Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group “Laboratory Error and Patient Safety” and EFLM Task and Finish Group “Performance specifications for the extra-analytical phases”

Introduction

One of the leading missions of the Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is to stimulate studies on the topic of errors in Laboratory Medicine, collect available data on this issue, and recommend strategies and procedures for improving patient safety in laboratory testing. A recent substantial body of evidence has demonstrated that most errors in Laboratory Medicine occur in the pre- and post-analytical phases of laboratory testing [1], [2], [3], [4], [5]. Therefore, improving the quality of laboratory testing requires a deep understanding of the many vulnerable steps involved in the total examination process (TEP), along with the identification of a hierarchy of risks and challenges that need to be addressed. From this perspective, the WG-LEPS is focusing its activity on implementation of an efficient tool for obtaining meaningful information on the risk of errors developing throughout the TEP, and for establishing reliable information about error frequencies and their distribution. The final purpose is to:

• improve the awareness of laboratory professionals regarding errors and patient safety;

• define performance specifications for the extra-analytical phases of the TEP, so providing laboratories with a benchmark for performance evaluation and increasing knowledge about the critical aspects needing improvement actions.

More recently, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has created the Task and Finish Group “Performance specifications for the extra-analytical phases” (TFG-PSEP) for defining performance specifications for extra-analytical phases [6]. Both the IFCC and EFLM groups are working to provide laboratories with a system to evaluate their performances and recognize the critical aspects where improvement actions are needed.

The WG-LEPS project, which commenced in 2008, aims to define a model of quality indicators (MQI), complying with harmonization criteria and requirements of the International Standard ISO 15189:2012 [7]. Specifically, the quality indicators (QIs) included in the MQI should be representative of all the critical activities comprised within the TEP and should also be measurable by most laboratories worldwide, and be designed to be independent of the health care context, laboratory testing’s purpose and goals, number and types of patients tested, type of activities, sensitivity and training of staff, etc. [8], [9], [10].

A preliminary MQI has been initially developed and tested under actual conditions, by involving laboratories over a 5-year period (2008–2013). All the main findings that emerged during the experimentation phase were discussed in a Consensus Conference held in Padova in 2013 (“Harmonization of quality indicators: why, how and when?”). The 2013 Conference reached a preliminary consensus on terms, rationale, criteria and purpose of each QI and its procedures for data collection [11].

A preliminary set of MQI, reviewed, approved and finally issued after the Consensus Conference, were used since 2014, when a second Consensus Conference was organized in Padova, on 26th October, 2016, entitled “Harmonization of quality indicators in Laboratory Medicine: 2 years later”. The aim of the meeting was to bring together all experts and interested parties for:

• discussing experience previously accumulated in the past few years;

• establishing whether or not the list of QIs should be revised, modified or improved;

• better understanding the feasibility of data collection by clinical laboratories worldwide and identifying additional tools (e.g. based on information technology) which may be effective to further improve the ongoing program;

• streamlining all other potential improvements and the best way to achieve a broad consensus for effective QIs harmonization.

Conference

The 2016 Conference was very successful, hosting participants from 14 different Countries: Australia, Austria, Brazil, China, Croatia, Estonia, France, Hungary, India, Italy, Serbia, Spain, the UK and the USA. The meeting was also attended by representatives of the Executive Board and Education and Management Division Executive Committee of the IFCC; the EFLM Executive Board; the EFLM Working Groups on “Pre-analytical phase” (WG-PRE) and “Post-analytical phase” (WG-POST); Italian scientific societies of laboratory medicine; the Italian accreditation body (Accredia); in vitro diagnostic (IVD) manufacturers.

In summarizing what was reported, the purpose of the 2016 Conference was to achieve wide consensus on which QIs and performance specifications should be used in clinical laboratories worldwide, so complying with the ISO 15189:2012 requirements, monitoring the main critical activities and promoting minimization of error risk. The data collected and published in the past years were discussed by all participants [12], [13], [14], [15].

