natgillin/translations-raw huggingface dataset:
Tissue establishments may accept tissues and cells from donors with plasma dilution of more than 50 % only if the testing procedures used are validated for such plasma or if a pre-transfusion sample is available.
Tkivne ustanove lahko sprejmejo tkiva in celice od darovalcev, katerih plazma je razredčena za več kot 50 %, le če so uporabljeni testni postopki validirani za tako plazmo ali če je na voljo vzorec, odvzet pred transfuzijo.
In the case of a deceased donor, blood samples must have been obtained just prior to death or, if not possible, the time of sampling must be as soon as possible after death and in any case within 24 hours after death.
V primeru umrlega darovalca se vzorci krvi pridobijo tik pred smrtjo, če pa to ni mogoče, mora biti čas pridobitve vzorca čimprej po smrti in v vsakem primeru v 24-ih urah po smrti.
In the case of living donors (except allogeneic bone marrow stem-cell and peripheral blood stem-cell donors, for practical reasons), blood samples must be obtained at the time of donation or, if not possible, within seven days post donation (this is the ‘donation sample’).
V primeru živih darovalcev (razen pri alogenskih darovalcih matičnih celic iz kostnega mozga in periferne krvi, iz praktičnih razlogov) se vzorci krvi pridobijo v času darovanja, ali če to ni mogoče, v 7 dneh po darovanju (to je „vzorec darovanja“).
Where tissues and cells of allogeneic living donors can be stored for long periods, repeat sampling and testing is required after an interval of 180 days.
Če so tkivo in celice alogenskih živih darovalcev lahko shranjene daljše obdobje, je treba čez 180 dni ponovno opraviti odvzem vzorca in testiranje.
In these circumstances of repeat testing, the donation sample can be taken up to 30 days prior to and 7 days post donation.
V takšnih okoliščinah ponovnega odvzema vzorca se vzorec darovanja lahko odvzame 30 dni pred in 7 dni po darovanju.
Where tissues and cells of allogeneic living donors cannot be stored for long periods and repeat sampling is therefore not possible, point 2(5)(a) above applies.
Če tkivo in celice alogenskih živih darovalcev ne morejo biti shranjene daljše obdobje in torej ni možen ponoven odvzem vzorca, se uporablja zgornji odstavek 2(5)(a).
If in a living donor (except bone marrow stem-cell and peripheral blood stem-cell donors) the ‘donation sample’, as defined in point 2(5)(a) above, is additionally tested by the nucleic acid amplification technique (NAT) for HIV, HBV and HCV, testing of a repeat blood sample is not required.
Če je pri živem darovalcu (razen pri darovalcih izvornih celic kostnega mozga in izvornih celic periferne krvi) „vzorec darovanja“, kot je opredeljen v zgornjem odstavku 2(5)(a), dodatno testiran s tehniko ojačanja nukleinske kisline (NAT) za HIV, HBV in HCV, se je mogoče izogniti testiranju ponovnega krvnega vzorca.
Retesting is also not required if the processing includes an inactivation step that has been validated for the viruses concerned.
Ponovnemu testiranju se je mogoče izogniti tudi, če predelava vključuje korak inaktivacije, ki je bil validiran za zadevne viruse.
In the case of bone marrow and peripheral blood stem-cell collection, blood samples must be taken for testing within 30 days prior to donation.
V primeru zbiranja kostnega mozga in izvornih celic periferne krvi se krvni vzorci odvzeti za testiranje v 30 dneh pred darovanjem.
In the case of neonatal donors, the biological tests may be carried out on the donor’s mother to avoid medically unnecessary procedures upon the infant.
Če so darovalci novorojenčki, morajo biti biološki testi opravljeni na darovalčevi materi, da se preprečijo zdravniško nepotrebni postopki na dojenčku.
