OSHA — which lost an epic battle with the infection control community to adopt a separate tuberculosis standard more than a decade ago — has decided to put TB back on its radar and update compliance requirements for healthcare settings.
An OSHA directive issued July 13 (http://1.usa.gov/1SjEWwI) essentially incorporates the Centers for Disease Control and Prevention’s 2005 TB guidelines,1 replacing the 1994 CDC version the agency had heretofore been using. As part of this, OSHA adopts the CDC’s TB risk classifications for healthcare settings: low, medium, and potential ongoing transmission.
“The employer’s decisions concerning medical surveillance should be based on up-to-date risk assessments,” the OSHA directive states. “In low-risk settings, annual screening is not necessary; however, if an exposure to a person with, or specimen containing, TB occurs, the employer should provide screening and update the risk assessment in accord with the 2005 CDC Guidelines. In medium risk settings, screening should be provided at least every year. In settings where there is the potential for ongoing trans-mission, workers should be tested every 8–10 weeks until a determination is made that there is no more ongoing transmission. At that point, the setting should be reclassified as medium risk, and should remain at that classification (at a minimum) for at least one year.”
Other changes in the new directive include inspecting additional healthcare settings, “in which emergency medical services are provided, and laboratories handling clinical specimens that may contain Mycobacterium tuberculosis,” the directive states.
Examples cited by OSHA include:
Inpatient settings: Patient rooms, emergency departments, intensive care units, surgical suites, laboratories, laboratory procedure areas, bronchoscopy suites, sputum induction or inhalation/respiratory therapy rooms, autopsy suites, and embalming rooms.
Outpatient settings: TB treatment facilities, medical offices, ambulatory care settings, dialysis units, and dental care settings.
Nontraditional facility-based settings: Emergency medical service facilities, medical settings in correctional facilities (e.g., prisons, jails, and detention centers), long-term care settings (e.g., hospices and skilled nursing facilities), drug treatment centers, and homeless shelters.
The new instructions to OSHA inspectors also allow less frequent TB screening of healthcare workers in some situations (e.g., low-risk classification). The update also includes newer screening methods like blood analysis for M. tuberculosis.
No comment period?
Most infection preventionists should already have their programs in line with the 2005 CDC guidelines, says Patti Grant, RN, BSN, MS, CIC, Director of Infection Prevention/Quality at Methodist Hospital for Surgery in Addison, TX.
“IPs traditionally are solid when it comes to treating a CDC/HICPAC guidance as a roadmap for patient, employee, and visitor protection,” she says. “Although OSHA is strictly employee safety driven, most IPs will take any CDC/HICPAC peer-reviewed, full-publication referenced document, and give it the respect and implementation it deserves.”
That said, Grant raises the “worrisome” question of whether OSHA has essentially established a TB standard without the requisite public comment period on a draft version published in the Federal Register.
“Regardless, this brings OSHA surveyors and inspections into current, realistic, and practical employee safety/TB elimination as sanctioned by the CDC — not something that is mired down in a document that cannot keep current with the evidence-based practice,” she says.
Still, one could take the view that OSHA is adding compliance demands in the absence of evidence of increased risk of occupational transmission of TB in healthcare settings.
“I am dismayed with this and feel it is another round of unnecessary new compliance expectations,” says Ruth Carrico, PhD, FSHEA, RN, CIC, a former IP who is now an infectious disease professor at the University of Louisville in KY. “There are so many ways to better use the limited resources we have in our efforts to prevent transmission of infection.”
Even in issuing the rule, OSHA conceded that 2013 saw the lowest recorded TB rate (three cases per 100,000 people) since national reporting began in 1953.
“In 2013, 9,582 TB cases were reported in the United States, and approximately 383 of those cases were among healthcare workers,” OSHA states. “Multi-drug-resistant and extremely drug-resistant TB continue to pose serious threats to workers in healthcare settings. [TB] is the second most common cause of death from infectious disease in the world after HIV/AIDS.”
Threat of XDR-TB
Given the current era of emerging infections that can travel internationally, OSHA cites the global threat of TB strains that are extremely drug resistant. Extensively drug-resistant tuberculosis (XDR-TB) is a relatively rare variety of multidrug-resistant tuberculosis (MDR TB), but it is loose in the world and therefore a plane ride away from the U.S. It is resistant to almost all drugs used to treat TB, including the two best first-line drugs: isoniazid and rifampin. XDR-TB is also resistant to the best second-line medications: fluoroquinolones and at least one of three injectable drugs (i.e., amikacin, kanamycin, or capreomycin), according to the CDC. Not surprisingly, mortality rates are off the charts, particularly if the patient is co-infected with HIV.
Researchers have described the cause and abiding threat of drug-resistant TB as “rooted in inadequate TB treatment and compounded by a vicious circle of diagnostic delay and improper treatment, MDR-TB/XDR-TB has become a global epidemic that is fueled by poverty, HIV and neglect of airborne infection control. … It is difficult and costly to treat MDR-TB/XDR-TB. Without timely implementation of preventive and management strategies, difficult MDR-TB/XDR-TB can cripple global TB control efforts.”2
The CDC notes the risk of acquiring XDR-TB in the U.S. “appears to be relatively low. However, it is important to acknowledge the ease at which TB can spread. As long as XDR-TB exists, the United States is at risk and must address the threat.”
OSHA states that the new TB directive applies to all agency interventions, inspections, and violation abatement assistance. All inspections related to occupational exposure to TB should include a review of the employer’s written plans for employee TB protection, OSHA states. Such plans may include a TB infection control program, a respiratory protection plan, and a medical screening program. Employee interviews and site observations are also an integral part of the evaluation process, the directive states.
Some key points on the OSHA inspection process include:
- Upon entry, the Certified Safety and Health Official (CSHO) should request the presence of the infection control director and the occupational health professional responsible for the control of occupational health hazard(s). Other individuals who may be responsible for providing records pertinent to the inspection include: the training director, the facility engineer, and the director of nursing.
- The CSHO must determine whether the facility has had a suspected or confirmed TB case among patients/clients or employees within the six months prior to the opening conference. This determination may be based, in part, upon interviews and a review of available infection control data. As soon as possible after an inspection has been initiated, the CSHO should contact the appropriate local or state health department to determine whether the facility has reported any TB cases during the previous year.
- The CSHO shall also review OSHA 300 log entries for confirmed cases of work-related TB. If the CSHO determines there are no suspected or confirmed TB cases among patients/clients or employees in the facility within the previous six months, he or she should suspend the TB portion of the inspection.
- If the facility has had a suspected or confirmed TB case within the previous six months, the CSHO shall proceed with the TB portion of the inspection. The CSHO should verify implementation of the employer’s plans for TB protection through employee interviews and direct observations where feasible. Compliance will be determined through review of the facility plans for employee TB protection, employee interviews, and an inspection of appropriate areas of the facility.
- Centers for Disease Control and Prevention. Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 2005 MMWR 2005 / Vol. 54 / No. RR-17: http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf
- Chang KC, Yew WW. Management of difficult multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis: Update 2012. Respirology 2013;18(1):8-21.