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1992.09.01 :  Clinical Laboratory Improvement Amendments of 1988

Contact:  HCFA Press Office (202) 690-6145
September 1, 1992

       The Clinical Laboratory Improvement Amendments of 1988
take effect today, providing new federal measures to assure that
laboratory medical testing for patients is performed accurately
and reliably in all settings.  
       HHS Secretary Louis W. Sullivan, M.D., said that the new
measures are designed to help health professionals in delivering
high quality care.  He emphasized that the new regulatory
structure "will continue to evolve, especially over the next few
months, in order to assure that the regulations do not produce
unintended harmful results for patients or physicians."
       Secretary Sullivan issued the following statement:
       "Regulations implementing the Clinical Laboratory
Improvement Amendments take effect nationwide today.  All
facilities that perform clinical tests for the purpose of
diagnosis, prevention and treatment of disease or impairment are
subject to the law.  

       "The intent of HHS and of Congress in bringing about CLIA
is to assure accuracy in clinical laboratory testing, and thus
the most effective possible treatment for patients.  Because it
extends review of labs not only to large clinical laboratory
facilities but also to any facility performing tests, including
individual physicians' offices where many lab tests are now
performed, CLIA will have a broad and significant effect on our
health care system and professionals.  

     "The Department of Health and Human Services has sought to
work closely with health care and laboratory representatives to
bring about improvement in the accuracy of lab tests without
unduly burdening our health care system or interfering with
patients' access to the clinical laboratory tests which are such
a central part of medical practice today.

       "CLIA goes into effect based on the final regulations
which were published Feb. 28.  Because of the importance of these
regulations and the extensive changes made from the original
proposed rules, the public was offered a second opportunity to
comment when the final regulations were published.  Those
comments are currently under review.  Certain minor regulatory
modifications will be made in the near future and the final CLIA
rule will be published at the end of the year.

       "As CLIA provisions go into effect today, it is important
to keep in mind the evolving nature of this regulatory structure. 
The department will continue to accept and analyze comments on
the impacts and effects of CLIA provisions.   It is our hope that
CLIA implementation will involve an ongoing partnership with the
community of health care professionals.  In this spirit, we can
continue to improve quality and access of clinical laboratory
tests for America's health care consumers."
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