Requirements for quality assessment in coronary angiograph and angioplasty.

The application of formal methods of quality assessment in medicine is a relatively new activity. Interventional cardiology is expected to be one of the fields of clinical medicine adopting formal schemes of quality assessment at a relatively early phase because of its invasive nature, the associated risks, the rapid growth of this treatment and the correspondingly increasing total cost. We therefore aim to compile the requirements for the development of quality assessment schemes in angioplasty and coronary angiography. The rather disparate nature of methodologies applied in previous and present quality initiatives is reviewed, grouping the numerous methods of organizing quality initiatives found in the literature into a few generic schemes. This new classification of methods is provided as a prerequisite for the discussion of general problems inherent in current quality initiatives in the medical field and for the selection of approaches to quality development best suited for the environment of the catheterization laboratory. Here we identify the concrete steps of goal definition, quality indicator selection, definition of standards and thresholds for these indicators and the selection of a quality management scheme for monitoring the aspects of quality previously defined. Because of the limitations of each of the original methodologies of quality assessment, we propose a synthesis of the most important approaches as the basis for new quality initiatives in interventional cardiology.