SELECTION CRITERIA AND LABORATORY TESTS REQUIRED FOR DONORS OF REPRODUCTIVE CELLS AS REFERRED TO IN ARTICLE 3(b) AND ARTICLE 4(2)
MERILA ZA IZBOR IN POTREBNO LABORATORIJSKO TESTIRANJE DAROVALCEV REPRODUKTIVNIH CELIC, KAKOR JE NAVEDENO V ČLENIH 3(b) IN 4(2)
Partner donation for direct use
Darovanje med partnerjema za neposredno uporabo
Donor selection criteria and laboratory testing do not need to be applied in the case of partner donation of reproductive cells for direct use.
Meril za izbor darovalcev in laboratorijskega testiranja ni treba uporabiti v primeru darovanja reproduktivnih celic med partnerjema za neposredno uporabo.
Partner donation (not direct use)
Darovanje med partnerjema (ne za neposredno uporabo)
Reproductive cells that are processed and/or stored and reproductive cells that will result in the cryopreservation of embryos must meet the following criteria:
Reproduktivne celice, predelane in/ali shranjene, in reproduktivne celice, ki so namenjene shranjevanju zarodkov z zamrzovanjem, morajo izpolnjevati naslednja merila:
the clinician responsible for the donor must determine and document, based on the patient’s medical history and therapeutic indications, the justification for the donation and its safety for the recipient and any child(ren) that might result;
Zdravnik, odgovoren za darovalca, mora na podlagi darovalčeve zdravstvene anamneze in terapevtskih indikacij določiti in dokumentirati obrazložitev za darovanje in varnost za prejemnika ter katerega koli otroka/otrok, ki bi se morda rodil(-i).
the following biological tests must be carried out to assess the risk of cross-contamination:
Opravljeni morajo biti naslednji biološki testi za oceno tveganja za navzkrižno kontaminacijo:
In case of sperm processed for intrauterine insemination and not to be stored, if the tissue establishment can demonstrate that the risk of cross contamination and staff exposure has been addressed through the use of validated processes, biological testing may not be required;
V primeru sperme, ki je predelana za intrauterino osemenitev in ni namenjena shranjevanju, ni potrebno biološko testiranje, če tkivna ustanova lahko dokaže, da se za nevarnost navzkrižnega onesnaženja in izpostavljenosti osebja uporabljajo validirani postopki.
where HIV 1 and 2, hepatitis B or hepatitis C test results are positive or unavailable, or where the donor is known to be a source of infection risk, a system of separate storage must be devised;
Če so rezultati testov za HIV 1 in 2, hepatitis B ali hepatitis C pozitivni ali niso na voljo ali če je znano, da je darovalec vir tveganja za okužbo, je treba uvesti sistem ločenega shranjevanja.
HTLV-I antibody testing must be performed for donors living in or originating from high-incidence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas;
Testi za protitelesa HTLV-I se opravijo pri darovalcih, ki živijo na območjih z visoko pojavnostjo ali izvirajo iz teh območij, ali darovalcih, katerih spolni partnerji izvirajo iz teh območij ali katerih starši izvirajo iz teh območij.
in certain circumstances, additional testing may be required depending on the donor’s travel and exposure history and the characteristics of the tissue or cells donated (e.g. Rh D, malaria, CMV, T. cruzi);
V nekaterih okoliščinah je morda potrebno dodatno testiranje, odvisno od darovalčevih potovanj in izpostavljenosti v preteklosti ter lastnosti darovanega tkiva ali celic (npr. RhD, malarija, CMV, T. cruzi).
positive results will not necessarily prevent partner donation in accordance with national rules.
Pozitivni rezultati v skladu z nacionalno zakonodajo ne preprečujejo nujno darovanja med partnerjema.
Donations other than by partners
Darovanje, ki ni med partnerjema
The use of reproductive cells other than for partner donation must meet the following criteria:
Uporaba reproduktivnih celic, ki niso namenjene za darovanje med partnerjema, mora izpolnjevati naslednja merila:
donors must be selected on the basis of their age, health and medical history, provided on a questionnaire and through a personal interview performed by a qualified and trained healthcare professional.
