natgillin/translations-raw huggingface dataset:
Številne študije so pokazale, da obstaja možnost 40 do 50 darovalcev na milijon prebivalcev v vsaki državi članici.
Numerous studies show that there is a potential between 40 to 50 donors per million population in every member state.
To pomeni, da vsaka država članica lahko poveča svoj obseg darovanja organov, tako da uvede sistematično analiziranje števila morebitnih darovalcev v vseh donorskih bolnišnicah, čemur sledijo meritve, da bi zagotovili, da se izčrpajo možnosti za darovanje.
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) standardnih postopkov za potrditev podrobnih podatkov o privolitvi darovalca oziroma njegove družine ali odobritve v skladu z nacionalnimi pravili;
(b) standard operating procedures for the verification of the details of donor or donor family consent or authorisation in accordance with national rules;
(b) standardnih postopkov za potrditev podrobnih podatkov o privolitvi ali nenasprotovanju darovalca oziroma njegove družine v skladu z nacionalnimi pravili;
(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;
Predlog spremembe upošteva privolitev, pri kateri se soglasje predpostavlja (opredelitev proti darovanju), ki se uporablja v večini držav članic.
This amendment takes into account the 'opting-out' character of consent which applies in most Member States.
(e) pravil za prevoz človeških organov v skladu s členom 8.
(e) rules for the transportation of human organs in accordance with Article 8.
(e) postopkov za prevoz človeških organov v skladu s členom 8.
(e) procedures for the transportation of human organs in accordance with Article 8.
Ta nova struktura, ki jo države članice močno podpirajo, pripomore k boljšemu razumevanju bistvenih elementov okvira za kakovost in varnost.
This new structure, highly supported by Member States, helps to better understand the essential elements of the quality and safety framework.
Nadaljnje natančne opredelitve o različnih elementih se nahajajo v ustreznih členih.
Further specifications on the different elements are provided in corresponding articles
Člen 4 – odstavek 2 – točke (e a) – (e d) (novo)
Article 4 – paragraph 2 – points e a – e d (new)
(eb) postopkov za natančno, hitro in preverljivo poročanje o hudih neželenih dogodkih in reakcijah v skladu s členom 11(1), vključno s pristojnostjo organizacij za pridobivanje organov in transplantacijskih centrov glede tovrstnega poročanja;
( 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) postopkov za obvladovanje hudih neželenih dogodkov in reakcij v skladu s členom 11(2), vključno s pristojnostjo organizacij za pridobivanje organov in transplantacijskih centrov glede tovrstnega obvladovanja;
( 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) standardnih operativnih postopkov za odkrivanje in omejitev tveganja za neetične ali nezakonite dejavnosti, zlasti za odločitve o pridobivanju in presajanju organov.
(ed) standard operating procedures for tracing and limiting the risks of unethical or illegal activities, particularly concerning decisions for organ procurement and transplantation .
Nadaljnje natančne opredelitve o različnih elementih se nahajajo v ustreznih členih.
Further specifications on the different elements are provided in corresponding articles.
Nacionalni programi za kakovost :
The national quality programmes shall
Okvir za kakovost in varnost organov zagotavlja, da je zdravstveno osebje, ki je na vsej stopnjah vključeno v verigo od darovanja do presaditve ali odstranitve, ustrezno strokovno izobraženo in usposobljeno, in razvije posebne programe usposabljanja za to osebje ter določi standardne operativne postopke:
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:
Ta nova struktura, ki jo države članice močno podpirajo, pripomore k boljšemu razumevanju bistvenih elementov okvira za kakovost in varnost: (a) in (b) sta bili premaknjeni (spremenjeno besedilo) v odstavek 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.
Izraz „zdravstveno“ je bil dodan, da bi izločili voznike, pilote itd., ki sodelujejo v postopku.
“Healthcare” has been included in order to leave out drivers, pilots etc. involved in the process.
Vključitev izraza "znanje" je primernejša zaradi nacionalnih razlik.
Including the word “competencies” better captures national realities.
To bi bilo treba upoštevati v celotnem besedilu direktive.
This should be taken into consideration for the entire text of the Directive.
Člen 4 – odstavek 3 – točka (b) – alinea 2
Article 4 - paragraph 3 - point b - indent 2
– odpoklic organov iz člena 11(2),
– the recall of organs as referred in Article 11(2),
– ravnanje v primeru hudih neželenih dogodkov in reakcij iz člena 11(2),
– the management of serious adverse events and reactions as referred in Article 11(2),
Ni nujno, da ukrepi, ki jih je treba sprejeti za primere hudih neželenih dogodkov ali reakcij, vključujejo odpoklic organov, kot je določeno v tej direktivi.
The measures to adopt for a severe adverse event or reaction do not include necessarily the recall of organs, as defined in this directive.
