New York vs. sepsis: a bold first step means new protocols and testing

June 20, 2013

Sepsis kills more than 250,000 patients in the United States each year, and there is a burgeoning population of survivors living with amputations, physical handicaps, and cognitive disabilities. As the founder and former chairman of the Sepsis Alliance, I’ve made it my personal mission to fight sepsis. That battle has taken me around the country and the world to educate healthcare professionals and the public about recognizing the symptoms of sepsis and about the importance of beginning treatment as quickly as possible.

My crusade against sepsis is deeply personal, and it is an example of how sepsis kills indiscriminately. After having routine surgery, a simple outpatient procedure, my healthy 23-year-old daughter Erin began having serious complications. Nevertheless, she was discharged, sent home in the care of her mother and me. When her pain worsened, we took her back to the hospital, yet she was sent home again without antibiotics, despite having an elevated white blood cell count. She continued to get worse and we returned to the hospital. But by the time the signs of sepsis were recognized, it was too late.

Sepsis killed Erin, and it was clear to me that had the hospital practiced an effective protocol for sepsis, Erin probably would have lived. I pledged to dedicate myself to fighting sepsis through education and communication so that there would be no more Erins.

The State of New York will soon be implementing what are being called “Rory’s Regulations.” These regulations, which will be issued by the New York Department of Health, will mandate that all hospitals in the state adopt and implement an evidence-based protocol for sepsis. They are expected to go into effect this summer and will have a profound impact on how New York hospitals identify sepsis risk and treat sepsis.

This mandate comes in the wake of the tragic death last year of 12-year-old Rory Staunton, who developed an infection following a minor injury he suffered playing basketball. His parents, much as I did in the case of my daughter, realized that their son would likely be alive if the hospital had practiced a sepsis protocol. They determined to create something positive out of their son’s tragic death and successfully worked with leaders in New York to gain the support of Governor Andrew Cuomo. Now, under Gov. Cuomo’s leadership, “Rory’s Regulations” will soon become reality.

For patients, the benefits are obvious, but hospitals-particularly clinicians and laboratory professionals-face a great deal of work in educating themselves on the available tools for recognizing and fighting sepsis. The new law will mandate that all hospitals adopt an evidence-based protocol for sepsis-but what kinds of evidence-based protocols exist for sepsis?

Early goal-directed therapy. EGDT is one evidence-based technique for severe sepsis and septic shock that is widely used, primarily in the critical care setting. It involves both monitoring and aggressive management, most commonly with broad-spectrum antibiotics and fluids. The pros to this method are clear; it enables active monitoring of patients with suspected risk of sepsis, and quick intervention with antibiotics and fluids saves lives and limbs. The cons are concerns about antibiotic resistance as well as some concern as to whether this approach does enough in the beginning to accurately identify sepsis risk.

Biomarker monitoring. Biomarkers such as lactate and procalcitonin are being used with great success to combat sepsis. These protein biomarkers elevate when conditions are favorable for sepsis and, as such, give strong indications of sepsis risk in patients. Lactate is a very useful biomarker for a number of diseases and conditions, and high levels of it can help clinicians confirm suspicions of sepsis when paired with other diagnostics. One such diagnostic is the procalcitonin test; because of procalcitonin’s elevation in the presence of systemic infection, it is widely seen as a good, sepsis-specific biomarker. This test is supported by revised guidelines from the Society of Critical Care Medicine that recommend the use of procalcitonin for guiding sepsis therapy, in addition to its use in early diagnosis.

These are also a couple of evidence-based practices that are being used right now. No doubt, clinicians, nurses, and laboratory professionals in New York will have a great deal on their plates as they work to research and adopt new sepsis protocols. I hope that everyone sees the value in this effort, however, and I am confident that they will: we can surely work to turn the tide of sepsis. Comparable efforts have helped to reduce the death rate from other causes. Before the Code Blue was put into practice, for example, heart attacks and similar traumas were often tantamount to death sentences. By implementing evidence-based best practices and thus arming themselves with the information and tools they need to recognize risk quickly and intervene with appropriate treatments, hospitals have helped to save lives of victims of myocardial infarction.

I look forward to seeing the rates of sepsis deaths and complications in New York decrease once the statewide mandate goes into place. While I wait to see those results, though, I will be working with legislators in my home state of Florida to discuss how we can implement a program or programs similar to “Rory’s Regulations.” I truly believe that if hospitals across the United States all practice proven methods for identifying and treating sepsis, deaths from sepsis will markedly decrease nationwide, and the tragedies the Stauntons and my own family endured will eventually be no more.

Carl J. Flatley, DDS, MSD, is founder and former chairman of The Sepsis Alliance. His many efforts have included the establishment of the Erin Kay Flatley Chair for Sepsis Education and Infection Control at St. Petersburg College, and initiation of the Endowment for Sepsis Awareness and Education at the University of South Florida and the Internet-based Advanced Technical Certification Program in Sepsis Awareness and Education.