2021_Book_TextbookOfPatientSafetyAndClin

24 Patient Safety in Laboratory Medicine
The ISO 15189 is a worldwide International
Standard, specifically designed for the accreditation
of medical laboratories. The ISO 15189
accreditation is issued by the national accreditation
body, a unique body recognized by the
national government for the issuing of accreditation.
Obligatory in some countries and voluntary
in others, accreditation is based on comparative
logics between homogeneous organizations, typical
of benchmark systems. Its purpose is not to
satisfy a fixed target but goals that vary continuously
over time and space and hinge upon quality
of professional performance (best practice).
Since best practice is affected by contextual
change, technological evolution, scientific
advancements, and so forth, the aim of accreditation
is to help the laboratory achieve continued
improvement and compare its performance with
the best possible performance, as determined by
the state-of-the-art and/or the reference model.
The maintenance of accreditation, a dynamic
process, calls for continuous evaluation of excellence
in the respective discipline.
24.2.2 Quality Indicators
Despite the availability of laboratory accreditation
and compliance with mandatory and/or voluntary
standards calling for the application of the
best available criteria and procedures, and the
harmonization of staff behavior, its effectiveness
is closely related to continuous monitoring of all
TTP steps and outcomes.
In recent years, laboratory professionals have
developed and implemented a number of QIs
focusing on the main critical TTP steps that are to
be included in a coherent and well-integrated
quality improvement system [36–41]. This has
come about because of the need to reduce error
rates, the difficulty in recognizing and isolating
undesired events, and a willingness to meet ISO
15189 accreditation requirements.
An internal evaluation process and participation
in an inter-laboratory comparison must be
implemented in order to guarantee the effectiveness
of QIs.
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The internal evaluation process includes the
definition of:
• A list of QIs focused on the critical activities.
• A document for each indicator describing its
specifications (e.g., what must be measured,
how to collect data, measurement limitations,
acceptability limits of results, areas of application,
responsibilities).
• A standard operating procedure describing all
steps to be followed in order to guarantee
effective use of QIs.
Moreover, participation in inter-laboratory
comparison aims to evaluate the quality level
achieved in comparison with other national or
international laboratories. This calls for the use
of common QIs and of criteria and procedures for
data collection. A coordinator center is needed to
perform data processing that complies with
approved quality specifications and to provide
each laboratory with a report describing the
resulting performance evaluation pertaining to
each QI.
The Working Group on “Laboratory Errors
and Patient Safety” (WG-LEPS) of the
International Federation of Clinical Chemistry
and Laboratory Medicine (IFCC) has put in
motion a project for the definition of a Model of
Quality Indicators (MQI) along with data collection
specifications, to be used in all laboratories
regardless of logistics, technological level,
and complexity. In two Consensus Conferences
held in 2013 and 2016, experts on this topic discussed
and ultimately approved the list of QIs,
the procedure for data collection, the criteria
for performance evaluation, and the information
to be included in a periodic report concerning
the analysis of data for participating
laboratories. The progress of the project and its
findings are reported in literature as well as
through a dedicated website that is www.ifccmqi.com.
Currently the MQI includes 53 measurements
to evaluate 26 indicators concerning key processes,
support processes, and outcome measures.
To facilitate implementation, a priority