On April 12, 2013, the CDC issued:  Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice.  CDC Health Alert Network:  http://emergency.cdc.gov/HAN/han00345.asp.

The CDC notice stated that new supplies will not be available until the end of May.

The Section for Long-Term Care Regulation (SLCR) received the following updated information from the CDC on April 26, 2013.  If you have any questions, please contact Joan Brundick, BSN, RN, telephone (573) 751-6308 or joan.brundick@health.mo.gov.

“A company official for Sanofi has notified DTBE-CDC that Tubersol tuberculin PPD antigen solution for skin testing is available directly from the company.  See quotation, below.  Tubersol, by 10-dose vial only, is available by contacting Sanofi; the supply chain through distributors is still being reestablished.  I called the customer service number in the announcement, and the sales representative told me that the product is NOT under allocation for customers, but it is under allocation for wholesalers.” 

“TUBERSOL® Diagnostic Antigen 10-test vials are available to be ordered immediately on VaccineShoppe.com ® or by contacting Sanofi Pasteur directly at: 1-800-VACCINE (1-800-822-2463).  TUBERSOL Diagnostic Antigen 10-dose vials will also be available through wholesalers and distributors as inventories are replenished.  TUBERSOL Diagnostic Antigen 50-test vials are presently unavailable until late May 2013.”

SLCR recognizes that there may still be some delay in obtaining the supplies needed to do the required TST testing and will allow the following:

• Make every effort to obtain the TST testing supplies including checking with your local health department, all suppliers, etc. in a timely manner
• Document all attempts to obtain the TST testing supplies and estimated times of delivery
• Until you can obtain the necessary TST testing supplies
• Establish a written plan for the TST shortage for testing of potential new employees and new residents within the same timeframes as required for the TST testing
• The plan must at a minimum include assessing new employees for signs and symptoms of TB prior to allowing direct contact with residents
• The plan must include assessing any new resident upon admission for signs and symptoms of TB 
• For residents who have had a chest X-ray within one month prior to admission, complete an evaluation to rule out signs and symptoms of TB and postpone the TST until supplies are available.  (The current requirement already says that this is acceptable on an interim basis).
• Document this assessment
• Delay the annual testing of current employees, but if the annual comes due during this time, assess the current employee for signs and symptoms. 
• If the assessment of any employee or resident results in signs and symptoms of possible TB, instruct them to see their physician or their local public health department.
• Once the TST testing supplies become available all employees or residents who required testing and were not tested, must be tested.
• TST testing is not an annual requirement for residents.  Some homes have elected to do the TST instead of an annual review of symptoms.  The only requirement for residents after the admission two- step TST is an annual review of symptoms to assure no sign of TB. 

OR

 You may follow the CDC guidance as noted below:

CDC recommends any of three general approaches for addressing the shortages of tuberculin skin test antigens:

1. Substitute IGRA blood tests for TSTs.  The costs associated with using the blood tests can be greater than the cost of TSTs.  The blood tests require phlebotomy, preparation of blood specimens, and specific laboratory services for analysis.  Thus, these tests are not available in all practice settings.  Clinicians who use the IGRA blood tests should be aware that the criteria for test interpretation are different than the criteria for interpreting TSTs (1).
2. Allocate TSTs to priority indications, such as TB contact investigations, as determined by public health authorities.  This might require deferment of testing some persons.  CDC does not recommend testing persons who are not at risk of TB (4).
3. Substitute APLISOL® for TUBERSOL® for skin testing.  In cross-sectional studies, the two products give similar results for most patients.