ANALYTICAL QUALITY SPECIFICATIONS OF INTER … · Comparación especificación consensual vs. preceptiva ... HOR PRO TUM CEIEC: RESULTS Robust mean Especificación consensual en %

International Congress on Quality MedicineLabquality Days 2018

CALIDAD DE LA DEMANDA

ANALYTICAL QUALITY SPECIFICATIONS OF INTER-LABORATORY COMPARISONS

Interdisciplinary Expert Committee for QualitySpecifications 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

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

Spanish Societies involved in Laboratories with EQA

Spanish Association of Clinical Laboratory Spanish Association of Medical

Biopathology- Laboratory Medicine


Spanish Society of Hematology

and Hemotherapy

Spanish Society of Laboratory Medicine

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

Interdisciplinary Expert Committee for QualitySpecifications 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

CEIEC: OBJECTIVES

• To establish the minimum analytical quality(MQS) to be demanded from Spanishlaboratories based on the reality (state of theart)

• To propose specifications similar to those


• To propose specifications similar to thosebased on the state of the art and that aremandatory in other countries

• To use a system transparent and reproducibleto obtain the MQS

Common performances of 4 Spanish EQA

• Non profit organizations, independent ofcommercial interests

• Maintaining confidentiality of laboratory data

• Proved experience ( programs began around1980)


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

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 of


• Target values are peer-group means of

participant results, excluding outliers

• 12 (biochemistry) and 24 (hematology) control

materials per year and asking for monthly

results

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


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

CEIEC: MATERIALS

• All results are obtained from EQAP of the 4societies, from 2011 to 2015

• More than 4.5 million results are compiled inthe database (Datum)


the database (Datum)

• 2794 laboratories are involved

• 143 analytes are included: serum and urinebiochemistry, blood gas, hematology,coagulation

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

BASIC CALCULATIONS. GLUCOSE


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 MQS accepted


• If cMQS ≥ robust mean MQS accepted

• If cMQS < robust mean Procedure B

• If not mandatory specification 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

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

YesNo


C alcio . Procedim iento BLa

bora

torio

s (%

)

6065707580859095

100

CEIEC: METHODS. PROCEDURE B

CalciumLa

bo

rato

rie

s (%

) 75% results

within

Lím ite de error (% )

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Labo

rato

rios

(%)

05

1015202530354045505560


Error limit (%)

Lab

ora

tori

es

(%)

