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By Anne Freedman

Evelyn McKnight was fighting a reoccurrence of breast cancer when she was diagnosed with hepatitis C (HCV), which is most often spread through IV drug use.

Eventually, however, she and her husband Tom, a family physician, began to investigate how the infection occurred. With the help of Tom's nurse, Jean Schafersman, whose teenage son was fighting testicular cancer at the time and also became infected with HCV, they began focusing on the oncology clinic in Fremont.

"It was the only one in town," Evelyn McKnight said.

After they found four more cases of HVC in the small farming community, they approached Dr. Tahir Ali Javed, who owned and operated the clinic. Javed expressed surprise, said he would investigate the problem and "in a few days, he absconded to Pakistan where he became the minister of health in Punjab province," McKnight said.

Ultimately, 99 of Javed's patients contracted HVC, and several of them died, because the nurses in the oncology clinic had reused syringes, according to the state's investigation of the 2002 incident. Reusing the syringes contaminated large bags of saline that were used at the clinic to clean out implanted devices utilized in the chemotherapy treatment regimens.

"The lack of compliance with safe injection practices is clearly a public health risk based on the number of outbreaks that we have seen," said Emily Rhinehart, an Atlanta-based registered nurse and vice president and division manager for AIG Casualty Loss Prevention Health Care. "It's a huge problem."

Unsafe Practices

Data from the U.S. Centers for Disease Control and Prevention indicate that about 90 percent of outbreaks of blood-borne pathogens, such as HCV, HIV or hepatitis B (HBV), are associated with unsafe injection practices in outpatient settings.

And the number of ambulatory surgery centers has been exploding, with a 240-percent increase from 1996 to 2006, according to the CDC. In addition, more than 1 million cancer patients receive outpatient chemotherapy and radiation treatment annually. In all, there are about 1.1 billion patient visits to outpatient clinics and physician offices each year -- and those CDC statistics are from 2006, the most recent available.

"This is where health care is being delivered," said Dr. Joseph Perz of the CDC's Division of Healthcare Quality Promotion, "and yet so many of those outpatient facilities just aren't subject currently to the kinds of oversight that consumers probably take for granted."

Some outpatient clinics and offices operate with less regulatory oversight than fast-food restaurants, said Russ Nassof, executive vice president of RiskNomics, an environmental and health care risk management consultancy in Scottsdale, Ariz. Some just need a business license to go into operation. Many are not routinely inspected and operate without oversight from state, federal and/or appropriate licensing boards.

"It's pretty scary when you think about it," Nassof said.

"The tendency is to have a laxity in many of these facilities," he said. "It's just a basic failure to comply with regular, good, old, basic infection-control practices."

"I think," said Dr. Perz, "we are starting to see where this system has some gaps in terms of the safety net it provides."

Costly Contaminations

For a time, the Nebraska outbreak was the largest outbreak at an outpatient facility, but that was eclipsed in 2008, when about 63,000 patients of an endoscopy clinic in Nevada were notified they were potentially exposed to the blood of other patients through unsafe infection practices.

That outbreak -- caused by reusing syringes that contaminated single-use drug vials -- cost between $16.3 million to $21.9 million for laboratory testing of exposed patients and treatment of the 115 patients infected with HCV, according to a state public health report.

The state indicted the physician and two nurse anesthetists (one of whom recently pleaded guilty) for multiple felonies, including second-degree murder, as one of the infected patients died. In addition, more than 200 civil lawsuits were filed, and two separate juries levied more than $250 million in damages against the manufacturers and distributors of propofol, an anesthetic agent that was used to sedate patients.

And the hits keep on coming. The CDC reported that, since 2001, nearly 90,000 patients in dozens of states -- not including the Nevada endoscopy patients -- had to be notified to be tested for potential infections of blood-borne pathogens.

Even with a heightened interest in reporting, tracking outbreaks is "very hard to gauge," Dr. Perz said, noting the CDC often relies on hearing single reports that may lead them to identify a cluster of infections or an outbreak.

He noted that the CDC had created a safe injection practices coalition (www.OneandOnlyCampaign.org) to promote the use of one needle, one syringe, only one time.

McKnight used the proceeds from her legal settlement to create HONOReform.org, which advocates for the protection of patients through safeguarding the medical injection process.

The most recent outbreaks, in January 2013 and November 2012, occurred at two New York hospitals, where more than 2,000 patients may have been exposed to HIV, HBV or HCV because nurses were changing the needles on insulin pens designed to be used on a single individual and using them on multiple patients.

"If I was a hospital risk manager," Dr. Perz said, "I'd want my institution to look very closely at insulin pen reuse and handling of prefilled syringes, and all syringes for that matter."

Unsafe injection practices "certainly can be a professional liability risk," said AIG's Rhinehart, "so we are very proactive when we visit our clients to make sure they are aware of the risk of unsafe injection practices and that the risk manager and infection preventionists not only look at policies and procedures, but go to the clinic area and observe those people administering the meds and talk to them about how they are doing it and what their practices are."

The expense of unsafe injection practices that can cascade through an outpatient facility can be extensive, she noted, with administrative costs to identify and test potentially exposed patients, as well as treat and monitor them.

Woody Hill, vice president, loss control, at the San Francisco office of the insurance company Employers, said "outpatient procedures now represent more than three-quarters of all operations performed. The cost of insurance is going to be dictated by the type of controls they have for these exposures."

Some experts still see more infection problems emanating from hospitals, rather than outpatient facilities.

"My company data would suggest [infection rates are] actually lower in ambulatory surgery centers," said Robert Allen, senior vice president, global healthcare, at Torus Specialty Insurance Co. in Jersey City, N.J.

He said it is disconcerting, however, to consider how effortlessly some medical-care providers are setting up outpatient clinics.

"So you could be a dentist and one day wake up and think I will start putting Botox into somebody's cheek today," he said. "It's not quite that simple, but there's an ease of doing that business that is concerning as an underwriter."

Nancy Lamo, a clinical risk consultant at Lockton Cos. in Minnesota, said that, while the number of infections may be trending up in outpatient settings, "in terms of absolute numbers, I think there are still more hospital-acquired infections."

Nonetheless, she said, infection-control procedures "aren't quite as developed [in outpatient settings] and there is going to continue to be an increasing problem."

Mistakes will happen, Nassof said. Basic risk mitigation procedures would be to standardize the products and practices used, he said.

"Any time you have an opportunity for something to be misused because of how busy and stressed everyone is," he said, "it will be misused."

ANNE FREEDMAN is senior editor of Risk & Insurance®. She can be reached at afreedman@lrp.com.

March 1, 2013

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