natgillin/translations-raw huggingface dataset:
seznam posebnih meril in pogojev, ki jih morajo izpolnjevati evropske referenčne mreže, vključno s
a list of specific criteria and conditions that the European reference networks must fulfil, including
seznamom redkejših bolezni, ki jih je treba zajeti, in
also a list of rarer disease areas to be covered and
pogoji in merili, ki jih morajo izpolnjevati izvajalci storitev zdravstvenega varstva, ki se želijo pridružiti evropskim referenčnim mrežam, zlasti za zagotovitev, da evropske referenčne mreže:
the conditions and criteria required from healthcare providers wishing to join the European reference networks, in order to ensure, in particular, that the European reference networks:
imajo ustrezne zmogljivosti, da lahko postavijo diagnozo, spremljajo in upravljajo paciente z dokazi o dobrih rezultatih, v kolikor je to ustrezno;
have appropriate capacities to diagnose, to follow-up and manage patients with evidence of good outcomes so far as applicable;
imajo zadostne zmogljivosti in dejavnosti za zagotavljanje pomembnih storitev in ohranjanje kakovosti storitev;
have sufficient capacity and activity to provide relevant services and maintain quality of the services provided;
imajo zmogljivosti za zagotavljanje strokovnih nasvetov, diagnoze ali potrditve diagnoze, oblikovanje in izpolnjevanje smernic za dobro prakso ter izvajanje ukrepov in nadzora kakovosti;
have capacity to provide expert advice, diagnosis or confirmation of diagnosis, to produce and adhere to good practice guidelines and to implement outcome measures and quality control;
lahko izvajajo večdisciplinarni pristop;
can demonstrate a multi-disciplinary approach;
zagotovijo visoko raven strokovnega znanja in izkušenj s pomočjo publikacij, nepovratne pomoči ali častnih nazivov, učenja in usposabljanja;
provide high level of expertise and experience documented through publications, grants or honorific positions, teaching and training activities;
zagotovijo pomemben prispevek k raziskavam;
provide strong contribution to research;
sodelujejo pri epidemiološkem spremljanju, na primer pri registrih;
are involved in epidemiological surveillance, such as registries;
imajo tesne stike in sodelujejo z drugimi strokovnimi središči in mrežami na nacionalni in mednarodni ravni ter zmogljivost povezovanja v mreže;
have close links and collaboration with other expert centres and networks at national and international level and capacity to network;
imajo ustrezen in učinkovit odnos s ponudniki tehnologij.
have appropriate and effective relationships with technology providers.
postopek za vzpostavitev evropskih referenčnih mrež.
the procedure for establishing European reference networks.
Ukrepi iz odstavka 3, ki so namenjeni spremembi nebistvenih določb te direktive z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz
The measures referred to in paragraph 3, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article
Komisija lahko v sodelovanju z državami članicami določi obmejna območja kot poskusna območja, kjer se lahko inovativne pobude glede čezmejnega zdravstvenega varstva preskusijo, analizirajo in ovrednotijo.
The Commission, in cooperation with the Member States, may designate border regions as trial areas in which innovative cross-border healthcare initiatives can be tested, analysed and evaluated.
Komisija v skladu s postopkom iz
The Commission shall, in accordance with the procedure referred to in Article
sprejme posebne ukrepe, ki so potrebni za doseganje medobratovalnosti sistemov informacijske in komunikacijske tehnologije na področju zdravstvenega varstva, ki se uporabljajo, kadar se države članice odločijo, da jo bodo uvedle.
(2), adopt specific measures necessary for achieving the interoperability of information and communication technology systems in the healthcare field, applicable whenever Member States decide to introduce them.
