HICPAC Revises Isolation and TB Guidelines
By John Roark
The Centers for Disease Control and Prevention (CDC)s long awaited Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Setings will most likely be published in late August/early September 2005, says Michele Pearson, MD, of the CDC. Infection control practitioners (ICPs) have anxiously awaited the new guidelines, which will expand on the 1996 Guidelines for Isolation Precautions in Hospitals.
The CDCs Healthcare Infection Control Practices Advisory Committee (HICPAC) issued a draft guideline open for public comment through January 2005 an extension of the original deadline of mid- August 2004.
As co-chair of he Association for Professionals in Infection Control and Epidemiology (APIC) Practice Guidance Counsel, Georgia Dash, RN, MS, CIC, director of the infection prevention and control department at Temple University Hospital, serves as the liaison between APIC and HICPAC, and has been on the front lines of this revision.
There have been numerous comments to the guidelines directly to HICPAC not just from the APIC practice guidance, but from individual infection control professionals and from APIC chapters as a whole, says Dash, who cites the following hot buttons of discussion:
Isolation from multidrug-resistant organisms HICPAC invited discussion from representatives from long-term care, in reviewing the guidance for multidrug-resistant organisms and what one would do both ordinarily and in special circumstances where one believes that there is an outbreak, says Dash. The idea of the isolation guidance is that it should go across the continuum of care. In the past, isolation guidance was mainly focused on acute care. Its quite different when youre taking care of a patient in long-term care, where the facility really is their home. There were a lot of requests for clarification with regard to that.
Dash also notes that in the revisions, wording was addressed concerning transmission-based vs. enhanced precautions. We felt that enhanced may be more correct terminology from a logic or vocabulary point of view.
Other healthcare sites, including correctional facilities and shelters One of the phrases in the guidance was infection control measures, and areas designated for healthcare are the same as for other ambulatory care settings, says Dash. These areas must be equipped to observe standard and expanded precautions. Some practitioners felt that it was unrealistic to require a donation-supported homeless shelter to have facilities to support expanded precautions such as airborne infection isolation.
Administrative responsibilities, support of infection control programs and the number of ICPs to support a program The original document cited one ICP per 250 acute-care beds, says Dash. That language has been changed substantially. The recommendation of 0.8 to 1 full-time employee per 100 beds not 250 beds, has been cited in the document. The 1 to 250 ratio is just referred to from a historical standpoint.
The protective environment Should the protective environment be listed with airborne contact droplet precautions as an additional transmission-based precaution? They decided that no, the protective environment should not be listed as a category of transmission-based precautions, but it would be described in the document.
Contact precautions Should gown and gloves be donned upon entry to the contact precautions room, or put on only for certain tasks? Additionally, should there be a differentiation for acute care vs. long-term care? They felt that gowns and gloves should be put on upon entry to the room of the patient in contact precautions in an acute care facility. However, in a non-acute care facility, the donning of gowns and gloves should be based upon the activity that is being undertaken.
There also was some discussion about whether an additional category of precaution such as strict isolation be developed for those instances when two types of isolation precautions are required, continues Dash. For example, with chicken pox you would require airborne precautions and contact precautions. They decided on no additional category of precautions. At this moment, that is the decision.
One question on the minds of many is whether the new guidelines will in any way clash with existing Society for Healthcare Epidemiology of America (SHEA) guidelines. Dash stresses CDCs awareness of SHEAs concerns. I think that what they have tried to do is to recognize the SHEA guidelines, and to incorporate those SHEA guidelines when there is a specific concern about outbreak with multidrug-resistant organisms. I think that theyve worked very hard to incorporate the SHEA guidelines in those special circumstances.
CDCs TB Prevention Guidelines
CDC also is revisiting the Guidelines for Preventing the Transmission of Mycobacterium tubucerlosis in Health-Care Facilities. Originally issued in 1994, these guidelines are being reissued to update TB control recommendations reflecting shifts in the epidemiology of TB, advances in our scientific understanding, and changes in health-care practice that have occurred in the United States in the last decade.1 The public comment period is scheduled to end February 4, 2005. At the crux of the revision is the contentious issue of annual fit testing of N95 respirators for healthcare personnel. APIC has long waged a battle over the issue, citing the expense and logistical nightmare that mandatory fit testing present.
APIC spent seven years trying to negotiate/talk to/testify with OSHA about this document, and thought they had put it to rest, says Nancy Bjerke, RN, MPH, CIC, an independent infection control consultant and co-chair of the APIC Practice Guidance Council. In fact, it wasnt being supported by the administration. Then, lo and behold, OSHA came around and got it under general industry recommendations.
Jeff Weed, product manager for TSI, Incorporated, sees APICs stance as a face-saving measure that contributes to the uncertainty surrounding the issue. I think a lot of people are still confused, he says. If they listen to APIC, they only get part of it. [APIC] seems to be fighting this as kind of an unfunded mandate. I think part of the reason theyre more concerned this time is that they are trying to save face.
There was a special provision that OSHA had for TB. In 1998 OSHA rewrote the respiratory protection standard for everybody, except for TB. They retained the old standard, renamed it and said, This is for TB only, because were working on a new TB standard. That new standard draft was out for public comment, and it included annual fit testing. The medical community, most notably APIC and other associations, was fighting with OSHA on the provisions of that draft for a long, long time. APIC and others finally succeeded in getting OSHA to trash the whole thing. What they didnt know was going to happen was that when OSHA trashed the special TB standard, they didnt need the temporary one anymore. They said, okay, now everybody is under the one standard that we released in 1998, which includes annual fit testing. I think APIC is doing a lot of this to kind of save face, because they should have predicted that would happen. It was naïve of them not to know. I think theyre trying to make up for their mistake.
