Väline kvaliteedi kontroll- milline oleks optimaalne valik? Agnes Ivanov Tartu Ülikooli Kliinikum, Ühendlabor

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1 Väline kvaliteedi kontroll- milline oleks optimaalne valik? Agnes Ivanov Tartu Ülikooli Kliinikum, Ühendlabor

2

3 PT ülevaade, USA New Jersey, Pennsylvania ja Delaware laboritevaheline võrdluskatse 12 proovimaterjali, kliiniline keemia ja hemoglobiin

4 Interlaboratory variation Belk WP and Sunderman FW. Am J Clin Pathol 1947;17:

5 PT ülevaade, USA 2008 CAP (College of American Pathologist) otsus 1965, CLIA`67 3 korda aastas 5 proovi = 15 80% (4/5) tulemustest peab olema piiride sees

6 PT anekdoodid PT protsess Korduvmõõtmised, keskmine tulemus Kõrgema kvalifikatsiooniga personal Tulemuse võrdlemine teiste laboritega PT/EQA proov = patsiendi proov

7 PT sagedus ja proovide arv CLIA, USA- 3 korda x 5 proovi= 15 ERNDIM (European( Research Network for evaluation and improvement of screening, Diagnosis and treatment of Inherited disorders of Metabolism) ) - 1 kord 8 proovi Canada - 6 korda x 3 proovi= 18 IUPAC (International Union of Pure and Applied Chemistry) PT protokoll korda

8 EQALM, 2008 The EEE - PT working group was established as a joint activity by EA, Eurolab and Eurachem (EEE) to provide support on the use of proficiency testing to laboratory personnel and accreditation assessors. EA-European co-operation for Accreditation Eurolab-European Federation of National Associations of Measurement, Testing and Analytical Laboratories EUROCHEM is formed by the common interest of European basic chemical manufacturers, to experiment the most recent findings of their Research and Development Laboratories in real field applications.

9 EQALM, 2008 Survey results Questionnaires were distributed by to 35 members. Results were returned from 22 members organisations.

10 Välise kontrolli sagedus 80 kliiniline keemia(191) hematoloogia (45) hüübimine (16) mikrobioloogia (142)

11 Reference Measurement Procedures used in EQAS in the EU Belgium Denmark electrolytes, total protein, steroid hormones, thyroxine creatinine, bilirubin Germany electrolytes, total protein, substrates, steroid hormones, thyroxine, HbA1C, blood cell concentrations, enzymes, drugs Netherlands cholesterol, creatinine UK creatinine, steroid hormones

12 Välise kontrolli sageduse töörühm Ave Lellep Mehis Bakhoff Liisa Kuhi Piret Kedars Agnes Ivanov

13 Sverre Sandberg Anders Kallner Wim Huisman Kasutatud kirjandus: 1. Essentials of Clinical Laboratory Management in Developing Regions, IFCC 2. Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality, GP35

14 Sisemise kontrolli sagedus Analüüside arv/päevas Plaanilised väheteostatavad Erakorralised väheteostatavad IFCC soovitus Kontrollide arv/päevas 1 kontroll (N või P) 1 kontroll (N või P) >25 2 taset (N ja P) 1 kord >75 2 taset (N ja P) Suurema mahuga seeriad 2 korda Koos seeriaga 2 tasemel (N ja P) ELMÜ töörühma soovitus 1 kontroll (N või P) 1 kontroll (N või P) 1 kontroll (N või P) 2 kontrolli (N ja P, 2N, 2P) Koos seeriaga 2 tasemel (N ja P)

15 Analüüside arv aastas Välise kontrolli sagedus CLSI soovitus Kõik analüüsid Kord aastas erinevatel tasemetel ELMÜ töörühma soovitus Kord aastas >100 1 kontrollproov Kord aastas >1000 >1 kontrollproov 1 kord aastas 2/3 tasemel või 2 korda 1 tasemel >10000 >10 kontrollproovi 2 korda aastas 2/3 tasemel või 4 korda 1 tasemel

16 Küsimustik Laborimeditsiini eriala Välise kontrolli sagedus 2008a. (kordade arv/ proovide arv ühes kontrollis) Välise kontrolli ELMÜ sageduse kooskõlastus (nõus-elmü, ei ole nõus-oma ettepanek) Kliiniline keemia 12/1 ELMÜ

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