Committee on Proficiency Testing (C-PT)

Membership

Aims

• To facilitate the introduction of international proficiency testing schemes for uncommon but clinically important measurands.
• To use the information to select measurands that may be suitable for method harmonization as a means to improving patient outcomes.

Objectives

• To establish a small group of clinical and scientific experts who represent both suppliers and users of 'uncommon but clinically important' laboratory medicine methods.
• To agree a definition of an 'uncommon but clinically important' measurand and the body of evidence that is required to meet that definition.
• To write a specification for operating an international proficiency testing scheme.
• To survey IFCC Members and IFCC functional units to receive suggestions for 'uncommon but clinically important' measurands.
• To prioritize the suggestions received and to assess the potential for international proficiency testing and the likely support of manufacturers of available methods.
• To establish the availability of proficiency testing schemes for the identified measurands. Where proficiency testing schemes exist to assess their potential for expansion at an international level. 
• In the absence of suitable proficiency testing schemes to invite bids to provide measurand specific proficiency testing in accordance with the agreed specification.
• To recommend to the Executive Board proficiency testing schemes that may be set up under the auspices of IFCC.
• To monitor performance in IFCC supported proficiency testing schemes and to support the preparation of scientific publications at appropriate points in time.
• To use performance data from IFCC supported proficiency testing schemes to propose measurands for harmonization in line with www.harmonization.net.

Background

IFCC has been recognized for his leading role and efforts towards the standardization of Clinical Laboratory methods. Many commercially available IVD tests acknowledge, in their inserts, the use of the IFCC methods. The work of the federation also led to new analytical approaches, that although recognized by the different regulating bodies there are not still unanimously accepted worldwide as with the HbA1c.

However, for the more recent tests, but also for some of the simplest and oldest assays where new calibration definitions are recently established form IFCC work and approved by the IVD industry, still harmonization of the results is far to be achieved. In order to resolve these issues AACC introduced the project of the harmonization of clinical laboratory test results.

The role of Proficiency Testing schemes (or External Quality Control programs) is of primordial importance to the analytical quality, to the standardization of the methods and to the harmonization of the results, but there is a lack of interest from the commercial providers of such schemes, either for the more new and complex tests and for the very old and simple measurands that involve a new calibration curve, because of the very subtle problems induced at the interpretation of the statistical results of their, already well-established and running, schemes. Meanwhile, IFCC has already the resources and knowledge by the involvement of member societies running Proficiency Testing schemes as non-profit organizations, but also by the expertise of some of their distinguished scientists, as they have the know-how to design and produce the necessary novel control materials for specialized External Quality Control programs.

A multidisciplinary effort had assigned to the Committee on Proficiency Testing (C-PT) (ex. Task Force on Proficiency Testing or TF-PT) involved in the analysis and the exploration of the above mentioned of Proficiency Testing issues. This could lead to the establishment of specialized schemes under the hospices and recommendations of the IFCC and could greatly enhance and help to the prevalence of the methods derived from the work of the federation and to the harmonization of laboratory results.

Achievements during 2013-2017

The central project of the C-PT is the creation of an online database - web application or PT-DB, accessible via web browsers but also via specific applications for the major mobile platforms with much more functionalities and ease of use. The roots of this database are the analytes (tests, measurands) that can be filed with all possible synonyms (one of them will be the "official" as proposed from the Nomenclature, Properties and Units (C-NPU) committee of the SD) as also as the methods (assays, instruments, reagents etc) also with all possible synonyms.
All register users can add any term in the database, although the application will propose similar ones if there are already filed, searching all the possible synonyms (according to the database of methods and analytes of the C-NPU), and if there is already filed they can "vote" expressing their desire for the introduction of a PT for this analyte.

Another part of the PT-DB, maintained with the cooperation of C-AQ and of EQALM, is the PT providers section containing all their contact information, their programs with the analytes, frequencies, type of statistics, commutability of control materials, their accreditation or certification status etc.

The database is accessible for consultation freely to all visitors of IFCC site, but only registered users have modification privileges. The registration of users is by invitation from the NR and the CM, via the IFCC secretariat and from the EQALM. The registered users have the possibility to invite more members via the application.

The access of this database - application via the IFCC web site allows the use of institutional computers, workstations and networks (at public laboratories, universities etc.), that are often blocking the access to similar open source platforms as doodle, election buddy etc., by their policies and their IT administrators, reaffirming the authority of the IFCC. In conclusion, this database interactively links our colleagues, final users of the tests, with PT providers, IVD manufacturers, accreditation bodies etc. and facilitates the search for a PT scheme for "rare" esoteric or new analytes, or the introduction of a new one if needed. Automated algorithms with well-defined thresholds will send request to appropriate PT providers, if an analyte has exceeded the limit of the required votes, and if a corresponding PT scheme will be implemented the analyte will be removed from the list and the new scheme will be registered care of C-PT assigned members. IVD manufacturers want also to establish such PT schemes prior to the introduction of new assays (as for example, those concerning the personalized medicine and the companion diagnostics). Moreover, it can be used for the tasks of harmonization project of the AACC.

The TF-PT had his kick-off meeting during EuromedLab 2014 in Istanbul, in presence of the invited members of the C-AQ. Afterwards, the members of the TF-PT had a meeting with the board of EQALM in Toulouse at the end of October 2014, in order to request a close cooperation and the participation of EQALM to the PT-DB.

Early October 2015, TF-PT and EQALM agreed to co-organize a symposium on EQA issues at the EuroMedLab Athens 2017 congress.

