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.
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