External Quality Assessment
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1 External Quality Assessment
2 AIM of QUALITY SYSTEM
3 The aim of QUALITY SYSTEM A valid instrument for the self-evaluation of diagnostic quality in laboratories. Validation of the internal quality control is assured by the periodical external quality control. Comparison between laboratories placed on the same territory increase the quality of the analitycal proficiency. Integration between internal and external control allows constant t Total Quality improvement.
4 SCHEMES
5 CLINICAL CHEMISTRY Albumin Ck Nac Iron (Fe) Magnesium (Mg) Alfa Amylase Chloride Gamma GT Phosphate ALP AMP HDL Cholesterol Glucose Potassium (K) Bicarbonates LDL Cholesterol GOT (AST) Sodium (Na) Biliar Acids Total Cholesterol GPT (ALT) Total Proteins Direct Bilirubin Cholinesterase LDH Triglycerides Total Bilirubin Copper (Cu) Lipase Urea Calcium (Ca) Creatinine Lithium (Li) Uric Acid
6 IMMUNOLOGY Alfafetoprotein Ferritin Prolactine AntiTyreoglobuline Antibody Folic Acid PSA Free CA 125 FSH PSA Total CA 15-3 FT3 Testosteron CA FT4 Tireoglobuline Carbamazepine HCG TMAB CEA IgE TPO Corthisole LH TSH Digoxin Progesteron T3 Estradiol T4
7 COAGULATION PT Quick Time APTT Antithrombin III Fibrinogen
8 ELECTROPHORESIS Albumin Alpha 1 Globuline Alpha 2 Globuline Beta Globulin Gamma Globulin
9 HEMATOLOGY WBC/GB RBC/GR HGB/HBG HCT MCV/VMG MCH/TCMH RDW/IDR-CV PLT/PLQ
10 SEROLOGY Chlamydia IgG HbcAb IgM HIV 1-2 Chlamydia IgM HBeAb Rubella IgG Cytomegalovirus IgG HBeAg Rubella IgM Cytomegalovirus IgM HBsAb Syphilis IgG Ebstein-Barr VCA IgG HBsAg Syphilis IgM Ebstein-Barr VCA IgM HCV Toxoplasma IgG EB HIV Helicobacter Pylori IgG Toxoplasma IgM HAV IgG Herpes virus I IgG Troponema Pallidum IgG HAV IgM Herpes virus II IgG Troponema Pallidum IgM HbcAb HV
11 SPECIFIC PROTEINS Alpha 1 Glicoprotein Antistreptolisine O C3 C4 CReactiveProtein IgA IgG IgM Reumathoid Factor Transferrin
12 URINE Ascorbic Acid Specific Weight Albumine ph Bilirubine Proteins Ketone Blood Glucose Urobilirogen Leucocyte MicroAlbumine Nitrite
13 DRUGS OF ABUSE Amphetamine Ecstasy Metamphetamine Morphine Opiates Brupernophine Methadone THC Barbiturate Benzodiazepine Cocaine
14 CARDIAC MARKERS CK - Tot pro-bnp CK - MB BNP Hs CRP TnI HCY TnT Myo
15 MICROBIOLOGY HBA1C ESR FOB HEMATOLOGY OG SMEAR URINE SEDIMENTATION
16 PROGRAM OPTIONS
17 Programs Assay per year Vial per assay Shipment per year 4 2 (2 levels) 1 CLINICAL CHEMISTRY (2 levels) 1 COAGULATION (2 levels) 1 IMMUNOLOGY ELECTROPHORESIS SPECIFIC PROTEINS 4 1 1
18 Programs Assay per year Vial per assay Shipment per year URINE URINE + SEDIMENTATION FILE 4 SEDIMENTATION 4 FILE 4 HEMATOLOGY HEMATOLOGY + SMEAR FILE 4 SMEAR 4 FILE 4 SEROLOGY BACTERIOLOGY HBA1C DRUG OF ABUSE FECAL OCCULT BLOOD ESR CARDIAC MARKER 4 1 4
19 STEPS OF QS
20 STEPS OF QUALITY SYSTEM Each laboratory receives samples of different analytes with unknown concentration; specimen with a long expiry date are delivered once per year Operators have to analyze the Operators have to analyze the sample and send the results on web site
21 STEPS OF QUALITY SYSTEM Data will be statistically elaborated by the University of Urbino; Values of each laboratory will be compared between them, allowing to have informations about results, methods, instruments and reagents The laboratories will receive reports easy to read and understand; a graph combine the results from all partecipants in the survey
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23 QS WEB SITE QS WEB SITE allows direct access to a dedicated page for each customer with the following features: -Entry results -Download reports -Profile edit -License status
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29 STATISTICAL ELABORATION Data submitted are checked by Bio- Group Medical System s Quality Control Department and further statistically analyzed in collaboration with the University of Urbino Medical Statistic Department.
30 STATISTICAL ELABORATION Result of the statistical analysis are send to participants in order to verify quality data, opening discussions on eventually correlated problems. The laboratory operator, checking the results on a graph, will be soon able to establish the course of quality for each analyte.
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35 REPORT AIM WEB CONCLUSION STEPS ANALYTES PROGRAMS
36 Quality is the set of characteristics for a product or a service that t allows to satisfy fixed and implicit needs.
37 Clinical Laboratories have to work under specific quality rules and control the analytical phase with a quality program and examine the whole analytical process by taking part to an External Quality Program.
38 CONCLUSION The implementation of QUALITY SYSTEM The implementation of QUALITY SYSTEM in laboratory will raise quality to a high standard of excellence.
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