On the importance of proficiency tests for pathology
In general, a proficiency test is a self-contained aptitude or performance test organized for a group of participants (pathology institutes). It is defined and described in accordance with the relevant standards (source: DIN EN ISO/IEC 17020 and 15189).
Information and checklists for the standard norm can be obtained from the responsible accreditation body.
Proficiency tests are important and indispensable instruments of external and internal quality management (QM). They make it possible to certify the validation of technical processes. The participants of a proficiency test receive the necessary test sets for their analyses from QuIP. Their proficiency test results are collected and statistically analysed at QuIP. The comparison of the results of immunohistological proficiency tests enables statements to be made regarding the analysis quality and in case of educational proficiency testing, also regarding the staining quality of the participating institutes. Upon the successful completion of a proficiency test, the participant receives a certificate, which not only documents the test results, but with which the participating institute can prove the quality of their results. By participating in proficiency tests, the institutes collect and receive data, which, when compared to previous performances, can be seen as their own quality management. They can also see where they stand in comparison to other participants through the anonymous benchmarking that is included in the evaluation and proficiency test report. They will be able to empirically evaluate the performance of their core processes in both cases.
Proficiency tests are considered a suitable tool within the framework of an internal quality management system and for the confirmation of the internal validation of diagnostic procedures. The relevant standards of certification and accreditation procedures demand the participation in proficiency tests as well. Moreover, proficiency tests are also an instrument for the validation of investigation procedures. They provide an important boost to the quality assurance, as they serve to guarantee and prove quality-assured structures and processes (source: DIN EN ISO/IEC15189 or 17020).
For the use of antibodies and devices, especially with regard to the IVD regulation coming into force, proficiency tests help to confirm the success of the validation measures performed.
enable the proof of quality
Proficiency tests can fulfil some important tasks in the context of an external quality management system and in proving the competence and performance of testing procedures. This is particularly true with the increase in the challenges of individualized medicine, particularly in regards to targeted cancer therapy. The external proof of performance will also increase in importance in the future to enable the most precise therapy to be planned. More weight should therefore be given to the results of molecular and immunohistological proficiency tests in the future as well.
An additional benefit of participating in proficiency testing is the access to the data, analyses and evaluations - and in the case of a successful participation – the opportunity to demonstrate your performance externally.
From this perspective, the participation in proficiency tests serves as a validation of one's performance quality, both internally - for the ongoing quality improvement and externally - as proof of competence, and in some cases, as a prerequisite for the provision of certain services.
Furthermore, the participation in proficiency tests, along with the results obtained from them (data, analyses, as well as evaluation of the results), can also serve as a catalyst for peer dialogues. As often observed in a peer review process, a professional, collegial and collaborative dialogue among scientists takes place when results are examined, evaluated and discussed.
The guidelines of the Scientific Medical Societies have been systematically developed to help physicians make decisions in specific situations. They are based on current scientific knowledge and best practices. They should increase safety in medicine, while taking economic aspects into account. The guidelines are not legally binding for physicians and therefore have no effect on the justification for liability claims nor exemption from liability. They are therefore only a guidance that is based on the latest scientific findings for patient care. Relevant guidelines provided by ESMO and the American Cancer Society can be found in the links below:
In order to obtain the market authorization for a new drug or diagnostic test, the manufacturer must provide proof of performance (in diagnostics). This includes, among other things, the successful participation in proficiency tests that prove and demonstrate the diagnostic competence of the pathologists. In addition, proficiency tests can also verify the quality of a diagnostic test. In the European Union (EU), drug approvals are processed by the European Medicines Agency (EMA), while local authorities such as the FDA, are responsible for new drug approvals in other countries.
The EMA approval procedure requires that pharmaceutical companies submit approvals and proof of quality in all cases (binding proof of quality).
The development of a prototype proficiency test can take up to half a year. The starting point is the requirement of a successful proficiency test as part of the approval process for a new drug. Upon successful participation in the proficiency test, participants receive a certificate and the pharmaceutical company that is applying for the approval receives the final report. This report is a fundamental and crucial document in the drug approval process for companion diagnostics. The tests can be performed using material from a patient material pool, as well as with artificial material from cell lines.
There are two available instruments within the framework of an internal quality management system that can be considered as alternatives to proficiency testing.
Consensus training: the results must be comparable for this alternative method. This can be achieved through subjective evaluations by different pathologists. The comparability of the results is ensured through regular offerings of training. The institutes must regulate when and how all relevant authorized pathologists should independently evaluate suitable samples. The results are compared subsequently to determine which evaluations require follow-up trainings. The consensus trainings must be conducted and documented regularly.
Working in quality circles: Quality circles are made up of small groups of pathologists that meet at regular intervals, under the direction of a moderator, for professional discussions. This is where the professional exchange and comparison of knowledge in pathology take place. The objective of a quality circle is to determine and minimize risks and errors, as well as to continuously improve the processes in pathology. The results of a quality circle must also be documented in writing.