OSHA outflanks infection control professionals with surprise TB move
APIC vows to fight annual respirator fit-testing
In a move that stunned infection control professionals, the Occupational Safety and Health Administration (OSHA) recently announced that it will require one of the most contentious provisions of its failed tuberculosis standard — annual respirator fit-testing — under its existing general respiratory protection standard.
The 1998 general respiratory provisions have not been applied previously to health care because OSHA’s plan was to create a separate TB regulation, which was issued as a proposed rule in 1997.1,2 With TB in steep decline nationally, ICPs led a successful effort to scuttle the proposed TB standard.
According to the most recent data available from the Centers for Disease Control and Prevention, 15,075 TB cases were reported in the United States in 2002. That represents a 5.7% decrease from 2001 and a 43.5% decrease from 1992 when the number of cases most recently peaked in the United States.
However, in a one-two punch delivered on New Year’s Eve 2003, OSHA announced it was dropping the proposed TB standard but folding some of its provisions into the existing 1998 respiratory standard. As a result, OSHA appears poised to enact some of the same requirements ICPs successfully staved off during several years of debate and hearings.
"It is unfortunate that OSHA has bypassed our own government process, grounded in democracy," says Patti Grant, RN, MS, CIC, an ICP at RHD Memorial Medical Center and Trinity Medical Center, both in Dallas. "I was shocked, astounded, and profoundly disappointed. We were cut off at the knees for trying to save health care resources."
New requirements under enforcement of the general standard will include updating the facility’s respirator program, complying with amended medical evaluation requirements, annual fit-testing of respirators, and some training and record-keeping provisions. Enforcement of the new requirements will be phased in to allow affected employers to come into compliance, the agency said. A six-month grace period began Jan. 1, 2004, with publication of the action in the Federal Register.3
The scope of the action primarily is aimed at hospitals that have workers who may be exposed to TB patients. However, other facilities potentially affected include nursing homes, correctional facilities, substance abuse treatment facilities, and others who deal with people with the disease.
"If you don’t have any provisions for taking care of a TB patient, it wouldn’t apply to you," says Sue Sebasco, RN, an ICP at Arlington (TX) Memorial Hospital and chairwoman of public policy at the Association for Professionals in Infection Control and Epidemiology (APIC). "If you transfer them out, it doesn’t apply to you. It applies to facilities that have the potential for caring for a patient with TB."
OSHA estimated that the total cost of compliance will be close to $12 million nationally, with more than 90% comprised of fit-testing and training expenditures for the N95 particulate respirators commonly used for TB protection. Still, the agency said the costs represent only 0.005% of the revenues of the affected establishments in the hospital sector. While OSHA downplayed the fiscal impact in announcing the plan, Sebasco says the impact will be substantial.
"This will have a tremendous impact on any health care facility that will need to go to annual fit-testing," she says. "It will have a dramatic impact because it will take a lot of manpower, supplies, and will take a lot of employee time"
Having led the fight to defeat the TB standard, the Washington, DC-based APIC is weighing its options to reverse the action. "As our members are well aware, APIC has long opposed the notion of mandatory annual fit-testing, since there is no solid scientific justification for this practice," the association said in a statement posted on its web site. "This was one of our biggest concerns with the proposed OSHA TB rule. We will be contacting OSHA and working with Congress in an attempt to address this issue. We will also let you know if it becomes necessary to enlist your assistance in contacting your representative. Please know that APIC is prepared to do all we can to reverse this decision."
However, interviews with OSHA officials indicate there may be little recourse because the TB provisions are being added to the existing 1998 respiratory protection standard for industry. OSHA notes that the fit-testing provisions in the general standard have already withstood legal challenges. In announcing the action, OSHA stated that courts "have concluded that the requirement is supported by substantial evidence in the record, even though some evidence’ indicated that such frequent retesting might not be necessary."
That means that annual respirator fit-testing for health care workers — a procedure many ICPs have protested is labor-intensive and unnecessary — will now be required. While it is not clear how many ICPs are already doing annual fit-testing, many apparently have gone to a policy of fit-testing on hire and then asking questions during an annual employee screening.
"Fit-testing is necessary so the employee knows they have the right size and they understand and can feel what a proper fit is like," Grant says. "But that does not translate into doing it year after year after year."
Instead, Grant and colleagues ask employees a series of questions annually to determine if another fit test is necessary. "We ask them about facial scarring, any dental changes, cosmetic surgery, or obvious weight change," she says. "If they answer yes to any of those questions then they have to be fit-tested [again]. Otherwise they just have to show the employee health nurse that they know how to put the mask and do a quick fit check."
The actual fit test involves donning the respirator and doing a series of talking and breathing exercises, including trying to determine seal leakage by asking the worker if they can smell or taste a benign agent like saccharin.
"Unless there is a product change or unless they answer yes’ to one of those questions, there is no reason to fit test them again," Grant says. "This is why I am so disappointed that OSHA bypassed the [rule-making] system."
