GENERAL PROGRAM DESCRIPTION
Congress passed the Clinical Laboratory Improvement Amendments (CLIA)
in 1988 establishing quality standards for all laboratory testing to
ensure the accuracy, reliability and timeliness of patient test
results regardless of where the test was performed. A laboratory is
defined as any facility which performs laboratory testing on specimens
derived from humans for the purpose of providing information for the
diagnosis, prevention, treatment of disease, or impairment of, or
assessment of health. CLIA is user fee funded; therefore, all costs of
administering the program must be covered by the regulated facilities,
including certificate and survey costs.
The final CLIA regulations were published on February 28, 1992 and are
based on the complexity of the test method; thus, the more complicated
the test, the more stringent the requirements. Three categories of
tests have been established: waived complexity, moderate complexity,
including the subcategory of provider-performed microscopy (PPM), and
high complexity. CLIA specifies quality standards for proficiency
testing (PT), patient test management, quality control, personnel
qualifications and quality assurance for laboratories performing
moderate and/or high complexity tests. Waived laboratories must enroll
in CLIA, pay the applicable fee and follow manufacturers'
instructions. Because problems in cytology laboratories were the
impetus for CLIA, there are also specific cytology requirements.
The Centers for Medicare & Medicaid Services (CMS) is charged with
the implementation of CLIA, including laboratory registration, fee
collection, surveys, surveyor guidelines and training, enforcement,
approvals of PT providers, accrediting organizations and exempt
states. The Centers for Disease Control and Prevention (CDC) is
responsible for the CLIA studies, convening the Clinical Laboratory
Improvement Amendments Committee (CLIAC) and providing scientific and
technical support/consultation to DHHS/CMS. The Food and Drug
Administration is responsible for test categorization.
To enroll in the CLIA program, laboratories must first register by
completing an application, pay fees, be surveyed, if applicable, and
become certified. CLIA fees are based on the certificate requested by
the laboratory (that is, waived, PPM, accreditation, or compliance)
and, for moderate and high complexity laboratories, the annual volume
and types of testing performed. Waived and PPM laboratories may apply
directly for their certificate as they aren't subject to routine
inspections. Those laboratories which must be surveyed routinely;
i.e., those performing moderate and/or high complexity testing, can
choose whether they wish to be surveyed by CMS or by a private
accrediting organization. The CMS survey process is outcome oriented
and utilizes a quality assurance focus and an educational approach to
assess compliance.
Data indicates that CLIA has helped to improve the quality of testing
in the United States. The total number of quality deficiencies has
decreased approximately 40% from the first laboratory survey to their
second and further on subsequent surveys. Similar findings were
demonstrated in the review of PT data. The educational value of PT in
laboratories was known before CLIA existed. Initial PT failures are
also addressed with an educational, rather than punitive, approach by
CLIA.
Work is currently in progress with the CDC and CMS to develop a final
CLIA rule which will reflect all comments received, quality systems
and new technologies.
Contact: Judy Yost, E-mail: jyost@cms.hhs.gov
Last Modified on Thursday, September 16, 2004
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