Regulatory compliance associated with contrast media

A basic understanding of the role of regulatory agencies in governing the healthcare environment and their influence over contrast media use is required of radiographers and imaging administrators to meet the many standards of compliance. In addition, radiology management teams must consider cost effectiveness, departmental efficiency, workplace safety, and compliance in choosing to implement new products. Regulatory agencies may be classified into 2 groups, voluntary and involuntary. Involuntary agencies are governmental agencies mandating regulatory compliance by local, state, or federal laws. Voluntary agencies are precisely that, those agencies an institution voluntarily chooses to participate with, to demonstrate the quality of care they provide. Failure to follow involuntary regulatory guidelines or to participate in voluntary best practice standards jeopardizes patient safety and the quality of care provided, and exposes the institution and the individual to liability risks. Severe penalties may result from a failure to maintain regulatory compliance, including the possibility of large fines, criminal indictments, and loss of third-party reimbursement. Achieving regulatory compliance is never an easy venture with the number of regulatory agencies and standards needing to be addressed. Combining regulatory compliance with the effects of doing business provides quite a challenge for today's imaging departments. A solid knowledge base in regulatory standards along with continuous investigation of new standards will allow departments to evaluate their own processes involved in providing patient care. Recognition of areas of high risk/high volume, including contrast media use, will assist in directing the departments' focus appropriately. A thorough evaluation of the products used and their respective handing and administration, in regard to patient and workplace safety, and appropriate documentation of workplace injuries due to contrast media packaging, will assist in maintaining a high level of compliance.