Navedeni ukrepi
Those measures shall
so v skladu z zakonodajo, ki se uporablja za varstvo podatkov v posamezni državi članici, in
conform to the applicable data protection laws in each Member State and shall also
odražajo razvoj na področju zdravstvene tehnologije in medicine
reflect developments in health technologies and medical science,
, tudi telemedicine in telepsihiatrije,
including telemedicine and telepsychiatry,
spoštuje enake kakovostne in varnostne standarde medicinske stroke, kot veljajo pri nudenju neelektronskega zdravstvenega varstva;
adhere to the same professional medical quality and safety standards as those in use for non-electronic healthcare provision;
Sodelovanje pri upravljanju ▌zdravstvene tehnologije
Cooperation on management of ▌health technologies
Mreža temelji na načelih dobrega upravljanja, vključno s preglednostjo, objektivnostjo, poštenimi postopki in širokim ter polnim sodelovanjem zainteresiranih strani vseh skupin, tudi – vendar ne izključno – zdravstvenih delavcev, predstavnikov pacientov, socialnih partnerjev, znanstvenikov in industrije, ob upoštevanju pristojnosti držav članic na področju ocenjevanja zdravstvene tehnologije.
That network shall be based on the principles of good governance including transparency, objectiveness, fairness of procedures, and broad and full stakeholder participation of all relevant groups, including - but not limited to - health professionals, patients" representatives, social partners, scientists and industry, whilst respecting Member States' competence in the area of health technology assessment.
podpiranje sodelovanja med nacionalnimi organi ali telesi;
to support cooperation between national authorities or bodies;
iskanje trajnih načinov, kako uravnovesiti cilje dostopa do zdravil, nagrajevanja inovacij in upravljanja proračuna za zdravstveno varstvo;
to find sustainable ways to balance the objectives of access to medicines, reward for innovation and management of healthcare budgets;
podpiranje zagotavljanja objektivnih, zanesljivih, pravočasnih, preglednih in prenosljivih informacij o kratkoročni in dolgoročni učinkovitosti zdravstvene tehnologije ter omogočanje učinkovite izmenjave teh informacij med nacionalnimi organi ali telesi
) to support provision of objective, reliable, timely, transparent and transferable information on the short- and long-term effectiveness of health technologies and enable an effective exchange of this information between national authorities or bodies
preučitev narave in vrste informacij, ki se lahko izmenjujejo.
to analyse the nature and type of information that can be exchanged.
Komisija v skladu
The Commission shall, in accordance with the
sprejme potrebne ukrepe za vzpostavitev
, adopt the necessary measures for the establishment
in pregledno delovanje
and the transparent functioning
te mreže ▌.
of this network ▌.
Zbiranje podatkov za namene statistike in spremljanja
Data collection for statistical and monitoring purposes
Države članice zbirajo statistične ▌podatke, potrebne za spremljanje izvajanja čezmejnega zdravstvenega varstva, zagotovljene oskrbe, izvajalcev in pacientov, stroškov in rezultatov.
Member States shall collect statistical ▌data needed for monitoring purposes on the provision of cross-border healthcare, the care provided, its providers and patients, the cost and the outcomes.
Takšne podatke zbirajo kot del svojih splošnih sistemov za zbiranje zdravstvenih podatkov v skladu z nacionalnimi zakonodajami in zakonodajo Skupnosti za pripravo statistike in o varstvu osebnih podatkov
They shall collect such data as part of their general systems for collecting healthcare data, in accordance with national and Community law for the production of statistics and on the protection of personal data
, zlasti pa s členom 8(4) Direktive 95/46/ES
, and specifically Article 8(4) of Directive 95/46/EC
Države članice Komisiji vsaj enkrat na leto predložijo podatke iz odstavka 1, razen podatkov, ki se že zbirajo v skladu z Direktivo 2005/36/ES.
Member States shall transmit the data referred to in paragraph 1 to the Commission at least annually, except for data that are already collected pursuant to Directive 2005/36/EC.
, sprejme ukrepe za izvajanje tega člena.
adopt measures for the implementation of this Article.
Izvedbene in končne določbe
Implementing And final provisions
Pri tem Komisija zagotovi ustrezno posvetovanje s strokovnjaki iz zadevnih skupin pacientov in zdravstvenih delavcev, zlasti glede na izvajanje te direktive, in pripravi utemeljeno poročilo o teh posvetovanjih.
