natgillin/translations-raw huggingface dataset:
m) "alvorlig uønsket hændelse": enhver uønsket og utilsigtet tildragelse i forbindels e med udtagning, præservering eller tilvejebringelse af organer , der kan resultere i overførsel af en smitsom sygdom , død eller en livstruende eller invaliderende tilstand hos donorerne, eller som kan nødvendiggøre et hospitalsophold eller kan resultere i en anden sygdom , for så vidt der ikke er tale om immunsuppression
(m) ‘serious adverse event’ means any undesired and unexpected occurrence associated with the procurement, preservation or making available of organs that might lead to the transmission of an infectious disease, to death or a life-threatening condition or to the disabling of donors or recipients, or that might necessitate hospitalisation or cause another illness, providing it is not a matter of the side-effects of immune suppression;
Definitionen på en alvorlig utilsigtet hændelse er så bredt formuleret, at der ville indløbe en masse indberetninger, uden at disse er kvalitets- eller sikkerhedsrelevante.
The definition of serious adverse unexpected event is so broad that it would inevitably lead to a large number of reports having nothing to do with quality or safety standards being filed.
Derfor bør definitionen svarende hertil afgrænse begrebet noget skarpere.
It should therefore be made slightly more restrictive, as proposed above.
Artikel 3 – litra n
Article 3 – point n
m) "alvorlig bivirkning": en utilsigtet komplikation, herunder en overførbar sygdom, hos donor eller recipient i et hvilket som helst led i kæden fra donation til transplantation, der er dødelig, livstruende eller invaliderende, som medfører uarbejdsdygtighed, eller som udløser eller forlænger hospitalsophold eller sygdom
(n) ‘serious adverse reaction’ means an unintended response, including a communicable disease, in the donor or in the recipient associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in , or prolongs, hospitalisation or morbidity;
Definitionen på en alvorlig bivirkning er så bredt formuleret, at der ville indløbe en masse indberetninger, uden at disse er kvalitets- eller sikkerhedsrelevante.
The definition of serous adverse reaction is so broad that it would inevitably lead to a large number of reports having nothing to do with quality or safety standards being filed.
p) "transplantation": at genoprette bestemte funktioner i det menneskelige legeme ved at overføre tilsvarende organer til en recipient
(p) ‘transplantation’ means the process of restoring certain functions of the human body by transferring equivalent organs to a recipient;
p) "transplantation": at genoprette bestemte funktioner i det menneskelige legeme ved at overføre menneskelige organer til en recipient
(p) ‘transplantation’ means the process of restoring certain functions of the human body by transferring human organs to a recipient;
Begrebet transplantation defineres klarere.
Clarification of the meaning of ‘transplantation’.
Kapitel II - overskrift
Chapter II - title
ORGANERS KVALITET OG SIKKERHED
THE QUALITY AND SAFETY OF ORGANS
Ramme for organers kvalitet og sikkerhed
Framework for the quality and safety of organs
Nationale kvalitetsprogrammer
National quality programmes
Ramme for nationale kvalitets- og sikkerhedsprogrammer
Framework for national quality and safety programmes
(Denne ændring finder anvendelse på hele teksten).
(This amendment applies throughout the text).
Artikel 4 – stk. 2 – litra -a (nyt)
Article 4 - paragraph 2 - point - a (new)
-a) standardprocedurer for identifikation og henvisning af potentielle donorer
(-a) standard operating procedure s for the identification and referral of potential donors ;
Identifikation af potentielle donorer i intensivafdelingerne og efterfølgende henvisning af samme er en nødvendig forudsætning for alle organdonationsaktiviteter.
Identification of potential donors in the intensive care units and their referral is the indispensable prerequisite for all organ donation activities.
Talrige undersøgelser viser, at der er et potentiale på mellem 40 og 50 donorer pr. million indbyggere i hver medlemsstat.
Numerous studies show that there is a potential between 40 to 50 donors per million population in every member state.
Det betyder, at hver enkelt medlemsstat kan øge sin organdonationsrate ved at indføre en systematisk analyse af det eksisterende donorpotentiale på alle donorhospitaler efterfulgt af måling for at sikre, at donorpotentialet er fuldt udnyttet.
