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Izvedba verifikacije merilnih postopkov v medicinskem laboratoriju na hematološkem analizatorju = Performance verification measurement procedures in medical laboratory on hematology analyzer : magistrski študijski program Laboratorijska biomedicinaGoručan, JanaMednarodni akreditacijski standard za medicinske laboratorije SIST EN ISO 15189:2012 – Medicinski laboratoriji – Zahteve za kakovost in kompetentnost zahteva, da so analizni postopki, instrumenti in ... reagenčni paketi, ki so uporabljeni v laboratorijih, validirani in verificirani. Validacijo in vitro diagnostike (IVD Medical Device Directive 98/79/EC) izvede proizvajalec, medtem ko smo z verifikacijo pred začetkom vpeljave analiznega postopka in analizatorja v rutinsko delo dolžni izvesti uporabniki. Z verifikacijskimi postopki želimo overiti in potrditi, da lahko značilnosti, prikazane med validacijo, uspešno ponovimo tudi v praktični klinični situaciji. Namen naloge je prikazati primere verifikacijskih postopkov (ocena merilne natančnosti in pravilnosti) na hematološkem analizatorju Advia 120, izvedenih v diagnostičnem laboratoriju Zdravstvenega doma Šentjur. Verifikacijske postopke smo izvedli po priporočilih CLSI standarda. Oceno merilne natančnosti smo izvedli z rezultati hemograma IQC proizvajalca za naslednje parametre: levkocite, eritrocite, hemoglobin, hematokrit, MCV, MCH, MCHC, MPV in trombocite. Pri oceni merilne pravilnosti smo uporabili rezultate SNEQAS v letih 2018, 2019 in 2020 za naslednje parametre hemograma: levkocite, eritrocite, hemoglobin, hematokrit, MCV in trombocite. Pridobljene rezultate smo vnesli v statistične preglednice, ki so dostopne na spletni strani organizacije The Association for Clinical Biochemistry and Laboratory Medicine – Measurement Verification. Rezultati ocene merilne natančnosti kažejo na dobro ponovljivost znotraj serije pri levkocitih, eritrocitih, hemoglobinu, hematokritu, MCV, MCH, MPV in trombocitih. Slabšo ponovljivost znotraj serije smo zaznali predvsem v visoki kontroli pri levkocitih, eritrocitih, hemoglobinu, hematokritu in MCHC. Pri oceni merilne natančnosti med serijami ne zaznavamo odstopanj v primerjavi standardnih odklonov med našimi rezultati in podanimi podatki proizvajalca pri prav vseh parametrih hemograma: levkocitih, eritrocitih, hemoglobinu, hematokritu, MCV, MCH, MCHC, MPV in trombocitih. Pri oceni merilne pravilnosti ugotavljamo, da imamo odstopanje med rezultati EQA in srednjo vrednostjo skupine, ki ni različno od nič, samo pri trombocitih, medtem ko imamo odstopanje pri levkocitih, eritrocitih, hemoglobinu, hematokritu in MCV. Rezultati EQA in srednja vrednost skupine se ne razlikuje pri levkocitih in trombocitih, medtem ko se razlikuje pri eritrocitih, hemoglobinu, hematokritu in MCV.Type of material - master's thesis ; adult, seriousPublication and manufacture - Ljubljana : [J. Goručan], 2022Language - slovenianCOBISS.SI-ID - 123933443
Author
Goručan, Jana
Other authors
Skitek, Milan
Topics
Laboratorijska medicina |
hematološki analizator |
validacija |
verifikacija |
merilna natančnost |
nenatančnost |
merilna pravilnost
Library/institution |
City | Acronym | For loan | Other holdings |
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Faculty of Pharmacy, Ljubljana | Ljubljana | FFALJ |
reading room 1 cop.
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Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Goručan, Jana | |
Skitek, Milan | 11331 |
Source: Personal bibliographies
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