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.


Introduction
Laboratory testing is an integral part of modern medicine as it impacts patient management regarding both screening, early diagnosis, prognosis, appropriate treatment and monitoring [1]. Assessing the quality of medical laboratories has become increasingly important not only for pressures to reduce costs, but also for the evidence of testing-related diagnostic errors [2]. It has been demonstrated that performance and outcome measures improve the quality of patient care [3]. In particular, quality indicators (QIs) represent valuable tools for quantifying the quality of selected aspects of care by comparing it against a defined criterion. QIs therefore may support accountability, help to make judgements and set priorities, enabling comparison over time between providers and the effectiveness of interventions [4]. Laboratory medicine is one of the most dynamic discipline of the health care system and the dramatic decrease in the analytical error rates achieved in the last decades is due, at least in part, to the development and implementation of valuable QIs and quality specifications for the effective management of analytical procedures [5]. Current evidence, however, emphasizes the vulnerability of pre-and post-analytical phases of the total testing process (TTP) which, in turn, translates into risk for patient safety [6].
According to the last version of the international standard for clinical laboratory accreditation (ISO 15189: 2012) "quality indicators can measure how well an organization meets the needs and requirements of users and the quality of all operational processes" [7]. In addition, the document specifies that "the laboratory shall establish QIs to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post-examination processes". Clinical laboratories can now measure, monitor and improve their analytic performances over time thanks to internal quality control rules, objective analytical quality specifications, and proficiency testing (PT)/external quality assessment (EQA) programs, which have provided clinical laboratories with a valuable benchmark based on objective data. The identification of reliable QIs in the TTP is therefore a key step in enabling users to quantify the quality of laboratory services, but the current lack of attention to extra-laboratory factors is in stark contrast with the numerous studies on the multitude of errors that continue to occur in the pre-and post-analytical phase. In the last decade, interesting programs on indicators of the extra-analytical phases have been developed in some countries, such as Australia and New Zealand [8], Brazil [9], and Catalonia [10], and other surveys and programs have been promoted in the UK [11,12], in China and Croatia [13].
However, there is no consensus for the production of joint recommendations focusing on the adoption of universal QIs and common terminology in the TTP [14].
In 2008 the IFCC launched a working group named "Laboratory Errors and Patient Safety" (WG LEPS), its primary goal being to identify a list of valuable QIs and related quality specifications to be used as a benchmark between different laboratories around the world and to promote the reduction or errors in the TTP as well as an improvement in quality and patient safety. The preliminary model of quality indicators (MQI) has been developed, evaluated by some voluntary laboratories at an international level and preliminary results reported [15]. As a further step of this initiative, the WG LEPS has organized a Consensus Conference to design a road map for the harmonization of QIs. The conference, held in Padua on 24 October, 2013 and titled "Harmonization of quality indicators: why, how and when?" aimed to bring together all experts and interested parties and to find a preliminary consensus on the steps towards harmonization of QIs.
Here we report the main results of the conference in order to spread the information to all possible interested individuals and organizations, and to promote further efforts to harmonizing QIs in laboratory medicine.

The conference organization: background and preliminary work
Although the invited experts have been aware of the state-of-the-art of QIs in laboratory medicine, a series of preliminary documents and questions have been circulated among all invited delegates to achieve a preliminary consensus on terminology, rationale, purpose of each and all QIs. It should be highlighted that the different steps required to develop and test QIs previously described [16][17][18] have been carefully followed.
In particular, as concerns laboratory medicine, since a variety of QIs and terminology are currently used. Therefore, the path towards harmonization should be based on sound criteria, and in particular, a consensus has been achieved regarding the main characteristics of QIs. In particular, they should be: 1) patient-centered to promote total quality and patient safety; 2) consistent with the definition of "laboratory error" which has been specified in the ISO/ TS 22367: 2008 [19] and conducive to addressing all stages of the TTP, from initial pre-pre-analytical steps (test request and patient/sample identification) to post-post-analytical steps (acknowledgment of data communication, appropriate result interpretation and utilization); 3) consistent with the requirements of the ISO 15189: 2012 [7].
In addition, essential pre-requisites of QIs, as measurable and objective tools, appear to be: 1) importance and applicability to a wide range of clinical laboratories at an international level; 2) scientific soundness with a focus on areas of great importance for quality in laboratory medicine; 3) the definition of evidence-based thresholds for acceptable performance; and 4) timeliness and possible utilization as a measure of laboratory improvement.
Another fundamental issue is the awareness that the process of harmonization of QIs consists of two compulsory steps: the identification of common QIs and a standardized reporting system. While the identification of harmonized and universal QIs seems to be the "core" issue, standardization of systems for data collection and reporting represent critical steps towards effective harmonization initiatives [17]. After discussing a preliminary document, and answering to a series of related questions, all experts did agree to work on the revision of currently available QIs, starting from the already described IFCC MQI [15], taking into consideration the relevance of each QI, its generalizability and applicability by clinical laboratories from different countries. All speakers accepted to present their experience on QIs focusing on the main advantages and limitations of their experiences, as well as on eventual agreement and disagreement with the IFCC WG LEPS program.

Revised list of QIs
The QI chart (Table 1) developed by IFCC LEPS was presented as a means of harmonizing measurement of TTP. This list contains a comprehensive series of QIs, covering all steps of the TTP, that have been considered to be applicable to all laboratories despite their complexity, technological level, and need of close interaction with clinicians and other healthcare staff. This was considered to be too ambitious as a first step and a priority score (1 is the highest priority) was performed to determine the critical QI that could be used as an initial international survey. For each QI, the reporting system has been simplified to allow homogeneous data collection and reporting. Each attendee agreed to pilot this error analysis in a number of laboratories in their country. Table 2 reports the proposed definitions of all QIs and some examples to allow a better comprehension of the meaning of each indicator to interested laboratory professionals.

Documents
In the IFCC WG LEPS website (www.ifcc-mqi.com) interested professionals may find the program of the Consensus Conference, the list of QIs, and questionnaire on the feasibility of data collection for the selected QIs.

Further steps
Further steps of the harmonization project are: 1) testing of the revised list of QIs by clinical laboratories that are already involved in existing programs to collect data during a 6-month period, and establishing preliminary quality specifications of the individual QI; 2) collect data on the proposed questionnaire by potentially interested clinical laboratories that up to now have no experience in the management of QIs; 3) organize a further Consensus Conference for discussing the results (steps 1 and 2) in order to better understand the feasibility of data collection for all QIs by clinical laboratories operating at an international level and in different countries.

Conclusions
Indicators for performance and outcome measurement allow the quality of care and services to be measured and provide a quantitative basis for interested parties aiming to achieve improvement in care and processes by which patient care and services are provided. The measurement and monitoring of QIs in laboratory medicine serve many purposes: 1) document the quality of the service provided; 2) improve performance and patient safety; 3) make comparison (benchmarking) over time between laboratories; 4) make judgments and set priorities (corrective actions to be performed); and 5) support accountability, quality improvement and accreditation.
In particular, the implementation and revision of QIs represent fundamental requirements of the ISO 15189: 2012 [7]. 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. Therefore, the experts participating at the Consensus Conference did agree to revise existing QIs at the light of both their importance and applicability.
As quality is a never-ending journey, the implementation and adoption of QIs should be viewed as dynamic process, starting from a high priority QIs and moving toward a more sophisticated level which necessitates of a close interaction between laboratory professionals and other healthcare operators. Table 1 List of QIs (order of priority: 1, mandatory; 2, important; 3, suggested; 4, valuable).

Conflict of interest statement
Authors' conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding: None declared.