Asked if annual questions about worker changes are sufficient, John Steelneck, OSHA directorate of standards and guidance, emphasized that that the standard calls for "physically doing a new fit test every year."
"Fit-testing is a specific requirement that has to be done annually," he tells Hospital Infection Control. "It is redone annually because people change in size — they gain weight, they lose weight, or they have something else happening. The more they wear them and the longer they wear them, the more [complacent] they get about fit. The annual fit test is to make sure that the particular respirator they are wearing is the one that gives them a good fit."
However, ICPs argue that the drain on resources will be considerable because annual fit-testing is a labor-intensive process. Sebasco says the test takes about 15 minutes a person, and it is difficult to limit those tested to a small cadre of employees.
"We will have to do it while they are on duty, so they will have to leave their station and come to be fit-tested," Sebasco says. "I certainly agree that we need to teach our employees how to use these respirators and give them appropriate training. But the annual fit-testing is just going to take a tremendous amount of manpower and time and energy away from our patients."
OSHA argues that ICPs and their employee health colleagues must strive to keep the number of workers in a respirator program to a minimum.
"If they want to be smart, they should actually decide that it is only going to be this group of nurses and doctors who are going to be dealing with it and don’t include in the program other people who may never be even peripherally [involved]," Steelneck says. "[People say], Now we have to fit test everybody in the hospital.’ That’s not true. They really need to only fit test the people who are going to be wearing the respirators and dealing with the people with TB, SARS, or any of the other biological agents that they may be exposed to."
But that is a taller order when translated to actual clinical practice. The number of ancillary worker contacts who may have to come into a patient’s room run the gamut from housekeeping to plant services to social work, ICPs note.
"We tried to limit fit-testing when we started it," Sebasco says. "We tried to pick and chose people to do fit-testing on, but we had to broaden and expand that because you just don’t know who is going to be in there at any given time. We had to open it up."
Dearth of data
While acknowledging that some ICPs cited additional costs and a perceived lack of benefits from repeating fit-testing, OSHA said there was insufficient data for it to drop the requirement. The agency conceded that a study cited by the Infectious Disease Society of America found that use of respirators, negative-pressure isolation rooms, and other measures reduced a hospital’s skin test conversions by 90% without annual fit-testing.3
"The fact that a single study of workers whose respirators were fit-tested only once did not show excess TB infections does not overcome the evidence supporting OSHA’s conclusion in the revised respiratory protection standard that annual fit-testing is appropriate to protect employee health," the agency said in the ruling.
In addition, a large number of participants in both the respiratory protection and TB rulemakings supported annual fit-testing, OSHA stressed. Those participants agreed that fit is not static, and that a one-time, initial fit test without a requirement for annual re-fitting does not ensure that the appropriate level of protection would continue to be sufficient, OSHA argued.
Indeed, proponents of the action say OSHA made the right call and ICPs need to demand the resources to protect workers. "It has been documented that annual fit testing makes sense," says Bill Borwegen, health and safety director at the Service Employees International Union in Washington, DC.
"I think OSHA did a pretty good job of articulating that in the Federal Register notice. The bottom line is if [hospitals] are willfully not doing this, then OSHA can issue willful citations. Instead of $7,000, they are $70,000 per incident. This an excellent opportunity for ICPs to go to their supervisors and say, We need more resources to protect health care workers.’"
Still, it is instructive to look at the bigger picture by going back to the 2001 report by the Washington, DC-based Institute of Medicine (IOM), which effectively killed the OSHA TB rule by determining it would put inflexible and expensive requirements on institutions at "negligible risk for occupational transmission of TB."4
While citing a paucity of data on the fit-testing issue, the IOM panel said the respiratory protection, in general, does not appear to be a major component of TB outbreak control. Instead, administrative measures such as identifying and isolating suspect TB cases in negative isolation rooms provided the essential protection from further transmission.
"These data, although imperfect and limited, support CDC’s emphasis on administrative controls and suggest the lesser contribution of a respiratory protection program in the hierarchy of tuberculosis infection control," the IOM concluded.
"OSHA forgot their first rule of thumb," Grant says. "Engineering controls are the least important on their three rungs of control of any occupational exposure. The first [rung] is administrative, followed by work practice, followed by engineering controls. On Dec. 31, they took the engineering control and made it the most important."
1. Department of Labor. Occupational Safety and Health Administration. Respiratory protection; final rule. 63 Fed Reg 1,152-1,300 (Jan. 8, 1998).
2. Department of Labor. Occupational Safety and Health Administration. Occupational exposure to tuberculosis; proposed rule. 62 Fed Reg 54,160-54,307 (Oct. 17, 1997).
3. Blumberg HM, Watkins DL, Berschling JD, et al. Preventing the nosocomial transmission of tuberculosis. Ann Intern Med 1995; 122:658-663.
4. Institute of Medicine — Committee on Regulating Occupational Exposure to Tuberculosis. Tuberculosis in the Workplace. Washington, DC: National Academy Press; 2001.