Darovalci so izbrani na podlagi njihove starosti, zdravstvenega stanja in zdravstvene anamneze, zbrane z vprašalnikom in v osebnem razgovoru, ki ga opravi kvalificiran in usposobljen zdravstveni delavec.
This assessment must include relevant factors that may assist in identifying and screening out persons whose donation could present a health risk to others, such as the possibility of transmitting diseases (such as sexually transmitted infections), or health risks to themselves (e.g. superovulation, sedation or the risks associated with the egg collection procedure or the psychological consequences of being a donor);
Ta ocena vključuje ustrezne dejavnike, ki lahko pomagajo pri odkrivanju in presejanju oseb, katerih darovanje bi lahko ogrozilo zdravje drugih, kot je možnost za prenos bolezni (kot so spolno prenosljive okužbe) ali ogroženost lastnega zdravja (npr. superovulacija, sedacija ali tveganja, povezana s postopkom pridobivanja jajčec ali psihološke posledice darovalcev).
the donors must be negative for HIV 1 and 2, HCV, HBV and syphilis on a serum or plasma sample, tested in accordance with Annex II, point 1.1, and sperm donors must additionally be negative for chlamydia on a urine sample tested by the nucleic acid amplification technique (NAT);
Testi za HIV 1 in 2, HCV, HBV ter sifilis, opravljeni v skladu s Prilogo II, točko 1.1 na vzorcu seruma ali plazme darovalca, morajo biti negativni, pri darovalcih sperme pa morajo biti poleg tega negativni tudi testi za bakterijo Klamidija, opravljeni na vzorcu urina s tehniko ojačanja nukleinske kisline (NAT).
in certain circumstances, additional testing may be required depending on the donor’s history and the characteristics of the tissue or cells donated (e.g. RhD, malaria, CMV, T. cruzi).
V nekaterih okoliščinah je morda potrebno dodatno testiranje, odvisno od darovalčeve preteklosti in lastnosti darovanega tkiva ali celic (npr. RhD, malarija, CMV, T. cruzi).
for autologous donors, Annex I, point 2.1.1 applies;
Za avtologne darovalce velja Priloga I, točka 2.1.1.
genetic screening for autosomal recessive genes known to be prevalent, according to international scientific evidence, in the donor’s ethnic background and an assessment of the risk of transmission of inherited conditions known to be present in the family must be carried out, after consent is obtained.
Presejalno genetsko testiranje na prisotnost avtosomnih recesivnih genov, za katere je znano, da so prevladujoči v skladu z mednarodnimi znanstvenimi dokazi v etničnem okolju darovalca, in ocena tveganja za prenos dednih stanj, za katere je znano, da so prisotna v družini, se opravi po pridobitvi soglasja.
Complete information must be provided, in accordance with the requirements in force in Member States.
Zagotoviti je treba popolne informacije, v skladu z zahtevami, ki veljajo v državah članicah.
Complete information on the associated risk and on the measures undertaken for its mitigation must be communicated and clearly explained to the recipient.
Popolne informacije o povezanih tveganjih in sprejetih ukrepih za njihovo ublažitev se sporočijo in jasno razložijo prejemniku.
The tests must be carried out in accordance with Annex II, points 2.1 and 2.2.
Testi se opravijo v skladu s Prilogo II, točkama 2.1 in 2.2.
Blood samples must be obtained at the time of donation.
Vzorci krvi se pridobijo v času darovanja.
Sperm donations other than by partners will be quarantined for a minimum of 180 days, after which repeat testing is required.
Darovana sperma ki ni med partnerjema je v karanteni najmanj 180 dni, potem pa se zahteva ponovno testiranje.
If the blood donation sample is additionally tested by the nucleic acid amplification technique (NAT) for HIV, HBV and HCV, testing of a repeat blood sample is not required.
Če je vzorec krvi darovalca, odvzet med darovanjem, dodatno testiran s tehniko ojačanja nukleinske kisline (NAT) za HIV, HBV in HCV, se je testiranju ponovnega krvnega vzorca mogoče izogniti.
