natgillin/translations-raw huggingface dataset:
Member States shall ensure that organisations, bodies and laboratories involved in organ and donor characterisation have appropriate operating procedures in place to ensure that the information on organ and donor characterisation reaches the transplantation centre in due time.
Države članice zagotovijo, da organizacije, organi in laboratoriji, ki so vključeni v določanje značilnosti organa in darovalca, uporabljajo ustrezne operativne postopke, da zagotovijo, da transplantacijski center pravočasno prejme informacije o značilnostih organa in darovalca.
Where organs are exchanged between Member States, those Member States shall ensure that the information on organ and donor characterisation, as specified in the Annex, is transmitted to the other Member State with which the organ is exchanged, in conformity with the procedures established by the Commission pursuant to Article 29.
Kadar gre za izmenjavo organov med državami članicami, te države članice zagotovijo, da se informacije o značilnostih organa in darovalca, kakor je določeno v Prilogi, posredujejo drugi državi članici, s katero se organ izmenja v skladu s postopki, ki jih določi Komisija na podlagi člena 29.
Transport of organs
Prevoz organov
Member States shall ensure that the following requirements are met:
Države članice zagotovijo, da so izpolnjene naslednje zahteve:
the organisations, bodies or companies involved in the transportation of organs have appropriate operating procedures in place to ensure the integrity of the organs during transport and a suitable transport time;
organizacije, organi in podjetja, ki so vključeni v prevoz organov, uporabljajo ustrezne operativne postopke, da se zagotovi, da se organ med prevozom ne poškoduje in da je čas prevoza ustrezen;
the shipping containers used for transporting organs are labelled with the following information:
vsebniki za prevoz organov so označeni z naslednjimi podatki:
identification of the procurement organisation and the establishment where the procurement took place, including their addresses and telephone numbers;
navedba organizacije za pridobivanje in ustanove, kjer je potekalo pridobivanje, vključno z njihovimi naslovi in telefonskimi številkami;
identification of the transplantation centre of destination, including its address and telephone number;
navedba namembnega transplantacijskega centra, vključno z njegovim naslovom in telefonsko številko;
a statement that the package contains an organ, specifying the type of organ and, where applicable, its left or right location and marked ‘HANDLE WITH CARE’;
izjava, da paket vsebuje organ, pri čemer je navedena vrsta organa in, kadar je to primerno, ali gre za levo ali desno stran ter opomba „RAVNAJ PREVIDNO“;
recommended transport conditions, including instructions for keeping the container at an appropriate temperature and position;
priporočeni pogoji prevoza, vključno z navodili glede primerne temperature in položaja, v katerih mora biti vsebnik;
the organs transported are accompanied by a report on the organ and donor characterisation.
organi, za katere se opravi prevoz, so opremljeni s poročilom o značilnostih organov in darovalcev.
The requirements laid down in paragraph 1(b) need not be met where the transportation is carried out within the same establishment.
Za zahteve iz točke (b) odstavka 1 ni treba, da so izpolnjene, kadar gre za premeščanje znotraj iste ustanove.
Transplantation centres
Transplantacijski centri
Member States shall ensure that transplantation takes place in, or is carried out by, transplantation centres that comply with the rules laid down in this Directive.
Države članice zagotovijo, da se presaditve izvajajo v transplantacijskih centrih, ki upoštevajo pravila, določena s to direktivo, ali da jih izvajajo ti centri.
The competent authority shall indicate in the authorisation which activities the transplantation centre concerned may undertake.
Pristojni organ v odobritvi navede, katere dejavnosti lahko izvaja zadevni transplantacijski center.
The transplantation centre shall verify before proceeding to transplantation that:
Transplantacijski center pred začetkom presaditve preveri, ali:
the organ and donor characterisation are completed and recorded in accordance with Article 7 and the Annex;
je opis značilnosti organa in darovalca pripravljen in evidentiran v skladu s členom 7 in Prilogo;
the conditions of preservation and transport of shipped organs have been maintained.
so bili pogoji konzerviranja in prevoza organov med prevozom ohranjeni.
Member States shall, upon the request of the Commission or another Member State, provide information on the national requirements for the authorisation of transplantation centres.
Države članice na zahtevo Komisije ali druge države članice posredujejo informacije o nacionalnih zahtevah za odobritev transplantacijskih centrov.
