CROATIAN SOCIETY OF MEDICAL BIOCHEMISTRY AND LABORATORY MEDICINE

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1 CROATIAN SOCIETY OF MEDICAL BIOCHEMISTRY AND LABORATORY MEDICINE Croatian Centre for Quality Assessment in Laboratory Medicine Dear colleagues, Boskoviceva 18, Zagreb Croatia Tel/Phone & Fax: hdmblm@hdmblm.hr OIB: Zagreb, September 13, 2016 Welcome to the third exercise of external quality assessment in 2016 conducted by Croatian Centre for Quality Assessment in Laboratory Medicine, within Croatian Society of Medical Biochemistry and Laboratory Medicine. All necessary information is included below. MODULE I II III IV VI VII VIIa VIII IX X XI XII Biochemistry parameters (A,B,C) Specific proteins, CRP Laboratory hematology Laboratory coagulation (PV, INR, APTT, TT, AT III, Fibrinogen, D-dimer) Urinalysis (urine test strip) Analysis of ph, blood gases and electrolytes POC analysis of ph, blood gases, electrolytes, glucose and lactate Hormones, Vitamins, Cardiac and Tumor Markers HbA1c Preanalytical phase of laboratory testing Postanalytical phase of laboratory testing Sweat chloride test DYNAMICS OF CYCLE: Informatics coordinator RESULTS ENTRY 13/09/2016 until 30/09/2016 after 20/10/2016 Ana Grzunov Adriana Bokulic Valentina Vidranski SAMPLE DISTRIBUTION RESULTS ENTRY ANALYSED RESULTS ARE AVAILABLE contact: croqalm@gmail.com with mandatory laboratory code entry through the official CROQALM website in the "Reults Entry" section or via website: Annexes: Sample A, B and C for Module 1 (Biochemistry parameters) and sample for Module 3 (Laboratory Hematology) should be determined immediately upon receipt of the shipment. We suggest that you download the certificate of your loading operator, to avoid messages about insecure network address. In case the message appears, your further work will not be disturbed.

2 INTRODUCTIONS FOR SAMPLE PREPARATION Samples for module I, II, III, IV, VI, VIII and IX are human origin, so they must be treated as any other laboratory sample. I BIOCHEMISTRY PARAMETERS Samples for Module 1: A, B and C Samples A, B and C should be analyzed immediately after delivery, after preparation of samples, within the same run on the instrument. Sample A: Sample type: Lyophilised, human-based control sample Storage: 2-8 C Preparation: Dissolve lyophilised serum sample in 5.0 ml of destilled or deionised water, close and leave at room temperature at least 30 minutes with occasionally mixing. Before the analysis, gently stir the sample several times with circular movements in order to ensure homogeneity of the sample. Stability: Dissolved sample is stable 24hrs on +25 o C,7 days on 2-8 C and one month on -20 C Tests: Glucose, Total bilirubin, Direct bilirubin, Creatinine, Urea, Uric acid, Sodium, Potassium, Total calcium, Inorganic phosphate, Chloride, Iron, Total iron binding capacity (TIBC), Unsaturated iron binding capacity (UIBC), Copper, Cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), Creatine kinase (CK), Lactate dehydrogenase (LDH), Alpha amylase (AMS), Total protein, Albumin, Cholinesterase, Total magnesium, Lactate, Lipase (LPS). Sample B and C: Sample type: human serum Preparation: Mix carefully to ensure homogeneity and centrifuge briefly Stability: Because of limited stability of some analytes in fresh serum, it is important to analyze the sample immediately after delivery. Tests: Glucose, Total bilirubin, Direct bilirubin, Creatinine, Urea, Uric acid, Sodium, Potassium, Total calcium, Inorganic phosphate, Chloride, Iron, Cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), Creatine kinase (CK), Lactate dehydrogenase (LDH), Alpha amylase (AMS), Total protein, Albumin, Total magnesium. After preparation, it is important to analyze samples within the same run on the instrument. (Results can be submitted by September 30th Please note the day of analysis next to one of the results from the Module 1.) II SPECIFIC PROTEINS Tests: α-1-antitrypsin, β-2-microglobulin, Ceruloplasmin, Complement-component C3, Complement-component C4, C- reactive protein (CRP), Haptoglobin, Immunoglobuline A (IgA), Immunoglobuline E (IgE), Immunoglobuline G (IgG), Immunoglobuline M (IgM), Transferrin Sample type: lyophilized commercial control sample of human origin Storage: 2-8 C Preparation: Reconstitute the sample in 1.0 ml of destilled or deionized water, close and leave at room temperature at least 30 minutes with occasionally mixing. Before the analysis, gently stir the sample several times with circular movements in order to ensure homogeneity of the sample. Inverse, vigorous mixing is not allowed.

