AKREDITACIJA ZA MEDICINSKE LABORATORIJE
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1 AKREDITACIJA ZA MEDICINSKE LABORATORIJE
2 PREGLED IDEJA U OBLASTI AKREDITACIJE ISO Guide ISO/IEC Guide ISO TC/176 Formiran ISO 9000 Series ISO/IEC Guide ISO 9000 Series ISO/IEC ISO 9000:2001 ISO 17025:2005/ISO 15189:2007
3 TEHNIČKI ZAHTEVI ISO/IEC17025 OPŠTI KADAR PROSTOR I MIKROKLIMATSKI USLOVI METODE ZA ISPITIVANJE I ETALONIRANJE I METODE VALIDACIJE OPREMA METROLOŠKA SLEDIVOST UZORKOVANJE RUKOVANJE UZORCIMA I OPREMOM IZVEŠTAJI O REZULTATIMA
4 Svaki broj je život ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories.
5 Šta je akreditacija u smislu ISO 15189:2007 Program akreditacije koji je usmeren na : Poboljšanje nege pacijenata Ojačavanje avanje kompletnog sistema upravljanja kvalitetom u bolnici Smanjenje grešaka i kontrola rizika Kontrolu troškova u zdravstvu
6 Oblasti primene ISO Anatomska, hemijska i klinička ka patologija Mikrobiologija Imunologija Molekularna genetika i citogenetika Hematologija Medicinski imidžing ing Medicinska ispitivanja Vetrinarska ispitivanja
7 Oblasti primene ISO Merenje u akustici i merenje vibracija Električna ispitivanja Forenzika Optika i radiometrija Informacione tehnologije
8 Razlika ISO i ISO 9000 ISO 9000:2001 se odnosi na: - upravljanje sistemom kvaliteta svih preduzeća a (generički standard) - obezbeđuje poverenje u organizacionom smislu ISO 15189:2007 se odnosi na: - usmeren je ka kliničkim i medicinkim laboratorijama - uključuje i elemente QMS, ali i tehničku kompetenciju laboratorija i njihove mogućnosti da daju pouzdane i tačne rezultate ispitivanja
9 Odnos ISO i ISO ISO je verzija ISO primenjena na medicinske laboratorije u širem smislu
10 ISO Tehnička kompetencija Tehnička kompetencija osoblja Validnost i adekvatnost metoda ispitivanja Sledivost merenja i etaloniranja do SI Okruženje neophodno za ispitivanje Uzorkovanje, čuvanje i transport uzoraka Validnost informacionog sistema
11 ISO Kompetencije i menadžment ment Sistem upravljanja kvalitetom Kontrola dokumenata i zapisa Kontrola eksternih usluga i dobavljača Rešavanje po žalbama Procena povratnih informacija od strane klijenata Interno ocenjivanje
12 Procena uslova akreditacije na licu mesta Treća godina Nadzor Bol Gapanaliza Višednevna detaljna procena na licu mesta Ulaz u ciklus ocene Bol Predocenjivanje Jednodnevna poseta na licu mesta Bol. Detaljan pregled dokumenata kvaliteta Intervjui sa rukovodstvom i osobljem u i van laboratorije Izveštaj o neusaglašenostima Zbirni izveštaj o neusaglaenostima Prva godina Održavanje QA i usavršavanje Nadzor UPRAVLJANJE Lab/godišnje Druga godina od dobijanja akreditacije preispitivanje rukovodstva -Interne procene -- kontinalno usavravanje
13 Tehnički zahtevi, Tačka 5.6. Obezbeđuju kvalitet procedure medicinskog pregleda (ispitivanja) i sprovodi se kroz: 1) Kontrolu kvaliteta, QC 2) Osiguranje kvaliteta, QA 3) Kvalitet, Q
14 Kontrola kvaliteta QC Ispitni i nadzorni procesi Provera kvaliteta internih procedura Eksterna provera procedura Procedure za proveru konkretnih uređaja, metoda, procenu merne nesigurnosti, zaštitu softvera isl.
