international eqa surveys for calibration laboratories€¦ · international eqa surveys for...
TRANSCRIPT
www.rfb.bio
International EQA surveys
for calibration laboratories
Dr. Anja Kessler
Reference Institute for Bioanalytics
Bonn, Germany
1 JCTLM Members‘ and Stakeholders‘ Meeting, 2017
www.rfb.bio
2
The results of the laboratories can be
evaluated equally, regardless of the
method used.
Target values assigned by a primary
reference measurement procedure
680 participants
Measurement principles:
Luminescence detection
Radioactivity detection
Fluorescence detection
Mass spectrometry
...
RMV in EQA Schemes for Routine Labs
www.rfb.bio
3
Secondary reference measurement
procedure
Secondary calibrator
Primary reference measurement
procedure
Primary calibrator
Manufacturer‘s working calibrator
Result of patient sample
SI unit
Manufacturer‘s product calibrator
Laboratory‘s routine measurement
procedure
Manufacturer‘s selected measurement
procedure
Manufacturer‘s standing measurement
procedure
EQA for Calibration Laboratories
An EQA scheme can visualise the link
between Calibration/Reference
Laboratories in Laboratory Medicine
and National Metrology Institutes.
Calibration laboratories can
demonstrate their competence.
Resultes of candidate reference
measurement procedures can be
compare to established RMP.
www.rfb.bio
The laboratory has to be accreditated according to ISO/IEC 17025
and ISO 15195.
The calibration laboratories have to verify their competence
through collaborative surveys between laboratories working at the
highest metrological level.
The laboratory has to make use of a reference measurement
procedure approved according to ISO 15193 and reference materials
approved according to ISO 15194.
4
Criteria for Listing a Reference Measurement Service
www.rfb.bio
JCTLM Members‘ and Stakeholders‘ Meeting, 2017
Each participant receives two different control materials.
The analysis has to be performed under the same conditions as for providing reference measurement procedure values for a customer.
This requires a reasonable number of repetitive measurements under reproducibility conditions - e.g. using separate calibrations – in order to calculate an expanded uncertainty.
Therefore, 5 vials of each individual sample are provided.
Documents for shipment on request in advance
Proforma Invoice
Material Safety Data Sheet
Declaration of non-objection
Certificate of Accreditation of RfB
Individual Contracts
RELA – Annual Process
www.rfb.bio
JCTLM Members‘ and Stakeholders‘ Meeting, 2017
More than 4500 samples are
shipped to participating
calibration laboratories and
candidated reference
laboratories.
RELA – Annual Process
www.rfb.bio
8
0
50
100
150
200
250
300
350
400
2002 2004 2006 2008 2010 2012 2014 2016 2018
Nu
mb
er
Year
Number of results
Number of labs
Number of participants:
2003 25
2016 48
Number of results:
2003 111
2016 361
17 participants are
listed in the JCTLM
database.
RELA Statistics
www.rfb.bio
9
Canada 1
USA 1
Argentina 1
China 24
South Korea 1
Japan 1
Singapore 1
Great Britan 1
France 1
Spain 2
Italy 3
Turkey 1
Netherlands 2
Sweden 1
Belgium 1
Germany 6
RELA Participants Worldwide
www.rfb.bio
10
RELA – Metabolites & Substrates
0
10
20
30
40
50
60
70
80
90
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Uric Acid
Urea
Total Glycerol
Total Cholesterol
Total Bilirubin
Glucose
Creatinine
www.rfb.bio
11
RELA – Enzymes
0
20
40
60
80
100
120
140
160
180
200
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
LDH
GGT
CK
AST
ALP
Amylase
ALT
www.rfb.bio
12
RELA – Non-peptide Hormones
0
5
10
15
20
25
30
35
40
45
50
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Testosterone
Progesterone
Estriol
Estradiol-17b
Cortisol
Aldosterone
17OH-Progesterone
www.rfb.bio
JCTLM Members‘ and Stakeholders‘ Meeting, 2017
RELA Results - Example Glucose -
5 of 9 JCTLM listed services
www.rfb.bio
JCTLM Members‘ and Stakeholders‘ Meeting, 2017
RELA Results – Regional Distribution - Example GGT -
South America
Europe
Asia
Participants from
5 of 9 JCTLM listed services
www.rfb.bio
JCTLM Members‘ and Stakeholders‘ Meeting, 2017
RELA Results with less participants - Example Estriol -
www.rfb.bio
18
680 routine labs
3 calibration labs
Results of Routine and Calibration Laboratories
Limits of Acceptance: 35%
HM 1/16 vs. RELA2014
Testosterone
www.rfb.bio
19
RELA – To all whom it may concern
Calibration laboratories providing their service
to organiser of external quality assessment schemes,
Calibration laboratories of manufacturers,
Auditors of accreditation bodies.
The RELA surveys address:
Candidate laboratories which are investigating a new
analytical principle,
JCTLM review teams,
Customers looking for support of calibration laboratories,
www.rfb.bio
20
RELA is an EQA scheme for calibration laboratories which
supports them to demonstrate their competence.
All results are published and the website is of open access.
Scientific work is necessary to develop reference
measurement systems for further measurands in laboratory
medicine.
In parallel, the portfolio of RELA should be extended to
support this process.
In addition, it has to be discussed how the data can be used
to make a statement about the quality of the calibration
laboratories.
Summary and Outlook
SI unit
