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 hnctioning of clinical laboratories are discussed. Professional standards of practice for laboratories in the United States(US) arise From a complex matrix that includes (1) regulations of Federal, state and local government, and (2) the accreditation standards of the Joint Commission on Accreditation of Healthcare Organizations(JCAH0) and the College of American Pathologists(CAP). The history of the evolution of laboratory regulations in the United States’ reflects the complex relationship between local, state and federal authority, as well as the uneven geographic pattern of regulatory enforcement, only recently standardized on a national basis by the passage of the Clinical Laboratory Improvement Amendments of 1 988(CLIA88).2 Regulations established by federal, state or local government are supplemented by standards established by other professional organizations as well as commonly-accepted “standards of care” that are recognized by custom and partially enforced by medical liability considerations.’ Implementation and enforcement of standards are dependent on an inter-related system of mandatory and voluntary inspection of laboratories by external teams composed of professional and peer-group inspectors. In addition, payment to laboratories, hospitals, and other providers of laboratory services is linked to documentation of compliance with regulatory and professional standards. The most important standards that determine daily practice in US laboratories are those of the Federal Government (Clinical Laboratory Amendments of 1988, or CLIA88),4 the JCAHO’ and the Hospital and laboratory inspection and accreditation programs of the latter two organizations are recognized separately by the Federal Government through an arrangement known as “deemed status.” Deemed status confers upon these two organizations, as well as several other state and private sector organizations, the authority to inspect and accredit laboratories on behalf of the federal government subsequent to demonstration that their standards are equivalent to or more stringent than those of the CLIA88 regulations. The JCAHO, whose accreditation standards for all aspects of performance for hospitals and other organizations are very widely recognized, accepts CAP accreditation as equivalent to their own laboratory accreditation process. In fact, the CAP Laboratory Accreditation Program is widely recognized as the unofficial benchmark for laboratory inspection and accreditation; many of the other programs for laboratory inspection utilize key concepts and practices that have been developed by the CAP. Recently, a new organization -the Commission on Office Laboratory Accreditation (COLA) -has implemented a program for accreditation of physicians office laboratories that has achieved deemed status and has become widely-recognized as a source of accreditation for these laboratories.