It was a horrible tragedy. paramedics responding to an emergency call late last year at an 84-bed nursing home in Bellbrook, a suburb of Dayton, Ohio, found not one, not two, but six residents all exhibiting symptoms of cardiac trauma at the same time.

The cause was easy to guess. The oxygen-delivery system in the wing fed up to six tanks at a time, and all the victims were on the same set of tanks. A close investigation of the oxygen-delivery system confirmed the paramedics’ fears. A lone, 196-liter tank of nitrogen had mistakenly ended up at the home in a routine delivery of what was supposed to be oxygen only and had been hooked up to the in-house oxygen system by a maintenance worker.

Authorities say the nitrogen tank was labeled as containing nitrogen and had special fittings to make it impossible to hook up to a standard oxygen system without changing the fittings. However, the “nitrogen” label was pasted atop a larger one bearing the word “oxygen”—a violation of Food and Drug Administration (FDA) safety guidelines—and the maintenance worker changed fittings on the nitrogen tank after finding it impossible to connect to that system, police officials said. In addition, the tank looked like the type that can contain oxygen, even though its shiny aluminum skin bore no painted color to suggest that it did in fact hold oxygen, a fire department official told reporters.

In the end, four women died of nitrogen asphyxiation, in which the brain is deprived of oxygen. As politicians scrambled to react, Ohio HME companies that deal with oxygen delivery systems worried that a bill working its way through the state legislature would choke them with burdensome safety rules concerning medical gases. Today, those companies are breathing a bit easier after discovering the proposed law threatens to do little more than reiterate regulations already in effect at the federal level. However, analyzing what happened in Ohio can help all HMEs prepare for political fallout if a similar disaster happens in their state.

Ohio’s SB 117
At press time, the state Senate had passed the measure, SB 117, and sent it to the Ohio House of Representatives for debate, possible amendment, and vote. As adopted by the Senate, the law applies only to cryogenic vessels—portable tanks designed to hold medical gases that have been liquified by extreme reductions in temperature. SB 117 calls for proper labeling of cryogenic vessels and requires color-coding the top six inches of each tank to identify what is inside. Green means oxygen, black means nitrogen, blue means nitrous oxide, gray means carbon dioxide, yellow means ordinary air, and so forth. Alternatively, oxygen providers may affix a color-coded, 360-degree wraparound label to the upper portion of the tank.

If a tank is reused and filled with gas of a type other than what it previously contained, the old labeling and color-coding must be completely removed and replaced with the correct new label and color, SB 117 stipulates. In addition, SB 117 requires the connector between the vessel and the valve through which the gas is delivered be either:

• A threaded or socket connection that is silver-brazed or welded to the valve.

• A permanent and integral part of the valve.

The bill also makes it a crime for unqualified persons to remove a connector and replace it with another or to attach an adapter. Anyone convicted of such an offense would be guilty on a charge of tampering with drugs.

HME Reaction
One organization keeping an informal watch on SB 117 is the Ohio Association of Medical Equipment Services (OAMES). The Columbus-based body has taken no official position for or against SB 117, but the sense among members is that the measure poses little menace to the HME industry. “The proposed legislation doesn’t seem as though it would encumber HME suppliers any more than is already the case under FDA guidelines,” says Kamela Yuricich, executive director of OAMES.

OAMES member Craig Wood, executive vice president of O.E. Meyer, a re-packager and distributor of medical gases in Sandusky, allows that the legislation might adversely impact some companies, but only those that are doing business the wrong way. “We are comfortable with this bill,” he says. “It will have little impact on the way we are doing business. As a company, we have already taken steps to protect people along the lines being called for in SB 117. For example, we recently began to silver-braze all the fittings on our liquid oxygen cylinders, and have been using 360-degree wraparound labeling.”

Even so, industry insiders have reservations about the bill, Yuricich says. “The biggest concern that showed up in my informal polling of OAMES member opinion was over a provision requiring use of a wrap around the top six inches of each tank,” she says. “Some of our members think it would be better if the requirement was less exacting. Rather than the top six inches, the requirement should be stated as, possibly, a percentage or proportion of the tank. That would be a more reasonable specification and would make it easier for producers to deal with.”

Another concern is the demand for color-coding of tanks. Some HME industry advocates argue that experience has shown color-coding can actually cause rather than eliminate confusion. “There are going to be people handling the cylinders who are color-blind,” Wood says. “Color-coding, for them, would be meaningless. Also, exposure to severe environmental conditions over time can cause colors to fade or even look like different colors altogether. Under certain lighting conditions, one color can be easily mistaken for another.”

Wood says he favors proper identification of cylinder contents. But he thinks identification that wraps around the upper part of the tank makes more sense. “This method overcomes the weaknesses inherent to color-coding,” he says.

Repainting Responsibility
Another issue raised by the bill but not addressed in the SB 117 is compliance. “If this bill becomes law, who will be required to repaint and relabel all the tanks in your warehouse?” Yuricich says. “Is it the HME dealer? Is it the gas distributor? Is it the gas manufacturer? This isn’t made clear. But it needs to be because we in the HME industry will not want to be in the business of repainting tanks.”

One other sticking point is a provision in SB 117 mandating creation of a medical gases safety program. This program would be developed and administered by the Ohio Board of Pharmacy. Although the legislation never details the content of the program, Yuricich predicts it will feature a demand for more and better education of gas-handlers and technicians. She hopes responsibility for supplying that instruction will not fall on the shoulders of HME companies.

Perhaps the most fundamental question not being addressed is whether SB 117—or any law, for that matter—can actually prevent future mishaps. “The person who is alleged to have caused the tragedy at the nursing home had to ignore or be totally ignorant of the roughly half-dozen safeguards already in place to protect patients from exactly this kind of thing,” Yuricich says. “Will SB 117 stop this sort of tragedy? It is impossible to tell.”

PRESSURE TO “DO SOMETHING”
In the aftermath of the deaths, Ohio media pounced on the story and played it from virtually every conceivable angle. Many in Ohio’s HME industry believe SB 117 was introduced simply to quell the media.

“The legislature was under pressure to ‘do something,’ to prevent an ‘epidemic’ of tank switchings,” Yuricich says. “The sponsor, the co-sponsors, and everyone in the Senate who voted for the bill did not wish to be portrayed in the press or by their re-election opponents as indifferent or even hostile to consumer safety, particularly as it applies to helpless grandmothers. So there was enormous pressure to get this bill passed as quickly as possible.”

Which explains why hearings into the situation that necessitated SB 117 featured little in the way of opposing testimony, Yuricich says. “SB 117 is the kind of bill that—from a public relations standpoint—is difficult for anyone to oppose. Being against something like this is akin to being opposed to clean water.”

Wood offers a different rationale: “The reason there’s not been any real opposition to the bill is that we are all interested in making things as safe as possible.”

As of mid September, the Ohio House of Representatives had yet to scheduled SB 117 for consideration. However, observers were confident it would do so before the end of the year.

Rich Smith is a contributing writer for Dealer/ Provider.