Member States shall ensure that all organs procured, allocated and transplanted on their territory can be traced from the donor to the recipient and vice versa in order to safeguard the health of donors and recipients.
Države članice zagotovijo sledljivost vseh organov, pridobljenih, dodeljenih in presajenih na njihovem ozemlju, od darovalca do prejemnika in obratno, da se zavaruje zdravje darovalcev in prejemnikov.
Member States shall ensure the implementation of a donor and recipient identification system that can identify each donation and each of the organs and recipients associated with it.
Države članice zagotovijo uporabo sistema za identifikacijo darovalcev in prejemnikov, s katerim se lahko identificira vsako darovanje ter vsak z njim povezan organ in prejemniki.
With regard to such a system, Member States shall ensure that confidentiality and data security measures are in place in compliance with Union and national provisions, as referred to in Article 16.
Države članice v zvezi s takim sistemom zagotovijo ukrepe za zaupnost in varstvo podatkov v skladu s predpisi Unije in nacionalnimi predpisi, kakor je navedeno v členu 16.
the competent authority or other bodies involved in the chain from donation to transplantation or disposal keep the data needed to ensure traceability at all stages of the chain from donation to transplantation or disposal and the information on organ and donor characterisation as specified in the Annex, in accordance with the framework for quality and safety;
pristojni organ ali drugi organi, vključeni v postopek od darovanja do presaditve ali uničenja, shranijo potrebne podatke, da se zagotovi sledljivost na vseh stopnjah postopka od darovanja do presaditve ali uničenja, ter informacije o značilnostih organa in darovalca, kakor je določeno v Prilogi, v skladu z okvirom za kakovost in varnost;
data required for full traceability is kept for a minimum of 30 years after donation.
se podatki, potrebni za popolno sledljivost, hranijo najmanj 30 let po darovanju.
Such data may be stored in electronic form.
Takšni podatki se lahko shranijo v elektronski obliki.
Where organs are exchanged between Member States, those Member States shall transmit the necessary information to ensure the traceability of organs, in conformity with the procedures established by the Commission pursuant to Article 29.
Kadar gre za izmenjavo organov med državami članicami, te države članice posredujejo potrebne informacije za zagotovitev sledljivosti organov v skladu s postopki, ki jih določi Komisija na podlagi člena 29.
Reporting system and management concerning serious adverse events and reactions
Sistem za poročanje in obvladovanje hudih neželenih dogodkov in reakcij
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 that may influence the quality and safety of organs and that 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.
Države članice zagotovijo sistem za poročanje, raziskovanje, registracijo ter pošiljanje ustreznih in potrebnih informacij o hudih neželenih dogodkih, ki lahko vplivajo na kakovost in varnost organov ter ki 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 an operating procedure is in place for the management of serious adverse events and reactions as provided for in the framework for quality and safety.
Države članice zagotovijo operativni postopek, ki omogoča obvladovanje primerov hudih neželenih dogodkov in reakcij, kakor je določeno v okviru za kakovost in varnost.
In particular, and with regard to paragraphs 1 and 2, Member States shall ensure that operating procedures are in place for the notification, in due time, of:
Države članice zlasti, in v zvezi z odstavkoma 1 in 2, zagotovijo, da so vzpostavljeni operativni postopki za pravočasno uradno obveščanje:
any serious adverse event and reaction to the competent authority and to the concerned procurement organisation or transplantation centre;
pristojnega organa in zadevne organizacije za pridobivanje ali transplantacijskega centra o kakršnih koli hudih neželenih dogodkih in reakcijah;
the management measures with regard to serious adverse events and reactions to the competent authority.
pristojnega organa o ukrepih ravnanja v primeru hudih neželenih dogodkov in reakcij.
Where organs are exchanged between Member States, those Member States shall ensure the reporting of serious adverse events and reactions in conformity with the procedures established by the Commission pursuant to Article 29.
Kadar gre za izmenjavo organov med državami članicami, te države članice zagotovijo poročanje o hudih neželenih dogodkih in reakcijah v skladu s postopki, ki jih določi Komisija na podlagi člena 29.
Member States shall ensure the interconnection between the reporting system referred to in paragraph 1 of this Article and the notification system established in accordance with Article 11(1) of Directive 2004/23/EC.
Države članice zagotovijo povezavo med sistemom za poročanje iz odstavka 1 tega člena in sistemom za poročanje, vzpostavljenim v skladu s členom 11(1) Direktive 2004/23/ES.
