As health care services move into the outpatient setting, is infection control being overlooked?
The US Food and Drug Administration (FDA) recently hosted an informational webinar drawing attention to the importance of infection control in the outpatient oncology setting. The webinar focused on infectious disease outbreaks that occurred in outpatient oncology areas, especially those related to failures in injection practices and sterile compounding standards.
In 2010, there were 1.5 million new cases of cancer diagnosed within the United States. Over 1 million cancer patients receive outpatient chemotherapy or radiation and with the focus on moving more and more services to outpatient centers, this number will likely increase. Moving oncology treatments to outpatient settings is beneficial for many reasons: 1) hospitalizations are avoided, which saves money; 2) treatment is scheduled around the patient’s needs and convenience; and 3) drug administration is performed under the supervision of an oncologist. Furthermore, with approximately 1.7 million health care-associated infections occurring in US hospitals each year, efforts to avoid hospitalization for chemotherapy or radiation are understandable.
Patients who are undergoing outpatient oncology treatment are at an increased risk of infection not only because of underlying malignancy and chemotherapy, but also because they tend to frequent multiple health care settings. In addition, these patients often undergo surgical procedures and have indwelling intravascular access devices.
Although infection control in outpatient oncology is critical; it is an often-overlooked aspect of patient safety. The risks are apparent, but the issue is that most outpatient oncology clinics lack infection control policies and procedures to ensure staff are following proper guidance. In many ways, these settings are a weak link in the chain of patient safety. In these environments, infection control failures come in the form of hand hygiene failures, poor isolation precautions, breaches in sterile compounding standards, and failure to adhere to safe injection practices. The FDA focused on the latter 2 infection control failures in their webinar.
The presenters underscored that the US Centers for Disease Control and Prevention (CDC) Standard Precautions are minimum standards that include using aseptic technique when preparing and administering injections, and never using single-dose or single-use medications for more than 1 patient, etc. In terms of sterile drug compounding, they explained why actions such as preparing multiple chemotherapy infusion bags for administration later in the day and combining multiple medications in a saline bag may be dangerous.
Breaches in health care delivery from inpatient to outpatient settings can be devastating and can translate into thousands of patients being exposed to a nefarious pathogen. Whether it is insanitary medication preparation areas or the practice of reusing single-dose vials and saline bags for more than 1 patient, breaches can and do occur. Even something as simple as wearing a face mask during spinal injections is something that can put the patient at an increased risk for infection.
Outbreaks that have occurred in outpatient oncology settings range from Burkholderia cepacian infection due to lack of adherence to sterile compounding standards when preparing chemotherapy, to Exophiala dermatitidis related to lack of adherence to safe injection practices, and more. The presenters on the webinar detailed a Tsukamurella bloodstream infection outbreak within an oncology clinic linked with several infection control failures, such as a sterile compounding hood located adjacent to an open window and medication preparation being completed next to an adjacent sink. Medication preparation next to a sink was a surprisingly common offense throughout the presentation.
Solving these problems with infection control within the outpatient setting is not without challenges. These include a lack of infrastructure and resources to support infection control practices, and a lack of oversight and accreditation of outpatient settings relative to inpatient settings. There is no clearly established authority that monitors infection control adherence within these settings. Although Centers for Medicare & Medicaid Services-certified facilities do receive some oversight related to infection control compliance, few are certified, and even fewer receive surveys to ensure adherence to infection control standards.
As health care trends move toward increase utilization of these outpatient settings, the infection control within these environments must be reinforced. Failure to adhere to safe injection practices and sterile compounding standards puts patients at risk, especially those who are immunocompromised, such as oncology patients. Moreover, facilities may have to respond to these violations with disciplinary action and can set themselves up for malpractice lawsuits. It is important that as these settings become more common, infection control guidelines in these settings are established, infection preventionists are made available to educate and ensure compliance, and stronger regulator focus on infection control compliance is enforced.