An Audit Study of the Changes in Hepatitis C Virus (HCV) Testing Services among Labtests, Northland Pathology Laboratory and LabPLUS in New Zealand
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Hepatitis C virus (HCV) is internationally recognised as a global burden according to the World Health Organisation (WHO). HCV is a major cause of chronic liver disease, including the liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC). With the development of direct-antiviral agents (DAAs), the treatment regimen of HCV has improved significantly. Medical laboratories play an important role in the diagnosis and monitoring of HCV treatment by using anti-HCV antibodies and HCV RNA. Prior to April 2016, laboratory pathologists had concerns regarding both under- and over-utilisation of HCV RNA tests, impacting on patient’ outcomes and detrimentally affecting clinical resources. In April 2016, the HCV test protocol was changed at Northland Pathology Laboratory, Labtests, and LabPLUS to address this issue. An audit was performed to assess the effectiveness of the changes. This audit found evidence of mis-use of both anti-HCV antibody tests and HCV RNA tests. It was recognised that around 60% of reactive (or positive) anti-HCV antibody test results were inappropriately requested, reflecting an over-utilisation of anti-HCV antibody tests. Out of 70 appropriately requested reactive anti-HCV antibody tests, less than half had appropriate follow up HCV RNA testing, suggesting under-utilisation of the HCV RNA test. Follow up HCV RNA tests are important to determine active HCV infection from resolved HCV infection. Conversely, it was recognised that 35-50% of HCV RNA requests were inappropriately over-requested, resulting in over-utilisation of HCV RNA tests. The HCV protocol changes introduced in April 2016 improved the medical laboratory services to referrers where all reactive anti-HCV antibody results are reviewed, appropriate follow up HCV RNA and/or genotypes are added, and inappropriate HCV RNA requests are rejected by pathologists. This process change has been demonstrated in this audit to have improved the value of HCV tests and to have reduced unnecessary waste of resources. This audit emphasises the need for primary and secondary care to follow current guidelines for HCV testing protocols, from screening populations at high risk of HCV infection to better utilisation of available HCV tests. Hence I order to provide excellent patient care, both appropriate test requesting and minimising over-requesting where-ever possible is required.