Scientific Research and Technological Development , Laboratories/legislation & jurisprudenceABSTRACT
El documento tiene algunos problemas de nitidez, que dificultan un tanto su lectura y está un poco inclinado a la derecha. Incluye las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada centro, incluidos el equipo y recurso humano y técnico. Presenta también las características técnicas así como el perfil del personal que las maneja y el equipo de deben contener.
Subject(s)
Humans , Male , Female , Pathology Department, Hospital/legislation & jurisprudence , Laboratories/legislation & jurisprudence , Laboratories/organization & administration , Pathology/legislation & jurisprudence , Pathology/organization & administration , Pathology Department, Hospital/organization & administration , Cadaver , Morgue/legislation & jurisprudence , Morgue/organization & administration , GuatemalaABSTRACT
A Política Nacional de Medicamentos tem como importante diretriz a qualidade dos medicamentos oferecidos à população. Objetivou-se definir prioridades para análise pelo Programa Nacional de Verificação da Qualidade de Medicamentos. Como critério, utilizou-se a presença do medicamento em, no mínimo, três Programas de Assistência Farmacêutica do Ministério da Saúde. Critérios adicionais foram a presença na Relação Nacional de Medicamentos Essenciais de 2002 (RENAME) e a indicação para as vinte principais causas de Anos de Vida Perdidos Ajustados por Incapacidade (DALY). Informações do Ministério da Saúde e legislação foram fontes da pesquisa. Classificaram-se os medicamentos segundo o Anatomical Therapeutic Chemical Classification System (ATC) da OMS. Nos 13 programas de assistência farmacêutica, existiam 893 produtos classificados em 449 diferentes códigos ATC. Foram considerados prioritários 28 fármacos, 26 constantes na RENAME e 12 indicados nas causas de DALY. Recomenda-se, à Agência Nacional de Vigilância Sanitária e à Secretaria de Ciência, Tecnologia e Insumos Estratégicos, estabelecer estratégia integrada para garantia de qualidade integral desses medicamentos, abrangendo qualidade laboratorial, registro, boas práticas de fabricação e informações para profissionais de saúde e população.
A key objective of the Brazilian National Drug Policy is the quality of medicines supplied to the population. This study aimed to set priorities for the analysis of the National Program for Quality Control of Medicines. The main criterion was the drug's presence in at least three Pharmaceutical Care Programs under the Ministry of Health. Additional criteria were presence on the National List of Essential Drugs (RENAME) in 2002 and its indication for the 20 main causes of disability-adjusted life years (DALY). The sources were data from the Ministry of Health and related legislation. The drugs were classified according to the Anatomical Therapeutic Chemical Classification System (ATC) of the WHO. The 13 pharmaceutical care programs included 893 products classified in 449 different ATC codes. Twenty-eight drugs were considered priorities, 26 of which were listed on the RENAME and 12 indicated as causes of DALY. It is recommended that the National Health Surveillance Agency and Secretariat of Science, Technology, and Strategic Inputs establish an integrated strategy to guarantee comprehensive quality of these drugs, including laboratory quality, registration, good manufacturing practices, and information for health professionals and the general population.
Subject(s)
Humans , Drugs, Essential/standards , Health Policy , Laboratories/standards , Pharmaceutical Services/standards , Terminology as Topic , Brazil , Drugs, Essential/supply & distribution , Federal Government , Government Agencies , Government Regulation , Legislation, Drug , Laboratories/legislation & jurisprudence , Quality ControlABSTRACT
In order to assure the reliability of the results of laboratory services, clinical laboratories are regulated in the Philippines. This started with the passage of the Clinical Laboratory Law in 1965, which required the Licensing of clinical laboratories by the Bureau of Research and Laboratories, Department of Health (BRL, DOH) before they can operate. Standards were set for the various types of laboratory services. In 1988, the minimum standards of laboratory services were formulated for three categories, ie, primary, secondary and tertiary categories. Subsequently, to permit clinical laboratories to offer 'special service', accreditation of clinical laboratories was instituted. In 1968, the Philippine Society of Pathologists (PSP) decided to accredit clinical laboratories for Residency Training Program in Anatomic and Clinical Pathology. The following year after the passage of the Medical Technology Law, the BRL, DOH began accrediting clinical laboratories that trained Medical Technology Interns. A few years later, the BRL, DOH started to accredit clinical laboratories who did Water Analysis. In 1989, after realizing the serious implications of HIV Testing, the DOH mandated the BRL, DOH to set standards for clinical laboratories performing HIV testing. In 1997, upon request of the Philippine Health Insurance Corporation (PhilHealth), the PSP formulated and submitted standards for the accreditation of clinical laboratories, both hospital and free-standing, for reimbursement of fees for laboratory services rendered to patients enrolled in the PhilHealth social insurance program. In 2000, the Philippine Council for Accreditation of Healthcare Organizations (PCAHO) approved the Standards for the accreditation of Hospitals for the provision of quality medical services. Included were the standards for the Department of Pathology.
Subject(s)
Accreditation , Facility Regulation and Control , Humans , Laboratories/legislation & jurisprudence , PhilippinesABSTRACT
Abordando tópicos como os aspectos que visam à segurança daqueles que trabalham em laboratórios, o manuseio e o descarte de resíduos e produtos químicos, o risco de câncer na atividade laboratorial, além de levantar questões quanto à legislação e qualidade total pertinentes ao tema, este livro torna-se um manual indispensável para todos os laboratórios de pesquisa, de ensino ou de rotina, que trabalham com produtos químicos, material biológico, medicamentos, cosméticos e correlatos, radioisótopos e organismos geneticamente modificados.