Nevada may tap infection preventionists in light of growing HCV clinic outbreak
Nevada may tap infection preventionists in light of growing HCV clinic outbreak
'Sweeping changes' coming for ambulatory care
The largest look-back investigation in medical history — involving some 50,000 patients seen at two endoscopy clinics in Las Vegas — has netted a growing total of hepatitis C infections; at least 11 unconfirmed HIV cases, lawsuits involving thousands of patients, multiple criminal proceedings, and a nonstop media blitz that only will increase the likelihood of more infection-related claims in other states, speakers recently said at the annual APIC conference in Denver.
"People have lost faith in the health care system in Southern Nevada," said Gail Harris, RN, MS, MA, CIC, senior risk consultant for GE Medical Protective in Las Vegas. "This whole thing has set colonoscopy screening back probably 20 years in our city. Anecdotally, you talk to folks who say, 'I was supposed to get a colonoscopy; not going to now.'"
However, the aftermath of the HCV outbreak also should include dramatic, positive changes in Nevada and other states that take a hard look at this horrific cautionary tale of blatant infection control violations involving alleged syringe reuse. "There will be a lot of sweeping changes for medical practice in general in Southern Nevada," said Brian Labus, MPH, a lead investigator on the case for the Southern Nevada Health District in Las Vegas. "We have talked a lot about the issues related to the outpatient settings, [including] having Joint Commission come in and having that as part of the licensing process. We also are discussing having infection control nurses have some sort of affiliation with these types of settings. We should have the same attention to infection control issues as we do in a hospital."
Indeed, APIC audience members expressed concern that a similar incident could occur in their state. The situation in Vegas is considered by many more reflective of the current state of infection prevention in ambulatory care than an isolated incident. "We have no idea what's going on, and I suspect most states don't," an audience member from Wisconsin told Labus. It's too early to impart the lessons from the Las Vegas outbreak, he noted, but the intense interest in infection prevention is a good sign.
"These facilities don't get inspected on a regular basis, and that is one of the challenges we face," Labus said. "But even having regular inspections doesn't necessarily mean everything is going to work correctly when that person leaves. The issue of [having health inspectors] goes into these settings more frequently is an issue I think every state is going to have to face."
In addition to having health inspections conducted more frequently at ambulatory clinics, the survey process itself will likely become much more concerned with infection prevention, he said. "When licensing people come in, infection control isn't really a high priority a lot of the time," he added.
Reused syringes, vials cited
The practices described as resulting in HCV transmission included using a syringe to administer anesthetic to a colonoscopy patient, then changing the needle — but not the syringe — before drawing up additional medication to be used on the same patient. The process of redrawing medication using the same syringe could have contaminated the medication vial. The same vial of anesthetic then was used for a second patient with a clean needle and syringe, investigators report.
The health department reports that eight acute hepatitis infections were acquired during medical care, seven at the Endoscopy Center of Southern Nevada, and one at an affiliated clinic — the Desert Shadow Endoscopy Center, Labus said. Both clinics have been shut down as an investigation continues that could result in confirmation of many more cases. While it has been determined the acute HCV case is linked to the Desert Shadow center, there is not sufficient information to determine the likely source of disease transmission, the health department reported. However, the department noted that a clinic staff person was observed reusing single-use vials of propofol at the facility during an inspection by the State Health Division Bureau of Licensure and Certification in January 2008, and propofol logs provided further documentation the bottles of anesthesia were reused on multiple patients. The health department has not been able to document the reuse of syringes because the clinic location was closed prior to the identification of the HCV case.
"At this point, we have eight acute hepatitis C cases, and those are the only ones that we can classify as clinic-associated because we have a finite time period," Labus told APIC attendees. "For acute HCV, the incubation period is at most six months, more typically six to eight weeks." In addition, 77 clinic patients have tested positive for HCV and are being listed as "possible cases" because they report no traditional risk factors for the disease (e.g., IV drug use.) "These are the 77 people who don't report any risk factors, who had positive tests for HCV, and didn't have any prior positives — they weren't positive before going to the clinic," he added.
