Reducing medical errors and enhancing patient and staff safety is a prime focus in modern medicine. But what is “risk”?

Put simply, a risk is any uncertainty about a future event that might threaten an organization's ability to accomplish its mission. It is the chance of something happening that will have a negative impact on an organization's objectives. In particular, risk is the possibility of suffering “loss”: loss of quality of outcome, loss of professional regard or profile, loss of referrals, loss of patient/staff health (or even loss of life), loss of profitability, loss of success. It is said that failure is a key part of learning, and that in business risk and opportunity often go hand-in-hand, with risk per se not only being not bad, but even essential to progress. Clearly such a perception of risk “as a good thing” is not acceptable in IVF Centers.

Continued developments in reproductive biomedicine, combined with heightened regulatory requirements, have led to more, unexpected, and often complex, risk issues for IVF Centers. It is now more important than ever to be proactive in identifying risk and taking appropriate preventative measures, hence IVF Centers must embrace risk analysis and risk minimization. Together these constitute risk management which is an integral part of total quality management or “TQM” (see Chapter 3) and any ISO 9000 family-compliant quality system or laboratory accreditation scheme.