Michigan hospital at forefront in national fight against outbreak from tainted injections
During the past eight weeks, officials and staff at a hospital in Ypsilanti, Mich., have been feeling around in the dark, scrambling without the benefit of clinical guidelines or experience as they try to manage a virulent outbreak of an infection that had not been seen in humans.
Due most likely to chance, the region surrounding 530-bed St. Joseph Mercy Ann Arbor has found itself at the center of a national outbreak of fungal meningitis that has so far infected 469 patients in 19 states, killing 33, according to the most recent federal data. The infections have been traced to contaminated lots of injectable steroids, distributed by the Framingham, Mass.-based New England Compounding Center.
St. Joseph has treated 123 patients with the disease, 73 of whom are currently hospitalized and five of whom have died, officials said. The hospital has cared for about 85% of the total number of fungal meningitis cases seen in Michigan thus far.
“Twenty-five percent of the cases in the country are sitting in one hospital,” said Rob Casalou, St. Joseph's president and CEO.
The surge of new patients and the unprecedented nature of their illness have turned St. Joseph into a learning laboratory, as the hospital collaborates with its parent health system, other local providers and federal health officials to track the outbreak, identify treatments and manage complications.
All of St. Joseph's fungal meningitis patients received steroid injections at Michigan Pain Specialists in Brighton, a physician-owned pain clinic roughly 26 miles from the hospital. Michigan Pain Specialists was one of four clinics in Michigan to receive contaminated shipments of steroids, Casalou said, and the lot that arrived in the Brighton area seems to have been more highly contaminated than others.
“The clinic received one of the 'hot lots,' ” Casalou said, using a term that has been used to describe lots of the drug that have been linked to large numbers of infections. “Some of the lots had higher concentrations than others.”
About 620 patients received a total of about 750 contaminated steroid injections at Michigan Pain Specialists, according to figures cited by the hospital.
In the first week of October, just after Tennessee health officials first reported a cluster of fungal meningitis cases, St. Joseph began to identify patients with the disease, said Dr. Lakshmi Halasymani, the hospital's chief medical officer.
As the hospital quickly became known as one of the few that had some degree of familiarity with the infection, St. Joseph officials decided to gather and treat all affected patients from the region at their facility.
“It became clear very early on that this population was going to need very consistent care delivery and care management,” Halasymani said. “We're dealing with a period of real clinical uncertainty, and it helped to have a centralized approach.”
As part of becoming the region's go-to facility for the outbreak, St. Joseph initiated its emergency preparedness plan, which allowed it to increase staffing levels and more easily coordinate with other hospitals in the region, Casalou said. The incident command center has now been operational for nearly two months. “Disasters usually have a defined time period, and we quickly realized we were going from a sprint to marathon,” he added.
In the rush to prepare the hospital for the influx of serious, high-acuity patients, St. Joseph's opened 16 additional beds that were at the time licensed but offline. Those beds were opened in less than a week, Casalou said.
Trinity Health, St. Joseph's parent health system, stepped in, too. The Livonia, Mich.-based system sent nurses from multiple locations, including its hospitals in Pontiac, Mich., and Columbus, Ohio.
State officials granted licenses to out-of-state nurses in just 24 hours, Casalou said. They also approved an emergency certificate of need for an additional MRI machine and granted a license request for another operating room in just one day.
To ensure treatments that were deemed effective were put into practice right away, Trinity helped to build order sets for the health system's electronic health record that corresponded with protocols identified by St. Joseph clinicians and by the Centers for Disease Control and Prevention, said Dr. Donald Bignotti, Trinity Health's senior vice president and CMO. “We now have evidence-based treatments,” he said.
Trinity also added clinical decision-support alerts into the EHR that help physicians identify which patients are at risk of fungal meningitis.
And the health system is poised to assist with supply-chain gaps, preparing to move additional shipments of anti-fungals if probable drug shortages occur, Bignotti said.
“The other area that we think is really important is advocacy in Washington,” he said. “We're trying to raise awareness about what the patients and St. Joseph are going through.”
For instance, before last week's congressional hearings on the outbreak, Trinity officials spoke with Rep. John Dingell (D-Mich.), who attended the hearings, and provided him with information about experiences at St. Joseph and about an impending drug shortage.
In particular, Bignotti said, Trinity is trying to make sure St. Joseph is not penalized for failing to meet certain targets on quality metrics, such as readmissions. More than 30% of the patients who have received treatment for fungal meningitis at St. Joseph have been readmitted to the hospital, many because of spinal abscesses at their injection sites, a recently identified and serious complication.
Also, patients may incur thousands of dollars in out-of-pocket costs because they need to be on expensive drugs for long periods of time, Casalou said, adding that there will be “huge financial ramifications for patients and hospitals.”
“We're at the tip of the spear when it comes to not only the clinical but the operational aspects of this disease,” Casalou said. “We are having conversations with payers and we will have conversations with CMS because this is clearly outside of the parameters of anything we have ever seen. I have a lot of faith that they will look at this differently.”
For now, the focus is on the ongoing management of patients' infections. As more patients are readmitted with abscesses and fluid collections, the problem is shifting from a medical disease that is treated with anti-fungals to one that requires surgery and antibiotics, Halasymani said.
Some of the readmitted patients have no symptoms and their abscesses were identified only after multiple MRI scans, highlighting the complex and slow-moving nature of the infection, she added.
To accommodate the needs of patients after discharge, St. Joseph opened a fungal-outbreak clinic in an ambulatory facility on its campus staffed with volunteer infectious-disease specialists and clinicians from St. Joseph and other Trinity Health facilities. The clinic sees patients on an outpatient basis, coordinating their care and monitoring them for any new signs of illness.
“Having the patient as our core focus throughout this process has really allowed us to be very nimble,” Halasymani said. “I think we've mobilized the best aspects of our organization.”
The hospital has been in regular contact with officials at the CDC as the agency tries to facilitate communication among hospitals and identify which treatments are working best.
While the CDC usually works with state health departments, the nature of this outbreak made it necessary to communicate directly with hospitals, said Dr. Tom Chiller, a medical epidemiologist and deputy chief of the CDC's mycotic diseases branch.
“St. Joseph has been instrumental in helping to understand how this problem is evolving and how to manage it,” Chiller said.
Despite the gains of the past two months, there are still more questions than answers, he said. For instance, he rejected the notion of “hot lots,” arguing that the large number of infected patients could have been a result of differences in vial size, the age of the drug or the number of injections patients received. “We just don't know,” Chiller said.
It's also unclear, said Casalou, St. Joseph's CEO, how long it will be before the outbreak begins to taper off.
“At some point—we don't know when—this will start to wane,” he said. “We thought it would have happened by now, but then these readmissions started. We're just not sure now.”
TAKEAWAY: One Midwestern hospital's experience with a deadly outbreak has shown the benefits of emergency preparedness, informatics and collaboration among providers.