This means that every member state can increase its organ donation rate by installing a systematic analysis of the existing donor potential in all donor hospital followed by measurement in order to ensure that the donor potential is exhausted.
b) standardprocedurer for kontrol af oplysninger om samtykke eller autorisation fra donor eller donors familie i overensstemmelse med national lovgivning
(b) standard operating procedures for the verification of the details of donor or donor family consent or authorisation in accordance with national rules;
b) standardprocedurer for kontrol af oplysninger om , at donor eller donors familie har givet deres samtykke eller i kke har gjort indsigelse, i overensstemmelse med national lovgivning
(b) standard operating procedures for the verification of the details of the consent, or absence of any objection, of the donor or donor family in accordance with national rules;
Dette ændringsforslag vedrører den mulighed for "opting out", som findes i de fleste medlemsstater.
This amendment takes into account the 'opting-out' character of consent which applies in most Member States.
e) bestemmelser om transport af menneskelige organer, jf. artikel 8.
(e) rules for the transportation of human organs in accordance with Article 8.
e) procedurer for transport af menneskelige organer, jf. artikel 8.
(e) procedures for the transportation of human organs in accordance with Article 8.
Denne nye struktur, som medlemsstaterne i høj grad støtter, bidrager til forståelsen af de vigtigste elementer i rammen for kvalitet og sikkerhed.
This new structure, highly supported by Member States, helps to better understand the essential elements of the quality and safety framework.
Yderligere oplysninger om de forskellige elementer findes i de tilsvarende artikler.
Further specifications on the different elements are provided in corresponding articles
Artikel 4 – stk. 2 – litra e a – e d (nye)
Article 4 – paragraph 2 – points e a – e d (new)
eb) procedurer for præcis, hurtig og verificerbar indberetning af alvorlige uønskede hændelser og bivirkninger, jf. artikel 11, stk. 1, herunder udtagningssteders og transplantationscentres ansvar med hensyn til rapporteringen
( eb) procedures for the accurate, rapid and verifiable reporting of serious adverse events and reactions in accordance with Article 11(1), including the responsibilities of procurement organi s ations and transplantation centres with regard to such reporting;
ec) procedurer for håndtering af alvorlige uønskede hændelser og bivirkninger, jf. artikel 11, stk. 2, herunder udtagningssteders og transplantationscentres ansvar med hensyn til håndteringen
( ec) procedures for the management of serious adverse events and reactions as referred to in Article 11(2), including the responsibilities of procurement organi s ations and transplantation centres with regard to such management.
ed) standardprocedurer for sporing og begrænsning af risikoen for uetiske eller illegale aktiviteter, især hvad angår beslutninger om udtagning og transplantation af organer.
(ed) standard operating procedures for tracing and limiting the risks of unethical or illegal activities, particularly concerning decisions for organ procurement and transplantation .
Yderligere oplysninger om de forskellige elementer findes i de tilsvarende artikler.
Further specifications on the different elements are provided in corresponding articles.
De nationale kvalitetsprogrammer skal omfatte følgende:
The national quality programmes shall
R ammen for organers kvalitet og sikkerhed skal sikre, at sundhedspersonale i alle led i kæden fra donation til transplantation eller anden disponering har de nødvendige kvalifikationer og den relevante kompetence, og at der udvikles særlige uddannelsesprogrammer for dette personale , og indføre standardprocedurer for:
T he framework for the quality and safety of organs shall ensure that the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal are suitably qualified and competent, and shall develop specific training programmes for such personnel , and shall establish standard operating procedures for:
Denne nye struktur, som medlemsstaterne i høj grad støtter, bidrager til forståelsen af de vigtigste elementer i rammen for kvalitet og sikkerhed: a) og b) er blevet flyttet til stk. 2.
This new structure, highly supported by Member States, helps to better understand the essential elements of the quality and safety framework: (a) and (b) have been moved (reworded) to paragraph 2.
Ordet “sundhedspersonale” er blevet indføjet for at udelukke chauffører, piloter m.fl., der deltager i processen.
“Healthcare” has been included in order to leave out drivers, pilots etc. involved in the process.
Indførelsen af begrebet “kompetence” dækker i højere grad de nationale forhold.
Including the word “competencies” better captures national realities.
Dette bør tages i betragtning i direktivet som helhed.
This should be taken into consideration for the entire text of the Directive.
