The drafting of the rulebook on external quality assurance (EQA) for Serbian clinical microbiology laboratories started roughly a year ago as part of the Twinning project, when an ad hoc working group was established.
The document went through numerous rounds of discussions by the experts participating in the working group and finally it was moved under the spotlight of a wider audience. On 25 April, a meeting was organized to discuss in detail, paragraph by paragraph, what has been done and proposed for implementation.
The starting point is that there is no regulated or systematic external quality assurance programme for microbiology laboratories in Serbia. Yet, the participation of laboratories in external quality rounds is a prerequisite for patient safety and public health control, for diagnostic integrity, testing consistency and credibility. Setting up a functional model of external quality assurance requires certain preconditions, and a regulatory framework is one of them.
The meeting convened relevant experts from various Serbian public health organisations and Serbian Ministry of Health. Also, THL experts took active and constructive part. The discussions went at times quite dynamic and vigorous, and covered a great diversity of issues from small details to the wider scope of the subject matter under preparation, including organizational and legal aspects.
Substantial portion of the meeting was dedicated to the discussion and clarification of the key terminology, as the participants seemed to have ambiguous and diverse notions.
One of the most challenging issues discussed was the minimum frequency by which participation in EQA rounds should take place, which depends e.g. on testing volumes. The THL experts explained the practices on EQA in Finland and proposed, as a starting point for the rulebook, that the tests which are performed at least weekly in the laboratory should undergo EQA rounds at least every two years. This seemed to be agreeable to the audience, which also suggested that the situation on the overall implementation of EQA in the Serbian microbiology laboratories should be assessed after a couple of years after the rulebook has taken force.
The THL experts reinforced their position that National Reference Laboratories should not be defined as the primary organizers of national EQA rounds in their specific microbiological mandates. The NRLs should concentrate on different tasks and leave the EQA rounds to organisations specializing in this type of work.
Last but not least, the EQA oversight and coordination bodies should be clearly defined and nominated.
All comments and suggestions were collected at the meeting, and an updated version of the EQA manual will soon be produced and circulated to experts.