3 Stability: Reconstituted sample is stable for 7 days at 2-8 C and one month at -20 C. III LABORATORY HEMATOLOGY Tests: Leukocytes (Lkc), Erythrocytes (Erc), Hemoglobin (Hb), Hematocrit (Htc), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Thrombocytes (Trc).,. In third round 2016 of EQA, Module 3 have one sample. Note: Sample should be analyzed immediately upon receipt of and in same way like patient samples. Exact date and time of sample receipt should be noted in an appropriate comment box while entering results. It is sufficient to note the time and date only once (with the first result entered). The parameters of the differential blood count: Neutrophil granulocytes (%), Lymphocites (%), Monocytes (%), Eosinophilic granulocytes (%), Basophilic granulocytes (%), MID (Monocytes, Eosinophilic Granulocytes, Basophilic Granulocytes) and Reticulocytes (analyzer/manual) and Mean Platelet Volume (MPV), same like RDW are not a mandatory part of the program. Your results will help us to finding the most optimal hematological sample for this module. Sample type: Whole blood, human origin, 1x2 ml Storage: 2-8 C. Preparation: Sample should be analyzed immediately upon receipt and just before determining on the hematology analyzer, mix carefully and thoroughly by inversion of the tube 8-10 times. Stability: Once opened, sample is stable for 7 days on 2-8 C. Sample cannot be frozen. IV LABORATORY COAGULATION Tests: Prothrombin Time activity percentage (PV activity percentage), Prothrombin Time INR (PV INR), Activated Partial Thromboplastin Time (APTT), Activated Partial Thromboplastin Time ratio (APTT ratio), Fibrinogen, Antithrombin activity, D-dimer. Sample type: Lyophilised, human plasma sample. Preparation: Dissolve lyophilised plasma sample in 1,0 ml of distilled or deionised water, close and leave at room temperature 30 minutes with occasional mixing. Before the analysis, gently stir the sample several times with circular movements in order to ensure homogeneity of the sample. Stability: Dissolved and once opened sample is stable for maximum 1 day on 2-8 C. The Prothrombin Time activity percentege is reccommanded to analyse immediately upon the sample is dissolved and stabilized. VI URINALYSIS (URINE TEST STRIP) Tests: Test strip: Glucose, Ketones, Specific gravity, Bilirubin, Urobilinogen, Erythrocyte/hemoglobin, ph, Proteins, Nitrite, Leukocyte esterase, appearance and color. Sample type: liquid control sample of human origin, 12 ml.. Preparation: Sample is ready to use when it reaches room temperature (18-25ºC) with occasional inverse mixing in order to ensure homogeneity of the sample. Stability: 30 days on 2-25 ºC