In that process, the Commission shall ensure the consultation of experts from the relevant patient and professional groups in an appropriate manner, especially in the context of the implementation of this Directive, and shall provide a reasoned report on those consultations.
Če se izvedbeni ukrepi nanašajo na obdelavo osebnih podatkov, je potrebno posvetovanje z Evropskim nadzornikom za varstvo podatkov.
Where implementing measures relate to the processing of personal data the European Data Protection Supervisor shall be consulted.
Pri sklicevanju na ta odstavek se uporabljata člen 5a(1) do (4) in člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.
Where reference is made to this paragraph, Article 5a (1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Komisija v petih letih po datumu iz
The Commission shall within five years after the date referred to in Article
pripravi poročilo o izvajanju te direktive
(1) draw up a report on the operation of this Directive
, skupaj s statistiko o odtekanju in pritekanju virov pacientov, ki izhajajo iz te direktive,
, including statistics on patient outflows and inflows resulting from this Directive,
ter ga predloži Evropskemu parlamentu in Svetu.
and submit it to the European Parliament and to the Council.
Države članice v ta namen in brez poseganja v
To that end and without prejudice to Article
Sklicevanja na drugo zakonodajo
References to other legislation
Od datuma začetka uporabe Uredbe (ES) št. 883/2004 ║:
As from the date of applicability of Regulation (EC) No 883/2004 ║:
se sklicevanja na člen 22 Uredbe
references to Article 22 of
v tej direktivi štejejo za sklicevanja na člen 20 Uredbe
1408/71 in this Directive shall be construed as references to Article 20 of Regulation
Države članice do …
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by …
Komisiji nemudoma posredujejo besedila teh predpisov in korelacijsko tabelo med temi predpisi in to direktivo.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Zakonodajna resolucija Evropskega parlamenta z dne 23. aprila 2009 o predlogu Priporočila Sveta o varnosti pacientov, vključno s preprečevanjem in obvladovanjem okužb, povezanih z zdravstveno oskrbo ( KOM(2008)0837 – C6-0032/2009 – 2009/0003(CNS) )
European Parliament legislative resolution of 23 April 2009 on the proposal for a Council recommendation on patient safety, including the prevention and control of healthcare associated infections ( COM(2008)0837 – C6-0032/2009 – 2009/0003(CNS) )
ob upoštevanju predloga Komisije Svetu ( KOM(2008)0837 ),
having regard to the Commission proposal to the Council ( COM(2008)0837 ),
ob upoštevanju člena 152(4) Pogodbe ES, v skladu s katerim se je Svet posvetoval s Parlamentom ( C6-0032/2009 ),
having regard to Article 152(4) of the EC Treaty, pursuant to which the Council consulted Parliament ( C6-0032/2009 ),
ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ( A6-0239/2009 ),
having regard to the report of the Committee on the Environment, Public Health and Food Safety ( A6-0239/2009 ),
Ocenjuje se, da v državah članicah EU od 8 % do 12 % hospitaliziranih pacientov med zdravljenjem utrpi varnostne zaplete.
It is estimated that in EU Member States between 8% and 12% of patients admitted to hospitals suffer from adverse events whilst receiving healthcare.
Ocenjuje se, da v državah članicah EU od 8 % do 12 % hospitaliziranih pacientov med zdravljenjem utrpi varnostne zaplete,
It is estimated that in EU Member States between 8% and 12% of patients admitted to hospitals suffer from adverse events whilst receiving healthcare
Ocenjuje se, da okužbe, povezane z zdravstveno oskrbo, v povprečju prizadenejo enega od dvajsetih pacientov, kar pomeni 4,1 milijona pacientov v Evropski uniji, ter da zaradi posledic tovrstnih okužb vsako leto umre približno 37 000 ljudi.
