Hidden viral hepatitis epidemic may be simmering in ambulatory care 

HICPAC discussions reveal a formidable problem 

Emerging data in elderly patients indicate that a stealth epidemic of hepatitis C and hepatitis B virus may be going undetected in ambulatory care settings, Hospital Infection Control has learned. If the data are verified, the infectious risk extends to all patients in ambulatory care, as elderly patients are essentially a surrogate marker for health care transmission due to their lack of other risk factors.

Amid increasing reports of outbreaks due to reused needles and other infection control breeches in ambulatory care, the Centers for Disease Control and Prevention (CDC) began scanning its limited surveillance data on infections beyond the hospital. Because the viral hepatitis viruses circulate in higher blood titers than HIV, the primary bloodborne infectious agents appear to be hepatitis B virus (HBV) and hepatitis C virus (HCV).

"We are actively following up on all national reporting of acute HBV and HCV cases for patients 60 years of age and older," said Ian Williams, PhD, an epidemiologist in the CDC division of viral hepatitis, during a recent monthly Healthcare Infection Control Practices Advisory Committee (HICPAC) meeting. "Older adults were chosen because the overall risk is reduced given the low frequency of high-risk behaviors such as injection drug use and multiple sex partners."

Based on historic surveillance data, people 60 and older only represent about 5% of all reported cases of HBV and HCV. Yet when investigators looked at data for acute hepatitis from sentinel counties in the United States, they found that for those 60 and older — with no identified source of infection — hospitalization or same-day surgery in the previous six months was reported by 35% of the HBV cases and 42% of the HCV cases. Investigators suspect patients are being infected primarily in ambulatory care settings, where infection control lacks the rigor and oversight of hospital settings.

In an attempt to verify or refute the data, the division of viral hepatitis is planning a case control study to examine risk factors for HCV and HBV for patients older than 60, Williams said.

As a result of the findings and several highly publicized outbreaks, the CDC and its advisors are having frank discussions, which suggest the hepatitis outbreaks reported in recent years may be dwarfed by the infections going undetected.

"Clearly [it’s] a big problem, and probably this is just the tip of the iceberg," said Robert Weinstein, MD, chairman of HICPAC, which has formed a working group to address the issue.

"It seems like what needs to be done is well known, but how to get it done, how to get it disseminated and regulated is going to be the challenge to the group," he added.

Guidance or compliance? 

The aim of the HICPAC working group is to develop evidence-based recommendations for infection control and patient safety in ambulatory care. That said, the primary problem is less a lack of guidance than a lack of compliance with well-established infection control measures.

"The guidelines are out there," noted Raymond Chin, MD, the HICPAC member who was tapped to lead the ambulatory care working group. "It is just the fact that they are not being practiced. That’s our challenge."

One goal of the group is to at least reach the low-hanging fruit and improve compliance with basic measures such as single-use of disposable syringes, he explained.

"[These measures] are almost intuitive but not consistently applied in ambulatory care settings. Ambulatory care is not regulated, and usually the administrative oversight is minimal. Even in ambulatory care centers that are part of a larger hospital, I think that the program is in place but the oversight is not as [good] as the hospital setting. Joint Commission [on Accreditation of Healthcare Organizations] accreditation is voluntary, and only 5% of ambulatory settings are accredited," Chin added.

Because the CDC lacks regulatory power, HICPAC is considering whether to seek partnerships with patient safety advocacy groups such as Consumers Union or The Leapfrog Group. The panel wants to assist in the development of legislative language and improve surveillance methods to detect target health care-associated infections in ambulatory care. Current discussions include a focus on surgical-site infections in surgery centers and bloodstream infections linked to infusion centers for oncology patients.

A recently published paper co-authored by Williams, which was distributed at the HICPAC meeting, underscored that ambulatory care settings now account for most patient encounters with the health care system in the United States.

Increasingly complex procedures are being performed in ambulatory care settings, driven by changes in reimbursement mechanisms and advances in medical technologies.1

"Actually, the whole issue of what’s going on in ambulatory care is pretty interesting," said Robert Wise, MD, HICPAC member and vice president for standards at the Joint Commission.

"One of the reasons that ambulatory care is growing so large is that practitioners are leaving the hospital setting because there are too many regulations," he pointed out.

"They are flooding to the ambulatory centers where people will [presumably] leave them alone. . . . The issue of infection control is one of those things that is out there simmering, but nobody knows about it," Wise explained.

Accreditation or regulation?

Regarding an appeal to patient safety advocates such as the Consumers Union, he said nothing short of regulation will improve the situation. "We have an accreditation program for ambulatory care," Wise told HIC at the meeting. "The issue is that there are no drivers. There’s no reason right now for an ambulatory center to actually seek accreditation. That is really the issue. We have a program, and we have issues around infection control. Our sense is that until there is a driver that really requires [them] to do it, I don’t think consumer opinion is going to do it. It is probably going to require legislation from the states."

However, another member of the HICPAC panel said state health departments cannot assume the regulatory burden for ambulatory care. Noting that states do not have the resources to regulate ambulatory settings, Rachel Stricof, MPH, said she favors a push for accreditation that would include infection control requirements. "We, as a state, cannot afford to regulate all of these settings — basically it is regulating the private practice of medicine," said Stricof, an epidemiologist in the New York State Department of Health in Albany. "We do not do that; we will not be able to do that. There are not enough resources out there."