Artikel 4 – stk. 3 – litra b – led 2
Article 4 - paragraph 3 - point b - indent 2
­ – tilbagekaldelse af organer , jf. artikel 11, stk. 2
– the recall of organs as referred in Article 11(2),
– forvaltning af alvorlige uønskede hændelser og bivirkninger , jf. artikel 11, stk. 2
– the management of serious adverse events and reactions as referred in Article 11(2),
De foranstaltninger, der skal træffes i forbindelse med en alvorlig uønsket hændelse eller bivirkning, omfatter ikke nødvendigvis tilbagekaldelse af organer som defineret i dette direktiv.
The measures to adopt for a severe adverse event or reaction do not include necessarily the recall of organs, as defined in this directive.
Undertiden indtræffer hændelserne eller bivirkningerne først, når organet er allerede blevet transplanteret, og i så fald er tilbagekaldelse af organet i form af transplantat-ektomi ikke nødvendigvis den mest hensigtsmæssige foranstaltning.
Occasionally, the events or the reactions appear when the organ has already been transplanted and, in that case, the transplantectomy for the recall of the organ may not be the most appropriate measure to adopt.
Desuden vil håndteringen af et konkret sikkerhedsproblem også omfatte en revurdering af procedurer og resultater med henblik på at indføre afhjælpende eller præventive foranstaltninger.
Besides, the management of a particular safety problem would also include the revision and assessment of the procedures and results, in order to introduce corrective or preventive measures.
Artikel 4 – stk. 3 – litra b – led 3
Article 4 - paragraph 3 - point b - indent 3
- udtagningssteders og transplantationscentres ansvar i forbindelse med rapportering
– the responsibilities of procurement organisations and transplantation centres in the process of reporting.
- udtagningssteders og transplantationscentres ansvar i forbindelse med rapportering og forvaltning
– the responsibilities of procurement organisations and transplantation centres in the process of reporting and management .
Når en alvorlig uønsket hændelse eller bivirkning indtræffer, skal der træffes en række modvirkende foranstaltninger.
When a serious adverse event or reaction appears it is mandatory to adopt a series of measures targeted to prevent.
Sådanne foranstaltninger omfatter ikke nødvendigvis tilbagekaldelse af organet som defineret i direktivet.
These measures do not necessarily include the recall of the organ, as defined in this Directive.
Undertiden indtræffer de alvorlige uønskede hændelser eller bivirkninger først, når organet er allerede blevet transplanteret, og transplantat-ektomi (tilbagekaldelse af organet) er i disse tilfælde ikke nødvendigvis den mest hensigtsmæssige foranstaltning.
Sometimes serious adverse events and reactions appear when the organ has been already grafted and transplantectomy (recall of the organ) might not be the most adequate measure to be adopted.
Artikel 4 – stk. 3 – litra b a (nyt)
Article 4 – paragraph 3 – point b a (new)
ba) tilladelse i akutte og livsvigtige tilfælde til anvendelse af et ikke optimalt organ til en transplantation efter samråd mellem sundheds personalet og patienten eller dennes nære familie, hv is patienten ikke er i stand til at udtrykke sin mening
(ba) authorise, in life-threatening emergencies, transplant operations using an organ which is not optimal, after consultation between the healthcare personnel and the patient , or the patient's family where the patient is unable to state his or her choice.
Artikel 4 – stk. 3 – litra c
Article 4 – paragraph 3 – point c
c) fastlæggelse af, hvilke kvalifikationer der kræves af personale i alle led i kæden fra donation til transplantation eller anden disponering, samt udvikling af særlige uddannelsesprogrammer for personale i overensstemmelse med anerkendte internationale standarder .
(c) establish the qualifications required by the personnel involved at all stages of the chain from donation to transplantation or disposal, and develop specific training programmes for personnel in accordance with recognised international standards .
c) fastlæggelse af, hvilke kvalifikationer eller kompetencer der kræves af sundhedspersonale i alle led i kæden fra donation til transplantation eller anden disponering, samt udvikling af særlige uddannelsesprogrammer for dette personale.
(c) establish the qualifications and competencies required for the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal, and develop specific training programmes for such personnel.
Situationen i medlemsstaterne afspejles bedre, hvis ordet "kompetencer" medtages.
Including the word “competencies” better captures national realities.
Artikel 4 – stk. 3 – litra c a (nyt)
Article 4 – paragraph 3 – point c a (new)
ca) fastlæggelse af status som transplantationskoordinator fra organdonation til overvågning af transplantationspatienten
(ca) determine the status of transplant coordinators from the stage of organ donation to that of monitoring of the recipient.
