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Lab groups criticize OSHA rules for AIDS, hepatitis B protection.

Lab groups criticize OSHA rules for AIDS, hepatitis B protection

Having been deluged by written industry comments and public testimony, the Occupational Safety and Health Administration now turns to the task of refining its proposed regulations to protect workers against exposure to bloodborne pathogens.

Several national organizations, particularly those representing blood banks and pathologists, have criticized the proposal for being too rigid in some areas, too vague in others, and generally off the mark in its estimates of compliance costs to employers. Some officials suggest the first draft reflects OSHA's lack of experience in regulating the health care industry.

The agency proposal issued in May seeks to minimize or eliminate the risk of occupational exposure to blood or other potentially infectious materials. Concerns have centered on the risk of exposure to the hepatitis B and AIDS viruses. OSHA seeks to reduce those dangers through a combination of engineering and work practice controls, personal protective clothing and equipment (abbreviated as PPE) requirements, training, medical follow-up of exposure incidents, vaccination, and other provisions.

OSHA reportedly received more than 1,300 written comments on its draft, plus additional public comments at recent hearings in Washington, D.C., Chicago, and San Francisco. The final hearing, in New York, was scheduled to end Nov. 13.

One of the broadest swipes at the proposal was filed by the College of American Pathologists. At the Washington hearing, CAP member Gerald A. Hoeltge, M.D., testified that the group believes "a number of the proposed regulations are excessive, unnecessary, and costly and may have negative effects on the quality of life at the workplace." Dr. Hoeltge added that CAP is concerned about the inflexibility of certain requirements, considering that they would apply to many different work settings.

Those concerns were echoed in written comments submitted by the American Association of Blood Banks. According to AABB, "Given the complexities of the practice of medicine and the health care environment, employers should be allowed considerable flexibility" in meeting their duties to provide a safe workplace.

"As proposed," AABB continued, "the rule is excessively rigid. In addition, the standard ignores the differences in risk exposure among work environments, and the minimal risk of occupational exposure in blood banks. The CDC recognizes that the risk of exposure differs between jobs, but the proposed OSHA standard imposes the same stringent regulations on everyone regardless of the potential risk for occupational exposure to bloodborne pathogens."

In contrast to those concerns, the organizations also warned that the proposal is too vague as to circumstances that would require use of PPE or barrier protection. Such requirements are estimated to comprise roughly half the cost of regulatory compliance, placed at an average of about $1,400 per year for each employer facility.

"The phrase `potential for occupational exposure' is left undefined," Dr. Hoeltge stated. "The range of activities in clinical labs to which this term might apply is very broad. There are devices in our lab, for example, that constrain human blood and pump the contents under pressure. As long as the tubing and gaskets are free of defects and the equipment is properly operated, there will be no exposure. Yet a part of the system could fail and result in a spray of blood. Does this mean the operator must don fully protective and fluid-proof clothing to press the `start' button?"

Both CAP and AABB believe OSHA is too imprecise in use of such terms as "fluid-proof" and "fluid-resistant" materials. AABB said the CDC's guidelines are more helpful in selecting the appropriate protective equipment.

Blood banks are also upset by provisions stating that phlebotomists must wear gloves for all procedures in which exposure to blood is possible. Officials say there is no scientific proof to support that proposal, although they agree gloves should be available to workers who prefer to wear them and that requirements should apply to workers with open cuts or lesions.

In general, pathologists prefer less emphasis on PPE and more on engineering and work practice controls, in conjunction with employee training. The latter is especially important, they say, in reducing injuries from sharps.

CAP does not, however, endorse the widespread use of biological safety cabinets in "routine" clinical labs, one of the engineering and practice controls proposed by OSHA. As Dr. Hoeltge stated, "Aerosols have not been shown to be important in the epidemiology of HIV, and biological safety cabinets are expensive. Installation of one hood costs about $10,000 and, if mandated, large facilities would probably require several of them."

Charges that OSHA staffers lack a good understanding of the health care industry were most pointed in comments from AABB. The most glaring example, the group notes, is the definition of the term "patient" in the proposed regulations. OSHA uses that term to include "individuals who donate blood, plasma, or blood components"--a usage AABB says is factually, legally, and medically incorrect.

According to the AABB, "A patient is one who, by definition, is ill and seeking diagnosis and treatment. Blood donors on the other hand are, by definition and Federal regulation, healthy individuals. A patient cannot be a blood donor, except possibly for himself or herself.

"In fact, in some states it may be a crime for a patient to even attempt to donate blood, plasma, or blood components. Furthermore, classifying a blood donor as a patient is a major disservice to the blood service and health care communities that continually work to dispel any perception that unhealthy individuals donate blood."

The group would like to see OSHA delegate responsibility of enforcing the final standards for blood establishments to the Food and Drug Administration. Under Federal law, FDA has the primary registration, licensing, and regulatory authority. AABB says the OSHA standards could easily be incorporated into FDA inspections handled by those more familiar with blood service organizations.

On other fronts, a number of groups and individual employers maintain that OSHA has grossly underestimated employers' cost of regulatory compliance, the total tab for which is put at $852 million by OSHA.

According to CAP's Hoeltge, "We believe cost estimates of $1,379 per facility or even $33,035 per hospital are far too low. Some of our members have documented increases in hospital costs of 15 per cent, and increases of 50 to 60 per cent in glove costs alone....This is at a time when payers are actively reducing reimbursement to providers. We urge the agency to reconsider these cost estimates and that explicit consideration be given to Government payment for its fair share of the cost of these rules."

AABB estimates that compliance will cost blood banks double what OSHA projects, and makes similar projections for hospitals.

Cost is also very much a factor in the proposed requirement that employers vaccinate workers against hepatitis B virus. The Health Industry Manufacturers Association, which represents product vendors, notes that OSHA reports the cost of HBV vaccination at $108. But its members have experienced charges of about $140, plus $15 to $25 per visit for the actual injections. That represents a 41 per cent increase over Government estimates.

CAP officials support efforts to expand HBV vaccination of at-risk workers, although they express concern over employer costs and potential strains on vaccine manufacturers. The group further opposes pre-vaccination testing of HB surface antibody status on request. Dr. Hoeltge noted the tests are expensive, and a positive result may not reflect adequate immune status because it could represent a low level of antibody insufficient to guarantee immunity.

A conflicting appraisal of the overall cost issue was filed by the Service Employees International Union (SEIU), which first petitioned for OSHA regulation in 1986. At the Washington hearing, union president John J. Sweeney stated, "We must express our outrage at the scare campaign being mounted by hospitals and other employers to deliberately exaggerate the costs of this standard in the hope that OSHA would gut its most effective provisions."

SEIU believes OSHA has over-estimated compliance costs through a number of data deficiencies and incorrect assumptions. For example, union officials say the agency has used outdated numbers in estimating the extent to which facilities have already undertaken recommended steps to protect workers.

SEIU also challenges cost projections for PPE. It notes, for example, an assumption that dentist office personnel don a fresh mask for three out of every four visits--a projected expense of $113 million. Simply assuming personnel change masks every other visit lowers the total by $38 million.

OSHA thus begins the task of sorting through the volume of comments it has received. No timetable has been set for completion, but the final regulations are scheduled to be phased in beginning 30 days after publication in the Federal Register.
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Title Annotation:Occupational Safety and Health Administration
Publication:Medical Laboratory Observer
Date:Nov 1, 1989
Previous Article:Practicing the two Rs.
Next Article:Legal aspects of self-testing.

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