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Capacidad Tecnica9.1. requisitos documentales ...", "description": "En el enciso g)  y el enciso h) esta repetido. Sera que uno de ellos seria : Habilitacion vigente como importador de Dispositivos medicos emitida por la Direccion Nacional de Vigilancia Sanitario (DINAVISA) del MSPYBS?", "author": {"name": "G T SCIENTIFIC S.A.", "id": "PY-RUC-80000084-6"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en la Adenda N\u00b0 3.", "dateAnswered": "2021-01-28T14:20:31-04:00"}, {"id": "1", "date": "2020-12-30T16:37:50-04:00", "title": "Autorizacion del Fabricante", "description": "Solo requiere para el item 1 al 101. No se requerira Autorizacion del Fabricante del Equipo automatizado Citometro de flujo?", "author": {"name": "G T SCIENTIFIC S.A.", "id": "PY-RUC-80000084-6"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en la Adenda N\u00b0 3.", "dateAnswered": "2021-01-28T14:20:20-04:00"}, {"id": "12", "date": "2021-01-03T21:42:14-04:00", "title": "EETT del Equipo en Comodato", "description": "En el punto \"ESPECIFICACIONES T\u00c9CNICAS DEL EQUIPO EN COMODATO\", el PBC establece que el equipo en cuesti\u00f3n debe \"Contar con Certificaci\u00f3n IVD\". Al respecto de dicha certificaci\u00f3n solicitamos que la misma sea eliminada o, en su defecto, que se establezca otra certificaci\u00f3n como alternativa. Ello, teniendo en cuenta que la gran mayoria de los anticuerpos monoclonales solicitados por el \nPBC son RUO (research use only) y, estos, de acuerdo con la FDA, al estar destinados para el uso en investigaciones relacionadas al desarrollo de productos, no est\u00e1n aprovados para uso clinico de diagn\u00f3stico. Otro punto a tener en cuenta es los laboratorios cl\u00ednicos especializados pueden manejar los reactivos RUO en la t\u00e9cnica de citometr\u00eda de flujo en el tamizaje en pacientes oncol\u00f3gicos, ya que dicha tipificaci\u00f3n no genera un diagn\u00f3stico directo, puesto que este \u00faltimo debe ser realizado mediante un reactivo de diagn\u00f3stico in vitro. Ademas se considera que los laboratorios deben tener a disposici\u00f3n los protocolos y las validaciones necesarias que determinen la seguridad de los procesos.", "author": {"name": "G T SCIENTIFIC S.A.", "id": "PY-RUC-80000084-6"}, "answer": "Se aclara que la Certificaci\u00f3n solicitada es para el equipo Cit\u00f3metro de Flujo, es la Certificaci\u00f3n para Dispositivos de Diagn\u00f3stico in Vitro (IVD). El oferente deber\u00e1 remitirse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2021-01-28T14:22:04-04:00"}, {"id": "7", "date": "2021-01-01T10:54:28-04:00", "title": "CONSULTA 1", "description": "En la secci\u00f3n de especificaciones t\u00e9cnicas en los \u00edtems N\u00b0 2, 7, 11, 64 y 74 se solicita que los anticuerpos est\u00e9n marcados con fluorocromos ECD, la relevancia diagn\u00f3stica y/o de investigaci\u00f3n cl\u00ednica del uso de los anticuerpos marcados con dicho fluorocromo no est\u00e1 clara con respecto a la utilizaci\u00f3n de otros fluorocromos habituales, lo que excluye la participaci\u00f3n a varios fabricantes con certificaci\u00f3nes internacionales y reconocidas a nivel mundial.consulta: \u00bfSe podr\u00eda ofertar los mismos marcadores con otro fluorocromo equivalente para estos \u00edtems (2, 7, 11, 64 y 74)?", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Se aclara que para los \u00edtems N\u00b0 2, 7, 11, 13, 64 y 74, se podr\u00e1 ofertar los mismos marcadores con fluorocromos equivalentes a ECD.", "dateAnswered": "2021-01-28T14:21:09-04:00"}, {"id": "2", "date": "2020-12-30T16:48:45-04:00", "title": "9. Capacidad Tecnica - Habilitacion de Servicio Tecnico", "description": "No se observa como requerimiento de capacidad Tecnica  \"Constancia de Habilitacion de Servicio tecnico emitido por la Direccion Nacional de