Do the benefits of the new OSHA HIV/HBV standard justify the costs?

On December 6, 1991, OSHA published its "final standard" for controlling occupational exposure to HIV and HBV. While the main thrust of the standard is sound, in some physicians' assessment, some of the detailed emphasis may be misdirected. They fear that the burdens imposed by the standard may be greater than the benefits derived from it. "Health Law" is a regular feature of Physician Executive contributed by Epstein, Becker, and Green. Mark Lutes of the firm's Washington, D.C., offices serves as editor for the column.

The Occupational Safety and Health Administration (OSHA) has taken a bold step in enlarging, amplifying, and giving the force of law to the Centers for Disease Control's protocols regarding bloodborne pathogens Standard," OSHA claims it will prevent more than 9,200 infections and 200 deaths per year.

The standard, which was published December 6, 1991, in the Federal Register, (*) relates to occupational exposure to blood and body fluids that are potentially infected with human immunodeficiency virus (HIV) or hepatitis B (HBV). The standard applies to all health care workers who could be "reasonably anticipated" to contaxt potentially infectious materials as a result of performing their jobs.

Somewhat controversially, OSHA has estimated the cost of compliance for hospitals to be just under $52,000 annually. The standard required health facilities to develop an "exposure plan" that identifies job classifications, tasks, and procedures where occupational exposure to potentially infectious material occurs. The new standard mandates implementation of "universal precautions." Under the system of universal precautions, health care workers assume that, absent testing and labeling to the contrary, all specimens of body fluids or tissue are infectious.

The new OSHA standard also mandates development of specific health care facility procedures. For instance, the standard dictates that hospitals and other health facilities set forth and formalize procedures to minimize the splashing and spraying of blood, to ensure appropriate packaging of specimens and regulated wastes, to minimize needle sticks, and to maintain rigorous decontamination practices and procedures. Additionally, the use of gloves, gowns, masks, and other prophylactic devices is specifically required.

Under the new standard, hepatitis B vaccinations are to be made available to all health care workers with occupational exposure to potentially infectious materials. Vaccinations, which must be provided at employers' cost, must be made available within 10 working days of employee assignment. Vaccinations must be administered under the supervision of a physician or other licensed health care professional and according to the latest recommendations of the U.S. Public Health Service. Employees must sign a form if they choose not be vaccinated. Employees who decline may later opt to receive the vaccination of employer's cost.

The highly specific standard also addresses a broad range of topics from needle recapping techniques to the color of biohazard warning symbols. The standard takes effect on March 6, 1992, 90 days after publication in the Federal Register. Exposure control plans must be in place by May 5, 1992. Information dissemination and training requirements take effect June 4, 1992.

OSHA is taking aggressive steps to disseminate the information contained in the standard. The employee training mandated under the standard must include making a copy of the regulatory text of the standard and an explanation of its contents accessible to workers. Discussions of:

* Bloodborne diseases and their transmission.

* Exposure control plans.

* Engineering and work practice controls.

* Personal protective equipment.

* Hepatitis B vaccines.

* Response to emergencies involving blood.

* Handling of exposure incidents.

* Postexposure evaluation and follow-up programs.

* Labeling and color-coding of wastes.

At information and training sessions, there must be an opportunity for questions and answers. Fact sheets and booklets outlining the provisions of the standards are being published, as are specialized books targeted for long-term care facilities, acute care facilities, dental offices, and emergency responders.

The new OSHA standard is a bold move to codify and give legal force to protocols designed to stem concerns of both health care recipients and health care providers about the transmission of HIV and HBV in health care settings. That the new developments will carry a heavy cost is certain. Just how heavy that cost will be, of course, will vary by facility.

Few medical executives will object to the spirit of the OSHA standard. There are, however, two perceived flaws in OSHA's effort. The first flaw may be inherent in proscriptive government regulations of any type. Because of the standard's high level of specificity, less rigorous providers may tend to view the standard as the last word on occupational exposure to bloodborne pathogens. Moreover, current scientific knowledge and technology and health care facility practices may well change too rapidly to be adequately governed as specifically as the OSHA standard attempts.

The second perceived flaw in the standard lies in the cost element. Again, few physician executives would argue against the implementation of enhanced safety practices in theory, but they may be concerned that patients/consumers will ultimately bear the potentially significant cost of compliance. In a time of increasing consumer dissatisfaction with rising health care costs, perhaps OSHA, in its attempt to help both providers and consumers of health care, has done both a disservice.

(*) "Occupational Exposure to Bloodborne Pathogens." Federal Register 64,004 (1991) (to be codified at 29 C.F.R. (section sign) 1910.1030).

Daniel J. Weissburg is an attorney in the Washington, D.C., offices of Epstein, Becker, and Green.