Quality Indicators in Laboratory Medicine

Project

The adoption of Quality Indicators (QIs) has prompted the development of tools to measure and evaluate the quality and effectiveness of laboratory testing, first in the hospital setting and subsequently in ambulatory and other care settings. The use of QIs to assess and monitor the quality system of the laboratory that, in the past, considerably benefited quality management, may prove extremely valuable in keeping the total testing process under control in a systematic and transparent way as it promotes and encourages investigations when errors occur, and leads to the identification of strategies and procedures for improvement.

While Laboratory Medicine has an important role in the delivery of high-quality care, no consensus exists as yet on the use of QIs focusing on all steps of the laboratory total testing process (TTP), although the International Standard ISO 15189:2012 for Accreditation of Medical Laboratory requires their implementation.

In order to promote the harmonized use of QIs and reduce errors in laboratory testing, the IFCC Working Group on ‘‘Laboratory Errors and Patient Safety’’ (WG-LEPS) developed a project on QIs. The purpose of the project is to design a routine, formal, proactive system of monitoring that uses validated measures to focus strictly on laboratory performance creating a common reporting system based on standardized data collection, and to define the state-of-the-art and quality specifications for each QI independently from:

• the size of organization and type of activities;
• the complexity of processes undertaken;
• different degrees of knowledge and ability of the staff.

The achievement of a consensus on the typology and the limits of acceptability for quality indicators, above all for the extra-analytical processes, should allow a reliable comparison between the data collected from the different laboratories and the achievement of effective benchmarking at international level, for the development and the application of standardized operative procedures and scientific recommendations to manage the various critical processes.

The final goal is to define a Model of Quality Indicators (MQI) that will be proposed to, and applied by, all clinical laboratories in order to monitor processes and encourage improvement in performances so as to decrease the error rate in the total testing process. A MQI managed within the framework of an External Quality Assurance Program (EQAP) would provide laboratories with a tool to monitor and control the pre-, intra- and post-analytical activities and allow identification of risks predisposing to errors resulting in patient harm. In fact, quality improvement is now a part of the daily routine for laboratory professionals, but quality cannot be improved without being measured. Measures of events under observation closely depend on the method used for data collection and on staff involvement.

The WG-LEPS project, commenced in 2008, has been developed a preliminary MQI that was tested under real conditions by involving laboratories for a few years (2008-2013). All the main findings collected during the experimentation phase were discussed in the Consensus Conference held in Padova in 2013 (”Harmonization of quality indicators: why, how and when?”) to achieve a preliminary consensus on terminology, rationale, purpose of each and all QIs and procedures of data collection. A preliminary set of quality indicators  reviewed, approved and issued after the Consensus Conference has been used since 2014, when a second Consensus Conference was organized in Padova on 26th October, 2016 and entitled “Harmonization of quality indicators in Laboratory Medicine: two years later?”. A new MQI has been issued after the Consensus Conference of 2016, that includes 53 measurements to monitor 27 QIs and some explanatory notes have been added to facilitate the interpretation of events to be measured. A priority index has been assigned to each quality indicator (“1” is the higher priority; “4” the lower).

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.

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. A confidential report, concerning the evaluation of laboratories results is periodically issued, in which the following information are provided for each indicator:

• Laboratory result;
• Short term sigma value (allows drift of 1.5) and its 95% confidence interval, when appropriate;
• Trend of the laboratory results and of the sigma values, over time;
• Distribution of frequency of laboratory results and of the sigma values.

All laboratories can participate in the project requiring the login.

Future Activities

In order to achieve a large and steady participation of clinical laboratories all over the world the following actions have been planned:

• Involvement of National Scientific Societies, Accreditation bodies and  Providers of External Quality Assessment Schemes/Proficiency Testing of different Countries, as a mean for dissemination of the project and promoting participation of laboratories in the MQI project.
• Selection and nomination of a National Leader to coordinate and manage the MQI project in each Country. In particular, the National Leader should: encourage the use of MQI; “personalize” the use of QIs in routine practice according to national practices, requirements and regulations; co-operate with the members of the WG-LEPS, providing valuable suggestions or improving projects.
• Identification of an automated and computerized system for an easy and systematic data collection and recording.

Model of Quality Indicators

Quality Indicators - Key Processes	Quality Indicators - Outcome Measures	Quality Indicators - Support Processes