Europa-Parlamentet fremhævede i sin beslutning af 22. april 2008 i punkt 12 den centrale rolle, som transplantationskoordinator spiller med hensyn til aktivt at identificere potentielle donorer.
In Paragraph 12 of its resolution of 22 April 2008, the European Parliament stressed the central role played by transplant coordinators with a view to actively identifying potential donors.
Det er derfor afgørende, at de nationale kvalitetsprogrammer som omhandlet i artikel 4, stk. 3, også omfatter fastlæggelsen af en status som transplantationskoordinator.
It is therefore essential that the national quality programmes referred to in Article 4(3) should provide for the establishment of a status of transplant coordinator.
Medlemsstaterne sikrer, at udtagning finder sted på udtagningssteder , der opfylder bestemmelserne i dette direktiv.
Member States shall ensure that the procurement takes place in procurement organisations that comply with the rules laid down in this Directive.
Medlemsstaterne sikrer, at udtagning og tilvejebringelse af organer gennemføres af en eller flere offentlige eller private nonprofitinstanser , organisationer eller institutioner , der opfylder bestemmelserne i dette direktiv.
Member States shall ensure that the procurement and making available of organs takes place in public or private non-profit making bodies , organisations or institutions that comply with the rules laid down in this Directive.
Der er tale om en følgebestemmelse i forbindelse med myndighedsbegrebet og tilvejebringelse af organer.
This amendment brings the text into line with the definition of authorities and the making available of organs.
Udtagningssteders organisationsstruktur og arbejdsprocedurer skal omfatte:
The organisational structure and operational procedures of procurement organisations shall include:
a) en organisationsplan med detaljerede jobbeskrivelser, hvoraf det klart fremgår, hvem der har ansvaret for hvad, og hvem der refererer til hvem
(a) an organisational chart which clearly defines job descriptions, accountability and reporting relationships;
b) standardprocedurer som fastsat i nationale kvalitetsprogrammer.
(b) standard operating procedures as specified in national quality programmes.
Så præcise detaljer hører ikke hjemme i direktivets dispositive del.
These excessively precise details should not be included in the body of the directive.
Medlemsstaterne sikrer, at alle lægelige aktiviteter på udtagningssteder, såsom udvælgelse af donorer, udføres efter samråd med og under tilsyn af en læge som defineret i direktiv 2005/36/EF.
Member States shall ensure that medical activities in procurement organisations, such as donor selection, are performed under the advice and the supervision of a medical doctor as defined in Directive 2005/36/EC.
Medlemsstaterne sikrer, at alle lægelige aktiviteter på udtagningssteder, såsom udvælgelse og vurdering af donorer, udføres efter samråd med og under tilsyn af en læge som defineret i direktiv 2005/36/EF.
Member States shall ensure that medical activities in procurement organisations, such as donor selection and evaluation , are performed under the advice and the supervision of a medical doctor as defined in Directive 2005/36/EC.
Medlemsstaterne sørger for, at udtagning finder sted i faciliteter , der udelukkende anvendes hertil, og som er udformet og indrettet samt vedligeholdes og anvendes på en måde, der sikrer overholdelse af dette direktiv og gør det muligt at minimere risikoen for bakteriel eller anden kontaminering af de udtagne menneskelige organer i overensstemmelse med bedste medicinske praksis.
Member States shall ensure that procurement takes place in dedicated facilities, which are designed, constructed, maintained and operated so as to comply with the requirements laid down in this Directive and which allow minimising bacterial or other contamination of procured human organs in accordance with best medical practices.
Medlemsstaterne sørger for, at donationen finder sted i egnede faciliteter, som er udformet og indrettet samt vedligeholdes og anvendes på en måde, der sikrer overholdelse af dette direktiv og gør det muligt at minimere risikoen for bakteriel eller anden kontaminering af de udtagne menneskelige organer i overensstemmelse med bedste medicinske praksis.
Member States shall ensure that donation takes place in appropriate facilities, which are designed, constructed, maintained and operated so as to comply with the requirements laid down in this Directive and which allow minimising bacterial or other contamination of procured human organs in accordance with best medical practices.
Disse faciliteter opfylder sædvanlig standard for operationsstuer.
