ANALYTICAL QUALITY SPECIFICATIONS OF INTER-LABORATORY COMPARISONS - PowerPoint PPT Presentation

International Congress on Quality Medicine Labquality Days 2018 CALIDAD DE LA DEMANDA ANALYTICAL QUALITY SPECIFICATIONS OF INTER-LABORATORY COMPARISONS Interdisciplinary Expert Committee for Quality Specifications in the Clinical Laboratory (CEIEC) Spanish Association of Spanish Association of Spanish Society of Spanish Society of Medical Biopathology – Clinical Laboratory Hematology and Laboratory Medicine Laboratory Medicine Hemotherapy C. Perich. Helsinki, february 2018

Current situation of EQA in Spain Spanish laboratories are involved in EQA programs Participation is mandatory in most regions of Spain There are not mandatory quality specifications for each analyte C Perich, Helsinki february 2018

Spanish Societies involved in Laboratories with EQA Spanish Association of Clinical Laboratory Spanish Association of Medical Biopathology- Laboratory Medicine Spanish Society of Laboratory Medicine Spanish Society of Hematology and Hemotherapy C Perich, Helsinki february 2018

AIM • To establish common analytical minimum quality analytical specifications for total error, based on the current state of the art in Spain • These specifications should be considered the • These specifications should be considered the minimum level of quality that each laboratory has to reach, to assure harmonized analytical services C Perich, Helsinki february 2018

Interdisciplinary Expert Committee for Quality Specifications in the Clinical Laboratory (CEIEC) A Buño, E Prada B Barceló , R Blazquez , R Calafell , J Morancho J Alcaraz, G Gutiérrez, JM Jou , A Molina C Perich , F Ramon, C Ricós , A Salas C Perich, Helsinki february 2018

CEIEC: OBJECTIVES • To establish the minimum analytical quality (MQS) to be demanded from Spanish laboratories based on the reality (state of the art) • To propose specifications similar to those • To propose specifications similar to those based on the state of the art and that are mandatory in other countries • To use a system transparent and reproducible to obtain the MQS C Perich, Helsinki february 2018

Common performances of 4 Spanish EQA • Non profit organizations, independent of commercial interests • Maintaining confidentiality of laboratory data • Proved experience ( programs began around 1980) 1980) • Certified according to the ISO 9001 standard, in process of accreditation to ISO 17043 • Follow recommendations of the IFCC/ Education and Management Division/ Committee of Analytical Quality C Perich, Helsinki february 2018

Common performances of 4 Spanish EQA • Blind stabilized control materials, covering a wide range of concentration values for the analytes studied • Target • Target values values are are peer-group peer-group means means of of participant results, excluding outliers • 12 (biochemistry) and 24 (hematology) control materials per year and asking for monthly results C Perich, Helsinki february 2018

CEIEC: PHASES Year Nº Analytes Type Period Data 1 2007 24 Basic biochemistry in serum 2005 – 2006 2 2009 37 Serum biochemistry, basic 2005 – 2006 hematology 3 2011 3 2011 Review Review 2007 – 2010 2007 – 2010 4 2013 20 Urine biochemistry, HbA1c, 2007 – 2010 hematology 5 2017 Review Biochemistry (serum, urine, 2011 - 2015 62 new blood), hematology and basic coagulation C Perich, Helsinki february 2018

CEIEC: MATERIALS • All results are obtained from EQAP of the 4 societies, from 2011 to 2015 • More than 4.5 million results are compiled in the database (Datum) the database (Datum) • 2794 laboratories are involved • 143 analytes are included: serum and urine biochemistry, blood gas, hematology, coagulation C Perich, Helsinki february 2018

CEIEC: METHODS. PROCEDURE A • Calculating percentage difference of each result vs the target value (in absolute value) • Plotting distribution of the differences • Eliminating 5% of the greatest differences • Eliminating 5% of the greatest differences • Defining the 95th percentile as the candidate minimum quality specification (MQS) • Rounding this specification up to whole values C Perich, Helsinki february 2018

BASIC CALCULATIONS. GLUCOSE C Perich, Helsinki february 2018

CEIEC: METHODS.PROCEDURE A Candidate MQS was compared with the robust mean obtained from mandatory specifications of Germany, USA and Russia: • If cMQS ≥ robust mean • If cMQS ≥ robust mean MQS accepted MQS accepted • If cMQS < robust mean Procedure B • If not mandatory specification Procedure B C Perich, Helsinki february 2018

CEIEC: METHODS PROCEDURE B cMQS cMQS increases 0.01% (probe error) Count number of laboratories with a minimum of 75% of their results within the probe error Is the number of laboratories Yes No Accept the accounted equal or higher than probe error the 90% of the amount of as MQS participants in the programme? End of the process C Perich, Helsinki february 2018

CEIEC: METHODS. PROCEDURE B Calcio. Procedim iento B Calcium 100 95 90 85 80 75% results 75 ries (%) within 70 s (%) 65 Laboratories Laboratorios ( 60 60 55 50 45 40 35 30 25 20 15 10 5 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Error limit (%) Lím ite de error (% ) C Perich, Helsinki february 2018

