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

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

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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

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SLIDE 1

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)

  • C. Perich. Helsinki, february 2018

Spanish Society of Laboratory Medicine Spanish Society of Hematology and Hemotherapy Spanish Association of Clinical Laboratory Spanish Association of Medical Biopathology – Laboratory Medicine

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SLIDE 2

Current situation of EQA in Spain

C Perich, Helsinki february 2018

Spanish laboratories are involved in EQA programs Participation is mandatory in most regions of Spain There are not mandatory quality specifications for each analyte

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SLIDE 3

Spanish Societies involved in Laboratories with EQA

Spanish Association of Clinical Laboratory Spanish Association of Medical Biopathology- Laboratory Medicine

C Perich, Helsinki february 2018

Spanish Society of Hematology and Hemotherapy Spanish Society of Laboratory Medicine

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SLIDE 4

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

C Perich, Helsinki february 2018

  • These specifications should be considered the

minimum level of quality that each laboratory has to reach, to assure harmonized analytical services

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SLIDE 5

Interdisciplinary Expert Committee for Quality Specifications in the Clinical Laboratory (CEIEC)

A Buño, E Prada B Barceló, R Blazquez, R Calafell , J Morancho

C Perich, Helsinki february 2018

J Alcaraz, G Gutiérrez, JM Jou, A Molina C Perich , F Ramon, C Ricós , A Salas

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SLIDE 6

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

C Perich, Helsinki february 2018

  • 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

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SLIDE 7

Common performances of 4 Spanish EQA

  • Non profit organizations, independent of

commercial interests

  • Maintaining confidentiality of laboratory data
  • Proved experience ( programs began around

1980)

C Perich, Helsinki february 2018

1980)

  • Certified according to the ISO 9001 standard,

in process of accreditation to ISO 17043

  • Follow

recommendations

  • f

the IFCC/ Education and Management Division/ Committee of Analytical Quality

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SLIDE 8

Common performances of 4 Spanish EQA

  • Blind stabilized control materials, covering a

wide range of concentration values for the analytes studied

  • Target

values are peer-group means

  • f

C Perich, Helsinki february 2018

  • Target

values are peer-group means

  • f

participant results, excluding outliers

  • 12 (biochemistry) and 24 (hematology) control

materials per year and asking for monthly results

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SLIDE 9

CEIEC: PHASES

Year Nº Analytes Type Period Data 1 2007 24 Basic biochemistry in serum 2005 – 2006 2 2009 37 Serum biochemistry, basic hematology 2005 – 2006 3 2011 Review 2007 – 2010

C Perich, Helsinki february 2018

3 2011 Review 2007 – 2010 4 2013 20 Urine biochemistry, HbA1c, hematology 2007 – 2010 5 2017 Review 62 new Biochemistry (serum, urine, blood), hematology and basic coagulation 2011 - 2015

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SLIDE 10

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)

C Perich, Helsinki february 2018

the database (Datum)

  • 2794 laboratories are involved
  • 143 analytes are included: serum and urine

biochemistry, blood gas, hematology, coagulation

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SLIDE 11

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

C Perich, Helsinki february 2018

  • Eliminating 5% of the greatest differences
  • Defining the 95th percentile as the candidate

minimum quality specification (MQS)

  • Rounding this specification up to whole values
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SLIDE 12

BASIC CALCULATIONS. GLUCOSE

C Perich, Helsinki february 2018

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SLIDE 13

CEIEC: METHODS.PROCEDURE A Candidate MQS was compared with the robust mean obtained from mandatory specifications

  • f Germany, USA and Russia:
  • If cMQS ≥ robust mean

MQS accepted

C Perich, Helsinki february 2018

  • If cMQS ≥ robust mean

MQS accepted

  • If cMQS < robust mean

Procedure B

  • If not mandatory specification

Procedure B

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SLIDE 14

cMQS cMQS increases 0.01% (probe error) Count number of laboratories with a minimum of 75% of their results within the probe error

CEIEC: METHODS PROCEDURE B

Is the number of laboratories accounted equal or higher than the 90% of the amount of participants in the programme? Accept the probe error as MQS End of the process Yes No

C Perich, Helsinki february 2018

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SLIDE 15
  • Calcio. Procedim iento B

s (%)

