Sharps law: OSHA to question frontline workers

Inspectors will check for needlestick log

(Editor’s note: We continue coverage of enforcement and compliance issues raised by recent passage of a landmark federal needle safety law. See Hospital Infection Control, December 2000, pp. 165-167, for Part I of this report.)

Infection control professionals who do not involve frontline workers in selection of needle safety devices and maintain a separate sharps-injury log could find themselves in trouble with federal inspectors when a new national law becomes effective this year.

The Occupational Safety and Health Admini-stration (OSHA) is planning to enforce those two new requirements under the Needlestick Safety and Prevention Act, which has been passed by Congress and signed by President Clinton. The law will be published in the Federal Register within six months of its Nov. 6, 2000, signing date. That is more of a fair warning than a comment period, as the law becomes effective as written 90 days after it is published.

In addition to the two new requirements, the law essentially codifies a Nov. 5, 1999, compliance directive issued by OSHA to enforce needle safety in the nation’s hospitals. Under the law, hospitals can be cited and fined unless needle safety devices such as retractable or self-sheathing needles are being regularly evaluated. The law requires that employers review and update the exposure control plan at least annually to reflect changes in technology, such as the use of effective engineering controls that can eliminate or minimize exposures.

"We will enforce [those provisions] right now," says Melody Sands, director of health compliance at OSHA in Washington, DC. "[But] the other two provisions in that law were not part of our [previous] changes to our compliance directive. One of those is the requirement that employers include frontline employees in the choice of devices. And the other requirement is for them to keep a needlestick log, which they don’t specifically have to do [currently]. Those two additional requirements will become enforceable 90 days after they appear in the Federal Register. We will probably issue changes to our compliance instruction [to inspectors]."

Worker input will be case by case

While that compliance revision remains to be completed, Sands says it will likely involve asking employees if workers had input on the selection of devices.

"Generally, OSHA conducts employee interviews whenever we do an inspection," she tells Hospital Infection Control. "For a requirement like that, I believe that would be the most effective way to find out [if] they have been included. Of course, decisions have to be made on that. Is that everybody, somebody, or most of them? If you have a 10-person operation, that is different than 100 people working in an area. I think we will have to make some decisions on that on a case-by-case basis."

The agency is not planning a special initiative to enforce the law but will respond to workers’ complaints, she says. "Most of our inspections are generated by employee complaints. That could increase if and when employees become aware of this legislation and want to make sure that their employers are providing them with these protections," she says.

Indeed, health care unions and nursing advocates have been vocal about blowing the whistle on facilities that try to evade such edicts. They have been true to their word in California, which passed the first state needle safety law in 1998.

"Seven of our facilities already have been cited, and there are ongoing inspections in additional facilities," says Cynthia Fine, MSN, CIC, infection control and employee health consultant for Catholic Healthcare West (CHW) in Oakland, CA.

"I think throughout the United States it will be the same, because federal OSHA plans on doing it the same way. They are not going to just go out and inspect everyone," she says. "They will inspect when there are complaints, and we’ve had a lot of union activity going on. The unions have been very instrumental in complaining and bringing OSHA into the facilities."

In the kind of situation that could well be a preview for other ICPs, Fine says health care unions have been pressuring hospital officials to implement particular devices, including a retractable-needle syringe. "We actually piloted the devices and found that they were good for some applications, and for other applications, we felt that there was something that was as good or better," Fine says. "So some of our facilities, are using them in some wards, but it is not the most commonly used syringe that we are using."

Cal-OSHA, the state plan enforcing the law, has advised Fine that it will allow some flexibility on the choice of device as long as certain conditions are met.

"[Cal-OSHA] says you have to use a device that is safe and effective and that you have had frontline health care worker input into [purchasing]," Fine says. "[It is] not going to let you off with using something really cheap, just because it is cheap. But it does allow some flexibility."

Endless implementation of new technology?

Similar concerns have been raised about the new federal law, with an ICP questioning whether the process could descend into endless evaluation, implementation, and inservicing as technology marches on.

"Why should I fix something that is not broken?" asks Patti Grant, RN, MS, CIC, director of infection control at RHD Memorial Medical Center and Trinity Medical Center, both in Dallas.

"[For example], I am using vendor A’ for my protective IV catheter in 2001. In 2002, it is still working, but the way that [federal law] was worded it looks like I should change products or upgrade. What is the point?" she asks. "That is an unnecessary burden. You are asking me to go through a motion [after] we implement something and it works. Why would I want to look at another vendor the next year?"

Sands clarified that endless device implementation is not OSHA’s intent, but the evaluation process must be ongoing.

"You could be using a perfectly effective device that has been on the market for 10 years," she says. "Even if somebody is using an engineering control and the compliance officer knows that another is clearly more effective — and I don’t just mean just a little bit — that is not an automatic citation, because we are not dictating which devices. What that is meant to get around is somebody using a clearly inferior device. It really would be a situation where we see somebody using a first-generation device and even experiencing needlesticks.

"In that situation, we have instructed our compliance offices to consult with regional bloodborne pathogen coordinators. But they do have to update the plan every year. That just forces them to look at, in addition to some of the devices, the number of people who are being exposed," Sands adds.

Grant also expressed concern with the wording in the federal law that calls for needle safety for medical care including administration of medication and fluids.

"It will be very interesting to see how we all decide to interpret that and what exact citations involve around that if there is no blood or body fluid involved," she says. "A lot of interdermal, subcutaneous or even [intramuscular] injections don’t have anything to do with blood. I question that. That caused me the greatest concern because I see waste of health care funds in implementing a needleless device when there is not a risk for body fluids or blood."

Hazard = exposure to blood

OSHA first will look to see if there is a hazard, Sands says, agreeing that, for example, if someone is using an unprotected syringe to withdraw medication out of a pharmaceutical vial to put into another vial, there is no blood-exposure risk.

"What OSHA will look for is the hazard. If there is no hazard, that means no exposure to blood, then there is no need to have the safety needle device."

From a health care economic view, Grant says it appears the new law will be the death knell for traditional types of group purchasing contracts.

"I think it will eliminate single-vendor contract awards," she signs.

The experience in California foretells that as well, Fine adds. "Cal-OSHA has been real clear on this, and I’m sure federal OSHA will do the same thing."

"You can’t just put a device in because it is on your buying contract. You must look at what is available and what your health care workers choose," she says. "OSHA doesn’t care if you save money on it or not. [It doesn’t] consider it of any relevance if you have a group buying contract or not."

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