The document discusses harmonization of quality indicators (QIs) in medical laboratories. It notes that while QIs are important for quality improvement, there is currently no consensus on common QIs or how they should be defined and measured. The Working Group on Laboratory Errors and Patient Safety has developed a Model Quality Indicator (MQI) to address this issue, which defines 53 measurements across 27 QIs. Laboratories can now report results to the MQI website voluntarily. Statistical analysis of early participation in the MQI shows the most widely used QIs relate to pre-analytical errors, analytical test performance, and post-analytical issues. However, broader adoption remains a challenge.

1. Harmonization of
Laboratory Indicators
Ola H. Elgaddar
MD, PhD, MBA, CPHQ, LSSGB
Lecturer of Chemical Pathology
Medical Research Institute
Alexandria University
ola.elgaddar@alexu.edu.eg

6. Sources of Medical Errors
ØAvailable data used to focus on medication
related errors
ØHowever, in recent years, large scale
surveys have demonstrated that diagnostic
errors are a common occurrence including
errors related to laboratory testing

8. Quality Indicators (QIs) …... Why?
ØAssess and monitor the quality system of
the lab….......
ØPromotes and encourages investigations
when errors occur….....

9. Quality Indicators (QIs) …... Why?
ØIdentify strategies and procedures for
improvement
ØEvaluate lab performance in relation to
the State-of-the-Art (i.e. benchmarking)

10. Quality Indicators (QIs) …... Why?
ØAccording to the ISO 15189:2012,
clinical laboratories should identify critical
TTP activities and implement QIs in order
to highlight and monitor errors when they
occur.

12. Harmonization
Harmonization, in music, is the
implementation of harmony, usually by
using chords, including harmonized scales

13. Harmonization – Lab Medicine
According to a patient-centered
viewpoint, harmonization is that the
information should be comparable
irrespective of the measurement
procedure used and where and/or
when a measurement is made.

14. Provision of an accurate
and actionable
laboratory information

15. Harmonization – Lab Medicine
SCOPE = TTP
ØTests and test profiles request
ØAnalytical processes and methods
ØTerminology
ØUnits
ØReport formats
ØReference intervals
ØDecision limits

16. Back to
Are they harmonized??

17. Unfortunately, there is no consensus
on common QIs covering the whole
TTP, nor there is an agreement on
common terminology or targets!

18. Identifying a suitable State-of-the-Art
is challenging, because it calls for the
knowledge of error rates measured in
a variety of laboratories throughout
the world that differ in their
organization and management,
context, and population served

19. The Working Group “Laboratory Errors and
Patient Safety” (WG-LEPS) of the IFCC has,
since 2008, implemented a project aimed at
defining a common Model of QIs (MQI), a
harmonized method for data collection,
managed as an External Quality Assurance
Program (EQAP) in which confidentiality is
guaranteed

21. Preliminary MQI that was tested under real
conditions by involving laboratories between 2008
& 2013, then the main findings were discussed in
the Consensus Conference held in Padua in 2013

22. The achieved preliminary consensus on
terminology, rationale, purpose and
procedures of data collection resulted in a
preliminary set of reviewed and approved
quality indicators issued after the Consensus
Conference, and used since 2014

23. A new MQI has been
issued after the
Consensus Conference
of Padua 2016, that
includes:
Ø 53 measurements to
monitor
Ø 27 QIs
Ø Explanatory notes
Ø A priority index has
been assigned to
each quality indicator
(“1” is the higher
priority; “4” the lower)

24. Indicators and measurements
ØDifferent measures are often required to
ensure that an indicator is appropriately
monitored.
ØIt is advisable to split an indicator into
different measures in order to consider
all the events causing a specific error,
and to benchmark data entered by
different laboratories to avoid misleading
comparisons (Ex: In and outpatients)

25. All laboratories can use the new MQI, available in the website,
since 2017. The laboratory results are collected on the
specifically-developed website (www.ifcc-mqi.com) and
managed within an EQAP through which laboratory results are
evaluated in comparison to the results of all participating
laboratories.

26. In order to encourage laboratories to
participate in the project, they are not
compelled to use all QIs proposed in the
model and they can, at least at the beginning,
select the most appropriate QIs (chosen from
those with “priority 1” assigned) and then, they
may eventually introduce and use further QIs.

27. A confidential report is periodically issued for each
lab containing the following information for each QI:
- Laboratory result;
- Sigma value
- Trend of the laboratory results and of the sigma
values, over time;
- Distribution of frequency of laboratory results and
of the sigma values.

32. Statistical data of QIs collected in the 2014,
2015 and 2016 (6 months)

33. QIs most widely used:
ØPre-analytical phase: a) unsuitable
samples and b) misidentified errors
ØAnalytical phase: a) unacceptable
performance in PT and b) tests with
inappropriate IQC performance
ØPost-analytical phase: a) incorrect
reports issued and b) inappropriate TAT

34. QIs most widely used:
For QIs of Outcome Measures and Support
Processes, all indicators proposed in MQI
appear to be used in a similar fashion, but
only by a small number of laboratories.

35. Most reported difficulties:
ØInadequate participation in QI data
collection by most labs, attributing this to
the ‘excessive’ number of QIs included in
the MQI
ØDifficulties in data collection, especially
when automated collection is unavailable.

36. Most reported difficulties:
ØDifficulty in meeting the deadline for
collecting and entering data in the MQI-
dedicated website. Laboratories are more
inclined undertake the retrospective
collection of data, with trans- mission
delayed by months or, in extreme cases, a
year.