{"id":2090,"date":"2018-10-09T15:47:00","date_gmt":"2018-10-09T13:47:00","guid":{"rendered":"http:\/\/srvwww1.cai.internal\/?page_id=2090"},"modified":"2019-02-23T12:35:22","modified_gmt":"2019-02-23T11:35:22","slug":"principy-akreditace-zdravotnickych-laboratori","status":"publish","type":"page","link":"https:\/\/www.cai.cz\/?page_id=2090","title":{"rendered":"Principy akreditace zdravotnick\u00fdch laborato\u0159\u00ed"},"content":{"rendered":"\n<p>Podle prohl\u00e1\u0161en\u00ed IFCC&nbsp;<a href=\"http:\/\/www.ifcc.org\/\">(<span style=\"text-decoration: underline;\">International Federation of Clinical Chemistry and Laboratory Medicine<\/span>)<\/a>&nbsp;je v z\u00e1jmu pacient\u016f, spole\u010dnosti a vl\u00e1d, aby zdravotnick\u00e9 laborato\u0159e pracovaly na vysok\u00e9 \u00farovni profesn\u00ed a odborn\u00e9 zp\u016fsobilosti.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Rozhodov\u00e1n\u00ed o diagn\u00f3ze, progn\u00f3ze a postupu l\u00e9\u010den\u00ed je \u010dasto postaveno na v\u00fdsledc\u00edch a interpretaci laboratorn\u00edch vy\u0161et\u0159en\u00ed. Chybn\u00e9 v\u00fdsledky nebo interpretace mohou zp\u016fsobit nevratn\u00e9 po\u0161kozen\u00ed pacienta.<\/li><li>U\u017eivatel\u00e9 slu\u017eeb zdravotnick\u00fdch laborato\u0159\u00ed (pacienti, l\u00e9ka\u0159i) nemus\u00ed m\u00edt dostate\u010dnou schopnost posoudit, zda laborato\u0159 pracuje na \u017e\u00e1douc\u00ed \u00farovni.<\/li><li>Pacienti a \u010d\u00e1ste\u010dn\u011b i l\u00e9ka\u0159i mohou b\u00fdt omezeni ve v\u00fdb\u011bru laborato\u0159e.<\/li><li>Ti, kdo hrad\u00ed mnohdy n\u00e1kladn\u00e1 laboratorn\u00ed vy\u0161et\u0159en\u00ed (da\u0148ov\u00ed poplatn\u00edci, pacienti a zdravotn\u00ed poji\u0161\u0165ovny) cht\u011bj\u00ed m\u00edt z\u00e1ruku, \u017ee laborato\u0159e produkuj\u00ed validn\u00ed informace.<\/li><\/ul>\n\n\n\n<p><strong>Akreditace laborato\u0159e<\/strong>&nbsp;znamen\u00e1&nbsp; form\u00e1ln\u00ed uzn\u00e1n\u00ed odborn\u00e9 a organiza\u010dn\u00ed zp\u016fsobilosti laborato\u0159e k proveden\u00ed konkr\u00e9tn\u00ed slu\u017eby, jak je pops\u00e1no v rozsahu akreditace laborato\u0159e. Zp\u016fsobilost je kl\u00ed\u010dem k transparentnosti, spolehlivosti a srovnatelnosti \u010dinnosti laborato\u0159e.<br>\nPodle IFCC je z\u00e1jmem ka\u017ed\u00e9 dob\u0159e funguj\u00edc\u00ed zdravotnick\u00e9 laborato\u0159e nechat si nez\u00e1visle posoudit svou zp\u016fsobilost. Na z\u00e1klad\u011b kladn\u00e9ho v\u00fdsledku posouzen\u00ed podle p\u0159\u00edslu\u0161n\u00fdch standard\u016f pak laborato\u0159 m\u016f\u017ee ve\u0159ejn\u011b dolo\u017eit vysokou kvalitu sv\u00e9 pr\u00e1ce.<\/p>\n\n\n\n<p>Akreditace je zalo\u017eena na z\u00e1sad\u00e1ch:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>nez\u00e1vislosti,<\/li><li>nediskrimina\u010dn\u00edho p\u0159\u00edstupu,<\/li><li>jasn\u011b stanoven\u00fdch a dokumentovan\u00fdch krit\u00e9ri\u00ed posuzov\u00e1n\u00ed,<\/li><li>transparentnosti proces\u016f posuzov\u00e1n\u00ed.<\/li><\/ul>\n\n\n\n<p>Akreditovan\u00e1 laborato\u0159 poskytuje slu\u017eby na vysok\u00e9 odborn\u00e9 \u00farovni a prokazuje:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>shodu s po\u017eadavky uveden\u00fdmi v p\u0159\u00edslu\u0161n\u00e9 norm\u011b,<\/li><li>funk\u010dnost zaveden\u00e9ho syst\u00e9mu \u0159\u00edzen\u00ed jakosti, v\u010detn\u011b intern\u00edho a extern\u00edho zabezpe\u010den\u00ed kvality, kter\u00fd je dokumentov\u00e1n v p\u0159\u00edru\u010dce kvality, eventu\u00e1ln\u011b v dal\u0161\u00edch souvisej\u00edc\u00edch dokumentech.<\/li><li>Na posuzov\u00e1n\u00ed v r\u00e1mci akreditace se pod\u00edl\u00ed odborn\u00edci doporu\u010den\u00ed jednotliv\u00fdmi odborn\u00fdmi l\u00e9ka\u0159sk\u00fdmi spole\u010dnostmi, pro\u0161kolen\u00ed v po\u017eadavc\u00edch p\u0159\u00edslu\u0161n\u00fdch norem, v principech akreditace a auditorsk\u00fdch praktik\u00e1ch.