Using three external quality assurance schemes to achieve equivalent international normalized ratio results in primary and secondary healthcare.

OBJECTIVES: Accurate prothrombin time international normalized ratio (INR) results are essential for safe anticoagulation treatment. Patients are treated both in primary and secondary healthcare, therefore equivalence of INR results from point-of-care (POC) and hospital measurement procedures (MPs) are important. It is not possible to evaluate this equivalence in traditional external quality assessment (EQA). The aim of this paper is to describe a special quality assurance system consisting of three different EQA schemes to monitor the harmonization of INR results in Norway. METHODS: The EQA scheme for hospital laboratories uses commutable control materials and evaluates participant performance and the equivalence of hospital MPs. The EQA scheme for primary healthcare laboratories uses non-commutable control materials and evaluates participant performance. A third EQA scheme for selected primary healthcare laboratories uses native patient split samples and evaluates the equivalence between POC and hospital MPs. RESULTS: The relationship between the three EQA schemes is presented. The split sample EQA scheme provides a link between the hospital scheme and the scheme for primary healthcare. Results from 2017 to 2022 are presented for all three schemes. When aberrant EQA results occur Noklus takes actions to be able to have a sustainable equivalence between INR results. CONCLUSIONS: All three EQA schemes are important for monitoring the harmonization of INR results in Norway. This quality assurance system, including help and guidance of the participants, will reduce the risk of harm to patients due to non-equivalence of results from different MPs.