Will CA lead the way? Airborne rule could lead to state, national standards

Novel provision: Fit-testing every two years for some HCWs

California may once again be setting a trend that could influence protection of health care workers who are exposed to infectious diseases — this time with a bold proposed standard to prevent aerosol transmissible diseases.

Like the bloodborne pathogen standard, which also originated in California, the proposed standard requires an exposure control plan and annual training — though the specific requirements differ based on the employees' potential for exposure. As opposed to annual fit testing the state rule would allow testing every two years for some health care workers. However, it would require the use of powered air-purifying respirators (PAPRs) with most high-hazard procedures. Those procedures include bronchoscopy and sputum induction, unless PAPR use would interfere with the accomplishment of the medical task. Respiratory protection would be required when dealing with "novel or unknown pathogens," including pandemic influenza.

Groups that have typically been at odds over respiratory protection have expressed support of the California proposal. Representatives of the hospital association, labor unions, infection control, occupational health, and industrial hygiene worked together on an advisory panel as the standard was drafted.

"The standard is comprehensive and will close a lot of the gaps in the protection of health care workers with potential exposure," says Mark Catlin, an industrial hygienist with the Service Employees International Union (SEIU) in Washington, DC.

Roger Richter, senior vice president for professional services with the California Hospital Association in Sacramento, notes that the standard goes far beyond fit-testing in "addressing various risks for airborne transmissible disease. The whole standard is based on risk management, while the fit-testing, no pun intended, is one size fits all," he says.

The lengthening of the period between fit-tests (after an initial fit-test) was a carefully crafted provision. It was designed to encourage hospitals and other health care employers to prepare for health care surge events, such as possible pandemic flu, by preparing additional employees for respirator use, says Deborah Gold, MPH, CIH, senior safety engineer in the research and standards health unit at Cal-OSHA in Oakland.

The biannual fit-testing provision automatically reverts to annual fit-testing in 2015. At that time, Cal-OSHA could revise the fit-test requirement based on new research from the National Institute for Occupational Safety and Health (NIOSH) on appropriate intervals of fit-testing. Hospitals and other employers are loath to spend a substantial amount of time and money on a provision that hasn't been scientifically validated, says Gold. "It's hard to enforce a regulation on a regulated public that doesn't understand the basis for it," she says. "We try to make our regulations scientifically sound."

However, in comments to the Cal-OSHA Standards Board, NIOSH stated that "[t]he study is not designed to establish a scientifically validated periodicity for fit-testing of respirators. The study is designed to track changes in test subjects' key facial dimensions and fit factors with designated respirator models and sizes for six-month intervals over three years."

While that will provide insight into the relationship between changes in facial dimensions over time and the impact on fit, it won't analyze the effectiveness of annual fit-testing, NIOSH said. In fact, NIOSH asked the standards board to correct or remove the information about the NIOSH study from the proposed standard.

However, the study protocol states that it will "provide a basis for quantifying the benefit of periodic fit-testing and determining the appropriate periodicity."

More effective than feds?

States with their own Occupational Safety and Health Administration (OSHA) plans must set standards that are at least as effective as federal OSHA regulations. Gold contends that California meets that requirement because its proposed standard is much more comprehensive than the federal respiratory protection standard.

OSHA issued a proposed tuberculosis standard in 1997 but rescinded it in late 2003, citing advances in controlling TB. The federal agency has never addressed the hazard of airborne infectious diseases as a broad category and has no standard related to pandemic influenza.

"We're already being considerably more protective and broader than federal OSHA is right now," Gold says.

Cal-OSHA has been in discussions with OSHA over the proposed standard and (not surprisingly) the two-year fit-testing provision has been the main area of concern. "We're working toward having a positive resolution with them," she says.

Meanwhile, employees performing high-hazard procedures who may use N95 or other tight-fitting facepiece respirators still must have annual fit-testing under this proposed standard. Employees conducting high-hazard procedures would need to use a PAPR, "unless the employer determines that this use would interfere with the successful performance of the required task or tasks."

At-a-glance: CA drafts rules against airborne diseases

California's proposed Aerosol Transmissible Diseases standard covers a range of issues, including the minimum air exchanges per hour in negative pressure rooms (12, although they can be six if HEPA filtration is used), vaccination and fit-testing. The standard would require employers to:

  • implement "source control measures" such as a respiratory hygiene/cough etiquette program, as recommended by the Centers for Disease Control and Prevention.
  • identify patients needing airborne infection isolation in a timely manner. If the facility doesn't treat patients with airborne infectious diseases, it must transfer the patient within five hours (or by 11 a.m., if the initial patient encounter occurs after 3:30 p.m.). Exceptions are provided when rooms are not available, and when a transfer is medically contraindicated.
  • maintain an exposure control plan that outlines the job classifications that may involve aerosol transmissible disease exposure, high-hazard procedures, tasks requiring respiratory protection, and the control measures. The plan also must address medical surveillance, reporting of exposures, and evaluation of exposure incidents. It must be reviewed annually, and employees must be involved in that review.
  • have a system of communicating the infectious disease status of patients to which employees may be exposed that complies with medical confidentiality requirements. Employees who the evaluating physician determines may be infectious, and therefore need to be removed from their normal assignment for infection control purposes, must be provided with an appropriate alternate assignment or be paid if they are furloughed. This "precautionary removal" period ends when either the person has passed the incubation period or if the employee gets sick or is otherwise unable to work.
  • provide annual training to employees with potential exposure to patients with aerosol transmissible diseases.
  • have adequate supplies of personal protective equipment.
  • provide fit-tests every two years for employees who do not perform high-hazard procedures and at least annual fit-tests for those in areas where high hazard procedures are performed. Additional fit-tests would be required for employees who have a physical change, such as significant weight gain or loss, dental changes, or cosmetic surgery.
  • provide powered air-purifying respirators (PAPRs) to employees performing high-hazard procedures "unless the employer determines that this use would interfere with the successful performance of the required task or tasks."
  • provide vaccines for susceptible health care workers with the potential for exposure. Employees who decline a recommended vaccine must sign a declination statement.
  • conduct TB tests at least annually for employees with occupational exposure (or perform annual symptoms screens for employees who are baseline positive for latent tuberculosis infection).

Employers would be able to use a streamlined version of the respirator medical evaluation questionnaire, which would potentially reduce the number of employees who are referred to a physician for further evaluation.

As with existing regulations, the proposed rule establishes a fit factor of 100 as the minimum acceptable fit factor for quantitative testing.

(Editor's note: You can view the proposed standard and explanatory information at www.dir.ca.gov/oshsb/atd0.html.)

While hospitals will save money with the longer period between fit-tests, other provisions will actually cost more, says Richter. "But we do know that some of the things that are being required are more effective than fit-testing, so you get a bigger bang for the buck," he says.

Conversely, the SEIU is asking Cal-OSHA to reconsider the extended fit-testing time frame. "We thought it was premature to weaken the protections first and then wait for the studies to see if that's appropriate," says Catlin.

However, that isn't enough to erode the union's support for the standard as a whole. "We see that as the weakest part of the proposal, but when we look at the whole proposal together, it looks really good," he says.

Catlin notes, for example, that the standard specifically applies to a variety of employers, including laboratories, home health and long-term care agencies, homeless shelters, and first responders such as firefighters and police.

The specter of pandemic influenza and severe acute respiratory syndrome (SARS) underlies the efforts to create an airborne transmissible diseases standard.

During the SARS epidemic in Toronto in 2004, the effectiveness of N95 respirators was called into question when some health care workers contracted the infection despite their use. Many of the health care workers who wore respirators had not been fit-tested. Those performing aerosol-generating procedures were at the highest risk of contracting the virus.

SARS receded to the history books and medical journals, but pandemic influenza is a growing concern. As California emphasizes stockpiling of personal protective equipment and other preparedness measures for pandemic influenza, Cal-OSHA wants a broad number of health care workers to receive medical evaluation and training for respiratory protection and fit-testing, says Gold.

The burden of an annual fit-test rule actually leads many hospitals to limit the number of employees who are fit-tested and ready to wear a respirator, she says.

"We don't want to discourage hospitals and other health care institutions from preparing to use respirators, should it be [preparedness for] pandemic flu, SARS or anything else," says Gold. "[Fit-testing] encourages them to more narrowly define respirator use. At this point, we feel it's important to broadly define respirator use.

"We think it's a much better approach to surge to have people at least initially fit-tested and trained. The fit-test won't be older than two years," she says. "We think it's a relatively good compromise."

EHPs play a large role

For employee health professionals, the proposed standard offers some subtler benefits. Occupational health plays a prominent role in many of the tasks that are required under the standard, such as immunization of health care workers, hazard assessment, medical evaluation for respirator use, and fit-testing.

Hospitals may recognize the importance of the role of employee health and may provide more resources to allow for compliance, says Sandy Domeracki Prickitt, RN, FNP, COHN-S, executive president of the Association of Occupational Health Professionals in Healthcare (AOHP) and employee health services coordinator/nurse practitioner at Novato Community and Marin General hospitals in Greenbrae, CA. AOHP was involved with the advisory panel that provided feedback on the draft standard.

"[The roles of] occupational health and employee health are more clearly addressed than in other state and federal standards," she says. "This hopefully will make [employee health] a little more visible."

For example, the proposed standard outlines the duties of the "physician or other licensed health care professional" who will conduct medical evaluations of employees who have been exposed to an airborne transmissible disease.