Včasih se dogodki ali reakcije pojavijo, ko je bil organ že presajen, in v tem primeru transplantektomija za odpoklic organa morda ni najustreznejši ukrep.
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.
Poleg tega bi reševanje določenega problema v zvezi z varnostjo vključevalo tudi pregled in oceno postopkov in rezultatov, da bi uvedli popravljalne ali preventivne ukrepe.
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.
Člen 4 – odstavek 3 – točka (b) – alinea 3
Article 4 - paragraph 3 - point b - indent 3
– pristojnosti organizacij za pridobivanje organov in transplantacijskih centrov glede postopka poročanja;
– the responsibilities of procurement organisations and transplantation centres in the process of reporting.
– pristojnosti organizacij za pridobivanje organov in transplantacijskih centrov glede postopka poročanja in upravljanja ;
– the responsibilities of procurement organisations and transplantation centres in the process of reporting and management .
Kadar pride do hudega dogodka ali reakcije, je obvezno treba sprejeti vrsto preventivnih ukrepov.
When a serious adverse event or reaction appears it is mandatory to adopt a series of measures targeted to prevent.
Ni nujno, da ti ukrepi vključujejo odpoklic organa, kot je določeno v tej direktivi.
These measures do not necessarily include the recall of the organ, as defined in this Directive.
Včasih se hudi neželeni dogodki in reakcije pojavijo, ko je bil organ že presajen, in transplantektomija (odpoklic organa) morda ni najustreznejši ukrep.
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.
Člen 4 – odstavek 3 – točka (b a) (novo)
Article 4 – paragraph 3 – point b a (new)
(ba) v nujnem primeru, ko je ogroženo življenje, privolijo v uporabo neoptimalnih organov za presaditev, v dogovoru med zdravstvenim osebjem in bolnikom oziroma njegovo družino, kadar bolnik ne more izraziti svoje odločitve;
(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.
Člen 4 – odstavek 3 – točka (c)
Article 4 – paragraph 3 – point c
(c) določijo, kakšno strokovno izobrazbo mora imeti osebje, ki je vključeno v katero koli od stopenj postopka od darovanja do presaditve ali odstranitve, in razvijejo posebne programe za usposabljanje osebja v skladu z veljavnimi mednarodnimi standardi .
(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) določijo, kakšno strokovno izobrazbo in znanje mora imeti zdravstveno osebje, ki je vključeno v katero koli od stopenj postopka od darovanja do presaditve ali odstranitve, in razvijejo posebne programe za usposabljanje tega osebja.
(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.
Vključitev izraza „znanje“ je primernejša zaradi nacionalnih razlik.
Including the word “competencies” better captures national realities.
Člen 4 – odstavek 3 – točka (c a) (novo)
Article 4 – paragraph 3 – point c a (new)
(ca) določijo statut transplantacijskih koordinatorjev od trenutka darovanja organov do spremljanja bolnika, ki je organ prejel.
(ca) determine the status of transplant coordinators from the stage of organ donation to that of monitoring of the recipient.
Evropski parlament je v resoluciji z dne 22. aprila 2008 v točki 12a poudaril osrednjo vlogo transplantacijskih koordinatorjev pri dejavnem iskanju možnih darovalcev.
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.
Zato morajo nacionalni programi kakovosti, ki jih sedaj ureja člen 4(3), predvideti oblikovanje statuta transplantacijskih koordinatorjev.
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.
Države članice zagotovijo, da se pridobivanje izvaja v okviru organizacij za pridobivanje organov , ki izpolnjujejo pravila, določena s to direktivo.
Member States shall ensure that the procurement takes place in procurement organisations that comply with the rules laid down in this Directive.
Države članice zagotovijo, da se pridobivanje in dajanje organov na voljo izvaja v okviru javnih ali zasebnih nepridobitnih organov, organizacij ali institucij , ki izpolnjujejo pravila, določena s to direktivo.
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.
Predlog spremembe usklajuje besedilo z opredelitvama „pristojnih teles“ in „dajanjem organov na voljo“.
This amendment brings the text into line with the definition of authorities and the making available of organs.
Organizacijska struktura in operativni postopki organizacij za pridobivanje organov zajemajo:
The organisational structure and operational procedures of procurement organisations shall include:
(a) organigram, ki jasno opredeljuje opise delovnih mest ter razmerje med odgovornostjo in poročanjem;
(a) an organisational chart which clearly defines job descriptions, accountability and reporting relationships;
(b) standardne postopke, ki jih določajo nacionalni programi za kakovost.
(b) standard operating procedures as specified in national quality programmes.
Besedilo direktive ne sme biti preveč podrobno.
These excessively precise details should not be included in the body of the directive.