Moreover, at the EuroMedLab 2015 congress in Paris the members of the TF-PT had their second annual meeting. The result of this meeting was the production of two draft documents: one entitled “Exploration and Clarification of Specifications for the PT-DB Project” containing analytically the terminology of the project, and one entitled “Webpage IFCC Market Place Forum Supply and Demand EQA” describing the basic workflow diagram of the proposed application-database with various examples in a table form and the IT provider of the IFCC, using this preliminary workflow and schematic of the database - web application started the implementation of the PT-DB project.

A functional prototype of the database - web application has been presented at the Madrid General Conference of IFCC. During this meeting the Chair of the TF-PT presented an interactive workshop entitled “Meeting the clients with the producers on Proficiency Testing of rare analytes” describing the aims, the projects, and the prototype of the online database - web application. This presentation can be found at the following address: http://www.ifcc.org/media/412855/S6.12.Haliassos_WS_GC2016.pdf. Moreover, at the Madrid General Conference, the members of the TF-PT had their third annual meeting. Following this meeting, the TF-PT in cooperation with the Committee on Analytical Quality (C-AQ), prepared two mails, to be sent automatically by the database - web application when this project will be rolled out, to the scientific community. These mails invited the PT-EQA providers to cooperate for the PT-DB project and register or update the data of their organizations in the database, and requested the cooperation of the National Representatives of the IFCC in order to spread the word about the functionalities of the database - web application project to the PT-EQA providers of their countries.

During the fall of 2016 at the EQALM EB meeting in Barcelona, was finalized the participation and the help of the EQALM members for the implementation, updating and maintenance of the PT-DB, especially the “P”roviders section. The final details of the scientific program for the co-organized symposium on “EQA-PT issues” at the EuroMedLab Athens 2017 congress had been discussed during this meeting.

The roll out of the “P”roviders database has been achieved at the middle of February 2017 and the, previously mentioned, letters to the PT providers and the National Representatives had been sent during March 2017. As a result, the PT database has been updated by the organizations already included and amended by new PT providers listing their schemes. As for today (January 2018) we have 68 providers from all around the world registered in the PT-DB and the latest additions are from Mexico, Russian Federation, Iran and India. The PT-DB can be consulted directly at http://ptdb.ifcc.org/providers

During the EuroMedLab 2017 congress in Athens, the members of the TF-PT had their fourth annual meeting and decided to start the development and the implementation of the “A”nalytes section of the PT-DB and to start adding all the common analytes from the already registered EQA-PT providers. In order achieve this goal they initiated the production a document describing all the fields required for the creation of an Analyte record and documenting this procedure. As a starting point the biomarkers of neurodegenerative diseases had been selected, as they are quite complicated, but well documented and members at the committee have expertise in these markers. 

During the EuroMedLab 2017 congress in Athens, the symposium on EQA-PT issues entitled: “External quality assurance - just a necessary evil or a valuable tool in laboratory management?” has been co-organized with the EQALM with great success.

From January 2018, according to the re-organization plan of the IFCC TFs, the TF-PT has become a Committee, the C-PT, under the Education and Management Division (EMD).  

Plans for 2018-2020

After the implementation of the document, describing all the fields required for the creation of an “A”nalyte record and documenting this procedure, the development of the “A”nalytes database of the PT-DB will be started. At the same time, the C-PT will start the development of e-documents describing the use of the database - web application (manuals).

During the fall of 2018 at the EQALM EB meeting at Zagreb the next steps of the participation and the help of the EQALM members for the implementation, updating and maintenance of the PT-DB and the panning of a new co-organized symposium during EuroMedLab Barcelona 2019 congress will be discussed.

In addition, during the winter of 2018, the next meeting of the C-PT members is planned by teleconference and their fifth, face-to-face, annual meeting is planned during the next IFCC General Conference. 

Cooperation:

1. The Committee works in close association with the IFCC Committee for Analytical Quality (C-AQ).
2. The Committee will work in cooperation with the Join Committee for Traceability in Laboratory Medicine (JTLM).
3. The Committee will work in close association with the IFCC Committee Nomenclature, Properties and Units (C-NPU).
4. The Committee liaises with the EQALM and many relevant international or regional providers of proficiency testing in laboratory medicine. 

List of Corresponding Members, nominated by National Societies

Chair

Dr. Alexander Haliassos
ESEAP - Greek Proficiency Testing Scheme for Clinical Laboratories
GSCC-CB
47 Alopekis Str
GR-106  76 Athens
Greece
email: haliassos@moleculardiagnostics.gr

Members

Berna Aslan
Associate Director, External Quality Assessment
QMP-LS/IQMH
393 University Avenue, Unit 1500
Toronto ON M5G 1E6
Canada
email: aslan_berna@hotmail.com

Anna Carobene
Standardization Laboratory in Clinical Chemistry
San Raffaele Hospital
Via Olgettina 60
20132 Milano
Italy
email: carobene.anna@hsr.it

Armand Perret-Liaudet
Directeur laboratoire des maladies à Prion et d'Alzheimer
Centre de Biologie et pathologie Est
Hôpitaux de Lyon
59, Bd Pinel 69500 Bron
France
email: armand.perret-liaudet@chu-lyon.fr

Cas W. Weykamp
Queen Beatrix Hospital
Clinical Chemistry
Beatrixpark 1
7101 BN Winterswijk
The Netherlands
email: c.w.weykamp@skbwinterswijk.nl 

Jian Dai
Siemens Healthcare Diagnostics Inc.
Newark DE 19702
USA
email: j.dai@siemens.com

Michael Rottmann
Director, assay development Endocrinology
Thyroid, Sepsis, RA
Roche Diagnostics GmbH
Roche Professional Diagnostics
Nonnenwald, 2
82372 Penzberg
Germany
email: michael.rottmann@roche.com