Richard Fairfax of OSHA talks about the Bloodborne Pathogens Standard

Feb. 1, 2003

Interview by Dennis Ernst, MT(ASCP)

Dennis Ernst: The revision of the OSHA Bloodborne Pathogens Standard mandating employers to implement safety needles has been in effect for over a year now. The effect it has had on healthcare managers and employers has been dramatic. Are you finding that most facilities are in compliance, or have employers been slow to respond?

Richard Fairfax: It is difficult for us to measure nationwide compliance with the requirement to use safer medical devices, since the data that OSHA collects illustrates the numbers of inspections performed and the numbers of violations issued under each standard. However, we have overwhelmingly seen that since the incorporation of the Needlestick Safety and Prevention Act into OSHAs Bloodborne Pathogens Standard in 2000, heightened awareness among healthcare professionals regarding the requirement to use safer medical devices to protect against needlesticks has increased the number of complaints that OSHA has received from hospitals. Because of this, and OSHAs National Emphasis Program in Nursing and Personal Care Facilities and Local Emphasis Programs for bloodborne pathogens, we have seen a steady increase in the number of violations issued under the Bloodborne Pathogens Standard since 2000. Strong enforcement, coupled with increased public awareness, to us would mean that, yes, employers have been switching to safer devices and safer control systems.

Ernst: Last summer, you made it clear in your Letter of Interpretation that tube holders are to be discarded immediately after use without disassembling the needle. What has been the reaction from the industry? Have there been any challenges on this requirement?

Fairfax: Many employers have not been pleased with this clarification of our requirements, but many others recognize the safety issues involved in removing needles in order to reuse blood tube holders and have made the transition to single-use. Increased manipulation of any contaminated device increases the risk of injury to the worker. The Bloodborne Pathogens Standard is clear and states that contaminated needles are not to be removed unless required by a medical procedure, or if no other alternative is feasible. During blood draws, we cant imagine many scenarios where this would be the case. Therefore, the safest practice would be to discard blood tube holders with needles attached immediately after activation of the safety feature. Of course, we recognize that increased waste is a negative endpoint of this policy; therefore, we are hoping that it drives device manufacturers to make products that not only satisfy safety requirements, but also the needs of their customers.

Ernst: Its now crystal clear where OSHA stands in regard to sharps and tube holders, but lets talk about how it applies to other engineering controls, such as skin puncture devices, sharps containers, autorelease tube holders and plastic blood collection tubes. First, skin-puncture devices used for fingersticks and heelsticks. Many of these devices are available in which the blade retracts into the housing, preventing an accidental exposure. Since these are available, does the use of steel lancets and other nonretractable lancets subject the employer to a citation?

Fairfax: We published our enforcement policy on the use of safer devices in the last two Compliance Directives; CPL 2-2.44D and most recently, CPL 2-2.69. It states, Where engineering controls will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used. Clearly, a contaminated sharp that immediately retracts into a protective housing after use, as it does in single-use safety lancets, removes the hazard of the contaminated sharp. Safety lancets were among the first safer devices available on the market; they are available from multiple manufacturers and suppliers. Therefore, we see no reason why employers shouldnt have already implemented these types of safety products.

Ernst: Some containers mechanically unwind the contaminated needle at the point of use,dropping it into the container in a one-handed needle-removal-and-disposal step. Does the Letter of Interpretation mean that this type of engineering control cannot be used?

Fairfax: Again, the Bloodborne Pathogens Standard states that needles must not be removed unless it is medically necessary or unless no other means of disposing of the sharp are feasible. The Letter of Interpretation that we issued further explains that blood tube holders with needles attached must be immediately discarded after the activation of the safety feature. As stated in the letter, close to half of all injuries from contaminated sharps occur to those who are not in immediate control of the device, but to those who come in contact with the unprotected needle downstream, like waste haulers or housekeepers. Since the back-end of the needle is not protected if the tube holder is removed, the risk of injury still exists. If needles are discarded as one unit with the tube holders attached, it affords a greater degree of protection at the point of use, as well as downstream. If someone came up with better technology, technology that somehow eliminated the back-end hazard, either blunting the back-end or allowing removal in a completely closed, nonfail mechanical system, we would reassess our enforcement policy.

