Look back in anger: HCV outbreak may bring IC changes to ambulatory care

What happens in Vegas . . . can happen anywhere

The largest patient "look-back" notification in medical history — involving some 40,000 patients potentially exposed to hepatitis C, HBV, and HIV in a Las Vegas endoscopy clinic — allegedly was driven by policies designed to save money and carried out by medical staff who should have known they were putting patients at risk, Hospital Infection Control has learned.

Unsafe needle practices and the reuse of single-dose vials have resulted thus far in six cases of HCV — including five patients treated on the same day: Sept. 21, 2007. "Every time an incident like this occurs, it shocks and disappoints us," says Joseph Perz, PhD, acting team leader for prevention in the Centers for Disease Control and Prevention's division of healthcare quality promotion. "We feel strongly that we need to communicate with all providers and all settings across the country. This kind of injection safety is the most basic type of infection control during patient care. It has to be met as a very basic expectation."

Physicians' offices and clinics should look closely at their practices, he adds. "They should review infection control practices of all staff under their supervision with an eye toward injection safety," Perz says. "Syringe reuse is not something that can be tolerated in terms of patient risk."

The latest outbreak in ambulatory care related to unsafe needle practices invoked a stunning familiarity, as a series of similar incidents involving blatant violations in basic infection prevention have occurred in grim succession in recent years. "We should be reminding each one of these ambulatory units right now if this can happen in Las Vegas, it can happen in North Carolina," says William Schaffner, MD, chairman of the department of preventive medicine at Vanderbilt University Medical Center in Nashville, TN. "This is the biggest [look-back effort] ever. It's hepatitis C, but of course lurking in the background is hep B, HIV, maybe even syphilis. Bloodborne infections of all kinds are potentially involved here."

If there is any solace to be taken from the most recent outbreak, it is that it may finally be the wake-up call that leads to sweeping changes and increased oversight in ambulatory care, physician offices and clinics. Still, that same alarm has been muted to "snooze" time and again after egregious violations have been documented, clinics shuttered and lives ruined. In the most recent incident, there are the aforementioned six cases of HCV, which could lead to chronic infection, cirrhosis, and in 1% to 5% of cases, death. It is the No. 1 indication for liver transplant. Of course, as noted, all patients are being advised to be tested for HBV and HIV as well in a look-back effort that will extend testing at least into this summer to account for the window period for all patients seen between March 2004 and Jan. 11, 2008, at the Endoscopy Center of Southern Nevada. The clinic's principal owner, Dipak Desai, MD, denied any wrongdoing and the clinic issued a statement. Due to the investigation, the clinic reportedly eliminated the unsafe needles practices as of Jan. 12, 2008. Regardless, city officials shut it down on Feb. 29 shortly after the massive look-back effort was announced.

Single-use vials likely contaminated

The practices described at the clinic involved using a syringe to administer anesthetic to an endoscopy 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. "They used the same syringe, but a new needle, and went back to the [same] vial," Perz says. "That practice can result in the introduction of blood into the vial. Then downstream patients, who are not sharing the needle or syringe, are at risk."

Infection control professionals are all too familiar with contamination of multidose vials, but the anesthetic vials being used in the clinics were packaged as single use. "We are not even talking about a multidose vial here," Perz emphasizes to HIC. "We are talking about a vial that is only intended for single use. Just because the catalogue may have the larger size [single-use] vial, which is appropriate for some procedures — doesn't mean that it is appropriate to order that vial and use it for multiple patients. It wasn't designed that way and, that in itself is a violation."

The vials typically were used up over the course of a day, suggesting that cases may have been more likely to occur in clusters through cross-transmission between patients than intermittently over time as contaminated vials remained on the shelves. "I don't think they reused vials day to day," says Devin Barrett, BS, disease investigation and intervention specialist with the Southern Nevada Health District. "They had a lot of patients going through there, so the vials were pretty much used up at the end of the day."

Given the well-established risk of such practices — which are in clear violation of recommended precautions — the first question among infection control professionals and epidemiologists was whether the case was caused by greed or ignorance. Maybe it was a bit of both, as some staff members told investigators they were instructed to deliver the pain medications in such a manner. "Going by what they said in employee interviews, it was a practice that the managers had impressed upon them to do," Barrett tells HIC. "That's what they said. I have no idea what the actual cost savings were by doing that, but that is what we were told."

Perz adds, "It seems like this was a suggested practice which some people did go along with, which should have been against their better judgment. Why some practice that way we can only speculate, but it does appear that this was something that was suggested to them by their managers."

Some staff members reportedly refused to comply with the practice, but a cloud has settled over the case as a class-action lawsuit and a criminal investigation are under way. At least four members of the staff who worked during 2007 were certified registered nurse anesthetists (CRNAs), Perz says. The American Association of Nurse Anesthetists (AANA) — which provides such certification — harshly reminded that guidelines for safe needle practices should be well known and have been reiterated in recent years due to other incidents. "It is astounding that in this day and age, there are nurse anesthetists, anesthesiologists, and other health care professionals who still risk using needles and syringes on more than one patient, or know of such activities and don't report them," Wanda Wilson, CRNA, PhD, president of the 37,000-member AANA, said in a statement. "Published standards and guidelines dictate that single-use and disposal of these products is the best way to ensure patient safety. Patient safety is our primary focus — not cost savings, time savings, or any other factor."