It is estimated that, on average, healthcare-associated infections (HCAIs) occur in one patient in twenty, that is to say 4,1 million patients a year in the EU, and that about 37 000 deaths are caused every year by the after-effects of such infections.
Slaba varnost pacientov je hud problem za javno zdravstvo in velika ekonomska obremenitev za omejene zdravstvene vire.
Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources.
Velik del varnostnih zapletov
A large proportion of adverse events
, vključno s tistimi, ki so posledica napačnih diagnoz in/ali zdravljenja,
, including those resulting from misdiagnosis and/or inappropriate treatment,
bi bilo mogoče preprečiti, in sicer v bolnišnicah pa tudi v primarnem zdravstvu, saj se zdi, da se jih da večino razložiti s sistemskimi vzroki
are preventable, both in the hospital sector and in primary care, with
in omejenimi finančnimi sredstvi
limited financial resources and
Ocenjuje se, da je v okviru varnostnih zapletov pri zdravstvenem varstvu okužbe, povezane z zdravstveno oskrbo, možno z lahkoto preprečiti.
Among the adverse events associated with healthcare, HCAIs are easily avoidable.
Države članice morajo vzpostaviti instrumente za 20-odstotno zmanjšanje števila oseb, ki so v Evropski uniji vsako leto prizadete zaradi varnostnih zapletov.
Member States need to provide the means to enable the number of persons a year in the European Union affected by adverse events to be reduced by 20 %.
Podatki kažejo, da države članice dosegajo različne ravni pri oblikovanju in izvajanju učinkovitih in celovitih strategij za varnost pacientov.
Evidence suggests that EU Member States are at different levels in the development and implementation of effective and comprehensive patient safety strategies.
Zato je ta pobuda namenjena oblikovanju okvira za spodbujanje razvoja politike in nadaljnjega ukrepanja v državah članicah in med njimi za obravnavo ključnih vprašanj v zvezi z varnostjo pacientov, s katerimi se spopada EU,
Therefore, this initiative intends to create a framework to stimulate policy development and future action in and between Member States to address the key patient safety issues confronting the EU
predvsem odgovornost zavodov in ustanov zdravstvenega varstva za zdravje ljudi.
, above all the responsibility of healthcare establishments and institutions for people's health
Posamezna država članica je pristojna za vrsto odškodnine in odškodninski postopek.
The individual Member State should, however, be competent for the type and method of compensation.
kar je Komisija priznala v svojem Priporočilu 2008/594/ES z dne 2. julija 2008 o čezmejni medobratovalnosti sistemov za vodenje elektronskih zdravstvenih spisov
, as has been recognised in Commission Recommendation 2008/594/EC of 2 July 2008 on cross-border interoperability of electronic health record systems
Države članice morajo biti sposobne zmanjšati število oseb, ki jih prizadenejo okužbe, povezane z zdravstveno oskrbo.
Member States need to be able to reduce the number of persons affected by HCAIs.
Države članice in njihove zdravstvene ustanove bi morale preučiti uporabo osebja za povezavo za pomoč specializiranim medicinskim sestram v urgentnih službah in lokalnih zdravstvenih ustanovah.
Furthermore, Member States and their healthcare institutions should consider the use of link staff to support specialist nurses at clinical level in acute and community facilities.
Za zmanjšanje neželenih zapletov v zdravstveni oskrbi je treba države članice spodbujati, da določijo lokalne in nacionalne cilje za zaposlovanje zdravstvenih delavcev, specializiranih za nadzor okužb, ob upoštevanju priporočila, da se do leta 2015 doseže razmerje ena medicinska sestra na 250 bolnišničnih postelj.
In order to reduce adverse events resulting from healthcare, Member States should be encouraged to set local and national targets for recruitment of health professionals specialising in infection control, taking into account the recommended target ratio of one nurse for every 250 hospital beds by 2015.
Komisija bi morala vložiti predloge za preprečitev širjenja ponarejenih zdravil ter poškodb, ki jih pacientom in zdravstvenim delavcem povzročajo injekcijske igle.