CEIEC: PROCEDURE A. EXAMPLE

cMQS: 3.2%

Germany: 5%

Russia: 2%

USA: 2.4%Robust mean: 2.9%

3.2% > 2.9%

Sodium


3.2% > 2.9%

cMQS: 3.2%

MQS acceptedCEIEC review

CEIEC: PROCEDURE B. EXAMPLE

cMQS: 7.1%

Germany: 13%

Russia: 7%

USA: 10%Robust mean: 10%

7.1% < 10%

Cholesterol


7.1% < 10%

cMQS: 9.1%

Procedure B

MQS acceptedCEIEC review

CEIEC: RESULTS

143 analytes

Procedure A

7 analytes 70 analytes 66 analytes


7 analytes 70 analytes 66 analytes

Procedure BMQS

MQS

CEIEC: RESULTS.ANALYTES

18 basic biochemistry serum 6 cardiac markers

21 proteins 13 urine biochemistry

6 therapeutic drugs 8 blood gas


6 therapeutic drugs 8 blood gas

23 Hormones 18 basic hematology

12 tumor markers 8 basic coagulation

Comparación especificación consensual vs. preceptiva

Esp

ecifi

caci

ón p

rece

ptiv

a en

%

20

30

40

+ SUEORIHEMGASCARHORPROTUM

CEIEC: RESULTS

Ro

bu

st m

ea

n

Especificación consensual en %

0 10 20 30 40

Esp

ecifi

caci

ón p

rece

ptiv

a en

%

0

10

-TUM

�� ant� nue


Spanish MQS

Ro

bu

st

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


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

CEIEC: RESULTS. SERUM Basic Biochemistry


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


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 -

CEIEC: RESULTS. Urine Biochemistry


Albumin 38 26 - 26 -

Amylase 15 - - - -

Calcium 16 17 - 10 7

Chloride 8.3 - - - -

Creatinine 13 21 - 21 -

Glucose 8.4 30 - 22 38


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 -

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 -

CEIEC: RESULTS. SERUM Hormones


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

CEIEC: RESULTS. SERUM Protein


α 1-acid Glycoprotein 11 -

α 1-antitrypsin 13 -

Apolipoprotein A 12 -

Apolipoprotein B 10 -

Ceruloplasmin 12 -

Complement C3 10 -


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 -

CEIEC: RESULTS. SERUM Protein


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 -


α 2- macroglobulin 19 -

β 2-microglobulin 14 -

Prealbumin 16 -

Transferrin 8.3 12 - 12 -

CEIEC: RESULTS. Drugs / Cardiac markers


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 -


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 -

CEIEC: RESULTS. Tumor markers


AFP 18 24 - 24 -

CA 125 11 -

CA 15.3 13 24 - 24 -

CA 19.9 13 -

CA 72.4 11 -


CEA 15 24 - 24 -

Cyfra 21.1 11 -

NSE 13 -

PSA total 15 25 - 25 -

PSA free 13 -

Protein S-100 14 -

Tyroglobulin 17 -

CEIEC: RESULTS. Blood gas


Calcium (ionized) 5.4 17 - 18 -

Chloride 1.9 -

Glucose 6.5 -

Lactate 9.2 18 - 18 -


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 -

CEIEC: RESULTS. Hematology


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 -


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 -

CEIEC: RESULTS. Coagulation


APTT (seconds) 24 17 15 18 -

APTT (ratio) 12 -

AT III 34 -

Factor VIII 37 -


Fibrinogen 21 20 20 - -

PT (ratio) 13 23 - 23 -

PT (%) 31 -

CEIEC: RESULTS

30%

40%

50%

60%

70%

80%

90%

100%


0%

10%

20%

30%

mandatory not mandatory

Comparación especificación consensual actual vs. previa

Esp

ecifi

caci

ón c

onse

nsua

l pre

via

(200

7-20

10)

en %

30

40

50

60

+ SUEORIHEMGASCARHORPROTUM

RESULTS. COMPARISON PREVIOUS MQS

MQ

S

(p

eri

od

20

07

–2

01

0)

Especificación consensual actual (2011-2015) en %

0 10 20 30 40 50 60

Esp

ecifi

caci

ón c

onse

nsua

l pre

via

(200

7-20

10)

en %

0

10

20

-TUM


Current MQS (period 2011 – 2015)

Pre

vio

us

MQ

S

(

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

COMPARISON BETWEEN MQS PERIODS 2011/2015 vs 2007/2010

α-Amylase (serum)

Period

2011/2015

Period

Lab

ora

tori

es

%

F.Ramón, Málaga, Noviembre 2017

Period

2007/2010

Error limit %

Lab

ora

tori

es

%

CEIEC: CONCLUSIONS

• Methodology reliable, big data, based on theSpanish reality, reproducible

• MQS for 143 analytes obtained by consensus ofthe Committee, versus 77 analytes withmandatory specifications


mandatory specifications

• In 87% of analytes the MQS are more demandingthan the robust mean

• Spanish laboratories have improved theiranalytical performance in relation to previousMQS (2011)

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


certification bodies

• To be proposed as mandatory minimum level of

quality, if required by the government

CEIEC: PRACTICAL USES OF MQS

Could MQS be used as goals

by individual laboratories?



CEIEC: LIMITATION OF MQS

Should not be used as goals for individual

laboratories

Except for:

• Analytes with no outcome and BV data


• Analytes with no outcome and BV data

available

• Poorly regulated body measurands, such as

urinary components

Kiitos


Documents

ANALYTICAL QUALITY SPECIFICATIONS OF INTER … · Comparación especificación consensual vs. preceptiva ... HOR PRO TUM CEIEC: RESULTS Robust mean Especificación consensual en %