The look-back effort thus far as been little short of overwhelming, as some 50,000 people may have sought HCV testing following the outbreak report. "We told [area laboratories] how many people we were notifying, but I don't think they expected them all to show up in the same week," Labus said. "It was just this huge rush of people that had a kind of ripple effect for everybody else needing [routine] testing. They had to [blood] draw 40,000 to 50,000 people in addition to all the things they normally do. But the labs did a phenomenal job with this. They opened clinics after hours and on the weekends."
The health department used a poison control center in Denver as a call center, he added. "Without them this entire response would have collapsed because we would have had 30,000 phone calls at the health district and it would have overwhelmed the phone system," Labus said. "We set records for everything possible at the call center: The most calls in a week — I think it was 12,000; there were 4,000 or 5,000 calls one day; several hundred calls in one hour. Any record they had, we shattered it."
High noon
The story broke on local television news in Las Vegas at around noon Feb. 27. Harris recalled. "By the 6 o'clock news, there were at least four law firms that had ads running," she said. "'Have you been seen at this particular endoscopy center? [They said,] 'Call us, we'll help you get tested and you are probably due some money. Six hours and four law firms were out there.'"
The hue and cry has not stopped since, Harris added, noting that 11 former patients of the center who are HIV-positive have retained lawyers. "It hasn't been sorted out as to whether they had other risk factors that may have caused this," she said. Regardless there has been no lack of legal advice or press coverage.
"By the end of March, five different law firms indicated that they are representing 9,970 individuals, including more than 300 who tested positive for hepatitis C," Harris reported. In addition to the eight confirmed and 77 possible HCV cases, there are 300 more patients that have tested positive "but the health department has not ruled out that they didn't have another risk factor involved," she said.
Background rate of 4%
The Centers for Disease Control and Prevention is conducting gene sequencing testing to help confirm that transmission occurred in the clinics, but it is clear that many HCV patients are going to have acquired the disease due to other risk factors (e.g., IV drug use). Indeed, Labus said the health department projected a 4% background rate of HCV for the clinic patients, meaning that thousands of people may have chronic hepatitis due to other risk factors, he said. The health department has set up an "exposure registry" to try to get at other risk factors among the patients, but it is an open question whether people will tell the truth. "You ask them about something very personal like IV drug use they may not want to admit it," Labus says. "We ask them to certify on the forms if everything they tell us is true. But there is no way that I tell for certain if a person had a history of IV drug use in the 1970s."
The current situation boils down to almost 10,000 lawsuits for potentially 400 cases, Harris said.
"I don't want to minimize that," she said. "The fact that even one case occurred for this reason to me is just abominable. I think that this is horrific."
Indeed, a Nevada licensing board publication recently urged nurses to speak out if they are aware of such practices, which apparently were never reported by any of the nurse anesthetists or other staff members. "If we notice something like this is going on we need to pick up the phone and report it," Harris said. "This had been happening for four years. Amazes me. It's just an amazing scenario."
More details will emerge as the lawsuits and the criminal investigation unfold, with the latter including potential insurance fraud charges for they way reimbursement records were reported to payers, Labus said. "These sorts of things don't happen quickly," he noted. "It looks like the civil suit is going to proceed in September of 2009. There are multiple criminal trials potentially with the issues related to patient [endangerment] and issues related to insurance fraud. I have a feeling I will be going to court for the rest of my career."
The largest look-back investigation in medical history involving some 50,000 patients seen at two endoscopy clinics in Las Vegas has netted a growing total of hepatitis C infections; at least 11 unconfirmed HIV cases, lawsuits involving thousands of patients, multiple criminal proceedings, and a nonstop media blitz that only will increase the likelihood of more infection-related claims in other states, speakers recently said at the annual APIC conference in Denver.Subscribe Now for Access
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