Statement of the Joint Diagnostics Commission of DVV and GfV on the planned changeover of accreditation to the new DIN EN ISO 15189 and the exclusion of externally provided laboratory services

Statement of the Joint Diagnostics Commission of DVV and GfV on the planned changeover of accreditation to the new DIN EN ISO 15189 and the exclusion of externally provided laboratory services

The planned changeover to the new DIN EN ISO 15189 and the associated regulation on the exclusion of externally provided laboratory activities, in particular the external dispatch of sequencing, raises serious concerns. The Joint Diagnostics Commission of the DVV and GfV would like to give its critical opinion on this and point out the practical effects of this change on virological diagnostics.

The new accreditation requirement that laboratories can only claim conformity with DIN EN ISO 15189 for the activities at their location means that external laboratory services, such as the external dispatch of sequencing, are no longer permitted for DAkkS accreditation. This has a direct impact on the performance of diagnostic procedures involving sequencing and represents a significant restriction.

Important arguments and effects of the planned change:

1. Accreditation of the sequencing laboratory: The laboratory that performs the sequencing is usually accredited and the sequencing meets the high quality standards of the DAkkS. The requirement that all sequencing steps must be carried out in the same laboratory represents an unnecessary bureaucratic burden and does not lead to an improvement in diagnostic quality. Also, not all diagnostic laboratories are able or equipped to carry out sequencing themselves.
2. Economic burden and resource problems: Smaller laboratories with lower throughput rates are particularly affected by this regulation. They have to incur higher costs for carrying out sequencing, as more work is involved and the economies of scale cannot be utilized as they can at larger facilities. The need to set up a specific workflow for sequencing, including the provision of material and human resources, involves additional financial and human resources that may not always be available.
3. Extended processing time: A change in accreditation, which excludes the external dispatch of sequencing, will lead to longer processing times. This is a significant disadvantage, especially for virological tests where rapid diagnosis is crucial.

Conclusion:

The introduction of the new accreditation regulation for DIN EN ISO 15189 is problematic from the point of view of the Joint Diagnostics Commission and represents a significant restriction for virological diagnostics. The non-practical requirements, which are aimed at the exclusivity of laboratory activities at one location, could lead to a deterioration in efficiency and a higher burden on laboratory resources as well as significantly increased costs. The impact on smaller laboratory operations and the availability of personnel must also be taken into account. It should be examined whether a more flexible handling of externally provided laboratory activities is still possible in line with the quality requirements and efficiency of diagnostic procedures.

The Commission is therefore in favor of reviewing and, if necessary, adapting these regulations to ensure that the quality of virological diagnostics is not impaired and that practical and economic aspects are taken into account at the same time.

For the Joint Diagnostics Commission of DVV/GfV.

PD Dr. Nadine Lübke and Prof. Dr. Marcus Panning, Düsseldorf and Freiburg on 10.02.2025
(Chairwoman of the Joint Diagnostics Commission of the DVV/GfV)