All QIs included in the last MQI were revisited and discussed, in an effort to investigate to what extent each indicator may still be valid or should be modified, or whether more accurate explanations should be provided (as a note) for better understanding by the users (i.e. laboratory professionals). The discussion was continued after the conference with electronic correspondence exchange.

Despite the importance of using QIs as a quality assurance tool, it was also recognized that the number of participating laboratories applying QIs is not as large as it could and should be. The underlying reasons may be mainly attributable to time constraints and shortage of human resources for data collection, which may make it difficult to implement most QIs and to assure continuous participation over time. Moreover, some national surveys organized by national scientific societies or external quality assessment (EQA)/proficiency testing (PT) providers, using a limited number of QIs proposed by WG-LEPS, have potentially distracted the focus on the MQI project.

According to the consensus of the 2014 EFLM Strategic Conference “Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory Medicine”, for the definition of performance specifications the models based on the impact on clinical outcome and on the state-of-the-art have been discussed, as the biological variation model is not applicable to extra-analytical QIs [16]. In particular, it has been widely recognized that performance specifications based on a reliable state-of-the-art, defined on QIs’ data, is the most feasible and attainable criterion to be immediately applicable because no data can be collected from clinicians’ opinion. Participants’ views have been exchanged regarding the opportunity to define one, two or even three limits for defining laboratory performance. In particular: one limit set at the 25th percentile to define the acceptable or unacceptable performance; two limits set at 10th–80th percentiles for high, medium and low performance; three limits set at 25th–50th–75th for high, medium, low, unacceptable performance, respectively [17].

Finally, considerations about the information in the reports currently generated for the single laboratories participating in the WG-LEPS project have been exchanged, in order to evaluate their completeness, adequacy and effectiveness. Importantly, all participants approved the reports without modifications, so judging them to be adequate and useful for identifying local laboratory performance and allowing benchmarking with other laboratories both in the same country and around the world.

Consensus statement

A general agreement was achieved. The main outcomes of the conference have been the release of a new version of MQI, the approval of a criterion for establishing performance specifications and the definition of the type of information that should be provided within the report to the clinical laboratories participating in the QIs project.

Future achievements

Despite the large number of papers published and the many presentations during international scientific meetings, a large and steady participation of clinical laboratories to the MQI project has been difficult to achieve. At the 2016 Conference, the need of using QIs has been emphasized once again, and proposals on applicable strategies were discussed among participants. An agreement on the following activities was finally reached:

• involvement of national scientific societies, accreditation bodies and EQA/PT providers of different countries, as a means for disseminating the MQI project and promoting the participation of laboratories;

• selection and appointment of a National Leader, who should coordinate and manage the MQI project in each country. It is expected that the National Leader should (i) encourage the use of MQI; (ii) “personalize” the use of QIs in daily practice according to national practices, requirements and regulations; (iii) co-operate with members of the WG-LEPS and TFG-PEPS providing valuable suggestions or improving the project;

• definition of guidelines supporting the use of QIs along with implementation of improvement actions in clinical laboratories.

• update of the website www.ifcc-mqi.com (i.e. entering QIs data).

• identification of automated and computerized systems for a easy and systematic data collection and recording [18].

Conclusions

The valuable experts’ contribution and the consensus statements described in this article should hopefully pave the way to better understand the need of a harmonized MQI. On the other hand, the definition of performance specifications for each of the identified QI is as an essential prerequisite for improving the quality and safety in Laboratory Medicine. Although the conclusions of the Consensus Conference should be disseminated to the laboratory community to allow for further advancements in this area, supplementary changes and improvements should probably be introduced in the future according to experience and information from collected data.

The projects aimed to lower the risk of errors in the TEP, and in particular in extra-analytical phases of the TEP, require continuous monitoring of laboratory performances by measuring QIs combined with reliable corrective/preventive actions driven by the evidence collected. Therefore, the MQI developed and managed by the WG-LEPS shall be seen as an external quality assurance project which may allow clinical laboratories to receive a report of their performances over time and a trustworthy benchmark with other laboratories participating in the project and, most importantly, with objectively established performance specifications. This may also provide evidence-based information for worldwide benchmarking and definition of efficient improvement policies.