On August 18, 2016, the Illinois Hospital Licensing Act (210 ILCS 85/6.23a) was amended to require hospitals to adopt, implement, and periodically update sepsis screening protocols. These protocols should be carefully considered, with contribution from multiple specialists and stakeholders. With recent developments in the definition and assessment of sepsis, and the potential for the use of sepsis protocols against hospitals and physicians in medical malpractice litigation, the preparation of these protocols should be done with great care.

The Act requires hospital sepsis screening protocols to be “based on generally accepted standards of care.” Such language is certain to be used in lawsuits by plaintiffs claiming that the hospital’s protocols reflect the standard of care and demand rigid adherence. They will suggest any deviation from the written protocols constitute professional negligence, i.e., deviation from the standard of care.

The Act requires that hospital sepsis protocols include such components as:

1. a process for the screening and early recognition of patients with sepsis, severe sepsis, or septic shock;

2. a process to identify and document individuals appropriate for treatment through sepsis protocols, including explicit criteria defining those patients who should be excluded from the protocols, such as patients with certain clinical conditions or who have elected palliative care;

3. guidelines for hemodynamic support with explicit physiologic and treatment goals, methodology for invasive or non-invasive hemodynamic monitoring, and timeframe goals;

4. for infants and children, guidelines for fluid resuscitation consistent with current, evidence-based guidelines for severe sepsis and septic shock with defined therapeutic goals for children;

5. identification of the infectious source and delivery of early broad spectrum antibiotics with timely re-evaluation to adjust to narrow spectrum antibiotics targeted to identified infectious sources; and

6. criteria for use, based on accepted evidence of vasoactive agents.

When drafting sepsis protocols the hospital should carefully consider recent recommended advancements in sepsis definitions and assessment criteria. Earlier this year, a multinational, multidisciplinary task force completed an 18-month study and proposed new definitions and clinical criteria for sepsis and septic shock. These recommendations include the abandonment of the Systemic Inflammatory Response Syndrome (SIRS) paradigm, and elimination of the classification of “severe sepsis.” On February 23, 2016, the Journal of the American Medical Association published “The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3),” JAMA 2016: 315(8): 801-810, Singer M, et al. This was the first revision of sepsis definitions and clinical criteria attempted since the 2001 (Sepsis-2) and 1991 (Sepsis-1) iterations.

This recent article proposes a new definition of sepsis: evidence of infection plus life-threatening organ dysfunction, clinically characterized by an acute change of 2 points or greater in the Sequential Organ Failure Assessment - SOFA score. The article recommends new clinical criteria for septic shock (sepsis with fluid-unresponsive hypotension, serum lactate level greater than 2 mmol/L, and the need for vasopressors to maintain mean arterial pressure of 65 mm HG or greater). This shift from a SIRS to a SOFA-paradigm includes introduction of a new bedside index called Quick SOFA (qSOFA), to be used for the identification of patients outside critical care units who are likely to develop complications of sepsis. qSofa assesses respiratory rate (22/min or greater), altered mentation, and systolic blood pressure (100 mm Hg or greater) for the immediate screening of those suspected septic.

In its article, the task force acknowledged the challenges in re-defining sepsis and septic shock, the first being that sepsis is a broad term applied to an incompletely understood process. “There are, as yet, no simple and unambiguous clinical criteria or biological, imaging or laboratory features that uniquely identify a septic patient.” Id.

Some questioning the task force recommendations suggest that calculating a SOFA score in sufficient time to make clinical decisions might not be realistic in some environments, and that the adoption of such protocols for assessment has the potential to drive excessive laboratory testing.

Illinois hospitals are now required by law to have sepsis protocols that reflect generally accepted standards of care. As the stakes are significant, both in regard to the use of the protocols in the treatment of patients and in possible litigation, the creation of such protocols should be a collaborative and thoughtful exercise. The hospital should consider contributions from all administrative, academic, and clinical disciplines, including critical care and infectious disease physicians as well as surgeons. The hospital should also establish a mechanism to ensure that the sepsis protocols are periodically updated and that they reflect the most recent advancements in this serious and difficult area of medicine.