September 3, 2003

The Honorable Cass Ballenger
U.S. House of Representatives
Washington, D.C. 20515\

Dear Congressman Ballenger:

Thank you for your March 13, 2003 letter to the Occupational Safety and Health Administration (OSHA) regarding the implementation of the Needlestick Safety and Prevention Act [Pub. L. 106-430, 114 Stat. 1901 (2000)] (NSPA) passed by Congress to amend OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030). I know the important role you had in passage of the Act, and I appreciate your continued interest in the implementation of the law. I apologize for the delay in responding to your letter. You expressed interest in how healthcare facilities are complying with the revised standard since April 2001, when the new requirements became effective. We have responded to your paraphrased questions below.

Question 1: What has OSHA done to educate healthcare organizations and OSHA compliance officers about the legislation?

Response: Shortly after the passage of the NSPA, OSHA revised its Bloodborne Pathogens Standard to reflect the changes mandated by the Act. The changes included adding a new definition for engineering controls to include such examples as sharps with engineered sharps injury protections (SESIPs) and needleless systems; requiring that employers document the annual review of engineering controls; requiring that employers solicit the opinions of non-managerial employees in the selection of engineering controls; and requiring that employers maintain a sharps injury log. As you know, the revised standard was published in January 2001 and became effective in April 2001 in federal OSHA states. OSHA-approved state plan states were expected to adopt a comparable standard by October 2001.

On November 27, 2001 OSHA issued OSHA Instruction CPL 2-2.69 Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, which explains the changes to the standard and provides enforcement guidance to OSHA field staff. This document is available on OSHA's Internet Homepage and through OSHA's Office of Publications. In a further effort to educate OSHA personnel regarding the changes to the standard and subsequent enforcement guidance, OSHA created several documents, all of which are available to the public on OSHA's Internet homepage. These documents and e-tools include a "Fact Sheet," a PowerPoint presentation to use as a training tool, and a "Frequently Asked Questions," all of which are available at http://www.osha.gov/SLTC/bloodbornepathogens/index.html.

In June 2002 OSHA held a training class at the OSHA Training Institute in Des Plaines, Illinois. More than 200 OSHA compliance personnel attended. The training was specifically designed for OSHA compliance assistance, enforcement, and consultation personnel. The goals of the training were to promote consistent enforcement and provide comprehensive outreach approaches for issues relating to exposures to blood and other potentially infectious materials (OPIM). As part of this training, OSHA invited dozens of safer medical device manufacturers to showcase their products in order for OSHA staff to be more educated about the options that are available to healthcare facilities and to be able to get "hands on" experience with the devices to see which ones were easy to operate and provide safe alternatives to traditional devices.

OSHA continues to hold bi-monthly conference calls on issues relating to bloodborne pathogens, including needlestick prevention, as well as newly emerging issues in healthcare, and non-healthcare worker exposure to contaminated sharps. Participants on the calls include OSHA National Office staff, OSHA Regional Bloodborne Pathogens Coordinators, and personnel from OSHA Office of Training and Education and the Salt Lake Technical Center.

In an effort to provide outreach and compliance assistance to the public, OSHA has made and continues to make all resources available through the Internet. Each of the OSHA Education Centers also offers training classes on the new and existing requirements of the bloodborne pathogens standard. Additional resources to the public include access to the Regional Bloodborne Pathogens Coordinators and the compliance assistance specialists available in each OSHA Area Office.

Inquiries regarding worker exposures to blood and OPIM continue to be the topic on which OSHA receives the highest number of questions. OSHA regularly answers requests for information on this topic electronically, over the phone, and through letters of interpretation. In addition, since the largest percentage of requests for OSHA presentations relate to occupational exposure to blood and OPIM, OSHA National and Regional Office staff and Compliance Assistance Specialists regularly respond to requests for public speaking engagements on this topic. OSHA has given presentations in public and professional forums, including the American Industrial Hygiene Conference and Exposition, over the past several years. This year, a member of the OSHA Office of Health Enforcement staff participated in a roundtable on biohazards in the healthcare industry. These and other engagements are representative of the efforts OSHA puts forward in order to make this standard comprehensible to the regulated community.

Question 2: What percentage of hospitals, doctors' offices, outpatient clinics, long-term care, and other facilities are in compliance with the requirements of the law?

Response: OSHA does not have surveillance tools in place that measure national compliance with safety and health standards. There are over 6 million healthcare workers in the United States working in hundreds of thousands of healthcare settings. Compiling information of such magnitude is beyond the resources available to OSHA. However, we collect data on OSHA inspections and information on the citations that have been issued under the bloodborne pathogens standard.

OSHA does not currently have resources for the comprehensive survey you have suggested. Such a survey would be a somewhat more complex and resource-intensive project than it may initially appear; it would require not only considerable staff or contractor effort for implementation of the actual survey, but would necessitate a notice in the Federal Register initiating a period for public comment, followed by OMB review and clearance under the Paperwork Reduction Act of 1995, 44 U.S.C. 3506-07.

Fortunately, OSHA is in a position to observe compliance directly. OSHA checks for compliance during inspections of health care facilities, and maintains a database on the number of citations. These data provide a direct measure of compliance without the expense, time, and paperwork burden of a survey.

As you may know, OSHA began enforcing the requirement to use safer medical devices in November 1999 after issuing OSHA Instruction CPL 2-2.44D, Enforcement Procedures for Occupational Exposure to Bloodborne Pathogens. NSPA was based in large part on that directive.

Data on the total number of inspections conducted by Federal OSHA in industry sectors where compliance with OSHA's Bloodborne Pathogens standard is most often assessed is presented below. Also presented is current OSHA data for workplaces under Federal jurisdiction which include inspections in which violations of the bloodborne pathogens standard were cited. The data cannot detect all sites that are in compliance, but rather only those workplaces where an inspection has been conducted and violations have been cited.

Question 3: Why are some healthcare market segments (e.g., physician practices, long-term care facilities, emergency and surgical departments) slower to comply with the needlestick law, and how does OSHA plan to provide compliance assistance to these segments?

Response: OSHA does not have any information on "market segments." Again, OSHA inspection data only identifies industries through their standard industrial classification (SIC) codes, as presented above. Elements of compliance assistance for the bloodborne pathogens standard are available for these facilities, as listed in the answer to #1, above.

Question 4: What are OSHA's goals for the percentage of healthcare facilities that are in compliance with the law and does OSHA intend to document and communicate these goals?

Response: As discussed above, OSHA does not have surveillance tools in place to measure national compliance ("in compliance" rates). Since the bloodborne pathogens standard applies to all employers with employees who have occupational exposure to blood or OPIM, OSHA is concerned not just with compliance in healthcare settings, but also compliance in general industry, including for example, housekeepers, waste haulers, and loggers. OSHA's "goal" for compliance with the provisions of the Bloodborne standard is, of course, that 100 percent of inspected worksites be in compliance. Since inspection of all worksites is not possible, however, OSHA will continue its extensive efforts to promote outreach and compliance assistance to worksites where occupational exposure to blood and other potentially infectious materials is an issue.

We hope you find this information helpful. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,

John L. Henshaw
Assistant Secretary