Vigilancia Sanitaria del MSPYBS. Considerando la complejidad del instrumento requerido con comodato es un requisito  fundamental que debe tener el perfil del oferente.", "author": {"name": "G T SCIENTIFIC S.A.", "id": "PY-RUC-80000084-6"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en la Adenda N\u00b0 3.", "dateAnswered": "2021-01-28T14:20:25-04:00"}, {"id": "8", "date": "2021-01-01T10:56:02-04:00", "title": "CONSULTA 2", "description": " En la secci\u00f3n de especificaciones t\u00e9cnicas en el \u00edtem N\u00b0 100 se solicita que el anticuerpo est\u00e9 marcado con el fluorocromo KRO, la relevancia diagn\u00f3stica y/o de investigaci\u00f3n cl\u00ednica del uso del anticuerpo marcado con KRO utilizado en forma individual o en la construcci\u00f3n de paneles no est\u00e1 clara en comparaci\u00f3n a la utilizaci\u00f3n de otros fluorocromos habituales, lo que excluye la participaci\u00f3n a varios fabricantes y solo se direcciona una marca en especial.\nConsulta: \u00bfSe podr\u00eda ofertar el mismo marcador con otro fluorocromo equivalente para este \u00edtem?", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Se aclara que para el \u00edtem N\u00b0 100, se podr\u00e1 ofertar el mismo marcador con fluorocromo equivalentes a KRO.", "dateAnswered": "2021-01-28T14:21:17-04:00"}, {"id": "15", "date": "2021-01-04T08:50:48-04:00", "title": "Para los \u00edtems 2, 7,11,13,64 y 74 :", "description": "Solicitan anticuerpos marcados con fluorocromo ECD para uso en t\u00e9cnica de citometr\u00eda de flujo  \n\nConsulta: Teniendo en cuenta la participaci\u00f3n de potenciales oferentes: podr\u00edamos cotizar los Anticuerpos marcados con fluorocromos EQUIVALENTES?, ya que el ECD es exclusivo de la marca Beckman Coulter ?en \u00e9ste caso limita la libre participaci\u00f3n de Proveedores.", "author": {"name": "INDEX S.A.C.I.", "id": "PY-RUC-80002742-6"}, "answer": "Se aclara que para los \u00edtems N\u00b0 2, 7, 11, 13, 64 y 74, se podr\u00e1 ofertas los mismos marcadores con fluorocromos equivalentes a ECD.", "dateAnswered": "2021-01-28T14:22:47-04:00"}, {"id": "18", "date": "2021-01-04T09:01:54-04:00", "title": "CRONOGRAMA DE ENTREGA DE BIENES", "description": "Cual es el plazo para la entrega del Cronograma de entregas por parte del Servicio al Proveedor?\n", "author": {"name": "INDEX S.A.C.I.", "id": "PY-RUC-80002742-6"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en las Especificaciones T\u00e9cnicas y Suministros Requeridos, punto 1. Especificaciones T\u00e9cnicas.", "dateAnswered": "2021-01-28T14:23:14-04:00"}, {"id": "11", "date": "2021-01-01T11:00:26-04:00", "title": "CONSULTA 5", "description": "En el PBC en solicitan al oferente: \nDemostrar la experiencia en provisi\u00f3n de reactivos para laboratorio con equipos en comodato con Contratos y/o Facturas a instituciones p\u00fablicas o privadas por un monto equivalente al 50 % como m\u00ednimo del monto total ofertado en la presente licitaci\u00f3n, dentro de los \u00faltimos: 5 (cinco) (2015 \u0096 2016 \u0096 2017 \u0096 2018 \u0096 2019) a\u00f1os. En caso de lograr el porcentaje requerido, en uno o en m\u00e1s a\u00f1os, que correspondan a los a\u00f1os establecidos en el presente punto, el mismo ser\u00e1 considerado como valedero para la participaci\u00f3n. Oferente en consorcio: Requisitos M\u00ednimos.\nConsideramos que este requisito as\u00ed formulado es una limitante para que marcas de renombre puedan participar de este llamado favoreciendo solo a una o dos empresas en espec\u00edfico.  Lo que la convocante debe considerar es la calidad / precios y servicios post venta requeridos y expresado de la manera expuesta limita el acceso a m\u00e1s competidores.-  \n\nSolicitamos que la convocante incluya la experiencia de provisi\u00f3n de equipos, reactivos e insumos en general en el \u00e1mbito sanitario como experiencia del oferente. De esta manera se podran recibir mayores oferentes y lograr mayor transparencia y competitividad en el presente concurso.-", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Se aclara que debido a las caracter\u00edsticas del llamado, de adquisici\u00f3n de reactivos para realizar el estudio laboratorial de Citometr\u00eda de Flujo, estudio altamente, complejo y especializado, es imprescindible que el oferente tenga experiencia en provisi\u00f3n de reactivos de laboratorio con equipos en comodato, en instituciones p\u00fablicas o privadas. El oferente deber\u00e1 remitirse a lo establecido en el Pliego de Bases y Condiciones", "dateAnswered": "2021-01-28T14:21:55-04:00"}, {"id": "6", "date": "2020-12-30T17:26:37-04:00", "title": "Condiciones del Equipo:", "description": "Solicita: 3- Calibradores y controles deben ser prove\u00eddos por la empresa adjudicada seg\u00fan requerimiento y especificaciones del equipo ofertado. Fecha de vencimiento de los reactivos m\u00ednimo de 1 (un) a\u00f1o.  En caso que el producto por su naturaleza no cumpla con este requerimiento, cual sera el procedimiento que se optara para la recepcion del producto, mas aun considerando que la facturacion sera por cada evento o determinacion", "author": {"name": "G T SCIENTIFIC S.A.", "id": "PY-RUC-80000084-6"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en la Adenda N\u00b0 3.", "dateAnswered": "2021-01-28T14:20:58-04:00"}, {"id": "10", "date": "2021-01-01T10:58:34-04:00", "title": "CONSULTA 4", "description": "En el apartado N\u00b0 4 de condiciones generales en la secci\u00f3n de especificaciones t\u00e9cnicas se cita lo siguiente; En caso de que el equipo sufra desperfectos y estos dependan de repuestos provenientes del exterior, las muestras deber\u00e1n ser derivadas a otros laboratorios referenciales que utilicen la misma metodolog\u00eda y los resultados de estos deber\u00e1n ser reportados dentro y como un m\u00e1ximo de 48 horas,\n\nSolicitamos amablemente a la convocante que el tiempo de contingencia de respuesta sea de 7 d\u00edas, debido a que no se puede inferir o acortar los tiempos de los laboratorios y muchas veces a nivel local la respuesta no es satisfactoria y los resultados son emitidos en mayor tiempo que lo requerido en el PBC\n\n", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Se aclara que debido a la naturaleza del Servicio y a la poblaci\u00f3n de pacientes que requieren el estudio de Citometr\u00eda de Flujo, que son mayormente pacientes inmuno -comprometidos, con patolog\u00edas oncol\u00f3gicas, es imprescindible dar una respuesta r\u00e1pida ante un evento adverso. El oferente deber\u00e1 remitirse a lo establecido en el Pliego de Bases y Condiciones", "dateAnswered": "2021-01-28T14:21:34-04:00"}, {"id": "17", "date": "2021-01-04T08:56:09-04:00", "title": "VENCIMIENTO DE LOS REACTIVOS:", "description": "Teniendo en cuenta la naturaleza del producto se podr\u00eda entregar reactivos con vencimientos menor a 12 meses?, con la debida autorizaci\u00f3n del Administrador de Contrato o del Servicio, y con carta de compromiso de canje en el caso que los mismos no fuesen utilizados antes de su vencimiento.", "author": {"name": "INDEX S.A.C.I.", "id": "PY-RUC-80002742-6"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en la Adenda N\u00b0 3.", "dateAnswered": "2021-01-28T14:23:06-04:00"}, {"id": "21", "date": "2021-01-04T09:36:49-04:00", "title": "CRONOGRAMA DE ENTREGA REACTIVOS E INSUMOS", "description": "Como ser\u00eda el cronograma de entrega para los reactivos e insumos? Cual es el plazo de entrega para estos?", "author": {"name": "CHACO INTERNACIONAL SA", "id": "PY-RUC-80026564-5"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en las Especificaciones T\u00e9cnicas y Suministros Requeridos, punto 1. Especificaciones