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By Kelly M. Pyrek
In a dance of one step forward, two steps back, theOccupational Health and Safety Administration (OSHA) backed off from a proposedtuberculosis (TB) standard but announced in January it will apply its generalrespiratory protection standards to the healthcare environment. This seeming contradiction and the accompanying mandate ofannual fit-testing of respirators has caught the infection control communityoff guard, with clinicians scrambling to gather pertinent details. OSHA hasannounced a six-month grace period for implementing the new requirements; facilities are expected to be in compliance by July 1, 2004.
Jeff Weed, product manager for the PortaCount Universal FitTest System from TSI, says the fit-testing of respirators is justified. OSHA does have legitimate reasons to require fit testingand to require that it be done annually, he says. He points to the preamble to the OSHA respiratoryprotection standard 29CFR1910.134 published in the Jan. 8, 1998 Federal Register(63 FR 1223) that explains OSHAs reasoning:
Physiological changes that affect facepiece fit can occurgradually over time and are easily overlooked by observers, and by the usersthemselves. Individuals with poorly fitting respirators were oftendetected only through fit testing, and not by other methods such as observationof changes in facepiece fit, failure to pass a user seal check, or an employeereporting problems with the fit of the respirator. Retesting facepiece fitsolely on the basis of physical changes in individual respirator users would notbe a reliable substitute for fit testing on an annual basis.
Weed says, Examination of that document reveals that all ofthe arguments against annual fit testing that are currently being made wereraised and fully considered by OSHA back then. In fact, the annual fit testing requirement was specificallychallenged in court and upheld in 1999.
(For more details about fit-testing and what to consider whencomplying with OSHAs requirements, see the accompanying sidebar to thisarticle on www.infectioncontroltoday.com.)
In essence, OSHA is extending the same high level ofrespiratory protection to workers exposed to TB that is provided to workersthroughout general industry, an enhancement that results from OSHAs decisionto withdraw its 1997 proposal on TB. When the general industry respiratoryprotection standard was promulgated in 1998, OSHA announced that it would waituntil the conclusion of the tuberculosis rulemaking to decide whether to applythat standard to workers exposed to tuberculosis or to include TB-specificprocedures in a tuberculosis rule. Those workers remained under a 1974 standardin the interim. Enforcement of the new requirements will be phased in to allowaffected employers to come into compliance.
OSHA published a proposed standard on Oct. 17, 1997, tocontrol occupational exposure to tuberculosis. It was estimated at that timethat a standard would protect roughly 5.3 million workers in more than 100,000hospitals, nursing homes, hospices, correctional facilities, homeless shelters, and other work settings with a significantrisk of TB infection. Since the proposal, however, a number of factors haveemerged that alleviate the necessity of developing a TB-specific regulation.
In addition to the decrease in the number of TB casesnationwide, OSHA has concluded that occupational risk is lower than originallyreflected because of greater implementation of TB controls and greatercompliance with CDCs guidelines; and a rule would not substantially reducethe spread of TB from undiagnosed sources.
Since 1993, the number of TB cases in the United States hasdeclined by more than 40 percent due, in large part, to the success ofguidelines issued by the Centers for Disease Control and Prevention (CDC),said OSHA administrator John Henshaw in a prepared statement. This is especially true in high-risk workplaces such ashospitals where TB cases are diagnosed, treated and isolated. Given thesepositive results, its appropriate to let CDC continue the successful work itis doing, and focus our resources on reducing workplace hazards that are notbeing addressed through other control efforts. In addition, based on ourextensive review of the issues related to respiratory protection, workersexposed to tuberculosis should have the same protections as those exposed toother types of hazards in the workplace.
