How egregious were the infection control violations in an outbreak in a New York City outpatient oncology clinic? Three patients died and investigators agreed it could have been much worse. The staggering array of breaks in basic practice prompted investigator Joel Ackelsberg, MD, MPH, to dub the outbreak “the wild, wild west.”
“It’s quite possible that this is a fairly common situation in all outpatient settings, let alone in oncology practices,” says Ackelsberg, an epidemiologist in the bureau of communicable disease at the New York City Department of Health and Mental Hygiene. “We heard about this outbreak because it was noticed in an ICU where two patients from the same provider were hospitalized at the same time. It was fortunate we heard about it. It was also fortunate that a more pathogenic and virulent [infection] wasn’t involved in this outbreak.”
Several investigators involved in the outbreak recently participated in a webinar held by the CDC. Among them was Amber Vasquez, MD, MPH, an EIS officer in the CDC division of healthcare quality promotion.
“The investigation began on May 24, 2016, when an infectious disease physician at hospital A notified the New York City Department of Health and Mental Hygiene of two cases of Exophiala dermatitidis bloodstream infections that occurred on May 14-15,” she says. “This prompted review of hospital A’s network laboratory to search for more cases. Two more were found. All four of these case patients had underlying cancer and were receiving care from the same physician at an outpatient oncology clinic.”
The clinic physician reached out to patients to be tested, even if they had no symptoms, and on May 27 a fifth case was found of E. dermatitidis, a common environmental fungus, she says.
“It has been seen in prior healthcare-associated outbreaks, including an outbreak of neurologic infections resulting from steroid injections from a compounding pharmacy in 2002,” Vasquez says. “But infections with this fungus are quite rare, and generally affect the nervous or respiratory systems. Bloodstream infections are extremely rare.”
The CDC acted quickly, knowing that oncology patients are at high risk because they are immunosuppressed.
“They are on therapy as well as [having] their underlying cancer,” she says. “They can also be at increased risk of bloodstream infections due to the long-term presence of central venous catheters [CVCs], such as implanted port catheters and peripherally inserted central catheters.”
The outbreak occurred at a small, independently managed clinic, unaffiliated with any hospital. In addition to the physician, the clinic had a nurse, a phlebotomist, and a few staff running the front desk.
“They do medical evaluations and follow-up visits, phlebotomies, and infuse chemotherapy,” she says. “Patients often use Hospital A, a nearby but separate facility for select services such as inpatient admission, or procedures like port placement.”
After the first cases were discovered in the hospital, the CDC conducted a thorough look-back investigation that included current, former, and deceased patients at the clinic.
“Since the fifth patient had no symptoms and was only found because of a surveillance blood culture, we asked all patients with a CVC or who had received IV medication at the clinic to have surveillance blood cultures drawn,” she says. “Review of the clinic records revealed an additional case from March who had been seen at a hospital out of state. This patient was infected with another type of fungus called Rhodotorula mucilaginosa, which is also a common environmental yeast.”
Ultimately, a total of 17 cases were identified, primarily infected with E. dermatitidis. None of the deceased patients had evidence of infections. All 17 case patients had an underlying cancer malignancy, including 15 with solid organ disease.
“All of the case patients had a CVC present, and nearly all of those were port catheters.” Vasquez says. “All 17 case patients were hospitalized for CVC removal and to initiate antifungal therapy. This included 12 asymptomatic patients.”
The 90-day mortality rate was 18%, with three of the 17 patients dying, respectively, at 10 days, 74 days, and 78 days after the diagnosis.
“All of the cases were exposed to a compounded IV flush solution that was used to flush CVCs,” she says.
Median flushes for cases were 12, compared to four for non-cases, suggesting a dose-response relationship. A further review of the records found all patients had been exposed to the same bag of flush solution, which was drawn in advance and used over a prolonged period. The bag was no longer available for culturing, but the epidemiological evidence was compelling.
“This was a solution compounded at the clinic by taking a 1-liter bag of normal saline and adding small amounts of two antibiotics and a blood thinner to it,” Vasquez says. “It was stored in a refrigerator and accessed multiple times a day with individual 10 ml syringes drawn from the bag over a four- to eight-week period until it was depleted. This was a highly unusual practice.”
The compounding was performed by a clinic nurse who had no pharmaceutical training nor performance assessment, she says. In addition, no pharmacist or pharmacist-trained staff were providing supervision. “For compounding the flush, the nurse had handwritten notes she used for reference,” she says.
The compounding was performed under a biological safety cabinet, which is intended to protect healthcare workers and the product being created.
“There were potentially contaminated materials in the critical sterile area such the outside plastic coverings of saline bags and the use of non-sterile gloves,” she says. Adding considerable insult to this series of injuries, the safety cabinet had not been inspected since 2014, when it was rejected for failing to meet adequate air flow requirements. The rejection notice was still on the hood, she says.
Procedures in Question
What else happened? The better question might be what didn’t, as Vasquez went through a damning comparison and contrast between CDC recommended practices and those being performed at the clinic.
For example, the CDC recommends that outpatient clinics develop written infection control and prevention policies and procedures based on guidelines, regulations, and standards. In addition, healthcare personnel should be trained in infection control on hire and annually thereafter.
“No formal or written policies or procedures were found at the clinic. Nor could we find an individual designated to enforce infection control standards,” she says. “Only one staff member had reportedly received infection control training four years prior, but no documentation could be provided.”
The CDC recommends that medications should be drawn in a designated “clean” medication area, and prefilling and storing batch-prepared syringes should be avoided.
“No designated clean medication area existed and IV medications were in multiple areas of the clinic, including in the lab area and patient rooms,” she says. “In the clinic, batches of IV flush syringes were being prepared every morning based on the number of patients scheduled that day. And this was recurring for weeks at a time with repeated entry allowing for more opportunities for potentially contaminating solutions.”
In addition, the CDC recommends that medications that require refrigeration be stored in a dedicated, labeled refrigerator. Medications should always be discarded according to the manufacturer’s expiration date, even if not opened.
“The IV flush solution bag and syringes were stored in a refrigerator that was also used for the occasional storage of staff food items,” she says. The expiration date “is the final day that the manufacture guarantees full potency and safety of a medication. But we found 39 vials of expired medications at clinic A. Some had been expired for years, but it is unclear how many may have been in use.”
Failed Awareness
Thus, in addition to the substandard compounding of the IV flush solution and prolonged storage which allowed repeated re-entry into the bag, there was a profound absence of an infection control culture.
“Most important was a lack of awareness in basic infection control and prevention practices,” Vasquez says. “There was a failure to be aware of and meet minimum standards for infection control and patient safety.”
Public health officials shut down the clinic for several months, allowing it to be reopened only after thorough evidence of infection control training and establishment of proper policies and protocols. Compounding is no longer conducted on site.
Similar challenges “exist across many outpatient settings, such as pain management and orthopedic clinics, where injections often occur,” she says. “There are likely many more outpatient facilities performing similar medication and injection services. Few outpatient healthcare facilities are licensed or accredited. As a result, many facilities are opened and operated without being held to minimum safety standards for infection control or other aspects of patient care.”
To use Ackelsberg’s analogy, patients seeking care at such clinics may run a risk akin to walking into a bar in the old west.
“It’s unclear to what extent the comprehensive guidelines developed by the CDC have actually penetrated into the ongoing practice of ambulatory care medicine in general, and in oncology specifically,” he says. “I think it is a cautionary tale. There is probably more of this going on.”
