Clinical Laboratory Regulation

The clinical laboratory environment in the United States is one of the most extensively regulated areas of medical practice and comes under the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988 (http://www. cms.hhs.gov/clia/). Any implementation of molecular diagnostic is therefore governed by the provisions of the CLIA. The history of the CLIA dates back to the 1980s, when public and congressional concern was raised by reports of serious errors being made in clinical laboratories. In response to these concerns, legislation was introduced with the intention of improving laboratory testing. These regulations cover most aspects of laboratory practice. Any laboratory testing that is performed in the United States for clinical purposes such as diagnosis, monitoring, deciding appropriate treatment, and establishing prognosis must be performed in a CLIA- certified laboratory. These regulations, however, do not apply to purely research studies or to early research and development work for molecular or other testing in a non-CLIA-certified environment, but as soon as testing that has genuine clinical utility is made available, it must be performed in a certified environment.

The initial application for a CLIA certificate is usually made to the state office of the Centers for Medicare and Medicaid Services (CMS). A successful application will result in a certificate of registration, which allows a laboratory to perform clinical testing pending its first formal inspection. Depending on whether the laboratory is certified by CMS or by an accrediting organization, a successful inspection will result in a grant of either a certificate of compliance or a certificate of accreditation (Figure 1). These are essentially equivalent for

Accreditation, Compliance,

Accreditation, Compliance,

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Figure 1 Distribution of CLIA certificates by type in non-CLIA-exempt states in 2007. (Data from the CLIA database, http://www.cms.hhs.gov/CLIA/.)

the purposes of offering clinical testing. Accrediting organizations function as surrogates for CMS in the laboratory accreditation process and must be approved by CMS to accredit clinical laboratories. The accrediting organizations are the College of American Pathologists (CAP), the Council on Laboratory Accreditation (COLA), the Joint Commission, the American Association of Blood Banks (AABB), the American Society for Histocompatibility and Immunogenetics (ASHI), and the American Association of Bioanalysts (AAB). Some of these, such as the ASHI, accredit laboratories that perform only limited types of testing. Others, such as the CAP, accredit laboratories for all types of clinical testing, including molecular diagnostic testing.

Clinical tests are categorized for the purposes of the CLIA into several levels of complexity. This categorization is the function of the U.S. Food and Drug Administration (FDA). The type of CLIA certificate that a laboratory requires parallels the complexity of its test menu. The lowest level of test complexity is the waived category. Tests in this category are typically simple methods with little likelihood of error or of serious adverse consequences for patients if performed incorrectly. Commonly, such tests are performed in physician office laboratories. It should be noted that the term waived applies to a test, not to the need for the laboratory to have a CLIA certificate to perform any clinical testing. The next-highest level is the moderate-complexity test, including a category known as provider-performed microscopy. The highest level is the high-complexity test, which is applicable to most molecular tests. Laboratories that perform high-complexity testing must have a certificate to perform this type of testing. When the CLIA was written 20 years ago, there was relatively little molecular testing, and as a result, molecular diagnostics does not have specific requirements in the regulations as do most areas of clinical laboratory practice, such as clinical chemistry, microbiology, and hematology. Nevertheless, the general requirements of CLIA can be adapted to molecular testing. Accrediting organizations such as the CAP do have specific requirements for laboratories that perform molecular diagnostic testing. These are available in their laboratory inspection checklists [1]. Whereas the FDA is responsible for categorizing tests, the Centers for Medicare and Medicaid Services (CMS) are responsible for the oversight of the CLIA program, including granting certificates, approving accrediting organizations, approving proficiency testing (PT) programs, inspections, and enforcement actions.

The CLIA is a federal law and applies to all clinical testing performed in the United States and in foreign laboratories that are certified under the CLIA. There are provisions in the CLIA under which individual states can substitute their own laboratory oversight programs if it is determined that such programs are at least as stringent as the federal program. Currently, such programs exist only in New York and Washington. These are known as "CLIA-exempt" states, although CMS reserves the authority to inspect any aspect of laboratory performance in these states. The CLIA includes the following areas of laboratory testing: proficiency testing, preanalytic testing, analytic testing, and personnel requirements.

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