Clinical governance: implications for point-of-care testing.

With the introduction of clinical governance in the UK during 1997 and the shift in focus from a purely financial perspective to one of quality, it has become even more important that laboratories become involved with in vitro diagnostic devices (IVDs) used outside the laboratories by non-laboratory personnel, namely, point-of-care testing (POCT). The demand for POCT is increasing and its growth will continue with advances in technology, increasing pressure to shorten patient length of stay and requirements to decrease turnaround times, alongside the national initiatives to consolidate laboratories. However, clinical governance is about practising evidence-based medicine, and both the clinical and cost-effectiveness of POCT continue to be debated. Accountability and leadership are pivotal in the implementation of clinical governance. Thus, the onus is on laboratories to take the lead for POCT and ensure that there is a robust risk management strategy to protect not only the staff, but, importantly, the patient. A rigorous POCT policy and national guidance must be adhered to. For a high quality POCT service to be delivered, fulfilling the requirements of clinical governance, a multidisciplinary local group must be established with recognized accountability, appropriate resources and, importantly, management support.