natgillin/translations-raw huggingface dataset:
To fulfil the requirement set out in point (ii) of Article 12(4)(a) of Directive 2011/24/EU (‘follow a multi-disciplinary approach’), the Networks must:
Za izpolnjevanje zahteve iz točke (ii) člena 12(4)(a) Direktive 2011/24/EU („izvajajo večdisciplinarni pristop“) morajo mreže:
identify areas and best practices for multi-disciplinary work;
opredeliti področja in dobre prakse za večdisciplinarno delo;
be made up of multi-disciplinary healthcare teams;
biti sestavljene iz večdisciplinarnih zdravstvenih ekip;
offer and promote multi-disciplinary advice for complex cases.
nuditi in spodbujati večdisciplinarno svetovanje za zapletene primere.
To fulfil the requirement set out in point (iii) of Article 12(4)(a) of Directive 2011/24/EU (‘offer a high level of expertise and have the capacity to produce good practice guidelines and to implement outcome measures and quality control’), the Networks must:
Za izpolnjevanje zahteve iz točke (iii) člena 12(4)(a) Direktive 2011/24/EU („nudijo visoko raven strokovnega znanja in imajo zmogljivosti za oblikovanje smernic za dobro prakso ter izvajanje merjenja izidov in nadzorovanja kakovosti“) morajo mreže:
exchange, gather and disseminate knowledge, evidence and expertise within and outside the Network, in particular on the different alternatives, therapeutic options and best practices with regard to the provision of services and the treatments available for each particular disease or condition;
izmenjevati, zbirati in širiti znanje, dokaze in strokovno znanje v okviru mreže in zunaj nje, in sicer zlasti o različnih alternativah, možnostih zdravljenja in dobrih praksah v zvezi z izvajanjem storitev in zdravljenja za vsako posamezno bolezen ali stanje, ki so na voljo;
promote expertise and support healthcare providers in order to bring local, regional and national provision of healthcare closer to patients;
spodbujati strokovno znanje in podpirati izvajalce zdravstvenega varstva, da bi lokalno, regionalno in nacionalno izvajanje zdravstvenega varstva približale pacientom;
develop and implement clinical guidelines and cross-border patient pathways;
razviti in izvajati klinične smernice in čezmejne poti pacientov:
design and implement outcome and performance indicators;
oblikovati in izvajati rezultate in kazalnike uspešnosti;
develop and maintain a quality, patient safety and evaluation framework.
razviti in ohraniti kakovost, varnost pacientov in ocenjevalni okvir.
To fulfil the requirement set out in point (iv) of Article 12(4)(a) of Directive 2011/24/EU (‘make a contribution to research’), the Networks must:
Za izpolnjevanje zahteve iz točke (iv) člena 12(4)(a) Direktive 2011/24/EU („prispevajo k raziskavam“) morajo mreže:
identify and fill research gaps;
opredeliti in zapolniti vrzeli v raziskavah;
promote collaborative research within the Network;
spodbujati skupne raziskave v okviru mreže;
reinforce research and epidemiological surveillance, through setting up of shared registries.
krepiti raziskave in epidemiološko spremljanje, in sicer z vzpostavitvijo skupnih registrov.
To fulfil the requirement set out in point (v) of Article 12(4)(a) of Directive 2011/24/EU (‘organise teaching and training activities’), the Networks must:
Za izpolnjevanje zahteve iz točke (v) člena 12(4)(a) Direktive 2011/24/EU („organizirajo izobraževalne dejavnosti in usposabljanja“) morajo mreže:
identify and fill training gaps;
opredeliti in zapolniti vrzeli v usposabljanju;
encourage and facilitate the development of training and continuous education programmes and tools for healthcare providers involved in the chain of care (within or outside the Network).
spodbujati in lajšati razvoj programov usposabljanja in stalnega izobraževanja ter orodij za izvajalce zdravstvenega varstva, ki sodelujejo v verigi oskrbe (v okviru mreže ali zunaj nje).
