OSHA looks for 'good-faith efforts' in enforcing N95 respirator use with H1N1
OSHA looks for 'good-faith efforts' in enforcing N95 respirator use with H1N1
Hospitals must document any shortage to avoid citations
Faced with the prospect of a citation by the U.S. Occupational Safety and Health Administration, hospitals are adjusting to the updated federal guidance to use fit-tested N95 respirators when caring for 2009 H1N1 patients.
The Centers for Disease Control and Prevention reaffirmed its guidance calling for respirators rather than masks - acknowledging that influenza may be transmitted by airborne particles over short distances. Yet CDC said the respirator programs should be in the context of other precautions and could be modified if there is a respirator shortage.
OSHA will inspect health care facilities under the Respiratory Protection Standard "to ensure that health care workers are protected and that protection is in line with CDC [guidance]," acting OSHA administrator Jordan Barab said in a conference call announcing the CDC position.
In fact, when the updated guidance was released in October, OSHA had already cited at least one hospital for failing to provide fit-tested N95 respirators. Flushing (NY) Hospital Medical Center was cited in August for three "serious" violations based on a May inspection. OSHA asserted that the hospital failed to fit-test and train employees annually, did not address respiratory hazards other than tuberculosis, did not use an OSHA-accepted fit-testing protocol, and didn't train employees required to wear N95 respirators to protect against novel H1N1 influenza. (Officials from Flushing Hospital did not respond to requests for comment from Hospital Employee Health.)
Barab made it clear that hospitals will be responsible for limiting employee exposure to H1N1 patients and using other measures, such as partitions or isolation rooms, to protect health care workers. "We will be requiring hospitals to comply with the hierarchy of controls," he said. That includes administrative and engineering controls, which reduce hazards through changes in work practices or the work environment.
The CDC guidance to use respirators has been controversial and hotly debated almost since the onset of novel H1N1 last spring. Many infection control practitioners asserted that the novel H1N1 virus was comparable to seasonal influenza in its virulence and transmission routes, and that droplet precautions were sufficient. In fact, some state health departments diverged from CDC and called for surgical masks unless health care workers were performing aerosol-generating procedures. (Editor's note: The guidance is available at www.cdc.gov/h1n1flu/guidelines_infection_control.htm.)
The Healthcare Infection Control Practices Committee (HICPAC), a CDC advisory panel, endorsed the use of surgical masks rather than respirators. But the influential Institute of Medicine panel charged with reviewing the available science concluded that surgical masks would not protect workers from airborne influenza particles. "[T]here is evidence that work-related exposures to patients infected with H1N1 virus result in health care workers becoming infected," the IOM report stated.
The answer, said CDC director Thomas Frieden, is to use respirators but to limit their use through other measures. "Use a scarce resource carefully. Follow a hierarchy of controls and limit the number of people who are potentially exposed and would need a higher level of protection," he said in a telephone briefing on the guidance.
CDC is no longer recommending contact precautions - the use of gowns and gloves - but Frieden noted that influenza is spread through droplet, fomite, and aerosol transmission. "It is an unfortunate fact that we do not have definitive evidence on the portion of transmission that occurs from each of those three routes," said Frieden, noting that "the preponderance of belief" was that droplets were the most common route. "With that lack of knowledge and with the newness of H1N1 ... we are recommending that N95s ... would be clearly superior to surgical masks."
Extended use, reuse allowed in shortage
Still, CDC is providing some flexibility to hospitals. If respirators are in short supply, you must ensure that they are available for the highest-risk activities - for aerosol-generating procedures, for health care workers with conditions that put them at high-risk for complications from influenza, and for those caring for tuberculosis patients.
That means in some circumstances, health care workers may reuse respirators, continue to wear them while caring for more than one patient, or may even wear surgical masks as a last-resort option. CDC states that extended use (in which the respirator is not removed while the health care worker cares for more than one patient) is preferred over reuse.
"We recognize that there may be shortage situations," said Frieden. "The need is for us not just to provide respiratory protection now, but the flu season lasts through May. We need to ensure we have a reliable supply."
The CDC guidance states that "When in prioritized respirator use mode, respirator use may be temporarily discontinued for employees at lower risk of exposure to 2009 H1N1 influenza or lower risk of complicated infection."
OSHA also will take supply shortages into consideration, Barab said. "Where N95 respirators are not commercially available, we will consider the employer to be in compliance if the employer can show a good-faith effort to obtain the respirators," he said.
Hospitals will need to be able to show documentation of orders that have been placed or statements from a manufacturer that the respirators are on back order. "We're looking for some evidence that the employer has attempted to purchase N95 respirators," he said. "We're looking for a good-faith effort."