Late in 2004, Congress passed, and President Bush signed, the Consolidated Appropriations Act (CAA) for fiscal year 2005. Included in the omnibus funding bill is the Wicker Amendment, providing that no federal funds may be used to enforce the annual fit-testing provision for TB through fiscal year 2004 (until Sept. 30, 2005). In an email bulletin to association members, Jennifer Thomas, director of public affairs for APIC wrote:
During FY 2005, employers may not be inspected or cited for the requirement to do annual fit testing of respirators for occupational exposure to tuberculosis. This prohibition applies to all OSHA compliance inspections, including programmed inspections, employee complaints, and imminent danger situations. The appropriations restriction also prohibits referrals for potential violations of the annual fit testing requirements for respirators and occupational exposure to tuberculosis that result from Section 11C investigations. The appropriations restriction, however, does not prohibit OSHA from conducting Section 11C investigations.
If inspection activity regarding the annual fit testing of respirators for tuberculosis has already taken place, the Area Director shall ensure that no citations are issued and no penalties proposed. If already issued, but not yet contested, any citation or proposed penalty shall be withdrawn. If an employer has already filed a notice of intent to contest, the Area Director shall inform the Regional Solicitor, who shall take appropriate action to ensure that the specific citation regarding annual fit testing and tuberculosis is not pursued before the Occupational Safety and Health Review Commission. No other provisions of the respiratory protection standard are affected by this appropriations restriction. We may continue to cite the remainder (non-annual fit testing requirements) of 29 CFR 1910.134 as it relates to tuberculosis including the provisions of 29 CFR 1910.134(f)(2) for the lack of initial fit testing or whenever a different respirator face-piece is used. The appropriations restriction also does not affect 29 CFR 1910.134(f)(3), requiring an additional fit test when facial changes have occurred that could affect the proper fit of the respirator.
Thomas goes on to provide examples of conditions which would require additional fit testing of an employee to include:
- the use of a different size or make of respirator
- weight loss
- cosmetic surgery
- facial scarring
- the installation of dentures or absence of dentures that are normally worn by the individual
Employers must also be following one of the fit testing methods detailed in Appendix A to the standard and maintaining records of each fit test performed, Thompson continues. In addition, the appropriations restriction affects only annual fit testing of respirators used for protection against tuberculosis. All requirements of the respiratory protection standard, including annual fit testing, may continue to be cited for respirator use against other hazards, such as Severe Acute Respiratory Syndrome (SARS) or other bioaerosols.
With respect to outreach and assistance activities (e.g., education and training and compliance assistance), the appropriations restriction prohibits OSHA from stating that 29 CFR 1910.134(f)(2) requires annual fit testing of respirators for tuberculosis or recommending to employers that they implement an annual fit testing program for respirators if their only use of respirators is for the protection of employees against tuberculosis.
If asked in the course of providing training or compliance assistance what the agencys position is on the annual fit testing of respirators for tuberculosis, Thompson continues, We should explain that our FY 2005 appropriations prevent us from obligating or expending funds to administer or enforce the provisions of 29 CFR 1910.134(f)(2), to the extent that they require annual fit testing of respirators for occupational exposure to tuberculosis.
In addition, OSHA may not require annual fit testing of respirators for tuberculosis as a condition for participation in OSHAs recognition programs or strategic partnerships. The appropriations restriction does not prohibit employers who participate in those programs from adopting, on their own, annual fit testing of respirators for tuberculosis.
OSHAs onsite consultation program must also abide by the applicable appropriations restrictions in the CAA during consultation visits and other compliance assistance activities. The restrictions above apply to the use of federal funds appropriated under the CAA. State Plan states and consultation projects may not expend federal or state matching funds to perform activities prohibited by the appropriations restriction.
State Plan States may use 100 percent of state funds to continue to conduct prohibited activities regarding tuberculosis and the respiratory protection standard, provided they maintain auditable accounting systems to document the separation of funding sources.
Thompson goes on to point out that OSHA cannot cite anyone for not fit testing up until October. But after October, we anticipate that theyre going to press with this. So the thing people are hoping is that the CDCs TB guidelines that have come out say that initial fit testing for new hires, but then periodic after that which would be dependant on your risk classification for your facility. In that guideline, they break out what your risk is, and the frequency that you need to do it.
While she supports APIC, Bjerke stresses that from a practical aspect, the associations stance seems impractical in light of attrition and the changing physique of todays healthcare workers. As we get older, we tend to put on a little weight, she says. Gravity sets in; the physical structure of our faces will change. You cant assume that if you wore a small mask when you were in your 20s that the same size will fit 20 years in the future. Im in my 60s now, and a small mask would barely cover my nose. Some might not have the common sense to go in and be fitted for a larger mask.
The argument purports that annual fit testing takes time and money. For those organizations that have not been keeping up annually, the cost would be burdensome. But for those programs that never dropped annual fit testing, that felt it was for the occupational health of the employee this is a no-brainer, says Bjerke. They have no beef with it. If you were to canvas a bunch of facilities, large and small, rural and urban, you might find in fact that this is not a real problem.
Weeds involvement in the military and industrial sectors where annual fit testing is standard has him questioning the whole debate. There doesnt seem to be too much argument about having some annual respirator training of some kind, he says. I cant understand how they can have respirator training without having fit testing. They go hand-in-hand; you just cant do respirator training without having that final fit test.
APIC and others will argue that theres no scientific study that says annual fit testing is a good idea. I bet there are dozens and dozens of things that healthcare workers get refreshers on every year and there are no studies on those either. The vast experience in the industrial side of things and that includes disposable respirators has been that fit testing is essential. It can be qualitative or quantitative, but either way, its absolutely essential if youre really going to get the protection that those respirators are designed to give.