sible for administering Medicare, Medicaid, HIPAA

(Health Insurance Portability and Accountability Act),

CLIA (Clinical Laboratory Improvement Amendments),
and several other health-related programs.
CMS is charged with inspection of nonlicensed blood
banks.

Clinical Laboratory Improvement Amendments

of 1988
In 1967, the Clinical Laboratories Improvement
Act was passed in an effort to improve the quality of
clinical laboratory operations. The Act was revised in
1988 (CLIA), with CMS retaining the responsibility for
CLIA enforcement and certification of laboratories.
Objectives
The Clinical Laboratory Improvement Amendments
of 1988 were enacted to ensure that Americans receive
high-quality, reliable testing in laboratories of all
types and sizes throughout the nation. In passing
CLIA, Congress greatly expanded federal regulatory
authority, from the 13,000 laboratories already regulated
by the Department of Health and Human
Services to an estimated 200,000 laboratory sites,
including those located in physician offices. See
Box 19-6 for a list of some of the goals of CLIA.
No laboratory, or other test site, may perform clinical
tests on human specimens without a certification
issued by CMS. This applies to physician office laboratories,
hospital laboratories, or any site in the hospital
where a test is performed (e.g., operating rooms,
emergency rooms, bedside), independent testing laboratories,
or even testing done at a shopping mall
health fair. Tests are categorized according to complexity,
as shown in Box 19-7; Table 19-1 lists the test
categories.
CLIA also specifies requirements for personnel
qualifications, based on test complexity level. These
are listed in Table 19-2.
As of January 1, 1994, each laboratory performing
high- or moderate-level tests must enroll in a CMSapproved
Proficiency Testing Program for each specialty
or subspecialty in which it is certified. Box 19-8
outlines proficiency testing requirements.
General Provisions
Subpart A 21 CFR 493.1 sets forth the conditions that
all laboratories must meet to be certified to perform
testing on human specimens under CLIA. It is applicable
to all laboratories as defined under laboratory
in 493.2 of this part. This part also applies to laboratories
seeking payment under the Medicare and Medicaid
programs.
Laboratory means a facility for the biologic, microbiologic,
serologic, chemical, immunohematologic,
hematologic, biophysical, cytologic, pathologic, or

Goals of the Clinical Laboratory

Improvement Act

 Ensure safe and accurate laboratory work

Preserve patient access to clinical tests
Encourage continued technological innovation
BOX 19-6

Criteria for Categorization of Tests

Knowledge required
Training and experience required
Level of reagent and materials preparation required
Characteristics of the operating steps
Availability of calibration, quality control, and
proficiency-testing materials
Test system, trouble shooting, and equipment maintenance
requirements
Level of interpretation and judgment involved in
the test
BOX 19-7
Category Description
Waived ~1% of all classified tests
Home testing kits, spun
hematocrits, HemoCue
Moderately complex ~75% of all classified tests
Automated chemistry procedures
requiring no operator intervention
during the analytic process,
hematology equipment
Highly complex ~24% of all classified tests
All histocompatibility and cytology
procedures, radioimmunoassays,
and bacteriology serogrouping
and typing automated tests
that require operator intervention
during the analytic process