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:
- A list of laboratories that have been convicted, under Federal or State laws relating to fraud and abuse, false billing, or kickbacks.
- A list of laboratories that have had their CLIA certificates suspended, limited, or revoked, and the reasons for the adverse actions.
- 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.
- A list of laboratories on which alternative sanctions have been imposed, showing—
- the effective date of the sanctions;
- the reason for imposing them;
- any corrective action taken by the laboratory;
- if the laboratory has achieved compliance, the verified date of compliance.
- A list of laboratories whose accreditation has been withdrawn or revoked and the reasons for the withdrawal or revocation.
- All appeals and hearing decisions.
- A list of laboratories against which CMS has brought suit under Section 493.1846 and the reasons for those actions.
- 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.