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Occupational Tuberculosis (TB) risks

OSHA officially withdraws proposed tuberculosis standard

Occupational TuberculosisThe U.S. Occupational Safety & Health Administration (OSHA) announced in the May 27, 2003, Federal Register that it withdrew a proposed 1997 TB Rule because it did not meet the burden of risk to justify the enactment and publication of a final standard.

In 2002, OSHA reopened the comment period on the rule in light of an Institute of Medicine (IOM) report that found the standard could be inflexible. The proposed standard, published in October 1997, would have required employers to protect TB-exposed workers using infection control measures similar to procedures outlined by the Centers for Disease Control and Prevention (CDC) 1994 guidelines for preventing the transmission of M. tuberculosis. Many professional organizations, including the American Hospital Association (AHA) and the Association for Professionals in Infection Control and Epidemiology (APIC), noted in past letters to OSHA that hospitals have spent considerable time and resources developing TB control programs consistent with the CDC guidelines. AHA and APIC felt that OSHA’s proposed requirements go beyond those recommendations, placing an unnecessary burden on hospitals and staff.

This does not mean that regulations related to control and prevention of tuberculosis are suspended. A 1996 OSHA directive remains in effect, using OSHA’s “general duty” clause to enforce the 1994 CDC Guidelines for the Prevention of Transmission of M. tuberculosis. Administrative controls such as early identification of possible pulmonary tuberculosis (TB) cases, engineering controls such as airborne infection isolation rooms, personal protective equipment such as N95 respirators, and tuberculin skin testing are all elements addressed in the directive. Healthcare facilities using respirators for protection from M. tuberculosis continue referencing OSHA’s respiratory protection standard for TB. (Download the Federal Register announcement below.)

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Background

Critics of the proposed regulation pointed out steady decline in TB cases since the early 1990s, and supporters argued that TB remained a risk to healthcare workers. To address many of the issues raised, the US Congress requested the National Academy of Science to examine the risks of occupational TB among healthcare workers and the possible effects of federal regulations to address this risk. In August 2000, a committee of the Institute of Medicine, the health policy arm of the National Academy of Science, met to review research and data on TB risks and control from a number of groups, including Premier’s Safety Institute. Gina Pugliese of Premier’s Safety Institute presented results of a national survey, conducted by Premier in collaboration with the CDC, to assess the status of TB control programs in US hospitals. Pugliese reported that more than 95% of US hospitals have isolation rooms that meet the CDC criteria, wear N95 TB respirators, and perform routine TB skin testing on workers (download abstract of Premier-CDC study below).

In its final report, the Institute of Medicine committee concluded that TB remains a threat to some healthcare, correctional facility, and other workers in the U.S. Although the risk has been decreasing, vigilance is still needed. Moreover, the CDC guidelines have been effective and the primary risk to workers now comes from patients or inmates with undiagnosed or unsuspected infectious tuberculosis. The committee also concluded that an OSHA standard on occupational TB could have a positive effect if it met three conditions: (1) was consistent with TB control measures that were effective; (2) increases the level of compliance with those measures; (3) allows flexibility for organizations to adopt TB control measures that are appropriate to the level of risk.

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2006 Update

In 2005, the Centers for Disease Control and Prevention (CDC) is revising the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities, 1994, that were the basis of OSHA’s proposed standard and are used as the standard of practice for TB control measures when enforcing worker protection under the General Duty Clause.

The newly revised guidelines have been expanded to address a broader definition of a "health-care setting." The term encompasses inpatient and outpatient settings, TB clinics, areas in correctional facilities in which health care is delivered, where home-based health-care and emergency medical services are provided, and in laboratories handling clinical specimens that might contain MTB. The guidelines are intended to minimize exposures to healthcare workers (HCW), a threat primarily from patients or others with unsuspected and undiagnosed infectious TB disease. Administrative, environmental and respiration protection control measures remain the hierarchy of controls to be utilized within a risk assessment process.

N95 respirators. In terms of respiratory protection, CDC recommends the use of N95 respirators, and that N95 fit-testing be done initially and periodically. Although OSHA is referenced (respiratory protection standards require annual fit-testing), CDC appears to give more importance to annual training on respiratory protection, noting there is insufficient evidence to support more than periodic fit-testing. Fit-testing is determined by defined criteria such as weight loss that affects facial features. In a recent "Update," the Association for Professionals in Infection Control and Epidemiology (APIC) noted that the recently signed appropriations bill (H.R. 3010) for the Departments of Labor, Health and Human Services, Education and related agencies contains a provision prohibiting federal funds from being used to implement or enforce annual fit-testing for Fiscal Year 2006 (October 1, 2005-September 30, 2006). This appears to be the same type of provision passed in FY 2005 and addressed in OSHA's 2005 directive.

TB blood test. The 2005 guidelines also include the option of using a new simple, one-step blood test to detect TB infection. The QuantiFERON-TB GOLD (QFT-G) test can be used in all circumstances under which the traditional tuberculin skin test (TST) is used. The CDC recommends that QFT-G be used with contact investigations, evaluation of recent immigrants, and sequential-testing surveillance programs for infection control (e.g., those for healthcare workers). The complete guideline, published in the CDC's December 16 Morbidity and Mortality Weekly Report, states that the sensitivity of QFT-G was statistically similar to that of the tuberculin skin test (TST) for detecting infection in persons with untreated culture-confirmed tuberculosis. QFT-G can detect latent or non-symptomatic TB in individuals while eliminating those who have had BCG vaccinations for TB, a common cause for false-positive readings with the TST. The QFT-G test is highly specific because it measures immune responses to peptides that simulate MTB proteins not present in the BCG vaccine. QFT-G also eliminates the need for multiple visits and any variation in placement, reading and interpretation. Some disadvantages include higher cost, laboratory proficiency issues, and the need for the specimen to be set up within 12 hours. The Centers for Medicare and Medicaid Services also approved QFT-G for reimbursement effective January 1, 2006.

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