Eliminating manual steps, reducing opportunities for errors, and improving quality are among today’s labs most pressing challenges that are being addressed by Lean quality management. One area where Lean principles have not been broadly addressed is immunosuppressant drug (ISD) testing, which often requires specialized analyzers, dedicated personnel, and complex sample handling techniques.
Because organ rejection in transplant patients can occur at any time, lifelong administration and monitoring of ISDs is required to prevent graft rejection and minimize serious adverse drug reactions. Consequently, transplant physicians and coordinators require rapid and accurate ISD test results to appropriately manage their patients. Unfortunately, not all laboratories perform ISD testing as part of their routine workload. In those that do, ISD results are not always available 24 hours a day, 7 days a week. Hence, the information clinicians need to make critical decisions may not always be available.
In many labs, ISD tests are performed in batch mode by dedicated laboratory personnel because the testing requires complex, specialized handling procedures including manual pretreatment and extraction steps that extend the turnaround time (TAT) for reporting results. Slow TAT due to less efficient processes could impact transplant patient management.