The Reference Institute for Bioanalytics (RfB) is one of the two German proficiency testing organizations designated by the German Medical Association as an approved reference institution for carrying out external quality control in the areas B1 to B3 and in the area B5 for molecular genetic tests. As part of the NACHGEFRAGT interview series, MedLabPortal spoke to the Chairman of the Foundation for Pathobiochemistry and Molecular Diagnostics (SPMD), Gunther Schabio, and the Head of the RfB, Dr. Anja Kessler.

MedLabPortal: Dr. Kessler, Mr. Schabio, hand on heart: Do doctors in private practice who carry out laboratory tests in their own practice know what an EQA scheme is?

Schabio: Thank you for this question, the answer to which I can only speculate on. We hope, of course, that doctors who carry out laboratory tests in their own practices know what an EQA scheme is and what obligations are associated with it for the doctors concerned. The term is also mentioned more than 70 times in the guidelines of the German Medical Association for the quality assurance of laboratory medical examinations, the so-called Rili-BÄK. For example, it states that external quality assurance in medical laboratories must take place through regular participation in interlaboratory tests in accordance with the procedures prescribed in the B parts of this guideline.

However, based on feedback from supervisory authorities, we know that – at least in some regions – only a small proportion of doctors in private practice take part in EQA schemes, i.e. external quality assurance as defined by the Rili-BÄK. It can therefore be assumed that not all doctors who carry out laboratory tests themselves are aware of the meaningfulness and necessity of participating in external quality assurance in general and the associated mandatory participation in proficiency tests carried out by reference institutes as defined by the Rili-BÄK. We therefore try to raise awareness of participation in EQA schemes carried out by reference institutions, such as the RfB, through various measures. It is also important to know that participants in EQA schemes only fulfill the requirements of the Rili-BÄK if they participate in EQA schemes from a provider as defined by the Rili-BÄK. This in turn is only the case if the corresponding EQA scheme provider is accredited in accordance with DIN EN ISO/IEC 17043 and also fulfills the other requirements of the Rili-BÄK described in chapters E1 and E2. The DAkkS checks whether the provider fulfills these requirements. The EQA scheme provider is then officially listed by the German Medical Association as a reference institute for the respective areas of the Rili-BÄK in which the provider is permitted to offer EQA schemes. It goes without saying that we fulfill all requirements as an EQA scheme provider as defined by the Rili-BÄK and have therefore also been listed accordingly by the German Medical Association.

MedLabPortal: The need for proficiency testing is therefore a result of the requirements of the Rili-BÄK. What exactly should a doctor who carries out laboratory medical examinations bear in mind?

Schabio: The need to carry out external quality assurance, i.e. to participate in interlaboratory comparisons, arises understandably from the requirement to make quality-assured diagnoses and treatments on the basis of available diagnostics. It was precisely for this reason that the Rili-BÄK was created in the 1970s and continues to exist in the version dated May 30, 2023. As a guideline of the German Medical Association, it is neither a law nor a regulation, but is nevertheless mandatory for doctors to observe as a chamber guideline.

Compliance with the Rili-BÄK is also advisable due to the presumption of conformity in the new Section 10 of the MPBetreibV. This is because the application of the Rili-BÄK fulfills the requirement contained in § 10 for a suitable quality assurance system when operating and using laboratory medical applications. Non-compliance with this requirement is then at least subject to a fine.

However, the change in the content of the regulations due to the new version in Section 10 MPBetreibV compared to the “old” version in Section 9 MPBetreibV is also very important here.

In the old version, the presumption of conformity was triggered by compliance with Part A of the German Medical Association’s guideline on the quality assurance of laboratory medical examinations, whereas now the presumption of compliance with a

quality management system within the meaning of § 10 MPBetreibV only takes place if the Rili-BÄK is observed in its entirety, i.e. parts B1 to B5, for example, are also observed.

Compliance with the Rili-BÄK was also introduced in the contract physicians’ billing regulations. According to § 25 Para. 7 BMV-Ä, compliance with Part A and Part B1 of the Rili-BÄK is required in order to be able to bill the corresponding laboratory services. This means that anyone who does not comply with the corresponding requirement and still carries out corresponding billing, at least within the scope of application of the Bundesmantelvertrag Ärzte, does not meet the requirements for corresponding billable services.

Section 25 BMV-V also contains the following: “The contract doctor who personally provides the in-vitro diagnostic services is responsible for the quality of the services provided, in particular by ensuring that the “Guidelines of the German Medical Association for Quality Assurance of Laboratory Medical Examinations” of the analyses have been complied with.”

Finally, non-compliance with the requirements could not only result in claims for damages under civil law in the event of damage occurring, but could also be relevant under criminal law.

It is therefore advisable to observe the requirements of the Rili-BÄK. This is only the case if a proficiency test at a reference institute listed by the German Medical Association is also participated in for the proficiency tests listed as mandatory in the Rili-BÄK. Participation in proficiency tests at a proficiency testing provider accredited in accordance with DIN ISO 17043 therefore does not fulfill the requirements of the Rili-BÄK if it is not listed by the German Medical Association due to the absence of the other requirements of the Rili-BÄK.