Države članice zagotovijo, da se zdravstvene dejavnosti organizacij za pridobivanje, kot je izbira darovalca, izvajajo s svetovanjem in pod nadzorom zdravnika, kot je opredeljeno v Direktivi 2005/36/ES.
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.
Države članice zagotovijo, da se zdravstvene dejavnosti organizacij za pridobivanje, kot sta izbira darovalca in vrednotenje , izvajajo s svetovanjem in pod nadzorom zdravnika, kot je opredeljeno v Direktivi 2005/36/ES.
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.
Države članice zagotovijo, da se pridobivanje organov izvaja v temu namenjenih prostorih, ki so oblikovani, zgrajeni, vzdrževani in upravljani v skladu z zahtevami te direktive, v katerih je mogoče tveganje bakterijske ali druge okužbe kar najbolj zmanjšati v skladu z najboljšo zdravniško prakso.
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.
Države članice zagotovijo, da darovanje poteka v ustreznih prostorih, ki so oblikovani, zgrajeni, vzdrževani in upravljani v skladu z zahtevami te direktive, v katerih je mogoče tveganje bakterijske ali druge okužbe kar najbolj zmanjšati v skladu z najboljšo zdravniško prakso.
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.
Prostori ustrezajo standardom, ki veljajo za operacijske sobe.
The facilities shall meet operating theatre standards.
Ti prostori morajo biti v skladu z normalnimi standardi za operacijske sobe in imeti:
Those facilities shall comply with normal standard for operating theatres, including:
(a) omejen dostop;
(a) Restricted access;
(b) osebje, ki je oblečeno ustrezno za sterilne operacije, in nosi sterilne rokavice, kape in zaščitne maske.
(b) personnel that are appropriately dressed for sterile operations, wearing sterile gloves, hats and facemasks.
Evropska direktiva ne sme določati takih podrobnosti.
Such details should not be included in a European directive.
Člen 8 – odstavek 1 – točka (a)
Article 8 – paragraph 1 – point a
(a) organizacije, organi in podjetja, ki so vključeni v prevoz organov, uporabljajo ustrezne standardne postopke, da se zagotovi, da se organ med prevozom ne poškoduje in da je čas prevoza čim krajši ;
(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) organizacija, vključena v prevoz organov, zagotovi ustrezno skrbnost pri prevozu organov ;
(a) the organisation involved in the transportation of organs ensure s that the organ is transported with due care ;
S predlogom spremembe se poskuša skrčiti birokratske postopke.
This amendment seeks to cut red tape.
Bistveno je, da se z organom ravna v skladu s predpisi, ki veljajo pri prevozu.
What is essential is that the organ should be treated according to the rules during transport.
Člen 8 – odstavek 1 – točka (b) – alinea 1
Article 8 – paragraph 1 – point b – indent 1
– navedba organizacije za pridobivanje, vključno z naslovom in telefonsko številko,
– identification of the procurement organisation, including its address and telephone number;
– navedba organizacije za pridobivanje in bolnišnice darovalca , vključno z naslovom in telefonsko številko,
– identification of the procurement organisation and the donor's hospital , including its address and telephone number;
Predlagani predlog spremembe ustrezno upošteva zahteve glede kakovosti in varnosti ter obravnava posebne zahteve glede presaditve organov.
The proposed amendment takes due account of the quality and safety requirements and addresses the specific requirements relating to organ transplantation.
Člen 8 – odstavek 1 – točka (b) – alinea 4
Article 8 - paragraph 1 - point b - indent 4
– priporočeni pogoji prevoza, vključno z navodili glede temperature in položaja, v katerih mora biti vsebnik,
- recommended transport conditions, including instructions for keeping the container at a certain temperature and in a certain position
– priporočeni pogoji prevoza, vključno z navodili glede primerne temperature in primernega položaja, v katerih mora biti vsebnik,
- recommended transport conditions, including instructions for keeping the container at an appropriate temperature and in an appropriate position
Pristojni organ v akreditaciji, imenovanju, odobritvi ali dovoljenju navede, katere dejavnosti lahko izvaja zadevni transplantacijski center.
The Competent authority shall indicate in the accreditation, designation, authorisation or licence which activities the transplantation centre concerned may undertake.
Pristojni organ v akreditaciji, imenovanju, odobritvi ali dovoljenju navede, katere programe lahko izvaja zadevni transplantacijski center.
The Competent authority shall indicate in the accreditation, designation, authorisation or licence which programmes the transplantation centre concerned may undertake.
Države članice zagotovijo uporabo sistema za identifikacijo darovalcev, s katerim se lahko identificira vsako darovanje in vsak z njim povezan organ.
Member States shall ensure the implementation of a donor identification system that can identify each donation and each of the organs associated with it.