<\/li><\/ul>\n\n\n\n<p><strong>Akreditace zdravotnick\u00fdch laborato\u0159\u00ed<\/strong>&nbsp;je prov\u00e1d\u011bna podle mezin\u00e1rodn\u011b platn\u00e9 normy \u010cSN EN ISO 15189, jak je doporu\u010deno organizacemi IFCC a pl\u00e1tci zdravotn\u00edho poji\u0161t\u011bn\u00ed.<\/p>\n\n\n\n<p><strong>Akreditace a legislativa<br>\n<\/strong>Akreditace je v sou\u010dasn\u00e9 dob\u011b v Evropsk\u00e9 unii&nbsp;upravena souborem&nbsp;na\u0159\u00edzen\u00edm&nbsp;EP a Rady&nbsp;\u010d. 765\/2008. Syst\u00e9m akreditace funguj\u00edc\u00ed podle z\u00e1vazn\u00fdch pravidel p\u0159isp\u00edv\u00e1 k pos\u00edlen\u00ed vz\u00e1jemn\u00e9 d\u016fv\u011bry&nbsp;v odbornou zp\u016fsobilost subjekt\u016f posuzov\u00e1n\u00ed shody a tedyi d\u016fv\u011bry v jimi vyd\u00e1van\u00e9 v\u00fdstupn\u00ed dokumenty (protokoly o zkou\u0161k\u00e1ch\/v\u00fdsledkov\u00e9 listy nebo osv\u011bd\u010den\u00ed o shod\u011b).&nbsp;Org\u00e1ny ve\u0159ejn\u00e9 moci \u010dlensk\u00fdch st\u00e1t\u016f EU maj\u00ed pova\u017eovat akreditaci za v\u00fdsadn\u00ed prost\u0159edek dokl\u00e1daj\u00edc\u00ed odbornou zp\u016fsobilost subjekt\u016f posuzov\u00e1n\u00ed shody.<\/p>\n\n\n\n<p>Akreditace zdravotnick\u00fdch laborato\u0159\u00ed je b\u011b\u017enou agendou akredita\u010dn\u00edch org\u00e1n\u016f sdru\u017een\u00fdch v EA&nbsp;<strong><a href=\"http:\/\/www.european-accreditation.org\/default_flash.htm\">(<span style=\"text-decoration: underline;\">European Co-operation for Accreditation<\/span>)<\/a><\/strong>&nbsp;nebo ILAC&nbsp;<strong><a href=\"http:\/\/www.ilac.org\/\">(<span style=\"text-decoration: underline;\">International Laboratory Accreditation Co-operation<\/span>).<\/a><\/strong><br>\nTyto akredita\u010dn\u00ed org\u00e1ny pracuj\u00ed v souladu s po\u017eadavky ISO\/IEC 17011 a&nbsp;pln\u011bn\u00ed t\u011bchto po\u017eadavk\u016f uveden\u00fdch v tomto mezin\u00e1rodn\u00edm standardu je p\u0159edm\u011btem pravideln\u00fdch audit\u016f, jejich\u017e \u00fasp\u011b\u0161n\u00e9 absolvov\u00e1n\u00ed je podm\u00ednkou pro mo\u017enost b\u00fdt signat\u00e1\u0159em Multilater\u00e1ln\u00ed dohody v r\u00e1mci EA (EA MLA) nebo ILAC (ILAC MRA).<\/p>\n\n\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\n\n\n\n<p><strong>POKRA\u010cOVAT D\u00c1L:<\/strong>\u00a0\u00a0 <br><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.cai.cz\/?page_id=54\">Akreditace ><\/a><\/span>\u00a0\u00a0 <a href=\"https:\/\/www.cai.cz\/?page_id=1798\"><span style=\"text-decoration: underline;\">Laborato\u0159e<\/span><\/a>\u00a0\u00a0 <span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.cai.cz\/?page_id=2008\">Zdravotnick\u00e9 laborato\u0159e<\/a><\/span><br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Podle prohl\u00e1\u0161en\u00ed IFCC&nbsp;(International Federation of Clinical Chemistry and Laboratory Medicine)&nbsp;je v z\u00e1jmu pacient\u016f, spole\u010dnosti a vl\u00e1d, aby zdravotnick\u00e9 laborato\u0159e pracovaly na vysok\u00e9 \u00farovni profesn\u00ed a&hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":2008,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":"","_tec_slr_enabled":"","_tec_slr_layout":""},"class_list":["post-2090","page","type-page","status-publish","hentry"],"acf":[],"ticketed":false,"_links":{"self":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/pages\/2090","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cai.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2090"}],"version-history":[{"count":4,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/pages\/2090\/revisions"}],"predecessor-version":[{"id":4101,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/pages\/2090\/revisions\/4101"}],"up":[{"embeddable":true,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/pages\/2008"}],"wp:attachment":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2090"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}