February 12, 1993

(Name Withheld)

Dear (Name Withheld):

Thank you for your letter regarding your concerns about the Occupational Safety and Health Administration's (OSHA) Final Standard for Occupational Exposure to Bloodborne Pathogens. You expressed your concerns about the necessity for the standard, and the standard's requirements and costs.

The Bloodborne Pathogens standard is designed to protect the Nation's workers, particularly health care workers, from exposure to the Hepatitis B Virus (HBV), the Human Immunodeficiency Virus (HIV), and other bloodborne pathogens. Of the diseases caused by these viruses, Hepatitis B is the most common, with 8,700 cases per year among workers in the health care profession. Hepatitis B infection may result in serious illness, potential long term disability and death. The HIV virus causes AIDS, for which there currently is no cure and which eventually results in death. These viruses, as well as other organisms that cause bloodborne diseases, are found in human blood and certain other human body fluids. Therefore, employers have a particular responsibility to ensure that workers do not come into direct contact with blood or other potentially infectious materials while performing their job.

The development of this standard by OSHA took more than five years, beginning with close cooperation on the development of a proposed standard with the Centers for Disease Control, Department of Health and Human Services. The proposed standard was based on the scientifically sound infection control practice of "universal precautions" originally established by the CDC for handling of body fluids known to transmit HIV.

Following the publication of the proposed standard the public, particularly the dental and medical communities, submitted approximately 3,000 comments to the official record. In addition, OSHA held 5 public hearings, in Washington, D.C., Chicago, New York City, Miami and San Francisco, where 440 individuals and organizations testified. The comments and testimony underwent extensive review and analysis, and many of the suggested changes were adopted in the final rule. In addition, the U.S. Congress held a series of hearings concerning the proposed Bloodborne Pathogens standard. Many individuals and groups testified at these hearings, including the American Medical Association and the American Dental Association.

Furthermore, Congress attached an "appropriations rider" to the FY 1992 OSHA funding bill which required the agency to finalize the Bloodborne Pathogens standard by December 1, 1991. During debate, members of Congress indicated that the risks to workers were significant and that the possibility of illness and death could no longer be ignored; it therefore used the appropriations rider to encourage the agency to expedite the promulgation of the standard.

During the development of the standard, compliance costs, those costs incurred to meet the requirements, were extensively analyzed. All OSHA workplace safety and health standards undergo a similar, very stringent, review. A key component of this review was a 3,500-facility survey, which included both large and small physicians' and dentists' offices, funeral homes, nursing homes, and blood banks among others. This survey showed that many offices already were complying with many provisions of the standard, including practicing "universal precautions."

For example, disposable gloves were in use by 96% of the direct patient care workers in dentists' offices before the standard became final. The costs for items already being used and procedures already in place were not included in the cost estimates for full compliance with the final standard. Therefore, the costs which were analyzed were the additional costs to those employers not currently providing their workers with items such as disposable gloves.

We understand your concerns about the increase in medical costs and the effect on health care availability. The standard was designed to protect the lives and health of workers from serious and deadly diseases, such as Hepatitis B and AIDS. OSHA believes that the relatively modest costs necessary to comply with the standard will neither put small, independent physicians and dentists out of business, nor reduce the availability of health care for American families.

In order to explain the general requirements of the standard, OSHA published five fact sheets and six Bloodborne Pathogens compliance assistance booklets, including booklets for acute care facilities, emergency responders, dentists, and nursing homes. OSHA also produced a motivational video titled, "As It Should Be Done". The enclosed sheet lists titles and ordering information for all of these materials.

OSHA has ten regional offices around the United States, each with a Bloodborne Pathogens Coordinator to respond to inquiries about the standard. A listing of telephone numbers and addresses is enclosed. Since December 1991, the OSHA staff in the National, Regional and Area Offices have been conducting extensive outreach, training and education meetings on the Bloodborne Pathogens standard with a wide range of groups, including physicians and dentists. Over 1,000 individual meetings have been held and over 80,000 individuals have participated. This is the largest, most extensive, training and education effort in the 20 year history of OSHA. This effort is ongoing and will continue. Please contact the OSHA office in your area to request a speaker or other assistance.

We understand that the cost of complying with this standard is of concern, and that most American health care professionals follow safe practices; however, the risks of illness and death from HBV and HIV for workers are too great to ignore and they mandate the full employee protection and training required by the standard.

Sincerely,



Roger A. Clark,
Director
Directorate of Compliance Programs

Enclosures



September, 1992

Honorable Christopher Bond
SR-293
United States Senate
Washington, DC 20510

Dear Mr. Bond:

As a private practicing physician here in the Kansas City area, I am absolutely dumbfounded by the OSHA regulations recently imposed on physician's offices. I can certainly understand government's concern at decreasing blood borne disease. To this end, regulations involving protective practices in drawing blood, handling blood, etc. make sense. I also concur with hepatitis B immunization programs for at least at risk individuals. In trying to implement these practices in a medical office, OSHA has also burdened the individual practitioner with an enormous volume of regulations which are not only monumental in size but virtually impossible to totally apply. Nonetheless the government has assured us that failure to comply with regulations will be met with severe penalties.

To this end, my personal office has spent numerous hours and a rather extraordinary amount of expense in trying to comply with OSHA regulations. The catch-22 is, I have a very limited understanding of how to properly comply with these regulations, despite attending several lectures and meetings on this subject. In most instances OSHA is dealing with small medical offices that do not have the time nor resources to deal fully with OSHA regulations, nor time and resources to support the legal aid needed to fight OSHA in the event of a citation. What concerns me as a physician is the time and effort spent in labelling and placing of typewriter whiteout and then turning, with perhaps precious little time left, to educate my staff in proper handling of blood products. This seems to be disproportionate in its risk benefit.

I do not believe a medical office is a reasonable place to institute full OSHA regulations and it is my feeling in this case, that Federal legislation should mandate an abbreviated OSHA package that focuses on the primary issues needing to be addressed such as blood borne contamination. In general, physicians do not have the resources, as do large businesses - where the OSHA answer seems to be "send the examiner away, tell him to bring a search warrant and if there are any problems, talk to our legal department"!

Sincerely



Charles J. Siegel, M.D.