Researchers raise controversial questions about the safety of home infusion therapy

Editor's note: This article was updated to add comments from the National Home Infusion Association.

Between 2008 and 2019, the use of home infusion therapy grew by 300%, according to the National Home Infusion Association (NHIA).

While that may be convenient for patients who don’t want to go to the hospital, those who administer the infusions might not have enough training or supervision to do the procedure properly, according to a brief report published in the American Journal of Infection Control (AJIC). Researchers with Johns Hopkins University School of Medicine sought to find out the scope of training about and understanding of central line-associated bloodstream infection (CLABSI) among home infusion therapy providers.

AJIC is a publication of the Association for Professionals in Infection Control and Epidemiology, an organization representing about 15,000 infection preventionists worldwide.

“Infection prevention and surveillance training for home infusion therapy have not been well defined,” the brief report states.

Sara Keller, M.D., an associate professor at the division of infectious diseases at Johns Hopkins University School of Medicine and the corresponding author for the brief report, tells Fierce Healthcare that CLABSI surveillance “is basically determining whether a patient meets a strict definition of whether there is a CLABSI or not, and calculating the rate at which these occur. This determination is very difficult and requires extensive and ongoing training.”

Sara Keller at-home infusion
Sara Keller, M.D. (Johns Hopkins University School of Medicine)

The National Institutes of Health states that “of all the healthcare-associated infections, CLABSIs are associated with a high-cost burden, accounting for approximately $46,000 per case. Most cases are preventable with proper aseptic techniques, surveillance and management strategies.”

For the brief report, the Johns Hopkins researchers interviewed professionals in five large home infusion therapy agencies that cover 13 states and Washington, D.C., conducting 21 in-depth interviews between November 2020 and April 2021.

Many interviewees said they learned on the job—often from a predecessor—and passed that information on to fellow employees. Some had prior clinical experience in managing CLABSIs, and some took advantage of training offered by APIC and the National Healthcare Safety Network (NHSN), which is a division of the Centers for Disease Control and Prevention (CDC). The interviewees described three main barriers to CLABSI oversight.

“First, many described lacking resources for learning, such as user-friendly toolkits that support learning key points quickly given a high workload and time pressures,” the brief report states. “Second, surveillance staff were unaware of available professional development resources. [One nurse] explained that she wished she had known about available resources when she first started doing surveillance work. Third, many surveillance staff stated that no formal training was provided by their organization. They learned on the job, often from a co-worker who was also never formally trained.”

Connie Sullivan, NHIA’s president and CEO, pushed back on the findings of the AJIC study, saying that while the NHIA certainly appreciates how serious of a problem CLASBIs can be, the organization strongly disagrees “with the study’s conclusions and generalizations about the infection prevention workforce in home infusion. The infusion industry absolutely has specific requirements around monitoring and reporting rates of CLABSI and several independent, peer reviewed studies of home-based patients demonstrate lower rates of CLABSI compared to hospital settings. We do not agree that a qualitative study of five agencies is reflective of the entire industry, which consists of nearly 1,000 organizations.”

NHIA officials cite a meta-analysis in Critical Care Medicine of 63 studies covering 396,951 catheter days that found a CLABSI rate of 4.59 per 1,000 catheter days (4.59/1000) in hospitalized patients.

Meanwhile, home and ambulatory care literature consistently shows CLABSI rates of less than 1 per 1,000 catheter days, according to the NHIA. For instance, a study in Infection Control & Hospital Epidemiology involved an 11-year surveillance of the North Carolina Health Care System found that its home care CLABSI rate was between 0 and 0.73/1,000.

Keller agrees with Sullivan to some extent. “While there have not been studies across multiple organizations using the same definition applied in the same way, the best available evidence suggest that these infections occur at a lower rate in home infusion than in the hospital,” say says. “For this reason, we can likely learn from home infusion what works so well.”

Nonetheless, Keller maintains that “it’s important for an individual agency to know what their CLABSI rate is, whether it is going up or going down, whether there are certain groups of patients who are getting more CLABSIs, to know what interventions to put into place and to see whether the interventions are working. This study showed that the home infusion staff did not get much formal training in surveillance for CLABSIs, so it may be difficult for them to do this surveillance.”

Some interviewees referred to trickle-down learning that led to misinterpretation of data and also some confusion concerning just how CLABSI surveillance should be conducted.

Researchers concluded that “as home infusion CLABSI surveillance is currently not mandated by the [CDC], and the NHSN does not have a module specific to home infusion CLABSIs, home infusion CLABSI surveillance has not been emphasized. Therefore, approaches to train HIT staff on reproducible and reliable CLABSI surveillance are lacking.”

But again, that’s a debatable point. Tim Affeldt, the vice president of specialty/infusion operations at Fairview Pharmacy Services in Minneapolis, says in the NHIA statement that “as part of a major health system with a large home infusion program, I can say that the portrayal of the information in this very small study is not at all reflective of my experience and how our home infusion program works. Home infusion is a valued link in the continuum of care, allowing lower acuity patients to return to home and work sooner. With good patient education and regular contact from our multidisciplinary care team, we see excellent outcomes.”

Home infusion therapy providers must always consider that they’re working in a home setting, which comes with its own challenges. Keller says that “a home setting—with children, kitchens, bathrooms and pets, to say nothing of the fact that most patients do not stay strictly in the home but are going on with their daily lives and going to work or school—is very different from a hospital setting. The best strategies for how patients can keep themselves safe in home infusion therapy need to account for these different challenges.”

Johns Hopkins researchers suggest that HIT surveillance staff be made aware of training opportunities available through the CDC or APIC. “Infection preventionists should help with this training, and more infection preventionists should be employed in home infusion. APIC would be a logical source for much of this training.”

However, the infection preventionist profession faces some daunting demographic challenges. An AJIC article published earlier this month cites a 25% vacancy rate for infection preventionists nationally and also notes that 40% of the workforce is expected to retire in the next 10 years.