Healthcare personnel
Zdravstveno osebje
Member States shall ensure that healthcare personnel directly involved in the chain from donation to the transplantation or disposal of organs are suitably qualified or trained and competent to perform their tasks and are provided with the relevant training, as referred to in Article 4(3).
Države članice zagotovijo, da je zdravstveno osebje, ki je neposredno vključeno v postopek med darovanjem in presaditvijo ali uničenjem organa, ustrezno kvalificirano ali usposobljeno in sposobno za izvajanje svojih nalog ter prejme ustrezno usposabljanje, kakor je navedeno v členu 4(3).
DONOR AND RECIPIENT PROTECTION AND DONOR SELECTION AND EVALUATION
ZAŠČITA DAROVALCA IN PREJEMNIKA TER IZBIRANJE IN OCENJEVANJE DAROVALCA
Principles governing organ donation
Načela, ki urejajo darovanje organov
Member States shall ensure that donations of organs from deceased and living donors are voluntary and unpaid.
Države članice zagotovijo, da je darovanje organov umrlih in živih darovalcev prostovoljno in brezplačno.
The principle of non-payment shall not prevent living donors from receiving compensation, provided it is strictly limited to making good the expenses and loss of income related to the donation.
Načelo brezplačnega darovanja živim darovalcem ne preprečuje, da prejmejo nadomestilo, če je omejeno izključno na povračilo za stroške in izgubo dohodka, povezano z darovanjem.
Member States shall define the conditions under which such compensation may be granted, while avoiding there being any financial incentives or benefit for a potential donor.
Države članice določijo pogoje, pod katerimi se dovoli plačilo takšnega nadomestila, pri čemer se prepreči nastanek kakršnih koli finančnih spodbud ali koristi za potencialnega darovalca.
Member States shall prohibit advertising the need for, or availability of, organs where such advertising is with a view to offering or seeking financial gain or comparable advantage.
Države članice prepovejo oglaševanje potrebe po organih in njihove ponudbe, če je namen tega oglaševanja ponujanje ali iskanje dobička ali podobnih koristi.
Member States shall ensure that the procurement of organs is carried out on a non-profit basis.
Države članice zagotovijo, da se pridobivanje organov izvaja na nepridobitni podlagi.
Consent requirements
Zahteve glede soglasja
The procurement of organs shall be carried out only after all requirements relating to consent, authorisation or absence of any objection in force in the Member State concerned have been met.
Pridobivanje organov se izvaja šele potem, ko so izpolnjene vse zahteve glede soglasja, odobritve ali v odsotnosti kakršnega koli nasprotovanja, ki veljajo v zadevni državi članici.
Quality and safety aspects of living donation
Kakovostni in varnostni vidiki darovanja organov živih darovalcev
Member States shall take all necessary measures to ensure the highest possible protection of living donors in order to fully guarantee the quality and safety of organs for transplantation.
Države članice sprejmejo vse potrebne ukrepe za najvišjo možno zaščito živih darovalcev, da se v celoti zagotovi kakovost in varnost organov za presaditev.
Member States shall ensure that living donors are selected on the basis of their health and medical history, by suitably qualified or trained and competent professionals.
Države članice zagotovijo, da žive darovalce izbirajo ustrezno kvalificirani ali usposobljeni in sposobni strokovnjaki na podlagi njihovega zdravja in zdravstvene anamneze.
Such assessments may provide for the exclusion of persons whose donation could present unacceptable health risks.
Takšne ocene lahko prispevajo k izločanju oseb, katerih darovanje bi lahko pomenilo nesprejemljiva tveganja za zdravje.
Member States shall ensure that a register or record of the living donors is kept, in accordance with Union and national provisions on the protection of the personal data and statistical confidentiality.
Države članice zagotovijo, da se vodi evidenca živih darovalcev po darovanju v skladu s predpisi Unije in nacionalnimi predpisi o varovanju osebnih podatkov in zaupnosti statističnih podatkov.
Member States shall endeavour to carry out the follow-up of living donors and shall have a system in place in accordance with national provisions, in order to identify, report and manage any event potentially relating to the quality and safety of the donated organ, and hence of the safety of the recipient, as well as any serious adverse reaction in the living donor that may result from the donation.