60 65 70 75 80 85 90 95 100

CEIEC: METHODS. PROCEDURE B

Calcium

ries (%) 75% results within

Lím ite de error (% )

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Laboratorios (

5 10 15 20 25 30 35 40 45 50 55 60

C Perich, Helsinki february 2018

Error limit (%) Laboratories

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SLIDE 16

CEIEC: PROCEDURE A. EXAMPLE cMQS: 3.2%

Germany: 5% Russia: 2% USA: 2.4%

Robust mean: 2.9% 3.2% > 2.9% Sodium

C Perich, Helsinki february 2018

3.2% > 2.9% cMQS: 3.2% MQS accepted CEIEC review

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SLIDE 17

CEIEC: PROCEDURE B. EXAMPLE cMQS: 7.1%

Germany: 13% Russia: 7% USA: 10%

Robust mean: 10% 7.1% < 10% Cholesterol

C Perich, Helsinki february 2018

7.1% < 10% cMQS: 9.1% Procedure B MQS accepted CEIEC review

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SLIDE 18

CEIEC: RESULTS

143 analytes Procedure A 7 analytes 70 analytes 66 analytes

C Perich, Helsinki february 2018

7 analytes 70 analytes 66 analytes Procedure B MQS MQS

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SLIDE 19

CEIEC: RESULTS.ANALYTES

18 basic biochemistry serum 6 cardiac markers 21 proteins 13 urine biochemistry 6 therapeutic drugs 8 blood gas

C Perich, Helsinki february 2018

6 therapeutic drugs 8 blood gas 23 Hormones 18 basic hematology 12 tumor markers 8 basic coagulation

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SLIDE 20

Comparación especificación consensual vs. preceptiva

ción preceptiva en %

20 30 40

+

SUE ORI HEM GAS CAR HOR PRO TUM

CEIEC: RESULTS

bust mean

Especificación consensual en %

10 20 30 40

Especificació

10

  • TUM
  • ant

nue

C Perich, Helsinki february 2018

Spanish MQS Robus

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SLIDE 21

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 22 24 20 22 33

C Perich, Helsinki february 2018

Bilirubin 22 24 20 22 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

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SLIDE 22

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 9 9.9 10 10 9

C Perich, Helsinki february 2018

Protein 9 9.9 10 10 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
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SLIDE 23

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

8.4 30

  • 22

38

C Perich, Helsinki february 2018

Glucose 8.4 30

  • 22

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
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SLIDE 24

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
  • C Perich, Helsinki february 2018

T3 20 24

  • 24
  • T4

20 22

  • 24
  • T4 free

16 20

  • 20
  • Testosterone

22 35

  • 35
  • TSH

16 24

  • 24
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SLIDE 25

CEIEC: RESULTS. SERUM Hormones

Analyte MQS R Mean USA Germany Russia ACTH 51 Androstenedione 31 C-Peptide 12 DHEA-S 19