Asked about the cost-savings aspect of the case, Perz says the practice would not result in any great financial benefit. "We have seen with some of the expensive drugs — such as in dialysis — there is perhaps an incentive to scavenge," he says. "In this case, syringes are cheap; this is not an expensive [anesthetic]."

Seeking 120 patients treated on two days

In terms of the actual outbreak, one case occurred on July 25, 2007, and the cluster of five patients was seen Sept. 21. DNA sequencing of the HCV virus then was used at the CDC to link the cases. "The attempt here is to look very carefully at the subset of the 40,000 patients who were treated on days where we believe transmission occurred," Perz says. "The health department is going out of its way to try to contact those patients, arrange testing, and look very carefully at those results. They will be sending serum to the CDC from people who do have evidence of hepatitis for further molecular testing."

The clinic saw approximately 60 patients a day, so there are some 120 patients who were seen on the days transmission was known to occur. "We already have acute hepatitis [cases] on those days and particularly the one day with five cases — that is certainly beyond coincidence," Perz says. "That is not to say that in the last four years there weren't other days where transmission occurred and it just simply was not evident because infections lacked symptoms or for whatever reason were not reported. Some of that is going to get sorted out as time goes on."

Going beyond the notification letter sent to all patients, the health department is calling the patients who were treated at the clinic on the two days in question. "We want them tested here at the health district so that if we do find any positives we will send it to the CDC for genetic testing," Barrett says. "I would say we have reached at least 75% of them."

The health department uncovered the outbreak because health care exposure is listed as a risk factor on newly reported cases of HCV. The first two cases were detected last December. "As part of our regular hepatitis C and hepatitis B interviews, we always ask — first about general surgical procedures — and then specifically about endoscopic or colonoscopy procedures," Barrett says. "The first case we asked that and we got a 'yes.' The second case we asked that again and we got a 'yes.' Both of them had procedures at the endoscopy center. That's when we started looking closer and we got a third case a week later. That sealed it, we called in the CDC and we went to the clinic."

The surveillance for surgical- or endoscopy-related outbreaks was added due to other reported hepatitis outbreaks in recent years, she adds. "It is hard to pick up sometimes because new hepatitis C infections are often asymptomatic," Perz says. "Not every health department necessarily would have made the connection. The index of suspicion in the U.S. is still generally low, even though we have tried to build awareness through our reports of these outbreak investigations. The average clinician and many public health professionals don't associate health care in the U.S. as a risk for HCV of HBV transmission."

Labs inundated, probe may expand

Local labs in the Las Vegas area are inundated with patients seeking testing and, as this issue went to press, there were ongoing efforts to set up some kind of free testing or compensation system. "Clinics have called and said they are overwhelmed with patients calling and trying to get in, but I do not know how many have been tested up to this point," Barrett says, adding that about 1,500 of the 40,000 letters mailed have been returned because the patient no longer is at that address. Another major difficulty will be determining if a patient's bloodborne infection is the result of clinic exposure or another risk factor. For example, the generally elderly patient population could expect to have a higher incidence of hepatitis infections and liver problems than average. According to estimates distributed by the health department to local clinicians, the pre-existing background rate of infection for the clinic patient population should be about 4% for HCV and 0.5% for HIV. Regarding HBV, about 0.5% will show evidence of current infection and another 5% will show past HBV infection. Looking at the universe of 40,000 patients, those percentages mean there are some 4,000 clinic patients who acquired their bloodborne infection elsewhere. Ruling out that they didn't acquire it in the clinic is the the unenviable epidemiological challenge. "We're going to have to do the best we can with in-depth interviews, [gathering information] on past exposures or risk factors," Barrett says. "Good old-fashioned detective work, basically."

That will prove all the more difficult because the clinic's records are incomplete, and it is not easy to determine patient admission order and other factors that could epidemiologically suggest cross transmission, she adds. Making the case via molecular epidemiology also will be challenging, particularly for HCV, Perz adds. "This virus is hard to analyze in a molecular way," he says. "There are [viral] regions where the PCR tests and the sequencing can proceed fairly quickly. But it is sometimes necessary to apply quasi-species analysis, which is a whole other story and very labor-intensive."

In response to the hepatitis C outbreak, Nevada health inspectors are investigating all of the state's ambulatory surgery centers, where several violations of standard practice already have been found, according to the Associated Press. Since 1999, the CDC has reported 14 hepatitis outbreaks in the United States linked to improper injection practices. "I don't know how it is in other states and other counties, but I know here in Nevada there is just not a lot of oversight for ambulatory care centers," Barrett says. "This is what can happen if there isn't a governing body to make sure that people are doing what they are supposed to do. A lot of people are pushing for change now because of this situation, which is a good thing."