Sustaining clinical laboratory services inspite of crisis is a recurring challenge to core laboratories. Whether it be responding to pandemics and the related challenges to supply chain, workforce, and workload; cyberattacks and wide spread compromise to critical IT infrastructure; or any other situation where rapid decision making and execution of service change is required, the response to the challenge has common elements. While it is not possible to prepare for every challenge or crisis that may present itself, taking certain preparitory steps can better equipt core laboratories to assure service sustainability and allow more progressive recovery after the challenge. The real world always carries the potential for crisis. Failure to adequately respond can inflect damage that might take years to recover from even threathen the survival of the laboratory. While it is important for laboratory leaders to align with organizational strategic plans under usual conditions, it is also important to make laboratory services robust and sustainable so that services continue to be provided in crisis and out. Adopting innovative approaches can help navigate through both secure and uncertain times. This session will provide participants with insights into: • How to respond to complicated and unexpected challenges. • Turning the times of crisis into times for strengthened value-based laboratory operations. • Making laboratories more resilient and less volunerable during times of crisis.

Specialists in Clinical Pathology and Microbiology support physicians in medical decisions by numerous in vitro diagnostic (IVD) techniques employed by medical technologists and other lab specialists. Leadership in the medical laboratory was mainly focused on supervision and running the laboratory and react on the demands of the attending physicians. This situation has changed recently, in particularly triggered by the Corona pandemic and the novel regulations for the approval of IVD tests (in particular by the IVDR in the EU, sustainability issues such as REACH, the challenging definitions of lab developed tests (LDT), and by alternative ways to get approved tests such as by emergency use authorization). Many of these changes are quite demanding and are able to jeopardize the established system of IVD testing and to endanger patient safety. This session provides insights and ways to react to the participants 1. On the current challenges related to the IVDR and on sustainability issues [1] 2. Threats and options when Laboratory Medicine is no longer restricted to laboratory specialists [2, 3]