These sharps rules can stick you—big time

This expert explains how to improve safety and avoid hefty OSHA fines.

By Michael Garvin, MHA

You may not have heard of the Needlestick Safety and Prevention Act—which went into effect in April 2001—but if you don't follow its rules, you may be stuck with a hefty fine.

As mandated by the act, the Occupational Safety and Health Administration now requires all physicians' offices to annually document that they have evaluated and, where feasible, begun using new sharps technology designed to reduce employees' exposure to blood borne pathogens such as HIV and hepatitis C. If your practice has more than 10 employees, you'll also need to keep a log that describes all sharps-related injuries—including when, where, and how injuries occurred and what device was involved.

In enforcing the new regulations, the Feds are also taking a closer look at how disposable items such as IM injection devices, blood draw sets, scalpels, pediatric winged-infusion devices, IV insertion devices, implanted catheters, and blood transfer devices are used and discarded. For example, OSHA has begun fining facilities that use blood-draw tube holders more than once because their reuse requires the removal of used needles, posing a hazard to the health care worker.

The focus for now is on large group practices, clinics, and hospitals, but no doctor's office is immune from scrutiny. While you could be fined as much as $7,000 per violation, penalties to date have typically been small because the program is in its early stages. The fines begin at $700 per violation, but if the transgression is deemed willful, OSHA may increase the dollar amount 10-fold.

Get employee input—or else

You aren't required to purchase every new device that's advertised as a safer sharps alternative, but OSHA looks for documentation that you've made a good-faith effort to determine which of these devices is applicable to your practice.

You'll need to involve your staff, too. The rules say that nonmanagerial, front-line employees who are handling the sharps must help choose, evaluate, and implement safety-engineered devices. OSHA inspectors will question staffers to gauge the extent of their participation.

Employees needn't all agree on a device, however. Let's say two-thirds of the clinicians in your practice like a particular device and give their nod to purchasing it. But the rest of the clinicians object, saying, "We've been using a certain device for years without sticking ourselves, and you shouldn't force us to use this new, bulkier device."

The disgruntled few may lodge a complaint with OSHA, and that could lead to an inspection, regardless of the size of your practice. What will happen in cases like that? OSHA will most likely say the majority rules, and the unhappy few are instructed to get with the program.

How the safety law is enforced

The vast majority of OSHA inspections are prompted by complaints from employees. The rest are selected from a random, computer-generated list of offices and hospitals. The agency doesn't regularly scrutinize smaller employers unless a complaint draws their attention.

To be in compliance, you must show evidence that the staff has been evaluating products and involving a representative sample of employees who are likely to be exposed in those evaluations. It's a good idea to run some clinical trials on the products you evaluate. The trial can be as simple as bringing in a device, having clinicians use it for a period of time, and developing a reporting mechanism to let management know how well the device works. Let's say you have three nurses drawing blood in your office. Teach them how to use a new device, then have them try it out and report back. Document how the device was evaluated, whether it was deemed beneficial, and whether it was adopted in the practice.

Employers have the right to contest or appeal any citation for a violation before an administrative law judge. The results of all such appeals are made public, but the National Practitioner Data Bank doesn't record incidents of noncompliance with OSHA. "This is not malpractice," an agency official recently told me. "We're in the business of protecting employees, not telling doctors how to practice medicine."

To help you comply with the Needlestick Safety and Prevention Act, OSHA consultants will come to your office—free of charge—and help develop safety programs. An OSHA spokesperson assured me that such visits are intended to be educational, and aren't related to enforcement.

The new regulations may even prove a boon to your practice. A nursing director for a large physician group in Massachusetts told me that if the new standards hadn't been in place, they may never have discovered a new safety syringe that they like. The one-hand-activation device allows pediatric nurses to keep their other hand on the patient.

"It's hard to get to a sharps disposal box when you are holding down a squirming 3-year­old," she says. "This way we keep ourselves safe while doing our job."

The ins and outs of compliance

Getting information on new safety devices doesn't have to be onerous. Assign someone on your staff to report on new products once a year, say every Jan. 15.

How to get the information? The International Sharps Injury Prevention Society, a group that provides information on the safety devices, has a Web site at www.isips.org. Another Web site that lists new products is EPINet at the University of Virginia (www.med.virginia.edu/epinet ).

You may be surprised at the reasonable price and reliable performance of the devices covered by this new standard. The safest models cost about 10 cents more than traditional devices. Related costs, such as those connected to staff time monitoring the safety device market and getting a sharps injury log up and running, could be more substantial. Still, most practices can get up to speed on new devices for no more than $100 or so per month. Compliance cost analyses can be found at the OSHA Web site.

Establishing a safety device program is important to avoid OSHA fines and negative publicity, but its biggest value lies in protecting your office's greatest asset: your staff.

The author is a safety consultant at the University of Iowa Hospitals and Clinics in Iowa City.

Michael Garvin. These sharps rules can stick you--big time.

Medical Economics

2002;13:74.