The California Department of Public Health (CDPH) has recently been made aware of a nationwide shortage of Tuberculin Skin Test Antigens. In an effort to adapt to this shortage, this All Facilities Letter (AFL) is being issued so that health facilities may request program flexibility for the use of an alternate method for testing.
CDPH has developed proposed regulations that allow for the use of any test for tuberculin infection that is recommended by the federal Centers for Disease Control and Prevention (CDC) and licensed by the federal Food and Drug Administration (FDA). These regulations have been submitted to the Office of Administrative Law (OAL) for final review. In the meantime, attached is a template letter for health facilities to use to request program flexibility from the District Offices. In light of the current situation the District Offices will do their best to expedite these program flexibility requests.
For additional information regarding the shortage of Tuberculin Skin Test Antigens and CDC recommendations for addressing the shortages of tuberculin skin test antigens, please visit the CDC Health Alert Network at:
CDC - Emergency Preparedness and Response: Nationwide Shortage of Tuberculin Skin Test Antigens
One of the recommendations of the CDC to address the shortage is to substitute the Interferon Gamma Release Assay (IGRA) blood tests to identify tuberculosis (TB). The Clinical Guidelines for IGRA in California can be found at:
California Tuberculosis Controllers Association - CDPH Joint Guidelines
Please contact your local District Office if you have further questions.
Original signed by Debby Rogers
Debby Rogers, RN, MS, FAEN