January 20, 2004

Mr. Mark B. Evans
Vice President
Strickler Medical Incorporated
503 Libbie Ave, Ste 2C
Richmond, Virginia 23226

Dear Mr. Evans:

Thank you for your November 12, 2003 letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP) regarding the applicability of OSHA's bloodborne pathogens standard to small health care facilities (clinics, oncology practices, physician offices, etc.). This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question(s) not delineated within your original correspondence. Your questions are restated below, followed by OSHA's response.

Question #1: Are physician offices and clinics required to provide safety-engineered sharp devices and needleless systems to employees? Is there a minimum number of employees that must be employed to be governed by this Act [Needlestick Safety and Prevention Act]?

Reply #1: The Needlestick Safety and Prevention Act directed OSHA to revise its bloodborne pathogens standard [29 CFR 1910.1030]. On January 18, 2001, OSHA published the revised standard, which took effect on April 18, 2001. OSHA's bloodborne pathogens standard, including its 2001 revisions, applies to all employers who have employees with reasonably anticipated occupational exposure to blood or other potentially infectious materials (OPIM).

However, workplaces classified in certain Standard Industrial Classification (SIC) codes are not required to keep OSHA injury and illness records, including sharps injury logs. Health care facilities with SIC codes 801, 802, 803, 804, 807, and 809 are included in this partial exemption for recordkeeping. These employers are still, as stated above, required to be in compliance with the provisions of the bloodborne pathogens standard. They are also required to report any workplace incident that results in a fatality or the hospitalization of three or more employees [29 CFR 1904.39].

Question #2: Are health care facilities, even those that currently use appropriate safety devices, required to review any new technological developments with regards to safety devices if these may reduce the risk of exposure? Do they have to have this review at least annually and document these reviews?

Reply #2: OSHA's bloodborne pathogens standard requires employers to review and update the Exposure Control Plan (ECP) at least annually [29 CFR 1910.1030(c)(1)(iv)], even those who currently use appropriate safety devices. It is also a requirement that the annual review and update of ECPs reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens and that employers document annually their consideration and implementation of appropriate commercially available and effective safer medical devices [29 CFR 1910.1030(c)(1)(iv)(A-B)]. Solicitation of input from non-managerial employees who are potentially exposed to sharps injuries is an important component of the selection and implementation of safety devices [29 CFR 1910.1030(c)(1)(iv)-(v)].

If, after employee input, an employer determines that an engineering control is effective, the employer must simply keep abreast of new and emerging technologies and document this in the ECP. It is not necessary to evaluate all newly emerging engineering controls each year, but an employer must make a concerted effort to evaluate new technologies in order to determine which device is effective in reducing injuries.

Question #3: Can an individual manager choose not to review a new safety device without the input from non-managerial workers?

Reply #3: It is the employer's responsibility to determine which engineering controls are appropriate for specific hazards, based on what is appropriate to the specific medical procedures being conducted, what is feasible, and what is commercially available. However, it is necessary that employers include solicitation of input on the identification and selection of available engineering controls from non-managerial employees who are potentially exposed to sharps injuries [29 CFR 1910.1030(c)(1)(iv)-(v)]. This should be documented in the ECP.

You should be aware that the Commonwealth of Virginia operates its own OSHA-approved occupational safety and health plan. Your state plan keeps pace with federal standards in safety and health. Further inquiries regarding this or any other workplace health and safety matter should be addressed to your state office for assistance.

Virginia Occupational Safety and Health
Attn: Glenn Cox, Director
13 South 13^th Street
Richmond, VA 23219
(804) 786-7776

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,

Richard E. Fairfax, Director
Directorate of Enforcement Programs