1. Kliknij, aby dodać tekst ”EA – 4/17 position paper on the description of scopes of accreditation of medical laboratories” Miroslawa Pietruczuk Lodz, Poland, 2015

2. Position on the description of scopes of accreditation of medical laboratories 1. ” The scope of accreditation should normally cover a substantial majority of the overall service provided by the laboratory within a medical laboratory field ”

3. 2. „A laboratory may start with a limited scope to become acquainted with the accreditation process and requirements” 2. „The accreditation bodies should encourage the laboratories to cover the relevant part of their examinations within each medical laboratory field in their scope”

4. Medical laboratory fields Types of examination/Technical fieldsMaterials HematologyBlood morphology examination Erytrocytes count (RBC) 2 Scope: 0-8,0 T/L Hemoglobin concentration (HGB) 3 Scope: 0-25 g/dl Hematocrit (HCT) 4 Scope: 0-60% Mean corpuscular volume (MCV) 4 Mean hemoglobin content (MCH) 4 Mean hemoglobin cell concentration (MCHC) 4 Red distribution width (RDW) 4 Hemoglobin distribution width-(HDW) 4 Platelets count(PLT) 1,2 Scope: 0-2000 G/L Mean platelet volume (MPV) Platelets distribution width (PDV) Thrombocrit (PCT) Methods: 1 flow cytometry 2 impedance 3 spectrophotometry 4 counted parameters Blood (EDTA)

5. Medical laboratory fieldsTypes of examination/Technical fieldsMaterials Hematology Blood morphology examination with WBC differentiation RBC and PLT parameters as above White blood cells count (WBC) 1 Absolute Neutrophil Count (ANC) 1 Absolute Lymphocyte Count(ALC) 1 Absolute Monocyte Count (AMC) 1 Absolute Eosinophil Count (AEC) 1 Absolute Basophil Count (ABC) 1 Scope: 0-440 G/L Method: 1 flow cytometry Blood (EDTA)

6. Medical laboratory fields Types of examination/Technical fieldsMaterials Hematology Blood morphology examination with WBC differentiation and Reticulocyte differentiation 1 RBC, PLT, WBC parameters as above Reticulocyte count (RETIC) 1 Scope: 0-0,72 T/L Reticulocytes fractions: Low Fluorescence Ratio (LFR) Medium Fluorescence Ratio (MFR) High Fluorescence Ratio (HFR) Method: 1 flow cytometry Blood (EDTA)

7. Medical laboratory fields Types of examination/Technical fields Materials HematologyBlood smear examination Method: Microscopic examination Blood (EDTA)

8. Morphology and WBC differentiation Morphology and RBC and PLT indicators

9. What is important 5 diff morphology and blood smear examination: Clear criteria which describe the values of morphology parameters or flags that indicate the need to perform blood smear.

12. The differentiation of WBC is impossible. The microscopic examination is obligatory.

13. The next lab tests …. ESR Cytochemical staining (eg.the presence of sideroblasts, alkaline phosphatase activity in neutrophils …..) Bone marrow examination

14. Medical laboratory fields Types of examination/Technical fields Materials CoagulologyProthrombin time (PT) 1 and international normalized ratio (INR) 2 Scope: PT: 10 – 180 sec INR: 0,8 – 1,2 Methods 1 coagulolometric 2 counted parameter Blood (sodium citrate)

15. Extended to…. APTT and R TT D-dimer Clotting factors

16. 3. „ A flexible scope of accreditation is preferred”

17. Medical laboratory fields Types of examination/Technical fields Materials HematologyFlow cytometry Spectrophotometry Impedance Microscopic evaluation (morphology, bone marrow examination, cytochemical staining, CDs) Blood (EDTA, Heparin, sodium citrate) CoagulologyMechanical Photo-optic Nephelometric Chromogenic Immunological (PT, APTT, TT, D-dimer, fibrinogen, clotting factors) (sodium citrate)

18. „EA – 4/17….” 4. „For each medical fields mentioned in the scope, the laboratory is expected to provide the full service, which includes all pre-examination, examination and post-examination aspects” „A medical laboratory should be able to demonstrate its competence in interpreting the results”

19. Pre-examination Patients instructions and requirements Type and volume of the material to be tested Method of sample collection Time and temperature requirements for samples transport to the medical lab How a lab identifies and qualifies samples

20. Examination procedures 1. Type of methods and equipments 2. Validation procedures (qualitative and quantitative methods) 3. External/ Internal Quality Control procedures 4.Staff qualification

21. Post examination procedures The results: reference values, lab interpretation !!!) List of criticical parameters prepared in collaboration with physicians Consulting and advertising services Sample storage procedures

22. „EA – 4/17…..” 5. „At the level of scope of accreditation shall be defined as a medical field. 6. At ther second level this scope must include the type of examination/ technical fields”

23. 7. „the first and the second level are mandatory along with a description of the materials „ The first level: Hematology Coagulology Immunology Clinical chemistry The second level: ESR, optic method, blood D-Dimer concentration, immunological method, plasma The presence of HBs Ag, ECLIA, serum LDH activity spectrophotometry, serum, body fluid

24. „ The flexible scope may include named examinations” eg. Hormones (LH, PTH, T3, T4, TSH…. Vitamins (eg. B12, D…. Cancer markers (CEA, AFP, PSA, CA 125, CA 19-9, Blood group antigens (eg. ABO, RhD … Lipid profile (TCH, TG, LDL-CH, LDH – CH… Cluster of differentiation antigens (CDs: CD13, CD33, CD19, CD10, TdT….

25. „The flexible scope” Serology tests for viruses: eg. CMV IgM, CMV IgG, anti-HBs Ab, anti-HBc IgM, anti-HCV Ab, … Cardiac markers eg. hs-cTnT, CK-MB mass, myoglobin, BNP and NT-proBNP,….. Enzymes eg. AST, ALT, LDH, Amylase, Lipase, GGT,…..

26. Summary Clinical point of view is different Liver function tests (PT, albumin level, AST, ALT, GGT, ammonium,….. IDA tests (morphology, Fe, TIBC, ferritin, sTfR…..

27. References EA-4/17 M:2008