In the Dec. 31, 2003 Federal Register, OSHA proclaimed itsrevocation of Respiratory Protection for M. Tuberculosis (29 CFR1910.139), which was a re-codification of OSHAs 1971 General IndustryRespiratory Protection standard that was revised in 1998. At the time of therevision of the 1971 standard, OSHA decided that because its proposedstandard for occupational exposure to TB, published three months earlier,included a comprehensive respiratory protection revision the agency wouldallow compliance with the previous respirator standard for TB protection untilcompletion of the TB rulemaking. Pending conclusion of the TB rulemaking, OSHAre-designated the old Respiratory Protection Standard in a new section titledRespiratory Protection for M. Tuberculosis. However, OSHA withdrew itsproposed TB standard, and because this withdrawal concludes the TB rulemaking,OSHA revoked the re-designated Respiratory Protection Standard, and will beginapplying the General Industry Respiratory Protection Standard (29 CFR 1910.134)to respiratory protection against TB.
The Association for Professionals in Infection Control andEpidemiology (APIC) and its director of public policy, Jennifer Thomas Barrows,are working with OSHA standards representatives to ascertain the details of theruling.
The first thing our members are going to want to know iswhen they need to be in compliance because they dont want to be fined, says Sue Sebazco, chair of public policy for APIC. We needsome good information for them, and thats what we are trying to gather.Everyone is trying to get a good feel for the details.
Theres no doubt about one aspect of the ruling, and that isOSHAs position on the mandatory annual fit-testing of respirators worn forprotection against airborne particulates and infectious agents. While OSHA saysfit testing is an important component of an effective respiratory protectionprogram, APIC states on its Web site: As our members are well aware, APIC haslong opposed the notion of mandatory annual fit-testing, since there is no solidscientific justification for this practice. We will be contacting OSHA andworking with Congress in an attempt to address this issue.
Our members are asking, How did this happen? and weare saying, We didnt expect this to happen, Sebazco says. Ourmembership knows we have worked very hard over the past seven years so we havedeveloped trust with them and they know we will do everything we possibly can totake care of this. We dont know if it can be reversed, but we hope so. If wethought there was no chance not to, we wouldnt work in that direction.
With OSHAs withdrawal of the TB proposal, the agency willbegin applying the general industry respiratory protection standard forprotection against the disease. New requirements include updating the facilitysrespirator program, complying with amended medical evaluation requirements,annual fit testing of respirators, and some training and recordkeepingprovisions. While all of these provisions were included in the TB proposal, theonly one that elicited a significant amount of public comment was therequirement for annual fit testing.
We appreciate what OSHA did by withdrawing the proposed TBrule and realizing we can control TB without it, Sebazco says. We have limited resources in healthcare and we want to makesure we use these resources for the best reason. Doing annual fit testing is notsomething that is warranted. When we first started doing respirator fit testingafter the CDC guidelines came out, it was very time consuming. If we have to doannual fit testing on employees it will be a tremendous financial burden on oursystem. We have to figure out how this is going to be accomplished.
We recognize that continued vigilance is necessary,Henshaw said. We will enforce the respiratory protection standard and otherrelevant requirements when employers fail to protect their workers against TBexposure.
The Federal Register notice is available for downloading fromthe APIC Web site at: www.apic.org/pdf/FederalRegister.pdf
Jeff Weed, product manager for the PortaCount Universal Fit Test System from TSI, says the fit-testing of respirators is justified. "OSHA does have legitimate reasons to require fit testing and to require that it be done annually," he says. He points to the preamble to the OSHA respiratory protection standard 29CFR1910.134 published in the Jan. 8, 1998 Federal Register (63 FR 1223) that explains OSHA's reasoning: "Physiological changes that affect facepiece fit can occur gradually over time and are easily overlooked by observers, and by the users themselves. Individuals with poorly fitting respirators were often detected only through fit testing, and not by other methods such as observation of changes in facepiece fit, failure to pass a user seal check, or an employee reporting problems with the fit of the respirator. Retesting facepiece fit solely on the basis of physical changes in individual respirator users would not be a reliable substitute for fit testing on an annual basis."
