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FACT SHEET

CMS-2226F -- Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications.

BACKGROUND

The Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578, set forth uniform quality standards for laboratories and applies to all entities that perform tests for health purposes on human specimens. On February 28, 1992, a CLIA final regulation with comment period, was published in the Federal Register. The CLIA requirements are based on the complexity of tests, (high, moderate and waived), and not the type of entity where the testing is performed.

Because many affected entities (physician office laboratories, clinics, small laboratories, etc.) were previously not subject to regulation, certain requirements were included as "phased-in" standards. This allowed time for those small facilities to understand and comply. The phase-in dates were extended four times and expired on December 31, 2002. The phase-ins included limited quality control (QC) requirements for moderate complexity testing, board certification for high complexity doctoral degreed directors, and an FDA review of manufacturers' test system QC instructions for CLIA compliance.

On December 28, 2001, we published in the Federal Register (66 FR 67163) a proposed rule to revise and expand the qualification requirements by which an individual with a doctoral degree may qualify to serve as a director of a laboratory that performs high complexity testing. This publication was in response to comments received to the February 28, 1992, rule and the subsequent publication of date extension regulations (extending the phase-in provisions).

The final rule for CMS-2226F was published in the Federal Register on January 24, 2003.

OVERVIEW OF CMS-2226F CHANGES

This final rule—

  • Provides one set of QC standards for nonwaived testing.
  • Reduces QC frequency in most of the subspecialties and specialties areas, and merges moderate and high complexity QC requirements to simplify compliance.
  • Removes the prospective FDA review of manufacturers' QC instructions for compliance with CLIA that was to occur after the end of the QC phase-in (delayed effective date).
  • Eliminates redundancy, clarifies, simplifies and uses plain language where possible.
  • Reorganizes the existing requirements to parallel the flow of a patient specimen through the laboratory facilitating the prevention of errors. Studies indicate that most laboratory errors occur in the pre-analytical (specimen collection and handling) phase of testing. Thus all CLIA requirements applicable to this phase of testing are in one place in logical order, and we anticipate that this will help the laboratory decrease errors.
  • "Grandfather" individuals with a doctoral degree without board certification who have served or are currently serving as a director of a laboratory performing high complexity testing and requires board certification for all future doctoral-degreed directors of high complexity testing.

Additionally, based on recommendations by the Clinical Laboratory Improvement Advisory Committee (CLIAC) and CMS survey data we have added a requirement for moderate complexity laboratories to validate a test once before use to ensure the test works accurately before patients are tested. To balance these requirements and to reflect new technologies that may be more robust, we are making QC more flexible via surveyor guidelines. This permits laboratories to determine their quality needs based on their own unique environment and personnel. There is a default (status quo) for those that choose not to use the new flexibility.