However, the obligation to participate in proficiency tests also arises from other requirements. For example, there is also an obligation for accredited laboratories in accordance with DIN EN ISO 15189 to participate in proficiency tests. The laboratories in question fulfill this obligation if they participate in proficiency tests conducted by accredited proficiency test providers in accordance with DIN EN ISO/IEC 17043. However, the doctors then do not fulfill their obligation under the Rili-BÄK, as only the providers listed with the German Medical Association are eligible for this. I have already pointed this out.

MedLabPortal: So, to put it in layman’s terms, a successful proficiency test is a kind of “TÜV” badge for laboratory medicine?

Schabio: Yes and no. The “TÜV sticker”, i.e. the main inspection and emissions test for cars, is intended to ensure that no unroadworthy or non-compliant vehicle is on the road.

The proficiency test in laboratory medicine is also an external quality assurance. However, it is not (only) about a product, e.g. the quality of an IVD. Rather, it is about the accuracy or measurement precision of laboratory medical examinations. The Rili-BÄK defines the requirements for interlaboratory tests in five areas:

B1 Quantitative laboratory medical examinations

B2 Qualitative laboratory medical examinations

B3 Direct detection and characterization of infectious agents

B4 Ejaculate examinations

B5 Molecular genetic and cytogenetic laboratory medical examinations

However, both the TÜV badge and the round robin test have the idea of quality assurance in common. This is because only those participants who have successfully taken part in the round robin test in accordance with the requirements of the Rili-BÄK receive a corresponding certificate. The certificate certifies that, for example, the required target values have been met, which is why it can be assumed that the respective diagnostics were carried out properly at least on the day of participation – the same applies to the TÜV sticker. Here, the proper condition of the vehicle at the time of the inspection is certified.

MedLabPortal: We have noticed that the Rili-BÄK does not prescribe a mandatory proficiency test for all analytes. Why is that the case?

Kessler: The number of different measurement parameters and examinations that are used for diagnostic purposes is huge and constantly growing thanks to research. The aim of the Rili-BÄK is to continuously improve quality and keep risks for patients and users as low as possible. Therefore, the defined criteria are to be understood as minimum requirements. When selecting the analytes, both the frequency of the examinations and their medical significance according to the current state of science were decisive. In order to continue to meet this requirement in the future, the requirements are regularly reviewed and the listed parameters/examinations are continuously updated. For example, the requirements for molecular genetic examinations have been expanded in the current version, which illustrates the growing importance of this area.

MedLabPortal: To stay with the TÜV image. As you know, it has had a competitor for a very long time. Do you now also have to compete with an increasing number of competitors for customers in the area of proficiency testing at the RfB?

Schabio: Thank you again for this interesting question.

As with TÜV, there are also several competitors in the field of external quality assurance. Competition promotes innovation, better quality and market-driven prices. However, it is important to define exactly who is considered a proficiency testing provider within the meaning of the Rili-BÄK and who is not. Many providers are accredited in accordance with DIN EN ISO/IEC 17043, but only a few – including the RfB as a non-profit reference institute – are also listed with the German Medical Association and are permitted to certify compliance with the Rili-BÄK. Apart from us, only Instand e.V. is listed for B1, B2 and B3 and Instand e.V. for B5 (molecular genetic examinations) and BVDH e.V. for cytogenetic examinations. The requirements for B4 are fulfilled by QuaDeGa GmbH.

If a laboratory participates in proficiency tests of a non-listed provider, it does not fulfill the Rili-BÄK requirements with the consequences already described. The Rili-BÄK also prevents excessive commercialization through clear specifications and ensures that reference institutes act independently and must offer the complete required portfolio listed in the Rili-BÄK for the analytes. This can be a deterrent for new providers, as some analytes are challenging both in terms of the possible number of participants and the specification. Nevertheless, market entry is of course possible at any time.

Incidentally, there are also other EQA schemes outside the scope of the Rili-BÄK. We are therefore already operating in an exciting competitive environment. However, we are very well positioned to successfully master existing and future challenges. Our aim is to optimize existing services and introduce new ones. In the Education service area, for example, we have established debriefing sessions with participants for two proficiency tests this year. Our first face-to-face seminar will take place in November, naturally in Bonn. Of course, we will also be expanding our EQA scheme portfolio. In 2025, we plan to set up a total of 15 new EQA schemes on various issues – including in areas that are not subject to Rili-BÄK requirements. I am sure that we will be able to report on further important innovative solutions at the DKLM.

MedLabPortal: And why should a customer not have the proficiency tests carried out by the cheapest provider? Many hospitals now also employ radiologists in India to carry out the diagnostic work for cost reasons…

Schabio: I can understand the question very well, especially in view of the fact that, according to the DKG, the economic situation of hospitals has reached an all-time low and the new GOÄ has been passed, which, according to statements from some professional associations, would mean a significant financial reduction for laboratory diagnostics.

