New York State DOH Guidance on Shortage of Tuberculin Skin Test Solution

June 27, 2019

The New York State Department of Health (DOH) issued the attached June 19 advisory for health care facilities experiencing a shortage of purified protein derivative (PPD) solution for tuberculin skin testing, in response to an anticipated three- to 10-month Aplisol® shortage. At this time, Tubersol®, another US Food and Drug Administration (FDA)-approved solution, is still available. DOH is temporarily recommending an adjustment to tuberculosis (TB)-testing procedures for employee testing programs if institutions experience a shortage of testing product.

New York State regulations still require serial testing for health care personnel in various clinical settings. However, in facilities experiencing a shortage of PPD testing solution, repeat testing can be deferred for persons with the appropriate baseline testing and no new risk for infection or disease on annual assessment.

Summary of DOH Recommendations

PPD Solution Shortage

Hospitals experiencing a shortage of PPD solution can defer repeat testing for persons with appropriate baseline testing or no new risk for infection or disease. Highest-priority individuals for testing include persons who:

  • are contacts to infectious cases
  • are being evaluated for suspected active TB
  • are at increased risk for TB due to medical conditions
  • recently arrived from countries with a high incidence of TB

Any of the available interferon-gamma release assay (IGRA) blood tests or tuberculin skin tests (TST) can be used in these situations, based on availability of product, population group, and provider preference, in accordance with current guidance. See attached advisory notice for detailed recommendations on assessing risk to guide testing decisions.

Pre-Employment Screening

New York State regulations require hospitals to perform a TB history (TB exposure, infection, or disease and any prior diagnostic testing or treatment), along with a review of symptoms suggestive of active disease. Refer to the attached advisory notice for detailed recommendations for pre-employment screening using IGRA and TST for persons with no prior history of TB. Any change in pre-employment or serial testing procedures must be documented and lists of persons needing screening should be tracked. Similarly, clients should be evaluated for signs or symptoms of active TB prior to entry into long term care or other DOH-regulated settings, and can be subsequently tested with IGRA or TST when feasible to do so, as soon as possible.

Coalition for a TB-Free New York City

GNYHA recently hosted a meeting of the Coalition for a TB-Free New York City, a multi-stakeholder group led by the New York City Department of Health and Mental Hygiene. The meeting featured Dr. Lynn Sosa, Deputy State Epidemiologist at the Connecticut Department of Public Health and lead author of the new Centers for Disease Control and Prevention (CDC) guidelines on screening, testing, and treatment of health care personnel. In response to the new CDC guidelines, Dr. Margaret Oxtoby, Director of the DOH Bureau of TB Control, announced, at the meeting, that DOH is reviewing State regulations related to screening health care personnel for TB, which currently remain in effect. GNYHA will keep you apprised of any change in State regulations.

GNYHA will continue to track the Aplisol® shortage and share guidance from State and Federal agencies and any developments in the review of TB-testing regulations.

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