The Commission should bring forward proposals to prevent the circulation of counterfeit drugs and harm to patients and health workers from needlestick injuries.
CILJI ZA ZMANJŠANJE
REDUCTION TARGETS
Del I – Poglavje I a (novo) – točka 1
Part I – Chapter I a (new) – point 1
Države članice bi morale vzpostaviti instrumente za 20-odstotno zmanjšanje števila oseb, ki so v Evropski uniji vsako leto prizadete zaradi varnostnih zapletov pri zdravstvenem varstvu, kar ustreza cilju za zmanjšanje teh zapletov za 900 000 primerov na leto do leta 2015.
Member States should provide the means necessary to bring about a 20 % reduction in the number of persons in the European Union affected annually by adverse events resulting from healthcare, the target thus being to reduce such events by 900 000 cases a year by 2015.
Del I – Poglavje II – točka 1 – točka a
Part I – Chapter II – point 1 – point a
pristojnega organa ali
authority or
pristojnih organov, odgovornih za varnost pacientov na njihovem ozemlju;
authorities responsible for patient safety on their territory;
c) podpiranjem razvoja varnejših
Supporting the development of safer
sistemov, procesov in orodij, vključno z uporabo informacijske in komunikacijske tehnologije.
systems, processes and tools, including the use of information and communication technology.
Del I – Poglavje II – točka 2 – točka b a (novo)
Part I – Chapter II – point 2 – point b a (new)
Del I – Poglavje II – točka 3 – točka a
Part I – Chapter II – point 3 – point a
a) zagotavljajo ustrezne informacije o obsegu, vrstah in vzrokih napak, varnostnih zapletov in problemih, ki so se jim komaj izognili,
Provide adequate information on the extent, types and causes of errors, adverse events and near misses
Del I – Poglavje II – točka 3 – točka b a (novo)
Part I – Chapter II – point 3 – point b a (new)
Del I – Poglavje II – točka 4 – točka b a (novo)
Part I – Chapter II – point 4 – point b a (new)
Del I – Poglavje II – točka 5 – točka c
Part I – Chapter II – point 5 – point c
c) zbiranja in izmenjave primerljivih podatkov in informacij o rezultatih v zvezi z varnostjo pacientov po vrsti in številu na ravni EU zaradi lažjega vzajemnega učenja in ozaveščenega določanja prednostnih nalog.
To gather and share comparable data and information on patient safety outcomes in terms of type and number at EU level to facilitate mutual learning and inform priority setting.
Del I – Poglavje II – točka 6 – točka b a (novo)
Part I – Chapter II – point 6 – point b a (new)
Del I – Poglavje III – točka 1 – točka -a (novo)
Part I – Chapter III – point 1 – point -a (new)
(-a) zagotavljanje učinkovitih mehanizmov ocenjevanja tveganj pacientov, vključno s pregledom za postavitev diagnoze pred njihovim sprejetjem v bolnico, da se hitro ugotovi primere, ki zahtevajo dodatne previdnostne ukrepe;
(-a) Provide effective risk assessment mechanisms, including pre-admission diagnostic screening of patients, in order to rapidly identify conditions requiring additional precautionary measures.
Del I – Poglavje III – točka 1 – točka -a a (novo)
Part I – Chapter III – point 1 – point -a a (new)
(-aa) zagotavljanje ustrezne zaščite zdravstvenemu osebju s cepljenjem, postekspozicijsko profilakso, rutinskimi diagnostičnimi pregledi, nudenjem osebne zaščitne opreme in uporabo zdravstvenih tehnologij, ki omejujejo izpostavljenost okužbam, ki se prenašajo s krvjo;
(-aa) Provide adequate protection for healthcare staff, through vaccination, post-exposure prophylaxis, routine diagnostic screening, provision of personal protective equipment and the use of medical technology that reduces exposure to blood-borne infections;
Del I – Poglavje III – točka 1 – točka -a b (novo)
Part I – Chapter III – point 1 – point -a b (new)
(-ab) zagotavljanje učinkovitih zaščitnih sredstev v zdravstvenih ustanovah ter v centrih za dolgoročno rehabilitacijo;
(-ab) Provide effective infection prevention and control in long-term nursing and rehabilitation facilities.