15 Interna kontrola kvaliteta Zahtevi u pogledu opreme, kadra i prostora QC programi interne/eksterne kontrole obuhvataju: prijemna ispitivanja, redovna i vanredna ispitivanja, dokumenta Metode za procenu usaglašenosti, korektivne i preventivne akcije Definisane kritične tačke
16 Interna kontrola kvaliteta- kritične kontrolne tačke Kriitčna tačka Dokumentacija Pozitivna identifikacija pacijenta Zahtev za nadzorom ispitivanja- obrazac/ uzorak Na posebnom formularu/ primer popunjenog formulara/ potpis Formular za inicijalni zahtev Elektronski- nije zvanično no
17 Interna kontrola kvaliteta- kritične kontrolne tačke Kritična kontrolna tačka Datum prijema i popunjavanja obrasca Označavanje avanje primljenog materijala Istorijski pregled prethodnih rezultata Dokumentacija Zahtev za proeduru Na zahtevu za proceduru Karton pacijenta
18 Zahtev Merna nesigurnost rezultata ispitivanja ili pregleda Izvori merne nesigurnosti: Uzorkovanje Priprema uzorka Deljenje uzorka za različita ita ispitivanja Etaloniranje Referentni materijali Korišćena merna oprema (merila) Uslovi okoline Stanje i priroda samog uzorka Promena merioca
19 Za različite ite vrste ispitivanja prepoznajemo: Mernu nesigurnost rezultata merenja Mernu nesigurnost koja uključuje uje reproducibilnost i dugoročnu stabilnost
20 Korak 1. Merna nesigurnost rezultata merenja Kontrolni uzorak se izmeri u toku dana 30 puta: n=30 Izračuna se aritmetička sredina i SD Merna nesigirnost u wr = SD/ n
21 Korak 2. Merna nesigurnost dugoročna stabilnost Uobičajenu kontrolu sprovesti jedanput dnevno, sukcesivno u toku 30 dana Izračunati srednju vrednost i SD Merna nesigurnost: u br = SD/ n
22 I dalje Korak 3. Kombinovana merna nesigurnost u c = (u wr ) 2 + (u br ) 2 Korak 4. Proširena merna nesigurnost U = 2xu c
23 Primer: kalijumu krvi U izveštaju treba da piše: Vrednost kalijuma u krvi je (3.56 ± 0.05) mmol/l sa mernom nesigurnošću 2SD ZNAČI: 95 % smo sigurni da se prva vrednost sadržaja aja kalijuma u krvi nalazi u intervalu 3,61 mmol/l tj. (3,56+0,05) mmol/l i 3,51 mmol/l tj. (3,56-0,05) mmol/l
24 Zahtev Etaloniranje (Kalibracija)-sledivost Verifikacija rezultata merenja kroz program interlaboratorijskih komparacija i primenom referentnih mateijala Dokumentacija procedura i izjava u vezi merne nesigurnost i metrološke sledivosti Obuka trenera i operatera Programi metrološkog obezbeđenja
25 Template za proces provere ID broj laboratorije Naziv programa Frekvencija distribucije Metoda koja se primenjuje+instrumentacija Karakteristike Akcije za neusaglašenost enost Trendovi u toku 3 poslednje provere Rezultati provere i predlozi
26 Prednosti uvođenja ISO Ispunjenje regulatornih zahteva (ISO & 17025) Poboljšanje kvaliteta ispitivanja Marketinško ko sredstvo Potencijalno smanjuje ukupne troškove i poboljšava ekonomsku efikasnost identifikacije dijagnoze Smanjenje troškova zdravstvenog osiguranja Sprečava nepotrebna ispitivanja i izbegava dupliranja Dokumentuje personalnu kompetenciju i identifikuje potrebu za dodatnom specijalizacijom i obukom
27 Legislativa vezana za akreditaciju u medicini Test and Calibration Laboratories (ISO/IEC 17025:2005) Medical Laboratories (ISO 15189:2007) Veterinary Laboratories (ISO/IEC & OIE 2008 Quality standard and Guidelines for Veterinary laboratories) Certification Bodies (ISO/IEC 17021: 2006) Inspection Bodies (ISO/IEC 17020:1998) Proficiency Test providers (ISO/IEC Guide 43:1997) - (ISO/IEC 17043).
28 ISO/TS 22367:2008 Medical laboratories - Reduction of error through risk management and continual improvement Odnosi se na primenu ISO Smanjenje grešaka Poboljšanje sigurnosti pacijenta primenom principa upravljanjem rizikom Daje metodologiju zaiznalaženje grešaka
29 ISO/TR 15801:2004 Electronic imaging - Information stored electronically -- Recommendations for trustworthiness and reliability
30 European Federation Clinical Chemistry and Laboratory Medicine
31 World organization 1955 European branch 1991 EFCC 2007 EU section 1993
32 ČLANICE Albania, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Serbia- Montenegro
33 EFCC Structure
34 Osnovni ciljevi i aktivnosti EFCC Profesionalna obuka i obuka pre diplomiranja Promocija profesije Razvoj specijalističkih laboratorija (u širem smislu) Harmonizacija evaluacije kvaliteta Procedure akreditacije
35 EFCC Workshops; The Balkan BCLF, Centre for Continuous Education 2005 in Belgrade:Total quality management 2006 in Novi Sad: New Diagnostic Tools and Quality in Laboratory Medicine Belgrade: Evidence Based Medicine 2008 Pre-analytical Phase In co-operation with the University of Belgrade
36 SHAPING THE FUTURE OF LABORATORY MEDICINE IN THE GLOBAL HEALTH COMMUNITY Prof V Blaton KU-Leuven and Az ST Jan Av Brugge(Be)
37 Postdiplomska obuka EFCC Standardizacija na osnovu ISO Upravljanje kvalitetom Međunarodni standardi u medicinskoj praksi Kontinualni profesionalni razvoj kroz nacionalna društva
38 Proces obezbeđenja sigurnog okruženja Inicijalna evaluacija Implementacija planova i postavljenih ciljeva Politika obezbeđenja sigurnosti radnog mesta i okruženja pacijenta Obuka tima za odabrane elemente sigurnosti Pomoć u primeni sigurnosnih, incidentnih i akcidentalnih tehnika Nadzor nad izvršenjem ciljeva Praćenje svih koraka procesa sigurnosti Povećanje efikasnosti za poboljšanje bezbednosti Incorporcija rezultata u standardizovane procedure Upravljanje postignutom i predviđenim rezultatima
39 EAL- European Cooperation for Accreditation of Laboratories ECLM European Confederation of Laboratory Medicine
CCBE LAWYERS STATISTICS 2016
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