Harmonization of pre-analytical quality indicators

Abstract

Quality indicators (QIs) measure the extent to which set targets are attained and provide a quantitative basis for achieving improvement in care and, in particular, laboratory services. A body of evidence collected in recent years has demonstrated that most errors fall outside the analytical phase, while the pre- and post-analytical steps have been found to be more vulnerable to the risk of error. However, the current lack of attention to extra-laboratory factors and related QIs prevent clinical laboratories from effectively improving total quality and reducing errors. Errors in the pre-analytical phase, which account for 50% to 75% of all laboratory errors, have long been included in the ‘identification and sample problems’ category. However, according to the International Standard for medical laboratory accreditation and a patient-centered view, some additional QIs are needed. In particular, there is a need to measure the appropriateness of all test request and request forms, as well as the quality of sample transportation. The QIs model developed by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a valuable starting point for promoting the harmonization of available QIs, but further efforts should be made to achieve a consensus on the road map for harmonization.

Harmonization of quality indicators in laboratory medicine. A preliminary consensus

“…This document recognizes the need to assure quality in all aspects of the TTP, from the "pre-pre-analytical" phase ("Right test choice at the Right time on the Right patient") through analytical steps ("Right results in the Right form") to the post-post-analytical" phase ("Right interpretation with the Right advice as to what to do next with the result") [20]. QIs, therefore, should cover all aspects of the TTP, including the evaluation of the appropriateness of test request and result interpretation [21]. However, the harmonization of currently available QIs should take into consideration also the feasibility by all potentially interested clinical laboratories around the world of data collection and reporting.…”

Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE)

“…Further activities shall be aimed towards raising the awareness of all stakeholders and to highlight the importance of QIs for improving the quality of laboratory services and patient safety. Simplification of the current model of QI by identifying a selection of several 'mandatory' indicators seems to be the reasonable compromise for laboratories worldwide [71].…”

The quality indicator paradox

“…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]. The collection of data received by clinical laboratories participating in the MQI programme on the list of harmonized QIs has recently led to the definition of preliminary performance specifications in the pre-analytical phases [21].…”