CELL AND/OR TISSUE DONATION AND PROCUREMENT PROCEDURES AND RECEPTION AT THE TISSUE ESTABLISHMENT AS REFERRED TO IN ARTICLE 5
DAROVANJE CELIC IN/ALI TKIVA TER POSTOPKI PRIDOBIVANJA IN SPREJEM V TKIVNO USTANOVO, KAKOR JE NAVEDENO V ČLENU 5
Donation and procurement procedures
Postopki darovanja in pridobivanja
Consent and donor identification
Soglasje in identifikacija darovalca
Before the procurement of tissues and cells proceeds, an authorised person must confirm and record:
Pred začetkom pridobivanja tkiv in celic mora pooblaščena oseba potrditi in evidentirati:
that consent for the procurement has been obtained in accordance with Article 13 of Directive 2004/23/EC; and
da je bila privolitev o pridobivanju pridobljena v skladu s členom 13 Direktive 2004/23/ES; in
how and by whom the donor has been reliably identified.
na kakšen način je bil darovalec zanesljivo identificiran ter kdo ga je identificiral.
In the case of living donors, the health professional responsible for obtaining the health history must ensure that the donor has:
V primeru živih darovalcev zdravstveni strokovnjak, odgovoren za pridobitev zdravstvene anamneze, zagotovi, da je darovalec:
understood the information provided;
razumel zagotovljene informacije;
had an opportunity to ask questions and been provided with satisfactory responses;
imel možnost, da zastavi vprašanja in dobil ustrezne odgovore;
confirmed that all the information provided is true to the best of his/her knowledge.
potrdil, da so vse informacije resnične, kolikor mu je znano.
Donor evaluation (this section does not apply to partner donation of reproductive cells or to autologous donors)
Ocenjevanje darovalca (ta del ne velja za darovanje reproduktivnih celic med partnerjema ali avtologne darovalce)
An authorised person must collect and record the donor’s relevant medical and behavioural information according to the requirements described in section 1.4.
Pooblaščena oseba mora pridobiti in evidentirati ustrezne informacije o zdravstvenem stanju in vedenju darovalca v skladu z zahtevami, opisanimi v Oddelku 1.4.
In order to acquire the appropriate information, different relevant sources must be used, including at least an interview with the donor, for living donors, and the following when appropriate:
Za pridobitev ustreznih informacij je treba uporabiti druge ustrezne vire, ki vključujejo vsaj razgovor z darovalcem, če gre za žive darovalce, in če je primerno še:
the medical records of the donor;
zdravstveno dokumentacijo darovalca;
an interview with a person who knew the donor well, for deceased donors;
razgovor z osebo, ki je dobro poznala darovalca, če gre za umrle darovalce;
an interview with the treating physician;
razgovor z darovalčevim lečečim zdravnikom;
an interview with the general practitioner;
razgovor z bolnikovim izbranim osebnim zdravnikom;
the autopsy report.
obdukcijski izvid.
In addition, in the case of a deceased donor, and in the case of a living donor when justified, a physical examination of the body must be performed to detect any signs that may be sufficient in themselves to exclude the donor or which must be assessed in the light of the donor’s medical and personal history.
Poleg tega se v primeru umrlega darovalca in živega darovalca, če je to upravičeno, opravi fizikalni pregled telesa za odkritje znakov, ki sami po sebi zadoščajo za izključitev darovalca ali ki so lahko ocenjeni glede na zdravstveno anamnezo in osebno preteklost.
The complete donor records must be reviewed and assessed for suitability and signed by a qualified health professional.
Popolna dokumentacija o darovalcu se pregleda, oceni se njena primernost in jo podpiše usposobljen zdravstveni strokovnjak.
Procurement procedures for tissues and cells
Postopki pridobivanja tkiv in celic
The procurement procedures must be appropriate for the type of donor and the type of tissue/cells donated.
Postopki pridobivanja ustrezajo vrsti darovalca in vrsti darovanega tkiva/celic.
There must be procedures in place to protect the safety of the living donor.
Izvedeni so postopki za zaščito varnosti živega darovalca.