Države članice si prizadevajo za izvedbo nadaljnjega spremljanja živih darovalcev in vzpostavijo sistem v skladu z nacionalnimi predpisi, da se identificira, poroča in nadzira kakršen koli dogodek, ki bi lahko vplival na kakovost in varnost darovanega organa ter s tem na varnost prejemnika, kot tudi kakršno koli hudo neželeno reakcijo v živem darovalcu, ki je lahko posledica darovanja.
Protection of personal data, confidentiality and security of processing
Varovanje osebnih podatkov, zaupnost in varnost obdelave
Member States shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ donation and transplantation activities, in conformity with Union provisions on the protection of personal data, such as Directive 95/46/EC, and in particular Article 8(3), Articles 16 and 17 and Article 28(2) thereof.
Države članice zagotovijo, da se temeljna pravica do varovanja osebnih podatkov v celoti in učinkovito spoštuje pri vseh dejavnostih darovanja in presajanja organov v skladu s predpisi Unije o varovanju osebnih podatkov, kot je Direktiva 95/46/ES in zlasti členi 8(3), 16, 17 in 28(2) Direktive.
Pursuant to Directive 95/46/EC, Member States shall take all necessary measures to ensure that:
Države članice na podlagi Direktive 95/46/ES sprejmejo vse potrebne ukrepe za zagotovitev, da:
the data processed are kept confidential and secure in accordance with Articles 16 and 17 of Directive 95/46/EC.
so obdelani podatki zaupni in varovani v skladu s členoma 16 in 17 Direktive 95/46/ES.
Any unauthorised accessing of data or systems that makes identification of donor or recipients possible shall be penalised in accordance with Article 23 of this Directive;
Vsak nepooblaščen dostop do podatkov ali sistemov, ki omogočajo identifikacijo darovalca ali prejemnika, se kaznuje v skladu s členom 23 te direktive;
donors and recipients whose data are processed within the scope of this Directive are not identifiable, except as permitted by Article 8(2) and (3) of Directive 95/46/EC, and national provisions implementing that Directive.
darovalcev in prejemnikov, katerih podatki se obdelujejo v okviru področja uporabe te direktive, ni mogoče prepoznati, razen kadar to dopušča člen 8(2) in (3) Direktive 95/46/ES ter nacionalne določbe za izvajanje navedene direktive.
Any use of systems or data that makes the identification of donors or recipients possible with a view to tracing donors or recipients other than for the purposes permitted by Article 8(2) and (3) of Directive 95/46/EC, including medical purposes, and by national provisions implementing that Directive shall be penalised in accordance with Article 23 of this Directive;
Kakršna koli uporaba sistemov ali podatkov, ki omogočajo identifikacijo darovalcev ali prejemnikov, da bi jih izsledili za namene, ki niso dovoljeni s členom 8(2) in (3) Direktive 95/46/ES, vključno z zdravstvenimi nameni, ter z nacionalnimi predpisi za izvajanje navedene direktive, se kaznuje v skladu s členom 23 te direktive;
the principles relating to data quality, as set out in Article 6 of Directive 95/46/EC, are met.
so izpolnjena načela o kakovosti podatkov, kakor je določeno v členu 6 Direktive 95/46/ES.
OBLIGATIONS OF COMPETENT AUTHORITIES AND EXCHANGE OF INFORMATION
OBVEZNOSTI PRISTOJNIH ORGANOV IN IZMENJAVA INFORMACIJ
Designation and tasks of competent authorities
Imenovanje in naloge pristojnih organov
Member States shall designate one or more competent authorities.
Države članice imenujejo enega ali več pristojnih organov.
Member States may delegate, or may allow a competent authority to delegate, part or all of the tasks assigned to it under this Directive to another body which is deemed suitable under national provisions.
Države članice lahko prenesejo ali dovolijo pristojnemu organu, da del nalog ali vse naloge, ki so mu dodeljene v skladu s to direktivo, prenese na drug organ, ki velja za primernega v skladu z nacionalnimi predpisi.
Such a body may also assist the competent authority in carrying out its functions.
Takšen organ lahko pristojnemu organu tudi pomaga pri izvajanju njegovih funkcij.
