An ongoing shortage of a skin test to screen for tuberculosis has prompted the state Bureau of Human Services Licensing to relax its regulatory policy against any human-service facility that can document its unsuccessful attempts to have employees and patients tested under a deadline.
Early this year, the pharmaceutical company, Sanofi Pasteur, which produces the "tuberculin skin test antigens" used to screen a person for exposure to or an infection of tuberculosis, announced a shortage of Tubersol, a purified protein derivative of tuberculin used in the test. Tuberculin is an extract from Mycobacterium tuberculosis, which is the bacterium that causes the highly contagious infection.
The death rate from tuberculosis worldwide has dropped by more than 40 percent in the past 21 years. But it is highly contagious and difficult to treat, especially with its growing resistance to antibiotics.
Sanofi Pasteur expects a full supply of testing materials to be available by late May, said Michael Szumera, spokesman for the company's U.S. operations.
In early March, the Allegheny County Health Department announced it was limiting TB screening to high-risk patients or employees who may have been exposed to tuberculosis. Any employee of a facility that helps people with physical or intellectual disabilities, mental illness or the elderly, had to go elsewhere for screening, including his or her own physician, whose supplies of testing material might also be limited.
The U.S. Centers for Disease Control and Prevention updated its alert on April 26 that the two-month shortage would extend until the end of May.
Under state regulations, the Department of Public Welfare will cite a human service organization if its employees or the residents it serves are not tested for tuberculosis on schedule. But that regulation can be put on hold "if every effort has been made" to get the required tuberculin skin test but without success.
In those cases, the bureau "will not cite a regulatory violation," provided the facility can document its attempt to obtain the required testing, bureau Director Ronald Melusky said in its April 29 announcement.
"We had to ask, is it fair to cite a facility for a regulatory violation that's completely outside its control?" he said. The announcement didn't happen as a result of actual violations. "It came to our attention in the past two weeks. We consulted with the Department of Public Welfare medical director and felt the best course of action was what we did."
That position will be re-evaluated on June 30 and based on the availability of the necessary antigens at that time, he said.
Licensed facilities that have limited access to the skin test are advised to use the test only for employees or residents at increased risk for contracting tuberculosis from close contact with any of the following:
• A person with the infection.
• People who have emigrated from countries with high TB rates.
• Groups with high rates of TB transmission, including the homeless and injection drug users.
• Those who work or reside with people at high risk for TB.
• And people with the many medical conditions that weaken the immune system.
So far, no one has stepped forward publicly with concerns about the shortage of testing materials affecting their ability to meet state screening regulations.
Achieva, an Allegheny County organization that provides services for intellectually disabled and physically ill patients, and Community Human Services, which also provides social services in the county, report no problems complying with testing requirements.
UPMC and West Penn Allegheny Health Systems also said they have sufficient supplies of the tuberculin skin test for employees and patients, with UPMC having 30,000 skin tests available, or enough to last for several months.
"We currently have a very healthy supply of this product and there's no concern here about testing. I guess there's enough supply on hand right now for something like 30,000 tests and our surveys show we should be able to test all UPMC employees who are due for testing at least for the next few months," UPMC spokeswoman Wendy Zellner said.
Dan Laurent, WPAHS spokesman, said the health system also has adequate supplies of testing materials.
Cases of TB
Allegheny County had 24 cases of tuberculosis in 2011, the most recent numbers available. Previously, there were 19 cases in 2008; 18 in 2009 and 11 in 2010.
Surrounding counties at most had two cases in 2011.
Pennsylvania had 260 cases of tuberculosis that year, or about two cases per every 100,000 people. Despite the low incidence rate, the state Department of Health says screening remains necessary because tuberculosis is a communicable disease that's difficult to treat. The bacterium from sneezing and coughing is transmitted through the air.
TB infections worldwide have been declining but slowly. Still, the world "is on track to achieve the Millennium Development Goal to reverse the spread of TB by 2015," according to the World Health Organization. But tuberculosis remains a serious threat.
The CDC reports the nation had 9,951 new cases of TB in 2011, with a national infection rate of 3.2 people per 100,000.
Worldwide, tuberculosis is second only to HIV/AIDS as the greatest killer due to a single infectious agent, according to WHO. In 2011, 8.7 million people got ill from TB with 1.4 million deaths, more than twice the worldwide death rate of malaria.
More than 95 percent of TB deaths occur in low- and middle-income countries, and it is among the top three causes of death for women aged 15 to 44, with 10 million children orphaned due to TB deaths among parents.
WHO reports that multidrug-resistant TB was present in all countries surveyed.
David Templeton: email@example.com or 412-263-1578.