T\u00e9cnicas.", "dateAnswered": "2021-01-28T14:23:38-04:00"}, {"id": "9", "date": "2021-01-01T10:57:19-04:00", "title": "CONSULTA 3", "description": "n el apartado de condiciones generales en la secci\u00f3n de especificaciones t\u00e9cnicas se cita lo siguiente; Ante desperfectos del equipo, el tiempo estipulado entre la denuncia telef\u00f3nica realizada a un n\u00famero de la empresa y la presencia del t\u00e9cnico en el laboratorio no debe exceder en ning\u00fan caso m\u00e1s de (60) minutos, previo cumplimiento del protocolo de trabajo. Es muy acotado el tiempo y los traslados al hospital se ven muchas veces impedidos por el tr\u00e1fico y las distancias de nuestros talleres y t\u00e9cnicos influyen muchas veces para dar la respuesta en tan poco espacio de tiempo. -\nSolicitamos que se modifique a un tiempo de 4 horas o 240 minutos posteriores al reclamo por v\u00eda telef\u00f3nica.\n\n ", "author": {"name": "CASA BOLLER S.A.", "id": "PY-RUC-80001556-8"}, "answer": "Se aclara que debido a la naturaleza del Servicio y a la poblaci\u00f3n de pacientes que requieren el estudio de Citometr\u00eda de Flujo, que son mayormente pacientes inmuno -comprometidos, con patolog\u00edas oncol\u00f3gicas, es imprescindible dar una respuesta r\u00e1pida ante un evento adverso. El oferente deber\u00e1 remitirse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2021-01-28T14:21:23-04:00"}, {"id": "4", "date": "2020-12-30T17:08:44-04:00", "title": "9. Capacidad Tecnica9.1. requisitos documentales ", "description": "j) Certificado anal\u00edtico de los \u00edtems ofertados donde se especifique la metodolog\u00eda utilizada para el peritaje del mismo.  El certificado analitico se emite por cada lote de producto. Solicitamos modificar el requerimiento permitiendo que el mismo deba ser entregado en cada provision de reactivo.\nTomese en cuenta que la metodologia ya se encuentra en inserto/tecnica que si se puede proporcionar para la evaluacion.", "author": {"name": "G T SCIENTIFIC S.A.", "id": "PY-RUC-80000084-6"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en la Adenda N\u00b0 3.", "dateAnswered": "2021-01-28T14:20:38-04:00"}, {"id": "5", "date": "2020-12-30T17:17:35-04:00", "title": "Especificaciones tecnisas del Equipo", "description": "Solicita con Certificacion IVD. No se observa el mismo requerimiento para los Reactivos.  Pues para que tenga fundamento analitico pedir esta Certificacion al equipo la misma debe ser extensible a los Reactivos. ", "author": {"name": "G T SCIENTIFIC S.A.", "id": "PY-RUC-80000084-6"}, "answer": "Se aclara que la Certificaci\u00f3n IVD es requerida para el equipo Cit\u00f3metro de Flujo, NO NECESARIAMENTE debe ser extensible a los reactivos.  El oferente deber\u00e1 remitirse a lo establecido en el Pliego de Bases y Condiciones", "dateAnswered": "2021-01-28T14:20:50-04:00"}, {"id": "14", "date": "2021-01-04T08:45:06-04:00", "title": "Para los \u00edtems 2, 7,11,13,64 y 74 :", "description": "Solicitan anticuerpos marcados con fluorocromo ECD para uso en t\u00e9cnica de citometr\u00eda de flujo:\n\nPara dar participaci\u00f3n a potenciales oferentes: Se podr\u00eda cotizar los Anticuerpos marcados con fluorocromos EQUIVALENTES, ya que el ECD solicitado es exclusivo de la marca Beckman Coulter, y en ese caso limita la libre competencia entre Proveedores.