The competent authority shall, in particular, take the following measures:
Pristojni organ sprejme zlasti naslednje ukrepe:
establish and keep updated a framework for quality and safety in accordance with Article 4;
vzpostavitev in posodabljanje okvira za kakovost in varnost v skladu s členom 4;
ensure that procurement organisations and transplantations centres are controlled or audited on a regular basis to ascertain compliance with the requirements of this Directive;
zagotavljanje rednega nadzora ali revizije organizacij za pridobivanje in transplantacijskih centrov, da se preveri izpolnjevanje zahtev te direktive;
grant, suspend, or withdraw, as appropriate, the authorisations of procurement organisations or transplantation centres or prohibit procurement organisations or transplantation centres from carrying out their activities where control measures demonstrate that such organisations or centres are not complying with the requirements of this Directive;
dodelitev, začasna prekinitev ali odvzem odobritev organizacijam za pridobivanje ali transplantacijskim centrom, ali prepoved opravljanja dejavnosti organizacijam za pridobivanje ali transplantacijskim centrom, kadar nadzorni ukrepi pokažejo, da takšne organizacije ali centri ne izpolnjujejo zahtev te direktive;
put in place a reporting system and management procedure for serious adverse events and reactions as provided for in Article 11(1) and (2);
vzpostavitev sistema za poročanje o hudih neželenih dogodkih in reakcijah ter obvladovanje teh primerov, kakor je določeno v členu 11(1) in (2);
issue appropriate guidance to healthcare establishments, professionals and other parties involved in all stages of the chain from donation to transplantation or disposal, which may include guidance for the collection of relevant post-transplantation information to evaluate the quality and safety of the organs transplanted;
izdajanje ustreznih smernic zdravstvenim ustanovam, strokovnjakom in drugim zainteresiranim stranem, ki so vključeni v katero koli stopnjo postopka od darovanja do presaditve ali uničenja, kar lahko zajema smernice za zbiranje ustreznih informacij po presaditvi za oceno kakovosti in varnosti presajenih organov;
participate, whenever possible, in the network of competent authorities referred to in Article 19 and coordinate at national level input to the activities of that network;
sodelovanje, kadar koli je to mogoče, v mreži pristojnih organov iz člena 19 in usklajevanje prispevkov na nacionalni ravni k dejavnostim navedene mreže;
supervise organ exchange with other Member States and with third countries as provided for in Article 20(1);
nadzor izmenjave organov z drugimi državami članicami in s tretjimi državami, kakor je določeno v členu 20(1);
ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ transplantation activities, in conformity with Union provisions on the protection of personal data, in particular Directive 95/46/EC.
zagotavljanje, da se temeljna pravica do varovanja osebnih podatkov v celoti in učinkovito spoštuje pri vseh dejavnostih presajanja organov v skladu s predpisi Unije o varovanju osebnih podatkov, zlasti z Direktivo 95/46/ES.
Records and reports concerning procurement organisations and transplantation centres
Evidence in poročila v zvezi z organizacijami za pridobivanje in transplantacijskimi centri
Member States shall ensure that the competent authority:
Države članice zagotovijo, da pristojni organ:
keeps a record of the activities of procurement organisations and transplantation centres, including aggregated numbers of living and deceased donors, and the types and quantities of organs procured and transplanted, or otherwise disposed of in accordance with Union and national provisions on the protection of personal data and statistical confidentiality;
vodi evidenco dejavnosti organizacij za pridobivanje in transplantacijskih centrov, vključno s številkami živih in umrlih darovalcev, vrste in števila pridobljenih in presajenih ali na drug način odstranjenih organov v skladu s predpisi Unije ter nacionalnimi predpisi o varovanju osebnih podatkov in zaupnostjo statističnih podatkov;
draws up and makes publicly accessible an annual report on activities referred to in point (a);
pripravi in objavi letno poročilo o dejavnostih iz točke (a);
establishes and maintains an updated record of procurement organisations and transplantation centres.
vzpostavi in vzdržuje posodobljeno evidenco organizacij za pridobivanje in transplantacijskih centrov.
Member States shall, upon the request of the Commission or another Member State, provide information on the record of procurement organisations and transplantation centres.
Države članice na zahtevo Komisije ali druge države članice posredujejo informacije o evidenci organizacij za pridobivanje in transplantacijskih centrov.
The Commission shall set up a network of the competent authorities with a view to exchanging information on the experience acquired with regard to the implementation of this Directive.
Komisija vzpostavi mrežo pristojnih organov za izmenjavo informacij o pridobljenih izkušnjah pri izvajanju te direktive.