4 VII ANALYSIS OF PH, BLOOD GASES AND ELECTROLYTES Tests: Partial pressure of oxygen (po 2 ), partial pressure of carbon dioxide (pco 2 ), ph, ionized calcium, ionized potassium, ionized sodium, ionized chloride Sample type: buffered water solution. Storage: room temperature Preparation: The temperature of the determine sample is C. Before determining the sample should stir times to balance gas concentrations in the aqueous phase. Before determining the sample should stir 10 seconds to balance gas concentrations in the aqueous phase. The sample for ph and blood gases must be analyzed immediately after opening the ampoule or within 60 minutes if it is used only to determine the ionized electrolyte. The control sample is buffered aqueous solution, and the analysis must be done according to manufacturer instructions for analyzing a control material. VIIa POC ANALYSIS OF PH, BLOOD GASES, ELECTROLYTES, GLUCOSE AND LACTATE Tests: Partial pressure of oxygen (po 2 ), partial pressure of carbon dioxide (pco 2 ), ph, ionized calcium, ionized potassium, ionized sodium, ionized chloride, glucose, lactate Sample type: dyed buffered aqueous solution. Storage: room temperature Preparation: The temperature of the determine sample is C. Before determining the sample should stir times to balance gas concentrations in the aqueous phase. The sample for ph and blood gases must be analyzed immediately after opening the ampoule or within 60 minutes if it is used only to determine the ionized electrolyte, glucose or lactate. The control sample is dyed buffered aqueous solution, and the analysis must be done according to manufacturer instructions for analyzing a control material. VIII HORMONES, VITAMINS, CARDIAC and TUMOR MARKERS Tests: Triiodothyronine, total (T3), Thyroxine, total (T4), Thyroid-stimulating hormone (TSH), Thyroxine, free (free T4), Triiodothyronine, free (FT3), Estradiol, DHEA-sulfate (DHEA-S), Follicle stimulating hormone (FSH ), Luteinizing hormone (LH), Progesterone, Prolactin (PRL), Binding globulin sex hormone (SHBG), Testosterone, total, Cortisol, Thyroglobulin (Tg), Parathyroid hormone (PTH ), Insulin, C-peptide, NT-pro BNP, Troponin I, hs Troponin I, Troponin T, hs Troponin T, CK-MB mass, Folic acid (folate), Vitamin B12 (cobalamin), Chorionic gonadotropin (HCG), Ferritin, CA 15-3, CA 125, Alpha-fetoprotein (AFP), CEA, CA 19-9, PSA (total) PSA free (fpsa), PSA free/psa (total), Sample type: Lyophilised human serum sample, 3 ml Preparation: Dissolve control sample in 3,0 ml of destilled or deionized water whose temperature is C, close, swirl the bottle several times and leave to stand at room temperature for 30 minutes, stirring occasionally. Coat all surfaces of the bottle by rotating and inverting the bottle. Continue mixing until the solution is homogeneous and all lyophilized material is reconstituted. Inverse, vigorous mixing is not allowed. Stability: After reconstitution, all analytes are stable for 10 days when stored tightly capped in the original vial at 2-8 C with the following exceptions: C-peptide is stable for 3 days, folate is stable for 8 days and NT-proBNP, troponin I and hs troponin I are stable for 6 days at 2-8 C. PTH will decrease 5 % per day at 2-8 C.

5 IX HbA1c Tests: Hemoglobin A1c Sample type: Liquid sample of human origin Preparation: Dissolve control sample in 0,5 ml of destilled or deionized water, close, swirl the bottle several times and leave to stand at room temperature for 15 minutes. After 15 minutes, coat all surfaces of the bottle by rotating and inverting the bottle. Continue mixing until the solution is homogeneous and all lyophilised material is reconstituted. Inverse, vigorous mixing is not allowed. The manufacturer recommends a double deionized water. Controls are treated the same as samples and in accordance with kit or reagent being used. Stability: The reconstituted control is stable for 1 month when stored refrigerated at +2 C to +8 C. Do not freeze the reconstituted controls. X PREANALYTICAL PHASE OF LABORATORY TESTING Please for each described case (question) select one of the answers that are in descending order. This module is educational. The results will be summarized and included in the final report marks of the laboratory. XI POSTANALYTICAL PHASE OF LABORATORY TESTING Please for each described case / questions choose one of the answers that are in descending order, and best suites laboratory practice according to your opinion and knowledge. This module is educational. The results will be summarized and included in the final report marks of the laboratory. XII SWEAT CHLORIDE TEST Tests: Sweat chloride test. Sample type: NaCl solution ("in-house" control material).. Preparation: The sample is ready for analysis when it reaches room temperature (18-25ºC) with occasionally inversely mixing to achieve homogeneity of the sample. On the pre-weighed filter paper (gauze), pipette 100 µl of sample and continue handle as the sample of patients. Stability: Sample is stable for 3 months on 2-8 C. Note: The sample was primarily designed for determining chloride test with mercurimetric titration method. Kind regards, CROQALM Tim