The use of safety-engineered devices and work practice controls in operating rooms; hospital responsibility to protect independent practitioners under BBP standard

January 18, 2007

Mr. Erik Frederick
Director of Safety
Baptist Medical Center
111 Dallas Street
San Antonio, Texas 78224

Dear Mr. Frederick:

Thank you for your letter to the United States Occupational Safety and Health Administration (OSHA). Your letter was forwarded to the Directorate of Enforcement Programs (DEP) for a response. You have questions about the use of safety-engineered devices and work practice controls, such as implementing safe zones in operating rooms. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question not delineated within your original correspondence. For clarification, your specific questions are paraphrased below, followed by OSHA's response. We apologize for the delay in addressing your concerns.

Question 1: Members of our hospital operating room (OR) committee, including surgeons, nurses, and technicians, are requesting an interpretation of what the hospital's responsibility is in evaluating and implementing the use of sharps with engineered sharps injury protections (SESIPs) and safe zones for hands-free passing of sharps in the surgical suite. What does the bloodborne pathogens standard at 29 CFR §1910.1030 require in this regard?

Reply 1: OSHA's bloodborne pathogens standard requires that employers use engineering and work practice controls to eliminate occupational exposure or reduce it to the lowest feasible extent [29 CFR §1910.1030(d)(2)(i)]. One type of engineering control is a SESIP. 29 CFR §1910.1030(b) (definition of "[e]ngineering controls"). Therefore, where feasible, hospitals must implement the use of SESIPs and proper work practices, such as designated neutral or safe zones, which allow hands-free passing of sharps, to prevent sharps injuries in operating rooms. See CPL 2-2.69, XIII D.2 (2001) ("eliminating hand-to-hand instrument passing in the operating room" noted as engineering control in directive implementing the standard). The practitioner's preference is not an excuse for failure to use engineering controls and work practices. In many cases, surgeons may simply need additional practice or training to feel comfortable using a new and different device or work practice. However, if the use of a particular device or work practice could adversely affect the performance of a particular procedure and, ultimately, the safety of a patient, the device or practice does not have to be used. A determination not to use a particular device or work practice must be documented in the facility's exposure control plan (ECP), 29 CFR §1910.1030(c)(1)(iv).

if a hospital-selected safety device or work practice would adversely affect patient safety, the hospital must ensure that an alternative safe device or practice is implemented for the handling of sharps in the OR. For example, in a situation where all practicable engineering devices have been implemented and it is not feasible to perform the surgical procedure safely using a neutral zone, the hospital must ensure that surgeons and other staff in the operating room do not perform "hand-to-hand" passing of devices without first verbally notifying each other. In this way, operating room nurses, technicians, and surgeons will not be caught off-guard and will thus avoid "blind" retrieval of contaminated sharps.

Question 2: The surgeons in our facility are independent practitioners and are not employees of the hospital. What are the responsibilities of the hospital and the surgeons to protect hospital personnel in the OR under the bloodborne pathogens standard in this situation?

Reply 2: The hospital is responsible under the OSH Act for affording the protections of the bloodborne pathogens standard to its employees, regardless of the independent practitioners performing surgery in its operating rooms. It may not absolve itself of these responsibilities. We assume that the independent practitioners you discuss are surgeons with staff privileges at the hospital. The relationship between a hospital and a surgeon or other physician with staff privileges at the hospital is contractual. Therefore, the practitioner has a contractual responsibility to comply with hospital procedures as set forth in the contract, and the surgeon has an obligation to follow them. Hospitals have the right to make a practitioner's adherence to the hospital's procedures a condition of staff privileges.

Furthermore, the practitioner or the medical practice with which he or she is associated, like a partnership or a professional corporation, usually would also be obligated to comply with the OSH Act and its standards, like the bloodborne pathogens standard, so as to protect employees. Surgeons or their medical practices usually employ at least one employee, such as a secretary or receptionist, and thus are employers under the OSH Act. 29 USC §652(5). Under the OSHA multi-employer worksite doctrine, an employer (here, the practitioner or his or her medical practice), that creates or controls a hazard, is obligated to comply with the standard so as not to endanger hospital employees.¹ See CPL 2-2.69 XI D (2001), which refers to CPL 2-0.124, Multi-Employer Citation Policy. These directives are available on OSHA's web site, http://www.osha.gov.

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 General Industry Enforcement at (202) 693-1850.

Sincerely,



Richard E. Fairfax, Director
Directorate of Enforcement Programs


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