Once a year the Centers for Medicare & Medicaid Services (CMS) makes available to physicians and to the general public specific information (including information provided to CMS by the Office of the Inspector General) that is useful in evaluating the performance of laboratories. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) and implementing regulations at 42 CFR 493.1850 require that this listing include the following:

(1) A list of laboratories that have been convicted, under Federal or State laws relating to fraud and abuse, false billing, or kickbacks.

(2) A list of laboratories that have had their CLIA certificates suspended, limited, or revoked, and the reasons for the adverse actions.

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

(4) A list of laboratories on which alternative sanctions have been imposed, showing—

    (i) the effective date of the sanctions;

    (ii) the reason for imposing them;

    (iii) any corrective action taken by the laboratory;

    (iv) if the laboratory has achieved compliance, the verified date of compliance.

(5) A list of laboratories whose accreditation has been withdrawn or revoked and the reasons for the withdrawal or revocation.

(6) All appeals and hearing decisions.

(7)   A list of laboratories against which CMS has brought suit under Section 493.1846 and the reasons for those actions.

(8) A list of laboratories that have been excluded from participation in Medicare or Medicaid and the reasons for exclusion.

Civil settlements reached with clinical laboratories are also noted.

The Laboratory Registry is compiled for the calendar year preceding the date the information is made available and also contains corrections of any erroneous statements of information that appeared in the previous registry. A final section includes other specific information that may be useful in evaluating the performance of laboratories, as specified in 42 CFR 493.1850(a). It also includes information provided by CLIA exempt states.

Refer to the downloads below for specific Laboratory Registry information.

Downloads
2007 Laboratory Registry [PDF, 273 KB] 2006 Laboratory Registry [PDF, 105 KB] 2005 Laboratory Registry [PDF, 308 KB] 2004 Laboratory Registry [PDF, 235 KB] 2003 Laboratory Registry [PDF, 214 KB] 2002 Laboratory Registry [PDF, 386 KB] 2001 Laboratory Registry [PDF, 531 KB] 2000 Laboratory Registry [PDF, 545 KB] 1999 Laboratory Registry [PDF, 338 KB] 1998 Laboratory Registry [PDF, 129 KB] 1997 Laboratory Registry [PDF, 200 KB] 1996 Laboratory Registry [PDF, 161 KB]
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