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"justification": [
"PerkinElmer Finland Oy:n tarjoamasta laitteistosta ja reagensseista on voimassa oleva sopimus k\u00e4ytt\u00f6korvausperiaatteella 28.2.2023 asti. T\u00e4ll\u00e4 suorahankinnalla pyrit\u00e4\u00e4n jatkamaan ja turvaamaan varhaisraskauden yhdistelm\u00e4seulonnan merkkiaineiden analysoinnit my\u00f6s jatkossa. ",
"",
"Seulonta-asetus (1339\/2006, 339\/2011) on velvoittanut kunnat tarjoamaan kaikille raskaana oleville mahdollisuutta osallistua varhaisraskauden yhdistelm\u00e4seulontaan yleisimpien siki\u00f6n kromosomipoikkeavuuksien selvitt\u00e4miseksi 1.1.2009 l\u00e4htien. Asetuksen mukaisessa varhaisraskauden yhdistelm\u00e4seulonnassa mitataan ultra\u00e4\u00e4nitutkimuksessa siki\u00f6n niskaturvotus (NT-mittaus) raskausviikoilla 11+0 \u2013 13+6 ja \u00e4idin seerumin\u00e4ytteest\u00e4 (raskausviikoilla 9+0 \u2013 11+6) analysoidaan laboratoriossa tietyt merkkiaineet (PAPP-A ja hCGBV). Kunkin raskauden 21-trisomian ja 18-trisomian riskisuhde lasketaan erityisell\u00e4 riskinlaskentaohjelmalla perustuen siki\u00f6n niskaturvotukseen, merkkiainepitoisuuksiin sek\u00e4 tiettyihin \u00e4idin demografisiin tietoihin.",
"",
"Sosiaali- ja terveysministeri\u00f6ss\u00e4 toimi asiantuntijaty\u00f6ryhm\u00e4 tukemassa seulonta-asetuksen t\u00e4yt\u00e4nt\u00f6\u00f6npanoa. Ty\u00f6ryhm\u00e4n muistiossa esitet\u00e4\u00e4n suositukset, jotka kaikkien kuntien ja kuntayhtymien pit\u00e4isi toteuttaa seulonta-asetuksen sis\u00e4ll\u00f6n ja tavoitteen saavuttamiseksi sek\u00e4 laatuvaatimukset siki\u00f6n poikkeavuuksien seulonnan toteuttamisen kokonaisuudelle ja osille. Suosituksen mukaan siki\u00f6n kromosomipoikkeavuuksien riskilaskennassa k\u00e4ytt\u00e4vien mediaanien (S-hCGB-V, S-PAPP-A, NT) tulee perustua suomalaisesta v\u00e4est\u00f6st\u00e4 saatuihin lukuihin seulonnan laadun takaamiseksi. Suomessa kaikki varhaisraskauden yhdistelm\u00e4seulonnan merkkiaineanalyysej\u00e4 tekev\u00e4t laboratoriot k\u00e4ytt\u00e4v\u00e4t PerkinElmer Finland Oy:n laitteita, reagensseja ja analyysilaitesidonnaista riskinlaskentaohjelmistoa. Riskinlaskenta perustuu suomalaisesta aineistosta laskettuihin merkkiainepitoisuuksien mediaaniarvoihin \/-yht\u00e4l\u00f6ihin, jotka ovat siis valtakunnallisesti samat kaikissa seulontaa tekeviss\u00e4 keskuksissa. Menettely yhdenmukaistaa riskinlaskennan laadun valtakunnallisesti.",
"",
"Suorahankinnan perusteena on markkinoiden ainoa toimittaja ja laitteisto, joka soveltuu yll\u00e4 mainittujen tutkimusten suorittamiseen niin analysaattorien, riskinlaskentaohjelmiston kuin tarvittavien reagenssienkin osalta (Laki julkisista hankinnoista ja k\u00e4ytt\u00f6oikeussopimuksista 2016\/1397, 40 \u00a7 2mom). ",
"",
"Varhaisraskauden yhdistelm\u00e4seulonnan merkkiaineiden analysointi ja riskinlaskenta hankitaan k\u00e4ytt\u00f6korvausperiaatteella, jolloin k\u00e4ytt\u00f6kustannukset perustuvat suoritettujen tutkimusten m\u00e4\u00e4r\u00e4\u00e4n. Tutkimuskohtainen n\u00e4ytehinta sis\u00e4lt\u00e4\u00e4 laitteet, huollot, reagenssit ja riskinlaskentaohjelmiston p\u00e4ivityksineen.",
" ",
"PerkinElmer Finland Oy tarjoaa yhdistelm\u00e4seulonnan hCGBV ja PAPP-A hinnaksi 18,49\u20ac\/n\u00e4yte. Analysaattoreilla analysoitavien n\u00e4ytteiden arvioitu kokonaism\u00e4\u00e4r\u00e4 on 5000 n\u00e4ytett\u00e4\/vuosi eli arvioitu vuosikustannus on 92 450,00\u20ac.",
"",
"Hankinnan arvioitu kokonaisarvo on hankintakauden (1.3.2023 \u2013 28.2-2025) ja mahdollisten optiokausien (1.3.2025 \u2013 28.2.2027) aikana yhteens\u00e4 369 800,00\u20ac. "
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