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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
C Perich, Helsinki february 2018
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
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
Interdisciplinary Expert Committee for QualitySpecifications 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
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
C Perich, Helsinki february 2018
• 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)
C Perich, Helsinki february 2018
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
C Perich, Helsinki february 2018
• 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
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
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)
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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
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
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 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
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 Perich, Helsinki february 2018
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
C Perich, Helsinki february 2018
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
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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
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7.1% < 10%
cMQS: 9.1%
Procedure B
MQS acceptedCEIEC review
CEIEC: RESULTS
143 analytes
Procedure A
7 analytes 70 analytes 66 analytes
C Perich, Helsinki february 2018
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
C Perich, Helsinki february 2018
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
C Perich, Helsinki february 2018
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
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
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
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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
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 -
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 -
CEIEC: RESULTS. SERUM Hormones
Analyte MQS R Mean USA Germany Russia
ACTH 51
Androstenedione 31
C-Peptide 12
DHEA-S 19
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Folate 20
hCG 14
hGH 13
Insulin 38
LH 14
Prolactin 20
PTH 23
Vitamin B12 14
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 -
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 -
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 -
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 -
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 -
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 -
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 -
CEIEC: RESULTS
30%
40%
50%
60%
70%
80%
90%
100%
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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
C Perich, Helsinki february 2018
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
C Perich, Helsinki february 2018
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
C Perich, Helsinki february 2018
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?
C Perich, Helsinki february 2018
C Perich, Helsinki february 2018
CEIEC: LIMITATION OF MQS
Should not be used as goals for individual
laboratories
Except for:
• Analytes with no outcome and BV data
C Perich, Helsinki february 2018
• Analytes with no outcome and BV data
available
• Poorly regulated body measurands, such as
urinary components
Kiitos
C Perich, Helsinki february 2018