Weed says, "Examination of that document reveals that all of the arguments against annual fit testing that are currently being made were raised and fully considered by OSHA back then. In fact, the annual fit testing requirement was specifically challenged in court and upheld in 1999. It is also worth reviewing OSHA's reasons for requiring annual fit testing that are clearly stated in the Federal Register (68 FR 75776). That is the document that officially revokes the interim TB standard 29CFR1910.139 issued by OSHA on December 31, 2003. It is readily apparent that OSHA believes respirator usage and annual fit testing are inexorably linked and that annual fit testing and annual respirator training are just as important to an effective respiratory protection program as the respirators themselves. Unless some strong evidence surfaces showing that respirator usage for TB protection is fundamentally different than respirator usage for other hazards, OSHA will not be making any changes."
The following is a Q&A with Jeff Weed about the new fit-testing requirement:
Q: Do you have a feel yet for the increase in fit-testing activity the OSHA ruling will
A: "The recent OSHA ruling that has made annual fit-testing mandatory is certain to increase demand, but it's impossible to predict how much. TSI has been very successful selling the PortaCount Universal Fit Test System to hospitals and other healthcare organizations since the instrument was introduced in 1997. Many of these organizations have already been doing annual fit-testing voluntarily because of their high concern for employee health, and because OSHA highly recommended (not required) doing so. Employers have a choice between qualitative or quantitative fit-testing, so even though the PortaCount together with the N95-Companion accessory is the only instrument on the market for quantitative fit-testing of series-95 disposable respirators, it does not mean that everyone has to use it."
Q: Many hospital administrators and even clinicians are not happy about the requirement, citing time and expense as objections to annual fit-testing; how are you assuring them that fit-testing can be easy, quick and unobtrusive in their busy schedules?
A: "We make fit testing as painless as we can. There are limits to how fast the test can be done due to the OSHA requirement to use a specific exercise protocol. PortaCount software automates the fit test, stores the results and eliminates the operator errors and fatigue that plague qualitative methods. It is almost impossible to do a fit test wrong when you use the PortaCount. Anyone who has spent a day performing an alternative qualitative method like Saccharin or Bitrex will tell you how difficult and unreliable it is. Familiarity with qualitative methods is necessary before the advantages of the PortaCount can be fully appreciated."
Q: Numerous infection control practitioners say there are no over-riding clinical or scientific imperatives for mandatory, annual fit-testing, so how are you prepared to soothe any ruffled feathers? Do you point to any independent or company-sponsored studies that underscore the importance of fit-testing?
A: "TSI is not the entity that mandates or justifies annual fit testing. OSHA does that. TSI provides the best solution to organizations that need to comply with OSHA fit-testing requirements and also want to make sure workers get full performance from their respirators. This results in a friendly relationship with our customers because we offer to make OSHA compliance easier and fit testing more effective."
Q: What are the most important considerations when selecting equipment and software for fit-testing and why?
A: "First, organizations need to make a choice between qualitative fit-testing and quantitative fit-testing. The equipment for the Saccharin or Bitrex qualitative methods consists of a hood to go over the test subject's head and a pair of hand-operated nebulizers (atomizers) for spraying the challenge aerosol into the hood. There is no computer or software involved, just an instruction sheet and perhaps a training video. Most respirator manufacturers offer qualitative fit test kits. Quantitative fit-testing requires a fit-test instrument, software and a computer. Quantitative fit test instrumentation must be easy to use, reliable and OSHA compliant. Associated software should automate the fit test in such a way that there can be no mistakes that could void the efficacy of the fit test or violate OSHA requirements. Recordkeeping and report generation features provided by the software are an important benefit. TSI is currently the only company offering quantitative fit test instrumentation and software for fit testing series-95 disposable respirators. Something that is arguably just as important to an effective fit testing program as the method or equipment used is the expertise of the fit test operator with regard to respirator usage. The operator has to be familiar with the masks and be able to identify and solve problems. A good fit-test operator can make a huge difference in how smoothly the process goes by identifying poor donning practices before the fit test even starts and by expediently determining if a failed fit test was due to improper mask size or insufficient training. This type of expertise is usually obtained on-the-job through trial and error, however there are some good respiratory protection seminars available that cover the subject as well as assistance from the specific respirator manufacturer."