procedures, regardless of whether or not the laboratory charges for the testing.[1] When the laboratory's CLIA certificate is limited for the specialty of hematology, the laboratory will not be permitted to perform any hematology testing, including waived testing and provider performed microscopy procedures, regardless of whether or not the laboratory charges for the testing[2]. Also, upon revocation of a laboratory's CLIA certificate 42 U.S.C. § 263a(i)(3) and 42 C.F.R. § 493.1840(a)(8) prohibit the owners or operator(s) (including the laboratory director—see 42 C.F.R. § 493.2) from owning or operating (or directing) a laboratory for at least two years from the date of the revocation. This prohibition applies to the owner, operator, and laboratory director at the time the deficiencies which led to the proposal of sanctions were identified by CMS.
When the sanctions become effective as referenced above, in accordance with 42 C.F.R. § 493.1850(a)(2), information regarding the actions against the laboratory's CLIA certificate will appear in the Laboratory Registry for the calendar year in which the actions are imposed. In addition, pursuant to 42 C.F.R. § 493.1844(g)(1), CMS will notify the general public by means of a notice published in a local newspaper when these actions become effective as referenced above.
Instructions for Sending in Your Response
The laboratory has ten calendar days from the date of this notice, or until March 28, 2016 to submit in writing any evidence or information as to why the sanctions detailed above should not be imposed. If a response is not made, is untimely, or does not successfully rebut the bases for the proposed sanctions, we will notify the laboratory in writing that we will proceed to impose the above-referenced sanctions. We will provide information regarding the laboratory's hearing rights and a description of the appeals process at that time.
All responses, including written evidence or information as to why the proposed sanctions should not be imposed, as well as any future correspondence pertaining to this sanction action should be sent to:
Karen Fuller, Manager
State Oversight and CLIA Branch
Division of Survey and Certification
Centers for Medicare & Medicaid Services
90 7th Street, Suite 5-300 (5W)
San Francisco, CA 94103-6707
A copy of any response the laboratory makes to CMS' San Francisco Regional Office must also be sent to CMS' Central Office at the following address:
Division of Laboratory Services
- ↑ The laboratory may continue to perform parallel testing on patient specimens if needed to implement corrective actions. However, the laboratory may not report any patient test results during the period when its CLIA certificate is revoked.
- ↑ The laboratory may continue to perform parallel testing on patient hematology specimens if needed to implement corrective actions. However, the laboratory may not report any patient hematology test results during the period when its CLIA certificate is limited for the specialty of hematology.
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