\n", "author": {"name": "INDEX S.A.C.I.", "id": "PY-RUC-80002742-6"}, "answer": "Se aclara que para los \u00edtems N\u00b0 2, 7, 11, 13, 64 y 74, se podr\u00e1 ofertar los mismos marcadores con fluorocromos equivalentes a ECD", "dateAnswered": "2021-01-28T14:22:40-04:00"}, {"id": "19", "date": "2021-01-04T09:26:07-04:00", "title": "SISTEMA DE ADJUDICACI\u00d3N", "description": "Solicitamos a la Convocante, modificar el sistema de adjudicaci\u00f3n de TOTAL a ITEMS, debido a que este sistema de adjudicaci\u00f3n limita la participaci\u00f3n de m\u00e1s oferentes al presente llamado.", "author": {"name": "CHACO INTERNACIONAL SA", "id": "PY-RUC-80026564-5"}, "answer": "Se aclara que la modalidad de contrataci\u00f3n por Comodato implica la adjudicaci\u00f3n por el total y no por \u00edtems, pues el equipo Cit\u00f3metro de Flujo no ser\u00e1 propiedad del IPS sino del firma adjudicada y los reactivos utilizados (bien adjudicado) deben ser todos de la firma adjudicada. No es admisible pensar en tener tantos Cit\u00f3metros de flujos como empresas adjudicadas haya. El oferente deber\u00e1 remitirse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2021-01-28T14:23:24-04:00"}, {"id": "22", "date": "2021-01-04T09:52:26-04:00", "title": "PLAN DE ENTREGA", "description": "Solicitamos a la Convocante que se modifique el plazo de entrega de 30 d\u00edas a 45 d\u00edas.", "author": {"name": "CHACO INTERNACIONAL SA", "id": "PY-RUC-80026564-5"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en las Especificaciones T\u00e9cnicas y Suministros Requeridos, punto 2. Plan de Entregas.", "dateAnswered": "2021-01-28T14:23:46-04:00"}, {"id": "13", "date": "2021-01-04T07:21:06-04:00", "title": "SISTEMA DE ADJUDICACION", "description": "Solicitamos respetuosamente a la Convocante, modificar el sistema de adjudicaci\u00f3n por \u00cdtems, debido a que originalmente se encuentra por el TOTAL, imposibilitando a los potenciales oferentes completar todos los items para ofertar, por lo que constituye una violaci\u00f3n a los principios establecidos en el Art. 4\u00b0 de la Ley de Contrataciones Publicas", "author": {"name": "INFOTEC SA", "id": "PY-RUC-80021897-3"}, "answer": "Se aclara que seadopt\u00f3 el modelo de adjudicaci\u00f3n por el total, con el objetivo de optimizar los recursos financieros de la Instituci\u00f3n, de lograr un mejor desempe\u00f1o administrativo, y de asegurar la provisi\u00f3n de la totalidad de los reactivos necesarios para realizar el estudio, considerando de que el equipo Cit\u00f3metro de Flujo no ser\u00e1 adquirido por la Instituci\u00f3n, sino ser\u00e1 prove\u00eddo en calidad de comodato, por el t\u00e9rmino fijado del Contrato. El oferente deber\u00e1 remitirse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2021-01-28T14:22:31-04:00"}, {"id": "20", "date": "2021-01-04T09:32:28-04:00", "title": "PLAN DE ENTREGAS", "description": "Solicitamos amablemente a la Convocante ampliar el plazo de entrega a 45 d\u00edas contados desde la recepci\u00f3n de la Orden de Compra.", "author": {"name": "CHACO INTERNACIONAL SA", "id": "PY-RUC-80026564-5"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en las Especificaciones T\u00e9cnicas y Suministros Requeridos, punto 2. Plan de Entregas.", "dateAnswered": "2021-01-28T14:23:31-04:00"}, {"id": "16", "date": "2021-01-04T08:52:45-04:00", "title": "El Pliego dice:  Contingencia:", "description": "Enti\u00e9ndase que el sistema de contingencia s\u00f3lo podr\u00e1 ser utilizado por un periodo no mayor a 15 (quince) d\u00edas, salvo alg\u00fan inconveniente por falta de repuesto del pa\u00eds de fabricaci\u00f3n del equipo \u00f3 inconvenientes de fuerza mayor en la recepci\u00f3n del reactivo del pa\u00eds de origen, en este caso deber\u00e1 comunicarse por escrito a la Gerencia de Salud, a la Direcci\u00f3n M\u00e9dica y a la Jefatura del Departamento de Hematolog\u00eda para los tr\u00e1mites pertinentes.\n\nConsulta:  En caso de que el equipo pare por alg\u00fan inconveniente, se podr\u00eda prever como contingencia la derivaci\u00f3n de las muestras en un centro con equipo de la misma marca y tecnolog\u00eda, hasta la reparaci\u00f3n del inconveniente ?", "author": {"name": "INDEX S.A.C.I.", "id": "PY-RUC-80002742-6"}, "answer": "El oferente deber\u00e1 remitirse a lo establecido en las Especificaciones T\u00e9cnicas y Suministros Requeridos, punto 1. 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