Hospitals rethink respiratory protection
In the wake of the updated guidance, hospitals began boosting their respirator use. "We're going to have no choice but to change [from masks to respirators] because of the issue of OSHA," says Thomas R. Talbot, MD, MPH, chief hospital epidemiologist at Vanderbilt University Medical Center in Nashville, TN.
The Tennessee Department of Health had recommended the use of surgical masks except in aerosol-generating procedures, in line with World Health Organization guidelines but not the CDC.
Tennessee now has changed its guidance to match that of CDC. The new guidance, with detailed information on other measures to control transmission and prioritize the use of respirators, is much more useful, says Marion Kainer, MD, MPH, director of the hospital infections program.
Kainer says she is urging hospitals to apply the guidance to all cases of febrile respiratory illness. In one case, health care workers who were intubating a patient in the intensive care unit didn't know tests for H1N1 were being run on the patient. Several health care workers had unprotected exposures during the aerosol-producing procedure and one developed the illness, she says.
Early identification and communication is critical, Kainer says. Vaccinating health care workers also is a state priority, she adds.
"We have had cases of severe disease in previously healthy young adults here in Tennessee. We want to make sure we protect our health care workers," Kainer says. "The best way they can protect themselves overall is vaccination."
California previously allowed hospitals to set priorities on respirator use when the supplies were limited. But Gov. Arnold Schwarzenegger ordered the release of up to half the state's stockpile of 51 million respirators, and Cal/OSHA directed hospitals to provide respirators for contact with "all potentially infectious patients." The California Department of Public Health defined a suspect H1N1 case as anyone under the age of 60 with a fever above 100°F and a new onset of cough.
"The purpose of distributing these respirators is to ensure that every health care worker who is in direct contact with an H1N1 patient will be able to use an appropriate respirator as required," Cal/OSHA said in a statement. Respirator use also is required with novel pathogens under the state's Aerosol Transmissible Disease standard.
Obtaining respirators sometimes has required switching to a new brand - and a massive job of fit-testing employees. "Everybody's doing the best they can to meet the standard with the supply that is available," says Sandra Domeracki Prickitt, RN, FNP, COHN-S, executive president of the Association of Occupational Health Professionals in Healthcare and coordinator of Employee Health Services at Marin General Hospital/Novato Community hospitals in California, where employees had to switch to new respirators as many as three times.
Even hospitals that have been proactive in stockpiling respirators have run into problems with supply in this ongoing epidemic. Yale-New Haven (CT) Hospital spent a million dollars stockpiling respirators in its pandemic preparedness but still ran out of the small size. While waiting months for more 3M 1860 respirators, the hospital purchased the small size of a different brand and repeated the fit-tests on employees who needed them.
Meanwhile, Yale is setting priorities for the respirator use in case of a shortage, in line with CDC recommendations to provide respirators for the highest-risk activities (such as bronchoscopy and intubation) and the health care workers at greatest risk (such as pregnant workers or those with certain chronic conditions).
"One hopes a month or two from now we'll have a well-vaccinated health care population. In the interim, we want to make sure everyone is protected," says Mark Russi, MD, director of occupational health at the hospital and associate professor of medicine and public health at the Yale University School of Medicine. He also is chair of the Medical Center Occupational Health section of the American College of Occupational and Environmental Medicine.
In a shortage scenario, health care personnel at lower risk of exposure or of complications from influenza may wear a nonfit-tested respirator until the fit-testing can be completed, the CDC states.
Meanwhile, the CDC guidance could change again in the future if much of the population is immune and it is no longer considered a "novel" strain - or if the virus mutates to become more virulent. Influenza is notoriously unpredictable, public health experts say. In fact, CDC notes that the guidance could even be revisited during this influenza season.
"[The guidance] applies uniquely to the circumstances of the current 2009 H1N1 pandemic," said Toby Merlin, MD, senior medical advisor to the CDC director. "We anticipate that we will be acquiring more information about the transmission of H1N1 in the health care setting and steps that can be effectively taken to prevent its transmission. We are actively promoting a research agenda to look at this season in a variety of modalities.
"After this season, after immunity has developed in a substantial portion of the population either through exposure or immunization, this virus will no longer be the threat that it currently is - unless it changes."
(Editor's note: CDC has provided Q&A information on the guidance and respiratory protection at www.cdc.gov/h1n1flu/guidance/control_measures_qa.htm and www.cdc.gov/h1n1flu/guidelines_infection_control_qa.htm.)
Faced with the prospect of a citation by the U.S. Occupational Safety and Health Administration, hospitals are adjusting to the updated federal guidance to use fit-tested N95 respirators when caring for 2009 H1N1 patients.Subscribe Now for Access
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