In addition to concerns about ongoing, below-the-radar transmission, there have been highly publicized outbreaks recently in ambulatory care settings. Indeed, it was the outbreaks that spurred the CDC to take a closer look at the limited surveillance data. Unlike inpatient care, in which patient stays are of typically limited duration, care in ambulatory settings may involve repeated visits for several weeks to many years. That pattern has the potential to result in a large number of patients becoming infected, as was observed in several recently reported outbreaks that involved patient-to-patient transmission, Williams reported.

"Viral hepatitis associated with health care settings in the United States has been recognized primarily in the context of outbreaks," he told HICPAC members. "When identified, most of the outbreaks have been found to be due to unsafe injection practices associated with the reuse of syringes and needles or contaminated multidose medication vials."

In recent years, four large outbreaks of HBV and HCV infections occurred in the United States among patients in ambulatory care facilities that included a private medical practice, a pain clinic, an endoscopy clinic, and a hematology/oncology clinic. The 2002 pain clinic outbreak in Oklahoma reached staggering proportions, resulting in 31 clinic-associated HBV infections and 71 clinic-associated HCV infections.

"This clinic served outpatients and was affiliated with a hospital and used space within this hospital," Williams said. "From interviews with clinic and hospital staff, it was unclear who had primary responsibility for infection control oversight of this clinic. In reviewing practices at the clinic, the nurse anesthetist reported routinely filling a single syringe with multiple doses of medication at the start of each clinic session for use in hep locks of patients. . . . The probable mechanism of transmission in this outbreak was routine use of a single needle/syringe to administer medication to multiple patients."

Prior to the outbreak, the nurse had been reported at two separate times to the infection control staff in the hospital as having poor aseptic practice. No action was taken after the first report, Williams said. The second report led to a formal reprimand but no further action or investigation ensued, he added.

In the endoscopy clinic outbreak, it appears that reinserting needles into contaminated multiple-dose anesthetic vials resulted in HCV infection to 19 patients. In the hematology/oncology clinic outbreak, syringe reuse apparently led to the contamination of saline bags used to flush out implanted catheters, resulting in 99 identified HCV infections. All four outbreaks could have been prevented by adherence to basic principles of aseptic technique for needle use and the preparation and administration of parenteral medications, Williams stressed.

Common themes and few answers

"Common themes emerge from these recent outbreaks. None were identified by current surveillance systems, but by alert clinicians. These outbreaks occurred in outpatient settings in which oversight of infection control practices was less stringent than it was in inpatient [settings]," he said. "All were associated with unsafe injection practices involving obvious violations of standard procedures. They could have been prevented with adherence to basic infection control practices, such as single use of disposable needles and syringes. However, health care workers did not know that their routine practices were in error," Williams added.

Could that possibly be true? Two surveys of anesthesiologists published in 1995 provide evidence of either entrenched ignorance or flagrant disregard for long-established infection control practices with syringes and needles. In one survey, 39% of 2,530 members of the American Society for Anesthesiologists reported having reused syringes from one patient to another.1 Another survey found that 20% of responding anesthesiologists reported they "frequently or always reused syringes on multiple patients, and 34% reported they never or rarely disinfected the septum of multidose vials prior to use."2-4

The problem is not confined to bloodborne pathogens, but they are much easier to pick up than bacterial infections, said Dan Jernigan, MD, MPH, a medical epidemiologist in the CDC division of health care quality promotion.

"The hepatitis [cases], at least in the United States, are reportable; so when the cases do occur, they do somehow make their way to the public health establishment," he said. "Whereas with bacterial problems, you probably do not detect them through any formal methods. Through serendipity, some are reported."

Prevention of bacterial infections in ambulatory care requires appropriate use of multidose vials, intravenous administration sets and line flushing preparations, Jernigan said.

In addition, proper storage, aseptic technique and care, and maintenance of preparation areas — including separating infective materials from materials to be injected — are required to limit bacterial infections.

"We want to determine if the efforts to address the bloodborne viral pathogens will cover issues that have to do with bacteria, mycobateria, and fungi associated with unsafe injection practices," Jernigan told HICPAC.

After CDC officials reviewed a litany of recent outbreaks beyond the hospital, HICPAC member Stricof said, "I honestly feel like an elephant is on my chest, because every one of the things you brought up is critically important; but I don’t even know where to start with our interventions."

The number of procedures is increasing exponentially in ambulatory care, but there is little regulatory oversight, and infection control is not a priority, she noted.

"Education and training are grossly inadequate," Stricof said. "It’s like a vicious circle, and I’m not sure where we’re going to start and where it’s going end."


1. Williams IT, Perz JF, Beel BP. Viral hepatitis transmission in ambulatory health care settings. Clin Infect Dis 2004; 38:1,592-1,598.

2. Rosenberg AD, Bernstein DB, Bernstein RL, et al. Accidental needlesticks: Do anesthesiologists practice proper infection control precautions? Am J Anesthesiol 1995; 22:125-132.

3. Tait AR, Tuttle DB. Preventing perioperative transmission of infection: A survey of anesthesiology practice. Anesth Analg 1995; 80:764-769.

4. Green ES. Hepatitis C Outbreak: More than 50 infected by reused needles and syringes. ASA Newsletter 2002; 66(12). Web: www.asahq.org/Newsletters/2002/12_02/greene.html.