June 12, 2002

Mr. Douglas E. Kline
Infection Control Practitioner
1101 Wellesley Terrace
Westchester, PA 19382

Dear Mr. Kline:

Thank you for your March 20, 2001 letter to the Occupational Safety and Health Administration (OSHA) regarding the applicability of OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) to the safe practice of phlebotomy and blood tube holder use. 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.

We apologize for the extreme delay in our response to you. As you know, based on your phone conversations with our staff, we were awaiting the release of the revised compliance directive (CPL 2-2.69, November 2001) to address similar issues with sweeping national implications. Removing contaminated needles in order to re-use blood tube holders has gained more national attention, and we felt it best to address such an important issue first in our compliance directive. You can access that document on the World Wide Web [http://www.osha.gov/OshDoc/Directive_pdf/CPL_2-2_69.pdf].

Thank you for your understanding in this matter. Your question is summarized below followed by OSHA's interpretation.

Question: What is OSHA's position regarding the use of blood tube holders, specifically removing a needle in order to re-use a tube holder? Must each blood tube collection device be disposed of with the needle attached each time they are used?

OSHA's Bloodborne Pathogens Standard (29 CFR1910.1030, paragraph (d)(2)(vii)(A)) provides: “Contaminated needles and other contaminated sharps shall not be bent, recapped, or removed, unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure.” More specifically, our new compliance directive, CPL 2-2.69 at XIII.D.5 states, “removing the needle from a used blood-drawing/phlebotomy device is rarely, if ever, required by a medical procedure. Because such devices involve the use of a double-ended needle, such removal clearly exposes employees to additional risk, as does the increased manipulation of a contaminated device.” In order to prevent potential worker exposure to the contaminated hollow bore needle at both the front and back ends, blood tube holders, with needles attached, must be immediately discarded into an accessible sharps container after the safety feature has been activated.

Using a syringe to collect blood would be an example of a situation where clinical or medical necessity would dictate the need for transferring the collected blood to a test tube before disposing of the contaminated blood collection device. If drawing blood with a syringe is necessary, engineering controls (engineered sharps injury protection) and safe work practices (including mechanical means of removal if available) must be used and needleless blood transfer devices must be implemented.

Removing contaminated needles and subsequently reusing blood tube holders poses multiple potential hazards. The increased manipulation required to remove a contaminated needle from a blood tube holder is unnecessary and may result in a needlestick from either the front or back end of the needle. According to information available from the International Health Care Worker Safety Center at the University of Virginia, injuries occurring in phlebotomy are among the highest-risk for transmitting bloodborne pathogens such as HIV, HCV and HBV, because they involve hollow-bore, blood-filled needles.

Further, improper disposal of used, unprotected needle devices potentially affects more than just the user. According to data presented by the California Department of Health Services (January 2002), 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 (e.g., nursing assistants, housekeepers, maintenance personnel). Therefore, disposing of single-use safety-activated blood collection devices decreases potential injuries downstream.

While patient safety is not within the scope of OSHA's mission, we recognize that tube holder reuse poses a potential health hazard to patients. Some clinical studies show that 50-80% of blood tube holders may be contaminated after just one use (Advance/Laboratory, p. 70, January 2000). While it may be difficult to document a patient-to-patient cross-contamination exposure, the risk does exist and should be weighed when making decisions regarding overall safety.

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 Compliance Assistance at (202) 693-2190.

Sincerely,



Richard E. Fairfax, Director
Directorate of Compliance Programs