Harmonization of quality indicators in laboratory medicine. A preliminary consensus

Abstract

Quality indicators (QIs) are fundamental tools for enabling users to quantify the quality of all operational processes by comparing it against a defined criterion. QIs data should be collected over time to identify, correct, and continuously monitor defects and improve performance and patient safety by identifying and implementing effective interventions. According to the international standard for medical laboratories accreditation, the laboratory shall establish and periodically review QIs to monitor and evaluate performance throughout critical aspects of pre-, intra-, and post-analytical processes. However, while some interesting programs on indicators in the total testing process have been developed in some countries, there is no consensus for the production of joint recommendations focusing on the adoption of universal QIs and common terminology in the total testing process. A preliminary agreement has been achieved in a Consensus Conference organized in Padua in 2013, after revising the model of quality indicators (MQI) developed by the Working Group on "Laboratory Errors and Patient Safety" of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The consensually accepted list of QIs, which takes into consideration both their importance and applicability, should be tested by all potentially interested clinical laboratories to identify further steps in the harmonization project.

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

“…Consequently, criteria for setting and harmonization of extra-analytical quality indicators have been developed and data collected [34]. This, in turn, should provide the premise to define reliable PS for the extra-analytical phases (Figure 2) [35,36].…”

The quality indicator paradox

“…As a further step in this initiative, a Consensus Conference bringing together all experts and interested parties was organized in order to design a road map for the harmonization of QIs. An account of the consensus achieved in the Conference on the characteristics of harmonized QIs, and on the standardized system of data collection and reporting has been given [13]. The list of harmonized QIs and information on a dedicated website designed to explain the rationale of the MQI project and enable clinical laboratories to collect data and to compare individual performances with all participating laboratories (benchmark) have been made available thanks to participation in national and international scientific meetings, issuing of documents through the International Federations and national societies, and publications in scientific journals [14][15][16][17][18][19][20].…”

Patient identification and tube labelling – a call for harmonisation

“…Finally, we recommend continuous monitoring of identification errors, preferably by repeated direct observations of phlebotomy practices and by using pre-analytical quality indicators [7,[26][27][28]. Ongoing monitoring is valuable, because it is strongly associated with a lower misidentification rate [14].…”