Ernst: There are several autorelease tube holders on the market that allow the contaminated needle to be released from the tube holder with one hand so that it can fall directly into the sharps container immediately after being removed from the patients arm. Even though the needle release mechanism on these devices requires only one hand to activate, the Letter of Interpretation doesnt exempt this class of tube holders from the single-use mandate is that correct?

Fairfax: Correct. The same applies. Again, unwinding or autoreleasing still exposes employees to the back-end of the needle. Since work practices are not perfect, and since the busy environment of healthcare cause employees to rush more than they would like, needles miss the sharps container and fall to the floor or on a patients bed. Because of these potentially hazardous situations, weve tried to override the potential problems that exist with needle removal by supporting a policy to not remove needles.

Ernst: The emergence of plastic blood collection tubes on the market now make it possible for facilities to completely eliminate the use of glass tubes. Since glass tubes are more likely to break and pose a greater risk of an exposure, can an employer be cited for a violation if they are still using them?

Fairfax: The most complete control against occupational hazards, identified by the industrial hygiene hierarchy of controls, is substitution. Since plastic can be easily substituted for glass in most all cases, we expect employers to use plastic where appropriate. Glass puncture wounds are among the most common injuries in healthcare, and glass that is contaminated with blood or other potentially infectious materials (OPIM) poses a more extreme danger. Since plastic tubes are readily available that do not compromise specific clinical or diagnostic tests, a facility that is not using them would have to justify why they are not being used for each specific procedure or test, and document that in their exposure control plan.

Ernst: Many employers have an image of OSHA being strictly punitive in nature and dont realize that your agency is more of an ally for compliance. Can a facility invite OSHA in to perform a survey on its policies and practices without fear of being issued citations? How can employers arrange for this service?

Fairfax: Yes. OSHA offers a free on-site consultation service for small and medium-size employers through a program that is funded primarily by federal OSHA but delivered by the state governments. An employer may use this service without fear of enforcement measures being taken. Using this service, employers can find out about potential hazards at their worksites, improve their occupational safety and health management systems, and even qualify for a one-year exemption from routine OSHA inspections. Most consultations take place on-site, though limited services away from the worksite are available.

Because consultation is a voluntary activity, you must request it. Your telephone call or letter sets the consulting machinery in motion. The consultant will discuss your specific needs with you, and set up a visit date based on the priority assigned to your request, your work schedule, and the time needed for the consultant to adequately prepare to serve you. OSHA encourages a complete review of your firms safety and health situation; however, if you wish you may limit the visit to one or more specific problems. Contact information for consultation services are available on OSHAs website.

Employers covered by a state plan are subject to a state Bloodborne Pathogens Standard, which is identical to or at least as effective as the federal OSHA standard. State plans are required to extend coverage to state and local government employers.

State, county and municipal employers in states without an OSHA-approved state plan are not covered by the federal Bloodborne Pathogens Standard, but may be subject to similar requirements, including those of a state needlestick law.

Remember, the federal Bloodborne Pathogens Standard (or parallel state plan standard), applies to all employers who have employees with occupational exposure to blood or OPIM not just those in healthcare facilities, but also employers in general industry where occupational exposure to blood or OPIM is anticipated. Again, this includes not only hospitals, but physicians offices, dental offices, and even designated first-aiders in manufacturing if their job categories involve potential exposure to blood.

Ernst: How can employees and employers contact their OSHA representative?

Fairfax: Our website,, has a contact page with lists of phone numbers and addresses of our local OSHA area offices, as well as all of the OSHA state-plan offices. We encourage employers and employees to contact the OSHA Office nearest them for the best service. We also have a toll free number: (800) 321-OSHA (6742). Its important to remember that a phone call to OSHA requesting information or compliance assistance will not generate an OSHA inspection.

Ernst: If a facility is not in compliance and an employee is concerned about his safety, can he bring it to OSHAs attention without fear of repercussions?

Fairfax: Workers who file a complaint or bring a safety and health issue to their employer are protected against discrimination (demotion, dismissal, harassment, etc.) under section 11 (c) of the OSHA Act. An employee who believes he has been discriminated against may file a complaint in writing or by telephone with OSHA, and OSHA will investigate that complaint.

A member of MLOs Editorial Advisory Board and a nationally known phlebotomy expert,
Dennis Ernst is director of the Center for Phlebotomy Education in Ramsey, IN.

February 2003: Vol. 35, No. 2

© 2003 Nelson Publishing, Inc. All rights reserved.