To comply with the requirement set out in point (vi) of Article 12(4)(a) of Directive 2011/24/EU (‘collaborate closely with other centres of expertise and networks at national and international level’), the Networks must:
Za izpolnjevanje zahteve iz točke (vi) člena 12(4)(a) Direktive 2011/24/EU („tesno sodelujejo z drugimi strokovnimi centri in mrežami na nacionalni in mednarodni ravni“) morajo mreže:
exchange and disseminate knowledge and best practices, in particular by supporting national centres and networks;
izmenjevati in širiti znanje in dobre prakse, in sicer zlasti s podpiranjem nacionalnih centrov in mrež;
set up networking elements, such as communication tools, and methodologies to develop clinical guidelines and protocols; exchange clinical information in accordance with EU data protection provisions and national implementing measures, in particular Directive 95/46/EC, and Article 3 of this Delegated Decision; develop training alternatives and models and operation and coordination practices, etc.;
vzpostaviti elemente mreženja, kot so komunikacijska orodja, in metodologije za razvoj kliničnih smernic in protokolov; izmenjevati klinične podatke v skladu s predpisi EU o varstvu podatkov in nacionalnimi izvedbenimi ukrepi, zlasti v skladu z Direktivo 95/46/ES in členom 3 tega delegiranega sklepa; razviti alternative in modele za usposabljanje ter prakse za delovanje in usklajevanje itd.;
collaborate with Associated National Centres and Collaborative National Centres chosen by Member States with no Member of a given Network, particularly if the objectives of the Network are among those listed under Article 12(2)(f) and (h) of Directive 2011/24/EU.
sodelovati s povezanimi nacionalnimi centri in sodelujočimi nacionalnimi centri, ki so jih izbrale države članice, ki nimajo člana v določeni mreži, zlasti če so cilji mreže med tistimi s seznama v členu 12(2)(f) in (h) Direktive 2011/24/EU.
CRITERIA AND CONDITIONS FOR APPLICANTS FOR MEMBERSHIP OF A NETWORK
MERILA IN POGOJI, KI JIH MORAJO IZPOLNJEVATI KANDIDATI ZA ČLANSTVO V MREŽI
General criteria and conditions for all applicant healthcare providers
Glavna merila in pogoji za vse kandidate za izvajalce zdravstvenega varstva
All applicants wishing to join a Network shall comply with the following criteria and conditions:
Vsi kandidati, ki se želijo pridružiti mreži, izpolnjujejo naslednja merila in pogoje:
as regards patient empowerment and patient-centred care, applicant providers must:
v zvezi s krepitvijo vloge pacientov in v pacienta usmerjeno oskrbo morajo kandidati za izvajalce:
have put strategies in place to ensure that care is patient-centred, that patients' rights (such as the right to informed consent; the right to information concerning their own health; the right to access to their medical records; the right to privacy; the right to complain and the right to obtain compensation, the right to be empowered and to participate (for example, through customer relations management strategies, patient education strategies and active engagement strategies for patients and families throughout the healthcare institution)) are respected;
imeti vzpostavljene strategije za zagotovitev, da je oskrba usmerjena v pacienta, da so spoštovane pacientove pravice (kot so pravica do svobodne privolitve po predhodni seznanitvi, pravica do podatkov o lastnem zdravju, pravica do dostopa do zdravstvene kartoteke, pravica do zasebnosti, pravica do pritožbe in pravica do odškodnine, pravica do krepitve pacientove vloge in do sodelovanja (na primer s strategijami za upravljanje odnosov s strankami, strategijami za izobraževanje pacientov in strategijami za aktivno vključevanje pacientov in družin v okviru zdravstvenega zavoda));
provide clear and transparent information about complaint procedures and the remedies and forms of redress available to both domestic and foreign patients;
zagotoviti jasne in pregledne informacije tako domačim kot tujim pacientom o pritožbenih postopkih in pravnih sredstvih ter oblikah odškodnin, ki so na voljo;
ensure feedback on patient experience and the active evaluation of patient experience;
zagotoviti povratne informacije o izkušnjah pacientov in aktivno ocenjevanje izkušenj pacientov;
apply personal data protection rules and ensure access to medical records and clinical information in compliance with EU data protection provisions and national implementing measures and in particular with Directive 95/46/EC;
uporabljati pravila o varstvu osebnih podatkov in zagotoviti dostop do zdravstvenih kartotek in kliničnih podatkov v skladu z določbami EU o varstvu podatkov in nacionalnimi izvedbenimi ukrepi ter zlasti z Direktivo 95/46/ES;
ensure that the informed consent of the data subject complies with the requirements set out in Article 2(e) of this Delegated Decision, in particular informed consent given freely, unambiguously and explicitly by the subject or his/her legal representative after being informed of the purpose, nature, significance and implications of the use of his/her personal and health data, if personal health data is exchanged under this Delegated Decision, and being informed of his/her rights under the applicable data protection rules.
zagotoviti, da je svobodna privolitev po predhodni seznanitvi posameznika, na katerega se nanašajo osebni podatki, skladna z zahtevami iz člena 2(e) tega delegiranega sklepa, zlasti da je svobodna privolitev dana prostovoljno, nedvoumno in izrecno s strani posameznika ali njegovega/njenega zakonitega zastopnika po tem, ko je ta obveščen(-a) o namenu, naravi, pomenu in posledicah uporabe njegovih/njenih osebnih in zdravstvenih podatkov, če so ti izmenjani v skladu s tem delegiranim sklepom, ter o pravicah, ki jih ima v skladu s pravili o varstvu podatkov, ki se uporabljajo.
