OSHA gets tough on needle safety with high fines

No reuse of tube holders allowed, agency insists

The Occupational Safety and Health Administration (OSHA) is hanging tough on enforcement of safer needle devices, with a new information bulletin that clearly restates its prohibition against reuse of blood tube holders.

OSHA also has continued to issue citations and fines, including a $102,000 fine of a Pennsylvania nursing home for failing to provide needle safety devices to protect employees.

In the fiscal year ending Sept. 30, 2002, OSHA issued 183 citations to hospitals, 29 to clinics and doctors' offices, and 703 to nursing and personal care facilities related to the bloodborne pathogen standard. At press time, release of the OSHA information on blood tube holders was pending.

"Employees are more and more aware of their ability to file a complaint [related to needle safety]. They are more aware of the requirements of the standard," says Amber Hogan, MPH, an industrial hygienist in OSHA's office of compliance assistance.

"There's been an influx of complaints." Hosp-itals have made a dramatic shift to safety devices since the Needlestick Safety and Prevention Act went into effect in 2001. However, smaller facilities such as nursing homes and physicians offices have been slower to convert, she says.

One area of controversy involves the reuse of blood tube holders. That practice leaves health care workers vulnerable to a needlestick from the back end of the needle, Hogan adds.

"[OSHA’s bulletin] reemphasizes the requirements of the standard, which state that needle removal is prohibited unless it’s required by a medical procedure," she says. "The safest practice is to not remove the needle but to throw away the whole unit."

Clinical labs fight rule

Clinical laboratories have hotly contested that rule, arguing that the long-standing practice of reusing blood tube holders does not pose a workplace hazard.

When OSHA cited corporate laboratory giants Laboratory Corp. of America and Quest earlier this year for failing to comply, the companies vowed to fight.

OSHA withdrew the citations, but it has not backed down from its position, Hogan explains. The prohibition is included in the 1991 bloodborne pathogen standard, the 1999 compliance directive, the revised bloodborne pathogen standard and 2001 compliance directive, and a letter of clarification in 2002. (See Hospital Employee Health, August 2002, p. 92.) After pulling back on the citations, OSHA officials met with manufacturers, clinical laboratory representatives, and union officials.

"We felt it was unfair to go forward until we had time to meet with everyone and come up with a comprehensive policy," she says. However, OSHA now will move forward "because we’ve given due notice to the public."

Data shows back-end injuries

The clinical laboratories and laboratory associations argue that single use of blood tube holders would not be practical because the high volume of use would create an overwhelming burden of biohazardous waste and increased costs. They also assert that the reuse is safe when the health care worker uses a mechanical device to remove the tube holder, and thus it doesn’t violate the standard.

Yet a review of nine years of data by the International Health Care Worker Safety Center at the University of Virginia in Charlottesville found evidence of injuries from the back end of needles.1

About one-fourth of needlesticks (28%) from phlebotomy needles occurred after use but before disposal, a higher proportion than for all other devices (22%). About one in 10 of the phlebotomy injuries occurred during disassembly of the device, and 17% of injuries occurred while putting the sharp in a disposal container.

Some injured health care workers offered details of their injuries that describe a needlestick by the back end of the needle. It is likely that other health care workers had similar experiences that they did not describe — or even report, says Jane Perry, the center’s director of communications.

"It is a real hazard. The data show that," she says. "We would assume that the workers who do put down that their injury was from the back end [of a needle] are only a portion."

Yet compliance with the OSHA directive on single use of blood tube holders has been spotty, at best, says Katherine West, MSEd, CIC, an infection control consultant with Infection Control/ Emerging Concepts in Manassas, VA.

"OSHA is very much on the move with inspections," she cautions. "If you look at the top seven OSHA citations for 2001-2002, about four of them deal with safety sharps. That’s their focus and it’s appropriate that that’s their focus because that’s where the health care risk is."

The sting of enforcement was felt by Beaver Valley Nursing and Rehabilitation Home near Pittsburgh, which was inspected as part of the National Emphasis Program targeting long-term care facilities with high injury rates.

OSHA hit the nursing home with a citation for "willful violation" for failing to provide safety devices. A willful violation means "the employer intentionally and knowingly commits [the violation] with plain indifference to the law," OSHA says. That citation alone brought a $70,000 fine.

OSHA also cited the nursing home for deficiencies in training and post-exposure evaluation and counseling; overfilled sharps containers; not providing an attending physician with a copy of the OSHA regulation; and use of improper protective equipment.

The nursing home, part of the Extendicare Health Services long-term care chain based in Milwaukee, issued a statement: "We disagree with the citations imposed and are working to resolve the matter in a satisfactory manner. The health and safety of our employees is important at Beaver Valley Nursing & Rehabilitation Center, and we are taking this situation very seriously."

Worker advocates lauded the OSHA enforcement. The Beaver Valley case could have a ripple effect and influence other health care facilities to improve their compliance, says Bill Borwegen, MPH, health and safety director of the Service Employees International Union.

"This could be very useful ammunition for the health and safety professionals that are working in the hospitals trying to get employers to give them the resources they need to do the job," he says.

Employers can’t just buy the cheapest safety devices to meet the requirements, Hogan cautions. They must involve employees in the selection of the devices, and they need to purchase devices based on employee preference, she says. "That [employee] feedback actually needs to be constructive and it needs to be taken into account," she says.

Soon, it will not even be possible to buy certain conventional needles. Becton-Dickinson, based in Franklin Lakes, NJ, announced it would discontinue some conventional devices, including IV catheters, winged needle sets, lancets, and glass blood collection tubes. Other manufacturers have taken similar action.

"The decision to phase out the sale of certain conventional devices in the U.S. was really prompted by our customers themselves in terms of their buying patterns," says Ed Thompson, BD senior director. The phaseout of conventional devices will expand as use of safety devices evolves, he says.

"To the extent that we can eliminate certain conventional devices, we will," Thompson adds. "The key is to do it in a way that’s not disruptive to our customers or to patient care."


1. Perry J, Jagger J. EPINet data report: Injuries from phlebotomy needles. Advances in Exposure Prevention 2003; 6:43-45.