CDC Presents Core Elements for Sepsis Programs

Sepsis, which is defined as life threatening organ dysfunction caused by dysregulated host response to infection, ¹ is a leading cause of mortality and hospitalizations in the United States and throughout the world. It is estimated that 1.7 million cases occur in the US annually with approximately 350,000 hospital deaths.² Prior studies have demonstrated that quality care improvement programs decrease mortality, length of stay, and health care. ^3,4

With this aim in mind, on August 24, 2023, the CDC published its Hospital Sepsis Program Core Elements guideline.⁵ In this 34-page document the CDC breaks down sepsis core measurements into seven categories: hospital leadership commitment, accountability, multi- professional expertise, action, tracking, reporting, and education. In the following piece I will summarize components of this document as well as view it through the lens of the accompanying survey the CDC performed on hospital sepsis programs in 2022 and evidence based medical literature.

An important initial statement in the document is that each sepsis program performs an in-depth assessment of what is currently being done at their institution. The National Healthcare Safety Network Survey of acute care hospitals that the CDC performed in 2022 revealed that 73-95% of hospitals had sepsis monitoring committees with hospitals of 251 beds more likely to have an existing program.⁶

The CDC document provides hospitals with existing sepsis programs a very useful assessment tool by which to ascertain holes in their programs. For the minority of hospitals that do not have a sepsis program, a “getting started tool” which includes identifying sepsis program leaders, securing hospital and healthcare leadership support, conducting a needs analysis of applicable regulatory or reporting requirements and establishing initial goals for the program is provided.

The first three Core Elements: Hospital Leadership Commitment, Accountability and Multi-Professional Expertise could best be grouped as who needs to be involved and who is responsible. The document makes a clear case that the Chief Medical Officer and Chief Nursing Officer should be the champions of the hospital sepsis program and make it clear to the staff that this activity is a hospital priority. Since the CMO and CNO are not usually the “boots on the ground” in patients care, the document makes clear that 1 or 2 leaders of the program are appointed with dedicated time.

This statement falls short in clearly indicating financial carve out (percentage of an FTE) should be paid by the hospital or healthcare system for the time these individuals and other members spend on this activity. The Multi-professional expertise section of this document was probably best placed before accountability as it is clear a program will not succeed without appropriate representation. Important members of the team include but are not limited to Infectious Disease, Pharmacy, Nursing, Hospitalists, Emergency Medicine, Intensivists. IT and Quality. The document omits important additional members including respiratory therapists and statistics. The Accountability section of the core elements should pertain to all members of the sepsis team. Clear goals that can be measured should be analyzed by someone skilled in statistics and reported periodically. At least a portion of the compensation, in the form of bonuses and raises, for all team members should be tied to the outcomes achieved by the program.

The next core element is termed “Action” and related to sepsis recognition, management as well as per-discharge care. The document recommends that each program have a sepsis recognition tool but falls short of recommending any specific tool or how the tool is implemented. A review of the NHSN survey data reveals that 65% of hospitals utilize the SEP-2 sepsis definition (SIRS criteria) while 13% use the qSOFA (SEP-3).⁷ It has been well described that the presence of 2 or more SIRS criteria, while highly sensitive, lacks specificity⁸ while qSOFA has improved specificity for poor outcomes ⁸ but is often a late finding preventing early intervention.⁹

It would be useful to CDC in concert with the appropriate medical societies to establish a clearer guidance on the appropriate sepsis screening tool. The core elements also do not endorse an EMR automatic tool over a manual screening tool even though the latter is labor intensive and will likely lead to delays in diagnosis.

The next item covered under “action” relates to the need for a standardized order set for the management of sepsis which includes antimicrobial selection, source control, fluid resuscitation and antimicrobial narrowing and stopping. Unfortunately, this core element lacks sufficient detail and directs the users to evidence-based literature and guidelines. With respect to the complicated issue of antimicrobial use, the CDC may have pointed out that Infectious Disease consultation, even when sepsis bundles are utilized, is associated with improved outcomes.¹⁰ This core element does not provide guidance to providers that dynamic measures to assess fluid responsiveness when providing fluid resuscitation are superior to static measurements.¹¹ 

The action element does make 2 very concrete suggestions for improving management.

