Laboratory medicine faces unprecedented challenges worldwide. Demand continues to grow year on year both in volume and complexity as populations age and healthcare becomes ever more sophisticated. Crude test numbers are rising at between 6% and 10% per annum1 and revenue continues to fall, at least in relative terms, irrespective of the type of funding system. In the UK, the Department of Health is looking to an absolute cut in annual pathology costs of 20%.2 In Australia, the federal government has capped growth in the pathology budget at 5% per annum for the next 5 years, closely linked with a variety of strategies effectively focusing on demand management. The equivalent move in the USA is a cut in the clinical laboratory fee schedule for Medicare of 1.75% year on year until 2015, capped off by an additional 2% cut enacted by Congress in February 2012. With a stagnant general economy, patients benefiting from employer based health schemes are expected to meet an increasing percentage of their health costs and this is leading to an escalating bad debt problem for commercial pathology in the USA.

Falling revenue needs to be set against a background of rising overheads, not simply in terms of consumable costs and maintenance but due to the increasing diversion of resources to manage regulatory compliance and an upward trend in litigation. In the USA, federal and state clinical laboratory regulators are tightening enforcement of the demands of the Clinical Laboratory Improvement Act well beyond the hospital environment. In the UK, Clinical Pathology Accreditation and peer review processes are now complicated by the introduction of the Care Quality Commission. And there is a global trend towards the use of the more demanding ISO 15189 as a benchmark for competence. In North America, traditionally in the vanguard of medicolegal …