Abstract

Hospitals and other institutions routinely use laboratory tests to make medical diagnoses, for instance by performing blood or urine tests. Diagnostic laboratories can use commercially available In-Vitro Diagnostics (IVDs) for this purpose. However, they can also develop their own diagnostic tests (known as In-House IVDs), for instance to test for rare diseases, where marketing a diagnostic test does not offer a sufficient return on investment for manufacturers. The commercially available tests qualify as medical devices and must meet certain statutory requirements before they are authorized for the European market. Such requirements do not apply to In-House IVDs. The Netherlands Health Care Inspectorate (IGZ) commissioned the Dutch National Institute for Public Health and the Environment (RIVM) to investigate how frequently In-House IVDs are used, and whether adequate measures are in place to assure their quality. The results showed that over 1200 In-House IVDs are used by 80 of the 122 hospital laboratories and other institutions that took part in this study. In some cases these diagnostic tests are also performed for third parties, e.g. for other hospitals that do not possess the required in- house expertise or equipment. The organizations surveyed devote a great deal of attention to quality assurance during the development and use of these diagnostic tests. Nearly all tests are included in the quality management system of the laboratory where they are used, thus providing sufficient assurances of the accuracy of test results. In addition, the quality management systems in place comply with the applicable guidelines and standards.