STT
Consulting
dietmar@stt-consulting.com
linda.thienpont@ugent.be
Mid to long-term peer group comparison of patient percentile data and
[optional] external quality assessment with commutable single donation sera
Project
Continuous monitoring of outpatient percentiles (50th percentile or median) across laboratories
and manufacturers by STT Consulting/Laboratory for Analytical Chemistry (Ghent University).
Participation: hospital or private laboratories (medium-sized and large ones).
Optional: Participation in External Quality Assessment surveys with 20 commutable, single
donation serum samples (= master comparisons).
Participants: (i) laboratories using homogeneous systems (instrument, reagent, calibrator from
the same manufacturer); Peer Group sizes of 20 or more laboratories are intended; (ii)
manufacturers’ application laboratories.
Laboratory contribution
Percentile monitoring
IT surrounding that is capable of “automatic background generation” of daily out-patient
percentiles and transfer of those data to an external receiver (STT Consulting).
An exemplary solution (e-mail transfer, no costs) has been worked out for laboratories that use
the GLIMS laboratory information system from MIPS, Belgium (see Annex I).
Master comparisons (optional)
Laboratories perform singlicate measurements (once a year) for 8 clinical chemistry analytes in
20 single donation samples (= 8 x 20 = 160 measurements).
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STT/UGent contribution
Development of data visualization and interpretation software based on graphical presentation of
moving medians and summary statistics. Regular individual reports to laboratories. Regular,
general reports about assay quality and stability. After a successful pilot study, a user interface
shall be developed that gives the individual laboratory access to the peer group comparisons.
Costs
Participation in the percentile/IQC monitoring part will be free of charge during the pilot phase
(September 2015).
Participation in the master comparison 2014 is free for laboratories, but 500/750 € for
manufacturers (1/2 systems included).
Timeline
Single laboratory participation: immediately
Peer Group recruitment: March 2014
Regular reports: March 2014
Duration of overall pilot phase: September 2015
Development of professional user interface to the database: January 2016 (when pilot is
successful).
Data Ownership
Data ownership will be addressed in a contract, if wanted.
Data use
Every laboratory can use its own data for its own purposes.
Use of data comprising different laboratories will be addressed separately.
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Benefits for the laboratory participating in the Empower project
Direct, internal benefits
Master comparisons: give a calibration fix-point and information of the basic quality of the assay
and the laboratory performance.
Patient percentile monitoring: gives the laboratory a direct, real-time quality indicator for the
analyses of patient samples, as requested by the ISO 15189. Added values of the quality
indicator are:

Monitoring the effect of analytical (in)stability on a surrogate medical outcome, for example,
the frequency of “flagged results”;

Comparison of patient data among laboratories belonging to a network;

Monitoring is done by an independent third party.
Combination of patient monitoring and own IQC data: creates evidence about mid- to long-term
variation of the instrument, calibrator, and reagent of the manufacturer (lot-to-lot consistency,
drifts). This evidence is backed-up by information from other laboratories using the same assay.
Linking patient data with IQC information generally strengthens the laboratory’s quality
management/quality assurance system (see ISO 15189).
Longer-term, internal benefits
Creation of evidence about the reasons for assay variation: own performance or manufacturer
performance (for example, lot-to-lot-variation).
Strengthening of the laboratory’s position in claims versus the manufacturer.
Creation of a tool for developing realistic quality goals and a tool for strengthening the
physician/laboratory interface by more transparent communication of performance.
Provides data about assays from other manufacturers, which might be helpful in decisions for
the acquisition of new instruments.
External (“Profile”) benefits
Empower laboratories can develop a “high-profile” and set peer-performance standards.

Can document long-term performance when applying for contracts for clinical studies and
when applying for government contracts for creating epidemiological data.

Can act as a group in the improvement of the laboratory/clinician interface, in the relationship
with manufacturers, in the relationship with health-care authorities, and ministry of
economics.

Show fit for future tasks, such as contribution to the development, implementation, and
control of global health-care policies. Its high profile may be an advantage in the ever
increasing battle for money.
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ANNEX I
Data to be transmitted for patient percentile monitoring
e-mail to dietmar@stt-consulting.com (SMTP server)
Example from GLIMS (MIPS, Belgium)
Production Statistics
Time period: 29/05/13 00:00 - 29/05/13 23:59 (produced)
Selection: no QC, no unassessed, no unsolicited, status 'Confirmed' until 'Validated', classification
'statPERCSTUDIE'
Contents: Median of numeric value, per statPERC_STUDIE (rows)
______________________________________________________
StatPERC_STUDIE
______________________________________________________
?
UZG;29/05/2013;COBAS8000C;POL;ALB;g/L;47.50
UZG;29/05/2013;COBAS8000C;POL;ALKFOS;U/L;61.70
UZG;29/05/2013;COBAS8000C;POL;ALT;U/L;19.00
UZG;29/05/2013;COBAS8000C;POL;AST;U/L;19.60
UZG;29/05/2013;COBAS8000C;POL;BILTOT;mg/dL;0.59
UZG;29/05/2013;COBAS8000C;POL;CA;mmol/L;2.42
UZG;29/05/2013;COBAS8000C;POL;CHOL;mg/dL;189.30
UZG;29/05/2013;COBAS8000C;POL;CL;mmol/L;102.50
UZG;29/05/2013;COBAS8000C;POL;CRP;mg/L;2.50
UZG;29/05/2013;COBAS8000C;POL;GGT;U/L;24.70
UZG;29/05/2013;COBAS8000C;POL;GLUC;mg/dL;93.10
UZG;29/05/2013;COBAS8000C;POL;K;mmol/L;4.29
UZG;29/05/2013;COBAS8000C;POL;KREAT;mg/dL;0.94
UZG;29/05/2013;COBAS8000C;POL;LDH;U/L;187.30
UZG;29/05/2013;COBAS8000C;POL;MG;mmol/L;0.75
UZG;29/05/2013;COBAS8000C;POL;NA;mmol/L;140.90
UZG;29/05/2013;COBAS8000C;POL;P;mmol/L;1.07
UZG;29/05/2013;COBAS8000C;POL;PROT;g/L;69.50
UZG;29/05/2013;COBAS8000C;POL;UREUM;mg/dL;37.00
UZG;29/05/2013;COBAS8000C;POL;URINZ;mg/dL;5.64
______________________________________________________
Codes
Lab identifier;Date(DD/MM/JJJJ);Instrument ID;Outpatient code;Analyte;unit;median (or 50th percentile)
[future: serum/plasma?; calibrator lot; reagent lot].
20 Analytes (serum or plasma)
Albumin; Alkaline Phosphatase; Alanine aminotransferease (ALT); Aspartate aminotransferase (AST); totalBilirubin; Calcium; total-Cholesterol; Chloride; C-reactive protein (CRP); Gamma-glutamyl transferase (GGT);
Glucose; Potassium; Creatinine; Lactate dehydrogenase (LDH); Magnesium; Sodium; Inorganic phosphor
(phosphate); total-Protein; Urea; Uric acid (urate)
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