Imagine you're a cancer patient like Evelyn McKnight. You're getting your next dose of chemotherapy at an outpatient clinic, or perhaps in a special infusion room attached to your oncologist's office.
You pray the horrible process will kill your disease. You don't expect it will infect you with a life-threatening virus or bacteria.
But just before you arrive, the clinic nurse draws blood from the infusion port of another patient – call him Mr. Jones – to send to the lab. She changes the needle on the syringe, then inserts it into a large, multi-dose saline bag to draw out saline for Mr. Jones' port flush. But in doing so, the negative pressure draws particles of Mr. Jones' blood into the bag.
Now it's your turn. The nurse repeats the process, again drawing from the saline bag to flush the line, the one now entering your bloodstream.
Unfortunately, Mr. Jones is infected with hepatitis C, and this simple procedural error ends up transmitting his virus to you and every other patient who unknowingly comes in contact with the fluid in that bag.
As astonishing as this seems, this is what happened to McKnight, an audiologist and wife of a physician in a rural Nebraska town 40 miles northwest of Omaha. It also happened to 98 other cancer patients treated at that doctor's oncology practice.
One by one, four other chemotherapy patients who had blood work weeks and months later tested positive for hepatitis C, prompting the state to launch an investigation.
The Centers for Disease Control and Prevention stepped in, too, investigating the Nebraska episode as well as several other oncology clinic outbreaks over the last decade. Those that received media attention include:
- A10-case cluster of Burkolderia cepacia bloodstream infections in a Georgia oncology clinic,
- 29 patients infected with hepatitis B in a clinic in New Jersey,
- 27 patients infected with Klebsiellea oxytoca and Enterobacter cloacae in an Illinois chemo center,
- A variety of bacterial bloodstream infections in a clinic in Mississippi
Nearly 6,000 additional cancer patients treated at those clinics were called in for testing.
Alice Guh, MD, a CDC clinical epidemiologist, says these are "just the tip of the iceberg.
"We don't have a good handle on how just many of these outbreaks have occurred," she told me during an interview. The agency does know, however, that these clusters occurred because solid infection control practices were not in place. These were due to lapses in handling syringes or other types of injectable devices appropriately, she said.
That's because these procedures take place in largely unregulated, not-routinely inspected outpatient clinics, "pavilions," or offices, the places where most of the 650,000 chemotherapy patients a year receive their infusions.
"There have been situations where syringes of heparin were reused directly between patients to flush lines, and also situations where saline bags that should [have been] dedicated to an individual patient were instead shared among multiple patients," Guh says.
These are patients whose chemotherapy makes them especially vulnerable to harsh consequences from infections, such as prolonged illness, neutropenia, delayed chemotherapy treatments to push back their cancer, hospitalizations, or even death.
The problem is seen as so critical, that the CDC this week released an 18-page Basic Infection Control and Prevention Plan for Outpatient Oncology Settings, a documentdesigned to give guidance to "all outpatient oncology facilities. It is directed "especially [at] those that don't have a written plan that includes infection control policies and procedures," which the CDC says many facilities now lack.
Guh says care practices have evolved this way because, "the way our healthcare system is right now, only hospital settings and certain types of outpatient settings (such as dialysis centers and ambulatory surgery centers) are routinely inspected."
Some states have regulatory programs to cover these types of facilities, but oversight is spotty and purviews vary. Outpatient facilities that operate under a physician's medical license also are not subject to the same regulatory review. "I think it's something that we all, as federal agencies, should try to work toward," says Guh.
Researchers and clinicians haven't been tuned into the problem because, Guh says, it only comes to light "if an astute clinician notices something, or a patient presents with an infection and after further investigation and interviews, someone realizes additional infections are cropping up and are all linked to the same cluster at the same facility."
The ramifications are severe. About 60,000 patients with cancer who have received chemotherapy are hospitalized with neutropenia in the United States each year.
Among those hospitalized, approximately 1 in 14 (or 4,100) will die of the infection. It's hard to know how many of those deaths were the result of lax infection control practices in a healthcare setting, but it's a topic Guh says investigators are taking very seriously.
It's increasingly important because more medical procedures are moving from inpatient facilities to outpatient. With doctors in private practice expected to take on more of the healthcare load to avoid hospital costs, volume is expected to grow exponentially.
"Outpatient oncology facilities vary greatly in the attention to and oversight of infection control and prevention," the CDC plan says. "This is reflected in a number of outbreaks of viral hepatitis and bacterial bloodstream infections that resulted from breaches in basic infection prevention practices (e.g., syringe reuse, mishandling of intravenous administration sets)."
McKnight has recovered from her infection and her recurrence of breast cancer. But she didn't just wait for someone else to take action on this problem. She launched a national advocacy organization called HonoReform (Hepatitis Outbreaks' National Organization for Reform) to safeguard the medical injection process.
These days, she travels to medical groups and government agencies to make her point, and there are great rewards. "Practitioners are telling me, 'Thank you for pointing that out. Now I understand the risks and I will never do that again.' Or, 'I tried to convince my colleagues and they didn't see what I was concerned about. Now they do.'
"We're convinced it's made a difference," McKnight said. The CDC report will help get the message out. "Reporting [of questionable practices] is getting better, and although outbreaks still happen, we think we're drawing more attention to the problem," she said.