Healthcare Inspection - Informed Consent and Prevention of Disease Progression in Veterans with Chronic Kidney Disease

The OIG assessed the extent to which informed consent was documented for veterans with chronic kidney disease who underwent procedures that involved intravascular injection of contrast media, and described efforts to minimize kidney injury. OIG identified 107 patients with pre-existing kidney impairment who underwent cardiac catheterizations or peripheral vascular procedures during April 1-July 30, 2010. These patients needed to be aware of their higher risk of kidney injury in order to give informed consent. OIG found that, although 101 patients (94 percent) signed informed consent documents, only 24 of informed consent documents (22 percent) included any information about the risk of kidney injury. Explicit reference to the increased risk of kidney injury associated with contrast media for patients with pre-existing kidney disease was present in only two informed consent documents. However, practitioners evidently were aware of the increased risk of kidney injury because they ordered interventions to mitigate kidney injury in 93% of these high-risk patients. OIG recommended that the Under Secretary for Health implement a plan to ensure that patients with chronic kidney disease who are undergoing procedures requiring contrast media be provided sufficient information to give informed consent.