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OSHA: new player in the battle against AIDS.

OSHA: New player in the battle against AIDS

This is the first time that OSHA has found itself in the disease business!" With that opening comment, then-Secretary of Labor Ann McGlaughlin annouced in the late fall of 1987 an intent to draft a proposed Federal standard to prtect workers from contracting bloodborne diseases in the workplace.

The implications of this document for the American health care industry are considerable and alarming to many, as witnessed by a public response unprecedented in OSHA history. The proposal was published May 30, 1989. By August, the agency had received more than 1,400 written responses to it and more than 300 requests to comment at public hearings to be held over the months to follow. So many parties wished to voice their concerns that OSHA increased the number of hearings across the country from four to five. The last of these was held in San Francisco from Jan. 9 to 17, 1990, postponed from October 1989 because of the earthquake.

The Occupational Safety and Health Administration, created by an act of congress in 1970 "to assure so far as possible evry working man and woman in the nation safe and healthful working conditions," has historically focused on the industrial workplace, where its inspectors have monitored the protection of employees from toxic chemical and physical agents. Only gradually did compliance officers venture into the hospital setting. * Enter the unions. Why the sudden concern for biologic hazards? The change was largely initiated by several unions whose health care worker members felt their employers were insufficiently protecting them from the AIDS virus on the job. Yet ironically, the main petitioning union - the American Federation of State, County, and Municipal Employees (AFSCME) - is excluded by law from OSHA regulation.

Having determined that the unions' petition had merit, OSHA proceeded to develop a Proposed Standard for the Protection of Workers from the Hazards of Bloodborned Pathogens. Remarkable in itself is the broad spectrum of workers and types of facilities covered by the standard, including hospitals, physician and dentist offices and labs, EMT personnel, fire fighters, and police and correctional officers. All told the standard embraces more than 600,000 facilities and nearly 5.5 million employees, 15 per cent of whom work outside the health care field.

The total annual cost of implementing the program has been estimated by OSHA at roughly $850 million, of which $60 million during the first year will cover the HBV vaccination program. While OSHA has placed the average cost to hospitals at $33,000 per year, knowledgeable observers in the industry have stated that this figure underestimates the true cost by several orders of magnitude. * Requirements. The proposed standard uses as a framework the CDC guidelined for prevention of HIV and HBV transmission in health care settings. OSHA also adopted appropriate recommendations from the preliminar draft on protection of laboratory world as M29, developed by the National Committee for Clinical Laboratory Standards and published in January 1989.

At the heart of the OSHA standard is the requirement that employers first identify procedures and workers who may be exposed to blood or certain body fluids on the job and then develop an Infection Control Plan designed to minimize their risk of infection. The plan must include a formal staff training program on the nature of bloodborne infections and the methods available by which to avoid occupational transmission and the provision of sufficient and suitable protective materiel, including gowns, gloves, eye guards, and devices for disposing of sharps. As part of their plan, employers are required to explain the basis for selecting work practices, engineering controls, and protective equipment. They must also provide information on the safe disposal of such clothing and equipment as well as the disposal of other biohazardous waste.

In addition, the employer must provide an HBV vaccination program. Implicit in the proposed standard is that the program must be provided free to all workers at risk. Yet although a safe and effective vaccine has been available. in the United States since 1982, usually offerd free by employers, health care workers have been loath to avail themselves of it The CDC reported that only 30 per cent of health care workers ar risk had been vaccinated up to February 1989. Nor have the unions, suddenly so vocal on the subject of worker protection from HIV and HBV, done much to educate their members about the advantages of vaccination against HBV or encourage them to be vaccinated.

According to the survey reported in this issue of MLO, the vast majority of hospital laboratories already comply with much of the proposed standard, particularly provisions related to personal protection devices and infectious waste disposal. The aspect of the proposed rule for which we are least prepared is the mountain of paperwork it will entail. Each comprehensive infection control plan as mandated by the proposed standard must include an inventory of all tasks performed in the laboratory along with an ongoing list of who is performing them. Employee records must be maintained for the duration of employ plus 30 years. Moreover, these records must be kept confidential and secure from the eyes of fellow workers. The logistics involved in this requirement alone connot be overestimated. * Factions. The process by which a proposed OSHA standard becomes final involves a period of initial written comment, a period for public hearings, and a second round of written comment. When all of this has been completed, an agency task force prepares a Final Rule for approval by the Secretary of Labor and the Office of Management and Budget.

The issues raised in the current proposed regulations for lab safety have caused lines of interest to be sharply drawn. On one side are labor organizations, including unions and professional groups of nurses, lab workers, police, and fire fighters, pressing for guidelines as explicit as possible. The labor groups urge OSHA to leave minimal room for interpretation of the regs and to exact severe fiscal penalties for noncompliance.