First, is the suggestion that measures should be put in place to allow for rapid administration of antibiotics. Secondly, the suggestion that a rapid response team be put in place to respond to a “Code Sepsis” is particularly important. Such teams are already in place for other clinical conditions where rapid intervention is of the utmost importance including stroke and acute ST- elevation myocardial infarction. The “action” core element concludes with important activities related to the care of patients in the post-sepsis period; an aspect of sepsis care that is critically important but often not fully emphasized.

The next set of elements in the CDC’s publication for sepsis programs relate to tracking, reporting and education. The “Tracking” and “Reporting” measures outlined necessitate that a hospital have the requisite information technology and statistical support. The survey conducted by the CDC indicated that overall, only 41% of hospitals had IT support for a sepsis program with IT support particularly lacking at smaller facilities. An important feature of the “Tracking” element is that overall data and case specific data should be shared with individual hospital units and individual treating physicians. This feedback should provide both good and aspects of care. The “Education” core element provides useful suggestions that go beyond the infrequent Grand Rounds that are done on sepsis at most hospitals. The element includes making sepsis-specific training part of the on-boarding process for hospital staff. It also suggests that sepsis knowledge be determined during nursing competency assessments. Finally, hospital reminders in common areas and posts on the recognition of sepsis are emphasized.

The CDC’s recently published Core Sepsis Elements provides a useful framework for evaluation of established sepsis programs as well as for initiating new sepsis programs. Future iterations of the document should strive to provide more granularity as it relates to sepsis screening measures as well as treatment measures.

References

1. Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (SEPSIS-3). JAMA. 2016;315(8):801-810. Doi:10.1001/jama.2016.0287.
2. Rhee C, Dantes, R, Epstein, L, et al. Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014. JAMA. 2017 Oct 3;318(13):1241-1249. doi: 10.1001/jama.2017.13836.
3. Afshar M, Arain E, Ye C, et al. Patient outcome and cost effectiveness of a sepsis care quality improvement program in a health system, Crit Care Med. 2019;47:1371-1379.PMID:31306176 https://doi.org/10/1097/CCM.0000000000003919.
4. Reeramoju P, Voy-Hatter K, White C, et al. Results and lessons from a hospital-wide initiative incentivised by delivery system reform to improve infection prevention and sepsis care. BMJ Open Qual. 2021;10:e00189.PMID:33547154 https://doi.org/10.1136/bmjoq-2020-001189.
5. CDC. Hospital Sepsis Elements Core Elements. Atlanta, GA; US Department of Health and Human Services, CDC;2023. https://www.cdc.gov/sepsis/core-elements.html.
6. Dantes RB, Kaur H, Bouwkamp BA, et al.Sepsis Program Activities in Acute Care Hospital- National Health care Safety Network, United States, 2022.MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72(34): 907-911.doi: 10.15585/mmwr.mm7234a2.
7. Sprung CL, Sakr Y, Vincent JL, et al. An evaluation of systemic inflammatory response syndrome signs in the Sepsis Occurrence in Acutely Ill patients (SOAP) study. Intensive Care Med. 2006; 32:421-427. DOI 10.1007/s00134-005-0039-8.
8. Seymour CW, Liu VX, Iwashyna TJ, et al. Assessment of Clinical Criteria for Sepsis For the Third International Consensus Definitions for Sepsis and Septic Shock (SEPSIS-3). JAMA. 2016;315(8):762-774. Doi 10.1001/jama.2016.0288.
9. Churpek M, Snyder A, Han X, et al. Quick Sepsis-related Organ Failure Assessment, Systemic Inflammatory Response Syndrome, and Early Warning Scores for Detecting Clinical Deterioration in Infected Patients outside the Intensive Care Unit. Am J Respir Crit Care Med. 2017 Apr 1;195(7):906-911. doi: 10.1164/rccm.201604-0854OC.
10. Madaline T, Montagne FW, Eisenberg R, et al. Early Infectious Disease Consultation Is Associated With Lower Mortality in Patients With Severe Sepsis or Septic Shock Who Complete the 3-Hour Sepsis Treatment Bundle. Open Forum Infect Dis. 2019 Oct 31;6(10): ofz408. doi: 10.1093/ofid/ofz408. eCollection 2019.
11. Bednarczyk JM, Fridfinnson JA, Kumar A, et al. Incorporating dynamic assessment of fluid responsiveness into goal-directed therapy: a systemic review and meta-analysis. Crit Care Med. 2009;45 (9):1538-1545. Doi 10.1097/CCM.0000000000002554.