External assessments performed by hospital and laboratory accrediting agencies can help healthcare facilities/laboratories understand where they may need to improve in order to manage risk.
Since all accreditation programs are voluntary, it is not required that each laboratory become accredited in order to become licensed by their state. Nevertheless, participation in accreditation is viewed as essential to the laboratory's commitment to meeting high standards. In addition, accreditation provides laboratories with benchmarks for maintaining those standards.
To date the Centers for Medicare and Medicaid Services (CMS) has approved seven organizations for the accreditation of clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CMS grants this “deeming authority” to an Accreditation Organization if its requirements for laboratories accredited under its program are equal to or more stringent than the applicable CLIA program requirements in 42 CFR Part 493. Of the seven accrediting bodies, three are more specialized in the type of laboratories they accredit, such as laboratories limited to histocompatibility, immunogenetics, or transfusion medicine.
The four accrediting bodies discussed next are broader in scope and have the authority to grant to those laboratories they accredit “deemed” status. These laboratories with “deemed” status not only meet the requirement for reimbursement from Medicare and certain managed care organizations, but they also are not required to undergo CLIA surveys (other than random validation surveys). “Deemed” status, however, does not ordinarily provide an exception from state requirements for state licensure.