The procurement procedures must protect those properties of the tissue/cells that are required for their ultimate clinical use, and at the same time minimise the risk of microbiological contamination during the process, particularly when tissues and cells cannot subsequently be sterilised.
Postopki pridobivanja zaščitijo lastnosti tkiva/celic, ki so potrebne za njihovo končno klinično rabo, in hkrati zmanjšajo tveganje za mikrobiološko okužbo med postopkom, zlasti če tkiva in celice ne morejo biti pozneje sterilizirani.
For deceased donation, the area of access must be restricted.
Če gre za umrlega darovalca, je območje dostopa omejeno.
A local sterile field using sterile drapes must be used.
Uporabiti je treba lokalno sterilno polje z uporabo sterilnih zaves.
Staff conducting procurement must be clothed appropriately for the type of procurement.
Osebje, ki opravi pridobivanje, mora biti primerno oblečeno za vrsto pridobivanja.
Usually, this will extend to being scrubbed, gowned in sterile clothing and wearing sterile gloves, face shields and protective masks.
Običajno to pomeni, da mora imeti ustrezno umite roke, da mora biti oblečeno v sterilna oblačila in imeti sterilne rokavice, ščitnike za obraz in zaščitne maske.
In the case of a deceased donor, the place of procurement must be recorded and the time interval from death to procurement must be specified so as to ensure that the required biological and/or physical properties of the tissues/cells are retained.
V primeru umrlega darovalca se zabeleži kraj pridobivanja in navede čas, ki je pretekel od smrti do pridobivanja, da se zagotovi ohranitev zahtevanih bioloških in/ali fizičnih lastnosti tkiv/celic.
Once the tissues and cells have been retrieved from a deceased donor body, it must be reconstructed so that it is as similar as possible to its original anatomical appearance.
Po odvzemu tkiv in celic iz telesa umrlega darovalca je treba telo rekonstruirati tako, da je čim bolj podobno svojemu prvotnemu anatomskemu videzu.
Any adverse event occurring during procurement that has or may have resulted in harm to a living donor and the outcome of any investigation to determine the cause must be recorded and reviewed.
Vsak zaplet, ki se zgodi med pridobivanjem in škoduje ali bi lahko škodoval živemu darovalcu, ter izsledki vsake preiskave za določitev vzroka, se evidentirajo in pregledajo.
Policies and procedures must be in place to minimise the risk of tissue or cell contamination by staff who might be infected with transmissible diseases.
Vzpostavijo se politika in postopki za čim večje zmanjšanje tveganja za okužbo tkiv in celic s strani osebja, ki je lahko okuženo z nalezljivimi boleznimi.
Sterile instruments and devices must be used for tissue and cell procurement.
Za pridobivanje tkiva in celic je treba uporabiti sterilne instrumente in naprave.
Instruments or devices must be of good quality, validated or specifically certified and regularly maintained for the procurement of tissues and cells.
Instrumenti ali naprave morajo biti dobre kakovosti, validirani ali izrecno potrjeni ter redno vzdrževani za pridobivanje tkiv in celic.
When reusable instruments must be used, a validated cleaning and sterilisation procedure for removal of infectious agents has to be in place.
Kadar se morajo uporabiti instrumenti za večkratno uporabo, se mora uporabiti validiran postopek čiščenja in sterilizacije za odstranitev infektivnih snovi.
Wherever possible, only CE marked medical devices must be used and all concerned staff must have received appropriate training on the use of such devices.
Kadar je mogoče, se uporabljajo samo medicinski pripomočki z oznako CE, vso zadevno osebje pa mora biti ustrezno usposobljeno za delo s temi napravami.