The given consent should be duly documented;
Privolitev bi bilo treba ustrezno dokumentirati;
ensure transparency, including providing information about clinical outcomes, treatment options and the quality and safety standards put in place;
zagotoviti preglednost, vključno z dajanjem informacij o kliničnih rezultatih, možnostih zdravljenja in vzpostavljenih standardih kakovosti in varnosti;
with regard to organisation, management and business continuity, applicant providers must:
v zvezi z organizacijo, upravljanjem in neprekinjenim poslovanjem morajo kandidati za izvajalce:
apply transparent and explicit organisation and management rules and procedures, including in particular the procedures for managing cross-border patients in their area of expertise;
uporabljati pregledna in nedvoumna pravila in postopke v zvezi z organizacijo in upravljanjem, vključno zlasti s postopki za obravnavanje čezmejnih pacientov na njihovem strokovnem področju;
ensure that tariffs are transparent;
zagotoviti preglednost tarif;
have a business continuity plan over a given time frame, including ensuring:
imeti načrt za neprekinjeno poslovanje v določenem časovnem obdobju, vključno z zagotavljanjem:
the provision of essential medical care in the case of unexpected resource failure, or access or referral to alternative resources if necessary,
izvajanja osnovne zdravstvene oskrbe v primeru nepričakovanega izpada vira ali po potrebi dostopa ali napotitve k alternativnemu viru,
the maintenance of the stability and technical capacity and expertise of the provider, such as a plan for managing human resources and updating technology;
vzdrževanja stabilnosti in tehnične zmogljivosti ter strokovnega znanja izvajalca, kot sta načrt za upravljanje s človeškimi viri in posodabljanje tehnologije;
ensure coordination with and easy access of the provider to other resources or specific units or services necessary for managing patients;
zagotoviti usklajevanje izvajalca z drugimi viri ali posebnimi enotami ali storitvami, potrebnimi za obravnavanje pacientov, ter enostaven dostop izvajalca do navedenega;
have good general facilities, such as surgery theatres, an intensive care unit, an isolation unit, an emergency ward and laboratories;
imeti dobre splošne prostore, kot so operacijska soba, oddelek za intenzivno nego, oddelek za izolacijo, urgenca in laboratoriji;
have the capacity to communicate with relevant post-discharge services, including the capacity for cross-border communication;
komunicirati z ustreznimi službami po odpustitvi, vključno s čezmejno komunikacijo;
with regard to research and training capacity, applicant providers must:
v zvezi z zmogljivostjo na področju raziskav in usposabljanja morajo kandidati za izvajalce:
have the capacity to provide academic, university or specialised level training;
biti zmožni zagotoviti usposabljanje na akademski, univerzitetni ali specialistični ravni;
have human, technical and structural capacity, skill mix and resources;
imeti človeške vire, tehnične in strukturne zmogljivosti, različno usposobljenost in vire;
have research capacity, and demonstrated research experience or production in the area of expertise of the Network, at national and international level;
imeti zmogljivosti na področju raziskav in dokazati raziskovalne izkušnje ali delovanje na strokovnem področju mreže na nacionalni in mednarodni ravni;
carry out teaching and education activities related to the area of expertise aimed at improving the knowledge and technical capacity of the healthcare providers involved in the same chain of care within and outside the provider facility, such as continuing medical education and distance learning;
izvajati učne in izobraževalne dejavnosti, povezane s strokovnim področjem, katerih cilj je izboljšati znanje in tehnično zmogljivost izvajalcev zdravstvenega varstva, ki sodelujejo v isti verigi oskrbe v okviru ustanove izvajalca ali zunaj nje, kot sta stalno medicinsko izobraževanje in učenje na daljavo;
with regard to the exchange of expertise, information systems and e-health tools, applicant providers must:
v zvezi z izmenjavo strokovnega znanja, informacijskimi sistemi in orodji e-zdravja morajo kandidati za izvajalce:
be able to exchange expertise with other healthcare providers and to support them;
biti sposobni izmenjevati strokovno znanje z drugimi izvajalci zdravstvenega varstva in jih podpirati;
have established procedures and a framework for ensuring the management, safeguarding and exchange of medical data, including established outcomes, process indicators and patient registers for the specific area of expertise in accordance with the EU data protection legislation, in particular with Directive 95/46/EC, and with Article 2(e) of this Delegated Decision;
imeti vzpostavljene postopke in okvir za zagotavljanje upravljanja, varstva in izmenjave zdravstvenih podatkov, vključno z ugotovljenimi rezultati, kazalniki procesa in registri pacientov za določeno strokovno področje v skladu z zakonodajo EU o varstvu podatkov, zlasti Direktivo 95/46/ES in členom 2(e) tega delegiranega sklepa;
be able to foster the use of telemedicine and other e-health tools within and outside their facilities, by fulfilling the minimum interoperability requirements and when possible, using agreed standards and recommendations;
biti sposobni spodbujati uporabo telemedicine in drugih orodij e-zdravja znotraj in zunaj ustanove, in sicer z izpolnjevanjem minimalnih zahtev glede interoperabilnosti in, ko je to mogoče, z uporabo dogovorjenih standardov in priporočil;
use a standardised information and coding system in line with nationally or internationally recognised systems, for example International Classification of Diseases and complementary codes when appropriate;
uporabljati standardiziran informacijski in kodirni sistem v skladu z nacionalno ali mednarodno priznanimi sistemi, na primer mednarodno klasifikacijo bolezni in dopolnilnimi kodami, če se uporabljajo.
with regard to expertise, good practices, quality, patient safety and evaluation, applicant providers must:
v zvezi s strokovnim znanjem, dobrimi praksami, kakovostjo, varnostjo pacientov in ocenjevanjem morajo kandidati za izvajalca:
have a quality assurance or management system and plans including governance and evaluation of the system;
imeti sistem za zagotavljanje kakovosti ali sistem upravljanja kakovosti in načrte, vključno s sistemom vodenja in ocenjevanja;
have a patient safety programme or plan consisting of specific goals, procedures, standards and process and outcome indicators focusing on key areas, such as information, a system for reporting on and learning from adverse events; training and education activities; hand hygiene; healthcare related infections; medication errors and the safe use of medication; safe procedures and surgery; safe patient identification;
imeti program za varnost pacientov ali načrt, sestavljen iz določenih ciljev, postopkov, standardov ter kazalnikov za procese in rezultate, ki se osredotoča na ključna področja, kot so informiranje, sistem za poročanje o neželenih dogodkih in učenje o njih; dejavnosti za usposabljanje in izobraževanje; higiena rok; z zdravstvenim varstvom povezane okužbe; napake pri zdravilih in varna uporaba zdravil; varni postopki in kirurgija; varna identifikacija pacientov;
commit itself to using the best knowledge- and evidence-based health technologies and treatments;
se zavezati, da bodo uporabljali najboljše zdravstvene tehnologije in zdravljenja, ki temeljijo na znanju in dokazih;
develop and use clinical guidelines and pathways in their area of expertise.
razviti in uporabljati klinične smernice in poti na področju svojega strokovnega znanja.
Specific criteria and conditions for applicant providers with regard to the area of expertise, disease or conditions the Networks they wish to join focus on
Posebna merila in pogoji za kandidate za izvajalce v zvezi s strokovnim področjem, boleznijo ali stanji, na katera se osredotočajo mreže, ki se jim želijo pridružiti
with regard to competence, experience and outcomes of care, applicant providers must:
v zvezi s kompetencami, izkušnjami in rezultati oskrbe morajo kandidati za izvajalce:
document competence, experience and activity (e.g. the volume of activity, referrals and accumulated experience and when possible, the minimum/optimal number of patients/year, in accordance with professional/technical standards or recommendations);
dokazati kompetence, izkušnje in dejavnost (npr. obseg dejavnosti, napotitve in zbrane izkušnje ter, če je mogoče, najmanjše/optimalno število pacientov na leto, in sicer v skladu s poklicnimi/tehničnimi standardi ali priporočili);
provide evidence of good clinical care and outcomes according to available standards, indicators and knowledge, and evidence that the treatments offered are recognised by international medical science in terms of their safety, value and potential positive clinical outcome;
zagotoviti dokazila o dobri klinični oskrbi in rezultatih glede na standarde, kazalnike in znanje, ki so na voljo, ter dokazila o tem, da so ponujena zdravljenja priznana v mednarodni medicini v smislu njihove varnosti, vrednosti in potencialnega pozitivnega kliničnega rezultata;
with regard to the specific human, structural and equipment resources and the organisation of care, applicant providers must document:
v zvezi posebnimi človeškimi in strukturnimi viri in opremo ter organizacijo oskrbe morajo kandidati za izvajalce dokazati:
the characteristics of human resources such as type, number, qualifications and skills;
značilnosti človeških virov, kot so vrsta, število, kvalifikacije in spretnosti;
the characteristics, organisation and functioning of the specific multidisciplinary healthcare team;
značilnosti, organizacijo in delovanje določene večdisciplinarne zdravstvene ekipe;
specific equipment within the centre or easily accessible (such as radiotherapy laboratories or hemodynamic facilities), including the capacity, when appropriate and based on the area of expertise, to process, manage and exchange information and biomedical images (such as in the case of radiology x-ray machines, microscopy, video-endoscopy and other dynamic explorations) or clinical samples with external providers.
