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1993.
10.14 :  CLIA Registry of Adverse Actions

Contact:  Bob Hardy (202) 690-6145
October 14, 1993

     Bruce C. Vladeck, administrator of the Health Care Financing
Administration, announced today that a list of clinical
laboratories which have been the subject of enforcement actions for
poor, performance or fraud and abuse is available to physicians and
the general public.
     The Clinical Laboratory Improvement Amendments of 1988, which
set broad health and safety standards for the nation's
laboratories, requires that this list be made available to the
public and to the physician community.  The CLIA program is
administered by the Health Care Financing Administration, an agency
of the U.S. Department of Health and Human Services.
     "We want both physicians and patients to have access to this
information so they can select the best labs available for
diagnostic testing to support their medical decisions," Vladeck
said.
     Under the legislation, HHS is obligated to make available an
annual list of laboratories that have been the subject of adverse
actions by the-federal or state governments, so that doctors and
the public may make more informed decisions about the laboratories
they use.
     The laboratory standards published by the department have been
in effect since Sept. 1, 1992.  Future lists may be more extensive
than the current list as the federal government focuses greater
scrutiny on the manner in which laboratories comply with federal
standards, and the range of sanctions that may be imposed against
deficient laboratories is felt throughout the industry.  The
listing of laboratories is attached.    Copies of this listing, as
well as future listings, will be available at the 10 regional
offices of the Health Care Financing Administration.
 
                        LABORATORY REGISTRY

  As required by Section 353(n) of the Public Health Service Act

                    Activity thru Dec. 31, 1992


     Laboratories subject to CLIA that have been convicted, under
federal or state laws relating to fraud and abuse, false billing or
kickbacks.

     8/92 - Clinical Regional Laboratory, Hazelcrest, Ill., was
convicted of false billing under the Medicaid program and is
excluded from participating in the Medicare or Medicaid programs
for 10 years.

     12/92 - National Health Laboratories (NHL), a Delaware
corporation, pleaded guilty to submitting false claims to
government health insurance programs (including the Medicare and
Medicaid programs), and agreed to pay more than $110 million in
civil and criminal penalties.  This settlement permits NHL to
continue to participate in the Medicare and Medicaid programs.  NHL
operates laboratories in 33 states.

     12/92 - Daniel Wallach, M.D., who operated a medical practice
in Owings Mills, Md. (CLIA Identification Number 21DO215545), was
convicted of one count of felony Medicaid fraud.  The practice has
been sold and is no longer operated by Dr. Wallach.  Dr. Wallach
surrendered his license to practice medicine in Maryland and agreed
not to participate in the Medicaid program for five years.

     2.   Laboratories that have had their CLIA certificates
suspended, limited or revoked, and the reason for the adverse
action.

     None.

     3.   Persons who have been convicted of violating CLIA
requirements, as specified in Section 353(1) of the Public Health
Service Act, together with the circumstances of each case and
penalties imposed.

     None.

     4.   Laboratories on which alternative sanctions have been
imposed, showing:
          (a)  effective date of sanctions;
          (b)  reasons for imposing them;
          (c)  corrective action taken by laboratory; and
          (d)  if laboratory has achieved compliance, the verified
date of compliance.

     None.

     5.   Laboratories whose accreditation has been withdrawn or
revoked and the reasons for the withdrawal or revocation.

     None.

     6.   Appeals and hearing decisions.

     None.

     7.   Laboratories against which HCFA has brought suit under 42
CFR Section 493.1846 and the reasons for those actions.

     None.

     8.   Laboratories that have been excluded from participation
in the Medicare or Medicaid programs and reasons for the exclusion.

     8/92 - Clinical Regional Laboratory, Hazelcrest, Ill., was
convicted of false billing under the Medicaid program and is
excluded from participating in the Medicare or Medicaid programs
for 10 years.