C Perich, Helsinki february 2018

Folate 20 hCG 14 hGH 13 Insulin 38 LH 14 Prolactin 20 PTH 23 Vitamin B12 14

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SLIDE 26

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

10

  • C Perich, Helsinki february 2018

Complement C3 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

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SLIDE 27

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

19

  • C Perich, Helsinki february 2018

α 2- macroglobulin 19

  • β 2-microglobulin

14

  • Prealbumin

16

  • Transferrin

8.3 12

  • 12
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SLIDE 28

CEIEC: RESULTS. Drugs / Cardiac markers

Analyte MQS R Mean USA Germany Russia Carbamazepine 12 23 25 20

  • Digoxin

21 25 20 30

  • Phenobarbital

14 20 20 20

  • Phenytoine

13 23 25 20

  • Theophyline

12 25 25 24

  • Valproic Acid

11 23 25 20

  • C Perich, Helsinki february 2018

Valproic Acid 11 23 25 20

  • CK-MB

15

  • Homocystein

17

  • Myoglobin

11

  • NT-proBNP

19

  • Troponin I

21 33

  • 33
  • Troponin T

22 33

  • 33
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SLIDE 29

CEIEC: RESULTS. Tumor markers

Analyte MQS R Mean USA Germany Russia AFP 18 24

  • 24
  • CA 125

11

  • CA 15.3

13 24

  • 24
  • CA 19.9

13

  • CA 72.4

11

  • C Perich, Helsinki february 2018

CEA 15 24

  • 24
  • Cyfra 21.1

11

  • NSE

13

  • PSA total

15 25

  • 25
  • PSA free

13

  • Protein S-100

14

  • Tyroglobulin

17

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SLIDE 30

CEIEC: RESULTS. Blood gas

Analyte MQS T Mean USA Germany Russia Calcium (ionized) 5.4 17

  • 18
  • Chloride

1.9

  • Glucose

6.5

  • Lactate

9.2 18

  • 18
  • C Perich, Helsinki february 2018

Lactate 9.2 18

  • 18
  • pCO2

7.1 10 8 12

  • pH

0.2 0.8

  • 0.8
  • pO2

7.4 15

  • 18
  • Potassium

3.1

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SLIDE 31

CEIEC: RESULTS. Hematology

Analyte MQS T Mean USA Germany Russia Hematocrit 8.5 7.5 6 9

  • Hemoglobin

4.6 7.2 7 6 9 %Lymphocytes 19

  • MCH

4.9

  • MCHC

8.2

  • MCV

7.3

  • C Perich, Helsinki february 2018

MCV 7.3

  • % Neutrophils

8.4

  • Platelets

16 17 25 13

  • RBC

4.1 8.1 6 8 11 WBC 10 17 15 18

  • Reticulocytes

33

  • Hemoglobin A2

22

  • Hemoglobin F

24

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SLIDE 32

CEIEC: RESULTS. Coagulation

Analyte MQS T Mean USA Germany Russia APTT (seconds) 24 17 15 18

  • APTT (ratio)

12

  • AT III

34

  • Factor VIII

37

  • C Perich, Helsinki february 2018

Fibrinogen 21 20 20

  • PT (ratio)

13 23

  • 23
  • PT (%)

31

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SLIDE 33

CEIEC: RESULTS

30% 40% 50% 60% 70% 80% 90% 100%

C Perich, Helsinki february 2018

0% 10% 20% 30% mandatory not mandatory

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SLIDE 34

Comparación especificación consensual actual vs. previa

nsensual previa (2007-2010) en %

30 40 50 60

+

SUE ORI HEM GAS CAR HOR PRO TUM

  • RESULTS. COMPARISON PREVIOUS MQS

(period 2007 – 2010)

Especificación consensual actual (2011-2015) en %

10 20 30 40 50 60

Especificación conse

10 20

  • TUM

C Perich, Helsinki february 2018

Current MQS (period 2011 – 2015) Previous MQS (

In 59 (78%) analytes Current MQS more restrictive than previous MQS

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SLIDE 35

COMPARISON BETWEEN MQS

PERIODS 2011/2015 vs 2007/2010 α-Amylase (serum) Period 2011/2015 Period ratories %

F.Ramón, Málaga, Noviembre 2017

Period 2007/2010 Error limit % Laborato

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SLIDE 36

CEIEC: CONCLUSIONS

  • Methodology reliable, big data, based on the

Spanish reality, reproducible

  • MQS for 143 analytes obtained by consensus of

the Committee, versus 77 analytes with mandatory specifications

C Perich, Helsinki february 2018

mandatory specifications

  • In 87% of analytes the MQS are more demanding

than the robust mean

  • Spanish

laboratories have improved their analytical performance in relation to previous MQS (2011)

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SLIDE 37

CEIEC: PRACTICAL USES OF MQS

  • To give a single numerical analytical quality

specification for each analyte according to the analytical total error concept

  • To provide a useful tool for accreditation and

certification bodies

C Perich, Helsinki february 2018

certification bodies

  • To be proposed as mandatory minimum level of

quality, if required by the government

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SLIDE 38

CEIEC: PRACTICAL USES OF MQS

Could MQS be used as goals by individual laboratories?

C Perich, Helsinki february 2018

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SLIDE 39

C Perich, Helsinki february 2018

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SLIDE 40

CEIEC: LIMITATION OF MQS Should not be used as goals for individual laboratories Except for:

  • Analytes

with no

  • utcome

and BV data

C Perich, Helsinki february 2018

  • Analytes

with no

  • utcome

and BV data available

  • Poorly regulated body measurands, such as

urinary components

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SLIDE 41

Kiitos

C Perich, Helsinki february 2018