However, the answer to this question is somewhat more complex. First of all, it should be noted that we are a charitable foundation that is also audited by the supervisory authority, among others. This means that, in addition to operating the reference institute, our foundation’s purpose also includes promoting research in the field of laboratory medicine. The purpose of the foundation does not include the optimization of returns, but in particular measures that serve the continuous improvement and quality assurance of laboratory diagnostic examinations. The employees work towards these goals every day. This also fills them with pride, as they are committed to improving patient safety through their work.

Due to the requirements of the Rili-BÄK, we also offer and carry out proficiency tests that would not be considered profitable by an organization geared towards economic profit, as there would not be sufficient coverage against the background of the development costs, the number of participants and the proficiency test price. We are therefore of the opinion that the price structure of our proficiency tests is very attractive. Every laboratory is welcome to check this, insofar as there is any price comparability at all due to the heterogeneity of the portfolio of the various providers. We are also happy to help with this, as we are convinced of the cost-effectiveness of our offer. Incidentally, we are also of the opinion that, in addition to the price situation, other points could be decisive in connection with the choice of the proficiency testing provider. These include factors such as the handling of the sample material, processing and the presentation of results. These criteria could also be important in the selection process, as process costs are also a very important factor in laboratories today.

But regardless of all these important factors, quality always comes first for us. We owe this to our customers. That is why we focus all our efforts on it.

MedLabPortal: Time plays an important role, especially in the private practice sector. What do the logistics from the sample to the result look like?

Kessler: In my opinion, time always plays an important role nowadays, regardless of whether we are talking about the private practice sector or the hospital sector. We have a clearly and transparently structured EQA program in order to integrate EQA schemes into everyday laboratory work in the best possible way. This means that the laboratory already knows when the program is published, at the latest in October, when the samples will be sent out in the following year and by when the results must be reported to us. In order to keep the time from sample production to delivery as short as possible, we use various parcel service providers to ensure that the samples are delivered as quickly as possible. Transport is particularly challenging for samples such as native whole blood, which must be analyzed promptly and therefore within a short “processing time” of e.g. 3 days. Where justifiable, we therefore also use materials that are lyophilized and therefore very stable in handling until analysis.

In addition to the transportability of the proficiency test samples, the suitability of the materials is very important. This is a challenge when evaluating POCT analyses, for example. In order to meet these requirements, we are continuously working on improving the sample properties.

Once the laboratory has analyzed the proficiency test samples, the results can be sent to us online and forwarded for evaluation.

MedLabPortal: Now, of course, we are wondering in what way you can have your own measurements checked. Simplified: Who checks the inspectors?

Kessler: In the external quality control of our laboratory tests, the target values used for evaluation are crucial. In the field of quantitative analysis, there are target values that are determined statistically from the results of a group of participants – either in relation to all laboratories with identical test systems or to the entire group. On the other hand, there are reference method values: these are determined by accredited calibration laboratories using particularly precise, metrologically traceable measurement methods. The competence of these calibration laboratories is regularly checked as part of accreditation in accordance with ISO 17025 and ISO 15195, and they also take part in international comparison measurements, such as the international round robin test for calibration laboratories “RELA”. This ensures that the “inspectors” are also subject to independent control.

Schabio: In the qualitative area – for example when detecting viruses – control samples are analyzed by reference laboratories, which must also be accredited – in this case in accordance with ISO 15189. Additional laboratories can be consulted in the event of ambiguities or deviating results. This multi-stage system ensures that both the routine and control laboratories work at the highest quality level and that the results are reliable and comparable.

MedLabPortal: Let’s take a look at other countries. RfB EQA schemes enjoy a very high status in Germany – are there plans for RfB expansion abroad?

Schabio: As already mentioned, one of the foundation’s purposes is to implement measures that serve the continuous improvement and quality assurance of laboratory diagnostic examinations. Many of our employees are heavily involved in national and international organizations.

In addition, we are also trying to make the reference method concept, the implementation of which is required by the Rili-BÄK in Germany – a requirement that has a pioneering character worldwide – better known internationally. The concept enables a correct target value that can be retraced and serves as a uniform basis for evaluation for the results of all manufacturers and kits. In our opinion, this strengthens quality assurance, which also leads to an improvement in patient safety internationally.

Our commitment shows: Only through consistent quality control and international networking can we ensure long-term trust in laboratory results. In this way, we make an important contribution to making laboratory quality transparent and comprehensible – today and in the future, both nationally and internationally.

MedLabPortal: Dr. Kessler, Mr. Schabio, thank you very much for your time.

The questions were asked by MedLabPortal editors Marita Vollborn and Vlad Georgescu

Read also:

NEW: RfB offers proficiency test for determination of neurofilament light chain (NfL) in serum – MedLabPortal

_{Editorial office: X-Press Journalistenbürö GbR}

Gender note. The personal designations used in this text always refer equally to female, male and diverse persons. Double/triple references and gendered designations are avoided in favor of better readability.