The impact of regulations, accreditation standards, and 'healthcare reform' on laboratory practice in the United States

Professional standards of laboratory practice are partially derived from regulatory and accreditation standards of the federal government as well as those of non-government organizations and professional societies. These standards are monitored by on-site inspection and encompass personnel standards, patient test management requirements, quality control and assurance standards and proficiency testing stipulations. Problems related to these standards are reviewed and the impact of the volatile changes in the provision and financing of healthcare (''healthcare reform'') on the organization and functioning of clinical laboratories are discussed.