Del I – Poglavje III – točka 1 – točka b
Part I – Chapter III – point 1 – point b
b) krepitev preprečevanja in obvladovanja okužb na ravni zdravstvenih zavodov
Enhance infection prevention and control at the level of the healthcare institutions
ter zagotavljanje večje čistoče, higiene in po potrebi asepse:
and ensure the highest standards of cleanliness, hygiene, and, where necessary, asepsis:
(i) opreme, ki se uporablja pri sprejemu in bivanju pacientov;
(i) as regards supplies used at the time of admission of patients or during their stay;
(ii) medicinske in paramedicinske opreme, električnih medicinskih naprav za zdravljenje pacientov in postopka razdeljevanja zdravil;
(ii) as regards medical and paramedical equipment, electro-medical devices used for patients, and dispensing of medicines;
Del I – Poglavje III – točka 1 – točka b a (novo)
Part I – Chapter III – point 1 – point b a (new)
Del I – Poglavje III – točka 1 – točka b b (novo)
Part I – Chapter III – point 1 – point b b (new)
Del I – Poglavje III – točka 1 – točka d
Part I – Chapter III – point 1 – point d
d) pospeševanje izobraževanja in usposabljanja delavcev v zdravstvu
Foster education and training of healthcare
ter paramedicinskega osebja
and paramedical
na ravni držav članic in zdravstvenih zavodov,
workers at Member State level and at the level of healthcare institutions
Del I – Poglavje III – točka 1 – točka e
Part I – Chapter III – point 1 – point e
e) izboljšanje informacij,
Improve the information given to patients
Del I – Poglavje III – točka 1 – točka f
Part I – Chapter III – point 1 – point f
f) podpiranje raziskav,
Support research
Del I – Poglavje III – točka 1 – točka f a (novo)
Part I – Chapter III– point 1 – point f a (new)
Evropskemu centru za preprečevanje in nadzor bolezni poročati o vsakem izbruhu okužbe, povezanem z zdravstveno oskrbo, ki bi prizadel večje število pacientov;
Report every HCAI outbreak affecting a significant number of patients to the European Centre for Disease Prevention and Control;
Del I – Poglavje III – točka 1 – točka f b (novo)
Part I – Chapter III – point 1 – point f b (new)
Komisija mora preučiti možnosti za poostritev zakonodaje Skupnosti, da bi se izboljšala varnost pacientov, na primer z zagotavljanjem, da si upravni organi pri čezmejnem delovanju zdravstvenih delavcev v Evropi izmenjujejo informacije o vsakem disciplinskem postopku proti posamezniku, ki se je že zaključil ali je še v teku, in ne samo o njihovi usposobljenosti na začetku službovanja.
The Commission should consider where existing Community legislation could be strengthened to improve patient safety, for example by ensuring that, when healthcare professionals cross borders within Europe, the professional regulators share information about any disciplinary procedures concluded or pending against individuals, and not just their initial qualifications.
Del II – točka 1 b (novo)
Part II – point 1 b (new)
Komisijo se poziva, naj na podlagi priročnika Svetovne zdravstvene organizacije o preprečevanju nosokomialnih okužb iz leta 2002
Using the practical guide drawn up by the World Health Organisation in 2002, entitled "Prevention of hospital-acquired infections"
pripravi dokument v zvezi s preprečevanjem nosokomialnih okužb, namenjen pacientom.
, the Commission is invited to produce a document aimed at patients on the prevention of nosocomial infections.
Priloga 1 – opredelitve – "Varnostni zaplet" – stolpec 2
Annex 1 – Definitions − "Adverse event" – column 2