posebno opremo v okviru centra ali zlahka dostopno opremo (npr. laboratoriji za radioterapijo ali oprema za hemodinamiko), vključno s sposobnostjo obdelave, upravljanja in izmenjave informacij in biomedicinskih slik (na primer za radiologijo rentgenske naprave, opremo za mikroskopijo, videoendoskopijo in druge dinamične preiskave) ali kliničnih vzorcev z zunanjimi izvajalci, če je to primerno in temelji na strokovnem znanju.
setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks
o določitvi meril za ustanavljanje in vrednotenje evropskih referenčnih mrež in njihovih članov ter za lažjo izmenjavo informacij in strokovnega znanja o ustanavljanju in vrednotenju takih mrež
Having regard to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare [1], and in particular Article 12(4)(b) and (c) thereof,
ob upoštevanju Direktive 2011/24/EU Evropskega parlamenta in Sveta z dne 9. marca 2011 o uveljavljanju pravic pacientov pri čezmejnem zdravstvenem varstvu [1] ter zlasti člena 12(4)(b) in (c) Direktive,
Commission Delegated Decision 2014/286/EU [2] sets out the criteria and conditions that European Reference Networks (‘Networks’) and healthcare providers wishing to join such Networks must fulfil.
Delegirani sklep Komisije 2014/286/EU [2] določa merila in pogoje, ki jih morajo izpolnjevati evropske referenčne mreže („mreže“) in izvajalci zdravstvenega varstva, ki se želijo pridružiti takšnim mrežam.
Pursuant to Article 12(4)(b) and (c) of Directive 2011/24/EU, the Commission is to decide the criteria for establishing and evaluating the Networks and the measures for facilitating the exchange of information and expertise on establishing and evaluating the Networks.
Komisija v skladu s členom 12(4)(b) in (c) Direktive 2011/24/EU določi merila za ustanavljanje in vrednotenje mrež ter ukrepe za lažjo izmenjavo informacij in strokovnega znanja o ustanavljanju in vrednotenju mrež.
Networks should be established and healthcare providers approved as Members of the Networks on the basis of an open and transparent procedure.
Mreže bi morale biti ustanovljene in izvajalci zdravstvenega varstva odobreni kot člani mreže na podlagi odprtega in preglednega postopka.
The procedure should include: (1) the call for interest; (2) Member States' endorsement of applications of their healthcare providers; (3) the submission of applications to the Commission; (4) the verification of the completeness of applications; (5) the technical assessment by an independent body of applications to form the Networks and of applications from individual healthcare providers wishing to be Members of a Network, to determine whether the applicants fulfil the criteria; (6) the communication of the assessment outcomes; (7) the approval of the Networks and their membership by Member States; and (8) the publication of the list of established Networks and of their Members.
Postopek bi moral vključevati (1) razpis za prijavo interesa; (2) odobritve vlog izvajalcev zdravstvenega varstva s strani njihovih držav članic; (3) predložitev vlog Komisiji; (4) preverjanje popolnosti vlog; (5) tehnično oceno vlog, ki bodo sestavljale mrežo, s strani neodvisnega organa, ter vlog individualnih izvajalcev zdravstvenega varstva, ki želijo biti člani mreže, da se ugotovi, ali kandidati izpolnjujejo merila; (6) obvestilo o rezultatih ocene; (7) odobritev mrež in njihovega članstva s strani držav članic ter (8) objavo seznama ustanovljenih mrež in njihovih članov.
In order to increase the coverage of the Networks, individual healthcare providers wishing to join a Network should be allowed to do so at any time.
Za povečanje zajetja mrež bi morali individualni izvajalci zdravstvenega varstva, ki se želijo pridružiti mreži, vedno imeti to možnost.
Their applications should be assessed according to the same procedure as that used to assess applications for the initial Network, including the endorsement of applications by the Member State in question.
Njihove vloge bi morale biti ocenjene po istem postopku, kot je bil uporabljen za oceno vlog za začetno mrežo, vključno z odobritvijo vlog s strani zadevne države članice.