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"justification": [
"Laite on yhteensopiva n\u00e4ytteiden jatkok\u00e4sittelyss\u00e4 k\u00e4ytett\u00e4v\u00e4n valukeskuksen kanssa, jolloin oheishankintoja laitetta vaihtaessa ei tarvitse tehd\u00e4. Samoin nykyisen laitteen kalliit oheistarvikkeet (mm. n\u00e4ytekorit) sopivat VIP 6 A1 malliin, ja niit\u00e4 voidaan t\u00e4ten k\u00e4ytt\u00e4\u00e4 tarvittaessa uuden laitteen varaosina. Eri valmistajan laite vaikeuttaa n\u00e4ytteen l\u00e4pivientiprosessia, mik\u00e4 aiheuttaa lis\u00e4kustannuksia ja mahdollisesti tarpeita uusille merkitt\u00e4ville hankinnoille. Markkinakartoituksessa on my\u00f6s tullut ilmi, ett\u00e4 muiden toimittajien laitteet eiv\u00e4t mahdu histologian laboratoriossa laitteelle varattuun tilaan.\n\nN\u00e4ytteiden laadun pysyv\u00e4 korkea taso on \u00e4\u00e4rimm\u00e4isen t\u00e4rke\u00e4\u00e4 laissa kuolemansyyn selvitt\u00e4misest\u00e4 (459\/1973, 1065\/2009) annetun teht\u00e4v\u00e4n toteuttamikseksi. Saman valmistajan laitteissa ohjelman validointia ei tarvitse tehd\u00e4 uudelleen saman k\u00e4ytt\u00f6j\u00e4rjestelm\u00e4n johdosta. T\u00e4m\u00e4 takaa, ett\u00e4 oikeusl\u00e4\u00e4k\u00e4reilt\u00e4 saadun asikaspalautteen perusteella todettu n\u00e4ytteiden korkeatasoinen laatu sek\u00e4 Kiwa Inspectan sertifiointiin (ISO 9001:2015) sis\u00e4ltyv\u00e4 toiminta, kuolemansyynselvitys histologisista leikkeist\u00e4, eiv\u00e4t vaarannu laitteen vaihdon ja k\u00e4ytt\u00f6\u00f6noton yhteydess\u00e4. Eri valmistajan laitteen validointi voi heikent\u00e4\u00e4 n\u00e4ytteiden laatua ja tulosten vertailukelpoisuutta ainakin hetkellisesti, mik\u00e4 vaarantaisi lainmukaisen teht\u00e4v\u00e4n suorittamisen. Lis\u00e4ksi Helsingin toimipisteen vanhaa laitetta pystyt\u00e4\u00e4n hy\u00f6dynt\u00e4m\u00e4\u00e4n varalaitteena mahdollisten toimintah\u00e4iri\u00f6iden aikana, mik\u00e4 vahvistaa jatkuvaa toimintavalmiutta. Muutamankin p\u00e4iv\u00e4n huoltotauko ruuhkauttaa n\u00e4ytteenk\u00e4sittelyn ja vaikuttaa n\u00e4in laboratorion palveluvarmuuteen.\n\nTurun histologia yhdistyi Helsingin toimipisteen kanssa 1.2.2018, ja samanlainen laitekanta on t\u00e4rke\u00e4\u00e4 toimintojen yhten\u00e4ist\u00e4misen ja tasaisen laadun kannalta. Helsingin toimipisteen histologian laboratorio on sertifioitu, ja Turun toimipisteelle on my\u00f6s tarkoitus hakea sama sertifikaatti. Yhten\u00e4inen laitekanta varmistaa n\u00e4ytteiden tasaisen laadun.\n\nTHL katsoo, ett\u00e4 sill\u00e4 on lainmukainen suorahankintaperuste, Hankintalain 40 \u00a7 mukainen yksinoikeus, ostaa em. laitteet Algol Immunodiagnostics Oy:lt\u00e4, sill\u00e4 markkinakartoituksen my\u00f6t\u00e4 on tullut ilmi, ett\u00e4 markkinoilla ei ole toista toimijaa, joka pystyisi vastaavan laitteen THL:n tarpeisiin toimittamaan."
]
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"dateCreated": "2019-12-31T13:53:16.2594734",
"dateModified": "2020-01-08T22:18:50.9920509"
}