CEIEC: PROCEDURE A. EXAMPLE Sodium Germany: 5% cMQS: 3.2% Robust mean: 2.9% USA: 2.4% Russia: 2% 3.2% > 2.9% 3.2% > 2.9% cMQS: 3.2% CEIEC review MQS accepted C Perich, Helsinki february 2018

CEIEC: PROCEDURE B. EXAMPLE Cholesterol Germany: 13% cMQS: 7.1% Robust mean: 10% USA: 10% Russia: 7% 7.1% < 10% 7.1% < 10% Procedure B cMQS: 9.1% MQS accepted CEIEC review C Perich, Helsinki february 2018

CEIEC: RESULTS 143 analytes Procedure A 7 analytes 7 analytes 70 analytes 70 analytes 66 analytes 66 analytes MQS Procedure B MQS C Perich, Helsinki february 2018

CEIEC: RESULTS.ANALYTES 18 basic biochemistry serum 6 cardiac markers 21 proteins 13 urine biochemistry 6 6 therapeutic drugs therapeutic drugs 8 8 blood gas blood gas 23 Hormones 18 basic hematology 12 tumor markers 8 basic coagulation C Perich, Helsinki february 2018

CEIEC: RESULTS Comparación especificación consensual vs. preceptiva 40 + SUE ción preceptiva en % ORI 30 HEM GAS CAR bust mean HOR 20 PRO Robus Especificació TUM TUM � ant � � � � nue 10 - 0 0 10 20 30 40 Spanish MQS Especificación consensual en % C Perich, Helsinki february 2018

CEIEC: RESULTS. SERUM Basic Biochemistry Analyte MQS R Mean USA Germany Russia ALT 17 23 20 21 33 Albumin 11 11 10 20 9 Alkaline phosphatase 21 18 30 18 10 Amylase 18 29 30 - 27 AST 16 21 20 21 22 Bilirubin Bilirubin 22 22 24 24 20 20 22 22 33 33 Calcium 9.1 9.8 - 17 - Chloride 6 5.2 5 8 3 Cholesterol 9.1 10 10 13 7 HDL Cholesterol 26 30 30 - - CK 19 30 30 20 44 Creatinine 22 18 15 20 18 Glucose 8.4 11 10 15 11 LDH 26 20 20 18 22 C Perich, Helsinki february 2018

CEIEC: RESULTS. SERUM Basic Biochemistry Analyte MQS R Mean USA Germany Russia Iron 24 25 20 20 29 GGT 18 24 - 21 27 Lithium 15 16 20 12 - Phosphate 13 12 - 16 7 Potasium 5.4 9.1 - 8 9 Protein Protein 9 9 9.9 9.9 10 10 10 10 9 9 Sodium 3.2 2.9 - 5 2 Triglicerides 14 17 25 16 15 Urate 13 16 17 20 18 Urea 14 18 9 13 22 HbA1c 7.7 18 - 18 - C Perich, Helsinki february 2018

CEIEC: RESULTS. Urine Biochemistry Analyte MQS R Mean USA Germany Russia Albumin 38 26 - 26 - Amylase 15 - - - - Calcium 16 17 - 10 7 Chloride 8.3 - - - - Creatinine 13 21 - 21 - Glucose Glucose 8.4 8.4 30 30 - - 22 22 38 38 Phosphate 11 20 - 20 - Potasium 8.6 15 - 15 - Protein 21 37 - 24 50 Sodium 7.2 12 - 12 - Urate 11 23 - 23 - Urea 13 21 - 21 - C Perich, Helsinki february 2018

CEIEC: RESULTS. SERUM Hormones Analyte MQS T Mean USA Germany Russia Cortisol 19 28 25 30 - Estradiol 21 35 - 35 - FSH 15 21 - 21 - Progesterone 22 35 - 35 - T3 20 24 - 24 - T4 20 22 - 24 - T4 free 16 20 - 20 - Testosterone 22 35 - 35 - TSH 16 24 - 24 - C Perich, Helsinki february 2018

CEIEC: RESULTS. SERUM Hormones Analyte MQS R Mean USA Germany Russia ACTH 51 Androstenedione 31 C-Peptide 12 DHEA-S 19 Folate 20 hCG 14 hGH 13 Insulin 38 LH 14 Prolactin 20 PTH 23 Vitamin B12 14 C Perich, Helsinki february 2018

CEIEC: RESULTS. SERUM Protein Analyte MQS T Mean USA Germany Russia α 1-acid Glycoprotein 11 - α 1-antitrypsin 13 - Apolipoprotein A 12 - Apolipoprotein B 10 - Ceruloplasmin 12 - Complement C3 Complement C3 10 10 - - Complement C4 11 - CRP 12 20 - 20 - Ferritin 18 25 - 25 - α 1-globulin 28 - α 2-globulin 16 - β -globulin 19 - γ -globulin 16 - C Perich, Helsinki february 2018

CEIEC: RESULTS. SERUM Protein Analyte MQS T Mean USA Germany Russia Haptoglobin 11 - Ig A 15 20 - 20 - Ig E 13 - Ig G 12 22 25 18 - Ig M 18 26 - 26 - α 2- macroglobulin α 2- macroglobulin 19 19 - - β 2-microglobulin 14 - Prealbumin 16 - Transferrin 8.3 12 - 12 - C Perich, Helsinki february 2018