
@article{ref1,
title="A quantitative approach to clinical risk assessment: The CREA method",
journal="Safety science",
year="2006",
author="Trucco, Paolo and Cavallin, Michela",
volume="44",
number="6",
pages="491-513",
abstract="Similarly to the industry sector in the late '80s, nowadays leading organisations in the healthcare sector acknowledge the fact that human errors and system failures can never be totally eliminated; accordingly, hospitals are moving into the challenge of designing &quot;fault tolerant&quot; systems within care management processes. This new perspective leads analysis in a new direction: from a merely retrospective approach to a joint prospective-retrospective one, based on a complete Clinical Risk Management (CRM) process. Current Clinical Risk Assessment (CRA) methods show their inadequacy when healthcare organisations try to set safety targets or to assess safety performance improvements on a quantitative basis. It is here that the call for further methodological developments clearly emerges. This paper deals with the description of a new CRA method, called CREA (Clinical Risk and Error Analysis), showing improved features with respect to the state of the art. CREA implements not only a quantitative risk analysis of error modes, but also a quantitative assessment of critical organisational factors affecting patient safety, based on Vincent's framework [Vincent, C., Taylor-Adams, S., Stanhope, N., 1998. Framework for analysing risk and safety in clinical medicine. British Medical Journal 316, 1154-1157]. Providing a consistent method for the integration of data analysis and expert judgement, CREA presents a higher level of accuracy and reliability with respect to FMEA/FMECA or HFMEA methods.The method has been tested in a vascular surgery department, where over 2500 surgical operations (5% of which take place in the Emergency Unit) and 15,000 outpatient services are performed in a year. The experimental study concerns risk analysis in drug administration, one of the most common and frequent clinical processes during a general hospitalisation.<p />",
language="en",
issn="0925-7535",
doi="10.1016/j.ssci.2006.01.003",
url="http://dx.doi.org/10.1016/j.ssci.2006.01.003"
}