The facilities shall meet operating theatre standards.
Disse faciliteter skal opfylde sædvanlig standard for operationsstuer og skal bl.a. opfylde følgende krav:
Those facilities shall comply with normal standard for operating theatres, including:
a) Adgangen til området skal være begrænset.
(a) Restricted access;
b) Personalets påklædning skal være egnet til sterile operationer og skal omfatte sterile handsker, operationshue og ansigtsmaske.
(b) personnel that are appropriately dressed for sterile operations, wearing sterile gloves, hats and facemasks.
Sådanne detaljer hører ikke hjemme i et europæisk direktiv.
Such details should not be included in a European directive.
a) De organisationer, instanser eller virksomheder , der beskæftiger sig med transport af organer, opererer med hensigtsmæssige standardprocedurer, som sikrer, at organet ikke forringes under transporten, og at transporttiden minimeres .
(a) the organisation s, bodies or companies involved in the transportation of organs have appropriate standard operating procedures in place to ensure the integrity of the organ during transport and that transport time is minimised .
a) Den organisation , der beskæftiger sig med transport af organer, sikrer, at organet transporteres med fornøden omhu .
(a) the organisation involved in the transportation of organs ensure s that the organ is transported with due care ;
Artikel 8 – stk. 1 – litra b – led 1
Article 8 – paragraph 1 – point b – indent 1
- oplysninger, der identificerer udtagningsstedet, herunder adresse og telefonnummer
– identification of the procurement organisation, including its address and telephone number;
- oplysninger, der identificerer udtagningsstedet og donorhospitalet , herunder adresse og telefonnummer
– identification of the procurement organisation and the donor's hospital , including its address and telephone number;
Med den foreslåede ændring tages der højde for kvalitets- og sikkerhedskravene, og der tages hensyn til de specifikke krav i forbindelse med organtransplantation.
The proposed amendment takes due account of the quality and safety requirements and addresses the specific requirements relating to organ transplantation.
Artikel 8 – stk. 1 – litra b – led 4
Article 8 - paragraph 1 - point b - indent 4
- anbefalede transportforhold, herunder oplysninger om, at beholderen skal transporteres ved en bestemt temperatur og i en bestemt position
- recommended transport conditions, including instructions for keeping the container at a certain temperature and in a certain position
- anbefalede transportforhold, herunder oplysninger om, at beholderen skal transporteres ved en hensigtsmæssig temperatur og i en hensigtsmæssig position
- recommended transport conditions, including instructions for keeping the container at an appropriate temperature and in an appropriate position
Den kompetente myndighed angiver i akkrediteringen, udpegelsen, godkendelsen eller den udstedte licens, hvilke aktiviteter transplantationscentret må varetage.
The Competent authority shall indicate in the accreditation, designation, authorisation or licence which activities the transplantation centre concerned may undertake.
Den kompetente myndighed angiver i akkrediteringen, udpegelsen, godkendelsen eller den udstedte licens, hvilke programmer transplantationscentret må varetage.
The Competent authority shall indicate in the accreditation, designation, authorisation or licence which programmes the transplantation centre concerned may undertake.
Dette ændringsforslag skal vise, at der er forskel på transplantationscentre, idet nogle udfører alle former for transplantationsvirksomhed, og andre udelukkende er godkendt til visse transplantationsprogrammer, som f.eks. til nyre-, men ikke hjertetransplantationer.
This amendment is intended to reflect the variety which exists among transplantation centres, as some perform all types of transplantation while others are approved only for certain transplantation programmes, for example for kidney transplants but not heart transplants.
Medlemsstaterne sørger for, at der indføres et donoridentifikationssystem, som gør det muligt at identificere enhver donation og ethvert organ i tilknytning hertil.
Member States shall ensure the implementation of a donor identification system that can identify each donation and each of the organs associated with it.
Medlemsstaterne påser, at dette donoridentifikationssystem udformes og udvælges i overensstemmelse med målsætningen om ikke eller i mindst muligt omfang at indsamle, behandle eller anvende personoplysninger .
Member States shall ensure that this donor identification system are designed and selected in accordance with the aim of collecting, processing or using no personal data or as little personal data as possible.
Der skal især gøres brug af mulighederne for pseudonymisering eller anonymisering af privatpersoner .
In particular, use is to be made of the possibilities for pseudonymisation or rendering individuals anonymous .