This All Facilities Letter (AFL) is being sent to notify you that the Office of Administrative Law has approved regulatory action pursuant to section 11349.3 of the Government Code to amend Title 22, California Code of Regulations (CCR) requirements relating to tuberculosis (TB) screening and testing. Prior regulations required health facilities to use a TB intradermal skin test (TST) for TB screening. In order to be compliant with the previous requirements, health facilities were required to submit program flexibility to the department if they sought usage of an alternate method.
Effective May 30th, 2013, health facilities no longer are required to submit program flexibility for TB screening tests that are licensed by the Federal Food and Drug Administration (FDA) and recommended by the Centers for Disease Control (CDC). Program flexibility is still required if using a test that is outside of FDA or CDC recommendations. For your convenience, the updated portions of Title 22 CCR have been attached.
Additionally, the CDC recommendations for TB Screening can be found at:
CDC Tuberculosis Testing and Diagnosis Guidelines
For verification of licensed FDA drugs, please go to:
FDA - Approved Drug Products Index
Facilities are responsible for following all applicable laws. The California Department of Public Healthās failure to expressly notify facilities of statutory or regulatory requirements does not relieve facilities of their responsibility for following all laws.
If you have any additional questions, please contact your respective Licensing & Certification District Office.
Sincerely,
Original signed by Debby Rogers
Debby Rogers, RN, MS, FAEN
Deputy Director
Attachment: CCR, Title 22 Chapters: Tuberculosis (TB) Screening