Donor documentation
Dokumentacija o darovalcih
For each donor, there must be a record containing:
Za vsakega darovalca obstaja karton, ki vsebuje:
the donor identification (first name, family name and date of birth — if a mother and child are involved in the donation, both the name and date of birth of the mother and the name, if known, and date of birth of the child);
identifikacijo darovalca (ime, priimek in datum rojstva – če sta v darovanje vključena mama in otrok, ime, priimek in datum rojstva mame ter datum rojstva in ime otroka, če je znano);
age, sex, medical and behavioural history (the information collected must be sufficient to allow application of the exclusion criteria, where required);
starost, spol, zdravstveno anamnezo in vedenje v preteklosti (zbrane informacije morajo zadoščati za uporabo meril za izključitev, kjer se to zahteva);
outcome of body examination, where applicable;
rezultate pregleda telesa, kjer je primerno;
haemodilution formula, where applicable;
formulo za hemodilucijo, kjer je to primerno;
the consent/authorisation form, where applicable;
obrazec za privolitev/dovoljenje, kjer je to primerno;
clinical data, laboratory test results, and the results of other tests carried out;
klinične podatke, rezultate laboratorijskih testov in rezultate drugih opravljenih testov;
if an autopsy was performed, the results must be included in the record (for tissues and cells that cannot be stored for extended periods, a preliminary verbal report of the autopsy must be recorded);
če je bila opravljena obdukcija, morajo biti rezultati vključeni v karton (za tkiva in celice, ki se ne morejo hraniti dalj časa, se v karton zapiše ustno sporočen obdukcijski izvid);
for haematopoietic progenitor cell donors, the donor’s suitability for the chosen recipient must be documented.
za darovalce hematopoetskih progenitornih celic obstaja dokumentacija o darovalčevi ustreznosti za izbranega prejemnika.
For unrelated donations, when the organisation responsible for procurement has limited access to recipient data, the transplanting organisation must be provided with donor data relevant for confirming suitability.
Če darovalec in prejemnik nista v sorodu, kadar ima organizacija, odgovorna za pridobivanje, omejen dostop do podatkov o prejemniku, se organizaciji, ki opravi presaditev, zagotovijo podatki o darovalcu, potrebni za potrditev ustreznosti.
The organisation performing the procurement must produce a procurement report, which is passed on to the tissue establishment.
Organizacija, ki opravi pridobivanje, mora napisati poročilo o pridobivanju, ki se predloži tkivni ustanovi.
This report must contain at least:
To poročilo vsebuje vsaj:
the identification, name and address of the tissue establishment to receive the cells/tissues;
identifikacija, ime in naslov tkivne ustanove, ki prejme celice/tkiva;
donor identification data (including how and by whom the donor was identified);
podatki o identifikaciji darovalca (vključno s tem, na kakšen način je bil darovalec identificiran in kdo ga je identificiral);
description and identification of procured tissues and cells (including samples for testing);
opis ter identifikacijo pridobljenih tkiv in celic (vključno z vzorci za testiranje);
identification of the person who is responsible for the procurement session, including signing;
identifikacijo osebe, ki je odgovorna za postopek pridobivanja, vključno s podpisom;
date, time (where relevant, start and end) and location of procurement and procedure (SOP) used, including any incidents that occurred; where relevant, environmental conditions at the procurement facility (description of the physical area where procurement took place);
datum, čas (po potrebi začetek in konec), lokacija pridobivanja in uporabljeni postopek (SOP), vključno z vsemi vmesnimi zapleti, ki so se zgodili. Po potrebi okoljski pogoji objekta za pridobivanje (opis fizičnega območja, kjer je potekalo pridobivanje);
for deceased donors, conditions under which the cadaver is kept: refrigerated (or not), time of start and end of refrigeration;
za umrle darovalce pogoje, pod katerimi je shranjeno truplo: v hladilnici (ali ne), čas začetka in konca shranjevanja v hladilnici;
ID/batch numbers of reagents and transport solutions used.
identifikacijo/serijske številke uporabljanih reagentov in prevoznih tekočin.
The report must also contain the date and time of death where possible.
Poročilo mora vsebovati tudi datum in uro smrti, kjer je to mogoče.
Where sperm is procured at home, the procurement report must state this and must contain only:
Če se sperma pridobi doma, je to navedeno v poročilu o pridobivanju, ki vsebuje samo: