*This is an archive page. The links are no longer being updated. 
1991.11.29 :  Clinical Laboratory Improvement Amendments (CLIA)

Contact: Bob Hardy (202) 245-6145
November 29, 1991
                                                             
       The Department of Health and Human Services announced today 
it has launched the largest-ever federal survey of medical
laboratories, as well as other entities which may conduct
laboratory tests on human specimens. 
       The survey and explanatory materials, which were mailed
today to about 640,000 entities, is a key step toward a uniform
system of clinical laboratory regulation in the United States.  The
new regulatory structure is required under the Clinical Laboratory
Improvement Amendments of 1988, known as CLIA.
       "We are seeking to contact every clinical laboratory or
other facility which may be affected under CLIA," said HHS
Secretary 
Louis W. Sullivan, M.D., in announcing the survey.  "This
information will help the facilities learn how they will be
affected by CLIA, and it will give HHS a much more complete picture
of the clinical laboratory industry as we move toward full
implementation of CLIA next year."
       The CLIA law mandates a broad new regulatory system for
clinical laboratories.  It expands federal authority from some
13,000 hospital and larger independent laboratories, which are
already regulated by HHS, to lab sites of all sizes which perform 
testing of human specimens for diagnosis and treatment.  It is
estimated that more than 200,000 entities will be subject to CLIA,
although the number will not be known until today's surveys are
returned and CLIA regulations become effective.
       The purpose of the new CLIA system is to improve the quality
and reliability of clinical laboratory testing.
       "Our goal in the implementation of CLIA is to ensure high-
quality laboratory work, wherever it is performed, and at the same
time to preserve good access to laboratory testing for patients,"
Secretary Sullivan said.  "We also want a system that continues to
encourage technological innovation, which can improve testing
accuracy and enhance cost effectiveness."
       Current federal regulation of the 13,000 laboratories is
carried out by HHS' Health Care Financing Administration.  Final
CLIA regulations are being developed jointly by HCFA and the U.S.
Public Health Service.
       "HCFA is working with PHS agencies, and in consultation with
medical and technical experts, to develop a workable new system
that will deliver reliable lab results with continuing rapid access
to lab services for patients and health care providers," said HCFA
Administrator Gail R. Wilensky, Ph.D.

       Final regulations implementing CLIA are expected to be
published early in 1992.  The survey mailed today is being
undertaken before final regulations are issued in order to identify
the location and characteristics of all affected facilities.

       Final rules will establish laboratory standards and
enforcement procedures.  Additional rules will establish user fees,
charging each lab for its share of the program's cost.  However,
Secretary Sullivan said no user fees will be collected now.  "We
are simply seeking information at this time," he said.

       The HHS announcement said any facility performing a
laboratory test used for health purposes, no matter how simple or
routine, is subject to the CLIA requirements.  That would include,
for example, a physician's office, health fair or nursing home.

       Among the questions in the survey are the type of
laboratory, ownership, tests performed and professional
qualifications of personnel working in the lab.

       In a letter accompanying the survey, the laboratories are
told that if they appear to be subject to CLIA, they should return
the enclosed form within 60 days.  However, some individuals or
organizations may receive the letter, even though they perform no
laboratory testing, because comprehensive mailing lists were used
to identify all laboratories.

       Among its limited exceptions, CLIA does not apply to any
laboratory that conducts testing solely for forensic purposes.  It
also does not cover research laboratories that test human
specimens, but do not report any patient-specific results for the
diagnosis, treatment or assessment of the health of individual
patients. Also not included are individuals or entities which serve
as collection stations, but which send all specimens out to a
certified laboratory for analysis.

                                ###