When the laboratory's CLIA certificate is revoked, the laboratory will not be permitted to perform any testing, including waived testing and provider performed microscopy procedures, regardless of whether or not the laboratory charges for the testing. Also, pursuant to 42 U.S.C. § 263a(i)(3) and 42 C.F.R. § 493.1840(a)(8), the owners and operator(s) (including the laboratory director) are prohibited from owning or operating (or directing) a laboratory for at least two (2) years from the date of the revocation. See 42 C.F.R. § 493.2 (defining "operator" and "owner").
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)(l), we will notify the general public by means of a notice published in a local newspaper when these actions become effective as referenced above.
If you have any question regarding this notice, please call Gary Yamamoto of my staff at (415) 744-3738.
Sincerely,
Karen Fuller, Manager
State Oversight and CLIA Branch
Division of Survey and Certification
| cc: | California Department of Public Health, Laboratory Field Services | ||
| Ramesh Balwani, Owner Theranos, Inc. 1701 Page Mill Road Palo Alto, CA 94304 |
Certified Mail Number: 7000 1670 0007 4103 6770 | ||
| Sunil Dhawan, M.D. East Bay Dermatology Medical Group 2557 Mowry Avenue, Suite 25 Fremont, CA 94538 |
Certified Mail Number: 7000 1670 0007 4103 6787 | ||
