Above reproach: developing a comprehensive ethics and compliance program.

How can a healthcare organization improve the public's confidence in the conduct of its business operations? What can it do to ensure that it can thrive despite being the subject of public and governmental scrutiny and doubt? Healthcare providers must establish standards of conduct that are above reproach and ensure that those standards are clearly articulated and strictly adhered to. This article describes the merits of a comprehensive ethics and compliance program, suggests five basic elements of such a program--organizational support/structure, setting standards, creating awareness, establishing a mechanism for reporting exceptions, and monitoring and auditing--and then demonstrates how those elements should be applied in several high-risk areas. Fundamentally, an ethics and compliance program has two purposes: to ensure that all individuals in an organization observe pertinent laws and regulations in their work; and to articulate a broader set of aspirational ethical standards that are well-understood within the organization and become a practical guideline for organization members making decisions that raise ethical concerns. Every ethics and compliance program should contain certain fundamental aspects. First, the effort must have the active support of the most senior management in the organization. To instill a commitment to ethics and compliance absent a clear and outspoken commitment to such purposes by organization leaders is simply impossible. Second, an ethics and compliance program is fundamentally about organizational culture--about instilling a commitment to observe the law and, more generally, to do the right thing. Third, ethics and compliance are responsibilities of operating management (sometimes called line management). Although staff such as compliance officers are obligated to provide the necessary resources for a successful program and to design the program, such staff officers cannot achieve implementation and execution. Only operating managers can do that. Fourth, an ethics and compliance effort should be about the conduct of individuals, not about "checking the boxes" in a model plan or generating attractive written or educational materials. Such an effort is about individuals on a day-to-day basis knowing what is expected of them and doing it and about never compromising integrity, regardless of pressures faced. A great deal of progress has been made in healthcare organizations in the development of increasingly sophisticated ethics and compliance programs. A particularly energetic focus has been placed on these programs since formal government guidance regarding compliance programs was first issued in the laboratory area about two years ago and as more sophisticated automated monitoring tools have been developed. As ethics and compliance programs have become more sophisticated, certain best practices have been established. This discussion will set forth approaches to ethics and compliance in the context of what are believed to be illustrative best practices. Much of what is described here is descriptive of the efforts of Columbia/HCA Healthcare Corporation from October 1997 to the present; however, this article has been presented not as a mere descriptive piece but rather as a set of normative guidelines. We hope that other healthcare providers will find this to be of practical use. Provider settings pose certain unique challenges that are specifically addressed in this discussion; however, many of the issues raised can be adapted to other healthcare organizations. For simplicity's sake, because the authors of this article all work on a daily basis primarily with hospitals, the article is written from a hospital perspective.