*This is an archive page. The links are no longer being updated.
1993.03.31 :  Sanctions -- Clinical Laboratory Improvement Amendments of 1988

Contact:  Anne Verano (202) 690-6145
March 31, 1993

     The Health Care Financing Administration has imposed
sanctions against two laboratories, marking the first enforcement
actions taken under the provisions of the Clinical Laboratory
Improvement Amendments of 1988.  The sanctions were effective
Feb. 1.
       Cited were:  Pioneer Medical Laboratories of Jersey City,
N.J.; and Stroink Pathology Laboratories, Inc., of Bloomington,
Ill.  Medicare payments to the two facilities have been
suspended.
       HCFA regulations implementing the CLIA statute became
effective Sept. 1, 1992.  On that date, all testing of human
specimens for medical purposes became subject to federal
regulation.
       Responding to a complaint, the New Jersey survey agency
found that Pioneer, which performs more than 140,000 tests
annually, was routinely "reporting fictitious patient test
results; fabricating quality control records; reporting invalid
results for proficiency testing purposes; and improperly
performing analytical procedures."
       Because these deficiencies posed "immediate jeopardy" to
the health and safety of the patients served by the laboratory,  
Pioneer's CLIA certificate was suspended, forcing the lab to stop
all testing.
       At Stroink, a HCFA cytology survey contractor acting on a
complaint, found deficiencies in diagnostic pap smear testing
that posed "immediate jeopardy" to patients whose specimens were
tested there.
       Diagnostic cytology, including pap smear testing, is the
study of human cell structure.  The survey team found
inaccuracies in 57 of 79 patient pap smears tested.
       CLIA records indicate that Stroink performs more than one
million tests annually, approximately 85,000 of which are in the
specialty of cytology.
       Stroink's CLIA certificate has been limited so the
facility may no longer conduct cytology testing.
       State agencies are notifying referring physicians and
providers of patients whose specimens were tested at the two labs
so that necessary retesting of patients may be arranged with
other facilities.
       The laboratories may request resurvey after actions have
been completed to bring them into compliance with CLIA.

                               # # #

Editor's Note:  HCFA, an agency of the U.S. Department of Health
and Human Services, directs the Medicare and Medicaid programs,
which help pay the medical bills of more than 67 million
Americans.  HCFA's estimated fiscal year 1993 expenditures are
almost $230 billion.