*This is an archive page. The links are no longer being updated. 
1992.02.20 :  Regulations -- Clinical Laboratory Improvement Amendments (CLIA)

Contact:  HCFA Press Office 202-245-6145
CDC Press Office 404-639-3286
February 20, 1992

     HHS Secretary Louis W. Sullivan, M.D., today announced the
issuance of regulations to ensure the quality and reliability of
medical tests performed by clinical laboratories throughout the
nation.  
     The regulations are required by the Clinical Laboratory
Improvement Amendments of 1988, which extended federal regulatory
authority to facilities of all sizes which test human specimens.
     Secretary Sullivan emphasized that "HHS has pursued twin goals
in implementing the law.  We must ensure the reliability of tests,
and at the same time we must preserve access to laboratory testing
for all patients."
     Under CLIA law, some 200,000 laboratory sites will be
affected, including an estimated 130,000 physicians' offices where
lab tests are performed.
     "HHS agencies have consulted closely with medical and
laboratory experts to carry out the law that Congress passed,"
Secretary Sullivan said.  "These rules provide the flexibility
necessary to expand federal quality standards to many new sites
while preserving access for patients."

     Added costs of assuring test reliability under the regulations
are estimated at about 25 cents per lab test.
     The first of the three regulations issued today sets standards
for the reliability of laboratory testing, including quality
assurance and quality control standards to ensure the accuracy of
test systems and procedures;  proficiency testing to measure the
accuracy of test performance;  and personnel standards that ensure
laboratory workers have the appropriate training and experience.

     The nature of the quality standards a laboratory must follow
will depend on the complexity of tests performed by the laboratory.

     Three levels of complexity are defined in the regulation.  The
testing levels, based on factors specified in the CLIA law, were
developed by the U.S. Public Health Service:

o    WAIVED TESTS: Eight simple tests:  dipstick/tablet urinalysis;
     ovulation tests; urine pregnancy tests; non-automated
     erythrocyte sedimentation rate; hemoglobin (copper sulfate);
     fecal occult blood; spun micro-hematocrit; and blood glucose
     testing using glucose-monitoring devices cleared by the FDA
     specifically for home use. 

o    MODERATE COMPLEXITY:  About 75 percent of the estimated 10,000
     testing procedures: for example, direct Group A Strep
     Kit; ASO screen slide test; theophylline; sickle cell screen;
     urine sediment exam; and ABO/Rh grouping (non-transfusion).

o    HIGH COMPLEXITY:  The remaining 25 percent of the 10,000
     testing procedures, including all tests pertaining to
     cytogenetics, histopathology, histocompatibility and cytology
     (for example, Pap smears for the detection of cervical
     cancer).  Most of these tests are done in laboratories already
     regulated by the federal government.

     A laboratory which performs only the eight waived tests and
adheres to basic elements of good laboratory practice can apply for
a waiver from CLIA oversight.  Laboratories that perform moderately
or highly complex tests will be inspected at least every two years,
and must successfully participate in a proficiency testing program. 
They must also meet standards for personnel training and
experience.

     All laboratories, regardless of the level of the tests they
perform, must register with the Health Care Financing
Administration and demonstrate good laboratory practice. 

     James Mason, M.D., HHS assistant secretary for health and head
of the Public Health Service, said the regulations "also  rely on
existing product evaluation processes administered by the Food and
Drug Administration to ensure continued technological innovation in
the laboratory field."

     Gail R. Wilensky, Ph.D., administrator of HHS' Health Care
Financing Administration, said: "Because of its scope, this
regulation will require the cooperation and patience of all
involved.  But it will deliver to millions of Americans safer, more
accurate laboratory testing."  HCFA is responsible for
administering the CLIA regulations.

     Because of the importance of the regulations, another
opportunity for public comment is being provided before the
regulations take effect later this year, Secretary Sullivan said.

     The two other regulations released today are:

o    ENFORCEMENT PROCEDURES:  This regulation will provide flexible
     responses to deal with any non-compliance, from relatively
     minor infractions to situations that pose an immediate and
     serious threat to patients.  Before CLIA, the only available
     penalty for a noncomplying laboratory was suspension or
     revocation of its Medicare approval or interstate license. 
     This rule would add a range of sanctions appropriate to the
     seriousness of the problem.

o    LABORATORY FEES:  This regulation will implement the statutory
     mandate that CLIA be funded through user fees.  Each
     laboratory will pay its own share of the costs of 
     registration and inspection.  Registration fees will range
     from $100 to $600.  Inspection fees will not be collected
     until inspections begin.

     In addition, a Complexity Test Notice listing all procedures
by level of complexity was released today.
     
     A fourth and final CLIA regulation, establishing criteria for
nonprofit and state accrediting agencies, will also be published
early in *This is an archive page. The links are no longer being updated. 
1992.
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**** EDITORS NOTE:  Additional background will be available at noon
today (Feb. 20) in the Great Hall of the Humphrey Building, 200
Independence Ave., SW.