Example of the impact of laboratory processes on patient safety: Reflection of 'HBsAg' test results on analytical and post-analytical process management

SUMMARY: Hepatitis B virus (HBV) infections are a group of infections that primarily affect the liver and cause inflammatory hepatitis. This group of infections; In Turkey, it develops as acute hepatitis at a rate of 2% to 10%, and 4% to 6% of these cases later develop as chronic hepatitis. 10% of chronic hepatitis cases face the risk of developing hepatocellular carcinoma (HCC) in the future. Various methods are used in the diagnosis of HBV infections. The most commonly used method in diagnosis is the screening of serological indicators (ELISA tests: HBsAg, Anti-HBs, Anti-HBc IgM and Anti-HBc IgG) in serum. Among these indicators, the 'HBsAg' test is the first test used for screening purposes for HBV infection and in the study and interpretation of test results; Evaluation is made by taking into account various factors related to the patient, employee and test procedure. Accuracy and reliability of laboratory test results; It is a very important parameter in terms of both patient safety and control of laboratory test processes. In our case; Based on the 'HBsAg' test result of one patient, our studies and recommendations regarding the false positive HBsAg test results detected in a total of three patients are included. In the root cause analysis studies conducted on the process of 3 patients with unusual 'HBsAg' positivity; Lack of training among the relevant personnel, lack of awareness, failure to carry out device technical service maintenance checks on time, and deficiencies in communication with clinicians came to the fore. As a result of our work on these inappropriate test results; Regular service maintenance and checks of ELISA devices, follow-up and traceability of quality-control studies, and effective communication between the patient's physician and the patient's clinic will prevent the development of situations that may jeopardize patient safety on a laboratory basis.