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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

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Source Normalized Impact per Paper (SNIP) 2018: 1.205

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1437-4331
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Volume 55, Issue 10

Issues

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”

Laura SciacovelliORCID iD: http://orcid.org/0000-0003-3156-1399 / Mauro Panteghini
  • Department of Biomedical and Clinical Sciences ‘Luigi Sacco’, University of Milan, Milan, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Giuseppe LippiORCID iD: http://orcid.org/0000-0001-9523-9054 / Zorica Sumarac / Janne Cadamuro / César Alex De Olivera Galoro / Isabel Garcia Del Pino Castro / Wilson Shcolnik / Mario PlebaniORCID iD: http://orcid.org/0000-0002-0270-1711
Published Online: 2017-07-08 | DOI: https://doi.org/10.1515/cclm-2017-0412

Abstract

The improving 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 Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) 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. 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. 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. A Consensus Conference was organized in Padova, Italy, in 2016 in order to bring together all the experts and interested parties to achieve a consensus for effective harmonization of quality indicators (QIs). A general agreement was achieved and the main outcomes have been the release of a new version of model of quality indicators (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 to the QIs project.

Keywords: extra-analytical phases; harmonization; patient safety; performance specifications; quality indicators; total testing process

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.

Model of quality indicators

The reviewed MQI are reported in Tables 13. A general agreement was achieved for all QIs included in the MQI. Several measurements (53) have been identified to monitor 27 QIs (Table 4) and some explanatory notes have been exploited for facilitating interpretation of measurable events.

Table 1:

Quality Indicators concerning the key processes.

Table 2:

Quality indicators concerning the support processes.

Table 3:

Quality indicators concerning the outcome measures.

Table 4:

Number of QIs and measurements included in the model of quality indicators issued in the Consensus Conference in 2016.

The agreed MQI are now (2017) available from the dedicated WG-LEPS website (www.ifcc-mqi.com), as an External Quality Assurance Program (EQAP). The participating laboratories are not required to use all the QIs proposed in the MQI. They can, at least in the initial phase, select the most appropriate QIs for their specific setting (particularly from among those rated as “priority 1”) and collect and report the corresponding data. Afterwards, they may eventually implement and use additional QIs.

Data of participating laboratories will be collected through the dedicated website and each participant will have a confidential username and password for assuring confidentiality.

Performance specifications

The limits for evaluation of laboratory performance are fixed at the 25th and 75th percentile according to the QIs data collected during the previous year. The performance is then classified as follows:

  • individual results <25th percentile of value distribution=performance of high quality;

  • individual results between 25th and 75th percentile of value distribution=performance of medium quality;

  • individual results >75th percentile of value distribution=performance of low quality.

At the end of each year of data collection, QIs data from participating laboratories will be processed and analyzed, so allowing the calculating of the 25th and 75th percentiles to be used as performance limits for the following year (for 2017, 2016). The new performance specifications will be introduced only if the state-of-the art is improving, otherwise previous quality specifications should be active. This criterion, based on the state-of-the-art, allows aligning performance specifications to the path of general laboratory improvement and, at the same time, laboratories will not be discouraged from reaching unattainable limits, but will still acknowledge that achieving better performance is possible.

Notably, when the QIs data were used to measure the desirable events (Post-Comm, Supp-Train, Supp-Cred, Supp-Phys, Supp-Pat), the high and low levels of performance corresponded to the 75th and 25th percentiles, respectively. When the percentile values were equal, the use of a single value was feasible.

Table 5 reports, as an example, quality specifications concerning some QIs based on results collected in the 2016 year.

Table 5:

Example of performances specifications for some QIs of the key processes.

Data reporting for laboratories

The participants’ reports to the EQAP should include the following information.

  1. Statistical data:

    1. laboratory result related to the specific period during which data has been collected and the relative value calculated using Six-Sigma Metric (sigma value=short-term sigma, which allows drift of 1.5);

    2. mean of sigma values for participants of the same country;

    3. mean of sigma values for all participants.

  2. Time trends of both results and sigma values.

  3. Frequency distribution of both results and sigma values.

  4. Laboratory performance categorization according to the performance specifications.

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.

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About the article

Published Online: 2017-07-08

Published in Print: 2017-08-28


Participants at the conference: Mario Plebani (Italy), Laura Sciacovelli (Italy), Eva Ajzner (Hungary), Tony Badrick (Australia), Janne Cadamuro (Austria), Alex De Olivera Galoro (Brazil), Paul L. Epner (USA), Maurizio Ferrari (Italy), Elisabeth Frank (India), Isabel Garcia Del Pino Castro (Spain), Mercedes Ibarz (Spain), Agnes Ivanov (Estonia), Giuseppe Lippi (Italy), Keila Furtado Vieira (Brazil), Frederick Meier (USA), Mauro Panteghini (Italy), Rui Zhou (China), Rui Zhang (China), Wilson Shcolnik (Brazil), Xiaomei Tang (China), Zorica Sumarac (Serbia), Anne Vassault (France).

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 55, Issue 10, Pages 1478–1488, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2017-0412.

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