Države članice zagotovijo, da je ta sistem za identifikacijo darovalcev zasnovan in izbran tako, da zbiranje, obdelava in uporaba osebnih podatkov ni potrebna, oziroma v čim manjši meri.
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.
Zlasti je treba uporabljati psevdonime ali posameznike spremeniti v anonimne .
In particular, use is to be made of the possibilities for pseudonymisation or rendering individuals anonymous .
Države članice zagotovijo, da se zaupnost podatkov pacientov spoštuje v skladu z nacionalnimi predpisi .
Member States shall ensure that the confidentiality of patient data is respected in accordance with national rules .
Preveč natančno, saj je bilo že določeno sklicevanje na direktivo o varstvu osebnih podatkov.
Too detailed since the reference to the data protection directive has been already established.
Člen 10 – odstavek 3 – točka (b a) (novo)
Article 10 – paragraph 3 – point b a (new)
(ba) je dostop do sistemov, ki omogočajo identifikacijo darovalca ali prejemnika, kolikor se da omejen.
(ba) access to systems permitting the identification of a donor or recipient is as restricted as possible.
Če ima manj ljudi dostop do teh občutljivih podatkov, je manjše tveganje, da bi kdo do njih nezakonito dostopal.
With fewer people having access to data the risks of unlawful access of such sensitive data is reduced.
Države članice v skladu s členom 24 določijo pravila o kaznih za:
Member States shall, in accordance with Article 24, lay down rules on penalties applicable to:
(a) vsako nepooblaščeno dostopanje do podatkov ali sistemov, ki omogočajo identifikacijo darovalca ali prejemnika;
(a) any unauthorised accessing of data or systems that makes identification of donors or recipients possible ;
(b) vsako uporabo sistemov ali podatkov, ki omogočajo identifikacijo darovalca ali prejemnika, da bi jih izsledili za namene, ki niso potrebni iz zdravstvenih razlogov.
(b) any use which is made of systems or data that makes the identification of donors or recipients possible with a view to tracing donors or recipients other than for necessary medical purposes.
Kazni so potrebne, da bi ljudi odvrnili od uporabe sistemov za nepooblaščeno iskanje.
Penalties are needed to deter people from attempting to use the systems for unauthorized searches.
Države članice zagotovijo sistem za poročanje, raziskovanje, registracijo ter pošiljanje ustreznih in potrebnih informacij o hudih neželenih dogodkih in reakcijah, ki lahko vplivajo na kakovost in varnost človeških organov ter se jih lahko pripiše pridobivanju, testiranju in prevozu organov, kakor tudi o ugotavljanju kakršnih koli hudih neželenih reakcij med presaditvijo ali po njej, ki bi lahko bile povezane s temi dejavnostmi.
Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the procurement, testing, and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.
Države članice zagotovijo sistem za poročanje, raziskovanje, registracijo ter pošiljanje ustreznih in potrebnih informacij o hudih neželenih dogodkih in reakcijah, ki lahko vplivajo na kakovost in varnost človeških organov ter se jih lahko pripiše testiranju , določanju značilnosti, pridobivanju, konzerviranju in prevozu organov, kakor tudi o ugotavljanju kakršnih koli hudih neželenih reakcij med presaditvijo ali po njej, ki bi lahko bile povezane s temi dejavnostmi.
Member States shall ensure that there is a reporting system in place to report, investigate, register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the testing, characterisation, procurement, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.
Določanje značilnosti je prav tako vključeno v področje uporabe: člen 2(1).
Characterisation is also included under the scope - Article 2(1).
Pridobivanje mora biti navedeno po testiranju zaradi usklajenosti s kliničnim postopkom.
Procurement should move after testing in order to follow the clinical process.
Tretje strani
Third Parties
Organizacije za pridobivanje organov in transplantacijski centri lahko sklenejo pisne sporazume s tretjimi stranmi za izvrševanje svojih nalog.
Procurement organisations and transplantation centres may conclude written agreements with third parties for the carrying out of their functions.
Če organizacije za pridobivanje organov in transplantacijski centri sklenejo pisne sporazume iz 1. odstavka, morajo:
Where procurement organisations and transplantation centres enter into written agreements as referred to in paragraph 1 , they shall:
(a) oceniti in izbrati tretje strani na podlagi njihove sposobnosti, da dosežejo standarde iz te direktive;
(a) evaluate and select third parties on the basis of their ability to meet the standards laid down in this Directive;
(b) imeti popoln seznam sporazumov iz 1. odstavka, ki jih sklenejo s tretjimi stranmi;
(b) keep a complete list of the agreements referred to in paragraph 1 that they have concluded with third parties;
(c) posebej navesti pristojnosti tretjih strani in podrobne postopke;
(c) specify the responsibilities of the third parties and detailed procedures;