On the other side are the employer-management groups, such as the American Hospital Association and the College of American Pathologists, seeking a rule that retaiins some flexibility, considers the low likelihood of actual transmission of HIV in the workplace, and demands less stringent penalties for noncompliance.

One reason for the polarity of these views - besides financial self-interest - is the groups' different perceptions about the risk of occupational transmission of HIV infection. The unions' position, put forth most vocally by AFSCME (whose representatives have appeared at all five public hearings), is that the medical establishment's current assessment of a 0.4 per cent risk of transmission of HIV by accidental needlestick vastly underestimates the true risk. The low figure, these groups charge, is the result of two factors: underreporting of accidents and seroconversions, and the reality of careelong exposure to these agents by most workers who come into contact with them.

In this belief, the unions and their supporters are fueled by the minority view of such advocates of strict protectionism as Lorraine Day, M.D., who resigned her post as chief of orthopedic surgery at San Francisco General Hospital, saying - among many other things - that her jon had become too dangerous and she owed it to her children to survive. * Opposing view. Medical authorities in the field of laboratory safety take the position that the rules should retain some flexibility, depending on where they are being applied. One such authority is Stanley Bauer, M.D., chair of the NCCLS subcommittee that framed M29. Dr. Bauer has expressed doubts about the feasibility of formulating a strictly uniform code that would be equally appropriate for a community hospital in Nebraska as for his own institution, Bronx-Lebanon Hospital Center in New York City.

Other experts in the field - including Gerald Hoeltge, M.D., who chairs tha CAP Committee on Health, Safety, and the Environment, and Paul Bachner, M.D., chair of the CAP AIDS Task Force - have publicly urged OSHA to develop a more flexible rule than is currently proposed, one that is based on a "performance standard." Such a plan would be in line with OSHA's Final Rule on Occupational Exposures to Hazardous Chemicals in Laboratories - published in the Federal Register on Jan. 31, 1990 - which requires the development of a Chemical Hygiene Plan. Here, it is left to the medical director of the laboratory to identify the specific hazards and develop a safety program appropriate for the facility in question.

Each plan is to be judged on its ability to avoid untoward events over time. The facility is held by the inspecting agency to comply with its own plan. Such a point of view would give greater emphasis and latitude to each institution in developing its own infection control plan rather than placing great emphasis on specific safety requirements that may not be universally applicable. * Becoming law. Close observers predict that the OSHA task force will mull over public responses for another six months before coming up with a final rule. It is anticipated that the only substantive changes from the proposed rule will consist of modifying or abandoning the categorization of workers by three tiers of risk.

In the three-tiered system, all laboratory workers would be classified as Category I, consisting of workers normally exposed to blood in the course of their work. It makes little sense, however, to place the technologist who oversees the operation of an automated chemistry analyzer in the same HIV/HBV risk category as an autopsy assistant. In addition, because of the confusion created by the CDC's recent official exclusion of certain body fluids (urine, feces, and saliva) from universal precautions, many hospitals are switching to the more inclusive policy of body substance isolation. BSI may possibly replace UP in the final OSHA document.

We will probably have the final rule by early 1991. Meanwhile, the case of perhaps the first health care worker with occupationally acquired AIDS to sue the employer for negligence (here, $175 million) did not, as expected, establish a legal precedent as to a hospital's responsibility to protect its personnel from the AIDS virus. In an out-of-court settlement on March 8, just befor the case would have gone to the jury, New York City's Health and Hospitals Corporation agreed to pay an undisclosed sum - reportedly over $1 million - to Veronica Prego, a young physician who said she had developed AIDS after experiencing a needlestick while serving as an extern at a municipal hospital in 1983. In the settlement, neither side acknowledged negligence.

The hospital industry will closely monitor future cases regarding its potential liability in maintaining a safe workplace.

[1.] Department of Labor, Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens; proposed rule and notice of hearing. Federal Register, pp. 23041-23139, May 30, 1989.

[2.] National Committee for Clinical Laboratory Standards. Protection of laboratory workers from infectious disease transmitted by blood, body fluids, and tissue; tentative guideline. NCCLS Document M29-T, Villanova, Pa., NCCLS, 1989.

The author is director of laboratories and nuclear medicine at Northern Westchester Hospital Center, Mount Kisco, N.Y.; vice chairman of the CAP Committee on Health, Safety, and Environment; and a member of the CAP AIDS Task Force and the NCCLS Subcommittee on Protection of Laboratory Workers.
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Title Annotation:Occupational Safety and Health Administration
Author:Alpert, Laurence I.
Publication:Medical Laboratory Observer
Date:Apr 1, 1990
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