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OSHA rules on AIDS protection due by Dec. 1.

One way or another, it appears likely that tougher new standards to protect health care workers from bloodborne disease infection will be in place starting next month. The key question at press time was whether the Occupational Safety and Health Administration would issue final rules by Dec. 1 or Congress would force OSHA's hand by requiring the proposed rules to take effect on that date.

The choices became part of a touchy debate over how far and how fast the Government should move in preventing the spread of HIV and other infectious diseases. By early October, lawmakers had rejected two of the most stringent proposals, but analysts considered some action essential to an agreement on a budget appropriations package.

Much of the debate centered on the OSHA protection standards proposed May 30, 1989. The agency received nearly 3,000 public comments on its proposals and steadily pushed back the date for final regulations while considering modifications.

In early September, however, the Senate overwhelmingly approved a measure ordering OSHA to issue final rules by Dec. 1 or see them take effect in the proposed form.

Offering the amendment to an appropriations bill, Sen. Edward Kennedy (D-Mass.) called the OSHA proposal "the most effective means of stopping both HIV and hepatitis B transmission in health care settings."

Among the key provisions of the May 1989 OSHA proposals:

* Employers must develop a written infection control plan that covers all workers who could be exposed to body fluids or contaminated waste. The plan would detail how the employer will implement the bloodborne infectious disease standard and would be updated when workers' tasks or procedures change.

* Employers must provide their workers with personal protective equipment, including gloves, gowns, laboratory coats, fluid-proof aprons, face shields or masks, head and foot coverings, eye protection, mouthpieces, resuscitation bags, and pocket masks or other ventilation devices. The equipment must be available in the right sizes, and workers must wear fluid-proof clothing when their clothing could be soaked with body fluids or contaminated waste.

* Workers must wash their hands immediately after removing their gloves or other protective equipment and after contact with body fluids or contaminated waste. Employers must provide access to leakproof, hard plastic containers for disposal of needles and other sharps. Universal precautions must be observed.

* All work surfaces must be disinfected with an approved hospital disinfectant chemical germicide after use, after contamination, and at the end of the work shift. Equipment and work surfaces may have protective coverings, but they must be removed and replaced after contamination and at the end of the work shift. Equipment must be checked for contamination before it is used, serviced, or moved, and must be cleaned if contaminated.

* Employers must provide hepatitis B vaccine to all workers who are exposed at least once a month to body fluids or contaminated waste. Booster shots must be provide if needed.

After a worker is exposed, the employer must provide a confidential medical checkup and follow-up, including at least: a report on how the worker was exposed; blood testing of the worker and patient (if permission is obtained); and follow-up with the worker on repeat testing and counseling, sympton reporting, and education to prevent exposure to others.

* Workers must receive information and training on bloodborne diseases within 90 days of hire and at least once a year thereafter. That training must be geared to workers' education levels and provided in their own languages.

The training must cover: how hepatitis B, HIV, and other bloodborne diseases are transmitted, how to avoid contact with blood and other infectious materials, how to dispose of contaminated materials, how to use protective equipment, what to do after an exposure, information on the hepatitis B vaccine, and an explanation of the labeling system for potentially contaminated materials.

OSHA has estimated its standard could prevent 9,000 cases of hepatitis B and 220 related deaths among health care workers. The Centers for Disease Control estimates that 40 health care workers have been infected with HIV on the job.

The Senate implementation deadline drew criticism from some provider groups that anticipated OSHA may not be able to issue final regulations in time. Richard Pollack, the American Hospital Association's executive vice president for Federal relations, said hospitals could be "required to waste time, money, and effort complying with a law they know will be changed."

Similarly, Labor Secretary Lynn Martin said, "Issuing the proposal as a final rule would cause confusion and wasted resources in the regulated community if it takes steps to comply with the rule and the rule is changed shortly thereafter." An OSHA spokeperson, however, while making no promises, said the agency is making every effort to meet next month's deadline. There has been no indication of what specific changes OSHA is considering for its final rules.

At this writing, the Kennedy amendment was under review by a House-Senate appropriations conference committee. But analysts gave it good chance for final approval, possibly as a compromise to more stringent measures approved by the Senate but rejected by conferees.

Those tandem proposals were introduced by Sen. Jesse Helms (R-N.C.) in July. The first would have imposed criminal sanctions, including a 10-year prison term, for any HIV-infected health care worker who performed a risky procedure without first informing the patient. Although that measure would not have explicitly required HIV testing, many experts assumed the liability issues it raised would have amounted to a testing mandate.

The second Helms proposal would have allowed any surgeon about to perform an invasive procedure to request HIV testing of a patient without that patient's consent.

The decision to reject the Helms proposals came just one day after Congress considered the plight of Kimberly Bergalis, a young Florida woman who is dying of AIDS contracted during treatment by her dentist. In her brief but emotional testimony Bergalis exhorted a Congressional panel to pass legislation requiring health care workers to be tested. Lawmakers, however, were apparently more persuaded by estimates that mandatory testing would cost the health care system $1.5 billion a year while saving only a handful of lives at best.

Senate negotiators said it would be virtually impossible to pass a compromise spending bill without some AIDS amendment, and other possibilities were still being developed at press time. One measure basically sought to require that states enforce CDC guidelines that call on health care workers who perform invasive procedures to be tested for AIDS and hepatitis, to avoid risky procedures without permission of medical reviewers, and to inform patients if they are infected.

Congresssional sources were unable to predict how quickly negotiators would be able to agree on details of the spending bill and submit it to floor votes.

Hanlester decision

overturned, sent back

The first test case of the Health and Human Services Department's authority to exclude providers from Federal programs on anti-kickback grounds will receive further review by an administrative law judge (ALJ).

The case involves HHS allegations that Hanlester Network of Santa Ana, Calif., established joint venture, limited partner "shell" laboratories in order to funnel business from physician investors.

ALJ Steven Kessel last March rejected the HHS Inspector General's key arguments, finding that an anti-kickback violation occurs only "when physician limited partners agree to refer their patients to the partnership as a condition of being a partner." In addition, Kessel found that the statutory term "remuneration" is limited to payments that are the equivalent of kickbacks, bribes, or rebates.

A three-judge HHS appeals board, however, disagreed with the interpretation of the ALJ. The board found, among other things, that the term "remuneration" signifies "anything of value in any form or manner whatsoever," and that the return of such does not require an "agreement to refer or . . . any guaranteed flow of business."

The appeals panel thus referred the case back to Kessel with instructions to review his decision based on its guidance. While the ALJ's new judgment could come by the end of this year, it is still possible that the case could end up back in Federal court.
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Title Annotation:Washington Report; Occupational Safety and Health Administration
Author:Albertson, David
Publication:Medical Laboratory Observer
Date:Nov 1, 1991
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